WASHINGTON – The Food and Drug Administration on Dec. 20 issued a proposed rule that, if finalized, would require food manufacturers to address hazards that may be introduced intentionally by acts of terrorism. Under the proposed rule titled “Focused mitigation strategies to protect food against intentional adulteration,” domestic and foreign food plants registered under the Federal Food, Drug and Cosmetic Act would be required to develop and implement strategies aimed at preventing them from becoming targets of intentional attempts to contaminate the food supply.

“The goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine for the FDA. “Such events, while unlikely to occur, must be taken seriously because they have the potential to cause serious public health and economic consequences. The FDA’s goal is to devise an approach that effectively protects the food supply in a practical, cost-effective manner.”

The FDA pointed out intentional adulteration may have catastrophic results, including human illness and death, loss of public confidence in the safety of food, and significant adverse economic impacts, including trade disruption, all of which may lead to widespread public fear.

“Efforts to protect against intentional adulteration require a shift in perspective from what is taken for traditional food safety,” the agency emphasized. “The FDAproposes an approach that targets certain processes within a facility that are most likely to be vulnerable, rather than targeting specific foods or hazards.”

The FDA said it has identified four activities within the food system that are most vulnerable to intentional adulteration. They include bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities.

“Facilities would be required to review their production system to determine if they have any of these activity types or complete their own vulnerability assessments,” the FDA said. “Once that is completed, they would need to identify actionable process steps, which are points, steps or procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration. Facilities are also required to complete a written food defense plan. Once in place, this proposed rule would establish measures that a food facility would be required to implement to protect against the intentional adulteration of food.”

The written food defense plan that would be required under the proposed rule must address significant vulnerabilities in a food plant’s food production process. Facilities would have to identify and implement strategies to address the vulnerabilities, establish monitoring procedures and corrective actions, verify the system is working, ensure personnel assigned to the vulnerable areas receive appropriate training, and maintain certain records.

The proposed rule would not apply to farms and food for animals. The rule proposed exemptions based on the size of the business, sales and certain types of operations, such as holding and repacking food. The proposed rule would not apply to the packing, repacking, labeling or re-labeling of food where the container that directly contacts the food remains intact.

The FDA proposed staggered implementation dates, ranging from one year to three years after publication of the final rule, based on business size. “Very small businesses” that have less than $10 million in total annual sales of food would have to comply within three years of publication. “Small businesses” that employ fewer than 500 people would have to comply within two years. Other business would have to comply within one year of publication of the final rule.

The proposed rule, which was required by the FDA’s Food Safety Modernization Act, builds on the efforts of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The FDA estimated the annualized costs of the actions in the proposed rule to be about $370 million. The benefits of the actions were a reduction in the possibility of illness, death and economic disruption resulting from the intentional adulteration of food, but the FDA said it was unable to quantify those benefits.

The FDA will hold a public meeting on the rule on Feb. 20, 2014, in College Park, Md. The proposed rule is available for public comment until March 31, 2014. Comments should be identified by Docket No. FDA-2013-N-1425 and/or Regulatory Information Number (RIN) 0910-AG63. To send electronic comments, visit www.regulations.gov. Mailed comments should be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.