Washington, DC
October 6, 2008
The U.S. Department of
Agriculture's Animal and
Plant Health Inspection Service (APHIS) proposes 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.
Proposed changes include aligning the regulations with the plant
pest and noxious weed provisions of the PPA of 2000. 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.
APHIS proposes to discontinue the notification procedure but
retain the permitting procedure for authorizing the importation,
interstate movement or environment release of those GE organisms
that fall within the scope of the regulations. The proposed
permitting system could be adapted to address a wide variety of
different species and genetic modifications.
The proposed regulations would improve and clarify the petition
procedure to approve nonregulated status, whereby a GE organism
is no longer subject to APHIS’ biotechnology regulations. All
previous determinations of nonregulated status made under the
current regulations would continue to have nonregulated status
under the revisions being proposed.
The proposed regulations would also establish a new petition
procedure for APHIS to approve new conditional exemptions from
the requirement to obtain a permit, which is currently done by
amending the regulations. The proposed procedure would be more
efficient, yet still allow for public comment.
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. Meeting dates and locations
will be published in the same Federal Register notice announcing
the proposed rule.
APHIS’ broad biotechnology regulatory authority falls under the
scope of the PPA of 2000, which combined and modernized the
authorities under which APHIS regulates certain GE organisms,
including the Federal Plant Pest Act, the Plant Quarantine Act
and the Noxious Weed Act.
The proposed rule is available on the APHIS Web site at
http://www.aphis.usda.gov.
Notice of this proposed rule is scheduled for publication in the
Oct. 9 Federal Register. Consideration will be given to comments
received on or before Nov. 24. Send two copies of postal or
commercial delivery comments to Docket No. APHIS-2008-0023,
Regulatory Analysis and Development, PPD, APHIS, Station
3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.
Comments can be submitted on the Federal eRulemaking portal at
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0023.
Click on “Add Comments,” to view public comments and related
materials available electronically.
Comments received are posted on the Regulations.gov Web site and
also can be viewed at USDA, Room 1141, South Building, 14th St.
and Independence Ave., S.W., Washington, D.C., between 8 a.m.
and 4:30 p.m., Monday through Friday, excluding holidays. To
facilitate entry into the comment reading room, please call
(202) 690-2817. |
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