Modified by Georgia Agricultural Education Curriculum Office Biotech Regulations Modified by Georgia Agricultural Education Curriculum Office June, 2002

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 signed 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

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 products 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.

The Federal Register The official document of the U.S. government for informing the public about the regulation of biotech products.

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 they interfere with people gaining benefits from 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

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 Information is protected & not released to insure that the investment of the company is protected Information known as trade secrets