September 2009 -- Regulations: Eggs and Food Safety

Eggs.  On July 9, 2009, (74 FR 33030) the Food and Drug Administration issued its Final Rule on the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation. The Final Rule amends 21 CFR Part 16, but the most important provisions of the regulation can be found at 21 CFR 118.

Part 118.1 identifies persons who are covered in whole or in part by the Final Rule, as (1) shell egg producers with 3,000 or more laying hens at a particular farm; (2) who do not sell directly to consumers and; (3) who produce for the “table market.” If eggs are “treated” at the farm, “mean(ing) 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,” only the refrigeration requirements of section 118.4(e) and the registration requirements of section 118.11 apply. If a person with 3,000 or more laying hens transports or holds shell eggs, that person must comply with the refrigeration requirements.

Persons are required to have a written SE prevention plan “specific to each farm where you produce eggs and that includes, at a minimum, the following SE prevention measures...” Sec. 118.4(a) “pullets” through (b) “biosecurity.” Persons “must have one or more supervisory personnel... to be responsible for ensuring compliance with each farm’s SE prevention plan.”

The Final Rule provides for “environmental testing” (sec. 118.5); “egg testing” (sec. 118.6); “sampling methodology” (sec. 118.7); and “testing methodology” (sec. 118.8).

Section 118.11 requires registration for shell egg producers who come within the section 118.1(a) definitions (above).

Any person who has any question about whether their operation is covered or whether their operation meets the requirements should read and review the Final Rule.

Food Safety Working Group: Key Findings
Salmonella. The President’s Food Safety Working Group has announced it is “starting immediately to implement long-overdue actions to improve the safety of the U.S. food supply.”  The first action is FDA’s July 9 Final Rule on SE in shell eggs. FSIS is to announce, by the end of the year, “new standards to reduce the prevalence of Salmonella in turkeys and poultry.”  The goal is to have 90% participation by poultry establishments by the end of 2010.

E. coli 0157:H7.  By the end of July, FSIS is to develop new procedures for its inspectors to limit E. coli in inspected beef and ground beef establishments.  Again, by the end of July, FDA is to develop new guidance to reduce microbial contamination in fresh vegetables.

National Traceback and Response System: Agencies within their statutory authority should undertake efforts in: Developing Industry Product Tracing Systems (FDA); Creating Unified Incident Command System (federal agencies); Strengthening the Public Health Epidemiology Program (FSIS); Updating Emergency Operations Procedures (federal agencies); Improving State Capacity (CDC); and Using New Technologies to Communicate Critical Food Safety Information (

In addition, new organizational changes are planned, including the creation of a deputy commissioner of foods at FDA and a chief medical officer at FSIS.

These measures, individually and collectively, indicate a renewed emphasis on the role of the federal government in food safety. As recorded by the Working Group, “There are certain things that only a government can do. And one of these things is ensuring that the foods we eat...are safe and don’t cause us harm.”  President Barack Obama, 3/14/2009.

Mark Hostetler is an attorney at Husch Blackwell Sanders LLP. Experienced in advising consumer product companies and focusing primarily in the food industry, he has guided producers, advertisers and marketers through regulatory proceedings, product recalls, new product introductions, and new advertising and promotional campaigns. He can be reached at pf