New mandate would apply to major U.S. and international food processors and handlers.
On December 24, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule, Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (Rule), establishing requirements for major U.S. and international food facilities to prevent acts on the food supply intended to cause large-scale public harm. The Rule, which is mandated by the FDA Food Safety Modernization Act (FSMA), would require the largest food facilities to have a written food defense plan that addresses significant vulnerabilities in a food operation.
By pursuing a risk-based approach to this issue, the Rule contemplates the need for preventive control requirements targeting what the Agency considers to be the most vulnerable elements of the food processing and handling chain rather than specific food product categories. FDA’s underlying goal is to protect food against intentional adulteration caused by acts of terrorism. Accordingly, the facility types contemplated under the Rule are those engaged in activities within the food system that are vulnerable to such intentional adulteration and, generally, those larger facilities at which intentional adulteration could have an impact on a sizeable portion of the United States’ food supply.
In its guidance on the Rule, the Agency notes that adulteration of the food supply with intent to cause public health harm is “unlikely to occur.” However, the Rule seeks to address the potentially catastrophic results of intentional adulteration of food, including human illness and death, loss of public confidence in the safety of food, and significant adverse economic impacts, such as trade disruption—all of which can lead to widespread public fear.
FDA acknowledges that efforts to protect against intentional adulteration require a shift in perspective from what is considered adequate for traditional food safety. Accordingly, the Agency is proposing an approach that targets certain processes within a facility that are most likely to be vulnerable, rather than targeting specific foods or hazards.
The Agency has identified four “key activities” within the food system that are most vulnerable to forms of intentional adulteration. They include the following:
Under the Rule, all nonexempt facilities would be required to review their production systems to determine if they engage in any of these activity types or to complete their own vulnerability assessments. Once that is completed, the facilities would need to identify actionable process steps, i.e., the points, steps, or procedures in a food process that will require focused mitigation strategies to reduce the risk of intentional adulteration. Facilities would also be required to complete written food defense plans. Once in place, the Rule would establish measures that a food facility would be required to implement to protect against the intentional adulteration of food.
Each facility covered by the Rule would be required to prepare and implement a written food defense plan, which would include the following:
Covered Entities; Exemptions
Generally, the Rule would apply to both U.S. and international facilities that manufacture, process, pack, or hold food and are required to register as food facilities under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Rule would not apply to farms or other food facilities that are not required to register under section 415 of the FD&C Act. The following types of facilities or operations would be exempted from the Rule’s requirements:
The Rule contains the following staggered compliance dates, based on business size:
Comments on the Rule; Public Meeting
Interested parties are encouraged to submit comments on the Rule, identified by Docket No. FDA–2013–N–1425 and/or Regulatory Information Number (RIN) 0910–AG63, by March 31, 2014. Additionally, the Agency will hold a public meeting on the Rule on February 20, 2014.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Robert G. Hibbert
Jonathan A. Havens
. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration, 78 Fed. Reg. 78,014 (proposed Dec. 24, 2013) (to be codified at 21 C.F.R. pts. 16 and 121), available at http://www.gpo.gov/fdsys/pkg/FR-2013-12-24/pdf/2013-30373.pdf.
. For more information on the public meeting, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm377956.htm.