While most of FSMA applies equally to animal and human food companies, one exception to this is found in the part of FSMA addressing preventive measures. One key component is the requirement that facilities create a written hazard analysis and preventive controls plan. Although similar to a HACCP plan, which many companies already have in place, the FSMA requirement is broader and more comprehensive. Voluntary programs, such as the Safe Feed/Safe Food Certification Program developed by the AFIA, will give companies a head start on complying with the new requirements. However, because we do not yet have regulations from FDA providing details of what exactly companies must do to comply with this provision, it is unclear whether these voluntary plans will satisfy the mandatory requirements.
FDA is required to release regulations related to the Hazard Analysis & Risk-based Preventive Controls plan provision by July 2012. In the mean time, companies should review any similar plans in place, and be prepared to reanalyze those plans to determine compliance once regulations are released.
Some animal feed companies may ultimately be exempted from this provision. FSMA allows FDA to modify the preventive controls requirements for facilities that are “solely engaged in the production of food for animals other than man” or to even fully exempt those facilities from the requirements. However, for this to occur, FDA needs to issue a regulation detailing the modification or exemption. This has not yet occurred, meaning that for the time being, animal feed companies should be prepared to comply with the hazard analysis provision. Further, based on FDA comments in a recent public hearing on FSMA implementation, it is unlikely FDA will fully exempt most, if any, feed companies.
What if you classify yourself as “just a farmer,” who processes and sells a little feed as well? FDA regulations require farms must register with FDA if (1) the farm packs or holds food or animal feed not grown, raised or consumed on that farm or another under the same ownership, or (2) the farm manufactures or processes food (including animal feed) that is not consumed on that farm or another under the same ownership. FDA is now required to issue regulations that specify what activities fall under each of these categories. In addition, FDA must issue regulations that will exempt certain on-farm activities from the preventive control plan requirement. There may also be exemptions or modifications for small or very small businesses.
Detection and response
FSMA also gives FDA the authority to issue a mandatory recall of a food product. Up to this point, FDA could only request a company issue a voluntary recall, but could not order one. What is significant about this provision is that it establishes a formal process FDA must follow and give companies the opportunity to challenge a recall, although only after the fact. A related provision lowers the standard that must be met before FDA may administratively detain food articles.
FSMA also expands FDA’s authority to review company records, and provides authority for FDA to suspend a company’s registration in Class I recall-type situations. The increased authority to review records (in addition to the various new record keeping requirements within FSMA) means companies need to ensure they have a well-organized record keeping system.
The provision most directly affecting the largest number of feed and grain companies is the requirement that FDA increase inspections of all regulated facilities. High-risk facilities and/or foods will be identified by FDA, based on factors such as compliance history, inspection history, or types of food more commonly tied to outbreaks. If designated high-risk, a facility can expect to be inspected once by 2016 and then at least once every three years. Other facilities must be inspected by FDA once by 2018 and then at least once every five years thereafter. Inspections of foreign facilities are also set to dramatically increase over the next five years.