August 3, 2019

Forum Highlights New Biotechnology Regulations

Janice F. Booth Maryland Correspondent

President Donald Trump signed an Executive Order Modernizing the Regulatory Framework for Agricultural Biotechnology Products on June 11. The affected agencies — USDA, Food and Drug Administration and Environmental Protection Agency — are halfway to the first 90-day review and evaluation deadline to comply with that order.

In part, the order reads, “Every 90 days after the date of this order, for a period of two years, each of the agencies shall provide an update regarding its progress in implementing section six of this order” Section six is the review of current authorities, regulations and guidance of “genome-edited-specialty- crop-plant products designed to have significant health, agricultural or environmental benefits, in particular those that are likely to benefit rural communities significantly.”

That review specifically focuses on streamlining, speeding up and eliminating the regulatory process for biotech products.

The Farm Foundation held a forum on this order in Washington, D.C., on July 23.

Representatives from the government were asked to speak about the short- and long-term impacts of a streamlined regulatory regime on: 1. The research process, 2. Crop and livestock producers, 3. The international trade environment.

Megan Provost, Farm Foundation vice president of policy and programs, moderated the forum. The speakers were:

• Stanley Abramson, Esq., cochair of the Life Sciences Group for the Arent Fox Law Firm in Washington, D.C.
• Fan-Li Chou, Ph.D., biology coordinator in the Office of Pest Management Policy at USDA.
• Laura R. Epstein, J.D., senior policy advisor, Office of the Center Director at FDA’s Center for Veterinary Medicine.
• Michael Mendelsohn, chief of the EPA’s Emerging Technologies Branch in the Biopesticides and Pollution Prevention Division of the Office of Pesticide Programs.

The representatives were to focus on examining current policies at their agencies, exploring and analyzing alternative policy options, and voicing new proposals.

Abramson, who was involved in the 1986 institution of the original biotechnology regulatory framework, spoke about the development of biotech resources worldwide and the impact of the international biotech markets on his clients. He pointed out that in 2017, 469 million acres of biotechnologically modified crops were planted worldwide. Sixty-seven countries, according to Abramson, regulate biotech products and have approved over 4,000 products. Between 1996 and 2017, 6 billion acres of biotech crops have been planted and $186 billion in economic gains can be identified. Those gains were shared by 17 million farms, and 95% of those farms were in underdeveloped countries.

Abramson emphasized that all these modified products were “without any evidence that any of these products have had adverse effects to health, safety or the environment.”

Abramson sees two challenges facing the USDA, the FDA and the EPA. First, selecting the right level of product oversight, if at all, and second, “avoiding duplicative and overlapping agency jurisdictions.”

EPA’s Mendelsohn has worked with the regulation of biopesticides for 30 years. He noted that the EPA is evaluating ways to streamline the approval process for low-risk products to get them to market more quickly and efficiently.

“An area (the EPA) may evaluate is a limited subset of plant incorporated protectants,” he said. Mendelsohn also suggested that EPA may continue to develop streamlined regulatory requirements for plant incorporated protectants.

Epstein, with the FDA, pointed out that FDA deals with biotechnology that involves plants and animals. Her work is specifically with animals. The FDA monitors products for safety for both the animal and the consumer as well as the product’s effectiveness. Epstein reviewed adjustments that have already been implemented in FDA’s reviews of biotech products.

Changes in the regulation of intentional genomic alteration “will clarify risk-based approach, eliminate confusing jargon, (and) respond to commenters’ concerns,” she said.

Epstein emphasized the FDA’s guidance for industry approach to regulation. She said that the FDA will help sponsors of biotech products to prepare the material for submission. The evaluation process can even be paused.

“We can ‘stop the clock’ and help developers through the process, then restart the process again,” she said.

Epstein was keen to clarify for farmers some of the misconceptions circulating about farms involved with IGAs. She noted that farms that are simply raising animals containing IGAs are not drug manufacturing facilities, do not have to register with FDA, are not required to report adverse events to FDA and do not need FDA approval to breed animals with IGAs with other animals.

As part of the FDA’s efforts to streamline procedures, there is a new Veterinary Innovation Program. The FDA’s Center for Veterinary Medicine has developed a kit to guide sponsors seeking approval.

USDA’s Chou emphasized Agriculture Secretary Perdue’s mantra, “Do right; see everyone.” With that mission, the USDA’s approach to regulating biotech products endeavors to: 1. Insure there is a market for the product.

2. Insure agriculture biotech tools are safe and effective.

3 . Develop biotech tools for agriculture.

4. Maintain and gain market access for biotech products.

The oversight and regulation of biotech products, according to USDA, “should be based on the best available scientific knowledge, and both encourage innovation and advance oversight and protection goals.”

Chou pointed to a USDA regulatory proposal memo of June 15, in which two mandates regarding regulatory and market access were acknowledged; first, how to promote international engagement, and second, the need for an international trade strategy to remove barriers to America’s marketing of its biotech products.

Among the questions from the audience were concerns about deadlines and completion dates for the publication of regulations. Chou emphasized that the executive order covers a two year period and that each 90-day review would include reports on progress and plans for ongoing adjustments.

The USDA anticipates completing their biotech regulatory review sometime in 2020.

Epstein pointed out that FDA is coupling outreach with regulatory changes. She acknowledged that the industry needs certainty, and the FDA will do its best to provide that certainty expeditiously.

Mendelsohn pointed to the example of EPA’s handling of genomeedited PIPs and the streamlined review process implemented in that case.

Janice F. Booth is a freelance writer in Maryland.

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