(CNSNews.com) -- The Food and Drug Administration (FDA) released a final rule last week mandating that food-related facilities implement “food defense plans” to prevent “intentional adulteration of food” with the intent to cause “wide scale public health harm,” including “intentional adulteration related to terrorism.”
The regulation, which is the seventh and final rule of the 2011 Food Safety Modernization Act (FSMA), requires an “owner, operator, or agent in charge of a facility” that manufactures, processes, or stores food to “prepare and implement a written food defense plan.”
“Very small businesses” - defined as averaging less than $10 million in revenue per year - are exempt from the rule.
“Our interactions with the intelligence community, as well as the conclusions reached during vulnerability assessments conducted in collaboration with industry, have identified the inside attacker as the highest threat,” FDA stated.
The food defense plan must “identify any significant vulnerabilities” in the food manufacturing process that would allow an attacker to introduce foreign substances into the food, and then “implement mitigation strategies” that significantly minimize these vulnerabilities.
The FDA identified “four key activity types” – “bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities” – that leaves food “at high risk of intentional adulteration caused by acts of terrorism.”
Suggested mitigation strategies include adding locks and barriers to restrict physical access to food supplies, use of a “buddy system” to prevent employees from adding anything to the food undetected, and “food defense awareness” training for employees present at vulnerable steps in the process.
A standardized training curriculum is set to be released by the FDA sometime in the future. However, the FDA allows for flexibility in both mitigation strategies and training curriculum, noting that various facilities have differing needs and that “many food defense awareness trainings exist and may already be utilized.”
Food-processing facilities will have 3 to 5 years to comply with the regulation, based on their size. Reanalysis of the “food defense plan” must be conducted every three years, or when the FDA requires it, including whenever there is a “credible threat” of food-related terrorism.
The regulation states that the “first year cost is between $680 and $930 million….The average annualized cost per covered facility is between $9,000 and $16,000.”
The regulation states: “For attacks that are similar in impact to acts of intentional adulteration that have happened in the United States in the past, the breakeven threshold, counting only producer costs, is 28 to 48 attacks prevented every year.
"For attacks causing similar casualties as major historical outbreaks of food-related illness, the breakeven threshold is one or two attacks every year.
“For catastrophic terrorist attacks causing thousands of fatalities, the breakeven threshold is one attack prevented every 270 to 460 years.”
But FDA press officer Lauren Kotwicki says the potential benefits of the new rule are worth the high costs of creating “food defense plans”.
“The benefits of the actions required by the rule are a reduction in the possibility of illness and death resulting from intentional adulteration of food, when the intent of the adulteration is to cause wide scale public health harm,” she told CNSNews.com.
"While such an event is unlikely, the final rule takes a preventive approach to ensuring the safety of the food supply. In the event that it occurs, intentional adulteration could have significant consequences for public health and significant adverse economic impacts.”
Foreign facilities that export food to the U.S. are also covered by the rule, according to FDA.
In response to a question from CNSNews about how the rule will be enforced abroad, Kotwicki said: “Consistent with the implementation and enforcement strategy for other FSMA rules, FDA intends to educate the community. FDA anticipates implementation and enforcement of the IA [Intentional Adulteration] rule in a staged approach to enable both regulators and industry to gain knowledge and work cooperatively as the food defense expertise of all stakeholders matures.”
The new regulation will be enforced in addition to the Foreign Supplier Verification Program, another component of the FSMA which requires foreign food suppliers to “to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection” as the U.S., and “is not adulterated or misbranded with respect to allergen labeling.”
The regulation also cooperates with the Bioterrorism Act of 2002, which also seeks to prevent terrorist attacks on the food supply, Kotwicki said.
In the FBI’s February 2012 Law Enforcement Bulletin, Capt. Dean Olson of the Douglas County, Nebraska Sheriff’s Department, opined that America is vulnerable to “agroterrorism,” citing plans for an attack on agriculture that were found in an al Qaeda storehouse in 2002.