Earlier today, the Food and Drug Administration (FDA) issued a constituent update by email (and posted to the FDA website) regarding the Food Safety Modernization Act (FSMA) and the agency’s plan to use enforcement discretion for some of the provisions. In essence, the agency announced that it would not be enforcing specific provisions in four regulations of FSMA. The rules where discretion will be used include:
From the Facts Sheet, several of the areas discussed, which are affected by regulatory discretion, impact our industry, including:
#1: Farm-related regulatory discretion applies because some of the botanicals used as raw materials are covered under the Produce Safety rule. Farm-related activities for industry might include drying of herbs used in dietary supplements as raw materials or dietary ingredients.
#2: Regulatory discretion in the area of written assurances in the “customer provision” in the PC Human Food rule applies in that written documentation (disclosures) can be provided disclosing a hazard has been identified, and it has not yet been controlled; however, it will be controlled by another processor before it reaches the consumer. FDA has acknowledged in the Facts Sheet that this responsibility may take additional time and it states in the Facts Sheet that it recognizes the difficulty with the resources to comply with this provision and the complexity of the supply chain relationships.
#4: Human food by-products for use as animal food includes botanical tinctures and tea manufacturers, who may be using the excess or spent biomass for use as animal feed to local ranchers. Regulatory discretion will be used for the by-product dependent on if the by-product is further processed as an animal food. The Facts Sheets clarify the expectations for GMPs for the handling of human food by-product for use as an animal food.With warm regards,
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Center for Food Safety and Applied Nutrition
View Past Updates
FDA Announces Enforcement Discretion Policy for Certain FSMA Regulations
January 4, 2018
The FDA announced today that it intends to exercise enforcement discretion for certain provisions in four of the rules that implement the FDA Food Safety Modernization Act (FSMA). This means that during the enforcement discretion period, the agency does not intend to enforce these provisions as they currently apply to certain entities or activities.
In general, the FDA is exercising enforcement discretion to allow time to consider changes or other approaches to address concerns regarding the application of these provisions to certain activities or entities. FDA had previously extended the compliance dates for many of the provisions covered by this enforcement discretion guidance (see August 2016 compliance date extension) but is now exercising enforcement discretion.
The enforcement discretion announced today pertains to specific provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to:
Additional questions can be directed to the FSMA Technical Assistance Network.