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American Seed Trade Association
And
American Organization of Seed Certifying Agencies
Joint Annual Convention
Lester M. Crawford, D.V.M., Ph.D.
Acting
Commissioner of the FDA
June 29, 2004
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.
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Good morning, thank you Jim (Jim Tobin, Monsanto, Vice-Chair of ASTA) for your kind introduction. I’m pleased to meet with you this morning, and to participate in this historic joint meeting of ASTA and the Association of Seed Certifying Agencies (AOSCA).
I congratulate ASTA on its distinction of being one of the oldest trade organizations in the US, (founded in 1883). Both ASTA and AOSCA (established in 1919) are organizations with a long and distinguished history of working together in the development, production, preservation, distribution, and quality assurance of plant seeds. Certainly seeds are the foundation for both human and animal life on earth, providing food, fiber for clothing, and many industrial products that we all use every day.
As your meeting schedule for the remainder of the day illustrates, both organizations play an essential role in certification and conservation of seeds of all types ranging from lawn grasses, trees, and shrubs to all types of food crops nationally and globally.
Yesterday you heard from Department of Agriculture Secretary Ann Veneman about the many areas of overlapping interest between your industry and activities of USDA. There are also many areas of mutual importance and potential collaboration for FDA and the seed industry, including food security, food safety, biotechnology and nutrition. I’d like to touch briefly on each of these areas this morning.
FOOD SECURITY
As organizations involved in the international trade of seed for human and animal foods, your collaboration is essential in assisting the FDA in its lead role of protecting the nation’s food supply from acts of Bioterrorism. Under new authorities granted to the agency by Congress following the terrorist attacks of 9/11, FDA has implemented four new food security regulations to prevent and respond to food safety threats.
It is important for you, the Seed Industry to understand how these new regulations apply to you. Whether seeds are subject to the rules of Prior Notice of Importation depends on whether the seeds meet the definition of food.
FDA considers a seed to be a food if it will be used for human or animal food or if those involved in importing or offering the product for import reasonably believe that the seed will be directed to a food use. For example, seed that is imported for use in animal feeds would require prior notice, as would seed to be used for human food such as sesame seeds or poppy seeds to be used in baking, or oilseeds for processing into edible oils, or seed to be used in the production of edible sprouts. If the seed is to be used only for cultivation, prior notice of importation is not required.
These new rules represent innovative solutions to 21 st century problems. They offer us new information on food production and distribution for the first time, including a complete inventory of food facilities both foreign and domestic, comprehensive information on all imported foods, and information on precisely who is handling the food throughout the entire chain of custody on either side of the border. These new rules will allow FDA to better identify potentially dangerous foods, as well as respond more quickly to new threats and to handle foodborne illness outbreaks more efficiently.
Since the passage of the Bioterrorism Act, our agency has devoted intensive efforts to implementing it. We’ve developed the necessary rules and guidance, and conducted extensive outreach to food exporters in Canada, Mexico, and South America, and elsewhere around the world. We are also working with Canada and Mexico on food security systems and infrastructure at both borders. We have set up internet-based programs to be available around the clock where firms can register prior notice of intended imports.
By the end of this summer, this in-depth comprehensive protective system will be fully in place and functioning.
FDA is also extensively involved and committed to the Food Emergency Response Network (FERN), a national initiative designed to integrate America’s laboratory infrastructure to better detect and respond to bioterror agent threats to the food supply at local, state, and federal levels. The key goals of FERN are:
FERN offers a tiered screening and confirmation testing laboratory network of federal, state, and local government laboratories responsible for analyzing food samples implicated in threats, terrorist events, or contamination; responding to large-scale emergencies involving food; and conducting ongoing programs to monitor foods for the presence of threat agents.
State participants of the FERN include agricultural, public health, veterinary diagnostic, and environmental laboratories. Laboratories from a variety of federal agencies are also members of the FERN. These laboratories represent the FDA, FSIS, the Environmental Protection Agency, the Department of Defense, Bureau of Customs and Border Protection, the Agricultural Marketing Service, the Animal and Plant Health Inspection Service, and the Grain Inspection Packers and Stockyards Agency. Other federal members of the FERN include the Agricultural Research Service, the Federal Bureau of Investigation, and the Department of Homeland Security. In addition, the FERN is working closely with the Laboratory Response Network (LRN) and the National Animal Health Laboratory Network (NAHLN) to ensure there are no gaps in our nation’s safety net for human health. This is an ambitious effort, but it is an important one. And we hope we can count on your support of this strategic initiative.
All this does not mean we have eliminated the possibility of a terrorist attack on our food supply. But I’m happy to say we are far better prepared to prevent, mitigate, or cope with it than we were three years ago.
FOOD SAFETY
Of course, hand-in-hand with our new responsibilities in food security are our ongoing responsibilities and activities relative to protecting our food supply from unintended contamination.
As you know, FDA is responsible for ensuring the safety and proper labeling of ALL plant-derived foods and feeds. Regardless of whether they are of imported or domestic origin, or whether they are derived from crops modified by conventional breeding techniques or genetic engineering techniques, they must meet the same rigorous safety standards. Under the FFDCA, it is the responsibility of you, the industry, to ensure that the products you market are safe and properly labeled.
Just as ASTA’s motto “ first the seed” indicates the role you play in sustaining human and animal life, so does FDA believe that in many instances food safety of plant foods must begin with the seed.
Certainly, of ongoing concern to FDA are the recurring outbreaks of foodborne illness related to consumption of sprouts. In almost all cases, contaminated seed was the source of the contaminated sprouts both for Salmonella sp. and E. coli 0157:H7. In fact, just in the past several weeks FDA has worked with at least six individual sprout producers relative to product recalls of alfalfa sprouts distributed throughout the western US due to a possible seed contamination with Salmonella Bovismorbificans, an organism rarely seen in the US.
It is crucial that you, who are in the business of seed production, ensure that seeds for sprout production are grown under good agricultural practices (GAPs) in order to minimize the likelihood that they will contain pathogenic bacteria. This is especially important since only a small fraction of the seed produced is used for sprouting so at the time of production, seed growers may not be aware that the seed will be used for human consumption. FDA’s guidance on good agricultural practices (GAPs) can be found in the "FDA Guide to Minimize Microbial Hazards for Fresh Fruit and Vegetables."
Key sources of contamination in seed production include:
In October, 1999, as many of you may know, FDA issued guidance for the industry, "Reducing Microbial Food Safety Hazards For Sprouted Seeds". Most of FDA's resources have been focused on conditions and practices at the sprouting facility, however, the first 2 of 5 recommendations in this guidance deal with seed production and post-harvest conditioning, storage and transport.
FDA strongly recommends that seed suppliers and distributors establish a sampling plan and criteria for seed sold to sprouters, and that testing seed for pathogens be considered.
The educational video that FDA produced in partnership with California Department of Health Services goes into a lot more detail (Module 3A, pp 14 - 20) concerning the challenges and practices associated with seed production, conditioning, storage, assigning of lot numbers and microbial testing. This video would be useful for producers, distributors and others that handle seed that may be destined for food use, i.e., sprouting.
Increasing awareness of the potential for contamination from the field through the sprouting facility and implementing GAPs and GMPs to improve handling of seeds and sprouts will not only reduce the risk of foodborne disease and assist FDA in its mission of protecting the public health, but also enhance food security.
Food GMPs
With respect to food GMPs, I would also mention that FDA is currently undertaking two important initiatives – the modernization of the current food GMPs and development of GMPs for dietary supplement manufacturers – which are aimed at improving the quality of the foods that we eat and reducing the risk of adverse health effects to consumers.
The food GMPs were originally promulgated in the late 1970’s and were last revised in 1986 in response to the identification of several newly emerging food-borne pathogens such as Salmonella enteriditis, and hemorrhagicE. coli. Food GMPs are an important part of the nation’s control over food safety problems. Processing failures resulting from a lack of the application of modern GMP controls are a major cause of food product recalls.
Since the last revision of food GMPs, we have continued to greatly expand our understanding of food-borne illness and have recognized the importance of several new bacterial, viral, and protozoan foodborne pathogens, such as Listeria monocytogenes, Norovirus, and Cryptosporidium. In many cases, these pathogens can be adequately controlled only by the implementation of appropriate GMPs in food processing.
Food allergens and certain other food ingredients are now recognized as a hazard for sensitive individuals. Cross-contamination of food products with a food allergen can also be prevented through the implementation of appropriate GMPs in food processing.
Rapid advances in food processing technology have also occurred since the GMPs were last revised. Modernization of the GMPs will be essential in creating opportunities for incorporation of newer technologies and better manufacturing techniques and process controls.
We believe this effort, like our work on current good manufacturing practices for medical products, will improve the safety of conventional foods and dietary supplements.
FDA (CFSAN) began the effort to examine the underlying health basis and enforceability of its preventive controls, including GMPs by establishing a Food GMP Modernization Working Group in July of 2002. This Working Group initiated research in two areas: the impact of current GMPs on food safety, and the impact of revised GMPs on food safety and the likely economic impact of such revisions.
I am pleased to announce that as a part of this continuing process to modernize the food GMPs, FDA will hold three public meetings this summer to obtain stakeholder input (especially from small businesses) on ways in which the food GMPs should be updated. These meetings will be held in different regions of the country, with one in College Park, MD, one in Chicago, IL and one in Monterey, CA. The three meetings were recently announced in the Federal Register and include a list of specific questions about food GMP modernization that FDA would like participants to address.
FDA intends to evaluate the data and information received from these public meetings to determine appropriate revisions to food GMP regulations. We will be accepting written comments through September 10, 2004, at which point we will proceed with rulemaking.
In concert with this review and modernization of food GMPs, FDA is also pushing hard on finalizing the first GMP and labeling guidelines for dietary supplement manufacturers.
Consumer interest in dietary supplements has increased exponentially in recent years. According to a recent Institute of Medicine report, American consumers are spending $18 billion annually on dietary supplements and there are about 29,000 such products on the market, with another 1,000 new products introduced each year.
Last spring, FDA proposed comprehensive new regulations that will set manufacturing and labeling standards for the first time for all dietary supplements marketed in the United States, focusing on their quality, consistency and potency .
When finalized, this rule will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled. It will also place dietary supplement labeling under closer scrutiny. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.
In short, the dietary supplement GMPs will eliminate the “buyer beware” situation Americans now commonly face when they purchase these types of health products.
In keeping with our risk management strategy, FDA will continue to coordinate future revisions of the food GMPs with dietary supplement GMPs to ensure we are doing all we can to protect and advance the public health.
BIOENGINEERED FOODS
Perhaps one of the great success stories for your industry in the past decade has been the development of bioengineered foods. Your success in bringing these food crops into production has gone hand in hand with FDA’s development of rational procedures to ensure the safety of these new food products. And your success with the first generation of bioengineered crops has been phenomenal.
Food crops developed by genetic engineering were first introduced for commercial production in the US in 1996 and by 2001 more than 109 million acres worldwide were planted with bioengineered crops and this acreage continues to grow.
The United States accounts for about two-thirds of all the bioengineered crops planted globally including corn, cotton, soybeans, canola, squash, and papaya. As of 2001, 68 percent of the soybean crop planted in the U.S. consisted of bioengineered varieties, along with 26 percent of the corn crop, almost 70 percent of the cotton crop and about 55 percent of the canola crop. In Hawaii, 53 percent of the papaya crop is bioengineered varieties.
Most of the bioengineered crop varieties planted today consist of herbicide or insect resistant varieties, but I know that your industry is hard at work on the development of new and better seeds that will provide advantages not just to the producer, but also to the consumer in terms of altered nutrient composition to enhance health, altered processing characteristics and even production of pharmaceuticals.
Let me just restate FDA’s policy upfront relative to these bioengineered food crops. FDA established its basic policy on bioengineered foods in 1992 when it issued its guidance “ Policy on Foods Derived from New Plant Varieties”. This policy has not changed, but has been clarified on several occasions.
New substances introduced into food via plant breeding (either traditional or bioengineered) are considered food additives if they are not GRAS or pesticides. In 1995, we provided additional guidance on a voluntary consultation process. According to this policy, we at the agency rely on you the seed developers and producers to voluntarily notify the agency before marketing a bioengineered crop seed or food.
Notification leads to a two-part consultative process that involves a discussion of relevant safety issues and a subsequent submission by the developer of a safety assessment report.
Subsequently, we provided additional draft guidance regarding the use of antibiotic resistance marker genes in bioengineered plants, suggesting that when these genes are used they should be assessed to determine whether the presence in food of the enzyme or protein encoded by the antibiotic resistance marker gene would compromise the therapeutic efficiency of orally administered antibiotics.
More recently we issued draft guidance for industry on voluntary labeling to indicate whether foods have or have not been developed using bioengineering. This document lays out four guiding principles on appropriate ways the industry could voluntarily provide information on a food label about bioengineering.
All foods, whether conventional or bioengineered, pose the same types of inherent risks to human health: the potential to contain toxins, allergens, and antinutrients. Safety assessments for bioengineered foods thus should focus on whether the genetic change alters the potential toxicity, allergenicity or level of antinutrients compared to the conventional food source. In addition, the agency suggests that you also evaluate the safety of intended changes to nutrient composition and perform compositional analysis for unintended changes.
To date, bioengineered foods have proven to be no different from their conventional counterparts and so, although FDA issued a proposed rule in 2001 concerning making the voluntary notification of intent to market mandatory, this rule has not been finalized and the voluntary notification procedures remain in effect. We encourage you to continue to voluntarily seek FDA consultation prior to commercial marketing of your new products.
I’m pleased to report that to date all developers of bioengineered foods have voluntarily consulted with FDA prior to marketing their products, and FDA maintains a listing of these completed consultations on our website.
I know that you as an industry are keenly aware of the numerous trade issues that have arisen relative to bioengineered food crops. The EU has been consistently hostile towards bioengineered agriculture and food products. US corn cannot be shipped to the EU because of their concerns that shipments may contain varieties of corn unapproved in the EU. The EU has also instituted mandatory traceability and labeling requirements. Some African countries have refused US food aid for the same reason. However, with recent statements by WHO and FAO relative to the potential importance of bioengineered food crops for alleviating hunger in developing countries perhaps we will start to see changes in this area.
We are currently nearing completion of a draft guidance concerning field trials of bioengineered food crops. The development of this guidance is a high priority for the Administration and the industry, to enhance public confidence, avoid product recalls, and provide an international model to address the adventitious presence of bioengineered plant material in non-bioengineered crop fields.
The goal of this guidance is to ensure that material from field trials is safe prior to any inadvertent entry into the food supply. In essence, this would be the protein safety component of a full voluntary consultation relative to the protein’s toxicity or allergenicity. It would not replace the full consult prior to marketing.
In addition, FDA in conjunction with USDA and EPA commissioned the National Academy of Sciences and the Institute of Medicine to develop a science-based framework to assess or predict unintended health effects of bioengineered foods to assist us in our evaluation of these products prior to commercialization. We anticipate that the National Academies will release this report at the end of July.
Pharmaceutical Crops
With continued and rapid advances in biotechnology come many new and interesting challenges for FDA. The production of food crops engineered to produce pharmaceutical and industrial compounds is one of these challenges. While FDA has sole responsibility for ensuring the safety and efficacy of the pharmaceutical products produced by plants for use in humans, we share the responsibility for ensuring the safety of these products developed for use in animals with USDA. Initially, FDA considered a rule to facilitate enforcement actions if material from pharmaceutical crops entered the food supply, but this was found not feasible.
Currently, FDA is considering an adventitious presence guidance document analogous to that for food-use crops, but USDA and WHO want a mandatory regulatory process so there will undoubtedly be future interagency meetings to discuss these issues. FDA and USDA jointly issued draft guidance on this topic in September of 2002
Bioengineered Plants for Better Nutrition
Two other important FDA initiatives I’d like to bring to your attention are ones in which ASTA members may ultimately play a major role. These are FDA’s initiative on qualified health claims and the Agency’s initiative to help reverse the obesity epidemic in this country. Advances in the nutritional sciences relative to the importance of various nutrients in maintaining and enhancing health, and the role of fats and carbohydrates in the current worldwide obesity epidemic may well highlight major opportunities for the bioengineering of food crops for improved nutrition and health.
Qualified Health Claims
FDA is acting on the recommendations of its Health Claims Task Force that builds on a number of other ongoing initiatives focused on improving food safety and nutrition…
Most notably, FDA has been hard at work defining a process and long-term regulatory alternatives to help consumers get more information about the health consequences of their food choices by providing interim guidance to industry on qualified health claims in labeling foods and dietary supplements. This is an area were development of bioengineered foods for better nutrition and health could play an important role.
This past year also witnessed a major change in the nutrition label on foods to include a separate listing of trans fatty acids. This was the first significant change on the Nutrition Facts panel since it was established in 1993.
We are also in the early stages of discussion on developing guidance relative to the definition of, and use on, the NFP of net carbohydrate content.
Obesity
In tandem with these recommendations from its health Claims Task force, FDA is also acting on recommendations from its Obesity Working Group (OWG). In March of this year, FDA released the final report of its OWG. This report highlights how FDA can contribute to the solution of this obesity problem in the context of its mission and regulatory authority.
This report is comprehensive, and offers a number of compelling recommendations on how to combat obesity. The report also maps closely to our Strategic Plan, in particular our goal of providing consumers with better information to help them lead healthier lives through better nutrition.
The cornerstone of the Obesity Working Group report is the idea that America must get back to basics and that “Calories Count.” In other words, there is no substitute for the simple formula that ‘calories in must equal calories out’ in order to control weight. The report builds on these nutrition fundamentals through a comprehensive, science-based and consumer-friendly set of initiatives.
Food Labels
The first critical set of recommendations involves enhancing the food label. The report recommends that FDA evaluate how the Nutrition Facts panel (NFP) can be revised to highlight the critical role calories play in consumers’ diets. The goal in modifying the food label is to arm consumers with more of the information they need to make sound food choices:
Calories – A notice of proposed rule making on possible revisions to the food label relative to calories. We want to increase the font size for caloric content to make it more visible and easier to read on the label. We also propose to have the % of the daily value for calories appear right next to the calorie content rather than in tiny print at the bottom of the NFP. That way a consumer can easily tell what proportion of their day’s allotment of calories they are consuming with a single food item
Serving Sizes – We are encouraging food manufacturers to consider revision of certain labels as single-servings if the food item can be reasonably consumed as one serving. For example, a 20 oz bottled soft drink would have the calorie content listed on the basis of the full 20 oz being a single serving rather than having the calorie content listed on the basis of an 8 oz serving and saying the bottle contains 2.5 servings. Flexibility in the current regulations would allow this change to be implemented immediately and we want to encourage manufacturers to take advantage of that.
Carbohydrates – FDA has received petitions from manufacturers and is in the process of publishing a proposed rule to provide for nutrient content claims related to the carbohydrate content of foods. The content of sugars and starches relative to fiber content of plant foods may be an area ripe for genetic modification
Comparative Labeling Statements – FDA is also encouraging the use of comparative labeling statements to make it easier for consumers to compare different types of foods and make healthy substitutions.
The second major recommendation of this report involves initiating an education campaign focused on the “Calories Count” message. Because the obesity epidemic is particularly alarming in children, we are focusing our education efforts to children and young adults.
The third set of recommendations from FDA’s Obesity Working Group is focused on encouraging restaurants to provide nutrition information. American consumers now spend approximately 46 percent of their total food budget on food consumed outside of the home, and these foods account for a significant portion of total calories consumed.
FDA is urging the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign for customers. FDA also encourages consumers to routinely request nutrition information when eating out. In addition, the final report calls for the development of options for providing voluntary, standardized, simple, and understandable nutritional information, including calorie information, at the point-of-sale in a restaurant setting. And it recommends that FDA involve restaurants in a pilot program to study these options in a well-controlled setting.
I’m pleased to say that we have already gotten responses from a number of ‘fast-food’ restaurant chains.
The fourth set of recommendations involves various enforcement activities to ensure the accuracy of the information in the NFP and ensure that consumers can monitor their intake of calories and nutrients.
FDA has issued a general letter to food manufacturers, encouraging them to review nutrition information and ensure that the serving size declared is appropriate for the commodity in question. The report also calls for stricter enforcement activities against those manufacturers that declare inaccurate serving sizes, and we intend to follow this guideline to make sure Americans have the best, safest information about the foods they are consuming.
The final set of recommendations involves increased collaboration on obesity research – on everything from the relationship between overweight/obesity and food consumption patterns to incentives for product reformulation. It calls for joint research with USDA’s Agricultural Research Service on a USDA-sponsored obesity prevention conference to be held in October 2004. And we also want to convene a nationwide dialogue with interested stakeholders over the course of the year.
CONCLUSION
I thank you for your attention, and the opportunity to share with you some of FDA’s many activities relative to enhancing food security, food safety and nutrition in furthering its mission of protecting and promoting the public health.