[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Notices]
[Pages 9077-9078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04537]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2017-0075]
Verdeca LLC; Availability of a Draft Plant Pest Risk Assessment
and a Draft Environmental Assessment for Determination of Nonregulated
Status of Soybean Genetically Engineered for Yield Increase and
Resistance to Glufosinate
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 is making available for public comment a draft plant
pest risk assessment (PPRA) and a draft environmental assessment (EA)
for the new plant variety HB4 soybean designated as event IND-00410-5,
which has been genetically engineered for increased yield and
resistance to the herbicide glufosinate. We are making the draft PPRA
and draft EA available for public review and comment.
DATES: We will consider all comments that we receive on or before April
12, 2019.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0075.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2017-0075, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-
0075 or in our reading room, which 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) 799-7039 before coming.
The petition is also available on the APHIS website at: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under
APHIS petition 17-223-01p.
FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Chief, Plants
Branch, Environmental Risk Analysis Programs, Biotechnology Regulatory
Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236;
(301) 851-3901; email: [email protected]. To obtain copies of the
petition, contact Ms. Cindy Eck at (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.''
The regulations in Sec. 340.6(a) provide that 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
17-223-01p) from Verdeca LLC (Verdeca), seeking a determination of
nonregulated status for the new plant variety called HB4 soybean
(Glycine max) designated as event IND-00410-5 (also OECD unique
identifier IND-00410-5), which has been genetically engineered for
increased yield. The Verdeca petition states that information collected
during field trials and laboratory analyses indicates that HB4 soybean
is not likely to be a plant pest and therefore should not be a
regulated article under APHIS' regulations in 7 CFR part 340.
According to our process \1\ for soliciting public comment when
considering petitions for determinations of nonregulated status of GE
organisms, APHIS accepts written comments regarding a petition once
APHIS deems it complete. In a notice \2\ published in the Federal
Register on November 15, 2017 (82 FR 52873-52874, Docket No. APHIS-
2017-0075), APHIS announced the availability of the Verdeca petition
for public comment. APHIS solicited comments on the petition for 60
days ending on January 16, 2018, 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.
APHIS received five comments on the petition (a sixth comment
addressing an entirely different topic was erroneously submitted). Of
the five comments, four were opposed to the deregulation and one
comment was in support. In May 2018, Verdeca provided supplemental
information to APHIS informing us that its HB4 soybean variety also had
field-level resistance to the herbicide glufosinate. APHIS reviewed the
supplemental information and has included it in its analyses in the
draft plant pest risk assessment (PPRA) and draft environmental
assessment (EA). We are making the supplemental
[[Page 9078]]
information available along with the draft PPRA and draft EA for public
comment.
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\1\ 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.
\2\ To view the notice, the petition, and the comments we
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2017-0075.
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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 1), the second opportunity for
public involvement follows one of two approaches, as described below.
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 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.
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 will follow Approach
2. Under Approach 2, APHIS first solicits written comments from the
public on a draft PPRA and draft EA for a 30-day comment period through
the publication of a Federal Register notice. Then, after reviewing and
evaluating the comments on the draft PPRA and draft EA and other
information, APHIS will revise the PPRA as necessary and 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). For this petition, we are
using Approach 2.
APHIS has prepared a draft PPRA and has concluded that HB4 soybean
designated as event IND-00410-5, which has been genetically engineered
for increased yield and resistance to the herbicide glufosinate, 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 submitted by Verdeca, a
review of other scientific data, field tests conducted under APHIS
oversight, and comments received on the petition. APHIS is considering
the following alternatives: (1) Take no action, i.e., APHIS would not
change the regulatory status of HB4 soybean designated as event IND-
00410-5, or (2) make a determination of nonregulated status of HB4
soybean designated as event IND-00410-5.
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) U.S. Department of Agriculture
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
In accordance with our process for soliciting public input when
considering petitions for determinations of nonregulated status for GE
organisms, we are publishing this notice to inform the public that
APHIS will accept written comments on our draft PPRA and our draft EA
regarding the petition for a determination of nonregulated status from
interested or affected persons for a period of 30 days from the date of
this notice. Copies of the draft PPRA and the draft EA, as well as the
previously published petition, are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the 30-day comment period closes, APHIS will review and
evaluate any information received during the comment period and any
other relevant information. After reviewing and evaluating the comments
on the draft PPRA and the draft EA and other information, APHIS will
revise the PPRA as necessary and prepare a final EA. Based on the final
EA, APHIS will prepare a NEPA decision document (either a FONSI or a
notice of intent to prepare an environmental impact statement). If a
FONSI is reached, APHIS will furnish a response to the petitioner,
based on APHIS' conclusions in the PPRA, either approving or denying
the petition. APHIS will also publish a notice in the Federal Register
announcing the regulatory status of the GE organism and the
availability of APHIS' final PPRA, EA, FONSI, and our regulatory
determination.
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 7th day of March 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-04537 Filed 3-12-19; 8:45 am]
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