FSIS Proposes Egg Products HACCP Rule That Expands Jurisdiction

On February 13, 2018, the USDA Food Safety and Inspection Service (FSIS) published a proposed rule that would amend the egg products inspection regulations. The proposal had been announced on January 9, 2018. The 48-page proposal (including the preamble) covers more than a change in good manufacturing practices and has the potential to be far-reaching.

Introduction of HACCP Requirements

The purpose of the proposed rule is to modernize food safety inspection systems at egg products plants. To that end, FSIS proposes to require that an official establishment that processes egg products (a term that FSIS proposes to redefine to include additional products) use Hazard Analysis and Critical Control Point (HACCP) systems and Sanitation Standard Operation Procedures (SSOPs). FSIS also proposes to eliminate those “command and control” regulations that are incompatible with the regulations for HACCP and SSOPs.  Regulations that will be amended or deleted include those relating to egg products plant grounds and pest management; plant sanitation and requirements for plant construction, including rooms, doors, and windows; lighting; ventilation and odors.

According to FSIS, HACCP systems provide flexibility to tailor food safety systems to a particular product, facility, and equipment. The amendments to the regulations would align FSIS regulations for egg products with the regulations for meat and poultry.

FSIS notes that about 93 percent of egg products plants already operate under written HACCP plans. Consequently, the cost of the implementation of the new regulations will be “mitigated.”  However, the rule may come as a surprise to facilities that thus far have not been subject to FSIS jurisdiction.

FSIS intends to phase in the HACCP requirements over a 2-year period and the SSOP measures and requirements one year after the publication of a final rule.

Egg Products are Ready-to-Eat

FSIS considers pasteurized egg products ready to eat. To clarify this, the Agency proposes to specify in the regulations that official establishments must process egg products to be edible without additional preparation to achieve food safety; egg products must be free of detectable pathogens.  Plants are to maintain control of egg products that have been sampled and tested for public health hazards, until the test results become available.

Egg Products Definition

Under the Egg Products Inspection Act (EPIA), FSIS regulates egg products. The EPIA defines the term “egg product” in relevant part as “dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in a relatively small proportion or historically have not been . . . considered by consumers as products of the egg food industry.” FSIS has the authority to exempt certain products from this definition.  The implementing regulation defines egg products to include a list of specific exemptions.  FSIS is now proposing to revise that definition.  Specifically, FSIS is considering removing the exemption of egg substitutes and freeze-dried egg products from the definition of egg products.

As discussed in the proposal, FSIS considers a product to be subject to the EPIA if it consists of dried, frozen, or liquid eggs, with or without added ingredients. Traditionally egg substitutes have been excluded from this definition; the addition of a color additive caused them to fall outside the definition of egg product.  However, FSIS now has determined this is incorrect; since the “fundamental ingredient” in egg substitutes is egg white, they are egg products and should not be excluded from the definition.  Similarly, FSIS has concluded that there is no justification for the exclusion of freeze dried egg products.  FSIS does not know the number of facilities that might become subject to FSIS jurisdiction as a result of this action.  In light of the FSIS requirements for import of products under its jurisdiction (including the requirement for the exporting country to be determined equivalent), this change in definition may have far reaching consequences for foreign establishments that manufacture freeze dried egg products and egg substitutes.

Other Amendments

FSIS proposes several additional amendments to make the requirements for egg products more similar to those applicable to meat and poultry products. For example, FSIS proposes to require special handling instructions such as “Keep Refrigerated,” “Keep Frozen,” and “Perishable Keep Under Refrigeration,” on egg products.  Also, egg products plants would be incorporated into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions.

Some amendments that likely will be welcomed by egg products establishments include the proposal to change the interpretation of the requirement for “continuous inspection” to be consistent with current inspection requirements applicable to meat and poultry processing facilities; if finalized as proposed, egg products plants would be required to be inspected at least once per shift, instead of during all processing operations.

In a move certain to be welcomed by industry, FSIS proposes to amend the labeling regulation to allow for generic label approval for egg products, an option currently not available. FSIS estimates that about 50% of labels will be eligible for generic label approval.

Concurrently, FSIS issued draft guidance to help small and very small plants producing egg products to meet the proposed new regulatory requirements.

Because of the “magnitude of the proposed action and the need to provide for possible public meetings on the proposed action,” FSIS provides for a comment period of 120 days; comments to the proposed rule and the draft guidance must be received on or before June 13, 2018.