On August 20, 2012, FDA issued new industry guidance that clarifies the agency’s enforcement policies that apply to shell egg producers and distributors under the final rule issued in 2009 entitled Prevention of Salmonella Enteritidis (“SE”) in Shell Eggs During Production, Storage, and Transportation (“Egg Rule”). The Egg Rule requires producers to implement certain measures to prevent SE contamination and requires transporters to comply with certain temperature restrictions to prevent SE contamination.

Using a question and answer format, FDA’s guidance covers the following topics:

Compliance dates for the final rule: The compliance date for the Egg Rule was July 9, 2010 for all egg producers and transporters, except that producers with fewer than 50,000 but at least 3,000 laying hens had to comply by July 9,2012. At this point, all farms covered by the rule must be in compliance.

Coverage of the Egg Rule: If any eggs produced at any given farm are not treated (i.e., subject to a process that achieves at least a 5-log destruction of SE), then all eggs at the farm must comply with all requirements of the Egg Rule. Farms that do use such a treatment on all of their eggs must only comply with the refrigeration requirements. Also, members of an egg co-operative with fewer than 3,000 layers at a particular farm do not have to comply with the egg rule.

Definitions: FDA defines “farm” as “all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program.” “Biosecurity program” is defined as “a program, including the limiting of visitors on the farm and in poultry houses, maintaining personnel and equipment practices that will protect against cross contamination from one poultry house to another, preventing stray poultry, wild birds, cats, and other animals from entering poultry houses, and not allowing employees to keep birds at home, to ensure that there is no introduction or transfer of Salmonella Enteritidis (SE) onto a farm or among poultry houses.” Producers may not divide their farms into smaller operations of fewer than 3,000 layers with separate biosecurity programs in order to avoid having to comply with the Egg Rule

SE prevention measures: Producers may take other measures in addition to those required by the egg rule to prevent SE, such as vaccination, treatment of feed or water, and utilization of competitive exclusion products, but these additional measures may not be used I lieu of any of the measures required by the Egg Rule.

Cleaning and disinfection: Under the Egg Rule, all visible manure must be removed from the poultry house, even during times of the year when the manure cannot be applied to fields. FDA notes that the manure could then be used in composting or stored in manure barns.

Refrigeration: The requirement that eggs be refrigerated within 36 hours of lay is triggered at the end of the egg collection shift. The eggs may be brought back up to room temperature beginning no sooner than 36 hours before processing to prevent thermal checks. Individuals who transport or hold shell eggs for egg processing must also comply with the refrigeration requirements.

Environmental testing: A positive environmental test for SE does not automatically trigger a recall. FDA recommends that producers consider the extent of the positive findings, whether the farm has had positive test results previously, and whether impacted eggs are still on the market when deciding whether or not to recall eggs after a positive environmental test result.

Egg testing for SE: Eggs containing SE are considered adulterated, and FDA expects that most findings of positive egg tests will result in recalls of eggs produced on or after the day the sampled eggs are placed in the market. Eggs that test positive that have not been placed in the market may be diverted for treatment.

Sampling Methodology for SE: All testing methods FDA determines to be equivalent to the methods cited in the Egg Rule will be listed on Testing methodology for Salmonella Enteritidis (SE) on the FDA’s website.

Enforcement and Compliance: FDA will conduct training with inspectors in states that contract with FDA to enforce the Egg Rule, and will inspect domestic and foreign egg producers “as necessary” to ensure compliance.