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Patricia O'Connell
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Sonali Gunawardhana Discusses Food Safety Proposals on The Knife and Fork Show

The Knife and Fork Show
August 7, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was interviewed for an August 1 episode of The Knife and Fork Show that focused on the U.S. Food and Drug Administration’s (FDA) implementation of the 2011 food safety law.

The food industry is likely to see “a much more aggressive” FDA as rules take effect under the Food Safety Modernization Act (FSMA), she told Food Chemical News editor-in-chief Jason Huffman, who hosts the Web-based program.

The law gave the agency new regulatory tools, said Ms. Gunawardhana, who served as regulatory counsel in the FDA’s Center for Food Safety and Applied Nutrition before joining Wiley Rein last year.  For example, the FDA can now charge to reinspect and may mandate recalls—regulatory actions the FDA was unable to pursue prior to the law’s enactment.

Ms. Gunawardhana was at the FDA in 2009, when a nationwide salmonella outbreak linked to tainted peanuts sickened more than 700 people—killing nine—and led to one of the biggest food recalls in U.S. history.

At the time, the agency had “very limited regulatory authority” to take steps that might have prevented such an outbreak, “beyond just going out and inspecting and maybe issuing a warning letter and trying to get them to do a voluntary recall,” she said.  This outbreak—one of the nation’s worst in terms of deaths, reported illnesses and costs to industry—served as a catalyst for bipartisan support of this landmark legislation.

As part of its implementation of FSMA, the FDA issued the preventive controls proposed rule requiring food companies to strengthen their food safety plans and work in partnership with the agency to reduce future food borne illnesses.  Stakeholders have until September 16 to comment on this rule.

The preventive controls proposed rule reiterates the fact that the FDA has limited resources and that industry must do their part to ensure that their products are safe before distribution to consumers.  Ms. Gunawardhana goes on to explain some of the key regulatory differences that surrounded a separate peanut butter recall that occurred last year in a post-FSMA world.

To watch Ms. Gunawardhana’s interview with The Knife and Fork Show, click here.