[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]
 BILLING CODE 3410-34-P