On August 20, 2012, the U.S. Food and Drug Administration (“FDA”) announced the availability of the final guidance document entitled “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.” Found here, the Guidance details the new requirements for industry under the Egg Safety Rule. The full-text of the Rule, as found in 21 CFR part 118, may be accessed here. According to the FDA, the Guidance explains the requirements of the Egg Safety Rule and in particular, answers the questions asked by industry since the publication of the final rule on July 9, 2009.
Under 21 CFR part 118, shell egg producers are required to implement preventative measures in an effort to thwart Salmonella Enteritidis (SE) contamination. In addition to these preventative efforts, shell egg producers are required to maintain certain records detailing their compliance with the final rule and to register their facilities with the FDA. According to the FDA, these measures are aimed at protecting the public health, as SE is one of the leading bacterial causes of foodborne illnesses in the United States, with shell eggs being the primary source of such infections.
While FDA guidance documents do not carry the force of law, they represent the Agency’s current thinking on the particular topics set forth therein. Accordingly, the views contained in guidance documents are indicative of the Agency’s prevailing interpretation of the rules and regulations that it enforces. Thus, in order to achieve compliance with the laws and regulations enforced by the FDA, as well as other federal agencies, it is important to look to current guidance documents to fully understand the regulatory responsibilities under federal law.