APHIS updates biotech regulatory petitions
The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced the Agency has sent several biotechnology regulatory actions to the Federal Register for publication in the near future.
Petitions for Nonregulated Status Available for Public Review Under Improved Regulatory Review Process
Under the Agency’s improved regulatory review process, APHIS now provides the public an earlier opportunity to provide input on petitions for nonregulated status submitted by developers of new genetically engineered (GE) plants. Once APHIS determines that petitions for nonregulated status submitted by developers are complete, the Agency makes them available for public review for 60 days. By reviewing the petitions and submitting comments during this time, 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 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)
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’ notices of availability in the Federal Register.
Actions Taken Under Prior Regulatory Review Process
As APHIS continues its transition to an improved regulatory process, the Agency will ensure a thorough regulatory review for those petitions for nonregulated status remaining under the Agency’s previous process. Under that process, APHIS is making the following petition for nonregulated status available for a 60-day public review and comment period, along with the Agency’s ensuing draft plant pest risk assessment and draft environmental analysis:
- Insect-resistant/herbicide-tolerant maize (Pioneer)
Following the comment period, the Agency will thoroughly review public comments and carefully consider input as it proceeds with finalizing the plant pest risk assessment and environmental assessment for the GE maize.
In addition, APHIS is making available its final plant pest risk assessment, final environmental analysis, and determination of nonregulated status for the following petition:
- Rootworm-resistant corn (Syngenta)
More information 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.
Extensions of Nonregulated Status
APHIS also posted to the Agency’s website today its decision to extend nonregulated status for the following product:
- Herbicide-tolerant cotton (Bayer)
In addition, the Agency is making available for a 30-day public review and comment period a
plant pest risk assessment, environmental assessment, and preliminary determination of nonregulated status for the following product:
- Herbicide-tolerant corn (Stine Seeds)
These two GE products are similar to products that have previously completed APHIS review. APHIS determined the two products are unlikely to pose a plant pest risk after completing the following: thorough evaluations of the extension requests for nonregulated status and review of plant pest risk assessments and environmental assessments.
For the latter product, provided that public comments do not raise additional issues that need to be addressed by APHIS, the Agency would publish a final determination of regulatory status in the Federal Register.
Further information on these products and APHIS’ determinations can be found at www.aphis.usda.gov/biotechnology/news.shtml. The public comment period will close 30 days after the date of publication of APHIS’ notice of availability in the Federal Register.
Other Regulatory Actions
APHIS is making available today a petition for nonregulated status, along with the Agency’s Notice of Intent to prepare an environmental impact statement, for the following product:
- Freeze-tolerant eucalyptus (ArborGen)
APHIS is making available the petition and the Notice of Intent to prepare an environmental impact statement for the GE eucalyptus tree for a 60 day public review and comment period. APHIS will hold a series of online virtual meetings to solicit public comment. Information on those meetings is available at http://www.aphisvirtualmeetings.com/. Following the comment period, the Agency will thoroughly review public comments and carefully consider input as it proceeds with developing an environmental impact statement for the GE eucalyptus.
Finally, APHIS is also seeking public comment on a proposed rule to amend the Agency’s regulations by adding provisions and safeguards for sharing certain confidential business information (CBI) with State and Tribal agencies. This proposal is intended to improve APHIS’ and its State and Tribal regulatory partners’ review of permits and notifications for regulated GE organisms, improve oversight of GE introductions, and strengthen APHIS’ compliance activities. CBI submitted by the developers of regulated GE organisms will be safeguarded from inappropriate public release. The proposal will be open for a 60 day public comment period following publication in the Federal Register. More information can be found at www.aphis.usda.gov/biotechnology/news.shtml.
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