80 FR 57741 - Changes to Requirements for Field Testing Regulated Genetically Engineered Wheat

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 186 (September 25, 2015)

Page Range		57741-57741
FR Document		2015-24553

We are advising the public that the Animal and Plant Health Inspection Service is seeking public comment regarding plans to require the authorization of field testing of regulated genetically engineered (GE) wheat under permit. Currently, GE wheat field trials are authorized under notification. Authorizing GE wheat field trials under permit will help prevent future compliance issues, protect plant health and the environment, and allow for flexibility in the length of the volunteer monitoring period and the specific permit conditions to address how volunteers of GE wheat will be appropriately managed.

Federal Register, Volume 80 Issue 186 (Friday, September 25, 2015)

[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Page 57741]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24553]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / 
Proposed Rules

[[Page 57741]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2015-0070]


Changes to Requirements for Field Testing Regulated Genetically 
Engineered Wheat

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of request for comments.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is seeking public comment regarding plans to require 
the authorization of field testing of regulated genetically engineered 
(GE) wheat under permit. Currently, GE wheat field trials are 
authorized under notification. Authorizing GE wheat field trials under 
permit will help prevent future compliance issues, protect plant health 
and the environment, and allow for flexibility in the length of the 
volunteer monitoring period and the specific permit conditions to 
address how volunteers of GE wheat will be appropriately managed.

DATES: We will consider all comments that we receive on or before 
October 26, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0070.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0070, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0070 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.

FOR FURTHER INFORMATION CONTACT: Ms. Rachel Windsberg, Lead Management 
and Program Analyst, Regulatory Operations Programs, BRS, APHIS, 4700 
River Road Unit 91, Riverdale, MD 20737; 301-851-3109.

SUPPLEMENTARY INFORMATION: The Animal and Plant Health Inspection 
Service (APHIS) administers regulations regarding genetically 
engineered (GE) organisms 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'' (referred to below as the regulations). The current regulations 
govern the introduction (importation, interstate movement, or release 
into the environment) of certain GE organisms termed ``regulated 
articles.'' Regulated articles are essentially GE organisms which might 
pose a risk as a plant pest. APHIS first promulgated these regulations 
in 1987 under the authority of the Federal Plant Pest Act and the Plant 
Quarantine Act, two acts that were subsumed into the Plant Protection 
Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, along with other provisions.
    Certain regulated articles may be introduced into the environment 
without a permit if developers follow the requirements for 
authorizations under notification in Sec.  340.3. These requirements 
include, among other things, that, when the introduction of regulated 
articles is an environmental release, regulated articles must be 
planted in such a way that they are not inadvertently mixed with non-
regulated plant materials of any species which are not part of the 
environmental release. In addition, the field trial must be conducted 
such that the regulated article will not persist in the environment, 
and no offspring can be produced that could persist in the environment.
    In 2013 and 2014, APHIS responded to, and investigated, the 
detection of the unauthorized release of regulated GE wheat found 
growing in fields in Oregon and Montana, respectively. As part of its 
response to these incidents, APHIS has carefully assessed its 
regulatory requirements for field trials of GE wheat and determined 
that it is necessary to enhance those requirements. Therefore, we are 
advising the public that we have determined that field trials of GE 
wheat should be authorized only with a permit. This change will help 
prevent future compliance issues, protect plant health and the 
environment, and allow for flexibility in the length of the volunteer 
monitoring period and the specific permit conditions used to address 
how volunteers of GE wheat will be appropriately managed. Requiring 
authorization with a permit also allows APHIS to require the submission 
of volunteer monitoring reports on a regular basis.
    Due to the change in authorization allowed for GE wheat trials, we 
are requesting public review and comment on this change. To better help 
us determine specific permit conditions and volunteer monitoring 
requirements, we are particularly interested in receiving comments 
regarding biological or ecological issues, and we encourage the 
submission of scientific data, studies, or research to support your 
comments. We also request that, when possible, commenters provide 
relevant information regarding specific localities or regions as wheat 
growth, crop management, and crop utilization may vary considerably by 
geographic region.
    After the comment period closes, APHIS will review all written 
comments received during the comment period. APHIS will notify the 
public through an announcement on our Web site of the effective date of 
our decision whether to authorize GE wheat field trials only with a 
permit and any additional information regarding any change if APHIS 
decides to authorize wheat only under permits. APHIS will also announce 
on our Web site information regarding a stakeholder meeting to answer 
questions from developers on how to comply with this change.

    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 23rd day of September 2015.
Michael C. Gregoire,
Associate Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-24553 Filed 9-24-15; 8:45 am]
 BILLING CODE 3410-34-P

57741

Proposed Rules Federal Register
Vol. 80, No. 186

Friday, September 25, 2015

This section of the FEDERAL REGISTER and Independence Avenue SW., response to these incidents, APHIS has
contains notices to the public of the proposed Washington, DC. Normal reading room carefully assessed its regulatory
issuance of rules and regulations. The hours are 8 a.m. to 4:30 p.m., Monday requirements for field trials of GE wheat
purpose of these notices is to give interested through Friday, except holidays. To be and determined that it is necessary to
persons an opportunity to participate in the sure someone is there to help you, enhance those requirements. Therefore,
rule making prior to the adoption of the final
please call (202) 799–7039 before we are advising the public that we have
rules.
coming. determined that field trials of GE wheat
FOR FURTHER INFORMATION CONTACT: Ms. should be authorized only with a
DEPARTMENT OF AGRICULTURE Rachel Windsberg, Lead Management permit. This change will help prevent
and Program Analyst, Regulatory future compliance issues, protect plant
Animal and Plant Health Inspection Operations Programs, BRS, APHIS, 4700 health and the environment, and allow
Service River Road Unit 91, Riverdale, MD for flexibility in the length of the
20737; 301–851–3109. volunteer monitoring period and the
7 CFR Part 340 specific permit conditions used to
SUPPLEMENTARY INFORMATION: The
address how volunteers of GE wheat
[Docket No. APHIS–2015–0070] Animal and Plant Health Inspection
will be appropriately managed.
Service (APHIS) administers regulations
Changes to Requirements for Field Requiring authorization with a permit
regarding genetically engineered (GE)
Testing Regulated Genetically also allows APHIS to require the
organisms in 7 CFR part 340,
Engineered Wheat submission of volunteer monitoring
‘‘Introduction of Organisms and
reports on a regular basis.
Products Altered or Produced Through
AGENCY: Animal and Plant Health Due to the change in authorization
Genetic Engineering Which are Plant
Inspection Service, USDA. allowed for GE wheat trials, we are
Pests or Which There is Reason to
ACTION: Notice of request for comments. requesting public review and comment
Believe are Plant Pests’’ (referred to
on this change. To better help us
below as the regulations). The current
SUMMARY: We are advising the public determine specific permit conditions
regulations govern the introduction
that the Animal and Plant Health and volunteer monitoring requirements,
(importation, interstate movement, or
Inspection Service is seeking public we are particularly interested in
release into the environment) of certain
comment regarding plans to require the receiving comments regarding biological
GE organisms termed ‘‘regulated
authorization of field testing of or ecological issues, and we encourage
articles.’’ Regulated articles are
regulated genetically engineered (GE) the submission of scientific data,
essentially GE organisms which might
wheat under permit. Currently, GE studies, or research to support your
pose a risk as a plant pest. APHIS first
wheat field trials are authorized under comments. We also request that, when
promulgated these regulations in 1987
notification. Authorizing GE wheat field possible, commenters provide relevant
under the authority of the Federal Plant
trials under permit will help prevent information regarding specific localities
Pest Act and the Plant Quarantine Act,
future compliance issues, protect plant or regions as wheat growth, crop
two acts that were subsumed into the
health and the environment, and allow management, and crop utilization may
Plant Protection Act (PPA, 7 U.S.C. 7701
for flexibility in the length of the vary considerably by geographic region.
et seq.) in 2000, along with other After the comment period closes,
volunteer monitoring period and the
provisions. APHIS will review all written comments
specific permit conditions to address Certain regulated articles may be
how volunteers of GE wheat will be received during the comment period.
introduced into the environment
appropriately managed. APHIS will notify the public through an
without a permit if developers follow
DATES: We will consider all comments announcement on our Web site of the
the requirements for authorizations
that we receive on or before October 26, effective date of our decision whether to
under notification in § 340.3. These
2015. authorize GE wheat field trials only
requirements include, among other
with a permit and any additional
ADDRESSES: You may submit comments things, that, when the introduction of
information regarding any change if
by either of the following methods: regulated articles is an environmental
APHIS decides to authorize wheat only
• Federal eRulemaking Portal: Go to release, regulated articles must be
under permits. APHIS will also
http://www.regulations.gov/#!docket planted in such a way that they are not
announce on our Web site information
Detail;D=APHIS-2015-0070. inadvertently mixed with non-regulated
regarding a stakeholder meeting to
• Postal Mail/Commercial Delivery: plant materials of any species which are
answer questions from developers on
Send your comment to Docket No. not part of the environmental release. In
how to comply with this change.
APHIS–2015–0070, Regulatory Analysis addition, the field trial must be
and Development, PPD, APHIS, Station conducted such that the regulated Authority: 7 U.S.C. 7701–7772 and 7781–
3A–03.8, 4700 River Road Unit 118, article will not persist in the 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
mstockstill on DSK4VPTVN1PROD with PROPOSALS

371.3.
Riverdale, MD 20737–1238. environment, and no offspring can be
Supporting documents and any produced that could persist in the Done in Washington, DC, this 23rd day of
comments we receive on this docket environment. September 2015.
may be viewed at http://www. In 2013 and 2014, APHIS responded Michael C. Gregoire,
regulations.gov/#!docketDetail;D= to, and investigated, the detection of the Associate Administrator, Animal and Plant
APHIS-2015-0070 or in our reading unauthorized release of regulated GE Health Inspection Service.
room, which is located in Room 1141 of wheat found growing in fields in Oregon [FR Doc. 2015–24553 Filed 9–24–15; 8:45 am]
the USDA South Building, 14th Street and Montana, respectively. As part of its BILLING CODE 3410–34–P

VerDate Sep<11>2014 17:43 Sep 24, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4702 Sfmt 9990 E:\FR\FM\25SEP1.SGM 25SEP1

Document Created: 2018-02-26 10:19:47
Document Modified: 2018-02-26 10:19:47

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		Proposed Rules
Action		Notice of request for comments.
Dates		We will consider all comments that we receive on or before October 26, 2015.
Contact		Ms. Rachel Windsberg, Lead Management and Program Analyst, Regulatory Operations Programs, BRS, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737; 301-851-3109.
FR Citation		80 FR 57741

80 FR 57741 - Changes to Requirements for Field Testing Regulated Genetically Engineered Wheat

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 186 (September 25, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service