FDA Learns from ‘Listening Sessions’ on the Re-proposed FSMA Rules

 

Senior Food and Drug Administration officials, including Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, traveled to Georgia, North Carolina, Florida, California and Vermont in recent weeks for “listening sessions” with stakeholders to discuss the agency’s re-proposed Food Safety Modernization Act rules. The agency also hosted a public meeting November 13 in College Park, Md. on the supplemental rules.

In a recent FDA Voice blog, Taylor says the emphasis in these sessions has shifted from concerns about the cost of certain measures to “mostly clarifying questions about the content of the rules,” and what has to be done once the rules take effect. “We’re getting down to the nitty gritty of implementation,” he says. However, there appears to be ongoing confusion about the water quality and testing requirement for produce growers. The agency is “committed to providing clear guidance so that expectations are understood,” Taylor says.

In the listening sessions and in their discussions with state representatives, the FDA officials were asked how the agency plans to pay for its FSMA-related activities.

“It is urgent that FDA receive adequate funding for the training, technical assistance, state partnerships and import oversight that is essential for sound implementation of the FSMA rules beginning in late 2016 and 2017,” Taylor says.

The agency will be relying heavily on its state counterparts to provide training, technical assistance and compliance oversight, he said.

He reported separately on the New England listening session in another blog post, noting that many stakeholders are “finding the complexity of the proposed rules daunting, such as the technical underpinnings of the E.coli benchmark for water quality and the various boundary lines and exemptions that determine who is covered.” The agency has opted not to take a “one size fits all” approach, which has contributed to making the rules more complicated.

“This only underscores our responsibility to explain the rules clearly and to provide education, technical assistance and guidance,” Taylor says.

Indeed, these activities are likely to be among the agency’s biggest challenges in achieving a successful implementation of FSMA both for domestic and imported foods.

FDA has declined requests for extensions of the December 15 deadline for public comment on its re-proposed rules, citing its urgent need to move forward because of its court-imposed deadlines for implementing the final rules.

Posted in 2014, 2014 December, FSMA Perspective.