AG-RELATED REGULATORY APPROVALS BACKGROUNDER

ASA Position

Biotech Trait Approvals – ASA supports increasing funding for the Biotechnology Regulatory Service at APHIS/USDA by $6.0 million to accelerated approvals of pending applications for new biotech traits.

Pesticide Approvals – ASA supports maintaining science-based processes for approval of pesticide products by EPA.

Background

Biotech Trait Approvals

ASA has long supported deregulation of new agricultural biotechnology traits by APHIS and EPA when they are determined to be safe for both human and animal consumption and for the environment through evaluations based on sound science, as established under the National Environmental Protection Act (NEPA).  In the 1990’s, these evaluations took an average of less than 200 days from the time of application to approval.  In recent years, evaluations have taken an average of more than 1,000 days.  There are currently 18 applications pending at APHIS.

Reasons for the growing delays in deregulation include documentation requirements under NEPA and limited funding for staff and foreign registration support at APHIS’s Biotechnology Regulatory Service (BRS).  ASA and other agriculture-based organizations support increasing annual funding at BRS by $6.0 million, including $4.0 million to accelerate application reviews and $2.0 million for foreign support activities.

The lawsuit filed in 2006 by the Center for Food Safety and Geertson Farms, Inc., challenging the BRS/APHIS deregulation of Monsanto’s Roundup Ready alfalfa in 2005, has added to the uncertainties and delays in the approval process.  The District Court for Northern California found in favor of the complainants, and directed APHIS to carry out a full Environmental Impact Statement (EIS) rather than the shorter Environmental Assessment (EA) they had conducted.  In the interim, the Court halted further sale and planting of RR alfalfa.  In 2008, the Ninth Circuit Court of Appeals upheld the District Court’s decision.  On June 21, 2010, the Supreme Court ruled 7-1 in favor of Monsanto, stating in its opinion that the District Court had abused its discretion.  APHIS must still complete the EIS, but can decide to partially deregulate RR alfalfa, allowing it to be planted before the EIS is finished.

This ruling has had the positive effect of returning the decision on how applications for new biotech traits will be handled to APHIS, rather than the courts.  While this removes uncertainties caused by the case, delays in biotech approvals will remain until additional funding can be found to augment BRS staff and foreign support activities.

Pesticide Approvals   

Soybean farmers are concerned about recent events at EPA, where the agency is conducting a “special review” of atrazine, outside the established review and approval process.  ASA supports maintaining science-based processes for approval of pesticide products by EPA.