Statements on Introduced Bills and Joint Resolutions

CONGRESSIONAL RECORD
SENATE
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

By Mr. DURBIN:

S. 2546. A bill to amend the Federal Food, Drug, and Cosmetic Act to require premarket consultation and approval with respect to genetically engineered foods, and for other purposes; to the Committee on Agriculture, Nutrition, and Forestry.

Mr. DURBIN. Mr. President, today I am introducing legislation that will strengthen consumer confidence in the safety of genetically engineered food and genetically engineered animals that may enter the food supply. This bill, known as the Genetically Engineered Food Act (GEFA) of 2004, requires the Federal Food and Drug Administration (FDA) to conduct an environmental and safety review of all genetically engineered plants and animals that may enter the food supply.

Our country has been blessed with one of the safest and most abundant food supplies in the world but we can do better. Genetically engineered foods have become a major portion of the American food supply and promise to become a larger part in the future. The next generation of genetically engineered foods will be more complex, will possess more novel genetic variations and will challenge regulatory agencies' ability to assess and manage their food safety and potential environmental effects.

Currently, the FDA screens genetically engineered foods through a voluntary consultation program. Despite assurances from the FDA for the past two years that the proposed and more stringent "pre-market biotechnology notification" (PBN) rules governing genetically engineered foods were imminent, those rules have yet to appear.

The Genetically Engineered Food Act of 2004 will create a transparent process that promotes public participation as decisions are made regarding the safety and environmental impact of genetically engineered plants and animals.

This bill will make the review process mandatory in place of the current voluntary system, which will reduce the chance that a potentially harmful product could bypass or receive inadequate regulatory oversight. The measure will establish unambiguous and predictable pathways for developers of genetically modified foods to gain approval to go to market and will ensure consumer confidence in the integrity of the system through a fully transparent review process.

An improved regulatory system for genetically engineered foods will boost consumer confidence in biotechnology derived foods, give federal agencies clear legal authority to deal with new technology and provide a process to detect problems even after genetically engineered foods are approved.

The Genetically Engineered Food Act of 2004 will strengthen government oversight in several important ways.

Mandatory Review: Producers of genetically engineered foods will be required to receive approval from the FDA before introducing their products into interstate commerce. The FDA will ensure, based on the best scientific evidence, that genetically engineered foods are just as safe as comparable food products before allowing them on the market.

Public Involvement and Transparency: In order for our country to gain the benefits that genetically engineered plants and animals can offer as additional sources of food, public confidence must be maintained in the safety of these products. My bill will provide for public involvement in the approval process by providing information to consumers, and giving them the opportunity to provide comments. Adding transparency will increase the public's understanding and confidence in the safety of these animals as they enter the food supply.

Scientific studies and other materials submitted to the FDA as part of the mandatory review of genetically engineered foods will be made available for public review and comment. Members of the public will be able to submit any new information on genetically engineered foods not previously available to the FDA and request a new review of a particular genetically engineered food product even if that food is already on the market.

Testing: The FDA, in conjunction with other Federal agencies, will be given the authority to conduct scientifically-sound testing to determine whether genetically engineered foods are inappropriately entering the food supply.

Communication: The FDA and other Federal agencies will establish a registry of genetically engineered foods for easy access to information about those foods that have been cleared for market. The genetically engineered food review process will be fully transparent to give the public access to all non-confidential information.

Environmental Review with Respect to Animals: While genetically engineered foods such as corn and soybeans are already part of our food supply, genetically engineered animals will also soon be ready for market approval. These animals hold much promise as an additional source of food for our nation. However, we must ensure not only the safety of these genetically engineered animals as they enter the food supply, but also the impact of these animals as they come in contact with the environment.

The provisions of my bill are consistent with the recommendations made in the 2004 National Academy of Sciences report, "Biological Confinement of Genetically Engineered Organisms"; the Pew Initiative on Food and Biotechnology 2004 report, "Issues in the Regulation of Genetically Engineered Plants and Animals"; and the 2004 report from the Ecological Society of America, "Genetically Engineered Organisms and the Environment".

The FDA has a mandatory review process in place that is used to review the food safety of genetically engineered animals before they enter the food supply. However, this bill will provide the FDA with additional oversight authorities to address the potential environmental impact of genetically engineered animals prior to their safety approval.

Environmental issues have been identified as a major science-based concern associated with genetically engineered animals. Therefore, to obtain approval to market a genetically engineered animal, the developer must include an environmental assessment that analyzes the potential effects of the genetically engineered animal on the environment. A plan must also be in place to reduce or eliminate any negative effects. If the environmental assessment is not adequate, approval will not be granted.

I urge my colleagues to join me in this effort to strengthen consumer confidence in the safety of genetically engineered foods and genetically engineered animals that may enter the food supply. The Genetically Engineered Foods Act of 2004 will help provide the public with the added assurance that genetically engineered foods and animals are safe to produce and consume. I ask unanimous consent that the text of the legislation be printed in the RECORD.