21 CFR 118.10 - Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.

§ 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 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.
(b) General requirements for records maintained by shell egg producers. All records required by § 118.10(a) must include:
(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 creating the record. The written SE prevention 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 observed, if applicable.
(c) Length of time records must be retained. You must retain all records required 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 permanently 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 retrieve and provide the records at your place of business within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location.
(e) Official review of records. You must have all records required by this part available for official review and copying at reasonable times.
(f) Public disclosure of records. Records required by this part are subject to the disclosure requirements under part 20 of this chapter.

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 118 after this date.

  • 2013-07-24; vol. 78 # 142 - Wednesday, July 24, 2013
    1. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers With Outdoor Access); Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of availability.
      Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by September 23, 2013.
      21 CFR Part 118