[Federal Register Volume 68, Number 46 (Monday, March 10, 2003)]
[Proposed Rules]
[Pages 11337-11340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5427]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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 

  Federal Register / Vol. 68, No. 46 / Monday, March 10, 2003 / 
Proposed Rules  

[[Page 11337]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. 03-031-1]


Field Testing of Plants Engineered To Produce Pharmaceutical and 
Industrial Compounds

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Request for comments.

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SUMMARY: The Animal and Plant Health Inspection Service is providing 
information to the public on technical aspects of its biotechnology 
regulatory program as it relates to permit conditions for field testing 
plants that have been genetically engineered. The Agency is also 
seeking public comment on ways to improve specific aspects of its 
program. The specific topics on which we are seeking comment include 
permit confinement measures, procedures to verify compliance, and ways 
to enhance the transparency of the permitting system.

DATES: We will consider all comments that we receive on or before May 
9, 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. 03-031-1, 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. 03-031-1. 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. 
03-031-1'' 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, is available on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Rebecca Bech, Acting Director, 
Regulatory Policy Division, Biotechnology Regulatory Services, APHIS, 
4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-7324.

SUPPLEMENTARY INFORMATION:

I. Background

    The Coordinated Framework for Regulation of Biotechnology, issued 
by the Office of Science and Technology Policy in 1986 (51 FR 23302), 
describes the authorities the Federal Government uses to ensure that 
the development, testing, and use of the products of biotechnology 
occur in a manner that is safe for plant and animal health, human 
health, and the environment. The statutes include those administered by 
the Animal and Plant Health Inspection Service (APHIS), the Food and 
Drug Administration (FDA), and the Environmental Protection Agency.
    Under the Plant Protection Act (7 U.S.C. 7701-7772), 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 into 
the United States. The Secretary's authority under the Plant Protection 
Act has been delegated to the Administrator of 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.'' Part 340 (referred to below as the 
regulations) governs 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, or any organism that is unclassified and/or 
whose classification is unknown. The regulations refer to such 
organisms as ``regulated articles.''
    With certain limited exceptions, the importation or interstate 
movement of any regulated article is prohibited unless that movement is 
authorized by a permit issued by APHIS. Similarly, the release into the 
environment of any regulated article is likewise prohibited unless the 
release is authorized by a permit or, for specific classes of regulated 
articles, the Administrator has been notified of the release in 
accordance with Sec.  340.3 of the regulations, which provides for the 
use, under certain circumstances, of a streamlined permitting procedure 
called notification.
    Field test permits include detailed descriptions of the conditions 
under which the permit is issued. These conditions address movement of 
the regulated articles to the field test site, conduct of the field 
test, and then any movement of the regulated articles to facilities 
where the compounds of interest are extracted. Section 340.8 of the 
regulations provides specific container requirements for the movement 
of regulated articles. Other conditions are designed to confine the 
regulated articles to the test site during the test and ensure that 
they do not persist in the environment beyond the conclusion of the 
field test. APHIS will continue to require, on a case-by-case basis, 
that applicants submit additional protocols for review and approval 
when such protocols are deemed to be pertinent to the applicant's 
compliance with the regulations. Permit conditions also cover the 
period after harvest when the test site is monitored for any volunteer 
plants (plants originating from seeds of the crop planted the previous 
season). APHIS officers inspect field test sites, audit records, and 
review field data reports to verify compliance.

[[Page 11338]]

    The APHIS Biotechnology Permitting Program is a flexible system 
that allows the Agency to tailor permit conditions to address new 
information, technical innovations, and experience gained from 
compliance monitoring, as well as feedback from the public. This 
flexibility enables the Agency to address new advances in science that 
affect current and future uses of the technology with genetically 
engineered plants.
    In the past, most field testing has been done with plants 
engineered to achieve agronomic improvements, such as resistance to 
diseases and pests or tolerance to specific herbicides. Recently, 
however, a small number of field tests have been authorized for plants 
engineered to produce compounds that are intended for pharmaceutical 
uses. APHIS authorized over 1,000 field tests during 2002, of which 
fewer than 20 were for field tests of plants engineered to produce 
pharmaceutical compounds. In 2002, approximately 130 acres of 
pharmaceutical producing plants were planted in experimental field 
tests at 34 sites. Most of these test sites were less than 5 acres. It 
is anticipated, however, that the number of requests for permits for 
field tests, and the scale of production, will increase significantly 
over the next few years.
    Very few permits have been issued to date for plants in which the 
modification was made for the expressed intent of producing an 
industrial compound. However, as with plants engineered to produce 
pharmaceutical compounds, we anticipate an increase in requests for 
field tests of these types of plants. ``Industrial'' plants include 
those genetically engineered plants that are not intended for use as 
food or feed, but rather are intended to produce compounds that will be 
extracted for industrial uses. The range of potential uses of such 
substances includes, for example, applications in detergent 
manufacturing, paper production, mineral recovery, or in purely 
experimental research.

II. Changes in the Permit Conditions for 2003

    APHIS is modifying its permit conditions and administrative 
procedures from those APHIS used in 2002. An example of a complete 
permit, with all conditions, can be viewed on the Internet at http://www.aphis.usda.gov/ppq/biotech/pdf/sample_permit.pdf. Some of the 
changes are related to scientific issues to achieve confinement, 
whereas other changes are related to ways APHIS administers the 
program. For all of the conditions described below, APHIS will consider 
variances proposed by applicants if they are appropriate for the 
specific case.

1. APHIS will institute the following changes in conditions for all 
plant species engineered to produce pharmaceutical and/or industrial 
compounds field tested under permit.

    A. APHIS will increase the size of the perimeter fallow zone (not 
in production) around the field test site from 25 to 50 feet. This 
measure is designed to ensure that test plants are not inadvertently 
commingled with plants to be used for food or feed. APHIS currently 
prohibits the use of the field test site and its perimeter fallow zone 
to be used to produce food or feed crops during the tests. APHIS is 
increasing the size of the perimeter fallow zone around the test site 
to allow farm machinery to move around the site and yet still prevent 
physical mixing of the regulated plants with surrounding plants that 
may be used for food or feed.
    B. APHIS will restrict the production of food and feed crops at the 
field test site and perimeter fallow zone in the following season in 
cases where there is a potential for volunteer plants to be 
inadvertently harvested with the following crop.
    C. APHIS will require that planters and harvesters be dedicated to 
use in the permitted test site(s) for the duration of the tests. In 
addition, while tractors and tillage attachments, such as disks, plows, 
harrows, and subsoilers, do not have to be dedicated, they must be 
cleaned in accordance with protocols approved by APHIS (see item II.1.E 
below). To ensure the regulated articles are not inadvertently removed 
from the site, APHIS authorization will be required before the 
machinery is used elsewhere.
    D. APHIS will require the use of dedicated facilities for the 
storage of equipment and regulated articles for the duration of the 
field test. Facilities must be cleaned according to APHIS-approved 
protocols prior to general use of the facilities.
    E. APHIS will require cleaning procedures to be submitted and 
approved to minimize the risk of seed movement by field operations or 
equipment (movement of seed on tires of tractors, etc.) from the 
authorized test site.
    F. APHIS will require procedures to be submitted and approved for 
seed cleaning and drying in order to confine the plant material and 
minimize the risk of seed loss or spillage.
    G. APHIS will require the permittee to implement an approved 
training program to ensure that personnel are prepared to successfully 
implement and comply with permit conditions.

2. APHIS will institute the following changes in field test permit 
conditions for pharmaceutical corn.

    A. APHIS will require that there will be no corn grown within 1 
mile (5,280 feet) of the field test site throughout the duration of any 
field test which involves open-pollinated corn. This establishes a 
physical isolation distance that is eightfold greater than the 
isolation distance required for the production of foundation seed (660 
feet). When pollen flow is controlled by placing bags around the corn 
tassels, there will be no other corn within 2,640 feet of the field 
test site, and the pharmaceutical corn must be planted no less than 28 
days before or 28 days after any corn growing in a zone extending from 
2,640 to 5,280 feet from the field test site, ensuring there is no 
overlap in anthesis.
    B. With the establishment of isolation distances of 1 mile for 
open-pollinated corn and one-half mile for controlled pollination corn 
field tests, APHIS will not allow the use of border rows to reduce 
these isolation distances. APHIS believes that other methods are 
available and do not pose the difficulties inherent in using border 
rows. For example, by eliminating the use of border rows/buffer strips, 
there will be a reduction in the amount of plant material that must be 
disposed of after the field test is terminated (border rows are handled 
the same as the regulated article, as their proximity to the plots make 
them possible pollen recipients). This should reduce the possibility of 
inadvertent mixing of regulated articles with nonregulated plant 
material.

III. Compliance

    In order to ensure compliance with the regulations, as well as all 
permit conditions, APHIS will increase the number of field site 
inspections during the upcoming growing season to correspond with 
critical times relevant to the confinement measures. Examples might 
include inspection at the pre-planting stage to evaluate the site 
location; at the planting stage to verify site coordinates and adequate 
cleaning of planting equipment; at midseason to verify reproduction 
isolation protocols and distances; at harvest to verify cleaning of 
equipment and appropriate storage; at post-harvest to verify cleanup at 
the field site; and for the following growing season, inspections will 
be timed to ensure that regulated articles

[[Page 11339]]

do not persist in the environment. For example, a field test may have 
five inspections during the growing season and two additional 
inspections post-harvest; however APHIS may inspect more frequently in 
some cases.
    The permittee must, as always, maintain records of activities 
related to meeting the permitting conditions. APHIS will increase the 
auditing of the permittee's records to verify that required permit 
conditions were accomplished. APHIS will continue to require permittees 
to regularly inspect sites and maintain accurate records that will be 
available for APHIS auditing. The permittee will be required to record 
all efforts undertaken to meet the confinement protocols and other 
permit conditions. Some of this information will be related to 
agronomic information (i.e., detasselling, pollination time of test 
crop, pollination time of surrounding crops, etc.). Frequent APHIS 
audits will enable the Agency to identify any discrepancies and 
mitigate any potential adverse effects.

IV. Information to the Public--Transparency

    Transparency of the regulatory system and information about its 
effectiveness are essential ingredients for informed dialogue with the 
public. APHIS believes that effective communication and dialogue with 
interested parties and the public are necessary to enable continued 
refinement of its regulatory system and help instill confidence in the 
safety of field testing.
    APHIS recognizes the need to provide relevant and timely 
information to the public on all aspects of the regulations, including 
information on APHIS authorizations for field testing. APHIS is 
responding to the increased public interest in the types of genetically 
engineered plants that are being developed for potential use in 
medical, veterinary, food processing, and other applications in 
addition to the more traditional uses in plant variety development for 
growers.
    For example, APHIS provides information on its website on field 
tests the Agency has authorized and also those pending authorization. 
In light of increased public interest in the types of confinement 
standards APHIS uses for field tests of plants engineered to produce 
pharmaceutical compounds, the Agency posted a letter to potential 
permit applicants regarding such standards on its website (http://www.aphis.usda.gov/ppq/biotech/pdf/pharma_2000.pdf).
    In addition, FDA, in collaboration with APHIS's Biotechnology 
Regulatory Services and Center for Veterinary Biologics, recently 
published draft guidance for scientific questions and information to be 
considered during development of a protein pharmaceutical in a 
genetically engineered crop (see 67 FR 57828, published September 12, 
2002). The document outlines manufacturing and pre-clinical 
considerations for such products in addition to the stringent 
procedures for drug and biologic approval under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) and the Virus-Serum-Toxin Act 
(21 U.S.C. 151 et seq.). In the coming months, the agencies will 
respond to comments received regarding the notice.
    This Federal Register notice is a step in our program to increase 
awareness and establish effective dialogue about APHIS' regulatory 
program and the permit system. APHIS anticipates providing further 
opportunities for public involvement in coming months as the Agency 
continues to evaluate its regulatory program.

V. Issues for Comment

    1. As explained above, APHIS is taking steps to increase 
transparency of its regulatory approach to plants engineered to produce 
pharmaceutical and industrial compounds. APHIS seeks comment on 
additional measures that the Agency can take or employ to increase 
transparency and to enhance the flow of information to interested 
parties and the public.
    2. APHIS seeks comment on alternative procedures, and the 
scientific data or technical rationale on which they are based, for 
ensuring adequate confinement for field tests.
    3. APHIS seeks comment on appropriate training standards, the use 
of third party auditors, standard-setting organizations, or other 
quality control mechanisms to monitor and ensure compliance. In 
addition, commenters are asked to provide information on other measures 
or approaches that APHIS might use to verify compliance.

VI. Conclusion

    We welcome all comments on the scope and approach of the actions 
outlined above and encourage the submission of ideas on any associated 
topics or other suggestions. APHIS will consider all comments and 
recommendations in developing additional guidance.

Paperwork Reduction Act

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements associated with the application of the 
procedures described in this notice were submitted for emergency 
approval to the Office of Management and Budget (OMB). OMB has assigned 
control number 0579-0216 to the information collection and 
recordkeeping requirements.
    We plan to request continuation of that approval for 3 years. 
Please send written comments on the 3-year approval request to the 
following addresses: (1) Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) 
Docket No. 03-031-1, Regulatory Analysis and Development, PPD, APHIS, 
Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. 
Please state that your comments refer to Docket No. 03-031-1 and send 
your comments within 60 days of publication of this notice.
    The changes in permit conditions described in this notice will 
result in additional recordkeeping and reporting.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our information collection and recordkeeping 
requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 7.4444 hours per response.
    Respondents: Universities and pharmaceutical companies.
    Estimated annual number of respondents: 12.
    Estimated annual number of responses per respondent: 9.
    Estimated annual number of responses: 108.
    Estimated total annual burden on respondents: 804 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)

[[Page 11340]]

    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

    Authority: 7 U.S.C. 166, 1622n, 7756, and 7761-7772; 31 U.S.C. 
9701; 7 CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 4th day of March 2003.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-5427 Filed 3-7-03; 8:45 am]
BILLING CODE 3410-34-P