FDA's New Controls On the Food Industry

Saint Petersburg, FL - June 20, 2011)

The FDA and the U.S. Centers for Disease Control and Prevention have been aggressively monitoring the recent outbreak of E. coli O104 and tracking any illnesses in the U.S. that may be related to the outbreak. However, both consumers and industry in the United States want to know how the FDA plans to prevent the same issues in this country.

As an immediate action, the FDA has initiated import controls where these fresh vegetables coming from out of the country are sampled and tested prior to release into the U.S. In addition, the Food Safety Modernization Act, signed into law in January, gives the FDA new authority related to the prevention of foodborne illness. As part of this act, the FDA is currently developing regulations that will require food processing facilities to generate and implement plans that will reduce the risk that food will be contaminated. The FDA expects that these new rules will be completed by the beginning of 2012.

Advanced Biomedical Consulting (ABC), LLC, a leading quality and regulatory compliance consulting firm, expects that the FDA's actions as part of the Act will focus on new

complicated regulations with which food processors will need to comply. Jonathan M. Lewis, a principal with ABC, expects that food processors will be subjected to new regulations that are more consistent with current good manufacturing practices (cGMPs) for pharmaceutical and medical device manufacturers than what is currently expected for food processors. Lewis states, "For example, we expect that thorough risk assessment programs will need to be implemented by food processors to identify potential issues for contamination. The most common programs often consist of Failure Modes and Effects Analyses (FMEA) or Fault Tree Analyses (FTA). ABC also expects that processors will be expected to formalize processing facility programs for:

•Gowning and Hygiene

•Equipment and Facility Cleaning and Cleaning Validation

•Facility and Equipment Maintenance

•Internal Audits

Lewis also stated that in the FDA's current thinking, "formalize" should be interpreted by industry as documenting the programs (i.e. writing preapproved procedures and associated forms), training resources associated with those activities (and documenting the training), and periodically assessing the programs to ensure effectiveness.

While ABC, LLC does not expect a massive industry crackdown by the FDA immediately following implementation of the new regulations, the company expects that the FDA will act swiftly and come down hard on a subset of U.S. food processors to set an example for industry and let the American public know that the FDA is "doing its job".

Saint Petersburg, FL - June 20, 2011)