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Lester M. Crawford, D.V.M., Ph.D. - AACC 2005 Annual Meeting

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

Speech before
2005 International Annual Meeting of the American Association of Cereal Chemists


Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Commissioner of Food and Drugs


September 12, 2005

(Delivered via Live Video Broadcast)

Good morning and thank you Linda (Linda Paulson, AACC 2005 Program chair) for your kind introduction. I regret that I am not able to be in Orlando this morning to talk to you in person and want to thank the AACC staff for their efforts in accommodating this last minute change that enables me to talk to you by video hook-up.

As you know, the Department of Health and Human Services and FDA are heavily involved in the disaster relief activities in the Gulf coast states struck by Hurricane Katrina and it was essential for me to remain in Washington to coordinate FDA responses to this horrific situation.

I’ll just briefly highlight some of FDA’s ongoing activities relative to Katrina. FDA has deployed approximately 300 Commissioned Corps Officers to the affected areas, these individuals are all health experts, including doctors, registered nurses, pharmacists, veterinarians and others, all of whom are playing significant roles in the relief efforts.

Our FDA website is providing information about the safety of medications and medical devices potentially damaged by flooding or high temperatures and our Center for Biologics is an active participant in monitoring the blood supply and other biological products such as vaccines and immune globulins. We’ve issued recommendations on insulin storage and switching of product for patients who need insulin but have lost access to their normal healthcare providers in the aftermath of Hurricane Katrina. We’ve also made sure that antivenins will be available for treating bites from poisonous snakes in the flood waters.

FDA has also created a website to assist pet owners that includes advice on preparation for evacuation, animal health, and how to care for pets before, during, and after a natural disaster.

FDA is actively distributing important food safety messages to the Gulf region, providing consumers with information on how to deal with food that may have been temperature abused due to power outages, how to treat drinking water and how long to boil it to destroy bacterial pathogens.

Clearly, FDA personnel will be involved with the aftermath of Katrina for a long time. We’ll be working closely with both pharmaceutical and food processing industries in the affected regions as they work on restarting their businesses, especially since facility and equipment contamination as well as the purity of the water supply needed for processing will be major issues. Last week our Center for Food Safety and Applied Nutrition published a notice to growers, food manufacturers, food warehouse managers and food transporters about crops and processed foods that will have to be destroyed due to contamination by flood waters.

We’ve had to move our New Orleans district office and personnel to Nashville for the foreseeable future. Of course, this huge effort on the part of all FDA employees is in addition to our normal activities and responsibilities of protecting and promoting public health.

Some of you may be aware that 2006 marks the 100th anniversary of the passage of the Pure Food and Drug Act, the founding law that transformed FDA into a scientific regulatory agency, thus making it the oldest consumer protection agency in the nation. This Centennial year is a major milestone in FDA’s history and will be a year in which FDA and the entire country can take pride in and reflect on the richness of that history as well as the many challenges that lie ahead.

We plan to have Centennial related events throughout 2006 and we’re excited about how the Centennial offers a unique opportunity to work with our stakeholders to broaden public awareness of FDA’s responsibilities and to increase the Agency’s ability to carry out its mission.

Today, many Americans are understandably interested in FDA’s programs, and the steps the Agency is taking to ensure that the promise of new science translates into longer and healthier lives. Consumers also want the opportunity to participate, in a meaningful way, in our work, whether we are discussing a complex scientific issue, proposing a regulation to address a particular problem or implementing a new law.

In recognition of the public’s interest in contributing to the work of the FDA I have scheduled a series of public meetings entitled “Vision 2006 – A conversation with the American Public”. We are holding these meetings to update the public on current agency programs, engage the public in discussion, and obtain consumer input on specific issues. We may use this public input to strengthen our understanding of the public's expectations and concerns and to evaluate and modify, if necessary, our programs and activities. These meetings will be held in an open format in which the public can interact with the top leadership of FDA in a discussion of a broad range of issues.

Now, let me update you on various activities within the Agency and specifically within our Center for Food Safety and Applied Nutrition that I believe may be of interest to you.

As many of you may know, FDA publishes the Food Code which is a model food safety guideline for retail food operations and institutions. The Food Code assists food protection jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segments of the industry. Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules to be consistent with national food regulatory policy, and to promote uniformity across the country.

FDA updates the Food Code every four years to provide best practices for the retail and food service industries on how to prevent foodborne illnesses. The last full edition was published in 2001. FDA collaborates with the Conference for Food Protection, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture to update the Food Code with respect to current science, emerging food safety issues, and imminent health hazards related to food safety. In addition to new Federal rules or initiatives, the Food Code may also be revised based on suggestions from regulators, industry, consumers, academia, and professional organizations such as AACC. We have just completed the update for 2005.

Some of the changes made in the 2005 Food Code are minor and include editorial changes made for consistency and clarity. More significant changes include added and changed definitions of terms; amended practices for consistency with new federal guidance on Listeria monocytogenes; information about food defense; and, information about major food allergens, including wheat and soybeans, that is consistent with the Food Allergen Labeling and Consumer Protection Act of 2004.

And speaking of labeling, I know the ability to identify the healthful benefits of consuming whole grain products is of interest to many of you attending this conference. During the development and implementation of the National Labeling and Education Act back in 1993, Congress and FDA considered the available science at that time and recognized the benefits of fiber, and whole grains as a source of fiber. FDA authorized two health claims, which, as you may know, must be based on significant scientific agreement.

The first claim that was permitted stated that low-fat diets rich in fiber-containing grain products, fruits and vegetables may reduce the risk of some cancers. This claim can be applied only to foods that contain grain, fruit, or vegetable products and meet the nutrient content claim of a “good” source of dietary fiber (without fortification or supplementation). These products must also meet the nutrient content claim for being a “low” fat product.

The second health claim that was authorized with the implementation of the NLEA has to do with the soluble fiber content. In this case, the claim may state that soluble fiber (primarily beta-glucans) from food such as whole oat products, as part of a diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease. The eligible sources of soluble fiber allowed include oat bran, rolled oats, whole oat flour, oatrim and psyllium husk.

The 1997 FDA Modernization Act (FDAMA) specifically provided for the use of health claims based on authoritative statements from a scientific body of the U.S. Government or the National Academy of Sciences. We issued Guidance to Industry in 1998 that outlined submission procedures for health claims based on authoritative statements, and defined what would be considered an authoritative statement.

In 1999, we approved the first health claim for whole grain foods under FDAMA. The approved labeling statement can indicate, “Diets rich in whole grain foods and other plant foods and low in fat, saturated fat, and cholesterol may help reduce the risk of heart disease and certain cancers”.

In 2003 we approved a second, similar health claim for whole grain foods. The difference between the two statements is that because fat, per se, is not associated with increased risk of heart disease, it’s the saturated fat and cholesterol that are the problem; foods bearing the second health claim do not need to meet the nutrient content claim of a “low fat” food, but can contain moderate levels of fat.

So, where are we today with respect to label claims for whole grain foods?

Currently FDA allows truthful and non-misleading statements such as: “whole grain”, “multi-grain”, or similar statements, if all of the grain ingredients are whole grain. We do not object to the use of the term “whole grain” to refer to ingredients or foods that meet the Cereal Chemists’ Definition of whole grain. That is, the intact, ground, or flaked grain, where the principal anatomical components of the grain (starchy endosperm, germ, bran) are present in the same relative proportion, as they exist in the intact grain.

CFSAN has, as one of its priorities for the coming year, the development of a strategy to initiate rulemaking on label claims for whole grains. As a part of this priority we expect to define the term “whole grain” and establish the framework for appropriately using claims about whole grains considering the recommendations of the Dietary Guidelines.

Before I leave the topic of labeling I want to comment on the rapidly approaching deadline of January 1, 2006 for implementation of the mandatory listing of trans fat on the food label. The trans fat nutrition labeling rule responds, in part, to a citizen petition from the Center for Science in the Public Interest (CSPI), and is based on recently published human studies and health expert advice on trans fat.

The Institute of Medicine, National Academies of Science published a report a couple of years ago that found that trans fatty acids increase low density lipoprotein cholesterol, thereby increasing the risk of coronary heart disease. The IOM report recommended that "trans fat consumption be as low as possible while consuming a nutritionally adequate diet." Similar recommendations are made for saturated fat and cholesterol.

This regulation will provide information on food labels about the amount of trans fat in foods so that consumers can select foods with lower levels of trans fat. FDA is not banning food manufacturers from using trans fat in packaged foods. Rather, we are requiring food manufacturers, processors, and distributors to label the amount of trans fat in a serving of food on the Nutrition Facts panel. As a result, Americans will have information they need to reduce their intake of trans fat as part of a heart-healthy diet.

FDA estimates that 3 years after the effective date, trans fat labeling would prevent from 600 to 1,200 cases of Coronary Heart Disease and 250-500 deaths each year.

Based on informal reports from industry, the requirement to declare trans fat on product labeling is already changing consumer demand and prompting product reformulation. Representatives from industry have indicated to FDA that the transition from use of oils containing trans fats to healthier oils that are both suitable for various processing techniques and continue to meet consumer taste preferences will take time as supplies of healthier oils catch up with demand. High consumer demand for healthier oils, and the accompanying industry response, is a testament to the success of the agency's trans fat labeling rule and industry's move to using healthier oils.

FDA estimates that industry will incur a one-time cost of approximately $140 to $250 million. These costs include: determining the amount of trans fat in the food products, relabeling the Nutrition Facts panel to add trans fat, and reformulating products voluntarily to decrease the amount of trans fat.

Before I sign off with you this morning, there is one more issue I would like to mention that concerns your industry. In 2002, Swedish scientists discovered that the substance acrylamide forms in certain foods during traditional cooking practices, such as frying and baking. Because acrylamide causes cancer in laboratory animals at high doses, it is a potential human carcinogen. At this time, however, it is not clear whether acrylamide causes cancer in humans particularly at the much lower levels found in food.

Guided by our “Action Plan for Acrylamide in Food,” FDA has initiated a broad range of activities on acrylamide since the 2002 discovery. First, we developed a very sensitive method for measuring acrylamide in food. Then we analyzed acrylamide levels in more than 2100 food samples, sharing the results on the FDA website. The most recent data release, for more than 875 samples, occurred in June 2005.

We then conducted exposure assessments to determine how much acrylamide U.S. consumers are exposed to through the diet, and what foods are the primary sources of exposure. In a 2005 update of the exposure assessment, cereal products accounted for 4 of the top eight sources of acrylamide intake for U.S. consumers, along with potato chips, french fries, and coffee.

FDA carried out research at its National Center for Food Safety and Technology in Chicago on factors affecting formation of acrylamide in food and the effect of home cooking, including toasting bread, on acrylamide levels. FDA’s National Center for Toxicological Research is the leader on new toxicology research on acrylamide. Since the discovery of acrylamide in food, FDA has completed at least nine research papers on acrylamide toxicology. The agency will complete a chronic carcinogenicity assay in 2007.

FDA is planning to conduct an authoritative risk assessment on acrylamide after completion of the toxicology studies, including the chronic carcinogenicity assay. We have worked with other U.S. and international government agencies, private organizations, and industry to encourage research and data sharing on acrylamide and to develop international approaches for managing acrylamide, such as work through the Codex Committee on Food Additives and Contaminants (CCFAC). CCFAC is initiating development of a draft code of practice for mitigating acrylamide levels in food that will include recommendations for cereal products.

In the future, FDA is planning to release new information for consumers who are concerned about acrylamide in food on ways they can reduce acrylamide intake. FDA’s best advice for a healthy diet remains that consumers eat a balanced diet, choosing a variety of foods that are low in trans fat and saturated fat, and rich in high-fiber grains, fruits, and vegetables.

In closing, I want to add my congratulations to AACC on their name change that became effective in February of this year. Adding the “International” to your name truly reflects the global scope of your activities. I wish you a very successful annual meeting.

Thank you.