The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, imposes significant new regulations designed to prevent the sale and consumption of contaminated food products, to proactively respond to foodborne illness and minimize contamination risk, and to secure the food chain, ensuring that imported food comes from registered foreign facilities and meets US health, safety, and quality standards.
The FSMA regulations establish a framework of enforceable safety standards; everyone, from the producers to the consumers, will be impacted by the new regulations. For importers, a thorough review of your current supply-chain, including verification of overseas suppliers (audits of a supplier’s facility, sampling and testing of food, or a review of the supplier’s relevant food safety records), will be essential to identify risk areas which could lead to noncompliance.
Since January 2013, the FDA has proposed seven fundamental regulations to implement the FSMA. Businesses must comply with each rule one year after it is released. All regulations become final by year-end in 2016.
1. Preventive Controls for Human Food (Final Rule): Facilities that manufacture, process, pack, or hold human food must maintain and implement a written food safety plan (hazard analysis, preventive controls, monitoring procedures and corrective action).
2. Preventive Controls for Animal Food (Final Rule): Animal feed manufacturers must comply with various aspects of operations such as good hygiene practices, proper maintenance of plants, pest control, sanitation principles, and labeling of ingredients and finished products.
3. Fresh Produce Safety (Final Rule): Companies that grow, harvest, pack, and hold produce that is typically consumed raw must comply with standards around water, health, hygiene, equipment, facilities, and training.
4. Foreign Supplier Verification Program (FSVP) (Final Rule): Importers must verify their suppliers are employing prevention-based food safety practices. Importers will need to have a plan in place that identifies potential hazards for all food items they are importing.
5. Third Party Accreditation (Final Rule): The combination of this rule, plus the FSVP, shifts the focus from relying on the FDA to find problems at import to proactively preventing problems.
6. Sanitary Transportation (Proposed Rule): Shippers, carriers,receivers, and others transporting food must comply with requirements for vehicle and transportation equipment, transportation operations, training, and documentation.
7. Intentional Adulteration (Proposed Rule): Facilities that use certain processes that are likely targets of terrorism must have a written defense plan.
*Two rules were published in September, 2015 (Preventive Controls for Human Food and Preventive Controls for Animal Food), three more were published in November 2015 (Foreign Supplier Verification Program, Third Party Accreditation, and Fresh Produce Safety). The final two rules are schedule for Spring, 2016 (Sanitary Transportation in April, 2016, and Intentional Adulteration in June, 2016).
In addition to the FDA’s proposed regulations, the FSMA expands upon the FDA’s ability to oversee food safety by improving their ability to identify and resolve issues of food contamination,enhancing detection and response to food safety issues, and establishing a safer food import system.
In its entirety, the FSMA will have a profound effect on both importers and the food industry. Giving the FDA and US Customs and Border Protection (CBP) more authority in carrying out mandates that ensure food safety, the FSMA will require importers, warehouses,and distributors to install precautionary measures to proactively fight against food contamination. For importers, this means ensuring compliance throughout the supply-chain. Importers must verify foreign suppliers, assess safety plans and high risk areas, establish and document preventive measures (to address potential audits), create a recall plan outlining how each product is manufactured/managed, and plan for increased surveillance and sampling at the border. Noncompliance with the FSMA regulations could result in CBP seizing, and possibly destroying, food imports (the FDA and CBP can retain goods with only a reasonable belief that they are noncompliant – opposed to the previous regulation requiring credible evidence).
Deringer remains committed to supporting clients throughout the implementation phase of the FSMA. For information and guidance about the FSMA, please visit the FDA website. For additional questions, please send an email to Deringer’s Compliance Department.