With December’s release of proposed rules for food security, FDA completed the last significant preliminary step toward implementation of the Food Safety Modernization Act (FSMA), the legislation the agency calls the most sweeping change to the Code of Federal Regulation governing the food industry in 70-plus years.
Three years after FSMA passage and 18 months behind schedule, the implementation roadmap for the act’s Section 106, Protection Against Intentional Adulteration, arrived as a stocking stuffer on Christmas Eve. Comments are due by the end of March, preceded by a series of public meetings for additional stakeholder feedback in Anaheim, Calif., Chicago and College Park, Md.
“This is the final preventative control rule, and it’s filling a slightly different gap: the purposeful human element of food contamination,” notes John Shapiro, a partner with law firm Freeborn & Peters LLP, Chicago. FDA is under a court order to finalize FSMA regulations by June 30, 2015, he points out, but Shapiro advises, “Get the ball rolling in 2014 to figure out how you’re going to comply rather than wait for the final rule to be published.”
In many respects, the rules are a continuation of a security focus that began with passage of the Bioterrorism Preparedness and Response Act of 2002, the legislative reaction (along with U.S. Department of Homeland Security and other initiatives) to the Sept. 11 attacks on the World Trade Center and Pentagon. The Bioterrorism Act touched off a wave of physical security initiatives at production facilities, with guard checkpoints, access cards, container seals and restricted-access policies becoming common practices.
The key difference under FSMA -- as with the other preventive rules -- is that food companies must establish a written plan backed by the logic of their vulnerability assessments and a record of ongoing procedures to enforce controls, take corrective actions and maintain continuous improvement.
To a large extent, FSMA proposals are an attempt to harmonize the rules of the separate regulatory authorities. FSMA affects food companies that answer to FDA, and the preventive rules for food safety reflect USDA’s HACCP approach by a different name. Likewise, intentional adulteration proposals mirror guidelines strongly encouraged by USDA’s Food Safety and Inspection Service.
“Technically, there is no requirement for food defense in FSIS-inspected plants, but there absolutely is a template for it,” observes Jennifer McEntire, vice president and chief science officer at the Acheson Group, a consultancy with close ties to FDA. The agency “very strongly encourages establishment of a food defense plan,” and most meat, poultry and other processors have taken the hint.
Eight years ago, 27 percent of USDA-inspected facilities had functional defense plans. By 2012, the ratio had climbed to 77 percent, and by 2015, the agency wants more than 90 percent to have a plan. “The writing is on the wall,” says McEntire.
McEntire has helped develop some of the security assessment tools available on the FDA website and was involved in the evaluation of 30 different food products and processes to determine common areas of vulnerability and the amount of contamination that would be necessary to kill people and cause large-scale public harm. As a result of that assessment, four specific activities are highlighted in the rules for special attention. They are:
- Bulk liquid receiving
- Liquid storage and handling
- Secondary ingredient handling
- Mixing, blending and similar ingredient-combination processes.
Those processes were flagged not only because they are deemed vulnerabilities but because the cost of hardening them was judged to be justified by the risk reduction they provide. Primary raw materials were excluded because there is a greater focus on them and because they usually go through a kill step, according to Don Hsieh, director of commercial and industrial marketing for Tyco Integrated Security in Boca Raton, Fla. Secondary ingredients, on the other hand, often are added after the kill step -- think icing on a Danish or salt on a chip.
Bulk storage tanks often are in remote areas of a facility, Hsieh adds, and agitation often is done to keep the liquid homogenous. Agitation also would help disperse a contaminant, making detection more difficult.
Mixing and blending are the most common of the flagged activities and arguably the most difficult to control. “Because they are done in the heart of the plant, there usually aren’t any doors to lock down,” he says. “A virtual hot zone can be created with sensors to detect motion and cameras with analytics to provide alerts if a rule is broken,” such as the presence of someone in clothing that violates a color-coding rule. Whether or not technology is brought into play, “the key point is that plants should only allow authorized people to have access to these areas,” concludes Hsieh.
Burden or blessing?
Cases involving deliberate adulteration of food seem few and far between. A study by Singapore-based Centre of Excellence for National Security documented 398 confirmed events globally over a 59-year period ending in 2008, including 220 in the U.S.