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.
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