BIOSAFETY PROTOCOL FOR GENETICALLY MODIFIED ORGANISMS: OVERVIEW

Report for Congress
Biosafety Protocol for Genetically Modified
Organisms: Overview
Updated January 18, 2001
Alejandro E. Segarra
Agricultural Policy Analyst
Resources, Science, and Industry Division
Susan R. Fletcher
Senior Analyst in International Environmental Policy
Resources, Science, and Industry Division

Congressional Research Service The Library of Congress

Biosafety Protocol for Genetically Modified Organisms:
Overview
Summary
The Biosafety Protocol to the 1992 Convention on Biological Diversity (CBD)
was adopted in January 2000, by the 176 nations that are parties to the CBD. Not
having ratified the CBD, the United States participated in the negotiations as an
observer, but nevertheless was an active participant in the discussions. The Protocol
addresses a major area of concern that was not resolved by the parent CBD in 1992
— the safe handling, transfer and trade of biological organisms. In recent years, this
issue has gained new prominence — and controversy — as genetically modified
organisms (GMOs) have become widely used as agricultural crops, and have become
the focus of concern by U.S. trading partners and citizens around the world. While
GMOs are widely used in U.S. crops, citizens and governments in many countries,
particularly in Europe, have questioned the environmental and health safety of such
products, and have rejected them in the marketplace.
The Biosafety Protocol sets forth a number of procedures and rules concerning
trade in biological products, including agricultural commodities. These rules are
therefore of key importance to U.S. economic interests, including those who develop
biotechnology. The Protocol applies to the transboundary movement, transit,
handling and use of most GMOs. It incorporates a number of principles that are still
under development and in the process of being defined. These include some
controversial concepts such as the precautionary approach (popularly known as the
“precautionary principle”), which is generally understood to mean that if definitive
scientific certainty is lacking, it is valid to err on the side of caution. This approach
is a source of concern for critics, who worry about the erection of trade restrictions
justified by using this concept. The Protocol also calls for “Advance Informed
Agreements” between exporting and importing countries regarding first shipments of
a GMO and labeling of subsequent shipments; and the establishment of a Biosafety
Clearinghouse as a means to share scientific, technical, environmental, and legal
information on GMOs. Issues relating to these provisions are discussed in this report,
including concerns about trade restrictions that might ensue from the protocol, the
possibility of burdensome information responsibilities, and others.
Given the importance of the Protocol to U.S. interests, the United States is likely
to remain an active participant in refining the elements set forth in it. A related issue
is whether the United States is hampered in this participation by the fact that it has not
ratified the parent Convention on Biological Diversity. Consequently, the United
States cannot sign the Protocol and attends the related negotiations as an “observer.”
In general, the issues related to GMOs and how the Biosafety Protocol may affect
U.S. interests related to them are likely to be of continuing interest to Congress in
terms of possible economic impacts and trade considerations.

Contents
Introduction ................................................... 1
Background –The Convention on Biological Diversity................2
Framing the CBD Biosafety Protocol.................................3
Biosafety Protocol Negotiations.................................4
The Biosafety Protocol: Key Provisions and Related Issues............5
Impacts on Trade................................................9
Conclusion .................................................... 9

Biosafety Protocol for Genetically Modified
Organisms: Overview
Introduction
In general, “biosafety” refers to efforts to ensure safety in using, transporting,
transferring, handling, releasing and disposing of biological organisms–including
genetically modified organisms (GMOs)--when they are considered potentially
capable of harming human, animal or plant health, or the environment. Currently,
most developed countries have laws and regulations that ensure the biosafety of¹
potentially hazardous organisms in domestic use and in trade. However most
developing countries lack similar legal biosafety safeguards.
The Cartagena Biosafety Protocol,² completed in January 2000, is the
international agreement that addresses safety concerns related to trade in genetically
modified organisms.³ The Protocol applies to the transboundary movement, handling
and use of those GMOs that may have impacts on human health, the environment, or
biological diversity. The Protocol is viewed by many as the main mechanism for⁴
dealing with biosafety concerns when GMOs cross international borders. This
Biosafety agreement is a protocol to the 1992 Convention for Biological Diversity
(CBD–also popularly known as the Biodiversity Convention), a global agreement that
addresses major aspects of biological diversity, including species conservation, genetic
resources, and ecosystem protection, with a general goal of reducing species
extinctions. The CBD entered into force in 1993, and at present, 179 nations are
parties to this treaty. ⁵ The United States is not a party to the CBD (the Senate has
declined to approve the treaty, as discussed below), and thus could not participate
directly in the official proceedings that drafted the biosafety Protocol. However, U.S.
observer delegations have attended all CBD meetings since 1992, and have played an

¹ In the U.S., biotechnology is regulated jointly by the Department of Agriculture, the
Environmental Protection Agency, and the Food and Drug Administration. For a thorough
discussion of biotech regulation in the U.S. see CRS Report RL30198, Food Biotechnology
in the United States: Science, Regulation and Issues, by Donna Vogt & Mickey Parish.
² This Protocol is named after the city of Cartagena, Colombia, where the 1st Extraordinary
Meeting of Conference of Parties (ExCOP) drafted significant portions of this key accord on
February 14-22, 1999.
³GMOs are organisms altered by using recombinant DNA and RNA techniques.
⁴ The Biosafety Protocol refers to GMOs alternatively as “Living Modified Organisms” or
LMOs.
⁵Countries become parties after signing and ratifying the CBD. Currently, 12 nations have
not ratified the CBD: Afghanistan, Andorra, Bosnia-Herzegovina, Brunei, Iraq, Kuwait,
Libya, Malta, Saudi Arabia, Somalia, Thailand, and the United States.

active role in making its positions known and influencing treaty deliberations.
Drafting of the Biosafety Protocol started in 1996, and in January 2000, the parties
to the CBD agreed upon a final draft Protocol in Montreal, Canada.
Many, especially within the Clinton Administration, thought that U.S. actions
were key in shaping the draft Protocol to protect U.S. interests, yet they
acknowledged the U.S. capacity to influence CBD’s deliberative bodies was affected
by its non-party status. Other analysts think that the Protocol will change
international trade rules for biotechnology in ways contrary to U.S. interests. They
have argued that provisions in the Protocol are mostly based on controversial
concepts, such as the precautionary approach (popularly known as the “precautionary
principle”; see page 6), which they see as veiled threats to fair trade.
Other potentially controversial Protocol provisions, still subject to further
negotiation, will require mandatory labeling of bulk commodities or could call for
environmental studies, and may establish compulsory product information and
disclosure procedures. In general, provisions in the Biosafety Protocol are likely to
shape market rules and impact U.S. interests in biotechnology trade.
Background –The Convention on Biological Diversity
As noted above, the Biosafety Protocol is an outgrowth of the Convention on
Biological Diversity. Only parties to the parent treaty, the CBD, are part of the
official negotiations on protocols, which are effectively adjunct treaties on specific
issues that the parties believe require elaboration or treatment. The United States
played an active role in the negotiations that produced the CBD, even though the
Congress has declined to approve its ratification. Similarly, because of the importance
of the Biosafety Protocol to U.S. agricultural and biotechnology interests, the United
States has remained actively involved, sending observer delegations, to the
negotiations on it. These delegations actively participated in substantive discussions
and formulation of positions that were made part of the official proceedings of the
protocol negotiations. Because the United States is not a party to the CBD, it is not
in a position to sign the Protocol, and thus the history and status of the Biodiversity
Convention is a key element in considering the U.S. role in the Biosafety Protocol.
The Convention on Biological Diversity (CBD) dates back to intensive
negotiations in the early 1990s. In 1992, world leaders came together in Rio de
Janeiro, Brazil, to attend the world’s largest summit –the United Nations Conference
on Environment and Development (UNCED–popularly known as the “Earth
Summit”) to take up the wide array of issues relating to environmentally and
economically sustainable use of the world’s resources. One major area of concern
was biological diversity – the concern that rapid loss of species around the world is
occurring and international cooperation was needed to address the problem. The
CBD was one of two major treaties opened for signature at UNCED (the other was
on climate change).
In 1992, President Bush declined to sign the CBD treaty, citing concerns
including the lack of sufficient protection for intellectual property. In 1993, President
Clinton signed the CBD and sent it to the Senate for its advice and consent for
ratification. The Administration accompanied the proposed treaty with a statement

of interpretation in order to allay concerns raised by detractors (see CRS report 95-
598 ENR, Biological Diversity: Issues Related to the Convention on Biological
Diversity). In 1994, the Senate Foreign Relations Committee reported favorably on^r^d
ratification, but the full Senate did not act on the treaty before the end of the 103
Congress. Since 1995, consideration of the treaty has received little or no attention
from the U.S. Senate. Currently, the treaty remains pending in the Senate Committee
on Foreign Relations. The CBD treaty contains few binding obligations, relying
instead on largely voluntary measures. Also, the United States is in compliance with
the treaty on the basis of current U.S. law, so no changes in U.S. law would be
needed if it should become a party.
There are differences of opinion regarding U.S. ratification of the CBD. Some
observers consider that the treaty is flawed and could be harmful to U.S. trade and
national security interests. Some critics question the need for the United States to
become a party to the CBD because, as the number one producer and exporter of
biotechnology, the United States is already in a position of strength to set market
rules. Some critics are concerned that other nations could use the Protocol provisions
as disguised protectionism. Conversely, others feel that the CBD is needed to protect
biological diversity, and that the United States is paying a growing price by its refusal
to ratify. Backers of ratification cite a growing sense of isolation of the United States
from some of its key trading partners, and they worry that the United States will have
less leverage in future CBD decisions.
Framing the CBD Biosafety Protocol
The use of biotechnology has led to broad changes in medicine, industrial
processes, engineering and agriculture. In agriculture, biotechnology is being used
to improve crops’ resistance to pests and environmental stresses and to enhance their
nutritional content. Controversies have developed among various nations over
whether certain types of GMOs constitute a potential hazard to human health or to
the environment. GMOs have long been considered the subject of a number of
biosafety concerns. Many genetically modified plants, for example, are produced with
techniques that include the DNA sequences from common plant pathogens. Other
biosafety concerns commonly cited are: the possibility of adverse impacts on
non-target species or ecosystems; the potential for enhanced weediness of GM crops
(i.e. a plant becomes invasive, or transfers resistance genes to its wild relatives); and
the instability of inserted genes (i.e. the possibility that a gene will lose its
effectiveness.)⁶ To date, transfer of genes to weedy relatives has been observed, and
a controversial laboratory study has shown potential damage to a non-target species

⁶The consensus among U.S. scientists is that no strict distinction exists between the health and
environmental risks posed by GM plants and those modified by conventional breeding
practices. Opponents counter that risks are potentially irreversible, untraceable and
uncontrollable.

(the monarch butterfly).⁷ Whether such effects prove to be widespread or manageable
has not been fully established.
Biosafety Protocol Negotiations
The CBD’s Biosafety Working Group (BSWG) negotiated the Biosafety
Protocol in six meetings that took place between 1996 and January of 2000. After
the Earth Summit in Rio, the BSWG became the principal forum for deliberations and
negotiations for biosafety issues, regarded by parties to the CBD as an important area
of “unfinished business.”
According to observers, one difficulty in these negotiations was the fact that the
United States, as the largest exporter and producer of GMOs, was not officially part
of the proceedings. However, the United States actively participated as part of the
“Miami group,” a coalition of leading agricultural exporters that also included CBD
parties: Argentina, Australia, Canada, Chile and Uruguay. This group developed
proposals and positions during the drafting of the Protocol.⁸
According to the CBD Secretariat, the Protocol will enter into force by August

2000, having met the criterion in Article 37 of the Protocol at the closing of the 5^th

Meeting of the Conference of the Parties (COP5) in Nairobi, Kenya on May 26,

2000.⁹ For many parties, signature to a protocol automatically confers ratification,

since they have ratified the parent treaty; in others, like the United States, each
protocol must be separately considered for ratification after signature. The Protocol
is currently open for signatures by parties and will remain open at the United Nations
Headquarters until June 5, 2001. Nations that wish to sign onto the Protocol after
that date would have to do so by accession, which includes ratification.
Analysts agree that, while the Protocol is a substantially complete document, the
pact delays final negotiations on a number of controversial issues for up to 4 years
after its adoption. For example, the door has been left open for parties to revise or
strengthen rules for ‘contained use’ GMOs (discussed below) that are not likely to
propagate in the environment (i.e., bulk commodities.) The Miami group is expected
to oppose any move to increase documentation and notification requirements for bulk
commodities, arguing that the cost of segregation and identity preservation (i.e.,
tracing a GMO product from the farm to the consumer’s table) could lead to
irreparable harm to biotechnology trade.

⁷ Metz, et al. 1997. The impact on biosafety of phosphinothricin-tolerance transgene in
interspecific B. rapa x B. napus hybrids and their successive backcrosses. Theor. Appl.
Genet. 95:442-450. Springer-Verlag (weeds).; and Losey, J., et al., 1999. Transgenic pollen
harms monarch larvae. Nature 399: 214.
⁸ Other key interest groups that formed and were active during drafting of the Protocol were
the European Union (EU), the “Like-minded” group of developing countries (the G-77/China,
less the members of the Miami group), and the “Compromise group,” ( Japan, Mexico,
Norway, the Republic of Korea and Switzerland.)
⁹Article 37 specifies that the Protocol will enter into force on the 90^t^h day after the date of
deposit of the fiftieth instrument of ratification. As of December 22, 2000, two countries
(Bulgaria and Trinidad Tobago) have ratified the protocol and 79 others have signed it.

Several important aspects of current provisions have been left for future
negotiations such as: (1) how to apply the “precautionary approach” to the Protocol;
(2) how to develop rules to integrate the Protocol with other trade agreements, such
as the WTO, into a “mutually supportive” framework; and (3) how to develop rules
and procedures based on international law that would establish liability and redress
for damages resulting from the movement of GMO (these are to be finalized within

4 years).

The Biosafety Protocol: Key Provisions and Related Issues
The Protocol addresses the major concerns that have arisen in connection with
GMOs, and it bears directly on GMO trade. Most GMOs are covered by the Protocol
except for those used to produce human pharmaceuticals. The key provisions, and
the issues related to them, are briefly summarized below.
Advance Informed Agreements. The Protocol establishes the use of ‘Advance
Informed Agreements’ (AIA) between the importing and exporting parties that cover
the first transboundary movement of any GMO. The purpose of AIAs is to ensure
that recipient countries have the opportunity to assess environmental risks associated
with the importation of biotechnology products. The Biosafety Protocol creates the
procedure by requiring exporters to seek consent from importers before the first
shipment of a GMO is introduced into the environment (applies to seeds for planting,
fish for field release, and microorganisms for environmental bioremediation). In
addition, article 11 also requires that bulk shipments of GMO commodities to be used
as food, feed, or for processing must be accompanied by declarations stating that such
shipments “May Contain” GMOs and are “Not intended for intentional introduction
into the environment.”
Two categories of GMO are recognized according to their intended use: GMOs
for ‘contained’ or ‘direct’ use (i.e., food, feed, or for processing) that require minimal
biosafety precautions; and GMOs for ‘intentional introduction’ to the environment
(i.e., agricultural seeds and other propagation materials, and live fish), which require
more stringent biosafety procedures. GMOs unlikely to cause adverse effects on
biological diversity, and those intended for contained use (i.e., feed, food, or
processing) can be exempted from the application of AIA procedures. Confidential
information received under Protocol procedures must be protected by importing and
exporting parties. Further, parties are required to cooperate in developing and/or
strengthening the biosafety capabilities of developing countries.
Key Issues. The rationale for Advance Informed Agreements (AIA), espoused
in 1992 by article 19.3 of the CBD, is the perception that international trade in GMOs
could adversely affect the environment and that trade should not proceed without the
informed agreement of the recipient country. While support for some form of AIA
is widespread, differing positions about their scope and breadth were among the
principal issues under discussion. For example, as negotiations progressed it became
clear that the GMO’s intended use should determine the level of risk assessment and
risk management needed to attain biosafety. Similarly, negotiators decided that the
intended use of a GMO should determine the level of information disclosure needed
from the exporting party. However, the issue of labeling and proper documentation

for bulk commodities will be revisited by the Conference of Parties (COP) within 2
years, thus opening the door for the introduction of additional restrictions and
mandatory requirements.
Precautionary Approach. The Protocol reaffirms the importance of the
precautionary approach in its preamble and in articles 10 and 11, which prescribe
trading procedures for the importing parties. These articles, for instance, state that
even in the case of a lack of scientific certainty (due to insufficient scientific data,
analysis or information) importers could deny entry to undesired GMOs. At the same
time, risk assessments and risk management are prominent features of the Protocol.
The Protocol allows the importer to require that the exporter carry out and pay for
risk assessments as well as any needed mitigation actions. In addition, the Protocol
allows parties to use socioeconomic considerations in reaching a decision on
importing GMOs.
The “precautionary approach” was established as a guiding tenet of the CBD,
which directly referred to Principle 15 of the non-binding Rio Declaration. Principle

15 states that:

“In order to protect the environment, the precautionary approach shall be
widely applied by States according to their capabilities. Where there are
threats of serious or irreversible damage, lack of full scientific certainty
shall not be used as a reason for postponing cost-effective measures to
prevent environmental degradation.”
Key Issues. In general, most interpretations agree that the precautionary
approach urges policymakers to err on the side of caution in the face of scientific
uncertainty.¹⁰ Environmentalists, particularly in Europe, consider this approach to
be a valid policy option in the face of incomplete or inadequate scientific knowledge
about health or environment impacts. Defenders of the application of this approach
maintain that it is only “a temporary mechanism” that gives time for scientific inquiry.
Policymakers in Europe recognize, as do those in the United States, the need for an
assessment of risks based on accepted scientific facts.¹¹ However, critics worry that
elevating the precautionary approach to the level of a ‘political principle’ may create
false public expectations for absolute safety and the demand for zero environmental
risks. At worst, some critics maintain, the precautionary approach can easily be used
as a form of disguised protectionism.
Current language in the Protocol leaves the development of procedures for trade
and/or entry decisions subject to further refinement by the CBD’s Conference of
Parties. Presently, few countries agree on just what the precautionary approach is.
Analysts believe that future refinements may be affected by this lack of accepted

¹⁰ For a discussion on the precautionary approach see CRS Report RS20310, Science behind
the regulation of food safety: risk assessment and the precautionary principle by Mickey
Parish.
¹¹ Internal political disagreements exist within the EU over the use of the precautionary
approach. E.g, France is at odds with the EU over France’s use of precautionary approach
for not admitting British beef into the country after the “mad cow” disease.

disciplines to guide the uniform application of the precautionary approach. The
current situation has enticed international bodies, like the EU, the Codex Alimentarius
Commission, and the Organization for Economic Cooperation and Development
(OECD), to offer comprehensive views on the subject in hopes of setting a world’s
standard for the application of the principle in GMO trade.¹²
Biosafety Clearinghouse. The Protocol establishes the Biosafety Clearing-
House (BCH), which will be used as the mechanism to share scientific, environmental,
and legal information on GMOs.
As currently envisioned, the BCH will be a centralized source for information on
national laws, guidelines and regulations for the implementation of the Protocol, as
well as on other agreements on biotechnology. The need for a centralized information
source on scientific and technical data about GMO trade was also envisioned in 1992
by the CBD (Articles 18.3 and 19.) To accomplish this, Article 20 of the Protocol
establishes an internet-based “Biosafety Clearing-House” to help countries exchange
information about GMOs. Currently, the BCH is housed at the CBD’s Executive
Secretariat in Montreal, Canada.
The Protocol requires that transboundary movements of GMOs between parties
and non-parties be consistent with the Protocol and encourages non-parties to
contribute information through the BCH. Parties are required to notify the BCH of
unintended or illegal movements of GMOs, and must adopt measures to prevent and
penalize illegal transboundary movements.
Key Issues. Two critical issues were foremost in the minds of negotiators in
establishing the BCH: (1) how to adequately balance the rights of parties to access
and use relevant information about traded GMOs; and (2) how to protect the
intellectual property rights of owners of biotechnology products. Article 20(3) and
Article 21 address the protection of confidential and proprietary information by
making both trading parties responsible for protecting confidential information
received under the Protocol under AIA requirements. However, some controversy
exists because the Protocol does not prescribe explicit liabilities for failures to protect
intellectual property. Some critics would like to see clear-cut mechanisms in the
Protocol to sanction failures to protect confidential information. Recent proposals by
by Canada to establish a pilot implementation phase and to have each country apply
its domestic laws and requirements to information sharing seem to be favored by other
Miami group members.¹³ Formal procedures and measures of intellectual property
protection are to be developed by the Conference of Parties within 2 years.

¹²OECD deliberations on the precautionary approach can be found at
http://www.oecd.org/subject/biotech/edinburgh.htm . The European Union’s position is
presented in “Communications from the Commission on the precautionary principle”
February 2, 2000. Brussels. (see http://europa.eu.int/comm/trade/whats_new/dpp_en.htm.);
Codex Alimentarius position found in “Report of the First Session of the Codex Ad Hoc
Intergovernmental Task Force on Foods Derived from Biotechnology”, April 2000, in
http://www.fao.org/waicent/faoinfo/ECONOMIC/esn/codex/default.htm.
¹³First Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP)
December 11-15, 2000 . Montpellier, France.

Relationship of The Protocol with Other Agreements: The Savings Clause.
One of the most contentious issues faced by negotiators was to establish how the
Protocol’s measures would relate to other bilateral or international trade agreements,
notably those under the World Trade Organization (WTO). The issue became
important after the 1997 Biosafety Working Group meeting in Montreal, where the
Miami group insisted on the need for consistency between the Protocol and WTO
agreements such as the Sanitary Phytosanitary-Standards (SPS) accord.¹⁴ The key
question revolved around how to reconcile differing perspectives in environmental
protection philosophies between advocates of the precautionary approach (e.g., the
EU), and countries where environmental protection systems stress the use of the best
available scientific evidence and risk assessment (i.e., the Miami Group and the United
States).
A compromise position was reached through the inclusion of a “savings clause”
in the Protocol’s preamble that states: “...nothing in the Protocol implies a change
in the rights and obligations of governments under the WTO or other existing
international agreements.” However, the preamble further clarifies that the Biosafety
Protocol will not be subordinated to other international agreements, and that they
should be mutually supportive.
Key Issues. The Clinton Administration and industry analysts interpret the
‘savings clause’ to mean that trade disputes originating from Protocol implementation
could be handled through existing mechanisms, such as the WTO dispute settlement
agreements and its appellate review bodies. Others, especially EU policymakers, are
inclined to stress that the Protocol is not subordinated to any agreement, and do not
necessarily extend the ‘savings clause’ to future agreements or to existing ones, which
do not adhere to the Protocol.
Notification/Labeling. The Protocol establishes mandatory entry notifications
by exporting countries to the competent national authority in importing countries
about trade of non-exempted GMOs. A key feature of the Protocol is the
requirement for bulk shipments of GMO commodities to be accompanied by
documentation stating that such shipments “May Contain” GMOs, and that they are
“Not intended for intentional introduction into the environment,” in lieu of a formal
AIA. This applies only to GMOs intended for food, feed, or processing (e.g., corn
or soybeans).
Other provisions. Finally, parties are allowed to enter into bilateral, regional
or multilateral agreements provided that such agreements and arrangements do not
result in a lower level of protection than that provided by the Protocol. Also, in the
case of unintended or illegal movements, the Protocol also allows the affected party
to request the party of origin to dispose of the GMO in question at the expense of the
latter. In addition, the Protocol calls for the elaboration and adoption of a liability and
redress process for damages resulting from transboundary movements of GMOs.

¹⁴ This accord establishes disciplines on the use of sanitary and phytosanitary measures in
restricting trade. For a complete discussion on SPS see CRS Report 98-254 ENR.
Agricultural Negotiations in the World Trade Organization by Charles E. Hanrahan.

Impacts on Trade
Analysts agree that the future impact of the Protocol on trade is difficult to
gauge because so many key aspects are still to be decided. Also, the current climate
of controversy surrounding trade in agricultural GMOs in many countries, especially
in Europe, further complicates assessments of trade implications. The Clinton
Administration and the U.S. biotechnology industry have stated that the new rules
will make it easier to harness the promise of biotechnology without unduly disrupting
world food trade.¹⁵ Others, especially critics in Congress, have viewed the accord
with skepticism, and have charged that many of its provisions will harm biotechnology
trade by opening a potential “flood gate” to restrictive and costly labeling and
documentation requirements for U.S. goods.
Conclusion
The United States has pioneered the use of biotechnology and is the world’s
leading producer of GMO crops. While most U.S. analysts consider that the current
Protocol language is a victory for GMO trade, others point to likely future battles and
continued friction between the United States and Protocol parties over unresolved
areas. Some, particularly in Congress, felt that the Clinton Administration had gone
too far in giving concessions for the inclusion of the precautionary approach, and
criticize U.S. negotiators for placing the future of GMO trade on a slippery slope by
allowing even a modicum of labeling requirements in bulk commodities. Others
within that Administration defended their efforts for keeping human health issues out
of the Protocol; for lobbying to protect existing trade obligations by introducing the
‘savings clause’; and for insisting upon increased intellectual property protection
guarantees. They saw these efforts as victories fought and won under the handicap
of U.S. non-party status within the CBD. Differences in viewpoints on ratification
persist, with some who feel that ratification of the CBD would give the United States
a seat at the table and the power to make its full weight be felt, and others who feel
that the United States can continue to have adequate influence on the process without
being party to a treaty that they consider to be flawed.
These issues related to GMOs and how the Biosafety Protocol may affect U.S.
interests related to them are likely to be of continuing interest to Congress in terms
of possible economic impacts and trade considerations.

¹⁵ The United States, through the Miami Group, was a key lobbyist for the “savings clause”
and for securing minimal AIA procedures for bulk shipments of GMO foods and feed. The
savings clause establishes the relationship between the Protocol and other international trade
agreements.