Introduction of Organisms and Products Altered or Produced Through Genetic Engineering, 39021-39025 [07-3474]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 72, Number 136 (Tuesday, July 17, 2007)]
[Proposed Rules]
[Pages 39021-39025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3474]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2006-0112]
RIN 0579-AC31


Introduction of Organisms and Products Altered or Produced 
Through Genetic Engineering

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability of draft environmental impact statement 
and request for comments.

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SUMMARY: We are evaluating our regulatory program to determine whether 
we should revise our regulations regarding the importation, interstate 
movement, and environmental release of genetically engineered 
organisms. We are seeking public comment on the draft environmental 
impact statement (DEIS) we have prepared relative to the regulatory 
revisions we are considering. The DEIS evaluates the alternatives we 
have identified in terms of their potential effects on the human 
environment compared to the effects of our current regulatory program. 
We believe our ongoing evaluation of these alternatives would benefit 
from the submission of additional views and data from the public, and 
we are especially interested in receiving comments on the subset of 
DEIS alternatives described in this notice.

DATES: We will consider all comments that we receive on or before 
September 17, 2007.

ADDRESSES: You may submit comments addressing the draft environmental 
impact statement by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0112 to submit or view public 
comments and to view supporting and related materials, including the 
DEIS, that are available electronically. Information on using 
Regulations.gov, including instructions for accessing documents, 
submitting comments, and viewing the docket after the close of the 
comment period, is available through the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0112, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0112.
    Issues in the DEIS are organized using 10 numbered issue areas 
developed through the scoping process. When possible, please relate 
each point in your comment to one of these 10 issue areas.
    Public Meetings: APHIS intends to hold public meetings to encourage 
additional public comment on the DEIS. The locations and dates of the 
public meetings will be announced on the APHIS Web site (https://
www.aphis.usda.gov/brs/brs_meetings.html) and in a future Federal 
Register notice.
    Reading Room: You may read any comments that we receive on this 
notice and the DEIS in our reading room. The reading room 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) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Michael Wach, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0485.

[[Page 39022]]


SUPPLEMENTARY INFORMATION: 

Background

    Under the Plant Protection Act (PPA) (7 U.S.C. 7701 et seq.), the 
Secretary of Agriculture may prohibit or restrict the importation, 
entry, or movement in interstate commerce of any plant, plant product, 
biological control organism, noxious weed, article, or means of 
conveyance, if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction or the 
dissemination of a plant pest or noxious weed into the United States. 
The Secretary's authority under the PPA has been delegated to the 
Administrator of the Animal and Plant Health Inspection Service 
(APHIS).
    Under that authority, APHIS administers 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'' (referred to below as the 
regulations). The regulations govern the introduction (importation, 
interstate movement, or release into the environment) of any organism 
or product altered or produced through genetic engineering that is a 
plant pest or that there is reason to believe may be a plant pest, or 
any product that contains such an organism that is unclassified and/or 
whose classification is unknown. The regulations refer to such 
genetically engineered organisms as ``regulated articles.''

Current APHIS Regulations

    Current APHIS regulations for genetically engineered organisms are 
based on authority in the PPA to regulate the introduction of organisms 
that are plant pests or for which there is reason to believe may be 
plant pests. Applicants must submit required information for review by 
APHIS scientists who evaluate the potential risks posed by the 
introduction and the procedures that the applicant will use to minimize 
those risks. Depending on the nature of the genetically engineered 
organism, an applicant applies for either a permit or a notification. 
APHIS authorizes introductions after considering the organism, the 
nature of the genetic engineering, and the ways in which the 
genetically engineered organism is likely to interact with the 
environment.
    A notification is a more streamlined authorization process that is 
used only for plants with traits considered to be low risk. To qualify 
for a notification, the genetically engineered plant must meet strict 
eligibility requirements to ensure that it poses a minimal plant pest 
risk. The genetically engineered plant must also be grown under 
conditions designed to meet performance standards ensuring confinement 
of the regulated material. The remaining organisms--including plants 
that are genetically engineered to produce pharmaceutical or industrial 
compounds--are subject to the permitting process.
    The permit process is designed to ensure the safe introduction of 
any genetically engineered organism over which APHIS has authority. All 
required information submitted in a permit application is reviewed by 
APHIS scientists. Permits will prescribe confinement conditions and 
standard operating procedures tailored on a case-by-case basis to 
maintain confinement of the genetically engineered organism throughout 
the course of the introduction. APHIS requires that all plants 
genetically engineered to produce pharmaceutical or industrial 
compounds be grown under extremely strict management protocols. These 
plants are required to be grown in a way that maintains confinement of 
the plant to the release area, with additional precautions taken to 
prevent the escape of pollen, seeds, or plant parts from the field test 
site.
    After a genetically engineered organism has been field tested 
extensively and the developer demonstrates that the organism does not 
pose a plant pest risk, the developer may request the deregulation of 
the organism by filing a petition for a ``determination of nonregulated 
status.'' After the applicant submits the required data and it has been 
carefully evaluated, APHIS prepares an environmental assessment or, if 
warranted, an environmental impact statement (EIS) to analyze the 
potential impacts the plant may have on the human environment and seeks 
public comment. APHIS approves a petition only when it reaches the 
conclusion that the genetically engineered organism does not pose a 
plant pest risk. Once APHIS has deregulated an organism, it may be 
freely moved and planted without the requirement of permits or other 
regulatory oversight by APHIS. Deregulated status may be extended to 
genetically engineered organisms which APHIS determines are similar to 
previously deregulated organisms. Conversely, given new information, 
APHIS may determine that a previously deregulated genetically 
engineered organism poses a plant pest risk and should, therefore, be 
brought back under Agency oversight.

The Draft Environmental Impact Statement

    APHIS is evaluating its regulatory program to determine if there is 
a need to revise its regulations in light of our current knowledge and 
experience and advances in science and technology. It is important that 
any regulations we may develop effectively carry out the purposes of 
the PPA, ensure environmental protection, provide regulatory processes 
that are transparent to stakeholders and the public, efficiently use 
Agency resources, minimize regulatory burdens, adhere to the principles 
of E.O. 12866, and are consistent with our international agreements, 
such as the World Trade Organization Agreement on the Application of 
Sanitary and Phytosanitary Measures.
    We have prepared a draft EIS (DEIS) evaluating all of the 
regulatory alternatives we are currently considering for a future 
proposed rule to revise our biotechnology regulations. A copy of the 
DEIS may be obtained through the Federal eRulemaking Portal as 
described under ADDRESSES above. When commenting on the DEIS, please 
identify which of the 10 issue areas identified in the DEIS each point 
in your comment addresses.
    While we invite comments on all alternatives in the DEIS, this 
notice identifies specific areas where we are particularly interested 
in further public input and data that will assist us in evaluating and 
refining these regulatory alternatives. We are requesting data on 
specific topics for some of the alternatives listed below, and we also 
welcome comments on how each alternative would affect areas such as the 
overall effectiveness of our biotechnology program, its operational 
efficiency, industry compliance, and other issues that would be 
associated with the development, adoption, and implementation of an 
alternative.
    The DEIS alternatives highlighted in this notice are discussed in 
depth in the DEIS, and readers should refer to that document in 
preparing comments in response to this notice. The issues from the DEIS 
for which we are especially seeking additional public comment are 
listed below, with some notes on the particular types of data or views 
we believe would be most helpful.

DEIS Issue 1 and 5--Scope of the Program

    Given the rapid advances in biotechnology, the present scope of the 
regulations may not be of sufficient breadth to cover the full range of 
genetically engineered organisms and

[[Page 39023]]

the full range of potential agricultural and environmental risks posed 
by these organisms, including risks to public health. Historically, the 
Agency has relied exclusively on its authority to protect against plant 
pests as the basis for regulating genetically engineered organisms. 
This authority, which is found in the PPA, was derived from the Federal 
Plant Pest Act and the Plant Quarantine Act. The PPA, however, 
consolidated and redefined the Agency's plant health authorities. The 
PPA authorizes the regulation of noxious weeds--defined as 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--
and biological control organisms--defined as any enemy, antagonist, or 
competitor used to control a plant pest or noxious weed. Regulatory 
alternatives are now being considered with due regard for the revised 
plant health authorities of the PPA and in light of the many advances 
in biotechnology.
    Based on our evaluation of several alternatives in the DEIS, APHIS 
has made a preliminary determination that regulatory oversight should 
be enhanced by expanding the scope of regulations to utilize the range 
of authorities in the PPA, not just the plant pest provision, to 
include the authority over noxious weeds and biological control 
organisms. The noxious weed provision would allow oversight of 
genetically engineered plants by expanding the scope of what is 
regulated and by allowing a broader consideration of potential risks, 
including risks to public health. This would allow APHIS to consider 
what is known about the potential hazards of the introduced proteins 
and other substances to humans or animals, if inadvertently consumed or 
released. This information could, in turn, be used to develop 
appropriate regulatory safeguards in connection with introductions of 
genetically engineered organisms.
    APHIS has also made a preliminary determination that it would be 
beneficial to regulate nonviable plant material originating from field 
tests when there is reason to believe, based on scientific review, that 
such debris might be harmful to the environment if it were allowed to 
remain. Such an approach would allow the Agency to maintain regulatory 
control if nonviable material poses a hazard (e.g., potential food 
contamination).
    APHIS is interested in receiving comment on these preliminary 
determinations and the other alternatives discussed in the DEIS. In 
particular, APHIS requests comment on whether APHIS should broaden the 
scope of its regulations to reflect its authority over noxious weeds 
and biological control organisms. If APHIS does propose to broaden its 
regulatory scope to include consideration of noxious weed risk, how 
should oversight and evaluation of genetically engineered plants differ 
from what is done under the current plant pest risk-oriented 
regulations? If APHIS does propose to establish regulations regarding 
genetically engineered biological control organisms, on what risks 
should the regulations be focused? Should APHIS tailor the scope of 
such regulations to focus on specific risks? If so, how?

DEIS Issue 2--Transparent, Risk Based Permit System

    APHIS has always used a risk-based approach in regulating 
genetically engineered organisms. The Agency has concluded that there 
is public interest in biotechnology regulation and how APHIS regulates 
various types of organisms based on to risk and Agency familiarity with 
a given organism. In addition, there is a trend toward more highly 
varied organisms and the regulatory process may need greater 
flexibility and rigor to more appropriately regulate the increasing 
variety of organisms. Accordingly, the Agency is considering revising 
the regulations to make the Agency's use of risk-based categories--
where genetically engineered organisms are classified according to risk 
and familiarity so that oversight and confinement vary by category--
more refined, more explicit and more transparent to the industry and 
the public. Redefined risk categories, we believe, can provide added 
flexibility, improving the Agency's ability to regulate diverse 
organisms and new types of traits, and provide better clarity to the 
regulated community and to the public, which may in turn promote 
greater confidence in the regulatory system.
    Accordingly, APHIS' has made a preliminary determination to adopt 
an expanded tiered permitting system based on potential environmental 
risk and Agency familiarity with the organism. A detailed example of 
such a system is described in this DEIS. The goals of such a tiered 
system would be to increase transparency with respect to how the Agency 
regulates various types of genetically engineered organisms and to 
increase regulatory flexibility such that the Agency could move 
genetically engineered organisms among the tiers as new information 
becomes available. For well characterized low-risk genetically 
engineered organisms, APHIS would continue to use a process similar to 
the current notification process found in 7 CFR 340.3; however, the 
term notification would no longer be used. Such a process would become 
the lowest risk ``permit.'' This change would, we believe, increase 
transparency and avoid any potential confusion about the status of 
these organisms as regulated articles.
    APHIS is interested in receiving comment on this alternative, and, 
in particular, requests comment on the criteria that should be used to 
establish risk-based categories. What characteristics of genetically 
engineered plants should be considered in establishing such categories? 
How many categories should there be? Which types or species of plants 
should be assigned to which categories? What specific regulatory 
requirements or restrictions would be appropriate for each such 
category and why would they be appropriate?

DEIS Issue 3--Nonregulated Status

    Once an article has been deregulated, APHIS does not place any 
restrictions or requirements on its use. Restrictions have not been 
deemed necessary because BRS risk assessments have concluded that the 
genetically engineered plants APHIS has deregulated pose no plant pest 
risk. APHIS recognizes, however, that future development and 
commercialization of plants with less familiar traits may pose new 
challenges for the Agency because even a thorough and comprehensive 
assessment may not resolve all unknowns regarding an article proposed 
for deregulation. These unresolved issues may justify continued 
scrutiny and data collection or use restrictions, but be of such a 
minor nature and minimal risk or concern that allowing planting of the 
article without a permit would be appropriate. APHIS is exploring the 
concept of a system that could give increased flexibility for handling 
special cases involving less familiar traits by creating provisions 
that allow for imposition of conditions for unconfined release. This 
could facilitate commercialization, while requiring appropriate 
restrictions or monitoring.
    APHIS has made a preliminary determination to propose a new feature 
for its regulatory system whereby the Agency would retain oversight in 
specific cases as appropriate. We envision, of course, that the vast

[[Page 39024]]

majority of organisms would be fully deregulated and that this 
determination would be identical to deregulation under our current 
regulations. The new system could include processes and criteria to 
allow release and use, with some restrictions, for special cases where 
there were minor risks that could be mitigated with conditions to 
ensure safe commercial use.
    We are therefore interested in receiving comments on how to manage 
genetically engineered organisms that present only minor unresolved 
risks that can be mitigated effectively, and on what factors should be 
considered in establishing appropriate mitigations. APHIS is also 
considering the use of new terminology to describe both deregulation as 
it currently exists and the more limited deregulation where some 
oversight would be retained. One possibility is to use the term 
``approval'' to indicate that specific genetically engineered organisms 
are ``unconditionally approved.'' This would be synonymous with full 
deregulation under our current regulations. Other genetically 
engineered organisms could be ``approved with conditions'' but would 
remain subject to continuing regulatory oversight in some respects. 
Alternatively, APHIS could retain the term ``deregulation'' and use 
``deregulation in part'' or another term to refer to situations where 
genetically engineered organisms remain subject to regulatory oversight 
in some respects. We are interested in receiving comment on this 
potential change in terminology.

DEIS Issue 4--Oversight of Pharmaceuticals and Industrial Substances

    Genetic engineering technology has advanced to the point where 
organisms can be developed that produce novel proteins and other 
substances with biological activity or industrial utility. Because the 
gene products made by such pharmaceutical and industrial compound 
producing plants may pose hazards not associated with proteins and 
other substances commonly found in the food supply, it is particularly 
important to ensure effective confinement measures for these plants. At 
the same time, however, the confinement measures prescribed for plants 
producing pharmaceutical and industrial compounds would be based on 
risk, not on the type of plant alone.
    The Agency has considered various alternatives with respect to the 
regulation of genetically engineered plants producing pharmaceutical 
compounds, including whether food crops should be used and whether they 
should be allowable for open air introductions. We have made a 
preliminary determination that under stringent conditions and with 
rigorous oversight, including due consideration of substantive food 
safety issues, food crops can be safely used for production of these 
compounds.
    In connection with this preliminary determination, the Agency seeks 
input on the need for and development of new or additional regulatory 
mechanisms to ensure that genetically engineered organisms producing 
pharmaceutical or industrial compounds are subject to requirements and 
oversight commensurate with the potential risks. We are also interested 
in comments regarding the biological characteristics that the Agency 
should consider in imposing safeguards. What should be done to ensure 
that such crops are commercialized under appropriate safeguards?

DEIS Issue 6--Commercialization Under Multi-Year Permits

    For organisms that might be commercialized but that do not meet the 
criteria for deregulation, APHIS is considering whether a new type of 
permitting system would be more appropriate in terms of efficiency and 
effectiveness than the current system. In addition, there is much 
public and State interest in these types of plantings and a new 
mechanism may increase transparency and allow for greater State 
involvement.
    Based on considerations more fully described in the DEIS, APHIS has 
made a preliminary determination to create a multi-year permit for 
genetically engineered organisms, with stringent oversight, in cases 
where developers are not interested or would not qualify for 
deregulation but plan to produce under permit. This would cover 
situations where producers are able to commercialize with relatively 
small plantings (e.g., industrial and pharmaceutical plants). 
Regulatory rigor would remain high to protect the environment, but 
efficiency and transparency would increase. The State partnership would 
be strengthened under this new system. The system would rely on 
multiyear permits and intensive reviews of standard operating 
procedures (SOPs), as well as audits and inspections. Though the new 
system under consideration could be used for pharmaceutical and 
industrial plants, the Agency might also find it appropriate for other 
types of genetically engineered plants.
    We are seeking comments on such a system and are particularly 
interested in comments regarding new or additional regulatory 
mechanisms to ensure that genetically engineered organisms produced 
under multi-year permits would be subject to effective requirements and 
oversight commensurate with the potential risks.

DEIS Issue 7--Low Levels of Biotechnology-Derived Genes and Gene 
Products Occurring in Commerce That Have Not Gone Through All 
Applicable Regulatory Reviews

    As with traditional plant breeding, large scale annual field 
testing of genetically engineered plants that have not completed all 
applicable reviews may result in materials from these trials 
occasionally being detected at low levels in commercial commodities and 
seeds. Current regulations do not expressly allow for such occurrences, 
though experience continues to show that such occurrences can occur. In 
a notice published in the Federal Register on August 2, 2002 (67 FR 
50577-50580), by the Office of Science and Technology Policy, APHIS 
committed to conducting a risk-based regulatory program that minimizes 
the occurrence of these materials but includes safety criteria under 
which these materials would be allowed at low levels in commercial 
commodities and seeds. On March 29, 2007, APHIS published a policy 
statement in the Federal Register (72 FR 14649-14651, Docket No. APHIS-
2006-0167) to clarify how it currently handles cases of low-level 
presence of regulated materials in commodities and seeds.
    Based on our evaluation and assessment of alternatives in the DEIS, 
APHIS has made a preliminary determination to establish in regulations 
criteria under which the occurrence of regulated articles would be 
allowable, that is, considered not actionable by APHIS. The occasional 
detection of regulated material in commercial crops as seeds can occur 
as a result of field tests conducted under confinement conditions 
appropriate for notifications. This is due to cross-pollination and 
also commingling from shared equipment and facilities. In addition, 
such incidents will inevitably result from the importation of seeds and 
commodities from countries where such material has been fully approved 
but has not completed all U.S. reviews. In the majority of cases, this 
low-level occurrence of regulated articles will be of minimal risk, and 
this fact should be accounted for in any regulatory scheme since 
oversight should be commensurate with risk.
    APHIS is interested in receiving comment on this alternative, but 
in particular, requests comment on whether APHIS should establish a new

[[Page 39025]]

regulatory approach to address such incidents of low-level presence of 
genetically engineered plant material. If low-level presence incidents 
occur, what criteria should the Agency use to determine whether 
remedial action will be required, and to determine the nature and scope 
of any such remedial action?

DEIS Issue 8--Importation of Genetically Engineered Commodities Not 
Intended for Propagation

    APHIS anticipates an increasing number of requests to import 
regulated genetically engineered organisms that are not intended for 
propagation, such as organisms that are intended for direct use as 
food, feed, or for processing. The current system of permits and 
notifications was not designed to handle such requests on a case-by-
case basis. However, in anticipation of this increase, APHIS' goal is 
to design an efficient system that protects U.S. agriculture and human 
health without erecting unnecessary trade barriers. To that end, the 
Agency has evaluated several different alternatives.
    Based on considerations more fully described in the DEIS, APHIS has 
made a preliminary determination to have a new regulatory mechanism to 
allow for imports of commodities for nonpropagative use, that is, for 
food, feed, or processing, in cases where these commodities might not 
have been deregulated in the United States. With this approach, we 
could establish criteria to ensure safety and allow for additional 
environmental review when appropriate. Allowing such imports without 
prior deregulation would not obviate the need to comply with 
requirements at other agencies, such as FDA and EPA.
    APHIS is interested in receiving comment on this alternative and, 
more specifically, comments as to the commodity characteristics and 
other data that APHIS should consider when determining the appropriate 
safeguards for commodities coming in for processing or to be used 
directly as food or feed.

DEIS Issue 9--Interstate Movement of Well-Studied, Low Risk Organisms

    Currently, genetically engineered Arabidopsis spp. and a few other 
organisms are exempt from interstate movement restrictions under 7 CFR 
340.2 because they are well understood and extensively used in 
research. Based on considerations more fully described in the DEIS, 
APHIS is considering whether to expand the current exemption from 
interstate movement restrictions to other well-studied, low-risk, 
genetically engineered research organisms. Such a change would create a 
consistent, risk based approach to organisms with similar risk 
profiles.
    Are there other genetically engineered organisms that should also 
be exempt from regulation in the same or similar manner as genetically 
engineered Arabidopsis spp.? Which organisms, if any, should be 
considered for such an exemption? Should the quantity of seeds or plant 
material being moved be considered in any exemption? In connection with 
such an exemption, should there continue to be some limited regulatory 
oversight, and what should be the nature and scope of such oversight?
    As noted above, we are interested in receiving comments on all of 
the issues presented in the DEIS and particularly on the issues and 
alternatives outlined above.

    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 12th day of July 2007.
Bruce Knight,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 07-3474 Filed 7-13-07; 8:45 am]
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