BIO Testifies at Senate Hearing on Biotech Food

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WASHINGTON, D.C. (September 26, 2000) (Michael J. Phillips, executive director for food and agriculture of the Biotechnology Industry Organization (BIO) testified today at a Senate hearing on regulation of biotech crops and foods):

TESTIMONY

OF
MICHAEL J. PHILLIPS, PH.D.
EXECUTIVE DIRECTOR FOR FOOD AND AGRICULTURE
BIOTECHNOLOGY INDUSTRY ORGANIZATION
1625 K STREET NW SUITE 1100
WASHINGTON DC 20006

SENATE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
DIRKSEN SENATE OFFICE BUILDING ROOM 430
WASHINGTON DC
26 SEPTEMBER 2000

Good morning Mr. Chairman, Senators, Ladies & Gentlemen. I am Dr. Michael J. Phillips, Executive Director for Food and Agriculture at the Biotechnology Industry Organization (BIO). I am privileged to be here this morning on behalf of the BIO. Our membership includes over 900 member companies and research institutions in North America and around the world. These members are actively involved in research and development of new medicines, foods, and industrial products to benefit the lives of people and the environment.

I would like to thank Senator Tim Hutchinson (R-AR) and Senator Christopher Dodd (D-CT) for establishing the bipartisan Senate Biotechnology Caucus. And in the House of Representatives, I would like to thank Congressmen Calvin Dooley (D-CA), Thomas Ewing (R-IL), Robert Ehrlich (R-MD), and Congresswoman Lois Capps (D-CA) for forming the House Biotechnology Caucus. These bipartisan fora will provide a place where Senators and Congressmen can explore often pressing and controversial issues in a balanced and factual way.

In your letter inviting BIO to testify before you today, you asked that we provide you with our views on approaches for ensuring consumer safety and confidence with respect to foods derived through the use of biotechnology. I will attempt to meet your request by 1) describing some of the benefits of products in the marketplace today and those soon to come, 2) explaining the process by which companies and regulatory agencies evaluate the safety of new products, 3) stating our views on FDA’s recently announced changes in policy for foods derived through the use of biotechnology, and 4) providing our views on some of the challenges ahead.

Benefits of Current and Future Products

Because of the benefits of crops improved through biotechnology offer to the farmer, the market penetration of these new varieties has been rapid over the past four years. The best estimates for the 2000 growing season indicate that about a quarter of the corn, and over half of our soybeans and cotton consist of varieties improved through biotechnology. The fact of this rapid market penetration speaks eloquently of the benefits provided to farmers in terms of reduced input costs, increased yields, and reduced chemical inputs. For example, in a study released earlier this year entitled Genetically Engineered Crops for Pest Management in U.S. Agriculture by the U.S. Department of Agriculture’s Economic Research Service (ERS), their research showed that herbicide-tolerant soybeans have significantly increased yields and decreased herbicide use. In cotton, the study stated that adoption of Bt cotton in the Southeast has led to significant increases in yields and net returns and decreases in pesticide use.

Benefits to the farmer, however, are only the beginning. Benefits to the consumer, and to the environment are also significant and promise to be both healthy and nutritious. We already have genetically improved oilseeds that have given us improved cooking oils that lead to foods healthier for the heart -- holding promise to reduce the 500,000 deaths among American citizens from heart disease every year. Complementary improvements in food qualities are also being pursued, such as potato starch modified so that french fries absorb less oil in cooking. In addition, we see in the R&D pipeline now, fruits and vegetables modified to improve flavor, nutritional quality, and significantly reduce wastage, processing costs, and energy requirements. On the horizon are foods modified to contain increased amounts of anti-cancer compounds, or with enhanced levels of such essential dietary components as iron and vitamin A. Foods responsible for common or widespread allergens are being modified to reduce or eliminate their allergenicity. And plants, such as the widely publicized Golden Rice are being modified safely to eliminate nutritional or dietary deficiencies such as vitamin A deficiency that leads to night blindness or inadequate iron uptake that results in anemia.

A Rigorous Regulatory Process

Rigorous testing and government regulations are in place to ensure the safety of these products so that we can realize the benefits of biotechnology. In fact, crop varieties enhanced through the use of biotechnology are tested more thoroughly than conventional varieties before they ever come to market. In the United States, three government agencies - the Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) - work together to ensure that crops produced through biotechnology are safe. In 1992, FDA issued a policy concluding that foods derived from biotechnology, as a class, should be regulated the same as other foods entering the market. The FDA evaluates food biotechnology products on a case-by-case basis. These products are judged on their individual safety and nutritional characteristics - not the methods used to produce them. Testing results reviewed by FDA include 1) source of the new gene and history of its use, 2) toxicity, 3) nutritional profile, 3) chemical composition, 4) allergenic potential, and 5) potential development of antibiotic resistance. In addition, EPA and USDA demand rigorous testing on the effects on non-target insects and the environment. It is not until the FDA, EPA, and USDA are satisfied with the results of these and other tests that our member companies enter products into the market. The decisions made by regulatory agencies are thoroughly documented, open to public comment, and widely available in the public record. The openness and rigor of this process has been in good part responsible for the high levels of public confidence in these products and the regulatory process that we see in the United States today.

FDA’s Recent Policy Announcement

On May 3, 2000 FDA announced plans to refine its regulatory approach regarding foods derived through the use of biotechnology. The refinements were made in part from input received during FDA’s public outreach meetings last year and build upon programs already in place at FDA to help ensure the safety of all foods. In announcing these refinements, Dr. Jane Henney, MD, Commissioner of Food and Drugs stated that FDA’s scientific review continues to show that all bioengineered foods sold in the United States today are as safe as their non-bioengineered counterparts. We believe our initiatives will provide the public with continued confidence in the safety of these foods.

FDA has publicly stated that it will soon publish a proposed rule mandating that developers of bioengineered foods and animal feeds notify the agency when they intend to market such products. FDA will in turn require that specific information be submitted to help determine whether foods or animal feeds pose any potential safety, labeling, or adulteration issues.

This proposal strengthens the current consultation process that has worked very well. BIO supports the proposal. BIO member companies have consulted with FDA on all products that are in the market today. FDA will propose to strengthen this process by specifically requiring developers to notify the agency of their intent to market a food or animal feed from a bioengineered plant at least 120 days before marketing. BIO member companies typically consult with FDA one to three years in advance of marketing a food or animal feed.

To make sure that consumers also have extensive access to product information, FDA will propose that submitted information and the agency’s conclusions be made available to the public, consistent with applicable disclosure laws, by posting them on the FDA Web site for easy viewing. BIO is fully in favor of this proposal and in our comments to FDA during the public outreach meetings urged the FDA to place this type of information on its Web site.

Under current policy, the same labeling laws that apply to all other foods and food ingredients apply to products of food biotechnology. FDA requires labeling if a food has significant changes in nutritional content, has an allergen, or otherwise has changes in the composition or safety of the food. Food manufacturers may place voluntary claims on their product’s label as long as it is truthful and not misleading. However, for foods derived by the use of biotechnology there are no labeling guidelines for manufacturers to follow. In its May announcement, FDA stated that it plans to draft labeling guidance to assist food manufacturers who wish to voluntarily place claims on their label that their foods are made with or without the use of bioengineered ingredients. The guidelines will help ensure that labels for these products are truthful and not misleading. BIO recommended this step to FDA in its comments during the public outreach meetings and completely supports FDA’s decision to draft such guidelines.

These policy steps that FDA is enacting will further strengthen the existing regulatory system, and will further assure consumers of the safety of the food supply. BIO strongly endorses these steps and will cooperate with the FDA to see that they are successfully implemented.

Challenges Ahead

Consumer acceptance is the first and most important issue for the biotechnology industry. In the last week there have been many news stories about the Kraft announcement that it would voluntarily recall its Taco Bell shell products sold in grocery stores in the United States. Kraft’s recall decision comes as a result of tests that suggest the presence of StarLink corn in the taco shells. StarLink is a product of Aventis and contains the gene Cry9C, which has been approved for use in animal feed. It has not yet been approved for human consumption and should not have been present in the food chain if indeed tests confirm its presence. It should be noted, however, that StarLink is only one of eight biotechnology corn varieties on the market today, and is grown on less than half of one percent of the total US corn acreage. All of the other corn varieties improved through biotechnology have been thoroughly tested and fully reviewed by EPA and FDA for human consumption.

BIO supports Kraft’s voluntary recall even though there are no known health risks associated with this protein. We believe that confidence in the safety of all food products must be the first and only priority.

FDA, EPA, and USDA have rigorous policies in place, which in this instance may have been violated. If confirmed, measures must be taken to assure to the consuming public that this does not happen again. We will work with all the appropriate regulatory agencies to that end.

We are concerned that news stories about the voluntary recall by Kraft have implied questions about the regulation of agricultural biotechnology products. Some consumers may lack the context to fully understand and appreciate these questions. We therefore state unequivocally that as an industry, we strongly support and are committed to:

1. Ensuring that no grain products improved through biotechnology are brought to the domestic commercial commodity market without full U.S. regulatory approval for both human and animal consumption;

2. Ensuring validated test methods for grain are in place and accessible for use by the grain and food industry;

3. Ensuring appropriate, comprehensive, mandatory regulation by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and U.S. Department of Agriculture (USDA);

4. Ensuring the integrity of environmental stewardship for all products of biotechnology.

The U.S. regulatory system has dealt openly with such issues for more than a decade now, leaving an abundant record that critics often ignore because the results of the process clash with their own preconceptions. The facts are nevertheless there for all to see (e.g. published scientific literature, regulatory agencies’ websites, and scientific societies’ websites) -- foods and products produced through this technology have been subjected to more rigorous scrutiny than any others in our history. They are demonstrably at least as safe as, and in many cases safer than, those they would displace. Millions of consumers around the world have enjoyed their benefits for years, with no reported ill effects. The future promise is greater still.

Thank you for giving us the opportunity to provide this information to you today. I will try to answer any questions that you may have.

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.