APHIS announces availability of biotech regulatory petitions
The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced the Agency has sent several biotechnology regulatory actions to the Federal Register for publication in the near future.
Petitions for Nonregulated Status Available for Public Review Under Improved Regulatory Review Process
Under the Agency’s improved regulatory review process, APHIS now provides the public an earlier opportunity to provide input on petitions for nonregulated status submitted by developers of new genetically engineered (GE) plants. Once APHIS determines that petitions for nonregulated status submitted by developers are complete, the Agency makes them available for public review for 60 days. By reviewing the petitions and submitting comments during this time, the public can help APHIS identify any potential environmental and interrelated economic issues and impacts for its subsequent evaluation of the petitions. The public will then have another opportunity to review and comment on APHIS’ draft plant pest risk assessments and draft environmental assessments before APHIS prepares its final assessments and regulatory determinations.
APHIS is making the petitions for nonregulated status for each of the following GE plants available for 60 days of public review and comment:
- Insect-resistant/herbicide-tolerant soy (Dow)
- Herbicide-tolerant soy (Syngenta)
- Herbicide-tolerant cotton (Monsanto)
More information on each of these products can be found at www.aphis.usda.gov/biotechnology/news.shtml; the public comment period will close 60 days after the date of publication of APHIS’ notices of availability in the Federal Register.
Actions Taken Under Prior Regulatory Review Process
As APHIS continues its transition to an improved regulatory process, the Agency will ensure a thorough regulatory review for those petitions for nonregulated status remaining under the Agency’s previous process. Under that process, APHIS is making the following petition for nonregulated status available for a 60-day public review and comment period, along with the Agency’s ensuing draft plant pest risk assessment and draft environmental analysis:
- Insect-resistant/herbicide-tolerant maize (Pioneer)
Following the comment period, the Agency will thoroughly review public comments and carefully consider input as it proceeds with finalizing the plant pest risk assessment and environmental assessment for the GE maize.