Dow AgroScience LLC; Availability of Petition, Plant Pest Risk Assessment, and Environmental...

download Dow AgroScience LLC; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment for Determination of Nonregulated Status of Corn Genetically Engineered for

of 2

Transcript of Dow AgroScience LLC; Availability of Petition, Plant Pest Risk Assessment, and Environmental...

  • 8/3/2019 Dow AgroScience LLC; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment for Deter

    1/2

    80872 Federal Register / Vol. 76, No. 248/ Tuesday, December 27, 2011 / Notices

    of persistence in the environment aftercompletion of the test. Data are gatheredon multiple parameters and used by theapplicant to evaluate agronomiccharacteristics and productperformance. These and other data areused by APHIS to determine if the newvariety poses a plant pest risk.

    In section 403 of the Plant Protection

    Act, plant pest is defined as anyliving stage of any of the following thatcan directly or indirectly injure, causedamage to, or cause disease in any plantor plant product: A protozoan, anonhuman animal, a parasitic plant, a

    bacterium, a fungus, a virus or viroid, aninfectious agent or other pathogen, orany article similar to or allied with anyof the foregoing. APHIS has prepared aplant pest risk assessment to determineif soybean event MON 87769 is unlikelyto pose a plant pest risk.

    APHIS has also prepared a draftenvironmental assessment (EA) inwhich it presents two alternatives basedon its analyses of data submitted byMonsanto, a review of other scientificdata, and field tests conducted underAPHIS oversight. APHIS is consideringthe following alternatives: (1) Take noaction, i.e., APHIS would not change theregulatory status of soybean event MON87769 and it would continue to be aregulated article, or (2) make adetermination of nonregulated status ofsoybean event MON 87769.

    The draft EA has been prepared toprovide the APHIS decisionmaker witha review and analysis of any potentialenvironmental impacts associated with

    the proposed determination ofnonregulated status of soybean eventMON 87769. The draft EA was preparedin accordance with (1) the NationalEnvironmental Policy Act of 1969(NEPA), as amended (42 U.S.C. 4321 etseq.), (2) regulations of the Council onEnvironmental Quality forimplementing the procedural provisionsof NEPA (40 CFR parts 15001508), (3)USDA regulations implementing NEPA(7 CFR part 1b), and (4) APHIS NEPAImplementing Procedures (7 CFR part372).

    In accordance with 340.6(d) of the

    regulations, we are publishing thisnotice to inform the public that APHISwill accept written comments regardingthe petition for a determination ofnonregulated status from interested oraffected persons for a period of 60 daysfrom the date of this notice. We are alsosoliciting written comments frominterested or affected persons on theplant pest risk assessment and the draftEA prepared to examine any potentialenvironmental impacts of the proposeddetermination for the deregulation ofthe subject soybean line. The petition,

    draft EA, and plant pest risk assessmentare available for public review, andcopies of the petition, draft EA, andplant pest risk assessment are availableas indicated under ADDRESSES and FORFURTHER INFORMATION CONTACT above.

    After the comment period closes,APHIS will review all written commentsreceived during the comment period

    and any other relevant information. Allcomments received regarding thepetition, draft EA, and plant pest riskassessment will be available for publicreview. After reviewing and evaluatingthe comments on the petition, the draftEA, plant pest risk assessment, andother data, APHIS will furnish aresponse to the petitioner, eitherapproving or denying the petition.APHIS will also publish a notice in theFederal Register announcing theregulatory status of soybean event MON87769 and the availability of APHISwritten environmental decision and

    regulatory determination.Authority: 7 U.S.C. 77017772 and 7781

    7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and371.3.

    Done in Washington, DC this 19th day ofDecember 2011.

    Kevin Shea,

    Acting Administrator, Animal and PlantHealth Inspection Service.

    [FR Doc. 201133002 Filed 122211; 8:45 am]

    BILLING CODE 341034P

    DEPARTMENT OF AGRICULTURE

    Animal and Plant Health Inspection

    Service

    [Docket No. APHIS20100103]

    Dow AgroScience LLC; Availability ofPetition, Plant Pest Risk Assessment,and Environmental Assessment forDetermination of Nonregulated Statusof Corn Genetically Engineered forHerbicide Tolerance

    AGENCY: Animal and Plant HealthInspection Service, USDA.ACTION: Notice.

    SUMMARY: We are advising the public

    that the Animal and Plant HealthInspection Service has received apetition from Dow AgroScience LLCseeking a determination of nonregulatedstatus of corn designated as DAS402789, which has been geneticallyengineered for increased resistance to

    broadleaf herbicides in the phenoxyauxin group (such as the herbicide 2,4-D) and resistance to grass herbicides inthe aryloxyphenoxypropionate acetylcoenzyme A carboxylase inhibitor group(such as quizalofop herbicides). Thepetition has been submitted in

    accordance with our regulationsconcerning the introduction of certaingenetically engineered organisms andproducts. We are soliciting commentson whether this genetically engineeredcorn is likely to pose a plant pest risk.We are making available for publiccomment the Dow AgroScience LLCpetition, our plant pest risk assessment,

    and our draft environmental assessmentfor the proposed determination ofnonregulated status.DATES: We will consider all commentsthat we receive on or before February27, 2012.ADDRESSES: You may submit comments

    by either of the following methods: Federal eRulemaking Portal: Go to

    http://www.regulations.gov/#!documentDetail;D=APHIS201001030001.

    Postal Mail/Commercial Delivery:Send your comment to Docket No.APHIS20100103, Regulatory Analysis

    and Development, PPD, APHIS, Station3A03.8, 4700 River Road Unit 118,Riverdale, MD 207371238.

    Supporting documents and anycomments we receive on this docketmay be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS20100103orin our reading room, which is located inroom 1141 of the USDA South Building,14th Street and Independence AvenueSW., Washington, DC. Normal readingroom hours are 8 a.m. to 4:30 p.m.,Monday through Friday, exceptholidays. To be sure someone is there to

    help you, please call (202) 6902817before coming.The petition, draft environmental

    assessment, and plant pest riskassessment are also available on theAPHIS Web site at http://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdf,http://www.aphis.usda.gov/brs/aphisdocs/09_23301p _dea.pdf, and http://www.aphis.usda.gov/brs/aphisdocs/09_23301p _dpra.pdf.FOR FURTHER INFORMATION CONTACT: Mr.Evan Chestnut, Policy Analyst,Biotechnology Regulatory Services,APHIS, 4700 River Road Unit 147,Riverdale, MD 207371236; (301) 7340942, email:[email protected] copies of the petition, draftenvironmental assessment, or plant pestrisk assessment, contact Ms. Cindy Eckat (301) 7340667, email:[email protected].

    SUPPLEMENTARY INFORMATION:

    Background

    Under the authority of the plant pestprovisions of the Plant Protection Act (7

    VerDate Mar2010 22:00 Dec 23, 2011 Jkt 226001 PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 E:\FR\FM\27DEN1.SGM 27DEN1

    http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0103-0001http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0103-0001http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0103-0001http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103http://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfmailto:[email protected]:[email protected]://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dpra.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p_dea.pdfmailto:[email protected]:[email protected]://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.aphis.usda.gov/brs/aphisdocs/09_23301p.pdfhttp://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0103http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0103-0001http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0103-0001http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0103-0001
  • 8/3/2019 Dow AgroScience LLC; Availability of Petition, Plant Pest Risk Assessment, and Environmental Assessment for Deter

    2/2

    80873Federal Register / Vol. 76, No. 248/ Tuesday, December 27, 2011 / Notices

    U.S.C. 7701 et seq.), the regulations in7 CFR part 340, Introduction ofOrganisms and Products Altered orProduced Through Genetic EngineeringWhich Are Plant Pests or Which ThereIs Reason to Believe Are Plant Pests,regulate, among other things, theintroduction (importation, interstatemovement, or release into the

    environment) of organisms and productsaltered or produced through geneticengineering that are plant pests or thatthere is reason to believe are plant pests.Such genetically engineered organismsand products are considered regulatedarticles.

    The regulations in 340.6(a) providethat any person may submit a petitionto the Animal and Plant HealthInspection Service (APHIS) seeking adetermination that an article should not

    be regulated under 7 CFR part 340.Paragraphs (b) and (c) of 340.6describe the form that a petition for a

    determination of nonregulated statusmust take and the information that mustbe included in the petition.

    APHIS has received a petition (APHISPetition Number 0923301p) from DowAgroScience LLC (Dow) of Indianapolis,IN, seeking a determination ofnonregulated status of corn (Zea mays)designated as event DAS402789,which has been genetically engineeredfor increased resistance to broadleafherbicides in the phenoxy auxin group(such as the herbicide 2,4-D) andresistance to grass herbicides in thearyloxyphenoxypropionate acetylcoenzyme A carboxylase inhibitor group

    (such as quizalofop herbicides), statingthat this corn is unlikely to pose a plantpest risk and, therefore, should not bea regulated article under APHISregulations in 7 CFR part 340.

    As described in the petition, cornevent DAS402789 has beengenetically engineered to express thearyloxyalkanoate dioxygenase proteinAAD1. Corn event DAS402789 iscurrently regulated under 7 CFR part340. Interstate movements and fieldtests of corn event DAS402789 have

    been conducted under permits issued ornotifications acknowledged by APHIS.

    Field tests conducted under APHISoversight allowed for evaluation in anatural agricultural setting whileimposing measures to minimize the riskof persistence in the environment aftercompletion of the test. Data are gatheredon multiple parameters and used by theapplicant to evaluate agronomiccharacteristics and productperformance. These and other data areused by APHIS to determine if the newvariety poses a plant pest risk.

    In section 403 of the Plant ProtectionAct, plant pest is defined as any

    living stage of any of the following thatcan directly or indirectly injure, causedamage to, or cause disease in any plantor plant product: A protozoan, anonhuman animal, a parasitic plant, a

    bacterium, a fungus, a virus or viroid, aninfectious agent or other pathogen, orany article similar to or allied with anyof the foregoing. APHIS has prepared a

    plant pest risk assessment to determineif corn event DAS402789 is unlikelyto pose a plant pest risk.

    APHIS has also prepared a draftenvironmental assessment (EA) inwhich it presents two alternatives basedon its analyses of data submitted byDow, a review of other scientific data,and field tests conducted under APHISoversight. APHIS is considering thefollowing alternatives: (1) Take noaction, i.e., APHIS would not change theregulatory status of corn event DAS402789 and it would continue to be aregulated article, or (2) make a

    determination of nonregulated status ofcorn event DAS402789.The draft EA has been prepared to

    provide the APHIS decisionmaker witha review and analysis of any potentialenvironmental impacts associated withthe proposed determination ofnonregulated status of corn event DAS402789. The draft EA was prepared inaccordance with (1) the NationalEnvironmental Policy Act of 1969(NEPA), as amended (42 U.S.C. 4321 etseq.), (2) regulations of the Council onEnvironmental Quality forimplementing the procedural provisionsof NEPA (40 CFR parts 15001508), (3)

    USDA regulations implementing NEPA(7 CFR part 1b), and (4) APHIS NEPAImplementing Procedures (7 CFR part372).

    In accordance with 340.6(d) of theregulations, we are publishing thisnotice to inform the public that APHISwill accept written comments regardingthe petition for a determination ofnonregulated status from interested oraffected persons for a period of 60 daysfrom the date of this notice. We are alsosoliciting written comments frominterested or affected persons on theplant pest risk assessment and the draft

    EA prepared to examine any potentialenvironmental impacts of the proposeddetermination for the deregulation ofthe subject corn line. The petition, draftEA, and plant pest risk assessment areavailable for public review, and copiesof the petition, draft EA, and plant pestrisk assessment are available asindicated under ADDRESSES and FORFURTHER INFORMATION CONTACT above.

    After the comment period closes,APHIS will review all written commentsreceived during the comment periodand any other relevant information. All

    comments received regarding thepetition, draft EA, and plant pest riskassessment will be available for publicreview. After reviewing and evaluatingthe comments on the petition, the draftEA, plant pest risk assessment, andother data, APHIS will furnish aresponse to the petitioner, eitherapproving or denying the petition.

    APHIS will also publish a notice in theFederal Register announcing theregulatory status of corn event DAS402789 and the availability of APHISwritten environmental decision andregulatory determination.

    Authority: 7 U.S.C. 77017772 and 77817786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and371.3.

    Done in Washington, DC, this 19th day ofDecember 2011.

    Kevin Shea,

    Acting Administrator, Animal and PlantHealth Inspection Service.

    [FR Doc. 201133009 Filed 122211; 8:45 am]

    BILLING CODE 341034P

    DEPARTMENT OF AGRICULTURE

    Food Safety and Inspection Service

    [Docket No. FSIS20110028]

    Food Source Attribution; PublicMeeting

    AGENCY: Food Safety and InspectionService, USDA.ACTION: Notice of public meeting.

    SUMMARY: The Food Safety and

    Inspection Service (FSIS), incollaboration with the Food and DrugAdministration (FDA), and the Centersfor Disease Control and Prevention(CDC), is hosting a public meeting todiscuss Federal efforts to advance tri-agency understanding of food sourceattribution and develop harmonizedfood source attribution estimates usefulto informing targeted food safetystrategies. The public meeting will alsointroduce the Interagency Food SafetyAnalytics Collaboration (IFSAC), whichwas formed to collaborate on analyticprojects. The meeting will also serve as

    a platform to introduce IFSACs draftStrategic Plan. Foodborne illnessattribution was selected as the initialfocus in light of the CDC foodborneillness burden estimates released in2011 and in response to stakeholderinput to develop a unified approach toattribution. FSIS, FDA, and CDC are alsointerested in input from stakeholdersregarding existing data and methods forfood source attribution in the UnitedStates and the opportunities andchallenges in implementing the IFSACStrategic Plan.

    VerDate Mar2010 22:00 Dec 23, 2011 Jkt 226001 PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 E:\FR\FM\27DEN1.SGM 27DEN1