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Wonderware® eCompliance Solutions have been developed specifically to enable food processors to quickly and affordably address the US Food and Drug Administration's new requirements for establishment, maintenance, and availability of records for all food processing, transportation and distribution companies. The new regulations are known as 21 CFR Part 1 Subpart J and were made effective in December 2004. The FDA was required to develop the regulations by the “Public Health Security and Bioterrorism Preparedness and Response Act” of 2002, commonly known as The Bioterrorism Act, to protect the nation's food supply in the event of a terrorist attack or other incident.

Every food-processing company in the U.S. , excluding farms and restaurants, is required to follow these regulations, which require food companies to keep and make available to the FDA records that include information which identifies the specific source of each ingredient used to make every lot of finished product. The Bioterrorism Act and these FDA regulations also impact international organizations that import or export food or other biological products to the United States.

Wonderware recognizes that manufacturers will likely want assistance in providing the FDA with the information demanded by the Bioterrorism Act and the record keeping requirements of 21 CFR 1.326 through 368. Therefore, we have dedicated our resources to providing eCompliance solutions that are:

Affordable
Secure
Paperless
Easy to use
Quick to deploy

Wonderware can assist food-processing companies to comply with the regulations associated with the Bioterrorism Act by explaining the relevance of new terms like IPS and ISR and giving them the tools they need to provide precisely the right information as soon as possible, not to exceed 24 hours from the time of receipt of the original request. Wonderware is also prepared to help smaller companies not immediately affected but who may be asked by large merchandisers or wholesalers to achieve compliance much sooner than the law requires.

The FDA and The Bioterrorism Act

In the event of a bioterrorist attack, the FDA must be able to connect all the links in the supply chain – from the source of a biological threat to its possible destinations in our food supply. This will affect literally thousands of food processing operations of all sizes. Based on the comments submitted to the FDA, many are deeply concerned about their ability to manage and sort through two years' worth of paper records on sources and destinations of all their raw materials and finished products.

The Historical Perspective

On December 4, 2001, only weeks after the coordinated attacks on September 11th, U.S. Senator Bill Frist of Tennessee introduced Senate Bill S. 1765, described as "a bill to improve the ability of the United States to prepare for and respond to a biological threat or attack." On December 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 in their respective chambers, merged and reconciled back into a single piece of legislation under H.R. 3448. That Act was then signed into law by President George W. Bush on June 12, 2002 as the:

Public Health Security
and
Bioterrorism Preparedness and Response Act of 2002

Section 306 of that Act, titled Establishment and Maintenance of Records, required the Secretary of Health and Human Services through the Food and Drug Administration 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 to two years for foods with a shelf life of over six months.
Establish compliance dates based on the size of business. The size of the business is determined by total employees in the ENTIRE business, NOT each individual site.
- Firms with 500 or more employees must comply by December 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.
- Failure to establish or maintain records, or provide access to them, is defined as a "prohibited act" under the Federal Food, Drug, and Cosmetic Act, 21USC331.
- Penalty for those prohibited acts is defined in 21USC333: "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."
Take appropriate measures to ensure protection from disclosure of sensitive information. Information such as 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 CFO of a publicly held company affected by the Bioterrorism Preparedness and Response Act of 2002, may have an obligation under the Sarbanes-Oxley Act to certify in their published financial reports that their company is in compliance with the Bioterrorism Preparedness and Response Act of 2002.

After many months of impact analysis and dealing with hundreds of comments and issues raised by food processors around the world, in December 2004 the FDA published and made binding the new regulations under 21CFR Part 1 Subpart J, titled

"Establishment, Maintenance, and Availability of Records"
21CFR 1.326 through 1.368

To find out more about this national security initiative, how it affects your company and how Wonderware eCompliance Solutions can help insure compliance, simply call Q-mation.