Biotech Regulations

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Biotech Regulations

• Modified by Georgia Agricultural Education
  Curriculum Office
• June, 2002

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• REGULATIONS IN BIOTECHNOLOGY

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Regulations

• Are intended to allow us to safely use the
  benefits of biotech.
• Help in developing and using biotech products and
  services.

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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.

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Regulations

• GMOs are carefully tested and documented before
  products are available.
• GMOs must be labeled and used according to
  instructions.

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Regulations

• Users must have prescribed training and signed
  contracts.
• Agricultural producers must segregate GMO crops
  from other crops.

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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

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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.

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Who makes Regulations?

• Made by 3 branches of the federal government
• Legislative
• Executive
• Judicial

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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.

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Executive

• Executive branch can issue executive orders that
  influence biotech.
• Only president has the authority to issue these

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Responsible Agencies

• Three agencies in the federal govt have primary
  responsibilities for administering laws related
  to biotech.

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The USDA

• U.S. Department of Agriculture
• Decide whether products are safe to use on
  cultured crops or animals.

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The EPA

• U.S. Environmental Protection Agency
• Its role is to assure quality environment.

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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.

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Getting products approved

• Application forms must include reports of all
  testing needed to gain approval.
• Some products are granted only for experimental
  purposes.

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Permits

• Permit - a written approval granted by the
  appropriate government agency.
• Permits are needed to introduce products that are
  regulated.

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The Federal Register

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

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Organizations

• Organizations provide guidelines and
  opportunities for communication among
  biotechnologists.
• Dont have authority to regulate the use of
  biotech products.

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BIO

• Biotechnology Industry Organization
• Largest trade organization
• Provides leadership guidance to help its
  members advance the overall industry.

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Area of Leadership

• One area of leadership by BIO is bioethics.
• BIO promotes informed citizens
• Programs to promote the study of biotech to
  students

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CBC

• Council of Biotechnology Centers
• Membership made up of research and development
  centers

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CBC

• CBC is intended to provide dialogue among
  individuals with shared interests in
  biotechnology.

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Ethics and Regulations

• Regulations are to protect people.
• Regulations need to be changed when they
  interfere with people gaining benefits from
  biotech.

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International Perspective

• Nation benefit differently from biotechnology
• Nations are classified as developing or developed.

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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

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Confidentiality

• Confidentiality-keeping information secret or
  private
• Confidential business information(CBI)-application
  s to government agencies to gain approval to
  transport or release a regulated organism

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Confidentiality

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