FSIS Microbiological Sampling of Egg Substitutes, Freeze-Dried, and Agglomerated Egg Products
FSIS Notice
51-23
Issue Date
Sep 29, 2023
Expiration Date
Oct 01, 2024
Full Notice
- PURPOSE
This notice provides instructions to inspection program personnel (IPP) for the sampling of egg substitutes, freeze-dried, and agglomerated egg products under the existing EGG_LQ_MIC01 and EGG_DY_MIC01 project codes. Egg substitutes, freeze-dried, and agglomerated egg products will be eligible for sampling under the current routine sampling programs starting on November 1, 2023. - BACKGROUND
- On October 29, 2020, FSIS published the Egg Products Inspection Regulations final rule (85 FR 68640). In that rule, FSIS stated it will assert jurisdiction of egg substitutes, freeze-dried, and agglomerated egg products on October 30, 2023. Once under FSIS jurisdiction, these products will be eligible for sampling to analyze for the presence of Salmonella and Listeria monocytogenes (Lm).
- Egg substitutes, freeze-dried, and agglomerated egg products are defined as:
- Egg substitutes: Low cholesterol egg products characterized as egg whites with non-egg yolk replacers such as vegetable oil, nonfat dry milk, soy protein, gums, food coloring, artificial flavors, and vitamins and minerals (for nutritional fortification).
- Freeze-dried egg products: Egg products that are flash frozen and placed in a vacuum chamber to remove ice particles.
- Agglomerated egg products: Dried egg products that rehydrated and redried into larger particles to improve solubility.
- GENERAL SAMPLING INSTRUCTIONS
- IPP are to ensure that the Establishment Profile in the Public Health Information System (PHIS) reflects the total average daily production product volume and the days of production for egg substitutes, freeze-dried, and agglomerated egg products. IPP are to refer to FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System, Chapter II, for instructions on how to add new product groups (Section VII. Paragraph E.) and update the product volume (Section VIII.). Table 1 contains the list of egg products finished product groups, with the new groups highlighted.
TABLE 1: PHIS Product Category List (Egg Products Plants)
HACCP1 Process Category
Finished Product Category
Product Group Category
Production Volumes Categories (by Product Groups)
Raw Non-Intact
Raw non-intact egg products
Unpasteurized (bulk or packaged)
- Whole eggs or Yolks (<2% added ingredients)
- Egg Yolk (with or without ingredients)
- Whole eggs with added yolks (with >2% salt or sugar)
- Egg whites (w/wo added ingredients)
- Egg products (blends of whole egg, egg whites, and/or yolks w/wo added ingredients)
- Spray-dried egg whites (w/wo added ingredients)
- Pan dried egg whites
Fully Cooked - Not Shelf Stable
RTE2 fully-cooked egg products
Pasteurized (bulk or packaged)
- Whole eggs or yolks (<2% added ingredients)
- Egg Yolk (with or without added ingredients)
- Egg products (blends of whole egg, egg whites, and/or yolks)
- Whole eggs with added yolks (w >2% added salt or sugar)
- Whole egg or yolks (w/ >2% salt or sugar)
- Egg whites (w/wo added ingredients)
- Egg substitutes
RTE egg product fully-cooked w/o subsequent exposure to environment
Heat Treated - Shelf Stable
RTE dried egg products
Pasteurized Dried Egg Products
- Whole eggs or yolks (w/wo added ingredients)
- Egg products (blends of whole egg, egg whites, and/or yolks
- Whole eggs w/ added Yolks (w >2% salt or sugar)
- Spray-Dried Egg Whites (w/wo added ingredients)
- Pan Dried Egg Whites
- Freeze-Dried Egg Whites (w/wo added ingredients)
- Freeze-Dried whole egg or yolks (<2% added ingredients)
- Freeze-Dried egg yolk (w/wo added ingredients)
- Freeze-Dried Whole Eggs w/ added yolks (w/ > 2% salt or sugar)
- Freeze-Dried egg products (blends of whole egg, egg whites, and/or yolks)
- Agglomerated Egg Whites (w/wo added ingredients)
- Agglomerated Whole egg or yolks (<2% added ingredients)
- Agglomerated egg products (blends of whole egg, egg whites, and/or yolks)
- Agglomerated egg yolk (w/wo added ingredients)
- Agglomerated Whole Eggs w/ added yolks (w/ > 2% salt or sugar)
1 HACCP - Hazard Analysis Critical Control Point
2 RTE - Ready-to-Eat - IPP are to follow the instructions in FSIS Directive 10,230.3, FSIS Verification Testing of Domestic Egg Products, to:
- Schedule the sampling tasks;
- Select and collect the samples;
- Ship the samples; and
- Take action depending on the results.
- IPP are to be aware that the plant is required to hold or maintain control of the egg product lot(s) represented by the sample until all FSIS microbiological sample results are found acceptable, just like the liquid, frozen, and dried egg products.
- IPP are to sample egg substitutes under the EGG_LQ_MIC01 project code.
- IPP are to sample freeze-dried and agglomerated egg products under the EGG_DY_MIC01 project code.
- If an egg products plant produces more than one product group, IPP are to randomly select the egg product group to sample and then rotate through the different formulations, including the egg substitutes, freeze-dried, and agglomerated egg products, with each sampling task so that all formulations are sampled over time.
- IPP are to ensure that the Establishment Profile in the Public Health Information System (PHIS) reflects the total average daily production product volume and the days of production for egg substitutes, freeze-dried, and agglomerated egg products. IPP are to refer to FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System, Chapter II, for instructions on how to add new product groups (Section VII. Paragraph E.) and update the product volume (Section VIII.). Table 1 contains the list of egg products finished product groups, with the new groups highlighted.
- QUESTIONS
Refer questions regarding this notice to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-855-444-9904. When submitting a question, complete the web form and select Sampling for the inquiry type.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.