[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Notices]
[Pages 6225-6229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02247]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0054]


Environmental Impact Statement; Introduction of the Products of 
Biotechnology

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of intent to prepare an environmental impact statement.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) plans to prepare a programmatic 
environmental impact statement in connection with potential changes to 
the regulations regarding the importation, interstate movement, and 
environmental release of certain genetically engineered organisms. This 
notice identifies reasonable alternatives and potential issues to be 
evaluated in the environmental impact statement and requests public 
comments to further define the scope of the alternatives and 
environmental impacts and issues for APHIS to consider.

DATES: We will consider all comments that we receive on or before March 
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-2014-0054.
     Postal Mail/Commercial Delivery: Send your comments to 
Docket No. APHIS-2014-0054, 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-2014-
0054 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: Sidney W. Abel, Assistant Deputy

[[Page 6226]]

Administrator, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3943.

SUPPLEMENTARY INFORMATION:

Background

    The Plant Protection Act (PPA) authorizes the Animal and Plant 
Health Inspection Service (APHIS) to protect plant health in the United 
States. Under that authority, APHIS currently regulates the 
introduction (movement into the United States or interstate, or release 
into the environment) of genetically engineered (GE) organisms that may 
present a plant pest risk through its 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.'' These regulations are intended to protect 
against plant pest risks to plant health by providing for the safe 
importation, interstate movement, or release into the environment of 
certain GE organisms.
    APHIS' regulation of certain GE organisms to protect plant health 
is aligned with the Federal Coordinated Framework for the Regulation of 
Biotechnology (henceforth referred to as the Coordinated Framework), 
the comprehensive Federal regulatory policy for ensuring the safety of 
biotechnology research and products in the United States. The 
Coordinated Framework describes how Federal agencies will use existing 
Federal statutes to ensure public health and environmental safety while 
maintaining regulatory flexibility to avoid impeding the growth of the 
biotechnology industry. The Coordinated Framework sets forth a risk-
based, scientifically sound basis for the oversight of activities that 
introduce biotechnology products into the environment and describes the 
roles and responsibilities for the three major Federal agencies 
involved in regulating biotechnology products: APHIS, the Environmental 
Protection Agency (EPA), and the Food and Drug Administration (FDA). 
Currently, the Federal agencies are in the process of working with the 
Executive Office of the President to modernize a number of Coordinated 
Framework issues and activities; that effort is distinct from and 
entirely compatible with APHIS' effort to revise its biotechnology 
regulations at 7 CFR part 340. This notice only addresses proposed 
changes to the APHIS regulations. It is not intended to circumscribe, 
restrict, or otherwise preclude future actions taken under other 
Federal statutes and their respective authorities.
    During the past 28 years of APHIS' regulation of certain GE 
organisms pursuant to the PPA and 7 CFR part 340, advances in 
biotechnology and new issues raised by a range of stakeholders have 
emerged. Over this period, APHIS has also gained considerable 
experience in assessing the plant pest and noxious weed risks of GE 
organisms. Our evaluations of any potential plant pest risks of APHIS 
regulated GE organisms have included assessments of weediness of the 
regulated article or other plants with which it can interbreed. 
Accordingly, APHIS is considering amending the 7 CFR part 340 
regulations pertaining to introductions of certain GE organisms to 
address the advances in biotechnology and the new issues raised by 
stakeholders. This update to APHIS' biotechnology regulations will 
increase the efficiency and precision of our regulations. The proposed 
revisions would align the range of potential risks that may be 
considered under APHIS' regulations in 7 CFR part 340 with both the 
plant pest and noxious weed authorities of the PPA, to ensure a high 
level of environmental protection pursuant to APHIS' PPA authorities to 
regulate plant pest and noxious weeds, improve regulatory processes so 
that they are more transparent to stakeholders and the public, and 
provide regulatory relief to the extent possible so that unnecessary 
regulatory burdens are eliminated. Changes to the regulations would 
ensure that the Agency can continue to effectively regulate the 
products of biotechnology that may pose plant pest or noxious weed 
risks to U.S. agriculture and the environment.
    In our current regulations found at 7 CFR part 340, APHIS defines 
the term ``genetically engineered organisms'' to mean organisms that 
have been genetically modified by recombinant DNA techniques.
    The following terms are defined by the Plant Protection Act (7 
U.S.C. 7701-7772):
    Noxious weed: Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
    Plant pest: 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. A protozoan.
    B. A nonhuman animal.
    C. A parasitic plant.
    D. A bacterium.
    E. A fungus.
    F. A virus or viroid.
    G. An infectious agent or other pathogen.
    H. Any article similar to or allied with any of the articles 
specified in the preceding subparagraphs.
    Under the provisions of the National Environmental Policy Act of 
1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), Federal agencies must 
examine the potential environmental impacts of proposed Federal actions 
and alternatives. We are planning to prepare a programmatic 
environmental impact statement (EIS) in connection with the proposed 
revisions and amendments to APHIS' biotechnology regulations that are 
being considered. Aspects of the human environment that may be 
potentially affected by such proposed regulatory revisions and 
amendments that we have preliminarily identified for evaluation in the 
EIS will include: Potential impacts on U.S. agriculture and forestry 
production (e.g., conventional, biotechnology-based, and organic); 
potential impacts on current and potential future uses of products of 
biotechnology in agriculture and forestry; agronomic practices employed 
in biotechnology crop production that may have environmental 
consequences or impacts (i.e., tillage, crop rotation, and agronomic 
inputs); potential impacts on aspects of the physical environment that 
include soil quality, water resources, air quality, and climate change; 
potential impacts on aspects of the biological environment such as 
animal and plant communities, weed and insect resistance to herbicides 
and insecticides (respectively), the potential gene flow and weediness 
of regulated GE crop plants, and biodiversity; potential impacts on 
consumer health and agricultural worker safety; animal feed and health; 
and socioeconomic considerations, to include potential impacts of 
regulated GE crop plants on the domestic economic environment, 
international trade, and coexistence among all forms of U.S. 
agriculture, conventional, biotechnology-based, and organic, in 
providing market demand for food, feed, fiber, and fuel.
    This notice describes the range of proposed reasonable alternatives 
that are currently under consideration for evaluation in the EIS and 
the issues that will be evaluated in the EIS, and requests public 
comment to further define the issues and scope of the EIS' 
alternatives. We are also requesting public comment to help us identify

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other environmental issues that should be examined in the EIS.
    The EIS will be prepared in accordance with: (1) NEPA, (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).
    In considering the envisioned revisions to 7 CFR part 340, APHIS 
has preliminarily identified possible new definitions to be used in its 
proposed part 340 biotechnology regulations for consideration and 
analysis in the EIS:
    Biotechnology. Laboratory-based techniques to create or modify a 
genome that result in a viable organism with intended altered 
phenotypes. Such techniques include, but are not limited to, deleting 
specific segments of the genome, adding segments to the genome, 
directed altering of the genome, creating additional genomes, or direct 
injection and cell fusion beyond the taxonomic family that overcomes 
natural physiological reproductive or recombination barriers. This 
definition does not include and is intended not to include traditional 
breeding, marker assisted breeding, or chemical or radiation-based 
mutagenesis.
    Product of biotechnology. An organism developed using 
biotechnology.
    Regulated organism. An organism developed using biotechnology that 
poses plant pest or noxious weed risks as documented in an APHIS risk 
analysis that APHIS has determined to regulate.
    APHIS is considering, and invites public input on, these proposed 
definitions. Such input should address APHIS' regulatory objectives to 
safeguard agricultural plants and agriculturally important natural 
resources from plant pest or noxious weed damage (biological, chemical, 
or physical) caused by a ``product of biotechnology,'' including its 
potential, or lack of potential to pose plant pest or noxious weed 
risks.
    These proposed definitions will be used in the four proposed 
alternatives that are proposed to be examined in the EIS. These 
proposed alternatives are:
    First Alternative: Take no action. Under this ``no action'' 
alternative, APHIS would make no changes to the existing 7 CFR part 340 
regulations for certain GE organisms that pose a potential plant pest 
risk and APHIS would continue to regulate certain GE organisms as it 
does today. APHIS would not revise its current regulations to add the 
definitions outlined above. The No Action alternative represents the 
baseline against which the proposed revisions to the regulations will 
be compared.
    Second Alternative: Revise the current APHIS regulations concerning 
the introduction of certain GE organisms to provide for a process to 
review and regulate certain products of biotechnology to protect plant 
health; analyze potential plant pest and/or noxious weed risks first; 
and thereafter regulate only when appropriate and necessary.
    Under this alternative, APHIS would revise its current regulations 
to implement a two-step process that would ensure a thorough review of 
a product of biotechnology's potential to pose plant health risks 
(plant pest and/or noxious weed)--analyze such plant health risks first 
and only thereafter determine the use of any regulatory action as 
appropriate and needed. Such a two-step process will enable the agency 
to consider and place risk-appropriate regulatory controls on the 
importation, movement, or ``outdoor'' use of those products that are 
determined by the agency to pose actual plant pest or noxious weed 
risks (regulate only when APHIS has determined that certain plant 
health risks are appropriate and necessary to require some regulatory 
action to be taken and implemented).
    Analyze First: APHIS would use established and delineated criteria 
to identify certain products of biotechnology for which the Agency 
would conduct a review process. The Agency's review process would be 
used to determine whether the product of biotechnology poses an actual 
documented plant pest or noxious weed risk and should therefore be 
regulated. The criteria that would ``trigger'' the Agency's review 
process are those which would indicate the potential for the product of 
biotechnology to pose documented plant pest or noxious weed risks, and 
may include:
    1. Whether the recipient organism is a biocontrol organism, a 
microorganism that has been modified for altered plant-microbe 
interactions, or a plant; and
    2. Whether the product of biotechnology's donor or recipient 
organism, or the vector used in its development meet the definition of 
a plant pest, is included in the list of plant pest taxa, or is unknown 
or unclassified.
    APHIS is considering, and invites public input, on these two 
proposed regulatory review criteria and also invites public input on 
proposing other possible regulatory review criteria for APHIS' 
consideration.
    It is important that the public be aware that the Coordinated 
Framework has consistently held and proceeded pursuant to the concept 
and position that the process of genetic modification has not been 
shown to be inherently dangerous. The Executive Office of the President 
has, through the Coordinated Framework, underscored the importance of a 
risk based, scientifically sound, flexible regulatory approach that 
balances regulatory oversight with the need to avoid impeding 
biotechnology research and innovation. With that in mind, APHIS is 
considering and would like public input on potential justifiable 
exceptions or exemptions that would exclude certain ``products of 
biotechnology'' from APHIS' regulatory review and oversight because 
they lack the realistic potential to pose documented plant pest or 
noxious weed risks. For example, some possible candidates to be 
exempted from regulation might be:
    a. Plant products of biotechnology in which the genetic 
modification was obtained through a process of biotechnology including 
nucleotide deletions, single base pair substitutions, or other 
modifications that could reasonably be expected to be obtained through 
mutagenic techniques that have commonly been used for plant development 
since the early 1900s.
    b. Insects which are not plant pests transformed using the PiggyBac 
transposon, but not otherwise containing sequences from plant pests.
    Those products of biotechnology which APHIS determines do meet the 
proposed criteria 1 and 2 listed above and will not be exempted, would 
undergo a regulatory review. This regulatory review would employ a 
plant pest and/or noxious weed risk analysis process to determine 
whether the product of biotechnology poses either a plant pest or 
noxious weed risk, and therefore would be a regulated organism as 
defined above.
    Regulate When Necessary: Once the review process is completed by 
the Agency, the importation, interstate movement or ``outdoor'' use of 
those products of biotechnology that were determined to pose plant pest 
or noxious weed risks, as documented and confirmed in an APHIS risk 
analysis, would be subject to APHIS regulatory controls that ensure the 
protection of plant health. The regulatory control would typically be 
the issuance of permits with risk-appropriate conditions to mitigate 
risks.
    Under this second alternative, APHIS proposes to eliminate the 
notification

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procedure (currently 7 CFR 340.3), as APHIS anticipates that many GE 
organisms currently regulated under the notification procedures would 
not be regulated nor subject to further review under this alternative.
    Under this alternative, APHIS also proposes to eliminate the 
current petition process for non-regulated status (currently 7 CFR 
340.6), as APHIS will conduct new risk analyses consistent with the 
``analyze first, regulate when necessary'' when new information is made 
available.
    Under this second alternative, APHIS is considering whether or how 
products of biotechnology that are developed for pharmaceutical or 
industrial purposes would be regulated under the proposed revised 
regulations. APHIS appreciates that there are aspects of its regulatory 
program that are well suited to address these types of products, and 
would like public input on how public health and safety objectives 
might be achieved for pharmaceutical or industrial products of 
biotechnology that would pose plant pest or noxious weed risks.
    Third Alternative: Revise the current APHIS regulations concerning 
the introduction of certain GE organisms to provide for the regulation 
of ``products of biotechnology'' as either plant pests or noxious weeds 
using the existing plant pest ``analysis trigger'' or a noxious weed 
``analysis trigger'' that might classify plants produced through 
biotechnology as potential plant pests or noxious weeds.
    Under this third alternative, APHIS' proposed regulations would 
substantially increase oversight and resources over those currently 
used to regulate GE organisms. APHIS would not exempt certain 
``products of biotechnology'' from APHIS regulatory oversight if a 
``product of biotechnology'' was developed using a plant pest; or, if 
it posed a risk as a noxious weed pursuant to the PPA definition of a 
noxious weed. Introductions of products of biotechnology that posed a 
plant pest risk or noxious weed risk would require a permit and 
conditions would be applied for import, interstate movement, or 
``outdoor'' use.
    Under this third alternative, APHIS' proposed regulatory scheme 
would include the range of actions and processes that would enable 
APHIS to become, to the extent permitted by its PPA authorities, an 
all-encompassing, wide-scale regulatory permitting authority but still 
fully comply with the Coordinated Framework and support the continued 
development of products of biotechnology. APHIS would use its plant 
pest and/or noxious weed risk analyses to inform the establishment of 
appropriate permit conditions to protect agricultural plants and 
agriculturally important natural resources. For example, APHIS' 
proposed regulatory scheme under this alterative would evaluate and 
consider agricultural and mitigation practices such as crop exclusion 
zones, risk appropriate isolation distances, or other measures that 
would address and mitigate ``damage'' as included in the PPA definition 
of a noxious weed (e.g., direct or indirect damage to crops or other 
interests of agriculture). APHIS requests and would appreciate public 
input on these practices or others that might be appropriate for this 
third alternative.
    Under this third alternative, APHIS' proposed regulatory scheme 
would also eliminate the notification (currently 7 CFR 340.3) and 
petition procedures (currently 7 CFR 340.6) since this alternative's 
regulatory scheme would propose that all ``products of biotechnology'' 
that are plants and are captured by the existing plant pest or noxious 
weed ``analysis triggers,'' as defined by the PPA, and currently used 
and applied by APHIS pursuant to the regulations in 7 CFR parts 340 and 
360, would require a permit to enable the agency to establish risk 
appropriate conditions. APHIS would appreciate public input on its 
proposal, under this alternative, to eliminate notifications and 
petitions.
    Fourth Alternative: Withdraw the current 7 CFR part 340 regulations 
completely and implement a voluntary, non-regulatory consultative 
process for certain products of biotechnology whereby APHIS would 
document plant pest or noxious weed risks, if any, of certain products 
of biotechnology as defined above.
    Under this fourth alternative, developers would be responsible for 
ensuring that their respective products of biotechnology do not pose 
risks as a plant pest or noxious weed pursuant to their respective PPA 
definitions, and that their activities related to the importation, 
interstate movement, or release into the environment of their 
respective products of biotechnology are not in violation of any 
existing statutes or Federal regulations that relate to plant pests or 
noxious weeds.
    Under this fourth alternative, APHIS would not have a dedicated 
regulatory scheme to specifically regulate any products of 
biotechnology that may pose plant pest or noxious weed risks and 
therefore would not require consultation nor prescribe methods or 
practices related to any products of biotechnology. Any products of 
biotechnology that pose plant pests or noxious weed risks would be 
managed by APHIS using its other existing regulations pursuant to the 
PPA; e.g., 7 CFR parts 330 and 360. Those existing APHIS regulations 
relating to plant pests or noxious weeds, would be used as applicable 
to regulate any products of biotechnology, but would regulate them 
under their respective current regulatory schemes. Thus this 
alternative would be using a very different scheme than the current 7 
CFR part 340 or the regulatory schemes proposed in the second and third 
EIS alternatives since APHIS would not plan on revising, amending, or 
requiring any regulatory changes to 7 CFR parts 330 and/or 360 to 
address plant pest or noxious weed risks specifically related to 
products of biotechnology. However, APHIS would maintain expertise in 
regulating the products of biotechnology pursuant to its PPA plant pest 
and noxious weed risks and create a non-regulatory program providing 
voluntary, non-regulatory consultative services to provide developers 
with Federal support and services intended to facilitate importation, 
interstate movement or ``outdoor'' use of products of biotechnology 
that do not present PPA plant pest or noxious weed risks. Under this 
fourth alternative and approach, APHIS would provide, upon request for 
consultation, for an analysis of PPA plant pest or noxious weed risks 
as part of it routine and continuing operations, and such analyses 
might facilitate the commercialization of the products of biotechnology 
by providing an objective analysis of plant pest or noxious weed risks 
using APHIS risk analysis processes that document a scientific review 
of the literature and findings related to plant pest or noxious weed 
risks. APHIS would appreciate public input on its proposal, under this 
alternative.
    APHIS is requesting comments and information related to the topics 
and issues presented in this notice so that the scope of the analysis 
in the draft EIS, including the types and range of reasonable 
alternatives, is reasonable and appropriate, and proposed revisions to 
7 CFR part 340 are well-evaluated. Public input will be helpful in 
further defining the scope of the issues and reasonable alternatives 
under consideration. A notice will be published in the Federal Register 
to announce the availability of a draft EIS when it is issued and to 
invite the public to provide comments on it.


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    Done in Washington, DC, this 1st day of February 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-02247 Filed 2-4-16; 8:45 am]
BILLING CODE 3410-34-P