WASHINGTON, Feb. 22, 2013— U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) today announced several biotechnology regulatory actions sent to the Federal Register for publication. According to APHIS, the agency 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)

These products are reviewed under USDA’s new regulatory process, which includes two opportunities for public comment and is meant to accelerate approval timelines. More information on each of these products can be found at www.aphis.usda.gov/biotechnology/news.shtml

APHIS also announced it is making Pioneer’s insect-resistant and herbicide-tolerant maize available for a 60-day comment period under the previous approval process. Syngenta’s rootworm-resistant corn is available for its final plant pest risk assessment, final environmental analysis, and determination of nonregulated status.

In November of 2011, APHIS announced it would begin improving the overall timeline for biotechnology approvals by standardizing and streamlining its process. The agency is also asking for public input on pending petitions earlier in the review process. Under the updated program, APHIS intends to decide whether a petition is complete, which is the first step of the decision-making process, within three months of receiving the petition.

For complete petitions, APHIS will make it available for public comment before preparing an Environmental Assessment (EA) and Plant Pest Risk Assessment (PPRA). This means APHIS will publish two separate notices in the Federal Register—a notice announcing the availability of the petition, with an opportunity for public comment, followed by a notice announcing the availability of the EA and PPRA and another period of public comment.  

According to data presented by APHIS’s Biotechnology Regulatory Services (BRS) in December, the improved process should provide a decision on regulatory status within 12-15 months, which is half the average time needed under the previous process. At that time, the BRS presentation from December 2012 indicated USDA’s APHIS had 23 pending petitions.

APHIS’s analysis of its deregulation decisions indicate that from 1992 to 1999 the average time took 178 days, but the timeline more recently increased to two to five years or longer.



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