Title 21 CFR reference

(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.

Records:(a) You must maintain the following records documenting your SE prevention measures: (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. General requirements for…

(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: Electronic registration.http://www.access.fda.gov(1) To register electronically, you must register at , 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, including 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 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. Registration by mail or by fax.(2) If, for…

Authority.(a) This part is established under authority of the Public Health Service Act (the PHS Act). Under the FFDCA, the Food and Drug Administration (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 authority to make and enforce regulations for the control of communicable diseases. FDA has established the following administrative enforcement procedures for the diversion or destruction of shell eggs and for informal hearings under the PHS Act: et seq.(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 ) or by a treatment that achieves at least a 5-log destruction 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 following procedures: Order for diversion or destruction…

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: BiosecuritySalmonella means a program, including the limiting of visitors on the farm and in poultry houses, maintaining personnel and equipment practices that will protect against cross contamination from one poultry house to another, preventing stray poultry, wild birds, cats, and other animals from entering poultry houses, and not allowing employees to keep birds at home, to ensure that there is no introduction or transfer of Enteritidis (SE) onto a farm or among poultry houses. Egg products facility means a USDA-inspected egg products plant where liquid, 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…

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: Pullets.(a) 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: Procurement of chicks.(1) 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; Environmental testing.(2) (i) The pullet environment is tested for SE when pullets are 14 to 16 weeks of age; (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…

Environmental testing when laying hens are 40 to 45 weeks of age.(a) As one indicator of the effectiveness of your SE prevention plan, you must perform environmental testing for SE (as described in §§ 118.7 and 118.8) in a poultry house when any group of laying hens constituting the flock within the poultry 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, 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…

(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)…

Environmental sampling.(a) An environmental 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. Egg sampling.(b) When you conduct an egg test required under § 118.6, you must collect and test the following number of eggs from the positive poultry house: (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.

Testing of environmental samples for SE.SalmonellaSalmonellahttp://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htmSalmonellahttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(a) Testing to detect SE in environmental samples must be conducted by the method entitled “Environmental Sampling and Detection of in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. The April 2008 Environmental Sampling and Detection of Web site is located at , current as of June 26, 2009. The Director of the Federal Register approves the incorporation by reference of “Environmental Sampling and Detection of in Poultry Houses,” April 2008, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. FDA will request approval to incorporate by reference any updates to this Web site. 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 Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-436-2364, or you may examine a copy at the Food and Drug…

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.