More on the FSMA and the "Tester Amendment"

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.

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