Citation: "79 FR 51297"
Document Number: "Docket No. APHIS-2014-0055"
Page Number: "51297"
SUMMARY: We are advising the public that the Animal and
DATES: We will consider all comments that we receive on or before
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,
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
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.
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
In a notice /1/ published in the
FOOTNOTE 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. END FOOTNOTE
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
APHIS also prepared an environmental assessment (EA) for the antecedent organism MON 87701 soybean based on our analysis of data submitted by
APHIS has carefully examined the existing NEPA documentation completed for MON 87701 soybean and has concluded that
APHIS has analyzed information submitted by
Paragraph (e) of
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
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 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
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Administrator, Animal and
[FR Doc. 2014-20495 Filed 8-27-14;
BILLING CODE 3410-34-P
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