Chapter 20REGULATIONS IN BIOTECHNOLOGY

RegulationsAre intended to allow us to

safely use the benefits of biotech.

Help in developing and using biotech products and services.

Nature and Purposes of Regulations

• Regulation- a law, principle, or other directive.

• Regulations apply to the production, sale, and use of biotech products.

• GMO-genetically modified organism.

Regulations• GMOs are carefully tested and

documented before products are available.

• GMOs must be labeled and used according to instructions.

Regulations• Users must have prescribed

training and sign contracts.

• Agricultural producers must segregate GMO crops from other crops.

Purposes of Regulations

• Regulations are designed to protect people, other living organisms, and the environment

• They help those who are inclined not to do the right thing to follow acceptable procedures

Purposes• Some nations refuse to accept

GMO grain, cotton, and animal products.

• Harvested crops must be kept separate

• Overall purpose is to protect.

Agencies• Agencies that regulate biotech

are at the federal, state, and local levels.

• State and local level regulations vary, but not violate those of the federal government.

Who makes Regulations

• Made by 3 branches of the federal government–Legislative

–Executive

–Judicial

Legislative • Regulations are rooted in the

laws enacted by the Congress of the United States.

• Once passed by Congress, the president must sign approving the law.

Executive • Executive branch can issue

executive orders that influence biotech.

• Only president has the authority to issue these

Responsible Agencies• Three agencies in the federal

gov’t have primary responsibilities for administering laws related to biotech.

The USDA• U.S. Department of Agriculture

• Decide whether products are safe to use on cultured crops or animals.

The EPA• U.S. Environmental Protection

Agency

• Its role is to assure quality environment.

The FDA• U.S. Food and Drug

Administration

• It is responsible for all laws that are designed to assure the safety of food and drugs.

Getting a product approved

• Application forms must include reports of all testing needed to gain approval.

• Some products are granted only for experimental purposes.

Permits• Permit-a written approval

granted by the appropriate government agency.

• Permits are needed to introduce products that are regulated.

Permits• Regulated Organism-one that

has been genetically engineered.

• Permits are needed to transport regulated organisms.

The Federal Register• The official document of the U.S.

government for informing the public about the regulation of biotech products.

• Web site-www.aphis.usda.gov/biotechnology/

Organizations • Organizations provide

guidelines and opportunities for communication among biotechnologists.

• Don’t have authority to regulate the use of biotech products.

Bio • Biotechnology Industry

Organization• Largest trade organization• Provides leadership & guidance

to help its members advance the overall industry.

Area of Leadership• One area of leadership by BIO

is bioethics.

• BIO promotes informed citizens

• Programs to promote the study of biotech to students

CBC• Council of Biotechnology

Centers

• Membership made up of research and development centers

CBC• CBC is intended to provide

dialogue among individuals with shared interests in biotechnology.

Ethics and Regulations

• Regulations are to protect people.

• Regulations need to be changed when the interfere with people gaining benefits for biotech.

International Perspective

• Nation benefit differently from biotechnology

• Nations are classified as developing or developed.

International Perspective

• Developing nation-one that has low levels of economic activity.

• Have low standards of living and quality of life

• Developed nation-one that is highly industrial

Free Enterprise• Companies in biotech

development are in business to make a profit.

• The benefit of people and welfare of a company may conflict

Confidentiality • Confidentiality-keeping

information secret or private• Confidential business

information(CBI)-applications to government agencies to gain approval to transport or release a regulated organism

Confidentiality • Info is protected & not released

to insure that the investment of the company is protected

• Info known as trade secrets