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
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?
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
