APHIS Deregulates Genetically Engineered Monsanto Corn

Written by Katharine Richter

On October 27, 2015, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the federal register of its decision to deregulate a genetically engineered corn created by Monsanto Company.  The corn is engineered to protect against rootworm and for resistance to the herbicide glyphosate. 

Under 7 CFR part 340, APHIS is authorized to regulate genetically modified products that are plant pests or there is reason to believe they may be plant pests and are considered “regulated articles.”  Significantly, 7 CFR § 340.6(a), allows for the submission of a petition to APHIS which can have the product removed from regulated status. 

Accordingly, Monsanto sent in a petition for the deregulation of corn variety they designated as MON 87411.  Based on Monsanto field studies and laboratory analyses, Monsanto concluded MON 87411 should not be considered a plant pest under § 340.  APHIS conducted a plant pest risk assessment (PPRA) and environmental assessment (EA), and based upon its findings concluded the new corn strain was unlikely “to pose a plant pest risk to agriculture and other plants in the United States,” and “deregulation is not likely to have a significant impact on the human environment."

APHIS Environmental Assessment of HPAI Vaccine Finds No Impact

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.