21 CFR 118.8: Testing methodology for Salmonella Enteritidis (SE)
Requires SE testing of environmental samples to follow FDA's 2008 poultry house sampling method, and egg sample testing to follow BAM Chapter 5, or equivalent methods in accuracy, precision, and sensitivity.
Part 118, Production, Storage, and Transportation of Shell Eggs
How FDA words it
The opening lines investigators use most when they cite 118.8, from the 483s we hold.
For testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an…Most used
Recent 483s citing 118.8
- New Horizon Cooperative (Sparboe) · Brill, IowaJul 22, 2011
- Form 483 · FEI 3008778967 · Fremont, IowaJun 29, 2011
- Humboldt Egg Farms (Sparboe) · Humboldt, IowaFor testing to detect SE in environmental samples, you did not have the sample… Jun 21, 2011
- Sparboe Farms, Inc · Hudson, ColoradoFor testing to detect SE in environmental samples, you did not have the sample… May 12, 2011
- Nugent Nuggets, LLC · Radcliffe, IowaMay 10, 2011
The regulation text
§ 118.8 Testing methodology for Salmonella Enteritidis (SE).
(a)Testing of environmental samples for SE. Testing to detect SE in environmental 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, precision, and sensitivity in detecting SE. The April 2008 Environmental Sampling and Detection of Salmonella Web site is located at http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/ucm114716.htm, current as of June 26, 2009. The Director of the Federal Register approves the incorporation by reference of “Environmental Sampling and Detection of Salmonella 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 Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federal_register/code_of_federal_regulations/ibr_locations.html.
(b)Testing of egg samples for SE. Testing to detect SE in egg samples must be conducted according to Chapter 5 of FDA's Bacteriological Analytical Manual (BAM), December 2007 Edition, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. Chapter 5 of FDA's Bacteriological Analytical Manual, December 2007 Edition, 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. 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 Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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/federal_register/code_of_federal_regulations/ibr_locations.html.
[74 FR 33095, July 9, 2009, as amended at 81 FR 5590, Feb. 3, 2016]
Questions
What does 21 CFR 118.8 require?
Requires SE testing of environmental samples to follow FDA's 2008 poultry house sampling method, and egg sample testing to follow BAM Chapter 5, or equivalent methods in accuracy, precision, and sensitivity.
How do FDA investigators word a 118.8 observation?
The most common opening is: “For testing to detect SE in environmental samples, you did not have the sample testing conducted by the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current edition, or an…”
Which sections are cited alongside 118.8?
In the same 483s, investigators most often also cite 118.4 (Salmonella Enteritidis (SE) prevention measures), 118.10 (Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan), 118.7 (Sampling methodology for Salmonella Enteritidis (SE)), 118.5 (Environmental testing for Salmonella Enteritidis (SE)).