October 25, 2021

Volume XI, Number 298

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October 22, 2021

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FSIS Releases Proposed Egg Products HACCP Rule

On Tuesday, January 9, 2018, USDA’s Food Safety and Inspection Service (FSIS) released a proposed rule that would require egg products plants to develop and implement hazard analysis and critical control point (HACCP) plans, Sanitation Standard Operating Procedures (SOPs), and include safe-handling instructions on the labels of certain egg products.

FSIS explains that the proposed egg HACCP rule aligns its requirements for egg products with its HACCP requirements for meat and poultry products and would make products safer while conserving agency resources.

FSIS intends to phase in the egg HACCP requirements for domestic producers over a two-year period after the rule is finalized, and intends to enforce the Sanitation SOPs and sanitation requirements one year after publication of the final rule.

Key Changes in the Proposed Rule

The following are some of the key changes in the proposed rule, many of which are consistent with current requirements for meat and poultry products regulated by FSIS:

  • redefines the requirement for continuous inspection in 21 U.S.C. 1034(a) (proposes that instead of requiring inspection during all processing operations, inspections would take place at least once per shift);
  • requires egg products to be processed to be edible without additional preparation to achieve food safety;
  • allows generic approval for certain categories of egg product labels, limiting prior approval to labels: intended for temporary approval, for products produced under religious exemption, for products for export with labeling deviations, and with special statements and claims;
  • revises the labeling requirements for shell eggs held by egg handlers inspected by FSIS to be consistent with those in FDA’s regulations;  
  • requires special handling instructions on certain egg products;
  • eliminates the requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment;
  • incorporates egg products plants into the coverage of the “Rules of Practice” that FSIS follows when initiating administrative enforcement actions; and
  • aligns the import requirements for egg products to be more in line with those for meat and poultry products and to help facilitate the use of imported egg products in combination with domestic egg products for purposes of further processing.

Jurisdiction Over Freeze-Dried Egg Products and Egg Substitutes

FSIS proposes to assume jurisdiction over freeze-dried egg products and egg substitutes because it views these products as posing the same risks as egg products. FDA currently regulates certain categories of egg products that FSIS has exempted from its oversight (see Table 1). FSIS is requesting stakeholder input on the number of facilities that would be subject to dual jurisdiction (inspections from both FSIS and FDA) if these two product categories are no longer exempt from FSIS inspection and oversight shifts from FDA to FSIS.

Table 1 Current FDA and USDA FSIS Jurisdiction over Egg-based Products

FDA

USDA FSIS

Freeze-dried egg products (proposed rule would transfer to FSIS)

Dried eggs with or without added ingredients

Egg substitutes (proposed rule would transfer to FSIS)

Frozen eggs with or without added ingredients.

Imitation egg products

Liquid eggs with or without added ingredients.

Dietary foods

 

Dried no-bake custard mixes

 

Acidic dressings

 

Eggnog mixes

 

Noodles

 

Milk and egg dip

 

Cake Mixes

 

French toast

 

Sandwiches containing eggs or egg products

 

Cooked egg products (cooked egg patties, cooked omelets, freeze-dried cooked eggs)

 

Impact of FSMA food safety assessments

If finalized, FSIS’s egg products HACCP requirements would harmonize well with FDA’s FSMA food safety requirements. For example, for FDA-registered food facilities that use egg products subject to the new HACCP requirements as ingredients in foods subject to an FDA-required food safety plan, the facilities could request, review, and rely on the HACCP plans when conducting FSMA-related hazard analyses and supply-chain program activities. Presumably, for ingredients subject to the egg HACCP requirements, the HACCP plans would be a good resource for assessing potential food safety hazards and any relevant supply-chain applied controls.

There will be a 120-day period for comment once the proposed rule is published in the Federal Register.

© 2021 Covington & Burling LLPNational Law Review, Volume VIII, Number 11
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About this Author

Miriam Guggenheim, Covington, Food regulation attorney
Partner

Miriam Guggenheim, co-chair of Covington’s Food, Drug & Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Ms. Guggenheim serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and...

202-662-5235
Jessica O'Connell, Food and drug lawyer, Covington
Special Counsel

Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress. She assists clients in complying with U.S. regulatory requirements for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, and animal products, and the import and export of FDA-regulated products. In addition, she counsels clients regarding potential crises, such as recalls and unanticipated regulatory attention.​ 

202.662.5180
MaryJoy Ballantyne, Food and Drug lawyer, Covington Burling law firm
Special Counsel

MaryJoy Ballantyne combines a technical and policy background with expertise in all aspects of food (human and animal), cosmetic, and OTC law at both the state and federal level to help companies and trade associations navigate ever-changing regulatory and litigation risks.

Ms. Ballantyne helps clients assess and obtain authorizations of food and dietary ingredients, create competitive yet low-risk labeling and marketing strategies, and respond strategically to regulatory and competitor challenges. Ms. Ballantyne helps clients understand the nuances of clean label...

202-662-5933
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