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The Bioterrorism Act Section 306 -- What you need to know

What is section 306 of the Bioterrorism Act?
The Bioterrorism act of 2002 is far reaching legislation enacted in response to the 9/11 terrorist attacks on the United States. The purpose is to ensure the safety in the nation’s food supply. President Bush signed the Bio Terrorism act into law on June 12, 2002. The Bioterrorism Act includes a provision, section 306, which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding Maintenance and Inspection of Records requirements for the food industry. The goal of this legislation is that by requiring those who manufacture, process, import or pack food to create and maintain accurate records that show what ingredients and lot numbers were used, in what product they were used in and where, or to whom, the product was shipped. With this systemic approach to record keeping the aim is that in the advent of intentionally or inadvertently tainted food items Federal agencies can quickly trace the affected items and remove them from the food supply chain.

Who does it apply to?
Any individual, partnership, corporation, or association who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States are subject to these regulations. This covers a broad spectrum of business from the obvious such as large industrial bakers and food processors to the less obvious such as breweries and distilleries. In brief, if a company is producing edible or drinkable products, they must comply with the BTA and specifically section 306 maintenance and inspection of records. Exceptions have been granted for restaurants, farms, and institutional food service and not for profits, such as community food banks or soup kitchens.

Who are the regulating or enforcement agencies?
The Federal Food and Drug Administration (FDA) under the direction of the Secretary of Health and Human services is the agency that will inspect, monitor and enforce compliance. It as also assumed that the USDA under it’s authority from the Federal Meat Inspection act, Poultry Products Inspection act and Egg Products Inspection act will also be involved in the inspection and enforcement process.
In summary, food manufacturers must record what ingredients are in the products produced, use lot numbers to identify where these ingredients came from, identify what batches these ingredients are in and where these batches or finished product are shipped to.

How does section 306 fit in with HACCP?
Hazard Analysis Critical Control Points or HACCP is a systematic approach to ensure food safety. Government inspectors such as USDA or FDA review the HACCP documentation upon request. Many now consider the BTA 306 requirements as part of HACCP.

When Does Compliance to BTA Section 306 Become Mandatory?
Sub Section 1.368 states “The compliance date for the requirements in this subpart is December 9, 2005. However, the compliance dates for small and very small businesses are contained in paragraphs (a) and (b) of this section. The size of the business is determined using the total number of full-time equivalent employees in the entire business, not each individual location or establishment. A full-time employee counts as One full-time equivalent employee. Two part-time employees, each working half time, count as one full-time equivalent employee. (a) The compliance date for the requirements in this subpart is June 9, 2004, for small businesses employing fewer than 500, but more than 10 full-time equivalent employees. (b) The compliance date for the requirements in this subpart is December 11, 2006, for very small businesses that employ 10 or fewer full-time equivalent employees."

What Role Can a Scale Play in BTA 306 Compliance?
In most food processing applications the scale is a critical component to the process. It is where minor and major ingredients are weighed and formulas or recipes are controlled. The Scale can be and should be a critical part of ensuring accuracy, quality and efficiency. Because the weighing component is a focal point in these applications it is an obvious choice for BTA 306 compliance efforts. Instead of using the scale solely for process control or SPQC it can be used to track ingredients, lot numbers and batch ID’s. While a natural assumption is that “large” business are most affected and have the most funds available for BTA compliance, small and very small business in total represent the largest segment of the market.

What Solutions Do You Offer?
One of our manufacturers, Doran Scales offers two solutions for BTA 306 compliance:

2200 Advanced Weight Indicator
The new 2200 Advanced Weight Indicator is an ideal solution for small and very small business. The 2200 is configured with a Barcode Scanner (PN: MSCO173) and wired (PN: EXOPT101) or wireless (PN: EXOPT102) Ethernet option. As the operator prepares a batch of product they enter the batch number and scan in the Product UPC code or ID number and Lot number. Pressing the PRINT button
sends this information along with the Net Weight, Time and Date to an Excel worksheet using Doran’s Excelerator Data collection program. An ideal and very cost effective means for smaller companies to comply with the requirements of the Bio-Terrorism act Section 306.

FC6200 Formula Control Scale
The FC6200 Formula Control Scales is an advanced indicator or scale system to assist formula creation and recipe control for food based batching such as: Bakeries, Final Meat Processing or Spice. The FC6200 also is well suited for any formulation of industrial products, including Ink, paint, glass and many other industrial formulations. Developed over the last three years in conjunction with some of the top names in the industry to address the specific and challenging needs of Hazard Analysis and Critical Control Points (HACCP) Bioterrorism (BTA) Section 306 as well as improved productivity and product quality. Doran’s FC6200 provides outstanding benefits; by stepping the operator through the formula and assisting multitasking operators. No more missed ingredients or ingredient weights outside of desired tolerance and lot ID’s are recorded. Use of the FC6200 significantly reduces the chances of producing bad batches, keeps a digital record of all batches and lot numbers, formatted for Excel spreadsheet viewing. In the event of a problem, the FC6200 reports are easy to search for tainted lot ID’s in minutes, not days.

For additional information on the BTA go to www.fda.gov or
http://www.cfsan.fda.gov/~dms/frrecord.html