FSMA Rules in Public Comment

January 7th, 2013

On January 4th, two years to the date since President Obama signed the new law, dozens of news outlets nationwide reported that the FDA had released two of the 3 proposed rules implementing the Food Safety Modernization Act (FSMA).  The two published rules can be accessed via the FDA’s FSMA start page online.

The two new rules include:

  1. Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
  2. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Yet to come is a third rule that will govern how food importers will verify that their products meet U.S. standards.

The Administration has been criticized for delaying publication of these rules, possibly for the political reason to avoid a controversy over new regulations. However, most reports of the event cite the shift to risk-based prevention and tracking in the rules positively, coupling the rules with recent food borne illness breakouts as justification for them. The food safety lawyer Bill Marler has published an especially emotional version showing photos of victims of food borne illnesses as the reasons why the law is important.

Rolling Out the Rules

Publication of the rules is the first step toward final implementation.  There is a 120-day public comment period following publication in the Federal Register, followed by possible revisions.  The length of the review and revision period is not fixed, but the rules will take effect 60 days after final publication.  Following publication, small businesses (fewer than 500 employees) would have two years to achieve compliance, and large businesses not otherwise exempt would have one year.

In general, a covered small business will have about 2 and ½ years from right now to come into compliance with the rules.

Where do We Stand Now?

In one sense, these rules are old news. Their basic themes and content have been known for most of the past two years (and before that in the sense that the ideas have been developed over a long time).  When we list the highlights of the proposed Preventive Controls rule, we see very familiar items:

  • hazard analysis
  • risk-based preventive controls
  • monitoring procedures
  • corrective actions and verification
  • recordkeeping

Many producers already follow this basic process. In fact, one of the articles reporting the rule promulgation was this LA Times article, which focused on the fact that many California producers had already adopted a “culture of food safety.” Included in this culture are industry-published standards for best practices designed to give consumers confidence in a specific product.

Safety Begins with Sanitation

The rules, the plans, and the process contain good ideas.  They will be effective when they are properly implemented.  At the heart of the matter is the fact that good sanitation practices have to be incorporated into every step of the production process. Without them there will be no enhanced food safety, and under current funding, there will not be enough inspections or enforcement to force changes to happen.

As usual, it is up to producers to take proactive steps to make the rules redundant.



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