[Federal Register Volume 67, Number 149 (Friday, August 2, 2002)]
[Notices]
[Pages 50578-50580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19746]



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Part IV





Office of Science and Technology Policy





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Proposed Federal Actions To Update Field Test Requirements for 
Biotechnology Derived Plants and To Establish Early Food Safety 
Assessments for New Proteins Produced by Such Plants; Notice

  Federal Register / Vol. 67, No. 149 / Friday, August 2, 2002 / 
Notices  

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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Proposed Federal Actions To Update Field Test Requirements for 
Biotechnology Derived Plants and To Establish Early Food Safety 
Assessments for New Proteins Produced by Such Plants

AGENCY: Office of Science and Technology Policy.

ACTION: Request public comments on proposed federal actions.

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SUMMARY: These proposed federal actions are put forward to address 
regulatory issues associated with the expanding development and use of 
biotechnology-derived crops. Rapid developments in genomics are 
resulting in dramatic changes in the way new plant varieties are 
developed and commercialized. Scientific advances are expected to 
accelerate significantly over the next decade, leading to the 
development and commercialization of a greater number and diversity of 
biotechnology-derived crops. Consistent with the Coordinated Framework 
for the Regulation of Biotechnology Products (51 FR 23302, June 
26,1986), the Office of Science and Technology Policy (OSTP), working 
with Departments of Agriculture (USDA) and Health and Human Services 
(HHS) and the Environmental Protection Agency (EPA), is proposing these 
coordinated actions to update field testing requirements of 
biotechnology-derived food and feed crop plants and to establish early 
food safety assessments for new proteins produced by such plants.

DATES: The Office of Science and Technology Policy welcomes comments on 
the proposed federal actions. To be assured consideration by USDA, HHS, 
and EPA, comments must be postmarked no later than September 30, 2002.

ADDRESSES: Comments on this notice should be sent to OSTP by e-mail at 
[email protected] or by FAX at 202-456-6027.

Background

    The use of biotechnology-derived crops in the United States has 
increased markedly over the past decade. In 1994, approximately 7,000 
acres were planted under 593 USDA field-test authorizations, compared 
to 57,000 acres under 1,117 authorizations in 2001. The first 
biotechnology-derived crops were commercialized in 1996 and, in 2001, 
approximately 88 million acres were planted in the United States and 
130 million acres were planted worldwide (ISAAA). While the increases 
are most dramatic in the United States, other nations (e.g., Canada, 
Argentina, China) are also experiencing significant growth in the 
development and use of biotechnology-derived crops.
    Rapid developments in genomics (plant, animal, and microbial) are 
making this expansion possible. The genomes of the model plant 
Arabidopsis and rice have been sequenced. Such scientific advances are 
expected to accelerate significantly over the next decade, leading to 
the development and commercialization of a greater number and diversity 
of biotechnology-derived crops. In addition to developing plants 
expressing traits for improved agronomic properties (e.g., disease and 
pest resistance and drought and herbicide tolerance), scientists are 
adding traits for the benefit of the consumer (e.g., enhanced 
nutrition, other health benefits, and prolonged shelf-life), and traits 
that produce substances not intended for consumption through food or 
feed (e.g., industrial enzymes and pharmaceuticals).
    While the expansion of biotechnology-derived crops is expected to 
result in net benefits to producers, consumers, and the environment, 
the federal government must maintain appropriate regulatory oversight, 
adjusting its requirements based on scientific developments and 
industry trends. For example, the National Research Council's reports 
``Environmental Effects of Transgenic Plants'' (NRC, 2002) and 
``Genetically Modified Pest-Protected Plants: Science and Regulation'' 
(NRC, 2000) make several recommendations to strengthen various aspects 
of federal oversight of agricultural biotechnology.
    The overall federal regulatory structure for biotechnology products 
(Coordinated Framework) was adopted by federal agencies in 1986 (51 FR 
23302, June 26, 1986). The Coordinated Framework provides a regulatory 
approach that is intended to ensure the safety of biotechnology 
research and products, using existing statutory authority and building 
upon agency experience with agricultural, pharmaceutical, industrial, 
and other products developed through traditional genetic modification 
techniques. The oversight of biotechnology-derived plants rests with 
the USDA's Animal and Plant Health Inspection Service (APHIS), the HHS' 
Food and Drug Administration (FDA), and the EPA. The Coordinated 
Framework anticipated that agencies might need to develop specific 
regulations or guidelines under existing statutory authority. The 
Framework also anticipated further elaboration of federal biotechnology 
policy consistent with scientific advances and product development.
    Federal regulatory agencies recognized that the expansion in 
agricultural biotechnology increasingly will put pressure on seed 
production and commodity handling systems to ensure applicable seed, 
commodity, and food and feed safety standards are met. Those plants 
that have already been reviewed by federal regulatory agencies and 
found safe are not of concern. While existing field-testing 
requirements have been appropriate for current agricultural 
biotechnology development and commercialization activities, federal 
regulations must anticipate future activities. As the number and 
diversity of field tests increase, the likelihood that cross-
pollination due to pollen drift from field tests to commercial fields 
and commingling of seeds produced under field tests with commercial 
seeds or grain may also increase. This could result in intermittent, 
low-levels of biotechnology-derived genes, and gene products occurring 
in commerce that have not gone through all applicable regulatory 
reviews.
    Therefore, in anticipation of the expansion of the development and 
commercialization of agricultural biotechnology, these proposed federal 
actions would establish a coordinated regulatory approach to update 
field testing requirements of biotechnology-derived plants and to 
establish early food safety assessments for new proteins produced by 
such plants that are intended for food or feed use. The measures 
proposed in this Notice address only those biotechnology-derived crop 
plants intended for food and feed use. These measures are aimed at 
preventing low levels of biotechnology-derived genes and gene products 
from being found in commercial seed, commodities, and processed food 
and feed until appropriate safety standards can be met. Actions 
addressing other regulatory aspects of biotechnology-derived crop 
plants may be proposed in the future.

Proposed Federal Actions

    These proposals are aimed at further reducing in commercial seed 
lots, bulk commodities, and processed food and feed the likelihood of 
the occurrence of intermittent, low levels of biotechnology-derived 
genes and gene products from crops under development for food or feed 
use until all appropriate safety standards have been met. These actions 
are part of the government's continuing protection of public health

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and the environment and efforts to enhance public confidence in the 
regulatory oversight of biotechnology-derived food crops and foods/
feeds derived from such crops.
    These proposals would be implemented through the coordinated 
actions of FDA, USDA, and EPA. In developing these proposals, the U.S. 
government has relied on the following three principles:
     The level of confinement under which a field test of a 
biotechnology-derived plant is conducted should be consistent with the 
level of environmental, human, and animal health risk associated with 
the introduced protein and trait.
     If a trait or protein presents an unacceptable risk or the 
risks cannot be determined adequately, field test confinement 
requirements would be rigorous to restrict out-crossing and commingling 
of seed and the occurrence at any level of biotechnology-derived genes 
and gene products from these field tests would be prohibited in 
commercial seed, commodities, and processed food and feed.
     Even if a trait or protein does not present an 
unacceptable risk to the environment or public health, field test 
requirements should still minimize the occurrence of out-crossing and 
commingling of seed from these field tests, but intermittent, low 
levels of biotechnology-derived genes and gene products from such field 
tests could be found acceptable based on data and information 
indicating the newly introduced traits and proteins meet the applicable 
regulatory standards.

FDA

    FDA would publish for comment draft guidance on procedures to 
address the possible intermittent, low level presence in food and feed 
of new non-pesticidal proteins from biotechnology-derived crops under 
development for food or feed use, but that have not gone through FDA's 
premarket consultation process. The guidance would focus on proteins 
new to such plants, because FDA believes that at the low levels 
expected from such material, any food or feed safety concerns would be 
limited to the potential that a new protein could cause an allergic 
reaction in some people or could be a toxin. Through this guidance, FDA 
would encourage sponsors (domestic and foreign) to submit protein 
safety information once field testing was about to reach a stage of 
development such that there could be concerns that new non-pesticidal 
proteins produced in the field-tested plants might be found in 
commercial seed, commodities, or food/feed.
    For this kind of low-level intermittent exposure, FDA does not 
believe there is a need to evaluate potential unintended compositional 
changes in food that might be associated with separate transformation 
events. Consequently, the agency would propose to establish procedures 
under which developers could provide FDA with food/feed safety 
information on any non-pesticidal protein engineered into a food/feed 
crop when that protein has not previously been evaluated by FDA and is 
new to the food crop into which it was engineered. FDA would 
principally be interested in looking at data and other information 
addressing potential toxicity and allergenicity. For developers who 
have intentionally altered the composition of the food or feed, FDA 
would encourage them to consult with the agency about whether the 
presence in food/feed of such material at low and intermittent levels 
would raise any potential safety issues.
    Since this guidance would be focusing only on the new protein and 
its potential allergenicity and toxicity, FDA would not expect multiple 
submissions for the same protein from the same source gene. FDA also 
would not expect submissions for proteins moved within the same 
species, as such movement would not raise new toxicity or allergenicity 
issues for the food.
    Consistent with procedures the agency has implemented or has 
proposed to implement for its voluntary premarket consultation process 
and proposed mandatory premarket notification process for foods/feeds 
from bioengineered plants, the agency would propose in the draft 
guidance to provide developers with a written response at the 
conclusion of its evaluation, and to make the submission and FDA's 
response available through its web site. FDA would propose to maintain 
a list on its website, consistent with confidentiality requirements, of 
all proteins it had evaluated and considered acceptable (or 
unacceptable) through this procedure. FDA would still expect developers 
to conduct a complete consultation with FDA prior to marketing food or 
feed from the plant, consistent with current practices.

EPA

    EPA would rely on its existing processes to address residues of 
pesticidal proteins in food, and would publish for comment guidance for 
individuals and organizations conducting field-testing on plant-
incorporated protectants (PIPs). PIPs are pesticidal substances and the 
genetic material necessary to produce the substance, when produced and 
used in living plants, and are regulated as pesticides under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 
Federal Food, Drug and Cosmetic Act (FFDCA). This guidance would 
address broadly two issues: (1) The process for obtaining EPA review of 
the safety of the presence of low-level intermittent residues of PIPs 
in food and (2) guidance on containment controls that a person should 
employ when conducting experimental field trials, in order to minimize 
the potential occurrence of unapproved PIPs in food.
    EPA would encourage developers to seek approval for residues of 
PIPs in food very early in the research and development process, if 
there is a likelihood for the pesticide to be in food through gene 
flow. EPA decisions about the safety in food of low levels of PIPs 
would be made under the provisions of section 408 of the FFDCA, which 
requires that EPA determine whether there is a reasonable certainty of 
no harm from aggregate exposure to the pesticide. EPA would discuss its 
legal authority and would explain that, like all safety determinations 
for PIPs, EPA would need to issue a rule under FFDCA permitting the 
residues of the PIP to be present in food, even if the PIP is only 
found at low levels. Such rules typically would last only as long as 
necessary to allow any food that might contain residues to pass through 
the food distribution chain. A person seeking an approval under the 
FFDCA to allow the PIP residue to be present in food would need to 
submit PIP-specific information sufficient to establish the PIP's 
safety. In general, EPA would expect the same types and amount of 
information as FDA, with the focus on product identity and potential 
allergenicity and toxicity. In a few areas, however, EPA would likely 
need some additional data because the products regulated by EPA have a 
different character--they are intended to display pesticidal 
properties--from the products that FDA reviews.
    In addition, EPA would discuss the regulation of PIPs under FIFRA, 
focusing on the provisions which require a person to obtain an 
experimental use permit (EUP) prior to conducting field research with a 
pesticide. EPA would provide guidance on the circumstances under which 
the Agency would ``reasonably anticipate'' that PIP residues would be 
present in food, and thus would presumptively require an EUP. EPA would 
also describe the containment controls that would be appropriate for 
experimental field trials to minimize the potential for gene-flow to 
commercial seed production fields or commercial

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commodity production fields, either through pollen drift or other 
avenues of transfer of genetic material, such that those responsible 
for the field trials would not anticipate residues. EPA would 
coordinate its approach to containment controls for field testing with 
other federal agencies.

USDA

    USDA has strengthened field-testing controls for permits on those 
bioengineered traits that are not intended for commodity uses, such as 
pharmaceuticals, veterinary biologics, or certain industrial products. 
This has been accomplished by requiring specific additional safeguards 
as a condition of permits for confined release into the environment of 
such products. The potential for exposure would be mitigated through 
additional appropriate safeguards. These safeguards may include overall 
confinement procedures, performance standards, and monitoring/auditing 
practices for ensuring that out-crossing or commingling of non-
commodity appropriate traits with seeds and commodities are prevented.
    USDA would also propose, under its biotechnology regulations in 7 
CFR part 340, to amend its regulations to provide criteria under which 
regulated articles may be allowable in commercial seed and commodities, 
if they pose no unacceptable environmental risk. Criteria would be 
announced as part of an overall updating of 7 CFR part 340, 
incorporating APHIS' new authorities under the Plant Protection Act and 
in consideration of recommendations given to USDA in the National 
Research Council (February 2002) report ``Environmental Effects of 
Transgenic Plants: The Scope and Adequacy of Regulation.''
    USDA will also continue and expand a critical emphasis on 
transparency of the regulatory process and on the use of broad internal 
and external scientific expertise and review as the foundation for 
decision-making.

Barbara Ann Ferguson,
Assistant Director for Budget and Administration, Office of Science and 
Technology Policy.
[FR Doc. 02-19746 Filed 8-1-02; 11:20 am]
BILLING CODE 3170-01-P