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United States • Title 21 CFR • Part 115

Part 115 — PART 115—SHELL EGGS

This regulation mandates refrigeration of shell eggs held for retail distribution at or below 7.2°C (45°F) to prevent Salmonella contamination. Exemptions apply to specifically processed eggs. Enforcement can be carried out by FDA or authorized state/local agencies, with provisions for diversion or destruction of non-compliant eggs and administrative hearings.

What this part covers

Shell eggs held for retail distribution must be refrigerated at or below 7.2°C (45°F) upon receipt and during storage/display.
Eggs specifically processed to destroy Salmonella are exempt from refrigeration requirements.
Retail establishments are defined as operations providing food directly to consumers.
FDA or authorized state/local agencies can enforce these requirements.
Non-compliant eggs may be ordered for diversion to processing or destruction.
Administrative enforcement includes written orders, labeling/tagging of detained eggs, and options for appeal through informal hearings.
Retail establishments must permit FDA inspections of premises, eggs, equipment, and records.
No state or local entity can allow refrigeration temperatures above 7.2°C (45°F) for unpasteurized shell eggs at retail.

Sections in Part 115

§ 115.50

Refrigeration of shell eggs held for retail distribution.

(a) For purposes of this section a “retail establishment” is an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption directly to consumers. (b) Except as provided in paragraph (c) of this section, all shell eggs, whether in intrastate or interstate commerce, held for retail distribution: (1) Shall promptly be placed under refrigeration as specified in paragraph (b)(2) of this section upon receipt at a retail establishment, except that, when short delays are unavoidable, the eggs shall be placed under refrigeration, as soon as reasonably possible; and (2) Shall be stored and displayed under refrigeration at an ambient temperature not greater than 7.2 °C (45 °F) while held at a retail establishment. Salmonella(c) Shell eggs that have been specifically processed to destroy all viable shall be exempt from the requirements of paragraph (b) of this section. (d) Under sections 311 and 361 of the Public Health Service Act (PHS Act), any State or locality that is willing and able to assist the agency in the enforcement of paragraph (b) of this section, and is authorized to inspect or regulate retail establishments, may, in its own…

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