On November 7, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service withdrew the proposed rule to revise the agency’s biotechnology regulations that had been announced in January.
The information and documents below relate to that proposed rule, now withdrawn. We continue to make this information available to all stakeholders for reference purposes.
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is proposing to revise our regulations at 7 CFR part 340 regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and our accumulated experience in implementing the current regulations, as well as reduce the burden on regulated entities. This is the first comprehensive revision of the regulations since they were established in 1987. The proposed rule was open for a 150-day comment period from January 19, 2017 until June 19, 2017 on Regulations.gov, where over 200 submissions were received. In addition, APHIS held three public meetings during the open comment period.View Information and Transcripts from the Public Meetings
In concert with the proposed revised regulations ((now withdrawn), APHIS was developing a process that includes an evidenced-based, standardized approach to assessing risk prior to making the decision whether to require controls (e.g. movement permits). This upfront risk analysis process includes either (in most cases):
A Weed Risk Assessment (WRA) to characterize weed risk, if any, of genetically engineered (GE) plants,
A Plant Pest Risk Assessment (PPRA) for invertebrates, microorganisms, and GE plants (where appropriate), to characterize plant pest risk, if any.
As described in the proposed rule, APHIS proposed to maintain specific information regarding the regulation on a website.
On January 23, 2017, APHIS published a draft Programmatic Environmental Impact Statement (dPEIS) in compliance with the National Environmental Policy Act, for a 120-day public comment period in the Federal Register. APHIS prepared the EIS to evaluate the range of alternatives for the proposed revisions to 7 CFR part 340.View the Notice of Intent to Prepare an EIS