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STATEMENT BY
MICHAEL FRIEDMAN, M.D.
DEPUTY COMMISSIONER FOR OPERATIONS
FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE THE
SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS
COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT
U.S. HOUSE OF REPRESENTATIVES
MAY 10, 1996
FOR RELEASE ONLY UPON DELIVERY
Thank you for the opportunity to participate in today's hearing on "Protecting the U.S. Consumer from Food Borne Illnesses." My name is Dr. Michael Friedman. I am the Deputy Commissioner for Operations at the Food and Drug Administration (FDA). With me today are Dr. Stephen Sundlof, Director, Center for Veterinary Medicine and Dr. Fred Shank, Director, Center for Food Safety and Applied Nutrition.
As you are aware, the United States food supply is one of the safest, most abundant, and most affordable in the world. This has been accomplished through a program that relies on science, cooperative efforts with government agencies at all levels, increased cooperation with our international counterparts, as well as interaction with academia, industry, and consumers. FDA is committed to ensuring safety, and working to protect the American consumer from unsafe, adulterated, or misbranded food. The agency strives to improve its existing monitoring programs, research, product approval processes, and enforcement efforts. To these ends, we welcome your ongoing interest in this subject.
My discussion of food safety will center on foodborne pathogens in food derived from animals, which you have indicated is the focus of this hearing. I plan to describe what FDA is doing to protect the food supply from these pathogens; the roles of FDA's Center for Veterinary Medicine (CVM) and Center for Food Safety and Applied Nutrition (CFSAN) in developing policies to control foodborne pathogens; and how we work collaboratively with our federal and state counterparts to protect the public health by safeguarding the food supply.
Virtually all food available to the U.S. public is wholesome and unlikely to cause illness to the consumer. However, as with most things, health risks do exist. Foodborne illness originates from a variety of sources. Pathogenic organisms, such as viruses, bacteria, and parasites, represent the most widely recognized causative agents and are the focus of my remarks as you have requested in your letter of invitation. Other foodborne risks such as naturally occurring toxicants, animal drug residues, pesticides, and environmental contaminants also have the potential, individually or in combination, to be the cause of illness. Moreover, food production practices, processing, storage, distribution, handling and home preparation techniques either individually or in combination have the potential to increase the risk of microbiological or chemical caused illness. However, risks caused by chemical contaminants and food production practices are not the focus of my remarks for today's hearing.
Foodborne illness is not a new form of disease, nor is it one-dimensional. Foodborne illnesses have been with us as long as man has walked the earth. In the United States, foodborne microbial illness is a major cause of personal distress, preventable death, and avoidable financial loss. Several studies conducted over the past 10 years have indicated that an estimated 6.5 million to 81 million people become ill from pathogens in food every year, resulting in an estimated 9,000 deaths.
It is worth noting that the majority of the illnesses that occur are mild and of short duration and frequently are not even diagnosed. However, a small fraction can produce immediate, acute effects, sometimes involving many people in a single episode, with reactions ranging from gastrointestinal upset to death. There is also the potential for chronic, or long term risks, but these are not as clearly quantifiable.
Examples of some foodborne pathogens originating in animals include Salmonella spp., i.e., Salmonella enteritidis, Campylobacter jejuni, and Escherichia coli O157:H7.
Salmonella spp. are bacteria that cause gastrointestinal disease (nausea, vomiting, abdominal pain, diarrhea, fever, and headache), that is sometimes fatal. The illness has been associated with consumption of many different foods, including raw meats, poultry, eggs, milk and dairy products, fish, shrimp, frog legs, yeast, coconut, sauces and salad dressings, cake mixes, cream-filled desserts and topping, dried gelatin, peanut butter, cocoa, chocolate, and melons. The infectious dose may be very small. Infections with Salmonella may be followed by chronic arthritis symptoms three to four weeks after onset of acute symptoms. Salmonella enteritidis bacteria cause gastrointestinal disease (abdominal pain, nausea, diarrhea, vomiting, and fever) which has often been associated with consumption of undercooked or raw eggs. As with other Salmonella spp., the infectious dose may be very small, and infection may be followed by enteric fever, septicemia, or chronic arthritis symptoms.
Campylobacter jejuni bacteria cause campylobacteriosis, a gastroenteritis (watery diarrhea, malaise, fever, abdominal pain) associated with consumption of foods of animal origin, especially poultry and raw milk. A chronic symptom which may follow infection includes Guillain-Barr‚ syndrome.
Escherichia coli O157:H7 is a verotoxin-forming bacterium that causes hemorrhagic colitis and may, in the very young and the elderly, cause the sometimes fatal hemolytic uremic syndrome. Hemolytic uremic syndrome is characterized by renal failure. The infectious dose may be very low. Undercooked or raw ground beef, salami, mayonnaise-based salad dressings, raw milk, yogurt, and apple cider have been implicated in outbreaks and sporadic cases.
As you can see from the list above, the most likely animal-derived foods which present risks of food-borne disease are meat, poultry, milk, seafood and eggs. Food derived from animals can be exposed to these pathogens on the farm, at slaughter, or through mishandling anywhere from the farm to the table.
FDA is responsible for regulating the safety of a great many foods, including eggs, seafood, and dairy products. The U.S. Department of Agriculture (USDA) has the primary authority for regulating meat and poultry. FDA also is responsible for the safety of animal feeds. A significant part of FDA's responsibility is to keep both human foods and animal feeds free of microorganisms such as fungi or bacteria, and their toxins (mycotoxins and bacterial toxins), illegal residues of drugs, pesticides, and environmental contaminants that are harmful to public health. Our agency carries out these responsibilities in cooperation or partnership with other federal or state organizations by: working with the animal health industry to ensure that safe and effective drugs are available to treat animal diseases, particularly those that may impact human health; conducting and facilitating research in the area of food safety; inspecting firms; sampling and analyzing products to determine if the producers of these goods have complied with the provisions of the FDC Act; taking appropriate enforcement actions when the agency finds that firms are not complying with the law; and providing guidance, training, and technical assistance. But, the law places the burden of ensuring that animal drugs are used safely and appropriately and that contaminants are controlled as much as possible in the production of food through observance of good manufacturing practice (GMP), on food manufacturers, producers, and distributors.
FDA's food safety programs have evolved over many years to become both broad reaching and highly specialized. This evolution occurred due to a number of factors that, together, make the regulation of food an unusually complex undertaking.
Our program has three fundamental safety objectives: (1) targeting our efforts toward controlling known "acute" type pathogens (e.g., salmonella), through the use of safe and effective animal drugs and feed additives to treat infected animals, and other prevention programs; (2) monitoring the food supply in coordination with other agencies in order to prevent the consumption of unsafe food and to gather information on the known or emerging pathogens (i.e. transmissible spongiform encephalopathies); and (3) learning more about potential long term problems and taking steps to lower long term risk.
I would now like to describe some things that we are doing to meet these objectives with regard to foodborne pathogens.
Prevention of human illness from foodborne pathogens may begin with control of the pathogen in its animal host. CVM is responsible for evaluating and approving drugs to prevent, control, and treat diseases in animals. This includes food-producing animals, as well as companion pets and exotic animals. FDA requires drug sponsors to show that each new animal drug, including those intended for use in animal feeds, is safe and effective for its intended use before it can be approved for marketing. When a drug is used in food producing animals, CVM's charge is to assure that any food derived from the animals (meat, eggs, seafood, or dairy products) is free from potentially harmful drug residues. Evidence substantiating safety and effectiveness in the target animals, and safety of any food derived from treated animals must be submitted by the drug sponsor to CVM for evaluation by its scientific review experts.
Once a drug is approved, CVM monitors the drug's continued safety and effectiveness through post-marketing surveillance programs. An estimated 80 percent of U.S. livestock and poultry are treated with an animal drug during their lifetime. The availability of safe and effective drugs for use in food-producing animals has benefited the consuming public by increasing production at reduced cost, and improving the quality of these food items, while ensuring the safety of these foods.
The challenges faced by CVM in the area of food safety have become more complex over the last several years as the technology of food production has advanced. Animals are now grown in high density production facilities which have increased the efficiency of food production, but which also have put additional stress on the animals and made the control of diseases critical. Furthermore, recent changes in drug manufacturing production technology have created new and more sophisticated types of animal drugs for CVM to evaluate. Each of these advances presents a unique situation that must be evaluated before the drug can be approved. And, because of the newness of the technology associated with some of these drugs, the CVM has also had to respond to concerns about the public's perceived threat from the use of these new technologies. Such was the case in recombinant Bovine Somatotropin.
Aside from new safety issues in food production, technological advancements in recent years have also had a significant effect on the number of requests by drug sponsors to CVM for review. During the last six fiscal years, CVM has experienced a 29% increase in the number of submissions for review (from 5880 in 1990 to over 7595 in 1995). At the same time, the CVM's resources have decreased in terms of budget and manpower. In the face of increasing workloads and decreasing resources we have searched for innovative ways to lessen the impact of these trends.
Recently, CVM has undertaken a major initiative to reengineer the review and approval process for new animal drug applications (NADAs). This initiative has already proven to be a more speedy and effective process, which will serve to make more animal drugs available to treat animal disease.
The traditional animal drug approval process was very segmented. The drug sponsor decided what information would prove that a drug was safe and effective, and then the information was collected, compiled and submitted to the CVM for review. The CVM evaluated all the data and informed the sponsor of its assessment. If there were any deficiencies, the firm would collect more data, compile and submit it, and wait for CVM's decision. This process resulted in numerous iterations before the drug was finally approved. It was also very resource and time intensive.
Our new approach focuses on encouraging sponsors to involve CVM in their drug development process as early as possible, and encourages an interactive approach throughout the planning, research, and review of the drug. In this way, CVM and the drug sponsor can agree on requirements for the approval of a drug used for the specific indication, and identify any data needed. This approach helps the sponsor reach an understanding with CVM before development is started so that any project undertaken has an increased probability of resulting in the approval of the product. It also allows for modifications to the drug development plan to address any unexpected results as information becomes available.
The response from the participating sponsors has been very positive. They believe this new approach has proven itself to be beneficial in increasing the efficiency of the drug approval process. It also benefits them by assisting in management and coordination of their limited resources during drug development.
Some specific initiatives that are part of this reengineered drug approval process are:
Pre-Submission Conferences - CVM is encouraging sponsors of new animal drugs to participate in pre-submission conferences where the sponsor's objectives and CVM's requirements are discussed in detail. The result of these conferences is agreement on the information necessary to support approval for the desired use of the drug. These conferences help the sponsors to focus their efforts toward conducting studies which are pivotal in determining whether the drug is safe and effective, and help to decrease complaints about unexpected new requirements.
Review of Study Protocols - Although not required by regulation or statute, CVM is strongly encouraging sponsors to submit protocols for any pivotal studies for CVM's input and concurrence. Using this procedure to assure that the design of a study will result in adequate information to evaluate the drug, any subsequent shift in review personnel is seamless to the process. Although resource intensive to FDA, CVM believes this initiative will ultimately save time and make the drug approval process much more efficient, and has committed itself to a 50 day review time for protocols. The review of protocols enable reviewers to evaluate studies in a more timely manner, and the sponsors to embark on a development plan with more comfortable understanding and agreement with FDA on the requirements.
Phased Review of Data Submissions - Instead of waiting until all the supporting information is collected and compiled, the sponsors are now encouraged to submit critical studies during their drug development in the form of an Investigational New Animal Drug Application (INADA). CVM will then review the results of these studies so that any new concerns can be addressed prior to submitting a full NADA. It is advantageous to both the drug sponsor and CVM in identifying unexpected problems in the research, and facilitating any necessary modifications to the drug development. For example, early review of a dose determination study will ensure that clinical trials for efficacy and target animal safety are conducted with the effective formulation and dose of the drug.
Direct Review of Submissions - Another innovation to increase the efficiency of the review process is the distribution of administrative processing responsibilities to those areas responsible for the scientific evaluation of the data submitted for review. Previously, CVM endorsed the concept of a project manager for each drug product. This added a point of quality control with one CVM employee responsible for the drug product and its current status, but it was extremely resource intensive. This direct review process, linked with the phased review policy, has encouraged a more interactive and efficient review process. This distribution is only possible because the Center has a tracking system that can be used as a "Virtual Project Manager" that monitors the current status of the drug development. Although the tracking system and this policy is relatively new, both the sponsors and the scientific review staff believe this level of interaction has benefited the drug approval process tremendously.
Sponsor-Monitored Methods Trials - We have shifted the primary responsibility for validation of regulatory methods to the sponsor. Instead of relying on government laboratories (with other competing priorities) to schedule and complete a method trial, the sponsor may now contract with non-government laboratories to conduct method trials. This ensures prompt conduct of the necessary trials, and although both USDA and FDA laboratories may still participate in the method trial, this change assures that there is an adequate number of laboratories available for timely completion of this phase of drug approval.
CVM has implemented several other initiatives to improve drug availability, reduce regulations, increase food safety, and support the reengineered drug approval process. These initiatives include:
Expedited Review Status for New Animal Drugs - New and innovative products, such as a new chemical entity not yet approved for use in animals, or a drug targeted for a disease condition that has no approved therapy are important advances that may significantly impact on food safety. If a drug qualifies for CVM's expedited review program, target times for review of data are reduced from the statutory 180 days to 90 days. Since 1982, the center has granted expedited review status to 32 documents (3 NADAs, 1 Public Master File, and 28 INADAs for expedited data review).
Updated Guidance Documents - CVM has also focused on updating several guidance documents. These serve as aids to industry for various portions of drug development. Over the last several years, documents have been finalized to provide guidance for development of study protocols, clarification of responsibilities of clinical investigators, evaluation of food additives for fish, and submission of manufacturing chemistry master files. Several other documents are in various stages of preparation or revision, including efficacy and/or animal safety requirements for carcass quality, anticoccidial, anthelmentic and mastitis drugs.
Data Integrity - Improvements in the regulated industry's data collection and quality assurance is increasing the efficiency of the data review process within the CVM. This has been accomplished through use of guidance documents, workshops, and other educational initiatives. With the drug sponsors assuming more responsibility for the type and quality of data submitted for review, we can focus our resources on the evaluation of the studies with regard to the effect of the drug.
Treatment INADs for Minor Species - Approval of drugs for minor animal species (i.e., many pets, aquaculture species, exotic animals) provide limited incentive for traditional pharmaceutical sponsor drug development, and these voids in availability of therapy can impact on food safety. CVM has developed a system of "treatment INAD's" and "public master files" that allow clinical data to be gathered by those that need the drugs. The collected data are placed in public master files for future reference by pharmaceutical sponsors in support of NADAs. Public funds from USDA's National Research Supported Project No. 7 (NRSP-7) are also directed to this effort. NRSP-7 is a federally funded program established to assist animal producers and veterinarians obtain FDA approval of drugs for minor uses.
Environmental Requirement Changes - Based upon ten years of reviewing environmental assessments for animal drugs, CVM has found that many of the applications and requests that currently require assessments have no significant impact on the environment. Therefore, the agency is proposing to exclude these uses from preparing an environmental assessment. In most cases, elimination of these environmental assessments will result in no additional risk to the environment and will provide a substantial savings to the regulated industry and CVM. However, we will be coordinating this policy with EPA in case there are situations that do not have the potential for environmental impact. This focuses the agency's environmental review resources on those areas that have potential for significant environmental impacts.
STARS - CVM implemented a new Submission Tracking and Reporting System (STARS) in November 1992. This database plays a critical function in monitoring the status of CVM's pending applications and files. It assists in coordinating scientific reviews and CVM's responses to the industry's requests. With this new system, prioritized time frames are assigned to submissions based on the type of request and the amount and complexity of the data the firm submits. STARS has helped CVM focus to assure a complete and coordinated response to sponsors' applications. This database has also enabled the implementation of phased review and direct review of drugs, by providing a tool to help manage the complex process associated with drug approval.
CVM has initiated several programs and research projects that are designed to help prevent harmful pathogens from being transmitted to humans through the food supply and/or the environment. These include CVM's:
Bacterial Susceptibility Monitoring Program - CVM has initiated a collaborative bacterial susceptibility monitoring program with other FDA Centers, USDA, and the Center for Disease Control and Prevention (CDC), in response to the recommendations of an FDA Advisory Committee on fluoroquinolone antibiotics and a 1995 American Society of Microbiology Task Force on Antibiotic Resistance. This program grew out of concerns by FDA and other scientific experts about how to best maintain antibiotic effectiveness, ensure safety, and increase the availability of new products to veterinary practitioners and the food animal industry. Because the development of bacterial resistance to existing drugs or to future approved products would negatively impact both efficacy and safety, FDA has made the susceptibility monitoring a priority program.
The national surveillance program will monitor changes in bacterial susceptibilities of zoonotic pathogens from human and animal clinical specimens, from healthy farm animals, and from carcasses of food-producing animals at slaughter plants. Prior to this program, there was no comprehensive national or global surveillance system for monitoring antimicrobial resistance of enteric pathogens in humans or animals and none at all which combined the two populations.
Through this new program, baseline susceptibility patterns of Salmonella isolates from animals and Salmonella and E. coli O157:H7 isolates from humans already have been determined. The susceptibility profiles of these isolates form a baseline to which future changes in susceptibility and emergence of new resistance can be compared. On-going monitoring is underway at USDA's Agricultural Research Service's National Animal Disease Center in Ames, Iowa and at CDC's Foodborne Disease Laboratory in Atlanta.
The problem of antimicrobial resistance is complex and requires collaborative efforts by several agencies; the establishment of FDA's monitoring program is a significant milestone to its solution.
Salmonella Control Program in Feed and Feed Ingredients - In September 1990, CVM announced a program for attaining Salmonella negative feed ingredients and finished feeds. Since then, CVM has held numerous meetings with representatives of industry, academia, and other Federal and State agencies to coordinate the work of achieving Salmonella negative feed.
CVM initiated the formation of a Federal-State Steering Committee in July 1991. The Committee requested that the United States Animal Health Association (USAHA) serve as a scientific forum for debate on the means to best eliminate harmful microbial contamination from feed. In October 1991, USAHA established the Feed Safety Committee to serve as a venue for the forum. The work of this committee was divided among four subcommittees. The subcommittees are live production (poultry, beef, pork, dairy, and aquaculture); microbiology (sampling and techniques); feed manufacturing (to include ingredients, equipment, and additives); and feed transportation. The membership of the Feed Safety Committee and the Subcommittees consists of members of government industry and academia.
We believe that the best way to reduce Salmonella contamination in feed is through a quality assurance program and to achieve this we are focusing on the Hazard Analysis Critical Control Points (HACCP) approach. The Salmonella contamination which occurs during the production, and during storage and transportation, is largely preventable. Major segments of the feed industry have developed HACCP plans. To further reduce Salmonella contamination of feed requires that each manufacturer tailor a HACCP plan to each feed manufacturing facility. Currently, several firms in the feed and feed ingredients industries are working on developing generic HACCP plans. CVM encourages the feed industry to actively seek industry wide acceptance of HACCP-based plans. CVM is prepared to offer comments on specific plans if requested.
CVM also has reveiwed five Food Additive Petitions (FAP) for chemicals or processes to control Salmonella in feed have been accepted for review. Two have been approved, one is under review, and two are inactive because of the lack of adequate information from the sponsor.
On September 28, 1995, the regulations were amended to permit the irradiation of complete poultry feeds and poultry feed ingredients to achieve Salmonella negative feed. Based on the scientific information, we believe that this irradiation will also be effective against E. coli.
On April 9, 1996, the regulations were amended to permit the use of formaldehyde as an antimicrobial food additive for maintaining poultry feeds Salmonella negative for up to 14 days. Again, while the specific approval is for Salmonella control, the scientific literature suggests that the formaldehyde will also be effective against other common microbes in feed.
The approval of FAPs with antimicrobial activity is an important step toward the goal of Salmonella negative feed and of improving the safety of feed for animals and ultimately, increasing the safety of food products of animal origin.
Research - Research in CVM has as its mission the application of current scientific procedures to the solution of CVM regulatory issues. The primary focus of CVM's research is food safety. While CVM's food safety responsibilities encompass foodborne diseases, its resources address this particular aspect of human health primarily through the need to ensure that safe and effective animal drugs are available to treat these diseases.
Particular importance is placed on the priority for research in CVM. Recent Congressional interest in CVM has focused on the potential for drug residues in animal derived food and the availability of residue detection methods for monitoring. Drug residues in milk have been of particular interest to Congress and the subject of GAO reports.
The food safety focus of CVM research also has included the development and evaluation of procedures necessary to detect unsafe residues of unapproved animal drugs, metabolism studies in domestic animals as well as fish, evaluation and approval of drug residue screening tests for milk, and current issues on zoonotic disease of importance in domestic animals. All these programs are directed to food safety by ensuring that there are no unsafe drug residues in animal derived food; and by minimizing the human risk from animal disease by ensuring the health of domestic animals. Through a Federal/State/industry cooperative program, involving the National Conference on Interstate Milk Shipments and the milk industry, all Grade A milk is now screened with evaluated screening tests for beta-lactam drugs prior to introduction into the food chain.
Under the umbrella of food safety, CVM has supported studies on zoonotic disease in animals which could be transferred to humans. Animal feeds are considered a source of Salmonella spp. in animals and therefore, a source of this disease in humans. CVM research has been directed to the evaluation of procedures to detect Salmonella spp. in feeds.
CVM has previously conducted studies on the human health issue of the transfer of resistance organisms from animals to humans. Earlier studies were designed to develop data on comparison of Salmonella spp and Campylobacter jejuni in foods of animal origin and the occurrence of human illness caused by those two organisms. Other CVM research on the area of zoonotic disease has been to quantify the extent of drug resistance in select pathogenic bacteria isolated from food-producing animals. These studies were a primary reason for the current regulation requiring the development of data for new antibiotics on the shedding of resistant organisms from the use of the antibiotic in food producing animals.
FDA also recognizes that statutory changes also may be appropriate to make more animal drugs available to treat sick animals. FDA has worked very closely with the animal health industry to develop language that will provide adequate flexibility in the approval process while maintaining public and animal health safeguards. Although the agency still has several significant concerns with language proposed in bills before Congress, the agency has been actively involved in discussions with the animal health industry coalition to address our concerns. Our discussions have also included the possibility of an important new category of animal drugs for use in feed, "Veterinary Feed Directive Drugs." We are encouraged by the way these discussions are moving and hope that they may result in a bill that both the industry and Agency can support.
In the United States, the protection of the public from unsafe microbes in food is a shared responsibility between FDA, CDC, and USDA at the federal level, and state and local government agencies at their respective levels. CFSAN and FDA's Office of Regulatory Affairs (ORA) have the primary responsibility in this area for the Agency.
Effective surveillance is key to tracking foodborne pathogens. Such surveillance provides policy makers and health professionals with the basis for developing, implementing, and evaluating control policies that will lead to a healthier United States population in the new millennium.
Science is providing the regulatory community with new information, often through the use of sophisticated genetic techniques, which help us identify weaknesses in our system and points where preventive intervention strategies may be applied. From current epidemiologic data, we can conclude that our most important foodborne hazards are microbial, primarily Salmonella spp., Campylobacter jejuni, and Escherichia coli (E. coli) O157:H7. The Public Health Service has included foodborne disease risk reduction in the national health promotion and disease prevention objectives of Healthy People 2000. These objectives include reductions in the numbers of foodborne infections with Salmonella spp., Campylobacter jejuni, and E. coli O157:H7, and reductions in the number of outbreaks of Salmonella enteritidis infections.
CDC's experience with newly emerging foodborne pathogens, well-recognized pathogens appearing in new foods, and foodborne illnesses in immunocompromised consumers, suggests that foodborne disease is an ever changing public health challenge--a problem of emerging infectious disease. In partnership with representatives from state health departments, other federal agencies, medical and public health professional associations, and international organizations, CDC has developed a strategic plan entitled "Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States."
To assure close coordination and adequate support for this program, CFSAN has assigned one of its employees to CDC as a full-time liaison. FDA and USDA have also transferred funds to CDC to help support this program.
One important aspect of FDA's food safety program is its inspectional strategy. Inspections can determine the adequacy of conditions in a food plant at the time of the inspection, but not whether the company is operating reliably and consistently, over the long term, to produce safe food. Furthermore, the current system of regulatory controls is reactive, not preventive. That is, the system generally relies on detecting and correcting problems after they occur, rather than preventing them in the first place. Only in certain limited areas, such as low-acid canned foods, are mandated preventive controls currently in place.
FDA believes that it is time to consider improvements in the system and adopt a Hazard Analysis Critical Control Point (HACCP) approach to food safety, particularly for seafood. Such a change has been endorsed by such authoritative organizations as the National Academy of Sciences (NAS), the Codex Alimentarius Commission and the National Advisory Committee on the Microbiological Criteria for Foods (NACMCF).
As described by the NACMCF, HACCP has seven basic steps. It begins with an in depth analysis of potential hazards, followed by identification of points in the processing operation (critical control points) where the failure to control the hazard is likely to result in illness or injury to the consumer. Steps three and four are the establishment of critical limits associated with each identified critical control point and delineation of procedures to monitor the limits. The firm identifies corrective action procedures to be taken when monitoring indicates that a critical limit has been exceeded. Then, an effective recordkeeping system must be in place to document the HACCP system. Finally, the HACCP system should be verified to assure that it is functioning properly.
Actually, HACCP is not new. The FDA's low acid canned food program, established in 1973, uses HACCP principles. This program has been very effective in assuring the safety of canned foods.
In December of 1995, FDA issued a final rule for mandatory HACCP for the seafood industry, to become effective on December 18, 1997. Because we believe the future of food safety lies with the HACCP approach, FDA announced, in an August 1994 advance notice of proposed rulemaking, that it is considering the development of HACCP regulations for other segments of the U.S. food supply, including domestic and imported foods. FDA also initiated a program to help the agency obtain additional information and experience on whether, and how, to design HACCP systems for foods other than seafood. Seven major food companies are participating in FDA's HACCP pilot program, and the products involved represent a wide range of foods, manufacturing processes, and hazards.
HACCP takes on even more importance with globalization of the food supply and the need for a consistent system for assuring trading partners of the safety of imported products. The U.S. is importing more food, often in processed form rather than raw, than ever before. In the early 1970's, all imported products regulated by FDA numbered approximately 500,000 formal entries (i.e., those valued at $1250 or more). In 1995, 1,300,000 food products alone entered the U.S. Likewise, U.S. exports are increasing yearly. The U.S. must be prepared to demonstrate that American products introduced into international commerce meet high standards of quality and safety. Industry use of HACCP procedures is one way of accomplishing this. In fact, the European Union has incorporated the HACCP system into food safety standards and directives.
FDA's model Food Code also incorporated a framework for the application of HACCP at retail. The Food Code provides a set of food handling recommendations that can be used as models for retail establishments such as restaurants, grocery stores, vending operations and nursing homes. Its primary focus is the prevention of foodborne illness. The Food Code includes input from many sources, including the Conference for Food Protection, Association for Food and Drug Officials, industry, other federal agencies and academia.
One of the most important and cost-effective ways in which FDA works to assure the safety of the nation's food supply is through cooperative efforts with other federal, state, and private organizations. While FDA has traditionally collaborated with USDA and CDC, the intensity of our cooperation has increased significantly in the last several years. FDA and USDA have placed full-time liaisons at CDC to ensure that all foodborne illness activities are fully coordinated.
The federal agencies have also increased collaboration and cooperation with state and local agencies that have primary responsibility for regulating the activities of the retail segment of the food industry. We also have increased collaboration with trade associations, such as the National Food Processors Association and the Grocery Manufacturer's Association, to gain their support and cooperation in implementing food safety programs, and with training organizations, such as the Food Marketing Institute and the Educational Foundation of the National Restaurant Association, which conduct training programs and disseminate information on food safety to their members.
The agencies participate in numerous forums to discuss foodborne disease. These forums include:
Healthy People 2000: National Health Promotion and Disease Prevention Objectives, a prevention initiative to improve the health of the American people during the decade of the 1990s. One of the 22 priority areas is food and drug safety. FDA is the lead agency for this priority area, working closely with CDC and USDA and through the states and non-government organizations. Healthy People 2000 tracks yearly progress in food safety improvement through four objectives, including tracking the incidence of five foodborne bacterial diseases.
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF), an advisory committee formed in 1987 by USDA and coordinated by FSIS, FDA, National Marine Fisheries Service, and the Department of Defense. The Committee provides impartial scientific advice to federal food regulatory agencies for use in the development of an integrated food safety system approach to ensure the safety of domestic, imported, and exported foods. NACMCF has provided the agencies with outstanding advice, including development of HACCP principles, which are now incorporated in the HACCP programs mentioned above.
The Conference for Food Protection, comprises representatives from regulatory agencies at all levels of government, the food industry, academia, and consumer organizations. Its goal is to promote food safety at retail by identifying and addressing problems, providing uniform procedures, and promoting mutual respect and trust by establishing a working liaison among all parties concerned with food safety.
The Food Safety and Nutrition Education Task Force, co-chaired by FDA and an industry trade group, comprises food and nutrition consumer affairs and education representatives from industry, trade, consumer and public health organizations, government agencies, and public affairs firms. This group focuses on education strategies and initiatives.
The National Center for Food Safety and Technology (NCFST), a cooperative government/academia/industry research endeavor that includes the Illinois Institute of Technology (IIT), the IIT Research Institute, the University of Illinois Food Science Department, FDA/CFSAN, and food-related industries. Cooperative research endeavors at the NCFST provides FDA scientists access to highly technical expertise and provides the opportunity to conduct critical food safety research, which could not have been attained by FDA alone.
The Columbus Center CFSAN seafood and molecular biology researchers will soon be located at the Columbus Center in Baltimore's Inner Harbor. They will focus on applying new technologies to enhance the safety of the food supply for the American consumer. In this state of the art facility, CFSAN scientists will combine their expertise conducting research in molecular biology and seafood safety. Their research will be used to develop and evaluate new scientific approaches which aid the FDA in accomplishing its mission.
The University of Maryland On April 15, 1996, FDA entered into a partnership with the University of Maryland. Under this partnership, internationally recognized scientists from both organizations will share their expertise on significant issues pertaining to food safety, nutrition, and food science. We believe that pooling resources will enhance our ability to acquire and maintain state-of-the-art science facilities and equipment. Four areas of emphasis include: 1) the development of enhanced methods for detecting foodborne pathogens, contaminants, and toxins; 2) the designing of nutrition and clinical studies to better assess nutrient quality, safety, and proper labeling; 3) the evaluation of technological innovations that will assist in the review of food ingredients, risk assessment, international standards, and educational research; and 4) the ability to better anticipate and respond to technological developments that affect consumers, their behavior and the food industry.
Seafood HACCP Alliance and the Meat and Poultry HACCP Alliance, an affiliation of federal, state, industry, and academic organizations that, working together, have developed curricula to conduct training programs to facilitate the implementation of HACCP. These training programs will formally begin in the summer of 1996.
The Salmonella enteritidis Interagency Working Group, an integrated coordinated approach to the control of S. enteritidis in eggs. The group comprised representatives from USDA (FSIS, APHIS, Agriculture Marketing Service, Agriculture Research Service); CDC; FDA (Center for Food Safety and Applied Nutrition); the U.S. Animal Health Association; representatives from the egg industry; state animal health departments; and state departments of public health. The working group has considered issues like quality assurance programs as an alternative to the USDA S. enteritidis traceback regulation and requirements for the refrigeration of eggs during transportation and storage.
Implementation Group on Emerging Infectious Diseases, an interagency working group of the Committee on International Science, Engineering and Technology (CISET), formed in December, 1994. It published a report on emerging and re-emerging infectious diseases, including foodborne diseases, in September, 1995. Five sub-working groups, chaired by representatives from CDC, FDA, the National Institutes of Health (NIH), U.S. Agency for International Development, the Department of Defense (DOD) and the State Department, and including outside experts from academia, industry, and non-profit organizations are now working on implementation of recommendations from that report.
Research FDA cooperates with other agencies in research on a wide variety of topics including food safety. Research is joint, collaborative, or funded by other agencies. CFSAN cooperates with the CDC, USDA, NIH and DOD(NAVY), the National Aeronautics and Space Administration, the Department of Veterans Affairs, the National Institute for Standards and Technology and other agencies. The research function and ability to collaborate is essential to solving food safety, food technology and epidemiology questions.
We would like to highlight several special scientific collaborations that have resulted in successful outcomes. Two examples are illustrative:
Mr. Chairman, in your letter of invitation you requested that I speak today about FDA's regulatory actions related to the Transmissible Spongiform Encephalopathies (TSEs), and the relationship between Campylobacter jejuni and Guillain-Barr‚ Syndrome. While FDA shares responsibility in these areas with other federal and state agencies, we also have important information to provide.
Campylobacter jejuni is the most common cause of bacterial gastroenteritis in the U.S., causing an estimated 125,000 culture-confirmed and perhaps three million total cases of diarrhea annually. The predominant source of C. jejuni infections is raw or undercooked chicken. Poultry is regulated by the United States Department of Agriculture. Among the commodities which FDA regulates, C. jejuni outbreaks in the U.S. are primarily associated with the consumption of raw milk. Other foods regulated by FDA demonstrated to serve as vectors (rarely) for the dissemination of C. jejuni include mushrooms, raw or poorly cooked fish, and raw shellfish (mussels and oysters).
Guillain-Barr‚ syndrome can appear as a late developing illness following a C. jejuni infection. It may also follow illness caused by other bacterial pathogens, viral infections, immunizations, major surgery, and other (unknown) causes. The syndrome is characterized by acute neuromuscular paralysis in both adults and children. It develops one to three weeks after an acute respiratory or gastrointestinal infection. It is rare (only about four to five thousand cases per year) and most patients fully recover.
Research/Analysis - FDA conducts applied research on methods to quickly and accurately recover and identify C. jejuni in commodities under our jurisdiction. The FDA Bacteriological Analytical Manual contains a chapter on the "Isolation of Campylobacter Species from Food and Water." FDA Field Laboratories perform analytical tests for the presence of Campylobacter spp. in food commodities regulated by the FDA. To date, we have detected C. jejuni in only one sample of shellfish collected from a shellfish growing area that had been closed to harvesting.
Consumer Education - In a 1991 issue of <>FDA Consumer, FDA outlined ways to prevent foodborne illness in the home, including prevention tips on safe storage of food items, the importance of cleanliness, the need to keep hot foods hot and cold foods cold, and organisms that can cause disease and their likely source. Other information on C. jejuni and its relationship to seafood is available through the FDA Seafood Hotline. The Hotline is available 24 hours a day, seven days a week.
Retail Practices--Guidance - The 1995 Food Code published by the Food and Drug Administration serves as guidance to local, state, territorial, and tribal authorities, and to federal agencies in enforcement of their food safety laws covering, restaurants, food stores, institutional feeding, and vending operations. The 1995 Food Code includes specific poultry and seafood cooking advice and a consumer advisory regarding the risk associated with the consumption of raw or undercooked animal foods.
Prevention - The prevention of campylobacteriosis relies upon the avoidance of cross contamination in food-handling, maintenance of good kitchen hygiene, adequate cooking of meat and poultry, and the avoidance of those foods known to be vectors. Pasteurization is an effective way to eliminate Campylobacter jejuni in milk because the organism is sensitive to heat.
On May 2, 1990, FDA approved the irradiation of poultry up to a dose of 3 kGy for pathogen reduction. Treatment of poultry with radiation had been shown to be effective in significantly reducing the load of several pathogenic microorganisms on poultry products, among them, species of Salmonella, Yersinia and Campylobacter.
Other Activities - CDC, USDA, and FDA have initiated a pilot diarrheal disease reporting system. Working in cooperation with state health departments, CDC will collect and analyze illness data from five "Sentinel Sites" around the country (California, Connecticut, Georgia, Minnesota and Oregon). Data collected will provide a framework for identifying current and emerging trends in foodborne illness. The survey will collect data on diarrheal diseases (including campylobacteriosis) associated with dairy products, fruits, vegetables, and seafood, which are regulated by FDA, and with meat and poultry, which are regulated by USDA.
Food safety goals are part of the PHS program, Healthy People 2000: National Health Promotion and Disease Prevention Objectives. One of the goals is the reduction of infections caused by key foodborne pathogens including Campylobacter jejuni.
Transmissible Spongiform Encephalopothies (TSEs) are a group of transmissible, slowly progressive, degenerative diseases of the central nervous systems that are invariably fatal. Scrapie in sheep and goats, bovine spongiform encephalopathy (BSE), transmissible mink encephalopathy, chronic wasting disease of deer and elk, and Creutzfeldt-Jakob Disease (CJD) in humans are examples of TSEs. The agents believed to be responsible for transmitting TSEs are highly resistant to procedures that modify or destroy nucleic acids of living infectious organisms.
FDA has been active in the trying to understand TSEs. Since 1988 when UK scientists discovered an epidemiological link between rendered ruminant products in cattle feed and BSE, FDA has participated in BSE discussions nationally and world-wide to understand the agent and epidemic. Collaborations with such organizations as CDC, USDA and NIH have helped the Agency focus on appropriate actions.
USDA has confirmed that no cases of BSE have been diagnosed in the United States. However, as a means of helping to prevent the occurrence of BSE in the US, FDA issued a proposed rule (PR) on August 29, 1994. The PR declared specified offal from adult (more than 12 months of age) sheep and goats as not generally recognized as safe (GRAS) for use in ruminant feed. Since the PR issued, the Agency has evaluated the comments submitted on the proposal and monitored the scientific advances made in understanding the interrelationships among the animal TSEs.
Epidemiological evidence from the United Kingdom (UK) suggests that an outbreak of BSE may be linked to feeding of ruminant proteins to cattle. BSE has been diagnosed in over 155,000 head of cattle from almost 33,000 herds in the UK. A UK ban on the feeding of ruminant protein to ruminants is believed to have resulted in a steady decline in the number of cases of BSE.
Ten cases of CJD with a new neuropathological profile have been identified recently in the UK. Although sporadic cases of CJD occur world-wide at a rate of 1-2 cases per million population per year, these 10 cases appear to represent a new variant of CJD (v-CJD), which might be unique to the UK. The appearance of these 10 cases of v-CJD raises the possibility that they could be causally linked to BSE. However, a link with BSE cannot be confirmed on the basis of this epidemiological evidence alone.
Because of this potential association, an advanced notice of proposed rulemaking (ANPRM) will publish imminently in the Federal Register announcing that FDA is soliciting comments on the issue of using protein-derived from ruminants in ruminant feed. The Agency believes that this action will better protect the health of animals and minimize any risk which might be faced by humans. FDA will be soliciting comments on all aspects of the ANPRM, including, among other things: 1.) the occurrence in the United States of TSEs in animals, including BSE; 2.) how TSEs occur and are spread among animals, and among humans and what vectors might be involved; 3.) scientific information on the ecology of TSEs; 4.)scientific information supporting the exclusion of any ruminant-derived proteins from the proposed prohibition; 5.) establishment of Hazard Analysis Critical Control Points (HACCP) for the rearing of ruminants, and the rendering or other processing of ruminant derived feed ingredients, that could reduce the need to prohibit the feeding of ruminant protein to ruminants; and 6.) details of rendering or processing practices that may inactivate the TSE agents, and information and evidence of the effectiveness of rendering in the inactivation of TSE agents.
In addition to TSEs and Campylobacter, you have asked that I speak about the effect that regulatory delay may have on food safety. The agency currently faces a greater number of challenges and stresses than ever before. New food processing and packaging technologies, new food distribution and consumption patterns, increasing public health concerns about low levels of certain chemical contaminants, and new microbial pathogens all contribute to today's food safety challenges. The size, diversity, and international character of the food industry add to the stress on FDA's food safety assurance program as well, with FDA's current inventory listing over 49,400 food establishments. The number of foreign food products shipped to food products to the United States is continuing to increase. In 1995 alone, there were well over 1.3 million food import entries.
Given the current constraints on government resources, it is unlikely that FDA will ever have sufficient resources to inspect, sample, and analyze more than a small percentage of all food products, domestic as well as imported. Thus, it is FDA's goal to use our resources in the most effective way to minimize consumer exposure to unsafe products. The Agency is developing and implementing new and innovative strategies to meet these goals, through partnerships, improved product review and approval processes, HACCP, reduced number of regulations and environmental assessments.
Mr. Chairman, we would like to take this opportunity to highlight some of the activities that have taken place with regard to the agency's food additive petition process since we last testified before the Subcommittee on this issue and to announce several changes to be made to this process. As you know, on June 22, 1995, the Interim Deputy Commissioner for Operations, Ms. Linda Suydam, testified before this Subcommittee on the subject of food additive regulation. Ms. Suydam described the changes being made to speed up the food additive review process and additional planned reforms. Since then, we have made some important strides in reducing the petition inventory. I'd like to briefly describe these efforts for you:
At the time of the June 1995 hearing, there were a total of 295 petitions in the inventory. Program staff have made a commitment to have reached a final decision on at least 100 of these petitions by the end of FY 1996, and I am pleased to be able to report that as of April 30, 1996, 72 of that cohort of petitions have been acted on. (Of course, petitions continue to be received; for example, for the 12 months following May 1, 1995, 56 new petitions were received, and final actions were taken on a total of 82 petitions; of these 53 were approvals. Both of these latter two numbers are higher than for any calendar year since 1986). These gains were achieved because of steps we took during the last year, including:
At the June 1995 hearing, Chairman Shays noted that the statutory timeframe for review was 180 days, and that any review period in excess of that was in violation of the statute. Mr. Shays urged FDA to deal forcefully with the overdue petitions and requested FDA to suggest a new statutory timeframe that was achievable in practice.
In response to that request, FDA began a comprehensive review of its food additive review program. The results of this review were summarized in a concept paper that was submitted to the Department of Health and Human Services on October 2, 1995. The reform ideas outlined in the concept paper have been discussed with Subcommittee staff, and have, in addition, been the springboard for numerous discussions with representatives of interested food-industry and consumer groups.
FDA proposes a number of substantive changes that would significantly improve its food additive petition review performance, thereby achieving predictable and significantly faster petition reviews. A number of these changes would require amendments to the FD&C Act, and several others would require that new regulations be promulgated or that existing regulations be amended. Today I will describe in detail only the suggestions for statutory changes.
The primary recommended statutory change is that the present 90-day statutory time frame for petition approval (extendable for an additional 90 days) be changed to a:
6-month statutory time frame for conducting complete reviews (extendable for an additional 6 months) for food contact material (so-called "indirect additive") petitions; and
12-month statutory time frame for conducting complete reviews (extendable for an additional 12 months) for so-called direct food additive petitions.
These deadlines will be phased in and become effective over a five-year period. FDA's ability to achieve these statutory requirements and meet these timeframes will depend on reasonable flexibility to reallocate existing resources or development of new external resources, in conjunction with our initiatives to increase efficiency of the process.
By "complete review," FDA means that at the end of the specified time period, the agency will have completed the technical and scientific review and will have either made a decision that the petition is approvable and published a regulation, or has informed the petitioner that the petition is not approvable and the reasons that it is not. The petitioner would have the right to appeal a decision to deny a petition. These deadlines could be extended at the petitioner's request (if, for example, the petitioner prefers an extension to a denial).
These suggested statutory timeframes recognize the fact that some petitions are scientifically more complex than others and, therefore, require longer review. This fact was also recognized in the December 21, 1995, report of the Committee on Government Reform and Oversight on the food additive petition review process.
I should add an important note: There is currently no distinction between direct additives and food contact materials in the statute. This distinction would need to be established by regulation.
As noted earlier, FDA proposes to phase in its accomplishment of these deadlines over the next 5 years. FDA has already begun to act to reduce the backlog, and will continue to work toward its goal to eliminate the backlog within two to three years. Once the backlog is significantly reduced, FDA's goals are as follows:
For food contact material petitions, FDA's goal is to act on 60% of new petitions within 6 months in the first year of implementation of the new program; 75% of new petitions within 6 months in the second year; and 90% of new petitions within 6 months in the third and subsequent years.
For direct food additive petitions, FDA's goal is to act on 50% of new petitions within 12 months in the first year of implementation of the new program; 65% of new petitions within 12 months in the second year; and 80% of new petitions within 12 months in the third and subsequent years.
FDA recommends that additional statutory changes be made to direct the establishment of new appeal procedures, to streamline rulemaking procedures, to exempt food additive petition review from certain provisions of the Federal Advisory Committee Act and to amend section 721 of the Act to provide for parallel changes for color additive petition review.
Several other reforms will be needed in order for FDA's overall goals to be met. Perhaps most important among them is the promulgation of regulations to raise the threshold for filing petitions. Such regulations will improve the completeness and overall quality of petitions, which in turn will increase the likelihood that petitions, once accepted by the agency for review, will be approvable. In addition to the REGO proposals, mentioned earlier, other reforms are also contemplated, among them a requirement that petitioners certify that the data contained in a petition have been properly and correctly recorded, analyzed, and reported.
In FDA's June 1995 testimony, the agency committed to improve its food additive review performance without the benefit of additional resources. The reforms identified in the testimony and those discussed above will strengthen FDA's ability to speed petition reviews, and will go some distance toward structuring a workable program of food additive review. However, FDA anticipates that, unless the quality of the petitions it receives is significantly improved, many petitions will not be considered sufficient for filing, and many filed petitions will be denied because they contain unresolved safety questions. This is an outcome that both FDA and the food industry wish to avoid.
These points deserve amplification. With current resources, FDA is unable to devote sufficient resources for consulting with prospective petitioners before filing, because to do so would divert resources needed to review pending petitions. Without pre-filing consultation, and with a new filing threshold that sets higher standards for the information that petitions must contain, many submitted petitions are likely to be found insufficient for filing. For petitions that are filed, the situation is similar. With current resources, FDA is not able to devote the level of effort required to complete all scientific reviews and resolve all safety questions for filed petitions within a time period satisfactory to industry or to FDA. While this cooperative process has added significantly to the likelihood that petitions ultimately will be approved, it has also added significantly to the time required to approve petitions, contributed significantly to development of the present overly long average review times, and has therefore ultimately worked to the detriment of the goal of timely reviews. Were FDA to commit to new statutory deadlines to reach a decision within 12 to 24 months for direct food additive petitions, FDA scientists would be unable to continue their current practice of working substantively with petitioners to resolve the scientific issues and safety questions that arise during review. If required to reach a decision by the statutory deadline, it is likely, therefore, that FDA would deny many petitions as containing insufficient data to support approval.
The American food supply is among the safest if not the safest in the world. This has been achieved by incorporating the best science available in our regulatory research, by monitoring, and by education. Changing technologies, rapidly emerging and virulent pathogens, as well as globalization of the food supply present new and unique challenges to maintaining a safe food supply and protecting the consumer. FDA cannot do this alone and indeed has not - but in this time of decreasing resources, as outlined above, we are forming new partnerships, as well as strengthening others with our federal, state, and local counterparts as well as academia and industry to leverage our resources and capitalize on the needs and expertise of our counterparts and customers. These cooperative efforts also include a review of how we currently do business and how best to carry out our mission. As mentioned above, we have made changes such as in our new animal drug review process and will make changes in other areas to improve the way we function.
Thank you.
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