1. EVALUATING THE UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY’S
SAFE DRINKING WATER ACT:
AN ASSESSMENT ON
DI(2-ETHYLHEXYL)PHTHALATE
IN DRINKING WATER
A Q U I E R A H A L S E Y, M P H C A N D I D AT E
J E F F E R S O N S C H O O L O F
P O P U L AT I O N H E A LT H
M P H C A P S T O N E P R O J E C T
P R E S E N T AT I O N
A P R I L 1 , 2 0 1 5

2. KEYWORDS
ATSDR – Agency of Toxic Substances and Disease Registry
DEHP – Di(2-ethylhexyl)phthalate
EDC - Endocrine-Disrupting Compound
EPA – Environmental Protection Agency
EU – European Union
IARC - International Agency for Research on Cancer
MCL(G) – Maximum Contaminant Level (Goal)
MGD – Million Gallons per Day
NPDWR – National Primary Drinking Water Regulation
NPL - National Priorities List
PPB – Parts per Billion
PVC – Polyvinyl Chloride
REACH – Registration, Evaluation and Authorization of Chemicals
SDWA – Safe Drinking Water Act
TSCA – Toxic Substances Control Act

3. PROJECT GOAL
To evaluate the U.S. EPA’s SDWA in order to determine if the current MCL of
6ppb for DEHP in drinking water needs to be reassessed and lowered.

4. RESEARCH QUESTIONS
1. Does DEHP pose a significant human health risk that warrants additional
regulations under the current mandates of the SDWA?
2. Are adequate safeguards in place to limit safe exposure of DEHP in public
drinking water supplies or does the current MCL/MCLG standard need to
revised to further reduce risks?
3. Can more stringent regulation of DEHP be justified under the cost/benefit
guidelines required by the SDWA?

5. BACKGROUND
 Endocrine Disruptor
 Exogenous substance or mixture that alters the function(s) of the endocrine
system and consequently causes adverse health effects in an intact
organism, or its progeny, or (sub)populations (Snedeker, 2002)
 Found in plastics, personal care items, pharmaceuticals, and industrial
chemicals
 Exposure: ingestion, inhalation, and skin contact

6. POTENTIAL REPRODUCTIVE EFFECTS OF EDCS
Transgenerational and multigenerational effects
Cryptorchidism
 90% of boys will have normal fertility if only 1 testis is undescended at birth
Hypospadias
 Urethra forms abnormally during weeks 8–14 of pregnancy
 Opening of the urethra is on the underside of the penis, instead of at the tip
 Effects 5 boys out of every 1,000 born in the U.S. (CDC, 2014)

7. EDC: POTENTIAL BREAST CANCER RISK
(Snedeker, 2002)
 EDC exposure increases the growth of breast cancer (BCERC, 2007)

8. EDC: PHTHALATE ESTERS
 Phthalates or plasticizers – compounds made from alcohols and phthalic
anhydride (BCERC, 2007)
 Industrial chemicals added to plastics to increase pliability
 Exposures: air, soil, water, food, milk, medications and medical devices
 Bioaccumulation can occur in humans and wildlife

9. BIOACCUMULATION
Saeidnia and Abdollahi, 2013

10. DI(2-ETHYLHEXYL)PHTHALATE (DEHP)
 Introduced in 1939
 Production increased from 194 million pounds in 1975 to 397 million pounds in
2005 (NTP, 2014)
 1994, DEHP was added to EPA’s SDWA NPDWR
 Finished drinking water goal of 6ppb for MCL (enforceable limit) and 0 for
MCLG
 Exposure is based upon dose, duration and pathway

11. DEHP CHEMICAL STRUCTURE
 Formula: C24H38O4
 Diester of phthalatic acid and branded-chain 2-ethylhexanol

12. DEHP CLASSIFICATION
 In 2000, the IARC changed its classification for DEHP from “possibly
carcinogenic to humans” to “cannot be classified as a carcinogen to
humans”, because of the difference in how the livers of humans and primates
respond to DEHP as compared with the livers of rats and mice (ATSDR, 2002)
 U.S. and EU considers it a “probable human carcinogen”
 In 2011, IARC changed classification to “potentially carcinogenic”

13. DEHP IN CONSUMER GOODS
 PVC, food packing, medical devices, and surgical gloves
 Severely affects kidneys, liver, and reproductive system
 40% for medical devices, 30% for consumer goods, and 30% for
construction related applications (NTP, 2014)

14. DEHP IN THE ENVIRONMENT
Air
 Less than 3% of total U.S. domestic supply of DEHP is released to air
(ATSDR, 2002)
 Dust particles are carried back to earth through gravity, rain or snow (ATSDR,
2002)
Soil
 Sinks to sediments at bottom of water
 Found at 248 of 737 NPL sites (ATSDR, 2011)
 92% of U.S. domestic supplies are released in landfills (ATSDR, 2002)

15. DEHP IN THE ENVIRONMENT
Water
 DEHP has been found in wastewater, surface water and treatment plant
discharges
 Concentrations have been measured at 0.6 – 2,400 ppb in surface waters,
and at 0.04 – 420 ppb in ground water obtained from private wells, offsite
from landfills and facilities that use DEHP in manufacturing (ATSDR, 2002)
 Leaches when bottled water is above 75°F

16. DEHP METABOLITES
 Three DEHP metabolites: Mono-2-ethylhexyl phthalate (MEHP), Mono-(2-ethyl-
5-oxohexyl)phthalate (MEOHP) and Mono-(2-ethyl-5-hydroxyhexyl)phthalate
(MEHHP)
 65% of DEHP metabolites are excreted in urine
 2007-2009 Canadian Health Measures Survey
 5,600 Canadians ages 6-79
 2009-2011 Canadian Health Measures Survey
 6,400 Canadians ages 6-79

17. IARC 2011 STUDY
IARC, 2012

18. POPULATION AT RISK
 Pregnant and lactating mothers and patients undergoing medical procedures
 Male fetus’, male neonates, and peripubertal male children
 In 2005 EU banned the use of DEHP in children’s toys

19. DRINKING WATER REGULATIONS
 Safe Drinking Water Act (1974)
 Federal law that ensures drinking water quality
 National Primary Drinking Water Regulation
 Sets enforceable MCL for drinking water contaminants
 MCL – health based goal
 MCLG – non-enforceable goal

20. SAMPLE INTERVIEW QUESTIONS
 Is DEHP a persistent problem in drinking water?
 Which approach to the removal of DEHP yields the greatest drinking water
benefit?
 Are the three DEHP metabolites: MEHP, MEHHP, and MEOHP tested in
drinking water?
 Is DEHP significant enough to continue warranting national regulation?
 Does TSCA and REACH achieve adequate public health safeguards in applying
risk reduction strategies?

21. INTERVIEWS
Agency of Toxic Substances and Disease Registry
 Dimock site in Susquehanna, PA
Aqua America
 Consistent non-detects and GAC costs
Environmental Protection Agency
 Second Six-Year Review
 Third Six-Year Review Process for Phase V chemicals underway

22. AQUA AMERICA DEHP DETECTIONS

23. GRANULAR ACTIVATED CARBON COSTS
 1 million gallons of water can serve approximately 4,000 people daily
 Carbon is replaced every 24 months
 Philadelphia water system maximum capacity is 683 MGD (CoP, n.d.)
 4.2x larger than the 162 MGD system
Million Gallons
per Day
Process Cost System Cost
Operation &
Maintenance
Cost
0.500 MGD $127,693 $205,218 $38,037
1.000 MGD $424,944 $755,924 $103,013
10.000 MGD $1,946,151 $2,989,935 $634,150
75.072 MGD $11,347,113 $16,700,567 $4,432,122
108.104 MGD $15,793,110 $23,130,659 $6,299,662
162.000 MGD $23,130,878 $33,735,768 $8,783,318

24. POLICY ANALYSIS: TSCA (1976)
 Different approaches for handling new and existing chemicals
 Presumption of innocence
 EPA is responsible for burden of truth
 Least burdensome approach
 TSCA is ineffective in removing existing chemicals of risk from market

25. POLICY ANALYSIS: REACH (2006)
 Precautionary Principle – If effects are scientifically unknown then the product
or action should not be taken
 Data requirements are same for new and existing chemicals
 15 year DEHP risk assessment completed in 2008
 Environmental Quality Standards
 2014 - Substance of Very High Concern (European Chemicals Agency, 2014)
 Separate from industry and government decisions

26. LIMITATIONS
 Few epidemiological studies on humans due to exposure uncertainty
 Outdated risk assessments
 (ATSDR, 2002)
 Interviews with government officials

27. CONCLUSIONS
 DEHP is ubiquitous in the environment
 People are routinely exposed to DEHP from multiple sources
 Health risks associated with exposure are uncertain
 Interviewees stated DEHP is rarely detected in drinking water
 Third Six-Year Review screening in process for phthalates
 Current MCL of 6ppb is appropriate based upon Second Six-Year Review
 DEHP’s MCL for drinking water does not need to be revised

28. ACKNOWLEDGEMENTS
 Committee Chair: Richard Pepino, MSS
 Committee Preceptor: Lee Blum, PhD
 Capstone Coordinator: Nancy Chernett, MPH
 Interviewees: Lora Werner, MPH, Charles Hertz, PhD, Michael Pickle, ME,
Crystal Rodgers-Jenkins, MS and Rajiv Khera, P.E.
 Lauren Williams, M.Ed
 Family and Friends

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