FDA Urges Industry Groups to Develop FSMA Guidance

The Food and Drug Administration is encouraging industry groups and trade associations to develop their own guidance to help their members comply with new requirements under the Food Safety Modernization Act.

FDA laid out steps for developing guidance in a January 31 constituent update and said the agency would help by providing technical advice and by checking for any potential conflicts with federal regulations.

FDA would prefer the scope of the industry guidance be kept broad to increase its usefulness for any future FDA guidance. The agency is especially interested in guidance on topics not covered by existing or planned FDA guidances.

The recommended steps are:

  • Define the scope of the guidance – produce grown in a greenhouse, for example – and decide how much of the process will be included, whether just a single process or the entire supply chain, and whether the guidance is for regional, national or international use;
  • Establish a work group of experts from industry and academia – and invite both state and federal government;
  • Develop draft guidance;
  • Finalize the document and circulate it to stakeholders for comment – including state and federal regulators.

The agency said it may place links to final industry guidance on its website.

FSMA extended FDA’s authority to include produce all the way to the farm level. The agency issued a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption on November 27, 2015. That rule went into effect on January 26, 2016, with staggered enforcement dates depending mostly on size. Certain sprout growers were required to comply by January 2017 – because sprouts are considered to pose a higher food safety risk.

In January, the agency issued draft guidance for compliance of sprout operations with the produce safety rule. But there is plenty of room for additional guidance for other products.

FDA has said it will rely heavily on partnerships during the implementation phase of FSMA. Realistically, it has no other option. The call for industry-developed guidance is part of this strategy and it will certainly help both the agency to leverage its limited resources, and for industry groups to share best practices for safer food.