 |
 |
 |
|
 |
FDA
Home Page | Search FDA Site | FDA
A-Z Index | Contact FDA
Canada National Food Safety Summit
Lester M. Crawford, D.V.M., Ph.D.
Acting 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 afternoon, and thank you Gary (Gary Fread, President and CEO, Guelph Food Technology Centre) for your kind introduction. I’d like to thank both you and David Laird (President, Strategy Institute, the Conference Organizer) for the opportunity to be here today to tell you about FDA’s priorities for 2005 and beyond that will impact Canada’s food industry. I especially wanted to thank David Laird for his flexibility in scheduling that made it possible for me to attend.
It’s always a real pleasure to have the opportunity to meet with my colleagues from Agri-Food Canada, and Health Canada especially Debra Bryanton (Executive Director, Canadian Food Inspection Agency) and Virginia Poter (Assoc. Director General, Food Directorate, Health Canada) as well as the food industry representatives here today who are a vital part of the food system in both our countries. We have worked closely together on many occasions, particularly in the areas of food safety and food defense, and I know we will continue to do so.
Keeping in mind that we have all just eaten lunch, I didn’t want to start out talking about foodborne illness and microbial contamination, but I do I want to highlight for you this afternoon just a few major initiatives that are FDA priorities for the remainder of this year and beyond, relative to food defense, food safety, food labeling, and food GMPs.
The U.S. Food and Drug Administration (FDA) is responsible for assuring that all FDA-regulated imported goods meet U.S. requirements for safety and quality, and where applicable, efficacy. We are responsible for ensuring the integrity and safety of products offered for import and at the same time, we need to optimize import operations to expedite commerce. This is no easy task, especially in light of finite resources and the growing challenges we all face with the globalization of the food supply.
As a result of the events of September 11, 2001, FDA must now include in its import agenda the detection of terrorist acts and other acts of intentional adulteration and/or tampering. Securing the U.S. food supply is one of FDA’s highest priorities, one that we share with our colleagues at the U.S. Department of Agriculture (USDA) and the Centers for Disease Control (CDC), and one that we can’t accomplish without the close cooperation and collaboration of the food industry.
There are more than 300 designated U.S. customs ports of entry and 13 international mail facilities, all of which handle both personally and commercially shipped FDA-regulated goods. We expect more than 14 million lines of FDA-regulated goods will be offered to FDA for entry into the U.S. in 2005. We anticipate that these will continue to increase due to increasing global commerce, emerging industries and technologies, the volume of imported goods and the numbers of foreign manufacturers involved in exporting goods to the U.S.
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 regulatory partnerships and better information. 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 to develop audit procedures and reporting formats 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.
As many of you know, 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; establishment and maintenance of records; and administrative detention of suspect shipments.
In 2003 and 2004 we implemented these four new food security regulations under authorities provided under the Bioterrorism Act. These new regulations give FDA comprehensive new information on food production and distribution for the first time, including a 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.
In October of 2003, FDA and CBP jointly issued an interim final rule to implement the facility registration provision that took effect on December 12, 2003. We have been accepting registrations electronically and by mail since October 2003, and approximately 256,576 facilities (113,185 domestic and 143,391 foreign) have registered to date. This interim final rule requested comment on a limited set of issues relating to the expected cost impact of the U.S. agency requirement for foreign facilities.
Since publication of the rule, we have also published several sets of questions and answers as guidance to clarify issues related to registration requirements and have published a small entity compliance guide to help small businesses better understand the requirements. Last fall (November, 2004) we published a Compliance Policy Guide that provides information on FDA’s strategy for enforcing and achieving compliance with the registration interim final rule. We anticipate that the final rule on registration of food and animal feed facilities will respond to the comments received and will be published this summer
Like the rule on facility registration, the interim final rule on prior notification of importation was published on October 10, 2003 and went into effect on December 12, 2003. The primary purpose of prior notice is to give FDA time to review and evaluate information before a food product actually arrives at a port of entry so that we can better deploy resources to conduct inspections or take other action to intercept contaminated products. After publication of the rule FDA conducted a series of regional meetings here in Canada, as well as in Mexico and Europe, and hosted a satellite downlink conference presenting the requirements of the rule and associated procedures.
We have developed an electronic prior notice system interface (PNSI), which can receive prior notices from any submitter from anywhere in the world with Internet access. Alternatively, submitters may file prior notice with the CBP’s Automated Commercial System (ACS). The PNSI and ACS are linked so that all notices are screened in the same manner. We have also established a Prior Notice Center (PNC) that operates 24/7 with staff who review and evaluate all prior notices flagged by our system as potentially needing review. The staff also responds to questions filers may have in “real time”.
Currently, FDA/CBP are receiving approximately 150,000 prior notices per week. These notifications allow FDA to match these data with targeting information and thus focus inspection resources. The PNC estimates it will conduct 38,000 high-risk security reviews annually. Guidance and outreach materials are available on the FDA website in several languages.
FDA and CBP plan to issue a final rule this summer. Among areas under consideration for the final rule are food imported or offered for import for noncommercial purposes with a noncommercial shipper, or for quality assurance, research or analysis purposes only. We are also considering whether we can reduce the timeframes further for truck and air shipments while still ensuring that FDA can fulfill its statutory obligation to receive, review and respond to all prior notices before the food arrives.
In June of 2004, FDA published its final rule establishing procedures for administrative detention of food shipments. This rule included expedited procedures for perishable foods. We will soon be publishing a guidance document on the FDA website that explains the requirements of the rule. Fortunately, we have not had a public health emergency that has required us to use our administrative detention authority, but it is an essential tool for us to have should we need it.
The remaining new authority given to FDA by the Bioterrorism Act was the authority to inspect records of persons who manufacture, process, pack, hold, distribute, transport and receive human or animal foods if FDA has a reasonable belief the food presents a threat of serious adverse health consequences or death to humans or animals. The final rule on establishment and maintenance of records was published in December 2004.
The records that must be kept for inspection are those needed to allow identification of the immediate previous sources and subsequent recipients of food, including its packaging, in order to deal with credible threats of adverse health consequences.
The rule has different compliance dates based on the overall size of the business, ranging from one year for large businesses with more than 500 employees, to two years for very small businesses with less than 10 employees. The records required to be established must be maintained for up to 2 years depending on the type of food involved, and upon proper request by FDA, must be made available for inspection and copying to FDA as soon as possible from the time of request, but not to exceed 24 hours.
Before I leave this topic of Food Defense/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 types of 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 are focused on: Food Producers, Processors, Transporters and Retailers; Food Importers and Filers; Retail Food Stores and Food Service Facilities; Cosmetic Processors and Transporters; and Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors.
Using operational risk assessment strategies, we have conducted vulnerability assessments that evaluate the public health consequences of a range of product-agent scenarios associated with potential tampering, criminal, malicious, or terrorist activity. The food Industry has demonstrated tremendous leadership in working with FDA to assess individual commodity production and delivery vulnerabilities.
To help further reduce the risk of an attack on the food supply, FDA and USDA have joined forces to provide a free online food defense and security-awareness training program for industry.
Maintaining the safety and security of our global food supply is the responsibility of everyone in this room, the industry as well as local, state and national government food regulators.
I know you are all aware that food security is inextricably linked with food safety, especially with respect to food-borne pathogens. Food safety remains a real and compelling issue. In the United States we still have 76 million cases of food-borne illness each year. These result in approximately 325,00 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, as these two issues are part of a single continuum. Since 2003, we have launched three major initiatives against more traditional food-borne pathogens that I’ll describe just briefly.
Because of the importance of fresh produce in a healthy diet, and the continuing foodborne illness outbreaks associated with fresh produce we have experienced in the U.S., in October 2004, FDA issued the “Produce Safety Action Plan to Minimize Food-borne Illness Associated with Fresh Produce Consumption”. The plan covers fresh fruits and vegetables in the unpeeled natural form, raw, and minimally processed products (pre-cut or fresh-cut).
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.
FDA is developing guidance to industry to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. We believe this guidance document; in conjunction with our cGMP regulations for production, packing, or holding human food will provide a framework for identifying and implementing appropriate measures most likely to minimize microbial risk during processing of fresh-cut fruits and vegetables.
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. In the U.S., an estimated 118,000 illnesses are caused by consumption of SE-contaminated eggs annually. This current incidence is 3 times higher than it was in the 1970s when the CDC first reported the incidence.
An earlier 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. 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.
FDA received more than 2000 comments before the comment period ended in December 2004, and just last month (May 10 th) we reopened the comment period for an additional 30 days. 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 in the U.S. and occurs widely in both agricultural and food processing environments.
You may have heard yesterday from Merle Pierson (Acting Undersecretary for Food Safety, USDA) that in September 2003, FDA in collaboration with the USDA'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.
We will continue to coordinate with USDA, 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), and to develop new technologies that can eliminate or prevent the growth of L. monocytogenes in ready-to-eat foods.
Action items to be initiated or completed in 2005 include: development of a satellite training course for regulators and industry on LM preventive controls; publishing a guidance for industry on control of LM in refrigerated ready-to-eat foods; development of guidance for small dairy processors; recommendations for revisions of the Food Code; and review and redirection of enforcement and regulatory strategies including microbial product sampling (high risk food inspections)
Another topic that I know is of particular interest and importance to Canada’s food industry is anticipated changes to the U.S. requirements for food labels. Yesterday you heard from FDA’s former Director of the Center for Food Safety and Applied Nutrition, Joe Leavitt, on proposed changes in the U.S. food label to provide consumers with better information to aid in choosing a healthy diet. I’ll just highlight some of the most important actual and proposed changes.
On April 5 th 2005, FDA published in the Federal Register its advance notice of proposed rulemaking (ANPRM) to seek comment on how to give more prominence to calories on the food label. Some ideas for how to do this include increasing the font size for calories on the label, adding a percent “Daily Value” column for calories on the Nutrition Facts panel and possibly eliminating the column listing calories from fat. There is a 75-day comment period for this notice and I strongly urge all of you to review the announcement and submit your comments.
In conjunction with this ANPRM on the prominence of calories on the food label, we also published an ANPRM asking for comment on issues regarding the labeling of serving size on food packages. That is, either requiring dual column nutrition labeling for multiple serving packages that could reasonably be consumed as a single serving or simply requiring such packages to be labeled as single servings.
This ANPRM is also seeking public comments on how recent food consumption data should be factored into determining which reference amounts commonly consumed (RACCs) need to be updated. Again, this ANPRM is open for comment for 75 days and I encourage you to submit your comments.
Another issue both of great interest to consumers, and affecting information provided on the food label is that of carbohydrates. Petitions have been filed by a number of food manufacturers and consumer groups requesting that FDA define carbohydrate terms for use on the food label. These terms included “low”, “reduced”, and “-free. In response to these petitions, we are working on an ANPRM to define these terms.
In July of 2003, FDA published a final rule requiring the declaration of trans fat amounts directly under the saturated fat line in the Nutrition Facts Panel of the food label. This requirement becomes effective on January 1, 2006. After reopening the comment period on this final rule twice, the comment period ended in June 2004. FDA will publish an issues resolution paper once studies of consumer perception of trans fat nutrient content claims are complete.
Finally, let me just mention briefly where we are in terms of implementing the recently approved Food Allergen Labeling and Consumer Protection Act of 2004, also known as the Food Allergy Bill. This law requires that food labels identify in plain language if a product contains any of eight major food allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. These eight allergens cause about 90 % of food allergic reactions.
FDA has been working as a member of the Conference for Food Protection’s Food Allergens Committee to evaluate the Food Code and determine if additional allergen information is necessary. We are currently developing the petition process for the labeling of these food allergen ingredients as well as developing an on-line food allergens training course for industry and regulatory personnel.
As you know, in the U.S. dietary supplements are considered food and presumed safe under federal law. FDA prohibits the distribution of dietary supplements that present a significant and unreasonable risk of illness or injury.
Our evaluation of whether a dietary supplement presents a significant or unreasonable risk generally takes place after the product is already on the market. The Dietary Supplement Health Education Act (DSHEA) gives us the authority to take action against a dietary supplement under certain circumstances, including when the product presents a significant risk, an unreasonable risk, or an imminent hazard, does not comply with good manufacturing practices, or makes an unsubstantiated claim about the dietary supplement’s effect on the structure or function of the human body.
Federal law also requires companies to notify us and submit safety information to us before marketing dietary supplements containing new dietary ingredients (NDIs), i.e. ingredients not marketed in the United States before October 15, 1994. A dietary supplement containing an NDI is presumed to be unsafe until we complete our review of a company’s submission.
We are concerned that many dietary supplements currently available to consumers may contain NDIs even though the safety information required by law has not been submitted to us or the notification to us does not establish a reasonable expectation of safety. We are taking steps to ensure that ingredients first marketed in the United States before October 15, 1994, and dietary supplements containing these ingredients, do not pose a significant or unreasonable risk to consumers.
We intend to implement a transparent and systematic process for evaluating safety concerns about dietary ingredients and dietary supplements. The process would begin with “signal detection.” Signals of a possible safety concern may come from various sources, including other Federal, State, and local government agencies; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. We will determine when the quality or quantity of these signals raises a reasonable concern that health problems may result from consuming a dietary ingredient or dietary supplement. We will base our regulatory action upon the totality of the scientific evidence available.
As everyone in this room today is well aware, not only are food GMPs an important part of every nation’s control over food safety problems they are also integral to food defense. Processing failures due to a lack of the application of modern GMP controls are a major cause of food product recalls. With our increased knowledge and understanding of important food pathogens such as Listeria monocytogenes, we now know that in many cases, these pathogens can be adequately controlled only by the implementation of appropriate GMPs by food-processing establishments. The same is true for reducing food-borne illness from pathogens on fresh produce. We also know that cross-contamination of food products with food allergens can be prevented through the implementation of appropriate GMPs in food processing.
Last September following our public meetings on how the GMPs should be updated, I asked CFSAN to produce a white paper on food cGMP modernization that summarized the public comments and listed opportunities for cGMP modernization. The draft white paper has been completed and is currently undergoing review. Once internal review is complete it will be released for public comment.
In closing, you can see that FDA has many priorities for 2005 and beyond in food safety and related issues that will affect the way that Canada’s food industry does business. I hope the information I have provided you this afternoon will go along way in positioning you to continue providing safe and nutritious food products to U.S. consumers and in working with FDA to improve the safety and security of our food supply.
I look forward to continued close collaboration with you in the coming months and years to help achieve our shared goal of a safe and secure global food supply.
Thank you.
Get free
weekly updates about FDA press releases, recalls, speeches, testimony
and more.