81 FR 8035 - Monsanto Co.; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 81, Issue 31 (February 17, 2016)
Animal and Plant Health Inspection Service
Federal Register Volume 81, Issue 31 (February 17, 2016)
| Page Range | 8035-8037 | |
| FR Document | 2016-03194 |
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)] [Notices] [Pages 8035-8037] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03194] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2015-0048] Monsanto Co.; Availability of a Preliminary Plant Pest Risk Assessment, Draft Environmental Assessment, Preliminary Finding of No Significant Impact, and Preliminary Determination of Nonregulated Status for Maize Genetically Engineered for Resistance to Dicamba and Glufosinate AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- [[Page 8036]] SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary determination regarding a request from Monsanto Co. seeking a determination of nonregulated status for maize designated as event MON 87419, which has been genetically engineered for resistance to the herbicides dicamba and glufosinate. We are also making available for public review and comment our preliminary plant pest risk assessment, draft environmental assessment, and preliminary finding of no significant impact for the preliminary determination of nonregulated status. DATES: We will consider all comments that we receive on or before March 18, 2016. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0048, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737- 1238. Supporting documents for this petition and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0048 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 for this petition are also available on the APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 15-113-01p. FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, Biotechnology 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 petition, contact Ms. Cindy Eck at (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. APHIS received a petition (APHIS Petition Number 15-113-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of maize (Zea mays) designated as event MON 87419, which has been genetically engineered for resistance to the herbicides dicamba and glufosinate. The Monsanto petition states that information collected during field trials and laboratory analyses indicates that MON 87419 maize is not likely to be a plant pest and therefore should not be a regulated article under APHIS' regulations in 7 CFR part 340. According to our process \1\ for soliciting public comment when considering petitions for determinations of nonregulated status of GE organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. In a notice \2\ published in the Federal Register on August 13, 2015 (80 FR 48489-48490, Docket No. APHIS-2015- 0048), APHIS announced the availability of the Monsanto petition for public comment. APHIS solicited comments on the petition for 60 days ending on October 13, 2015, 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. APHIS received 21 comments on the petition, one of which included over 23,000 signatures opposing the petition. APHIS has evaluated the issues raised during the comment period and, where appropriate, has provided a discussion of these issues in our draft environmental assessment (EA). --------------------------------------------------------------------------- \1\ 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 http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129. \2\ To view the notice, the petition, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS- 2015-0048. --------------------------------------------------------------------------- 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 1), the second opportunity for public involvement follows one of two approaches, as described below. 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 preliminary 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 using Approach 1. Had APHIS decided, 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 would follow Approach 2. Under Approach 2, APHIS first solicits written comments from the public on a draft EA and preliminary 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 preliminary PPRA and other information, APHIS would revise the preliminary PPRA as necessary and 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, to 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. [[Page 8037]] APHIS has prepared a preliminary PPRA and has concluded that maize designated as event MON 87419, which has been genetically engineered for resistance to the herbicides dicamba and glufosinate, 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 submitted by Monsanto, a review of other scientific data, field tests conducted under APHIS oversight, and comments received on the petition. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of maize designated as event MON 87419, or (2) make a determination of nonregulated status of maize designated as event MON 87419. 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 our draft EA and other pertinent scientific data, APHIS has prepared a preliminary FONSI with regard to the preferred alternative identified in the draft EA. 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 preliminary PPRA, comments provided by the public on the petition, and discussion of issues in the draft EA, APHIS has determined that maize designated as event MON 87419 is unlikely to pose a plant pest risk. We have therefore reached a decision to make a preliminary determination of nonregulated status of maize designated as event MON 87419, whereby maize designated as event MON 87419 would no longer be subject to our regulations governing the introduction of certain GE organisms. We are making available for a 30-day review period APHIS' preliminary regulatory determination of maize designated as event MON 87419, along with our preliminary PPRA, draft EA, and preliminary FONSI for the preliminary determination of nonregulated status. The draft EA, preliminary FONSI, preliminary PPRA, and our preliminary determination for maize designated as event MON 87419, as well as the Monsanto petition and the comments received on the petition, 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. If, after evaluating the information received, APHIS determines that we have not received substantive new information that would warrant APHIS altering our preliminary regulatory determination or FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, APHIS will notify the public through an announcement on our Web site of our final regulatory determination. If, however, APHIS determines that we have received substantive new information that would warrant APHIS altering our preliminary regulatory determination or FONSI, substantially changing the proposed action identified in the draft EA, or substantially changing the analysis of impacts in the draft EA, then APHIS will conduct the additional analysis and prepare an amended EA, a new FONSI, and/or a revised PPRA, which would be made available for public review in a subsequent notice in the Federal Register, similar to an Approach 2 petition. APHIS will also notify the petitioner. 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 10th day of February 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2016-03194 Filed 2-16-16; 8:45 am] BILLING CODE 3410-34-P
![Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8035
active against D. virgifera virgifera and documentation completed for Pioneer determination of nonregulated status of
certain other coleopteran pests of corn. 4114 corn and has concluded that MZIR098 corn for a period of 30 days
The native Cry1Ab from B. thuringiensis Syngenta’s request to extend a from the date this notice is published in
subsp. kurstaki is active against certain determination of nonregulated status to the Federal Register. The preliminary
lepidopteran pests, however, the portion MZIR098 corn encompasses the same FONSI, as well as the extension request,
of Cry1Ab included in eCry3.1Ab does scope of environmental analysis as supporting documents, and our
not retain activity against lepidopterans. Pioneer 4114 corn. Therefore, based on preliminary determination with
The transgene pat-08 was derived from the similarity of MZIR098 corn to appended PPRSA for MZIR098 corn, are
the soil bacterium Streptomyces Pioneer 4114 corn, APHIS has prepared available for public review as indicated
viridochromogenes. The PAT enzyme a preliminary finding of no significant under ADDRESSES and FOR FURTHER
deactivates glufosinate herbicides thus impact (FONSI) on MZIR098 corn. The INFORMATION CONTACT above. Copies of
conferring glufosinate resistance to the FONSI was prepared in accordance these documents may also be obtained
plants. PAT was also used as a with: (1) NEPA, as amended (42 U.S.C. by contacting the person listed under
selectable marker in the development of 4321 et seq.); (2) regulations of the FOR FURTHER INFORMATION CONTACT.
MZIR098 corn. The antecedent Council on Environmental Quality for After the comment period closes,
organism, Pioneer 4114 corn, was implementing the procedural provisions APHIS will review all written comments
similarly genetically engineered to of NEPA (40 CFR parts 1500–1508); (3) received during the comment period
produce proteins which have the same USDA regulations implementing NEPA and any other relevant information. All
mechanisms of action as do the proteins (7 CFR part 1b); and (4) APHIS’ NEPA comments will be available for public
produced in MZIR098 corn. Based on Implementing Procedures (7 CFR part review. After reviewing and evaluating
the information in the request, we have 372). the comments, if APHIS determines that
concluded that MZIR098 corn is similar APHIS is considering the following no substantive information has been
to Pioneer 4114 corn. MZIR098 corn is alternatives: (1) Take no action, i.e., received that would warrant APHIS
currently regulated under 7 CFR part APHIS would not change the regulatory altering its preliminary regulatory
340. status of MZIR098 corn and it would determination or FONSI, our
As part of our decisionmaking process continue to be a regulated article, or (2) preliminary regulatory determination
regarding a GE organism’s regulatory make a determination of nonregulated will become final and effective upon
status, APHIS evaluates the plant pest status of MZIR098 corn. APHIS’ notification of the public through an
risk of the article. In section 403 of the preferred alternative is to make a announcement on our Web site at http://
PPA, ‘‘plant pest’’ is defined as any determination of nonregulated status of www.aphis.usda.gov/biotechnology/
living stage of any of the following that MZIR098 corn. petitions_table_pending.shtml. APHIS
can directly or indirectly injure, cause APHIS has analyzed information will also furnish a response to the
damage to, or cause disease in any plant submitted by Syngenta, references petitioner regarding our final regulatory
product: A protozoan, a nonhuman provided in the extension request, peer- determination. No further Federal
animal, a parasitic plant, a bacterium, a reviewed publications, and information Register notice will be published
fungus, a virus or viroid, an infectious in the NEPA documentation prepared announcing the final regulatory
agent or other pathogen, or any article for the antecedent organism. APHIS has determination regarding MZIR098 corn.
similar to or allied with any of the also analyzed information in the PPRA
for the antecedent organism and other Authority: 7 U.S.C. 7701–7772 and 7781–
foregoing. 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
APHIS completed a plant pest risk information. Based on APHIS’ analysis 371.3.
assessment (PPRA) on the antecedent of this information and the similarity of
organism in which we concluded that MZIR098 corn to the antecedent Done in Washington, DC, this 10th day of
February 2016.
Pioneer 4114 corn is unlikely to present organism Pioneer’s 4114 corn, APHIS
plant pest risks. APHIS also prepared a has determined that MZIR098 corn is Kevin Shea,
plant pest risk similarity assessment unlikely to pose a plant pest risk. We Administrator, Animal and Plant Health
(PPRSA) to compare MZIR098 to the have therefore reached a preliminary Inspection Service.
antecedent. As described in the PPRSA, decision to approve the request to [FR Doc. 2016–03193 Filed 2–16–16; 8:45 am]
the proteins expressed in MZIR098 corn extend the determination of BILLING CODE 3410–34–P
are similar to those expressed in Pioneer nonregulated status of Pioneer 4114
4114 corn, and APHIS has concluded corn to MZIR098 corn, whereby
that the proteins expressed in Pioneer MZIR098 corn would no longer be DEPARTMENT OF AGRICULTURE
4114 corn are unlikely to pose a plant subject to our regulations governing the
Animal and Plant Health Inspection
health risk. Furthermore, the introduction of certain genetically
Service
Environmental Protection Agency engineered organisms.
reviewed the safety of the proteins Paragraph (e) of § 340.6 provides that [Docket No. APHIS–2015–0048]
expressed in MZIR098 corn and APHIS will publish a notice in the
concluded that there would ‘‘no Federal Register announcing all Monsanto Co.; Availability of a
unreasonable adverse effects on the preliminary decisions to extend Preliminary Plant Pest Risk
environment’’ from exposures to these determinations of nonregulated status Assessment, Draft Environmental
proteins. Therefore, based on our PPRA for 30 days before the decisions become Assessment, Preliminary Finding of No
for Pioneer 4114 corn and the similarity final and effective. In accordance with Significant Impact, and Preliminary
asabaliauskas on DSK5VPTVN1PROD with NOTICES
between Pioneer 4114 corn and § 340.6(e) of the regulations, we are Determination of Nonregulated Status
MZIR098 corn as described in the publishing this notice to inform the for Maize Genetically Engineered for
PPRSA, APHIS has concluded that the public of our preliminary decision to Resistance to Dicamba and
proteins expressed in MZIR098 corn are extend the determination of Glufosinate
unlikely to pose a plant pest risk. nonregulated status of Pioneer 4114 AGENCY: Animal and Plant Health
In addition, APHIS has carefully corn to MZIR098 corn. Inspection Service, USDA.
examined the existing National APHIS will accept written comments
ACTION: Notice.
Environmental Policy Act (NEPA) on the preliminary FONSI regarding a
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![Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8037
APHIS has prepared a preliminary and preliminary FONSI for the ACTION:Notice of intent to prepare a
PPRA and has concluded that maize preliminary determination of supplemental environmental impact
designated as event MON 87419, which nonregulated status. The draft EA, statement.
has been genetically engineered for preliminary FONSI, preliminary PPRA,
resistance to the herbicides dicamba and and our preliminary determination for SUMMARY: The Ochoco National Forest is
glufosinate, is unlikely to pose a plant maize designated as event MON 87419, preparing a supplemental
pest risk. In section 403 of the Plant as well as the Monsanto petition and the environmental impact statement (EIS) to
Protection Act, ‘‘plant pest’’ is defined comments received on the petition, are analyze the effects of changing the
as any living stage of any of the available as indicated under ADDRESSES existing motorized trail system to create
following that can directly or indirectly and FOR FURTHER INFORMATION CONTACT and designate a sustainable system of
injure, cause damage to, or cause above. Copies of these documents may roads, trails and areas open to motor
disease in any plant or plant product: A also be obtained from the person listed vehicles that will provide legal public
protozoan, a nonhuman animal, a under FOR FURTHER INFORMATION access, enhance regulation of
parasitic plant, a bacterium, a fungus, a CONTACT. unmanaged wheeled motor vehicle
virus or viroid, an infectious agent or After the 30-day review period closes, travel, protect resources, and decrease
other pathogen, or any article similar to APHIS will review and evaluate any conflicts between motorized and non-
or allied with any of the foregoing. information received during the 30-day motorized use on the Ochoco National
APHIS has also prepared a draft EA in review period. If, after evaluating the Forest. Consistent with the Ochoco
which we present two alternatives based information received, APHIS determines National Forest Land and Resource
on our analysis of data submitted by that we have not received substantive
Monsanto, a review of other scientific Management Plan, as amended, this
new information that would warrant action is needed to provide to the public
data, field tests conducted under APHIS APHIS altering our preliminary
oversight, and comments received on a diversity of road and trail
regulatory determination or FONSI,
the petition. APHIS is considering the opportunities for experiencing a variety
substantially changing the proposed
following alternatives: (1) Take no of environments and modes of travel.
action identified in the draft EA, or
action, i.e., APHIS would not change the The original notice of intent to prepare
substantially changing the analysis of
regulatory status of maize designated as an environmental impact statement was
impacts in the draft EA, APHIS will
event MON 87419, or (2) make a published in the Federal Register on
notify the public through an
determination of nonregulated status of November 20, 2009 (74 FR 60235–
announcement on our Web site of our
maize designated as event MON 87419. 60236). The supplemental
final regulatory determination. If,
The draft EA was prepared in environmental impact statement is
however, APHIS determines that we
accordance with (1) NEPA, as amended being prepared because a 2014 wildfire
have received substantive new
(42 U.S.C. 4321 et seq.), (2) regulations in the project area changed the
information that would warrant APHIS
of the Council on Environmental altering our preliminary regulatory conditions initially analyzed so that
Quality for implementing the determination or FONSI, substantially additional analysis was required, and
procedural provisions of NEPA (40 CFR changing the proposed action identified because the responsible official desired
parts 1500–1508), (3) USDA regulations in the draft EA, or substantially to have additional discussions with
implementing NEPA (7 CFR part 1b), changing the analysis of impacts in the stakeholders prior to making a decision.
and (4) APHIS’ NEPA Implementing draft EA, then APHIS will conduct the The Ochoco Summit Trail System
Procedures (7 CFR part 372). Based on additional analysis and prepare an decision and the reasons for the
our draft EA and other pertinent amended EA, a new FONSI, and/or a decision will be documented in the
scientific data, APHIS has prepared a revised PPRA, which would be made record of decision. That decision will be
preliminary FONSI with regard to the available for public review in a subject to the Forest Service Project-
preferred alternative identified in the subsequent notice in the Federal level Predecisional Administrative
draft EA. Register, similar to an Approach 2 Review Process (36 CFR part 218).
Based on APHIS’ analysis of field and
petition. APHIS will also notify the DATES: The supplemental draft
laboratory data submitted by Monsanto,
petitioner. environmental impact statement is
references provided in the petition,
peer-reviewed publications, information Authority: 7 U.S.C. 7701–7772 and 7781– expected to be completed and available
analyzed in the draft EA, the 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and for public comment in February 2016.
preliminary PPRA, comments provided 371.3. The final environmental impact
by the public on the petition, and Done in Washington, DC, this 10th day of statement is expected to be completed
discussion of issues in the draft EA, February 2016. in the fall of 2016.
APHIS has determined that maize Kevin Shea,
ADDRESSES: Ochoco Summit Trail
designated as event MON 87419 is Administrator, Animal and Plant Health
System Planning Team, Ochoco
unlikely to pose a plant pest risk. We Inspection Service.
National Forest, 3160 NE Third Street,
have therefore reached a decision to [FR Doc. 2016–03194 Filed 2–16–16; 8:45 am]
Prineville, Oregon 97754.
make a preliminary determination of BILLING CODE 3410–34–P
nonregulated status of maize designated FOR FURTHER INFORMATION CONTACT:
as event MON 87419, whereby maize Marcy Anderson, Project Leader, at 3160
designated as event MON 87419 would DEPARTMENT OF AGRICULTURE NE Third Street, Prineville, Oregon
asabaliauskas on DSK5VPTVN1PROD with NOTICES
no longer be subject to our regulations 97754, or at (541) 416–6463, or by email
governing the introduction of certain GE Forest Service at marcelleanderson@fs.fed.us.
organisms. Ochoco National Forest, Lookout Dated: February 10, 2016.
We are making available for a 30-day
Mountain Ranger District; Oregon; Stacey L. Forson,
review period APHIS’ preliminary
Ochoco Summit Trail System Project Forest Supervisor.
regulatory determination of maize
Supplemental EIS [FR Doc. 2016–03174 Filed 2–16–16; 8:45 am]
designated as event MON 87419, along
with our preliminary PPRA, draft EA, AGENCY: Forest Service, USDA. BILLING CODE 3410–11–P
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Document Created: 2016-02-17 01:16:30
Document Modified: 2016-02-17 01:16:30
| 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 March 18, 2016. | |
| Contact | Dr. John Turner, Director, Biotechnology 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 petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected] | |
| FR Citation | 81 FR 8035 |
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