Regulatory Watchdogs

Center for Regulatory Effectiveness

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Genetic Regulation
Some NGOs are expressing scepticism about the about the FDAs draft Guidance to clarify the agencys regulation of Genetically Engineered (GE) Animals. The Center for Food Safety (CFS) stresses their concern over the protection of confidential business information by stating, "At a time when the FDA has inadequate resources to protect the food system and is reeling under allegations of conflicts of interest, this new proposal uses a secret approval process wherein no one other than FDA reviewers can see the data submitted before final approval."

While CFS claims concern about "secret approval" of GE animal products, their position may be based less on support for transparency than fundamental hostility to use of technology to improve the food supply. CFS states that it was established "for the purpose of challenging harmful food production technologies and promoting sustainable alternatives." CFS is an offshoot of the International Center for Technology Assessment which describes itself as "the country's primary legal organization fighting megatechnologies and technocracies."

While CFS and ICTA are free to oppose any or all technologies on a Luddite whim, the FDA must use quality science as the basis for their policy decisions. FDA is conducting an open public process on the draft guidance and is providing background and summary information about the proposal on their website. Moreover, the final guidance would be subject to challenges under the Data Quality Act if it does not adhere to federal and agency sound science standards.

If CFS, ICTA and other stakeholders would like to make a substantive contribution to the FDAs regulatory process, they should submit their comments to the agency by November 18th.

See CFS press release

See FDA GE Animal website

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