FDA Releases Final FSMA Preventive Controls for Human Food Rule

How do I Make Sense of this Document?
maple syrup

In September of 2015, the FDA released the final version of the Preventive Controls for Human Food Rule of the Food Safety Modernization Act (FSMA).  The rule became effective November 16, 2015 and from that date food facilities will have 1 to 3 years to come into compliance depending on their size and activities. 

The rule is intended to modernize “the longstanding current good manufacturing practice requirements” and add requirements to food facilities that “establish and implement hazard analysis and risk-based preventive controls for human food.”

The printable pdf full text of the rules can be found here. 

The online version can be found here.

The document starts out with the comments the public submitted during the comment period and the responses from the FDA.  It then moves on to references.  On pg 234 of 262 of the printable version, or approximately 85% of the way to the end of the document, the codified rules begin.  The codified rules are the specific legal requirements that facilities who are covered by the rules will need to follow. The formal text and legal language can be complicated to follow, so what follows are some tips to make it simpler.

Tips for Making Sense of the Document

  • Start with the codified rules.
  • Next use the find feature to search specific topics you have questions about.  For example if you are interested to learn more about the rules regulating the production of maple products search on “maple”, that will identify any place in the document that refers to maple syrup, maple candy, and maple sugar.