Bioterrorism Act: Burden or Benefit?
The event that has come to be known as 911 changed forever the American way of life. Around the world, in an instant, people recognized their vulnerability to catastrophe. In its wake grew new policies, procedures, and laws to attempt to prevent, or at least mitigate, future incidents. Among the most notable of those measures is the Bioterrorism Act of 2002, the basis for regulations governing ...
The event that has come to be known as 911 changed forever the American way of life. Around the world, in an instant, people recognized their vulnerability to catastrophe. In its wake grew new policies, procedures, and laws to attempt to prevent, or at least mitigate, future incidents. Among the most notable of those measures is the Bioterrorism Act of 2002, the basis for regulations governing tracking and tracing of food, beverages, pharmaceuticals, and other potential bioterrorist targets.
What is less often mentioned, however, is that awareness of biohazards and bioterrorism began long before 911. Deliberate tampering with products (the pain-reliever scare of two decades ago) and unintentional acts resulting in illness (the more-recent, unwitting tainting of green onions), while thankfully infrequent are certainly not unheard of.
In most cases, industry has responded responsibly. In fact, until the Bioterrorism Act, recalling a product was not mandatory . If there was a question about an adulterated product, the company involved made the decision to act. Action, by and large, was motivated by a desire to stay in business.
Today, the Bioterrorism Act gives the government the power to impound a product. Yet, overall, companies continue to respond responsibly, most continuing or extending existing efforts to protect the consumer. As a result, they are complying with the Act and, sometimes surprisingly, incurring unexpected benefits in efficiency and optimization.
On the compliance track
"A lot of these tracking and tracing activities would be taking place even if the Bioterrorism Act weren't in place," says Charley Rastle, beverage industry marketing leader, Rockwell Automation. "The law has simply opened doors to look at these systems, to re-evaluate them. Plants know an investment in regulatory compliance is a necessity, but they're also looking to get a return on their investment as well."
Pat Martin, product manager, batch and MES at ABB Inc., agrees. "I suspect most major manufacturers have mechanisms already in place for forward and backward material tracking. For some, the regulation may provide impetus to update or install new systems. There are a number of new solutions available today to help customers comply with requirements for material tracking and electronic record keeping, as well as improve overall batch consistency and traceability. The FDA Website is a good starting point for information about the regulation and how to comply." (See the "Resources to learn more" sidebar for the site address and more.)
Specifically, the Act requires the U.S. Food and Drug Administration (FDA) to, among other things, register all food-processing companies and establish maintenance and rapid access to all food-processing records. Record-keeping requirements mandated by Title III in essence require manufacturers to establish and maintain records that identify "the immediate previous sources and immediate subsequent recipients of food." Large manufacturing entities (those with more than 500 full-time equivalent employees) were required to comply by December 2005.
Small (those with 11 to 499 FTE) and very small (10 or less FTE) manufacturers have until June and December 2006, respectively, to comply. The record-retention period varies from six months to two years and is a function of food perishability. Companies must be prepared to provide records within 24 hr of a request for information.
Automation, controls, software
"Software solutions are a good answer" to compliance to the Bioterrorism Act, says Jay Jeffreys, marketing program manager, eCompliance Solutions, Wonderware. "An electronic system makes everything accessible in seconds."
According to Jeffreys, people are still in a wait-and-see mode. (It's only been a short time since the first compliance date: Dec. 9, 2005). "Manufacturers need to understand that this is not going away," he warns. "Right now, the FDA has no audit process in place. Discretion is left to the local or regional FDA inspector. But I would say the FDA is not going to be on the understanding side if or when something happens. Records better be in order."
Craig Nelson, founder and CTO of Vigilistics Software and an FDA consultant, supports Jeffreys view. "The FDA is very serious that this regulation has to be enforced," says Nelson. "Any accidental incidents that have happened in the last year or so are being treated as potential bioterrorism threats. If an antibiotic slips into milk, or a potential recall occurs, the FDA is treating the episode as if it could have been an intentional adulteration."
Nelson describes something of the development of the law. "Laws are written to be interpreted," he says, "and that's a good thing. It increases flexibility. A lot of trace and recall, like a lot of regulatory matters, depends on automation and controls engineering to bring information together to accomplish the federal mandate. Inspectors are trained in microbiology and in regulations, but they're not as strong as they should be on automation and controls. I'm working with them to help prepare inspection checklists and guidelines, and to show them how to interpret regulations based on a better understanding of automation in manufacturing in today's world."
One of the biggest problem areas of Bioterrorism Act compliance, says Nelson, is the extent of variations in how operations are controlled, how information is gathered, and how each plant meets those regulations. Right now, we're trying to standardize compliance efforts throughout the U.S. The FDA can't tell companies what software to use or what methods to use, but they can say, 'Here's the objective you need to accomplish.'"
The FDA requires manufacturers be able to trace anything that could be tainted or adulterated biologically. Remedial systems should be all-inclusive, says Nelson, "a broad-arms approach, if you will. Food and dairy manufacturers, for one, do a lot of mixed lots and co-mingling. If several small batches are combined into one large one, the plant monitoring program needs to embrace the entire batch, all the ingredients. Assumption must be that it all could be bad. This is a conservative approach, but it provides the highest level of protection for the American public."
Nelson admits, and the FDA concurs, that the "broad arms" approach could have an adverse affect on the economic health of an affected company. "It could lead to a huge recall for the primary company," he observes, "and affect maybe 50 to 100 other manufacturers who may not have an adulterated product, but who would have to be included in the recall until they could prove exclusion. In that length of time, a lot of manufacturers could incur problems."
Ideally, says Nelson, trace contaminations could be excluded. "If the amount was small, if the part per billion concentration level was small enough, those items would not require recall. But such action would need to be done very quickly, say, within an hour. A plant needs to be able to show which products have a high concentration of suspected material, which have trace contamination, and which are positively unaffected, and need to have proof to support their claims. Such activities could never be done manually. They would have to be done electronically."
Enforcement officials will want to obtain enough information to do a targeted recall. They want to be able to determine the ingredients causing a problem fast so that they can determine commonality. Where, or what, is the common denominator?
"Maybe the commonality isn't a product, but several," points out Nelson. "Maybe it's a trucking company, a truck stop, or a food additive that has found its way into many products."
Going beyond the law
The law has spoken, says Wonderware's Jeffreys, and now that it has, it is time to look past it. "The electronic system we put in as an insurance policy may actually be an investment portfolio," he surmises. "A system can pay for itself by helping improve operations; find bad suppliers, bottlenecks, mismatches between ingredients and equipment. Once you realize what's sitting idle, which operations take the longest, and what has the lowest yields, you can improve your system and increase your overall profit margin on the cost of doing business."
Rockwell's Rastle adds that most major companies have made significant investment in business systems over the past five years. These systems have helped, he notes, but business needs to get an even greater value from these investments. He explains: "That greater value is coming from linking the factory floor to the business systems. The Bioterrorism Act, specifically tracking and tracing, requires no quality analysis on the raw material, only the recording of the lot numbers. Whether we're making beer or cookies, we need to record lot numbers. But if we add information, we have a real opportunity to improve efficiency in our operations."
He uses a mixing operation as an example. "If you monitor lot numbers and actual quantities, then you're tracking inventory. You have an opportunity to update your business systems on a shift, even hourly, basis, instead of monthly. The result might be reduced stock. The company can order exactly what is needed. There won't be any time when the plant can't produce because it has run out of an ingredient."
Results include increased flexibility and responsiveness and optimized production. More than that, continues Rastle, it helps maintain quality, which is a growing concern in a global environment. "Food has to taste the same from area to area. Good tracking and tracing can help ensure that. Why does this batch taste different? What happened? What temperature was used? How long was it cooked, baked, or blended? Capturing those kinds of data can yield better product, and probably lower costs, as well as compliance."
Bioterrorism legislation can help everyone focus on what can be done within our infrastructure to protect people and the environment, says Marilyn Guhr, Cyber Security marketing and business development manager, Honeywell, adding that the legislation is important because it draws people's attention to the problem.
But physical security and safety are closely related issues, Guhr insists, and recommends manufacturers perform a security assessment at least annually. Many plants, she notes, find such an assessment uncovers unexpected points of vulnerability. Data are critical to Bioterrorism Act compliance. "Problems can arise from connecting your process control network to the corporate network," she warns. "Open ports on a system can give access to areas that should be secured. How well are your data backed up?"
It's all about return
Nothing matters without good data from the plant floor. Whether a company's goal is to comply with the Act, ensure uniform taste and quality in its products around the world, maintain inventory at precision levels, or optimize operations, it is data that will provide competitive advantage.
The trend is to install information management systems—for compliance and more. Automation and data collection systems today are far superior to those available even a few years ago. "It's not enough just to have good DCSs, or good controllers," insists Rockwell's Rastle. "A company needs a systems approach, an integrated architecture, a single platform. Then, data are collected in the same way, every time. It's not enough to have great software. It needs to be deployed in a way that will work for your operation."
And making it work is what is critical. Vigilistics' Nelson notes that the FDA enforces regulations in two ways:
Voluntary cooperation . Regulations are published and manufacturers strive to put best practices in place and comply because it's the right thing to do.
Instant enforcement . An incident occurs and the government immediately finds a way to enforce the law and impose penalties.
"The Enron scandal and resulting Sarbanes-Oxley Act is one example of the second approach," he says. "Laws didn't change significantly, but how they were enforced did. Laws acquire teeth. The second approach hasn't happened with the Bioterrorism Act yet."
If we're lucky, maybe it never will.
Are you ready for a recall?
The following guidelines are being taught to FDA and USPHS ratings officers to help them quickly narrow the search for an adulterated product. Fast discovery is especially significant in the case of dairy and food products manufactured in environments where lots are mixed and byproducts created and reused or sold to other manufacturers.
A good preparedness system should:
Include all products that could be affected;
Exclude products that could not be affected; and
Prove dilution or concentration of affected products.
Inclusion of affected products
One of the most important things the FDA wants to see when conducting an investigation is that the manufacturer can accurately include all products that could have been adulterated by the incident.
These elements should include:
Residual product left in a tank, silo, or processing equipment between qualified, full washes or CIP (clean-in-place) operations;
Residual product that could have been left in pipes or valves, even in minor amounts, between qualified, full washes on that CIP circuit;
Residual product left in a transport container, including tanker trucks, totes, and bins;
Any points of possible contamination, such as caused by cross connections of pipes, overflows, pressure relief valves, or bypasses.
Manufacturers can do this simply by including all products that could have been in storage and processing during the suspected time frame of the adulteration. Although this approach is commendably cautious, it doesn't build confidence that the correct products have been identified. It also doesn't allow investigators to identify quickly a common factor in all ingredients across multiple manufacturers.
Exclusion of unaffected products
It is equally important for a manufacturer to be able to exclude all products that could not have been adulterated. This effort should consist of:
Bulk dry or liquid materials added to a storage tank or silo after a downstream destination has changed;
Products made in any equipment after a full wash or CIP has been completed;
Product that could not have physically co-mingled with any other. Mix-proof routing valves and physical pipe connections are examples of physical breaks that make cross contamination impossible.
Ability to exclude products reduces the affect of the recall and allows isolation of suppliers and customers. This could be the one factor that allows your company to return to business quickly after an event.
Dilution or concentration of affected products
This information is typically the most difficult for manufacturers to furnish, but will reduce impact of the investigation and recall to the greatest degree. Being able to say quickly and accurately which products have the highest concentration of suspected ingredient, which have lower concentrations, and which have none will give investigators confidence in handling the event. These data can be gathered by:
Tracking electronically all movement of materials and products in manufacturing;
Placing meters in strategic locations to monitor bulk materials flow; and
Tying metered flow to lot genealogy accurately.
If meters are in the right places, investigators can estimate the percent dilution for each scenario. These products can be tested and any recall significantly reduced. A system needs to enable this investigation to occur within a few hours to give confidence that it can be trusted.
Ratings officers and inspectors are being taught these three simple guidelines. More detail and substance will be added to the training over time. Trace-and-track compliance with the Bioterrorism Act is a responsibility we all need to improve to protect the food we eat and the beverages we drink, for ourselves and for our children.
Craig Nelson, founder and chief technology officer, Vigilistics, Inc., has been teaching within the FDA and US Public Health Service for more than 12 yr. He is a recognized expert on federal regulatory affairs and their impact on dairy and food manufacturing automation. He is an author of the 2005 PMO (pasteurized milk ordinance) "Criteria for the evaluation of computerized systems for grade 'A' public health controls."
Resources to learn more
A great deal of information about the Bioterrorism Act and related issues is available on the Internet. Here is a brief selection of sites to visit to get started.
The Federal Register
Code of Federal Regulations - CFR titles
The Congressional Record
SEC rules under Sarbanes-Oxley
Sarbanes-Oxley Financial and Accounting Disclosure Information
Library of Congress
European Parliament EC 178/2002
When Every Moment Counts by Sen. Bill Frist, M.D. (