Card Set Information
How frequently does the average user replace their cell?
How many cell phones does the US replace every year and how many tons of waste does that equate to?
million cells/months = 65,000 tons of waste
What does CAA give in the Env Law Roadmap?
o not put anything up the stack
What does CWA give in the Env Law Roadmap?
do not put anything in the water
What does RCRA give in the Env Law Roadmap?
o not put it anywhere else
What does CERCLA give in the Env Law Roadmap?
if you put it in the ground in the past, dig it up now
What does EPCRA give in the Env Law Roadmap?
if you have it you must tell us about it
What does PPA give in the Env Law Roadmap?
if it is such bad news, do not make it in the first place
What does OSHA give in the Env Law Roadmap?
tell us how you are going to use it
What will GOTCHA do to the env law roadmap?
combine all the env laws into one
What is NAMBI?
not against my business or industry
What is BANANA?
build absolutely nothing anywhere near anything
How many coal plants in US?
How much ash does coal contain?
How many tons of coal does a coal plant use?
~4000 tons coal/day
How many tons of coal does a coal plant create?
~400 tons coal ash/day
In 2008, how much coal ash does a person create a day?
How much of coal ash is beneficial use?
How much of coal ash is in mine fills?
How much of coal ash is in landfills?
How much of coal ash is in surface impoundments?
What are the four types of surface impoundments?
How many coal ash surface impoundments are there?
Approximately how many have a high or significant hazard potential rating?
How many surface impoundments are over their life expectancy of greater than 40 years?
What was the TVA Kingston Dike Failure?
On Dec 22, 2008 coal ash dike failed
Resulted in ash laden water covering 300 acres
How many landfills lack liners?
How many landfills lack groundwater monitoring?
How many surface impoundments lack liners?
62% lack liners
How many surface impoundments lack groundwater monitoring?
58% lack groundwater monitoring
What did the bevill determination in 200 determine how coal ash should be regulated?
coal ash should be regulated as a solid waste under subtitle D (not as subtitle C hazardous waste
What two options did the EPA propose in May 2010?
1. Declare as RCRA subtitle C (except beneficial uses)
2. Continue as RCRA subtitle D
What does a pre-clinical study require in the FDA phased drug development?
Chemical and animal toxicology studies
What does a phase one require in the FDA phased drug development?
- initial human studies assess toxicity, pK, initial efficacy
- examine special populations (renally impaired)
- 20 – 80 patients per study
- $25,000 - $40,000/patient
What does a phase two require in the FDA phased drug development?
- small scale efficacy/safety studies
- dose/regimen selection/optimization
- 30 – 200 patients per study
What does a phase three require in the FDA phased drug development?
- rigorous controlled efficacy/safety studies
- 100-10,000 patients per study
What does a phase four require in the FDA phased drug development?
- post-approval studies of new uses or populations
- similar in scope to Phase 3 trials
What is the FDA definition of a drug?
Any substance used to diagnore, cure, mitigate, treat or prevent disease
What is effectiveness in the drug development process?
- req for “substantial evidence” from “adequate and well controlled trials” since 1962
- trials of adequate size and design to determine a difference should such a difference exist
- uncontrolled trials are usually not acceptable
- testing a hypothesis in a clinical trial, such as “drug X is superior to drug Y by Z%”
How is safety defined in the drug development process?
That no drug is completely safe
Implies risk of adverse effects is outweighed by benefits
Takes into account seriousness of disease and available alt therapies
What does a drug need to obtain fast track designation?
-products for serious/life threatening diseases
-products to meet potentially unmet medical needs
What did IOM say about evaluating the Drug safety system?
-recommend increased authority to FDA for postmarket monitoring/risk assessment
- proposes symbol on label for new drugs
- recommends safety related performance goals
-recommends making study results public
-recommending 6 yr term for FDA commsiioner
-Establish and safety communication cmt
-involve office of surveillance and epi to review team
-reduce financial conflicts of interest
What is the FTC-FDA Liaison Agreement?
For foods, drugs, cosmetics, & medical devices
How does the FDCA define devices?
-intended to diagnose, cure, mitigate, treat, or prevent a disease or condition
-affects the function or structure of the body
-does not achieve intended use through chemical action in/on body; and is not metabolized to achieve purpose
What are some examples of device types?
-would care products
What are Class one devices under FDCA?
-exempt from pre-marekt submission
What are class two devices under FDCA?
-pre-market notifications (501K)
What are Class three devices under FDCA?
-clinical data needed
-pre-market application (PMA)
How many FDA Advisory committees have at least one member with COI?
How many FDA Advisory Committees have more than have with COI?
What are the 2011 CDC estimates of food bourne illness?
What are the 2011 CDC estimates of food bourne deaths?
How many oubtreaks for USDA regulated products between 1990 - 2004?
How many outbreaks for FDA regulated products btw 1990-2004?
How many E-Coli illnesses a year?
70,000 and 1 of 15
Which of the food bourne illnesses is increasing?
How many foodbourne deaths each year are from known pathogens?
9.4 million from 31 specified pathogens
How many food deaths are from unknown pathogens?
38.4 million from unspecified agents
What causes the most annual number of food bourne illness a year from foodbourne illness?
Norovirus 5.46 million
What foodbourne causes the most hospitalizations?
Salmonella causes the most hospitalizations 19,336
What foodbourne causes the most deaths?
Salmonella cuases the most deaths
What do salmonella, campylobacter, e-coli, listeria cause?
What do staphylococcus and clostridium botulinum cause>
What are the most common sources of foodbourne disease in CDC Food Net?
salmonella and campylobacter
What is HACCP?
systematic approach to food safety through prevention rather than inspection of the final product
Food safety advice?
How much does salt water cover the earth?
~70% of earth’s surface
how much of the earth’s water is salt water?
How much of water is brackish?
How much of water is fresh water?
How much of freshwater is frozen?
2/3 of freshwater frozen in polar ice sheets
How much of water is readily accessible for human use?
0.3% or 125,000 cubic km of H20
What are sources of freshwater?
ground water, precipitation, run off, surface
How much of ground water is a water source for US?
50% of population
What do cisterns do?
capture and use rain water
how much land has NYC department of enviro protection set aside since 1997 to protect source water?
how much water is consumed each day per person?
50 gallons pdpp
What is the most consumed source of water?
toilets 15-25 gallons
how much water is used for cooking and drinking per person?
What is the the source of amoebiasis in waterbourne disease?
sewage, untreated drinking water
What is the source of cryptospodiosis in waterbourne disease?
animal manure, seasonal runoff, sewage
What waterbourne diseases are from sewage?
Cyclosporidiosis, cryptosporidiosis, amoebiasis
what isn’t sewage in waterbourn illness?
giardiasis and legionellosis
how did Bangladesh plummet the incidence of waterborne disease?
digging shallow tube wells
as a result of digging shallow tube wells, even though waterbourne disease plummeted, what increased?
arsenic 1/3 have As levels above suggested 10ppb and some are above 1000 ppb
What is ARUBA
uses coal ash to remove arsenic from drinking water
What doesn’t the safe drinking water act regulate?
private well and bottle water (FDA)
What is the national primary drinking water regulation (NPDWR)?
maximum contaminant levels and treatment techniques
What is the National Secondary Drinking Water Regulation (NSDWR)?
non-enforceable guideline – cosmetic effects (skin or tooth) and aesthetic effects (such as taste, odor, color)
What is the Maximum Contaminant Level Goal (MCLG)?
- no adverse effect expected
- drinking water consumption compared to RfD
- MCLG zero for carcinogens
- Does not consider ability to measure or treatment technology
What is Maximum Contaminant level (MCL)
based on technical feasibility and cost
set as close to MCLG as possible
If there is no reliable method to measure contaminant at low enough level what does EPA use instead of MCL?
Treatment Technique (TT) (lead and copper rules)
How often must the EPA review contaminants?
Must review at least 5 contaminants every 5 years
What must EPA show in order to regulate a contaminate?
-affects human health
-known or substantially likely to occur in public H20 system at freq/level of concern
-regulation of contaminant presents opportunity for health risk reduction
What are some concerns about disinfection by-products (DBPs)
Pros and cons of chlorine as disinfectants
cheap, very effective
produces THMs and other DBPs
Pros and cons of ozone as disinfectants
expensive, generated on site, very reactive
produces bromate and other DBPs
Pros and cons of chlorine dioxide as disinfectants
generated on site, explosive, costly
effective disinfectant, kills cryptospodium
Pros and cons of chloramines as disinfectants
usually used with another disinfectant – often to provide residual
generates DBPs can change water properties -
When was chlorination introduced?
how many deaths globally from diarrheal disease through water?
how much did clean water technologies reduce mortality between 1900-1936
half of total mortality in citiies
how much did clean water reduce infant mortality in cities 00-36?
how many bottles of water sold year in us and in world?
50 billion in US ~200 billion ww
how many miles of pipe in the DC?
how many ppl have no access to decent sanitation
2.6 billion ppl 2/3 in asia and subsarahan Africa
how many deaths could be prevented annually with good santiation?
how many US households have septic tanks?
How much sludge does the US generate?
8 million tons a year
What is sludge used for?
~60% used for fertilizer/soil amendments
What is point source pollution?
industrial sources and wastewater treatment facilities
Who administers the National Pollutant Discharge Elimination System (NPDES) and under authority?
EPA granted by CWA
What do pristine rivers have BOD?
what is the BOD of moderate polluted rivers?
what is the BOD of treated sewage?
20 mg/l or less
What is the BOD of raw sewage?
What is anticipation in industrial hygiene?
anticipate the hazards
what is recognition in industrial hygiene?
observe and recognize various health hazards
what is evaluation in industrial hygiene?
-compare exposure to risk base
when was the OSH Act passed?
what was OSH Act predecessor?
American Conference of Governmental Industrial Hygienists (ACGIH)
How did Benzene decision shape OSHA risk legislation
must find significant health risk and that a new lower standard is “reasonably” necessary
what is significant in benzene decision?
1 in a 1000 risk reasonably signficiant
how much does OSHA receive funding per worker?
how much funding does EPA receive?
$7.1 billion or $23 per resident
What is the PEL TLV STEL ODOR and IDLH for acetic acid?
What is the hierarchy of hazard controls?
Personal Protective Equipment
how many decibels does an jet engine 100 feet have?
how many decibels does a chainsaw have?
what was the rate of fatal work injuries per 100,000 workers in 2006?
What industry has the highest rate of fatalities?
what industry has the highest death counts?
what is the most common manner of workplace fatalities?
what body part has the most injuries in workplace injuries?