[Federal Register: March 10, 2003 (Volume 68, Number 46)]
[Proposed Rules]
[Page 11337-11340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr03-7]
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Proposed Rules
Federal Register
________________________________________________________________________
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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[[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 regulations@aphis.usda.gov. 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]
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