First of FSMA rules now in effect

September 20, 2016

After much anticipation, the first major compliance date for regulations under the Food Safety Modernization Act (FSMA) is here. Now, larger businesses must comply with certain new standards under the preventive controls rules for human and animal food, two of the main rules developed to drive down the incidence of foodborne illnesses in the U.S.

Overall, FSMA has been touted as the most sweeping reform of food safety laws in more than 70 years since it was signed into law by President Obama in 2011. According to the FDA, now large facilities are required to have a food safety system in place that includes an analysis of hazards and risk-based preventive controls (HARPC) to minimize or prevent those hazards. The standards that animal food facilities must meet mark the first time that CGMPs have been broadly required for the safe production of animal food.

While food facilities (companies that manufacture, process, pack, or hold food and are required to register with the FDA) were already subject to Current Good Manufacturing Practices (CGMPs), FSMA widely expands the preventative food safety measures that food facilities must undertake.

From an overarching perspective, HARPC requires food facilities to create a written food safety plan that identifies hazards that require some sort of control to minimize or eliminate the hazard, another article explains. Food facilities must implement, monitor, apply corrective actions (when necessary) to verify, and validate their food safety plan. The creation and implementation of a food safety plan must be overseen by a “preventive controls qualified individual” – that is, someone who has adequate training or experience and education necessary to fulfill that role.

But, what about other entities in the food chain and other requirements with compliance dates on the horizon? The article lays it out as follows:

    • Farms: Farms that grow, harvest, pack, and/or hold certain produce for consumption in the U.S. are subject to the Produce Safety Rule (PSR). This is the first time these entities have come under federal food safety regulations, and they must meet food safety standards in the categories of personnel qualifications and training; personnel health and hygiene; agricultural water; biological soil amendments; domesticated and wild animals; and growing, harvesting, packing, and holding activities, among a few other specific requirements. Most operations must be in compliance with the PSR by November 2017. For more information, click here.

    • Distributors: Entities involved in the transportation of food in the U.S. are now subject to sanitary transportation requirements under the Sanitary Transportation Rule. Generally speaking, the regulations apply to shippers, receivers, loaders, and carriers engaged in transportation of human and animal food in the U.S. Entities covered by this rule must be in compliance with its requirements by April 2017. For more information, click here.

    • Importers: Importers offering food from foreign countries for import into the U.S. must now conduct supplier verification activities under the Foreign Supplier Verification Program (FSVP). Some importers will also be categorized as “food facilities” and must comply with the requirements discussed above. For most importers, compliance with the FSVP starts on May 30, 2017. For more information, click here.

    • Supply-Chain Requirements for Food Facilities: Food facilities that receive raw ingredients requiring some sort of preventive control to minimize or eliminate the hazard must establish and implement a written risk-based supply chain program. In part, this involves investigation of and confirmation that their suppliers are conducting their operations in compliance with principles of food safety (either with food safety laws or other food safety standards) in accordance with the new Supply-Chain Program (part of the Preventive Controls Rules). Compliance with these requirements starts in March 2017. For more information, click here

    • Food Defense Plans for Food Facilities: In addition to the requirements discussed above, food facilities are required to create a written “food defense plan” to address the potential for intentional adulteration of food in their facilities. The approach to the food defense plan is modeled after the Hazard Analysis and Critical Control Point (HACCP) system and the HARPC requirements, as such, the plan must identify the facility’s vulnerabilities and create mitigation strategies and procedures for food defense monitoring, corrective actions, and verification, among other requirements. Compliance with these requirements starts in May 2019. For more information, click here.

Neogen has a site specifically dedicated to FSMA where more details can be found. To visit, click here.

Category: Food Safety