DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
College Park, MD 20740
July 6, 2012
Mr. Gene Gregory
President and Chief Executive Officer
United Egg Producers
1720 Windward Concourse
Alpharetta, Georgia 30005
Ms. Christine Bushway
Chief Executive Officer/Executive Director
Organic Trade Association
The Hall of the States
444 N. Capitol Street NW
Washington, D.C. 20001
Dear Mr. Gregory and Ms. Bushway:
As you are aware, July 9, 2012, is the compliance date for the Food and Drug Administration's (FDA) rule entitled, "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation" (the "egg safety rule") for egg producers that have between 3,000-49,999 layers. In an effort to ensure that egg producers subject to this compliance date are aware of the requirements of the egg safety rule, FDA has conducted outreach sessions in Puerto Rico, Wisconsin, Iowa, Pennsylvania, Missouri, and Montana. The agency has also issued guidance for industry, draft Questions and Answers, and a Small Entity Compliance Guide for the egg safety rule.* FDA intends to begin inspections for producers with a compliance date of July 9, 2012, in the fourth quarter of this calendar year.
FDA recognizes that a number of egg producers that are covered by the rule utilize outdoor access areas for layers as part of their egg production process. These producers, which include organic egg producers and free-range egg producers, face unique issues in the outdoor areas. In particular, egg producers utilizing a pasture-based system have raised questions about how to apply the egg safety rule in the pasture area.
FDA is developing a guidance document to assist egg producers who utilize outdoor access areas and are covered by the final rule in complying with the egg safety rule. This guidance document will be published initially as a draft document upon which comment may be made. This draft guidance will include enforcement information with respect to the outdoor areas described above.
We look forward to receiving any comments you submit on the draft guidance.
Michael M. Landa
Center for Food Safety and Applied Nutrition