An Overview of Biotechnology

BG0002E | Date: 2000-01-26

I. Introduction

"Genetically modified organisms" (GMOs) is the term used by some countries to identify products produced through modern biotechnology. Since animal and plant hybridization and fermentation have involved genetic modification for more than a century, U.S. regulators prefer the term "biotech" products.

Some of the goals of modern biotechnology include endowing a conventional product with a trait that enhances its nutritional composition or a host plant or animal with a desirable trait (such as pest or drought resistance that enhances a plant's yield, or a faster growth rate for animals). For example, genes from a common microbe found in the soil and widely used by organic farmers as a pesticide, bacillus thuringiensis (BT), can be inserted into the DNA of corn or other plants, to make the plant noxious to specific insect pests.

Today, modern biotechnology is used to produce enhanced seeds, grains,
fruits, vegetables, fish, sugars, cheeses, trees, paper products, cotton,
microorganisms for bioremediation, plastics, detergents, and
pharmaceuticals. The U.S. Department of Agriculture (USDA) reviews biotech
seeds, crops in the field, and animals for slaughter. The Environmental
Protection Agency (EPA) reviews the safety of pesticidal proteins in
biotech products. The Food and Drug Administration (FDA) reviews foods
produced from biotech crops, animals, fish and processes. Biotech foods
are not commercialized unless they meet the same rigorous safety standards
as their traditional counterparts.

In 1998, 25 percent of U.S. corn acreage, 38 percent of soybean acreage,
and 45 percent of cotton acreage were planted with biotech varieties
totaling more than 45 million acres, up 250 percent from 1997 levels.
Worldwide, more than 69 million acres of biotech crops were planted in
1998 (of which 15 percent were in developing countries), and the total
planted acreage is expected to rise again in 1999. Field tests are being
conducted on more than 50 new food, fiber, and feed crops. The United
States does not segregate biotech from non-biotech varieties destined for
consumption or processing. However, biotech varieties can be "identity-
preserved" for commercial reasons, such as those with a "value added" trait
(e.g., soybeans with high levels of oleic acid, or the Flavr Savr tomato).

II. U S. Safety and Labeling Regulations for Biotech Products

For more than a decade, U.S. biotech seed developers have submitted new
seed varieties to USDA and EPA for review and cooperated with these
agencies to monitor environmental impacts in field tests. The U.S. review
process uses a science-based approach to risk assessment. Once they have
successfully passed the review, all seeds (biotech and non-biotech) are
sold domestically and internationally with identifying transportation and
handling documentation for planting and/or crossbreeding (with previously-
approved biotech and non-biotech varieties). Biotech seeds imported into
the United States for purposes of planting are subject to pre-import review
and approval by USDA and, sometimes, by EPA. Seeds intended for crop
production for processing and consumption are reviewed on a case-by-case
basis.

-- Most agricultural grains and oilseeds derived from biotech plants, as
well as all bulk commodities for consumption or processing, are harvested
and co-mingled with non-biotech grains and oilseeds without special
labeling or transport documentation in the United States.

-- All foods and processed foods, including foods from bioengineered
plants, have to comply with all the provisions of the Federal Food, Drug,
and Cosmetic Act (FFDCA), including the provisions covering safety and
labeling. The FFDCA does not generally require that foods, whether from
biotech processes or not, undergo pre-market review and approval by FDA.
However, all food additives, including those introduced into foods by way
of bioengineering, are required to be approved by FDA before
commercialization.

-- In addition, FDA has established a process by which companies can
consult with the FDA on food safety and labeling issues on new products
before bringing them to market. To date, companies have consulted with FDA
on all biotech foods that have been brought to market.

-- Ten years of experience with commercialization of biotech food products,
and related numerous and ongoing findings, show that biotech foods
developed to date present no unique food safety risks.

-- The United States requires mandatory labeling of food, including biotech
food, whose composition has been significantly altered or whose nutritional
value, intended use, storage or processing characteristics are different
from its conventional food counterparts or when it contains an unexpected
allergen. Food labeling must be truthful and not be misleading. Some
biotech food products in the commercial stream are "identity preserved" and
sometimes so labeled for commercial reasons.

III. Problem: Restricted Market Access

Problems pertaining to the regulation and acceptance overseas of biotech
foods have arisen in a number of international fora. This reflects in part
the pressures to allay consumer fears in certain countries regarding biotech
food safety and, possibly, protectionist interests to require pre-import
approvals, documentation, segregation, and labeling of imported biotech
foods.

Since March 1998, with the exception of three biotech carnation varieties,
the EU has neither approved nor rejected any biotech products. (Prior to
that date, the EU approved, among others, one U.S. biotech soybean variety
and four U.S. biotech corn varieties.) European member states and the
European commission apparently fear going against public opposition by
approving the products. In France, for example, the government has declared
no further biotech approvals until 2000, pending an EU court of justice
review of whether the government has used appropriate regulatory mechanisms in biotech approvals. In the U.K., one U.S. product favorably reviewed by U.K. scientists in 1998 (Round Up Ready corn) is stalled in a newly required inter-ministerial review process that must be completed before an approval can be forwarded into the commission's approval procedures. Several U.K. supermarket chains have banned biotech inputs from their brand name products, and are advertising their grocery line as "GMO-free." It appears now that the U.S. affiliate of a Swiss baby-food manufacturer is moving in the same direction.

There are now at least seven varieties of biotech corn planted and harvested
in the United States that have yet to be approved in the EU. Although
producers signed grower agreements to market their new corn varieties for
domestic use only, exporters are unwilling to ship any U.S. corn to the EU
(and importers are unwilling to receive it) because of the risk that
shipments may be blocked. The United States lost $200 million due to
canceled corn exports to the EU because of EU delays in granting marketing
approval to two U.S. corn varieties in 1998, and we face similar losses in
1999.

The impact of this problem is affecting U.S. planting decisions. In 1999, a
German company decided not to market its new biotech soybean to U.S.
farmers, concerned that the variety had not been approved in the EU, and
that the output, once co-mingled, could cause the EU to reject all U.S.
soybeans and derivative products. Some European food processors and
distributors have indicated that they are attempting to use substitute
sources for soy or corn because they do not want any biotech components in
their products.

The problem may have been exacerbated by a May 1999 laboratory study
conducted by Cornell University that found that nearly half of monarch
butterfly caterpillars died when fed on milkweed dusted with biotech BT
corn pollen. The results of the Cornell study are not surprising, since BT
is designed to be noxious to the European corn borer and its relatives,
including monarch caterpillars (which do not feed on corn plants, but only
on milkweed plants). However, the EU cited this study as its reason for
placing a moratorium on the approval of one U.S. BT corn variety, even
though the study authors had characterized the results obtained in the
laboratory as "preliminary." Important studies in the field of BT pollen
on "non-target" organisms and pests have not been completed. Yet even if
field studies show some monarch caterpillars are affected by BT corn
pollen, these results must be considered in the context of the impact on
the caterpillars of traditional pesticides which are sprayed on or near
corn fields.

The EU's directive 90/220 regulates the environmental release of biotech
seeds and establishes safety and approval processes for all biotech foods
placed on the market. This directive has a history of non-transparency and
unpredictability, and the EU is in the process of determining how to revise
it. The most recent draft revision, proposed on June 25 by the EU
Environment Council, includes a 10-year limit on approvals, additional
procedures for handling biotech products already approved, mandatory public
consultations, labeling and tracking biotech products throughout the
commercial stream, and stricter use of the "precautionary principle" (see
below). The revised version is not expected to be approved until 2000, with
an implementation date of 2002. U.S. regulatory officials have commented on
the proposed legislation.

The EU adopted additional legislation (regulation 1813/97) in January 1997,
which set up mandatory labeling of "novel foods" and "novel food products,"
which include any food that is "no longer equivalent" to an existing food
or food ingredient. In May 1998, the EU adopted regulation 1139/98 that
clarified the "equivalency" standard triggering the mandatory labeling
requirement for food and food ingredients produced from two specific
biotech varieties (Round Up Ready soybeans and the first genetically
engineered corn approved in the EU) that were approved prior to the novel
foods regulation. The EU stated in the regulation that foods or food
products derived from these two genetically engineered varieties are "not
equivalent" to their conventional counterparts if they display the presence
of DNA or protein resulting from genetic modification. Such "non-equivalent"
foods or food ingredients require a label stating "derived from genetically
modified maize/soya," and indicating the characteristics or properties that
were genetically modified.

However, the EU has not yet clarified the details on how to implement the
law. This has created problems for U.S. producers of non-biotech
agricultural products as well. For example, a U.S. non-biotech soy protein
exporter is facing a $60 million loss in 1999, since many EU importers are
requiring "GMO-free" certification of its non-biotech soy product. Market
loss has resulted since no EU "GMO-free" certification, testing methodology
to detect the presence of biotech products, nor minimum thresholds to
accommodate "adventitious contamination" and false positives have been
established.

The question whether to make biotech food labeling mandatory is still being
debated in Australia, New Zealand, Japan, Brazil, and Korea. Through their
joint food authority, Australia and New Zealand have indicated that they
will likely require some sort of mandatory labeling, but are still
discussing the practical implications of how such labeling would be
implemented.

IV. Precautionary Approach

The United States has been a world leader in the development of rigorous
and effective regulations and, in regulating food and environmental safety,
the United States adopts a precautionary approach. Several U.S. domestic
statutes embody precaution, including the Federal Food, Drug and Cosmetics
Act, the Toxic Substances Control Act, and the Federal Fungicide,
Insecticide and Rodenticide Act. In international environmental instruments,
the United States has accepted references to "a precautionary approach" in
a number of different contexts, including in principle 15 of the 1992 Rio
declaration: "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." The United States
also supports article 5.7 of the World Trade Organization Sanitary and
Phytosanitary (SPS) Agreement (and a similar provision in the North
American Free Trade Agreement) that permits the adoption of provisional
measures to be taken to ensure safety on the basis of available pertinent
information in cases where scientific evidence is insufficient.

The EU has frequently referred to "the precautionary principle," but has not
defined what it is, or has defined it differently in different contexts.
For example, in the recent WTO trade dispute known as the beef hormones
case, the EU unsuccessfully argued that the "precautionary principle" must
be read into the WTO SPS agreement to justify its decision to ban imports
of U.S. beef treated with growth hormones. (For further background on this
case, see section on CODEX, below.) The EU also recently attempted to
introduce the "precautionary principle" as a factor for assessing food
safety in the CODEX Alimentarius, the international body that develops the
food safety standards that are relied on in SPS dispute settlement
decisions. At the biosafety protocol negotiations, the EU attempted to
elevate the "precautionary principle" to a new principle of customary
public international law, which would serve as a lens through which the
entire agreement would be implemented. The EU argued that, based on the
"precautionary principle," the most stringent regulatory measures, even
trade bans, could be imposed until it is affirmatively demonstrated by the
producer that each biotech product does not have and could never have an
adverse environmental or health effect. The United States has concerns that
the EU is fundamentally misinterpreting the "precautionary principle/
approach" by attempting to apply it to justify banning an entire technology,
rather than considering each biotech product on its scientific merits.

V. Fora Where Biotechnology Is Being Discussed

Biotechnology is on the agenda in more than 15 fora, the most important of
which are the CODEX Alimentarius Commission (CODEX), the Organization for
Economic Cooperation and Development (OECD), the Biosafety Protocol to the
Convention on Biological Diversity (CBD), and the Transatlantic Economic
Partnership (TEP) Biotechnology Working Group. Biotech has already been
raised in the G8 summit process and has been featured in the U.S.-EU summit.


The CODEX Alimentarius Commission (CODEX)

The CODEX Alimentarius has become the seminal global reference point for
food safety issues related to public health and fair practices in food
trade. Created under the UN's World Health Organization (WHO) and Food and
Agriculture Organization (FAO) in 1961, the CODEX system presents an
opportunity for the 165 member countries to enable the international
community to formulate and harmonize food safety standards and ensure their
global implementation.

CODEX standards, codes of practice, guidelines, and recommendations are
developed by specialized committees of scientific experts and approved by
the CODEX Alimentarius Commission (CAC). CODEX standards are acknowledged
in the WTO Sanitary and Phytosanitary (SPS) agreement and relied on as
benchmarks against which national food measures and regulations are
evaluated within the context of WTO SPS disputes.

For example, the EU had banned importing U.S. beef, claiming that it was
treated with hormones and was unsafe. When the United States disputed this
ban as a violation of the SPS agreement in the WTO, the dispute settlement
panel considered the risk assessments of CODEX scientists, and held in
favor of the United States that the beef from hormone-treated cattle was
safe. The EU appealed the WTO decision, claiming that the "precautionary
principle" and "other factors" besides scientific evidence should be taken
into account. The EU lost the appeal when the WTO appellate body confirmed
that SPS decisions would be made only on the basis of "sound science."

Note: Although the beef hormone case has nothing to do with biotechnology,
hormone-treated beef and BST (hormones given to dairy cows to boost milk
production) are often illogically cited together with biotech foods. (All
three cases are also often illogically cited together with BSE -- mad cow
disease -- creating further confusion).

On July 3, 1999, the CAC established an ad hoc inter-governmental task
force to elaborate standards or recommendations for biotech foods,
coordinate closely with appropriate CODEX committees, and to take full
account of work carried out by national authorities, FAO, WHO, and other
international organizations and fora. The task force, chaired by Japan, is
scheduled to meet in the first half of 2000, issue a preliminary report in
2001, and present standards for final adoption in June 2003.

The task force will likely consult with two CODEX committees already
addressing biotech issues: the CODEX committee on food labeling, which
established a working group of 23 countries in April 1999 to develop
guidelines for biotech food labeling by May 2000; and the CODEX committee
on general principles, which is continuing debate on the need to introduce
"other factors" (socio-economic, environmental, consumer choice, animal
rights) and "the precautionary principle" into the CODEX risk assessment
process. Other CODEX activities potentially addressing biotech include the
work of the ad hoc intergovernmental task force on animal feeding, and
proposed horizontal science-based work on food additives, contaminants,
pesticide and veterinary drug residues, food hygiene, food labeling, and
nutrition among the CODEX committees.

OECD

Scientists from two sub-groups of the OECD's Environmental Policy Committee
were identified by the G8 heads in June 1999 as experts in biotechnology
and asked to report back to the G8 by May 2000 on the "implications of
biotechnology and other aspects of food safety." The OECD working group for
the harmonization of regulatory oversight in biotechnology, which was
established in 1995, was recognized for its work on the environmental
aspects of biotech plantings, having produced consensus documents on traits
and on crops, and harmonization of molecular genetic characterization for
assessing planting approvals and environmental impacts. The OECD task force
on novel foods and feeds, which met in September 1999, was recognized for
its work on biotech food safety. The OECD has also developed and maintained
biotrack, which provides online information about biotech field tests,
commercial products, and regulatory developments of OECD member countries
and consensus documents. To advance information-sharing with developing
countries, biotrack online is "linked" with the UNIDO Biosafety Information
Network and Advisory Service (BINAS), and the secretariat of the Convention
on Biodiversity (CBD).

In order to respond to the G8 request and conduct a transparent work
program, the OECD may sponsor a conference with scientists, academicians,
consumers, and NGOs.

Biosafety Protocol

The original negotiating mandate for the Biosafety Protocol to the
Convention on Biodiversity (CBD) was to regulate the transboundary
movement of living modified organisms (LMOs) intended for deliberate
release into the environment (seeds for planting, fish for propagation,
microbes for bioremediation). Over the three-year course of negotiations,
however, the issues of biotech food and feed commodities for consumption or
processing, food safety, and labeling were introduced. The U.S. government
believes that these issues relate directly to human and animal health, and
are beyond the protocol's negotiating mandate. These issues are more
appropriately left to the CODEX Alimentarius, which has recognized
authority in such food safety issues and which has established working
groups to address them.

In addition to the issue of food safety, an informal, friends of the chair
meeting initially scheduled for September, 1999 attempted to bridge the
differences on several key protocol provisions: The proposed requirement
that bulk biotech agricultural commodities (e.g. corn, soybeans) receive an
importing government's approval prior to shipment; the proposed requirement
that biotech commodities be shipped, handled, processed, and packaged with
special documentation and tracking throughout the commercial stream; and
the proposition not to include a "savings" clause, which clarifies that the
protocol will not affect existing rights and obligations of the parties
under existing international agreements, including the WTO.

TEP

The Transatlantic Economic Partnership (TEP) Biotechnology Working Group
was initiated in 1998 to exchange information on the technical and
scientific issues that are part of the regulatory approval process for
biotech products. The TEP "pilot project" was established to enable a
comparison of certain U.S. and EU environmental review processes for
biotech products prior to commercialization. Under one activity of the
project, U.S. and EU regulators (USDA/APHIS and DG-XI respectively) will
compare certain aspects of their scientific review of biotech product
applications. Under the second activity, regulators will monitor each
other's processing of an application filed simultaneously in the United
States and an EU member state by an industry participant.

The biotech working group is supported by dialogues with industry,
consumers, environmentalists, and legislators, who meet regularly to
provide recommendations and guidance for the TEP pilot project.

Several other fora have established biotech working groups or committees,
including the UN (UNEP, UNECE, UNCTAD, UNCSTD, UNIDO), International Plant
Protection Convention (IPPC), and the Framework Convention on Climate
Change (FCCC). The Asian Pacific Economic Cooperation (APEC) initiative
has addressed biotech in several committees and workshops.

VI. Conclusion

U.S. policies are based on precaution and supported by science, rigorous
yet workable food and environmental safety standards, a history of open
dialogue with environmental and consumer non-government organizations
(NGOs) and industry groups, and an awareness of the potential environmental
and health benefits of biotechnology.

Over the next few years -- absent increased international public backlash
-- we might expect a wide array of new biotech-related food, detergent,
textile, paper, pharmaceutical, and other products to be developed and
commercialized worldwide. (Notably, biotech pharmaceuticals and non-food
biotech products have raised little controversy compared with biotech
foods.)

Therefore, this problem is not ours alone. Other countries with a stake in
this technology must be engaged to find solutions. The negotiating stance
of other governments and private groups will play an enormous role in the
outcome. Many scientists worldwide recognize that there could be numerous
potential benefits, including environmental benefits, from biotechnology.
However, many countries that have agricultural products in their biotech
development pipeline have expressed opposition to biotechnology development
in various fora.

We will be seeking a way for the United States and other governments to
come together to more effectively address the concerns surrounding biotech
products and encourage transparent regulatory procedures to address the
safety of future products. We wish to avoid access restrictions and
consequent trade disputes (under the WTO technical barriers to trade,
sanitary/phytosanitary agreements, and the trade-related aspects of
intellectual property rights agreement), a biosafety protocol requiring
procedures and containing obligations with which the United States cannot
comply, introduction of non-scientific criteria in the CODEX food safety
standard-setting process, and mandatory country-by-country or international
biotech product restrictions not commensurate with the potential risks
such products may pose.

Some Potential Benefits of Biotechnology

The world population is expected to double to more than 10 billion people
by 2030. By increasing crop yields for land currently in agricultural use,
we can ensure a more secure and sustainable agricultural future,
particularly for developing nations, without the need to reclaim more
natural habitats for agriculture. Biotechnology is expected to increase
crop yields by 20 percent for small-holder farmers profitably and without
degrading natural resources.

As former President Jimmy Carter stated: "Responsible biotechnology is not
the enemy; starvation is. Without adequate food supplies at affordable
prices, we cannot expect world health or peace."

Environmental Benefits

--Environmental stresses from insects and plant diseases require an
alternative to chemical treatments that are less harmful to natural
resources. Biotech crops can potentially decrease the need for pesticides
and herbicides to control pests, weeds, and plant diseases and allow more
selective application of agricultural chemicals. For example:

-Biotech potato, corn, and cotton plants have been engineered to
produce a bacterial toxin (bacillus thuringiensis or "BT" delta endotoxin)
to ward off destructive insects on their own, reducing the need for
externally applied chemicals;

-Biotech herbicide-tolerant cotton, corn, and soybeans have given
farmers a choice to make fewer applications of herbicides and to use more
environmentally friendly herbicides;

--Environmental stresses from frost and drought or flooding can devastate
yields. Biotechnology can potentially provide enhanced resistance to
natural climactic variations and lessen reliance on water source management.
For example:

-Plants can potentially be enhanced to withstand a drop in temperature
and frost by modifying their production of linoleic acid.

--Biotech can potentially decrease the need to reclaim new land for
agriculture, as soils considered unacceptable (due to salts, metals, acids)
can be made productive, and marginal lands can be cultivated.

--Biotech crops can potentially preserve the land's ability to support
continued farming by reducing the need for tillage, which causes both soil
and water runoff and soil nutrient depletion.

Farmer Benefits

--Biotech can potentially increase profitability for farmers. For example:

-Biotechnology has improved the quality of seed grains and the ability
to produce bigger harvests from currently cultivated land.

-Increased yields and reduced chemical and labor costs can represent
increased income for the farmer.

-U.S. farmers spend $12 billion yearly on fertilizer, almost half of
which evaporates or washes away. Some plants, such as corn, might be
modified to draw nitrogen from the soil and air, dramatically reducing the
need for fertilizer.

--Biotech crops can be safer to produce. For example, farm workers would be
less exposed to toxic agricultural chemicals when use of pesticides and
herbicides is reduced.

--Farmers receive capacity-building in new farming technologies and can
produce crops that require less handling, easier storage, no refrigeration,
and longer shelf life.

Human Health

--Beneficial traits can potentially be added to plants. For example:

-Corn, soybeans, canola, and other plants are being modified to
reduce the saturated fat content of cooking oils derived from these plants;

-Potatoes are being modified to absorb less fat while frying;
-"Nutriceuticals" are being developed, including fruits and vegetables
containing higher levels of certain nutrients such as vitamins C and E, and
beta carotene, to help reduce risk of chronic diseases such as some cancers
and heart disease; Rice is being produced with an improved protein profile
to include higher levels of the essential amino acid lysine.

--Traits harmful to human health can be eliminated. For example, allergen-
causing proteins can be removed from foods, including rice.

--Edible vaccines are under development. For example:

-The May 1998 Nature Medicine Magazine reported on the clinical trial
of the first edible vaccine. Researchers were successful introducing
antigens in potatoes and "are hoping to engineer bananas to produce
antigens." The results showed promise for the development of less costly,
safe, and effective medicine for intestinal diseases in developing nations.
(Currently thousands of infant deaths are caused by e. coli.)

-Biotechnology may be able to reduce the high costs, transportation
logistics, and the need for refrigeration for vaccines in developing
countries.

Animal Health

--Biotech can provide forage crops with increased levels of proteins, other
nutrients, and possibly disease-fighting vaccines.

Consumer Benefits

--Enhanced flavors and product uniformity of fruits and vegetables have been
developed through modern biotechnology.

--Biotech can help keep food prices low through future advances that can
enhance the production, distribution, packaging, and handling of biotech
food products.

Scientific Advances

--Biotech is providing new technologies for traditional production, such as
brewing, baking, and cheese-making. Biotech has already improved products
vital to food production, such as enzymes, proteins, and vitamins. For
example:

-Rennin, an enzyme used to make cheese, is traditionally taken from
the lining of calves' stomachs after slaughter. Biotech researchers have
isolated and copied the specific gene that produces rennin and reproduced
it in bacteria. This allows the production of rennin by bacteria. Today,
nearly 50 percent of rennin is produced through biotech, providing a source
of the enzyme that is more consistent and pure.

-- R&D will continue to advance better methods to identify and locate
toxins, pathogens, or contaminants in food.

--Licensing agreements with seed producers can allow for benefit-sharing in
patent rights.

--Capacity-building and information sharing will support world trade in
biotech products.