80 FR 43053 - Monsanto Co.; Availability of Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment of Maize Genetically Engineered for Increased Ear Biomass
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 80, Issue 139 (July 21, 2015)
Animal and Plant Health Inspection Service
Federal Register Volume 80, Issue 139 (July 21, 2015)
| Page Range | 43053-43055 | |
| FR Document | 2015-17845 |
[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)] [Notices] [Pages 43053-43055] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17845] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2014-0097] Monsanto Co.; Availability of Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment of Maize Genetically Engineered for Increased Ear Biomass AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment a preliminary plant pest risk assessment and draft environmental assessment for maize designated as event MON 87403, which has been genetically engineered for increased ear biomass. DATES: We will consider all comments that we receive on or before August 20, 2015. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0097. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0097, 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-2014-0097 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. [[Page 43054]] 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 14-213-01p. 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 petition, contact Ms. Cindy Eck at (301) 851-3892, email: cynthia.a.eck@aphis.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.'' 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 14-213-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of maize (Zea mays) designated as event MON 87403, which has been genetically engineered for increased ear biomass. The Monsanto petition states that information collected during field trials and laboratory analyses indicates that MON 87403 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 January 20, 2015 (80 FR 2674-2675, Docket No. APHIS-2014- 0097), APHIS announced the availability of the Monsanto petition for public comment. APHIS solicited comments on the petition for 60 days ending on March 23, 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 20 comments on the petition. Issues raised during the comment period include the contamination of conventional crop production, the potential for disruption of trade due to the presence of unwanted genetically engineered commodities in exports, the potential for negative impacts on plant fitness and the environment, and health concerns. 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- 2014-0097. --------------------------------------------------------------------------- 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 EA, preliminary finding of no significant impact (FONSI), and its 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. 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 will 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 Registernotice. Then, after reviewing and evaluating the comments on the draft EA and preliminary PPRA and other information, APHIS will revise the 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). For this petition, we are using Approach 2. 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. APHIS has prepared a preliminary PPRA and has concluded that maize designated as event MON 87403, which has been genetically engineered for increased ear biomass, 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 87403, or (2) make a determination of nonregulated status of maize designated as event MON 87403. The 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 [[Page 43055]] Implementing Procedures (7 CFR part 372). In accordance with our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments on our draft EA and our preliminary PPRA regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 30 days from the date of this notice. Copies of the draft EA and the preliminary PPRA, as well as the previously published petition, are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. After reviewing and evaluating the comments on the draft EA and the preliminary PPRA and other information, APHIS will revise the PPRA as necessary and prepare a final EA. Based on the final EA, APHIS will prepare a NEPA decision document (either a FONSI or a notice of intent to prepare an environmental impact statement). If a FONSI is reached, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will also publish a notice in the Federal Register announcing the regulatory status of the GE organism and the availability of APHIS' final EA, PPRA, FONSI, and our 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 15th day of July 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2015-17845 Filed 7-20-15; 8:45 am] BILLING CODE 3410-34-P
![Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43053
States. Under the regulations, certain use. The treatments were added to the revised treatment schedules for use for
plants, fruits, vegetables, and other PPQ Treatment Manual, but subject to the various plant commodities to the
articles must be treated before they may change or removal based on public PPQ Treatment Manual.
be moved into the United States or comment. Authority: 7 U.S.C. 7701–7772 and 7781–
interstate. The phytosanitary treatments We solicited comments on the notice 7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22,
regulations contained in 7 CFR part 305 for 60 days ending on May 27, 2014. We 2.80, and 371.3.
(referred to below as the regulations) set received one comment by that date,
Done in Washington, DC, this 15th day of
out standards for treatments required in from an importers association July 2015.
parts 301, 318, and 319 of 7 CFR chapter representative who raised concerns
Kevin Shea,
III for fruits, vegetables, and other about the revised treatment schedule for
asparagus. Administrator, Animal and Plant Health
articles. Inspection Service.
In § 305.2, paragraph (b) states that Specifically, the commenter stated
that there have been no pests detected [FR Doc. 2015–17840 Filed 7–20–15; 8:45 am]
approved treatment schedules are set
out in the Plant Protection and during post-fumigation inspections to BILLING CODE 3410–34–P
Quarantine (PPQ) Treatment Manual.1 justify the revision of the fumigation
Section 305.3 sets out the processes for process from 2 hours to 2.5 hours.
Furthermore, the commenter stated that DEPARTMENT OF AGRICULTURE
adding, revising, or removing treatment
schedules in the PPQ Treatment the additional 30 minutes of fumigation
would have a negative impact on the Animal and Plant Health Inspection
Manual. In that section, paragraph (b) Service
sets out the process for adding, revising, quality of the asparagus. The commenter
or removing treatment schedules when suggested that Animal and Plant Health [Docket No. APHIS–2014–0097]
there is an immediate need to make a Inspection Service (APHIS) and Peru
collaborate to develop a systems Monsanto Co.; Availability of
change. The circumstances in which an
approach to mitigate the plant pest Preliminary Plant Pest Risk
immediate need exists are described in
risks, rather than use the prescribed Assessment and Draft Environmental
§ 305.3(b)(1). They are:
fumigation treatment. Assessment of Maize Genetically
• PPQ has determined that an
As noted in the TED, in 2007, live Engineered for Increased Ear Biomass
approved treatment schedule is
Copitarsia spp. larvae were detected on
ineffective at neutralizing the targeted AGENCY: Animal and Plant Health
Peruvian asparagus during a post-
plant pest(s). Inspection Service, USDA.
fumigation inspection. As an interim
• PPQ has determined that, in order ACTION: Notice.
measure to ensure trade would continue
to neutralize the targeted plant pest(s),
uninterrupted, PPQ increased the SUMMARY: We are advising the public
the treatment schedule must be
treatment duration by 30 minutes for all that the Animal and Plant Health
administered using a different process
temperature ranges and monitored its
than was previously used. Inspection Service is making available
effectiveness against all stages of the
• PPQ has determined that a new pest. Since the revision was made there
for public comment a preliminary plant
treatment schedule is effective, based on pest risk assessment and draft
have been no interceptions of Copitarsia
efficacy data, and that ongoing trade in environmental assessment for maize
spp. larvae on asparagus imported into
a commodity or commodities may be designated as event MON 87403, which
the United States from Peru.
adversely impacted unless the new We understand the commenters’ has been genetically engineered for
treatment schedule is approved for use. concern regarding the negative effects increased ear biomass.
• The use of a treatment schedule is the fumigation process has on the DATES: We will consider all comments
no longer authorized by the U.S. quality of the vegetables. We that we receive on or before August 20,
Environmental Protection Agency or by acknowledge that there is a potential 2015.
any other Federal entity. risk of negative impacts on the quality ADDRESSES: You may submit comments
In accordance with § 305.3(a)(1), we or shelf life of commodities treated with by either of the following methods:
published a notice 2 in the Federal fumigation and seek to minimize those • Federal eRulemaking Portal: Go to
Register on March 28, 2014 (79 FR efforts to the extent possible, but note http://www.regulations.gov/
17496–17497, Docket No. APHIS–2013– that our primary concern must be to #!docketDetail;D=APHIS-2014-0097.
0009), announcing our determination prevent the introduction of plant pests • Postal Mail/Commercial Delivery:
that several additions to the PPQ into the United States. We will, Send your comment to Docket No.
Treatment Manual were necessary to however, add a statement to the APHIS–2014–0097, Regulatory Analysis
mitigate the risk from various plant treatment T101–b–1 regarding the and Development, PPD, APHIS, Station
pests, based on evidence presented in potential reduction in the shelf life of 3A–03.8, 4700 River Road Unit 118,
treatment evaluation documents (TEDs) the treated asparagus. Riverdale, MD 20737–1238.
we made available with the notice. We We welcome and encourage Supporting documents for this
also determined that the ongoing trade opportunities to collaborate with our petition and any comments we receive
of commodities would be adversely stakeholders and trading partners to on this docket may be viewed at http://
impacted unless the new and revised further mitigate the risks associated www.regulations.gov/
treatment schedules were approved for with the importation of commodities. If #!docketDetail;D=APHIS-2014-0097 or
we receive scientific information that in our reading room, which is located in
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1 The PPQ Treatment Manual is available at
supports the development of a systems room 1141 of the USDA South Building,
http://www.aphis.usda.gov/import_export/plants/
manuals/index.shtml or by contacting the Animal approach, we would consider the 14th Street and Independence Avenue
and Plant Health Inspection Service, Plant information and make appropriate SW., Washington, DC. Normal reading
Protection and Quarantine, Manuals Unit, 92 recommendations based on that room hours are 8 a.m. to 4:30 p.m.,
Thomas Johnson Drive, Suite 200, Frederick, MD Monday through Friday, except
21702.
information.
2 To view the notice, TEDs, and comment we Therefore, in accordance with our holidays. To be sure someone is there to
received, go to http://www.regulations.gov/ regulations in § 305.3(b)(3), we are help you, please call (202) 799–7039
#!docketDetail;D=APHIS-2013-0009. affirming our addition of the new and before coming.
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![Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43055
Implementing Procedures (7 CFR part immediately add to the Plant Protection • PPQ has determined that a new
372). and Quarantine Treatment Manual a treatment schedule is effective, based on
In accordance with our process for treatment schedule for methyl bromide efficacy data, and that ongoing trade in
soliciting public input when fumigation of figs for certain pests, a commodity or commodities may be
considering petitions for determinations including Chilean false red mite. In a adversely impacted unless the new
of nonregulated status for GE organisms, previous notice, we made available to treatment schedule is approved for use.
we are publishing this notice to inform the public for review and comment a • The use of a treatment schedule is
the public that APHIS will accept treatment evaluation document that no longer authorized by the U.S.
written comments on our draft EA and described the new treatment schedule Environmental Protection Agency or by
our preliminary PPRA regarding the and explained why we have determined any other Federal entity.
petition for a determination of that it is effective at neutralizing these In accordance with § 305.3(b), we
nonregulated status from interested or pests. published a notice 2 in the Federal
affected persons for a period of 30 days DATES: Effective July 21, 2015, we are Register on February 27, 2015 (80 FR
from the date of this notice. Copies of affirming the addition to the Plant 10661–10662, Docket No. APHIS–2015–
the draft EA and the preliminary PPRA, Protection and Quarantine Treatment 0007), announcing our determination
as well as the previously published Manual of the treatment described in that a new methyl bromide fumigation
petition, are available as indicated the notice published at 80 FR 10661– treatment schedule to control certain
under ADDRESSES and FOR FURTHER 10662 on February 27, 2015. pests, including Chilean false red mite
INFORMATION CONTACT above. FOR FURTHER INFORMATION CONTACT: Dr. (Brevipalpus chilensis), on figs (Ficus
After the comment period closes, Inder P.S. Gadh, Senior Risk Manager— carica) is effective, based on evidence
APHIS will review all written comments Treatments, PPQ, APHIS, 4700 River presented in a treatment evaluation
received during the comment period Road Unit 133, Riverdale, MD 20737; document (TED) we made available
and any other relevant information. (301) 851–2018. with the notice. We also determined
After reviewing and evaluating the that ongoing trade in figs would be
SUPPLEMENTARY INFORMATION: The
comments on the draft EA and the adversely impacted unless the new
regulations in 7 CFR chapter III are
preliminary PPRA and other treatment is approved for use. The
intended, among other things, to
information, APHIS will revise the treatment was added to the PPQ
prevent the introduction or
PPRA as necessary and prepare a final dissemination of plant pests and Treatment Manual, but was subject to
EA. Based on the final EA, APHIS will noxious weeds into or within the United change based on public comment.
prepare a NEPA decision document States. Under the regulations, certain We solicited comments on the notice
(either a FONSI or a notice of intent to plants, fruits, vegetables, and other for 60 days ending on April 28, 2015.
prepare an environmental impact articles must be treated before they may We received one comment by that date,
statement). If a FONSI is reached, be moved into the United States or from a private citizen. The commenter
APHIS will furnish a response to the interstate. The phytosanitary treatments stated that methyl bromide is known to
petitioner, either approving or denying regulations contained in 7 CFR part 305 deplete the stratospheric ozone layer,
the petition. APHIS will also publish a (referred to below as the regulations) set and that authorizing its use for treating
notice in the Federal Register out standards for treatments required in figs violates the Montreal Protocol, in
announcing the regulatory status of the 7 CFR parts 301, 318, and 319 for fruits, which the United States agreed to
GE organism and the availability of vegetables, and other articles. gradually reduce and ultimately
APHIS’ final EA, PPRA, FONSI, and our In § 305.2, paragraph (b) states that eliminate use of methyl bromide.
regulatory determination. approved treatment schedules are set The United States Government
Authority: 7 U.S.C. 7701–7772 and 7781– out in the Plant Protection and encourages methods that do not use
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and Quarantine (PPQ) Treatment Manual.1 methyl bromide to meet phytosanitary
371.3. Section 305.3 sets out a process for standards where alternatives are
Done in Washington, DC, this 15th day of adding, revising, or removing treatment deemed to be technically and
July 2015. schedules in the PPQ Treatment economically feasible, practical, and
Kevin Shea, Manual. In that section, paragraph (b) effective. At present, methyl bromide
Administrator, Animal and Plant Health sets out the process for adding, revising, fumigation is the only authorized
Inspection Service. or removing treatment schedules when treatment that meets the above criteria
[FR Doc. 2015–17845 Filed 7–20–15; 8:45 am] there is an immediate need to make a for the treatment of external pests on
BILLING CODE 3410–34–P change. The circumstances in which an figs. In addition, in accordance with
immediate need exists are described in Montreal Protocol Decision XI/13
§ 305.3(b)(1). They are: (paragraph 7), APHIS is committed to
DEPARTMENT OF AGRICULTURE • PPQ has determined that an promoting and employing gas recapture
approved treatment schedule is technology and other methods
Animal and Plant Health Inspection ineffective at neutralizing the targeted whenever possible to minimize harm to
Service plant pest(s). the environment caused by methyl
• PPQ has determined that, in order bromide emissions.
[Docket No. APHIS–2015–0007]
to neutralize the targeted plant pest(s), Paragraph 5 of Article 2H of the
Notice of Affirmation of Addition of a the treatment schedule must be Montreal Protocol does allow for
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Treatment Schedule for Methyl administered using a different process quarantine and preshipment uses of
Bromide Fumigation of Figs than was previously used. methyl bromide, and does not specify a
maximum number of such applications.
AGENCY: Animal and Plant Health 1 The Treatment Manual is available on the
Therefore, the application of this
Inspection Service, USDA. Internet at http://www.aphis.usda.gov/import_
export/plants/manuals/ports/downloads/
treatment is not in conflict with the
ACTION: Notice. treatment.pdf or by contacting the Animal and
Plant Health Inspection Service, Plant Protection 2 To view the notice, the TED, and the comment
SUMMARY: We are affirming our earlier and Quarantine, Manuals Unit, 92 Thomas Johnson we received, go to http://www.regulations.gov/
determination that it was necessary to Drive, Suite 200, Frederick, MD 21702. #!docketDetail;D=APHIS-2015-0007.
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Document Created: 2018-02-23 09:23:16
Document Modified: 2018-02-23 09:23:16
| 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 August 20, 2015. | |
| 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 petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected] | |
| FR Citation | 80 FR 43053 |
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