Agrivida, Inc.; Availability of a Petition for Determination of Nonregulated Status for Maize Genetically Engineered for the Production of Phytase Enzyme, 21170-21171 [2020-08065]

Download as PDF 21170 Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices certificate (PC) issued by the NPPO of Japan.3 • The sand pears are subject to inspection at the port of entry into the United States. • Only commercial consignments of Japanese sand pears may be imported into the United States. • The sand pears must be imported under permit. These revised conditions will be listed in the Fruits and Vegetables Import Requirements database (available at https:// epermits.aphis.usda.gov/manual). In addition to these specific measures, fresh sand pears from Japan will be subject to the general requirements listed in § 319.56–3 that are applicable to the importation of all fruits and vegetables. Paperwork Reduction Act In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the reporting and recordkeeping requirements included in this notice are covered under the Office of Management and Budget control number 0579–0049. E-Government Act Compliance The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this notice, please contact Mr. Joseph Moxey, APHIS’ Information Collection Coordinator, at (301) 851–2483. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), the Office of Information and Regulatory Affairs designated this action as not a major rule, as defined by 5 U.S.C. 804(2). Authority: 7 U.S.C. 1633, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. jbell on DSKJLSW7X2PROD with NOTICES Done in Washington, DC, this 1st day of April 2020. Michael Watson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–08030 Filed 4–15–20; 8:45 am] BILLING CODE 3410–34–P 3 We note that sand pears from Japan may continue to be imported into Hawaii under permit, and subject to inspection in Hawaii, without any further phytosanitary requirements. VerDate Sep<11>2014 18:20 Apr 15, 2020 Jkt 250001 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2019–0084] Agrivida, Inc.; Availability of a Petition for Determination of Nonregulated Status for Maize Genetically Engineered for the Production of Phytase Enzyme Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Agrivida, Inc. (Agrivida) seeking a determination of nonregulated status for maize designated as Maize Event PY203, which has been genetically engineered for the production of phytase enzyme. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Agrivida petition available for review and comment to help us identify potential issues and impacts that APHIS should be considering in our evaluation of the petition. DATES: We will consider all comments that we receive on or before June 15, 2020. SUMMARY: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2019-0084. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2019–0084, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. The petition and any comments we receive on this docket may be viewed at https://www.regulations.gov/ #!docketDetail;D=APHIS-2019-0084 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) 7997039 before coming. The petition is also available on the APHIS website at: https:// www.aphis.usda.gov/aphis/ourfocus/ biotechnology/permits-notificationspetitions/petitions/petition-status under APHIS petition 19–176–01p. ADDRESSES: PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 Ms. Cindy Eck, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 851–3892, email: cynthia.a.eck@ aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: 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 § 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. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition. APHIS has received a petition (APHIS Petition Number 19–176–01p) from Agrivida, Inc. (Agrivida) seeking a determination of nonregulated status for maize designated as Maize Event PY203, which has been genetically engineered for the production of phytase enzyme. The Agrivida petition states that this maize is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. As described in the petition, Maize Event PY203 was grown at six locations across the Midwestern United States including sites in Ohio, Indiana, Iowa, and Nebraska and at two locations in Argentina. Agronomic characteristics of Maize Event PY203 and near isogenic non-transgenic control plants grown at these locations were assessed throughout the life cycle of the plants. These and other data are used by APHIS to determine if the new variety poses a plant pest risk. The agronomic performance and phenotypic data generated demonstrate that the genetic modifications introduced into Maize Event PY203 did not have any unintended effects on seed germination, agronomic characteristics, or yield. These data support the SUPPLEMENTARY INFORMATION: E:\FR\FM\16APN1.SGM 16APN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices conclusion that Maize Event PY203 is unlikely to develop into feral persistent populations or to be more weedy or invasive in the environment compared to conventional maize varieties. Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment for petitions for a determination of nonregulated status. On March 6, 2012, we published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a notice 1 describing our process for soliciting public comment when considering petitions for determinations of nonregulated status for GE organisms. In that notice we indicated that APHIS would accept written comments regarding a petition once APHIS deemed it complete. In accordance with § 340.6(d) of the regulations and 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 regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review and comment, and copies are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments. After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. Any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decision-making documents. As part of our decisionmaking process regarding a GE organism’s regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an 1 To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. VerDate Sep<11>2014 18:20 Apr 15, 2020 Jkt 250001 environmental assessment (EA) or an environmental impact statement (EIS)— in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the Federal Register announcing the availability of APHIS’ EA and plant pest risk assessment. Should APHIS determine that an EIS is necessary, APHIS will complete the NEPA EIS process in accordance with Council on Environmental Quality regulations (40 CFR part 1500–1508) and APHIS’ NEPA implementing regulations (7 CFR part 372). (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 8th day of April 2020. Michael Watson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–08065 Filed 4–15–20; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2020–0014] Notice of Request for Renewal of an Approved Information Collection (Modernization of Poultry Slaughter Inspection) Food Safety and Inspection Service, USDA. ACTION: Notice and request for comments. AGENCY: In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to request renewal of the approved information collection regarding poultry slaughter inspection. There are no changes to the existing information collection. The approval for this information collection will expire on September 30, 2020. DATES: Submit comments on or before June 15, 2020. ADDRESSES: FSIS invites interested persons to submit comments on this Federal Register notice. Comments may be submitted by one of the following methods: • Federal eRulemaking Portal: This website provides commenters the ability SUMMARY: PO 00000 Frm 00010 Fmt 4703 Sfmt 4703 21171 to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for submitting comments. • Mail, including CD–ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250–3700. • Hand- or courier-delivered submittals: Deliver to 1400 Independence Avenue SW, Room 6065, Washington, DC 20250–3700. Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS– 2020–0014. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https:// www.regulations.gov. Docket: For access to background documents or comments received, call (202) 720–5627 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Room 6065, Washington, DC 20250–3700. FOR FURTHER INFORMATION CONTACT: Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065, South Building, Washington, DC 20250– 3700; (202) 720–5627. SUPPLEMENTARY INFORMATION: Title: Modernization of Poultry Slaughter Inspection. OMB Number: 0583–0156. Expiration Date of Approval: 9/30/ 2020. Type of Request: Renewal of an approved information collection. Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary as specified in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.). This statute provides that FSIS is to protect the public by verifying that poultry products are safe, wholesome, not adulterated, and properly labeled and packaged. FSIS is requesting renewal of the approved information collection regarding poultry slaughter inspection. The approval for this information collection will expire on September 30, 2020. There are no changes to the existing information collection. FSIS requires that all official poultry slaughter establishments, other than establishments that slaughter ratites, maintain as part of their HACCP plan, sanitation SOP, or other prerequisite E:\FR\FM\16APN1.SGM 16APN1

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[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21170-21171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08065]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0084]


Agrivida, Inc.; Availability of a Petition for Determination of 
Nonregulated Status for Maize Genetically Engineered for the Production 
of Phytase Enzyme

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) has received a petition from Agrivida, Inc. 
(Agrivida) seeking a determination of nonregulated status for maize 
designated as Maize Event PY203, which has been genetically engineered 
for the production of phytase enzyme. The petition has been submitted 
in accordance with our regulations concerning the introduction of 
certain genetically engineered organisms and products. We are making 
the Agrivida petition available for review and comment to help us 
identify potential issues and impacts that APHIS should be considering 
in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before June 
15, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0084.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0084, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The petition and any comments we receive on this docket may be 
viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0084 
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) 7997039 before coming.
    The petition is also available on the APHIS website at: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status under APHIS petition 19-176-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (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. Paragraphs (b) and (c) of Sec.  340.6 describe 
the form that a petition for a determination of nonregulated status 
must take and the information that must be included in the petition.
    APHIS has received a petition (APHIS Petition Number 19-176-01p) 
from Agrivida, Inc. (Agrivida) seeking a determination of nonregulated 
status for maize designated as Maize Event PY203, which has been 
genetically engineered for the production of phytase enzyme. The 
Agrivida petition states that this maize is unlikely to pose a plant 
pest risk and, therefore, should not be a regulated article under 
APHIS' regulations in 7 CFR part 340.
    As described in the petition, Maize Event PY203 was grown at six 
locations across the Midwestern United States including sites in Ohio, 
Indiana, Iowa, and Nebraska and at two locations in Argentina. 
Agronomic characteristics of Maize Event PY203 and near isogenic non-
transgenic control plants grown at these locations were assessed 
throughout the life cycle of the plants. These and other data are used 
by APHIS to determine if the new variety poses a plant pest risk.
    The agronomic performance and phenotypic data generated demonstrate 
that the genetic modifications introduced into Maize Event PY203 did 
not have any unintended effects on seed germination, agronomic 
characteristics, or yield. These data support the

[[Page 21171]]

conclusion that Maize Event PY203 is unlikely to develop into feral 
persistent populations or to be more weedy or invasive in the 
environment compared to conventional maize varieties.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for GE organisms. In that notice we indicated that 
APHIS would accept written comments regarding a petition once APHIS 
deemed it complete.
---------------------------------------------------------------------------

    \1\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------

    In accordance with Sec.  340.6(d) of the regulations and 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 regarding the petition for a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. The petition is available for 
public review and comment, and copies are available as indicated under 
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested 
in receiving comments regarding potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition. We are 
particularly interested in receiving comments regarding biological, 
cultural, or ecological issues, and we encourage the submission of 
scientific data, studies, or research to support your comments.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. Any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decision-making documents. As 
part of our decision-making process regarding a GE organism's 
regulatory status, APHIS prepares a plant pest risk assessment to 
assess its plant pest risk and the appropriate environmental 
documentation--either an environmental assessment (EA) or an 
environmental impact statement (EIS)--in accordance with the National 
Environmental Policy Act (NEPA), to provide the Agency with a review 
and analysis of any potential environmental impacts associated with the 
petition request. For petitions for which APHIS prepares an EA, APHIS 
will follow our published process for soliciting public comment (see 
footnote 1) and publish a separate notice in the Federal Register 
announcing the availability of APHIS' EA and plant pest risk 
assessment.
    Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

(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 8th day of April 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-08065 Filed 4-15-20; 8:45 am]
BILLING CODE 3410-34-P

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