On January 4, 2013, FDA published its proposed Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) regulations for food facilities, exactly one year after it was required to under the Food Safety Modernization Act (“FSMA”). HARPC is a new set of food safety regulations that essentially copies existing food safety principles previously only applicable to seafood and juices (HACCP Principles) and applies them to the production of almost all other food types. FDA posted the proposed regulations today with a comment deadline of May 16th, 2013.
HARPC, with some exceptions, applies to any food facility that is required to register with FDA. The proposed HARPC regulations, unsurprisingly, look similar to the HACCP regulations and require a facility to develop and implement a written food safety plan, and maintain records.
However, tucked away in this list is the requirement that a facility must develop and maintain a recall plan. This is the first time FDA has ever mandated such a requirement for food facilities. FSMA granted FDA the authority to mandate recalls when a company fails to voluntarily recall unsafe food after being asked to by FDA. This new requirement that food facilities have a recall plan developed in advance is obviously part of FDA’s overall goal to have recalls implemented more quickly.
The proposed rule also uses the language of ‘food safety plan’ to describe a HARPC plan that would include a hazard analysis, preventive controls that would be established and implemented to address those hazards determined to be reasonably likely to occur; procedures for monitoring, corrective actions, and verification; but also includes the recall plan. The written plan and other documentation would be required to be made promptly available to FDA upon oral or written request.
So when will a facility have to have this plan in place? That depends on (1) how big the business is, (2) how FDA decides to define “very small” and “small” businesses, and (3) how long FDA takes to publish the final version of the HARPC rules. FDA will be accepting comments on the regulations for the next 120 days. Sometime after that, and it could be quite a long time if past experience is any indicator, FDA will publish a final version of the HARPC regulations.
Companies that are not “very small” and “small” businesses must comply with the final rules 60 days after they are published. Small businesses, currently defined as a business that employs fewer than 500 persons, would have to comply two years after publication of the final rule. Very small businesses, not currently defined but likely to mean businesses making somewhat less than $1M in annual food sales, would have to comply three years after publication of the final rule.
It will likely be two years before any business must comply with the new HARPC rules, it will likely take a significant time to develop all of the procedures and plans that will be required. Now that FDA has released these rules, however, facilities would be wise to start preparing now so they are not caught unprepared during the big rush to come into compliance as the deadlines draw near. Stay tuned to the FDAImports.com blog and our new site, www.harpc.com for more updates as they are available.
