1. What is biotechnology, and how is it
different from traditional plant breeding?
Biotechnology
is the use of modern scientific techniques, including genetic engineering, to
improve or modify plants, animals, and microorganisms.
In
agriculture, crop improvement is not new.
For centuries, farmers, nurserymen, and others have crossbred
(intermingled the genes of) various plants in an effort to produce more and
better foods. Using advanced scientific
methods, biotechnology greatly expands our capabilities to introduce new traits
into food crops.
Traditional
breeding techniques typically involve the repeated mixing of thousands of genes
over several years and many generations of plants to achieve a desired
trait. Thanks to science, biotechnology
accelerates this lengthy process by allowing scientists to insert selected
genes directly into a plant. This brings about the desired results much more
efficiently. Although traditional
breeding has been able to overcome some natural barriers to crossbreeding
plants of different species, and sometimes even of different genera,
biotechnology greatly expands that capability.
2.
Beyond increased yields, what are some of the benefits of biotech products?
The
first genetically engineered products were medicines designed to combat human
diseases. Insulin, used to treat
diabetics, and blood clot-reducing enzymes for heart attack victims are now
produced easily and cheaply as a result of biotechnology. In agriculture, first generation
biotechnology products have traits that result in reduced pesticide use or
higher yields due to reduced pest losses.
Bt cotton, for example, is a widely grown biotech crop that kills
several important cotton pests. These
products provide indirect benefits for consumers and the environment through
lower agricultural chemical usage.
Every
day, more and more seed varieties with potential direct benefits for consumers
are being field tested in the United States under approvals from U.S. regulatory
agencies. Some of the products of this
research are already appearing on grocery shelves in the United States and in
the European Union, such as cheeses, yogurts, and new cooking oils derived from
soybeans. Products in development also
include those with improved nutritional value.
For example, a new rice variety developed in Switzerland under a
Rockefeller Foundation grant provides vitamin A. Each year nearly 1 million child deaths and 14 million children
with blindness and other eye problems have been linked to vitamin A
deficiency. Another variety of rice
will soon provide twice the iron as currently available rice varieties. Also in development are soybeans with
enhanced nutrient content for use in animal feed and corn that contains phosphorus
in a form more easily absorbed by livestock.
This latter product could reduce the use of supplements while at the
same time helping the environment by lowering the amount of phosphorous in
animal waste.
Biotechnology
developments also have tremendous benefit for developing countries where almost
a billion people live in poverty and suffer from chronic hunger. Seventy percent of those people are poor
farmers who face huge crop productivity losses owing to insects, drought, and
low soil fertility. New varieties of grains, many of which provide a stable
calorie source for developing country populations, are being developed that can
grow on land that is currently unsuitable for cultivation. The fact is that land under cultivation
worldwide simply is no longer sufficient to feed the growing global
population. Biotechnology can improve
agricultural production for subsistence farmers, driving rural economic
development and increased food security. Using biotechnology to grow crops in
poor soil, rather than seeking increased yields through more irrigation,
fertilizers and chemicals, or by bringing new lands into cultivation, would be
the environmentally more responsible approach.
In
addition to creating better foods and feeds, biotechnology helps fiber producers
and manufacturers, too. For example,
cotton varieties are being developed that will produce sturdier,
wrinkle-resistant or fire-retardant fibers.
Biotechnology
also can contribute to the development of new products that would be otherwise
unavailable and products that could replace nonrenewable petroleum-based
chemicals with renewable, agriculturally based specialty oils and chemicals for
use by industry.
3. Is biotechnology safe?
Yes, if
properly regulated, as is the case with all foods.
Many
international organizations - such as the Food and Agriculture Organization of
the United Nations, the World Health Organization, and the Organization for
Economic Cooperation and Development - have recognized that biotechnology, when
properly used, does not affect the safety of a product. In the United States, foods developed
through biotechnology face the same regulatory requirements that the Food and
Drug Administration uses to safeguard other foods and food ingredients in the
marketplace. There is no evidence that
biotech foods currently on the market present a risk to human health.
Biotechnology
is regulated in the United States under a risk-based system that focuses on the
end product and its uses. Over the
years, Federal agencies with authority to regulate agriculture, the
environment, and the nation's food and drug supply have developed regulations
and oversight processes for biotechnology.
Under this regulatory framework, USDA's Animal and Plant Health Inspection
Service (APHIS) ensures that new biotech plant varieties are as safe to use in
agriculture as conventional varieties.
The Food and Drug Administration consults with developers of transgenic
plants to ensure that the new crops and foods produced from them are as safe to
consume as conventional foods. The
Environmental Protection Agency (EPA) conducts extensive scientific reviews to
ensure public health and environmental protection of new plant-pesticidal
substances (i.e., genes that work as a pesticide in a plant, for example, the
Bt gene in corn or cotton) introduced into plants or new uses of herbicides in
conjunction with transgenic plants.
Under
the safety guidelines imposed by APHIS and the other regulatory agencies,
thousands of field tests with genetically engineered crops have been conducted
since the mid 1980s. Resulting products
have been grown commercially since the early 1990s and currently account for
over 40 varieties and comprise a large percentage of the acreage of corn,
soybeans, and cotton. Our system of
regulatory oversight has contributed to there being no known cases of harm to
humans or the environment resulting from the development and use of these
plants.
4.
How open to public scrutiny is the U.S. regulatory process for biotechnology
products?
The U.S.
regulatory system involves the public in the decision-making process. For example, the Administrative Procedures
Act (APA) requires that all federal agencies provide the public with an
opportunity for "notice and comment" before adopting final
regulations. In addition, APHIS, FDA,
and EPA ensure "transparency" in their oversight system through the
use of public meetings, Federal Register notices, and postings on the World
Wide Web. Lastly, the agencies have been
open to modifying their regulations based on experience with technology and
scientific advancements. It should be
noted that extensive scientific evaluations by USDA, EPA and FDA have
identified no significant or unexpected concerns unique to products resulting
from biotechnology. FDA has conducted public
sessions on various aspects of biotech foods and received tens of thousands of
written comments. On January 21, 2000,
Secretary of Agriculture Dan Glickman announced a new Advisory Committee on
Agricultural Biotechnology that will bring together individuals with a broad
range of expertise to advise the U.S. government on policies related to the
creation, application, marketability, trade and use of agricultural
biotechnology. The Secretary formed
this committee not because of concerns about products currently on the market,
but to ensure that USDA is fully prepared for the future.
5. What are some of the concerns about
biotechnology regarding human health and biodiversity?
Biotechnology
is a tool. Like any tool, if used
properly and with care, it can be safe and beneficial. Many of the concerns that have arisen
regarding biotechnology stem from concerns about its potential uses. The U.S. regulatory system ensures that
products that are commercially grown, sold, processed, and consumed are safe. Every biotechnology plant variety
commercially grown in the United States has gone through the necessary
regulatory process in USDA, the EPA (if it has a pesticide component), and the
Food and Drug Administration (if it is used as a human food or animal
feed). We recognize the right of every
country to establish its own product evaluation system. However, we believe
that such regulatory decisions must be open to public comment, predictable, and
based on science.
6. Is
the United States the only industrial country that has developed genetically
engineered agricultural products?
The
United States is not alone in developing new biotech products or in offering
them for commercial production. Several
European countries, including Germany and Switzerland, as well as Canada,
China, Argentina, South Africa, and Japan, have already approved several
biotech varieties, such as corn, soybeans, and other crops. What's more,
European companies are very active in developing and offering transgenic
varieties for commercial planting in the United States. For example, AgrEvo, a German company, and
Novartis, a Swiss company, both have offered commercial varieties of
genetically modified corn and soybean to U.S. farmers. Moreover, about one-half of the applications
for approval of transgenic varieties currently pending in the EU regulatory
system are sponsored by EU companies.
7.
Why is it difficult for the United States to segregate genetically engineered
products from "biotech-free" products?
Some
companies are attempting to maintain the identity of their biotech product from
farm to manufacturer. Often these products have value-added traits that need to
be preserved throughout the distribution process. This is called "identity
preservation" and is normally done on a small scale. This niche market
requires an entirely different and more costly marketing system than bulk
agricultural trading, in which products go to market without segregating and
preserving the identity of the products in each shipment.
Other
companies have requested that farmers segregate transgenic crops from
conventional varieties when the commodities are marketed. Some processors and
importers, in turn, are specifying conventional commodities only, and sometimes
paying a premium for them.
Our farms,
grain storage, and transportation systems are not designed to segregate bulk,
unbagged, genetically engineered agricultural products, on a large scale and
with precision, from conventional varieties. Therefore, we cannot easily ship
"biotech-free" corn and soybeans to individual markets. While
identity preservation is taking place on a contractual basis, farmers and
exporters are paid a substantial premium to keep these varieties separate from
others. If customers do not want to buy biotech products, U.S. producers and
exporters will try to provide an alternative -- usually at an additional cost.
However, exporters of bulk agricultural commodities cannot guarantee that a
given shipment will be 100-percent "biotech-free," just as they
cannot guarantee that a shipment of any product in a bulk commodity will be
100-percent identity preserved. Importers will have to establish realistic
tolerances and testing methodologies before "biotech-free" shipments
can occur.
8.
How is the United States ensuring that biotech varieties unapproved in other
countries are not finding their way to export channels?
Seed
companies operating in the United States - including European companies --
advise and work with farmers to channel varieties that are unapproved in
potential export markets to domestic livestock feed and other uses. Some of the
safeguards by seed companies include: requiring farmers to sign a grower
agreement that, lacking all required international approvals, the grain will be
held for domestic livestock use; maintaining lists of farmers to whom the seed
was sold; helping farmers identify nearby outlets for grain in order to
facilitate the proper marketing of unapproved varieties; establishing toll-free
telephone numbers for farmers to call for additional information about how and
where to market the corn domestically.
Also,
major corn refiners have said that they will only buy corn varieties that have
been approved by the EU, helping to preserve the integrity of the system.
Furthermore, there are identity preservation systems in place for value-added
products, such as non-biotech high-oil corn. Under this system, farmers and
handlers are paid premiums at each stage of the marketing chain to keep the
product apart from the other products.
The U.S.
Government does not have the authority to force farmers to market their crop in
one channel or another. Therefore, the U.S. Government cannot certify that
certain varieties are completely absent from export channels. The USDA believes
that the safeguards described above are helpful in preventing varieties not yet
approved in any country from reaching the export market, but the USDA does not
monitor the companies' safeguarding efforts.
9.
Does the U.S. support the development of international standards for food
biotechnology?
In terms
of safety assessment and scientific reviews, the United States supports the
work of the CODEX Alimentarius, the international standard setting body for
food safety organized under the United Nations Food and Agriculture
Organization (FAO) and the World Health Organization (WHO). CODEX committees
and specially organized task forces and working groups are addressing issues of
standards. CODEX has the knowledge and expertise in the area of food safety and
can build on work that has been done under the FAO and WHO. The FAO/WHO has
drafted a report based on a meeting of experts on biotechnology and food safety
in 1996, which confirmed the safety of processed food containing biotech
inputs, based on rigorous scientific risk assessments.
10. Why
not just stop all marketing and development of biotech products for five years,
just to be safe, as some advocate?
A freeze
would deny hundreds of millions of people the benefits of this technology. As more than 500 noted scientists recently
wrote in a letter supporting biotechnology: "In developing countries,
biotechnology advances will provide the means to overcome vitamin deficiencies,
to supply vaccines for killer diseases, like cholera and malaria, to increase
production and protect fragile natural resources, and to grow crops under
normally unfavorable conditions."
When there is no credible evidence of a risk to human health from use of
biotechnology, why would anyone want to deny the world these benefits?