NSAC's Blog

FDA Settles Lawsuit over FSMA Rules

February 21, 2014


The Food Safety Modernization Act (FSMA) became law in January of 2011.  FSMA directed FDA to complete the corresponding rule-making process by the following year.  It is not unusual for Congress to include in statute very aggressive time frames for rulemaking.  In this instance, as it became increasingly clear that FDA could not possibly accomplish these very complex tasks within the statutory time frames, the Center for Food Safety (CFS) took action and filed a lawsuit against the agency for failing to meet the established deadline.  FDA argued that the timeline for rule-making was within their discretion, but the Court disagreed.

As a result, an injunction was issued that mandated completion of the draft rules by December 2013, and the finalization of the rules by July 2015.  With the outcome of the lawsuit pending, FDA began steadily issuing draft rules with the July deadline set as their target.  Currently, seven draft (proposed) rules have been published, though no draft rule has yet been issued on an important FSMA provision for farmers who market through farmers markets, community-supported agriculture, and other similar direct marketing channels.

Meanwhile, FDA appealed the court’s decision and requested a motion for relief.  The motion was denied by the court, but the broader appeal continued.  Yesterday, a settlement agreement was announced between the CFS and FDA.  FDA agreed to drop its appeal in return for extended deadlines for the final rules.

Outcome of the Settlement

Now, with court-ordered deadlines in place, FDA has a staggered rule-making schedule to adhere to: due first, by 8/30/15, are preventive controls for human and animal food, followed by imported food and foreign suppliers and produce safety both due by 10/31/15, food transportation by 3/31/16, and lastly, intentional adulteration of food by 5/31/16.

Importantly, the settlement also removes prior deadlines established by the Court for public comment periods on the proposed rules.  Those deadlines would have restricted the public’s right to comment on the proposed rules.

Our Take

NSAC helped lead a campaign focused on the preventive control rule and the produce rule to urge FDA to undertake a very thorough overhaul of these two proposed rule to remove very significant barriers to the survival of small and mid-sized family farms, local and regional food system development, value-added farm-based enterprises, organic agriculture, and conservation and wildlife habitat enhancement.

In December 2013, FDA announced it would re-propose a number of very significant provisions in the rule, with the new proposals due out for public comment by early summer of this year.  As NSAC stated then, it is our view that it is more important to get the rules right than to meet any arbitrary deadlines for finalization of the rules.

We continue to hold that view.  We very much appreciate the relaxation of the court-imposed time frames announced yesterday, but more importantly we appreciate the immensity of the task of rewriting the proposals to make them help rather than harm the cause of a healthier food supply.  There is a very long way to go before there are rules that will help that cause.  We urge all parties to the debate to focus more on substance than on deadlines.

Categories: Food Safety

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