Earlier this week, I presented a webinar to the American Cheese Society entitled the "Food Safety Modernization Act and Product Liability." A link to the presentation is here. The presentation covered a number of topics and included a discussion of the so-called "Tester Amendment" to FSMA.
The "Tester Amendment" in section 103 of FSMA "exempts" from the hazard analysis and risk-based preventative controls requirements in section 103 certain "Qualified Facilities." To be a "Qualified Facility" you have to either (1) be a "Very Small Business" or (2) have "Limited Annual Monetary Value of Sales."
FSMA leaves it to FDA to define by regulation a "Very Small Business," so we have little guidance now on what this means.
FSMA does define what it means to have "Limited Annual Monetary Value of Sales":
a. You have average annual sales (over three years) of less than $500,000 (adjusted for inflation); and
b. Your sales to "Qualified End Users" exceed sales to others.
"Qualified End Users" mean consumers or restaurants/retailers located in the same state or within 275 miles from your facility who are selling directly to consumers.
BUT even if you qualify for the exemption to the hazard analysis and risk-based preventative controls, understand that it is not truly an exemption. Even qualified facilities will still have to provide documentation to FDA that either:
a. demonstrates you have “identified potential hazards associated with the food being produced” and “implementing” and “monitoring” preventative controls; or
b. “as specified” by FDA shows compliance with “State, local, county, or other applicable non-Federal food safety law.
A "Qualified Facility" also must provide to FDA “Documentation, as specified by FDA in a guidance document that the facility is a qualified facility.”
Hazard analysis and risk-based preventative controls provision of section 103 of FSMA will become effective in June 2012 irregardless of whether FDA completes its rule-making process.
SAVE THE DATE FOR THE ABA'S FOOD & SUPPLEMENTS FIRST ANNUAL WORKSHOP AT COCA-COLA IN ATLANTA THIS WINTER
Thursday, February 17, 2011 - Hosted by The Coca-Cola Company.
Please save the date for this first annual one-day CLE workshop sponsored by ABA’s Food and Supplements subcommittee that will include panels on the impact of federal statutory and regulatory reform on the food industry, state consumer laws and consumer class actions related to food packaging, labeling, and marketing, the evolving science of food safety and technology, ethical considerations in the labeling of bioactive foods, and in-house counsel's top predictions for the future of food regulation and litigation. Leslie M. Turner, General Counsel for Coca-Cola North America, will speak on "Protecting the Brand in the Food Industry" at our networking luncheon and a networking reception will follow the workshop.
Ricardo Carvajal from Hyman Phelps & McNamara and I will be moderating the panel on the impact of federal statutory and regulatory reform on the food industry.
More information and a full program agenda to come. Stay tuned.
UPDATE - This panel will address emerging issues related to the recalls and investigations related to the Peanut Corporation of America. The panel includes persons intimately involved with these issues. Anybody with an interest in the peanut recall should register and tune-in.
The American Bar Association is presenting its second Hot Topics in Food Law teleconference on February 10, 2009 at 10am Pacific Time (1pm EST). Anybody connected with the food industry and concerned with risks affecting the industry should consider registering. I have been involved with planning this event. No other use of 60 minutes will give you as much insight into the most current issues in food law. The cost begins at $35 for section of litigation members and ranges to $150 for non-ABA members.
Ricardo Carvajal, Of Counsel, Hyman, Phelps, & McNamara, PC, Washington, DC
Sherry A. Marcouiller, Chief Counsel, Food Law, Kraft Foods Global, Inc., Northfield, IL