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Pharmaceuticals and Personal Pharmaceuticals and Personal Care ProductsCare Products
Literature Review, Treatment Technologies, Research Literature Review, Treatment Technologies, Research and Regulatory Process and Regulatory Process
MWEA IPP SeminarMWEA IPP SeminarOctober 15, 2009October 15, 2009
Rich Grant, P.E. Rich Grant, P.E. –– Fleis & VandenBrink EngineeringFleis & VandenBrink Engineering
Brian Rice, P.E. Brian Rice, P.E. –– Fleis & VandenBrink EngineeringFleis & VandenBrink Engineering
[email protected]@fveng.com [email protected]@fveng.com
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory
Process
Conclusions
•• Initial need for dataInitial need for data
•• Wastewater treatment plantsWastewater treatment plants
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
• Interest
• PPCP/EDC
• Sources & Occurrence
Example
Compounds Wastewater treatment plantsWastewater treatment plants
•• Risk assessment / ToxicologyRisk assessment / Toxicology
•• Increased microbial resistance to Increased microbial resistance to antibioticsantibiotics
p
Research
Treatment
Regulatory
Process
Conclusions
2
PPCPPPCPs = s = PPharmaceuticals &harmaceuticals &
PPersonal ersonal CCare are PProductsroducts
AntibioticsAntibiotics FragrancesFragrances
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Interest
PPCP/EDC
Sources & Occurrence
Example
Compounds AntibioticsAntibiotics AntiAnti--inflammatory inflammatory
medicines medicines Antiepileptic medicinesAntiepileptic medicines Blood lipid regulatorsBlood lipid regulators Cough syrupCough syrup
FragrancesFragrances
HormonesHormones
Pain medicationPain medication
XX--ray contrast ray contrast mediamedia
p
Research
Treatment
Regulatory
Process
Conclusions
EDCEDCs = s = EEndocrine ndocrine DDisrupting isrupting CCompoundsompounds
•• PesticidesPesticides•• OrganohalogensOrganohalogens•• AlkyphenolsAlkyphenols•• Heavy metalsHeavy metals•• OrganotinsOrganotins•• PhthalatesPhthalates
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Interest
PPCP/EDC
Sources & Occurrence
Example
Compounds
•• Natural HormonesNatural Hormones
•• PharmaceuticalsPharmaceuticals
•• Phytoestrogens Phytoestrogens
•• PhenolsPhenols
•• Aromatic hydrocarbonsAromatic hydrocarbons
p
Research
Treatment
Regulatory
Process
Conclusions
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Interest
PPCP/EDC
Sources & Occurrence
Example
Compoundsp
Research
Treatment
Regulatory
Process
Conclusions
3
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Analytes
Dose –
Human
Analgesics Acetaminophen
Ibuprofen
Codeine
Lipid Regulators Clofibric Acid
Gemfibrozil
Antibiotics
Steroids 17b-estradiol
17a-ethinylestradiol
Estrone
Estriol
Coprostanol
Cholesterol
-adrenergic Blockers Atenolol
Research
Treatment
Regulatory
Process
Conclusions
Antibiotics Trimethoprim
Sulfamethoxazole
Lincomycin
Tylosin
Antidepressants Fluoxetine
Norfluoxetine
Atenolol
Metoprolol
Propranolol
Stimulants Caffeine
Antiepileptics Carbamazepine
•• AA “Dose” of Perspective
• Accomplish 200 mg/D Ibuprofen with 150 MGD water
• A “Sip” (synergic impact of some EDCs at lower doses)
• Consider - Potency at Low Dose
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Analytes
Dose –
Human
• Consider - Potency at Low Dose– Bioaccumulative, persistent
(PBC, THFs, DDT, etc)– Immunity build-up (antibiotics)– Designed for low-dose potency
(atrazines, triazines)
Research
Treatment
Regulatory
Process
Conclusions
USGS National USGS National Reconnaissance StudyReconnaissance Study
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
4
PPCPs/EDCs in MichiganPPCPs/EDCs in MichiganPharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
Water Cycle:Mean Concentrations - PPCPs
100.000
Huron River
Drinking Water
Wastewater Influent
Wastewater Effluent
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
•• 44--Season SamplingSeason Sampling
•• Lakes and RiversLakes and Rivers
•• SimilarSimilar
0.001
0.010
0.100
1.000
10.000
Sulfam
ethox
azole
Linco
myc
in
Tylosin
Trimet
hoprim
Aceta
mino
phen
Carbam
azepine
Ibup
rofe
n
Caffeine
Cotinin
e
1,4
Dioxan
e
Co
nc
en
tra
tio
n (
pp
b) Water Cycle:
Mean Concentrations - Hormones and Steroids
0.001
0.010
0.100
1.000
10.000
100.000
1000.000
Stigm
aste
rol
Sitoste
rol
Stigm
asta
nol
Copro
stano
l
Chole
stero
l
Dihydro
chloe
stero
l
Co
nc
en
tra
tio
n (
pp
b)
Huron River
Drinking Water
Wastewater Influent
Wastewater Effluent
Treatment
Regulatory
Process
Conclusions
Water Treatment ProcessWater Treatment ProcessAnn Ann ArborArbor Grand Grand RapidsRapids MonroeMonroe
Lime Lime SofteningSoftening
ClarifierClarifier
OzoneOzone
FlocculationFlocculation//SedimentationSedimentation
Rapid Rapid MixMix
Source Source WaterWater
FiltrationFiltration
Distribution Distribution SystemSystem
Final Final TreatmentTreatmentChloraminesChloramines
Final Final TreatmentTreatmentFree ChlorineFree Chlorine
Sand Sand FiltrationFiltrationGAC GAC FiltrationFiltration
OzoneOzone
Final Final TreatmentTreatmentFree Free ChlorineChlorine
SedimentationSedimentationSedimentationSedimentation
5
3
1 1
25
30
35
40
45
50
55
60
Co
nce
ntr
atio
n (
pp
t)
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
24
4 1 1 1
3
2
3
33
11 1
6
6
3
1
0
5
10
15
20
Mea
n
Antibio
tics
Antidep
ress
ants
Antiepil
eptic
s
Analgesics
Beta Blo
ckers
Lipid R
egulat
ors
Steroid
s
Stimulan
ts
Ann ArborGrand RapidsMonroe
Treatment
Regulatory
Process
Conclusions
Drinking WaterDrinking Water
25
30
35
40
45
50
55
60
on
cen
trat
ion
(p
pt)
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
1 1 1 11
66 3
11
10
5
10
15
20
Mea
n C
o
Antibio
tics
Antidep
ress
ants
Antiepi
leptic
s
Analges
ics
Beta B
lock
ers
Lipid
Reg
ulato
rs
Stero
ids
Stimula
nts
Ann ArborGrand RapidsMonroe
Treatment
Regulatory
Process
Conclusions
Water Treatment RemovalWater Treatment Removal
40%
50%
60%
70%
80%
90%
100%
rcen
t R
emo
val
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
0%
10%
20%
30%
Per
Antibio
tics
Antidep
ressa
nts
Antiepile
ptics
Analgesic
s
Beta B
lock
ers
Lipid
Reg
ulato
rs
Stero
ids
Stimula
nts
Ann ArborGrand RapidsMonroe
Treatment
Regulatory
Process
Conclusions
6
Surface/Ground Water InteractionSurface/Ground Water Interaction
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
Helena Valley Ground Water: Pharmaceuticals, Personal Care Products, Endocrine Disruptors (PPCPs) and Microbial Indicators of Fecal Contamination
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwaterof Fecal Contamination
Kathleen (Kate) J. Miller and Joseph Meek, both of the Montana Department of Environmental Quality, 2005
Treatment
Regulatory
Process
Conclusions
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
7
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
•32 of 38 PPCP analytes detected in GW•Sulfamethoxazole (SMX) 80%•Atrazine 40%
Treatment
Regulatory
Process
Conclusions
• High Density = 300 septic systems /mi2
• Moderate Density = 50 - 300 septic systems /mi2
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
8
• Occurrence and Fate of Pharmaceuticals and Personal Care Products in Groundwater Environments, EPA funded research by Stony Brook University, 2005
• Distribution of PPCPs
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
• Migration of PPCPs Treatment
Regulatory
Process
Conclusions
• Upper drift aquifer on Long Island, New York
• 18 sampling sites
• Septic tank plume
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
Treatment
Regulatory
Process
Conclusions
• Some pharmaceuticals detected in GW from drainfield plume
• Sorption and migration
• Drainfield is not the end to
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Surface Water
Groundwater
migration of PPCPs, EDCs Treatment
Regulatory
Process
Conclusions
9
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Drinking Water
Regulatory
Process
Conclusions
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Wastewater
• Goals - halt, minimize
Contamination by Pass-Through
Biosolids Contamination
DestructionDestruction
vsvsWastewater
Pass Thru
Biosolids
Treatment
Drinking Water
Regulatory
Process
Conclusions
RemovalRemoval
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t t
Physical, BioChemicalTreatment
WWTP WWTP Sorption Removal and Pass ThroughSorption Removal and Pass Through
BiosolidsBiosolids impactimpact
Limited BiodegradationLimited Biodegradation
Wastewater
Pass Thru
Biosolids
Treatment
Drinking Water
Regulatory
Process
Conclusions
10
WHAT WORKS?
Recent Studies:
“REDUCTION OF EMERGING CONTAMINANTS THROUGH CONVENTIONAL ANDADVANCED WASTEWATER TREATMENT PROCESSES”Joan Oppenheimer, Roger Stephenson, Samer Adham, James DeCarolis 2007
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Pass Thru
Biosolids
Treatment
Drinking Water
Regulatory
Process
Conclusions
• Six full-scale treatment facilities
• Twenty target PPCPs
• Percentage removal of each compound versus the solids retention time (SRT)
• Benchmark: SRT80%
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Pass Thru
Biosolids
Treatment
Drinking Water
Regulatory
Process
Conclusions
SO… WHAT WORKS?
AWWA Research Foundation (AWWARF)
R l f EDC d Ph ti l
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t t Removal of EDCs and Pharmaceuticals in Drinking Water and Reuse Treatment Processes, 2007
Wastewater
Drinking Water
Regulatory
Process
Conclusions
11
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t t
RECENT FINDINGS
-“SRT80%” not achievable for most compounds
Best biological removal performance noted with nitrification/denitrification system
Wastewater
Pass Thru
Biosolids
Treatment
Drinking Water
Regulatory
Process
Conclusions
-Microfiltration reverse osmosis (MF/RO)Optimal Removal, little/no destruction, high $
OBSERVATIONS
1) Bio-sorption
2) Advanced Oxidation
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t t 70%
80%
90%
100%
Wastewater
Pass Thru
Biosolids
Treatment
Drinking Water
Regulatory
Process
Conclusions
0%
10%
20%
30%
40%
50%
60%
70%
Per
cen
t R
emo
val
Ann Arbor
Grand Rapids
•Free chlorinePharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Drinking Water
Regulatory
Process
Conclusions
12
•Free chlorine•Ozone
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Drinking Water
Regulatory
Process
Conclusions
•Free chlorine•Ozone•Ultraviolet irradiation
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Drinking Water
Regulatory
Process
Conclusions
•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Drinking Water
Regulatory
Process
Conclusions
13
•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation•Activated Carbon
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t tWastewater
Drinking Water
Regulatory
Process
Conclusions
•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation•Activated CarbonR O i
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t t •Reverse OsmosisWastewater
Drinking Water
Regulatory
Process
Conclusions
•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation•Activated CarbonR O i
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
W t t •Reverse Osmosis•Biological Removal
Wastewater
Drinking Water
Regulatory
Process
Conclusions
14
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory ProcessEndocrine Disruptor Screening Program Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA.
$2.85 to $6 billion to fully screen EDC chemicals
Regulatory
Process
Regulate
Manage
Future
Conclusions
EDC chemicals(University of Minnesota, 2004)
If a substance is found to have an endocrine effect on humans, FFDCA section 408(p)(6) directs the Administrator to take action under available statutory authority to ensure protection of public health.
Should We Regulate Should We Regulate a Specific Chemical?a Specific Chemical?
Persistent and/or bioaccumulative?
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Evidence of antibiotic resistance?
Evidence of endocrine disruption?
Potential for allergic reactions?
Risks to environment, human health?
Regulatory
Process
Regulate
Manage
Future
Conclusions
Likely Regulatory TargetsLikely Regulatory Targets
Cardiovascular agents
Anxiolytic sedatives
hypnotics & antipsychotics
Gastrointestinal meds
Antivirals Based on combination of:
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Corticosteroids Based on combination of:
– Predicted relative
clinical dose
– Log Kow
– Removal in WWTPs
– Number of compounds
in class
Daphnid > Fish > Algae
- Sanderson et al., 2004
Regulatory
Process
Regulate
Manage
Future
Conclusions
15
What is happening now?What is happening now?
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory
Process
Regulate
Manage
Future
Conclusions
What is What is REALLY REALLY happening now?happening now?
“Potential Releases of Unused Medicines In Landfill Leachate”
Lial Tischler, Tischler/Kocurek, Virginia Cunningham, Doug Finan GSK, Mary Buzby, Merck & Co., Inc. Neil Parke, Eli Lilly & Co., Inc.
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory
Process
Regulate
Manage
Future
Conclusions
What is What is REALLY REALLY happening now?happening now?
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Direct Disposal (Toilet/Landfill)
Regulatory
Process
Regulate
Manage
Future
Conclusions
Trash
Flush
Store
16
CONSIDER THIS QUOTE:
“Landfill disposal of unused medicines will result in much lower surface water discharges of pharmaceutical active ingredients than flushing unused medicines to sewers.”
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
WHENconsidering the 20% or so that is not excreted
Regulatory
Process
Regulate
Manage
Future
Conclusions
Landfill Disposal of Unused Medicines Gaining Momentum & Publicity
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory
Process
Regulate
Manage
Future
Conclusions
PPCPs, PPCPs, EDCs, EDCs, SurvivalSurvival
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Biosolids to Biosolids to Landfill? Landfill?
Regulatory
Process
Conclusions
17
Historical Historical EPA methodsEPA methods
EDCs lowEDCs low--dose activitydose activity
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory
Process
Conclusions
Previous work missed EDC impacts
Ecologically, which is appropriate? “Innocent until proven guilty”
vs.
“U f til S f ”
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
“Unsafe until proven Safe”
87,000 compounds
Current tracking
Regulatory
Process
Conclusions
Need: ControlNeed: Control
Unacceptable discharge = Unacceptable discharge = unmanageable riskunmanageable risk
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Regulatory
Process
Conclusions
18
Pharmaceuticals& Personal CareProducts (PPCPs)
Background
Example Compounds
Research
Treatment
Necessary: 5Necessary: 5--10 10 year plans.year plans.
ConsiderConsider Efforts to Optimize EDC Efforts to Optimize EDC & PPCP & PPCP Destruction Destruction at the at the POTWPOTW
Consider AlsoConsider Also at Water Treatmentat Water Treatment Regulatory
Process
Conclusions
Consider Also Consider Also at Water Treatment at Water Treatment FacilitiesFacilities
AOP Upgradable?AOP Upgradable?
Pharmaceuticals and Personal Pharmaceuticals and Personal Care ProductsCare Products
Literature Review, Treatment Technologies, Research Literature Review, Treatment Technologies, Research and Regulatory Process and Regulatory Process
MWEA IPP SeminarMWEA IPP SeminarOctober 15, 2009October 15, 2009
Rich Grant, P.E. Rich Grant, P.E. –– Fleis & VandenBrink EngineeringFleis & VandenBrink Engineering
Brian Rice, P.E. Brian Rice, P.E. –– Fleis & VandenBrink EngineeringFleis & VandenBrink Engineering
[email protected]@fveng.com [email protected]@fveng.com
800.494.5202 or 616.977.1000800.494.5202 or 616.977.1000