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FACT from FICTION on Pilot Project to Enhance Quality, Timeliness and Cost-Effectiveness of Environmental Analyses and Documents Related to Biotechnology

Posted by Michael Gregoire, APHIS Deputy Administrator, Biotechnology Regulatory Services (BRS) in Animals Plants Research and Science
Apr 29, 2011

We have seen several stories and concerned comments circulating on blogs regarding USDA’s pilot project to examine ways to enhance quality, timeliness and cost effectiveness of environmental analyses and documents related to biotechnology. We want to separate fact from fiction and ensure that the public knows exactly what this pilot program will do and what it will not do.

The pilot program will test an approach where USDA’s Animal and Plant Health Inspection Service (APHIS) will work closely with petitioners and outside experts while maintaining responsibility for scope and content of its environmental analyses. The pilot program will not allow biotechnology firms to conduct their own environmental assessments (EA) or environmental impact statements (EIS).

Participating firms will have two options in this voluntary pilot program: 1) develop an “environmental report” that will serve as the base information for APHIS’ environmental analysis or impact statement; or 2) through a cooperative services agreement with APHIS, provide funding for APHIS to enter into a contract with an Agency-approved third-party to develop the environmental analysis or impact statement. Regardless of the approach taken, APHIS will fully evaluate and revise any and all environmental analyses developed under the pilot project. APHIS will maintain responsibility for the scope and content of the environmental analyses, which will continue to be made available for public review and comment as they are now.

Under the first option, the “environmental report” cited is not an environmental assessment (EA) nor is it an environmental impact statement (EIS). Under the first option of the pilot program, the petitioners have the option to submit supplemental environmental information, called an “environmental report,” to augment the required petition information.

Under the second option, the petitioner will not be in contact with the third party contractor.  Only APHIS will.

Not only is the pilot program approach consistent with the White House Council on Environmental Quality’s National Environmental Policy Act’s (NEPA) implementing regulations, this approach is widely used throughout the Federal government.

For more information, go straight to the source:!documentDetail;D=APHIS-2010-0117-0001