[Federal Register Volume 70, Number 85 (Wednesday, May 4, 2005)]
[Rules and Regulations]
[Pages 23009-23011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8860]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 70, No. 85 / Wednesday, May 4, 2005 / Rules
and Regulations
[[Page 23009]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 340
[Docket No. 03-038-2]
RIN 0579-AB89
Introductions of Plants Genetically Engineered To Produce
Industrial Compounds
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Affirmation of interim rule as final rule.
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SUMMARY: We are adopting as a final rule, without change, an interim
rule that amended our regulations regarding genetically engineered
organisms to require that introductions of plants genetically
engineered to encode compounds for industrial use be conducted only
under permit. Prior to the interim rule, such introductions could be
accomplished under notification, an expedited permitting procedure. The
interim rule was necessary to strengthen our regulations for
introductions of this small subgroup of genetically engineered plants
until such time as the issues related to these plants are fully
considered in conjunction with subsequent regulatory revision.
DATES: The interim rule became effective on August 6, 2003.
FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, Policy
Division, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-
1238; (301) 734-8365.
SUPPLEMENTARY INFORMATION:
Background
The 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), 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 is a plant
pest, or any product which contains such an organism that is
unclassified and/or whose classification is unknown. The regulations
refer to such organisms as ``regulated articles.''
With certain limited exceptions, the introduction of any regulated
article is prohibited unless that introduction is authorized by a
permit or, for specific classes of regulated articles, the
Administrator of the Animal and Plant Health Inspection Service (APHIS)
has been notified of the introduction in accordance with Sec. 340.3 of
the regulations, which provides for the use, under certain
circumstances, of an expedited permitting procedure called
notification.
The notification option was added to the regulations in 1993 (58 FR
17044-53043, Docket No. 92-156-02) in order to expedite introductions
for certain types of low risk plants with which APHIS had considerable
regulatory experience. Under the notification procedure, the regulated
article to be introduced must be a plant, and the types of genetic
modifications to the plant must meet the eligibility criteria described
in Sec. 340.3(b). Development of those criteria was based upon the
types of genetic modifications that APHIS had reviewed and evaluated
many times over the preceding years of issuing permits.
At the time the regulations were amended to provide for the use of
notification, the types of genetically engineered plants that had
industrial uses were typically those in which nutritional components,
such as oil content, were being engineered. Since APHIS had significant
regulatory experience with the types of traits then being introduced
into these plants, industrial plants were eligible for the notification
option. In contrast, the notification regulations in Sec.
340.3(b)(4)(iii) prohibited the use of notification for introductions
of plants genetically engineered to encode compounds for pharmaceutical
use, thus continuing to require a permit for such introductions,
because of our lack of regulatory experience and scientific familiarity
with these types of introduced traits.
In 2003, we noted that a number of more recent introductions of
plants engineered to produce compounds intended for industrial use had
been for traits different than what we were seeing in 1993. Those more
recent introductions were for non-food, non-feed traits with which
APHIS has little regulatory experience or scientific familiarity. Based
on the expansion of the technology and the new non-food, non-feed uses
of industrial plants being developed, we believed it to be prudent and
necessary to remove the notification option for all industrials pending
the completion of our ongoing review of part 340.
Therefore, in an interim rule effective and published in the
Federal Register on August 6, 2003 (68 FR 46434-46436, Docket No. 03-
038-1), we amended the regulations to require that introductions of
plants genetically engineered to encode compounds for industrial use be
conducted only under permit. For purposes of the interim rule, plants
engineered to produce industrial compounds include those plants that
meet the following three criteria: (1) The plants are engineered to
produce compounds that are new to the plant; (2) the new compound has
not been commonly used in food or feed; and (3) the new compound is
being expressed for non-food, non-feed industrial uses. Industrial uses
include, but are not limited to, detergent manufacturing, paper
production, and mineral recovery.
Comments on the interim rule were required to be received on or
before October 6, 2003. We received 12 comments by that date. The
comments were from companies and organizations involved in
biotechnology, an organic certification service, a university
biologist, a private citizen, an association of crop production and
protection companies, and associations representing food producers,
processors, and manufacturers. One of the commenters voiced opposition
to genetically modified plants generally, but offered no specific
comments relating to the interim rule. The remaining commenters
expressed their support for the interim rule, although several made
specific suggestions or
[[Page 23010]]
raised related issues. Those comments are discussed below.
Several commenters raised issues related to the potential for
plants engineered to produce industrial compounds to contaminate or
adulterate food crops. Some commenters urged APHIS to require that the
introduction of such crops be conducted under conditions of 100 percent
containment (e.g., in secure greenhouses) or geographic isolation to
ensure that adulteration does not occur. Other commenters stated that
APHIS should not allow food crops to be genetically modified to produce
industrial compounds in order to eliminate the potential for the spread
of transgenic pollen to sexually compatible non-modified plants. One of
these commenters further suggested that if food crops are to be used to
produce industrial compounds, self-pollinating crops should be used to
the maximum extent possible.
APHIS wishes to reiterate that the purpose of the interim rule was
to ensure that introductions of plants engineered to produce industrial
compounds will be conducted under permit rather than under
notification. Although there are administrative differences between
these procedures, the goal of each is to ensure that plants are
confined during movement and field testing and do not persist in the
environment, and both are designed to achieve high levels of safety. In
addition, use of any regulated article originating from a field test as
food or feed would be subject to the regulatory authority of the Food
and Drug Administration (FDA). Failure to meet any of the requirements
associated with APHIS permits and notifications can lead to substantial
fines, as provided in the Plant Protection Act.
One commenter agreed with the three criteria set out in the interim
rule to describe plants engineered to produce industrial compounds, but
suggested that food or feed plants genetically engineered to produce
dietary supplements that are acceptable only in dietary supplements
should also be considered industrial plants and thus ineligible for
introduction using the notification option.
Plants, whether genetically engineered or not, yield a variety of
compounds that are used to produce dietary supplements. If a food or
feed plant naturally produces a compound used in dietary supplements,
and that plant has been genetically engineered to produce more of that
compound, then that plant would not be considered an industrial plant
(and thus would be eligible for introduction using notification)
because the first of the three criteria is that ``the plants are
engineered to produce compounds that are new to the plant.'' However,
if the compound is new to the plant, has not been commonly used in food
or feed, and is being expressed for non-food, non-feed industrial uses,
then the plant would be considered an industrial plant under our
criteria and thus eligible for introduction only under permit.
Again with respect to the three criteria, one commenter suggested
that APHIS may wish to clarify those criteria regarding the
circumstances under which a permit will and will not be required for
field testing and to provide examples of both to assist the public and
those developing industrial proteins in better understanding those
circumstances.
APHIS may, when needed, provide additional written guidance
illustrating the criteria that define whether a field test qualifies
for the notification procedure or if it must be conducted under permit.
The agency has provided such written guidance since the implementation
of the regulations in part 340 in 1987, offering additional examples
that would not necessarily be appropriate for inclusion in the
regulations themselves and updating or clarifying that guidance as
necessary. When the notification option was added to the regulations in
1993, APHIS published a user's guide to notifications. Copies of our
user's guides are available in print form and may be viewed on the
Agency Web site at http://www.aphis.usda.gov/brs.
One commenter stated that, while it may be currently necessary to
require that introductions of industrial plants be conducted only under
permit, over time APHIS should gain sufficient familiarity with certain
industrial compounds to allow plants producing such compounds to be
grown under notification procedures. The commenter urged APHIS to adopt
this approach as it considers amending its regulations in 7 CFR part
340.
APHIS continually evaluates its regulations in the light of
increased experience and familiarity with scientific, technical, and
administrative considerations. In this or any other situation, the
accumulation of experience or the availability of additional
information may lead us to initiate rulemaking to update the
regulations.
Another commenter, also with an eye toward future amendments to the
regulations, suggested that APHIS provide for enhanced oversight for
industrial plants in the areas of confinement controls, site security,
and compliance verification and the use of third-party auditors,
standard-setting organizations, and standard operating procedures as a
quality control mechanism.
APHIS agrees that it is appropriate to take the considerations
identified by the commenter into account as we continue to review our
existing regulations in part 340 and develop potential amendments to
those regulations.
Continuing Effect of Amendment
The preamble of the interim rule stated that our amendment to the
regulations in part 340 to remove the notification options for plants
genetically engineered to encode compounds for industrial use would be
in effect until December 31, 2004. At the time we made that statement,
and as we explained in the interim rule, it was our intent to remove
the notification option for all industrials pending the completion of
our ongoing review of part 340. That review, which is not yet complete,
is being conducted as part of our consideration of possible amendments
to the regulations to, among other things, include genetically
engineered organisms that may pose a noxious weed risk and genetically
engineered biological control agents.
On January 23, 2004, we published a notice in the Federal Register
(69 FR 3271-3272, Docket No. 03-031-2), in which we advised the public
that we intend to prepare an environmental impact statement (EIS) in
connection with potential changes to the regulations regarding the
importation, interstate movement, and environmental release of certain
genetically engineered organisms. The notice identified potential
issues and alternatives that will be studied in the EIS and requested
public comment to further delineate the scope of the issues and
alternatives.
We believe that it is essential that we consider the findings of
the EIS as part of our review of the existing regulations in part 340,
but the EIS is not yet at a stage at which we may do so. Therefore,
consistent with our stated intent to remove the notification option for
all industrials pending the completion of our review of part 340, we
are announcing that the current requirement that introductions of
plants genetically engineered to encode compounds for industrial use be
conducted only under permit will continue in effect beyond December 31,
2004, until the completion of our review of the regulations in part
340. We expect that our review will include the publication in the
Federal Register of a proposed rule for public comment and
[[Page 23011]]
the subsequent publication of a final rule.
Therefore, for the reasons given in the interim rule and in this
document, we are adopting the interim rule as a final rule without
change.
This action also affirms the information contained in the interim
rule concerning Executive Order 12866 and the Regulatory Flexibility
Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.
Further, this action has been determined to be significant for the
purposes of Executive Order 12866 and, therefore, has been reviewed by
the Office of Management and Budget.
List of Subjects in 7 CFR Part 340
Administrative practice and procedure, Biotechnology, Genetic
engineering, Imports, Packaging and containers, Plant diseases and
pests, Transportation.
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
0
Accordingly, we are adopting as a final rule, without change, the
interim rule that amended 7 CFR part 340 and that was published at 68
FR 46434-46436 on August 6, 2003.
Done in Washington, DC, this 28th day of April 2005 .
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 05-8860 Filed 5-3-05; 8:45 am]
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