[Federal Register Volume 68, Number 151 (Wednesday, August 6, 2003)]
[Rules and Regulations]
[Pages 46434-46436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19877]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. 03-038-1]


Introductions of Plants Genetically Engineered to Produce 
Industrial Compounds

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending 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 this interim rule, such 
introductions could be accomplished under notification, an expedited 
permitting procedure. This action is necessary to strengthen our 
regulations for introductions of this small subgroup of genetically 
engineered plants.

DATES: This interim rule is effective August 6, 2003. We will consider 
all comments that we receive on or before October 6, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 03-038-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 03-038-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
03-038-1'' on the subject line.
    You may read any comments that we receive on this docket 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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

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:
    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.
    Recently, a number of introductions of plants engineered to produce 
compounds intended for industrial use have been for traits different 
than what we were seeing in 1993. The more recent introductions have 
been for non-food, non-feed traits with which APHIS has little 
regulatory experience or scientific familiarity. For purposes of this 
rule, plants engineered to produce industrial compounds include those

[[Page 46435]]

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.
    Based on the expansion of the technology and the new non-food, non-
feed uses of industrial plants being developed, we believe it is 
prudent and necessary to remove the notification option for all 
industrials pending the completion of our ongoing review of part 340.
    With this interim rule, which will be in effect only until December 
31, 2004, we amend the regulations in part 340 to remove the 
notification options for such plants. Therefore, for the remainder of 
the 2003-2004 growing seasons all introductions of plants genetically 
engineered to produce industrial compounds will be conducted pursuant 
to APHIS' rigorous permit system. We are continuing our review of this 
and other issues and of the regulations in part 340 generally and will 
announce our plans in a document published in the Federal Register 
within the next year.

Immediate Action

    Immediate action is necessary to strengthen our regulations with 
regard to the introductions of genetically engineered plants that 
encode compounds intended for industrial use because of our lack of 
regulatory experience and scientific familiarity with the kinds of 
traits in current and planned introductions. Under these circumstances, 
the Administrator has determined that prior notice and opportunity for 
public comment are contrary to the public interest and that there is 
good cause under 5 U.S.C. 553 for making this action effective less 
than 30 days after publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be not significant for the purposes of Executive 
Order 12866 and, therefore, has not been reviewed by the Office of 
Management and Budget.
    This interim rule amends the 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 this interim rule, such 
introductions could be accomplished under notification, an expedited 
permitting procedure.
    Since 1993, only five companies and two public sector organizations 
have submitted notifications or applied for permits to introduce plants 
producing industrial compounds. From 1993 to 2001, 10 notifications of 
introductions of plant-made industrials (by 2 companies and 1 public 
sector entity) were received by APHIS. One notification was withdrawn; 
nine were acknowledged. In 2003, five permit applications for 
introductions of plant-made industrials have been received by APHIS (by 
three companies and one public sector entity).
    It is difficult to predict how many organizations will apply for 
permits to introduce genetically engineered plants producing industrial 
compounds under the regulations in the future. Many unknowns will 
affect growth of the sector, including: Scientific/technological 
advances, consumer acceptance, market demand, production economics, the 
regulatory environment, intellectual property rights, and other 
critical factors.
    Under the current notification procedure, when APHIS receives a 
notification, it is usually reviewed by a biotechnologist within 10 to 
30 days, is forwarded to the State for further review, then returned to 
the applicant as either acknowledged or denied. Under the current 
permit procedures, it could take up to 3 months longer for each plant-
made industrial compound introduction to be approved. When a permit 
application is received by APHIS, scientists review the application for 
deficiencies. If deficiencies are found, the applicant is required to 
respond to the noted deficiencies and the permit is either issued or 
denied within 120 days. The permit and proposed conditions are then 
sent to the State in which the introduction would occur. The State may 
concur or add conditions and concur.
    Authorizations under notification require compliance with the 
performance standards described in Sec.  340.3(c). For each 
notification, the responsible person must describe the procedures they 
will take to meet the performance standards. APHIS reviews those 
procedures and approves or denies the notification request. 
Authorizations under permit require compliance with standard permit 
conditions and supplemental conditions based on the risks involved in 
each case.
    The requirement to introduce plants genetically engineered to 
produce industrial compounds under permit will result in an increased 
paperwork burden for applicants. Permits require the applicant to 
answer three more questions. The time per response is estimated to be 5 
hours, so the total additional paperwork burden per permit could be 
somewhere in the neighborhood of 15 hours.
    It is unlikely that the additional time for processing permits or 
the additional paperwork requirement would discourage applicants from 
applying for permits for the introduction of plants producing 
industrial compounds. Data on applications to introduce plants 
producing industrial compounds under the notification system (1993-
2001) versus the permit system (2003) suggest that voluntary compliance 
with the permit system has not discouraged applicants thus far.

                    Table 1.--Applications To Introduce Plants Producing Industrial Compounds
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                                                 Total
                                             applications                   Applications per year
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Notification system (1993-2001)...........              10  Slightly more than 1 per year.
Permit system (2003)......................               5  Five in the first 6 months.
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[[Page 46436]]

    Market research studies \1\ indicate that approximately 60 
companies and 60 research institutes are involved in biopharming (both 
pharmaceutical and industrial) product research and development 
worldwide. A subset of this group involved only in industrial or 
industrial/pharmaceutical biopharming research and development could be 
affected by this interim rule. It is unclear at this time exactly how 
many of them will be affected, or how many of them will qualify for 
consideration as small entities. The Small Business Association (SBA) 
defines small entities engaged in research and development in the life 
sciences as those with no more than 500 employees.
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    \1\ (1) Biopharming: The Emerging World Market of Plant-Based 
Therapeutics, Theta Reports, November 2002; (2) The Transgenic Plant 
Market--Profits from New Products and Novel Drugs, Drug and Market 
Development Corp., August 2002; (3) World Agricultural 
Biotechnology: Transgenic Crops, Freedonia Industry Study, March 
2002.
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    As of May 2003, only five companies and two research institutes had 
filed notifications or applied for permits to introduce plants 
genetically engineered to produce industrial compounds. Of the seven 
entities, two met the SBA criteria for small entities. Two were 
presumed small, and the remaining three were large organizations.
    Strengthening the conditions under which plants genetically 
engineered to produce industrial compounds are regulated is expected to 
provide some benefits to all affected biotechnology companies and 
organizations. While it is possible that a small entity would be 
affected by this interim rule, the number of such entities, if any, 
would be few. Regardless of the number of small entities affected, 
however, the rule is unlikely to have any significant economic impact 
on them. Costs of complying with the conditions set forth in this 
interim rule are expected to be negligible. All currently affected 
entities are already in voluntary compliance with the interim rule.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0216.
Government Paperwork Elimination Act Compliance
    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this interim rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

List of Subjects in 7 CFR Part 340

    Administrative practice and procedure, Biotechnology, Genetic 
engineering, Imports, Packaging and containers, Plant diseases and 
pests, Transportation.

0
Accordingly, we are amending 7 CFR part 340 as follows:

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
1. The authority citation for part 340 is revised to read as follows:

    Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.


Sec.  340.3  [Amended]

0
2. In Sec.  340.3, paragraph (b)(4)(iii) is amended by adding the words 
``or industrial'' immediately after the word ``pharmaceutical''.


Sec.  340.4  [Amended]

0
3. Section 340.4 is amended by adding an OMB control number citation at 
the end of the section to read as follows: ``(Approved by the Office of 
Management and Budget under control number 0579-0216)''.

    Done in Washington, DC, this 31st day of July 2003.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-19877 Filed 8-5-03; 8:45 am]
BILLING CODE 3410-34-P