Companies offering free consultation on FDA regulation 306 compliance

Published 27 January 2006

Sarbanes-Oxley created a veritable compliance industry, and the 2002 Bioterrorism Act, requiring the registration of 27 different kinds of farm and home animals, is creating another compliance industry

The need to register and keep records of farm animals is one of the central elements of the Bioterrorism Act of 2002 (not only farm animals — see story below). Just as Sarbanes-Oxley has created a small industry offering compliance solutions to businesses, FDA regulation 306 — prompted by the Bioterrorism Act — has created a small industry offering farm livestock compliance solutions. The emergence of such industry is not surprising given the taxing demands of animal registration requirements (see HSDW 1/11/06 ). Greenville, South Carolina-based Operations Technologies (OT) is one such company. It provides inventory, manufacturing, documentation, and traceability solutions for food and beverage manufacturers. Large companies were required to be compliant with the 2002 Bioterrorism Act by this past December. June 2006 is the deadline for compliance for medium-sized companies (those with more than ten and fewer than 500 full-time employees company-wide). Failure to comply is a prohibited act, subjecting companies and managers to civil as well as criminal actions.

OT is clever in the way it goes about promoting its solutions. Dave Miller, president of Operations Technologies, says the company will begin conducting complimentary phone conferences for U.S.-based companies to help determine levels of compliance. “There is a lot of confusion among food and beverage producers about what is actually required by FDA 306, and we wanted to offer a way for organizations to get a quick understanding about their level of compliance,” said Miller. Miller is a veteran in the development of traceability and documentation software. There is little doubt that companies, especially the smaller ones, would need some hand holding as they try to cope with the regulation. “The need is great because the alternative means wrestling your way through the regulation itself and trying to understand what you need to do — our people have already done that and are well prepared for this process,” stated Miller. Companies participating in these phone conferences have no cost or obligation to Operations Technologies.

-read more in this news release