From USDA: The U.S. Department of Agriculture’s (USDA)
Animal and Plant Health Inspection Service (APHIS) is announcing proposed
revisions to its biotechnology regulations in a notice that will publish in
the Federal Register on January
19, 2017. The proposed rule updates the regulations in a number of
areas, all within the Agency’s current statutory authority under the Plant
Protection Act passed into law in 2000. The proposed rule is based on the best
available science, will better enable APHIS to focus its resources on
regulating genetically engineered (GE) organisms that may pose plant pest or
noxious weed risks, and will enhance regulatory flexibilities that stimulate
innovation and competitiveness.
In developing the proposed rule, APHIS carefully
considered comments received during public scoping and comment periods related
to withdrawal of a 2008 proposed rule, as well as comments relative to a March 2016
notice of intent to conduct a programmatic environmental impact statement,
recommendations made in two Office of the Inspector General audits, recent
advances in biotechnology, provisions in the 2008 Farm Bill, and the Agency’s
accumulated experience in implementing the current regulations. This would be
the first comprehensive revision of the regulations since they were established
in 1987.
APHIS is proposing a regulatory program in which it first
assesses GE organisms to determine if they pose plant pest or noxious weed
risks. If APHIS concludes that a GE organism does not pose a plant pest or
noxious weed risk, then APHIS would not require a permit for the importation,
interstate movement, and environmental release (outdoor use) of the GE
organism. On the other hand, if APHIS determines, based on risk analysis that
controls on movement are needed, APHIS will work with the requestor to
establish appropriate permit conditions to manage identified risks to allow
safe movement. "Movement" means import, interstate movement, or
environmental release (regulated controlled outdoor use such as in field
trials).
GE plants that are not engineered with plant pest
sequences do not fall under USDA's current regulations even though they may
pose noxious weed risks. USDA is proposing to implement the noxious weed
authority to close this gap.
The goals for the proposed revisions are to ensure a high
level of plant health protection based on the best available science; improve
regulatory processes so that they are more transparent, efficient, and
predictable for stakeholders and the public; and provide regulatory relief that
will stimulate innovation and competitiveness.
APHIS’ proposed rule will be available for public review
and comments will be accepted for 120 days beginning January 19, 2017, through May
19, 2017. After the public comment period closes, APHIS will decide how
or whether to finalize the regulations based on our evaluation of public
comments to the proposed revisions. Additionally, a draft programmatic Environmental
Impact Statement (EIS) will be made available and published for
public comment soon, for stakeholder input. USDA also intends to have public
meetings on the proposed rule during the comment period.