The Food Safety Modernization Act (FSMA) is a set of new regulations from the FDA designed to improve the safety of food in the United States, and to shift the focus of food safety regulation from a system of inspection to one of hazard prevention. The requirements of the food safety modernization act impact the majority of companies involved in food processing and production. Seven rules have been finalized and food companies have a limited amount of time to comply with the various aspects of FSMA.
Neogen® offers many products and services which can facilitate compliance, as well as whitepapers, handbooks and guidance.
|FSMA Rule||Rule Enacted||Compliance Dates|
|Preventive Controls for Human Food. Requires facilities to have plans and personnel in place to minimize hazards. [Learn more]||09/10/2015||
Large Businesses – >500 Full Time Employees
Small Businesses – <500 Full Time Employees
Very Small Businesses – <$1M annual sales
Pasteurized Milk Ordinance related businesses
|Preventive Controls for Animal Food. Established cGMP’s and preventive controls (similar to the Human Food Rule), for food for animals. [Learn more]||09/10/2015|
|Produce Safety: Establishes science based standards for growing, harvesting, packing and holding produce. [Learn more]||11/13/2015||
Small Businesses – <$250k but no more than $500k in annual produce sales during the previous three years
Very Small Businesses – <$25k but no more than $250k in annual produce sales during the previous three years
All Other Farms
Water quality standards of the rule, testing and record keeping provisions are +2 years to each of the above.
|Foreign Supplier Verification Program: Requires importers to verify that imported food and ingredients are safe for consumption. [Learn more]||11/13/2015||
Six months after the foreign supplier of the food is required to comply with the preventive controls regulations or produce regulations. (Compliance dates above plus 6 months)
Third Party Accreditation: Creates a program for accreditation of auditors by the FDA. [Learn more]
|11/13/2015||Not yet defined by the FDA.|
|Sanitary Transport: Requires transporters of food to ensure proper sanitation and safety of food during transport. [Learn more]||03/31/2016||
Small Businesses – businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $25.5 million in annual receipts would have to comply two years after the publication of the final rule
Other Businesses – a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule
|Food Defense: Requires food facilities to address intentional adulteration of food through prevention and defense of process and facilities. [Learn more]||05/31/2016||
Small Businesses – a business employing fewer than 500 persons would have to comply two years after the publication of the final rule
Very Small Businesses – a business that has less than $10,000,000 in total annual sales of food would have to comply within three years after the publication of the final rule
Other Businesses – a business that is not small or very small and does not qualify for exemptions would have to comply one year after the publication of the final rule
Sanitation Verification Using Accupoint® Advanced
Sanitation verification, as part of the oversight and management of preventive controls can be used as a viable verification process. Sanitation verification actually addresses the Preventive Controls rules in two specific areas. It can be used to monitor sanitation procedures to ensure their effectiveness, and it can be used to verify that surfaces are clean and that the identified hazard is under control.
Food Allergen Control Plan
Food allergens are a foreseeable chemical hazard which can specifically be and monitored through an appropriate allergen control plan. Monitoring and verification of preventive controls as part of the allergen control plan would involve the use of Neogen’s Reveal®, and Reveal 3-D for environmental monitoring, and Veratox® for finished product testing. Alert® and Veratox products can be used for the validation of SSOPs for specific allergens.