[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Page 57741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]]


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-
    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]