Production, storage, and transportation of shell eggs (21 CFR 118.1-118.12)

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of the FDA; oth erwise, the Regional Food and Drug Di rector shall issue a written notice that the prior order is withdrawn.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 341 Food and Drug Administration, HHS § 118.4 (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 means a program, includ ing the limiting of visitors on the farm and in poultry houses, maintaining personnel and equipment practices that will protect against cross contamina tion from one poultry house to an other, preventing stray poultry, wild birds, cats, and other animals from en tering poultry houses, and not allowing employees to keep birds at home, to ensure that there is no introduction or transfer of Salmonella Enteritidis (SE) onto a farm or among poultry houses. Egg products facility means a USDA inspected egg products plant where liq uid, frozen, and/or dried egg products are produced. Farm means all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program. Flock means all laying hens within one poultry house. Group means all laying hens of the same age within one poultry house. Induced molting means molting that is artificially initiated. Laying cycle means the period of time that a hen begins to produce eggs until it undergoes induced molting or is per manently taken out of production and the period of time that a hen produces eggs between successive induced molt ing periods or between induced molting and the time that the hen is perma nently taken out of production. Molting means a life stage during which hens stop laying eggs and shed their feathers. Pest means any objectionable animal including, but not limited to, rodents, flies, and larvae. Positive flock means a flock that has had an egg test that was positive for SE. A flock is considered positive until that flock meets the egg testing re quirements in § 118.6(c) to return to table egg production. Positive poultry house means a poultry house from which there has been an en vironmental test that was positive for SE at any time during the life of a group in the poultry house until that house is cleaned and disinfected ac cording to § 118.4(d). Poultry house means a building, other structure, or separate section within a structure used to house poultry. For structures comprising more than one section containing poultry, each sec tion that is separated from the other sections is considered a separate house. Producer means a person who owns and/or operates a poultry house con taining laying hens which produce shell eggs for human consumption. Shell egg (or egg) means the egg of the domesticated chicken. Shell egg processing facility means a facility that processes (e.g., washes, grades, packs) shell eggs for the table egg market. Treatment (or treated) means a tech nology or process that achieves at least a 5-log destruction of SE for shell eggs, or the processing of egg products in ac cordance with the Egg Products Inspec tion Act. § 118.4 Salmonella Enteritidis (SE) pre vention measures. You must follow the SE prevention measures set forth in this section. In addition, you must have and imple ment 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. You must procure pullets that are SE monitored or raise pullets under SE monitored conditions. ‘‘SE monitored’’ means the pullets are raised under SE control conditions that prevent SE, including: (1) Procurement of chicks. Chicks are procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan’s standards for ‘‘U.S. S. Enteritidis Clean’’ status (9 CFR 145.23(d)) or equivalent standard; VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00351 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 342 21 CFR Ch. I (4–1–15 Edition) § 118.5 (2) Environmental testing. (i) The pul let environment is tested for SE when pullets are 14 to 16 weeks of age; (ii) If the environmental test re quired in paragraph (a)(2)(i) of this sec tion 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 re quired in paragraph (a)(2)(i) of this sec tion 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. If the en vironmental test required in paragraph (a)(2) of this section is positive, the pullet environment is cleaned and dis infected, to include: (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 appro priate disinfection method. (b) Biosecurity. As part of this pro gram, you must take steps to ensure that there is no introduction or trans fer of SE into or among poultry houses. Among such biosecurity measures you must, at a minimum: (1) Limit visitors on the farm and in the poultry houses; (2) Maintain practices that will pro tect against cross contamination when equipment is moved among poultry houses; (3) Maintain practices that will pro tect 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 con trol. As part of this program, you must: (1) Monitor for rodents by visual in spection and mechanical traps or glueboards or another appropriate monitoring method and, when moni toring indicates unacceptable rodent activity within a poultry house, use ap propriate methods to achieve satisfac tory rodent control; (2) Monitor for flies by spot cards, Scudder grills, or sticky traps or an other appropriate monitoring method and, when monitoring indicates unac ceptable 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 out side a poultry house that may provide harborage for pests. (d) Cleaning and disinfection. You must clean and disinfect the poultry house according to these procedures be fore new laying hens are added to the house, if you have had an environ mental test or an egg test that was positive for SE at any point during the life of a flock that was housed in the poultry house prior to depopulation. As part of the cleaning and disinfection procedures, you must: (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, aer osol, fumigation, or another appro priate disinfection method. (e) Refrigeration. You must hold and transport eggs at or below 45 °F ambi ent temperature beginning 36 hours after time of lay. If the eggs are to be processed as table eggs and are not processed for the ultimate consumer within 36 hours from the time of lay and, therefore, are held and trans ported as required at or below 45 °F ambient temperature, then you may then hold them at room temperature for no more than 36 hours just prior to processing to allow an equilibration step to temper the eggs. § 118.5 Environmental testing for Sal monella Enteritidis (SE). (a) Environmental testing when laying hens are 40 to 45 weeks of age. As one in dicator of the effectiveness of your SE prevention plan, you must perform en vironmental testing for SE (as de scribed in §§ 118.7 and 118.8) in a poultry house when any group of laying hens constituting the flock within the poul try house is 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, VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00352 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 343 Food and Drug Administration, HHS § 118.6 then you do not need to perform any additional environmental testing with in that poultry house, unless the poul try 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 en vironmental 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 treat ment as defined in § 118.3 for the life of the flock in that poultry house. Re sults of egg testing must be obtained within 10-calendar days of receiving no tification of the positive environ mental test. (b) Environmental testing after an in duced molting period. If you induce a molt in a flock or a group in a flock, you must perform environmental test ing for SE in the poultry house at 4 to 6 weeks after the end of any molting process. (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 environ mental testing in the poultry house at 4 to 6 weeks after the end of the molt ing process. (2) If the environmental test at 4 to 6 weeks after the end of a molting proc ess 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 treat ment as defined in § 118.3 for the life of the flock in that poultry house. Re sults 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 envi ronmental 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 speci fied in paragraphs (b) through (e) of this section. (b) Eggs must be sampled as de scribed in § 118.7 and tested using meth odology 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 inter vals. 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 posi tive for SE, you must divert, upon re ceiving 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 sec tion 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 nega tive for SE, you may continue to sup ply 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 pal let, case, or other shipping container must be labeled and all documents ac companying the shipment must con tain the following statement: ‘‘Federal VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00353 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 344 21 CFR Ch. I (4–1–15 Edition) § 118.7 law requires that these eggs must be treated to achieve at least a 5-log de struction of Salmonella Enteritidis or processed as egg products in accord ance with the Egg Products Inspection Act, 21 CFR 118.6(f).’’ The statement must be legible and conspicuous. § 118.7 Sampling methodology for Sal monella Enteritidis (SE). (a) Environmental sampling. An envi ronmental test must be done for each poultry house in accordance with § 118.5 (a) and (b). Within each poultry house, you must sample the environment using a sampling plan appropriate to the poultry house layout. (b) Egg sampling. When you conduct an egg test required under § 118.6, you must collect and test the following number of eggs from the positive poul try house: (1) To meet the egg testing require ments 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 col lect 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 ac cording to § 118.8. § 118.8 Testing methodology for Sal monella Enteritidis (SE). (a) Testing of environmental samples for SE. Testing to detect SE in environ mental samples must be conducted by the method entitled ‘‘Environmental Sampling and Detection of Salmonella in Poultry Houses,’’ April 2008, or an equivalent method in accuracy, preci sion, and sensitivity in detecting SE. The April 2008 Environmental Sam pling and Detection of Salmonella Web site is located at http://www.fda.gov/ Food/ScienceResearch/ LaboratoryMethods/ucm114716.htm, cur rent as of June 26, 2009. The Director of the Federal Register approves the in corporation by reference of ‘‘Environ mental Sampling and Detection of Sal monella in Poultry Houses,’’ April 2008, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The FDA will request ap proval to incorporate by reference any updates to this Web site. The FDA will change the date of the Web site in this paragraph with each update. You may obtain a copy from Division of Microbi ology (HFS–710), Center for Food Safe ty and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2364, or you may examine a copy at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD, 301– 436–2163, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulation/ ibrllocations.html. (b) Testing of egg samples for SE. Test ing to detect SE in egg samples must be conducted according to Chapter 5 of FDA’s Bacteriological Analytical Man ual (BAM), December 2007 Edition, or an equivalent method in accuracy, pre cision, and sensitivity in detecting SE. Chapter 5 of FDA’s Bacteriological An alytical Manual, December 2007 Edi tion, is located at http://www.fda.gov/ Food/ScienceResearch/ LaboratoryMethods/ BacteriologicalAnalyticalManualBAM/ ucm070149.htm, current as of June 26, 2009. The method is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The FDA will request approval to incorporate by ref erence any updates to this Web site. The FDA will change the date of the Web site in this paragraph with each update. You may obtain a copy from Division of Microbiology (HFS–710), Center for Food Safety and Applied Nu trition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2364, or you may ex amine a copy at the Center for Food Safety and Applied Nutrition’s Li brary, 5100 Paint Branch Pkwy., Col lege Park, MD, 301–436–2163, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00354 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 345 Food and Drug Administration, HHS § 118.10 codeloflfederallregulation/ ibrllocations.html. § 118.9 Administration of the Sal monella Enteritidis (SE) prevention plan. You must have one or more super visory 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 pro duction that is equivalent to that re ceived under a standardized curriculum recognized by the Food and Drug Ad ministration or must be otherwise qualified through job experience to ad minister the SE prevention measures. Job experience will qualify this person to perform these functions if it has pro vided 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 appro priate 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 cre ated the records. § 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan. (a) Records: You must maintain the following records documenting your SE prevention measures: (1) A written SE prevention plan re quired by § 118.4; (2) Documentation that pullets were ‘‘SE monitored’’ or were raised under ‘‘SE monitored’’ conditions, including environmental testing records for pul lets, 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 proce dures 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 ap plicable, performed under § 118.8 as re quired 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 de scribed in § 118.1(a)(2). (4) Records of review and of modifica tions of the SE prevention plan and corrective actions taken. (b) General requirements for records maintained by shell egg producers. All records required by § 118.10(a) must in clude: (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 cre ating the record. The written SE pre vention 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 ob served, if applicable. (c) Length of time records must be re tained. You must retain all records re quired by this part at your place of business, unless stored offsite under § 118.10(d), for 1 year after the flock to which they pertain has been taken per manently out of production. (d) Offsite storage of records. You may store the records required by this part, except for the written SE prevention plan, offsite. You must be able to re trieve and provide the records at your place of business within 24 hours of re quest for official review. Electronic records are considered to be onsite if they are accessible from an onsite loca tion. (e) Official review of records. You must have all records required by this part available for official review and copy ing at reasonable times. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00355 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 346 21 CFR Ch. I (4–1–15 Edition) § 118.11 (f) Public disclosure of records. Records required by this part are subject to the disclosure requirements under part 20 of this chapter. § 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 be coming an egg producer or, if already an egg producer, by each farm’s appli cable compliance date. (b) Shell egg producers may register their farms by any of the following means: (1) Electronic registration. To register electronically, you must register at http://www.access.fda.gov, which will be available for registration 24 hours a day, 7 days a week beginning May 10, 2010. This Web site is available from wherever the Internet is accessible, in cluding libraries, copy centers, schools, and Internet cafes. (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 elec tronic registration for the benefit of both FDA and the registrant. (iii) Once you complete your elec tronic registration, FDA will auto matically provide you with an elec tronic 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. If, for example, you do not have reason able access to the Internet through any of the methods described in paragraph (b)(1) of this section, an individual au thorized by the owner or operator of a farm, such as an agent in charge, may register by mail or 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 num ber 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 leg ible mailed and faxed registration sub missions 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 reg istration form a copy of the registra tion as entered, confirmation of reg istration, and your registration num ber. 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 pre viously submitted was incorrect at the time of submission, you must imme diately update your facility’s registra tion. If any information you previously submitted that was correct at the time of submission subsequently changes, you must update your facility’s reg istration within 60 calendar days. (vii) Your facility is considered reg istered once FDA enters your facility’s registration data into the registration system and the system generates a reg istration number. (3) Registration by CD–ROM for mul tiple submissions. If, for example, you do not have reasonable access to the Internet through any of the methods provided under paragraph (b)(1) of this section, you may register by CD–ROM. (i) Registrants submitting their reg istrations 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) ren dition of the registration form (FDA Form No. 3733) and be accompanied by one signed copy of the certification statement that appears on the registra tion form. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00356 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 347 Food and Drug Administration, HHS § 118.12 (iii) Each submission on the CD–ROM must contain the same preferred mail ing address in the appropriate block on FDA Form No. 3733. (iv) A CD–ROM may contain registra tions 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 Administra tion, 5600 Fishers Lane (HFS–681), Rockville, MD 20857. (vii) If FDA receives a CD–ROM that does not comply with these specifica tions, it will return the CD–ROM to the submitter unprocessed. (viii) FDA will enter CD–ROM sub missions that comply with these speci fications into its registration system, along with the complete and legible mailed and faxed submissions, as soon as practicable, in the order FDA re ceives them. (ix) For each facility on the CD– ROM, FDA will mail to the preferred mailing address a copy of the registra tion(s) as entered, confirmation of reg istration, and each facility’s assigned registration number. (x) If any information you previously submitted was incorrect at the time of submission, you must immediately up date your facility’s registration. If any information you previously submitted that was correct at the time of submis sion subsequently changes, you must update your facility’s registration within 60 calendar days. (xi) Your facility is considered reg istered once FDA enters your facility’s registration data into the registration system and the system generates a reg istration 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 infor mation 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 in clude a statement in which the indi vidual certifies that the information submitted is true and accurate, cer tifies that he/she is authorized to sub mit registration, and identifies by name, address, and telephone number, the individual who authorized submis sion of the registration. Each registra tion must include the name of the indi vidual registering the farm submitting the registration, and the individual’s signature (for paper and CD–ROM op tions). (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 pro vided in § 118.11(b). (g) Registered egg producers must no tify FDA within 120 days of ceasing egg production by completing sections 1b, 1c, and 2 of Form 3733. This notifica tion is not required if you are a sea sonal egg producer or you temporarily cease operation due to labor disputes, fire, natural disasters, or other tem porary conditions. [74 FR 33095, July 9, 2009, as amended at 75 FR 18751, Apr. 13, 2010] § 118.12 Enforcement and compliance. (a) Authority. This part is established under authority of the Public Health Service Act (the PHS Act). Under the FFDCA, the Food and Drug Adminis tration (FDA) can enforce the food adulteration provisions under 21 U.S.C. 331 through 334 and 342. Under the PHS Act (42 U.S.C. 264), FDA has the au thority to make and enforce regula tions for the control of communicable diseases. FDA has established the fol lowing administrative enforcement procedures for the diversion or destruc tion of shell eggs and for informal hearings under the PHS Act: (1) Upon a finding that any shell eggs have been produced or held in violation VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00357 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 348 21 CFR Ch. I (4–1–15 Edition) § 118.12 of this part, an authorized FDA rep resentative or a State or local rep resentative in accordance with para graph (c) of this section may order such eggs to be diverted, under the su pervision of said representative, for processing in accordance with the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) or by a treatment that achieves at least a 5-log destruc tion of SE or destroyed by or under the supervision of an officer or employee of FDA, or, if applicable, of the State or locality in accordance with the fol lowing procedures: (i) Order for diversion or destruction under the PHS Act. Any district office of FDA or any State or locality acting under paragraph (c) of this section, upon finding shell eggs that have been produced or held in violation of this regulation, may serve a written order upon the person in whose possession the eggs are found requiring that the 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 by a treatment that achieves at least a 5-log destruction of SE or destroyed by or under the supervision of the issuing entity, within 10-working days from the date of receipt of the order, unless, under paragraph (a)(2)(iii) of this sec tion, a hearing is held, in which case the eggs must be diverted or destroyed consistent with the decision of the Re gional Food and Drug Director under paragraph (a)(2)(v) of this section. The order must include the following infor mation: (A) A statement that the shell eggs identified in the order are subject to di version 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 pro vided in paragraph (a)(1)(iv) 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 issuing the order and the name of its Director. (ii) Approval of District Director. An order, before issuance, must be ap proved by FDA’s District Director or the Acting District Director. If prior written approval is not feasible, prior oral approval must be obtained and confirmed by written memorandum as soon as possible. (iii) Labeling or marking of shell eggs under order. An FDA, State, or local representative issuing an order under paragraph (a)(1)(i) of this section must label or mark the shell eggs with offi cial tags that include the following in formation: (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 must 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 by a treat ment that achieves at least a 5-log de struction of SE or destroy them or (2) Move them to 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. (iv) 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 VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00358 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 349 Food and Drug Administration, HHS § 118.12 order must not sell, distribute, or oth erwise dispose of or move any eggs sub ject to the order unless and until re ceiving a notice that the order is with drawn after an appeal except, after no tifying FDA’s district office or, if ap plicable, the State or local representa tive, in writing, to: (A) Divert or destroy them as speci fied in paragraph (a)(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 Regional Food and Drug Director in accordance with the following procedures: (i) Appeal of a detention order. Any ap peal must 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 must be held within 5-working days after the appeal is filed or, if requested by the appellant, at a later date, which must 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 must 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 Regional Food and Drug Director or his or her designee determines that no gen uine and substantial issue of fact has been raised by the material submitted in connection with the hearing or from matters officially noticed. If the Re gional Food and Drug Director deter mines that a hearing is not justified, written notice of the determination 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 must be conducted by the Regional Food and Drug Director or his designee, and a written summary of the proceedings must be prepared by the Regional Food and Drug Director. (A) The Regional Food and Drug Di rector may direct that the hearing be conducted in any suitable manner per mitted by law and by this section. The 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 that 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 Re gional Food and Drug Director’s report of the hearing. (E) The Regional Food and Drug Di rector must prepare a written report of the hearing. All written material pre sented at the hearing will be attached to the report. Whenever time permits, the Regional Food and Drug Director may give the parties the opportunity to review and comment on the report of the hearing. (F) The Regional Food and Drug Di rector must 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 VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00359 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 350 21 CFR Ch. I (4–1–15 Edition) Pt. 119 a material issue, and must 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 Regional Food and Drug Director must render a decision on the appeal affirming or re voking the detention order 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 produced or held in vio lation of this section, he must affirm the order that they be diverted, under the supervision of an officer or em ployee of FDA for processing under the EPIA or by a treatment that achieves at least a 5-log destruction of SE or de stroyed by or under the supervision of an officer or employee of FDA; other wise, the Regional Food and Drug Di rector must issue a written notice that the prior order is withdrawn. If the Re gional Food and Drug Director affirms the order, he must 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 must be accompanied by a state ment of the reasons for the decision. The decision of the Regional Food and Drug Director constitutes final agency action, subject to judicial review. (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, if applicable, the State or local rep resentative 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 officer or employee. (b) Inspection. Persons engaged in production of shell eggs must permit authorized representatives of FDA to make, at any reasonable time, an in spection of the egg production estab lishment in which shell eggs are being produced. Such inspection includes the inspection and sampling of shell eggs and the environment, the equipment related to production of shell eggs, the equipment in which shell eggs are held, and examination and copying of any records relating to such equipment or eggs, as may be necessary in the judg ment of such representatives to deter mine compliance with the provisions of this section. Inspections may be made with or without notice and will ordi narily be made during regular business hours. (c) State and local cooperation. Under sections 311 and 361 of the Public Health Service Act, any State or local ity that is willing and able to assist the agency in the enforcement of §§ 118.4 through 118.10, and is authorized to inspect or regulate egg production establishments, may, in its own juris diction, enforce §§ 118.4 through 118.10 through inspections under paragraph (b) of this section and through adminis trative enforcement remedies specified in paragraph (a) of this section unless FDA notifies the State or locality in writing that such assistance is no longer needed. A state or locality may substitute, where necessary, appro priate State or local officials for des ignated FDA officials in this section. When providing assistance under para graph (a) of this section, a State or lo cality may follow the hearing proce dures set out in paragraphs (a)(2)(iii) through (a)(2)(v) of this section, or may utilize comparable State or local hear ing procedures if such procedures sat isfy due process. (d) Preemption. No State or local gov erning entity shall establish, or con tinue in effect any law, rule, regula tion, or other requirement regarding prevention of SE in shell eggs during production, storage, or transportation that is less stringent than those re quired by this part. PART 119—DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK AUTHORITY: 21 U.S.C. 321, 342, 343, 371. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00360 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