Saturday, October 23, 2021

FDA, Monsanto clash on GM crops. Here’

A lawmaker on Thursday proposed legislation to block federal regulators from trying to block the sale of genetically modified crops after the Food and Drug Administration said this week that a company had failed to follow federal law when making changes to two of its modified soybean strains.

The proposed bill, which is being promoted by Sen. Patty Murray (D-Wash.), would bar the FDA from considering whether the changes to the plants, Monsanto’s gene-edited versions of a shortening trait found in vegetable seeds and an innovation added to soybeans recently approved by the FDA, might be unsafe, either before or after they’re marketed.

“I’m introducing this legislation because the FDA is currently holding public hearings into commercializing GM crops like this,” Murray said in a statement. “I want to make sure this practice doesn’t get ahead of the agency’s responsibilities as they prepare for public hearings on the subject later this month.”

Murray’s bill comes as scientists and growers worry that federal regulators could propose regulations that could pre-empt the farmers and seed companies who could expand the technology beyond conventional crops to foods, including meats, that have already undergone federal approval.

Monsanto officials said the company was in discussions with FDA officials and pledged to work with them “on a practical, science-based approach” to issues raised by the FDA, including the safety of new genetically modified traits and their impact on plants that have not undergone federal approval.

For example, Monsanto said, the FDA seemed concerned about, as proposed in the proposed rules released by the agency on Monday, whether the modified crops could be genetically engineered to produce chemical ingredients and similar metabolites. Monsanto officials said the process of creating the substances was well understood in the industry and would not be a concern.

The issue of genetic modification, which is used widely in plants, animals and fish, is expected to be among the most hotly debated issues when the FDA hears from the public next week about companies’ plans to offer genetically modified foods that have not undergone federal approval.

Some genetically modified crops have been on the market for more than a decade and are often sold in packages that carry the name “Roundup Ready.” The Agriculture Department, which requires farmers to provide regular disclosures about the GE crops, allows the sale of such goods without making such disclosures.

That could change under Murray’s bill, which would prohibit the use of the word “Roundup Ready” on products that were modified with genetic modifications and have not been approved by the Food and Drug Administration or by the Environmental Protection Agency.

The biotech industry, meanwhile, has said that the government needs to be more flexible when it comes to GM crops that have not been approved for consumption and could potentially be widely used.

Monsanto, which developed the Roundup Ready gene, the first genetically modified crop in the United States, said in a statement on Thursday that it has been working with the FDA on issues stemming from “the impact of advanced genome editing techniques and the resulting applications of science.”

Murray’s bill would not attempt to block the companies from filing their own claims that their modified crops are safe to eat. Rather, Murray said, the bill “would ensure that any significant issues raised regarding safety issues raised by the technology and its companion applications are handled in a timely and transparent manner.”

The bill would also prohibit companies or universities from demanding that companies working on the biotech crops make payments as part of their involvement in the projects. “This is a fairness issue as well as an issue of safety and effectiveness,” Murray said.

The bill is opposed by the biotech industry, which argues that many companies that work on those technologies could not justify contributing their resources to research and testing because they would be unable to clear the end of the research process with the FDA.

“The biotech industry has seen no shortage of federal regulators throughout its history, from the USDA, FDA and CDC,” said David Balto, senior policy director for the Center for Food Safety, an advocacy group that has filed two lawsuits against biotech firms seeking to block GMOs on the grounds that they pose risks to human health.

Balto, though, said his group was open to working with Murray on

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