Why didn't FDA require a vaccine for hens in the egg rule? NEW
There are several commercially available vaccines for Salmonella Enteritidis (SE)
infection in laying hens.
These vaccines may help reduce the likelihood of SE infection, but do not eliminate it entirely. In the proposed egg rule issued in 2004, FDA considered the evidence on vaccination and determined that "vaccines show promise in reducing the prevalence" of SE in laying hens. However, FDA concluded that "more information on the effectiveness of vaccines needs to be generated before we would mandate vaccination as a (SE) prevention measure." FDA cited the small number of flocks vaccinated in existing trials of the vaccine.
FDA received public comments following publication of the proposed rule. A few commentors called for FDA to include vaccination as a required part of the rule; some of these recommended that producers using vaccination should be allowed to follow a reduced testing regimen. Others stated that vaccination should be included only as a recommendation in control programs. In the final rule, FDA stated, "While vaccines have shown some promise in the lab, there is insufficient evidence from field trials about their efficacy to estimate any benefit from their use? and ?there is no vaccine that has been shown to be efficacious in the field." As a result, FDA did not require vaccination. FDA did encourage the use of the vaccine as a prevention measure where individual producers have had success with vaccination.
FDA is now working with USDA to review all recent and relevant data on these vaccines and determine whether additional recommendations or requirements are appropriate.
What is the size and scope of the recall?
The recent Wright County Egg in Iowa and Hillandale Farms of Iowa, Inc. voluntary recalls of shell eggs are considered nationwide recalls. Shell eggs from Wright County Egg were sold to distributors and wholesalers in 22 states and Mexico, who then distributed the shell eggs further throughout the country. According to Wright County Egg, 380 million of their shell eggs are being recalled under many different brand names. Shell eggs under recall by Hillandale Farms of Iowa, Inc. were sold to grocery stores, distributors, and wholesalers in 14 states; these entities then distributed the shell eggs further throughout the country.
Is this the largest egg recall in history?
It is one of the largest shell egg recalls in recent history. However, the FDA investigation is still ongoing; and it is too early to determine if all of the shell eggs that should be covered by voluntary recalls are covered and to estimate the magnitude of this recall.
With the second egg producer recalling, is this indicative of a more widespread problem in the egg producing industry?
The Hillandale Farms of Iowa, Inc. recall is related to FDA?s ongoing investigation of the SE illnesses. As the outbreak investigation unfolded, the traceback conducted by FDA, along with help from the State of Minnesota, and FDA investigational findings lead to Hillandale Farms of Iowa, Inc. FDA investigators are onsite at both Wright County Egg and Hillandale Farms of Iowa, Inc., examining potential commonalities among the two egg producers.
Does the FDA expect more companies to recall?
This is an ongoing investigation. Should FDA uncover information that leads to more contaminated shell eggs, then the Agency will work with the necessary parties to have them voluntarily recall product and take the necessary steps to protect the safety of the public?s health.
What are FDA investigators looking for on the farms?
FDA investigators are performing environmental assessments of farm conditions and practices including pest and rodent controls, biosecurity plans and controls; environmental monitoring; sanitary controls; and feed and laying hen sources. The investigators are also looking at commonalities between Wright County Egg and Hillandale Farms of Iowa, Inc.
How are eggs regulated by the Federal Government?
FDA has jurisdiction over the safety of foods in general, including shell eggs, under the Federal Food, Drug, and Cosmetic Act. FDA also has authority to take actions to help prevent the spread of communicable diseases under the Public Health Service Act. This authority includes regulating foods when foods may act as a vector of communicable disease, as eggs may for SE.
The USDA has responsibility for implementing the Egg Products Inspection Act (EPIA), which it carries out through programs administrated by the Food Safety and Inspection Service (FSIS) and the Agricultural Marketing Service (AMS). FSIS has primary responsibility for the inspection of processed egg products to prevent the distribution into commerce of adulterated or misbranded egg products, while AMS conducts a surveillance program to ensure proper disposition of restricted shell eggs. Additionally, AMS provides grading and certification services on a voluntary basis. All shell eggs are eligible for these services, which are provided by the AMS Poultry Programs. The shell egg grading and certification services ensure that requirements are met for quality, weight, condition, and/or other factors. Finally, the USDA's Animal and Plant Health Inspection Service (APHIS) administers programs for animal health, including an SE control program for flocks that supply chicks to egg laying operations. FDA has primary responsibility for the parts of the continuum that involve the production and processing of shell eggs.
Are both farms subject to the Egg Safety Rule?
Yes, Wright County Egg in Iowa and Hillandale Farms of Iowa, Inc. are considered large egg producers with 50,000 or more laying hens. Therefore, they are subject to the rule that came into effect on July 9, 2010. The Egg Safety Rule requires preventive measures during the production of eggs in poultry houses and requires subsequent refrigeration during storage and transportation
Are both farms in compliance with the Egg Safety Rule?
As one part of the ongoing outbreak investigation, FDA investigators are on the farms examining their compliance with the Egg Safety Rule. But more importantly, the investigators are looking for the source of contamination in this outbreak. Our focus remains on the prevention of more illnesses due to the consumption of contaminated shell eggs.
Is this outbreak the first test of the Egg Safety Rule?
According to CDC, this outbreak started in May -- at least two months before the Egg Safety Rule took effect for large egg producers. Large egg producers are those with 50,000 or more laying hens. This outbreak underscores the need for egg standards on the farm and for all covered by the rule to be in full compliance with them.
If the Egg Safety Rule were instituted earlier, would it have prevented the massive egg recall that is now ongoing?
We believe the Egg Safety Rule, once it is fully implemented by all shell egg producers, will reduce these types of SE outbreaks and prevent thousands of illnesses. The Egg Safety Rule is currently in effect for large producers, those that have 50,000 or more laying hens. It takes full effect in July 2012, when smaller producers, those with 3000 or more but less than 50,000 laying hens, must be in compliance. However, FDA strongly encourages all egg producers to implement the measures in the Egg Safety Rule as soon as possible.
What is the FDA doing to help farms implement the Egg Safety Rule?
FDA is working with United Egg Producers and other organizations to educate producers and those who store and/or transport eggs about the new requirements. FDA will continue its outreach sessions with producers and others around the country this fall. In the meantime, the FDA continues to issue guidance to all shell egg producers on how to implement these regulations. Soon, the FDA will begin inspecting all large shell egg producers to make sure they are in compliance with the Egg Safety Rule.
If a consumer has eggs in his or her refrigerator that are not in a package, how does he or she know if the eggs are safe?
If consumers are unsure about the source of their shell eggs, they are urged not to eat them and to throw them away immediately or return them to the store. Pasteurized egg products and pasteurized in-shell eggs are not affected by this recall.
Are the recalled eggs incorporated into any processed products that consumers should be aware of, such as cookie dough or something else that is uncooked?
Many manufacturers use pasteurized egg products in ready-to-cook foods, such as raw cookie dough. FDA continues the traceback efforts to see if any smaller food operations may be using fresh eggs in ready-to-cook products. If we do find any, we will advise the public as necessary. But the FDA would like to remind all consumers against eating any raw cookie dough or any raw food products that may contain shell eggs that are supposed to be cooked or baked before eating because they could make you sick.