38587

Notices Federal Register Vol. 84, No. 152

Wednesday, August 7, 2019

This section of the FEDERAL REGISTER p.m., Monday through Friday, except According to our process 1 for contains documents other than rules or holidays. To be sure someone is there to soliciting public comment when proposed rules that are applicable to the help you, please call (202) 799–7039 considering petitions for determinations public. Notices of hearings and investigations, before coming. of nonregulated status of GE organisms, committee meetings, agency decisions and APHIS accepts written comments rulings, delegations of authority, filing of Supporting documents are also available on the APHIS website at regarding a petition once APHIS deems petitions and applications and agency 2 statements of organization and functions are http://www.aphis.usda.gov/ it complete. In a notice published in examples of documents appearing in this /petitions_table_ the Federal Register on November 15, section. pending.shtml under APHIS Petition 2017 (82 FR 52873–52874, Docket No. 17–223–01p. APHIS–2017–0075), APHIS announced the availability of the Verdeca petition DEPARTMENT OF FOR FURTHER INFORMATION CONTACT: Dr. for public comment. APHIS solicited Subray Hegde, Director, Biotechnology comments on the petition for 60 days Animal and Plant Health Inspection Risk Analysis Programs, Biotechnology ending on January 16, 2018, in order to Service Regulatory Services, APHIS, 4700 River help identify potential environmental Road, Unit 147, Riverdale, MD 20737– [Docket No. APHIS–2017–0075] and interrelated economic issues and 1236; (301) 851–3901; email: impacts that APHIS may determine Verdeca LLC; Determination of [email protected]. To obtain should be considered in our evaluation Nonregulated Status of Soybean copies of the supporting documents for of the petition. Genetically Engineered for Yield this petition, contact Ms. Cindy Eck at APHIS received five comments on the Increase and Resistance to Glufosinate (301) 851–3892, email: cynthia.a.eck@ petition (a sixth comment addressing an usda.gov. entirely different topic was erroneously AGENCY: Animal and Plant Health submitted). Of the five comments, four Inspection Service, USDA. SUPPLEMENTARY INFORMATION: The were opposed to the deregulation and ACTION: Notice. regulations in 7 CFR part 340, one comment was in support. In May ‘‘Introduction of Organisms and 2018, Verdeca provided supplemental SUMMARY: We are advising the public of Products Altered or Produced Through information to APHIS informing us that our determination that the new plant Which Are Plant its HB4 soybean variety also had field- variety HB4 soybean designated as event Pests or Which There Is Reason to level resistance to the herbicide IND–00410–5, which has been Believe Are Plant Pests,’’ regulate, glufosinate. APHIS reviewed the genetically engineered for increased among other things, the introduction supplemental information and included yield and resistance to the herbicide (importation, interstate movement, or it in its analyses in the draft plant pest glufosinate, is no longer considered a release into the environment) of risk assessment (PPRA) and draft regulated article under our regulations organisms and products altered or environmental assessment (EA). governing the introduction of certain produced through genetic engineering APHIS decided, based on its review of genetically engineered organisms. Our that are plant pests or that there is the petition and its evaluation and determination is based on our reason to believe are plant pests. Such analysis of the comments received evaluation of data submitted by Verdeca genetically engineered (GE) organisms during the 60-day public comment LLC in its petition for a determination and products are considered ‘‘regulated period on the petition, that the petition of nonregulated status, our analysis of articles.’’ involves a GE organism that raises available scientific data, and comments The regulations in § 340.6(a) provide substantive new issues. According to received from the public in response to that any person may submit a petition our public review process for such our previous notices announcing the to the Animal and Plant Health petitions (see footnote 1), APHIS is availability of the petition for Inspection Service (APHIS) seeking a following Approach 2, where we first nonregulated status and its associated determination that an article should not solicit written comments from the environmental assessment and plant be regulated under 7 CFR part 340. public on a draft EA and a draft PPRA pest risk assessment. This notice also APHIS received a petition (APHIS for a 30-day comment period through announces the availability of our Petition Number 17–223–01p) from the publication of a Federal Register written determination and finding of no Verdeca LLC (Verdeca), seeking a notice. Then, after reviewing and significant impact. determination of nonregulated status for evaluating the comments on the draft EA and the draft PPRA and other DATES: This change in regulatory status the new plant variety called HB4 information, APHIS revises the draft will be recognized August 7, 2019. soybean (Glycine max) designated as event IND–00410–5 (also OECD unique ADDRESSES: You may read the 1 On March 6, 2012, we published in the Federal documents referenced in this notice and identifier IND–00410–5), which has Register (77 FR 13258–13260, Docket No. APHIS– the comments we received at http:// been genetically engineered for 2011–0129) a notice describing our process for www.regulations.gov/ increased yield. The Verdeca petition soliciting public comments and information when considering petitions for determinations of #!docketDetail;D=APHIS-2017-0075 or states that information collected during nonregulated status for GE organisms (see http:// in our reading room, which is located in field trials and laboratory analyses www.regulations.gov/#!docketDetail;D=APHIS- Room 1141 of the USDA South indicates that HB4 soybean is not likely 2011-0129). Building, 14th Street and Independence to be a plant pest and therefore should 2 To view the notice, the petition, and the not be a regulated article under APHIS’ comments we received, go to http:// Avenue SW, Washington, DC. Normal www.regulations.gov/#!docketDetail;D=APHIS- reading room hours are 8 a.m. to 4:30 regulations in 7 CFR part 340. 2017-0075.

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PPRA as necessary and prepares a final response to those public comments, DATES: This change in regulatory status EA and, based on the final EA, a APHIS has determined that HB4 will be recognized August 7, 2019. National Environmental Policy Act soybean is unlikely to pose a plant pest ADDRESSES: You may read the (NEPA) finding document (either a risk and therefore is no longer subject to documents referenced in this notice and finding of no significant impact (FONSI) our regulations governing the the comments we received at http:// or a notice of intent to prepare an introduction of certain GE organisms. www.regulations.gov/ environmental impact statement). If a Copies of the signed determination #!docketDetail;D=APHIS-2018-0014 or FONSI is reached, APHIS furnishes a document, PPRA, final EA, FONSI, and in our reading room, which is located in response to the petitioner, either response to comments, as well as the Room 1141 of the USDA South approving or denying the petition. previously published petition and Building, 14th Street and Independence APHIS also publishes a notice in the supporting documents, are available as Avenue SW, Washington, DC. Normal Federal Register announcing the indicated in the ADDRESSES and FOR reading room hours are 8 a.m. to 4:30 regulatory status of the GE organism and FURTHER INFORMATION CONTACT sections p.m., Monday through Friday, except the availability of APHIS’ final EA, of this notice. holidays. To be sure someone is there to PPRA, FONSI, and our regulatory Authority: 7 U.S.C. 7701–7772 and 7781– help you, please call (202) 799-7039 determination. 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and before coming. APHIS sought public comment on a 371.3. Supporting documents are also draft EA, draft PPRA, and the available on the APHIS website at supplemental information provided by Done in Washington, DC, this 1st day of August 2019. http://www.aphis.usda.gov/ Verdeca from March 13, 2019, to April biotechnology/petitions_table_ 12, 2019.3 APHIS solicited comments on Kevin Shea, pending.shtml under APHIS Petition those documents and whether the Administrator, Animal and Plant Health 17–321–01p. Inspection Service. subject soybean is likely to pose a plant FOR FURTHER INFORMATION CONTACT: Dr. pest risk. APHIS received three [FR Doc. 2019–16920 Filed 8–6–19; 8:45 am] Subray Hegde, Director, Biotechnology comments on the petition and BILLING CODE 3410–34–P Risk Analysis Programs, Biotechnology supporting documents, all of which Regulatory Services, APHIS, 4700 River opposed a decision of nonregulated DEPARTMENT OF AGRICULTURE Road, Unit 147, Riverdale, MD 20737– status for HB4 soybean. Those 1236; (301) 851–3901; email: comments are addressed in our final EA. Animal and Plant Health Inspection [email protected]. To obtain National Environmental Policy Act Service copies of the supporting documents for this petition, contact Ms. Cindy Eck at After reviewing and evaluating the [Docket No. APHIS–2018–0014] (301) 851–3892, email: cynthia.a.eck@ comments received during the comment usda.gov. period on the draft EA and draft PPRA BASF Plant Science, LP; Determination and other information, APHIS has of Nonregulated Status of Canola SUPPLEMENTARY INFORMATION: The prepared a final EA. The EA has been Genetically Engineered for Altered Oil regulations in 7 CFR part 340, prepared to provide the public with Profile and Resistance to an ‘‘Introduction of Organisms and documentation of APHIS’ review and Imidazolinone Herbicide Products Altered or Produced Through analysis of any potential environmental Genetic Engineering Which Are Plant impacts associated with the AGENCY: Animal and Plant Health Pests or Which There Is Reason to determination of nonregulated status of Inspection Service, USDA. Believe Are Plant Pests,’’ regulate, HB4 soybean. The EA was prepared in ACTION: Notice. among other things, the introduction accordance with: (1) NEPA, as amended (importation, interstate movement, or (42 U.S.C. 4321 et seq.), (2) regulations SUMMARY: We are advising the public of release into the environment) of of the Council on Environmental our determination that canola organisms and products altered or Quality for implementing the designated as event LBFLFK, which has produced through genetic engineering procedural provisions of NEPA (40 CFR been genetically engineered to allow for that are plant pests or that there is parts 1500–1508), (3) USDA regulations the synthesis of long chain omega-3 reason to believe are plant pests. Such implementing NEPA (7 CFR part 1b), polyunsaturated fatty acids, including genetically engineered (GE) organisms and (4) APHIS’ NEPA Implementing eicosapentaenoic acid and and products are considered ‘‘regulated Procedures (7 CFR part 372). Based on docosahexaenoic acid, from oleic acid articles.’’ our EA, the response to public in canola seed, is no longer considered The regulations in § 340.6(a) provide comments, and other pertinent scientific a regulated article under our regulations that any person may submit a petition data, APHIS has reached a FONSI with governing the introduction of certain to the Animal and Plant Health regard to the preferred alternative genetically engineered organisms. Our Inspection Service (APHIS) seeking a identified in the EA (to make a determination is based on our determination that an article should not determination of nonregulated status of evaluation of data submitted by BASF be regulated under 7 CFR part 340. HB4 soybean). Plant Science, LP, in its petition for a APHIS received a petition (APHIS determination of nonregulated status, Petition Number 17–321–01p) from Determination our analysis of available scientific data, BASF Plant Science, LP, of Florham Based on APHIS’ analysis of field and and comments received from the public Park, NJ (BASF), seeking a laboratory data submitted by Verdeca, in response to our previous notices determination of nonregulated status of references provided in the petition, announcing the availability of the canola (Brassica napus L.) designated as peer-reviewed publications, information petition for nonregulated status and its event LBFLFK, which has been analyzed in the EA, the PPRA, associated environmental assessment genetically engineered to allow for the comments provided by the public, and and plant pest risk assessment. This synthesis of long chain omega-3 information provided in APHIS’ notice also announces the availability of polyunsaturated fatty acids (LC– our written determination and finding PUFAs), including eicosapentaenoic 3 84 FR 9077–9078. of no significant impact. acid (EPA) and docosahexaenoic acid

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