E. Environmental Testing for SE (21 CFR 118.5)

1. When does FDA consider “the end of any molting process” (§ 118.5) to have occurred?

FDA considers that the molting process has ended when the layers have reached 50 percent of production.  Although there are other possible indicators, FDA considers that this standard is the most objective, easy to apply indicator.  Further, FDA notes that many of the State egg quality assurance programs use this standard.

2. If an environmental test comes back positive for SE, and I choose to begin egg testing instead of diverting eggs to treatment for the life of the flock, as set forth at § 118.5(a)(2)(ii), must I hold eggs until the first egg test results come back?

No.  As was discussed in the preamble to the final rule (74 FR 33030 at 33042-43), producers in this situation are not required to hold eggs until test results are received.

3. Is a positive environmental test result cause for a voluntary recall or market withdrawal?

An egg producer should assess the implications of a positive environment test result for any product in the marketplace to determine if a voluntary recall or market withdrawal is appropriate.  Not all SE positive environmental test results lead to SE contaminated eggs, and so FDA does not expect that most findings of positive environmental test results will result in recalls.  Some factors egg producers should consider when making a decision whether to withdraw product from the marketplace include the extent of the positive findings (for example, several positives throughout the farm, or one positive remote from the eggs), whether the farm has had positive environmental test results previously, and whether it is likely that impacted eggs remain on the market.

F. Egg Testing for SE (21 CFR 118.6)

1. Is a positive egg test result cause for a voluntary recall or market withdrawal? 

FDA considers eggs containing SE to be adulterated.  An egg producer obtaining a positive egg test result should take appropriate action to determine if a voluntary recall or market withdrawal is the appropriate response to a positive finding of SE in an egg sample.  FDA expects that most findings of positive egg test results will result in recalls in situations where eggs produced by the flock on or after the day the eggs were sampled have been placed in the table egg market. 

2. If I initiate a voluntary recall or market withdrawal based on a positive egg test result, which eggs should be subject to the recall/withdrawal?

An egg producer who determines that a voluntary recall or market withdrawal is necessary in light of a positive finding of SE in an egg sample (see response to question F-1) should take appropriate action to determine what the scope of that recall or market withdrawal should be.  If an egg test result is positive, all eggs produced by that flock on or after the day those eggs were sampled would be considered SE-positive by FDA.  Eggs that were produced before the day on which the positive sample was taken would not automatically be considered SE-positive by FDA.  For example, for a producer conducting a series of four egg tests following an environmental positive test result as set forth in § 118.6(c), if the first egg test were negative and the second egg test were positive, absent other factors, FDA generally would only consider the eggs produced by the flock on or after the day on which the second sample was taken to be SE-positive.

3. Would all my eggs produced between the time I receive a positive environmental test result and the time I receive a positive egg test result for SE always be considered SE-positive by FDA?

No.  All eggs produced between the time a positive environmental test result is received and the time a positive egg test result is received would not automatically be considered SE-positive by FDA.  Only those eggs produced on or after the day eggs are sampled would automatically be considered SE-positive by FDA (when the egg sample leads to a positive egg test result).  However, under some circumstances, FDA may consider the conditions under which the eggs were produced to be such that the earlier produced eggs may be rendered injurious to health.  As an example, if the firm had a positive environmental test and had a major rodent infestation, FDA may consider the eggs produced between the time of the positive environmental test and the positive egg test to be adulterated because of the conditions under which the eggs were produced.

4. What can I do with my eggs after I receive a positive egg test result?

Under § 118.6(d), eggs from positive flocks must be diverted to treatment.  Treatment is defined in § 118.3 to refer to a technology or process that achieves at least a 5-log destruction of SE for shell eggs, or the processing of egg products in accordance with the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).  As was discussed above at question E-2, there is no obligation to hold eggs until the results of an egg test are received.  Therefore, the obligation to begin diverting eggs to treatment does not begin until a positive egg test result is received.  See 74 FR 33030, 33043.  However, as was discussed above at questions F-1 through F-3, if an egg test result is positive, all eggs produced by that flock on or after the day those eggs were sampled would be considered SE-positive by FDA, and a recall or market withdrawal of those eggs would likely be appropriate.

G. Sampling Methodology for SE (21 CFR 118.7)

Whom may I designate to collect environmental and egg samples at my farm?

You may designate any individual who is capable of following the sampling requirements in §118.7.

H. Testing Methodology for SE (21 CFR 118.8)

1. How can I determine whether the test methods I use for environmental and egg samples are equivalent in accuracy, precision, and sensitivity to the testing methods specified in the egg rule for detecting SE?

Under § 118.8(a), 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.  Under § 118.8(b), 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.  Alternative methods used to analyze environmental or egg samples for SE do not require a formal determination of equivalency or prior approval by FDA.  If you have information that you believe demonstrates that a method is equivalent to a method specified in the egg rule and want to obtain FDA's view regarding the method, you may contact FDA’s Microbial Methods Development Branch (MMDB).  Methods that have undergone a validation process through the Association of Official Analytical Chemists (AOAC International) Research Institute (RI) or the AOAC International Official Methods of Analysis (OMA) Program and that have been certified by that body as being equivalent to the FDA methods specified in the egg rule are not automatically considered equivalent by FDA.  To obtain FDA's view regarding whether such a method is equivalent to a method specified in the egg rule, you may contact MMDB, as set forth above. MMDB can be reached by phone at 240-402-2408, or by mail at: MMDB, Division of Microbiology, Office of Regulatory Science, CFSAN, HFS-711, 5100 Paint Branch Parkway, College Park, MD 20740.  All methods ultimately determined by FDA to be equivalent to the methods cited in the rule will be listed on Testing methodology for Salmonella Enteritidis (SE).

2. Is FDA evaluating any alternative test methods for SE, specifically any rapid test methods? 

Yes.  As of the date of this guidance, FDA is evaluating a rapid method for detection of SE in eggs.  FDA encourages the industry to evaluate rapid methods as well, using the protocol described in the response to question H-1, above.

3. Can I use any laboratory for testing my environmental and egg samples? 

You may use any laboratory that is capable of properly carrying out the testing methods specified in the egg rule. 

4. Do laboratories need to register with FDA or be acknowledged or authorized by FDA as a compliant tester for environmental and/or egg samples for SE under this regulation? 

No. 

I. Registration Requirements (21 CFR 118.11)

1. If I buy eggs from a producer and then sell them to a processor, am I required to register with FDA?

No.  Only shell egg producers covered under § 118.1(a) must register with FDA.

2. Must I register my farm with FDA if I send all of my surplus eggs from broiler breeder operations (as defined at question B-3) to an official egg products facility?

Yes, you must comply with the registration requirements in § 118.11.  Under § 118.1(a), you are covered by some or all of the requirements of the egg rule if you have 3,000 or more layers at a particular farm and do not sell all your eggs directly to consumers.  As set forth in § 118.1(a)(2), even if all of your surplus eggs receive a treatment, such as processing into egg products at an official egg products facility, you still must comply with the registration requirements in § 118.11. 

3. Who must register contract flocks?

The registration requirements of § 118.11 apply to “[s]hell egg producers covered under § 118.1(a).”  “Producer” is defined in § 118.3 as “a person who owns and/or operates a poultry house containing laying hens which produce shell eggs for human consumption.”    It is the producer who must comply with the registration requirements, regardless of who owns the flock.

J. Enforcement and Compliance (21 CFR 118.12)

1. How will FDA determine that eggs are in compliance with the rule?

FDA will inspect both domestic and foreign egg producers as necessary to ensure that eggs distributed in the United States are produced in compliance with the rule.

2. What biosecurity measures will FDA inspectors follow when inspecting a farm?

FDA’s Investigations Operations Manual, the primary source regarding Agency policy and procedures for field investigators and inspectors, discusses biosecurity measures for FDA inspectors in Chapter 5.2.10, “Routine Biosecurity Procedures for Visits to Facilities Housing or Transporting Domestic or Wild Animals”.  FDA inspectors will follow these procedures.

3. In those States that contract with FDA to enforce the egg rule, how will FDA ensure that individuals doing the inspections have received proper training?

Inspectors from States that contract with FDA to enforce the egg rule will first be trained by FDA using the same training module used to train FDA field staff.  This will ensure consistency among inspectors and inspections.

K. Other

FDA held two public meetings to discuss the egg rule.  Where can I obtain copies of the transcripts from these meetings and the presentations that were given?

The transcripts and presentations are available in PDF format: Egg Safety Final Rule Public Meeting Presentations and Transcripts.

The above guidance document supercedes the previous version dated July 2011.

^[1] This guidance has been prepared by the Division of Plant and Dairy Food Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.