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Lester M. Crawford, D.V.M., Ph.D. - American Society of Microbiology

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

Speech before
American Society of Microbiology Public and Scientific Affairs Board

Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of the FDA

February 11, 2005

Good afternoon and thank you Ruth (Ruth Berkelman, M.D., Chair, American Society of Microbiology’s Public and Scientific Affairs Board) for your kind introduction. It is a pleasure to be able to meet with you this afternoon and to join my colleagues from HHS in sharing with you the many issues facing our agencies that are of special interest to your Public and Scientific Affairs board members, and to your entire organization.

I’m sure if you read the newspapers, you are well aware that FDA has had many controversial issues on its plate this past year which have certainly kept us busy, but have not deterred us from moving forward on the six strategic priority areas that we identified for the agency as a part of our mission to protect and advance America’s health. One of those strategic priorities that I want to highlight for you this afternoon is one that we consider to be of the utmost importance, and that is our ability to protect the homeland by moving quickly to respond to the challenges of bioterrorism and threats to our food supply.

FDA’s counter-terrorism mission has five major goals: to facilitate development and availability of safe and effective medical countermeasures; to protect the safety and security of all FDA-regulated products; to implement a comprehensive food security strategy; to enhance the Agency’s emergency preparedness and response capabilities, and to ensure the safety and security of the Agency’s assets.

FDA has made significant progress in all of these areas. We are fostering innovation and development of novel medical countermeasures through our ‘Critical Path Initiative’. We are facilitating expansions of indications for existing products and approval of new medical products by developing streamlined approval processes for drugs, vaccines, antibiotics and antidotes to potential biological, chemical and radiological agents. Under the BioShield Act we also have the authority to allow the use of unapproved medical products during a declared emergency. FDA is partnering with other agencies to ensure adequate inventory of medical countermeasures.

Overall FDA, through its aggressive programs, has made significant progress in strengthening the safety and security of the Nation’s food supply. As part of our goal to implement a comprehensive food security strategy we have published a number of guidance documents for regulated industries including food security preventive measures for food producers, processors and transporters, for food importers, for retail food stores and food service establishments, for cosmetic processors and transporters, and for dairy farms, bulk milk transporters, bulk milk transfer stations, and fluid milk processors.

Using operational risk assessment strategies, we have developed a vulnerability assessment for foods that evaluates the public health consequences of a range of product-agent scenarios associated with potential tampering, criminal, malicious, or terrorist activity.

In 2003 and 2004 we implemented four new food security regulations under authorities provided to the Agency under the Bioterrorism Act of 2002, culminating with the announcement this past December of the final rule on record-keeping that outlines the requirements for establishment and maintenance of records.

These four new regulations (food facility registration, prior notice of importation, administrative detention, and establishment and maintenance of records) represent the most substantial expansion of food safety activities in three decades. These new regulations give FDA comprehensive new information on food production and distribution for the first time, including complete inventory of all food 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.

FDA’s overall food security strategy consists of five elements: awareness; prevention; preparedness; response and recovery. To increase awareness we are developing communication strategies among federal, state, local and tribal governments and the private sector by collecting, analyzing and disseminating information relative to potential risks and vulnerabilities in the food supply and infrastructure.

On the prevention front, FDA is continuing to develop the capacity for identification of a specific threat or attack on the food supply through its food defense research. With some supplemental funding and a redirection of resources, we have made substantial progress in developing test methods and sampling methodologies designed to rapidly detect adulteration of the food. The greatest priority is given to the detection of intentional adulteration of food and to tests that are suitable for inspection of foods at ports of entry into the U.S. In this regard, I am pleased to report that there have been some significant accomplishments.

Our Center for Food Safety and Applied Nutrition has been successful in developing rapid and field-deployable methods to detect Clostridium botulinum toxin (an agent that is potentially fatal) in food. We are currently negotiating a contract for bulk production of these test kits.

In addition, FDA scientists have developed a method to isolate and identify Bacillus anthracis (anthrax) and have made that method available to other Federal and State laboratory personnel through training and through the CDC’s Laboratory Response Network (LRN). We have also developed methods to isolate and identify Francisella tularensis (tularemia) and Yersinia pestis (plague) and posted those methods to the LRN.

To enhance our emergency preparedness, we have worked closely with USDA in the development of the Food Emergency Response Network (FERN), a system that integrates the Nation’s laboratory infrastructure for the detection and identification of biological, chemical or radiological threat agents in the food supply.

The primary purpose of FERN is to ensure that state and regional laboratories are adequately qualified to prevent, respond to, and aid recovery from terrorist attacks or a national emergency involving the food supply. FERN collaborates with CDC’s Laboratory Response Network and the National Animal Health Laboratory Network

To date, ninety-three laboratories in 43 States have satisfactorily completed the FERN Laboratory Qualification Checklist, and surveillance-sampling assignments to test the capacity of the system have been conducted.

Clear, reliable and authoritative information on food safety, and the ability to communicate this information is essential; not only for prevention and response measures but also for maintaining consumer confidence in the food supply. FDA participated in the debut of the World Health Organization’s International Food Safety Authorities Network (INFOSAN), which is designed to promote the exchange of food safety information and improve collaborations among Food Safety Authorities at the national and international level.

As the final step in our food security initiative, we are diligently working on strategies to enhance recovery from a food terrorism incident. We are in the planning stages of collaborative projects with the National Center for Food Safety and Technology, an industry/academia/government partnership, to develop the capacity for rapid, coordinated recovery from a food borne terrorist attack. Specific areas of collaboration include decontamination of food processing facilities and equipment, and determining the ability of various food processing technologies to inactivate anthrax spores and protein toxins (botulinum toxin, ricin).

As the organization representing the leading microbiologists in this country, I know you understand that food security is inextricably linked with food safety, especially with respect to food-borne pathogens. Food safety remains a real and compelling issue. We still have 76 million cases of food-borne illness each year in this country. These result in approximately 325,00 hospitalizations and as many as 5,000 deaths each year.

We at FDA, and particularly our Center for Food Safety and Applied Nutrition (CFSAN) have continued to advance our traditional food safety mandate in addition to our newer food security responsibilities, as these two issues are part of a single continuum.

We have undertaken new risk communications strategies to improve upon more routine food safety issues for consumers. Since 2003, we have launched three major initiatives against more traditional food-borne pathogens and I’ll describe each of these just briefly.

Over the past 30 years we have found food-borne illness outbreaks associated with fresh produce that have included all three categories of microorganisms. Bacteria, including Salmonella, E.Coli 0157, Shigella, Campylobactor and others were the cause of 62 outbreaks. Parasites, including Cyclospora, were identified as the causative agent in 16 outbreaks; and there were 21 outbreaks caused by viruses, both Hepatitis A and Norovirus.

In October 2004, FDA issued its “Produce Safety Action Plan to Minimize Food-borne Illness Associated with Fresh Produce Consumption”. This action plan covers f resh fruits and vegetables in the unpeeled natural form, raw, and minimally processed products (pre-cut or fresh-cut). The action plan covers the entire food chain.

The Action Plan components include: Risk Assessment, Intervention, Research, and Education with the objectives of preventing microbial contamination, minimizing public health impact when contamination occurs, and facilitating and supporting research that is relevant to preventing contamination in fresh produce.

CFSAN will facilitate and support research likely to make the most significant contributions to reducing the public health risk from contaminated fresh produce, with a focus on approaches that provide practical information. We are also taking steps to leverage research resources aimed at developing sampling and pathogen detection methods for fresh produce through cooperative efforts between federal agencies, state and local offices, academic institutions, and the private sector.

We are especially interested in developing risk–based approaches directed at preventing contamination of fresh produce or identifying effective interventions to address contamination that has occurred. We need to assess the relative risk associated with specific areas of production such as: agricultural and processing water quality, environmental contamination during production, unsafe handling practices, unsanitary equipment, employee health and hygiene, and the practices that hinder trace back. We also need to clarify mechanisms of contamination under commercial conditions.

Our Produce Safety Action Plan calls for development of additional sampling protocols to facilitate pathogen detection in or on fresh produce and in the fresh produce production environment, as well as development of revised or new analytical methods. Our focus is on the commodity/pathogen combinations of greatest public health concern.

Finally, our Produce Safety action plan will assess the efficacy of guidance, educational outreach, and training materials and validate the efficacy of industry practices and interventions. By identifying barriers to implementing best practices in the production, processing, and preparation of fresh produce we can assist in the development of effective intervention strategies and promote the technology transfer of research findings

On another major front in our battle against food-borne pathogens, in September 2004, FDA issued a proposed rule to address Salmonella Enteriditis (SE) in shell eggs during production. An earlier farm-to-table risk assessment of SE in eggs identified the implementation of on-farm measures as a very important step in reducing the occurrence of SE infections from eggs. An estimated 118,000 illnesses are caused by consumption of SE-contaminated eggs annually.

The proposed rule on SE prevention measures on the farm address provisions for the procurement of chicks and pullets; farm biosecurity; pest and rodent control; cleaning and disinfection of poultry houses that have tested positive for SE before new laying hens are added to the house; refrigerated storage of eggs at the farm; and p roducer testing of the environment for SE in poultry houses.

The proposed rule would not apply to producers who sell all of their eggs directly to consumers or to producers with fewer than 3,000 laying hens. We anticipate that the final rule will be published in FY 2006.

The third of our major food safety initiatives has focused on Listeria monocytogenes. This organism causes an estimated 2,500 serious illnesses and 500 deaths each year and occurs widely in both agricultural and food processing environments.

In September 2003, FDA in collaboration with the U.S. Department of Agriculture's Food Safety and Inspection Service published its assessment of the relative risk to public health from food borne Listeria monocytogenes among selected categories of ready-to-eat foods. FDA is now using this risk assessment to evaluate and focus its current and proposed policies, programs, and regulatory practices to minimize the public health impact of this bacterium.

We have initiated a multi-prong approach and plan to issue guidance for processors who manufacture or prepare ready-to-eat foods, provide technical assistance for industry and food safety regulatory employees, conduct consumer and health-care provider education efforts, revise enforcement and regulatory strategies, enhance surveillance, and conduct research to enhance preventive controls. FDA is also coordinating research activities to refine the Risk Assessment, and support regulatory, enforcement, and educational activities.

We will continue to coordinate, conduct and support research to evaluate the effectiveness of existing commercial treatments (e.g., post-packaging pasteurization, bacteriocins, irradiation, high pressure processing, and inhibitory compounds); to develop new technologies that can eliminate or prevent the growth of L. monocytogenes in ready-to-eat foods; and to determine the growth rate of L. monocytogenes in specific foods in order to provide information and guidance on (a) the establishment of scientifically based safety-related date marking and (b) practical means for consumers to more effectively control L. monocytogenes in ready-to-eat foods after purchase..

We are also working to develop methods for the detection of L. monocytogenes in various ready-to-eat foods, with a particular emphasis on the quantitative evaluation of food samples, and development of rapid and accurate means for assessing the virulence of food borne L. monocytogenes isolates. This will help us better estimate the potential of individual strains to cause disease, and thus lead to better estimates of the microorganism's infective dose.

In addition, FDA will continue to seek data on the frequency and concentration of L. monocytogenes in a variety of ready-to-eat foods in order to perform simulation studies as a means of enhancing the existing exposure assessment databases and determining the impact that various control programs are having on attributable risk.

We are working with the CDC to identify means for readily and objectively assessing the immune status of susceptible populations to better identify the subpopulations of consumers that are most susceptible to L. monocytogenes. We are also collaborating with the CDC in the development of methods for conducting enhanced case control studies, outbreak investigations, and related epidemiological tools for better identifying the foods, conditions, and practices that are associated with food borne listeriosis.

As the final step in our Listeria Action Plan, FDA is re-examining its "zero tolerance policy" and is developing a control strategy for L. monocytogenes using the best available science to produce a positive impact on public health. This control strategy will be consistent with our food cGMP modernization efforts.

Let me switch gears now and spend a little time on another aspect of microbiology that I know is of interest to your membership; the issues of antimicrobials and antimicrobial resistance. As I’m sure you are well aware, the veterinary use of antimicrobials has the potential to lead to resistant infections in people and may limit the treatment options for these infections. Our Center for Drugs (CDER) is working closely in conjunction with our Center for Veterinary Medicine (CVM) to further define the importance to human medicine of different classes of antimicrobials so that this information can be utilized by CVM in their regulatory activities.

FDA has developed an innovative regulatory strategy for managing the potential risks associated with the use of antimicrobial drugs in food-producing animals. This approach includes the use of risk assessment to quantify the human health impact from antimicrobial use in animals, robust monitoring, research, and risk management.

On October 23, 2003, CVM published the final Guidance for Industry document on antimicrobial resistance (GFI #152). This guidance, developed with public input, is significant because it provides a scientific, risk-based approach to preventing antimicrobial resistance that may result from the use of antimicrobial drugs in food-producing animals. This guidance applies not only to approval of new animal drugs but to currently approved antimicrobials as well. Typical risk management strategies required under the guidance include mandatory prescription status of the drug, limiting the administration to small groups of animals for short periods of time, and limiting the formulation to injectable forms.

CVM has also reviewed the currently approved subtherapeutic uses (those for growth promotion) of penicillins and is working with the relevant drug sponsors on bringing these products into compliance using GFI#152.

On November 23, 2004, FDA published a draft risk assessment on the use of streptogramins (Virginiamycin®) in animals and the development of Synercid® resistant Enterococcus faecium infections in humans. The draft document is open for public comment until February 25, 2005.

Antimicrobial drugs for use in food-producing animals are monitored for the development of resistance through the National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS), which is a program established in 1996 as a collaborative effort between the Food and Drug Administration's Center for Veterinary Medicine (FDA CVM), U.S. Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC). The NARMS program monitors changes in antimicrobial drug susceptibilities of selected enteric bacterial organisms in humans, animals, and retail meats to a panel of antimicrobial drugs important in human and animal medicine.

CVM has enhanced the retail meat arm of NARMS by expanding from 6 participating FoodNet sites in 2002 to 10 sites in 2004. These sites collect samples from local grocery stores and submit the isolates to the CVM for antimicrobial susceptibility testing thus allowing FDA to have a more representative picture of the contribution of the food supply to antimicrobial resistance. We completed the first annual NARMS retail meat report on September 30, 2004. This report provides data on the prevalence of antimicrobial resistant food-borne pathogens and commensal bacteria among retail meat and poultry samples.

CVM has also continued to improve NARMS methods through development of a Campylobacter broth micro-dilution assay that was approved by the National Committee for Clinical Laboratory Standards (NCCLS) for Veterinary Antimicrobial Susceptibility Testing (VAST).

I can assure you that FDA has placed a high priority on continuing to develop strategies to combat antimicrobial resistance, whether from the food supply of from the misuse of human pharmaceuticals.

On the human drug side, our strategy is to focus on encouraging the development of new antimicrobials while preserving the usefulness of existing drug products. We recognize that the factors responsible for increasing antimicrobial resistance are complex and the path towards solving this public health problem involves implementing a broad range of initiatives.

FDA’s Final Rule, Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use, went into effect on February 6, 2004. This rule places information in the product labeling which provides a framework for physicians to consider when prescribing antibiotics, and also provides information for patients to help them better understand the usefulness of antibiotic therapy.

FDA has established a national surveillance program to obtain antimicrobial resistance information in an effort to identify resistant organisms that pose a significant health threat to the public. We continue to participate in numerous public meetings with stakeholders to obtain information and establish a scientific basis for guidance on drug development for resistant pathogens and various indications.

At present, we are developing or revising the following Guidances for Industry:

 

  • Drug Development for Resistant Pathogens;
  • Acute Otitis Media;
  • Acute Bacterial Sinusitis; and,
  • Acute Exacerbation Chronic Obstructive Pulmonary Disease.

The completion of these guidances will provide stakeholders with the most current thinking regarding the conduct of clinical trials for new antimicrobials.

I’m pleased to tell you that FDA is implementing the Get Smart Campaign in cooperation with the Center for Disease Control and Prevention (CDC). This campaign is designed to provide public education and information about the proper use of antibiotics and the dangers associated with excessive or improper use of drugs.

The CDER drug shortage team continues to explore strategies to stimulate development of antiretroviral drug products to address HIV drug resistance. As part of our continued efforts in this important area of human medicine, FDA will coordinate and host a public workshop that will bring together leaders and scientists from the National Committee for Clinical Laboratory Standards (NCCLS), Pharmaceutical Research and Manufacturers of America (PhRMA), Susceptibility Testing Manufacturers Association (STMA), and other governmental agencies (Center for Disease Control and Prevention and Center for Medicare and Medicaid Services) to address harmonizing and establishing susceptibility breakpoints and defining antimicrobial resistance.

I would strongly encourage you and all the ASM members who work in this area to participate in these activities as much as possible. We will also continue to work with the Infectious Disease Society of America (IDSA) and other stakeholders in developing new tools for clinical trials of antimicrobials and programs that will stimulate antimicrobial drug development as part of FDA’s Critical Path to New Drug Development initiative.

In closing, I’m pleased to report that in 2004, FDA approved 3 antimicrobial new drug products: telithromycin for treatment of bacterial-associated respiratory illnesses; tinidazole for treatment of trichomoniasis, giardiasis and amebiasis; and rifaximin for the treatment of non-invasive E. coli -associated diarrhea. We recognize that there is still a great need for new antimicrobials to combat resistant microorganisms and we look forward to continued collaboration with ASM members and other stakeholders to develop new entities and maintain the effectiveness of existing compounds in this important class of human drugs to better protect the public health.

Thank you.