While the US Dept. of Agriculture’s Food Safety and Inspection Service has helped meat and poultry plants develop food-defense plans for their facilities, the Food and Drug Administration has been pushed by Congress to develop a complex anti-terrorism rule for food-processing facilities to prevent contamination being introduced into those facilities by intentional acts of terrorism.
The FSIS guidelines on “food defense” were first developed in 2007, and were updated a year later. The recently published FDA proposed rulemaking, which stems from the massive Food Safety Modernization Act (FSMA), is a complicated and complex 47-page regulation that the agency, which regulates most food beyond meat, poultry and processed egg products, was pressured into developing and putting out for public comment by December. It is the first time FDA has proposed regulations in this area since the September 2001 terrorist attack and the Bioterrorism Preparedness Act of 2002. Most of what FDA has done since is guidance for processors.
In fact, the agency wanted a 2015 deadline for this regulation, saying it had never developed a rule as complex. There will likely be plenty of changes to the proposal. FDA is holding a public meeting this month at its headquarters in suburban Maryland, outside of Washington, DC. The deadline for public comment is March 31, but that likely will be extended as more debate developed around the proposal. The agency has received criticism for not being able to complete its proposed rules, based on the FSMA, as quickly as Congress and others would like.
While USDA’s guidelines are aimed at a number of different types of potential situations, including organized terrorist or activist groups, terrorists posing as employees, disgruntled employees, contractors and cleaning crews, temporary employees, truck drivers, suspect suppliers and visitors, FDA’s proposed rule is aimed specifically and only at acts of terrorism.
A first attempt
The proposal is the first attempt to establish regulatory requirements to deal with intentional efforts to adulterate food. There already have been a number of questions raised about the plan. FDA does admit, however, that the problem this lengthy rule is attempting to minimize or deal with is exceedingly rare. The agency says there have only been a few documented cases of food terrorism in the United States, and refers to only three of them. There have probably been others, including some taking place outside the United States, but not many.
FDA says the consequence of food that is intentionally adulterated is high, but the chances of that happening are quite low. Despite that, as part of its rulemaking, FDA is setting up a large set of regulatory requirements to deal with intentional food terrorism carried out against plants.
The agency is requiring plants to use a HACCP plan to prevent terrorism that would cause food contamination. Plants would need a written food defense plan that addresses significant vulnerabilities in its food production process. It also would:
- Require plants to determine where in their food-processing steps they would be vulnerable or exposed to intentional contamination;
- Find places where they can take steps to control or prevent intentional adulteration;
- Implement strategies to lessen the risk of being vulnerable to intentional contamination;
- Monitor the prevention steps it is taking;
- Take corrective actions when preventive steps aren’t carried out properly;
- Verify the plant has carried out its actions to prevent problems, that it is monitoring them, or that it has taken corrective actions if it hasn’t carried out its preventive steps; and
- Maintain records showing the food processor has done everything required.
The proposed regulation seems to put major burdens on the food-processing facility. It requires another layer of HACCP paperwork for plants to complete, on top of extensive records they already keep. The agency admits it may be hard for plants to scientifically validate strategies in the same way preventive controls can be. Yet, FDA wants these strategies to be verified. The rule would be implemented on a staggered basis, depending on business size. The FDA is exempting food-processing businesses with annual sales of less than $10 million a year from this proposed regulation.
Businesses with fewer than 500 employees would have two years to comply. Larger businesses would have one year to follow the rule. In addition, other exemptions from the rule are based on holding and repacking of food. It would not apply to farms or food for animals, although the FDA is considering setting up special requirements for dairy farms.
Bernard Shire is a contributing editor and a feature writer based in Lancaster, Pa. Shire also works as a food safety consultant and writer for Shire & Associates LLC.