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Speakers: Biotech approval still a struggle in EU, China

 

By TIM ALEXANDER

Illinois Correspondent

 

BLOOMINGTON, Ill. — Synchronizing biotechnology regulatory systems in order to provide better world food security through increases in crop yield and food product quality were the drivers at the International Biotechnology Symposium, on Aug. 31 in Bloomington.

Feeding more than 9 billion people expected to inhabit Earth by the year 2050 makes the U.S. Food and Drug Administration (FDA), USDA, and EPA – as well as foreign governments’ – approval of biotech crops an important topic in agriculture today, noted Sara Wyant, president of Washington, D.C.-based event host and moderator Agri-Pulse Communications.

The symposium began with a trade and industry panel featuring Floyd Gaibler, director of trade policy and biotechnology for the U.S. Grains Council (USGC), Jeff Nawn, DuPont Pioneer’s global grain trade and biotech affairs lead, and Raymond Dobert, global regulatory policy lead and senior science fellow at Monsanto Co.

The theme was "Biotech Approvals: Routes and Roadblocks in China."

Biotech approval resistance is causing a worldwide trade disruption, said Gaibler. The logjam of new biotech traits vying for final authorization approval is because of the lack of a global, science-based system for approval. The USGC shares some common ground with the European Union (EU) in seeking a science-based, nonbiased regulatory system for biotech crop market approval. In addition, the USGC recently visited with Chinese trade officials, the World Trade Organization (WTO) and the Food and Agricultural Organization (FAO) of the United Nations to extol the benefits of biotechnology and genetically modified crops.

"We think it makes good sense to utilize the WTO and FAO to provide another platform from which to work on this issue," said Gaibler. "As producers and exporters we are put into a no-win situation.

"Either we lose access to beneficial technologies that improve our economic and environmental stability and address the challenges of global food security, or we lose access to markets because of asynchronous, non-science-based biotechnology and approval processes. This serves no one’s interest."

Plenty of hurdles remain before widespread approval of U.S. biotech crops becomes a reality in China, explained Nawn, who also serves as chair of the Biotech Industry Organization China Task Force. A big problem lies with China’s system of regulatory science studies and approval processes that are "out of sync with the rest of the world," he said.

"China is our largest, by far, agricultural export market. This matters to everyone in this room: seed technology providers, producers, handlers and everyone in the value chain. We have to work together to learn how to talk to the Chinese about regulatory systems that give our producers some predictability," Nawn said.

"There are two critical issues with China and biotech approvals. One, of course, is the process and requirements that China puts in place that are a little out of sync with the rest of the world. The second part is ... seed technology companies cannot submit a product risk assessment to China until that product has been approved in a major cultivation market.

"We are talking about six years in a best-case scenario until we can get that product through the regulatory system and into the hands of our customers," he noted.

The EU biotech regulatory ap-proval process is not without its frustrations, Dobert noted, but isn’t as stringent and drawn-out as Chinese proces-ses. A smaller number of import dossiers awaiting regula-tory review remain in the queue in the EU than in China, he said.

"The EU is a much, much smaller market than China is, but the EU is very dependent upon agricultural imports, especially from the Americans. It’s a market that has been relatively stable the last couple of years," said Dobert.

"I think the feed industry in Europe knows that this is not a situation that can stand the test of time. Eventually growers are going to be growing (biotech) products and the Europeans are so dependent on imported protein that they must do something to fix the system."

Transatlantic Trade and Investment Partnership trade deal, or T-TIP, negotiations should not be allowed to delay biotech products already in the European pipeline, he continued.

"T-TIP is an opportunity and a leverage point but is not a solution," he said. "These are difficult and complicated negotiations. Biotech traits are a small part of those negotiations but should be one of the elements before the U.S. and the EU agree on development."

The next round of negotiations are scheduled for October.

"It should be a pretty exciting fall, and hopefully when we return here next year, things will be more clear," Dobert concluded.

An underlying theme of the conference was that individual producers – through their commodity and state organizations – should become more active in promoting biotech traits in export markets.

9/9/2015