PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS 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. Editorial Note: Nomenclature changes to part 118 appear at 81 FR 49896, July 29, 2016. § 118.1 Persons covered by the requirements in this part. (a) If you are a shell egg producer with 3,000 or more laying hens at a particular 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 follows: (1) If any of your eggs that are produced at a particular farm do not receive a treatment as defined in § 118.3, you must comply with all of the requirements of this part for egg production on that farm. (2) If all of your eggs that are produced at the particular farm receive a treatment as defined in § 118.3, you must comply only with the refrigeration requirements in § 118.4(e) for production of eggs on that farm and with the registration requirements in § 118.11. (b) If you transport or hold shell eggs for shell egg processing or egg products facilities, you must comply with the refrigeration requirements in § 118.4(e). This section applies only to eggs from farms with 3,000 or more laying hens. § 118.3 Definitions. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the FFDCA) (21 U.S.C. 321) are applicable to such terms when used in this part, except where they are redefined in this part. The following definitions also apply: Biosecurity Salmonella Egg products facility Farm Flock Group Induced molting Laying cycle Molting Pest Positive flock Positive poultry house Poultry house Producer Shell egg Shell egg processing facility Treatment § 118.4 Salmonella Enteritidis (SE) prevention measures. You must follow the SE prevention measures set forth in this section. In addition, you must have and implement a written SE prevention plan that is specific to each farm where you produce eggs and that includes, at a minimum, the following SE prevention measures: (a) Pullets. (1) Procurement of chicks. (2) Environmental testing. (ii) If the environmental test required in paragraph (a)(2)(i) of this section is negative, you do not need to perform any additional testing of those birds or their environment until the environmental test at 40 to 45 weeks of age specified in § 118.5(a); and (iii) If the environmental test required in paragraph (a)(2)(i) of this section is positive, you must begin egg testing, as specified in § 118.6, within 2 weeks of the start of egg laying. (3) Cleaning and disinfection. (i) Removal of all visible manure; (ii) Dry cleaning the positive pullet house to remove dust, feathers, and old feed; and (iii) Following cleaning, disinfection of the positive pullet house with spray, aerosol, fumigation, or another appropriate disinfection method. (b) Biosecurity. (1) Limit visitors on the farm and in the poultry houses; (2) Maintain practices that will protect against cross contamination when equipment is moved among poultry houses; (3) Maintain practices that will protect against cross contamination when persons move between poultry houses; (4) Prevent stray poultry, wild birds, cats, and other animals from entering poultry houses; and (5) Not allow employees to keep birds at home. (c) Rodents, flies, and other pest control. (1) Monitor for rodents by visual inspection and mechanical traps or glueboards or another appropriate monitoring method and, when monitoring indicates unacceptable rodent activity within a poultry house, use appropriate methods to achieve satisfactory rodent control; (2) Monitor for flies by spot cards, Scudder grills, or sticky traps or another appropriate monitoring method and, when monitoring indicates unacceptable fly activity within a poultry house, use appropriate methods to achieve satisfactory fly control. (3) Remove debris within a poultry house and vegetation and debris outside a poultry house that may provide harborage for pests. (d) Cleaning and disinfection. (1) Remove all visible manure; (2) Dry clean the positive poultry house to remove dust, feathers, and old feed; and (3) Following cleaning, disinfect the positive poultry house with spray, aerosol, fumigation, or another appropriate disinfection method. (e) Refrigeration. § 118.5 Environmental testing for Salmonella Enteritidis (SE). (a) Environmental testing when laying hens are 40 to 45 weeks of age. (1) If an environmental test at 40 to 45 weeks is negative and your laying hens do not undergo induced molting, then you do not need to perform any additional environmental testing within that poultry house, unless the poultry house contains more than one group of laying hens. If the poultry house contains more than one group of laying hens, then you must perform environmental testing on the poultry house when each group of laying hens is 40 to 45 weeks of age. (2) If the environmental test at 40 to 45 weeks is positive, then you must: (i) Review and make any necessary adjustments to your SE prevention plan to ensure that all measures are being properly implemented and (ii) Begin egg testing (described in § 118.6), unless you divert eggs to treatment as defined in § 118.3 for the life of the flock in that poultry house. Results of egg testing must be obtained within 10-calendar days of receiving notification of the positive environmental test. (b) Environmental testing after an induced molting period. (1) If an environmental test at 4 to 6 weeks after the end of the molting process is negative and none of your laying hens in that poultry house is molted again, then you do not need to perform any additional environmental testing in that poultry house. Each time a flock or group within the flock is molted, you must perform environmental testing in the poultry house at 4 to 6 weeks after the end of the molting process. (2) If the environmental test at 4 to 6 weeks after the end of a molting process is positive, then you must: (i) Review and make any necessary adjustments to your SE prevention plan to ensure that all measures are being properly implemented; and (ii) Begin egg testing (described in § 118.6), unless you divert eggs to treatment as defined in § 118.3 for the life of the flock in that poultry house. Results of egg testing, when conducted, must be available within 10-calendar days of receiving notification of the positive environmental test. § 118.6 Egg testing for Salmonella Enteritidis (SE). (a)(1) If the environmental test for pullets at 14 to 16 weeks of age required by § 118.4(a) is positive, you must divert eggs to treatment (defined in § 118.3) for the life of any flock or conduct egg testing within 2 weeks of the start of egg laying, as specified in paragraphs (b) through (e) of this section. (2) If you have an SE-positive environmental test at any time during the life of a flock, you must divert eggs to treatment (defined in § 118.3) for the life of the flock in that positive poultry house or conduct egg testing as specified in paragraphs (b) through (e) of this section. (b) Eggs must be sampled as described in § 118.7 and tested using methodology as described in § 118.8. (c) You must conduct four egg tests, using sampling and methodology in §§ 118.7 and 118.8, on the flock in the positive poultry house at 2-week intervals. If all four tests are negative for SE, you are not required to do further egg testing. (d) If any of the four egg tests is positive for SE, you must divert, upon receiving notification of an SE-positive egg test, all eggs from that flock to treatment (defined in § 118.3) until the conditions of paragraph (c) of this section are met. (e) If you have a positive egg test in a flock and divert eggs from that flock and later meet the negative test result requirements described in paragraph (c) of this section and return to table egg production, you must conduct one egg test per month on that flock, using sampling and methodology in §§ 118.7 and 118.8, for the life of the flock. (1) If all the monthly egg tests in paragraph (e) of this section are negative for SE, you may continue to supply eggs to the table market. (2) If any of the monthly egg tests in paragraph (e) of this section is positive for SE, you must divert eggs from the positive flock to treatment for the life of the flock or until the conditions of paragraph (c) of this section are met. (f) If you are diverting eggs, the pallet, case, or other shipping container must be labeled and all documents accompanying the shipment must contain the following statement: “Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella § 118.7 Sampling methodology for Salmonella Enteritidis (SE). (a) Environmental sampling. (b) Egg sampling. (1) To meet the egg testing requirements of § 118.6(c), you must collect and deliver for testing a minimum of 1,000 intact eggs representative of a day's production. The 1,000-egg sample must be tested according to § 118.8. You must collect and test four 1,000-egg samples at 2-week intervals for a total of 4,000 eggs. (2) To meet the monthly egg testing requirement of § 118.6(e), you must collect and deliver for testing a minimum of 1,000 intact eggs representative of a day's production per month for the life of the flock. Eggs must be tested according to § 118.8. § 118.8 Testing methodology for Salmonella Enteritidis (SE). (a) Testing of environmental samples for SE. Salmonella Salmonella http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm Salmonella http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) Testing of egg samples for SE. http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070149.htm, http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. [74 FR 33095, July 9, 2009, as amended at 81 FR 5590, Feb. 3, 2016] § 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan. You must have one or more supervisory personnel, who do not have to be on-site employees, to be responsible for ensuring compliance with each farm's SE prevention plan. This person must have successfully completed training on SE prevention measures for egg production that is equivalent to that received under a standardized curriculum recognized by the Food and Drug Administration or must be otherwise qualified through job experience to administer the SE prevention measures. Job experience will qualify this person to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. This person is responsible for: (a) Development and implementation of an SE prevention plan that is appropriate for your specific farm and meets the requirements of § 118.4; (b) Reassessing and modifying the SE prevention plan as necessary to ensure that the requirements in § 118.4 are met; and (c) Review of records created under § 118.10. This person does not need to have performed the monitoring or created the records. § 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan. (a) Records: (1) A written SE prevention plan required by § 118.4; (2) Documentation that pullets were “SE monitored” or were raised under “SE monitored” conditions, including environmental testing records for pullets, as required by § 118.4(a)(2); (3) Records documenting compliance with the SE prevention measures, as follows: (i) Biosecurity measures; (ii) Rodent and other pest control measures; (iii) Cleaning and disinfection procedures performed at depopulation, when applicable; (iv) Refrigeration requirements; (v) Environmental and egg sampling procedures, when applicable, performed under § 118.7; (vi) Results of SE testing, when applicable, performed under § 118.8 as required in §§ 118.4(a)(2), 118.5, and 118.6; (vii) Diversion of eggs, if applicable, as required in § 118.6; and (viii) Eggs at a particular farm being given a treatment as defined in § 118.3, if you are a producer complying with the requirements of this section as described in § 118.1(a)(2). (4) Records of review and of modifications of the SE prevention plan and corrective actions taken. (b) General requirements for records maintained by shell egg producers. (1) Your name and the location of your farm, (2) The date and time of the activity that the record reflects, (3) The signature or initials of the person performing the operation or creating the record. The written SE prevention plan must be dated and carry the signature(s) (not initials) of the person(s) who administers the plan as described in § 118.9, and (4) Data and information reflecting compliance activities must be entered on records at the time the activity is performed or observed, and the records must contain the actual values observed, if applicable. (c) Length of time records must be retained. (d) Offsite storage of records. (e) Official review of records. (f) Public disclosure of records. § 118.11 Registration requirements for shell egg producers covered by the requirements of this part. (a) Shell egg producers covered under § 118.1(a) are required to register their farms with FDA within 30 days of becoming an egg producer or, if already an egg producer, by each farm's applicable compliance date. (b) Shell egg producers may register their farms by any of the following means: (1) Electronic registration. http://www.access.fda.gov (i) An individual authorized by the owner or operator of a farm, such as an agent in charge, may also register a farm electronically. (ii) FDA strongly encourages electronic registration for the benefit of both FDA and the registrant. (iii) Once you complete your electronic registration, FDA will automatically provide you with an electronic confirmation of registration and a permanent registration number. (iv) You will be considered registered once FDA electronically transmits your confirmation and registration number. (2) Registration by mail or by fax. (i) You must register using FDA Form No. 3733. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, 5600 Fishers Lane (HFS-681), Rockville, MD 20857, or by requesting the form by phone at 1-800-216-7331 or 301-575-0156. (ii) When you receive the form, you must fill it out completely and legibly and either mail it to the address in paragraph (b)(2)(i) of this section or fax it to the number on the form. (iii) If any required information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the form was received by the agency (i.e., by mail or fax). (iv) FDA will enter complete and legible mailed and faxed registration submissions into its registration system, along with CD-ROM submissions, as soon as practicable, in the order FDA receives them. (v) FDA will then mail to the address or fax to the fax number on the registration form a copy of the registration as entered, confirmation of registration, and your registration number. When responding to a registration submission, FDA will use the means by which the registration was received by the agency (i.e., by mail or fax). (vi) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration. If any information you previously submitted that was correct at the time of submission subsequently changes, you must update your facility's registration within 60 calendar days. (vii) Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number. (3) Registration by CD-ROM for multiple submissions. (i) Registrants submitting their registrations in CD-ROM format must use ISO 9660 (CD-R or CD-RW) data format. (ii) These files must be submitted on a portable document format (PDF) rendition of the registration form (FDA Form No. 3733) and be accompanied by one signed copy of the certification statement that appears on the registration form. (iii) Each submission on the CD-ROM must contain the same preferred mailing address in the appropriate block on FDA Form No. 3733. (iv) A CD-ROM may contain registrations for as many facilities as needed up to the CD-ROM's capacity. (v) The registration on the CD-ROM for each separate facility must have a unique file name up to 32 characters long, the first part of which may be used to identify the parent company. (vi) You must mail the CD-ROM to the U.S. Food and Drug Administration, 5600 Fishers Lane (HFS-681), Rockville, MD 20857. (vii) If FDA receives a CD-ROM that does not comply with these specifications, it will return the CD-ROM to the submitter unprocessed. (viii) FDA will enter CD-ROM submissions that comply with these specifications into its registration system, along with the complete and legible mailed and faxed submissions, as soon as practicable, in the order FDA receives them. (ix) For each facility on the CD-ROM, FDA will mail to the preferred mailing address a copy of the registration(s) as entered, confirmation of registration, and each facility's assigned registration number. (x) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration. If any information you previously submitted that was correct at the time of submission subsequently changes, you must update your facility's registration within 60 calendar days. (xi) Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number. (c) No registration fee is required. (d) You must submit all registration information in the English language. All information must be submitted using the Latin (Roman) alphabet. (e) Each registrant must submit the following information through one of the methods described in paragraph (b) of this section: (1) The name, full address, and phone number of the farm; and (2) The average or usual number of layers of each house and number of poultry houses on the farm. (3) A statement in which the shell egg producer certifies that the information submitted is true and accurate. If the individual submitting the form is not the shell egg producer in charge of the farm, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit registration, and identifies by name, address, and telephone number, the individual who authorized submission of the registration. Each registration must include the name of the individual registering the farm submitting the registration, and the individual's signature (for paper and CD-ROM options). (f) Registered egg producers must submit an update to a registration within 60-calendar days of any change to any of the information previously submitted by any of the means as provided in § 118.11(b). (g) Registered egg producers must notify FDA within 120 days of ceasing egg production by completing sections 1b, 1c, and 2 of Form 3733. This notification is not required if you are a seasonal egg producer or you temporarily cease operation due to labor disputes, fire, natural disasters, or other temporary conditions. [74 FR 33095, July 9, 2009, as amended at 75 FR 18751, Apr. 13, 2010] § 118.12 Enforcement and compliance. (a) Authority. (1) Upon a finding that any shell eggs have been produced or held in violation of this part, an authorized FDA representative or a State or local representative in accordance with paragraph (c) 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 under the PHS Act. et seq. (A) A statement that the shell eggs identified in the order are subject to diversion for processing in accordance with the EPIA or by a treatment that achieves at least a 5-log destruction of SE 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 must not be sold, distributed, or otherwise disposed of or moved except as provided in paragraph (a)(1)(iv) 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 issuing the order and the name of its Director. (ii) Approval of Division Director. (iii) 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 must 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. (iv) Sale or other disposition of shell eggs under order. (A) Divert or destroy them as specified in paragraph (a)(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 by 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 that 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 must 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 must 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 must include a recommended decision, with a statement of reasons. (iv) Written appeal. (v) Presiding FDA official's decision. (vi) No appeal. (b) Inspection. (c) State and local cooperation. (d) Preemption. [74 FR 33095, July 9, 2009, as amended at 82 FR 14146, Mar. 17, 2017; 85 FR 16554, Mar. 24, 2020]