[Federal Register Volume 70, Number 85 (Wednesday, May 4, 2005)]
[Rules and Regulations]
[Pages 23009-23011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8860]



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Rules and Regulations
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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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