United States
Environmental Protection
Agency
EPA745-F-93-003
June 1993
Office of Pollution Prevention and Toxics
EPA's Biotechnology
Oversight Program
Under the
Toxic Substances
Control Act
-------
What is Biotechnology?
In different forms, biotechnology has been going on
for centuries. People have long sought to change
the inherited characteristics of crops and domestic
animals. For example, farmers carefully select seed
from their best plants for the next year's planting;
good milk cows are chosen for breeding; plants are
cross-bred to produce valuable new hybrids.
Biotechnology is the modification of the
genetic material of plants, animals, and
microorganisms such as bacteria, viruses,
and fungi, in order to achieve certain
desired products or results.
Today, these efforts are taken a step
further to the direct modification of
genetic material in the laboratory.
Modern biotechnology developed /
in the early 1970s with new tech- (L-
niques that allowed genetic ' ^*~
material to be moved between
organisms.
Biotechnology promises
significant advances in medicine,
agriculture, cleanup of toxic wastes,
energy production, mining, and numer-
ous other fields. Applications of biotechnol-
ogy have already revolutionized the search for
vaccines, as well as advancing the develop-
ment of treatments for cardiovascular
illness, cancer, mental disorders, and
many other medical problems. The
potential for improvements in
other fields is equally promising.
-------
How Biotechnology is Regulated
Different types of biotechnology products are
covered by laws administered by the U.S. Food and
Drug Administration (drugs, foods, food additives,
and medical devices), the U.S. Department of
Agriculture (plants, plant pests, and certain veteri-
nary products), and the U.S. Environ-
mental Protection Agency. EPA
administers biotechnology regulatory
programs under two statutes: the
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) which
covers chemical and biological
pesticides, and the Toxic
Substances Control Act (TSCA).
This pamphlet describes EPA's biotechnology
oversight program under TSCA. (See the end of
this pamphlet for contacts and references for the
other federal biotechnology programs.)
TSCA authorizes EPA to regulate chemical
substances — including combinations of chemical
substances such as certain types of living organisms
— that present an unreasonable risk of injury to
health or the environment. TSCA does not cover
substances which are subject to other federal statutes.
TSCA contains special requirements relating to
new chemical substances. Under EPA's New
Chemicals Program, manufacturers and importers
must submit health and safety information to EPA
before introducing any new chemical substance into
the marketplace. (This information is referred to as
premanufacture notification, or PMN.)
EPA regulates biotechnology products under
TSGA under the terms of a coordinated federal
policy issued in 1986. Under this policy, EPA
focuses its biotechnology oversight program on
microorganisms that contain or express new
-------
combinations of traits. This includes "intergeneric
microorganisms" that are deliberately engineered to
contain combinations of genetic material from
different genera (groups of closely related species).
EPA considers these to be new microorganisms
subject to the Agency's oversight.
To determine the safety of these products, EPA
has specified a series of reporting steps and evalua-
tions, similar to the procedures of the Agency's
PMN program for new chemicals. EPA reviews
information on new microorganisms prior to their
introduction into the marketplace. In addition,
researchers are requested to notify EPA prior to any
environmental testing involving the introduction
into the environment of new microorganisms.
If EPA determines that the product may pose an
unreasonable risk to health or the environment,
EPA can also modify the conditions of use to
include additional safeguards for controlling the
microorganism. EPA can delay
or restrict the manufacture
or distribution of a biotech-
nology product if the
Agency believes that the
risks to public health and
the environment exceed
the benefits of the product.
In evaluating the information submitted on a
product, EPA considers the expected benefits of the
product as well as the following risk factors: the
types of organisms being used for the genetic ,
modification; characteristics of the microorganism
in question; the stability of the new genetic insert in
the environment; possible effects on the environ-
ment; and potential exposures of workers and
consumers to the biotechnology product.
-------
How Biotechnology Works
For over 10,000 years people have been using some
form of biotechnology to develop and maintain -
characteristics that are considered desirable in
other species. With rare exceptions, the tools
available have been limited to selecting organisms
with desired traits and enhancing or perpetuat-
ing them through conventional breeding
programs.
The techniques of modern biotechnolo
made new tools available. With these
now possible to move genetic material fro
organism to another. Thus, genetic inform'
tion expressing desirable traits can be move
between microorganisms, plants, and
animals. This type of exchange of genetic
material was -not previously possible using
the conventional techniques of selection
and breeding.
How do biotechnology techniques
work? Within every cell — the basic building block of
all organisms — are found a variety of materials,
including genetic material called DNA that contains a
The public also has the opportunity to become
involved in the review of a biotechnology product.
When EPA receives notification for a new microor-
ganism, public notice is given in the Federal Register
and members of the public are welcome to comment
on the notification. The public may also request, or
EPA may decide to convene, a public meeting of
EPA's Biotechnology Science Advisory Committee.
The United States is a world leader in biotechnol-
ogy. The techniques of modern biotechnology offer
-------
blueprint for the organism. The blueprint informa-
tion is arranged in segments of DNA called "genes"
that relate to a particular function or produce a
particular chemical product
The complete complement of DNA
in an individual organism (its
"genome") can be thought of as a tape
containing all the information necessary
to build an organism and cany out its
functions. Like any tape, DNA can be cut and
spliced. Information from one point on the tape
can be moved to another point or to the tape of
another organism, using various techniques. One
(technique, called "recombinant DNA," uses enzymes
TOfcut and splice genes. In another technique, "cell
fuaom" two or more cells from different organisms
are/fused into a single cell.
\H-
The^new biotechnology techniques are more
powerfulfecfinore precise than traditional breeding
techniques. The tools of modern biotechnology have
the advantage of permitting greater control over the
design and production of biotechnology products,
minimizing the likelihood of unexpected effects.
our society and the world at large the potential for
improvements in human health and environmental
quality. At the same time, any technology that deals
so directly with the basic processes of life inevitably
raises compelling questions. The novelty of modern
biotechnology has raised legitimate concerns on the
part of the public and a strong interest in an active
government role in regulating new products. EPA's
biotechnology oversight program attempts to strike a
balance between the concerns that biotechnology
raises and the promise that it offers.
-------
What Is Biotechnology Used For?
Biotechnology products can consist of genetically
engineered organisms themselves or of chemical
substances made using genetically engineered organ-
isms. Below are some of die applications of biotechnol-
ogy products that come under EPA's TSCA review.
Current Applications Biotechnology products are
already in use or under development in several
agricultural and industrial applications, such as
die following:
• Enhanced nitrogen-fixation — Nitrogen is an essential
element for plant growth. Some microorganisms can
be genetically engineered to;enhance their ability to
"fix" atmospheric nitrogen in a form that plants can
use as fertilizer. Seeds are coated with diese genetically
engineered microorganisms before planting; die
microorganisms dien colonize die roots as they grow,
enhancing die ability of die plant to obtain nitrogen
and grow better.
• Specialty chemicals— Microorganisms are genetically
engineered to enhance dieir production of complex
products such as enzymes, which are widely used in the
detergent, starch, and textile industries.
Future Applications Research is underway to develop
biotechnology products for applications such as die
following:
• Bioremediatim — Naturally occurring microorganisms
are already being used to break down contaminants in
die environment and convert diem to harmless
substances. Researchers are working to genetically
engineer microorganisms in such a way as to improve
their ability to clean up chemical contamination.
• Biosensors— Biotechnology could be used to develop
improved biosensors to detect die presence and
concentration of contaminants in die environment.
Ultimately, biological material may even prove useful in
developing new kinds of semiconducters ("biochips").
-------
For More Information on
Biotechnology:
U.S. Congress, Office of Technology Assessment, New
Developments in Biotechnology, 1: Ownership of Human
Tissues and Cells — Special Report, OTA-BA-337 (Wash-
ington, DC: U.S. Government Printing Office,
March 1987).
U.S. Congress, Office of Technology Assessment, New
Developments in Biotechnology, 2: Public Perceptions of
Biotechnology — Background Paper, OTA-BP-BA-45
(Washington, DC: U.S. Government Printing Office,
May 1987).
U.S. Congress, Office of Technology Assessment, New
Developments in Biotechnology, 3: Field-Testing Engineered
Organisms: Genetic and Ecological Issues — Special Report,
OTA-BA-350 (Washington, DC: U.S. Government
Printing Office, May 1988).
U.S. Congress, Office of Technology Assessment, New
Developments in Biotechnology, 4: U.S. Investment in
Biotechnology —Special Report, OTA-BA-360 (Washing-
ton, DC: U.S. Government Printing Office, July 1988).
U.S. Congress, Office of Technology Assessment, New
Developments in Biotechnology, 5: Patenting Life — Special
Report, OTA-BA-370 (Washington, DC: U.S. Govern-
ment Printing Office, April 1989).
U.S. Congress, Office of Technology Assessment,
Mapping Our Genes — The Genome Projects: How Big,
flow .Fort? OTA-BA-373 (Washington, DC: U.S.
Government Printing Office, April 1988).
(The above reports are available from the U.S.
Government Printing Office, Superintendent of
Documents, Washington, D.C. 20402-9325 (202-783-
3238) and the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161-
0001 (7034874650).)
' 7
-------
National Research Council, Field Testing Genetically
Modified Organisms: Framework for Decisions
(Washington, DC: National Academy Press, 1989).
For More Information on EPA's
Biotechnology Program Under TSCA:
Office of Science and Technology Policy, "Coordinated
Framework for Regulation of Biotechnology; An-
nouncement of Policy and Notice for Public Com-
ment," Federal Register (51 FR 23302), June 26,1986.
TSCA Hotline: 202-554-1404.
For Information on Other Federal
Biotechnology Programs:
Contacts:
i.
U.S. Department of Agriculture, Animal and Plant
Health Inspection Service (APHIS), Biotechnology
and Environmental Coordination Staff (regulatory
issues), Tel: 301-436-5762
U.S. Department of Agriculture, Office of Agricul-
tural Biotechnology (agricultural research issues),
Tel: 703-235-1505.
U.S. Environmental Protection Agency, Office of
Pesticide Programs, Tel: 800-858-7378 or 806-743-3091.
U.S. Food and Drug Administration, Office of
Biotechnology, Tel: 301443-7573.
« U.S. GOVERNMENT PRINTING OFFICE: 1993—721-069
8
------- |