View Rule

The Food Safety and Inspection Service (FSIS) is proposing to require official egg products plants to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (SOPs), consistent with HACCP and Sanitation SOP requirements in the meat and poultry products inspection regulations. FSIS also is proposing to require egg products plants to produce egg products using a process that will eliminate detectable pathogens from the finished product. Plants would be expected to develop HACCP systems that ensure that pathogens cannot be detected in finished egg products.

In addition, FSIS is proposing to amend the egg products inspection regulations by removing the current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to their use in official plants; providing for the generic labeling of egg products; requiring safe handling labels on shell eggs and egg products; and changing the Agency’s interpretation of the requirement for continuous inspection in official plants.

Statement of Need:

The actions being proposed are part of FSIS’s regulatory reform effort to better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg products regulations as consistent as possible with the Agency’s meat and poultry products regulations.

Summary of the Legal Basis:

The authority for this action is provided by the Egg Product Inspection Act (21 U.S.C. 1031 et seq.).

Alternatives:

The Agency considered the following regulatory alternatives for the implementation of government standards (HACCP) and related requirements for the egg products industry: 1) status quo; 2) intensify present inspection; 3) voluntary HACCP regulatory program; 4) mandatory HACCP regulation with exemption for small businesses; 5) modified HACCP recording deviations and responses only; 6) mandatory HACCP, Sanitation SOPs, and lethality performance standards adoption; and implementation of the sixth of these regulatory alternatives, mandatory HACCP, Sanitation SOPS, and lethality performance standards, should achieve immediate reductions in, and an eventual minimization of, foodborne hazards.

Anticipated Costs and Benefits:

Costs to the egg products industry come from the development of Sanitation SOPs and HACCP plans and compliance with the proposed HACCP requirements.  FSIS will incur costs to train egg products inspectors (EPIs) to ensure that they can competently perform inspection duties associated with HACCP and Sanitation SOPs at the 77 federally-inspected egg products plants.  While EPIs are in training, FSIS will also incur costs to pay for replacement inspectors so that egg products plants can continue to operate. 

Potential industry cost reductions from the proposed rule come from generic labeling, and the elimination of certain regulations, waivers, and no objection letters.  Under generic labeling, plants do not have to submit certain labels to FSIS for small changes, allowing plants to avoid a 60-day approval process and documentation of submissions for the approval of new labels.  In addition, plants receive cost savings from the elimination of outdated regulations.  The regulatory requirements in the current system may inefficiently use industry resources.  HACCP gives egg products plants the flexibility to decide how they wish to produce product in the manner that is most efficient to them, so that no detectable pathogens remain in the finished product. 

Under the current command-and-control based system, FSIS personnel must approve waivers and no objection letters for certain plant activities outside the current regulations and inspection program, personnel assume responsibility for "approving" production-associated decisions.  Under HACCP, industry would assume full responsibility for production decisions and execution.  FSIS would monitor plants' compliance with the requirement that finished egg products not contain detectable pathogens and within HACCP requirements. This allows industry and the Agency to reduce costs for approving activities and allows for better use of resources.

Risks:

None