Chapter 20 REGULATIONS IN BIOTECHNOLOGY Regulations Are intended

Chapter 20 REGULATIONS IN BIOTECHNOLOGY

Regulations § Are 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 sitewww. 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