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FDA Puts Out First Egg Guidance Since 2009 Egg Safety Rule

The U.S. Food and Drug Administration issued new guidance Monday to help clarify its 2009 egg rule, which outlined steps egg producers must take in order to reduce Salmonella Enteritidis in shell eggs.

FDA uses guidance documents to share its “current thinking” on how to best comply with its food safety regulations. This is the first egg guidance FDA has issued since the egg rule was finalized in July 2009.

During the three years since then, FDA has inspected all large egg production facilities in the U.S. and recently began inspecting medium sized shell egg operations across the country.

All except very small shell egg producers now must operate under FDA’s new egg rule. It first went into effect on July 9, 2010 for production facilities with 50,000 or more laying hens. On July 9, 2012, the Egg Rule went into effect for facilities with between 3,000 and 50,000 layers.

In a question and answer (Q&A) format, FDA uses the guidance document to help producers understand what they must do to comply with the egg rule. FDA is hoping increased compliance with the rule brings down the country’s stubbornly high levels of Salmonella Enteritidis or SE.

FDA wants to get egg producers to view their poultry houses and surrounding facilities as falling under a “single biosecurity program.”

Within that area, egg producers should be conducting an “SE Prevention Plan” that includes such steps as treating food and water, applying probiotics to prevent colonization of intestines by pathogenic bacteria and dispensing vaccines.

The new egg rule also requires producers to hold and transport eggs at 45 degrees F or below, beginning 36 hours after the time of the lay. The guidance document provides information how exactly how FDA will read that clock.

FDA is not through issuing guidance documents on eggs. Some of the mid-sized egg producers now regulated by the egg rule raise their hens the old-fashioned way, in the great outdoors – not in big laying houses.

Michael M. Landa, who is director of FDA’s Center for Food Safety and Applied Nutrition, recently wrote United Egg Producers and the Organic Trade Association, to warn about what’s coming.

“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,” Landa wrote. “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.”

Landa said “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.”

Some egg experts who are familiar with the Egg Rule say so-called free range organic egg producers are going to have a very difficult time adhering to the regulations designed to fight SE.

One aspect of the new rule requires an egg producer who obtains a positive test result for SE to “take appropriate action,” including a “voluntary” recall to a market withdrawal.

FDA says it is still evaluating rapid detection methods for SE and it encourages the industry to do the same.

Breakfast in America takes close to 80 billion eggs a year, according to the industry.

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