USDA Proposes Biotech Rule Changes

Comments are being sought on new regulations.

Tuesday the USDA's Animal and Plant Health Inspection Service proposed to revise existing regulations regarding the importation, interstate movement and environmental release of certain genetically engineered (GE) organisms under the Plant Protection Act (PPA) of 2000. These proposed revisions to the regulations are in response to emerging trends in biotechnology. New regulations will address the current and future needs of the agency and provide a high level of environmental protection.

"This is the most comprehensive review and revision of our biotechnology regulations since they were first developed in 1987," said Cindy Smith, administrator of APHIS. "Revising these regulations now will allow us to ensure effective oversight for years to come."

The proposed changes will also improve regulatory processes so they are more transparent to stakeholders and the public, make more efficient use of agency resources and eliminate unnecessary regulatory burdens. The proposed rule also addresses several provisions from the 2008 Farm Bill regarding the improvement of the management and oversight of GE organisms regulated under the PPA of 2000. This proposal does not cover vertebrate animals. Under the proposed rule, certain GE organisms would be subject to the regulations if they could pose a plant pest or noxious weed risk, or their plant pest or noxious weed risk is unknown.

The proposed rule is available on the APHIS Web site at Notice of this proposed rule is scheduled for publication in the Oct. 9 Federal Register. APHIS is seeking public comment on the proposed rule. APHIS will consider all public comments submitted during the comment period before any regulatory changes are put in place. Because the public is a key partner in the rulemaking process, APHIS is scheduling three public meetings that will take place in California on Oct. 28, in Missouri on Oct. 30 and the Washington, D.C., area on Nov. 13, to allow interested parties to express their views in person. Consideration will be given to comments received on or before Nov. 24.


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