FDA notified Wright County Egg LLC of Galt, Iowa, that the company has FDA’s concurrence to begin shipping shell eggs directly to the consumer market from two hen houses on one of its six farms. The firm has not shipped eggs to the consumer market since August 2010, when the company's eggs were associated with the multi-state outbreak of Salmonella Enteritidis (SE).

“During the outbreak, I said that FDA would not agree to the sale of eggs to consumers from Wright County Egg until we had confidence that they could be shipped and consumed safely,” said FDA Commissioner Margaret A. Hamburg, M.D., “After four months of intensive work by the company and oversight, testing, and inspections by FDA, I am satisfied that time has come.”

FDA’s decision is based on the agency’s verification that the company has taken the necessary corrective measures in these two houses to address all four pathways of contamination that may have contributed to the outbreak. These include:

o Contaminated egg-laying environment: The laying hens present in these houses at the time of the outbreak have been removed and the houses cleaned, sanitized and tested to ensure that they are no longer contaminated with SE. A biosecurity plan has been developed and implemented to minimize the risk of contamination from other houses or other farms.

o Infected pullets (pullets are young chickens before the start of egg-laying): Pullets previously in the houses were replaced with SE negative pullets that have been vaccinated for SE.

o Rodents: The severe rodent problem that could have contaminated feed and egg-laying environments has been corrected and a system put in place to control and monitor rodents on a weekly basis.

o Contaminated feed: Corrective actions included cleaning and disinfecting the feed mill; correcting the structural defects; eliminating egg shells, meat and bone meal from the feed; and testing of feed ingredients and feed for SE.

“These extensive corrective actions address the significant contamination problems and support the resumption of distribution of eggs to the table market from these two hen houses,” said Don Kraemer, deputy director of FDA’s Center for Food Safety and Nutrition.

The company has implemented controls to prevent recurrence of the problems that led to the outbreak. FDA has confirmed the corrective measures and implementation of the company’s preventive controls at these two houses through on-site inspections conducted in October and November 2010. Eggs from these two houses and the house environments tested negative twice by FDA for SE and tested negative once by Wright County Egg. The firm will continue to test these houses monthly for the presence of SE.

Since October, FDA inspections of the Wright County Egg facilities have involved 13 investigators and more than 900 man hours. During the past six weeks at Wright County Egg, FDA collected and analyzed 40 feed samples, 236 environmental samples and 13,900 shell eggs. Based on the totality of information, including FDA's inspection and testing data, FDA concluded that distribution of shell eggs from these two houses is warranted.

FDA will continue to conduct environmental and egg sampling and will conduct periodic inspections to verify the effectiveness of the safety measures in place. Corrective actions continue to be implemented for Wright County Egg’s remaining houses, operating on six farms. The Agency will work with Wright County Egg officials to assure appropriate steps are taken before permitting resumption of shipping to the shell egg market from other houses and farms.