pharmaceuticals and personal care products - mi-wea.org rice f v eng ipp 091015.pdf · •...

1

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 Fleis & VandenBrink EngineeringEngineering

Brian Rice, Brian Rice, P.E. P.E. –– Fleis & VandenBrink EngineeringFleis & VandenBrink Engineering

[email protected]@fveng.com [email protected]@fveng.com

Pharmaceuticals& Personal CareProducts (PPCPs)

Background

Example Compounds

Research

Treatment

RegulatoryProcess

Conclusions

•• Initial need for dataInitial need for data

•• Wastewater treatment plantsWastewater treatment plants


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

RegulatoryProcess

Conclusions

2

PPCPPPCPs = s = PPharmaceuticals &harmaceuticals &PPersonal ersonal CCare are PProductsroducts

AntibioticsAntibiotics FragrancesFragrances


BackgroundInterestPPCP/EDCSources & Occurrence

Example Compounds AntibioticsAntibiotics

AntiAnti--inflammatory inflammatory medicines medicines Antiepileptic medicinesAntiepileptic medicinesBlood lipid regulatorsBlood lipid regulatorsCough syrupCough syrup

FragrancesFragrancesHormonesHormonesPain medicationPain medicationXX--ray contrast ray contrast mediamedia

p

Research

Treatment

RegulatoryProcess

Conclusions

EDCEDCs = s = EEndocrine ndocrine DDisrupting isrupting CCompoundsompounds

•• PesticidesPesticides•• OrganohalogensOrganohalogens•• AlkyphenolsAlkyphenols•• Heavy metalsHeavy metals•• OrganotinsOrganotins•• PhthalatesPhthalates



Example Compounds

•• Natural HormonesNatural Hormones•• PharmaceuticalsPharmaceuticals•• Phytoestrogens Phytoestrogens •• PhenolsPhenols•• Aromatic hydrocarbonsAromatic hydrocarbons

p

Research

Treatment

RegulatoryProcess

Conclusions



Example Compoundsp

Research

Treatment

RegulatoryProcess

Conclusions

3


Background

Example Compounds

AnalytesDose –Human

AnalgesicsAcetaminophenIbuprofenCodeine

Lipid RegulatorsClofibric AcidGemfibrozil

Antibiotics

Steroids17b-estradiol17a-ethinylestradiolEstroneEstriolCoprostanolCholesterol

β-adrenergic BlockersAtenolol

Research

Treatment

RegulatoryProcess

Conclusions

AntibioticsTrimethoprimSulfamethoxazoleLincomycinTylosin

AntidepressantsFluoxetineNorfluoxetine

AtenololMetoprololPropranolol

StimulantsCaffeine

AntiepilepticsCarbamazepine

•• 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


Background

Example Compounds

AnalytesDose –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

RegulatoryProcess

Conclusions

USGS National USGS National Reconnaissance StudyReconnaissance Study


Background

Example Compounds

ResearchSurface WaterGroundwater

Treatment

RegulatoryProcess

Conclusions

4

PPCPs/EDCs in MichiganPPCPs/EDCs in MichiganPharmaceuticals& Personal CareProducts (PPCPs)

Background

Example Compounds


Treatment

RegulatoryProcess

Conclusions

Water Cycle:Mean Concentrations - PPCPs

100.000

Huron RiverDrinking WaterWastewater InfluentWastewater Effluent


Background

Example Compounds


•• 44--Season SamplingSeason Sampling

•• Lakes and RiversLakes and Rivers

•• SimilarSimilar

0.001

0.010

0.100

1.000

10.000

Sulfameth

oxazo

le

Linco

mycin

Tylosin

Trimeth

oprim

Acetam

inoph

en

Carbamazep

ine

Ibupro

fen

Caffeine

Cotinine

1,4 Diox

ane

Con

cent

ratio

n (p

pb) Water Cycle:

Mean Concentrations - Hormones and Steroids

0.001

0.010

0.100

1.000

10.000

100.000

1000.000

Stigmas

terol

Sitoste

rol

Stigmas

tanol

Copro

stano

l

Choles

terol

Dihydroc

hloeste

rol

Con

cent

ratio

n (p

pb)

Huron River

Drinking Water

Wastewater Influent

Wastewater Effluent

Treatment

RegulatoryProcess

Conclusions

Surface/Ground Water InteractionSurface/Ground Water InteractionPharmaceuticals& Personal CareProducts (PPCPs)

Background

Example Compounds


Treatment

RegulatoryProcess

Conclusions

5

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

3

1 1

25

30

35

40

45

50

55

60

Con

cent

ratio

n (p

pt)


Background

Example Compounds


24

4 1 1 1

3

2

3

33

1 1 16

6

31

0

5

10

15

20

Mea

n

Antibiotic

s

Antidep

ressants

Antiepil

eptic

s

Analgesics

Beta Block

ers

Lipid Regulat

ors

Steroids

Stimulan

ts

Ann ArborGrand RapidsMonroe

Treatment

RegulatoryProcess

Conclusions

Drinking WaterDrinking Water

25

30

35

40

45

50

55

60

once

ntra

tion

(ppt

)


Background

Example Compounds

Research

TreatmentW t t

1 1 1 11

66 3

11

10

5

10

15

20

Mea

n C

o

Antibiotic

s

Antidep

ressan

ts

Antiepil

eptic

s

Analgesics

Beta Block

ers

Lipid Regulat

ors

Steroids

Stimulan

ts


WastewaterDrinking Water

RegulatoryProcess

Conclusions

6

Water Treatment RemovalWater Treatment Removal

40%

50%

60%

70%

80%

90%

100%

rcen

t Rem

oval


Background

Example Compounds

Research

TreatmentW t t

0%

10%

20%

30%

Per

Antibiotic

s

Antidep

ressants

Antiepile

ptics

Analgesics

Beta Block

ers

Lipid Regulators

Steroids

Stimulan

ts



RegulatoryProcess

Conclusions

Helena Valley Ground Water: Pharmaceuticals, Personal Care Products, Endocrine Disruptors (PPCPs) and Microbial Indicators of Fecal Contamination


Background

Example Compounds

ResearchSurface WaterGroundwater of Fecal Contamination

Kathleen (Kate) J. Miller and Joseph Meek, both of the Montana Department of Environmental Quality, 2005

Treatment

RegulatoryProcess

Conclusions


Background

Example Compounds


Treatment

RegulatoryProcess

Conclusions

7


Background

Example Compounds


•32 of 38 PPCP analytes detected in GW•Sulfamethoxazole (SMX) 80%•Atrazine 40%

Treatment

RegulatoryProcess

Conclusions

• High Density = 300 septic systems /mi2

• Moderate Density = 50 - 300 septic systems /mi2


Background

Example Compounds


Treatment

RegulatoryProcess

Conclusions


Background

Example Compounds


Treatment

RegulatoryProcess

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


Background

Example Compounds


• Migration of PPCPsTreatment

RegulatoryProcess

Conclusions

• Upper drift aquifer on Long Island, New York

• 18 sampling sites

• Septic tank plume


Background

Example Compounds


Treatment

RegulatoryProcess

Conclusions

• Some pharmaceuticals detected in GW from drainfield plume

• Sorption and migration

• Drainfield is not the end to


Background

Example Compounds


migration of PPCPs, EDCsTreatment

RegulatoryProcess

Conclusions

9


Background

Example Compounds

Research

TreatmentW t tWastewaterDrinking Water

RegulatoryProcess

Conclusions


Background

Example Compounds

Research

TreatmentWastewater

• Goals - halt, minimize

Contamination by Pass-Through

Biosolids Contamination

DestructionDestruction

vsvsWastewaterPass ThruBiosolidsTreatment

Drinking Water

RegulatoryProcessConclusions

RemovalRemoval


Background

Example Compounds

Research

TreatmentW t t

Physical, BioChemicalTreatment

WWTP WWTP Sorption Removal and Pass ThroughSorption Removal and Pass Through

BiosolidsBiosolids impactimpact

Limited BiodegradationLimited Biodegradation

WastewaterPass ThruBiosolidsTreatment

Drinking Water


10

WHAT WORKS?

Recent Studies:

“REDUCTION OF EMERGING CONTAMINANTS THROUGH CONVENTIONAL ANDADVANCED WASTEWATER TREATMENT PROCESSES”Joan Oppenheimer, Roger Stephenson, Samer Adham, James DeCarolis 2007


Background

Example Compounds

Research

TreatmentW t tWastewaterPass ThruBiosolidsTreatment

Drinking Water


• Six full-scale treatment facilities

• Twenty target PPCPs

• Percentage removal of each compound versus the solids retention time (SRT)

• Benchmark: SRT80%


Background

Example Compounds

Research

TreatmentW t tWastewaterPass ThruBiosolidsTreatment

Drinking Water


SO… WHAT WORKS?

AWWA Research Foundation (AWWARF)

R l f EDC d Ph ti l


Background

Example Compounds

Research

TreatmentW t t Removal of EDCs and Pharmaceuticals

in Drinking Water and Reuse Treatment Processes, 2007


RegulatoryProcess

Conclusions

11


Background

Example Compounds

Research

TreatmentW t t

RECENT FINDINGS

-“SRT80%” not achievable for most compounds

Best biological removal performance noted with nitrification/denitrification system


Drinking Water


-Microfiltration reverse osmosis (MF/RO)Optimal Removal, little/no destruction, high $

OBSERVATIONS

1) Bio-sorption

2) Advanced Oxidation


Background

Example Compounds

Research

TreatmentW t t 70%

80%

90%

100%


Drinking Water


0%

10%

20%

30%

40%

50%

60%

70%

Perc

ent R

emov

al

Ann Arbor

Grand Rapids

•Free chlorinePharmaceuticals& Personal CareProducts (PPCPs)

Background

Example Compounds

Research


RegulatoryProcess

Conclusions

12

•Free chlorine•Ozone


Background

Example Compounds

Research


RegulatoryProcess

Conclusions

•Free chlorine•Ozone•Ultraviolet irradiation


Background

Example Compounds

Research


RegulatoryProcess

Conclusions

•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation


Background

Example Compounds

Research


RegulatoryProcess

Conclusions

13

•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation•Activated Carbon


Background

Example Compounds

Research


RegulatoryProcess

Conclusions

•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation•Activated CarbonR O i


Background

Example Compounds

Research

TreatmentW t t •Reverse OsmosisWastewaterDrinking Water

RegulatoryProcess

Conclusions

•Free chlorine•Ozone•Ultraviolet Disinfection•Advanced Oxidation•Activated CarbonR O i


Background

Example Compounds

Research

TreatmentW t t •Reverse Osmosis

•Biological RemovalWastewaterDrinking Water

RegulatoryProcess

Conclusions

14


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

RegulatoryProcess

RegulateManageFuture

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 a Specific Chemical?Chemical?

Persistent and/or bioaccumulative?


Background

Example Compounds

Research

Treatment

Evidence of antibiotic resistance? Evidence of endocrine disruption?Potential for allergic reactions?Risks to environment, human health?

RegulatoryProcess


Conclusions

Likely Regulatory TargetsLikely Regulatory TargetsCardiovascular agentsAnxiolytic sedatives hypnotics & antipsychoticsGastrointestinal medsAntivirals Based on combination of:


Background

Example Compounds

Research

Treatment

CorticosteroidsBased on combination of:– Predicted relative

clinical dose– Log Kow– Removal in WWTPs– Number of compounds

in classDaphnid > Fish > Algae

- Sanderson et al., 2004

RegulatoryProcess


Conclusions

15

What is happening now?What is happening now?


Background

Example Compounds

Research

Treatment

RegulatoryProcess


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.


Background

Example Compounds

Research

Treatment

RegulatoryProcess


Conclusions

What is What is REALLY REALLY happening now?happening now?


Background

Example Compounds

Research

Treatment

Direct Disposal (Toilet/Landfill)

RegulatoryProcess


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.”


Background

Example Compounds

Research

Treatment

WHENconsidering the 20% or so that is not excreted

RegulatoryProcess


Conclusions

Landfill Disposal of Unused Medicines Gaining Momentum & Publicity


Background

Example Compounds

Research

Treatment

RegulatoryProcess


Conclusions

PPCPs, PPCPs, EDCs, EDCs, SurvivalSurvival


Background

Example Compounds

Research

Treatment

Biosolids to Biosolids to Landfill? Landfill?

RegulatoryProcess

Conclusions

17

Historical Historical EPA methodsEPA methods

EDCs lowEDCs low--dose activitydose activity


Background

Example Compounds

Research

Treatment

RegulatoryProcess

Conclusions

Previous work missed EDC impacts

Ecologically, which is appropriate? “Innocent until proven guilty”

vs. “U f til S f ”


Background

Example Compounds

Research

Treatment

“Unsafe until proven Safe”

87,000 compounds

Current tracking

RegulatoryProcess

Conclusions

Need: ControlNeed: Control

Unacceptable discharge = Unacceptable discharge = unmanageable riskunmanageable risk


Background

Example Compounds

Research

Treatment

RegulatoryProcess

Conclusions

18


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 TreatmentRegulatoryProcess

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 MWEA IPP SeminarIPP 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

pharmaceuticals and personal care products - mi-wea.org rice f v eng ipp 091015.pdf · •...

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