- The U.S. Food and Drug Administration unveiled its new dashboard to measure progress and track compliance of companies with the Food Safety Modernization Act.
- Currently, the dashboard looks at metrics from three out of the seven food safety rules. The agency is tracking compliance with the preventative control rules for food and imported food safety through current good manufacturing practice measures, risk-based preventive controls and the foreign supplier verification program rule.
- Results show the majority of companies inspected are in compliance with preventive control rules and the time it takes from identifying an outbreak event to initiating a voluntary recall has decreased since 2016. The dashboard will be updated quarterly by the FDA with the eventual goal of tracking compliance metrics for all seven rules and drawing trend data.
Nearly a decade after the FSMA was signed into law to shift American food safety from reaction to prevention, the FDA is beginning to publicly track the efficacy of its efforts. At first glance, it appears the preventive controls part of the law — which requires large manufacturers to have plans to reduce the risk of contamination in their plants and puts them on a regular inspection schedule by the FDA — may be doing its job.
"At this point we cannot definitively say these are meaningful trends representative of the entire food industry," Acting FDA Commissioner Ned Sharpless and Deputy Commissioner Frank Yiannas, said in a statement. "However, this is an encouraging start as industry, the FDA and our regulatory partners work together to improve food safety and protect consumers."
Reports from 2017 indicated a spike in recalls. However, that year, Food Safety News reported that 43% of all FDA food recalls had been due to undeclared allergens rather than salmonella, E. coli or listeria. Data on the new dashboard shows a similar story with labeling and allergen issues outpacing any microbial concerns for recalled items. Triggers for recalls did not change under FSMA.
Compliance with the foreign supplier verification program rule requires importers to show their suppliers meet U.S. food safety standards. For U.S.-based importers, that means they must do hazard analyses, evaluate food risk and assess foreign suppliers and safety verification activities based on identified hazards. With 15% of U.S. food imported, that means hundreds of inspections, according to the dashboard data.
Despite the dashboard showing that food recalls have reached a five-year low, there have been doubts that this overhaul of food regulation would be effective. For starters, there is a high bar to entry with manufacturers needing to create a food safety plan that would identify all possible food safety risks and devise solutions for them, back up all of their assessments with data and implement testing and plans with meticulous records. Furthermore, the plans need to be periodically reviewed by both a manufacturer and regulatory enforcement.
The problem is that the government's ability to move forward with stringent enforcement may be lacking. According to a report from the Department of Health and Human Services' Office of Inspector General, the overall number of facilities FDA inspected in the four years since FSMA passed declined from about 19,000 in 2011 to 16,000 in 2015. In addition, for almost half of the significant inspection violations, FDA did not conduct a follow-up inspection within a year. For 17%, there was no follow-up inspection at all.
This underscores the FDA’s efforts requiring companies to be more exacting in their prevention efforts. It also reveals that perhaps the FDA should be measuring inspection frequency data alongside compliance. Since food safety is a multi-layered enforcement issue that requires meticulous and consistent oversight, it would be beneficial for the public that reads this dashboard to have insight into the regularity of the inspection process.
At the same time, the data is more oriented to government agencies such as the Centers for Disease Control and Prevention and food manufacturers themselves. Without more granular data showing where recalls have occurred and the reasons behind them, the data is not likely to reveal what the average consumer is looking for.
For companies though, the data is a useful barometer to understand where the overall industry is in terms of compliance. It is also beneficial since, although the dashboards will be updated quarterly, the underlying long-term data that make them up are slower to trickle in. As a result, monitoring the trends will offer a fuller picture as to where these new prevention laws are lacking and help lawmakers adjust accordingly.