What is FSMA?
The Food Safety Modernization Act (FSMA) is U.S. legislation, which provides the Food and Drug Administration (FDA) enforcement authorities to establish and regulate food safety standards for the growing, processing, manufacture, packing, storage, and distribution of domestic and imported food products. Since its enactment in 2011, a suite of rules was developed, which lays out the minimum requirements food operations must implement in their business when producing, handling and/or distributing food for sale and consumption in the U.S.
Rules affecting produce growers, food manufacturers, foreign suppliers, and businesses involved in the storage and distribution of food products include the following:
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
- Mitigation Strategies to Protect Food Against Intentional Adulteration
- Sanitary Transportation of Human and Animal Food
- Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Is your business affected by one or more of these rules? If so, accredited food safety certification to a GFSI-recognized scheme is one way to get your operation on track for regulatory compliance.
How do I comply to FSMA?
Certification to FSMA (Food Safety Modernisation Act) is available as an add on module to your BRC audit with FoodChain ID Certification in the UK from 2016.
Global Food Safety Initiative (GFSI) recognized certification programs are based on private food safety standards, which do not represent specific country legislation. Rather, GFSI benchmarked standards are HACCP-based food safety management systems, which align with many of the science and risk-based requirements across FSMA rules. Further, GFSI-recognized certification programs contain many requirements for ensuring that companies comply with all relevant legislation pertaining to the country of production and sale (e.g., hygiene standards, allergen labelling, product claims).
Since publication of the final rules, many GFSI certification program owners (CPOs) conducted independent studies to demonstrate how their standard aligned with Preventive Controls regulation. In general, results of the analyses demonstrated close alignment between benchmarked standards and the regulation with some CPOs developing additional modules and guidance documents to support certified companies in adapting their GFSI-recognized program to meet and exceed regulatory requirements.
In response to GFSI’s upgraded Benchmarking Requirements v7.0 document this past year, recognized standards are further closing the gap between their programs and FSMA rules to support GFSI certified sites in implementing a comprehensive food safety management system, which merges industry best practices and global food regulation.
Click on the links below to learn more about CPOs and FSMA.
Generally speaking, all food for sale and consumption in the U.S. is subject to applicable FSMA rules regardless of where it is produced or manufactured. To ensure compliance, foreign suppliers’ food safety management systems are verified through one of two ways with respect to the rules.
The first way is through a food manufacturer’s supply-chain program as required by subpart G of the Preventive Controls rule. Businesses subject to Preventive Controls requirements are responsible for establishing and implementing a risk-based supply-chain program to control identified hazards in raw materials and ingredients. The program requires the use of approved suppliers, application of material acceptance procedures and supplier verification activities to ensure that identified hazards are mitigated and prevented from entering the food supply chain.
The second way is through import requirements detailed in the Foreign Supplier Verification Program (FSVP). U.S. importers of record are required to conduct a hazard analysis for each type of imported food to identify significant food hazards as well as conduct a risk assessment to determine supplier fitness for the production of food which meets U.S. regulations. Depending upon the outcome of the hazard analysis and risk assessment, the importer is responsible for conducting one or more verification activities, which may include an on-site audit of the supplier’s operation, to ensure regulatory compliance.
Regulatory compliance with country specific food legislation such as FSMA can seem overwhelming in a global supply chain. Fortunately, there are globally recognized and standardized systems and tools to help your operation stay ahead of the curve.
- For environmental monitoring and product testing, ensure analysis by an ISO 17025 accredited laboratory
- For effective food safety management, certify to a GFSI-recognized program, which provides the framework for risk-based management of food hazards, fraud and security threats.
- For on-site supplier verification audits, ensure assessment by a qualified government inspector or third-party auditor of an accredited certification body.