lec 10 - risk assessments & bioremediation Flashcards
(60 cards)
1
Q
health and safety laws developed for… to ensure…
A
- medicine and food
- safety and reducing costs
2
Q
what products do these laws address?
A
both traditional and bioengineered products
3
Q
1974 asilomar conference
A
national institutes of health (NIH) assumed regulatory responsibility over biotechnology
4
Q
coordinated framework for regulation of biotechnology
A
- joint responsibility of NIH, USDA, EPA
- ensures crops and drugs are safe to grow, safe for environment, safe to consume
5
Q
list (3)
what are the groups governing canada’s laws
A
- health canada
- canada food inspection agency
- environment canada
6
Q
ultimate goal of agriculture grower
A
to harvest marketable produce
7
Q
list (3)
what must growers consider?
A
- plant pests: threats to other plants
- risks to other organisms: to wildlife and desirable insects
- weeds: invasic plants (e.g. dandelions)
8
Q
what are genetically engineered plants always considered?
A
invasive –> treated as plant pests
9
Q
list (4)
how are genetically engineered plants contained?
A
- several years of field trials
- disease resistance, drought tolerance, reproductive rates
- precautions to prevent accidental cross-pollination
- entire trial site kept uncultivated for a season following harvest trial
10
Q
list (7)
criterias to fast track new agricultural products
A
- must be 1 of 6 eligible plant species (corn, cotton, potatoes, soybeans, tobacco, tomato)
- new genetic material must be confined to nucleus of new plant –> no episomal vectors
- function of genes introduced must be known
- if not used for food, new genes cannot code for toxin, infectious diseases or substance used medically
- if gene derived from plant virus, it cannot have potential to create a new virus
- new genetic material must not be derived from animal or human viruses
- same precautions must be taken to prevent accidental spread of new plant and detailed records of trial must be maintained
11
Q
list (4)
environmental agencies purpose
A
- protects endangered species
- establishes emission standards for cars
- regulates pesticides and herbicides
- supervises use of herbicide-tolerant plants
12
Q
list (6)
data reviewed by environmental agencies
A
- source of gene
- how gene is expressed
- nature of pesticide-protein produced
- health effects of bioengineered plant (digestion, allergies)
- environment fate of pesticide protein
- effects on non-target species
13
Q
if environmental agencies give the all clear…
A
- product approved for market
- can be revoked if required
14
Q
legislation
GMO labeling
A
- matter of politics and science
- canada doesn’t require labeling GMO on food but EU does –> jurisdiction specific
15
Q
legislation
edited crops
A
- lower regulatory costs and timeframes for development of new plant varities
- canada and US still regard gene edited crops as equivalent to traditional breeding but europe has tight laws
16
Q
genome editing
cattle horns
A
- horn-growing allele naturally in cattle –> replaced with angus breed allele that stops horn from growing
- naturally in bovine DNA (no foreign DNA)
- FDA declined but approved by brazilian regulators
17
Q
genome editing
tiger puffer fish
A
engineered to grow bigger by disrupting leptin receptor genes (no control on appetite)
18
Q
international biotech regulation
A
we still have none –> world still in preliminary negotiations
19
Q
european agency for evaluation of medicinal products (EMEA)
A
created by EU as model for biotech regulation –> once product approved, marketed in all EU countries
20
Q
FDA/health canada
A
- ensures manufactured foods and medicines are safe and effective
- controls drug development pipeline
21
Q
list (3)
food and food additives development - criteria
A
- find unexpected or undesirable effects
- evaluate protein to see if it’s same as naturally occurring proteins in food
- any protein derived from source that’s already a common allergen must be considered potential allergen
22
Q
drug development pipeline
set of standards (4)
A
- good laboratory practice (GLP)
- good manufacturing practice (GMP)
- standard operating procedures (SOPs)
- good clinical practices (GCPs)
23
Q
paraquat
A
cheap, broad spectrum weed killer –> toxic if inhaled or ingested –> linked to parkinson’s
24
Q
drug development pipeline
generally-recognized-as-safe status (GRAS)
A
- research and discovery for new drugs
- companies use FDA’s expertise before bringing food product to market (consultations)
- if food additive poses no foreseeable threats, FDA grants GRAS status
25
# drug development pipeline
investigational new drug (IND) application
FDA considers results of previous experiments, nature of substance, and plans for additional testing
26
# drug development pipeline
phase I
- answers basic scientific questions, safety, dosage
- 20-80 healthy volunteers
27
# drug development pipeline
phase II
- efficacy and side effects
- 100-300 patients
28
# drug development pipeline
phase III
- comparative benefits to other current drugs
- 1000-3000 patients in double blind tests (clinical trials)
29
# drug development pipeline
new drug application (NDA)
- after phase III, FDA approves the drug
- only 20-30% of drugs make it here
30
# list (7)
NDA must fulfill...
- safe and effective
- benefits outweigh risks
- appropriate labelling (all necessary info abt drug)
- manufacturing methods preserve drug's identity
- strength
- quality
- purity
31
# drug development pipeline
phase IV
indefinite monitoring of drug safety and efficacy
32
# drug development pipeline
biological license agreement (BLA)
- filed by biotech companies if seeking approval of biologically derived products (viral therapy, blood compound, vaccine)
- BLA content must demonstrate purity
33
exceptions to phase testing procedure
- FDA allows approval of drugs and vaccines to counter biological, chemical, and nuclear terrorism without first proving safety and worth in phase II and III trials
- orphan drugs: rare diseases (not enough patients to test on)
34
orphan drugs act (ODA)
provides incentive for sponsors to develop products for rare diseases
35
drug pipeline is ____ and ____
long (8-15 years) and expensive ($1.2 billion) --> results from small phase II trials don't predict how drug will act in randomized phase III trial
36
adaptive phase testing
- allows for faster results
- flexible enrollment and dosing in response to incoming data
- target patient subgroups --> allows research to fail or succeed faster
37
patent
gives investor or researcher exclusive rights to a product and prohibits others from making, using, or selling it for certain # of years (20 yrs in north america)
38
# list (3)
criteria to be granted patent
- novel
- non-obvious
- have some utility
39
# list (2)
info included in patents
- adequately describes product
- discloses best use of product
40
how are patents awarded
on first come first serve basis
41
utility patents
protects useful processes, machines, manufactured goods
42
design patents
protect against unauthorized use of new and original designs for manufactured goods ("look" of a product)
43
plant patents
protects invented or discovered asexually reproduced plant varieties
44
strong patents = ...
- strong business
- primary methods by which biotech companies will be valued
- without patent, no company would invest in costly clinical trials or get FDA approval
45
bioremediation
process of cleaning up contaminated environmental sites using living organisms (their metabolism) to degrade hazardous materials into less toxic substances
46
environmental chemicals
- carcinogens: external factors that cause cancer
- mutagens: DNA mutations that cause cancer
- skin rashes, birth defects, poison plant and animal life
47
# list (4)
bioremediation advantages
- converts harmful pollutants into harmless materials (CO2, H2O, organic molecules)
- more sustainable (cleaner)
- cost effective
- conducted at site of pollution
48
indigenous microbes
- grown and studied in lab --> released back into treatment environments in large numbers or stimulated on site by bioaugmentation (nutrient enrichments) --> if survived, it means they're good
49
PCE
- in dry cleaning products --> common contaminant in groundwater --> toxic to humans in low []
- grows bacteria on iron sulfide (electron acceptors) --> thrive on PCE
50
cyanobacteria
- recycles CO2 into valuable chemicals --> engineered into various compounds
- production efficiencies improved for commercialization
- engineered strain uses CO2 and glucose to make 2,3-butanediol --> industrial viability
51
phytoremediation
- using plants to clean up chemicals in soil, water, air
- genetically engineer plants to capture high levels of CO2 by photosynthesis
52
# list (4)
phytoremediation advantages
- effective
- low cost
- low maintenance
- sustainable, eye-appealing
53
# list (2)
phytoremediation drawbacks
- only cleans surface layers (50m)
- takes several years
54
rubisco
- increases photosynthesis in plants --> inefficient protein so lots produced
- introduce cyanobacteria into plants or mutations to increase rubisco
55
exxon valdez oil spill
- tanker accident --> would take 100s of years to clean alaskan land
- N and P fertilizers applied to shorelines --> stimulate indigenous oil-degrading bacteria
56
deepwater horizon oil spill
- british oil rig exploded into gulf of mexico
- microbes degraded 50% of oil, reduced oil by half every 3 days
57
great pacific garbage patch
- macro and microplastics --> 9 million tons of plastic
- makes coral reefs sick (not enough O2)
58
why is the garbage patch hard to clean?
getting rid of plastic also gets rid of important bacteria to ocean
59
PET
common plastic --> LLC breaks down PET into its building blocks
60
engineered LLC variant
- 10,000 times more efficient and stable at 72 degrees C
- generates new pieces of PET --> circular recycling
