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Jane E. Henney, Ph.D - Consumer Federation of America

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery."

Remarks by:
Jane E. Henney, Ph.D

Commissioner of Food and Drugs
U.S. Food and Drug Administration
for

2000 National Food Policy Conference
Consumer Federation of America

Washington D.C.

April 18, 2000

Today we're seeing dramatic changes in food production methods, consumption patterns, and demographics in this country. We have a much more varied food supply-we're eating different kinds of foods-not only from domestic sources-but from all over the world. We're preparing less food at home--eating more ready-to-eat foods when we do eat at home--and eating more meals in restaurants.

Lastly, the proportion of our population that is especially vulnerable to foodborne illness-the very young, the very elderly, and immunocompromised individuals, is growing.

Foods reaching American consumers today are distributed very differently than they were just a decade ago. Food from a single source may be rapidly distributed to communities across the nation, or from around the world, increasing the negative consequences of a contaminated food product exponentially.

Imported foods are of particular concern, given the influx of foods to this country from all over the world. FDA regulated food product imports have increased 12% each year over the past few years. Today, over 50% of our seafood and 38% of our fruits and vegetables are imported into the United States.

The increasing number of foodborne pathogens such as Salmonella, E. coli 0157-H7, Campylobacter, Staphylococcus aureus, Listeria, and others, continue to present challenges to keeping our nation's food supply safe. New pathogens emerge and familiar ones grow resistant to treatment, further complicating a difficult problem.

The first phase of the President's Food Safety Initiative has to be regarded as a resounding success. We have better surveillance, faster outbreak response, stronger prevention programs, and effective education-all on a firm grounding in strong scientific research and risk assessment. But we need to follow through in our fight against pathogens, and expand the scope of our invigorated food safety program to address other pertinent issues in addition to the microbiological ones.

We are continually seeking ways to more quickly identify problems, find the source of food-borne illnesses or contamination, and communicate our findings to the public. It is critical that we have strategies in place to deal with food-related crises as they arise. And yet, prevention is key. In spite of our vigilance, there are still too many illnesses, hospitalizations and deaths related to food. Many of these incidences are preventable.

Effectively meeting these challenges means that we all need to do everything we can--individually and collectively--at the federal, state and local levels. Attention to food safety is not something that can be proclaimed but must be practiced every day by all of us.

Let me say just a few words focused on the FDA.

FDA is the government agency responsible for nearly 80% of the nation's food supply--everything we eat except for meat, poultry and processed egg products.

There have been a number of food safety crises in Europe in the recent past-problems with meat from cattle with BSE, and dioxin-contaminated food and feed, with a resulting loss of consumer confidence.

In Europe they are asking, "What is FDA's secret to world-wide recognition, respect and trust?"

I would suggest that our success relies on three principal factors.

  • Risk- and science-based decision-making from policy to enforcement,
  • Open and transparent processes, and
  • Consumer involvement

Let me elaborate on each of these issues. First...risk- and science-based decision-making.

The agency depends on having the very best science on which to base its decisions. This cannot be emphasized enough. We must be knowledgeable about foods and new food technologies as they are being developed. We must be able to respond quickly and effectively when a food-related problem arises.

To do so we must have exceptional scientific expertise within the agency, including field investigators with scientific education and training, and ready access to scientific expertise outside of FDA.

We need an active food safety research and risk assessment program to help us quickly characterize problems, validate interventions, and support our regulatory actions.

Collaboration with the scientific community outside of FDA is vital also to our success. Let me give you some examples. The National Center for Food Safety and Technology (the Moffett Center) is a joint effort between FDA, the Illinois Institute of Technology, and several food companies.

This center focuses on collaborative studies emphasizing the safety of food processing and packaging technologies and related outreach, and has made significant progress in improving the safety of sprouts and juices, and developing alternative sterilization procedures.

The Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a multi-disciplinary joint program of FDA and the University of Maryland, provides the foundation for partnerships with other federal and state agencies, academic institutions, private industry, consumer and trade groups, as well as international organizations. Risk assessment is at the top of JIFSAN's agenda. The Institute manages the Risk Assessment Clearinghouse of the Food Safety Initiative, and supports multidisciplinary research, outreach and educational programs.

PulseNet, the national computer surveillance network of public health laboratories developed by CDC in cooperation with FDA, USDA, and state health laboratories, has been enormously helpful in confirming the association between illness cases and foods implicated in outbreaks using DNA fingerprinting. FDA laboratories are able to submit information directly to the CDC database, allowing rapid and direct exchange of information. In several instances, PulseNet has been able to quickly confirm epidemiologic associations between seemingly unrelated cases of foodborne illness, some of which have been widely separated geographically.

FDA's National Center for Toxicological Research. NCTR has an agreement with the National Institute for Environmental Health Sciences to conduct toxicological testing and research on FDA-regulated products, such as chloral hydrate, fumonisin B1, malachite green, and endocrine disruptors.

These are but a few examples of the type of scientific and risk-based resources that must be maintained to provide a strong food safety system.

The second key asset is that in this country our decision-making is open and transparent. We make every effort to get broad input into our decisions, and we do it publicly through public meetings, advisory committee meetings, good guidance practices and notice and comment rulemaking. Public participation in policy formulation provides an opportunity for exchange of ideas and opinions between and among FDA, consumers and the regulated industry.

When we make a decision, all those that are affected by our decisions--know how we got there. This approach has increased the likelihood of consumer confidence in the integrity of the decisions made about products consumers will use. The industry clearly benefits from consumer confidence and from the knowledge that FDA's decisions are fair and based in science. And FDA benefits by gaining the information needed to reach the best policy decisions.

Finally, FDA implements and enforces the policies it has established. FDA's risk-based inspection system focuses first on establishments producing food at "high risk" of microbiological contamination, such as infant formula, ready-to-eat foods and seafood.

Inspections and the appropriate use of enforcement provide a level playing field for industry, and serve to protect consumers from unsafe food products.

Compliance by industry must be approached not only through inspection but must be coupled with strong education efforts to assure that industry knows exactly what is expected of them. And our educational efforts cannot stop with industry for it's equally important to educate consumers on food safety risks and practices that can protect against foodborne illness. FDA has participated in a coalition of industry, government and consumer groups formed to educate the public about safe food preparation through the Fight BAC! program.

In summary, there are many changes and many challenges in the area of food safety. As an agency we have had to be both adaptive and innovative in our approach but there are some things we will not change.

  1. Our high standards and expectations for safety,
  2. That science and risk be used to underpin all of our decisions and
  3. Openness and transparency guide our processes.

It is this winning combination that has served the public well and permitted this agency to be one in which consumers have confidence and trust.

For the reasons I've just discussed, FDA is respected worldwide as the leader in food safety matters.

I would like to switch gears now and talk about foods that have been developed using the tools of modern biotechnology-or "bioengineered foods."

You heard quite a bit on this topic yesterday, and will likely hear more from Secretary Glickman at lunch--but I would like to give you a report from FDA's recent public meetings.

We are quite aware that this topic--foods derived using the tools of biotechnology-has generated much controversy, particularly about whether these foods should be labeled or not. As I mentioned, FDA held three public meetings over the past several months about genetically engineered foods, the first one of which I chaired. We wanted to be sure that the public was clear about FDA's current policy and what we were already doing. And we wanted to determine whether there are new scientific issues the agency should consider.

We wanted to hear the views from all who attended, and importantly, we wanted to discuss, and obtain feedback on, ways in which information on biotech foods could be most appropriately and helpfully conveyed.

Let me summarize for you what we heard, and from the 25,000 plus comments we received from the open docket. First and foremost, there was not any current science presented that would call into question any decisions that have been made thus far regarding foods derived from the tools of biotechnology.

Second, we heard differing views about how the general public views biotechnology-derived foods. First, there were those who were not particularly concerned about food safety, but did not wish to participate in any practice that might harm the environment.

Then, there were those that did not document any current food safety issues, but were concerned about possible long-term effects.

And, there were those individuals who would readily eat biotech foods-they don't think there are any safety issues-but they're Americans, they love information and they just want to know whether the foods they are eating are genetically engineered or not.

The final perspective-one that I've heard more in my overseas trips than here--was that developing countries around the world desperately need this technology, both for the health of their people, and for their countries' economic health.

We respect all of these views and will consider them as we continue to shape our policy.

As we come to a decision on these matters, you have my commitment that FDA will operate in an open, transparent manner. It is important that the public clearly understand the FDA's policy on foods derived from biotechnology.

In closing, the message I'd like to leave you with is that FDA has a nearly 100 year track record of science-based public health regulation of foods. Our record on food safety is sound. As we prepare for the future we look forward to continued cooperation and communication with consumers, our counterpart agencies both here and abroad, and the food industry.

Thank you for the opportunity to be here today.