On September 9, 2020, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced their intent to publish The Egg Products Inspection Regulations final rule (EPIR) which changes the methods used in egg product inspection. This is the first update to the regulations implementing the Egg Products Inspection Act (EPIA) that was enacted in 1970. The goal of the EPIR is to align the egg products regulations with current meat and poultry products inspection regulations and attempts to do so by making several clarifications to jurisdiction, food safety requirements, sanitation, labeling, enforcement protocols, and inspection frequency.

More Egg Products Processing Oversight Shifting to FSIS

Traditionally, the regulation of eggs and egg products is split between FSIS and the United States Food and Drug Administration (FDA). FSIS was responsible for egg products and egg processing plants that break and pasteurize eggs, while FDA was responsible for shell eggs of domestic animals, egg substitutes, and plants that wash, sort and pack eggs.

The term “egg products” refers to eggs that have been removed from their shells for processing at facilities called “breaker plants.” The eggs are processed by filtering, mixing, stabilizing, blending, pasteurizing, cooling, freezing or drying, and packaging. Basic egg products include whole eggs, whites, yolks, and various blends—with or without non-egg ingredients—that are processed and pasteurized. The term “egg substitutes” refers to products that “consist of egg whites, artificial color, and other non-egg additives.” “Freeze dried eggs” are liquid eggs that have been mixed, frozen and then dried. Egg substitutes and freeze-dried eggs pose the same food safety risks as other egg products due to similar processing methods.

Under the EPIR, FSIS will oversee more egg products, including egg substitutes and freeze-dried eggs, and their processing facilities. Due to the similarities in the processing of egg products, egg substitutes, and freeze-dried eggs and their food safety risks, FSIS believes that regulation by the same agency will streamline the inspection process. Further, many plants that make egg substitutes and freeze-dried eggs are already inspected by FSIS because they also produce other FSIS regulated egg products. FSIS will take over regulation of egg substitutes and freeze-dried eggs as egg products within three years of the publication of the final rule.

Changes to Food Safety Requirements, Labeling, Enforcement Actions and Inspection Frequency.

A major change created by the EPIR is the requirement that egg product facilities under FSIS jurisdiction develop and implement a Hazard Analysis and Critical Control Point (HACCP) system and Sanitation Standard Operating Procedures (SSOPs). HACCP systems and SSOPs are typically associated with meat and poultry operations and have greatly reduced the prevalence of Salmonella in meat and poultry products. While traditionally associated with meat and poultry production, HACCP has crossed over into other areas of the food industry. For example, FDA requires a HACCP plan for juice and seafood producers. Because HACCP has become a common food safety tool, at least ninety-three percent of egg product facilities already have some type of HACCP system in place. The idea is that implementing and enforcing HACCP systems and SSOPs in all egg processing facilities will result in a reduction in food borne illness outbreaks connected to egg products. Plants will also have the ability to tailor a food safety system that best fits their particular facility and equipment while maintaining flexibility. However, if plants do not follow their HACCP plans, FSIS will take appropriate regulatory enforcement action

FSIS is re-emphasizing that official plants that produce pasteurized egg products are required to process their egg products to be edible without additional preparation to achieve food safety. To ensure compliance, FSIS will continue testing for Salmonella and Listeria monocytogenes in egg products. FDA has required that egg substitutes and freeze-dried eggs be “free of viable Salmonella organisms.” The new regulations consider a wider range of hazards in setting the food safety standard for egg products and do not allow unpasteurized egg products to be sold to retailers and consumers. However, unpasteurized egg products may still be sent to other official plants for further processing to achieve food safety.

The EPIR has also added changes to the labeling requirements for eggs and egg products. FSIS will now allow generic approval as part of the prior label approval system for egg products; make changes to labeling requirements for shell eggs consistent with those in the FDA regulations; and require special handling instructions on certain egg products that to maintain their wholesome condition. Currently, an egg products plant must submit a formal application along with a sketch of a product label to FSIS personnel for approval of new or changed labels. The approval process for certain labels will be streamlined, allowing egg products plants to use certain generically approved versions. Labels that will not qualify for generic approval include temporary approvals, labels for export only products that bear labeling deviations, or labels bearing special statements and claims. Further, EPIR requires “Keep Refrigerated” or “Keep Frozen” statements for all egg products that require special handling to maintain their wholesome condition.

FSIS is also replacing the enforcement procedures for egg product plants with those that apply to meat and poultry product establishments under 9 CFR part 500. This will allow FSIS to apply the same Rules of Practice to egg product plants that the agency uses for other administrative enforcement actions. The Rules of Practice used by FSIS allow for three types of enforcement actions: (1) regulatory control actions such as retention of product, rejection of facilities, slowing or stopping of line, or refusal to allow the processing of a specifically identified product; (2) withholding actions such as refusal to allow marks to be applied to products; and (3) suspension of a facility.

Regulatory control actions are typically issued when unsanitary conditions or practices are observed, product is adulterated or misbranded and conditions that preclude FSIS from determining that product is not adulterated occur. Withholding actions may be preceded by a prior notice when SSOPs or HACCP plans are inadequate or sanitary conditions and performance standards are not met. A withholding action with no notice may be issued where adulterated product is produced and shipped; a facility has no SSOPs or HACCP plan; a regulatory control action has been violated; or a facility has insanitary conditions. If FSIS takes a withholding action or imposes a suspension, the establishment will be notified orally and as promptly as circumstances permit in writing.

Perhaps the most significant change the EPIR makes is a new interpretation of “continuing inspection.” Generally, egg product facilities require reinspection of all egg products at the time they are brought into the official plant. This is similar to the continuous inspection that FSIS conducts in meat and poultry slaughtering plants. However, meat and poultry processing plants do not require this constant inspection during processing and generally have an inspection once during each shift. Due to the implementation and enforcement of HACCP systems and SSOPs in egg processing plants, the EPIR is shifting egg product processing inspection to mirror meat and poultry processing inspection rather that meat and poultry slaughtering. This will require that Inspection Program Personnel (IPP) need only be present for an inspection at least once per shift. FSIS intends for the new interpretation of “continuous inspection” to allow for more efficient and effective inspections and resource allocation while maintaining food safety standards through the implementation of HACCP plans and SSOPs, similar to meat and poultry processing plants. According to the FSIS, “[w]hile at each plant, IPP will monitor the plant’s sanitary operating practices and the execution of its HACCP plan, such as the critical control point (CCP) related to the heat treatment of egg products, conduct the Agency’s food safety related Public Health Information System (PHIS) tasks, and perform other consumer protection tasks, such as conducting product labeling reviews.”

FSIS Hopes That New Regulations Will Provide a Significant Food Safety Advancement with Little Cost to Industry

In its responses to comments, FSIS repeatedly stated that the intent of the EPIR is to use its inspection resources to conduct more efficient and effective inspections. The Agency believes that egg products operations are very similar to meat and poultry processing operations because the typical egg products processing operation is a streamlined, automated process, with a lethality step to destroy pathogens of concern in the finished product. Therefore, FSIS believes that the regulation of egg products should mirror the regulation of meat and poultry processing. According to the new rule, the reduction in inspection frequencies will give FSIS the flexibility to focus inspection coverage and tasks in consideration of public health risk.

While larger producers submitted comments that were generally supportive of the EPIR, smaller producers’ comments expressed concern over the cost of implementing a HACCP system and SSOPs. FSIS attempted to ease concerns over the cost of implementation by providing data that ninety-three percent of egg product facilities already have some type of HACCP plan and ninety-one percent conduct sanitation procedures. Further, FSIS states that implementing HACCP and SSOPs should not require any capital investment.

FSIS is set to publish the final rule in the Federal Register. The implementation date for SSOPs is one year from the date of the rule’s publication in the federal register, while the implementation date for HACCP systems is two years from the date of the rule’s publication in the federal register. Some exceptions to these implementation dates apply for very small processors. FSIS is providing several guidance documents before the rules are implemented in order to assist producers in creating their HACCP systems and SSOPs, including: Generic HACCP Models Guide for Egg Products (pending publication), FSIS Food Safety Guideline for Egg Products, and Compliance Guideline for Hazard Analysis Critical Control Point (HACCP) Systems Validation.

To read the USDA press release regarding the final rule, click here.

To read the pre-publication copy of the Egg Products Inspection Regulations final rule, click here.

To read the Egg Products Inspection Act, click here.

To learn more about the Agency Rules of Practice, click here.

To view the FSIS Food Safety Guideline for Egg Products, click here.

To view the Compliance Guideline for Hazard Analysis Critical Control Point (HACCP) Systems Validation, click here.

For more National Agricultural Law Center resources on food safety, click here.