National Egg Farmers Suggests Improvements in Egg Safety Rule

Dr. Scott Gottleib, Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD  20993


Dear Commissioner:


We read with interest the food safety concerns with eggs linked to Salmonella expressed on October 4th by Rep. Rosa DeLauro (D-CT). Of particular note was Rep. DeLauro question for FDA to suggest improvements to strengthen the food safety. The National Egg Farmers, comprised of approximately 200 egg farmers producing more than 10 billion eggs anuually, offers these suggestions to expand the areas for testing of Salmonella in the chain of eggs from breeders to pullets, to eggs for consumers. Every Salmonella outbreak linked to eggs publically harms the reputation all egg farmers in their programs of providing a safe, wholesome egg to their consumers.


On July 9, 2009 FDA published its final rule establishing the regulation (21 CFR part 118) entitled Prevention of Salmonella Enteritids in Shell Eggs During Production, Transportation, and Storage (74 FR 33030) [“the egg rule”].  This regulation in part 118 requires egg farmers to implement measures to prevent Salmonella from contaminating eggs on the farm and from further growth during storage and transportation, and requires these farmers to maintain records concerning their compliance with the rule and register with FDA.  The measures include standards to control risks associated with pests, rodents, and testing, cleaning, and refrigeration provisions to prevent Salmonella.


Expanding the Egg Rule: The Center for Disease Control and Prevention has repeatedly issued warnings of Salmonella associated with baby chicks. How did those baby chicks become infected? (https://www.cdc.gov/features/salmonellapoultry/index.html)

The Egg Rule acknowledges trans-ovarian transmission from the breeder to the chick, although the mechanism is still not well understood. Hens may have intermittent transmission of Salmonella throughout their life cycle.



The current regulation requires that chicks are procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or an equivalent standard. This monitoring does not include testing the macerated male chicks destroyed at the hatchery. If hens intermittently shed SE virus, this added test of the maceration tanks may expose the trans-ovarian route. More and more, the trans-ovarian transmission of Salmonella paradigm appears to apply from the breeder hen to the commercial pullet chick as one possible route of SE transmission to commercial laying hens.


Streamlining the Egg Rule: Sec. 118.7 (a) requires environmental tests of each poultry house.  If any environmental sample tests positive, Sec. 118.8 requires four 1,000 egg samples tested at 2-week intervals for a total 4,000 eggs. When it comes to food safety, testing is important, but the Iowa State University VDL test results show that Salmonella- positive environmental samples do not necessarily translate into contaminated eggs. From 2011 to 2015, ISU VDL test results showed a dramatic drop (14% to 2.4%) in positive tests of SE from environmental samples taken at egg laying facilities. After testing over 685,000 shell eggs from the summer of 2010 until March of 2016, ISU VDL found only one positive egg pool, which was during the 2010 national recall.


Farmers are required to test the environments of their farms. The cost of environmental sampling for Salmonella these farms are borne by the farmers with single drag swabs being cultured throughout the farm. Pooling the samples will help reduce the cost to farmers without compromising safety. This is demonstrated in the 2015 research article (published in Avian Diseases 59:548-553) entitled “Validation of Single and Pooled Manure Drag Swabs for the Detection of Salmonella Serovar Enteritids in Commercial Poultry Houses” by Dr. H. Kinde et.al., California Animal Health and Food Safety Laboratory System, School of Veterinary Medicine, San Bernardino, CA. This study showed there is no significant difference between the sensitivity of environmental sampling of four-swab pooled together using the National Poultry Improvement Plan culture method compared to the single swabs analyzed by FDA’s method, but the costs are significantly less, while not compromising the efficacy of the tests.


These suggestions are offered to enhance the Egg Rule so that Salmonella outbreaks linked to eggs can be reduced while helping egg farmers become more efficient in adhering to the FDA requirements for its prevention.




Ken Klippen, President

National Association of Egg Farmers

PO Box 1065

Oaks, PA 19456-1065


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cc: John Sheehan, FDA,CFSAN

     Nancy Bufano, FDA, CFSAN

     Dr. Jerry Ramirez, FDA,CFSAN