21 CFR 118.7: Sampling methodology for Salmonella Enteritidis (SE)
Requires producers to environmentally sample each poultry house using a plan suited to its layout, and, after a positive result, to collect and test four 1,000-egg samples two weeks apart, then 1,000 eggs monthly for the flock's life.
Part 118, Production, Storage, and Transportation of Shell Eggs
How FDA words it
The opening lines investigators use most when they cite 118.7, from the 483s we hold.
The poultry house environmental sampling plan was not appropriate to the poultry house layout.Most used
Recent 483s citing 118.7
- Form 483 · FEI 3008778967 · Fremont, IowaThe poultry house environmental sampl ing plan was not appropriate to the poultry… Jun 29, 2011
- Nugent Nuggets, LLC · Radcliffe, IowaTbe poullry hoase ~tal sampling plan was not appropriate to the poultry house… May 10, 2011
- Hillside Ranch · Petaluma, CaliforniaAn environmental test for SE was not done for each pouhry house as required… May 5, 2011
- Sparboe Farms · Goodell, IowaThe poultry house environmental sampling plan was not appropriate to the poultry… Apr 29, 2011
- Luoma Egg Ranch, Inc. · Finlayson, MinnesotaThe poultry house environmental sampling plan was not appropriate to the poultry… Apr 20, 2011
The regulation text
§ 118.7 Sampling methodology for Salmonella Enteritidis (SE).
(a)Environmental sampling. 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.
(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 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.
Questions
What does 21 CFR 118.7 require?
Requires producers to environmentally sample each poultry house using a plan suited to its layout, and, after a positive result, to collect and test four 1,000-egg samples two weeks apart, then 1,000 eggs monthly for the flock's life.
How do FDA investigators word a 118.7 observation?
The most common opening is: “The poultry house environmental sampling plan was not appropriate to the poultry house layout.”
Which sections are cited alongside 118.7?
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), 118.8 (Testing methodology for Salmonella Enteritidis (SE)), 118.5 (Environmental testing for Salmonella Enteritidis (SE)).