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51st International Congress on
Meat Science and Technology
Lester M. Crawford, D.V.M., Ph.D.
Commissioner of Food and Drugs
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.
Good morning and thank you Jeff (Prof. Jeff Wood, Head, Division of Farm Animal Sciences, University of Bristol, England) for your kind introduction. I also want to thank my good friend, R.B. Sleeth (Chair of the Conference) for inviting me to speak to you today and for graciously altering the schedule to enable me to be here this morning and still meet subsequent commitments.
Let me also add my welcome to the many international industry and government scientists attending this congress. As the U.S. Agency responsible for regulating all medical products and 80% of the U.S. food supply in a global market, FDA’s formal partnerships in the areas of manufacture, product inspections and regulatory coordination with many of the countries represented here today are not only absolutely crucial to our mission of protecting the U.S. food and drug supply, but also help all of our countries to enhance global food safety and security.
This is my first opportunity to speak to stakeholders in the food science and technology community since being confirmed as FDA Commissioner a few weeks ago, so I am especially pleased and honored to open the first scientific session of this International Congress. Some of you may know that in previous lives I served as Administrator of FSIS, and Executive Vice President for the Food Products Association so I have had the opportunity to work closely with the meat industry not only from my current perspective of protecting the public health but also in the production and processing sides of the industry.
I’d like to use my time with you this morning to give you a few highlights of FDA’s accomplishments over the last year, a brief outline of the agency’s 2005 priorities and our progress on those, and then focus on FDA activities that (1) highlight the role meat and meat products can play in a healthy diet, and (2) protect human health by ensuring the health and safety of the food animals that supply these products.
Over the last year, the FDA once again played a vital role in protecting and advancing public health in the United States. By creating new initiatives and improving existing performances, FDA was able to accomplish many goals that enhanced the lives of Americans. We strengthened the security of the nation’s food supply against potential bioterrorism attacks; we enhanced food safety through major initiatives and actions; and streamlined our paperwork processes to reduce errors, reform outdated practices, and enhance new product innovation.
We also introduced new initiatives to combat critical health threats such as obesity, counterfeit drugs and medical errors; and we approved a substantially greater number of medical products, including an unprecedented number of generic drugs. We are extremely proud of these accomplishments and we will continue to improve on these initiatives. However, emerging health threats, changes in technology and variant global market forces, continually challenge our successes.
FDA’s responsibilities are growing in scope and complexity, and we are responding by focusing on new and better ways to perform our core mission. FDA established four top priorities for 2005 and we have made substantial progress in each of these four priority areas of: (1) Improving Product Safety and Security; (2) Enhancing Patient and Consumer Protection; (3) Encouraging Technology Development and Innovation; and, (4) Improving Manufacturing Practices.
In addressing these priorities relative to food products, we have announced our strategies to fully implement the Dietary Supplement Health and Education Act (DSHEA) to protect consumers form unsafe dietary supplements. FDA has also made significant progress in implementing the recommendations of the report from our own Obesity Working Group that was released in March of 2004.
We have issued two Advanced Notices of Proposed Rule-making (ANPRMs) on changes to food labels to help consumers select healthier diets, and we contracted with the Keystone Center to develop a dialogue with our stakeholders on ways to enhance availability of nutrition information on foods eaten away from home.
Thanks to the work of many of you in this room, who have developed improved breeding and feeding practices for food animals as well as improved methods of meat processing and trimming fat, the American consumer now has a variety of healthful lean meat products available.
The Dietary Guidelines for Americans that were jointly developed by the Departments of Health and Human Services (DHHS) and Agriculture (USDA) and released in January of this year recommend that consumers choose lean cuts of meat as part of a healthful diet. Both the USDA Food Guide and the DASH (Dietary Approaches to Stop Hypertension) Eating Plan are healthful eating patterns that include lean meats. These eating plans are illustrated in the Dietary Guidelines, which describes a healthy diet as one that emphasizes a variety of fruits, vegetables, whole grains, and fat-free or low-fat milk and milk products; includes lean meats, poultry, fish, beans, eggs and nuts; is low in saturated fats, trans fats, cholesterol, salt, and added sugars, and stays within daily calorie needs
The Dietary Guidelines also include key recommendations for specific population groups. Substantial numbers of adolescent girls and women of child-bearing age are iron deficient, based on blood values. These groups especially, should eat foods high in heme-iron, such as meat, because a greater proportion of heme-iron is absorbed and the presence of heme-iron in the diet can also enhance the absorption of non-heme iron. And as you know, lean meat also contributes high quality protein, zinc and vitamin B 12 to a healthful diet.
In addition to our efforts to help consumers choose more healthful diets, FDA has also been working to make those foods more safe and secure. Securing the U.S. food supply is one of FDA’s highest priorities, one that we share with our colleagues at the USDA and the Centers for Disease Control (CDC), and one that we can not accomplish without the close co-operation and collaboration of the food industry.
We expect more than 14 million lines of FDA-regulated goods will be offered for entry into the U.S. in 2005, and these numbers will continue to increase due to increasing global commerce. To address the potential risks posed by the millions of lines of FDA-regulated goods that are offered for entry into the U.S. each year, we have taken steps to implement a risk-based import system rather than simply relying on the physical and visual inspection of products at the border.
This revised process for handling imports incorporates refinements of some existing operations and also proposes a more comprehensive risk-based system that leverages better information and regulatory partnerships at the local, state, national, and international level. We believe this approach can: increase our ability to conduct more effective foreign inspections; streamline our information technology capabilities; enhance our ability to use statistically valid sampling and analytical technologies integrate international and domestic inspection operations; and encourage international harmonization efforts that will enable FDA and other governments to share current inspectional information on firms engaged in the exportation of FDA-regulated goods to the United States.
The Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) required FDA and U.S. Customs and Border Protection (CBP) to jointly develop regulations pertaining to:
Registration of food and animal feed facilities
Prior notification of imported food shipments
Administrative detention of suspect shipments, and
Procedures for establishment and maintenance of records
These four new food regulations were implemented in 2003 and 2004. As a result, FDA now has comprehensive new information on food production and distribution for the first time, including: a complete inventory of all food and feed facilities both foreign and domestic; comprehensive information on all imported foods; and information on precisely who is handling food throughout the food distribution system and the entire chain of custody on either side of the border.
Before I leave this topic of Food Security I want to remind those of you representing the food industry that FDA has also published five guidance documents related to food security that identify preventive measures that companies can take to minimize the risk that food or cosmetics under their control will be subject to tampering, criminal or terrorist actions. Those five guidance documents focus on all segments of the food industry: Food Producers, Processors, Transporters and Retailers; Food Importers and Filers; and Retail Food Stores and Food Service Facilities as well as Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors. There is also guidance available for Cosmetic Processors and Transporters. In addition, FDA and USDA have jointly developed an on-line training course for food defense and security awareness
I’m sure you are all well aware that food security is inextricably linked with food safety, especially regarding food-borne pathogens. In the United States we still have 76 million cases of food-borne illness each year. These result in approximately 325,000 hospitalizations and as many as 5,000 deaths each year.
FDA has continued to advance its traditional food safety mandate in conjunction with our newer food defense responsibilities. FDA has launched several new initiatives to protect consumers from food-borne illness including our:
Listeria Action Plan
Proposed Rule on Salmonella Enteriditis in shell eggs
Final Risk Assessment for Vibrio infections in Raw Oysters
Consumer Advisory on Methyl Mercury in Fish
In September of 2003, FDA and USDA issued a document entitled “Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods”. This risk assessment estimates the largest contributors to foodborne listeriosis on a per serving basis are deli meats, frankfurters (not reheated), pate and meat spreads, unpasteurized fluid milk, smoked seafood, and cooked ready-to-eat crustaceans. The risk assessment also estimates the some of the largest contributors to foodborne listeriosis on an annual basis are deli meats, frankfurters (not reheated), and high fat and other dairy products. FDA will be issuing guidance on measures that industry can take to control Listeria monocytogenes in FDA-regulated products.
The risk assessment also predicted one of the most effective ways to combat growth of Listeria in refrigerated foods and protect the public health is to hold these foods at 41 o F or lower. In May of this year FDA, through the Partnership for Food Safety Education, launched the BAC DOWN campaign to advise consumers to keep their refrigerators at 40 o F to prevent foodborne illness, including listeriosis. This campaign also encourages consumers to keep thermometers in their refrigerators so that they can verify that they are maintaining a safe temperature. As a part of this campaign we are also communicating with refrigerator manufacturers about the need for actual thermometers in new models rather than lettered or numbered controls.
In October of 2004 FDA released its proposed rule on the prevention of Salmonella Enteriditis in shell eggs during production. We believe that when this rule is implemented in egg production facilities, it would reduce the number of SE-related illnesses by over 33,000, which would be a major step towards our public health goal of a 50% reduction in all salmonellosis and a 50 % reduction in SE outbreaks by 2010.
This proposed new rule is based on a farm-to-table risk assessment of SE in eggs that identified implementation of on-farm prevention measures as a very important step that could reduce the occurrence of SE infections from eggs. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is currently reviewing all the comments on the proposed rule and we will be finalizing that rule in the near future.
Just a few weeks ago, after completing an exhaustive risk assessment, FDA released its final recommendations to the seafood industry regarding food-borne illness linked to raw oysters. The risk assessment evaluated several harvest and handling practices and concluded that the level of risk of Vibrio parahaemolyticus, as well as risk of Vibrio vulnificans infections can be reduced substantially by practices such as reducing the time from harvest to refrigeration, and application of practices such as freezing, ultra-high pressure, or mild heating. For example, 85-90% of Vibrio illnesses in the gulf coast states could be eliminated if the product were iced within four hours or refrigerated within one hour of harvest.
The one other food safety initiative I want to highlight regards the Consumer Alert issued jointly last summer by FDA and the Environmental Protection Agency (EPA) on risks to pregnant and nursing women and young children of methyl mercury contamination found in fish. One of the main purposes of the advisory was to provide specific dietary guidance on amounts and various types of fish that could be safely consumed by these at-risk populations so as not to eliminate the healthful nutritional contribution of fish in the diet while maintaining a low exposure to methyl mercury.
I’m going to switch gears a little bit now and talk to you about an issue that I am sure is of keen interest to many of you in this room, and that is FDA’s regulatory activities related to protecting the American public from the risk of transmissible spongiform encephalopathies (TSEs) of animal origin.
Three TSEs have now been confirmed as existing in the United States. Of course, we have known about our scrapie infected sheep for many years, as well as the endemic areas where Chronic Wasting Disease (CWD) was frequently found in wild deer and elk. But CWD has now spread to other areas of the country, particularly the upper Midwest, and into farmed deer and elk herds, and is now an issue that our Center for Veterinary Medicine (CVM) is following closely. We now have a confirmed case of BSE in a cow that was born in Texas and spent its entire life in the United States. As you know, the first BSE-infected cow found in this country was from Canada and had been infected there.
Just last week we thought we might have found a second native cow, but USDA has announced that confirmatory testing of brain tissue from this cow by the lab in Weybridge, England has turned out to be negative. Both FDA and USDA currently have measures in place to protect the U.S. population from consuming or contacting potential infected material, though both agencies will continue to review the precautions and incorporate any new information that becomes available as the Texas case of BSE is investigated.
All the Product Centers within FDA (drugs, biologics, devices, foods, veterinary medicine) currently have rules in effect for BSE or TSEs because many FDA-regulated products contain bovine ingredients. Products ranging from animal feeds to soups, gravies and sausage casings; from cosmetics and dietary supplements to dental products, wound dressings, heart valves, ophthalmic devices, injectable drugs and vaccines.
FDA’s Center for Veterinary Medicine has the responsibility for implementation and enforcement of the BSE feed rule adopted in 1997, which is our first line of defense to prevent the establishment and amplification of BSE should it be found in the U.S.
The rule prohibits the use of proteins derived from mammalian sources in feed for cattle and other ruminants. All mammalian proteins are prohibited unless they are specifically exempted in the rule. Currently, proteins specifically exempted are: blood and blood products; milk products; pure porcine or equine proteins; and “Plate Waste” – inspected meat products that have been cooked and offered for human food and further heat processed for animal feed. Non-mammalian protein such as protein originating from poultry, marine, or vegetable sources are not subject to the feed rule.
Our enforcement program is based on inspection of records about ingredient sources and feed disposition, and inspection of the processes firms use when handling feed and ingredients to prevent cross-contamination. We inspect 100% of known renderers, protein blenders, and feed mills that process products containing prohibited materials.
In June of this year, CVM issued an update on their feed rule enforcement activities. Out of a total of over 15,600 firms inspected, approximately 4,000 handled prohibited materials, and of those 4000 + firms, only 10 firms, or 0.2% were classified as requiring official action due to lack of compliance in record keeping or processing and contamination-prevention procedures.
In July of 2004, FDA announced that it would propose a ban on the use of specified risk materials, or SRM, in all animal feeds. This rule is currently under development and could include for instance, brain and spinal cord of cattle 30 months and older. Earlier last year we had announced other potential changes being considered, including the prohibition of mammalian blood and blood products in ruminant feed, the prohibition of poultry litter, and the prohibition of “plate waste”. But, we are now focusing our efforts on specified risk materials. The SRM ban is designed to address continuing questions about the potential for infectious material getting into cattle feed.
FDA issued a CWD final Guidance in September of 2003. This guidance would prohibit the use of material from CWD-positive deer or elk in ANY animal feed. Feed containing CWD-positive deer or elk would be considered adulterated and would be recalled or otherwise removed from the marketplace. FDA continues to recommend against using animals from areas declared high-risk, which would include animals in an area declared endemic or a CWD eradication zone, or animals that were in a captive herd during the previous five years that contained a CWD-positive animal. Deer and elk from areas not considered high-risk or from herds without positive animals can be used for non-ruminant feeds but are prohibited from ruminant feeds under the BSE Feed Rule.
FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issued an interim final rule in July of 2004 that became effective immediately, prohibiting the use of specified risk materials (SRMs) in human foods, food ingredients, dietary supplements, infant formulas, food-contact substances, and cosmetics and cosmetic ingredients. At the same time, CFSAN proposed a rule requiring food and cosmetic firms covered by the Interim Final Rule to keep records that would demonstrate that the foods and cosmetics were in compliance with the rule.
SRMs for human foods and cosmetics include: (1) Material from non-ambulatory, disabled cattle; (2) Material derived from mechanically separated beef; (3) Material from cattle not inspected and passed for human consumption; (4) Brain, skull, eyes, trigeminal ganglia, spinal chord, vertebral column, and dorsal root ganglia from cattle 30 months of age or older; and, (5) the tonsils and the distal ileum of the small intestine from ALL cattle regardless of age.
These prohibitions are consistent with an interim final rule issued by USDA declaring these materials to be inedible and prohibiting their use as human food. FDA, USDA and other federal agencies apply consistent policies designed to give the consumer several layers of protection against TSEs. These policies have done a good job, but we are always interested in ways to further increase protections.
Development of tools that would permit us to better detect the infectious agents and to clean processing equipment of TSE contamination would provide even better protection. TSE prevention remains a top FDA goal and we welcome further scientific attention to finding even better solutions.
The last important area of FDA policy activity that I wanted to bring to your attention this morning is that of antibiotic resistance, and the possible role that the use of antibiotics in food animals plays in development of antibiotic–resistant human pathogens.
I’m sure many of you here today are well aware that this is an issue that has bounced in an out of the public eye for the last 20 years. As science increasingly found evidence of human health hazards from the use of antimicrobials in food animals, FDA realized it must address the issue. Our CVM decided from the beginning that this effort would be done in the open so that we could get input from all stakeholders.
We began the process in 1998 with the Guidance for Industry which announced that FDA would consider the potential human health effects from the development of resistance in food animals. This Guidance was followed by our Framework Document – first released in 1999 and finalized in 2003 following public meetings and review of hundreds of public comments – that outlined our policy concepts
These policy concepts, arrived at with industry help, were placed in guidance for industry titled “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern” which was issued in 2003 and finalized in 2004.
The general concept of this guidance is to develop a qualitative antimicrobial resistance risk assessment to allow informed risk management decisions by: (1) Describing the factors related to the antimicrobial drug and its use in animals that contribute to emergence of resistant bacteria or resistance determinants in the animal; (2) Describing the likelihood of human exposure to resistant bacteria or resistance determinants through animal-derived foods; (3) Describing the human health consequences of exposure to resistant bacteria based on the importance of the drug (or related drugs) in humans; and integrating the results to produce overall measure of risk
The Guidance also ranked antimicrobial drugs according to their importance in human medicine, rankings assigned were “High, Medium, or Low” – and were developed with the assistance of FDA’s Center for Human Drugs (CDER). Risk estimations of High, Medium, or Low are then associated with risk management categories:
Category 1 (high risk estimate) – strictly limited animal drug use
conditions
Category 2 (medium risk estimate) – intermediate restrictions
on drug use in animals
Category 3 (low risk estimate) – least restriction
on animal drug use.
Risk management strategies can include: limits on marketing – by prescription or Veterinary Feed Directive (equivalent of prescription feed) only; prohibition of extra-label use (use not specified on drug label); and limits on duration or method of administration
I am pleased to report that because of the extensive stakeholder input into its development, this policy works – we have received a number of antimicrobial new animal drug applications and all have survived review under this guidance.
On July 28, 2005, just a week and a half ago, FDA announced its final decision to withdraw the use of the antimicrobial drug enrofloxacin for treatment of bacterial infections in poultry. This ruling does not affect other approved uses of the drug. This animal drug belongs to the class of drugs known as fluoroquinolones.
FDA began proceedings to withdraw use of this drug in poultry because of mounting scientific evidence that use of enrofloxacin in poultry causes resistance to emerge in Campylobacter bacteria. Campylobacter is a significant cause of foodborne illness in the U.S. and antimicrobial treatment is recommended for people with severe illness as well as the very young, the elderly, and people with certain medical conditions. Early treatment can mitigate symptoms and may decrease the risk of complications. Fluoroquiniolones used in humans are ineffective if used to treat Campylobacter infections that are resistant.
Through the National Antimicrobial Resistance Monitoring System (NARMS) it became clear that the proportion of campylobacter infections that are resistant to fluoroquinolones has increased significantly since the use of enrofloxacin in poultry was approved in the U.S. Thus FDA issued this Final Rule to terminate use of this drug in poultry to take effect September 12, 2005.
For those of you who may not be familiar with NARMS, let me describe it briefly. NARMS is a collaboration of three federal Agencies, USDA, FDA, and CDC. The Animal Arm (collection of clinical and slaughter-healthy animal isolates) is managed by USDA/ARS; The Human Arm (collection of isolates submitted by 54 participating public health departments) is managed by CDC; and the newest Arm, Retail Meat Surveillance, which began in January 2002, is managed by FDA’s CVM.
CVM released its first annual Retail Meat Survey report in September of 2004. The survey collected samples of chicken breasts, ground turkey, ground beef, and pork chops from sites across the U.S.
Results indicated that retail meats, especially chicken breast are contaminated with Campylobacter, including resistant variants. Retail meats, especially ground turkey were contaminated with Salmonella. Results of the survey and the full report can be found on CVM’s website.
In closing, let me emphasize that FDA needs the input of the meat science and technology community in helping us further our efforts to protect the public health. Further scientific study is needed in areas such as technologies for decontamination of food processing equipment that may come in contact with TSE infected animals, as well the origins and causes of prion diseases. Further studies are needed to determine the relationship between antimicrobial use in food animal production and the development of resistant strains of human pathogens. More study is also needed to determine what mitigation strategies can reduce the presence of foodborne pathogens of food animal origin.
I hope the information I have given you this morning on FDA’s activities and priorities will stimulate further discussion throughout your meeting this week, and wish you a very successful conference.
Thank you, I will be happy to take your questions.
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