The Science of the Total Environment, 47 (1985) 7-26 7

Elsevier Science Publishers B.V., Amsterdam -Printed in The Netherlands

Organic Micropollutants in Drinking Water: An Overview

Joseph A. Cotruvo, U.S. Environmental Protection Agency

Office of Drinking Water

ABSTRACT

Biological contamination is still the most significant public health

risk from drinking water even in industrialized countries. High potential
for organic chemical transport to drinking water continues to exist even
with source protection because of the multitude of chemical types and quanti-
ties. Drinking water is usually not a unique source nor the most significant
contributor to total exposure from synthetic organic chemicals but it might
be one of the most controllable.

The major public concern with drinking water contamination has been
possible contribution to cancer risks from organic micropollutants. Even
though the actual risks are probably small in most cases it is clearly within
the public interest to prevent adulteration of water supplies and to protect
their quality for the future so that these concerns or risks can be avoided.

A risk assessment/management decision model is suggested which may

assist the process of making rational assessments of these contamination
problems and control decisions that consciously consider all of the available
data in a consi.stent manner.

The U.S. Environmental Protection Agency (1) is pleased to be associated

with the Netherlands National Institute of Public Health and Environmental

Hygiene, and the Netherlands Waterworks Testing and Research Institute Ltd.

and the World Health Organization in organizing this International Symposium

on Organic Micropollutants in Drinking Water and Health. This is a subject

of immediate and continuing interest especially in industrialized countries

and among all persons and organizations that are concerned with the protec-

tion of water resources, production of drinking water, and protection of

public health.

Within the last ten years the extension of analytical detection method-

ologies to water has resulted in identification of hundreds of natural and

synthetic organic chemical constituents in rivers, lakes, groundwaters and

finished drinking waters. These techniques are now capable of detecting

some substances at parts per trillion levels. It is likely that many of

these recent detections are actually identifying contamination that has

existed for some time. The concentration of any given substance is usually

quite low (parts per billion or less), but the number and variety of substances

detected in a particular water body can be large and generally unpredictable.

Public interest lies in both the protection of the quality of the water

environment but also in protection of public health, which may be at risk

from excessive exposures to contaminants from inhalation of purged volatile

substances from water into the air, residues that may accumulate in the

fish, dermal contact with processed water, inhalation of volatiles transported

to indoor air from showering and other water uses in the home, and ultimately

from direct consumption of contaminated drinking water.

The significance of this source of contaminant exposure relative to

human health risks is not completely known, but in general it is not likely

to be large in terms of numbers of cases of disease per million persons per

lifetime, nor large relative to other risks to public health and safety.

Nevertheless there are examples of egregious water contamination that have

been associated with improper waste disposal practices. There is great

public demand to protect the quality of our water resources for the future

and to avoid the unnecessary risks that may be associated with involuntary

exposure to environmental contaminants.

As an introduction to the Symposium this paper will briefly describe

the types and sources of these organic micropollutants in drinking waters.

management and control opportunities, risk assessment issues, and some recent

ideas concerning a regulatory management decision model regarding differenti-

ation between substances based upon their possible contributions to human

cancer risks.
 9

Sources
--- of Organic Micropollutants in Drinking Water

Contamination of drinking water sources by organic micropollutants may

occur from numerous sources including: natural products, by-products of the

chemical reaction between natural products and the oxidizing agents used in

the treatment of drinking water and waste water, commercial and industrial

production and use activities, and waste disposal. (2)

Water is usually neither a unique source nor the most significant contri-

butor to human exposure to these substances, with the principal exception of

the by-products of interaction between natural products and treatment chemi-

cals. Occupational exposures to chemicals in production may be three to six

orders of magnitude greater than drinking water. Inhalation of ambient air

is a continuing and general source of exposure to halogenated and petroleum

hydrocarbons often even in rural areas. Residues of many pesticides in

foods is an exposure source for the general population.

- Natural Products in Water

These diverse and mostly unidentified components of all natural waters

to a greater or lesser degree include broad classes such as humic or fulvic

acids which are relatively refractory by-products of decomposition: tannins;

terpines; amino acids and proteins and a variety of other nitrogen and

sulfur containing substances. Because of their complexity. variety and

water solubility these are usually not identified individually but rather in

surrogate general parameters such as total organic carbon (TOC), total organic

nitrogen (TON), color, or absorbance spectra. Total concentrations range

from about 0.1 mg/l in deep groundwaters to 1 to 5 mg/l in many surface

waters and 20 to 25 mg/l in some highly colored surface and groundwaters.

10

- Treatment By-products

The most studied treatment generated products are those derived from

chlorination: however, all chemically active treatment chemicals including

ozone, chlorine dioxide, iodine and chloramines are known to produce reaction

products in water. The most familiar identified substances include chloroform

and other trihalomethanes, chlorinated and brominated acetonitriles, chloro-

picrin, halogenated phenols which often produce undesirable tastes and odors,

and numerous acids, aldehydes and ketones. Quantities that have been detected

in finished drinking water range from several hundred micrograms per liter

for trihalomethanes to a few micrograms per liter or less for most of the

other substances.

- Industrial Products

A large number of halogenated hydrocarbon solvents, aerosol propellants

and refrigerants including trichloroethylene, tetrachloroethylene, carbon

tetrachloride, methylene chloride and freons are produced worldwide at rates

of several billion kilograms per year. They tend to be the most frequently

found synthetic contaminants in drinking water because of their huge produc-

tion, highly delocalized use patterns, chemical and biological stability,

volatility, and negligible adsorption to soils and sediments. Drinking

water contamination ranging from 0.1 ug/l to several milligrams per liter

has been reported with groundwater being the most significant and recent

concern. Results of the 1982 Ground Water Supply Survey are contained in

Table I (3).

Literally hundreds of other synthetic organic chemicals have been re-

ported at least once in drinking water. Individual frequencies and concen-

trations are usually at parts per billion or less in finished drinking water.

Principal contamination potential seems to be associated with surface waters

 11

TABLE 1

surmacy of raxnd water supply survey crxlxre"ce Lata

Randan sanple, "= 466

Cuantification Positives Msdian EQximun

Limit tug/l) NLmber (USA) (Wl)

Tetrachlorcethylene 0.2 34 1.3 0.5 23

Trichlorcethylene 0.2 30 6.4 78
l,l,l-Trichloroethaw 0.2 27 5.8 t.* 18
1,2-Dichlorcethane 18 3.9 0.5 3.2
1,2-Dichloroethylenes i:: 16 3.4 1.1 2
(cis and/or trans)
Carbon tetrachloride 0.2 15 3.2 0.4 16
l,l-Dichloroethylene 9 1.9 0.3 6.3
m-xylene 0":: B 1.7 0.3 1.5
o+p-xy1ere 0.2 a 1.7 0.3 .9
ToherE 0.2 6 1.3 0.8 2.9
1,2-Dichlorcqcpane 6 1.3 0.9 21
p-Dichlorobenzene i:: 5 1.1 0.7 1.3
BPZlKJbe"ZSN 0.5 4 .9 1.8 5.8
Ethylbenzene 0.5 3 .6 0.8 1.1
Benzene 3 3 3 15
1,2-Dichlorcethane E .6 0.6
vinyl chloride 1 : 1.1 1.1 :.1
1,2-Dib-3-
chlorqropane 5 1 5.5 5.5
1,1,2-Trichloroethane 0.2 0 ----- - ------5.5 -----
1,1,1,2-~etrachlorethane 0.2 0 --- .- ----
1,1,2,2-Tetrachlorcethane 0.5 0 ------ -------- ------
ChlOKObXlZ~W 0.5 0 -------- -----
"-Prcpylbe"ZeW 0.5 0 ----- - ------ _---
o-allorotoluene 0.5 0 ----- -
p-ullorotolue"e 0.5 0 ----- - - - - - - - _

m-Dichlorobenzene 0.5 0 ----- - - - - - - _

o-Dichlorobenzane 0.5 0 -----_ - - - - - - -

styrene 0.5 0 ------- ------- - - I -

Isoprcpylbe"zene 0.5 0 ------- - - - -

12

receiving industrial discharges and groundwaters in the vicinity of waste

disposal sites.

- Petroleum Products

Water contamination from gasoline and other refined fuels and solvents

is becoming a more frequent occurrance. These include especially gasoline

and its components such as benzene, toluene and xylenes which are enriched

in non leaded gasoline, and which tend to be more highly mobile than many

other hydrocarbons in the aquerous environment. The most significant pro-

blems appear to be during transportation (spills and leaks from pipelines)

and storage. In the United States we are just beginning to assess the con-

tamination potential from Leaking Underground Storage Tanks known as LUST.

More than l,OOO,OOO underground gasoline storage tanks are in use and since

they are subject to damage from mechanical stress and corrosion the ultimate

potential for leaks and environmental contamination is great.

- Pesticides

Hundreds of pesticides totaling hundreds of millions of pounds per year

are in use worldwide. Some such as alachlor are applied above ground and

they may migrate to surface waters by runoff or by evaporation and deposition

in rainfall. Irrigation return waters can contaminate surface and groundwaters.

Some herbicides such as atrazine are highly mobile in water and are frequently

found in surface waters. Nematocides such as aldicarb, and dibromochloropropane

are being found in ground waters. Most of this water contamination appears

to be the result of uses that are currently legally acceptable rather than

from manufacturing or disposal. Until recently it was mistakenly assumed

that many of these chemicals were sufficiently biologically or chemically

degraded or immobilized in soils so that surface and groundwater contamination

would not occur. Many of those assumptions must now be reexamined.

 13

- In Situ Transformation

Biological and chemical transformations of synthetic chemicals in the

environment is a well known phenomenon (eg. DDT DDD and DDE) and often

relied upon as a detoxification process. However this is not necessarily

always the case. For example aldicarb oxidizes readily to aldicarb sulfoxide

and then to aldicarb sulfone. The sulfoxide is more toxic than the parent

and the sulfone is somewhat less toxic: all these forms are found in water.

Of more widespread interest are the recent indications that vinyl chloride,

l.l-dichloroethylene and cis and trans-1,2-dichloroethylenes when found in

groundwaters may be principally the result of degradation of higher chlori-

nated compounds such as l,l,l-trichloroethane, trichloroethylene or tetra-

chloroethylene. This would be a case of generation of a product of signifi-

cant carcinogenic risk (vinyl chloride) from less toxic precursors.

- Waste Disposal

The disposal of chemical wastes is a mounting problem in industrialized

countries. Contamination of groundwaters from improper disposal practices

has been identified as the most significant source of their present and

future contamination.

Management of Contamination

- Source Protection

The most desirable means of assuring the quality and safety of drinking

water would be to prevent contamination of source waters by potentially

harmful organic chemicals. However, source protection at a high level may

not always be possible for these substances. The problem is attributable

to the potentially large number, variety and quantity of the contaminants

14

and ubiquitous sources and uses. Some are capable of migrating to surface

waters in solution and others adsorbed to particulates. Others can migrate

to groundwater in solution or suspended but not retarded by soils.

- Water Treatment

Drinking water supplies will always need to rely on treatment processes

tailored to the potential contaminants in the source to assure the safety of

the finished water. Conventional treatment processes normally applied to

surface waters, consisting of a particulate removal stage involving coagu-

lation and filtration are reasonably effective for removal of a number of

organic chemicals that are readily bound to sediments. These may include

polynuclear aromatic hydrocarbons, polychlorinated biphenyls and some pesti-

cides such as chlordane, and even chlorinated dioxins.

Aeration technology is a highly effective technology for removal of

volatile synthetic organic chemicals, i.e. those with a high Henry's Law

constant. These include such common contaminants as trihalomethanes, benzene,

trichloroethylene and vinyl chloride. Packed tower aeration systems can be

designed and operated to routinely achieve up to 99% removal of those types

of substances.

Aeration results in transport of volatile substances from water into

the ambient air so questions could be raised on its desirability and risks

from inhalation. Both theoretical calculations and field studies have demon-

strated that except for cases of extreme groundwater contamination, aeration

results in negligible risks to persons in the vicinity. Air concentrations

decline rapidly within only a few meters from the source and initial quantities

and total loadings are very small at the same time. For example aeration of

1 million liters per day containing 100 ug/l of trichloroethylene at 99%

efficiency results in total emission of only about 100 g/day.

 15

Granular activated carbon (GAC) and to a lesser degree powdered activated

carbons (PAC) are being used increasingly in both large and small public

water systems. GAC can effectively remove many high and low molecular weight

organic chemicals that are hydrophobic. including many volatile chemicals.

The GAC must be periodically reactivated to remove accumulated chemicals and

prevent breakthrough into finished water. The performance of a GAC system

for organic chemicals is a function of numerous factors including contact

time and the type of carbon. Carbons can be produced to have particular

affinities for certain types of substances. Treatment processes can be

simulated in the laboratory using adsorption isotherms to predict the design

and expected performance of full scale treatment plants.

Numerous additional treatment techniques can be mentioned which are not

currently widely used but which may have future potential for selective use,

eg. adsorption on macroreticular resins, and oxidation with ozone and ultra-

violet light. Small point-of-use units containing GAC have been shown to be

effective in some applications for removal of organic chemicals at the con-

sumer's tap or for a household water supply. Cases exist where with effective

external management the point-of-use approach is an effective and efficient

control measure.

- Legislative Controls

Legislation and regulations to protect drinking water supplies and their

sources and to control waste disposal have been installed in many countries.

For example in the USA the Water Pollution Control Act (also called the

Clean Water Act) requires control of effluent discharges to surface waters

through both technology requirements and permits. Ambient water quality is

regulated through criteria related to ultimate use eg. agricultural or

drinking water source.

16

Prevention of groundwater contamination is regulated in the U.S.A. by

the Underground Injection Control programs of the Safe Drinking Water Act,

and the hazardous waste controls under the Resource Conservation and Recovery

Act. The Superfund program in the U.S.A. is a fund provided from a tax on

chemical products that is used to mitigate and clean sites that have been

contaminated by disposal of chemical wastes. Approximately three fourths of

these cases to date have involved actions to recover or protect current or

potential groundwater drinking water supplies.

- Drinking Water Standards and Guidelines

Drinking water standards and guidelines have been recently prepared or

updated by several international organizations and individual countries.

The European Economic Communities' Directive on drinking water quality was

proposed in 1975. The World Health Organization in 1984 published Guidelines

for Drinking Water Quality for 20 organic chemicals. A WHO guideline repre-

sents the level of a constituent that ensures an esthetically pleasing water

and does not result in any significant risk to the health of the consumer.

Canada revised its Drinking Water Guidelines in 1978 to include 21

organic chemicals and pesticides (5). It is now considering further revisions

with an expected increase in the number of organic chemicals.

The USEPA has interim regulations in effect for ten organic chemicals

including six pesticides and four trihalomethanes (6). Revised regulations

are under development for up to 60 organic chemicals with emphasis on the

volatile synthetic organic chemicals and solvents and pesticides.

- Monitoring

Monitoring for organic chemicals becomes increasingly complicated and

costly as the number of chemicals of interest increases and the detectable

levels become lower with improvements in analytical and concentration tech-

 17

niques. With this explosion in the quantity of data that can be obtained,

it is essential to pay greater attention to the quality of that data. Any

laboratory that produces such data must maintain a rigorous quality control

program, and adequately document all aspects of the analyses. Accuracy and

precision information must be part of every data report.

In addition to numerical limits for a number of organic chemicals, the

U.S.A. is also planning to institute monitoring and reporting requirements

for all public water systems in two phases. The first phase would include

up to 50 volatile synthetic organic chemicals and the second would include

an unspecified number of other synthetic organic chemicals with special

attention paid to pesticides.

In a separate action EPA's Drinking Water and Pesticide offices are now

designing a comprehensive survey of pesticides in public and private ground-

waters. This survey will study those pesticides which because of chemistry

or use pattern are suspected of migrating to groundwaters. The study to

begin in 1986 will examine the environmental conditions that affect the

migration as well as drinking water concentrations so that future pesticides

registrations will be tailored to prevent such contamination.

Risk Assessment

Having identified the sources and extent of drinking water contamination,

public health officials must determine the type and extent of the risks

involved and then make judgements on the most reasonable method for allevi-

ating the risk. These two activities are called risk assessment and risk

management, respectively.

The principal concerns raised about the contamination of drinking water

by trace amounts of synthetic organic chemicals has been the possjble increased

risk of cancer in the population. There has also been some discussion on
18

the possibility of reproductive or teratogenic risks: however these have

been generally treated as threshold effects that occur at chemical doses

that are usually higher than those received from drinking water. Public

health officials usually assume conservatively that substances which have

been shown to cause cancers in animals may operate by non threshold mechan-

isms. It then follows that some albeit small risk of cancer is theoretically

assumed to exist at any dose above zero.

Because the normal concentrations of potential "carcinogens" in drinking

water are very small, the postulated risks are largely empirically unquanti-

fiable. If they do infact exist, they are small in magnitude relative to

overall cancer risk rates.

Projections of risks from chemicals in drinking water are attempted

using two principal means: retrospective epidemiology studies of exposed

populations and surrogate toxicology studies using experimental animals.

- Epidemiology

Numerous epidemiology studies have been made on populations exposed to

organic chemical contaminants in drinking water. Most of these have examined

possible correlations between THMs or some related parameter and incidents

of cancer of various types; a few have dealt with cases of water contamination

from chemical wastes.

The earlier THM studies sometimes reported correlation between THMs and

risks of bladder cancer. Later studies have focused mainly on colon/rectal

cancer risk, although no consensus has been reached on whether these studies

have discovered a true exposure risk relationship or just fortuitous correla-

tions. The basic problem with attempting to correlate drinking water contami-

nation and cancer risks are that the theoretical risks from drinking water

are small relative to the overall cancer risks in the population, thus the
 19

confounding factors are always very difficult to distinguish and quantify.

Thus epidemiology studies have not generally been effective in helping

decision makers to qualitatively and quantitatively assess drinking water

risks from organic micropollutants.

- Animal Experimentation

Apart from those few cases (eg. vinyl chloride and benzene) where a

substance has been shown to be a human carcinogen, controlled feeding studies

(bioasays) using rats and mice exposed to high chemical doses have been the

principal means of making judgements of the likelihood that a chemical may

be carcinogenic to humans. Groups of about 50 animals per sex and dose with

suitable controls are exposed for most of their lifetimes to 2 or 3 doses of

the test chemical by food, drinking water, corn oil gavage or by inhalation.

The highest dose employed is the Maximum Tolerated dose (MTD): the highest

dose at which no other significant adverse health effect should occur. The

human risk assessment requires mathematical conversion of the dose/response

effect in the high dose animal test to the projected dose/response risk in

humans at environmental exposures.

Numerous mathematical models have been developed in attempts to estimate

potential risks to humans from low dose exposure to carcinogens; each of

them incorporates numerous unverifiable assumptions. Low dose calculations

are highly model dependent leading to widely differing risk conclusions and

none of the models can be firmly justified on either statistical or biological

grounds.

One hit and a multistage model that is linear at low doses are commonly

used among the many choices because they tend to be conservative - unlikely

to underestimate the actual risk.

A recent series of analyses has been performed which illustrates the

range of uncertainties inherent in risk calculations for a number of volatile

20

synthetic organic chemicals. These uncertainties range from the inability

to precisely estimate the exposure of the population crossection, to inter-

pretation of the scientific data, to uncertainties in the models. It was

suggested that uncertainties in the toxicological data may be in the range

of 1 to 3 orders of magnitude; uncertainties in the choice of model may

exceed 6 orders of magnitude. Figure I illustrates a comparison of 4 models

applied to the same experimental data for trichloroethylene (7).

Note that at a drinking water concentration of about 50 ug/l the pro-

jected incremental lifetime risks range from 10-g (probit) to 10-3 (Weibull).

The decision-maker must as a matter of judgement choose which model(s) to

apply, which assumptions to incorporate and which "acceptable" risk to allow.

These huge variations aptly demonstrate that these seemingly systematic and

sophisticated calculation techniques must be used with great caution and

 21

skepticism. They are, however, the only quantitative tools available at

this time.

Risk Management --Decisions

Risk management is the public process of deciding what actions to take

where risk has been determined to exist. It includes integration of risk

assessment with consideration of engineering feasibility and a determination

of how the decisionmaker may apply imperatives to reduce risk in light of

all of the legal, social, economic and political factors (8).

If a substance is considered to be carcinogenic to humans, the most

conservative control approaches must be considered, whereas if it is a thresh-

old toxicant, then an acceptable daily intake can be calculated and less

stringent controls are possible. Thus the most critical initial judgement

to be made is whether or not a sufficient body of evidence exists to treat a

substance as a carcinogen (non-threshold toxicant) for the purposes of

regulation in drinking water.

In the USA, EPA has concluded that the ideal goal for drinking water is

that no carcinogen should be present. This is called a Recommended Maximum

Contaminant Level (RMCL) which is not a legally enforceable standard. RMCL

for carcinogens would thus be zero (9). Maximum Contaminant Levels (MCLs)

are enforceable standards and they must be set as close to the RMCL as is

technically and economically feasible.

gentification of Probable Human Carcinogensc)

The following section is a decision model proposal for systematically

determining the appropriate goal level based upon health consideration. It

involves use of a ranking system for evaluation of carcinogenicity evidence

which has been developed by EPA based upon a system used by the International

Agency for Research on Cancer (IARC)( Based upon the ranking the substance
22

is placed in one of three regulatory classes and the RMCL is determined from

selection of the appropriate data base.

- IARC Classifications

IARC has provided guidelines for assessing the epidemiological and

animal toxicology data base leading to a conclusion of the strength of the

evidence of the carcinogenicity of numerous substances. Substances are

classified into three groups as follows:

IARC
----- Criteria

Group 1 - Chemical is carcinogenic to humans (sufficient evidence from

epidemiological studies).

Group 2 - Chemical is probably carcinogenic to humans.

Group 2A - At least limited evidence of carcinogenicity to humans.

Group 28 - Usually a combination of sufficient evidence in animals and

inadequate data in humans.

Group 3 - Chemical cannot be classified as to its carcinogenicity to humans.

USEPA has recently proposed a five category scheme that is an expansion

of the IARC criteria (11). The primary difference is that the IARC three

categories do not distinguish between those chemicals with "inadequate"

animal evidence of carcinogenicity and those with no evidence of carcino-

genicity.

Group A - Human carcinogen (sufficient evidence from epidemiological studies).

Group B - Probable human carcinogen.

Group Bl - At least limited evidence of carcinogenicity to humans.

Group 82 - Usually a combination of sufficient evidence in animals and

inadequate data in humans.

Group C - Possible human carcinogen (limited evidence of carcinogenicity in

animals in the absence of human data).

 23

Group D - Not classified (inadequate animal evidence of carcinogenicity).

Group E - No evidence of carcinogenicity for humans (no evidence for carcino-

genicity in at least two adequate animal tests in different species

or in both epidemiological and animal studies).

Both of these classification schemes are based upon a qualitative review

of all available evidence, including: short term tests: long term animal

studies; human data; pharmocokinetics; comparative metabolism; and structure/

activity.

After the chemicals are examined and ranked based upon the qualitative

evidence, the next step in the model process is to establish a 3 level classi-

fication for quantitative regulatory decisions as follows:

Three-Category Approach for Setting RMCLs

Category I - Known or probable human carcinogens:

Strong evidence of carcinogenicity.

o EPA Group A or Group B

o IARC Group 1, 2A or 28

Category II - Equivocal evidence of carcinogenicity.

o EPA Group C

o IARC Group 3

Category III - Non-carcinogens: Inadequate or no evidence

of carcinogenicity in animals.

o EPA Group D or E

o IARC Group 3

Category I includes those chemicals which have sufficient human or

animal evidence of carcinogenicity to warrant their control as known or

probable human carcinogens. The carcinogenicity of these compounds has not

been demonstrated to exhibit a threshold and thus it can be assumed that any

exposure could contribute some finite level of risk.

24

Category II includes those chemicals for which some limited but insuffi-

cient evidence of carcinogenicity exists from animal data. Goals should

reflect the fact that some experimental evidence of carcinogenicity in animals

has been reported although not verified.

There are two main options for obtaining a quantitative goal for these

types of chemicals. The first consists of calculations based upon non-carcin-

ogenic endpoints (ADI) according to the adequacy of the data and toxicological

principles. To account for the equivocal evidence of carcinogenicity an

additional factor could be applied (e.g., AD1 divided by a factor of 10 or

some other value). The second option consists of a calculation based upon a

lifetime risk in the range of 10-S to 10-G using a conservative method such

as the linear multi-stage model. This is intended to be protective in a

conservative manner for compounds that are not being treated as carcinogens,

but for which questions have been raised concerning potential effects.

Either option may be employed depending on the quality of the data.

The goals for Category II chemicals should be less conservative than

those for Category I chemicals and more conservative than those for Category

III chemicals and that this is reflective of the quantity and quality of the

toxicology data that are available.

Category III includes those substances with inadequate or no evidence

of carcinogenicity. Goals would be calculated based upon chronic toxicity

data using ADIs. This approach is well accepted in the scientific community

as a method for determining acceptable exposure levels for threshold toxicants.

 25

VOCs Using Three Category Regulatory Approach

Category I - Known or Probable Human Carcinogens: Strong

evidence of carcinogenicity.

Benzene
Vinyl chloride
1,24ichloroethane
Trichloroethylene

Category II - Equivocal Evidence of Carcinogenicity.

Tetrachloroethylene
l,l-Dichloroethylene

Category III - Non-Carcinogens: Inadequate or no evidence

of carcinogenicity in animals.

l,l,l-Trichloroethane
p-Dichlorobenzene

The foregoing suggested risk assessment/management decision model pro-

vides a rationale and methodology for using all of the experimental data and

reasonable judgements for control decisions on potentially harmful chemicals

in the environment. The quality and quantity of the toxicology data are

considered along with technological and economic factors.

26

REFERENCES

1. The opinions expressed in this paper are those of the author, and they
do not necessarily reflect the policies of the U.S. Environmental
Protection Agency.

2. Cotruvo, J.A., "Risk Assessment and Control Decisions for Protecting

Drinking Water Quality", working paper prepared for the International
Agency for Research on Cancer Working Group on Drinking Water and Cancer
Risks, Lyon, December 14, 1985. In press.

3. Proposed Regulations: National Primary Drinking Water Regulations; Vola-

tile Synthetic Organic Chemicals, Federal
___-- Register Vol. 49, No. 114,
June 12, 1984.

4. Guidelines for Drinking Water Quality, Vol. 1, World Health Organization,

Geneva, 1984.

5. Guidelines for Canadian Drinking Water Quality, H 48 10/1978, Canadian

Government Printing Centre, Hull, Quebec, Canada.

6. National Interim Primary Drinking Water Regulations: Vol. 44(231) pp.

68624-68705, 1979: and 1975.

7. Cothern, C.R., Coniglio, W.A. and Marcus, W.L., in Assessment of Carcino

genie Risk to the U.S. Population due to Selected Volatile Organic Com-
pounds from Drinking Water via the Ingestion, Inhalation and Dermal
Routes. Draft Report, USEPA, Officr of Drinking Water, Criteria and
Standards Division 1984.

8. Ruckelshaus William D. "Risk in a Free Society", EPA Journal, P. 12.

April 1984.

9. Proposed Regulations: National Primary Drinking Water Regulations:

Volatile Synthetic Organic Chemicals, Federal Register Vol. 49, No.
114, June 12, 1984.

10. "Evaluation of the Carcinogenic Risk of Chemicals to Humans", IARC

Monographs Supplement 4, Lyon, France pp. 1114, October 1982.

11. U.S.E.P.A. 1984, Proposed Guidelines for Carcinogen Risk Assessment;

Request for Comments Federal Register 49(227): 46294-46301