The year 2014 has been an active year for food safety regulation, but we can expect 2015 to be exceptional in that regard, especially from the FDA. But before we get into what FDA will be doing in the new year, let’s focus on what the USDA's Food Safety Inspection Service is likely to do in 2015.
In order to know what lies ahead in 2015 from the FSIS one needs to understand what happened in the past and the FSIS strategic focus. There are a number of past factors that drive the future in the case of food safety: consumer expectation of safe, wholesome and unadulterated products, improving science and testing methodologies and a global supply chain to name a few.
FSIS is focusing on prevention of foodborne pathogens. The agency released its 2015 Annual Performance Plan (APP), which is an annual update that stems from the FSIS 2011-2016 Strategic Plan, which identified eight strategic goals to achieve by 2016
Each year, the annual plan sets high-priority initiatives, and this year is no different. Some notable initiatives are the Salmonella Action Plan (SAP) and the New Poultry Inspection System (NPIS) to modernize poultry slaughter based on existing science and available technology.
The 2015 key initiatives are translated into tactics that will be executed by the inspection personnel at federally inspected establishments. Here are a few examples of what FSIS plans to accomplish in 2015:
- Improve the Public Health Information System (PHIS) by Sept. 30, 2015.
- Follow up with establishments on voluntary food defense plans with a goal of 90 percent compliance by Sept. 30 by conducting outreach based on assessments of the 2014 Food defense survey.
- Develop new and enhance existing instructions in notices and directives and developing new policies, procedures and guidance to industry. (For example, sample, test and establish new Salmonella performance standards for raw ground chicken and parts, raw beef and raw pork.)
- Inspection personnel will verify HACCP validation and recordkeeping.
- Finalize the Listeria monocytogenes Interim Final rule.
- Ensure that greater than 80 percent of investigative and enforcement activities address food safety issues as a preventive measure.
- Improve and increase “in-home” messaging on food safety of meat, poultry and egg products.
In the FSIS Compliance Guideline HACCP Systems Validation (May 2013) the FSIS defined “HACCP System” as “the HACCP plan in operation, including the HACCP plan itself,” similar in approach to the new FDA human foods' Preventive Controls. The Acheson Group believes defining “HACCP System” provides good insight to understand the impact of the 2015 high-priority initiatives as they are cascaded down to the industry.
FSIS is using existing science and available technology to improve methods for verification testing, updating PHIS data collection and evaluation, defining Public Health Regulations “for prioritizing Food Safety Assessments (FSAs) and, when implemented, Hazard Analysis Verifications (HAVs).” This all leads to enforcement activities.
Clearly the biggest expectation from FDA for 2015 is the release of a series of final rules in relation to the Food Safety Modernization Act (FSMA). Many have asked if the publication of the final rules will be delayed. While there are no sure bets, our group believes it is highly probable that final rules will be published either on time or close to on time.
We expect to see final rules on the Preventive Controls for Human Food and Preventive Controls on Animal Food by the end of August. Then, at the end of October, we can expect final rules on Foreign Supplier Verification Program, Third Party Auditing and the Produce Rule.
The comment period for the four re-proposals FDA published in October is now past, and FDA will finalize these rules during the first eight months of 2015. It is our anticipation that the final rules will not change much from the revised proposals that were published in 2014. The re-proposals have filled in some of the expected gaps in the preventive control rules around environmental monitoring, supply chain controls and product testing. So there is not much else that the FDA can add and still follow what was in the original FSMA law.
During 2015, we also anticipate FDA will start to roll out FSMA training programs for its own inspectors and for those in the private sector. Questions remain as to what will be deemed a Qualified Individual, and FDA has signaled it will much better define this and offer clear guidance on appropriate levels of training and certification to meet this requirement.
When it comes to areas beyond regulation, it is likely that FDA, like FSIS, will continue to seek ways to reduce Salmonella in foods. This means the agency will continue to its environmental testing blitz. So if you are an FDA-regulated food company making ready-to-eat food, make sure you have a robust environmental monitoring program, because FDA may be paying you a visit.
One final point on FDA is that the Center for Food Safety and Applied Nutrition gets a new director this month. Dr. Susan Mayne will be taking over from Mike Landa. Dr. Mayne comes in with a focus on toxicology, chronic disease, obesity and nutrition more than microbiology. So it would not surprise us to see more FDA emphasis on chemicals, residues and heavy metals in food in 2015 and beyond as well as a greater focus on nutrition that we have seen historically in recent years.
Finally, continuing the theme of greater focus on nutrition in 2014, the FDA released two critical proposed rules in regard to product labels. The first, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels,” will update the content of the Nutrition Facts Panel (NFP) and Supplement Facts Panel, such as mandatory and voluntary nutrient labeling and the reference values for these nutrients. The second, “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion…,” will modify the Reference Amount Customarily Consumed (RACC) – the definition of a single serving size – and require some dual labeling for containers that may be consumed in one serving.
The proposed rule concerning the NFP received over 200,000 comments. This is a monumental change, it will be scrutinized as it will impact every FDA product label. It is possible the final rule will issue in 015 but no one knows at this point. Our group assumes that FSIS will respond and update the Meat Inspection Act and Poultry Product Inspection Act labeling regulations similar to how the agency responded in 1993 to the enactment of the Nutrition Labeling Education Act of 1990.
Overall, we expect 2015 to be an active year on the food regulatory front. It is anyone’s guess who will be in power in 2016, but we can assume that for 2015 the current administration will do its best to further its agenda in the time remaining before the next election.