Report Number: JIEE 2003-04
Regulatory Policy Toward Organisms
Produced through Biotechnology:
Evolution of the Framework and
Relevance for DOE’s
Bioremediation Program
Christine Dümmer
Law Office of Christine Dümmer
David J. Bjornstad
Oak Ridge National Laboratory
January 2004
Joint Institute for Energy and Environment
314 Conference Center Building
Knoxville, TN 37996-4138
Phone: (865) 974-3939
Fax: (865) 974-4609
URL: www.jiee.org
e-mail: [email protected]
Regulatory Policy Toward Organisms Produced through Biotechnology
JIEE Report 2003-04
CONTENTS
PREFACE AND ACKNOWLEDGEMENTS........................................................................iii
EXECUTIVE SUMMARY .................................................................................................iv-v
1.0
INTRODUCTION ....................................................................................................... 1
2.0
PRE-REGULATORY EVENTS ................................................................................. 3
3.0
REGULATION OF BIOENGINEERED ORGANISMS
UNDER EXISTING STATUTES ............................................................................... 6
3.1
3.2
3.3
3.4
4.0
Regulation under FIFRA.................................................................................. 6
Regulation under TSCA................................................................................... 7
Regulation under RCRA and CERCLA .......................................................... 9
Regulation of Agricultural Products under the
EPA, FDA, and USDA Statutes..................................................................... 9
CONCERNS WITH THE CURRENT SYSTEM OF REGULATION..................... 11
4.1
4.2
4.3
Issues in Domestic Regulation....................................................................... 11
International Regulation of Agricultural Products......................................... 12
Summary of Critiques .................................................................................... 14
5.0
CURRENT REGULATORY IMPACTS ON DOE’S USE
OF BIOREMEDIATION........................................................................................... 15
6.0
REFERENCES CITED.............................................................................................. 19
7.0
OTHER REFERENCES ............................................................................................ 21
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PREFACE AND ACKNOWLEDGEMENTS
This document examines the Federal regulatory framework that has evolved around
the products of recombinant DNA technologies and considers the relevance of this
framework for bioremediation applications in the Department of Energy’s legacy waste
cleanup program. The general conclusion is that proposed bioremediation cleanup
approaches are non-controversial, but that roadblocks remain for application. Not the least of
these is the current regulatory environment that works against reopening past decisions to
substitute new technologies, even if that technology is superior. Thus, the extant framework
is not fully satisfactory. It is sometimes duplicative and tends to focus on how products were
produced rather than the risks they pose.
The Department of Energy’s Office of Science provided support for this work, which
is background for further investigation into the question: What data should bioremediation
R&D research activities collect to promote effective regulation? Its principal audience is
researchers and administrators who manage R&D activities or cleanup activities.
The authors would like to thank Dr. Dan Drell of the Office of Science for his support
and guidance on this activity. Milton Russell provided a number of suggestions that served to
strengthen the analysis, and Sherry Estep edited the report. None of these individuals should
be held accountable for the remaining shortcomings.
Under the terms of our agreement with DOE, the authors are accountable for the
report’s contents. Neither DOE nor its employees bear any responsibility for the views
expressed herein.
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EXECUTIVE SUMMARY
Bioremediation presents an attractive alternative to traditional approaches to cleanup
of legacy wastes at Department of Energy (DOE) sites. Unlike cleanup remedies that are
destructive (dig and transport) or ineffective (pump and treat), bioremediation can transform
some wastes into benign states and immobilize others. Options range from the most passive
(natural attenuation), to more aggressive (use of accelerants or non-native organisms), to the
most aggressive (genetically engineered microbes). Current policy calls for a go-slow
approach that emphasizes natural attenuation.
Regulatory policy regarding bioremediation has evolved from the body of national
laws governing use of the environment and natural resources, and from the rules and
regulations that promulgate them. This paper describes this evolution, with particular
emphasis on the products of biotechnology and their implications for DOE cleanup.
In general, regulation of the products of recombinant DNA technologies is unsettled,
but developing. At present, regulatory jurisdiction is overlapping and risk-based measures
have been slow to develop. Supporters of these technologies argue for regulation by
“substantial equivalence,” the practice of treating new organisms like their prior counterparts.
Critics prefer a “precautionary” approach, whereby evidence of the absence of unreasonable
risks is required to proceed. The former approach seems to have influenced domestic policy
most strongly, whereas the latter dominates in international settings.
DOE’s cleanup benefits from unique regulatory treatment by the Environmental
Protection Agency (EPA) and its state counterparts. Cleanup is well documented, well
funded, and overseen by an established network of stakeholder interests. Many cleanup
remedies stem from DOE R&D programs. There is little reason to forecast that regulators
will dismiss bioremediation out of hand, particularly given the non-controversial proposals
now on the table. Evaluating genetically engineered microbes, however, will undoubtedly
call for expanding risk-related information bases and assessment protocols.
What may be troubling to the expanded use of bioremediation at DOE sites is the
institutional framework that now drives cleanup. The process has an incredible inertia, and
the substitution of new and unproven technologies for tried and true methods that continue to
pump dollars into communities subject to cleanup is less than fully attractive to locals. Other
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barriers include the long-term commitments necessary for bioremediation remedies to
succeed. These require continued budgets, responsible stewards, and, sometimes, continued
inputs to bioprocesses. At present, DOE policy calls for a more aggressive approach to riskbased cleanup and adoption of more cost-effective remedies, along with separation of
cleanup and stewardship responsibilities. Thus, the signals for future success are mixed.
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INTRODUCTION
The Department of Energy (DOE) carries out basic research into bioremediation
technologies that will immobilize or transform selected legacy wastes that were created from
R&D and production throughout its nuclear weapons complex. One major cleanup interest
lies in subsurface (vadose and groundwater) targets of relatively low concentration, many of
which are now routinely treated with relatively ineffective pump-and-treat technologies and
remediation technologies that require relocating contaminated media from one spot to
another. These targets include metals (chromium and mercury) and radionuclides (uranium,
technetium, and plutonium). Interactions of these contaminants with other contaminants,
such as carbon tetrachloride and other substances, are also of interest.
Bioremediation employs microbes, produced naturally or, potentially, through genetic
engineering, to reduce the risks posed by contaminants. Current DOE applications focus on
using naturally occurring microorganisms in immobilization processes, but this paper takes a
more general approach and examines a broader range of potential applications. By its nature,
bioremediation requires time. Biotransformation processes require long intervals for
microbes to convert harmful substances to benign ones, and immobilization processes, which
involve changing (reducing) oxidation states, require evidence that immobilization is
working and that reoxidation is not occurring. Biotransformation processes may also require
the continual injection of accelerants and will necessarily require monitoring to ensure that
biotransformation is progressing as planned. The process DOE intends to use to provide this
assurance, called long-term stewardship, is only now being developed.
Introduction of bioremediation to the DOE Complex will require extension of the
regulatory process now applied to the Complex, but such extensions will likely have their
roots in existing regulatory practices that guide the use of products produced through
biotechnology. This paper examines how these changes are likely to evolve and speculates on
how DOE’s R&D activities might assist the development of this process by gathering and
supplying relevant technical information.
This paper is one of a series intended to help develop the tools through which DOE
can better ensure the right information is developed and supplied to the regulatory process.
Termed Science-Informed Regulatory Policy (SIRP), this activity was supported through
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DOE’s Office of Science under the auspices of its Office of Biomedical and Environmental
Research (OBER) BASIC program.1
The next section of this paper discusses the events leading to the implementation of
formal regulations governing the introduction of natural or bioengineered plants and products
into the environment. The third section describes current regulatory practices. It provides a
separate discussion on the regulation of agricultural products because they are typically
thought to provide the greatest potential for human exposure. Moreover, agricultural products
may have special significance for DOE if cleanup through phytoremediation is contemplated.
The fourth section sets forth some concerns associated with the current regulatory
framework. Finally, the paper concludes with a discussion of how the regulatory framework
and the concerns raised about it may affect the use of these technologies in DOE cleanup. It
further considers steps DOE might take to help facilitate the deployment of bioremediation
technologies.
1
BASIC is an acronym that stands for Bioremediation and its Societal Implications and Concerns. It is part of
OBER’s Natural and Accelerated Bioremediation Research Program (NABIR).
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PRE-REGULATORY EVENTS
Initial pressures to develop a regulatory framework over the products and processes
of recombinant DNA technologies came from within the research community, as scientists
and others confronted the potential for the products of their research to present as yet
undiscovered health and safety risks. In 1973, concerns over these “unknown unknowns”
were voiced at the Gordon Research Conference on Nucleic Acids (Vito, 332). During this
conference, scientists petitioned the National Academy of Sciences (NAS) to address the
potential risks posed by genetically engineered organisms and to provide guidance for
dealing with the risks. These same concerns were reflected in letters to the editors of two
leading scientific publications, which called for the National Institutes of Health (NIH) to
convene a panel of experts to oversee recombinant DNA (also referred to as bioengineered or
genetic engineering) research. The authors of these letters also reiterated the need for
guidance and challenged the NIH to develop guidelines for recombinant DNA studies that
could potentially unleash previously unexperienced risks (Vandenbergh, 1535).
The NAS response to the Gordon Conference request was to convene a committee to
evaluate the safety of research on recombinant DNA. The committee, in turn, recommended
a voluntary cessation of research until issues of safety could be managed. In 1975, the NAS
and the NIH teamed with the National Science Foundation (NSF) to sponsor a conference
(hereafter the Asilomar Conference) at which researchers were called upon to offer their
views over alternatives for managing the still unknown risks. The outcome of this conference
was far from satisfactory; attendees principally agreed that more information was needed.
They also agreed to control their own research in such a way as to minimize risks to the
public until formal guidance could be developed.
In 1976, the NIH proposed a guidance-development process that incorporated the
spirit of the Asilomar discussions, and another panel of scientists was appointed by NIH to
assist in the development of safety guidelines. The resultant product, Guidelines for Research
Involving Recombinant DNA Molecules, called for levels of physical and biological
containment for recombinant DNA products sufficient to prevent release into the
environment. These guidelines, however, held force only over research funded by NIH (Vito,
333).
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Over the next few years, the guidelines were subject to several revisions. At their
inception, they prohibited any deliberate release of genetically engineered organisms into the
environment. By 1981, provision was made for controlled releases. Eventually, the NIH
delegated both oversight and approval authority to local regulators. Yet, with all of this
activity, non-NIH research and private research remained outside of regulatory purview. As
important, there was no basis for controlling commercial applications arising from the
research.
The process of extending the regulations began in 1983, when a House Subcommittee
conducted hearings on commercial applications of recombinant DNA technologies, focusing
on their potential for harm to human health or the environment. No significant initiatives
resulted from these hearings. Next, in 1984, a Senate Subcommittee held hearings on
potential risks posed by the deliberate release of genetically altered organisms. At these
hearings, the NIH, EPA, and the U. S. Department of Agriculture (USDA) asserted that
existing statutes and regulations adequately addressed concerns related to deliberate releases
(Vito, 334). At the same time, the White House Cabinet Council on Natural Resources and
the Environment established a working group to review existing regulations and to
coordinate federal agencies. By the end of 1984, the Office of Science and Technology
Policy proposed a regulatory plan called the Coordinated Framework for Regulation of
Biotechnology. The plan was designed to expand coverage of biotechnology research and
applications and to describe how these expanded regulatory duties would be divided among
Federal agencies.
The proposed Framework was first comprised of policy statements by the Food and
Drug Administration (FDA), EPA, and USDA describing how these agencies intended to
cooperate in the regulation of biotechnology. Nevertheless, there remained confusion about
how the Framework would address research outside the purview of the existing NIH
guidelines. To resolve remaining uncertainties, a Biotechnology Science Coordinating
Committee was established and assigned the responsibility for coordinating policy for the
agencies. A revised version of the Coordinated Framework, which separated responsibility
for various products among the USDA, FDA, and the EPA based on the products’ expected
use, was made public in 1986 (Vito, 335). The revision also sought to resolve jurisdictional
issues and regulatory responsibilities in the case of concurrent jurisdiction. The resultant
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Framework was essentially a crosswalk that divided regulatory responsibilities for
bioengineered substances among the various agencies that administer the applicable statutes,
according to the manner of development and uses of the substances. The next section
discusses these statutes and how they are applied to the various regulatory targets.
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REGULATION OF BIOENGINEERED ORGANISMS UNDER EXISTING
STATUTES
The policy delineated in the Coordinated Framework provides the basis for the
current system of regulation for bioengineered organisms and products. The EPA has been
assigned jurisdiction over any plants that produce substances that would be classified as
pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA also
has jurisdiction of certain commercial uses of these organisms under the Toxic Substances
Control Act (TSCA), and jurisdiction of their use in cleanup under the Resource
Conservation and Recovery Act (RCRA). The FDA is in charge of regulating any
bioengineered foods or food additives. USDA has jurisdiction over any release of organisms
that are classified as plant pests under the Federal Plant Pest Act (PPA) or the Plant
Quarantine Act (PQA). Thus, plants could face dual jurisdiction, such as a plant that
produces substances to protect from pests, but which is itself a food source.
3.1
Regulation under FIFRA
The EPA regulates bioengineered organisms under FIFRA if their use is comparable
to that of a pesticide. FIFRA’s basic regulatory scheme separates organisms into two groups.
The first group is considered lower risk than the second because it is limited to organisms
that contain DNA from a single genus and contain no DNA from a pathogenic
microorganism. The second group consists of organisms containing intergenetic DNA,
naturally occurring pathogenic organisms and/or genetically engineered pathogens (Vito,
339). Under FIFRA, EPA cannot authorize the sale or distribution of a substance until the
Agency has enough information to ensure that “when used in accordance with widespread
and commonly recognized practice, it will not cause or significantly increase the risk of
unreasonable adverse effects to humans or the environment.”2
For non-recombinant DNA (non-rDNA) pesticides, EPA requires information on
risks associated with infectivity, pathogenicity, toxicity, host range, virulence, and
survivability. Regulators believe that recombinant DNA pesticides present the same, and
possibly greater, risks in the form of increased survivability, greater virulence, and better
2
7 U.S.C. § 136a(c)(5)(D), c(7)
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ability to compete with other organisms, thereby justifying more detailed data requirements
for required risk assessments (Vandenbergh, 1544).
In order to gain EPA approval and to be allowed to register the pesticide for
commercial use, producers must submit the required non-rDNA data3 and may be required to
submit information pertaining to the specific gene sequence used, method of insertion,
regions controlling gene expression, likelihood of transfer to another organism, and the like.
Once EPA has received all this information, the Agency reviews the data and may ultimately
approve the new pesticide for commercial use.
Before approval for commercial use, EPA has the option to grant an Experimental
Use Permit (EUP). These permits bypass the registration requirements mentioned above and
are intended to facilitate further research and development of the pesticide. They do not
allow commercial use. Sometimes, small-scale field tests are allowed without use permits,
although EPA requires notification before any field tests are conducted to guard against
release of harmful organisms. These small-scale field tests are limited in size and are used to
demonstrate pesticide effectiveness.4
3.2
Regulation under TSCA
EPA is granted regulatory authority under TSCA because bioengineered organisms
are considered “new chemical substances.” Two types of genetically engineered organisms
fall under TSCA: (1) “organisms that have been modified by the insertion of genetic material
from organisms of different genera,” and (2) “those that are pathogenic or have received
genetic material from organisms that are pathogens” (Vandenbergh, 1547). During research
and development of these organisms, developers must follow one of three regulatory paths
depending on the level of containment intended for the organism. These regulatory paths are:
(1) Microbial Commercial Activity Notice (MCAN), (2) TSCA Experimental Release
Application (TERA), and (3) other specific exemptions.
3
Data is required on the identity of the organism, molecular composition to determine residues that remain after
application, potential harmful effects, and the environmental fate of the pesticide such as non-target organisms’
interactions and environmental expression, and the potential for formation of byproducts.
4
The EUP exemption applies only to field tests of less than ten acres in size if on land and one surface acre if
on water.
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To use a bioengineered organism for a commercial purpose, a research group must
submit an MCAN at least 90 days before the use of the organism. Submission of an MCAN
requires data describing the genetic makeup and characteristics of the organism, any
byproducts of the organism, information relating to risks posed through worker exposure and
environmental release, and health effects information. Specifically, an MCAN requires
detailed information describing the pathogenicity, toxicity, and immunological effects of the
organism as it relates to human health (US EPA, OPPT, 31). Data are also required as to any
ecological effects, as well as to survival and fate.
If a developer simply requires the use of an organism in furtherance of R&D, a TSCA
Experimental Release Application (TERA) is available. This application is required at least
60 days before the initiation of field trials. It provides more flexibility than does the MCAN
and allows for a shorter review period. TERA requires similar information as that required
for an MCAN, but does not require as much detail on the commercial practices of the
applicant (US EPA, OPPT, 12).
Several types of exemptions exist that allow for even more limited information
requirements. Examples of these include the Test Marketing Exemption (TME), the Tier I
and Tier II exemptions, and exemptions for small-scale field tests using Bradyrhizobium
japonicum or Rhizobium meliloti.5
Where there is insufficient information to assess risks, the EPA can require testing of
the organism if it might present an “unreasonable risk” or if “substantial quantities” are to be
produced (Chadwick, 235). To be able to require testing, the EPA need only find that the
organism “may present” an unreasonable risk, wherein “unreasonable risk” is often a matter
of judgment.6 EPA may also limit production of an organism if it finds “reasonable basis”
that unreasonable risk may be present, assuming the least restrictive regulatory requirements.
The findings required to limit production are much more stringent than those to require
testing.
5
These two bacteria are specifically mentioned in 40 CFR 725.239 as being exempt from certain review and
reporting requirements, provided specific conditions are met.
6
Toxicity and amount of human exposure are considered in this assessment.
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Regulation under RCRA and CERCLA
Bioengineered organisms have the potential to be useful in cleanup situations, but
their use faces regulatory obstacles because most current regulations were not developed with
the attributes of bioremediation in mind. When closing a facility under RCRA, current
regulations call for either the complete removal of all wastes (clean closure) or leaving
wastes and constituents in place (landfill closure). This closure process must typically be
completed within 180 days. Bioremediation, used in a closure procedure, would usually take
longer than the 180 allowable days, thereby triggering different RCRA requirements. To use
bioremediation to accomplish closure, approval of an amended closure plan would be
required. A time extension of the 180-day period would also be required. Beyond regulatory
approval, public notice and comment periods would submit the amendment requests to
additional scrutiny (Salamone, 72).
Under RCRA Corrective Action requirements, all cleanup options must be included
in the Corrective Measures Study. If bioremediation is approved, it must be included in the
Corrective Measures Implementation Plan. If the cleanup plan calls for any tank or unit use
that would require permits, the plans must reflect this requirement, and any permit or
corrective action order must be amended. Approval to use bioremediation for corrective
action is typically much easier to obtain than approval for use in closure, because the period
for corrective action is not as time constrained as is that for closure (Salamone, 73).
3.4
Regulation of Agricultural Products under EPA, FDA, and USDA Statutes
In 1994, the EPA announced its intention to regulate certain crops that had not
previously been regulated as pesticides. These were crops and garden plants that had been
genetically modified to resist specific diseases and pests. Following this, in 1996, a group of
scientific societies representing over 80,000 biologists and food professionals published a
report criticizing EPA’s proposal. The report argued that concerns over the safety of a
modified plant would be better directed at the use of the plant, i.e., whether or not it would be
eaten, rather than with the function of the plant, i.e., whether or not the modification protects
against pests (Miller 1999). The report concluded that implementation of this policy would
result in a decrease in research and development of new agricultural products along with
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other undesirable consequences.7 In October 1998, the Council on Agricultural Science and
Technology prepared a report concurring with these criticisms.
The crux of this argument was that the rule was flawed because risk was not a major
regulatory driver. Traditional plants were not regulated at all, regardless of risk, while
genetically altered plants were all regulated, again, regardless of risk. In 2001, EPA finalized
the rule after consulting with outside groups and concerned citizens. EPA also announced its
intention to withhold three areas from finalization to further consider public comment.8 The
public comments have been received and are currently being examined and evaluated by the
EPA.
The Department of Agriculture shares regulatory authority for genetically modified
crops with the FDA. USDA regulates crops under the Plant Pest Act and engineered poultry
and livestock under USDA meat inspection laws. If a crop is not deemed a “pest” or it does
not produce pesticides, then the USDA will apply the FDA guidelines. The same holds true
for herbicide resistant plants as long as they are not intended for human consumption and are
not modified to contain a pesticide (Hileman, 28-29). However, if a plant or crop is deemed a
pest or it produces pesticides, it is regulated under EPA’s FIFRA and is subject to very strict
testing requirements. In April 2000, the FDA announced a new requirement that all
genetically modified foods have a pre-market evaluation (Miller and Conko 2000, 47). This
requirement has been widely subjected to the criticism that fulfilling this requirement will
hinder innovation without taking best account of the risks posed.
7
This group also argued that implementation of the EPA’s proposal would result in the prolonged use of
chemical pesticides, increased regulatory burden for developers of new agricultural products, increased
regulatory costs, and a decrease in U.S. international competitiveness in the field.
8
These three areas include: 1) Plant-incorporated protectants (PIPs) derived through genetic engineering
between sexually compatible plants, 2) PIPs that act by affecting the plant itself, and 3) PIPs based on viral coat
proteins.
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CONCERNS WITH THE CURRENT SYSTEM OF REGULATION
The current U.S. system of regulation is subject to two principal sorts of criticism.
First, the system is disjointed and overlapping. This means that any given application may be
subject to scrutiny by more than one agency. Moreover, jurisdiction may not be fully
predictable. Table 1 illustrates the complete set of regulatory assignments.
Table 1—Applicable Statutes According to Organism Type
APPLICABLE
STATUTE
CROPS
EPA STATUTES
FIFRA If produces
pesticide
TSCA
RCRA
ANIMALS
NON-CROP
PLANTS
If produces
pesticide
If considered
“new chemical”
PESTICIDES
Regulated
If considered
“new chemical”
OTHER
GENETICALLY
ENGINEERED
ORGANISMS
If produces
pesticide
If considered
“new chemical”
All of these types of organisms are subject to RCRA if they are used in cleanup
USDA STATUTES
PPA & PQA If deemed a
plant pest
FDA STATUTES
FDCA Regulated
If deemed a plant
pest
Regulated
Regulated if they
produce or are
food additives
If deemed a plant
pest
If deemed a plant
pest
Regulated if they
produce or are
food additives
Second, the system developed with bottoms-up impetus and with the strong support
of the scientific community. This has led to a regulatory process that is focused on how
plants and organisms are developed and on the attributes of the plants and substances they
replace, rather than on the unique risks they may, in themselves, present. From this second
criticism one can argue two ways—some conclude that the system is insufficiently focused
on risks and therefore, insufficiently strict; others conclude that by focusing on risks that are
not demonstrably unique, the system is overly strict.
4.1
Issues in Domestic Regulation
Assigning regulatory treatment to U.S. agricultural products requires applying a series
of tests that describe the plant’s development and use. If a plant is not eaten and does not
produce a pesticide, the USDA regulates it. Such plants are subject to the National
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Environmental Protection Act (NEPA), which requires only a limited assessment and
disclosure. This is a much less stringent requirement than that applied to plants that are eaten
or those that produce a pesticide, and results in the rare suggestion that regulatory scrutiny
may be too lax. This leads to the concern that products that harm the environment will be
approved so long as they produce some benefits (Hileman, 29).
By extension, it can be argued that the FDA does not regulate genetically engineered
organisms stringently enough. It is the FDA’s practice to treat genetically engineered
organisms as “substantially equivalent” to conventional organisms, with the result that the
approval process may not require testing to determine potential effects on human health. For
example, the FDA treats substances added to food products through genetic engineering as
food additives only if they differ markedly in genetic structure from non-modified organisms.
Many of the food crops currently in development do not contain markedly different
substances from what already exists, with the result that they are exempt from some FDA
requirements (About.com). This practice ignores unique attributes that may characterize
bioengineered products and that could cause undesirable changes through cross breeding
with other, non-altered plants or by transmission to animals. For example, changes to
organisms that are designed to enhance resistance to disease might ultimately lead to
resistance to antibiotics (Hileman, 29). A second example is the transfer of pollen from an
herbicide-resistant plant to weeds or other wild plants allowing weeds or wild plants to
develop resistance to herbicides.
However, it is also possible to argue that less strict regulation is required. Some
analysts argue for less strict regulation, suggesting that bioengineering processes are superior
to earlier breeding processes, leading to greater control and predictability. It is contended that
regulating these products based on the product’s ultimate use or how it came to be rather than
on risk can subject the products to greater regulatory scrutiny than is necessary (Miller and
Conko 2001, 30).
4.2
International Regulation of Agricultural Products
International regulatory treatment of bioengineered agricultural products is also
surrounded by controversy. The process of developing an international consensus as to
regulation of bioengineered products began in 1992 with the United Nations Convention on
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Biological Diversity (Schweizer, 580). The Cartagena Protocol, finalized in January 2000,
grew out of this Convention and addresses the international treatment of these products. This
protocol sets forth a plan for regulating bioengineered products that some critics argue
subjects the most predictable products to the most regulation. It embraces what is called the
“precautionary principle.” In its extreme form, this principle provides that products that raise
even the most tenuous threat of harm to humans or the environment should be prevented or
restricted. The test is to require proof that plants or substances are safe, rather than evidence
that they are not (Miller and Conko 2001, 25).
Those critical of the use of the precautionary principle argue that modern-day
techniques for genetically altering organisms are simply improvements on older, less precise
ones,9 and that what should be regulated is not the technique used to develop the organism
but rather the risks inherent in the organism itself. Opponents of the use of this principle also
argue that those products derived using antiquated methods of random breeding could result
in much higher risks than those posed by new, precise, laboratory-controlled gene splicing
methods, because the actual process and genetic interactions with random breeding are
poorly understood.
In 1992, the United Nations (UN) Industrial Development Organization instituted a
policy to help developing countries build regulatory frameworks for biotechnology. Critics of
this policy argue that the UN proposes that recombinant DNA products be subject to a high
degree of scrutiny without evidence from risk analysis and despite the fact that similar,
conventionally developed products, may be unregulated (Miller and Conko 2000, 49). Critics
argue that these policies will lead developing countries to regulate these products more than
necessary, which could potentially result in loss of valuable opportunities for improving their
crop development or increasing their food supply.
9
Examples of these less precise technologies include crossbreeding to result in mutations. The genetic
engineering of mutations is a more exact science in that the desirable trait can be more easily isolated and
transferred without transferring undesirable traits. This type of isolation is difficult, if not impossible, with older
cross-breeding techniques.
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Summary of Critiques
Two outcomes result from these putative weaknesses. One, the regulatory concern, is
that plants may be given regulatory treatment unrelated to risk with the result that the public
may be inadequately protected. The second, the incentive concern, is that to the extent the
system is somewhat arbitrary, less than fully predictable, and biased toward neither potential
risks nor potential benefits, it may provide improper incentive effects to potential developers
of new products, depriving the public of potential benefits.
Two almost orthogonal conclusions result from the regulatory concern. If one
believes that new products from bioengineering are basically identical to existing products
because bioengineering provides precise control over plant and product modifications, he or
she can argue in favor of the principle of substantial equivalence. Under this principle, the
new product would be regulated along the same lines as its predecessor. If they believe that
products may differ in subtle, but potentially threatening ways, they would apply a
precautionary principle. This principle calls for demonstrating that the new products pose no
new risks—a difficult task.
To the extent that the current regulatory system chooses one philosophy over the
other, it will send different signals to potential product developers. All else being equal,
research dollars will flow away from targets subject to strict regulation and toward targets
with weaker controls. Likewise, all else being equal, development dollars will flow away
from targets for which regulatory jurisdiction and practices are uncertain and toward those
subject to greater uncertainty. This problem is not likely to be resolved quickly, as new
bioengineering technologies continue to stretch the imagination and in doing so instill new
fears over potential risks.
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CURRENT REGULATORY IMPACTS ON DOE’S USE OF
BIOREMEDIATION
The regulatory framework currently applied to DOE’s cleanup of legacy wastes
derives from the same regulations that would drive any domestic cleanup operation.
However, this framework has been modified in many, often substantial, ways to meet the
specific needs of the DOE Complex and the communities in which the various parts of the
Complex are located. DOE is subject to RCRA and CERCLA requirements, an extensive
stakeholder review and consultation process, and, to a degree, to the specific policies of the
Administration that happens to be in office.10
The cleanup also differs from typical RCRA or CERCLA operations, however,
because DOE (on behalf of the Federal government) has assumed responsibility for cleanup,
has collected extensive data about the nature of contaminants and the natural environment
throughout the Complex, and has developed an extensive, long-term stakeholder process. The
cleanup is also different in that it is a very long-term process. This time frame owes to the
scope of the operation, the fact that Congress could not supply sufficient financial resources
to meet typical cleanup schedules, and the fact that marshalling sufficient real resources to
operate a speedy cleanup would be highly inefficient. However, the principal difference lies
in the fact that many contaminated sites lie outside the reach of current technologies. In
particular, much DOE contamination is radioactive, and it has migrated into difficult-to-treat
places.
As a result, EPA has exercised a policy of “relaxed enforcement” toward DOE, in
which typical timetables have been suspended and substitute, negotiated timetables have
instead been put in their place. These timetables take the form of a series of consent decrees
whereby DOE, regulators, local governments, and stakeholders negotiate legally binding
cleanup agreements. Subject to all of these forces, DOE enjoys a certain degree of flexibility
when it comes to compliance and designing cleanup protocols. (For a detailed treatment of
the flexibility that DOE enjoys, see Dümmer, Bjornstad, and Jones 2000, and Dümmer,
Bjornstad, and Jones 1998.)
Thus, DOE finds itself in a unique situation. It is subject to conventional regulatory
protocols, albeit ones that have been applied in an atypical and flexible manner. It has data on
10
A complete listing of the directives and their full texts can be found at http://www.explorer.doe.gov.
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which to base risk analysis, if such analysis is required. It has a stakeholder process that must
be consulted. It has a set of legally binding long-term timetables that must be broken into if
new technologies are to be applied. In addition, it has a history of changing its own posture
toward cleanup. It also conducts its own research. It can therefore target bioremediation
technologies toward its specific cleanup targets and can potentially have at its disposal a
range of alternative cleanup technologies. Some, following current policy, could rely on
naturally occurring microorganisms. These could be from local or non-local sources or could
be stimulated artificially to perform at increased levels of effectiveness. Other members of
the set of alternatives could take full advantage of the power of bioengineering and tailor
microbes to the requirements specific to the DOE cleanup.
So, how might DOE’s implementation of bioremediation proceed? Insofar as the
current regulatory framework treats bioremediation as it does traditional methods of cleanup,
DOE’s use of bioremediation is subject to the same requisite approval and permit process as
these cleanup methods. There is also some evidence that this framework is becoming more
predictable as regards bioremediation.11 But DOE’s cleanup may present risks or benefits
that are otherwise not characteristic of methods that are more traditional. For example, most
DOE wastes involve radioactivity. Current bioremediation technologies are intended to
immobilize, rather than “digest” radioactivity, and to allow it to attenuate naturally. This
implies that current bioremediation technologies will require long periods, monitoring, and
possibly, “backdoors” through which improved approaches can be substituted. Conversely,
traditional cleanup technologies simply cannot address many sorts of contamination in
ground water or in vadose zones, well below the surface. Bioremediation might thus be
attractive to stakeholders. Applications of some bioremediation technologies emphasizing
“natural attenuation” are already underway.
Regulatory treatment of genetically engineered treatment alternatives has not yet been
settled. For example, categorizing bioremediation technologies as “new chemicals” under
TSCA or subjecting bioremediation-based cleanup to the RCRA 180-day rule might serve the
DOE cleanup poorly and, potentially, shut out what would otherwise be a viable alternative
to traditional cleanup technologies. However, there is no reason, given the precedent of
11
As an example, see USEPA, OPPT, Points to Consider in the Preparation of TSCA Biotechnology
Submissions for Microorganisms.
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relaxed enforcement, to believe that EPA would shut out a viable technology over regulatory
technicalities.
Nevertheless, there are additional institutional circumstances that are likely to present
difficulties. One such circumstance is the inertia that has characterized the consent decree
process. The time, energy, and resources that have been devoted to establishing the consent
decrees has been staggering, and DOE has constantly been subject to the criticism that it has
studied the dirt rather than moving it. Some would argue that the process is now working and
that there is no point to wholesale reopening of the agreements that continue to flood
communities with cleanup dollars.
A second circumstance lies in the timeframe required for bioremediation of
radioactive materials to work. The process must be monitored for the effective harmful life of
the radioactive materials and protective measures must be maintained as long as there is
danger. This process, termed long-term stewardship, is not well developed, and in its current
state is not likely to engender stakeholder trust. There is even reason to question when
cleanup ends and watchful waiting begins. To be effective, some bioremediation
technologies require continued applications or injections of “accelerants.” Without these,
cleanup will slow or even cease. Some technologies pose the threat of increasing risks if
these applications are not continued. Barrier technologies, for example, may concentrate
radionuclides, such that if applications cease, risks may be greater than if the contaminants
were not concentrated.
Nevertheless, there is reason to conclude that bioremediation provides a viable
alternative to destructive “muck and truck” or ineffective “pump and treat” technologies for
DOE applications. DOE is currently in a prime position to begin to assemble data pertaining
to the risks and benefits associated with bioremediation as a cleanup tool. Because DOE is
already conducting basic research into this tool, it could take this opportunity to gather
pertinent data that would be helpful in assessing the risks and benefits of bioremediation. As
importantly, because the tool will be applied at DOE sites, DOE already possesses intimate
knowledge of the current regulatory framework in place at those sites and the ways in which
bioremediation may differ from technologies currently being applied. There is also time to
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begin the stakeholder consultation process.12 When long-term monitoring is required,
stakeholders must be satisfied that “long-term stewardship” provisions are adequately
planned and will be supported in the future. Finally, DOE has ongoing research programs to
develop bioremediation technologies tailored to its needs.
12
DOE is required to provide a mechanism for public involvement in cleanup decision making through several
regulations. These include RCRA, CERCLA, and the Federal Facilities Compliance Act (FFCA).
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REFERENCES CITED
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http://www.biotech.about.com/library/weekly/aa_oversight.htm.
Dümmer, Christine L., David J. Bjornstad, and Donald W. Jones. 2000. Opportunities for
Regulatory Reform for DOE Cleanup. Knoxville, Tennessee: Joint Institute for Energy
and Environment.
Dümmer, Christine L., David J. Bjornstad, and Donald W. Jones. 1998. The Regulatory
Environment Guiding DOE’s Cleanup: Opportunities for Flexibility. Knoxville,
Tennessee: Joint Institute for Energy and Environment.
Chadwick, Robin. 1995. “Regulating Genetically Engineered Microorganisms under the
Toxic Substances Control Act.” Hofstra Law Review 24: 223-251.
Hileman, Bette. 2000. “Biotech Regulation Under Attack.” Chemical and Engineering News
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Miller, Henry I. 1999. “Commentary: The EPA’s War on Plants.” The Scientist 13, no. 10
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Miller, Henry I. and Gregory Conko. 2001. “The Perils of Precaution; Why Regulators’
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Miller, Henry I. and Gregory Conko. 2000. “The Science of Biotechnology Meets the
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Salamone, Teresa. 1995. “Bioremediation under the Resource Conservation and Recovery
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Schweizer, Gareth W. 2000. “The Negotiation of the Cartagena Protocol on Biosafety.” The
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U. S. Code, various titles and sections.
U. S. Environmental Protection Agency. Office of Pollution Prevention and Toxics. 1997.
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Vandenbergh, Michael. 1986. “The Rutabaga that ate Pittsburgh: Federal Regulation of Free
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Vito, Christine. 1993. “State Biotechnology Oversight: The Juncture of Technology, Law,
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OTHER REFERENCES
Auchincloss, Stuart. 1993. “Does Genetic Engineering Need Genetic Engineers? Should the
Regulation of Genetic Engineering Include a New Professional Discipline?”
Environmental Affairs 20, no. 3: 37-63.
Hoyle, R. 1995. “Biotechnology is Still Searching for a Bioethics Forum.” Biotechnology 13:
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Kappeli, O., and L. Auberson. 1997. “The Science and Intricacy of Environmental Safety
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Kim, Judy. 1992-93. “Out of the Lab and into the Field: Harmonization of Deliberate Release
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Miller, Henry I. 1997. Policy Controversy in Biotechnology: An Insider’s View. San Diego,
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Miller, Henry I. 1997. “The EPA’s War on Bioremediation.” Nature Biotechnology 15, no.
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Stormer, Kent. 2001. “Biotech Companies Face Stiff Penalties.” New Jersey Law Journal
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