Manic Monday: FSMA Compliance Starts Today!
Today, Sept. 19, 2016, is a big day for the food industry. It is the first compliance deadline1 for regulations under the Food Safety Modernization Act (FSMA) – the law we’ve been talking about since 2011, the law touted as the most sweeping reform of food safety laws in more than 70 years.
So, what’s all the big fuss about?
Yes, “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). But FSMA widely expands the preventative food safety measures that food facilities must undertake. Food facilities are now required to be in compliance with FSMA’s updated CGMPs as well as the Hazard Analysis and Risk-Based Preventive Controls (HARPC) portions of FSMA’s Preventive Controls for Human Food Rule.2
From a 30,000 foot 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. 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.
Finally, as of today, food facilities must have a written recall plan that meets certain requirements outlined in the regulations. FSMA also requires food facilities to maintain an increased number of records that document compliance with these new food safety measures (pro tip: i.e., DOCUMENT EVERYTHING!).
But, what about other entities in the food chain and other requirements with compliance dates on the horizon?
- 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 2017.3
- 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. 4
- 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. 5
- 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 2017.6
- 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 (discussed above); 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 2019.7
As you can see, FSMA represents a significant shift in the food industry’s approach to food safety. The rules are complicated and interact with one another in ways that make generalizations about the requirements (as we’ve done above) a tricky endeavor. We’ll explore some of these rules in more detail in future blog posts. However, we strongly encourage those of you in the food chain to seek professional assistance to ensure your entity is in compliance with FSMA’s numerous provisions.
1 Note: the FDA recently extended the enforcement date for other provisions.
2 Facilities that manufacture, process, pack, or hold food for animal feed must also comply with CGMPs and HARPC requirements.
3 Compliance with regulations regarding agricultural water starts in November 2019. Smaller operations covered by this rule have additional time to comply. Activities involving sprouts are subject to separate compliance dates.
4 Small businesses covered by this rule have an additional year to comply with the regulations.
5 Compliance dates vary depending on the size of the importer and on certain characteristics of the suppliers from whom the importers are importing food.
6 Small businesses covered by this rule have an additional year to comply with the regulations. Qualified facilities and businesses covered by the Pasteurized Milk Ordinance have two additional years to comply.
7 Small businesses and those subject to other modified requirements have additional time to comply.