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Electronic Code of Federal Regulations

e-CFR data is current as of April 3, 2020

Title 21Chapter ISubchapter BPart 118 → §118.10


Title 21: Food and Drugs
PART 118—PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS


§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.

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