Comments made to FDA Re Federal Coordinated Framework for the Regulation of Biotechnology

Federal docket number: FDA-2015-N-3403

COUNCIL FOR RESPONSIBLE GENETICS’ RESPONSES TO REQUEST FOR INFORMATION PUBLISHED AT 80 FED. REG. 60,414 – 60,416 (Oct. 6, 2015):

“Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology”

The Council for Responsible Genetics (“CRG”) is a thirty-two year old science-based nonprofit whose mission is to represent the public interest and foster public debate about the social, ethical and environmental implications of genetic technologies. CRG welcomes the Obama Administration’s initiative to modernize the regulatory system for biotechnology products. As the White House’s July 2, 2015 Memorandum (“Memorandum”) correctly states, this regulatory system “must protect public health, welfare, safety and our environment….” Memorandum, p. 1 (emphasis added). CRG herewith submits its responses to the Notice of Request for Information, 80 Fed. Reg. 60,414 – 60,416 (Oct. 6, 2015) (“RFI”), within the context of this mandatory purpose of the regulatory system, and in light of CRG’s mission of fostering public understanding of, and democratic participation in, decisions concerning the uses and implications of genetic technologies. Continue reading

Levin Testimony Supporting the Massachusetts GMO Labeling Bill

September 21, 2015

Testimony submitted by Martin E. Levin to the Joint Committee on Environment, Natural Resources, and Agriculture of the Massachusetts State Legislature

I have been practicing law in Massachusetts, in the public and private sectors, for over thirty years. I am writing in support of House bill No. 3242, “An Act Establishing the Genetic Engineering Transparency Food and Seed Labeling Act” (“House 3242”). The current regulatory system leaves Massachusetts families without reason to rely on regulatory judgments about or protection against possible health risks associated with certain genetically engineered (“GE”) foods, and yet denies Massachusetts families the information necessary to make those judgments for themselves.

As explained in greater detail below, the principle GE food products that have been made commercially available are composed of plants that have been engineered for pesticide-related traits, and there is sound scientific evidence indicating that this technology has increased incidence of pesticides in the plants that are being introduced into our foods. The present regulatory system puts pre-market review and judgments about the potential health effects of these GE plants largely in the hands of the developers of the plants, who have a significant economic incentive to insure that the products are brought to market. Continue reading

House Vote Imminent on Agribusiness-Friendly GMO Food Act

On July 14, H.R. 1599 was reported favorably out of the House Agriculture Committee on a voice vote, and is expected to reach a floor vote within the week.  Although titled the “Safe and Accurate Food Labeling Act,” this bill actually codifies quarter-century old, agribusiness-friendly practices concerning the safety testing of genetically modified foods.  It also preempts all state laws mandating labeling of GMOs without enacting a labeling requirement at the federal level.

Regarding safety, H.R. 1599 simply directs the FDA to continue its current “consultation process” for the review of genetically engineered plants intended for use in foods.  That process was established in a 1992 FDA policy statement.  In that process, a GMO developer submits a summary of the results of the developer’s own research in support of the developer’s conclusion that the plant or food is safe.  FDA is relegated to review of the summary and expression of any objections to the developer’s conclusion based on the data submitted.  H.R. 1599 does not mandate that the FDA independently reach its own determination whether the food is safe or unsafe.  Nor does H.R. 1599 grant to FDA the authority to require that all research conducted by the developer be submitted, in its complete form.   Nor does it provide for public input into the review process.    Continue reading