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 1862Regulation 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 1970Experimental 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

NovelNon-obviousSome UtilityPatenting 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