80 FR 43053 - Monsanto Co.; Availability of Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment of Maize Genetically Engineered for Increased Ear Biomass

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 139 (July 21, 2015)

We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment a preliminary plant pest risk assessment and draft environmental assessment for maize designated as event MON 87403, which has been genetically engineered for increased ear biomass.

[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)]
[Notices]
[Pages 43053-43055]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17845]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0097]


Monsanto Co.; Availability of Preliminary Plant Pest Risk 
Assessment and Draft Environmental Assessment of Maize Genetically 
Engineered for Increased Ear Biomass

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is making available for public comment a preliminary 
plant pest risk assessment and draft environmental assessment for maize 
designated as event MON 87403, which has been genetically engineered 
for increased ear biomass.

DATES: We will consider all comments that we receive on or before 
August 20, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0097, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents for this petition and any comments we receive 
on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097 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.

[[Page 43054]]

    Supporting documents for this petition are also available on the 
APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 14-213-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, 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 
14-213-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
seeking a determination of nonregulated status of maize (Zea mays) 
designated as event MON 87403, which has been genetically engineered 
for increased ear biomass. The Monsanto petition states that 
information collected during field trials and laboratory analyses 
indicates that MON 87403 maize 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 January 20, 2015 (80 FR 2674-2675, Docket No. APHIS-2014-
0097), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on March 23, 2015, 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 20 comments on the petition. Issues raised during the 
comment period include the contamination of conventional crop 
production, the potential for disruption of trade due to the presence 
of unwanted genetically engineered commodities in exports, the 
potential for negative impacts on plant fitness and the environment, 
and health concerns. APHIS has evaluated the issues raised during the 
comment period and, where appropriate, has provided a discussion of 
these issues in our draft environmental assessment (EA).
---------------------------------------------------------------------------

    \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-
2014-0097.
---------------------------------------------------------------------------

    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 EA, preliminary finding of no significant 
impact (FONSI), and its 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.
    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 EA and preliminary PPRA for a 30-day comment period 
through the publication of a Federal Registernotice. Then, after 
reviewing and evaluating the comments on the draft EA and preliminary 
PPRA 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.
    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, to 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 has prepared a preliminary PPRA and has concluded that maize 
designated as event MON 87403, which has been genetically engineered 
for increased ear biomass, 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 Monsanto, 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 maize designated as event MON 87403, or 
(2) make a determination of nonregulated status of maize designated as 
event MON 87403.
    The 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

[[Page 43055]]

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 EA and our preliminary 
PPRA 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 EA and the preliminary PPRA, 
as well as the previously published petition, are available as 
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. After reviewing and evaluating the comments on the draft 
EA and the preliminary PPRA 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, 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 EA, PPRA, 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 15th day of July 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-17845 Filed 7-20-15; 8:45 am]
 BILLING CODE 3410-34-P