By Daniel Pessar* (Guest Blogger)
In response to the COVID-19 pandemic, countless government agencies at the federal, state, and local levels are working to relax certain rules to help industry operate and respond to the needs of the public. For example, the U.S. Food and Drug Administration has issued a host of temporary policies to facilitate increased production of hand sanitizer, sterilization of respirators, and increased availability of shell eggs for retail sale. This last effort impacts countless Americans and will be the focus of this post.
Just as the FDA has an interest in helping medical supplies manufacturers and users to have enough inventory on hand, it seeks to respond to the changes in supply and demand in food markets, such as the current trends in the market for shell eggs. Shell eggs are the eggs many of us purchase in supermarkets, as distinguished from the processed egg products—available in liquid, frozen, or dried form—sold to restaurants and prepared foods manufacturers. Because of the pandemic, there are more people buying more shell eggs and fewer people eating in restaurants. As a result, the egg industry asked the FDA to help make it easier for them to direct more eggs to meet shell egg demand, rather than being sent for further processing.
The Egg Safety Rule, codified in 21 CFR 118, requires egg producers to follow certain rules meant to reduce the risk of Salmonella Enteritidis (SE), a leading cause of foodborne illness in the United States. While the safety rules for shell egg producers are much stricter than the safety rules for processed egg product producers, the relaxed rules for processed eggs are only available if all of a producer’s eggs receive the relevant treatments. Under the regulations,
If all of your eggs that are produced at the particular farm receive a treatment as defined in 118.3, you must comply only with the refrigeration requirements in 118.4(e) for production of eggs on that farm and with the registration requirements in 118.11.
21 CFR 118.1(a)(2)
As a result, processed eggs producers shifting even ten percent of their supply to the shell egg market would result in significant compliance effort and cost for all eggs being produced.
The FDA recognized this and provided conditions under which SE risk could be mitigated in a satisfactory manner without triggering most of the Egg Safety Rule requirements that would normally be triggered, including certain time-sensitive testing and inspection requirements.
Photo credit: Michael Bußmann from Pixabay
While the FDA has demonstrated flexibility, its guidance is narrowly tailored. The temporary policy regarding the Egg Safety Rule is meant to remain in effect only for the duration of the public health emergency and to apply only to producers of processed egg products—not to existing shell egg producers. As well, the FDA’s guidance does not apply to poultry houses with laying hens over 45 weeks of age at the time the guidance was issued. This is because SE is most likely to be detected in poultry houses with laying hens between 40 and 45 weeks old. Mandatory testing done under the new guidance, to hens already 45 weeks old, have a higher chance of missing the SE threat.
But the relief is real. As supply chain managers across the economy scramble to adapt to the coronavirus upheaval, some have to reimagine their operations. Equipment, staff, and logistics issues can come together to present a daunting challenge, especially to small businesses. With its emergency guidance concerning the Egg Safety Rule, the FDA plays a small but important role in helping industry adapt. Egg product suppliers will now have an easier time meeting the current demand for shell eggs.
*Daniel Pessar is a third-year student at Harvard Law School. Before law school, he worked in the real estate investment industry for six years. He is the author of three books and numerous articles. He can be contacted at email@example.com.