The Animal and Plant Health Inspection Service (APHIS) is making available for public comment a draft plant pest risk assessment (PPRA) and a draft environmental assessment (EA) for the new plant variety HB4 soybean designated as event IND-00410-5, which has been genetically engineered for increased yield and resistance to the herbicide glufosinate. APHIS is making the draft PPRA and draft EA available for public review and comment.
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 17-223-01p) from Verdeca LLC (Verdeca), seeking a determination of nonregulated status for the new plant variety called HB4 soybean (Glycine max) designated as event IND-00410-5 (also OECD unique identifier IND-00410-5), which has been genetically engineered for increased yield. The Verdeca petition states that information collected during field trials and laboratory analyses indicates that HB4 soybean is not likely to be a plant pest and therefore should not be a regulated article under APHIS' regulations in 7 CFR part 340.