Keeping pace with Bioterrorism regulations

To keep the U.S. food supply secure, the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act) went into full throttle on Dec. 12, 2003. Besides maintaining accurate records of where ingredients come from and where finished bakery foods are shipped, bakeries also must register their facilities in order to comply with the Dec. 12 deadline. However, FDA says stiff enforcement will be postponed for the time being.

Citing the possibility of a terrorism threat, FDA will be proactive in protecting the U.S. food industry. If food or ingredients are imported from other countries, it is more probable the products are affected by terrorist aggression, according to FDA. For bakeries and ingredient suppliers that receive their raw ingredients from overseas, the Bioterrorism Act will most affect their operations. It is important for high-volume bakeries to make sure their ingredient suppliers are fully registered and use prior notification procedures to ensure the safe import of ingredients, says Lee Sanders, American Baker's Association's vice president of regulatory and technical services.

"Bakers should set internal deadlines for their suppliers, if they do not, they should find new ingredient suppliers," Sanders says.

"We are happy someone is watching our country's borders, and has put something in place to monitor possible problems," Doug Wimberly, Butterkrust Bakery's president, says. "Our only concern is that some companies may try to take advantage of the situation and increase costs to us."

Prior notice and registration
To keep an imported food or ingredient shipment within accordance of the Bioterrorism Act, FDA must receive a prior notification of all human and animal food, drinks and dietary supplements imported or offered for import to the United States.

Before each shipment's arrival at the U.S. border, FDA must receive prior notification within two to eight hours of its arrival, depending on the mode of transportation. The prior notification responsibility rests with the company that is attempting to import the food product. However, FDA accepts prior notification from either the ingredient supplier or the high-volume bakery.

Prior notification can be completed with FDA's web-based system. FDA requires information on what the food or ingredient is, where it is coming from, who is sending it, and who is receiving it.

"Brokers have been doing this for years," Bob Lake, FDA's director of regulations and policy at center for food safety, says. "The real focus of the prior notice system is not to give us information we were not getting before; it is to give us information sooner. In the old system, we typically would not get that information until a week after the food was in the United States. Now we get it in advance of the food's arrival."

Keeping in line with the regulation, both ingredient suppliers and highvolume bakeries must be registered in order to send prior notification to FDA. In order to register, a bakery must receive an account number. Bakers can go to FDA's website (www.fda.gov) to start the registration process. A password also is given out with registration. FDA says that there is no charge and the process should take several minutes. Each bakery plant must be registered in accordance with the regulation.

Enforcing the regulation
FDA and Customs and Border Protection are not fooling around when it comes to regulation enforcement. Between Dec. 12, 2003, and Aug. 12, 2004, FDA says it will "communicate and educate" any company that is not registered or any ingredient supplier that does not send prior notification. However, if there is a category-one violation—credible evidence or information in the prior notification that indicates serious and adverse health consequences—the food shipment can be refused. The communication and education policy also affects companies that infringe category-two and three violations. These reflect repeated flagrancy and (or) intentional disregard for the regulations, according to FDA's Compliance Policy Guide.

On Aug. 12 2004, FDA and Customs and Border Protection will refuse food shipments of any ingredient suppliers refusing to send timely prior notification. During routine spot checks of food processing facilities and bakeries, FDA also will check to see if a facility is registered. If the bakery does not register after repeated warnings, FDA can file a lawsuit.

To gather information about the regulation's effectiveness, FDA and CBP plan to evaluate the eightmonth transitional period between Dec. 12, 2003 and Aug. 12, 2004.

FDA stresses that registration is important. With the terrorism threat continually looming, the U.S. food industry is moving in the right direction to prevent a future terrorist attack, according to FDA.

"If all information is filled out, the system will generate a registration number that is unique to that registered facility," Lake says. "FDA will not disclose that registration number to anyone else."

Q&A with Bob Lake, FDA's director of regulations and policy at center for food security How prepared do you think bakeries and the U.S. food industry are for the bioterrorism threat? Before September 11, 2001, we all had some level of concern, but we were not really focused on it. I think one thing that has happened since then, within government and within the food industry, is that there has been a lot more focus on security. Companies are paying more attention to who has access to their facilities, particularly their production lines. Generally, there has been a stepping up of security, but I don't know if everybody is where they ought to be yet. It is moving in the right direction. Will FDA be spot checking areas of the country to see if food processors have fallen in line with the Bioterrorism Act? We do inspections on a routine basis. Not all that frequently in the case of bakeries, but more so with other kinds of foods. As we do inspections, we will look to see if the facility is registered. In addition to that, if we start investigating a firm for other health violations, we will look to see if they are registered and then fold all of that together in any necessary action taken against them. What happens to a baker's product if it is contaminated and then contained by FDA through no fault of the baker? What are the steps involved? Lets assume it's a bakery product coming into the United States, if it is in violation of the law, we won't let it in. When products move within the United States, if we find a product contaminated in a way that could raise a public health concern, either because it contains a chemical or a pathogen, then as always (this predates the bioterrorism law), one of things we do, is suggest that the firm recalls the product. We also have the ability to go into U.S. courts and file a lawsuit against the bakery. Then the marshall would go out and take possession of the bakery foods. It is called a seizure. We don't care why it is contaminated, we just want to make sure the consumer is safe from the contamination. Ordinarily it is a court action and if any company thinks we are wrong, they can go into court and challenge it. If we prevail in a seizure, as we normally do, then those goods are destroyed. When will education stop and enforcement begin? It starts Aug. 12, 2003, and if people are ignoring it, within 6 months, we will do something about it. If we have told a company that is failing to register, then we will do something about that. What will FDA do exactly? For imported foods, failure to comply can result in the food being refused entry into the United States. Failure to comply is a prohibited act, and is susptible to court injunction or criminal prosecution. From our standpoint, people that know about the requirements are making attempts to comply. I think that will continue. The big players have figured this out. The most severe case is when someone is trying to get food into the United States without prior notice. Companies in United States don't need prior notice when shipping within borders. However, they do need to be registered. And FDA will periodically inspect firms, and will be checking to see if they are registered. What problems have surfaced with the Bioterrorism Act's regulations? The online system during the opening days had a few gliches and those have been fixed. There has been angst at what could happen at the border, but that is diminishing. We are getting questions about the regulations and those questions will be answered on the web shortly. Keep your eye on the web and we will answer them periodically.