There were several FDA representatives on the agenda at the recent meeting of the International Association of Food Protection conference in Providence, RI. You have to have sympathy for them — who could have envisioned that the rules scheduled to be out over six months ago would still be held up? FDA did a commendable job in delivering interesting presentations (without disclosing what the rules look like or when they might come out). Questions Needing to Be Tackled Jenny Scott, FDA Senior Advisor, gave some insight on some of the questions FDA needed to tackle in the development of the preventive control rule for food. She pointed out several areas that require interpretation that may be apparent to a lawyer but may not be as evident to the lay food safety person. As an overarching theme, Section 103 on Preventive Controls requires that firms conduct a hazard analysis, monitor the effectiveness of the preventive controls, take corrective actions, verify the adequacy of the controls and keep records documenting the monitoring, instances of non-conformance, and verification of the preventive controls. Sounds logical — until you consider these requirements in the context of the examples of preventive controls found in FSMA. Scott pointed out several examples of where the intent of FSMA wasn’t entirely clear:
– Under the header of Preventive Controls, FSMA lists “an environmental monitoring program to verify the effectiveness…” So, Scott asked the audience: Is the environmental program itself a preventive control (which then needs to be monitored, verified etc.), or is it one of the methods to monitor the effectiveness of other preventive controls? – Another “preventive control” is training. But is there a specific hazard that is being controlled through training? How do you effectively monitor this control? – Yet another “preventive control” is a recall plan. Is this really preventive, or do we rely on the argument that an effective recall plan prevents additional cases of foodborne illness after contamination has already occurred? Regardless, Scott questioned how a recall plan is monitored, what corrective actions could be taken, etc.
There were several other areas that also demanded discussion within the Agency:
– Firms must “identify and implement preventive controls, including at critical control points…” This implies that controls must be implemented that are not “critical.” Are these non-critical controls subject to the same monitoring, verification, record keeping, etc. requirements as critical control points? – What constitutes “adequate” control of a hazard?
Scott indicated that FDA needed to consider where to draw the line between what should be required in the rule versus what should be recommended via guidance documents. She also noted that industry should expect an array of guidance documents to roll out from FDA (eventually), including those that are specific to different types of food products as well as those addressing issues relevant to many sectors of the industry (such as allergen control). The Produce Safety Rule Although FSMA’s produce safety rule is (yes, you’ve heard it before) sitting on the desk of OMB, FDA Senior Advisor for Produce Safety Jim Gorny discussed some of the thinking behind the proposed regulation. Asserting that there are likely to be differences in the final rule from that which was proposed in FSMA, Gorny noted that the goal of the Standards for Produce Safety (Sec. 105) was to develop clear standards of modern preventive controls for fresh produce, while recognizing the variation within the industry. Thus, he said, as proposed, the rules provide flexibility and are commensurate with risk. Including minimum science-based standards, the rules would focus on both intentional and unintentional contamination, create no adverse impact on the environment or conflict/duplication of the National Organic Program (NOP), and define small and very small businesses. In addition, the rules would include the small-farm exemptions of the Tester-Hagen Amendment (included in the passage of FSMA). Additionally, issues brought to light during FDA’s 2011 farm tour were taken into consideration, including requests for “education before regulation,” that the rules be science- and risk-based and not be overly burdensome, that imports be held to the same standards, and that existing mechanisms been used for compliance (e.g., NOP). Perceptions of the European Union While not a comment from FDA, it was also striking to note that a representative from an EU office (Carlos Alvarez Antolinez), based in Washington DC, made it clear that the EU was not very happy with certain parts of FSMA. Some of the areas he specifically mentioned were inspections of foreign suppliers and third party audits. He told the International Association for Food Protection (IAFP) Monday that the 27 member EU countries he represents have some significant issues with FSMA. So what does all this mean? The rules are stuck in OMB probably for a variety of reasons, but the EU comment certainly supports the notion that there are potential trade issues causing some issues with OMB. But the big take-home message from FDA is that, if you aren’t doing so already, you need to start now to think about where your risks are and what you are doing to control them. The details will follow in the rules, but food companies can get out in front of these changes today with just a little planning.