The FDA intends to exercise enforcement discretion for certain provisions in four of the FSMA rules until it can work out issues presented in feedback from several entities or stakeholders, especially farms, packing facilities and importers.
In general, FDA needs time to consider changes or other approaches to address concerns regarding the consistent application of these provisions to certain activities or entities.
The enforcement discretion pertains to specific provisions in the Current Good Manufacturing Practice (CGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for human food (PC Human Food), HARPC for Food for Animals (PC Animal Food), Foreign Supplier Verification Programs (FSVP), and Standards for the Growing, Harvesting, and Holding of Produce for Human Consumption rules—and how these rules apply to:
- Facilities that would be farms except for certain factors and activities
- Written assurances provision in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health
- The animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food
- FSVP requirements for importers of food contact substances.
Enforcement has been put on hold for certain entities and/or activities.
According to James Gorny, VP food safety & technology, Produce Marketing Association, this is because feedback from regulated entities has raised complex questions about factors, such as farm-related activities and farm ownership, which have an impact on whether the determination of an entity is a “farm,” as well as other issues.
“Leading produce trade organizations have emphasized the need for additional regulatory guidance or changes to the regulations to provide practicality, clarity and certainty to the regulated industry,” says Gorney.
Farms and related activities
Farms are exempt from controls and requirements in the CGMP and PC rules.
However, produce farms are typically covered by the Produce Safety rule, unless an exemption applies.
The enforcement policy applies to certain facilities conducting farm-related activities. Some of these facilities also conduct activities not within the farm definition, even if conducted on farms (e.g., coloring raw agricultural commodities (RACs), according to FDA’s “Enforcement Discretion for Certain FSMA Provisions.”
Farm-related activities are activities within the definition of “farm,” if performed on farms. These activities include growing and harvesting of crops and some manufacturing/processing activities such as drying/dehydrating RACs to create a distinct commodity, treating RACs to manipulate ripening, and packaging and labeling RACs. RACs are a food in its natural state, including colored, washed or treated fruits in their unpeeled form. Grains and eggs are non-produce RACs.
Some establishments that fall outside the current “farm” definition perform activities that are also typically done on farms.
However, because these establishments aren’t considered farms, they are subject to PCs and CGMP requirements (unless another exemption applies).
FDA intends to initiate rulemaking that could change the way the requirements in the PC rules apply to facilities that conduct activities similar to those that occur on farms (as farms are currently defined).
Written assurances in the four rules
According to FDA, each of the four rules (PC Human Food, PC Animal Food, FSVP and Produce Safety) includes “customer provisions” intended to provide written assurance to a manufacturer, processor, importer or farmer that the food will be processed to control for hazards before the food reaches consumers.
For PC rules, these provisions apply when a manufacturer/processor relies on other entities (commercial customers) in the distribution chain to control certain identified hazards—when there will be no further processing before the food reaches consumers.
The FSVP rule includes customer provisions that apply when an importer imports food for which the hazards are controlled after importing. Also, produce is eligible for an exemption from many of the requirements in the Produce Safety rule if it will receive commercial processing that adequately reduces the presence of microorganisms of public health significance, and certain other conditions are met including requirements for disclosure statements and written assurances similar to what’s required by the CGMP and PC rules and FSVP.
FDA has received feedback that certain product distribution chains would require vastly more written assurances and resources to comply than was anticipated by FDA during the rulemaking process. FDA will look into the complexity of supply chain relationships, while exercising enforcement discretion through this process.
Importing food contact substances under FSVP
With stakeholder input, FDA has determined that because of certain characteristics related to the nature of food contact substances, FDA’s premarket review and oversight of food contact substances—and the regulatory framework for these substances—it is appropriate to exercise enforcement discretion with regard to the FSVP regulation. That is, FDA doesn’t intend to require importers of food contact substances to comply with FSVP requirements.
Food contact substances already undergo a thorough premarket review under FDA’s Food Contact Notification (FCN), which requires applicants to demonstrate that the intended use of the food contact substance is safe. In addition, if a food contact substance has not been authorized by FDA through the FCN or food additive petition processes, the agency would consider the food product adulterated.
Certain manufacturing activities for human food by-products for use as animal food
Since issuing the 2016 Draft Guidance for Industry #239 (“Human Food By-Products For Use As Animal Food”), FDA has become aware of concerns about how the preventive controls requirements apply to certain activities performed on human food by-products for use as animal food before they are stored or transported, and which do not affect their safety profile.
FDA intends to exercise enforcement discretion for the following activities:
- Drying/dehydrating. evaporating, pressing, chopping and similar activities to reduce weight, bulk or volume
- Mixing, centrifuging and similar activities to combine ingredients or separate components (e.g., water and solids).
This enforcement discretion does not apply when these activities are performed to prevent or significantly minimize animal food hazards, or when these activities introduce animal food hazards.
For more information, download “Enforcement Discretion for Certain FSMA Provisions.” For all the details, visit FDA’s web page, “Guidance for Industry,” which provides several links to resources on this new January 2018 regulatory action.