FSMA legislation, food labeling, and formal lawsuits drew much of the food industry spotlight in 2014. What do these FSMA proposed and re-proposed rules; controversies over GMO, nutrition, and COOL labeling; and lawsuits against federal agencies mean for the year ahead? Although I don’t have a crystal ball, I certainly see these areas as continuing to draw attention and continuing to impact the industry in 2015. Let’s take a look at a few and what they mean.
Last year was a busy year for FSMA legislation, from the January issuance of two newly proposed rules (Food Defense and Sanitary Transportation) to the September re-proposal of four previously proposed rules (Preventive Controls for both human and animal foods, the Produce Safety Rule, and the Foreign Supplier Verification Program). There was even publication of a final rule in April on FSMA’s provision on FDA Records Access Authority.
Deadlines for the final publication of the seven major rules have been court mandated to begin in 2015. Although FSMA has seen numerous delays, I would expect these deadlines to hold, and that you will see publication of the first final rule in late summer, followed by three more by the end of October. The schedule is:
- August 30, 2015 – Preventive Controls rules, both human food and animal food.
- October 31, 2015 – Produce Safety, Foreign Supplier Verification Program, Accreditation of Third-party Auditors.
- March 31, 2016 – Sanitary Transport.
- May 31, 2016 – Intentional Adulteration/Food Defense.
If the final rules aren’t published exactly according to this schedule, I would expect them to be close to these dates. Additionally, I doubt that we will see much variance in final rules from the proposals/re-proposals of 2014, particularly as the re-proposed rules filled in some of the gaps in the original proposals—such as the additions of environmental monitoring, supply chain controls, and product testing in the final Preventive Controls rule.
While FSMA will continue to top the legislative slate, it is not the only legislative action you can expect to see in 2016. Both FDA and USDA have increased emphasis on Salmonella in foods, with FDA focusing on environmental testing, particularly in ready-to-eat food facilities, and FSIS’s 2015 Annual Performance Plan including the Salmonella Action Plan (SAP) to address the threat of Salmonella in meat and poultry products.
Labeling issues, questions, and controversies were hot in 2014, and with continuing consumer trends along with pending legislation, I would expect these to get even hotter in 2015. While some of the trend revolves around providing consumer information for making healthy food choices, it seems that the greater issue is that of transparency—consumers want to know what is in their food (e.g., GMOs) and what isn’t (e.g., gluten), and they want to have the choice to say no to ingredients and foods they choose to not consume—for whatever reason. Additionally, although FDA has not yet detailed any requirements, key provisions of FSMA include measures to improve traceability, thereby also increasing this transparency.
Regardless of the accuracy of the general perceptions that gluten and GMOs are unhealthy, and natural and organic equate to healthy, the “healthy foods” movement is not showing any signs of letting up, and consumers will continue to push for labeling. What we would hope to see this year, however, is at least alignment on these questions, as was discussed at a Congressional Hearing in December. As I stated in my blog at the time with regard to GMO labeling: “Although the hearing did not bring resolution to the labeling question, there was general consensus on two items: that any regulation that is implemented should be at the national level rather than being left to a ‘patchwork of 50 states’ with 50 different rules, and that FDA needs to work on defining natural—which too often is interpreted by consumers as meaning GMO-free.”
We would hope that this consensus would bring some legislative action in 2015—at the very least to halt a push to regulate GMOs by 50 different rules.
Labeling also will continue to be a focus for the industry in the relabeling of foods according to two proposed regulatory revisions: that relating to the Nutrition and Supplement facts panel (NFP and SFP) which will update the content of the these and that relating to Reference Amount Customarily Consumed (RACC), updating the definition of serving size and adding requirements for dual labeling.
Businesses will have a while to comply with these, because both are still in the proposal stages, and FDA is anticipating the effective date will be 60 days after the final rule is published with 24 months for implementation. So while this won’t have a great deal of immediate impact in 2015, it is certainly something you need to anticipate and begin preparing for.
It started with a 2012 lawsuit filed by two consumer groups [Center for Food Safety (CFS) and the Center for Environmental Health] against FDA for failing to meet FSMA regulation publication deadlines. The consumer-group win—the 2014 consent decree specifying mandated FSMA deadlines for FDA—seems to have encouraged groups to take the federal agencies to court on other areas with which they were unsatisfied:
- In February, FDA was again sued by the CFS for failure to take action, this time for “indefinitely operating under a proposed rule.” The Substances Generally Recognized as Safe (GRAS) proposed rule was issued in 1997, but no final rule had yet emerged. As a result of the case, FDA has until August 31, 2016, to submit a final rule.
- In May, the Center for Science in the Public Interest (CSPI) sued USDA for “unreasonable delay” in responding to its petition to declare certain strains of antibiotic-resistant Salmonella in ground meat and poultry to be adulterants.
- In September, the precedence changed slightly, with Food & Water Watch (FWW) suing USDA not for delay but for the issuance of a rule with which it did not agree. The lawsuit strove to stop the implementation of the final Modernization of Poultry Slaughter Inspection rule, stating that the provisions of the rule are beyond the scope of USDA authority; violate the Poultry Products Inspection Act by eliminating mandatory inspection requirements; were finalized without adequate notice and opportunity for public comment; and are “otherwise arbitrary and capricious.”
The suing of federal agencies has changed the regulatory game. In the past, when an agency received a petition, especially from a consumer organization, it often chose to just let the petition lie and do nothing. This, however, is no longer a viable option. Rather, the food safety agencies now need to respond in a timely manner, even if to kick the petition back requesting more data.
Will such lawsuits continue in 2015? Possibly. … Probably, if the agencies don’t begin to submit some form of response to the increasingly vocal consumer groups. Are the lawsuits helpful? Although consumers have charted some “wins,” I’m not really sure that sidetracking these already underfunded and under-resourced agencies with lawsuits is the best way to keep the industry moving forward.
While I expect to see a lot of carryover from 2014 in all these areas, I also anticipate that some emerging technologies and issues will see more focus in 2015. Nanotechnology is not new, but it is likely to emerge with further prominence this year—providing new technological options for processors, while potentially being called to light as part of the increased transparency movement.
I also would expect that unexpected adulterants will show up in more unexpected places (such as the recent issues with nut allergens in cumin and Listeria in apples) in 2015 and onward, potentially including new pathogens that are spread through the global food chain that hadn’t previously been seen in the U.S.—one simply need think Ebola to know this is possible (even though that virus is not considered to be transmissible via food per se). I also see increased emphasis on long term chronic exposure concerns with heavy metals and other chemical contaminants.
Whether some unforeseen emerging issue takes precedence, or we continue to focus primarily on those that have been on their way, 2015 is likely to be as robust a year as have been that last few—for food safety issues, initiatives, and challenges from continuing globalization, regulation, and consumer trends.