Shell eggs (21 CFR 115.50)

337 Food and Drug Administration, HHS § 115.50 and of suppliers’ guarantees or certifi cations that verify compliance with Food and Drug Administration regula tions and guidance documents or ac tion levels. (b) Processing and production records showing adherence to scheduled proc esses, including records of pH measure ments and other critical factors in tended to ensure a safe product, shall be maintained and shall contain suffi cient additional information such as product code, date, container size, and product, to permit a public health haz ard evaluation of the processes applied to each lot, batch, or other portion of production. (c) All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified; these depar tures shall be recorded and made the subject of a separate file (or log identi fying the appropriate data) delineating them, the action taken to rectify them, and the disposition of the portion of the product involved. (d) Records shall be maintained iden tifying initial distribution of the fin ished product to facilitate, when nec essary, the segregation of specific food lots that may have become contami nated or otherwise unfit for their in tended use. (e) Copies of all records provided for in paragraphs (b), (c), and (d) of this section shall be retained at the proc essing plant or other reasonably acces sible location for a period of 3 years from the date of manufacture. [44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000] 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 con sumers. (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 re frigeration 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 tem perature not greater than 7.2 °C (45 °F) while held at a retail establishment. (c) Shell eggs that have been specifi cally processed to destroy all viable Salmonella shall be exempt from the re quirements of paragraph (b) of this sec tion. (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 en forcement of paragraph (b) of this sec tion, 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 offi cials or may utilize State or local hear ing procedures if such procedures sat isfy 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 pro visions under 21 U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the issuance of implementing enforce ment regulations; therefore, FDA has established the following administra tive enforcement procedures for the di version or destruction of shell eggs and for informal hearings under the PHS Act: VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00347 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 338 21 CFR Ch. I (4–1–15 Edition) § 115.50 (1) Upon finding that any shell eggs have been held in violation of this sec tion, an authorized FDA representative or a State or local representative in ac cordance with paragraph (d) of this sec tion may order such eggs to be di verted, under the supervision of said representative, for processing in ac cordance with the Egg Products Inspec tion Act (EPIA) (21 U.S.C. 1031 et seq.) or destroyed by or under the super vision of an officer or employee of the FDA, or, if applicable, of the State or locality in accordance with the fol lowing procedures: (i) Order for diversion or destruction. Any district office of FDA or any State or local agency acting under paragraph (d) of this section, upon finding shell eggs held in violation of this section, may serve upon the person in whose possession such eggs are found a writ ten order that such eggs be diverted, under the supervision of an officer or employee of the issuing entity, for processing in accordance with the EPIA (21 U.S.C. 1031 et seq.) or de stroyed by or under the supervision of said district office, within 10-working days from the date of receipt of the order. (ii) Issuance of order. The order shall include the following information: (A) A statement that the shell eggs identified in the order are subject to di version 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 pro vided in paragraph (e)(1)(v) of this sec tion; (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 re questing an informal hearing; (J) The name and phone number of the person issuing the order; and (K) The location and telephone num ber of the office or agency and the name of its director. (iii) Approval of District Director. An order, before issuance, shall be ap proved by the Food and Drug Adminis tration (FDA) District Director in whose district the shell eggs are lo cated. If prior written approval is not feasible, prior oral approval shall be obtained and confirmed by written memorandum as soon as possible. (iv) Labeling or marking of shell eggs under order. An FDA, State, or local agency representative issuing an order under paragraph (e)(1) of this section shall label or mark the shell eggs with official tags that include the following information: (A) A statement that the shell eggs are detained in accordance with regula tions 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 other wise disposed of or moved except, after notifying the issuing entity in writing, to: (1) Divert them for processing in ac cordance with the EPIA or destroy them; or (2) Move them to an another location for holding pending appeal. (C) A statement that the violation of the order or the removal or alteration of the tag is punishable by fine or im prisonment 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 govern ment representative who issued the order. (v) Sale or other disposition of shell eggs under order. After service of the order, the person in possession of the shell eggs that are the subject of the order shall not sell, distribute, or otherwise dispose of or move any eggs subject to the order unless and until the notice is withdrawn after an appeal except, after notifying FDA’s district office or, if ap plicable, the State or local agency in writing, to: (A) Divert or destroy them as speci fied in paragraph (e)(1)(i) of this sec tion; 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 the FDA Regional Food VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00348 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 339 Food and Drug Administration, HHS § 115.50 and Drug Director in accordance with the following procedures: (i) Appeal of a detention order. Any ap peal shall be submitted in writing to FDA’s District Director in whose dis trict the shell eggs are located within 5-working days of the issuance of the order. If the appeal includes a request for an informal hearing, the hearing shall be held within 5-working days after the appeal is filed or, if requested by the appellant, at a later date, which shall not be later than 20-calendar days after the issuance of the order. The order may also be appealed within the same period of 5-working days by any other person having an ownership or proprietary interest in such shell eggs. The appellant of an order shall state the ownership or proprietary interest the appellant has in the shell eggs. (ii) Summary decision. A request for a hearing may be denied, in whole or in part and at any time after a request for a hearing has been submitted, if the FDA Regional Food and Drug Director or his or her designee determines that no genuine and substantial issue of fact has been raised by the material sub mitted in connection with the hearing or from matters officially noticed. If the FDA Regional Food and Drug Di rector determines that a hearing is not justified, written notice of the deter mination will be given to the parties explaining the reason for denial. (iii) Informal hearing. Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. The informal hearing shall be conducted by the FDA Regional Food and Drug Director or his designee, and a written summary of the proceedings shall be prepared by the FDA Regional Food and Drug Director. (A) The FDA Regional Food and Drug Director may direct that the hearing be conducted in any suitable manner permitted by law and this section. The FDA Regional Food and Drug Director 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 con duct of hearings. (B) Employees of FDA will first give a full and complete statement of the action which is the subject of the hear ing, 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 writ ten information relevant to the hear ing. All parties may conduct reason able 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 relat ing to the admissibility of information and views will be made or considered, but any party may comment upon or rebut any information and views pre sented 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 fur nished to FDA. Any transcript of the hearing will be included with the FDA Regional Food and Drug Director’s re port of the hearing. (E) The FDA Regional Food and Drug Director shall prepare a written report of the hearing. All written material presented at the hearing will be at tached to the report. Whenever time permits, the FDA Regional Food and Drug Director may give the parties the opportunity to review and comment on the report of the hearing. (F) The FDA Regional Food and Drug Director shall include as part of the re port of the hearing a finding on the credibility of witnesses (other than ex pert witnesses) whenever credibility is a material issue, and shall include a recommended decision, with a state ment of reasons. (iv) Written appeal. If the appellant appeals the detention order but does not request a hearing, the FDA Re gional Food and Drug Director shall render a decision on the appeal affirm ing or revoking the detention within 5 working days after the receipt of the appeal. (v) Regional Food and Drug Director decision. If, based on the evidence pre sented at the hearing or by the appel lant in a written appeal, the Regional Food and Drug Director finds that the shell eggs were held in violation of this VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00349 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 340 21 CFR Ch. I (4–1–15 Edition) Pt. 118 section, he shall affirm the order that they be diverted, under the supervision of an officer or employee of the FDA for processing under the EPIA or de stroyed by or under the supervision of an officer or employee of the FDA; oth erwise, the Regional Food and Drug Di rector shall issue a written notice that the prior order is withdrawn. If the Re gional Food and Drug Director affirms the order he shall order that the diver sion or destruction be accomplished within 10-working days from the date of the issuance of his decision. The Re gional Food and Drug Director’s deci sion shall be accompanied by a state ment of the reasons for the decision. The decision of the Regional Food and Drug Director shall constitute final agency action, reviewable in the courts. (vi) No appeal. If there is no appeal of the order and the person in possession of the shell eggs that are subject to the order fails to divert or destroy them within 10-working days, or if the de mand is affirmed by the Regional Food and Drug Director after an appeal and the person in possession of such eggs fails to divert or destroy them within 10-working days, FDA’s district office or appropriate State or local agency may designate an officer or employee to divert or destroy such eggs. It shall be unlawful to prevent or to attempt to prevent such diversion or destruction of the shell eggs by the designated offi cer or employee. (f) Inspection. Persons engaged in re tail distribution of shell eggs shall per mit authorized representatives of FDA to make at any reasonable time such inspection of the retail establishment in which shell eggs are being held, in cluding inspection and sampling of such eggs and the equipment in which shell eggs are held and any records re lating to such equipment or eggs, as may be necessary in the judgement of such representatives to determine com pliance with the provisions of this sec tion. Inspections may be made with or without notice and will ordinarily be made during regular business hours. (g) Preemption. No State or local gov erning entity shall establish or con tinue in effect any law, rule, regula tion, or other requirement allowing re frigeration of unpasteurized shell eggs at retail establishments at any tem perature greater than 7.2 °C (45 °F). [65 FR 76112, Dec. 5, 2000] PART 118—PRODUCTION, STOR AGE, AND TRANSPORTATION OF SHELL EGGS Sec. 118.1 Persons covered by the requirements in this part. 118.3 Definitions. 118.4 Salmonella Enteritidis (SE) prevention measures. 118.5 Environmental testing for Salmonella Enteritidis (SE). 118.6 Egg testing for Salmonella Enteritidis (SE). 118.7 Sampling methodology for Salmonella Enteritidis (SE). 118.8 Testing methodology for Salmonella Enteritidis (SE). 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan. 118.11 Registration requirements for shell egg producers covered by the require ments of this part. 118.12 Enforcement and compliance. AUTHORITY: 21 U.S.C. 321, 331–334, 342, 371, 381, 393; 42 U.S.C. 243, 264, 271. SOURCE: 74 FR 33095, July 9, 2009, unless otherwise noted. § 118.1 Persons covered by the require ments in this part. (a) If you are a shell egg producer with 3,000 or more laying hens at a par ticular farm that does not sell all of your eggs directly to consumers and that produces shell eggs for the table market, you are covered by some or all of the requirements in this part, as fol lows: (1) If any of your eggs that are pro duced at a particular farm do not re ceive a treatment as defined in § 118.3, you must comply with all of the re quirements of this part for egg produc tion on that farm. (2) If all of your eggs that are pro duced at the particular farm receive a treatment as defined in § 118.3, you must comply only with the refrigera tion requirements in § 118.4(e) for pro duction of eggs on that farm and with the registration requirements in § 118.11. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00350 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B