This week the Food and Drug Administration (FDA) was required to submit the final rule for the Hazard Analysis and Risk-Based Preventive Controls (HARPC) for publication in the Federal Register. According to FDA, this was completed on August 31, but curiously FDA has not released the text publicly.
Historically for the FSMA rules, FDA provided to the public the text (preamble and the rule) prior to it being published in the Federal Register. This time FDA is making the public wait to see the text until its official publication.
As FDA acknowledged, we don’t know when this will happen because “the Federal Register can publish several days after they are submitted, with larger documents taking longer to process and display.”
HARPC is a set of food safety regulations that essentially mimics many existing food safety principles previously required only to seafood and juices (HACCP Principles) and applies them to the production of almost all other food types. It is one of many new provisions of the FDA Food Safety Modernization Act (FSMA).
Unless exempted by law, every food facility, both in the United States and abroad, that is subject to FDA’s Bioterrorism Facility Establishment registration, will need to establish and implement an adequate HARPC plan. Everything in a HARPC plan must be properly documented and must conform to FDA’s standards and definitions surrounding facilities, controls, hazards, and the adulteration of foods. FDAImports.com guides companies to develop new HARPC-compliant plans or to evaluate existing plans for compliance with the new HARPC provisions.
We will continue to monitor the situation and provide commentary once the HARPC rule is published.
