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Biotechnology Regulations
Chapter 12
The Regulatory Framework
U.S. Department of Agriculture
• Safe to Grow
Environmental Protection Agency
• Safe for the Environment
Food and Drug Administration
• Safe to Consume
All 3 agencies work together!
U.S. Department of Agriculture
Created in 1862
Regulation of plant pests, plants and veterinary
biologics (defined as any medical preparation
made from living organisms or products (e.g.
insulin and vaccines)
Animal and Plant Health Inspection Service
(APHIS) - Responsible for protecting U.S.
agriculture from pests and diseases
U.S. Department of Agriculture
Permitting Process
• Several years of field trials
• Petition for deregulation (plant pest consequences,
risk to other organisms, weed consequences)
• Notification Process or “fast track”
The Environmental Protection Agency
Established in 1970
Experimental Use Permit (plants themselves
must meet the same standards as chemical
pesticides used in the fields)
First one issued was to Advanced Genetic
Sciences Inc. in 1985
Next phase, deregulation and commercialization
(considers the gene, its regulation, and the
protein; then health effects; environmental fate,
effect on non-targeted species)
Food and Drug Administration
Consults with companies to produce safe
products
If a food or additive poses no foreseeable
threat, it is granted generally-recognized-as-safe
(GRAS) status (e.g. genetically engineered
chymosin and BST)
Food and Drug Administration
 The Drug Approval Process
• GLPs –regulations governing animal studies
• GCPs –regulations governing human studies
• After animal trials- apply for Investigational New Drug status (IND)
• Phase I(safety)-20 to 80 healthy people; determine ADME
• Phase II(efficacy)-100 to 300 patients
• Phase III- 1,000 to 3,000 patients in double blinded tests
• Only 20% make it to NDA
• EXCEPTION- fast track status to drugs that counter biological,
chemical and nuclear terrorism and orphan drugs
Legislation and Regulation
Philosophical values vs scientific evidence
• Stem Cell Research
• Labeling Biotech products
Introduction to Patents
US Patent and Trademark Office (USPTO) issued
the first patent on a bacterium in 1980
Simple guidelines to protect a product:
• Keep good records
• Do your homework
Introduction to Patents
Novel
Non-obvious
Some Utility
Patenting DNA Sequences
• Specific utility (what the sequence does)
• Substantial utility (“real world” use)
• Credible utility (sound science)
Biotechnology Products in the
Global Marketplace
The world community is still involved in
preliminary negotiations
• UN –voluntary code and a set of technical guidelines
concerning the release of GMOs
• FAO focusing its attention on biotech in developing
nations
• EU through the EMEA is the counterpart of the FDA
(except it doesn’t get involved in product
development)
Ethics and Biotechnology
Chapter 13
What is Ethics?
It considers social and moral aspects and
potential outcomes of the use of biological and
medical techniques
Ask yourself, “Should this be done?” and then
“How can it be done in the right way?”
What is Ethics?
Approaches To Ethical Decision Making
• The FIRST: Hippocratic Oath-”do not kill” or “to help
or at least do not harm”
• Two approaches:
• Utilitarian or consequences-the ends justify the means
• Deontological or objectivism-there are at least some
absolutes (definitive rules that cannot be broken)
What is Ethics?
Ethical Exercise Warm-Up
• Should you push that guys in front of the car
containing 3 children or not?
Biotechnology and Nature
Asilomar Conference- called for a
moratorium on DNA recombinant research
until guidelines could be established
Biotechnology and Nature
Cells and Products
• What are some of the ethical considerations associated
with animal trials for human drugs?
• Safety
• Efficacy
• Humane treatment of animals in studies
• How many animals and which animal model? (e.g. thalidomide
was originally tested in rodents and found safe however, after
birth defects occurred, it was then tested in marmosets and birth
defects occurred in the baby monkeys)
Biotechnology and Nature
 GM Crops: Are You What You Eat?
• Areas of concern:
• Do the alterations in the plant benefit it or at
least do not produce a less vigorous plant?
• Is the integrity of the species maintained?
• Is the biodiversity of the species altered or the
biodiversity of any insects dependent on this
plant?
• What is the statistical probability of a bad event
happening (e.g. transfer of the gene to another
plant)?
• How safe is the new product? (e.g can humans
become allergic to Bt?)
• What are the social and economic ramifications of
introducing this plant? (e.g. farmers who recycle
Roundup-Ready soybeans and therefore are
stealing from Monsanto)
Biotechnology and Nature
 Animal Husbandry or Animal Tinkering
• Raises some of the some questions as in plant tinkering
• What are some of the early modifications? (antibiotics and
hormone treatments)
• There is little concern about the effect of genetically modified ag
animals on the environment, but is this appropriate? The effect on
biodiversity?
• What about species integrity? Consider whether there is a point at
which the animal might acquire enough human genes to be
considered human? (what defines being a human?)
Biotechnology and Nature
The Human Question
• Controversial issues surround the testing of drugs on
humans, why?
• Who should get the drug (the sickest?)
• Why is informed consent so important-do you think
parents should be allowed to decide for a child?
• The placebo problem in the double-blind test (someone
is going to get a “sugar” pill)
Biotechnology and Nature
 What Does It Mean to Be Human?
• Current ethical debates revolve around the moral status of the
human embryo—is it a human being?
• Does it qualify for personhood (defines an entity that qualifies for
protection based not on an intrinsic value but rather on certain
attributes such as self-awareness)
• AND what about the idea of creating embryos for an ES cell source
vs spare or disregarded embryos?
• AND does creating embryos lead to human commercialization-
making human life a commodity to be bought and sold?
Biotechnology and Nature
Regulations in Flux
• Federal ban on federal funding of stem cell research
has been reversed.
Biotechnology and Nature
More or Less Human?
• What are the implications of germline genetic
engineering? (Who decides what makes a better human
being? What changes are allowed?)
Economics, The Role of Science,
and Communication
Grant funding is based on peer review

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biotechnology regulations.ppt

  • 2. The Regulatory Framework U.S. Department of Agriculture • Safe to Grow Environmental Protection Agency • Safe for the Environment Food and Drug Administration • Safe to Consume All 3 agencies work together!
  • 3. U.S. Department of Agriculture Created in 1862 Regulation of plant pests, plants and veterinary biologics (defined as any medical preparation made from living organisms or products (e.g. insulin and vaccines) Animal and Plant Health Inspection Service (APHIS) - Responsible for protecting U.S. agriculture from pests and diseases
  • 4. U.S. Department of Agriculture Permitting Process • Several years of field trials • Petition for deregulation (plant pest consequences, risk to other organisms, weed consequences) • Notification Process or “fast track”
  • 5. The Environmental Protection Agency Established in 1970 Experimental Use Permit (plants themselves must meet the same standards as chemical pesticides used in the fields) First one issued was to Advanced Genetic Sciences Inc. in 1985 Next phase, deregulation and commercialization (considers the gene, its regulation, and the protein; then health effects; environmental fate, effect on non-targeted species)
  • 6. Food and Drug Administration Consults with companies to produce safe products If a food or additive poses no foreseeable threat, it is granted generally-recognized-as-safe (GRAS) status (e.g. genetically engineered chymosin and BST)
  • 7. Food and Drug Administration  The Drug Approval Process • GLPs –regulations governing animal studies • GCPs –regulations governing human studies • After animal trials- apply for Investigational New Drug status (IND) • Phase I(safety)-20 to 80 healthy people; determine ADME • Phase II(efficacy)-100 to 300 patients • Phase III- 1,000 to 3,000 patients in double blinded tests • Only 20% make it to NDA • EXCEPTION- fast track status to drugs that counter biological, chemical and nuclear terrorism and orphan drugs
  • 8. Legislation and Regulation Philosophical values vs scientific evidence • Stem Cell Research • Labeling Biotech products
  • 9. Introduction to Patents US Patent and Trademark Office (USPTO) issued the first patent on a bacterium in 1980 Simple guidelines to protect a product: • Keep good records • Do your homework
  • 10. Introduction to Patents Novel Non-obvious Some Utility Patenting DNA Sequences • Specific utility (what the sequence does) • Substantial utility (“real world” use) • Credible utility (sound science)
  • 11. Biotechnology Products in the Global Marketplace The world community is still involved in preliminary negotiations • UN –voluntary code and a set of technical guidelines concerning the release of GMOs • FAO focusing its attention on biotech in developing nations • EU through the EMEA is the counterpart of the FDA (except it doesn’t get involved in product development)
  • 13. What is Ethics? It considers social and moral aspects and potential outcomes of the use of biological and medical techniques Ask yourself, “Should this be done?” and then “How can it be done in the right way?”
  • 14. What is Ethics? Approaches To Ethical Decision Making • The FIRST: Hippocratic Oath-”do not kill” or “to help or at least do not harm” • Two approaches: • Utilitarian or consequences-the ends justify the means • Deontological or objectivism-there are at least some absolutes (definitive rules that cannot be broken)
  • 15. What is Ethics? Ethical Exercise Warm-Up • Should you push that guys in front of the car containing 3 children or not?
  • 16. Biotechnology and Nature Asilomar Conference- called for a moratorium on DNA recombinant research until guidelines could be established
  • 17. Biotechnology and Nature Cells and Products • What are some of the ethical considerations associated with animal trials for human drugs? • Safety • Efficacy • Humane treatment of animals in studies • How many animals and which animal model? (e.g. thalidomide was originally tested in rodents and found safe however, after birth defects occurred, it was then tested in marmosets and birth defects occurred in the baby monkeys)
  • 18. Biotechnology and Nature  GM Crops: Are You What You Eat? • Areas of concern: • Do the alterations in the plant benefit it or at least do not produce a less vigorous plant? • Is the integrity of the species maintained? • Is the biodiversity of the species altered or the biodiversity of any insects dependent on this plant? • What is the statistical probability of a bad event happening (e.g. transfer of the gene to another plant)? • How safe is the new product? (e.g can humans become allergic to Bt?) • What are the social and economic ramifications of introducing this plant? (e.g. farmers who recycle Roundup-Ready soybeans and therefore are stealing from Monsanto)
  • 19. Biotechnology and Nature  Animal Husbandry or Animal Tinkering • Raises some of the some questions as in plant tinkering • What are some of the early modifications? (antibiotics and hormone treatments) • There is little concern about the effect of genetically modified ag animals on the environment, but is this appropriate? The effect on biodiversity? • What about species integrity? Consider whether there is a point at which the animal might acquire enough human genes to be considered human? (what defines being a human?)
  • 20. Biotechnology and Nature The Human Question • Controversial issues surround the testing of drugs on humans, why? • Who should get the drug (the sickest?) • Why is informed consent so important-do you think parents should be allowed to decide for a child? • The placebo problem in the double-blind test (someone is going to get a “sugar” pill)
  • 21. Biotechnology and Nature  What Does It Mean to Be Human? • Current ethical debates revolve around the moral status of the human embryo—is it a human being? • Does it qualify for personhood (defines an entity that qualifies for protection based not on an intrinsic value but rather on certain attributes such as self-awareness) • AND what about the idea of creating embryos for an ES cell source vs spare or disregarded embryos? • AND does creating embryos lead to human commercialization- making human life a commodity to be bought and sold?
  • 22. Biotechnology and Nature Regulations in Flux • Federal ban on federal funding of stem cell research has been reversed.
  • 23. Biotechnology and Nature More or Less Human? • What are the implications of germline genetic engineering? (Who decides what makes a better human being? What changes are allowed?)
  • 24. Economics, The Role of Science, and Communication Grant funding is based on peer review