21 CFR 118.9: Administration of the Salmonella Enteritidis (SE) prevention plan
Requires egg producers to designate trained or experienced supervisory personnel responsible for developing, implementing, reassessing, and modifying each farm's SE prevention plan and for reviewing the monitoring records, without needing to create them.
Part 118, Production, Storage, and Transportation of Shell Eggs
How FDA words it
The opening lines investigators use most when they cite 118.9, from the 483s we hold.
Supervisory personnel responsible for ensuring compliance with theSE prevention plan(s).Most used
Recent 483s citing 118.9
- Lesher Poultry Farm, Inc. · Chambersburg, PennsylvaniaSupervisory personnel responsible for ensuring compliance with the SE prevention… May 3, 2011
- E. Lavern Martin Farm · Lebanon, PennsylvaniaSupervisory personnel responsible for ensuring compliance with theSE prevention… Apr 25, 2011
- L & W Farms, LLC · Greencastle, PennsylvaniaSupervisory personnel responsible for ensuring compliance with the SE prevention… Apr 12, 2011
- Quint T Egg Farm · Halifax, PennsylvaniaSupervisory personnel responsible for ensuring compliance with theSE prevention… Apr 8, 2011
- Stuart Egg Farm, Inc. (Rose Acre Farms, Inc.) · Stuart, IowaYou lack qualified supervisory personnel who are responsible for reviewing records… Mar 31, 2011
The regulation text
§ 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.
Questions
What does 21 CFR 118.9 require?
Requires egg producers to designate trained or experienced supervisory personnel responsible for developing, implementing, reassessing, and modifying each farm's SE prevention plan and for reviewing the monitoring records, without needing to create them.
How do FDA investigators word a 118.9 observation?
The most common opening is: “Supervisory personnel responsible for ensuring compliance with theSE prevention plan(s).”
Which sections are cited alongside 118.9?
In the same 483s, investigators most often also cite 118.10 (Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan), 118.4 (Salmonella Enteritidis (SE) prevention measures), 118.5 (Environmental testing for Salmonella Enteritidis (SE)).