Bioterrorism: Technology, Legislation, and Our Food Supply
Processors and the federal agencies involved in supplying food to the public work hard to protect our food supply from pathogens, contaminants, and outright mischief. The U.S. Department of Agriculture (USDA) and the Food & Drug Administration (FDA) have adopted and enacted a technique for ensuring food safety that, interestingly enough, was first developed by the National Aeronautics and S...
Processors and the federal agencies involved in supplying food to the public work hard to protect our food supply from pathogens, contaminants, and outright mischief. The U.S. Department of Agriculture (USDA) and the Food & Drug Administration (FDA) have adopted and enacted a technique for ensuring food safety that, interestingly enough, was first developed by the National Aeronautics and Space Administration (NASA) to keep astronauts from contracting food-borne ailments while traveling in space. That program and process is known as Hazard Analysis and Critical Control Points (HACCP).
Beginning in the late 1990s, the FDA and USDA rolled out a series of regulations that make HACCP programs mandatory in low-acid canned foods, seafood, juices, meat, and poultry. Other food industry companies are conducting voluntary pilot HACCP programs with the FDA to gauge their impact and effectiveness for products like cheese, breads, and cereals.
But no matter how clever and resourceful the dedicated professionals in the food industry are, there still may be one or two equally clever and resourceful people who aim to cause grief for as many innocents as possible. What do we do then, when a combination of unlikely events has taken place, and people are getting sick all around us? HACCP can't help us at that point; the problem will already be in our cupboards and refrigerators. How do we turn back the invasion?
Response and recovery
On Dec. 4, 2001, only weeks after the coordinated attacks of Sept. 11, U.S. Senator Bill Frist of Tennessee introduced Senate bill S. 1765, described as legislation "to improve the ability of the United States to prepare for and respond to a biological threat or attack." On Dec. 11, 2001, Representative Billy Tauzin of Louisiana introduced its companion bill to the U.S. House of Representatives, H.R. 3448, with its description broadened slightly as "a bill to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies." That winter, the bills were passed, merged, and reconciled into a single piece of legislation under H.R. 3448. President George W. Bush signed the bill into law on June 12, 2002, as the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL 107-188)."
The Bioterrorism Act touches many issues beyond terrorism and food supply. There are actually five major subdivisions or titles in the Bioterrorism Act of 2002 (see link in "Resources" sidebar for details). But the most important section directly affecting the food industry is: Title III—Protecting Safety and Security of Food and Drug Supply. Section 305 of this title calls for the FDA to implement regulations that "require any facility engaged in manufacturing, processing, or holding food for consumption in the United States be registered with (the FDA)." The FDA began requiring registration in early 2004 and expects to ultimately have over 700,000 sites registered, of which well over 100,000 will be outside the U.S.
Section 307 of Title III calls for the FDA to require that all food shipments into the U.S. be preceded by a "Prior Notice" that identifies the food articles, producer, grower, place of origin, and point of entry. This, too, was implemented in early 2004. "Prior Notice" documents for a shipment can be filed directly with the FDA on its Web site.
Finally, Section 306 of the Bioterrorism Act, titled "Establishment and Maintenance of Records," requires the Secretary of Health and Human Services through the FDA to:
Publish requirements for the establishment and maintenance of records needed to determine the immediate previous sources (IPS) and the immediate subsequent recipients (ISR) of food. The record-keeping requirements will be for a minimum of six months for foods with a shelf life of 60 days or less and two years for foods with a shelf life of more than six months;
Establish compliance dates based on the size of business, as determined by total employees in the entire business, not at individual sites. Firms with 500 or more employees must comply by Dec. 9, 2005. Firms with 11 to 499 must comply by June 9, 2006. Firms with 10 or fewer must comply by December 11, 2006;
Set penalties for failure to comply with the law;
Define failure to establish or maintain records, or provide access to them, as a "prohibited act" under the Federal Food, Drug, and Cosmetic Act, 21USC331. Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both; and
Take appropriate measures to ensure protection from disclosure of sensitive information. Recipes, financial data, personnel data, research data, and sales data (other than shipment data regarding sales) are specifically excluded. This is not about intruding into anyone's intellectual property. It's about minimizing the time it takes to respond to what could be a national emergency.
In addition, the president or chief financial officer of a publicly held company affected by the Bioterrorism Act may be obligated under the Sarbanes-Oxley Act to certify in its published financial reports that the company is in compliance with the new law.
FDA weighs in
After many months of impact analysis and dealing with hundreds of comments and issues raised by food processors around the world, the FDA published and made binding on Dec. 9, 2004, the new regulations under 21CFR Part 1 in a subpart titled: "Establishment, Maintenance, and Availability of Records 21CFR 1.326 through 1.368."
This new set of rules, collectively cited as 21CFR Part 1 Subpart J, is designed to provide a new tool for agency investigators responding to an emergency or crisis in the food supply. It essentially calls on each processing or distribution company in the supply chain to maintain records on receipts and shipments for just one link up and one link down in the supply chain from themselves, including the transporter who carried the shipment. The investigator will be responsible for making the full set of connections up and down the supply chain.
Those records on IPS and ISR (see "IPS and ISR requirements" sidebar) must be made available "as soon as possible, not to exceed 24 hours from the time of receipt of the original request" and retained for a specific period of time:
6 months for foods with shelf life of 60 days or less;
1 year for foods with shelf life of 60 days to 6 months;
2 years for foods with shelf life of over 6 months; and
1 year for animal feeds and pet food.
Some companies that implement electronic systems to meet the letter of the law may find that what they expected to be a pure out-of-pocket expense actually delivers a tangible return to the bottom line. Companies that would never dream of investing in a manufacturing execution system (MES) may find that their FDA-mandated record-keeping system has helped with federal regulatory compliance and enhanced several other plant management activities.
Some unexpected benefits may include improved order fulfillment, product quality, and capacity utilization by applying structured procedures to disjointed or paper-based manufacturing processes, as well as increased inventory management/visibility, elimination of paper records, and more consistent record keeping. Companies also may experience shortened product release cycles, more flexibility and agility in operations management, enforced production sequencing, and an established audit trail. Addition results can include tighter integration of materials management, process control, and quality management can result, as well as knowledge-management capabilities give time-stamped context to information and data.
Many who think they're simply buying an electronic record-keeping system as an insurance policy to comply with regulations will also find they've bought an investment portfolio.
Jay R. Jeffreys, P.E., is marketing program manager, Wonderware eCompliance Solutions, Invensys Wonderware;
Code of Federal Regulations (CFR titles):
The Congressional Record:
The Federal Register:
Findlaw for Laws and Codes (
FDA Bioterrorism Act information page:
FDA "prior notice" document filing:
NIH listserver email updates (
Sarbanes-Oxley Financial and Accounting Disclosure Information:
SEC rules under Sarbanes-Oxley:
Thomas US Congress active bills and status (
For background on the thought processes, scientific analysis, and practical tradeoffs behind the Bioterrorism Act, get a copy of Dr. Bill Frist's book , "When Every Moment Counts," Rowman & Littlefield Publishers 2002; ISBN 0-7425-2246-6.
IPS and ISR requirements
U.S. FDA 21CFR Part 1 Subpart J describes exactly what IPS and ISR records must contain. For non-transporters, such as food processing and distribution companies, the records on incoming shipments (IPS) must tell the agency:
Who—the name of the non-transporter IPS firm, address, phone, fax, e-mail;
What—a description of the food received, brand name, and specific variety;
When—the date received;
Which—lot or code number or other identifier "to the extent this information exists";
How much—the quantity and how it is packaged (such as 32 each, 25-lb carton); and
By way of—name of the transporter who delivered the food, its address, phone, fax, and e-mail.
For outgoing shipments (ISR), the record must answer those same who, what, when, which, how much, and by-way-of questions, as well as:
Made from—identifies the specific source of each ingredient used to make every lot of finished product.
Internal genealogy—could prove vital in an investigation to contain a serious problem in the food supply.