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Agency Provides Additional Opportunity for Public Review and Comment as Part of Strong, Consistent Regulatory Review Process

R. Andre Bell (301) 851-4059
Lyndsay Cole (970) 494-7410

Agency Provides Additional Opportunity for Public Review and Comment as Part of Strong, Consistent Regulatory Review Process

WASHINGTON, July 6, 2012--The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is making available on the Agency's Web site today, for public review and comment, nine petitions for nonregulated status for genetically-engineered (GE) plants. Under an improved regulatory process announced by APHIS in November 2011, the Agency is providing the opportunity for earlier input from the public on these petitions for deregulation. The Agency is also committing to working closely with the U.S. Environmental Protection Agency to coordinate its review of GE products engineered for tolerance to multiple herbicides [ link to USDA statement]. USDA and EPA will work together to ensure that the best available information is used as part of the reviews, carefully considering the potential human health, plant health, environmental, and other relevant impacts, and that each Agency reaches conclusions that are consistent with and fulfill their responsibilities and statutory mandates. APHIS is also making available on its Web site three other petitions for nonregulated status and the Agency's draft scientific evaluations, in addition to two final regulatory decisions.

As described below, APHIS is opening sixty (60) day public comment periods on the twelve (12) petitions for nonregulated status and draft evaluations and will closely consider all comments on relevant impacts including the proposed nature and extent of environmental reviews. APHIS will publish notice of these actions in an upcoming issue of the Federal Register and the public comment period will close 60 days following the date of publication in the Federal Register.

Petitions for Nonregulated Status Available Under Improved Regulatory Review Process

Under the improved review process, APHIS is giving the public an additional and earlier opportunity to provide input on petitions for nonregulated status. The new process also improves the overall timeline by standardizing and streamlining process steps, while maintaining the integrity of the program.

Previously, APHIS made developers' petitions for nonregulated status available at the same time the Agency published its draft plant pest risk assessments and draft environmental assessments for new GE products. Under the improved review process, at the outset, 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 taking the first step of the improved regulatory review process and is making the petitions for nonregulated status for each of the following GE plants available for 60 days of public review and comment:

  • Glyphosate Tolerant Canola (Pioneer)
  • Low-Browning Apple (Okanagan Specialty Fruits)
  • Imidazolinone Tolerant Soybean (BASF)
  • Glyphosate Tolerant Canola (Monsanto)
  • High-Yield Soybean (Monsanto)
  • Hybridization System Corn (Monsanto)
  • 2,4-D, Glyphosate, and Glufosinate Tolerant Soybean (Dow)
  • Glyphosate Tolerant Corn (Genective)
  • Dicamba Tolerant Soybean (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' notice of availability in the Federal Register.

Actions Taken Under Prior Regulatory Review Process

As APHIS finalizes its transition to the improved process, the Agency will continue to complete a thorough regulatory review for several petitions for nonregulated status under the previous review process. Accordingly, APHIS' risk assessments for the following GE products indicate that the products are unlikely to pose a plant pest risk to agricultural crops or other plants or plant products:

  • 2,4-D and Glufosinate Tolerant Soybean (Dow)
  • Glyphosate and Isoxaflutole Tolerant Soybean (Bayer)
  • Rootworm-Resistant Corn (Syngenta)

APHIS is making the petitions for nonregulated status, as well as the Agency's plant pest risk assessments and draft environmental assessments for the products available for a 60 day public review and comment period. Following the comment period, the Agency will thoroughly review public comments and carefully consider input as it prepares its final plant pest risk assessments, environmental assessments, and regulatory determinations in response to the petitions for nonregulated status for each of these products. 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' notice of availability in the Federal Register.

Determinations of Nonregulated Status

APHIS also announced today determinations of nonregulated status for two GE plants that have completed review under the previous review process. APHIS determined the two products are unlikely to pose a plant pest risk after completing the following: thorough evaluations of the petitions for nonregulated status; preparation of plant pest risk assessments and environmental assessments; and careful review of all public review received on the petitions for nonregulated status and the draft assessments.

The following products will no longer be subject to APHIS regulation; the agency will publish its determination of nonregulated status of these events in an upcoming edition of the Federal Register.

  • Modified Oil Soybean (Monsanto)
  • Glufosinate Tolerant, Bollworm Resistant Cotton (Bayer)

Further information on these products and APHIS' determinations can be found at www.aphis.usda.gov/biotechnology/news.shtml.

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