Why didn’t FDA require a vaccine for hens in the Egg Rule?
There are several commercially available vaccines for 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 commenters 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
