This is a summary of the recently released FSMA rule for Preventative Controls for Human Food that was released on September 22, 2015 http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm.
After years for research and debate the FDA has finally released the Food Safety Modernization Act (FSMA) final rules for Preventative Controls for Human Food. The new rule will require facilities that manufacture, process, pack or hold human food, similar regulations apply to food for animal consumption. According the Ms. Jenny Scott, Senior advisor for the U.S. Food and Drug Administration, “this rule will require a food facility to have and implement preventative controls to significantly minimize or prevent the occurrence of hazards that could affect food manufactured, processed, packed, or held by the facility.” This directive is intended to prevent or, at a minimum, quickly identify foodborne pathogens before they get into the food stream.
Key requirements outlined by the FDA are:
- Food Safety Plan – this includes an evaluation of hazards and risk-based preventative controls. The requirements for a written food safety plan include:
- Hazard analysis – Identification of hazards which considers known or reasonably foreseeable biological, chemical and physical hazards. Hazards could occur naturally, unintentionally, or intentionally.
- Preventative Controls – Required measures include:
- Process controls
- Food allergen controls
- Sanitation controls
- Supply-chain controls
- Recall plan
- Management of Preventative Controls – practical flexibility for compliance outlined are:
- Monitoring
- Correction actions and corrections
- Verification
- Supply-chain Program has separate compliance dates to promote flexibility
- Manufacturing and processing facilities must have a risk-based supply chain program for those raw materials and other ingredients for which it has identified a hazard requiring “supply-chain applied controls.”
- Food facilities are responsible for using approved suppliers. Brokers or distributors can use used to conduct supplier verification activities.
- Food facilities will not be required to comply with supply-chain program dates before its supplier has.
- The definition of a “farm” has been modified to cover two types of farm operations
- Primary Production Farm – is defined as a singularly managed operation. Can include: growing, harvesting, and processing of crops.
- Secondary Activities Farm – an operation that is not located on the primary farm, usually a farm dedicated to harvesting, packing, and processing of raw goods. For further definition see Key Requirement Number 2 of the FSMA Final Rule for Preventative Controls for Human Food.
- Current Good Manufacturing Practices (CGMPs) are updated and clarified
- Final rules are to be considered more as guidance and do not include nonbinding provisions.
- Some of the prior nonbinding obligations, such as education and training are now binding. Management is required to uphold this for all appropriate employees.
- The FDA’s established stance that CGMPs address allergen cross-contact is now explicit in the regulatory text.
Compliance dates vary for businesses and are staged over several years to assist in adequate implementation of the new rules. For more information on compliance dates see page 5 of the FSMA Final Rule on Preventative Controls for Human Food fact sheet.
This new ruling builds on already established rules, making the final rule more comprehensive, based on modern technology, with flexibility to allow for successful achievement by food and beverage manufacturers. With regulations constantly changing you need a technology driven solution to help you meet the evolving compliance landscape. RKL eSolutions shows you how automated solutions can bring transparency to your business.
For more information on how the FSMA rules will affect you visit the final rule page on the FDA website. To learn about how a modern ERP solution can help food and beverage manufactures met these requirements visit.
