Rundown of Key Aspects to FSMA

Corrective actions are needed when a foreign supplier has not provided the same level control as required under the produce safety and PC regulations, or produces adulterated or misbranded food with respect to allergen labeling. Corrective actions depend on the nature of the issue but may include discontinuing use of the supplier until satisfactory actions have taken place to rectify the problem.

Produce Safety (and Environmental Impact)
The Produce Safety (PS) rule, also known as the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, is found in 21 CFR Part 112. The intent of the PS rule is to “establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.” The definition of “farm” is the same as defined in the Preventive Controls for Human Food rule and is used to determine entities that are exempted from the PS rule. The specifics concerning exemptions and staggered compliance dates are beyond the scope of this article, so please refer to the regulations for more information on these topics. The rule identifies and seeks to control five primary methods of potential contamination: 1) agricultural water, 2) biological soil amendments, 3) domesticated and wild animals, 4) worker training and health and hygiene, and 5) equipment, tools, and buildings. There are also specific provisions defined for the growing, harvesting, packing, packaging, and holding of sprouts, which are particularly vulnerable to microbial contamination due to the nutrient-rich conditions under which they are grown.

In order to address the PS rule’s overall impact on the environment, human health, and socioeconomic effects, the FDA released the Final Environmental Impact Statement. The agency believes public health will benefit due to the decrease in the number of illnesses tied to produce contamination. On the flip side, the FDA acknowledges that the regulation may cause a farmer to use ground water instead of surface water which may contribute to existing groundwater shortages, and that Native American farmers may be affected disproportionately by increases in operating costs as a result of the rule since their income average is 30 percent less than that of other farmers.

Sanitary Transportation of Human and Animal Food
On June 6, 2016, the Sanitary Transportation of Human and Animal Food rule was finalized. This body of regulation is found in 21 CFR Parts 1 and 11. The rule builds on safeguards established in the Sanitary Food Transportation Act of 2005 and sets “requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food.” The rule includes requirements for: 1) vehicles and transportation equipment to include proper design and maintenance, 2) transportation operations to protect food from contamination, 3) training of carrier personnel in sanitary transportation practices, and 4) records that include written procedures, agreements, and required training. The rule pertains only to food destined for distribution and consumption in the U.S. Please refer to the final rule for specifics on transporters or shippers who are exempted or waived from the regulations, including those governed by the Pasteurized Milk Ordinance, food establishments governed under the Retail Food Program, and exporters who transport food through the U.S. but do not distribute it in the U.S.

Protecting Food Against Intentional Adulteration
The Mitigation Strategies to Protect Food Against Intentional Adulteration rule of FSMA was effective July 26, 2016 and is published in 21 CFR Parts 11 and 121. The regulation requires registered domestic and foreign food facilities “to address hazards that may be introduced with the intention to cause wide scale public health harm.”The key phrase is “wide scale” as this rule is intended to prevent acts of adulteration, including acts of terrorism, which may greatly impact the U.S. population by causing a significant number of illnesses, death, or economic disruption of the food supply. This rule does not apply to acts that are motivated by strictly economic reasons, as these are covered in the PCs for Human and Animal Food rules.