05-03-00: FDA announces refined regulatory approach

This morning, the Food and Drug Administration (FDA) announced an initiative to strengthen its policy on regulating the safety of foods derived through biotechnology. In short, the FDA will propose a mandatory review process prior to the marketing of new biotech food products. In addition, FDA will develop guidelines for making voluntary label claims for "biotech" or "biotech-free" products.

Monsanto Company supports the FDA's announcement today to enhance elements of the regulatory system for foods produced through biotechnology. In the past five years, Monsanto has voluntarily submitted 14 products to the FDA as part of its consultation process. We believe the FDA's new steps will further strengthen the public's confidence in the regulatory system and safety of the food supply.

Monsanto has always supported the FDA's position on the labeling of biotechnology products. We welcome the additional guidance to the food industry that should result in informative and meaningful voluntary labels for consumers.

Additional support for the FDA's policy is coming from major industry organizations, including:

The Grocery Manufacturers of America "...praised the agency for
its proposal..."
See: http://www.gmabrands.com/news/docs/NewsRelease.cfm?docid=567&

The National Food Processors Association called the
initiative, "A win for consumer confidence in biotechnology." See: http://www.nfpa-food.org/

The Biotechnology Industry Organization supports the
decision to "make the approval process for foods improved through biotechnology more transparent."

See:http://216.33.110.200/news/article.html?XP_PUB=press_release&XP_TABL E=articles.db&XP_RECORD=2000_0503-01

Please access information about the FDA's initiatives directly from the White House and FDA websites at:
http://www.whitehouse.gov/library/PressReleases.cgi?date=0&briefing=2 and http://www.fda.gov/bbs/topics/NEWS/NEW00726.html

For your information, the following are Monsanto's answers to frequently asked questions regarding the FDA's policy:

Q: What is the FDA's current policy on labeling biotechnology products? How does today's announcement represent a change?

A: The current FDA policy on the labeling of food requires special labeling if there is a meaningful change in the composition, nutrition or allergenic potential of a food, regardless of the method used to produce the food. All meaningful changes in the nutritional characteristics and safety parameters have to be demonstrable and scientifically documented. The FDA does not require special labeling for biotechnology products that do not differ in composition, nutrition or allergenic potential.

Today's announcement provides guidance to the food industry on
how to voluntarily make product claims about biotechnology on labels. We believe this guidance will ensure that such labels are informative and meaningful to consumers.

Q: Are biotechnology products safe?

A: Yes, biotechnology products are safe. The framework for evaluating the safety of food and feeds developed through biotechnology by the FDA ensures that the United States has the safest food supply in the world.

Foods produced through biotechnology are more thoroughly tested
than foods produced from traditionally bred crops. For example, more than 1800 analyses have been conducted with Monsanto's Roundup Ready (r) soybeans - all of which confirm that these soybeans are as safe and nutritious as conventional soybeans.

Our food safety team conducts exhaustive safety studies,
which are reviewed by food safety regulatory experts around the world. In addition, Monsanto proactively publishes safety information on our products in peer-reviewed, scientific journals. The safety assessments we conduct meet the rigorous standards established by organizations such as the U.S. Food and Drug Administration and the United Nations' World Health Organization/Food and Agriculture Organization. While these safety summaries are available in its comments to the FDA, Monsanto encouraged the Agency to make them more accessible to the public.

Q: If FDA consultation was not mandatory in the past, does that mean that some products currently available on the market are not safe?

A: Absolutely not. The FDA has a robust regulatory process, and consultation is one additional check in the system. The FDA process has been based on:
* The Federal Food, Drug and Cosmetic Act (FFDCA)
and its amendments
* The 1992 Policy on Foods Derived from New Plant
Varieties (57 FR 22984)
* The FDA's implementation of the 1992 policy,
which to date has included a voluntary consultation process
These regulatory enforcement measures have ensured that
the United States has the world's safest food supply.

Q: Is the regulatory process (e.g., the FDA) working?

A: Three American regulatory agencies have primary responsibility [there are others that have minor roles] for oversight of products improved using biotechnology. The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) are responsible for evaluating the safety of agricultural biotechnology crops for consumption and the environment. These agencies have developed a web of checks and counterchecks to ensure that crops improved using advanced biotechnology techniques are as safe and wholesome as all of the other food products and crops they review. These safety reviews are conducted in accordance with guidelines provided by international entities such as the United Nations' World Organization/Food and Agriculture Organization and the Organization for Economic Co-operation and Development (OECD)

The FDA, the agency responsible for food safety in the United
States, has established clear guidelines on the type of safety testing companies must conduct on products of agricultural biotechnology. The food safety data companies generate is thoroughly reviewed by the FDA.

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