Written by Katharine Richter
On October 7, 2015, Animal and Plant Health Inspection Service (APHIS) issued a notice of the environmental assessment (EA) of Avian Influenza H5 vaccines has been prepared. The notice stated that “based on the environmental assessment . . . use of vaccines . . . will have no significant impact on the human environment.”
The notice states that “under the Virus-Serum-Toxin Act (21 U.S.C. 151 et. seq.), APHIS is authorized to promulgate regulations designed to ensure that veterinary biological products are pure, safe, potent, and efficacious.” The notice highlights the December 2014 outbreak of highly pathogenic avian influenza (HPAI) and the devastating affects it had on the poultry industry. The hardest hit sectors of the poultry industry was commercial meat turkeys and laying hens, with the total loss of “over 48 million birds between December 2014 and June 2015.”
APHIS states that after the comment period closes, if the comments raise issues not previously considered, APHIS will issue a supplement to the EA. Given that timeliness is so crucial with the cold weather setting back in, APHIS is aiming to authorize shipment and field use of the vaccine as quickly as possible, potentially before the close of the comment period.
The public comment period regarding the environmental assessment will be open until November 6, 2015.