80 FR 76261 - J.R. Simplot Company; Availability of Preliminary Finding of No Significant Impact, Similarity Assessment, and Preliminary Decision for an Extension of a Determination of Nonregulated Status to V11 Snowden Potatoes With Low Acrylamide Potential and Reduced Black Spot Bruise
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 80, Issue 235 (December 8, 2015)
Animal and Plant Health Inspection Service
Federal Register Volume 80, Issue 235 (December 8, 2015)
| Page Range | 76261-76263 | |
| FR Document | 2015-30878 |
[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)] [Notices] [Pages 76261-76263] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30878] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2015-0088] J.R. Simplot Company; Availability of Preliminary Finding of No Significant Impact, Similarity Assessment, and Preliminary Decision for an Extension of a Determination of Nonregulated Status to V11 Snowden Potatoes With Low Acrylamide Potential and Reduced Black Spot Bruise 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 Innate\TM\ potato to Snowden potato variety event SPS-00V11-6 (hereinafter V11 potato) in response to a request from the J.R. Simplot Company. V11 potato has been genetically engineered to exhibit low acrylamide potential in cooked potatoes and reduced black spot bruise. We are making available for public comment our preliminary finding of no significant impact, our similarity assessment, and our preliminary extended determination of nonregulated status. DATES: We will consider all comments that we receive on or before January 7, 2016. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0088. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0088, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737- 1238. The J.R. Simplot Company extension request, our preliminary finding of no significant impact, our similarity assessment, our preliminary determination, and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0088 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) 799-7039 before coming. Supporting documents and any comments we received regarding our determination of nonregulated status of the antecedent organisms (Innate\TM\ Potato events E12, F10, and J3), can be found at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067. Supporting documents may also be found on the APHIS Web site for V11 potato (the organism under evaluation) under APHIS Petition Number 15-140-01p, and the antecedent organisms (Innate\TM\ Potato events E12, F10, and J3) under APHIS Petition Number 13-022-01p. FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: john.t.turner@aphis.usda.gov. To obtain copies of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, email: cynthia.a.eck@aphis.usda.gov. 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 [[Page 76262]] 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 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. In a notice \1\ published in the Federal Register on November 10, 2014 (79 FR 66688-66689, Docket No. APHIS-2012-0067), APHIS announced our determination of nonregulated status of potatoes (Solanum tuberosum) designated as InnateTM potatoes (events E12, E24, F10, F37, J3, J55, J78, G11, H37, and H50), which have been genetically engineered for low acrylamide potential and reduced black spot bruise. Acrylamide is a human neurotoxicant and potential carcinogen that may form in potatoes and other starchy foods under certain cooking conditions. APHIS has received a request for an extension of a determination of nonregulated status of InnateTM potatoes (APHIS Petition Number 13-022-01p) to Snowden potato variety event SPS- 00V11-6 (hereinafter V11 potato) (APHIS Petition Number 15-140-01p) from the J.R. Simplot Company (Simplot) of Boise, ID. In the extension request, Simplot named three of the ten previously deregulated events as antecedents. Like the antecedents, V11 potato has been genetically engineered for low acrylamide potential and reduced black spot bruise. In its request, Simplot stated that V11 potato was produced by transforming an additional variety of potato, Snowden, using the same DNA and method that was used for the antecedent potatoes and, based on the similarity, is unlikely to pose a plant pest risk. Therefore, the request stated that V11 potato should not be a regulated article under APHIS' regulations in 7 CFR part 340. --------------------------------------------------------------------------- \1\ To view the notice, our determination, supporting documents, and the comments we have received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0067. --------------------------------------------------------------------------- As described in the extension request, V11 potato has been genetically engineered through the insertion of genetic elements from potato or wild potato (a group of related plant species that are sexually compatible with potato) using Simplot's InnateTM technologies. APHIS has previously assessed the risks associated with the insertion of these same genetic elements into potato and concluded that the resulting organisms did not pose a plant pest risk. Based on the information in the request, we have concluded that V11 potato is similar to the antecedent potatoes. V11 potato is currently regulated under 7 CFR part 340. 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 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 completed a plant pest risk assessment (PPRA) and an environmental assessment (EA) for the antecedent organisms. Based on those assessments, we concluded that the antecedent organisms are unlikely to present a plant pest risk. V11 potato expresses the same low acrylamide potential and reduced black spot bruise prevalence as the antecedent potatoes. Therefore, based on our PPRA for the antecedents and the similarity between V11 potato and the antecedents, APHIS has concluded that V11 potato is unlikely to pose a plant pest risk. The EA for the antecedent organisms was prepared using data submitted by Simplot, a review of other scientific data, and field tests conducted under APHIS oversight. The EA was prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status of the antecedent potatoes. The EA was 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). Based on the similarity of V11 potato to the antecedent potatoes, APHIS has prepared a preliminary finding of no significant impact (FONSI) on V11 potato using the EA prepared for InnateTM potato. APHIS considered the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of V11 potato and it would continue to be a regulated article, or (2) make a determination of nonregulated status of V11 potato. APHIS' preferred alternative is to make a determination of nonregulated status of V11 potato. APHIS has carefully examined the existing NEPA documentation completed for InnateTM potato and has concluded that Simplot's request to extend a determination of nonregulated status to V11 potato encompasses the same scope of environmental analysis as the antecedent potatoes. Based on APHIS' analysis of information submitted by Simplot, references provided in the extension request, peer-reviewed publications, information analyzed in the EA, and the similarity of V11 potato to the antecedent organisms, APHIS has determined that V11 potato 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 InnateTM potato to V11 potato, whereby V11 potato 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 the antecedent potatoes to V11 potato. APHIS will accept written comments on the FONSI regarding a determination of nonregulated status of V11 potato for a period of 30 days from the date this notice is published in the Federal Register. The FONSI, as well as the extension request, supporting documents, and our preliminary determination for V11 potato, 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 [[Page 76263]] the comments, if APHIS determines that no substantive information has been received that would warrant APHIS altering its preliminary regulatory determination or FONSI, our preliminary regulatory determination will become final and effective upon notification of the public through an announcement on our Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml. APHIS will also furnish a response to the petitioner regarding our final regulatory determination. No further Federal Register notice will be published announcing the final regulatory determination regarding V11 potato. 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 2nd day of December 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2015-30878 Filed 12-7-15; 8:45 am] BILLING CODE 3410-34-P
![Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices 76261
(FONSI) or a notice of intent to prepare references provided in the petition, DATES: We will consider all comments
an environmental impact statement). If peer-reviewed publications, information that we receive on or before January 7,
a FONSI is reached, APHIS furnishes a analyzed in the EA, the PPRA, 2016.
response to the petitioner, either comments provided by the public, and ADDRESSES: You may submit comments
approving or denying the petition. information provided in APHIS’ by either of the following methods:
APHIS also publishes a notice in the response to those public comments, • Federal eRulemaking Portal: Go to
Federal Register announcing the APHIS has determined that maize http://www.regulations.gov/
regulatory status of the GE organism and designated as event MON 87403 is #!docketDetail;D=APHIS-2015-0088.
the availability of APHIS’ final EA, unlikely to pose a plant pest risk and • Postal Mail/Commercial Delivery:
PPRA, FONSI, and our regulatory therefore are no longer subject to our Send your comment to Docket No.
determination. regulations governing the introduction APHIS–2015–0088, Regulatory Analysis
APHIS sought public comment on a of certain GE organisms. and Development, PPD, APHIS, Station
draft EA and a preliminary PPRA from Copies of the signed determination 3A–03.8, 4700 River Road Unit 118,
July 21, 2015, to August 20, 2015.3 document, PPRA, final EA, FONSI, and Riverdale, MD 20737–1238.
APHIS solicited comments on the draft response to comments, as well as the The J.R. Simplot Company extension
EA, the preliminary PPRA, and whether previously published petition and request, our preliminary finding of no
the subject maize is likely to pose a supporting documents, are available as significant impact, our similarity
plant pest risk. APHIS received 4 indicated in the ADDRESSES and FOR assessment, our preliminary
comments on the petition. One FURTHER INFORMATION CONTACT sections determination, and any comments we
commenter supported a decision of of this notice. receive on this docket may be viewed at
nonregulated status for MON 87403 Authority: 7 U.S.C. 7701–7772 and 7781– http://www.regulations.gov/
maize; two were opposed, and one was 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and #!docketDetail;D=APHIS-2015-0088 or
in support of nonregulated status but 371.3. in our reading room, which is located in
wanted APHIS to require continued Done in Washington, DC, this 2nd day of Room 1141 of the USDA South
oversight during the commercialization December 2015. Building, 14th Street and Independence
process. Issues raised during the Kevin Shea, Avenue SW., Washington, DC. Normal
comment period included concerns Administrator, Animal and Plant Health reading room hours are 8 a.m. to 4:30
regarding general safety, potential for Inspection Service. p.m., Monday through Friday, except
increased weediness, and the potential [FR Doc. 2015–30877 Filed 12–7–15; 8:45 am] holidays. To be sure someone is there to
for gene flow to other corn varieties. help you, please call (202) 799–7039
BILLING CODE 3410–34–P
APHIS has addressed the issues raised before coming.
during the comment period and has Supporting documents and any
provided responses to comments as an DEPARTMENT OF AGRICULTURE comments we received regarding our
attachment to the FONSI. National determination of nonregulated status of
Environmental Policy Act. Animal and Plant Health Inspection the antecedent organisms (InnateTM
After reviewing and evaluating the Service Potato events E12, F10, and J3), can be
comments received during the comment found at http://www.regulations.gov/
period on the draft EA and preliminary [Docket No. APHIS–2015–0088]
#!docketDetail;D=APHIS-2012-0067.
PPRA and other information, APHIS has Supporting documents may also be
J.R. Simplot Company; Availability of
prepared a final EA. The EA has been found on the APHIS Web site for V11
Preliminary Finding of No Significant
prepared to provide the public with potato (the organism under evaluation)
Impact, Similarity Assessment, and
documentation of APHIS’ review and under APHIS Petition Number 15–140–
Preliminary Decision for an Extension
analysis of any potential environmental 01p, and the antecedent organisms
of a Determination of Nonregulated
impacts associated with the (InnateTM Potato events E12, F10, and
Status to V11 Snowden Potatoes With
determination of nonregulated status of J3) under APHIS Petition Number 13–
Low Acrylamide Potential and
maize designated as event MON 87403. 022–01p.
Reduced Black Spot Bruise
The EA was prepared in accordance FOR FURTHER INFORMATION CONTACT: Dr.
with: (1) NEPA, as amended (42 U.S.C. AGENCY: Animal and Plant Health John Turner, Director, Environmental
4321 et seq.), (2) regulations of the Inspection Service, USDA. Risk Analysis Programs, Biotechnology
Council on Environmental Quality for ACTION: Notice. Regulatory Services, APHIS, 4700 River
implementing the procedural provisions Road Unit 147, Riverdale, MD 20737–
of NEPA (40 CFR parts 1500–1508), (3) SUMMARY: We are advising the public
that the Animal and Plant Health 1236; (301) 851–3954, email:
USDA regulations implementing NEPA john.t.turner@aphis.usda.gov. To obtain
(7 CFR part 1b), and (4) APHIS’ NEPA Inspection Service has reached a
preliminary decision to extend our copies of the supporting documents,
Implementing Procedures (7 CFR part contact Ms. Cindy Eck at (301) 851–
372). Based on our EA, the response to determination of nonregulated status of
InnateTM potato to Snowden potato 3885, email: cynthia.a.eck@
public comments, and other pertinent aphis.usda.gov.
scientific data, APHIS has reached a variety event SPS–00V11–6 (hereinafter
FONSI with regard to the preferred V11 potato) in response to a request SUPPLEMENTARY INFORMATION: Under the
alternative identified in the EA (to make from the J.R. Simplot Company. V11 authority of the plant pest provisions of
a determination of nonregulated status potato has been genetically engineered the Plant Protection Act (PPA) (7 U.S.C.
of maize designated as event MON to exhibit low acrylamide potential in 7701 et seq.), the regulations in 7 CFR
Lhorne on DSK9F6TC42PROD with NOTICES
87403). cooked potatoes and reduced black spot part 340, ‘‘Introduction of Organisms
bruise. We are making available for and Products Altered or Produced
Determination public comment our preliminary finding Through Genetic Engineering Which
Based on APHIS’ analysis of field and of no significant impact, our similarity Are Plant Pests or Which There Is
laboratory data submitted by Monsanto, assessment, and our preliminary Reason to Believe Are Plant Pests,’’
extended determination of nonregulated regulate, among other things, the
3 80 FR 43053–43055. status. introduction (importation, interstate
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![Federal Register / Vol. 80, No. 235 / Tuesday, December 8, 2015 / Notices 76263
the comments, if APHIS determines that Executive Office Building, 725—17th Total Burden Hours: 2,493.
no substantive information has been Street NW., Washington, DC 20503. Title: Stocks Reports.
received that would warrant APHIS Commenters are encouraged to submit Omb Control Number: 0535–0007.
altering its preliminary regulatory their comments to OMB via email to: Summary of Collection: The primary
determination or FONSI, our OIRA_Submission@omb.eop.gov or fax function of the National Agricultural
preliminary regulatory determination (202) 395–5806 and to Departmental Statistics Service (NASS) is to prepare
will become final and effective upon Clearance Office, USDA, OCIO, Mail and issue current official State and
notification of the public through an Stop 7602, Washington, DC 20250– national estimates of crop and livestock
announcement on our Web site at 7602. Copies of the submission(s) may production, stocks, disposition, and
http://www.aphis.usda.gov/ be obtained by calling (202) 720–8681. prices. As part of this function,
biotechnology/petitions_table_ An agency may not conduct or estimates are made for stocks of off-farm
pending.shtml. APHIS will also furnish sponsor a collection of information grains and oilseeds, potatoes, peanuts,
a response to the petitioner regarding unless the collection of information hops, and rice. Grain and oilseed stocks
our final regulatory determination. No displays a currently valid OMB control in all positions (on-farm and off-farm)
further Federal Register notice will be number and the agency informs are estimated quarterly. Grain stock
published announcing the final potential persons who are to respond to estimates are one of the most important
regulatory determination regarding V11 the collection of information that such NASS estimates, which are watched
potato. persons are not required to respond to closely by growers and industry groups.
Authority: 7 U.S.C. 7701–7772 and 7781– the collection of information unless it General authority for data collection is
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and displays a currently valid OMB control granted under U.S. Code Title 7, Section
371.3. number. 2204. The Hop Growers of America
Done in Washington, DC, this 2nd day of National Agricultural Statistics Service provides the data collection for much of
December 2015. the production information because of
Title: Egg, Chicken, and Turkey
Kevin Shea, sensitivity issues an impartial third
Surveys.
Administrator, Animal and Plant Health party, NASS, collects stocks and price
Omb Control Number: 0535–0004.
Inspection Service. Summary of Collection: The primary information.
[FR Doc. 2015–30878 Filed 12–7–15; 8:45 am] function of the National Agricultural Need and Use of the Information:
BILLING CODE 3410–34–P Statistics Service (NASS) is to prepare NASS collects information to administer
and issue current official State and farm program legislation and make
national estimates of crop and livestock decisions relative to the export-import
DEPARTMENT OF AGRICULTURE production. Thousands of farmers, programs. Estimates of stocks provide
ranchers, agribusinesses and others essential statistics on supplies and
National Agricultural Statistics Service contribute to orderly marketing. Farmers
voluntarily respond to nationwide
surveys about crops, livestock, prices, and agribusiness firms use these
Submission for OMB Review; estimates in their production and
Comment Request and other agricultural activities.
Estimates of egg, chicken, and turkey marketing decisions. Collecting this
December 2, 2015. production are in an integral part of this information less frequently would
The Department of Agriculture has program. General authority for these eliminate data needed by the
submitted the following information data collection activities is granted government, and industry and farmers
collection requirement(s) to OMB for under U.S. Code Title 7, Section 2204. to keep abreast of changes at the State
review and clearance under the This statue specifies the ‘‘The Secretary and national level.
Paperwork Reduction Act of 1995, of Agriculture shall procure and Description of Respondents: Business
Public Law 104–13. Comments preserve all information concerning or other for profit; Farms.
regarding (a) whether the collection of agriculture which she can obtain . . . by Number of Respondents: 6,630.
information is necessary for the proper Frequency of Responses: Reporting:
the collection of statistics . . . and shall
performance of the functions of the Monthly; Quarterly; Semi-annually;
distribute them among agriculturists’’.
agency, including whether the Annually.
Information published from the surveys
information will have practical utility; Total Burden Hours: 5,581.
in this docket is needed by USDA
(b) the accuracy of the agency’s estimate economists and government policy Title: List Sampling Frame Survey.
of burden including the validity of the makers to ensure the orderly marketing Omb Control Number: 0535–0140.
methodology and assumptions used; (c) of broiler chickens, turkeys and eggs. Summary of Collection: General
ways to enhance the quality, utility and Need and Use of the Information: authority for these data collection
clarity of the information to be Statistics on these poultry products activities is granted under U.S. Code
collected; (d) ways to minimize the contribute to a comprehensive program Title 7, Section 2204 which specifies
burden of the collection of information of keeping the government and poultry that ‘‘The Secretary of Agriculture shall
on those who are to respond, including industry abreast of anticipated changes. procure and preserve all information
through the use of appropriate All of the poultry reports are used by concerning agriculture which he can
automated, electronic, mechanical or producers, processors, feed dealers, and obtain . . . by the collection of statistics
other technological collection others in the marketing and supply . . .’’. The primary objective of the
techniques or other forms of information channels as a basis for their production National Agricultural Statistics Service
technology. and marketing decisions. Government (NASS) is to provide data users with
Lhorne on DSK9F6TC42PROD with NOTICES
Comments regarding this information agencies use these estimates to evaluate timely and reliable agricultural
collection received by January 7, 2016 poultry product supplies. production and economic statistics, as
will be considered. Written comments Description of Respondents: Farms; well as environmental and specialty
should be addressed to: Desk Officer for Business or other for profit. agricultural related statistics. To
Agriculture, Office of Information and Number of Respondents: 2,034. accomplish this objective, NASS relies
Regulatory Affairs, Office of Frequency of Responses: Reporting: heavily on the use of sample surveys
Management and Budget (OMB), New Weekly; Monthly; Annually. statistically drawn from ‘‘List Sampling
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Document Created: 2015-12-14 13:27:00
Document Modified: 2015-12-14 13:27:00
| 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 January 7, 2016. | |
| Contact | Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] To obtain copies of the supporting documents, contact Ms. Cindy Eck at (301) 851-3885, email: [email protected] | |
| FR Citation | 80 FR 76261 |
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