Food Safety Modernisation Act (FSMA):
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
As part of the Food Safety Modernization Act (FSMA), the US Food and Drug Administration has issued several rules to further clarify the requirements of the regulations, one of which relates to Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. The rule was developed after extensive consultation with numerous stakeholders.
The limitations and definitions of which facilities are covered by this rule are many and varied and take pages to define. A few examples of the exemptions include:
Requirements for Non-Exempt Facilities
All other facilities are covered by the rule and therefore must establish and implement a food safety system. This requires a written food safety plan that covers
Definition of a Farm
Farms are not subject to this rule; instead they are subject to the Produce Safety Rule, which has expanded and clarified the definition of what constitutes a farm. There are two main types identified:
This means that facilities that do off-farm packing are now included within the definition of a farm, as are companies that do nothing but harvest crops, and companies that merely hold or store RACs.
Supply Chain Programs
Another important area that is addressed by this rule is the supply chain. The aim is to make this process more flexible. As well, it establishes separate compliance dates so that a food facility does not have to comply before its suppliers do.
A facility must have a risk-based preventive assessment supply chain program for any ingredient or material that has been identified as needing one, unless it either institutes preventive measures to deal with the hazard itself or passes the ingredient on to a customer who will implement their own preventive measures.
Foods should be received from approved suppliers, which are defined as ones approved by the facility after an assessment of the hazard associated with that particular food and the track record of the entity that will be controlling that hazard. Of course, foods may be brought in temporarily from unapproved suppliers, but such ingredients are then subject to verification before they can be used.
Preventive controls are not required within the facility if the hazard will be controlled by a subsequent entity such as the final customer or another processor. However, the facility must disclose that this food has not been processed to control its associated risk (e.g. Salmonella or listeria) and must obtain written assurance that the subsequent entity will do so.
Another entity, such as a broker or a distributor, can conduct supplier verifications but the receiving facility must review and assess that entity’s documentation of the verification.
Current Good Manufacturing Processes (CGMPs)
The rule attempts to update and clarify CGMPs. As well, the rule no longer includes any non-binding provisions or guidelines. All provisions are now binding. These include:
The rule was passed on September 17, 2015 and compliance is required from that date as follows:
Compliance dates for the requirements of the supply chain program: