EOH #

~1.5 years

million cells/months = 65,000 tons of waste

o not put anything up the stack

do not put anything in the water

o not put it anywhere else

if you put it in the ground in the past, dig it up now

if you have it you must tell us about it

if it is such bad news, do not make it in the first place

tell us how you are going to use it

combine all the env laws into one

not against my business or industry

build absolutely nothing anywhere near anything

~500

~10%

~4000 tons coal/day

~400 tons coal ash/day

~2.5 lbs/person/day

37%

8%

34%

22%

• Cross valley
• Sidehill
• Diked
• Incised

~584

109

96

• On Dec 22, 2008 coal ash dike failed
• Resulted in ash laden water covering 300 acres
• 22 evacuated
• 42 properties

30%

10%

62% lack liners

58% lack groundwater monitoring

coal ash should be regulated as a solid waste under subtitle D (not as subtitle C hazardous waste

• 1. Declare as RCRA subtitle C (except beneficial uses)
• 2. Continue as RCRA subtitle D

Chemical and animal toxicology studies

• - initial human studies assess toxicity, pK, initial efficacy
• - examine special populations (renally impaired)
• - 20 – 80 patients per study
• - $25,000 - $40,000/patient

• - small scale efficacy/safety studies
• - dose/regimen selection/optimization
• - 30 – 200 patients per study

• - rigorous controlled efficacy/safety studies
• - 100-10,000 patients per study
• - $10,000/patient

• - post-approval studies of new uses or populations
• - similar in scope to Phase 3 trials

Any substance used to diagnore, cure, mitigate, treat or prevent disease

• - 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%”

• 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

• -products for serious/life threatening diseases
• -products to meet potentially unmet medical needs

• -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
• -increased funding
• -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

• For foods, drugs, cosmetics, & medical devices
• FTC=Advertising
• FDA=Labeling

• -intended to diagnose, cure, mitigate, treat, or prevent a disease or condition
• OR
• -affects the function or structure of the body
• AND
• -does not achieve intended use through chemical action in/on body; and is not metabolized to achieve purpose

• -catheters
• -would care products
• -dental
• -implanted device

• -general controls
• -exempt from pre-marekt submission

• -performance standards
• -pre-market notifications (501K)

• -clinical data needed
• -pre-market application (PMA)

73%

22%

48 million

3000

1,344

3,323

70,000 and 1 of 15

Vibrio

9.4 million from 31 specified pathogens

38.4 million from unspecified agents

Norovirus 5.46 million

Salmonella causes the most hospitalizations 19,336

Salmonella cuases the most deaths

Infection

Intoxication

salmonella and campylobacter

systematic approach to food safety through prevention rather than inspection of the final product

• Clean
• Separate
• Cook
• Chill

~70% of earth’s surface

96.5%

1%

2.5%

2/3 of freshwater frozen in polar ice sheets

0.3% or 125,000 cubic km of H20

ground water, precipitation, run off, surface

50% of population

capture and use rain water

70,000 acres

50 gallons pdpp

toilets 15-25 gallons

2 quarts

sewage, untreated drinking water

animal manure, seasonal runoff, sewage

Cyclosporidiosis, cryptosporidiosis, amoebiasis

giardiasis and legionellosis

digging shallow tube wells

arsenic 1/3 have As levels above suggested 10ppb and some are above 1000 ppb

uses coal ash to remove arsenic from drinking water

private well and bottle water (FDA)

maximum contaminant levels and treatment techniques

non-enforceable guideline – cosmetic effects (skin or tooth) and aesthetic effects (such as taste, odor, color)

• - no adverse effect expected
• - drinking water consumption compared to RfD
• - MCLG zero for carcinogens
• - Does not consider ability to measure or treatment technology

• based on technical feasibility and cost
• set as close to MCLG as possible

Treatment Technique (TT) (lead and copper rules)

Must review at least 5 contaminants every 5 years

• -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

• trihalomethanes
• bromate
• haloacetic acids

• cheap, very effective
• produces THMs and other DBPs
• provides residual

• expensive, generated on site, very reactive
• effective
• produces bromate and other DBPs
• no residual

• generated on site, explosive, costly
• effective disinfectant, kills cryptospodium
• generates DBPs
• no residual

• usually used with another disinfectant – often to provide residual
• generates DBPs can change water properties -

1908

1.7 million

half of total mortality in citiies

75%

50 billion in US ~200 billion ww

1300

2.6 billion ppl 2/3 in asia and subsarahan Africa

2.4 million

~35%

8 million tons a year

~60% used for fertilizer/soil amendments

industrial sources and wastewater treatment facilities

EPA granted by CWA

1mg/L

2-8 mg/l

20 mg/l or less

800 mg/l

anticipate the hazards

observe and recognize various health hazards

• -exposure assessment
• -compare exposure to risk base

1970

American Conference of Governmental Industrial Hygienists (ACGIH)

must find significant health risk and that a new lower standard is “reasonably” necessary

1 in a 1000 risk reasonably signficiant

$3.35

$7.1 billion or $23 per resident

• OSHA PEL: 10
• ACGHI TLV: 10
• ACGHI STEL: 15
• Odor Tr: 2
• NIOSH IDLH: 1000

• Eliminatin
• Sustitution
• Engineering
• Administrative
• Personal Protective Equipment

30

100?

4.0

agriculture

construction

transportation (40%)

back 21.2%