PART 115—SHELL EGGS Authority: 21 U.S.C. 342, 371; 42 U.S.C. 243, 264, 271. § 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. (c) Shell eggs that have been specifically processed to destroy all viable Salmonella (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 jurisdiction, enforce paragraph (b) of this section through inspections under paragraph (f) of this section and through administrative enforcement remedies identified in paragraph (e) of this section until FDA notifies the State or locality in writing that such assistance is no longer needed. When providing assistance under paragraph (e) of this section, a State or locality may follow the hearing procedures set out in paragraphs (e)(2)(iii) through (e)(2)(iv) of this section, substituting, where necessary, appropriate State or local officials for designated FDA officials or may utilize State or local hearing procedures if such procedures satisfy due process. (e) This section is established under authority of both the Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under the act, the agency can enforce the food adulteration provisions under 21 U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the issuance of implementing enforcement regulations; therefore, FDA has established the following administrative enforcement procedures for the diversion or destruction of shell eggs and for informal hearings under the PHS Act: (1) Upon finding that any shell eggs have been held in violation of this section, an authorized FDA representative or a State or local representative in accordance with paragraph (d) of this section may order such eggs to be diverted, under the supervision of said representative, for processing in accordance with the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq. (i) Order for diversion or destruction. et seq. (ii) Issuance of order. (A) A statement that the shell eggs identified in the order are subject to diversion for processing in accordance with the EPIA or destruction; (B) A detailed description of the facts that justify the issuance of the order; (C) The location of the eggs; (D) A statement that these eggs shall not be sold, distributed, or otherwise disposed of or moved except as provided in paragraph (e)(1)(v) of this section; (E) Identification or description of the eggs; (F) The order number; (G) The date of the order; (H) The text of this entire section; (I) A statement that the order may be appealed by written appeal or by requesting an informal hearing; (J) The name and phone number of the person issuing the order; and (K) The location and telephone number of the office or agency and the name of its director. (iii) Approval of Division Director. (iv) Labeling or marking of shell eggs under order. (A) A statement that the shell eggs are detained in accordance with regulations issued under section 361(a) of the PHS Act (42 U.S.C. 264(a)). (B) A statement that the shell eggs shall not be sold, distributed or otherwise disposed of or moved except, after notifying the issuing entity in writing, to: ( 1 ( 2 (C) A statement that the violation of the order or the removal or alteration of the tag is punishable by fine or imprisonment or both (section 368 of the PHS Act, 42 U.S.C. 271). (D) The order number and the date of the order, and the name of the government representative who issued the order. (v) Sale or other disposition of shell eggs under order. (A) Divert or destroy them as specified in paragraph (e)(1)(i) of this section; or (B) Move them to another location for holding pending appeal. (2) The person on whom the order for diversion or destruction is served may either comply with the order or appeal the order to an Office of Regulatory Affairs Program Director in accordance with the following procedures: (i) Appeal of a detention order. (ii) Summary decision. (iii) Informal hearing. (A) The presiding FDA official may direct that the hearing be conducted in any suitable manner permitted by law and this section. The presiding FDA official has the power to take such actions and make such rulings as are necessary or appropriate to maintain order and to conduct an informal, fair, expeditious, and impartial hearing, and to enforce the requirements concerning the conduct of hearings. (B) Employees of FDA will first give a full and complete statement of the action which is the subject of the hearing, together with the information and reasons supporting it, and may present oral or written information relevant to the hearing. The party requesting the hearing may then present oral or written information relevant to the hearing. All parties may conduct reasonable examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing. (C) The hearing shall be informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views will be made or considered, but any party may comment upon or rebut any information and views presented by another party. (D) The party requesting the hearing may have the hearing transcribed, at the party's expense, in which case a copy of the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding FDA official's report of the hearing. (E) The presiding FDA official shall prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. Whenever time permits, the presiding FDA official may give the parties the opportunity to review and comment on the report of the hearing. (F) The presiding FDA official shall include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and shall include a recommended decision, with a statement of reasons. (iv) Written appeal. (v) Presiding FDA official's decision. (vi) No appeal. (f) Inspection. (g) Preemption. [65 FR 76112, Dec. 5, 2000, as amended at 82 FR 14145, Mar. 17, 2017; 85 FR 16552, Mar. 24, 2020]