82 FR 17625 - Bayer CropScience LP.; Availability of Draft Environmental Assessment, Plant Pest Risk Similarity Assessment, Preliminary Finding of No Significant Impact, and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium Resistance
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 82, Issue 69 (April 12, 2017)
Animal and Plant Health Inspection Service
Federal Register Volume 82, Issue 69 (April 12, 2017)
| Page Range | 17625-17626 | |
| FR Document | 2017-07359 |
[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)] [Notices] [Pages 17625-17626] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07359] ======================================================================== Notices Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. ======================================================================== Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Notices [[Page 17625]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0015] Bayer CropScience LP.; Availability of Draft Environmental Assessment, Plant Pest Risk Similarity Assessment, Preliminary Finding of No Significant Impact, and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Canola Genetically Engineered for Male Sterility and Glufosinate-Ammonium 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 reached a preliminary decision to extend our determination of nonregulated status of InVigor[supreg] MS8 canola (hereinafter MS8 canola) to Bayer's canola event MS11 in response to a request from Bayer CropScience LP. MS11 canola has been genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium using the same mechanism of action as MS8 canola. We are making available for public comment our draft environmental assessment, preliminary regulatory determination, preliminary finding of no significant impact, and plant pest risk similarity assessment for the proposed determination of nonregulated status. DATES: We will consider all comments that we receive on or before May 12, 2017. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0015. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0015, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737- 1238. The Bayer CropScience LP. extension request, our draft environmental assessment, plant pest risk similarity assessment, our preliminary 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-2017-0015 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. Supporting documents and any comments we received regarding our determination of nonregulated status of the antecedent organism, MS8 canola, may be inspected in our reading room. Supporting documents may also be found on the APHIS Web site for MS11 canola (the organism under evaluation) under APHIS Petition Number 16-235-01p. FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Document Control Officer/Team Leader, Policy Coordination Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected]. 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 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. Further, the regulations in Sec. 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question. On March 31, 1999,\1\ APHIS announced its determination of nonregulated status of MS8 canola (Brassica napus L.), which was genetically engineered for male sterility and resistance to the herbicide glufosinate-ammonium. APHIS has received a request for an extension of that determination of nonregulated status of MS8 canola to canola designated as canola event MS11 (APHIS Petition Number 16-235- 01p) from Bayer CropScience LP. (Bayer) of Research Triangle Park, NC. MS11 canola expresses male sterility and resistance to the herbicide glufosinate-ammonium. In its request, Bayer stated that this canola is similar to the antecedent organism MS8 canola and, based on the similarity to the antecedent organism, 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\ https://www.federalregister.gov/documents/1999/03/31/99-7803/agrevo-usa-co-availability-of-determination-of-nonregulated-status-for-canola-genetically-engineered?utm_content=next&utm_medium=PrevNext&utm_source=Article. --------------------------------------------------------------------------- As described in the extension request, MS11 canola was developed using the gene cassette pTCO113 containing the same genetic events used to transform MS8 canola (gene cassette pTHW107) with male sterility and resistance to glufosinate-ammonium. Based on the information in the request, we have concluded that MS11 canola is similar to MS8 canola. MS11 canola 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 [[Page 17626]] 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 prepared a plant pest risk similarity assessment (PPRSA) to compare MS11 canola to the antecedent. As described in the PPRSA, the proteins expressed in MS11 canola are similar to those expressed in MS8 canola, and APHIS has concluded that the proteins expressed in MS8 canola are unlikely to pose a plant health risk. Therefore, based on the similarity between MS8 canola and MS11 canola as described in the PPRSA, APHIS has concluded that MS11 canola is no more likely to pose a plant pest risk than MS8 canola. APHIS has also prepared a draft environmental assessment (EA) in which it presents two alternatives based on its analysis of data submitted by Bayer, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of MS11 canola and it would continue to be a regulated article, or (2) make a determination of nonregulated status for MS11 canola. Based on the similarity of MS11 canola to MS8 canola, APHIS has also prepared a preliminary finding of no significant impact (FONSI) for MS11 canola. The draft EA and the FONSI were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (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). APHIS has analyzed information submitted by Bayer, references provided in the extension request, peer-reviewed publications, and supporting documentation prepared for the antecedent organism. Based on APHIS' analysis of this information and the similarity of MS11 canola to the antecedent organism MS8 canola, APHIS has determined that MS11 canola is unlikely to pose a plant pest risk. We have therefore reached a preliminary decision to approve the request to extend the determination of nonregulated status of MS8 canola to MS11 canola, whereby MS11 canola would no longer be subject to our regulations governing the introduction of certain genetically engineered organisms. Paragraph (e) of Sec. 340.6 provides that APHIS will publish a notice in the Federal Register announcing all preliminary decisions to extend determinations of nonregulated status for 30 days before the decisions become final and effective. In accordance with Sec. 340.6(e) of the regulations, we are publishing this notice to inform the public of our preliminary decision to extend the determination of nonregulated status of MS8 canola to MS11 canola. APHIS will accept written comments on the draft EA and preliminary FONSI regarding a determination of nonregulated status of MS11 canola for a period of 30 days from the date this notice is published in the Federal Register. The draft EA and preliminary FONSI, as well as the extension request, PPRSA, and our preliminary determination for MS11 canola, are available for public review as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of these documents may also be obtained by contacting the person listed under FOR FURTHER INFORMATION CONTACT. 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, APHIS will furnish a response to the petitioner regarding our final regulatory determination. APHIS will also publish a notice in the Federal Register announcing the regulatory status of MS11 canola and the availability of APHIS' written environmental decision and regulatory determination. 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 6th day of April 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2017-07359 Filed 4-11-17; 8:45 am] BILLING CODE 3410-34-P
![17625
Notices Federal Register
Vol. 82, No. 69
Wednesday, April 12, 2017
This section of the FEDERAL REGISTER • Postal Mail/Commercial Delivery: The regulations in § 340.6(a) provide
contains documents other than rules or Send your comment to Docket No. that any person may submit a petition
proposed rules that are applicable to the APHIS–2017–0015, Regulatory Analysis to the Animal and Plant Health
public. Notices of hearings and investigations, and Development, PPD, APHIS, Station Inspection Service (APHIS) seeking a
committee meetings, agency decisions and 3A–03.8, 4700 River Road Unit 118, determination that an article should not
rulings, delegations of authority, filing of
petitions and applications and agency
Riverdale, MD 20737–1238. be regulated under 7 CFR part 340.
statements of organization and functions are The Bayer CropScience LP. extension Further, the regulations in § 340.6(e)(2)
examples of documents appearing in this request, our draft environmental provide that a person may request that
section. assessment, plant pest risk similarity APHIS extend a determination of
assessment, our preliminary finding of nonregulated status to other organisms.
no significant impact, our preliminary Such a request must include
DEPARTMENT OF AGRICULTURE determination, and any comments we information to establish the similarity of
receive on this docket may be viewed at the antecedent organism and the
Animal and Plant Health Inspection http://www.regulations.gov/ regulated article in question.
Service #!docketDetail;D=APHIS-2017-0015 or On March 31, 1999,1 APHIS
in our reading room, which is located in announced its determination of
[Docket No. APHIS–2017–0015] room 1141 of the USDA South Building, nonregulated status of MS8 canola
14th Street and Independence Avenue (Brassica napus L.), which was
Bayer CropScience LP.; Availability of SW., Washington, DC. Normal reading genetically engineered for male sterility
Draft Environmental Assessment, room hours are 8 a.m. to 4:30 p.m., and resistance to the herbicide
Plant Pest Risk Similarity Assessment, Monday through Friday, except glufosinate-ammonium. APHIS has
Preliminary Finding of No Significant holidays. To be sure someone is there to received a request for an extension of
Impact, and Preliminary Decision for help you, please call (202) 7997039 that determination of nonregulated
an Extension of a Determination of before coming. status of MS8 canola to canola
Nonregulated Status of Canola Supporting documents and any designated as canola event MS11
Genetically Engineered for Male comments we received regarding our (APHIS Petition Number 16–235–01p)
Sterility and Glufosinate-Ammonium determination of nonregulated status of from Bayer CropScience LP. (Bayer) of
Resistance the antecedent organism, MS8 canola, Research Triangle Park, NC. MS11
may be inspected in our reading room. canola expresses male sterility and
AGENCY: Animal and Plant Health
Supporting documents may also be resistance to the herbicide glufosinate-
Inspection Service, USDA.
found on the APHIS Web site for MS11 ammonium. In its request, Bayer stated
ACTION: Notice. that this canola is similar to the
canola (the organism under evaluation)
under APHIS Petition Number 16–235– antecedent organism MS8 canola and,
SUMMARY: We are advising the public
01p. based on the similarity to the antecedent
that the Animal and Plant Health
organism, is unlikely to pose a plant
Inspection Service has reached a FOR FURTHER INFORMATION CONTACT: Ms.
pest risk and, therefore, should not be
preliminary decision to extend our Cindy Eck, Document Control Officer/ a regulated article under APHIS’
determination of nonregulated status of Team Leader, Policy Coordination regulations in 7 CFR part 340.
InVigor® MS8 canola (hereinafter MS8 Programs, Biotechnology Regulatory As described in the extension request,
canola) to Bayer’s canola event MS11 in Services, APHIS, 4700 River Road Unit MS11 canola was developed using the
response to a request from Bayer 147 Riverdale, MD 20737–1236; (301) gene cassette pTCO113 containing the
CropScience LP. MS11 canola has been 851–3954, email: cynthia.a.eck@ same genetic events used to transform
genetically engineered for male sterility aphis.usda.gov. MS8 canola (gene cassette pTHW107)
and resistance to the herbicide
SUPPLEMENTARY INFORMATION: Under the with male sterility and resistance to
glufosinate-ammonium using the same
authority of the plant pest provisions of glufosinate-ammonium. Based on the
mechanism of action as MS8 canola. We
the Plant Protection Act (PPA) (7 U.S.C. information in the request, we have
are making available for public
7701 et seq.), the regulations in 7 CFR concluded that MS11 canola is similar
comment our draft environmental
part 340, ‘‘Introduction of Organisms to MS8 canola. MS11 canola is currently
assessment, preliminary regulatory
and Products Altered or Produced regulated under 7 CFR part 340.
determination, preliminary finding of As part of our decisionmaking process
no significant impact, and plant pest Through Genetic Engineering Which
Are Plant Pests or Which There Is regarding a GE organism’s regulatory
risk similarity assessment for the status, APHIS evaluates the plant pest
proposed determination of nonregulated Reason to Believe Are Plant Pests,’’
regulate, among other things, the risk of the article. In section 403 of the
status. PPA, ‘‘plant pest’’ is defined as any
introduction (importation, interstate
DATES: We will consider all comments living stage of any of the following that
movement, or release into the
mstockstill on DSK30JT082PROD with NOTICES
that we receive on or before May 12, environment) of organisms and products can directly or indirectly injure, cause
2017. altered or produced through genetic damage to, or cause disease in any plant
ADDRESSES: You may submit comments engineering that are plant pests or that
1 https://www.federalregister.gov/documents/
by either of the following methods: there is reason to believe are plant pests.
1999/03/31/99-7803/agrevo-usa-co-availability-of-
• Federal eRulemaking Portal: Go to Such genetically engineered organisms determination-of-nonregulated-status-for-canola-
http://www.regulations.gov/#!docket (GE) and products are considered genetically-engineered?utm_content=next&utm_
Detail;D=APHIS-2017-0015. ‘‘regulated articles.’’ medium=PrevNext&utm_source=Article.
VerDate Sep<11>2014 18:45 Apr 11, 2017 Jkt 241001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1](https://thefederalregister.org/doc/82_FR_17694/page/1.svg)
![17626 Federal Register / Vol. 82, No. 69 / Wednesday, April 12, 2017 / Notices
product: A protozoan, a nonhuman Paragraph (e) of § 340.6 provides that SUMMARY: In accordance with the
animal, a parasitic plant, a bacterium, a APHIS will publish a notice in the Paperwork Reduction Act of 1995, this
fungus, a virus or viroid, an infectious Federal Register announcing all notice invites the general public and
agent or other pathogen, or any article preliminary decisions to extend other public agencies to comment on
similar to or allied with any of the determinations of nonregulated status this proposed information collection.
foregoing. for 30 days before the decisions become This is a revision of a currently
APHIS has prepared a plant pest risk final and effective. In accordance with approved collection. This collection is
similarity assessment (PPRSA) to § 340.6(e) of the regulations, we are the voluntary submission of data
compare MS11 canola to the antecedent. publishing this notice to inform the including nutrient data from the food
As described in the PPRSA, the proteins public of our preliminary decision to industry to update and expand the
expressed in MS11 canola are similar to extend the determination of Child Nutrition Database in support of
those expressed in MS8 canola, and nonregulated status of MS8 canola to the Healthy Hunger Free Kids Act.
APHIS has concluded that the proteins MS11 canola. DATES: Written comments on this notice
expressed in MS8 canola are unlikely to APHIS will accept written comments must be received by June 12, 2017 to be
pose a plant health risk. Therefore, on the draft EA and preliminary FONSI assured of consideration.
based on the similarity between MS8 regarding a determination of ADDRESSES: Comments may be sent to:
canola and MS11 canola as described in nonregulated status of MS11 canola for Natalie Partridge, Nutritionist, Nutrition
the PPRSA, APHIS has concluded that a period of 30 days from the date this Education, Training and Technical
MS11 canola is no more likely to pose notice is published in the Federal Assistance Division, Child Nutrition
a plant pest risk than MS8 canola. Register. The draft EA and preliminary Programs, Room 630, Food and
APHIS has also prepared a draft FONSI, as well as the extension request, Nutrition Service, United States
environmental assessment (EA) in PPRSA, and our preliminary Department of Agriculture, 3101 Park
which it presents two alternatives based determination for MS11 canola, are Center Drive, Alexandria, VA 22302.
on its analysis of data submitted by available for public review as indicated Comments may also be submitted via
Bayer, a review of other scientific data, under ADDRESSES and FOR FURTHER email to the attention of Natalie
and field tests conducted under APHIS INFORMATION CONTACT above. Copies of Partridge at natalie.partridge@
oversight. APHIS is considering the these documents may also be obtained fns.usda.gov with ‘‘CN Database
following alternatives: (1) Take no by contacting the person listed under Comments’’ in the subject line.
action, i.e., APHIS would not change the FOR FURTHER INFORMATION CONTACT. Comments will also be accepted through
regulatory status of MS11 canola and it After the comment period closes, the Federal eRulemaking Portal. Go to
would continue to be a regulated article, APHIS will review all written comments http://www.regulations.gov and follow
or (2) make a determination of received during the comment period the online instructions for submitting
nonregulated status for MS11 canola. and any other relevant information. All
Based on the similarity of MS11 comments electronically. All responses
comments will be available for public to this notice will be summarized and
canola to MS8 canola, APHIS has also
review. After reviewing and evaluating included in the request for Office of
prepared a preliminary finding of no
the comments, APHIS will furnish a Management and Budget approval. All
significant impact (FONSI) for MS11
response to the petitioner regarding our comments will be a matter of public
canola. The draft EA and the FONSI
final regulatory determination. APHIS record.
were prepared in accordance with: (1)
will also publish a notice in the Federal
The National Environmental Policy Act FOR FURTHER INFORMATION CONTACT:
Register announcing the regulatory
of 1969 (NEPA), as amended (42 U.S.C. Requests for additional information or
status of MS11 canola and the
4321 et seq.); (2) regulations of the copies of the information collection
availability of APHIS’ written
Council on Environmental Quality for instrument and instruction should be
implementing the procedural provisions environmental decision and regulatory
directed to Natalie Partridge at (703)
of NEPA (40 CFR parts 1500–1508); (3) determination.
457–6803.
USDA regulations implementing NEPA Authority: 7 U.S.C. 7701–7772 and 7781– SUPPLEMENTARY INFORMATION: Comments
(7 CFR part 1b); and (4) APHIS’ NEPA 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and are invited on: (a) Whether the proposed
Implementing Procedures (7 CFR part 371.3.
collection of information is necessary
372). Done in Washington, DC, this 6th day of for the proper performance of the
APHIS has analyzed information April 2017. functions of the Agency, including
submitted by Bayer, references provided Michael C. Gregoire, whether the information will have
in the extension request, peer-reviewed Acting Administrator, Animal and Plant practical utility; (b) the accuracy of the
publications, and supporting Health Inspection Service. Agency’s estimate of the burden of the
documentation prepared for the [FR Doc. 2017–07359 Filed 4–11–17; 8:45 am] proposed collection of information,
antecedent organism. Based on APHIS’ BILLING CODE 3410–34–P including the validity of the
analysis of this information and the methodology and assumptions used; (c)
similarity of MS11 canola to the ways to enhance the quality, utility, and
antecedent organism MS8 canola, DEPARTMENT OF AGRICULTURE clarity of the information to be
APHIS has determined that MS11 collected; and (d) ways to minimize the
canola is unlikely to pose a plant pest Food and Nutrition Service burden of the collection of information
risk. We have therefore reached a on those who are to respond, including
preliminary decision to approve the Agency Information Collection
mstockstill on DSK30JT082PROD with NOTICES
Activities: Proposed Collection; use of appropriate automated,
request to extend the determination of electronic, mechanical, or other
nonregulated status of MS8 canola to Comment Request—Child Nutrition
Database technological collection techniques or
MS11 canola, whereby MS11 canola other forms of information technology.
would no longer be subject to our AGENCY: Food and Nutrition Service Title: Child Nutrition Database.
regulations governing the introduction (FNS), USDA. Form Number: FNS–710.
of certain genetically engineered OMB Number: 0584–0494.
ACTION: Notice.
organisms. Expiration Date: August 31, 2017.
VerDate Sep<11>2014 18:45 Apr 11, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\12APN1.SGM 12APN1](https://thefederalregister.org/doc/82_FR_17694/page/2.svg)
Document Created: 2017-04-12 00:23:36
Document Modified: 2017-04-12 00:23:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | We will consider all comments that we receive on or before May 12, 2017. | |
| Contact | Ms. Cindy Eck, Document Control Officer/Team Leader, Policy Coordination Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] | |
| FR Citation | 82 FR 17625 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR