FDA extends FSMA rule comment periods

Those wishing to weigh-in on two proposed rules stemming from the 2011 Food Safety Modernization Act (FSMA) now have more time to do so.

Today, the Food and Drug Administration (FDA) extended the comment periods 120 days to September 16. The comment periods originally were slated to close in mid-May. Agency officials first indicated they might grant an extension last week, following requests from more than 250 groups to give them more time to review the large amount of material associated with the rules.

The first rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (also known as the preventive controls rule) requires food producers, domestic or foreign, to have a plan in place for preventing their products from causing foodborne illness  and to have additional plans for corrective actions if issues do occur.

The second, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (also known as the produce rule), will create science and risk-based safety standards for produce.

The rules initially were announced on January 4 and were published in the Federal Register on January 16. They are the first of five rules aimed at overhauling the U.S. food safety system to be more proactive rather than reactive. Other rules, including those for foreign supplier verification, third party audits and preventive controls for animal food, still are under review.

FDA also has extended the comment period on the Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm.

Earlier this week, a federal judge in California ruled FDA had violated FSMA by not meeting the deadlines set forth in the law. She then ruled the agency must present the rules to the court by May 20, according to the Wall Street Journal.

To comment on the produce rule, click here.

To comment on the preventive controls rule, click here.

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