The U.S. Bioterrorism act of 2002 is playing a major role in the worldwide food industry. With the U.S. Food and Drug Administration having authority over about 80 percent of the U.S. food supply, the Bioterrorism act has more impact on the worldwide food and beverage industry than all other regulations combined. While limited exemptions exist, the law is intended to be broadly applied to all companies that manufacture, process, pack, hold, transport, distribute, or receive regulated food products. It is estimated that the U.S. Bioterrorism act covers more than 400,000 U.S. and foreign facilities. Under this act, there are several new regulations to which food and beverage companies must comply. Two areas of the act have significant impacts on operations.
Establishment and maintenance of records
Companies must establish and maintain a record of the source and destination of ingredients and products. This is called the ‘one-up and one-down’ rule. When the FDA requests information, companies have four hours to respond to FDA inquiries.
Food importers must notify the FDA at least one day before a shipment arrives in the United States, disclosing details on the shipment and the contents and estimating the arrival time.
Global regulation fundamentals: tracking and tracing
The capacity to track (farm to fork) and trace (fork to farm) details per product or per lot is critical. Tracking and tracing is the core of most global regulations. The capability to track a product from farm to fork or using the ‘one-up and one-down’ rule combines collecting appropriate information, organizing the information, and retrieving it as required.
The components tracked often include much more than just final product or ingredients. The tracking procedure begins at receipt of materials. The date and time of receipt is recorded along with product name, shipping data, and supplier lot number. Quantity is recorded before the material is stored.
For a manufacturer, consumption must be recorded to link the consumed material to the end-product lot. This includes ingredients (such as flour, spice, and nuts) and packaging material (such as bottles and plastic wrap). Any equipment (such as weigh scale, mixer, or oven) that comes into contact with the ingredients in the creation of the intermediate or final products must be recorded.
The food manufacturers’ and distributors’ shipping information must be recorded, including lot numbers and selected shipping details. This data provides the final link for ‘one-up and one-down’ tracking.
Compliance in small and mid-sized companies
Other than a few differences in compliance deadlines, food-safety compliance regulations apply to all companies without regard to size. Therefore, small and mid-sized companies have the same requirements as large companies but with significantly fewer resources.
Regulations demand the collection, organization, and retrieval of information. For all but the simplest food companies, a manual recording approach to compliance is nearly impossible. Examples of simple food companies include a manufacturer with a very limited product line, few ingredients, a simple process, and few customers; or a distributor with a limited product line and few suppliers and customers. The vast majority of food manufacturers and distributors do not fit this definition.
For these companies, reliance on computer systems is necessary for successful compliance efforts. The core of every compliance effort is a company’s Enterprise Resource Planning (ERP) system. Computer systems can assist in collecting the information required. Computers can do an outstanding job of organizing data and producing the information required in a timely and organized fashion. For example, meeting the four-hour requirement established by the U.S. Bioterrorism act.
Large companies can afford complex, standardized, and expensive compliance solutions. Small and mid-sized companies need compliance options that are both affordable and effective.
TBS Automation Systems offers a wide range of solutions to help you meet the U.S. Bioterrorism requirements.