[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6759-6761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2878]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2010-0047]
Monsanto Company and KWS SAAT AG; Decision With Respect to the
Petition for Partial Deregulation of Genetically Engineered Roundup
Ready Sugar Beets
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our decision to ``partially
deregulate'' Roundup Ready[supreg] sugar beets developed by the
Monsanto Company (Monsanto) and KWS SAAT AG (KWS), designated as event
H7-1, in response to a supplemental Monsanto/KWS petition requesting
partial deregulation of event H7-1. APHIS has determined that it will,
for an interim period of time, grant the petition in part. APHIS will
grant a partial deregulation for event H7-1 sugar beet root crop
production activities when conducted under certain mandatory
conditions. APHIS has decided not to grant partial deregulation for
event H7-1 sugar beet seed crop production. Rather, APHIS has decided
that event H7-1 sugar beet seed production shall remain regulated under
APHIS' regulations governing the introduction of certain genetically
engineered organisms. Our decision granting the petition in part on an
interim basis is based on our evaluation of data submitted by Monsanto
and KWS in its supplemental petition for a determination of ``partial
deregulation,'' our analysis of other scientific data, and comments
received from the public in response to our previous notice announcing
the availability of the environmental assessment (EA) associated with
the supplemental petition for partial deregulation. This notice also
announces the availability of our written decision, final EA, and
finding of no significant impact.
DATES: Effective Date: February 8, 2011.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received in our reading room. The reading room is located
in room 1141 of the USDA South Building, 14th Street and Independence
Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to
4:30 p.m., Monday through Friday, except holidays. To be sure someone
is there to help you, please call (202) 690-2817 before coming.
Documents referenced in this notice are also available on the
Internet at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2010-0047.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Mr. David Reinhold, Assistant
Director, Environmental Risk Analysis Programs, BRS, APHIS, 4700 River
Road Unit 146, Riverdale, MD 20737-1238; (301) 734-0660.
[[Page 6760]]
To enter into a compliance agreement to introduce event H7-1 sugar
beet root crop, contact APHIS' Regulatory Operations Programs at (301)
734-5301. To obtain copies of the documents referenced in this notice,
contact Ms. Cindy Eck at (301) 734-0667, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Background
The regulations in 7 CFR part 340, ``Introduction of Organisms and
Products Altered or Produced Through Genetic Engineering Which Are
Plant Pests or Which There Is Reason to Believe Are Plant Pests,''
regulate, among other things, the introduction (importation, interstate
movement, or release into the environment) of organisms and products
altered or produced through genetic engineering that are plant pests or
that there is reason to believe are plant pests. Such genetically
engineered organisms and products are considered ``regulated
articles.''
On November 4, 2010, the Animal and Plant Health Inspection Service
(APHIS) published a notice \1\ in the Federal Register (75 FR 67945-
67946, Docket No. APHIS-2010-0047) announcing the availability of an
environmental assessment for a supplemental petition from the Monsanto
Company (Monsanto) and KWS SAAT AG (KWS) requesting ``partial
deregulation'' or similar administrative action under 7 CFR part 340
(referred to below as the regulations) for sugar beets (Beta vulgaris
ssp. vulgaris) designated as event H7-1. These sugar beets have been
genetically engineered for tolerance to the herbicide glyphosate and
are considered regulated articles under the regulations in 7 CFR part
340. The supplemental petition seeks action by APHIS that would
authorize the continued cultivation of H7-1 sugar beets, subject to
carefully tailored interim measures.
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\1\ To review the notice and the supporting and related
material, go to http://www.regulations.gov;fdmspublic/component/
main?main=Docket Detail&d=APHIS-2010-0047.
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APHIS received 3,722 comments during the comment period. There were
3,058 comments from groups or individuals who supported the ``partial
deregulation'' and 633 from those who opposed the ``partial
deregulation.'' APHIS has addressed the issues raised during the
comment period and has provided responses to these comments as an
attachment to the finding of no significant impact.
The supplemental petition is related to a petition submitted by
Monsanto and KWS to APHIS on November 19, 2003, seeking a determination
of nonregulated status for event H7-1 sugar beets (Petition 03-323-01).
On October 19, 2004, APHIS published a notice in the Federal Register
(69 FR 61466-61467, Docket No. 04-075-1) announcing that the Monsanto/
KWS petition and an environmental assessment (EA) were available for
public review. On March 17, 2005, we published a notice in the Federal
Register (70 FR 13007-13008, Docket No. 04-075-2) advising the public
of our determination, effective March 4, 2005, that event H7-1 sugar
beets were fully deregulated and no longer considered a regulated
article under the regulations. On September 21, 2009, the U.S. District
Court for the Northern District of California issued a ruling in a
lawsuit challenging APHIS' decision to deregulate event H7-1 sugar
beets, finding that APHIS should have completed an environmental impact
statement (EIS) prior to granting full deregulation of H7-1 sugar
beets. Later, on August 13, 2010, the Court vacated APHIS' decision to
deregulate event H7-1 sugar beets until APHIS prepares a full EIS prior
to a further decision on the petition for full deregulation and
remanded the matter to APHIS. Accordingly, event H7-1 sugar beets once
again became a regulated article subject to APHIS' regulatory oversight
under 7 CFR part 340 and the Plant Protection Act.
National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with
Monsanto/KWS' petition for ``partial deregulation'' for event H7-1
sugar beets, an EA was prepared in accordance with: (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
The draft EA considered and evaluated a range of alternatives.
APHIS' preferred alternative is an interim partial deregulation--a
combination of alternatives 2 and 3. The preferred alternative
incorporates specific aspects of both alternatives 2 and 3. Under this
preferred alternative, pursuant to Sec. 340.6 of the regulations,
APHIS will partially deregulate the event H7-1 sugar beet root crop.
APHIS has determined that they will not be subject to requirements of 7
CFR part 340 if they are grown under the mandatory conditions
established by APHIS. Event H7-1 sugar beet root crop production
activities conducted under these mandatory conditions will not be
considered regulated under 7 CFR part 340. Event H7-1 sugar beet seed
crop will remain regulated subject to requirements of 7 CFR part 340,
requiring a permit or notification for movement and environmental
release.
Under the partial, conditional deregulation, APHIS will require
compliance with mandatory conditions for the root crop that will
restrict its movement and environmental release via APHIS compliance
agreements authorized under the Plant Protection Act. Any person who
wants to enter into a compliance agreement must first contact APHIS'
Regulatory Operations Programs by calling the phone number listed under
FOR FURTHER INFORMATION CONTACT to enter into a compliance agreement in
advance of the introduction.
This preferred alternative, including a conditional, partial
deregulation, is an interim action that is limited in scope and
duration and will neither result in significant impacts to the human
environment nor prejudice any decision to be analyzed in the
forthcoming EIS for a determination regarding full deregulation of
event H7-1 sugar beets. APHIS has determined that the mandatory
conditions imposed pursuant to the partial deregulation of event H7-1
sugar beet root crop, as well as permitting of the seed crop under 7
CFR part 340, ensures that the implementation of this interim
regulatory action will not result in any environmental impacts which
may significantly affect the quality of the human environment. The
mandatory conditions will also effectively ensure that no potentially
harmful economic or marketing impacts will occur in the interim while
APHIS completes its EIS prior to making a determination on whether or
not to grant full nonregulated status to event H7-1 sugar beets.
Determination
Based on APHIS' analysis of data submitted by Monsanto and KWS,
references provided in the petition, information analyzed in the plant
pest risk assessment and the EA, comments provided by the public, and
information provided in APHIS' response to those public comments, APHIS
has determined that event H7-1 sugar beet root crop grown under
mandatory conditions is unlikely to pose a plant
[[Page 6761]]
pest risk and should not be subject to the requirements of 7 CFR part
340. APHIS has reached this determination based on its plant pest risk
assessment. APHIS has determined that event H7-1 sugar beet root crop
production does not pose a plant pest risk and should not be subject to
the requirements of our regulations in 7 CFR part 340 if grown under
the mandatory conditions established by APHIS. Further, APHIS has
concluded that granting partial deregulation of the H7-1 sugar beet
root crop under certain conditions and allowing the seed crop to be
planted under the requirements of 7 CFR part 340 will have no
significant environmental effect on the human environment.
This granting of a partial deregulation for root crop production is
an interim partial deregulation for the root crop with required
conditions until an EIS is completed regarding the Monsanto/KWS
petition for a full deregulation of event H7-1. APHIS expects to
complete the EIS by May 2012, but unforeseen conditions may affect the
specific completion date of the EIS. This interim partial deregulation
of event H7-1 root crop and root production activities, along with the
interim permitting of event H7-1 seed crop under 7 CFR part 340, will
remain in effect through December 31, 2012, to allow the harvesting and
processing of the 2012 commercial root crop and seed crop unless APHIS
issues a final EIS, record of decision, and a determination decision
for a full deregulation of event H7-1 sugar beets before those harvests
are completed in 2012.
Copies of the signed determination document, as well as copies of
the petition, pest risk assessment, EA, finding of no significant
impact, and response to comments are available as indicated in the
ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 4th day of February 2011.
Cindy J. Smith,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-2878 Filed 2-7-11; 8:45 am]
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