What is the Food Safety Modernization Act? FSMA was signed into law in January 2011. It is the most sweeping change to food safety in over 70 years. It fundamentally changes the way food is regulated in the U.S. and abroad and affects the entire supply chain from farm-to-fork. It aims to enhance the culture of food safety and requires a culture change for most food retailers, while providing consumers with important safeguards to enhance confidence in our food system.
FSMA’s focus is on prevention and will have a direct impact on manufacturing facilities, central kitchens, distribution centers, food imports and even transportation. The law also provides the U.S. Food and Drug Administration (FDA) with new enforcement authorities and new tools to hold imported foods to the same standards as domestic foods. All FSMA compliance documentation must be accessible within 24 hours and must be retained for at least 2 years.
Who is Responsible for FSMA Compliance?
All food supply chain participants must comply, where applicable. The Food Safety Modernization Act (FSMA) impacts many aspects of a company and requires additional resources for training, record-keeping, product information/traceability systems, auditors, and food safety and legal staff. FSMA also takes corporate liability to a new level by holding food executives accountable, which is similar to Sarbanes-Oxley.
The Food Safety Modernization Act (FSMA) is composed of seven rules that will have a major impact on participants in the global food supply chain.
- 1. Preventive Control - Human
- 2. Preventive Control-Animal
- 3. Foreign Supplier Verification Program
- 4. Third Party Auditor Accreditation
- 5. Produce Safety
- 6. Sanitary Transport
- 7. Food Defense
Preventive Controls – Human Food
- Facilities that manufacture, process, pack, or hold human food must maintain and implement a written food safety plan. It must contain elements like hazard analysis, preventive controls, monitoring procedures and corrective action.
- FSMA Final Rule for Preventive Controls for Human Food
Preventive Controls – Animal Food
- 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.
- FSMA Final Rule for Preventive Controls for Animal Food
Foreign Supplier Verification Program (FSVP)
- 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 each food they are importing.
- FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
Third Party Auditor Accreditation
- The combination of this rule, plus the Foreign Supplier Verification, shifts the focus from relying on FDA to find problems at import to proactively preventing problems.
- FSMA Final Rule on Accredited Third-Party Certification
- 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.
- FSMA Final Rule on Produce Safety
- Shippers, carriers, receivers and others transporting food must comply with requirements for vehicle and transportation equipment, transportation operations, training and documentation.
- FSMA Final Rule on Sanitary Transportation of Human and Animal Food
Intentional Adulteration – Food Defense
- Facilities that use certain processes that are likely targets of terrorism must have a written defense plan.
- FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration
When Will These Changes Happen?
The seven FSMA rules are now final. Some authorities have already gone into effect, such as the FDA’s new authority to order companies to recall food, and others require FDA to prepare and issue regulations and guidance documents. Compliance dates for each rule vary based on size of company. The first compliance date for companies with more than 500 employees is listed below. See dates for all company sizes here.
|Seven Major FSMA Regulations||Publication Date||Compliance Dates|
||Sep 17, 2015||Sep 17, 2016|
||Sep 17, 2015||Sep 17, 2016 cGMP
Sep 19, 2017 PC
||Nov 27, 2015||Jan 26, 2018|
||Nov 27, 2015||May 30, 2017|
||Nov 27, 2015||*TBD|
||Mar 31, 2016||Apr 6, 2017|
||May 31, 2016||Jul 26, 2019|
The Risk of Waiting?
There is no need to wait for the FDA to demand that you take action. Many of the requirements are already identified in the language of the law. If you are involved in the production or sale of food, it’s in your best interest to act now. You don’t want to rely on the regulators to ensure the safety of your products. Building a supply chain that protects your brand’s reputation from risk is more important now than ever before. Having systems to verify that your suppliers are meeting your expectations with respect to food safety, and having a well-documented, exercised recall plan in case things go wrong are necessary to the continued success and vitality of your business.