[Federal Register Volume 79, Number 167 (Thursday, August 28, 2014)]
[Notices]
[Pages 51297-51299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20495]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0055]


Monsanto Company; Availability of Preliminary Finding of No 
Significant Impact and Preliminary Decision for an Extension of a 
Determination of Nonregulated Status of Soybean Genetically Engineered 
for Resistance to Lepidopteran Insects

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has reached a preliminary decision to extend our 
determination of nonregulated status of soybean event MON 87701 to 
soybean event MON 87751 in response to a request from the Monsanto 
Company. Soybean event MON 87751 has been genetically engineered for 
resistance to lepidopteran insects, including resistance to fall 
armyworm beyond that provided to soybean event MON 87701. We are making 
available for public comment our preliminary finding of no significant 
impact for the proposed determination of nonregulated status.

DATES: We will consider all comments that we receive on or before 
September 29, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0055.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0055, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The Monsanto Company extension request, our finding of no 
significant impact, our preliminary determination, and any comments we 
receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0055 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.
    Supporting documents and any comments we received regarding our 
determination of nonregulated status of the antecedent organism, MON 
87701 soybean, can be found at http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0038. Supporting documents and any comments 
we received regarding our determination of nonregulated status of MON 
89034 corn, a referenced organism for this action, can be found at 
http://www.regulations.gov/#!docketDetail;D=APHIS-2007-0030. Combined 
supporting documents regarding our determination of nonregulated status 
for the referenced organism MON 15985 cotton can be found on the APHIS 
Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition 
Number 00-342-01p. Supporting documents may also be found on the APHIS 
Web site for MON 87751 soybean (the organism under evaluation) under 
APHIS Petition Number 13-337-01p, MON 87701 soybean (the antecedent 
organism) under APHIS Petition Number 09-082-01p, and MON 89034 corn (a 
referenced organism) under APHIS Petition Number 06-298-01p.

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 supporting documents, contact Ms. Cindy Eck at (301) 851-3885, 
email: [email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (PPA) (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 organisms (GE) 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. Further, the regulations in Sec.  340.6(e)(2) 
provide that a person may request that APHIS extend a determination of 
nonregulated status to other organisms. Such a request must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.
    In a notice \1\ published in the Federal Register on October 12, 
2011 (76 FR 63279-63280, Docket No. APHIS-2011-0038), APHIS announced 
our determination of nonregulated status of soybean (Glycine max) 
designated as event MON 87701, which was genetically engineered for 
lepidopteran resistance. APHIS has received a request for an extension 
of a determination of nonregulated status of soybean event MON 87701 
(APHIS Petition Number 09-082-01p) to soybean designated as event MON 
87751 (APHIS Petition Number 13-337-01p) from the Monsanto Company 
(Monsanto) of St. Louis, MO. MON 87751 soybean expresses resistance to 
lepidopteran pests similar to that of MON 87701 soybean, with the 
exception of increased resistance to fall armyworm (Spodoptera 
frugiperda). In its request, Monsanto stated that this soybean is 
similar to lepidopteran-resistant soybean event MON 88701 and, based on 
the similarity to the antecedent organism, is unlikely to pose a plant 
pest risk and, therefore, should not be

[[Page 51298]]

a regulated article under APHIS' regulations in 7 CFR part 340.
---------------------------------------------------------------------------

    \1\ To view the notice, our determination, supporting documents, 
and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0038.
---------------------------------------------------------------------------

    As described in the extension request, soybean event MON 87751 
soybean has been genetically engineered to express two Bacillus 
thuringiensis proteins (Cry1A.105 and Cry2Ab2) that confer resistance 
to certain lepidopteran pests of soybeans. The antecedent organism, MON 
87701 soybean, was similarly genetically engineered to express the B. 
thuringiensis Cry1Ac insecticidal protein. The Cry1A.105 and Cry2Ab2 
expressed in MON 87751 soybean are both similar to the Cry1Ac protein 
expressed in MON 87701 soybean. Based on the information in the 
request, we have concluded that soybean designated as event MON 88751 
is similar to soybean designated as event MON 88701. Soybean event MON 
87751 is currently regulated under 7 CFR part 340.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS evaluates the plant pest risk of the article. 
In section 403 of the PPA, ``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 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 completed a plant pest risk assessment (PPRA) on the 
antecedent organism, MON 87701 soybean, in which we concluded that MON 
87701 soybean is unlikely to present a plant pest risk. MON 87751 
soybean differs from MON 87701 soybean in the proteins expressed, 
specifically, Cry1A.105 and Cry2Ab2 are expressed in MON 87751 while 
only Cry1Ac is expressed in MON 87701. However, the activity spectra 
are quite similar. APHIS has evaluated Cry1A.105 and Cry2Ab2 when 
expressed in corn and cotton (MON 89034 and MON 15985, respectively). 
In the PPRAs that APHIS completed for MON 89034 corn and MON 15985 
cotton, we concluded that the organisms did not pose a plant pest risk. 
As mentioned previously, the Cry1A.105 and Cry2Ab2 expressed in MON 
87751 soybean are together similar to the Cry1Ac protein expressed in 
MON 87701 soybean, and APHIS has concluded that the increased activity 
toward fall armyworm from the proteins expressed in MON 87751 soybean 
is unlikely to affect the plant pest risk of MON 87751 soybean. 
Furthermore, the Environmental Protection Agency reviewed the safety of 
Cry1A.105 and Cry2Ab2 in corn and concluded that adverse effects will 
not occur to nontarget organisms. Therefore, based on our PPRAs for MON 
87701 soybean, MON 89034 corn, and MON 15985 cotton, the similarity 
between MON 87751 soybean and MON 87701 soybean, the limited difference 
in activity spectra between MON 87751 soybean and MON 87701 soybean, 
and other information, APHIS has concluded that Cry1A.105 and Cry2Ab2 
in MON 87751 soybean are unlikely to pose a plant pest risk and that 
MON 87751 soybean is unlikely to pose a different plant pest risk than 
MON 87701.
    APHIS also prepared an environmental assessment (EA) for the 
antecedent organism MON 87701 soybean based on our analysis of data 
submitted by Monsanto, a review of other scientific data, and field 
tests conducted under APHIS oversight. The EA was prepared to provide 
the APHIS decisionmaker with a review and analysis of any potential 
environmental impacts associated with the determination of nonregulated 
status soybean event MON 87701. The 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).
    APHIS has carefully examined the existing NEPA documentation 
completed for MON 87701 soybean and has concluded that Monsanto's 
request to extend a determination of nonregulated status to MON 87751 
soybean encompasses the same scope of environmental analysis as MON 
87701 soybean. Therefore, based on the similarity of MON 87751 soybean 
to MON 87701 soybean, APHIS has prepared a preliminary finding of no 
significant impact (FONSI) on MON 87751 soybean using the EA prepared 
for MON 87701 soybean. APHIS is considering the following alternatives: 
(1) Take no action, i.e., APHIS would not change the regulatory status 
of soybean event MON 87751 and it would continue to be a regulated 
article, or (2) make a determination of nonregulated status of soybean 
event MON 87751 soybean. APHIS' preferred alternative is to make a 
determination of nonregulated status of soybean event MON 87751.
    APHIS has analyzed information submitted by Monsanto, references 
provided in the extension request, peer-reviewed publications, and 
information in the EA of the antecedent organism MON 87701 soybean. 
APHIS has also analyzed information in the PPRA for the antecedent 
organism MON 87701 soybean, information in the PPRAs for MON 89034 corn 
and MON 15985 cotton, the limited difference in activity spectra 
between MON 87751 soybean and the antecedent organism MON 87701 
soybean, and other information. Based on APHIS' analysis of this 
information, the similarity of MON 87751 soybean to the antecedent 
organism MON 87701 soybean, our conclusion that the Cry1A.105 and 
Cry2Ab2 in MON 87751 soybean are unlikely to pose a plant pest risk, 
and our conclusion that MON 87751 is unlikely to pose a different plant 
pest risk than MON 87701, APHIS has determined that soybean event MON 
87751 is unlikely to pose a plant pest risk. We have therefore reached 
a preliminary decision to approve the request to extend the 
determination of nonregulated status of soybean event MON 87701 to 
soybean event MON 87751, whereby soybean event MON 87751 would no 
longer be subject to our regulations governing the introduction of 
certain genetically engineered organisms.
    Paragraph (e) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register announcing all preliminary decisions to 
extend determinations of nonregulated status for 30 days before the 
decisions become final and effective. In accordance with Sec.  340.6(e) 
of the regulations, we are publishing this notice to inform the public 
of our preliminary decision to extend the determination of nonregulated 
status of soybean event MON 87701 to soybean event MON 87751.
    APHIS will accept written comments on the FONSI regarding a 
determination of nonregulated status of soybean event MON 87751 for a 
period of 30 days from the date this notice is published in the Federal 
Register. The FONSI, as well as the extension request, supporting 
documents, and our preliminary determination for soybean event MON 
87751, are available for public review as indicated under ADDRESSES and 
FOR FURTHER INFORMATION CONTACT above. Copies of these documents may 
also be obtained by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. All comments will be available for public review. After 
reviewing and evaluating the comments, if APHIS determines that

[[Page 51299]]

no substantive information has been received that would warrant APHIS 
altering its preliminary regulatory determination or FONSI, our 
preliminary regulatory determination will become final and effective 
upon notification of the public through an announcement on our Web site 
at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. APHIS will also furnish 
a response to the petitioner regarding our final regulatory 
determination. No further Federal Register notice will be published 
announcing the final regulatory determination regarding soybean event 
MON 87751.

    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 22nd day of August 2014.
Kevin Shea,
 Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-20495 Filed 8-27-14; 8:45 am]
BILLING CODE 3410-34-P