The government’s Egg Safety Rule, a set of requirements designed to prevent Salmonella contamination at laying facilities, became fully fledged Monday when it went into effect for medium-sized operations after previously applying only to large producers. Since July of 2010, companies with over 50,000 laying hens have been required to comply with these standards – set forth by the U.S. Food and Drug Administration in 2009 – but as of yesterday the rule now covers facilities with more than 3,000 and less than 50,000 hens. These regulations do not apply to small producers – those with under 3,000 hens – or companies who sell directly to consumers. A separate guidance was issued for these facilities in 2010. The rule requires all producers who don’t pasteurize in-shell egg products to test for Salmonella Enteriditis bacteria and to refrigerate eggs at 45 degrees F or less during storage and transportation, starting within 36 hours of when they are laid. It also says that chicks and young hens may only be sourced from suppliers who monitor for Salmonella. Companies must implement biosecurity, rodent and pest control measures. According to the rule, if Salmonella is found on eggs or in a laying facility, the eggs must be pasteurized or diverted for non-food use, and the facility must be sanitized. In its Final Egg Safety Rule, FDA predicted that “implementing the preventive measures would reduce the number of Salmonella Enteritidis infections from eggs by nearly 60 percent.” Data from the 1990s suggested that approximately 2.2 million of the 65 billion eggs produced in the U.S. each year are contaminated with Salmonella Enteriditis, according to the Centers for Disease Control and Prevention (CDC). In the spring of 2010, almost 2,000 people were sickened in a Salmonella Enteriditis outbreak linked to eggs from two Iowa farms. Over 500 million eggs were recalled for potential contamination after the source of the bacteria was discovered. Since the rule went into effect for large-scale egg producers in 2010, FDA conducted inspections at all facilities in this category to ensure that they were in compliance with the new protocol. After first inspecting the 35 large farms that had previously been subject to an outbreak or recall in 2010, the agency assessed the remaining 514 to determine their level of compliance. Of these operations, 14 received Official Action Indicated (OAI) notices, meaning that “the objectionable conditions observed are egregious and warrant an official action by FDA, such as a Warning Letter to these establishments.” The majority of facilities (305) were classified as No Action Indicated (NAI), meaning that there were “no significant deviations” from the rule. In the middle were the 195 Voluntary Action Indicated (VAI) facilities, which did not meet all the requirements of the rule, but whose deviations could be corrected without regulatory action from FDA. FDA plans to begin inspecting medium-sized facilities in the final quarter of this year.