Food Safety Magazine

COVER STORY | February/March 2004

Protecting the Nation’s Food Supply from Bioterrorism

By Rhona S. Applebaun, Phd.D.

Protecting the Nation’s Food Supply from Bioterrorism

In the aftermath of the terrorist attacks on our country in 2001, and the resulting increased focus on national security, food security has become a top priority for the food industry. Food companies have placed a strong emphasis on reviewing security programs and procedures, in order to continually improve and enhance the strength and effectiveness of our nation’s food security systems.

The food industry has a long history of dealing with threats to food safety, from foodborne disease outbreaks and inadvertent contaminations to isolated incidents of product tampering and extortion. But, now, we are dealing with what heretofore was unthinkable: the intentional, widespread contamination of the food supply. The potential for the food supply being a target or tool of terrorism can no longer be viewed in hypothetical terms. Hoping and complacency are not an option.

In decades past, the food industry has faced various security challenges. For example, maintaining a drug-free workplace was an emerging security challenge in the 1980s. In the 1990s, there was a growing emphasis on preventing workplace violence. The 1990s also was the decade when the threat of biological and chemical weapons came into focus. Then—with the events of 2001—terrorism and bioterrorism became a key security issue. The issue of terrorism against the food supply is one that the food industry takes very seriously.

Assessing the Risk of Foodborne Terrorism
In assessing the risk of intentional contamination of the food supply in the United States, the food industry has focused on three areas—what we like to refer to as the “3 P’s of Protection”:

Personnel: Companies have increased both employee screening and supervision.

Product: Companies have established more controls on ingredients and products during receiving, production, and distribution, to ensure the highest level of food safety.

Property: Companies have ensured that they have the strongest barriers in place to guard against possible intruders.

The criteria for accurate risk assessment is to look at company assets, then determine both the type of potential threat that exists and the company’s vulnerabilities. It is where a company’s assets and vulnerabilities overlap with potential threats that the risk of bioterrorism lies.

Can risk be eliminated? No, because 100% security doesn’t exist. So, we must manage risk. In managing risk, deterrence and prevention are the key. The philosophy must be: “Prevent to Protect.”

In a perfect world, food companies would be able to deter or prevent bioterrorism before it occurs. However, this is not a perfect world, so food companies also must have the knowledge and tools to detect and mitigate any possible food security breaches. Certainly, the goal is to detect problems, before we have to mitigate their potential impact.

Protecting the Nation’s Food Security: The Food Industry’s Activities
Since the day following the terrorist attacks of 2001, the food industry has been extraordinarily active in reviewing existing food security programs and implementing, as appropriate, new preventive practices and effective controls. Food companies across the country have redoubled their commitment and increased their vigilance to ensure that systems are in place to minimize and, to the extent possible, eliminate the threat of intentional contamination of the food supply.

In order to be successful in enhancing their security efforts, food companies must establish a “security philosophy,” by understanding how security works, determining what their needs are, and then establishing priorities. They must review their current security practices and procedures; review their crisis management and security plans; and determine what changes or additions are needed.

It is important to note that “food security” and “food safety” are not the same thing. The basic distinction is that food safety deals with accidents, such as cross-contamination and process failure during production. Food security, on the other hand, is a broader issue dealing with intentional threats. It is the intentional versus the accidental; the diabolical intent versus the chance occurrence; the deliberate versus the unplanned.

These are immensely important distinctions to the food processing industry, particularly as they relate to our management and prevention practices. However, both food safety and food security activities have a common goal, which is to prevent problems that could undermine the safety of the end product to consumers.

It is vital that one underlying principle be kept in sight: Although security is critical to our business, ensuring security cannot be allowed to result in business paralysis. So, any changes to either industry security activities—or to the regulations governing food security—must be both realistic and workable. When all is said and done: Reason must rule!

The Bioterrorism Act of 2002: New Requirements for the Food Industry
The National Food Processors Association (NFPA) has been the food industry’s leader in the regulatory implementation of the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act), which was signed into law by President Bush in 2002. NFPA strongly supported the Bioterrorism Act and its stated purpose to improve the ability of the U.S. to prevent, prepare for and respond to bioterrorism and other public health emergencies.

The Bioterrorism Act directed the U.S. Food and Drug Administration (FDA) to implement regulations for the registration of food facilities; prior notice of imported food shipments; the establishment, maintenance and availability of records; and the administrative detention of food for human or animal consumption. Some of the regulatory changes FDA initially proposed were appropriate; others were not, and would have resulted in needless burden to the food industry and FDA, without any tangible increase in the security of food and food shipments.

NFPA and others in the food industry worked diligently to urge needed revisions to these proposed regulations, in order to ensure that the collective goal of the Act and the implementing regulations—i.e., to enhance our nation’s food security—was achieved. The intent of the Bioterrorism Act, and subsequent implementing regulations, was not to add onerous new requirements that were ineffective, or would act as a barrier to international trade. We also made the case that, with newfound awareness of potential terrorist threats, it is important that any actions taken do not weaken public confidence in food safety. Consumer confidence in the safety of the food supply remains paramount.

FDA clearly listened to the substantive recommendations of NFPA and other stakeholders on ways to improve these regulations. Changes were made, and rightfully so, including but not limited to removing private residences that may briefly hold cookies and other foods for charity sales from the list of ‘facilities’ that need to register with FDA and shortening the time required for prior notice of food imports, a key suggestion made by NFPA in its comments. These changes in the Interim Final Rules issued in October 2003 were a win-win for all stakeholders in the food industry, because they not only maintained the effectiveness of these new regulations, but also increased their workability (Table 1).

FDA issued Interim Final Rules for registration of food facilities and prior notice of imported food shipments on Oct. 10, 2003. These rules became effective on Dec. 12, 2003. Additionally, FDA is expected to issue Interim Final Rules for records and administrative detention shortly.

The food industry is committed to ensuring that an estimated 400,000 domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. are properly registered with FDA, and that all companies who export food products or ingredients to the U.S. are meeting the prior notice requirements established by the Bioterrorism Act. To this end, NFPA has taken a leadership role in helping to educate the food industry on complying with these new regulations.

NFPA has held several seminars on the Bioterrorism Act’s new requirements, to help companies understand both the technical requirements and what specifically must be done to be in compliance with these new rules. NFPA has been active not only in the United States but around the world in educational activities related to the new Bioterrorism Act requirements. For example, NFPA-Asia, NFPA’s new regional office in Bangkok, Thailand, held a conference in November 2003 on complying with the new Bioterrorism rules. The conference, which was held in cooperation with Thailand’s National Bureau of Agricultural Commodity and Food Standards (ACFS), drew more than 900 attendees. Another conference in Bangkok is planned for April 2004, in cooperation with Thailand’s Department of Foreign Trade.

Assisting the Food Industry in Enhancing Food Security
NFPA is working to assist the industry in organizing and conducting appropriately tailored food plant and product security assessments, and to help provide and implement the appropriate practices, tools, and countermeasures against bioterrorism. And we have led the industry’s response to the food security challenges facing our nation.

Within days after the attacks on World Trade Center and the Pentagon, NFPA helped launch the “Alliance for Food Security.” This government/industry alliance—which now has more than 130 participating organizations—helps to facilitate coordination and communication among all stakeholders, to minimize all threats to our nation’s food security.

NFPA also developed a Threat Exposure, Assessment and Management (TEAM) process for managing food security threats; created a security checklist of questions for its members, to focus on the “what” versus the “how” in food security; produced a poster of the “3 L’s of Food Plant Security” (Light It, Lock It, and Limit Access); and, in cooperation with the Food Marketing Institute, published the Food Security Manual for Food Processors, Distributors and Retailers.

NFPA is now is the process of working with the U.S. government on the establishment of an Information Sharing and Analysis Center (ISAC)) for the food processing industry. Terrorism is a real issue, and timely information on potential or threatened terrorist activities affecting the food industry is key. Questions now being addressed are: a) what is the objective of such an ISAC; b) what is the critical information to be shared; c) how is it determined that information is credible; d) just what information will be shared; and e) how will the information be shared.

NFPA also is working to develop a “Food Security Research Roadmap,” designed to help assess the food industry’s needs, advance its knowledge of food security issues, and avoid unnecessary duplication.

This is no simple task. While the food industry is a critical component of our nation’s infrastructure, it is not a monolithic industry. The dissimilarities between various industry sectors are enormous. The common element, however, is the strong need to ensure food safety and food security throughout the food chain—from production to consumption, and every activity in between—to the extent possible.

The following questions have been raised as we continue to further our knowledge and advance our understanding of food security. We realize there are no easy answers, but without first acknowledging that questions remain we cannot hope to attain our goal of enhancing communication, cooperation, collaboration, coordination and consultation.

• What information do we need to know?

• Who can provide accurate, credible information?

• How do we share such information in a secure fashion?

• Are food safety and foodborne terrorism hazards different?

• How do we determine what is an “incident” versus “background prevalence”?

• Can we assess the differences between a biological weapon and a natural incident? Does it make a difference?

• In the case of a biological weapon versus a natural incident, are the respective preventive practices, tools, or controls different?

• How do we detect the use of a biological weapon or a natural incident in the food or in the victim, and how is this reported?

• Who is being trained, and how?

• What more can we do?

All in all, we are undertaking an in-depth examination of the state of food security information exchange, which will provide valuable information for all stakeholders.

Looking Ahead: What Is Needed
The food processing industry continues to refine its food security systems, to ensure that they help prevent any dangers or disruptions to the food supply. And improved information sharing and coordination among the regulatory agencies is resulting in demonstrable improvements and a greater level of food safety and food security. But still more is needed.

To further enhance our nation’s food security, better communications networks are needed. They must be secure, rapid, and employ the appropriate information technology tools.

We need more information sharing, with an emphasis on collaboration, cooperation and coordination. The food industry needs to find ways to better share intelligence, assess threats, identify vulnerabilities, and rank risks.

We need the right tools to rapidly address foodborne terrorism. This means both scientific tools—laboratory capacity and competency, including rapid detection methods, biosensors, and other equipment and methodologies—and behavioral tools, including the ability to profile potential terrorists and to benchmark risks.
And we need to remove the communications hurdles, yet ensure that information shared remains confidential and secure.

Food processors are not just in the business of providing appealing, nutritious and affordable foods to consumers—they also are in the business of providing their customers with safe products. And the results of the food processing industry’s commitment to food safety are clear: American consumers—and consumers of U.S. food products exported around the world—have an extremely high level of confidence in the safety of foods produced in this country.

This outstanding record of food safety didn’t just happen; it reflects the strong cooperative efforts among all stakeholders—growers, suppliers, processors, retailers and government regulatory agencies—to take those measures needed to enhance the safety of the food supply. The industry’s continuing commitment to food safety–coupled with a new, heightened emphasis on food security—will mean that consumers can continue to purchase and serve the foods they enjoy with confidence in their safety.

Read the sidebar "Where to Secure Information"

Rhona S. Applebaum, Ph.D., is Executive Vice President and Chief Science Officer for the National Food Processors Association (NFPA). NFPA is the largest U.S. food trade association, representing the $500 billion food processing industry on scientific and public policy issues involving food safety, food security, nutrition, technical and regulatory matters and consumer affairs. NFPA’s three scientific centers, its scientists, government affairs experts and professional staff represent food industry interests on government and regulatory affairs and provide research, technical services, education, communications and crisis management support for the association’s U.S. and international members. Visit www.nfpa-food.org for information on food safety and security issues.


 

Where to Secure Information

All food processors and handlers should visit the FDA website for more complete information and to download Bioterrorism Act related publications, compliance guidance documents and notices of interim final rules and public comment periods (www.cfsan.fda.gov). Essentially, FDA is actively working on the regulatory implementation of the following four provisions in Title III, Subtitle A of the Bioterrorism Act:

• Section 303: Administrative Detention.
“Authorizes the Secretary of Health and Human Services, through FDA, to order the detention of food if an officer or qualified employee has credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals. The Act requires the Secretary, through FDA, to issue final regulations to expedite enforcement actions on perishable foods.”

A regulation regarding this provision, which will provide for the means and methods for the detaining of foods suspected of terrorist tampering, has been proposed by FDA and is expected to be implemented by June 2004.

• Section 305: Registration of Food and Animal Feed Facilities.
“Requires the owner, operator, or agent in charge of a domestic or foreign facility to register with FDA no later than Dec. 12, 2003. Facilities are defined as any factory, warehouse, or establishment, including importers, that manufacture, process, pack or hold food for human or animal consumption in the United States.”

In October 2003, the agency published an interim final rule mandating every food facility, large and small, domestic and foreign, to register with the FDA by Dec. 12, 2003. Registration consists of providing information, such as the firm name, address, product brands and categories. Farms, restaurants, retail food establishments, nonprofit establishments that prepare or serve food, and fishing vessels not engaged in processing are exempt from this requirement. Also exempt are foreign facilities, if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S., or if the facility performs a minimal activity such as putting on a label. Other than these exemptions, states FDA, “the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.”

FDA, which anticipates approximately 420,000 food facilities to register under this mandate, expects that such a roster will enable the agency to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food.

• Section 306: Establishment and Maintenance of Records.
“Requires the Secretary of Health and Human Services to establish requirements by Dec. 12, 2003 for the creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food, (i.e., one up, one down). Such records are to allow FDA to address credible threats of serious adverse health consequences or death to humans or animals. Entities subject to these provisions are those that manufacture, process, pack, transport, distribute, receive, hold or import food. Farms and restaurants are exempt from these requirements.”

A regulation regarding the provision pertaining to record keeping has been proposed by FDA and is expected to be implemented by June 2004. The record keeping requirements will be phased in over an 18-month period from the promulgation of the regulation. This regulation will require the traceability of all foods, “one up, one down,” much as we have been doing in the organic industry for decades. However, the regulations require significantly more information and facilities will be required to respond with the records within four hours of requests made Monday through Friday, and within eight hours at all other times.

• Section 307: Prior Notice of Imported Food Shipments.
“Requires that prior notice of imported food shipments be given to FDA. The notice must include a description of the article, the manufacturer and shipper, the grower (if known), the country of origin, the country from which the article is shipped, and the anticipated port of entry. The Secretary of Health and Human Services, through FDA, must issue final regulations by Dec. 12, 2003.”

This regulation, which mandates that importers of food must give the FDA prior notice of every shipment of food before it can enter into the U.S, was published as an interim final rule in the Oct. 10, 2003 issue of the Federal Register. Issued jointly with the U.S. Bureau of Customs and Border Protection (CBP), the advance notification of what shipments contain and when they will arrive at our nation’s ports of entry is designed to help these federal agencies better target and conduct inspections of imported foods. The agency has estimated that it expects to receive approximately 25,000 such notifications per day.

Currently, FDA requires that companies must provide prior notice and receive FDA confirmation no more than five days before its arrival at a U.S. port of entry and no fewer than two hours before arrival by land via road; four hours before arrival by air or by land via rail; or eight hours before arrival by water. The agency indicates that this rule will have a phase-in compliance period through Aug. 12, 2004.

Categories: Management: Food Defense