Monsanto Company; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance
| Published date | 16 October 2020 |
| Citation | 85 FR 65789 |
| Record Number | 2020-22917 |
| Section | Notices |
| Court | Animal And Plant Health Inspection Service |
Federal Register, Volume 85 Issue 201 (Friday, October 16, 2020)
[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65789-65790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22917]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2019-0050]
Monsanto Company; Availability of a Draft Plant Pest Risk
Assessment and Draft Environmental Assessment for Determination of
Nonregulated Status of Cotton Genetically Engineered for Insect
Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared a draft plant pest risk assessment and
draft environmental assessment regarding a request from Monsanto
Company seeking a determination of nonregulated status for cotton
designated as MON 88702, which has been genetically engineered for
resistance to certain insects, primarily Lygus spp. We are making these
documents available for public review and comment.
DATES: We will consider all comments that we receive on or before
November 16, 2020.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2019-0050, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
The draft environmental assessment, draft plant pest risk
assessment, and any comments we receive on this docket may be viewed at
http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050 or in our
reading room, which is located in Room 1620 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)
7997039 before coming.
Supporting documents for this petition are also available on the
APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.
FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; (301) 851-3892, email: [email protected].
SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), 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 (GE)
organisms and products are considered ``regulated articles.''
Pursuant to the terms set forth in a final rule published in the
Federal Register on May 17, 2020 (85 FR 29790-29838, Docket No. APHIS-
2018-0034),\1\ any person may submit a petition to the Animal and Plant
Health Inspection Service (APHIS) seeking a determination that an
article should not be regulated under 7 CFR part 340. APHIS received a
petition (APHIS Petition Number 19-091-01p) from Monsanto Company
(Monsanto) seeking a determination of nonregulated status of a cotton
event designated as MON 88702, which has been genetically engineered
for resistance to certain insects, primarily Lygus spp. The Monsanto
petition stated that this cotton is unlikely to pose a plant pest risk
and, therefore, should not be a regulated article under APHIS'
regulations in 7 CFR part 340.
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\1\ To view the final rule, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
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According to our process \2\ for soliciting public comment when
considering petitions for determination of nonregulated status of GE
organisms, APHIS accepts written comments regarding a petition once
APHIS deems it complete. On Sep 26, 2019, APHIS announced in the
Federal Register \3\ (84 FR 50818-50819, Docket No. APHIS-2019-0050)
the availability of the Monsanto petition for public comment. APHIS
solicited comments on the petition for 60 days ending November 25,
2019, in order to help identify potential environmental and
interrelated economic issues and impacts that APHIS may determine
should be considered in our evaluation of the petition.
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\2\ On March 6, 2012, APHIS published in the Federal Register
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing
our public review process for soliciting public comments and
information when considering petitions for determinations of
nonregulated status for GE organisms. To view the notice, go to
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
\3\ To view the notice, its supporting documents, or the
comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
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Thirty-five comments were received during the comment period.
Fifteen comments from the agricultural, academic, and private sector
were in support of Monsanto's petition. Fourteen comments from
individuals were opposed to approval of Monsanto's petition. Six
comments provided input on analyses to be considered in the
environmental assessment (EA), or comments on insect-resistant crops in
general. Issues raised during the comment period include evaluation of
potential ecological and economic impacts, and potential impacts on
non-target organisms. APHIS has evaluated the issues raised during the
comment period and, where appropriate, has provided a discussion of
these issues in our EA.
After public comments are received on a completed petition, APHIS
evaluates those comments and then provides a second opportunity for
public involvement in our decisionmaking process. According to our
public review process (see footnote 2), the second opportunity for
public involvement follows one of two approaches, as described below.
[[Page 65790]]
If APHIS decides, based on its review of the petition and its
evaluation and analysis of comments received during the 60-day public
comment period on the petition, that the petition involves a GE
organism that raises no substantive new issues, APHIS will follow
Approach 1 for public involvement. Under Approach 1, APHIS announces in
the Federal Register the availability of APHIS' preliminary regulatory
determination along with its draft EA, preliminary finding of no
significant impact (FONSI), and its draft plant pest risk assessment
(PPRA) for a 30-day public review period. APHIS will evaluate any
information received related to the petition and its supporting
documents during the 30-day public review period.
For this petition, we are following approach 2. Under this
approach, if APHIS decides, based on its review of the petition and its
evaluation and analysis of comments received during the 60-day public
comment period on the petition, that the petition involves a GE
organism that raises substantive new issues, APHIS first solicits
written comments from the public on a draft EA and draft PPRA for a 30-
day comment period through the publication of a Federal Register
notice. Then, after reviewing and evaluating the comments on the draft
EA and draft PPRA and other information, APHIS will revise the draft
PPRA as necessary. It will then prepare a final EA, and based on the
final EA, a National Environmental Policy Act (NEPA) decision document
(either a FONSI or a notice of intent to prepare an environmental
impact statement).
As part of our decisionmaking process regarding a GE organism's
regulatory status, APHIS prepares a PPRA to assess the plant pest risk
of the article. APHIS also prepares the appropriate environmental
documentation--either an EA or an environmental impact statement--in
accordance with NEPA. This will provide the Agency and the public with
a review and analysis of any potential environmental impacts that may
result if the petition request is approved.
APHIS concludes in its draft PPRA that MON 88702 cotton, which as
stated above has been genetically engineered for resistance to certain
insects, primarily Lygus spp., is unlikely to pose a plant pest risk.
In section 403 of the Plant Protection Act, ``plant pest'' is defined
as any living stage of any of the following that can directly or
indirectly injure, cause damage to, or cause disease in any plant or
plant product: A protozoan, a nonhuman animal, a parasitic plant, a
bacterium, a fungus, a virus or viroid, an infectious agent or other
pathogen, or any article similar to or allied with any of the
foregoing.
APHIS has also prepared a draft EA in which we present two
alternatives based on our analysis of data Monsanto submitted, a review
of other scientific data, field tests conducted under APHIS' oversight,
and comments received on the petition (see footnote 3). APHIS is
considering the following alternatives: (1) Take no action, i.e., APHIS
would not change the regulatory status of MON 88702 cotton, or (2) make
a determination of nonregulated status for insect-protected MON 88702
cotton.
The draft EA was prepared in accordance with (1) 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).
Based on APHIS' analysis of field and laboratory data submitted by
Monsanto, references provided in the petition, peer-reviewed
publications, information analyzed in the draft EA, the draft PPRA,
comments provided by the public on the petition, and discussion of
issues in the draft EA, APHIS has determined that cotton designated as
event MON 88702 is unlikely to pose a plant pest risk.
We are making available for a 30-day review period our draft PPRA
and draft EA. The draft EA and draft PPRA are available as indicated
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of
these documents may also be obtained from the person listed under FOR
FURTHER INFORMATION CONTACT.
After the 30-day review period closes, APHIS will review and
evaluate any information received during the 30-day review period.
APHIS will revise the draft PPRA as necessary and prepare a final EA
and, based on the final EA, a NEPA decision document (either a FONSI or
a notice of intent to prepare an environmental impact statement).
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 9th day of October 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-22917 Filed 10-15-20; 8:45 am]
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