The Bioterrorism Act: The cost of compliance

September 2, 2004
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With the final rules yet to come, food and beverage processors are gearing up for the expected requirements while implementing the systems they hope will make them compliant.

As a nation, our vulnerability to a malicious or non-malicious contaminated food incident remains high due to terrorist threats and the global nature of the American food supply. We've witnessed beef and poultry industries here and abroad crippled by recurring incidents of mad cow disease and bird flu. And while food safety is clearly a top priority for our industry, the Bioterrorism Act and subsequent FDA enforcement bring new challenges. With good reason then, the US food and beverage industry is greatly anticipating the FDA ruling on recall and records. It is difficult to predict the full impact of the ruling and Bioterrorism Act on the food industry or individual companies. It is important for the food industry to understand not only the history of the legislation but also its potential impact on plant operations and food distribution.

Ultimately, the question is: what is the cost-to the food and beverage industry and to your plant-of compliance? Following the events of September 11, the FDA conducted a risk assessment on food terrorism and other food safety concerns. It addressed the broad range of hazards available to terrorists intending to sabotage food, as well as hazards that are accidental. The Centers for Disease Control estimates that 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths occur annually in the US due to food that has been inadvertently contaminated by pathogens. These figures translate into annual health care costs of $6.5 billion.

FDA's report offered proof of the growing number of incidents of malicious and non-malicious food contamination worldwide. It stated: "If an unintentional contamination of one food, such as clams, can affect 300,000 individuals, a concerted, deliberate attack on food could be devastating, especially if a more dangerous chemical, biological, or radio-nuclear agent were used." Such an incident would also have an enormous economic impact, since one in eight Americans' occupation is directly linked to food production.

Defining security

Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Often referred to as the Bioterrorism Act, it was signed into law June 12, 2002. The threat of bioterrorism has resulted in heightened security measures that include restricted facilities access, personnel awareness training, and security auditing.

"I have been accustomed to going through the back door of food manufacturing facilities to visit my customers," says Bill Wilson, vice president of Anderson Instruments. "Now I must go through the front door and sign in and out, often waiting for my customer to escort me in and out of the facility. Food security is a top priority now."

But there are many aspects of food security beyond facilities security, including ingredient and product packaging for tracking, tracing, and tamper proofing, as well as operating procedures and manufacturing methods. Many food companies are asking the following questions:

  • Will the current FDA and Bureau of Customs and Border Protection (CBP) security recommendations become mandatory?
  • Will food companies have to increase inventory of packaging materials and ingredients in anticipation of some delays at border crossings?
  • Will importers have to consider US warehousing of finished goods to compensate for delays at the border due to prior notice requirements or increased inspection and quality testing of "higher risk categories" of imported foods?
  • What will the new record keeping requirements cost?
  • Will food processing itself change to reduce potential contamination threats?

One thing is certain: The greater the risk or perceived risk, the more stringent regulations and accepted financial costs become.

Industry impact

In an exclusive interview with Food Engineering, Dr. Robert Brackett, director of FDA's Center for Food Safety and Applied Nutrition, discussed FDA initiatives and current thinking about how the agency plans to meet the intent of the Bioterrorism Act. He provided encouraging information regarding several areas of concern to the food industry and its suppliers, including the yet to be promulgated ruling on records and the commercial impact of the FDA and CBP focus on enforcement that began on August 12, 2004.

According to Dr. Robert Brackett, director of FDA’s Center for Food Safety and Applied Nutrition, FDA recognizes that over-mandating would likely reduce the ability of industry to meet the intent of the Bioterrorism Act. Source: FDA.

Regarding prior notice enforcement, the FDA may have overestimated the total number of facilities by nearly a factor of two due to mergers, acquisitions, and business closures. Most facilities required to register may, in fact, be registered. Therefore, the impact of enforcement on trade and commerce may not be as significant as many fear. This, plus the close working relationship between FDA and CBP, may allow the fast track C-TPAT and FAST initiatives to remain on schedule, paving the way for completion of the final ruling on prior notice in June 2005. Since these fast track programs only include Mexico and Canada, completion will allow the FDA and CBP to consider programs for more than 140 other countries exporting to the US.

The FDA says it cannot specify when the interim final ruling on records will be issued, leaving many in the industry concerned about what to do today. But Dr. Brackett indicated that FDA has received much industry input, including questions and concerns stated earlier in this article . Based upon industry input, FDA recognizes this future ruling is different and over-mandating would likely reduce the ability of industry to meet the intent of the Bioterrorism Act.

The FDA also recognizes that most companies currently keep tracking and tracing records, so the ruling on records may not be so urgent. According to Dr. Brackett, FDA is not currently planning to include any product quality data in these records. Further, the law states that the FDA must show credible evidence that the product poses a threat of serious adverse health consequences or death to humans or animals before any request for records can be granted. FDA is working with industry officials to resolve how inspectors can verify that companies comply with the ruling in light of this aspect of the law. This is an issue that both government and industry want to resolve, Brackett says.

FDA does not look at Import Prior Notice Records as a basis for any stepped up quality auditing of imported foods. However FDA may be stepping up auditing of specific categories of imported foods it feels would pose higher risk under the imported foods initiative. With more than 600 new inspectors, FDA has the capability to increase monitoring. As a result, some foreign companies are considering US-based warehousing. However, it is too early to determine if that will be necessary.

Increased global regulation

The US Bioterrorism Act is only a part of a global effort to improve food safety and protect public health through improved tracking and tracing. Recent regulations or initiatives include: Australian Beef Traceability 2001, European Union (EU) Beef Traceability 2001, EU Genetically Modified Organisms (GMO) Traceability 2003, Japanese Beef Traceability 2003, Canadian Beef Traceability 2003, and EC Regulation 178 on Food Safety.

Effective January 1, 2005, EC Regulation 178 Articles 18, 19, and 20 are expected to have a dramatic impact on the European food and beverage industry. In fact, a summary of Article 18 of the EC Regulation 178 is similar to the requirements of the US Bioterrorism Act:

  • businesses must be able to identify from whom they have received any products
  • businesses must be able to identify to whom their products have been supplied
  • businesses must have in place tracing systems and procedures
  • tracing information must be made available to the competent authorities on demand
  • traceability must be guaranteed at all stages of production
  • products must be adequately labeled or identified.

Both regulatory and business requirements for improved tracking and tracing systems continue to increase throughout the world's supply chain from the farm to the fork. While there is certainly room for improvement, food safety has been and continues to be a top priority. Paul Moylan, Rockwell Automation's food industry manager, agrees. "In one-on-one conversations with food manufacturing executives in China, India, Europe, and Latin America, I consistently hear that tracking and tracing is a critical issue," he says. "Food manufacturers all around the world recognize the need for responsive and responsible food safety systems."

Better tracking and tracing systems, security technologies, and operating procedures come in all shapes and sizes. Cost and ease of use continue to improve as technology suppliers respond to increasing requirements to protect the US food supply chain and consumers.

As a result, new electronic tracking and tracing systems are quickly replacing traditional paper records systems in both large and small food manufacturing operations. These systems are helping manufacturers increase food safety and quality, reduce costs, increase productivity, and meet increasing regulatory requirements. In addition, they are increasing visibility into manufacturing operations and providing information to achieve operational excellence through effective continuous improvement programs. They are also eliminating many inevitable and often costly human errors. In fact, security technology has improved so dramatically that it is proving more effective and less costly than traditional security personnel. Electronic tracking and tracing systems and plant security systems are proving to be a business benefit rather than a business cost.

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