[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 http://
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 (http://
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 http://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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