Monsanto Company; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance, 65789-65790 [2020-22917]

Download as PDF Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices Comments should reference this docket number and be sent electronically to www.regulations.gov, or in writing to the USDA in care of the Docket Clerk at the address above. All comments received within the provided comment period will be available for public inspection during regular business hours at the same address. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. AMS 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. A 60-day comment period is provided to allow interested persons to respond to the notice. Bruce Summers, Administrator, Agricultural Marketing Service. [FR Doc. 2020–22924 Filed 10–15–20; 8:45 am] BILLING CODE P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2019–0050] Monsanto Company; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that the Animal and Plant Health Inspection Service has prepared a draft plant pest risk assessment and draft environmental assessment regarding a request from Monsanto Company seeking a determination of nonregulated status for cotton designated as MON 88702, which has been genetically engineered for resistance to certain insects, primarily Lygus spp. We are making these documents available for public review and comment. DATES: We will consider all comments that we receive on or before November 16, 2020. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docket Detail;D=APHIS-2019-0050. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2019–0050, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road, Unit 118, Riverdale, MD 20737–1238. The draft environmental assessment, draft plant pest risk assessment, and any comments we receive on this docket may be viewed at https:// www.regulations.gov/#!docketDetail;D= APHIS-2019-0050 or in our reading room, which is located in Room 1620 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. Supporting documents for this petition are also available on the APHIS website at https://www.aphis.usda.gov/ aphis/ourfocus/biotechnology/permitsnotifications-petitions/petitions/ petition-status. FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737–1236; (301) 851–3892, email: cynthia.a.eck@ usda.gov. 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.’’ Pursuant to the terms set forth in a final rule published in the Federal Register on May 17, 2020 (85 FR 29790– 29838, Docket No. APHIS–2018–0034),1 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. APHIS received a petition (APHIS Petition Number 19–091–01p) from Monsanto Company (Monsanto) seeking a determination of nonregulated status of a cotton event designated as MON 1 To view the final rule, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2018-0034. PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 65789 88702, which has been genetically engineered for resistance to certain insects, primarily Lygus spp. The Monsanto petition stated that this cotton is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS’ regulations in 7 CFR part 340. According to our process 2 for soliciting public comment when considering petitions for determination of nonregulated status of GE organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. On Sep 26, 2019, APHIS announced in the Federal Register 3 (84 FR 50818–50819, Docket No. APHIS– 2019–0050) the availability of the Monsanto petition for public comment. APHIS solicited comments on the petition for 60 days ending November 25, 2019, in order to help identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. Thirty-five comments were received during the comment period. Fifteen comments from the agricultural, academic, and private sector were in support of Monsanto’s petition. Fourteen comments from individuals were opposed to approval of Monsanto’s petition. Six comments provided input on analyses to be considered in the environmental assessment (EA), or comments on insect-resistant crops in general. Issues raised during the comment period include evaluation of potential ecological and economic impacts, and potential impacts on nontarget organisms. APHIS has evaluated the issues raised during the comment period and, where appropriate, has provided a discussion of these issues in our EA. After public comments are received on a completed petition, APHIS evaluates those comments and then provides a second opportunity for public involvement in our decisionmaking process. According to our public review process (see footnote 2), the second opportunity for public involvement follows one of two approaches, as described below. 2 On March 6, 2012, APHIS published in the Federal Register (77 FR 13258–13260, Docket No. APHIS–2011–0129) a notice describing our public review process for soliciting public comments and information when considering petitions for determinations of nonregulated status for GE organisms. To view the notice, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2011-0129. 3 To view the notice, its supporting documents, or the comments that we received, go to https:// www.regulations.gov/#!docketDetail;D=APHIS2019-0050. E:\FR\FM\16OCN1.SGM 16OCN1 jbell on DSKJLSW7X2PROD with NOTICES 65790 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices If APHIS decides, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises no substantive new issues, APHIS will follow Approach 1 for public involvement. Under Approach 1, APHIS announces in the Federal Register the availability of APHIS’ preliminary regulatory determination along with its draft EA, preliminary finding of no significant impact (FONSI), and its draft plant pest risk assessment (PPRA) for a 30-day public review period. APHIS will evaluate any information received related to the petition and its supporting documents during the 30-day public review period. For this petition, we are following approach 2. Under this approach, if APHIS decides, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises substantive new issues, APHIS first solicits written comments from the public on a draft EA and draft PPRA for a 30-day comment period through the publication of a Federal Register notice. Then, after reviewing and evaluating the comments on the draft EA and draft PPRA and other information, APHIS will revise the draft PPRA as necessary. It will then prepare a final EA, and based on the final EA, a National Environmental Policy Act (NEPA) decision document (either a FONSI or a notice of intent to prepare an environmental impact statement). As part of our decisionmaking process regarding a GE organism’s regulatory status, APHIS prepares a PPRA to assess the plant pest risk of the article. APHIS also prepares the appropriate environmental documentation—either an EA or an environmental impact statement—in accordance with NEPA. This will provide the Agency and the public with a review and analysis of any potential environmental impacts that may result if the petition request is approved. APHIS concludes in its draft PPRA that MON 88702 cotton, which as stated above has been genetically engineered for resistance to certain insects, primarily Lygus spp., is unlikely to pose a plant pest risk. In section 403 of the Plant Protection Act, ‘‘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 or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. APHIS has also prepared a draft EA in which we present two alternatives based on our analysis of data Monsanto submitted, a review of other scientific data, field tests conducted under APHIS’ oversight, and comments received on the petition (see footnote 3). APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of MON 88702 cotton, or (2) make a determination of nonregulated status for insect-protected MON 88702 cotton. The draft EA was prepared in accordance with (1) 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). Based on APHIS’ analysis of field and laboratory data submitted by Monsanto, references provided in the petition, peer-reviewed publications, information analyzed in the draft EA, the draft PPRA, comments provided by the public on the petition, and discussion of issues in the draft EA, APHIS has determined that cotton designated as event MON 88702 is unlikely to pose a plant pest risk. We are making available for a 30-day review period our draft PPRA and draft EA. The draft EA and draft PPRA are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of these documents may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT. After the 30-day review period closes, APHIS will review and evaluate any information received during the 30-day review period. APHIS will revise the draft PPRA as necessary and prepare a final EA and, based on the final EA, a NEPA decision document (either a FONSI or a notice of intent to prepare an environmental impact statement). 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 9th day of October 2020. Michael Watson, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2020–22917 Filed 10–15–20; 8:45 am] BILLING CODE 3410–34–P PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B–60–2020] Foreign-Trade Zone (FTZ) 90— Syracuse, New York; Notification of Proposed Production Activity; PPC Broadband, Inc. (Fiber Optic Cables); Dewitt, New York PPC Broadband, Inc. (PPC Broadband) submitted a notification of proposed production activity to the FTZ Board for its facility in Dewitt, New York. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on October 8, 2020. PPC Broadband already has authority to produce hardline coaxial cables within Subzone 90C. The current request would add finished products and foreign status components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreignstatus components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board. Production under FTZ procedures could exempt PPC Broadband from customs duty payments on the foreignstatus materials/components used in export production. On its domestic sales, for the foreign-status materials/ components noted below and in the existing scope of authority, PPC Broadband would be able to choose the duty rates during customs entry procedures that apply to fiber optic cables and fiber optic terminated jumpers or patchcords (duty-free). PPC Broadband would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment. The materials/components sourced from abroad include: Tight buffered fibers; aramid yarn, swellcoat blockers or equivalent; polymer pocan polybutylene terephthalate, crastin or equivalent; copper tone wires (0.182 mm); talc—magsil diamond; and, fiber optic connectors (duty rate ranges from duty-free to 8%). The request indicates that aramid yarn and swellcoat blockers or equivalent will be admitted to the zone in privileged foreign status (19 CFR 146.41), thereby precluding inverted tariff benefits on such items. The request also indicates that certain components are subject to duties under Section 301 of the Trade Act of 1974 (Section 301), depending on the country E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65789-65790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22917]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2019-0050]


Monsanto Company; Availability of a Draft Plant Pest Risk 
Assessment and Draft Environmental Assessment for Determination of 
Nonregulated Status of Cotton Genetically Engineered for Insect 
Resistance

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 prepared a draft plant pest risk assessment and 
draft environmental assessment regarding a request from Monsanto 
Company seeking a determination of nonregulated status for cotton 
designated as MON 88702, which has been genetically engineered for 
resistance to certain insects, primarily Lygus spp. We are making these 
documents available for public review and comment.

DATES: We will consider all comments that we receive on or before 
November 16, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2019-0050, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    The draft environmental assessment, draft plant pest risk 
assessment, and any comments we receive on this docket may be viewed at 
https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050 or in our 
reading room, which is located in Room 1620 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.
    Supporting documents for this petition are also available on the 
APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.

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.''
    Pursuant to the terms set forth in a final rule published in the 
Federal Register on May 17, 2020 (85 FR 29790-29838, Docket No. APHIS-
2018-0034),\1\ 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. APHIS received a 
petition (APHIS Petition Number 19-091-01p) from Monsanto Company 
(Monsanto) seeking a determination of nonregulated status of a cotton 
event designated as MON 88702, which has been genetically engineered 
for resistance to certain insects, primarily Lygus spp. The Monsanto 
petition stated that this cotton is unlikely to pose a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
---------------------------------------------------------------------------

    \1\ To view the final rule, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
---------------------------------------------------------------------------

    According to our process \2\ for soliciting public comment when 
considering petitions for determination of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. On Sep 26, 2019, APHIS announced in the 
Federal Register \3\ (84 FR 50818-50819, Docket No. APHIS-2019-0050) 
the availability of the Monsanto petition for public comment. APHIS 
solicited comments on the petition for 60 days ending November 25, 
2019, in order to help identify potential environmental and 
interrelated economic issues and impacts that APHIS may determine 
should be considered in our evaluation of the petition.
---------------------------------------------------------------------------

    \2\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \3\ To view the notice, its supporting documents, or the 
comments that we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0050.
---------------------------------------------------------------------------

    Thirty-five comments were received during the comment period. 
Fifteen comments from the agricultural, academic, and private sector 
were in support of Monsanto's petition. Fourteen comments from 
individuals were opposed to approval of Monsanto's petition. Six 
comments provided input on analyses to be considered in the 
environmental assessment (EA), or comments on insect-resistant crops in 
general. Issues raised during the comment period include evaluation of 
potential ecological and economic impacts, and potential impacts on 
non-target organisms. APHIS has evaluated the issues raised during the 
comment period and, where appropriate, has provided a discussion of 
these issues in our EA.
    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 2), the second opportunity for 
public involvement follows one of two approaches, as described below.

[[Page 65790]]

    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises no substantive new issues, APHIS will follow 
Approach 1 for public involvement. Under Approach 1, APHIS announces in 
the Federal Register the availability of APHIS' preliminary regulatory 
determination along with its draft EA, preliminary finding of no 
significant impact (FONSI), and its draft plant pest risk assessment 
(PPRA) for a 30-day public review period. APHIS will evaluate any 
information received related to the petition and its supporting 
documents during the 30-day public review period.
    For this petition, we are following approach 2. Under this 
approach, if APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises substantive new issues, APHIS first solicits 
written comments from the public on a draft EA and draft PPRA for a 30-
day comment period through the publication of a Federal Register 
notice. Then, after reviewing and evaluating the comments on the draft 
EA and draft PPRA and other information, APHIS will revise the draft 
PPRA as necessary. It will then prepare a final EA, and based on the 
final EA, a National Environmental Policy Act (NEPA) decision document 
(either a FONSI or a notice of intent to prepare an environmental 
impact statement).
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA. This will provide the Agency and the public with 
a review and analysis of any potential environmental impacts that may 
result if the petition request is approved.
    APHIS concludes in its draft PPRA that MON 88702 cotton, which as 
stated above has been genetically engineered for resistance to certain 
insects, primarily Lygus spp., is unlikely to pose a plant pest risk. 
In section 403 of the Plant Protection Act, ``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 or 
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 has also prepared a draft EA in which we present two 
alternatives based on our analysis of data Monsanto submitted, a review 
of other scientific data, field tests conducted under APHIS' oversight, 
and comments received on the petition (see footnote 3). APHIS is 
considering the following alternatives: (1) Take no action, i.e., APHIS 
would not change the regulatory status of MON 88702 cotton, or (2) make 
a determination of nonregulated status for insect-protected MON 88702 
cotton.
    The draft EA was prepared in accordance with (1) 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).
    Based on APHIS' analysis of field and laboratory data submitted by 
Monsanto, references provided in the petition, peer-reviewed 
publications, information analyzed in the draft EA, the draft PPRA, 
comments provided by the public on the petition, and discussion of 
issues in the draft EA, APHIS has determined that cotton designated as 
event MON 88702 is unlikely to pose a plant pest risk.
    We are making available for a 30-day review period our draft PPRA 
and draft EA. The draft EA and draft PPRA are available as indicated 
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of 
these documents may also be obtained from the person listed under FOR 
FURTHER INFORMATION CONTACT.
    After the 30-day review period closes, APHIS will review and 
evaluate any information received during the 30-day review period. 
APHIS will revise the draft PPRA as necessary and prepare a final EA 
and, based on the final EA, a NEPA decision document (either a FONSI or 
a notice of intent to prepare an environmental impact statement).

    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 9th day of October 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-22917 Filed 10-15-20; 8:45 am]
BILLING CODE 3410-34-P
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