United States
Environmental Protection
Agency
Office of Research and
Development
Washington, DC 20460
EPA 600 9-90 034
June 1990
&EPA
The Role of Health
Research in Support of
EPA's Regulatory Programs
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EPA/600'9-90'034
The Role of Health
Research in Support of
EPA's Regulatory Programs
June 1990
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NOTICE
This report has been reviewed by the U.S. Environmental Protection Agency and approved for publication. Mention
of trade names or commercial products does not constitute endorsement or recommendation for use.
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FOREWORD
Protection of public health from the adverse consequen-
ces of environmental pollution is a major responsibility
of the Environmental Protection Agency (EPA). Most of
the laws and regulations under EPA's purview are aimed
expressly at safeguarding the nation's environmental
health. The basis for promulgating environmental laws
and for related public policy decisions is based in large
part on scientific evidence of a link between pollution
sources, environmental exposures, and human health
effects.
The field of environmental health sciences has
progressed steadily since 1970 when EPA was formed.
Although our understanding of the health effects as-
sociated with specific pollutants has improved dramati-
cally, as for example with ozone, asbestos, lead, and
dioxin, for a broad array of chemicals there is an inade-
quate scientific data base by which to evaluate health
risks. As a result, EPA decisionmakers are often faced
with a dilemma; how to judge whether actions to reduce
public health risks are appropriate, given that the costs
of such actions are relatively well known, while the
benefits--in terms of decreased morbidity or mortality--
are ambiguous.
Informed public policy choices must be grounded firmly
in scientific facts that elucidate the relationships among
pollution sources, human exposures, and adverse health
consequences. The purpose of this document is to
highlight the ongoing role of environmental health re-
search in support of EPA's regulatory programs. It sum-
marizes the key legislation, emphasizing the uses of
health research, and identifies the most important re-
search needs for each Program Office. The document
was written to show the key role played by environmental
health research in EPA's regulatory activities and to point
out that certain research needs are common across all
programs. We hope that you will find the information
presented here to be useful in understanding the
relevance of EPA's health research program.
Ken Sexton, Sc.D.
Director
Office of Heatlh Research
in
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Table of Contents
Pago
NOTICE ii
FOREWORD iii
LIST OF TABLES ix
LIST OF FIGURES x
SECTION ONE INTRODUCTION 1
SECTION TWO AIR QUALITY PROGRAM 3
2.1 Program Description 3
2.1.1 Introduction to Statute and Overview of
the Program Area 3
2.1.2 Clean Air Act Standards 3
2.1.3 Indoor Air , 11
2.1.4 Air Pollution Problems of Regional and Global Significance 11
2.1.5 Radiation Programs 12
2.2 Program Organization 12
2.2.1 Development of National Ambient Air Quality Standards 13
2.2.2 Development of NESHAPs 13
2.2.3 Development of Radiation Standards 15
2.3 Health Research Needs 15
2.3.1 Introduction 15
2.3.2 Major Research Categories 15
2.3.3 Cross-Cutting Categories 17
2.3.4 Emerging Research Needs 18
2.3.5 Summary 18
SECTION THREE DRINKING WATER PROGRAM 19
3.1 Program Description 19
3.1.1 Introduction to the Statute and Overview of the
Program Area 19
3.1.2 The Regulated Public and Contaminants 19
3.1.3 Establishing MCLGs and MCLs 20
3.1.4 The Underground Injection Control Program 21
3.1.5 Other Program Components 22
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3.2 Program Organization 23
3.2.1 Organization of the Office of Drinking Water 23
3.2.2 Setting MCLGs 23
3.2.3 Developing Health Advisories (HAs) 24
3.2.4 Proposing and Promulgating MCLs 24
3.3 Health Research Needs 24
3.3.1 Introduction 24
3.3.2 Major Research Categories 25
3.3.3 Cross-Cutting Categories 25
3.3.4 Emerging Research Needs 26
3.3.5 Summary 26
SECTION FOUR WATER QUALITY PROGRAM 27
4.1 Program Description 27
4.1.1 Introduction to Statute and Overview of the
Program Area 27
4.1.2 Scope and Coverage of the Clean Water Act 27
4.1.3 Ambient Water Quality Criteria and Standards 29
4.1.4 Control of Pollution Sources 30
4.1.5 Sewage Treatment Plant Programs 32
4.1.6 Other Clean Water Act Programs 33
4.2 Program Organization 33
4.2.1 Development of Water Quality Criteria 34
4.2.2 Development of Sludge Disposal Criteria 34
4.2.3 NPDES Permitting 35
4.3 Health Research Needs 35
4.3.1 Introduction 35
4.3.2 Major Research Categories 36
4.3.3 Cross-Cutting Categories 36
4.3.4 Emerging Research Needs 37
4.3.5 Summary 37
SECTION FIVE THE PESTICIDE PROGRAM 39
5.1 Program Description 39
5.1.1 Introduction to Statute and Overview of the
Program Area 39
5.1.2 Coverage of the Pesticide Program 39
5.1.3 Registration of Pesticides 40
5.1.4 Reregistration of Existing Pesticides 42
5.1.5 Special Review, Cancellation, and Suspension 43
5.1.6 Ongoing Regulation and Monitoring of Pesticide
Use by EPA and the States 43
VI
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5.2 Program Organization 44
5.2.1 New Product Registration 45
5.2.2 Reregistration 45
5.2.3 Special Review 46
5.2.4 Development of Test Methods 46
5.3 Health Research Needs 47
5.3.1 Introduction 47
5.3.2 Major Research Categories 47
5.3.3 Cross-Cutting Categories 48
5.3.4 Emerging Research Needs 48
5.3.5 Summary 48
SECTION SIX THE TOXIC SUBSTANCES CONTROL PROGRAM 49
6.1 Program Description 49
6.1.1 Introduction to Statute and Overview of the
Program Area 49
6.1.2 Scope and Coverage of the Toxic Substances
Control Act 49
6.1.3 Premanufacturing Notification (PMN) 50
6.1.4 Chemical Testing Requirements 51
6.1.5 Reporting Requirements 52
6.1.6 Other Regulatory Options Under Sections 6 and 7 53
6.1.7 Relationship to Other Federal Laws 54
6.1.8 Asbestos Programs 55
6.2 Program Organization 55
6.2.1 Existing Chemical Review Process 56
6.2.2 Review of a Premanufacturing Notification (PMN) 57
6.3 Health Research Needs 57
6.3.1 Introduction 57
6.3.2 Major Research Categories 57
6.3.3 Cross-Cutting Categories 58
6.3.4 Emerging Research Needs 59
6.3.5 Summary 59
SECTION SEVEN HAZARDOUS AND SOLID WASTE PROGRAM 61
7.1 Program Description 61
7.1.1 Introduction to Statute and Overview of Program Area 61
7.1.2 Waste Characterization 61
7.1.3 The Hazardous Waste Program (Subtitle C) 63
7.1.4 The Nonhazardous Waste Program 66
7.1.5 Underground Storage Tanks Program 68
VII
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7.2 Program Organization 68
7.2.1 Development of Subtitle C Facility Standards 69
7.2.2 Development of Subtitle D Criteria 69
7.2.3 Development of Medical Waste Tracking Standards 69
7.3 Health Research Needs 70
7.3.1 Introduction 70
7.3.2 Major Research Categories 70
7.3.3 Cross-Cutting Categories 71
7.3.4 Emerging Research Needs 71
7.3.5 Summary 71
SECTION EIGHT SUPERFUND PROGRAM 73
8.1 Program Description 73
8.1.1 Introduction to Statute and Overview of the
Program Area 73
8.1.2 Scope and Coverage of the Superfund Program 73
8.1.3 Site Evaluation 74
8.1.4 Removal Response Program 75
8.1.5 Remedial Response Program 76
8.2 Program Organization 79
8.2.1 Preremedial Actions 80
8.2.2 Remedial Investigation/Feasibility Study 80
8.3 Health Research Needs 82
8.3.1 Introduction 82
8.3.2 Major Research Categories 82
8.3.3 Cross-Cutting Categories 83
8.3.4 Emerging Research Needs 84
8.3.5 Summary 84
SECTION NINE SUMMARY 85
9.1 EPA's Regulatory Programs 85
9.2 Program Organization 89
9.3 Health Research Needs 89
9.3.1 Introduction 89
9.3.2 Major Research Categories 89
9.3.3 Cross-Cutting Categories 92
9.3.4 Emerging Research Needs 93
9.3.5 Summary 94
VIII
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LIST OF TABLES
Table Page
2-1 National Ambient Air Quality Standards 4
2-2 Summary of New Source Performance Standards for Designated
Facilities and Pollutants 7-8
2-3 NESHAPS Emission Standards 10
2-4 U.S. Populations Living in Counties with 1988 Air Quality
Above Primary NAAQS 12
2-5 EPA Radiation Programs 14
2-6 Important Health Research Needs and Their Relative Priorities for the Air Program 18
3-1 Contaminants to be Regulated Under the SDWA 20
3-2 Secondary Standards for Drinking Water 22
3-3 Important Health Research Needs and Their Relative
Priorities for the Drinking Water Program 26
4-1 Toxic Pollutant Classes 28
4-2 Industries Subject to National Effluent Limitations 30
4-3 Important Health Research Needs and Their Relative
Priorities for the Water Quality Program 37
5-1 Important Health Research Needs and Their Relative
Priorities for the Pesticides Program 48
6-1 Important Health Research Needs and Their Relative
Priorities for the Toxics Program 59
7-1 Important Health Research Needs and Their Relative
Priorities for the Hazardous and Solid Waste Program 71
8-1 Review Team Members 81
8-2 Management Review Panel 81
8-3 Important Health Research Needs and Their Relative
Priorities for the Superfund Program 84
9-1 Regulatory Program Support 86-88
9-2 Major Environmental Legislation Administered by the
U.S. Environmental Protection Agency, Specific
Authorization for EPA to Conduct Health Research 90
9-3 Lead Offices in EPA Regulatory Programs 91
9-4 Research Needs for EPA Regulatory Programs 94
IX
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LIST OF FIGURES
Page
Figure 2-1 Organizational Chart for Office of Air and Radiation (OAR) 14
Figure 3-1 Organizational Chart for Off ice of Drinking Water (ODW) 23
Figure 4-1 Organizational Chart for Off ice of Water 34
Figure 5-1 Organizational Chart for Off ice of Pesticide Programs (OPP) 44
Figure 6-1 Organizational Chart for Office of Toxic Substances (OTS) 56
Figure 7-1 Organizational Chart for Off ice of Solid Waste (OSW) 68
Figure 8-1 Organizational Chart for Office of Emergency and Remedial Response (OERR) 79
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SECTION ONE
INTRODUCTION
In order to regulate environmental pollutants on a sound,
scientific basis, the EPA conducts environmental health
research. This research seeks to answer questions con-
cerning what pollutants are toxic, at what levels, and with
what effects; and who is exposed to them and to what
extent.
For each of the Agency's regulatory programs, this docu-
ment summarizes the role of health research and high-
lights pivotal health research questions. The regulatory
programs:
Air Quality
Drinking Water
Water Quality
Pesticides
Toxic Substances
Hazardous and Solid Waste
Superfund
are each discussed in a separate chapter in which three
categories of information are presented: program
description, program organization, and health research
needs.
Program Description
For each program, the statute(s) mandating the pro-
gram are summarized, and the major regulatory ac-
tivities that use health effects research are described.
For some programs, such as the Air Quality and Radia-
tion Program, most of the program's numerous
regulatory activities use health effects information. For
other programs, such as RCRA, the regulations are
more performance-oriented and do not require as
much analysis of possible impact on public health.
Program Organization
Subsection two of each chapter describes the
program's organization and defines step by step how
selected regulations are promulgated focusing on
those that involve the use of health effects information.
For example, the activities involved in developing Na-
tional Emission Standards for Hazardous Air Pol-
lutants (NESHAPS); promulgating national drinking
water regulations; and developing technical standards
for facilities that treat, store, and dispose of hazardous
waste are described.
Certain activities involved in preparing regulations (e.g.,
red-border review, Office of Management and Budget
[OMB] review) are generic to EPA rulemaking and are,
therefore, not covered. The focus is on the technical
activities that are unique to the programs in question.
Health Research Needs
Most EPA health research is conducted by the Health
Effects Research Laboratory (HERL). To address the broad
range of environmental contaminants regulated by EPA,
HERL research must evaluate the health risks for diverse
environmental agents including automotive and diesel ex-
haust, power plant emissions, pesticides and other toxic
chemicals, hazardous waste, municipal solid waste,
naturally occurring and genetically engineered microor-
ganisms, drinking water disinfectants and associated by-
products, and ionizing and non-ionizing radiation. While the
chemical and physical composition of these pollutants differ
significantly, the evaluation of their health effects must
address a common set of questions:
Exposure: How and to what extent are humans
exposed to the pollutant in the environment (i.e.,
route, magnitude, frequency, duration)?
Dose: What is the relationship between this ex-
posure and the dose of the pollutant received at the
site(s) of toxic action within the body?
Effect:
dose?
What is the health effect of the pollutant
These fundamental research questions underlie the re-
search needs of all EPA regulatory program areas. The
questions can be further subdivided into seven health
research topics (four principal topics and three cross-cut-
ting topics). These categories of issues, which are
presented for each program, are as follows:
Principal Topics
Hazard Identification Research develops, refines,
and validates approaches and methods for identify-
ing potential human health hazards. This research
includes the development of test methods for
screening and characterizing new and existing
chemicals and procedures to evaluate qualitative
and quantitative relationships between the chemical
structure of pollutants and their related biological
effects (structure-activity relationships [SARs]).
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Dose-Response Research elucidates (a) the
relationship among exposure (i.e., applied dose),
dose at the site of toxic action (i.e., target dose), and
biological effects; and (b) the basic biological
mechanisms responsible for the observed effects.
Research in this area includes developing better
methods to relate exposure to dose and physiologi-
cal and biological mechanisms of toxicity to improve
extrapolation of research results (e.g., extrapolating
results from animals to humans, from high to low
dose, and from acute to chronic effects).
Exposure Research defines the route, magnitude,
frequency, and duration of exposure of humans to
environmental pollutants. Most exposure research
efforts are focusing on investigating the exposures
experienced by individuals and populations during
normal daily activities, with emphasis on identifying
high-exposure groups. Other efforts in this area
focus on the development and validation of biologi-
cal markers for exposure, effects, and susceptibility
in human populations.
Chemical-Specific Research develops scientific
data on individual pollutants. This research is
generally short-term (1 to 2 years) and is aimed at
filling data gaps concerning specific chemicals or
chemical mixtures that are of immediate importance
to a regulatory program.
Cross-Cutting Topics
Biological Marker Research develops and
validates biological measurements that can be used
to calculate dose at the site of toxic action and to
detect effects at cellular and molecular levels. These
techniques can be used in epidemiological inves-
tigations to facilitate more direct assessment of ex-
posure and effects.
Pollutant Mixtures Research improves the scien-
tific foundation for assessing the extent to which
synergistic, antagonistic, or additive interactions
cause the effects of exposure to a mixture of pol-
lutants to differ from the effects that would be
predicted based on the characteristics of the in-
dividual pollutant components.
Human Data Development consists of the collec-
tion of information on exposure, dose, and effects in
human populations. Human data are used to assess
the status of public health, to identify potential en-
vironmental health problems, to evaluate the efficacy
of risk reduction measures, to identify and evaluate
subgroups that are at higher risk, and to ascertain
the degree to which effects observed in animals are
analogous (or homologous) to those observed in
humans.
Program officials were asked to assess the relative
priority of each of the seven categories of health issues
for their program and to identify their issues of concern
within each category. The results of these assessments
are presented within each program discussion in Sec-
tions Two through Eight and in summary form in Section
Nine of this document.
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SECTION TWO
AIR QUALITY PROGRAM
2.1 Program Description
2.1.1 Introduction to Statute and Overview of the
Program Area
EPA's program to protect air quality is authorized primari-
ly under the Clean Air Act (CAA). Other statutory
provisions authorizing EPA to regulate airborne con-
taminants include the Radon Gas and Indoor Air Quality
Research Act of 1986 (Title 4 of the Superfund Amend-
ment and Reauthorization Act of 1986); the Global
Climate Protection Act of 1987; the Low Level Radioac-
tive Waste Policy Amendment Act of 1985; the Nuclear
Waste Policy Act of 1982; the Atomic Energy Act of 1954;
the Comprehensive Emergency Response, Compensa-
tion and Liability Act of 1980; Superfund Amendments
and Reauthorization Act of 1986; and the Public Health
Service Act of 1970.
The CAA, which was initially passed in 1970 and
amended significantly in 1977, gives EPA authority to set
national standards for the quality of ambient air and to
regulate sources of pollution that may affect air quality.
The act requires States to set up programs to ensure that
air quality standards are achieved and maintained. Major
revisions to the CAA are currently before Congress. Of
particular importance are proposed changes in the
regulation of hazardous air pollutants from stationary
sources. Additionally, a number of special studies will
likely be mandated e.g., a Great Lakes Study and an
Urban Toxics Study.
EPA has established National Ambient Air Quality Stand-
ards (NAAQS)i for six pollutants or classes of pollutants and
emissions limits for mobile sources. EPA also regulates
stationary pollution sources under the New Source Perfor-
mance Standards (NSPS) and the National Emission
Standards for Hazardous Air Pollutants (NESHAPs).
States must publish and EPA must approve State Im-
plementation Plans (SIPs) that describe the measures to
be taken to ensure that the Federal standards under the
CAA are achieved and maintained.
In addition to the CAA programs, EPA implements
several other programs concerning airborne con-
taminants, including programs covering indoor air
quality, acid rain, stratospheric ozone depletion, global
warming, and radiation. The EPA air program is
described below in four sections.
Section 2.1.2 describes the programs authorized by
the CAA, including the NAAQS program, the mobile
sources program, the NSPS program, NESHAPs,
and the SIPs.
Section 2.1.3 describes the indoor air program.
Section 2.1.4 describes EPA programs concerning
issues of global significance including acid rain,
stratospheric ozone depletion, and global warm-
ing.
Section 2.1.5 covers EPA radiation protection
programs.
2.1.2 Clean Air Act Standards
2.1.2.1 National Ambient Air Quality Standards
Sections 108 and 109 of the Clean Air Act mandate the
establishment of National Ambient Air Quality Stand-
ards (NAAQS). The EPA Administrator must publish a
list of air pollutants that "may reasonably be an-
ticipated to endanger public health or welfare" and that
are emitted from "numerous or diverse mobile or sta-
tionary sources."
Within 1 year after the listing of a pollutant, the Ad-
ministrator must publish an air quality criteria document
that will form the basis for the air quality standard. The
criteria document must contain the "latest scientific
knowledge useful in indicating the kind and extent of all
identifiable effects on public health or welfare."
Simultaneously with publishing the criteria document,
the Administrator must propose primary and secondary
NAAQS, the maximum allowable concentration for each
pollutant in all areas of the country. A primary NAAQS is
one that is required to protect public health, while "allow-
ing an adequate margin of safety." This standard is
based on health considerations only; the costs of attain-
ment are not germane. In addition, a primary standard
must be set so that it protects particularly sensitive
persons, such as asthmatics and emphysemics, as long
as these people belong to an identifiable subgroup of the
population. HERL plays an important role in identifying
and assessing the health effects presented in the criteria
document.
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A secondary NAAQS specifies the level that protects the
"public welfare" against any known or anticipated ad-
verse effects. Public welfare is defined as including
effects on soils, water, crops, vegetation, manmade
materials, animals, wildlife, weather, visibility, property,
transportation, other economic values, and personal
comfort and well-being. Thus, the secondary NAAQS
can include virtually any identifiable negative effect from
air pollution.
The Administrator is required to promulgate final
standards within 6 months of the initial proposal. This
time is used to solicit public comments. In addition,
Agency personnel prepare a staff paper that evaluates
the key scientific studies that shape the criteria docu-
ment and identifies those issues to be considered in
review of the air pollution standard. The staff paper
does not present a summary judgment as to the ap-
propriate regulatory level, but it gives staff recommen-
dations on the range of standards appropriate to
protect public health and welfare given the scientific
evidence. As a result, the staff paper helps to bridge
the gap between the scientific studies referenced in
the criteria document and the judgments required in
setting standards.
EPA has established primary and secondary standards
for six air pollutants (the "criteria pollutants"). Table 2-1
presents the regulated air pollutants and their respective
regulatory limits. For some air pollutants, the primary and
secondary standards are identical. For these pollutants,
the scientific evidence did not justify setting secondary
standards for welfare effects at lower levels than the
primary standards.
EPA is required under the CAA to review and revise
the NAAQS periodically. The continuing evolution of
data on and techniques for examining health effects is
a key reason for the review requirement. Each review
(and all other reviews of NAAQS) centers on the
reevaluation of health and welfare effects of the air
pollutants.
The role of health effects in the reevaluation of standards
is illustrated by the recent revision of the standard for
airborne particulate matter. As shown in Table 2-1, the
standard for particulate matter is defined in terms of
particulates less than or equal to a nominal 10
micrometers (urn) in diameter. The previous standard
was based on total suspended particulates (TSP), as
determined by the reference method for measurement,
which employed a high-volume sampler that captured
particulates up to a nominal size of between 25 and 45
u.m in size. The change was made to focus the standard
on those particles that are deposited in the respiratory
system; particles larger than 10 u.m normally do not
penetrate beyond the natural defenses of the nose and
mouth.
Table 2-1 National Ambient Air Quality Standards
Carbon Monoxide
Particulate Matter
(PMio)a
Lead
Nitrogen Dioxide
Ozone
Sulfur Oxides
Primary - 35 parts per million (ppm)
averaged over 1 hour and 9.0 ppm
averaged over 8 hours; neither level
to be exceeded more than once per
year.6
Secondary - None.
Primary -150 u.g/m 3 averaged over
24 hours, with no more than one
expected exceedance per calendar
year; also, 50 u.g/m or less for the
expected annual arithmetic mean
concentration.
Secondary - Same as primary.
Primary - 1.5 ug/m3 arithmetic
average over a calendar quarter.
Secondary - Same as primary.
Primary -100 u.g/m3 (or 0.053 ppm)
as annual arithmetic mean con-
centration.
Secondary - Same as primary.
Primary - 235 u.g/m3 (0.12 ppm)
averaged over 1 hour, no more than
one expected exceedance per
calendar year. (Multiple violations in
a day count as one violation.)
Secondary - Same as primary.
Primary - 365 ng/m3 (0.14 ppm)
average over 24-hour period, not to
be exceeded more than once per
year; 80 ug/m (0.03 ppm) annual
arithmetic mean.
Secondary - 1,300 ug/m3 average
over a 3-hour period, not to be ex-
ceeded more than once per year.
aStandard applies only to particulate matter that is less
than or equal to a nominal 10 micrometers in diameter.
bExisting regulations state that air quality limits are not to
be exceeded more than once per year. EPA policy
specifies that the compliance determinations are to be
made in terms of calendar years.
Source: Part 50 - National Primary and Secondary Am-
bient Air Quality Standards. July 1,1987. Information on
changes in the standards since this publication were
provided by EPA personnel.
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2.1.2.2 Mobile Sources Program
Motor Vehicle Emission Controls
In the belief that motor vehicle pollutants constitute the
most difficult air pollution problem in the country, and
noting the limited progress in abating it, Congress took
the unusual step of specifying the level of control for
motor vehicle emissions and the deadlines for these
emission goals in the CAA. In 1970, Congress mandated
a 90 percent reduction in emissions of hydrocarbons and
carbon monoxide by 1975 and an equivalent reduction
in nitrogen oxides by 1976. Automobile manufacturers
argued that they could not comply with this schedule.
Therefore, in 1977, the amendments to the CAA pushed
the compliance schedule back. The hydrocarbon stand-
ard was set back to model year 1980; the carbon
monoxide standard was deferred to 1981; and the
nitrogen oxides limit was made less stringent and com-
pliance was deferred to 1981. The control of tailpipe
emissions from new vehicles varies from 96 percent for
carbon monoxide to 72 percent for nitrogen oxides.
EPA has also developed controls for heavy-duty engines
for the pollutants shown in Table 2-1. Manufacturers of
diesel heavy-duty engines must control paniculate emis-
sions as well. EPA added this requirement for diesels
based on findings that paniculate emissions from diesel
engines are small and highly respirable, increasing the
health risk.
The emission of hydrocarbons from mobile sources is a
major contributing factor to the ozone problem evident in
many nonattainment areas. Hydrocarbons combine with
sunlight and other chemicals to produce ozone. EPA
controls on vehicle emissions have greatly reduced the
amount of mobile source pollution that would otherwise
be generated. Nevertheless, ozone remains a difficult
regulatory problem because of the tremendous volume
of automobile traffic, the variety of stationary sources
that also contribute to the problem, and the proliferation
of new air pollution sources due to continued economic
growth.
EPA enforces its emission requirements on motor
vehicles through an extensive program of vehicle testing
and certification. Because automobile designs require
several years to develop, EPA performs an engineering
review of vehicle designs and tests prototype vehicle
emissions. EPA must also determine that compliance will
be maintained throughout the useful life of the vehicle.
The useful life is defined as 5 years of use or 50,000
miles. Industry personnel test vehicles under laboratory
conditions to determine the emissions expected over this
period. The deterioration in emission control is con-
sidered when evaluating the adequacy of the
automobile's design. Thus, EPA can identify potential
compliance problems before assembly-line production
begins.
EPA verifies that manufactured automobiles meet the
standards typified by the prototypes through assembly-
line testing. These tests verify that compliance levels for
emissions will be maintained throughout assembly-line
production. EPA uses a selected sample of vehicles from
each assembly line to determine the adequacy of the
mass-produced product. If the tested vehicles fail to
comply, a larger sample is chosen and testing continues.
In extreme cases, EPA could recall vehicles and revoke
the initial certification provided to the prototype vehicle.
To ensure that motor vehicles continue to meet the
standards in day-to-day use, EPA monitors the emission
levels of vehicles that are owned and driven by the
public. If a class of vehicles is found to be excessively
polluting, EPA will require the manufacturer to correct the
situation; the remedy could result in a recall.
Additional Controls Related to Mobile Sources
The CAA also authorized EPA to regulate motor vehicle
fuels and fuel additives. A central aspect of this program
has been to phase out the lead content of gasoline, which
has been achieved by requiring new cars to use un-
leaded gasoline and by expanding the classes of
automobiles and trucks to which the lead controls apply.
The lead phaseout has been enforced with inspections
and penalties imposed on gasoline refiners and upon
vehicle operators who illegally use leaded fuels. EPA has
also developed a registration system for fuel and fuel
additives where the fuel manufacturers have to provide
EPA with the chemical composition, including additives,
and provide any health effects information (usually in the
form of Material Safety Data Sheets) related to these
chemicals or their combustion by-products. EPA can use
this data base to identify fuels or additives that warrant
further investigation or regulation.
EPA has promoted the development of State programs
for prevention of vehicle tampering and fuel switching to
protect the gains from the emission control program.
These programs are designed to prevent drivers from
circumventing, removing, or otherwise rendering the
emission control system inoperative.
EPA has also developed programs and requirements to
encourage proper maintenance of vehicles on the road.
The driving public typically does not properly care for its
vehicles, leading to increased emissions due to misfiring
and improper engine adjustment. Under the authority of
the CAA, EPA has required States with high ozone and
carbon monoxide levels to develop automobile inspec-
tion and maintenance programs. EPA audits these State
programs.
A significant part of the health effects research on mobile
source emissions is conducted through the Congres-
sipnally mandated Health Effects Institute (HEI). HEI is
jointly funded by EPA and the automobile industry and
performs research on the health effects of pollutants
related to mobile sources.
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HEI's research focuses on various mobile source-related
pollutants, including carbon monoxide, oxidants (ozone
and nitrogen dioxide), diesel exhaust, and methanol and
aldehydes. Important areas of health research con-
ducted by HEI include development and use of biological
markers; identification and characterization of suscep-
tible populations; determination of dose to target tissue;
assessment of susceptibility to infection; examination of
mechanisms of injury and/or disease; and evaluation of
neurotoxicological and behavioral effects.
2.1.2.3 New Source Controls
Source Performance Standards
Under Section 111 of the CAA, EPA establishes New
Source Performance Standards (NSPS) that restrict
emissions from new industrial facilities or existing
facilities undergoing major modifications or
reconstruction. The NSPS program regulates emis-
sions from stationary sources that contribute "sig-
nificantly to air pollution which may reasonably be
anticipated to endanger public health and welfare."
The program covers both criteria pollutants and
"designated" pollutants. Designated pollutants, regu-
lated under Section 111(d) of the CAA, are pollutants
that endanger public health and welfare and are not
otherwise regulated by any other section of the CAA,
e.g., Sections 108 and 109 (NAAQS) and 112
(NESHAPS). Section 111 (d) of the CAA regulates both
new and existing designated pollutants.
In establishing the NSPS program, Congress believed
that facilities being newly constructed had the greatest
flexibility to control emissions by modifying their basic
design, and that air pollution control could be most
cost-effectively achieved in such cases. Additionally,
Congress wished to ensure that all new facilities of a
given type would face similar control requirements to
preclude interstate competition for new industry through
relaxed air pollution control requirements. Thus, NSPS
standards are uniform national rules for a defined in-
dustrial category, such as utility steam generators.
Under the CAA, EPA must set the NSPS control level
such that it reflects the Best Available Control Technol-
ogy (BACT). In developing these regulations, EPA
must consider the potential costs of compliance and
the need for and level of a uniform national standard.
To analyze these factors, EPA performs an intensive
study of each industrial category before promulgating
a NSPS regulation.
As of January 1,1989, EPA had promulgated standards
for approximately 60 NSPS categories; they are sum-
marized in Table 2-2. The EPA Regulatory Agenda of
October 1988 indicated that more than a dozen addition-
al categories were in some stage of development toward
eventual rulemaking. In December 1989, EPA published
a proposed regulation to control emissions from all new
and existing municipal waste combustors as a health-re-
lated standard under 111(d).
In addition to promulgating regulations, EPA conducts
research on the components of urban air to determine
what pollutants are hazardous and should be regulated.
This research is carried out by the Integrated Air Cancer
Project (IACP), which has three goals: to determine
which emission sources are major contributors of car-
cinogens to ambient air; to determine which chemicals
are carcinogen precursors; and to improve the estimate
of exposure and comparative human cancer risk from
specific air pollutant emission sources.
The health research component focuses on methods
development and data gathering to evaluate the human
cancer risk from individual and, ultimately, complex source
emissions (i.e., emissions from wood stoves, vehicles, and
home oil burners). IACP has developed methods for sam-
pling and testing organic mixtures for mutagenicity,
segregated non-volatile and volatile organic fractions con-
tributing to mutagenicity, demonstrated mutagenicity in
organic products of atmospheric reactions, and applied
receptor modeling to estimate source contributions to air-
borne organic mutagens.
Prevention of Significant Deterioration
As a result of litigation and the 1977 CAA amendments,
EPA has created a system for protecting and maintaining
air quality in "attainment areas" - those areas that satisfy
the NAAQS. All attainment areas are categorized into
one of three classes, ranging from relatively pristine
areas that include national parks and wilderness areas
(Class I) to areas that just satisfy the NAAQS levels
(Class III). EPA established different Prevention of Sig-
nificant Deterioration (PSD) increments for each of the
three classes, with the smallest increments allowed for
Class I areas. These increments serve as limits on
allowable degradation of air quality. Major new sources
of emissions are subject to BACT pollution control re-
quirements. In addition to the increments and BACT,
sources proposing to locate near Class I areas may be
subject to additional requirements to protect visibility and
other air quality-related values (e.g., deposition and
damage to plants and animals).
New Source Review
Stationary sources are also regulated under Part D of the
CAA, Plan Requirements for Nonattainment Areas.
These requirements mandate that, in nonattainment
areas, a new source must, at a minimum, install controls
to meet the "lowest achievable emissions rate" (LAER);
this emissions rate may be lower than the level permitted
under NSPS regulations. States may also require sta-
tionary sources to reduce emission to levels below NSPS
in order to comply with PSD increments (see Section
2.1.2.1) or to "offset" the emissions caused by their
facility by installing incremental emission controls at
another facility (whether they own it or not) in the same
area. The NSPS emissions level is, therefore, only the
maximum level that may be allowed for a new facility in
a given industrial category.
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Table 2-2 Summary of New Source Performance Standards for Designated Facilities and Pollutants *
Subpart Designated Facilities Designated Pollutants
D
Da
Db
E
F
G
H
1
J
K
Ka
Kb
L
M
N
Na
O
P
Q
R
S
T
U
V
w
X
Y
z
* Regulated
Fossil-fuel fire steam generators constructed after August 17, 1971
Electric utility steam generating units constructed after September 18, 1978
Industrial-commercial-institutional steam generating units
Incinerators
Portland cement plants
Nitric acid plants
Sulf uric acid plants
Asphalt concrete plants
Petroleum refineries
Storage vessels for petroleum liquids constructed, reconstructed,
or modified after June 11, 1973 and before May 19, 1978
Storage vessels for petroleum liquids constructed, reconstructed,
or modified after May 18, 1978 and before July 23, 1984
Storage vessels for volatile organic liquids constructed, reconstructed,
or modified after July 23, 1984
Secondary lead smelters
Secondary brass and bronze production plants
Basic oxygen process, furnaces constructed after June 11, 1973
Basic oxygen process, furnaces constructed after January 20, 1983
Sewage treatment plants
Primary copper smelters
Primary zinc smelters
Primary lead smelters
Primary aluminum reduction plants
Phosphate fertilizer industry: wet process phosphoric acid plants
Phosphate fertilizer industry: superphosphoric acid plants
Phosphate fertilizer industry: diammonium phosphate plants
Phosphate fertilizer industry: triple superphosphate plants
Phosphate fertilizer industry: granular triple superphosphate storage facilities
Coal preparation plants
Ferroalloy production facilities
under Section lll(d) of the Clean Air Act.
Particulates
Sulfur dioxide
Nitrogen oxides
Particulates
Sulfur dioxide
Nitrogen oxides
Particulates
Sulfur dioxide
Nitrogen oxides
Particulates
Particulates
Nitrogen oxides
Sulfur dioxide
Acid mist
Particulates
Particulates
Sulfur dioxide
Carbon monoxide
Volatile organic compounds
Volatile organic compounds
Volatile organic compounds
Particulates
Particulates
Particulates
Particulates
Particulates
Particulates
Sulfur dioxide
Visible emissions
Particulates
Sulfur dioxide
Visible emissions
Particulates
Sulfur dioxides
Visible emissions
Particulates
Sulfur dioxides
Visible emissions
Fluorides
Fluorides
Fluorides
Fluorides
Fluorides
Particulates
Particulates
Carbon monoxide
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Tabla 2-2 Summary of New Source Performance Standards for Designated Facilities and Pollutants (continued)
Subpart Designated Facilities
Designated Pollutants
AA
AAa
BB
CO
DD
EE
GG
HH
KK
LL
MM
NN
PP
QQ
RR
SS
TT
UU
VV
WW
XX
AAA
BBB
FFF
GGG
HHH
JJJ
KKK
ILL
OOO
PPP
Steel plants: electric arc furnaces constructed after October 21,1974
and before August 17.1983
Steel plants: electric arc furnaces and argon-oxygen decarburization
vessels constructed after August 7,1983
Kraft pulp mills
Glass manufacturing plants
Grain elevators
Surface coating of metal furniture
Stationary gas turbines
Lime manufacturing plants
Lead - acid battery manufacturing plants
Metallic mineral processing plants
Automobile and light-duty truck surface coating operatbns
Phosphate rock plants
Ammonium sulfate manufacture
Graphic arts industry: publication rotogravure printing
Pressure sensitive tape and label surface coating operations
Industrial surface coating: large appliances
Metal coil surface coating
Asphalt processing and asphalt roofing manufacture
Equipment leaks of VOC in the synthetic organic chemicals
manufacturing industry
Beverage can surface coating industry
Bulk gasoline terminals
New residential wood heaters
Rubber tire manufacturing industry
Flexible vinyl and urethane coating and printing
Equipment leaks of VOC in petroleum refineries
Synthetic fiber production facilities
Petroleum dry cleaners
Equipment leaks of VOC from onshore natural gas processing plants
Onshore natural gas processing
Nonmetallic mineral processing
Wool fiberglass insulation manufacturing plants
Industrial surface coating of plastic parts for business machines
Particulates
Particulates
Particulates
Total reduced sulfur
Particulates
Particulates
Volatile organic compounds
Sulfur dioxide
Nitrogen oxides
Particulates
Lead
Particulates
Volatile organic compounds
Particulates
Particulates
Volatile organic compounds
Volatile organic compounds
Volatile organic compounds
Volatile organic compounds
Particulates
Pumps, compressors,
pressure relief devices,
sampling connection systems,
open-ended valves or lines, etc.
Volatile organic compounds
Volatile organic compounds
Particulates
Volatile organic compounds
Volatile organic compounds
Pumps, compressors,
pressure relief devices,
sampling connection systems,
open-ended valves or lines,etc.
Volatile organic compounds
Volatile organic compounds
Pumps, compressors,
pressure relief devices,
sampling connection systems,
open-ended valves or lines, etc.
Sulfur dioxide
Particulates
Particulates
Volatile organic compounds
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2.1.2.4 National Emission Standards for Hazardous
Air Pollutants
The EPA NESHAP program, established under Section
112 of the CAA, limits the amount of hazardous air
pollutants that can be emitted from a point source. Haz-
ardous air pollutants are defined as those for which no
NAAQS is applicable and which may "reasonably be
anticipated to result in an increase in mortality or an
increase in serious irreversible, or incapacitating revers-
ible, illness." As this statutory language suggests,
NESHAPs may address dangerous pollutants that have
more serious health effects than pollutants regulated
under NSPS or that may not be emitted by enough
sources to justify a NAAQS.
In settipg NESHAPs, EPA considers the potential
severity" of health effects from the pollutants. The CAA
requwes EPA to set standards stringent enough to
protect public health, allowing an "ample margin of
safety." A1987 court ruling stated that a NESHAP does
not necessarily require zero emissions or no risk, but that
EPA must decide what is a "safe level" to protect public
health and set a NESHAP to guarantee that level. Cost
and technical feasibility can only be considered if the
Agency sets standards more stringent than the "safe
level." Prior to this court decision, cost considerations
played a larger role in setting NESHAPs standards.
Under the NESHAPs program, EPA has established
regulations for asbestos, beryllium, mercury, benzene,
vinyl chloride, radionuclides, and arsenic. Although
NESHAPs were originally defined in terms of emission
rates from the source, the 1977 amendments authorized
EPA to establish design, equipment, work practice, or
operational standards where numerical emission limits
would not be practical. The NESHAPs standards are
summarized in Table 2-3. As this table shows, ap-
proximately half of the standards are numerical emission
limits.
Under the proposed amendments to the CAA, sources
emitting one of approximately 191 listed chemicals will
be required to use the best control technology already in
use for a given type of industry - Maximum Achievable
Control Technology (MACT) - unless the plant can
demonstrate it poses a negligible public health risk. It will
be up to States to decide whether the risk is negligible,
but EPA will provide guidance on how to make this
determination. To do this. EPA will develop "health
benchmarks" within the first 2 years after passage of the
act to define levels that present a negligible health risk
for both cancer and noncancer endpolnts.
EPA will also be required to evaluate potentially sig-
nificant residual risks remaining after the application of
MACT (i.e., risks associated with post-control emis-
sions) . The Agency has up to 7 years to make determina-
tions concerning residual risks, and it is believed that
detailed risk assessments will be needed to support
these determinations.
2.1.2.5 State Implementation Plans
Most of the Federal air pollution laws are implemented
and enforced by the States. The States are given sub-
stantial responsibility and provided with substantial
flexibility to find the means to achieve the NAAQS levels
and to comply with designated pollutant standards and
other Federal requirements within their own boundaries.
Each State's approaches and timetables for compliance
with NAAQS are summarized in State Implementation
Plans (SI Ps), which are submitted to EPA for approval.
These plans must be updated as new regulations are
promulgated. Once a NAAQS is promulgated, the States
must each prepare and submit a SIP within 9 months.
Similarly, after a Federal NSPS standard for a desig-
nated pollutant is promulgated, the States have 9 months
to adopt an appropriate plan (including proposed State
laws) and submit it to the EPA for review.
The State's SIP may incorporate a number of regulatory
measures that go beyond Federal emissions limitations
in order to achieve compliance with Federal require-
ments. The plan may include, for example, more strin-
gent restrictions on motor vehicle emissions than
required under Federal motor vehicle emission stand-
ards, in order to meet NAAQS. A State plan may also
require stationary sources to install more stringent con-
trols than those required by Federal laws. The complex
economic, technological, and political ramifications of air
pollution regulations must be considered and resolved at
the State level.
EPA's review and approval of the SIPs focus on their
adequacy relative to Federal requirements. To help
States achieve their air pollution goals, EPA has en-
couraged consideration of the most cost-effective emis-
sions controls. As one aspect of this policy, EPA allows
States under some conditions to employ a "bubble
policy" for installations. Under this policy, a facility with
multiple sources may restrict its emissions to achieve
overall compliance without necessarily achieving com-
pliance at each distinct source within the facility. Emis-
sions are analyzed as though a bubble encased the
facility and all emissions could be measured at one
release point in the facility. This procedure provides
additional flexibility and may allow a more cost-effective
implementation of EPA-mandated controls on emissions
from stationary sources.
The complexity and political difficulty of achieving
NAAQS levels are evidenced by the fact that many
States have not met the required air quality levels in
some or all parts of the State. EPA estimates of the
populations living in counties with air quality above the
primary NAAQS indicate the extent of the noncom-
pliance problem (Table 2-4).
The CAA Amendments of 1977 established a system for
sustaining pressure for the improvement of air quality in
Regions lagging in compliance. The amendments re-
quired the States to develop new SIPs for nonattainment
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Table 2-3 NESHAPS Emission Standards
Subpart
Pollutant
Application
Standard
B
C
H
J
K
M
N
V
W
Radon-222
Beryllium
Beryllium
Mercury
Vinyl Chloride
Had ionucl ides
Radionuclides
Benzene
Radionuclides
Asbestos
Inorganic Arsenic
Inorganic Arsenic
Inorganic Arsenic
Volatile Hazardous
Air Pollutants (VAPs)
Radon-222
Underground uranium
mines
Applies to extraction
and ceramic plants,
foundries, incinerators,
propellant plants, and
machine shops
Applies only to rocket
motor test sites
Applies to sources that:
process mercury ore or use
mercury chloralkali cells;
incinerate or dry wastewater
treatment plant sludge
Ethylene dichbride plants,
vinyl chloride plants, and
polyvinyl chloride plants
Applies to emissions from
Department of Energy
Facilities
Applies to emissions from
Nuclear Regulatory
Commission facilities not
covered under Subpart H
Applies to equipment leaks
Applies to elemental
phosphorous plants
Mills, roadways,
manufacturing,
demolition and renovation,
spraying, fabricating
insulation materials,
waste disposal sites
Glass manufacturing plants
Primary copper smelters
Arsenic trioxide and
metallic arsenic
production facilities
Equipment leaks
Licensed uranium mill
tailings
Requires bulkheads to limit radon-222 emissions.
Emission cannot exceed 10 grams/24-hour unless
perm|ssion granted to meet ambient limit of 0.01
ug/nr/30-day period.
Emissions cannot exceed 75 microgram minutes per
m within 10 to 60 minutes accumulated during
any 2 consecutive weeks.
Emissions cannot exceed 2,300 grams/24-hr period.
Emissions cannot exceed 3,200 grams/24-hr
period.
There are separate standards for the various
operations carried out in these plants.
Emissions cannot exceed a dose equivalent of
25 mrem/y to the whole body or 75 mrem/yr to
a critical organ.
Emissions cannot exceed a dose of 25 mrem/yr to
the whole body or 75 mrem/yr to a critical organ.
Must comply with provisions of Subpart V.
Emissions of polonium-210
from calciners and nodulizing kilns cannot
exceed 21 curies per year.
Specifies allowable practices for removing,
applying, manufacturing, and disposing of
asbestos-containing material.
Existing plants: Emissions shall be less than 2.5
mg/yr or a control device must reduce emissions
by at least 85 percent.
New plants: Emissions shall be less than 0.4
mg/yr or a control device must reduce emissions
by at least 85 percent.
Design, equipment, work practice, and operational
requirements are mandated. No emissions from
the control device that contain more than 11.6
mg/m particulate.
Mandates work practice, operational requirements,
and performance standards.
Equipment, work practice, and operational
requirements specified for pumps, compressors, etc.
Mandates licensing and operating requirements for
uranium tailings impoundments.
10
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areas and to show "reasonable further progress," which
is defined as the accomplishment of "annual incremental
reductions in emissions." For States that have not met
these provisions, EPA may ban construction of new
emissions sources or cut off Federal highway funds and
CAA grants. EPAcurrently (1989) has construction bans
in effect in six urban areas for ozone and CO and in
seven urban areas
2.1.2.6 Assistance to State and Local Governments
In addition to promulgating regulations, EPA provides
technical assistance to State and local governments.
The Control Technology Center (CTC) is a joint effort of
the Air and Energy Engineering Research Laboratory in
Research Triangle Park, North Carolina; the Center for
Environmental Research Information (CERI) in Cincin-
nati, Ohio; and the Office of Air Quality Planning and
Standards (OAQPS) in Research Triangle Park, North
Carolina. CTC provides technical support to State and
local agencies and EPA's Regional offices in implement-
ing air pollution control programs and assists in develop-
ing control strategies for toxic emissions, implementing
State plans, developing regulations, evaluating opera-
tion and maintenance problems, reviewing new sources
to determine appropriate control technology, and
evaluating source emission and control strategies.
EPA's Air Risk Information Support Center (Air RISC),
which is a joint effort of the Office of Health and Environ-
mental Assessment (OHEA), CERI, and OAQPS, assists
State and local air pollution control agencies and EPA
Regional offices with technical matters concerning
health, exposure, and risk assessments for toxic air
pollutants. Air RISC's primary goal is to serve as a focal
point for obtaining information and, when needed, pro-
vide assistance in the review and interpretation of that
information. It provides health and risk assessment in-
formation for chemicals being evaluated in the permit
review process, assists with on-site risk assessments,
and provides guidance on current methods available to
conduct health risk analyses.
2.1.3 Indoor Air
The Radon Gas and Indoor Air Quality Research Act
of 1986 (Title 4 of the Superfund Amendment and
Reauthorization Act of 1986) requires EPA to establish
a research program for radon and indoor air quality
that gathers data and information, coordinates re-
search (Federal, State, local, and private), and asses-
ses appropriate Federal actions to "mitigate the
environmental and health risks associated with indoor
air quality problems." The research program must cover
the identification, characterization, and monitoring of the
sources of indoor air pollutants; human health effects;
mitigation measures; and dissemination of information to
ensure the public availability of these findings. The Agen-
cy has no regulatory authority and, therefore, cannot set
enforceable standards for indoor air quality. EPA ad-
visory information, however, may recommend safe
levels for specific contaminants.
EPA has initiated a research and information dissemi-
nation program concerning indoor air pollutants. A
variety of indoor air pollutants such as tobacco smoke,
fumes from combustion appliances, biological con-
taminants (e.g., molds, mildew, fungi), and fumes from
synthetic carpeting are known to have significant ad-
verse health effects. EPA's program encompasses the
following efforts:
Conduct research to identify harmful air pollutants.
Identify the health effects of contaminants and
levels at which these effects are likely to occur.
Provide advisory information on contaminant health
effects.
Provide information on mitigation of indoor air pollu-
tion problems.
Provide information concerning Federal research
and other activities related to indoor air pollution.
Coordinate State activities regarding indoor air pol-
lution.
2.1.4 Air Pollution Problems of Regional and Global
Significance
EPA is directing research into the potential for air
pollution to create climatic, ecological, and health
problems of regional and global significance. Complex
chemical interactions in the earth's atmosphere are
now suspected of increasing average temperatures
(global warming), changing climatic patterns, deplet-
ing stratospheric ozone, and contributing to acid rain.
To correct or reverse these trends, the United States
will need to achieve substantial progress in scientific
understanding of atmospheric processes and to help
build international consensus and cooperation on en-
vironmental control methods.
Several processes may be interacting to cause a gradual
increase in the average temperature of the earth. Various
gases from fossil fuel combustion continue to build up in
the earth's atmosphere. These gases prevent the
release of radiant energy into the atmosphere and thus
could cause an increase in the earth's average tempera-
ture. EPA is studying the policy options that could stabi-
lize the amount of gases in the atmosphere and control
future warming. EPA is also studying the health and
environmental effects of potential warming trends. Under
a Congressional mandate embodied in the Global
Climate Protection Act of 1987, EPA is helping to coor-
dinate a national policy on global warming.
Simultaneously, some types of gaseous emissions
from industrial processes and other sources are rising
11
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Table 2-4 U.S. Population Living hi Counties
with 1988 Air Quality Above Primary NAAQS
(Based on 1986 Population Data)
Pollutant
Population (million persons)
Ozone
Particulates
Carbon Monoxide
Nitrogen Dioxide
Lead
Sulfur Dioxide
111.9
25.6
29.5
8.3
1.6
1.7
Source: U.S. Enviromental Protection Agency. 1990.
National Air Quality and Emissions Trends Report, 1988.
EPA-450/4-90-002. Research Triangle Park, NC 27711:
Office of Air Quality Planning and Standards Technical
SUpport Division, March 1990.
to the stratosphere and causing a depletion in the layer
of ozone found there. This thin layer of ozone helps to
reduce the amount of ultraviolet radiation that reaches
theearth. Ultraviolet radiationcancauseskincancerand
possibly other health effects, such as impairment of the
visual and immune systems. Therefore, any increase in
radiation couldcreate healtheffects of concern. EPAand
otheragenciesarecooperatinginstudiestomeasurethe
changes in stratosphericozone. EPAalso assisted inthe
development of the Montreal Protocol, an international
agreement to reduce consumption of chlorofluorocar-
bons, halons, and other chemicals that reduce atmos-
pheric ozone. EPA's position was based partly on the
results of a 1987 risk assessment of the projected health
and environmental effects of reductions in atmospheric
ozone. The Montreal Protocol was signed in September
1987 and went into effect January 1,1989. EPApromul-
gated regulations (published in the Federal Register,
August 12, 1988) to implement the phaseout of
chlorofluorocarbons, halons, and other chemicals in
accordance with the Protocol.
Dramatic environmental effects are occurring due to
the phenomenon of acid rain. Natural precipitation is
somewhat acidic because of the influence of atmos-
pheric carbon monoxide. With the addition of nitrogen
oxide and sulfur oxide emissions, particularly from
power plants, the acidity of precipitation has in-
creased. The northeastern United States has been
particularly vulnerable, with loss of fish habitats in
many lakes and a decline in forest growth. Yet impor-
tant questions remain about the contribution of in-
dustrial sources to the problem and the best approach
to regulation and mitigation. In recent years, EPA has
directed large-scale research into the atmospheric
chemistry and long-range atmospheric transport
problems of acid rain formation, as well as into methods
for restoring lake habitats.
Radiation Programs
Although radioactive materials fall within the term "air
pollutants" in the CAA, the courts found in favor of
companies that challenged Minnesota when it used
the CAA in an attempt to regulate radioactive materials
more stringently than the Atomic Energy Commission.
To remedy this situation, an amendment was added to
the CAA in 1977, Section 122, that mandated that the
ERA Administrator had to review all "relevant informa-
tion and determine whether or not emissions of
radioactive pollutants (including source material, spe-
cial nuclear material, and byproduct material), cad-
mium, arsenic, and polycyclic organic matter into the
ambient air... may reasonably be anticipated to en-
danger public health." If so, the Administrator must
regulate the pollutant under Sections 108,111,112, or
any combination of these sections.
EPAcurrently implements a number of programs to protect
the public from the health hazards of radiation contamina-
tion. While the Department of Energy (DOE) and the
Nuclear Regulatory Commission (NRC) have jurisdiction
over many facilities that handle radioactive materials, EPA
regulates the exposure of the general public to radiation.
Virtually all of these regulatory, guidance, and analytical
programs are based to some degree on the health effects
of radiation exposure. EPA's major regulatory programs for
radiation hazards and the statutory authority for these
programs are shown in Table 2-5.
2.2 Program Organization
The EPA Assistant Administrator for Air and Radiation is
responsible for all of the air and radiation programs
described in Section 2.1. The Assistant Administrator's
Office, the Office of Program Management Operations,
the Office of Policy Analysis and Reviews, and the Office
of Program Development are headquartered in
Washington, D.C. These offices are responsible for over-
all program management, resource management, policy
analysis, and program development.
Four major offices within the Office of Air and Radiation
(Figure 2-1) carry out major program activities:
Office of Air Planning and Standards (OAQPS).
Office of Mobile Sources (QMS).
Office of Radiation Programs (ORP).
Office of Atmospheric and Indoor Air Programs.
The functioning of the Office of Air and Radiation is illustrated
below with respect to three major program activities:
12
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Development of NAAQS.
Development of NESHAPs.
Ğ Development of radiation standards.
2.2.1 Development of National Ambient Air Quality
Standards
National ambient air quality standards (NAAQS) are
developed in the Office of Air Quality Planning and
Standards (OAQPS) in Research Triangle Park, North
Carolina. The principal components of the regulatory
development process include preparation of a criteria
document, a staff paper, and an economic impact as-
sessment. Following the preparation of these com-
ponents, a regulation is proposed.
The Environmental Criteria and Assessment Office
(ECAO) within ORD takes the lead in assembling criteria
documents for NAAQS pollutants (see Section 2.1).
ECAO assembles a team of scientists inside and outside
of EPA to prepare the document. The team conducts a
literature search, performs a critical review of key
studies, and prepares a draft document. The draft docu-
ment is peer reviewed at a workshop attended by the
document authors and non-Agency experts. Following
this review, the draft is circulated for review and comment
by the Clean Air Science Advisory Committee (CASAC)
and the public. Following this review, EPA responds to
and incorporates, as appropriate, all comments. ECAO
normally submits its second draft for external review
before preparing the final document.
Once the criteria document has been reviewed by the
public and CASAC, OAQPS prepares a staff paper that
evaluates key studies in the criteria document and iden-
tifies critical elements to be considered in the review of
the standard. The staff paper identifies the key studies
that should be used in setting the standard. The paper
also discusses uncertainties in the medical evidence.
Finally, the paper presents recommendations concern-
ing the range of standards that appear reasonable given
the existing scientific knowledge.
The staff paper is published and reviewed by the public
and CASAC. A public meeting is held with CASAC to
receive their comments and comments from the public.
Once all comments have been reviewed, and the staff
paper revised, as necessary, the document forms the
basis for EPA's decision on revising the standard. The
revised standard is proposed and, following public com-
ment, promulgated as a final regulation.
During the rulemaking process, OAQPS prepares a
regulatory impact analysis of the options under con-
sideration. As explained in Section 2.1, economic im-
pacts cannot be used as a basis for setting the standard.
The regulatory impact study is, therefore, published for
informational purposes.
2.2.2 Development of NESHAPs
Although OAQPS has four divisions, only two are involved
in the development of NESHAPs: the Emissions Stand-
ards Division, which manages the development of
NESHAPs with support from its four branches, and the
Technical Support Division, which may provide air quality
modeling data. The process begins with the identification
of a pollutant or a category of sources meeting the criteria
for coverage under NESHAPs (see Section 2.1.3). The
Pollutant Assessment Branch (PAB) in the Emissions
Standards Division identifies the hazardous pollutant or
pollutant source of concern by considering the number of
sources, their potential to emit large quantities of the pol-
lutant, the degree of health hazard posed by the pollutant,
and whether there is significant exposure potential.
Once a pollutant or pollutant source category has been
identified, the PAB briefly analyzes the substance's risks
and the Agency's regulatory options. After the pollutant is
screened, the Office of Health and Environmental Assess-
ment (OHEA) (in the Office of Research and Development)
develops a health assessment document. ECAO takes the
lead in developing the health assessment document. The
Human Health Assessment Group (HHAG) or the RfD
Working Group may provide analysis of the health hazards
of the substance. The branch may receive input from:
The Industry Studies Branch or the Chemical and
Petroleum Branch, also within the Emissions Stand-
ards Division of OAQPS, which may provide infor-
mation on emissions levels.
The Technical Support Division of OAQPS, which
may provide air quality modeling to assist in ex-
posure assessment.
The PAB synthesizes the hazard, dose-response, and
exposure information to generate a preliminary risk as-
sessment. The PAB then develops a statement about the
health risks posed by a chemical or source category. Two
preliminary regulatory options are considered:
Coverage under NESHAPs (Section 112 of the
CAA).
Coverage under NSPS (Section 111 and 111d of the
CAA).
There is considerable uncertainty inherent in assessing
whether a pollutant "contributes significantly to air pollu-
tion which may reasonably be anticipated to endanger
public health or welfare" (the NSPS criteria) or whether
the pollutant is "reasonably anticipated to result in an
increase in mortality or an increase in serious irre-
versible, or incapacitating reversible, illness" (NESHAPs
criteria). Regulation under NSPS may be recommended
in cases where a source category is believed to generate
a variety of hazardous pollutants, not all of which are
"hazardous." The NSPS program, in those cases, may
13
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Table 2-5 EPA Radiation Programs
Programs
Statutory Authority
A NESHAP regulation for
radbnuclide contaminants
such as those emitted from
uranium tailings sites, DOE
facilities, NRG licensees, and
uranium mines.
A regulation protecting human
health from exposure to con-
taminants from low-level
waste (LLW) disposal sites.
Reissuance of a standard
protecting the public from
offsrte exposure to radiation
from high-level radioactive
waste disposal sites.
Rewriting regulations for
disposal of uranium mill
tailings, principally for
ground-water protection
but also for emissions risks.
Providing advice concerning
the Federal Emergency
Management Association's
(FEMA's) protective action
guidelines, which recommend
responses and corrective
action for nuclear power plant
accidents.
Developing occupational
guidance for worker
exposure to radiation.
Clean Air Act, NESHAPs.
Developing cleanup
standards for Superfund
sites with possible radiation
exposure hazards.
Radon surveys, mitigation
proficiency programs,
training centers, assistance
to states, public information,
federal coordination.
Radiation monitoring,
research, training, and
technical assistance to states.
Low Level Radioactive
Waste Policy Amendment
Act of 1985.
Nuclear Waste Policy Act
of 1982.
Uranium Mill Tailings Radia-
tion Control Act of 1978 (an
amendment to the Atomic
Energy Act of 1954).
Executive Order 12148,
"Federal Emergency
Preparedness Manage-
ment" (1979).
Executive Order 10831,
"Federal Compliance with
Pollution Control Standards"
(1959); Executive Order
12088, 'Federal Compliance
with Pollution Control Stand-
ards" (1978); and the Atomic
Energy Act of 1954.
Comprehensive Emergen-
cy Response, Compensa-
tion and Liability Act of
1980; Superf und Amend-
ments and Reauthoriza-
tionsActof 1986.
Indoor Radon Abatement
Act of 1988.
Public Health Service Act
(1970).
Evaluation of Federal
actions involving.*
Naturally occurring
radionuclides in waste.*
Commodities containing
naturally occurring radio-
nuclides.*
Radionuclides in drinking
and surface water.*
National Environmental
Policy Act of 1969.
Resources Conservation
and Recovery Act (1976)
Toxic Substances Control
Act (1970)
Federal Water Pollution
Control Act (1973) and
Safe Drinking Water Act
(1974)
'The Office of Radiation Programs is not the lead office in
these areas.
Figure 2-1 . Organizational Chart for Office of Air and
Radiation (OAR)
Office Assistant
Administrator
William Rosenberg
(202) 382-7400
Office of Air Quality
Planning and Standards
Gerald Emison
(919)541-5615
Office of Mobile Sources
Richard D. Wilson
(202) 382-7645
Off ice of
Radiation Programs
Richard J. Guimond
(202) 475-9600
Responsible for overall program
management, resource man-
agement, policy analysis, and
program development.
Located primarily in Research
Triangle Park, North Carolina,
this office develops NAAQS,
SNAAQS, NSPS, PSD, and
NESHAPs rules; guidelines
for implementing standards;
and policies related to the
control of stationary and
mobile sources.
Located in Ann Arbor,
Michigan, and Washington,
DC, this office oversees
development and implemen-
tation of mobile source
regulations including emis-
sions control requirements.
The office also oversees com-
pliance monitoring, testing,
and certification programs.
Headquartered in Washington,
DC, with supporting lab-
oratories in Montgomery,
Alabama, and Las Vegas,
Nevada, this office manages all
of the radiation regulatory
programs described in Section
2.1.5.
14
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be more appropriate since it can restrict all pollutants
from a source category.
Assuming a decision is made to cover the substance
under a NESHAP, the Emissions Standards Division
then conducts engineering studies of control tech-
nologies forthe substance. These studies are conducted
by the Industrial Studies Branch (generally for inor-
ganics) or the Chemical and Petroleum Branch (for
organics). The Standards Development Branch (SDB)
(also within the Emissions Standards Division) performs
cost and economic impact assessments of the options.
Following these studies, the Standards Development
Branch becomes the lead branch and develops the
preamble and the regulation.
The preamble, regulation, docket, and support materials
are reviewed internally by several EPA offices and the
Administrator before being published in the Federal
Register as a proposed regulation. During the comment
period, the Standards Development Branch takes the
lead in comment response. After the comments are
received, SDB revises the regulations and circulates
them for internal EPA review. Next, SDB writes a new
preamble and regulation and sends them to the Ad-
ministrator for promulgation.
2.2.3 Development of Radiation Standards
The Office of Radiation Programs within the Office of Air
develops most of the radiation standards described in
Section 2.1.5. In general, the Criteria and Standards
Division takes the lead in regulatory development, with
risk assessment, engineering, economic analysis, en-
vironmental research, and other support provided by the
Analysis and Support Division.
Development of the recently proposed NESHAPs
regulations for radionuclides is summarized here to il-
lustrate the regulatory development process in the Office
of Radiation Programs. (Standards that apply to radioac-
tivity are developed in the Office of Radiation Programs
ratherthan in OAQPS, where most NESHAPs standards
are developed.) For the radionuclide NESHAP, the En-
vironmental Standards Branch within the Criteria and
Standards Division took the lead in regulatory develop-
ment. Extensive technical assistance was provided by
the Analysis and Support Division and by the Las Vegas
facility.
The Analysis and Support Division developed three
major background papers for the proposed rule:
Volume One explains the methodology of the
analysis.
Volume Two consists of the risk assessment for the
12 point-source categories. The Las Vegas facility
and the Montgomery, Alabama, facility assisted the
Analysis and Support Division in preparing the risk
assessments.
Volume Three consists of the economic analysis,
which was prepared by the Economics and Control
Engineering Branch of the Analysis and Support
Division.
Additional information on control methods costs
were developed by a contractor reporting directly to
the Criteria and Standards Division.
A special committee of the EPA Science Advisory Board
peer reviewed the background documents. Based on the
background documents, the Criteria and Standards
Division prepared regulatory options and briefing papers
for internal Agency review. The proposed standards
were published in March 1989. The Agency will receive
and analyze comments from public hearings and written
submissions.
2.3 Health Research Needs
2.3.1 Introduction
This section describes health research needs relevant to
the air program, including issues of interest to NAAQS,
NSPS, NESHAPs, and mobile sources, as well as those
related to indoor air, global change, and radiation.
The air programs require basic toxicity and exposure
information on air pollutants in order to set National
Ambient Air Quality Standards and National Emissions
Standards for Hazardous Air Pollutants, and to make
decisions involving emissions standards for motor
vehicles. All air programs would generally benefit from
research strategies that integrate source and exposure
characterization and health effects research so that re-
search will generate more broadly applicable data.
HERL has a leadership role in air-related health re-
search. It contributes directly to the regulatory process
by anticipating future needs when selecting research
topics for study (e.g., pollutants from alternative fuels)
and coordinating technical interactions at EPA concern-
ing health research and exposure characterization. To
maximize the effectiveness of research, HERL must
work with ECAO, the engineering labs (AEERL and
AERL), the Federal program offices, and the local and
State programs in designing research strategies. A
specific core program should be developed to support
these activities.
2.3.2 Major Research Categories
A. Hazard Identification
Hazard identification is, overall, a medium priority for the
air programs. Although most hazard identification work
has been completed for the NAAQS programs, the iden-
tification of human health effects (particularly develop-
mental and reproductive toxicity, immunotoxicity, hepatic
toxicity, respiratory toxicity, neurotoxicity, mutagenicity,
and cancer) associated with exposures to indoor air,
15
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ultraviolet (UV) radiation, and mobile source emissions
is a high priority.
The mobile source program needs to establish bio-assay
and animal testing protocols (as mandated in Section 211
of the CAA) so that it can evaluate the health impacts of
new fuels and fuel additives. Ultraviolet (UV) radiation is an
important concern for the Global Atmospheric Program.
Although UV-B appears to affect the immune system in
mice, research is needed to determine if it is associated
with the same or other health effects in humans, what the
mechanisms of effects are, whether the effects are long-
lasting and specific, and whether they can be demonstrated
using in vitro assays. The indoor air program needs to know
what pollutants are harmful and at what concentrations,
and what the indicators of toxicity are in identifiable sensi-
tive subpopulattons, for example, the ill. In addition, this
program needs source characterization and health re-
search on biologicals, their organic by-products, and aller-
gic organic particulates.
A major focus of hazard identification research is under-
standing disease processes and their chemical induc-
tion. More sensitive, short-term screening tests for both
cancer and noncancer endpoints would increase EPA's
ability to regulate large numbers of pollutants by enhanc-
ing the specificity of effects data and decreasing testing
costs. Examples of such tests are the bronchtolar-al-
veolar lavage (BAL) technique and other noninvasive
techniques for measuring chronic lung damage, struc-
ture-activity relationship (SAR) methods for application
to diverse toxicologic endpoints, and the gene-tox ap-
proach to both cancer and noncancer endpoints.
B. Dose Response
Establishing what concentrations of substances result in
health effects is central to all health-based decisions;
therefore, dose response is a high priority research area
for all of the ambient air programs, i.e., NAAQS,
NESHAPS, mobile source, indoor air, and State assis-
tance programs. Extrapolating from route to route, and
species to species, across age groups, and from different
exposure scenarios are key issues in dose-response
assessment. Health research to improve understanding
of how and when to perform extrapolations, and how to
use scientific criteria is essential. Specifically, research
is needed to improve knowledge of pharmacokinetics
and pharmacodynamics, mechanism of action, the
variability of physiological parameters, and the relation-
ship between the toxic response and the actual disease
process.
In addition, research to improve dosimetry and to develop
biologically based models is essential to resolving dose-
response issues. Dosing differences for short- and long-
term exposures should be examined in relation to effect,
i.e., whether different effects are observed following one
short-term high dose, multiple low-level closes, and doses
of varying duration, of the same chemical. Most toxicity test
data (approximately 80 percent) are from oral studies.
Since the air program must evaluate the health effects due
to inhalation, route-to-route extrapolation is a very impor-
tant research area. Hypersensitivity reactions and tissue
sensitivity are other critical research areas for both can-
cer and noncancer endpoints. Research is also needed
to elucidate the mechanisms and dose-response
relationships between exposure to electromagnetic
radiation and its effects on the brain, the reproductive
system, and the immune system, and to determine what
frequencies and patterns of exposure increase the
response.
C. Exposure Assessment
Many of the regulated pollutants and many other sub-
stances emitted to ambient air have significant exposure
potential. Hence, exposure assessment remains a high
research priority for the ambient air programs. Research
is especially needed to determine what constitutes ex-
posure to electromagnetic radiation. Research to identify
exposure patterns from a variety of different exposure
scenarios would be useful for evaluating how real-life
dosing patterns affect health outcomes. The effects of
environmental factors, such as temperature and
humidity, on outdoor exposures should also be explored.
In addition, research is needed to characterize air pol-
lutants, particularly to identify atmospheric transforma-
tion products for commonly emitted air pollutants, e.g.,
xylene and toluene, and the constituents of aged atmos-
pheres. It is well documented that multiple chemical
reactions occur once a substance has been emitted to
ambient air and that these reactions modify or create
pollutants that may cause cancer and noncancer health
effects. To measure the potential carcinogenicity of aged
urban atmospheres, the Integrated Air Cancer Project is
using short-term tests for mutagenicity. Mutagenicity
testing can relate health outcomes to exposure in a more
precise way to generate an index of exposure. HERL
should assemble multidisciplinary research teams
similar to those in the Integrated Air Cancer Project to
develop and improve exposure tools for noncancer
endpoints.
D. Chemical-Specific Information
This is a high priority research area for the ambient air
programs, especially for the NAAQS program. NAAQS
pollutants pose a health concern because many areas
have still not attained the standards, resulting in
widespread exposure to unacceptable levels of ozone,
sulfur oxides, nitrogen dioxide, carbon monoxide, lead,
and particulates. Although many of these pollutants al-
ready have an extensive health research data base,
additional data, including an improved scientific base for
RfDs and the development of inhalation RfDs, are
needed to use in the review process and to support
further regulatory actions to achieve compliance.
Ozone is one NAAQS pollutant for which additional data
are especially critical. Over 100 million people currently
live in nonattainment areas for ozone. In addition, the
adequacy of the current ozone standard has been ques-
16
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tioned. Despite the extensive data base available for
ozone, the NAAQS program still needs to determine if
chronic exposure to ozone will result in permanent lung
damage.
Research is also needed on the health effects of sulfur
oxides. Most of the relatively scant epidemiological data
supporting the 24-hour SOa standard was collected in
England and the Netherlands during the 1950s and
1960s; more recent data are needed. The basis of the
annual standard is similarly weak as little data exist on
the health effects of long-term chronic exposure to low
levels of SO2. There is some data that suggest that the
health effects of SO2 depend, in part, on its interaction
with particulates and ozone. Therefore, epidemiological
studies are needed that evaluate long-term effects of
simultaneous exposure to ozone, particulates, and sul-
fur dioxide.
Acid aerosol research is important for current and future
environmental and health issues. HERL-funded re-
search first initiated concerns regarding the health im-
pacts of acid aerosols, to which large numbers of people
are exposed. Research is needed in a number of key
areas, including atmospheric characterization and ex-
posure scenarios; dose-response tpxicity data for these
different scenarios; variability and intensity of effects in
different populations; and specific clinical measure-
ments relating to tissue response.
Nitrogen dioxide is another NAAQS pollutant whose
supporting data base contains many uncertainties, as
many of the key studies were conducted in Great Britain.
Ongoing research in this area is focusing on the relation-
ship of concentration and duration of exposure to ef-
fects, and on understanding the potential mechanism of
nitrogen dioxide-induced chronic disease. New re-
search will focus on the health effects of repetitive,
short-term exposures to high concentrations of nitrogen
dioxide. A better understanding of exposure to
nitrosamines from nitrate is also needed.
Another important research area is the effect of carbon
monoxide on certain sensitive populations, i.e., angina
patients and fetuses. Due to limited funds, research is
limited to the potential impacts of carbon monoxide on
individuals with silent ischemia. Given the widespread
exposure to carbon monoxide, additional research in this
area is needed.
Lead is a compound with a large existing health research
data base. Additional research is needed to provide
guidance on extrapolating from existing oral toxicity data
to the inhalation route and developing pharmacokinetic
models; this information will facilitate estimating the criti-
cal tissue dose from the intake dose.
The mobile source program will need substantial health
research information on methanol and other alternative
fuels. For each alternative fuel, research is needed to
speciate emissions, identify and quantify components,
determine variance with the weather and car perfor-
mance characteristics, and evaluate possible public
health consequences. Since much of this information is
not available for gasoline, additional research may be
needed for gasoline, too.
The indoor air program needs research information on
the levels and effects of environmental tobacco smoke,
volatile organic compounds, acid aerosols, mutagens
from kerosene heaters, radon, fine particulates from
combustion sources, and microorganisms.
The importance of information on other chemical-
specific air toxics will depend on the reauthorization of
the Clean Air Act. With a technology-based approach,
health research needs will focus on establishing de
minimus risk levels for various exposure durations. If the
act includes chemical-specific requirements, additional
chemical-specific data will be needed.
2.3.3 Cross-Cutting Categories
A. Biological Markers
This is a relatively low priority research area for the
ambient air programs. However, because of the impor-
tance of human data in supporting regulations, develop-
ing biomarkers to use in epidemiological research and to
characterize human exposure would be of value. Most
useful would be biomarkers for the following endpoints:
neurotoxicity, immunotoxicity, developmental and
reproductive toxicity, and respiratory toxicity. Biomarkers
that measure early warning signs, thus allowing preven-
tive actions to be taken would be very useful for health
applications. Biomarkers are needed for physiologic
responses of the lung and for physiological measures of
effect for victims of the sick-building syndrome. Refining
information on cotenine in urine as a biomarker for
exposure to environmental tobacco smoke (ETS), for
example, is much needed.
B. Pollutant Mixtures
This is a medium priority health research area for the
ambient air programs. Since auto exhaust, urban air, and
emissions from industn'al and commercial facilities are
composed of hundreds of substances, mixtures research
is of particular concern for the mobile source, hazardous
air pollutant, and indoor air programs, and is also needed
by the NAAQS and urban toxics programs. Four questions
of particular interest are: (1) What are the combined health
effects resulting from exposures to mixtures? (2) What are
the components of concern in mixtures? (3) What are the
significant sources of health risks? (4) What test methods
can be used to evaluate the toxicity of mixtures?
Research is needed to determine the components of
health concern in mixtures and to determine whether
they interact synergistically or additively, under what
conditions, and for which health effects or chemical
classes. Of particular importance to the Agency is the
human response to mixtures of pollutants that are all at
or below their RfD level and to a mixture of the same
17
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pollutants where one or more components exceed their
RfO levels. In addition, methods should be developed
and validated for additional toxic endpoints as described
in Hazard Identification (see Section 2.3.2A), and then
applied to mixtures research.
Test methods are needed for evaluating the toxicity of
whole mixtures (e.g., auto exhaust and urban air) to
complement the information obtained from btoassay-
directed fracttonation (BDF), in which the mixture is
divided, preventing chemical interactions that may affect
its toxicity. Research is needed to improve the predictive
ability of mutagenicity assays for cancer and to develop
reliable short-term tests for noncancer health effects,
especially reproductive/developmental endpoints. Im-
proved testing would help to identify significant sources
of health risks and would lead to regulatory strategies
that focus attention on the mixtures or components of
mixtures of greatest concern.
C. Human Data
This is a high priority research area for the ambient air
programs which are increasing their emphasis on
epidemiotogic research. Human data, including informa-
tion for susceptible populations, are essential in develop-
ing and Devaluating the NAAQS and some of the
hazardous air pollutants; such data often provide key
validation of toxic effects observed in nonhuman
species. Frequently, little is known about the range of
population susceptibility to toxic air pollutants. As a con-
sequence, protecting sensitive subpopulattons has not
played a large role in NESHAPS regulations and urban
toxics programs. This type of data, if available, would
likely have substantial regulatory impacts. Major re-
search areas to be addressed include identifying the
effects, their seriousness or irreversibility, and how dif-
ferent dosing patterns affect them; and validating short-
term tests for noncancer endpoints and biomarkers for
carcinogen exposures.
The research needs of highest priority for ambient air
programs are human data on the chronic effects of ozone
and the acute and chronic effects of acid aerosols. The
mobile source program needs human data on ozone,
oxides of nitrogen, sulfur dioxide, carbon dioxide,
methanol, and aldehydes. In the indoor air program,
research is needed to investigate the biological basis for
hypersensitivity reactions and to develop biomarkers
that can be used to predict effects. The development of
potency estimates and biomarkers for ETS will greatly
facilitate understanding the impact of passive tobacco
smoke exposure on public health. Quantitative dosimetry
and epidemiological research on the effects of
electromagnetic radiation are also of particular impor-
tance, since some data show excess leukemia risk for
children exposed to magnetic fields in their homes.
2.3.4 Emerging Research Needs
Emerging health research needs for the ambient air
programs include epidemiotogic research on the effects
of chronic ozone, acid aerosol, and nitrogen dioxide
exposures. Research on risk assessment extrapola-
tions, including route-to-route, animal-to-human, high-
to-tow-dose, and across exposure durations, will be a
critical need for the ambient air programs for years to
come. To improve risk assessments, information is
needed on how different dosing patterns affect phar-
macokinetics and pharmacodynamics for different
population groups.
Research to examine the toxicity of urban and indoor
atmospheres and industrial and mobile source emis-
sions as well as reaction by-products is an extremely
important future need. Understanding the relationship
between disease processes and mechanisms of action
will also continue to be a major research need. Informa-
tion needs include information on the role of oncogenes
in cancer and development; validation of tests for cancer
and noncancer endpoints; development of noninvasive
methods that are early predictors of disease processes;
and information on the role of air pollutant exposure in
asthma, emphysema, immune dysfunction, and cancer.
2.3.5 Summary
Table 2-6 summarizes the health research priorities for
the air and radiation program. Of high priority are dose-
response issues, exposure assessment, chemical-
specific information, and human data. Of medium priority
are hazard identification and pollutant mixtures. Re-
search on biological markers is of low priority.
Table 2- Important Health Research Needs and
Their Relative Priorities for the Air Program
Research Needs Relative Priorities
1. Hazard Identification
2. Dose Response
3. Exposure Assessment
4. Chemical-specific Information
5. Biological Markers
6. Pollutant Mixtures
7. Human Data
XX
XXX
XXX
XXX
X
XX
XXX
x- Low priority
xx Medium priority
xxx- High Priority
18
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SECTION THREE
DRINKING WATER PROGRAM
3.1 Program Description
3.1.1 Introduction to the Statute and Overview of
the Program Area
EPA's program to ensure the quality of the nation's
drinking water is mandated by the Safe Drinking Water
Act of 1974 (SDWA). The statute was significantly
strengthened by the Safe Drinking Water Amendments
of 1986. The amendments require EPA to set national
drinking water standards for 83 specific contaminants by
1989, and to identify and regulate at least 25 additional
contaminants every 3 years thereafter.
In developing drinking water regulations, EPA estab-
lishes maximum levels of contaminants at which no
known or anticipated adverse health effects will occur
(i.e., Maximum Contaminant Level Goals or MCLGs).
These goals form the basis for National Primary Drinking
Water Regulations, which specify the maximum permis-
sible levels of these contaminants. These levels are
commonly referred to as Maximum Contaminant Levels
(MCLs). The MCLs take into account the MCLG, the
technological feasibility of control systems for the con-
taminant, the analytical detection limits for the con-
taminant, and the economic impact of regulating the
contaminant.
While the primary standards set maximum levels of
contaminants permissible in public water supply sys-
tems, they do not in themselves control the causes of
contamination. The Underground Injection Control (UIC)
Program, also authorized under the SDWA, controls the
use of injection wells to prevent the contamination of
underground sources of drinking water. Other EPA
programs such as the hazardous and nonhazardous
waste program, the pesticide program, the surface water
quality program, the ground-water protection program,
the toxic substances control program, and the Superfund
program all serve in part to protect or clean up drinking
water supplies. These programs are covered in other
sections of this document.
The EPA drinking water program is described here in four
sections:
Section 3.1.2 describes the water supply systems
and contaminants covered under the program.
Section 3.1.3 explains the development of MCLGs
and MCLs.
Section 3.1.4 describes the program to control con-
tamination from underground injection wells.
Section 3.1.5 covers a number of other components
of the drinking water program.
3.1.2 The Regulated Public and Contaminants
The Regulated Public
The MCLs apply to "public water systems," which are
defined in the regulations to include systems that
regularly supply water to 15 or more connections or to
25 or more individuals at least 60 days a year (40 CFR
141.11[e]). This definition encompasses most industrial
and commercial establishments that supply water to
employers and/or customers, although only residential
systems are required to meet all the MCLs. Suppliers of
drinking water are excluded from regulatory coverage if
they only store water, obtain water from a regulated
public water supply, or sell no water (provided that they
are not a carrier of persons in interstate commerce).
The Regulated Contaminants
Prior to the 1986 amendments, EPA had established
interim drinking water standards for 22 contaminants.
The 1986 amendments to the SDWA required EPA to set
MCLs for 83 specific contaminants (Table 3-1). All 22 of
the previously regulated contaminants are included in
this list of 83. The amendments allowed EPA to substitute
up to seven contaminants for those already on the list.
The Agency was required to publish any such proposed
substitutions and explain their rationale.
In evaluating substitutions to the list of contaminants, the
Agency considered the following criteria:
Are there sufficient health effects data upon which to
derive an MCLG?
Are there potential adverse health effects from ex-
posure to the contaminant via ingestion?
19
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Table 3-1 Contaminants to be Regulated under the
SDWA
Volatile Organic Chemicals (VOCs)
Trichloroethylene
Tetrachloroethylene
Carbon tetrachloride
1,1,1-Trichloroethane
1,2-Dichloroethane
Vinyl chloride
Methylene chloride
Benzene
Monochlorobenzene
Dichlorobenzene(s) (O,M,D-)
Trichlorobenzene(s)
1,1-Dichloroethylene
trans-1,2-Dichloroethylene
cis-1,2-Dichloroethylene
Microbiology And Turbidity
Total coliforms
Turbidity
Giardia lamblia
Inorganics
Arsenic
Barium
Cadmium
Chromium
Lead
Mercury
Nitrate
Selenium
Silver
Fluoride
Aluminum
Antimony
Organ ics
Endrin
Lindane
Methoxychlor
Toxaphene
2,4-D
2,4,5-TP
Aldicarb
Chlordane
Dalapon
Diquat
Endothall
Glyphosate
Carbofuran
Alachlor
Epichlorohydrin
Toluene
Adipates
2,3,7,8-TCDD (Dioxin)
Radionuclides
Radium 226 and 228
Beta particle and photon
radioactivity
Uranium
Viruses
Standard plate count
Legionella
Molybdenum
Asbestos
Sulfate
Copper
Vanadium
Sodium
Nickel
Zinc
Thallium
Beryllium
Cyanide
1,1,2-Trichloroethane
Vydate (Oxamyl)
Simazine
PAHs
PCBs
Atrazine
Phthalates
Aery lam ide
Dibromochloropropane (DBCP)
1,2-Dichloropropane
Pentachlorophenol
Picloram
Dinoseb
Ethylene dibromide (EDB)
Dibromomethane
Xylene
Hexachlorocyclopentadiene
Gross alpha particle activity
Radon
Does the contaminant occur in significant amounts
in drinking water? Has the contaminant been widely
detected in significant frequencies?
If data on the frequency and nature of contaminants
are limited, is there a significant potential for drinking
water contamination?
These factors are discussed in detail in 52 FR 25720.
EPA applied the above criteria to determine candidates
for substitution and removal from the list. Based on this
evaluation, the Agency in January of 1988 removed zinc,
silver, aluminum, sodium, dibromomethane, molyb-
denum, and vanadium from the list of 83 contaminants.
In place of these contaminants, EPA added aldicarb
sulfone, aldicarb sulfoxide, ethylbenzene, heptachlor,
heptachlor epoxide, nitrite, and styrene (53 FR 1892).
EPA must publish and update every 3 years a list of
contaminants (in addition to the 83 contaminants for
which MCLs must be promulgated) that may occur in
public water systems and may require regulation under
the SDWA (i.e., the Drinking Water Priority List). The first
Drinking Water Priority List (DWPL) was published on
January 22,1988 (53 FR 1892). This list included the 7
contaminants that were removed from the initial list of 83.
EPA must propose regulations for at least 25 con-
taminants on the list within 2 years following publication.
3.1.3 Establishing MCL Gs and MCLs
The 1986 amendments required EPA to set both MCLGs
and MCLs for the 83 contamir*arvts on an accelerated
schedule. EPA was required to promulgate both MCLGs
and MCLs for 9 contaminants by June 1987 and for an
additional 40 contaminants by June 1988. EPA was
required to publish MCLGs and MCLs for the remaining
contaminants by June 1989. After setting standards for
the 83 contaminants, the Agency must then develop and
propose standards for at least 25 contaminants on the
Drinking Water Priority List. As will be explained below,
the original schedule has been extended.
MCLGs
As the name suggests, MCLGs are goals and not enfor-
ceable standards. EPA must set MCLGs at a level at
which no adverse effects on the health of humans are
known or anticipated to occur, and which allows an
adequate margin of safety. In general, for human or
probable human carcinogens (Group A or B), EPA sets
the MCLG at 0. For possible human carcinogens (Class
C), EPA may set the MCLG based on noncancer
endpoints, allowing an additional margin of safety, or on
carcinogenic endpoints as represented by the 10 or
10 excess cancer risk estimate. For contaminants with
inadequate or no evidence of carcinogenicity, EPA sets
standards based on noncancer endpoints (i.e., the refer-
ence dose).
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Criteria Documents and Health Advisories
The health effects information underlying the MCLGs is
included in EPA's drinking water Criteria Documents.
These documents identify and describe the health ef-
fects information, both for noncancer and cancer effects,
used to develop the health basis for regulating a specific
contaminant. The Criteria Document typically includes
sections on:
Physical and chemical properties.
Toxicokinetics.
Health effects in animals.
Health effects in humans.
Mechanisms of toxicity.
Quantification of lexicological effects.
References.
In addition to the Criteria Documents, EPA publishes
Health Advisories (HAs) that summarize health effects
information for contaminants. These documents include
brief sections on general characteristics of the con-
taminants, occurrence/environmental fate, phar-
macokinetics, health effects, standards for exposure set
by organizations other than EPA, analytic methods, and
treatment technologies. The HAs are intended for
audiences that need basic information on the health
effects and recommended safe levels of contaminants,
but do not need the detailed information contained in the
Criteria Document. HAs are developed primarily for un-
regulated contaminants. They are also developed to
address less-than-lifetime exposure situations. For ex-
ample, operators of water systems that are temporarily
affected by contamination as the result of a spill may
need immediate, concise information on the health
hazards of that contaminant.
MCLS
The 1986 amendments require EPA to prepare and
promulgate MCLs concurrently with MCLGs. The MCL
must be set as close to the MCLG as is "feasible." EPA
evaluates feasibility based on several factors:
The capabilities of existing analytical methods to
detect the contaminant.
The contaminant control potential of the best avail-
able technology (BAT), treatment technique, or other
method to control the contaminant.
The cost of these treatment options.
The impact of the costs of treatment options on a
national, system-wide, and household basis.
The cost and implementation implications of the
treatment options at the State level.
The benefits of the treatment options in terms of a
reduction in disease cases.
The level of health risk associated with the treatment
method. (The Agency seeks to achieve MCLs within
the excess cancer risk levels of 10 to 10 .)
EPA is currently in the process of establishing MCLGs
and MCLs for the 83 contaminants listed in Table 3-1.
MCLs for eight VOCs and f luorite were promulgated
as of July 1988.
MCLs for lead, copper, and corrosion control have
been proposed and will be finalized in November of
1990.
MCLs for 38 contaminants, primarily inorganics and
synthetic organics, were proposed in May of 1989
and will be finalized in December of 1990.
MCLs for radionuclides will be proposed in Septem-
ber of 1990.
MCLs for the remaining contaminants on the initial
list of 83 were proposed in June of 1990.
In addition to the above rules, EPA has proposed require-
ments for disinfection and filtration for all public water
systems using surface water. Under this proposal, all
systems using surface water must disinfect, and may be
required to filter unless certain water quality source
requirements and site-specific conditions are met. The
proposal establishes treatment techniques in lieu of
MCLs for Giardia, viruses, heterotrophic plate count
bacteria, Legionella, and turbidity. Treatment must
achieve a 99.9 percent removal and/or inactivation of
Giardia lamblia cysts and 99.9 percent removal and/or
inactivation of enteric viruses. For systems using ground
water, EPA will propose a regulation covering disinfec-
tion, disinfectants, and disinfection by-products in the
1990-1991 time frame.
3.1.4 The Underground Injection Control Program
The Underground Injection Control (UIC) Program regu-
lates the subsurface emplacement of fluid in wells or
dug-holes with a depth greater than their width. The
program covers the disposal in wells of hazardous
waste, brine from oil and gas operations, certain mining
wastes, and a variety of other substances.
Principally to insure against the contamination of under-
ground sources of drinking water, EPA has established
a classification system and regulatory controls based on
the type of injection occurring in the well (40 CFR 146.5).
The most stringent controls apply to those Class I wells
that are used for injection of wastes classified under the
Resource Conservation and Recovery Act (RCRA) as
hazardous. Class I wells are subject to regulatory re-
21
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quirements concerning their location, the depth of the
injection zone, design and construction, injection rates,
monitoring, and well closure.
Class II wells are used for injection of fluids associated
with oil and gas production and storage. Class III in-
cludes a variety of wells used for solution mining opera-
tions such as the in situ production of uranium, metals,
and minerals such as sulfur, salts, or potash. Regulations
for Class II and III wells are industry-specific and include
construction, operating, monitoring, reporting, and
evaluation requirements (40 CFR 146.21-146.25).
Class IV wells, which are now banned, have been used
in the past for injection of radioactive wastes or RCRA-
classified hazardous wastes into or above underground
sources of drinking water. Class V is a general classifica-
tion that encompasses all injection wells not included in
other categories. Some of these wells may be used to
inject substances not classified as hazardous under
RCRA directly into a drinking water supply. EPA has, to
date, promulgated only reporting and notification require-
ments for Class V wells. A regulatory development initia-
tive was undertaken in 1990; it will encompass all Class
V injection wells in a generic fashion to insure the protec-
tion of underground sources of drinking water.
The UIC regulations are enforced through a well
authorization system using either permits or rules. States
have the option to develop a UIC program that enforces
the EPA standards, prevents unauthorized underground
injections, and allows underground injection only where
the process will not endanger drinking water sources (40
CFR 144.1[e]). States that did not choose to develop a
program are addressed through EPA-administered UIC
programs. All 50 states and the U.S.-administered ter-
ritories have promulgated UIC programs, some of which
are managed by EPA regions.
3.1.5 Other Program Components
State Programs
The SDWA requires States to establish programs to
ensure the quality of drinking water within their borders.
EPA reviews and approves the State programs and
oversees State implementation. At present, all but three
States have approved programs.
State programs must ensure that all MCLs and other
Federal requirements are complied with. To achieve this
requirement, State programs undertake inspections and
surveys, reviews of engineering plans, laboratory analyses
of drinking water supplies, enforcement actions, issuance
and review of operating permits, and training.
Monitoring
EPA and the States require that drinking water supplies
be monitored. Each MCL includes a monitoring require-
ment for that contaminant. Drinking water suppliers must
report their monitoring results to the States. The States
must report any noncompliance to EPA, and must ex-
plain to EPA their plans to correct the problem. In 1987,
EPA issued requirements to monitor for unregulated
contaminants.
Secondary Standards
As guidance to States and drinking water suppliers, EPA
has issued Secondary Drinking Water Standards (also
referred to as Secondary Maximum Contaminant Levels
[SMCLs]). These nonregulatory standards protect
values other than human health, such as esthetic proper-
ties including color, odor, and taste. EPA's secondary
standards are provided in Table 3-2. Additional SMCLs
are being developed and will be added to the standards
included in the table.
Table 3-2 Secondary Standards for Drinking Water
Parameter Standard
PH
Chloride
Copper
Foaming agents
Sutfate
6.5-8.5 mg/L
250 mg/L
1 mg/L
0.5 mg/L
250 mg/L
Total dissolved solids (hardness) 500 mg/L
Zinc 5 mg/L
Fluoride 2 mg/L
Color 15 color units
Corrosivity noncorrosive
Iron 0.3 mg/L
Manganese 0.05 mg/L
Odor
3 threshold
unit number
Prohibition of Lead Materials
The 1986 amendments and subsequent EPA regulations
(40 CFR 141.43) prohibit the use of lead materials in the
installation or repair of any pipe, solder, or flux installed
in a public water system or in a residential or nonresiden-
tial facility providing water for human consumption. The
SDWA amendments banned the installation of plumbing
materials containing more than 0.2 percent lead for
solders and fluxes, and more than 8.0 percent lead for
pipes and pipe fittings in any building connected to a
public water system after June 19, 1986. Each public
22
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water system is required to identify and notify any per-
sons that may be affected by lead contamination of their
drinking water as the result of lead materials in the
distribution system or corrosivity of the water supply
sufficient to cause leaching of lead.
3.2 Program Organization
3.2.1 Organization of the Office of Drinking Water
EPA's Office of Drinking Water (ODW) within the Office
of Water, conducts or oversees all of the regulatory
programs described in Section 3.1. The headquarters
office, located in Washington D.C., develops drinking
water standards and guidance and oversees State drink-
ing water programs.
ODW consists of an Office Director and four program
divisions, as shown schematically in Figure 3-1.
Office Director
Program Development and Evaluation Division
Criteria and Standards Division
State Programs Division
Technical Support Division
To illustrate the functioning of ODW, the role of each
division in the following three regulatory programs is
described below:
Setting MCLGs.
Developing Health Advisories.
Proposing and promulgating MCLs.
3.2.2 Setting MCLGs
The Health Effects Branch (HEB) within the Criteria and
Standards Division (CSD) has primary responsibility for
setting MCLGs and preparing the associated Criteria
Documents. The Environmental Criteria and Assess-
ment Office (ECAO) within the Office of Research and
Development may assist in developing the health-re-
lated assessments required for a MCLG. The process
of developing a MCLG consists of the following basic
steps:
1. HEB conducts a thorough literature review for the sub-
stance, including both computerized and manual searches.
2. HEB obtains the key literature references and reviews
the literature.
3. Based on the literature review, HEB prepares the
Criteria Document in the standard ODW format (see
Section 3.1.3).
Figure 3-1. Organizational Chart for Office of
Drinking Water (ODW)
Office Director
Michael B. Cook
(202) 382-5543
Program
Development and
Evaluation Division
Arnold Kuzmack
(202)382-5515
Criteria and
Standards Division
Margaret Stasikowski
(202) 382-7575
State Programs
Division
Robert J. Blanco
(202) 382-5522
Technical Support
Division
Alan A. Stevens
(513)569-7904
Overall management of
ODW; review and approval
of regulatory actions. The
National Pesticides Sur-
vey, the Hazardous Waste
Injection Task Force, and
the National Drinking
Water Advisory Council are
all located in the Director's
Office.
Resource management
within ODW; assessment
of the costs, benefits, and
impact of regulatory options
(part of the process of set-
ting MCLs).
Assessment of the health
effects of contaminants in
setting MCLGs; develop-
ment of exposure informa-
tion on contaminants;
development of proposed
MCLs and preparation of
the supporting regulatory
package.
Oversight of State drinking
water programs; develop-
ment and implementation
of UIC program.
Technical support in drink-
ing water quality assess-
ment and water supply
technology.
4. The Criteria Document provides ODW's estimate of
the reference dose (RfD) for the substance and the
Drinking Water Equivalent Level (DWEL); both numbers
assume 100 percent exposure through drinking water.
The latter represents the concentration of the substance
in drinking water not expected to cause any adverse
noncarcinogenic health effects in humans over a
lifetime of exposure.
5. The Science and Technology Branch (STB) within the
Criteria and Standards Division prepares a report on the
occurrence and exposure of the substance.
23
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6. Using the Agency-verified RfD and the DWEL, and
the occurrence and exposure information developed by
STB, HEB prepares a risk characterization which is the
basis for setting the MCLG. If the substance is a car-
cinogen, the MCLG is set at 0 (see Section 3.1.3).
7. The MCLG is used in setting the MCL as explained in
Section 3.1.3.
3.2.3 Developing Health Advisories (HAs)
HEB also is primarily responsible for preparing Health
Advisories (HAs). Unlike MCLGs, which are required by
statute, HEB has considerable latitude in determining for
which substances to prepare Health Advisories. HEB
considers specific substances as candidates for HAs
based on several sources of information:
Suggestions by States and EPA regions.
The National Pesticide Survey.
Substances that must be monitored based on Sec-
tion 1445 of the Safe Drinking Water Act but are not
regulated.
Once HEB decides to develop an HA, it uses the same
basic steps as in developing a Criteria Document and
a MCLG. The STB provides information for the HA
concerning the analytical methods for detecting the
contaminant and appropriate treatment technologies.
The HA document includes a RfD and a DWEL. It also
includes a Lifetime Health Advisory which is com-
parable to a MCLG for noncarcinogens. For car-
cinogens, information on lifetime cancer risk is
provided.
3.2.4 Proposing and Promulgating MCLs
The Drinking Water Regulations Branch within CSD
manages the development of MCLs and the support-
ing regulatory packages. As explained in Section
3.1.3, MCLs are set as close as "feasible" to MCLGs.
Feasibility is evaluated by assessing several techni-
cal and economic factors (described in Section
3.1.3).
The process of preparing the MCL and the associated
regulatory package consists of developing information
concerning the various components of the "feasibility"
determination. The Drinking Water Regulations Branch
is supported by several other divisions and branches in
developing this information.
STB within CSD develops a document on the treat-
ment technology and treatment cost for the con-
taminant.
STB and the Technical Support Division in Cincinnati
establish the analytical methods, detection limits,
and laboratory certification criteria for the con-
taminant.
The STB occurrence and exposure document,
described in Section 3.2.2, is used to establish
monitoring requirements and as input to the benefits
assessment.
The Program Development and Evaluation Division
prepares a regulatory impact assessment for major
rules (i.e., rules entailing more than $100 million in
total cost or other major economic impacts) or an
economic impact assessment for minor rules. These
assessments cover the costs, benefits, and
economic impact of the MCLs.
The Program Development and Evaluation Division
prepares an assessment of the paperwork burden
associated with the MCL.
The State Programs Division prepares an implemen-
tation plan for the MCL.
The Drinking Water Regulations Branch pulls together
all the above information in establishing a MCL, prepar-
ing the rulemaking package, and preparing the docket.
Following Agency and Office of Management and Budget
(OMB) review, the MCL is proposed. The Drinking Water
Regulations Branch may "farm out" comments for
response by the divisions that assisted in preparing the
rulemaking package. The branch also develops a com-
munications strategy for the rule in conjunction with the
EPA Office of Public Affairs.
3.3 Health Research Needs
3.3.1 Introduction
ODW's primary health research needs relate to its
responsibility for setting MCLGs and developing HAs.
The listing process for the Drinking Water Priority List
(i.e., the pollutants to be covered under MCLs) is also
driven primarily by health considerations.
Other required ODW activities that may utilize health
research information are development of criteria to deter-
mine the need for installing filtration systems to treat
surface water, treatment technology requirements for
disinfecting all public water systems, monitoring require-
ments for unregulated contaminants, and public notifica-
tion of health risks from drinking water contaminants.
ODW is interested in improving the scientific base on
which to assess the risks of drinking water contaminants.
Enhanced cross fertilization of disciplines within re-
search and development would accelerate scientific
progress. ODW needs general technical assistance from
HERL research scientists since the office does not have
any authority to request scientific information from in-
dustry, and since many of the chemicals regulated under
24
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this program are of little commercial importance, so
industry does not have an incentive to voluntarily test.
ODW's immediate need for the next few years is scien-
tific support for regulating contaminants as required by
the 1986 SDWA amendments.
D. Chemical-Specific Information
Generating chemical-specific information is a very high
priority for the drinking water program since large numbers
of compounds must be regulated in the next few years.
3.3.2 Major Research Categories
A. Hazard Identification
ODW's needs for new test methods for hazard iden-
tification are modest. A more urgent need is filling data
gaps on existing chemicals. However, test methods
currently in standard use may not reflect the most
sensitive toxicologic endpoints, i.e., reproductive and
developmental toxicology or cardiovascular toxicity.
The program would like to be confident that all impor-
tant toxicologic endpoints for a chemical being regu-
lated are taken into account. New methods must also
be capable of providing rapid results. The redesign of
studies and creation of new protocols to provide infor-
mation on mechanism of action are also needed. In
addition, research to develop biologically based
methods for detecting and identifying microorganisms
is needed.
B. Dose Response
Dose-response issues are of high priority to the drink-
ing water program, because extrapolation is the fun-
damental basis for the scientific rationale underlying
most MCLGs. Any research that would contribute to a
better scientific base for extrapolation would directly
benefit the program. Specific needs include research
to refine or develop a biologically based rationale for
applying safety factors, determine the relative sen-
sitivity of different toxicologic endpoints, refine the
shape of all types of dose-response curves, develop
better extrapolation models and methods for evaluat-
ing very low-level exposures, and improve the scien-
tific basis of NOELs.
C. Exposure Assessment
Exposure assessment is a low research priority be-
cause regulated contaminants are known to occur in
drinking water and monitoring requirements are in
place to provide ODW water exposure information.
However, there is significant uncertainty regarding
exposure to contaminants in drinking water from
volatilization and dermal absorption. The drinking
water program is mainly interested in the end result
of toxicology studies; refining exposure to percentile
ranges is not needed and will not affect regulatory
strategy. With human studies, however, charac-
terization of dose - particularly dose contributed by
drinking water exposure to other background ex-
posures - is important, and dose should be refined as
much as possible to improve evaluations of causality.
3.3.3 Cross-Cutting Categories
A. Biological Markers
Research on biological markers is a relatively tow priority for
this program. Biomarker research may be important in
elucidating mechanisms of toxicity and identifying persons
susceptible to xenobiotics in drinking water. Exposure
biomarkers may also be important in refining dose and effect
in human studies for many of the reasons stated above.
B. Pollutant Mixtures
Certain pollutant mixtures are a high research priority for
the drinking water program. Aside from these specific
mixtures, health research needs in this area are limited.
The mixtures research needs of paramount importance
concern disinfection by-products from ozonation,
chloramination, and chlorination. A tiered system, with
strong support from a research base, is needed to assess
these mixtures. Such a system would identify the most toxic
or active fractions and then narrow these fractions to
identify the most hazardous chemicals. This procedure
might lead to the application of control techniques to
remove these toxins or minimize their formation. In addition
to the practical applications of a tiered toxicity evaluation
approach to control health risks from drinking water con-
taminants, mixtures characteristically found in treated
drinking water might be a convenient choice for validating
tiered testing strategies and additivity. Trihalomethanes
were specifically mentioned as a potential model system
for these purposes since standard toxicity information for
many of the individual compounds already exists and
human data are also available.
Development of short-term tests for evaluating toxicity
will allow more rapid screening of infinite varieties of
mixtures. These short-term tests may also be utilized in
a tiered screening system. Such tests, if well validated,
would be of great benefit to many Agency programs.
C. Human Data
Health research needs for human data are a high priority
for the drinking water program. When human data are
available and of good quality, they add strong support to
the scientific base for regulation. Human data from short-
term controlled clinical studies (e.g., blood chemistries in
persons exposed to drinking water disinfectants; suscep-
tibility of glucose-6-phosphate dehydrogenase [G6PD]-
deficient persons to the effects of oxidizers generated
during disinfection) can be particularly useful in meeting
ODW's needs because they can generate information
more quickly and at lower cost than epidemiologic studies.
In addition, epidemiology studies of disease outbreaks
related to microorganisms are needed.
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3.3.4 Emerging Research Needs
The drinking water program has several emerging re-
search needs. Real data gaps exist for cardiovascular
toxicity and immunotoxicology endpoints; these should
be filled over the next decade. These endpoints are
important for several reasons. Human studies in Wiscon-
sin suggest that water hardness may be related to in-
creased low-density lipoprotein (LDL) cholesterol.
Effects on blood lipids have also been seen in animal
studies. Immunotoxicology is important because of the
immune system's role in cancer. Heart disease and
cancer are the two leading causes of death, so research
related to risk factors or mechanisms would have great
public health benefits.
3.3.5 Summary
The research priorities of the drinking water program are
summarized in Table 3-3. Overall the highest priority
health research needs for the drinking water program are
dose-response issues of all types, since animal (and
short-term test) data must be used to set standards;
pollutant mixture issues insofar as they pertain to disin-
fection by-products; human data, particularly from clini-
cal studies of specific design; and chemical-specific
information. The other research areas are of low priority.
Table 3-3 Important Health Research Needs and
Their Relative Priorities for the Drinking
Water Program
Research Needs
Relative Priorities
1.Hazard Identification
2. Dose Response
3. Exposure Assessment
4. Chemical-Specific Information
5. Biological Markers
6. Pollutant Mixtures
7. Human Data
x
xxx
x
xxx
x
xxx
xxx
x ğ Low priority
xx - Medium priority
xxx - High priority
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SECTION FOUR
WATER QUALITY PROGRAM
4.1 Program Description
4.1.1 Introduction to Statute and Overview of the
Program Area
EPA's program to protect the quality of the nation's water
bodies is authorized under the Federal Water Pollution
Control Act of 1972. Since its passage, the statute has
been amended in 1977, 1978, 1980, 1981, and 1987,
and renamed the Clean Water Act. The amended act and
associated regulations attempt to ensure that water
bodies are pure enough for their intended uses (e.g.,
swimming, fishing, navigation, agriculture, public water
supplies). The quality of drinking water is addressed
specifically in the Safe Drinking Water Act, which is
discussed separately in Section Three of this document.
Like many EPA programs, the water quality program invol-
ves both State and Federal governments. Each State is
required under the Clean Water Act to establish ambient
water quality standards for its water bodies. In setting these
standards, States use water quality criteria documents
published by EPA and other advisory information. The
Agency reviews and approves the State's standards.
EPA and the States ensure that ambient water quality
standards are achieved by controlling the sources of
pollution. EPA has established national minimum treat-
ment requirements for sewage treatment plants. The
Agency also has established national effluent limitations,
which constitute minimum levels of pollution control for the
major industries. If, however, sewage treatment plants and
industries are in compliance with the national effluent
limitations and a State's ambient water quality standards
are not being achieved, the State may require levels of
control above those of the national standards. The State
also implements controls on nonpoint sources of pollu-
tion. Thus, EPA's efforts to control water pollution consist
of both minimum national pollutant limitations and addi-
tional controls required to meet ambient water quality
standards (i.e., water quality-based controls).
Sewage treatment plants are large-volume dischargers in
many communities. Most of these facilities treat both
domestic and industrial wastewaters that are discharged
into sewer systems and, in turn, discharge purified effluents
into a water body. Sewage treatment plants have been the
focus of several other programs. EPA has funded sewage
treatment plant construction, established numerical criteria
and additional controls on the disposal of the residuals (i.e.,
sludges) removed during treatment, and provided grant
assistance for the development of innovative treatment
and sludge disposal methods.
EPA's clean water program is described below in five
sections:
Section 4.1.2 describes the scope and coverage of
the Clean Water Act.
Section 4.1.3 describes the ambient standards that
set forth the level of water quality required for the
nation's water bodies.
Section 4.1.4 describes the regulation of pollution
sources, including the effluent limitations for direct
dischargers and pretreatment standards.
Section 4.1.5 describes the Agency's efforts to con-
struct and regulate sewage treatment plants.
Section 4.1.6 describes a number of other EPA
programs to protect lakes, bays, estuaries, and
oceans.
4.1.2 Scope and Coverage of the Clean Water Act
The Clean Water Act primarily protects the nation's sur-
face waters. The term "surface waters" encompasses
rivers, streams, lakes, bays, estuaries, most natural
wetlands, and oceans. The act allows EPA and the
States to regulate all sources of pollution to these water
bodies.
Sources of Pollution
The Clean Water Act regulates three major sources of
pollution:
Direct Dischargers - Sources that discharge their
effluent from a pipe or outfall directly into a receiving
water body.
Indirect Dischargers - Sources that discharge their
effluent into a sewer that flows to a sewage treatment
plant and then, following treatment, into a receiving
water body.
Nonpoint Sources - Diffuse sources that are not
regulated as point sources and normally are as-
sociated with agricultural, silvicultural, construction,
mining, and urban runoff. In practical terms, nonpoint
27
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source pollution does not result from a discharge at
a specific, single location (such as a single pipe), but
generally results from land runoff, precipitation, at-
mospheric deposition, or percolation. However, legal
and regulatory decisions have sometimes resulted
in certain sources being assigned to either the point
or nonpoint source categories because of considera-
tions other than their manner of discharge. For ex-
ample, irrigation return flows are designated as
"nonpoint sources" by Section 402(1) of the Clean
Water Act, even though the discharge is through a
discrete conveyance.
EPA and the States must address all of these sources in
their water pollution control programs.
Type of Pollutants
In regulating sources of water pollution, EPA must address
several categories of pollutants. "Conventional pollutants"
are contaminants found in common household sewage
and, therefore, in the water that flows to sewage treat-
ment plants. Section 304(a)(4) of the Clean Water Act
specifically identifies four conventional pollutants that
must be regulated: biological oxygen demand,
suspended solids, fecal coliform, and pH. The Agency
subsequently has identified "oil and grease" as an addi-
tional conventional pollutant (44 FR 44501).
In addition to the conventional pollutants, EPA also must
regulate toxic pollutants. Section 307(a)(1) of the Clean
Water Act lists 65 toxic pollutant classes (Table 4-1).
From these 65 classes, EPA has identified 126 com-
pounds as "priority pollutants." The priority pollutants are
often referred to as "Section 307(a) pollutants" or simply
"toxic pollutants." Priority pollutants have a special sig-
nificance in that they must be addressed in several parts
of the EPA water quality program, as described below.
Table 4-1 Toxic Pollutant Classes (Listed under Section 307 of the Clean Water Act)
Acenaphthene
Acrolein
Acrylonitrile
Aldrin/Dieldrin
Antimony and compounds*
Arsenic and compounds
Asbestos
Benzene
Benzidine
Beryllium and compounds
Cadmium and compounds
Carbon tetrachloride
Chlordane (technical mixture and metabolites)
Chlorinated benzenes (other than dichlorobenzenes)
Chlorinated ethanes (including 1,2-dichloroethane, 1,1,1-
ethane, and hexachloroethane
Chlorinated naphthalene
Chlorinated phenols (other than those listed elsewhere;
includes trichlorophenols and chlorinated cresols)
Chloroalkyl ethers (chloromethyl, chloroethyl, and mixed
ethers)
Chloroform
2-Chlorophenol
Chromium and compounds
Copper and compounds
Cyanides
DDT and metabolites
Dichlorobenzenes (1,2-, 1,3-, and 1,4-dichlorobenzenes)
Dichlorobenzinine
Dichloroethylenes (1,1-and 1,2-dichloroethylene)
2,4-Dichlorophenol
Dichloropropane and dichloropropene
2,4-Dimethylphenol
Dinitrotoluene
Diphenylhydrazine
Endosulfan and metabolites
Endrin and metabolites
Ethylbenzene
Fluoranthene
Haloethers (other than those listed elsewhere; includes
chlorophenyl-phenyl ethers, bromophenylphenyl ether,
bis (dischloroisopropyl) ether, bis-(chloroethoxy)
methane, and polychlorinated diphenyl ethers)
Halomethanes (other than those listed elsewhere; includes
methylene chloride methylchloride, methylbromide,
bromoform, dichlorobromomethane,
trichlorofluoromethane, dichlorodifluoromethane)
Heptachlor and metabolites
Hexachlorobutadiene
Hexachlorocyclohexane (all isomers)
Hexachlorocyclopentadiene
Isophorone
Lead and compounds
Mercury and compounds
Naphthalene
Nickel and compounds
Nitrobenzene
Nitrophenols (including 2,4-dinitrophenol, dinitrocresol)
Nitrosamines
Pentachlorophenol
Phenol
Phthalate esters
Polychlorinated biphenyls (PCBs)
Polynuclear aromatic hydrocarbons (including
benzanthracenes, benzo-pyrenes, benzofluoranthene,
chrysenes, dibenzanthracenes, and indenopyrenes)
Selenium and compounds
Silver and compounds
2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)
Tetrachloroethylene
Thallium and compounds
Toluene
Toxaphene
Trichloroethylene
Vinyl chloride
Zinc and compounds
'The term "compounds" includes both organic and
inorganic compounds.
28
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The Agency, however, is not limited to these conventional
and priority pollutants in developing its regulatory programs
underthe Clean Water Act. The Agency typically considers
a working list of approximately 400 substances. This list
consists of conventional pollutants, priority pollutants, and
other pollutants that are known to have adverse effects and
for which accurate measurement techniques have been
developed. This latter group of pollutants is referred to as
"nonconventbnal pollutants."
In summary, the EPA's water quality program covers: (1)
all types of surface water bodies; (2) all sources of
pollution to these water bodies; and (3) conventional,
toxic, and nonconventional pollutants discharged by
these sources.
4.1.3 Ambient Water Quality Criteria and Standards
A cornerstone of EPA's water quality program is the
setting of standards for how clean specific water bodies
should be. Both EPA and the States are responsible for
determining acceptable levels of ambient water quality.
The States set and enforce water quality standards for
the waters within their borders. These standards desig-
nate the uses of specific water bodies and the associated
maximum permissible concentrations of pollutants. EPA
reviews and approves the State standards; the Agency
also publishes "water quality criteria" and other health-
related information, which guide the States in setting
maximum pollutant limits.
Water Quality Criteria and Associated Information
Under Section 304(a)(1) of the Clean Water Act, the EPA
must publish water quality criteria for the pollutants listed
under Section 307(a)(1). EPA's water quality criteria set
forth the maximum concentration of pollutants consistent
with the goals of the Clean Water Act. The criteria are
based solely on scientific data and judgment concerning
ecological and human health effects, and must not take
into account economic or technological feasibility.
As specified in the Clean Water Act, EPA's water quality
criteria must reflect the latest scientific knowledge on:
All identifiable effects of pollutants in a water body
(including ground water) on health and welfare.
These include effects on plankton, fish, shellfish,
wildlife, plant life, shorelines, beaches, esthetics,
and recreation.
The concentration and dispersal of pollutants or their
by-products through biological, physical, and chemi-
cal processes.
The effects of pollutants on biological community diver-
sity, productivity, and stability, including information on
the factors affecting rates of eutrophication and rates
of organic and inorganic sedimentation for varying
types of receiving waters.
EPA's criteria development program has focused on
establishing maximum concentrations of pollutants
consistent with the protection of aquatic life and
human health. The Agency has published guidelines
for developing these criteria (FR 44:15971), and for
preparing the associated documents (i.e., Criteria
Documents). In general, each Criteria Document
covers one of the 65 pollutant classes (encompassing
126 priority pollutants), and one or more priority pol-
lutants in that class.
The sections of the Criteria Documents pertaining to
aquatic life include:
Information on acute and chronic toxicity to fresh-
water and saltwater organisms (fish, aquatic inver-
tebrates, and aquatic plants).
Information on bioconcentration of the substance.
Data analysis, rationale, and mathematical deriva-
tion of the criteria (maximum allowable concentra-
tion of the pollutant) consistent with protecting
freshwater and saltwater life.
The health assessment sections of the Criteria Docu-
ments typically include:
Information on possible exposure routes.
Data on pharmacokinetics (to assess the biochemi-
cal fate of compounds in animals and humans).
Information on toxicity (including acute, subchronic,
and chronic toxicity; synergistic and antagonistic
properties; and mutagenicity, teratogenicity, and car-
cinogenicity).
Data analysis, rationale, and mathematical deriva-
tion of the health criteria for the pollutant.
To date, the Agency has developed human health
criteria for 108 of the 126 priority pollutants, and
aquatic life criteria for 26 priority pollutants. EPA also
has developed Water Quality Advisories, which pro-
vide information similar to the Criteria Documents. The
guidelines for derivation of the Water Quality Ad-
visories, and 16 advisories for protection of aquatic
life, will be published during 1990. The Water Quality
Advisories rely on a more limited data base than the
criteria documents and employ more conservative as-
sumptions in establishing recommended pollutant
limitations. They are intended to provide up-to-date
information on a pollutant's effects for contaminants
for which there are insufficient data to establish water
quality criteria. The Agency also maintains the In-
tegrated Risk Information System (IRIS), a com-
puterized data base that compiles environmental
health information for toxic chemicals.
29
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Water Quality Standards
Section 303 of the Clean Water Act requires States to
establish ambient water quality standards for the water
bodies within their borders. Each water quality standard
consists of two principal components:
Designated use of the water body - The States
must designate the intended use of the water body,
taking into consideration Its use and value for public
water supplies, propagation of fish and wildlife,
recreational purposes, agricultural, industrial, and
other purposes, and also taking into consideration
its use and value for navigation."
Water quality criteria consistent with such uses -
These "criteria" are maximum levels of specific pol-
lutants that are consistent with the water body's
intended use.
State standards also contain an antidegradation policy,
which requires that pollution control levels sufficient to
protect existing uses be maintained.
Under Section 303, the States are required to hold public
hearings to review and revise the water quality standards
at least once every 3 years. EPA reviews and approves
the results of these revisions. EPA also evaluates the
State standards to determine their consistency with the
EPA criteria and with the goals of the Clean Water Act.
Prior to the 1987 Amendments to the Clean Water Act,
States had greater flexibility in setting criteria in their
ambient water quality standards. In many cases, the
criteria for a specific water body were stated in qualitative
terms and may not have taken into account toxic pol-
lutants. The 1987 Amendments to the Clean Water Act
established much stricter requirements for the water
quality criteria in a State's standards.
When setting standards for a water body, the States are
required by the amendments to consider the toxic pol-
lutants listed in Section 307 of the Clean Water Act and
to determine whether:
The presence of any pollutant on the list could inter-
fere with the designated uses of the water body.
The EPA has published numeric criteria for those
pollutants under Section 304.
If both of these conditions are met, the State must adopt
specific numeric limits for those pollutants to protect the
designated uses of the water body. A State may consider
local conditions such as pH, temperature, and water
hardness in adapting the criteria to its waters. Depending
on the State's evaluation of local conditions, its numeric
pollutant limits may be more or less stringent than the
EPA criteria, but they must be specific numeric limits.
In cases where the State determines that a specific toxic
pollutant could interfere with a water body's designated
uses, but the EPA has not yet published numeric criteria,
the State must adopt pollutant limits based on biological
monitoring or assessment methods. The States may use
Water Quality Advisories and/or the IRIS data base in
this effort. EPA has prepared a document entitled
"Guidance for State Implementation of Water Quality
Standards for Clean Water Act Section 303(c)(2)(B)" to
assist the States in developing their water quality stand-
ards.
4.1.4 Control of Pollution Sources
EPA and the States control the discharge of pollutants
from all sewage treatment plants and major industrial
sources. These controls include uniform national pollu-
tion control standards for direct industrial dischargers,
indirect industrial dischargers, and sewage treatment
plants. The Agency and States may require controls
beyond those of the national standards, including non-
point source pollution controls, in certain circumstances.
National Effluent Limitations for Direct Dischargers
EPA is required under Sections 301 and 304 of the Clean
Water Act to establish national effluent limitations for the
major categories of industrial dischargers. The industrial
categories covered by this program are listed in Section
306 of the Clean Water Act (Table 4-2).
Table 4-2 Industries Subject to National Effluent
Limitations
Pulp and paper mills
Paperboard, builders' paper and board mills
Meat product and rendering processing
Dairy product processing
Grain mills
Canned and preserved fruits and vegetables processing
Canned and preserved seafood processing
Sugar processing
Textile mills
Cement manufacturing
Feed lots
Electroplating
Organic chemicals manufacturing
Inorganic chemicals manufacturing
Plastic and synthetic materials manufacturing
Soap and detergent manufacturing
Fertilizer manufacturing
Petroleum refining
Iron and steel manufacturing
Nonferrous metals manufacturing
Phosphate manufacturing
Steam electric power plants
Ferroalloy manufacturing
Leather tanning and finishing
Glass and asbestos manufacturing
Rubber processing
Timber products processing
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Some of these categories have been further divided into
"subcategories" based on differences in production
processes and associated pollutants. For each industry,
EPA promulgates several categories of technology-
based effluent limitations:
Best Practical Control Technology Currently
Available (BPT) - This regulation requires industrial
dischargers to implement control technologies
equivalent to the average performance of well-
operated plants in the industry. This was the first
regulation promulgated for most industries and it
represents the baseline from which the impact of
more stringent controls (described below) is
measured.
Best Available Technology Economically
Achievable (BAT) - For toxic and nonconventional
pollutants, this regulation requires industrial sources
to implement controls equivalent to the best existing
performance in their industry.
New Source Performance Standards (NSPS) -
For both toxic sand conventional pollutants, this
regulation requires new facilities to install the best
available demonstrated technology to control ef-
fluents.
Best Conventional Technology (BCT) - This
regulation requires existing dischargers to control
conventional pollutants to a degree that is
reasonable in light of the cost of removing the same
pollutants in sewage treatment plants.
A new plant in any of the industries covered by the
program is subject to NSPS regulations; an existing
facility is subject to BPT, BAT, and BCT standards. For
existing facilities, BAT (for toxics) or BCT (for convention-
al pollutants) may require more stringent controls than
BPT. In those cases, the BPT regulations, which were
the first rules promulgated for each industry, are super-
ceded by the BAT or BCT.
Developing these national industrial effluent limitations
has been a major regulatory activity of EPA for the past
16 years. While health considerations are taken into
account in identifying the pollutants that must be covered
(the toxic, conventional, and nonconventional pol-
lutants), the decision on the required level of control is
based primarily on technology and cost considerations,
and not on health concerns.
The relative toxicity of pollutants, however, may be a
factor in selecting the technology on which to base a
pollution control for an industry. In setting BAT and
NSPS, EPA may evaluate several different technologies
that vary in their effectiveness in removing certain toxic
pollutants. To compare the technologies, the Agency
may calculate the cost effectiveness of each technology
(i.e., the cost per weighted pound of toxic pollutants
removed). The "weightings" used in this calculation are
based on the toxic effects of the pollutants, using EPA
criteria as a measure of these effects.
EPA has set BPT, BCT, BAT, and NSPS for most of the
27 industrial categories listed in Section 306 of the Clean
Water Act, and the Agency is now completing its stand-
ards forthe remaining categories. These existing effluent
limitations, however, have not been developed for every
subcategory within the major categories. Furthermore,
industrial process technology and pollution control tech-
nology have changed since some of the initial effluent
limitations were promulgated. For these reasons, the
1987 Clean Water Act amendments require a substantial
review and consideration of revisions to the national
effluent limitations.
Section 304(m) of the 1987 amendments requires EPA
to publish every 2 years:
A schedule for review and revision of promulgated
effluent limitations.
An identification of sources of pollutants for which
effluent limitations have not been published.
A schedule for developing effluent limitations for the
uncovered categories.
In August of 1988, EPA proposed its first plan under
Section 304(m). The final plan will be issued in early
1990.
Effluent Limitations for Sewage Treatment Plants
EPA has also established specific effluent limitations for
sewage treatment plants. In general, municipal was-
tewater treatment plants must provide a minimum of
secondary treatment. Secondary treatment is defined as
a concentration of biological oxygen demand (BOD) and
total suspended solids (TSS) of 30 mg/L or less each.
EPA programs covering sewage treatment plants are
described in more detail in Section 4.1.5.
Pretreatment Standards
Concurrently with the development of effluent limitations
for direct dischargers, EPAdevelpps pretreatment stand-
ards for indirect dischargers in the major industrial
categories. Like the industrial effluent limitations, EPA
has promulgated national pretreatment standards for
most of these major industrial categories. EPA's review
and planning document for the national effluent limita-
tions, described above, also covers the Agency's plans
for revising the pretreatment standards. Where neces-
sary to meet permit limits or sludge use/disposal require-
ments, local sewage treatment authorities develop local
limits that go beyond the national categorical pretreat-
ment standards.
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Nonpolnt Sources
As part of the Water Quality Act of 1987, Congress added
specific new nonpoint source (NFS) provisions to the Clean
Water Act in the form of Section 319. Under these
provisions, each State was required to prepare and submit
to EPA by August 4, 1988, a NFS assessment of its
navigable waters and a 4-year NFS management program.
The NFS assessment was to identify all navigable waters
within the State which, without further action to control NFS
pollution, would not attain or maintain water quality stand-
ards. The management program was to identify best
management practices (BMPs), programs, and funding
sources, and to establish milestones for addressing, over
the next 4 years, the leading water quality programs iden-
tified in the State's NFS assessment. States were also to
identify in their management programs any Federal assis-
tance programs and development projects which they
wished to review for consistency with their NFS manage-
ment programs. EPA has 6 months from submittal to ap-
prove or disapprove the State's assessment and/or
management program; EPA may approve only a portion of
the management program.
Due to resource and experience limitations, a number of
States have been stow to submit final assessments and
management programs. However, as of December
1989, all States had submitted their assessments and
management programs. EPA Headquarters and Regions
are working actively with the States, through in-house
staff and contractual support, to provide the States with
needed technical, analytic, and management support.
EPA expects to take final action to approve, disapprove,
or approve in part all of the State management programs
by early 1990.
National Pollutant Discharge Elimination System
(NPDES)
EPA's control of water pollution sources is enforced through
the National Pollutant Discharge Elimination System
(NPDES). The NPDES program requires dischargers to
obtain permits specifying the permissible concentration or
level of contaminants in their effluent. EPA authorizes
States to operate the NPDES system, provided that the
State program meets all of the EPA requirements. For
States that have not received NPDES delegation, EPA
Regional offices issue NPDES permits. As of December
1989, 39 States had received NPDES delegation. Some
States without delegation issue their own permits in addi-
tion to the EPA-issued NPDES permits.
EPA and the States use the NPDES permitting system
to attain water quality standards. If a State is enforcing
the national effluent limitations and still is not meeting its
ambient water quality standards, it must require more
stringent controls, and incorporate these requirements
into NPDES permits for affected facilities. Permits incor-
porating these additional levels of control are referred to
as "water quality-based permits." EPA has developed
guidance publications to aid States and Regional EPA
officials in writing these permits.
4.1.5 Sewage Treatment Plant Programs
Construction Grants/Revolving Loans
As explained in Section 4.1.4, EPA requires sewage
treatment plants to achieve a minimum of secondary
treatment. The Agency has, in the past, provided much
of the funding for the construction of sewage treatment
facilities. Between 1972 and 1988, the Federal govern-
ment provided approximately $60 billion in grants to local
agencies to plan, design, and construct sewage treat-
ment plants. These grants have covered as much as 85
percent of the capital costs determined to be eligible
underthe EPA Construction Grants Program regulations.
Over the years, varying amounts of Construction Grants
funding appropriations have been set aside to fund spe-
cial programs such as nonpoint source control projects
or special estuarine projects.
The 1987 amendments provided for a gradual phase-
down of Federal financial assistance for plant construc-
tion, and grant funding will be phased out by 1991.
Between 1987 and 1994, the Federal government will
provide startup money to States to set up revolving loan
funds. These permanent State-run programs will provide
low-interest loans and other nongrant assistance to local
governments for building or improving sewage treatment
plants.
Pretreatment Programs
EPA requires all sewage treatment plants with wastewater
inflow greater than 5 million gallons per day to establish
pretreatment programs. Under these programs, the
sewage treatment plants regulate discharges into
municipal sewers by industries and other entities. The
sewage treatment plants must, at a minimum, enforce
the national pretreatment standards (described in Sec-
tion 4.1.4) and may implement additional controls or
limits based on local conditions (i.e., local limits). EPA
authorizes the States to review and approve the pretreat-
ment programs of individual sewage treatment plants.
Sewage treatment plants may implement local limits for
any of the following reasons:
A treatment plant's NPDES permit may require
removal of toxic pollutants that the plant itself cannot
remove.
Pollutants discharged into the sewage system may
adversely affect the performance of the removal
systems in the sewage treatment plant.
Pollutants discharged into the sewage system may
contaminate the treatment plant's residuals (sludge),
making sludge disposal more difficult and expen-
sive.
For all these reasons, sewage treatment plants may
require companies to control pollutants beyond the level
required under the national pretreatment standards.
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Sludge Disposal Regulations and Programs
Sewage treatment plants generate residual sludge in
their wastewater purification processes. Over the past
two decades, regulations have been issued under
several different statutes that directly impact various
sludge use and disposal practices. Under Section 405
of the Clean Water Act, EPA is required to regulate the
use and disposal of these sludges. EPA is currently
developing new comprehensive technical regulations
governing five major sludge use and disposal prac-
tices: (1) incineration, (2) landfilling in sludge-only
landfills (co-disposal of sludge with municipal solid
waste is covered under EPA's solid waste program),
(3) land application, (4) distribution and marketing, and
(5) surface disposal.
The new sewage sludge regulations were proposed for
public comment in February 1989 (FR 54:5746,
February 6, 1989). These proposed standards set
limits on the concentration of many contaminants in
sludge for each disposal practice. The pollutant limits
for most of these disposal methods are based on EPA's
health risk assessment of the various contaminant
transport pathways. For disposal methods that do not
have a significant impact on human health (e.g., non-
agricultural land application) and for pathogen control
requirements, EPA has proposed maximum con-
taminant levels that are not based on a detailed human
health risk assessment.
Other Sewage Treatment Plant Programs
To encourage the environmentally sound functioning of
sewage treatment plants, EPA operates a number of
research and grant programs. These programs cover:
Fate of toxics in wastewater treatment/sludge dis-
posal practices.
Advancements and improvements to wastewater
treatment and sludge management practices.
Health risks of wastewater and sludge management
practices.
Combined sewer and stormwater control alterna-
tives.
Useofwetlandsandothernaturalsystemsforwastewaler
treatment.
A number of other wastewater treatment and sludge
use and disposal topics.
4.1.6 Other Clean Water Act Programs
EPAand the States operate a number of programs aimed
at addressing the particular pollution problems of lakes,
estuaries, oceans, and bays.
Lakes - Each State must submit to EPA every 2
years a report on the status and trends of its lake
water quality, including a list of impaired and
threatened publicly owned lakes, and a description
of the methods and procedures to be used to control
sources of pollution, to restore lake quality, and to
mitigate the harmful effects of high activity. EPA, in
turn, must submit a Report to Congress every 2
years on lake quality throughout the nation. EPA
provides limited grant assistance to States for
programs to improve/protect lake quality. EPA also
operates, in conjunction with Canada, a program to
improve the quality of the Great Lakes.
Estuaries - EPA participates, along with several
other agencies, in a number of programs to study,
monitor, and improve the quality of the nation's es-
tuaries. This includes a nationwide study of pollution
problems in coastal areas, including an assessment
of pollutant concentrations, marine ecology, and
other environmental parameters. The Agency is also
developing management programs to improve the
quality of selected estuaries. These programs in-
clude recommended corrective action and com-
pliance schedules to control both point and nonpoint
sources of pollution.
Oceans - Under the NPDES program, EPA and the
States control the discharges of offshore sources of
pollution, such as oil and gas platforms. Under Section
403(c) of the act, EPA promulgates guidelines (i.e.,
ocean discharge criteria) for determining the effect of
pollution discharges on ocean water quality and other
esthetic, recreational, and economic values of the
oceans. No permit for an ocean discharge can be issued
unless it is determined that the discharge will not cause
unreasonable degradation of the environment.
Chesapeake Bay Program - EPA is working with
States contiguous to the Chesapeake Bay to
develop a program that coordinates Federal and
State efforts to improve the quality of the bay.
4.2 Program Organization
EPA's Office of Water (OW) oversees the surface water
quality programs described in Section 4.1. The headquarters
office in Washington D.C. develops national regulations and
oversees State programs. States and EPA Regional offices
are involved extensively in setting water quality standards
and in permitting. Five offices within the Office of Water
(Figure 4-1) are involved in surface water programs:
Office of the Assistant Administrator
Office of Water Regulations and Standards
Office of Water Enforcement and Permits
Office of Municipal Pollution Control
Office of Marine and Estuarine Programs
33
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Figure 4-1. Organizational Chart for Office of Water
Assistant Administrator
LaJuana Wilcher
(202) 382-5700
Office of Water
Regulations and
Standards
Martha G. Protho
(202) 382-5400
Office of Water
Enforcement and
Permits
James R. Elder
(202) 475-8488
Office of Municipal
Pollution Control
Michael J. Quigley
(202) 382-5850
Office of Marine and
Estuarine Protection
Tudor T. Davies
(202)382-7166
Oversees EPAsurface water
quality, drinking water, and
ground-water programs.
Devebps national regula-
tions including effluent
guidelines regulatbns,
sludge use and disposal
regulations, and pretreat-
ment standards.
Reviews and approves
State NPDES programs
and major State permits.
Issues permits in States
that dp not have NPDES
authority and in Federal off-
shore areas.
Directs programs related to
sewage treatment plants
including the Construction
Grants Program, the State
Revolving Fund program,
and technical assistance
and grant programs.
Oversees programs for
protection of marine waters,
lakes, bays, and estuaries.
To illustrate the functioning of the Office of Water, the role
of each office in the following three regulatory activities
is described below:
Development of water quality criteria.
Development of sludge disposal criteria.
NPDES permitting.
4.2.1 Development of Water Quality Criteria
The Criteria and Standards Division (CSD) within the
Office of Water Regulations and Standards (OWRS)
develops water quality criteria and the supporting
documentation. As explained in Section 4.1.3, Criteria
Documents provide estimates of acceptable pollutant
limits to protect aquatic life and human health. EPA's
Environmental Research Laboratories in Duluth, Min-
nesota, and Narragansett, Rhode Island, support CSD
in developing freshwater and saltwater criteria, respec-
tively, to protect aquatic life. The Environmental Criteria
and Assessment Office (ECAO) in Cincinnati supports
CSD in developing human health criteria.
The Duluth and Narragansett laboratories develop water
quality criteria based on procedures set forth in a docu-
ment entitled "Guidelines for Deriving Numerical Nation-
al Water Quality Criteria for the Protection of Aquatic
Organisms and Their Uses." The guidelines specify the
information required to establish criteria including acute
and chronic animal toxicity, plant toxicity, bioaccumula-
tion, and other data. Criteria writers must:
Conduct literature searches to determine the data
available.
Assess the qualitative and quantitative adequacy of
the data with respect to the guidelines.
Conduct additional tests to supply missing data.
Using formulas in the guidelines, derive estimated
aquatic criteria and supporting documentation.
The human health section of the Criteria Documents are
developed by ECAO using a guidance document entitled
"Human Health Water Quality Criteria Guidelines."
ECAO performs a literature review and identifies data
gaps. ECAO's health risk assessment results are
reviewed by the RfD Working Group (for noncancer
endpoints) and the Cancer Risk Assessment Verification
Endeavor (for cancer endpoints). Following this review,
ECAO drafts the human health sections of the document
for incorporation by CSD.
Once both the aquatic and human health criteria have
been derived, CSD reviews the information and compiles
a draft criteria document. This draft is peer reviewed by
the Science Advisory Board prior to publication. After the
review is completed, EPA publishes the criteria in the
Federal Register. CSD reviews and responds to public
comments, with the labs assisting as necessary, before
publishing final criteria.
4.2.2 Development of Sludge Disposal Criteria
CSD also develops EPA's municipal wastewater sludge
use and disposal regulations. In most national technol-
ogy-based regulations, the Industrial Technology
Division (ITD) within OWRS takes the lead role. The
sludge disposal criteria, however, are risk-based and
were, therefore, developed in CSD because the latter is
more typically involved in risk-related programs.
CSD developed the sludge disposal regulations with the
assistance of several other groups within the Agency.
34
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1. CSD, with the assistance of ECAO in Cincinnati,
developed risk assessment models to determine the
health impact of pollutants introduced into the en-
vironment through all sludge use and disposal path-
ways.
2. Using the risk assessment models, CSD determined
the maximum concentration of contaminants in sludge
for each disposal method that would result in an accept-
able level of risk.
3. Based on draft regulations, the Economic Analysis
Branch (EAB) with the Analysis and Evaluation Division
of OWRS performed a draft regulatory impact assess-
ment (RIA).
4. The regulations were refined in an interactive process
involving CSD and EAB. The Office of Water Enforce-
ment and Permits reviewed the draft to determine its
enforceability.
5. The regulatory package was subject to Agency and
OMB review and issued as a proposed rule.
6. The proposed rule was subject to public comment
prior to issuance of a final rule, expected in October of
1991.
4.2.3 NPDES Permitting
The Office of Water Enforcement and Permits (OWEP)
administers the NPDES permitting program. For States
that do not have NPDES authority, the EPA Regional
office issues NPDES permits. EPA's OWEP head-
quarters office reviews and oversees State programs,
reviews major permits, and develops guidance informa-
tion for permit writers.
Most NPDES permitting consists of the reissuance of
existing permits rather than the issuance of entirely
new permits. (NPDES permits must be renewed at
least every 5 years.) The basic steps in permit is-
suance are:
1. The permittee fills out an application form which
specifies the location, intake and effluent characteristics,
and treatment technologies of the facility.
2. This form is reviewed for completeness by the permit
writer. The permit writer may request additional informa-
tion from the permittee.
3. The permit writer develops permit limits using three
principal methods:
Effluent Guidelines - If the source is covered under
national emissions limitations, these limits are in-
cluded in the permit.
Water Quality Standards - Based on State water
quality standards (as described in Section 4.1), the
permit writer may require control of certain con-
taminants or of the toxicity of the whole effluent.
These controls may exceed the requirements of
applicable national effluent limitations. EPA Head-
quarters has prepared and is currently reviewing
technical support documents to assist permit
writers in water quality-based permitting. Material
currently under development will incorporate a
more explicit treatment of health effects issues in
this process.
Best Professional Judgment (BPJ) - In the ab-
sence of effluent guidelines applicable to a given
source, permit writers may develop technology-
based requirements using their best professional
judgment. BPJ permitting may involve an economic
feasibility determination.
4. Once the permit writer develops the applicable effluent
limitations, he/she sends the draft to the applicant and
publishes the draft permit in a manner which notifies the
general public of the proposed activity.
5. The permit writer accepts comments from all inter-
ested persons.
6. The permit writer responds to comments and issues
the permit in final form.
7. Any person who has participated in the process has
the right to appeal the permit's conditions as being too
lenient or too stringent.
4.3 Health Research Needs
4.3.1 Introduction
The water quality program uses health research informa-
tion in (1) establishing water quality criteria for open
water bodies, (2) setting emissions limitations for in-
dustrial discharges, (3) listing priority pollutants, (4)
generating various programmatic working lists, and (5)
setting limits for chemical and biological pollutants in
sludge for each use and disposal method. Additionally,
programs and criteria for lakes, bays, estuaries, and
oceans are based in part on the effects of pollutants in
fish and shellfish.
Because of the large numbers of substances that must
be regulated under the Clean Water Act, there is consid-
erable need for a steadily improving scientific base of
information. In addition to the Federal program needs
described above, States require health-related informa-
tion for developing water quality standards, setting per-
mit limits, and other activities. Some States have
developed health-based standards for ground-water
protection.
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4.3.2 Major Research Categories
A. Hazard Identification
Hazard identification is a high priority for the water pro-
gram. Because of the large numbers of substances that
must be regulated, test methods that are inexpensive
and relatively quick to conduct (e.g., using species other
than rats and mice) are critically needed, including reli-
able shorter term test methods for field samples. OW
believes that these test methods (even if only partially
validated) would still be useful for screening purposes
because of the complex nature and magnitude of the
emissions that must be regulated. In addition, due to the
decentralized nature of the regulated sources and the
large numbers of individual emitters whose emissions
vary from day to day, the water program critically needs
hazard identification methods that can be applied to
effluent emissions on a localized basis.
Hazard identification methods are needed to cover all
important toxicologic endpoints. Currently, cancer-re-
lated endpoints are overemphasized. Gaps in research
concerning short-term tests for all noncancer endpoints
need to be addressed. Cardiovascular toxicity was
specifically cited as one important research area.
While test methods are being developed, the use of
structure-activity relationship (SAR) methods to assess
various toxicologic endpoints should be validated. The
benefits and feasibility of SAR in generating or sup-
plementing other types of health research information
can then be evaluated.
B. Dose Response
Dose-response issues are a high priority for the water
program because of the large numbers of pollutants
that must be regulated and the unevenness of the
overall health research data base. Major emphasis
should be placed on validating assumptions used in
extrapolation. Research is needed to reduce scientific
uncertainties and to better characterize variability
among various parameters for toxic actions. While
fine-tuning of pharmacokinetic data is not seen as
having immediate benefit for regulatory activities,
some research in this area would be helpful in deter-
mining which target organs are at risk.
C. Exposure Assessment
Exposure assessment is of medium priority to the water
program, which has less need for this information than
other EPA programs.
D. Chemical-Specific Information
The water program must regulate approximately 500
chemicals from the National Sewage Sludge Survey.
Because of the large number of pollutants, the Health
Effects Research Laboratosy (HERL) may need to
generate health research information for specific chemi-
cals to fill data gaps. However, many of these chemicals
are also on lists from other EPA programs, so consider-
able health research information is expected to al-
ready exist. For this reason, the need for health re-
search information on specific chemicals is relatively
low; however, research will be a high priority for some
chemicals.
4.3.3 Cross-Cutting Categories
A. Biological Markers
Biological markers are a low research priority for the
water program because they are viewed as a tool for
performing exposure assessments. However, research
to develop biomarkers of effect for whole-animal studies
would be useful. If a biomarker seen early in a study is
found to predict the later development of certain toxic
endpoints, it might be possible to shorten the length of
the current tests. This research activity could be con-
ducted as a part of new test method development or
experimental protocols.
B. Pollutant Mixtures
Pollutant mixtures is the single most important health
research area for the water program. This program
must address risk issues for approximately 1,200 syn-
thetic organic chemicals from 60 chemical families.
Since there are only 400 or so chemical analysis
methods for pollutants, in many cases, the specific
chemicals being emitted cannot be determined. In
addition, the type and relative proportion of pollutants
in water bodies change continuously. For these
reasons, a chemical-by-chemical approach to testing
cannot guarantee sufficient health protection.
Likewise, the assumptions in the mixtures guidelines,
which rely on data from individual chemicals, will lead
to an excessively narrow approach. New methods for
testing the health effects of chemical mixtures are
critically needed, particularly short, simple tests that
can be done in the field on a daily basis.
A tiered approach for assessing health effects from
chemical mixtures should be considered. This approach
could integrate information from both new short-term
screening tests and standard chemical-specific whole-
animal studies. Health research would be needed to
provide scientific support for activities in each tier and
the critical path.
A tiered approach would benefit the water program sub-
stantially. For example, if the first tier results indicated
that controls should be imposed on an industry, but
economic analysis showed that the control cost would be
prohibitive, additional tiered tests could be done, includ-
ing biofractionation and chemical analysis. If a small
number of the many compounds present are identified
as having the greatest toxicologic risks, then industry and
the water program can focus on strategies for removing
these for a fraction of the cost of removing the whole
effluent. These types of strategies can foster effective
environmental and public health protection while mini-
mizing economic impacts.
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The rationale for a tiered system depends on a strong
health research base. The methods should be validated
and the usefulness of SAR data for tiered decision-
making should be explored.
C. Human Data
The generation of human data is a low priority for the
water program. Regulation of the large numbers of
chemical pollutants over the next few years will rely
overwhelmingly on existing research information and
whatever additional animal and short-term test data be-
come available. In general, the long time frames neces-
sary for obtaining human epidemiologic data make these
methods impractical for the water program needs.
4.3.4 Emerging Research Needs
Emerging health research needs are primarily in the
areas of methods development for chemical mixtures
and development of scientifically valid tiered strategies
for identifying and characterizing toxic risks. A related
need is for new and improved protocols for single chemi-
cals to provide a more complete scientific base for as-
sessing health risks. Because of the large number of
pollutants that will require regulation overthe next few
years, more rapid development of Rf Ds will be a critical
need.
Table 4-3 Important Health Research Needs and
Their Relative Priorities for the Water
Quality Program
Research Needs
Relative Priorities
1. Hazard Identification
2. Dose Response
3. Exposure Assessment
4. Chemical-Specific Information
5. Biological Markers
6. Pollutant Mixtures
7. Human Data
xxx
xxx
xx
x
x
xxx
x
x - Low priority
xx - Medium priority
xxx - High priority
4.3.5 Summary
The research priorities of the water program are sum-
marized in Table 4-3. The highest priority health research
needs for the water program are pollutant mixtures,
hazard identification, and dose response. Of medium
priority is exposure assessment. The lowest priorities for
this program are biological markers, human data, and
chemical-specific information.
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SECTION FIVE
THE PESTICIDE PROGRAM
5.1 Program Description
5.1.1 Introduction to Statute and Overview of the
Program Area
EPA's program to regulate the distribution and use of
pesticides is authorized under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Under this pro-
gram, pesticide companies must submit to EPA informa-
tion on the toxicity, residue chemistry, environmental
fate, and other environmental characteristics of each
pesticide product. EPA evaluates the information and
determines whether each pesticide is free of un-
reasonable adverse effects and, therefore, should be
registered (i.e., licensed) for use and, if so, whether to
place any safeguards or restrictions on such use. The
pesticide program, therefore, is essentially a licensing
program.
Pesticides have been regulated at the Federal level
since the Insecticide Act of 1910 [36 Stat. 331 (1910)].
The FIFRA law was originally passed in 1947 and was
amended in 1972, 1975, 1978, 1980, and 1988. The
most recent amendments and associated regulations
require manufacturers to submit more extensive testing
data than previously required. EPA not only evaluates
and registers new pesticides, but also requires that
previously registered pesticides be "reregistered" to en-
sure that they meet all the current FIFRA requirements.
Typically, EPA grants the registration and specifies the
labeling that must accompany the pesticide to ensure
safe use. Some pesticides, however, appear to pose an
unacceptable level of risk. In these cases, EPA may
institute a "special review" procedure to determine
whether to prohibit or restrict distribution and use of the
substance. In extreme cases, EPA can implement emer-
gency suspension procedures to take a hazardous
product off the market.
The following discussion describes EPA's pesticide pro-
gram in five sections:
Section 5.1.2 describes the substances covered
under the pesticide program.
Section 5.1.3 describes the registration process for
new pesticides.
Section 5.1.4 describes the program to reregister
previously registered pesticides.
Section 5.1.5 describes the Special Review process
used to evaluate pesticides that may present human
health or environmental problems.
Section 5.1.6 describes the regulations and restric-
tions placed on pesticides that are registered for use,
and other elements of the program.
5.1.2 Coverage of the Pesticide Program
FIFRA identifies four broad categories of substances for
regulatory coverage:
Pesticides - Substances or mixtures of substances
that prevent, destroy, or mitigate any pest. (The term
"pest" refers to insects, rodents, nematodes, fungi,
weeds, viruses, bacteria, and other microorganisms
that do not live in or on living humans or animals.)
Plant Regulators - Substances that retard, ac-
celerate, or otherwise alter through physiological
action the rate of growth, maturation, or behavior of
a plant.
Defoliants - Substances that cause leaves or foliage
to drop off a plant.
Deslccants - Substances that artificially accelerate
the drying of plant tissue.
In the following discussions, all these substances are
referred to as "pesticides."
Each pesticide product contains one or more "active
ingredients" that bring about its intended function. For
example, the active ingredient in a defoliant is the sub-
stance that causes the plant's leaves to fall off. Each
product also typically contains a number of inert in-
gredients (e.g., solvents). FIFRA refers to a pesticide's
active ingredients in specifying applicable requirements.
Rereglstratlon. Pesticides containing active ingredients
first registered prior to November 1, 1984, must be
reregistered in accordance with the 1988 FIFRA amend-
ments. Exceptions to this are pesticides that were
evaluated between November 1, 1984, and December
24,1988 (the effective date of the 1988 amendments),
and were found to meet all data, safety, and performance
requirements for registration. Approximately 600 active
ingredients present in 35,000 pesticides are covered in
the reregistration program.
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Registration. The registration program covers the
review of applications to register new products or to
amend registrations. If the product is identical or sub-
stantially similar to (e.g., has the same active ingredient
as) an existing pesticide, the registration process may be
expedited, and the requirements to generate new testing
data may be reduced. In a typical year, EPA registers
approximately 10 to 15 new active ingredients and
processes thousands of "me too" applications and
amendments (i.e., applications for products with the
same active ingredients as products that had been ap-
proved previously).
5.1.3 Registration of Pesticides
The procedures for registering new pesticides are out-
lined in Section 3 of FIFRA. Each applicant must file a
statement that provides:
The name and address of the applicant.
The name of the pesticide.
A complete copy of the labeling for the pesticide, a
statement of all claims made for it, and any directions
for use.
A full description of the tests and test results made
for the pesticide, or, alternatively, a citation to data
that have appeared in the literature or have been
submitted previously to EPA.
If the pesticide has a new active ingredient, EPA must
publish a Federal Register Notice informing the public
of the application. The Notice must provide for a 30-day
period during which interested parties may comment.
Data Submission Requirements
To support a registration application, EPA may require as
many as 150 different technical studies and data submis-
sions. FIFRA gives EPA a great deal of authority to
require industry to conduct tests and submit the results
to the Agency. The testing data required for a pesticide
registration are described in 40 CFR158. For each of six
general use patterns (terrestrial, aquatic, greenhouse,
forestry, domestic outdoor, indoor), the regulations iden-
tify the types of information that might be required,
including:
Data on product chemistry - These include infor-
mation on product composition and chemical and
physical characteristics (e.g., color, odor, physical
state, stability, corrosion, dielectric breakdown volt-
age).
Data on residue chemistry - These are used to
estimate the exposure of the general population to
pesticide residues in food, and to set and enforce
tolerances for pesticide residues in food or feed. The
data required may include the chemical identity and
composition of the pesticide product; the amounts,
frequency, and times of pesticide application; and
test results on the amount of residues remaining in
or on the treated food or feed.
Data on environmental fate - Environmental fate
studies are conducted to obtain data on pesticide
degradation, mobility, dissipation, and accumulation.
These studies are used to assess toxicity to humans
of pesticide residues remaining after application; the
presence of pesticides in the environment that may
result in loss of usable land, surface water, ground
water, and wildlife resources; and the potential en-
vironmental exposure of nontarget organisms, such
as fish and wildlife, to pesticides. These studies also
are used to estimate the expected environmental
concentrations of pesticides in specific habitats
where threatened or endangered species or other
wildlife populations at risk are found.
Data on hazards to humans and domestic
animals - These data are used to assess the health
hazards of pesticides to humans and domestic animals.
They may include data from acute studies, subchronic
studies, chronic feeding studies, teratogenicity and
reproduction studies, mutagenicity studies, on-
cogenicity studies, and metabolism studies.
Data on reentry hazards - These data are used to
assess the hazards to farm employees from reentry
into areas treated with pesticides. The required data
may include information on toxicity, residue dissipa-
tion, and human exposure. Monitoring data
generated during exposure studies are used to
develop reentry intervals and to determine the quan-
tity of pesticide to which people may be exposed
after application.
Pesticide spray drift evaluations - These data
include droplet size spectrum and spray drift field
evaluations. They are used to develop the overall
exposure estimate and to assess the potential
hazard of pesticides to humans, fish, and wildlife.
These data are also used to determine the need for
(and appropriate wording of) precautionary labeling
to minimize potential harm to nontarget organisms.
Data on hazards to nontarget organisms - These
data are drawn from short-term studies (acute and
subacute), reproduction studies, simulated field
studies, and full field studies. They are used to
determine the effects of pesticides on birds, mam-
mals, fish, terrestrial and aquatic invertebrates, and
plants. These data also help determine the need for
precautionary labeling to minimize potential adverse
effects to these organisms.
Data on product performance - Data on product
performance may be required to ensure that a pes-
ticide will control the pests listed on the product label.
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A special section of 40 CFR 158 describes the data
requirements for microbial pesticides. This category of
pesticides includes genetically engineered organisms
that entail qualitatively different risks than other pes-
ticides.
Because of the large volume of information that must be
generated and processed under the pesticide registra-
tion program, EPA has published a number of guidance
documents for industry applicants and EPA reviewers.
These documents include:
Guidelines and protocols for the testing required
under FIFRA.
Guidelines for reporting the data.
Standard procedures for EPA review of the data.
EPA Evaluation of the Data
EPA evaluates the test data as expeditiously as possible.
The Agency's lexicologists and other scientists review
the test data in accordance with EPA's standardized
evaluation procedures. EPA approves the registration of
the pesticide if:
Its composition warrants the claims made for it.
Its labeling and other requisite material comply with
FIFRA.
It will perform its intended function without un-
reasonable adverse effects on the environment.
When used in accordance with widespread and
commonly recognized practice, it will not generally
cause unreasonable adverse effects on the environ-
ment.
The phase "unreasonable adverse effects on the en-
vironment" is defined in FIFRA to mean "any un-
reasonable risk to man or the environment taking into
account economic, social, and environmental costs and
benefits of the use of the pesticides.'' Thus, EPA must
evaluate the human health and environmental risks as-
sociated with the use of the pesticide, the costs of
restricting or controlling the substance, and the benefits
of use.
The Agency has not published explicit guidance, nor is
there an established legal precedent, that defines the
level of risk considered acceptable under FIFRA. In
practice, a risk of 10"4 to 10* from dietary exposure is a
cause for concern, and initiates consideration of
methods by the Agency to reduce the risk, such as
limitations on use or denial of registration. Such limita-
tions might include restrictions on the crops on which the
pesticide can be applied, restrictions on the application
rate, or requirements that all applicators of the product
be certified.
In evaluating the data submitted for a new pesticide
registration, or in conjunction with a number of scientific
decisions under FIFRA, EPA may request assistance
from the FIFRA Science Advisory Panel. This panel
consists of 7 members appointed by the EPA from a list
of 12 nominees (6 nominated by the National Institute of
Health and 6 nominated by the National Science Foun-
dation). In general, the panel serves to advise, comment
on, and peer review the scientific underpinnings of the
Agency's decisions. For some decisions, such as the
cancellation or denial of a registration, input from the
Science Advisory Panel is required.
Tolerances
As part of the evaluation of applications, EPA sets a
"tolerance" for food-use pesticides. A tolerance is an
amount or concentration of the pesticide residue on food
that will not pose excessive risk. EPA's authority to set
tolerances is found within the Federal Food, Drug, and
Cosmetic Act (FFDCA). Section 408 of that law provides
the authority for setting tolerances for pesticide residues
on raw agricultural commodities. Pesticides that con-
centrate in processed food are covered under Section
409.
Section 408 stipulates that tolerances be set at levels
deemed necessary to protect the public health, while
taking into account the need for "an adequate,
wholesome, and economical food supply." Section 408
thus explicitly acknowledges the need to compare
benefits and risks in setting raw commodity tolerances.
In contrast, Section 409 prohibits the setting of toleran-
ces for chemicals that induce tumors in humans or
animals. EPA interprets this provision to allow the setting
of tolerances when risks are negligible.
Product Registration
After the evaluation process is complete, EPA may
register the pesticide for one or more uses. The registra-
tion provides the terms and conditions under which the
pesticide can be used. The registration specifies a num-
ber of requirements, including:
The types of crops for which the pesticide may be
used.
Whether applicators must be certified (i.e., permitted
to use "restricted use" pesticides by virtue of
demonstrated skill or training).
For worker protection, minimum time periods follow-
ing application during which workers may not enter
a treated area without protective clothing, and re-
quirements for protective clothing during application
of the product.
Rate and frequency of application.
Regional restrictions, including requirements to
protect endangered species.
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Labeling and precautionary statements required to
accompany the package, and other packaging re-
quirements.
Denial of Registration
EPA may deny an application for registration if a review
of data demonstrates that the use of the pesticide would
present an unreasonable risk. In practice, problems that
become evident during data evaluations for a new pes-
ticide are generally handled through restrictions on use
or, in some cases, withdrawal of the application.
Experimental Use Permits and Exemptions
The EPA registration program also includes the following
permits and exemptions:
Experimental Use Permits - EPA may issue a
permit to allow limited use of a pesticide, if such use
is necessary to develop information required for the
normal registration process. EPA or the States strict-
ly supervise such use, and may revoke the permit if
conditions are not met or environmental concerns
arise.
Emergency Exemptions - Under Section 18 of
Fl FRA, EPA may allow use of a pesticide without the
normal registration and tolerances if emergency
conditions exist (e.g., mite problems due to the 1988
drought). States request the emergency exemption.
Special Local Needs Exemptions - Under Section
24(c) of FIFRA, States may authorize the application
of a pesticide for uses not included in the current
registration if required because of special local con-
ditions. Such exemptions, which are subject to EPA
approval, may be granted only for: (1) pesticides for
which a tolerance has been published under the
FDCA; (2) uses that had not been previously denied,
disapproved, or canceled by the EPA; and (3) cur-
rently registered pesticides.
5.1.4 Registration of Existing Pesticides
Phase 1: Identification of Active Ingredients. The
1988 FIFRA amendments mandated a five-phase pro-
gram to reregister existing pesticides. In Phase 1, which
was completed during the first 10 months of 1989, EPA
published lists of the active ingredients subject to
reregistration.
Phase 2: Initial Response by Registrants. In this
phase, registrants who distribute or sell pesticides with
active ingredients on the EPA lists must inform EPA of
their intention to seek reregistration. Registrants seeking
reregistration must:
Compare the data submitted in their current registra-
tion with the requirements of 40 CFR 158, and
identify missing or inadequate data needed to sup-
port reregistration.
Agree to supply the missing or supplement inade-
quate data within prescribed deadlines.
Pay the first portion of the reregistration fee.
If none of the registrants for pesticides containing a
specific active ingredient listed in Phase 1 provide the
information required during Phase 2, the Agency will
cancel the registration of all pesticides containing that
active ingredient within 3 months of its appearance on
EPA's list. In such cases, EPA must first publish a
Notice of Intent to Cancel. Following a 60-day waiting
period, EPA may then issue a final order canceling the
registration of all pesticides containing that active in-
gredient.
Phase 3: Initial Data Submission by Registrants.
During Phase 3 of the reregistration program, firms seek-
ing to reregister pesticides must:
Summarize and reformat existing studies of their
pesticide to facilitate EPA review.
Certify that they possess or have access to raw data
supporting these studies.
Inform EPA specifically of any studies showing ad-
verse effects.
Pay the final portion of the reregistration fee.
These activities must be completed within 1 year of
publication of the Phase 1 list on which the active in-
gredient appears. As in Phase 2. EPA may cancel the
registration of all pesticides containing active ingredients
for which the Phase 3 requirements are not complied with
within the prescribed time period.
Phase 4: EPA Identification of Data Gaps. In Phase
4, EPA reviews the data submitted during Phase 2 and
Phase 3. EPA identifies the data gaps and issues require-
ments for registrants to fill those data gaps. These ac-
tivities will occur 2 to 4 years after enactment of the
FIFRA amendments (1990 through 1992).
Phase 5: Final Data Submission and EPA Review. In
Phase 5, which takes place in years 3 through 9 (ap-
proximately 1991 through 1997) following enactment,
EPA will conduct a comprehensive examination of all
data submitted to support pesticide reregistrations. EPA
must determine whether use of the pesticide presents an
unreasonable risk (i.e., risks exceed benefits). Based on
its review, EPA will initiate the appropriate regulatory
action. The Agency may elect to continue the registration
of the pesticide unchanged. If EPA's review indicates that
continued use of the pesticide may cause unreasonable
risks, the Agency may conduct a Special Review, as
described below.
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5.1.5 Special Review, Cancellation, and
Suspension
EPA's Special Review procedures are initiated after
evaluation of data supplied for reregistration. In theory,
the Special Review procedures also can be used in
reviewing a new pesticide application. A Special Review
is started if the Agency determines that the pesticide may
present an unreasonable risk, including:
A risk of serious acute injury to humans or domestic
animals.
A risk of inducing in humans an oncogenic, heritable
genetic, teratogenic, fetotoxic, or reproductive ef-
fect, or a chronic or delayed toxic effect.
Risks to nontarget organisms (e.g., acute or chronic
toxicity or adverse reproductive effects).
A risk to an endangered species.
Destruction of an endangered species habitat.
A risk to humans or the environment sufficiently large to
merit a determination of whether its benefits exceed its
risks.
Once EPA determines that a Special Review should be
initiated, the Agency follows procedures set forth in 40
CFR 154. The Agency must first send a confidential
certified letter to the registrant(s) that describes the
information supporting the decision. The registrant has
30 days to respond to the notification and dispute the
Agency's conclusions. The Agency must publish in the
Federal Register its final decision on whether to go
forward with a Special Review and the reasons for that
decision. Approximately 20 pesticides are in Special
Review at any given time.
To make an informed decision in a Special Review, EPA
thoroughly evaluates the risks and benefits of the pes-
ticide. This evaluation includes acute and chronic effects;
the exposure potential for farm workers, bystanders, and
consumers of affected food products; the benefits of
continued use; and potential mitigation strategies to
reduce or eliminate risks.
Following the completion of its study and the receipt and
evaluation of comments from interested parties, the
Agency publishes a preliminary notice in the Federal
Register of its decision. If the decision is to cancel, deny,
or change a pesticide's classification, the Agency must
take several additional steps:
Analyze the impact of the decision on the agricultural
sector of the economy.
Send the proposed notice to the Secretary of Agricul-
ture and to the Scientific Advisory Panel for com-
ment.
Send the preliminary notice to all affected applicants
and registrants.
Following the public comment period on the preliminary
notice, the Agency publishes its final determination. If the
final decision is to cancel a registration or to cancel a
registration unless certain changes in the use of the
product are made, the registrant may request a hearing
before an Administrative Law Judge.
Cancellation
The Agency may also issue a Notice of Intent to Cancel
a pesticide without going through the Special Review
process. Under this option, registrants are entitled to a
hearing before the use of the pesticide is prohibited.
Suspensions
In some cases, EPA may determine that an imminent
hazard presented by an existing pesticide requires im-
mediate action. In these cases, the Agency may issue
an order suspending some or all uses of the pesticide.
Under a suspension order, the registrant(s) has 5 days
to request a hearing. If the hearing is requested, it must
be held within 10 days. The presiding officer of the hearing
has 10 days to make a recommendation to the EPA
Administrator, who then has 7 days to issue a final order.
If EPA determines that an emergency exists, it may issue
an Emergency Order suspending the use of the pes-
ticide. Hearings and reviews are held as described
above; however, the use of the pesticide is suspended
immediately. This remedy is taken under the most ex-
treme cases; EPA has used this option four times in the
history of the FIFRA program (once with 2,4,5-T, twice
with ethylene dibromide, and once with Dinoseb).
5.1.6 Ongoing Regulation and Monitoring of
Pesticide Use by EPA and the States
As with many EPA programs, the Agency may delegate
to the States the authority to administer the pesticide
program. In most programs, the States can issue more
stringent requirements than the Federal program. How-
ever, the pesticide program limits State latitude in some
respects. For example, a State's labeling and packaging
requirements cannot be different from Federal rules.
Notwithstanding these limitations, many aspects of the
EPA pesticide program, such as inspection and enforce-
ment (for which 48 States have authority), are carried out
by the States.
The following ongoing activities are carried out by the
States or EPA to ensure that pesticides are used in
accordance with their registration:
Applicator Certification and Training - For
restricted use pesticides, applicators may be re-
quired to fill out a form that attests to their qualifica-
tions to apply the pesticide. The form may inquire
whether the applicant has completed an appropriate
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training program. Neither the application nor the
training program, however, can require a written
examination. (See Section 11 of FIFRAand 40 CFR
171 [under revision].)
Farm Worker Protection - Requirements for
programs to assure farm worker protection are pub-
lished as 40 CFR 170, which is currently under
revision. These requirements are designed to assure
compliance with all aspects of pesticide registrations
that affect farm worker health, including protective
clothing and reentry rules.
Inspection and Enforcement - To assure proper
use of pesticides, EPA or State officials may inspect
facilities involved in the sale, distribution, transport,
storage, use, or disposal of pesticides or their con-
tainers. Violators may be subject to fines and/or
criminal prosecution.
Another ongoing EPA activity is the implementation of
surveys and the collection of monitoring information con-
cerning pesticide use and pesticide residues in air, water,
ground water, and human tissue. The Agency is currently
conducting a national survey of household pesticide use.
EPA is also developing a centralized data base containing
descriptive information about pesticide monitoring studies
conducted by government agencies, universities, and other
organizations. One purpose of these data collection efforts
is to provide information to EPA regulators to supplement
the data submissions of the registrants.
5.2 Program Organization
The pesticide program is managed by the Office of Pes-
ticide Programs (OPP) from EPA's Headquarters office in
Crystal City, Virginia. The major regulatory activities within
the program (registration, reregistration, and Special
Review) are carried out at the headquarters office. OPP,
which is part of the Office of Pesticides and Toxic Substan-
ces, consists of an Office Director and seven program
divisions, as shown schematically in Figure 5-1.
OPP employs a matrix management approach (i.e.,
several divisions may work together to carry out a given
regulatory function). The divisions are as follows:
Office Director
Program Management and Support Division
Registration Division
Reregistration and Special Review Division
Health Effects Division
Environmental Fate and Effects Division
Biological and Economic Analysis Division
Field Operations Division
Figure 5-1. Organizational Chart for Office of
Pesticide Programs (OPP)
Office Director
Douglas D. Campt
(202) 557-7090
Program
Management and
Support Division
Allan Abramson
(202) 557-2440
Registration Division
Ann Lindsay
(202) 308-8000
Reregistration and
Special Review
Division
Edwin Tmsworth
(202) 308-8000
Health Effects
Division
Penelope Fenner-
Crisp
(202) 557-7351
Environmental Fate
and Effects Division
Ann Barton
(202) 557-7695
Biological and
Economic Analysis
Division
Allen Jennings
(202) 557-0500
Field Operations
Division
Steven Johnson
(202)557-7410
Management of OPP; the
Policy and Special Projects
Office reports to the Director
and analyzes continuing
policy issues (e.g.,definition
of "unreasonable risk,"
methodology for setting
tolerances).
Overall administration of
OPP, resource manage-
ment, and information ser-
vices.
Management of the new
pesticide registration
process.
Management of the new
reregistration program and
Special Review activities.
Health effects evaluation in
support of registration,
reregistration, and Special
Review.
Evaluation of the transport,
fate, and environmental ef-
fects of pesticides in support
of registration, reregistration,
and Special Review.
Evaluation of the effective-
ness of pesticides and the
economic benefits of their
use in support of registration,
reregistration, and Special
Review.
Public information and com-
munications support for OPP;
State program certification,
training, and occupational
safety activities.
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To illustrate the functioning of OPP, the role of each
division is described below with respect to four major
program activities:
New product registration.
Reregistration.
Special Review.
Development of test methods.
5.2.1 New Product Registration
The new product registration process, described in Sec-
tion 5.1.3, is an example of OPP's matrix management
approach. The Registration Division manages the
evajuation of the product and is responsible for the
decision to deny or approve the application. The three
science divisions (i.e., the Health Effects Division, the
Environmental Fate and Effects Division, and the
Biological and Economic Analysis Division) provide spe-
cialized expertise and evaluations.
The specific steps in the product registration process can
be summarized as follows:
1. A pesticide company develops a new product in its
laboratory.
2. The company tests the product in its laboratory and
greenhouse and determines that the product is sufficient-
ly promising to merit larger scale testing.
3. The company applies for an Experimental Use Permit
(EUP), which allows the pesticide to be tested in the field
on up to 10,000 acres of land.
4. The application is received and recorded by the Pro-
gram Management and Support Division.
5. A product manager is assigned in the Registration
Division. The product manager maintains the official file
for the product and oversees the evaluation of the pes-
ticide.
6. The product manager forwards the health effects data
submitted with the EUP to the Health Effects Division.
The Health Effects Division assesses the risks of the
pesticide for the period of use that would be allowed
under the EUP.
7. The product manager forwards data to the Environ-
mental Fate and Effects Division. The latter provides an
evaluation of the environmental fate and effects of the
pesticide to supplement the EUP risk assessment
described in #6.
8. The Registration Division makes a decision to grant
or deny the EUP. If granted, the permit may incorporate
limitations on the use of the product (e.g., concentration,
frequency, duration of use). The limitations may vary
geographically.
9. The company uses the product under the EUP and is
encouraged by the results.
10. The company conducts long-term, subchronic, and
field tests to generate data required under 40 CFR 158
(see Section 5.1.3). The company may need to apply for
a second EUP in order to generate the requisite data.
11. The company submits all testing data required under
40 CFR 158 and a completed application, which includes
the proposed labeling of the pesticide. At this point, 3 to
5 years may have elapsed since the original EUP ap-
plication.
12. The product manager determines the completeness
of the data in conjunction with science teams in the three
scientific support divisions.
13. If the data are not complete, EPA informs the com-
pany that the missing data must be submitted within 75
days or the application is deemed withdrawn.
14. The science divisions conduct an in-depth analysis
of the data. The Health Effects Division performs a risk
assessment. For new active ingredients, the risk assess-
ment results are peer reviewed by the OPP Science
Advisory Panel. A special assistant in the Director's office
coordinates the work of the Science Advisory Panel.
15. The Registration Division recommends a final
decision based on input from the science divisions,
including the risk assessment conducted by the Health
Effects Division and environmental fate and effects infor-
mation provided by the Environmental Fate and Effects
Division.
16. The Agency either grants or denies the product
registration.
5.2.2 Reregistration
The reregistration program, authorized under the 1988
FIFRA amendments, is a five-phase process (see Sec-
tion 5.1.4). Like new product registration, reregistration
is a coordinated effort involving several program
divisions. Because the reregistration process required
under the 1988 amendments has begun within the past
year, however, the Agency's operating procedures are in
a formative stage. The discussion that follows, therefore,
describes procedures that may change as the program
evolves.
The five-step reregistration prog ram is managed by
the Reregistration and Special Review Division (RSRD)
with support from the science divisions.
Phase 1: Identification of Active Ingredients -
RSRD has developed four lists of active ingredients
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to be regulated under the reregistration program.
The lists indicate the priority of the substances based
on factors such as their prevalence in food and/or
ground water. Lists B, C, and D must be addressed
in accordance with fixed schedules; list A consists of
substances that the Agency will evaluate, but has not
established a fixed schedule for. The science
divisions provide support to RSRD in establishing
the priority lists.
Phase 2: Initial Response by Registrants - In
Phase 2, registrants must identify missing data,
agree to supply missing data, and pay the first part
of their fee. To review these submissions, RSRD will
probably assign product or active ingredient
managers. RSRD initiates a procedure to cancel the
registration if Phase 2 submissions are not received.
In the Federal Register Notice of Cancellation,
RSRD gives parties other than the registrant a
chance to support the registration.
Phase 3: Initial Data Submission - In the initial
data submission phase, registrants must summarize
and reformat existing data (according to specifica-
tions published in the Federal Register by RSRD),
certify that they have supporting information, and
commit to supplying missing data. If registrants do
not make an effort in good faith to supply the infor-
mation at this point, RSRD will cancel the registra-
tion.
Phase 4: Identification of Data Gaps - In Phase
4, EPAcompares the data submissions of registrants
to the requirements of 40 CFR158. RSRD manages
this process with input from the science divisions in
their areas of expertise. RSRD requires that
registrants submit the missing data or face cancella-
tion of their product.
Phase 5: Final Data Submission and Review by
EPA - In Phase 5, EPA reviews the complete data
submission and determines whether the products
are free of unreasonable adverse effects. Like the
new product registration process, the Health Effects
Division develops the risk assessment using ex-
posure information developed by the Environmental
Fate and Effects Division. RSRD may recommend
that the Agency grant the reregistration. If RSRD
suspects that the product may present unreasonable
risk, or that the risks exceed the benefits, a Special
Review may be initiated.
5.2.3 Special Review
Special Review may be initiated, as described above,
based on information received or analyses performed
during a reregistration. In addition, the Agency may
initiate a Special Review at any other time it encounters
evidence that a product may present unreasonable risk.
RSRD manages the Special Review process with the
support of the science divisions.
Once a concern arises based on toxicological and ex-
posure information received by the Agency, EPA estab-
lishes an internal consensus that there is a good reason
to believe that the risks associated with the substance
exceed the benefits. This initial analysis is managed by
RSRD with assistance from the science divisions. Unlike
the normal reregistration or registration decisions, the
Biological and Economic Analysis Division conducts a
formal benefits assessment as part of the Special
Review. At the initial stage, the benefits assessment
would not be completed, but enough information would
be available to determine preliminarily that the risks of
the substance exceed the benefits.
Once EPA's internal consensus has been generated,
RSRD confidentially informs the registrant that there is a
problem. The registrant has 30 days to respond to the
confidential letter. If no information is received that dis-
proves the Agency's initial conclusions, the Agency
proceeds to finalize and publish Position Documents #1,
#2, and #3. These documents present (1) toxicological
information verifying the risks of the substance
(developed by the Health Effects Division), (2) exposure
information documenting the extent of exposure
(developed by the Environmental Fate and Effects
Division), and (3) completed benefits assessment
(developed by the Biological and Economic Analysis
Division) stating that either the risks exceed the benefits
or the risks exceed the benefits unless changes are
made in the use of the product.
Position Documents #1, #2, and #3 are published in the
Federal Register followed by a 60-day comment period.
The registrant again may attempt to rebut the Agency's
position. Following the comment period, the Agency
publishes Position Document #4. If Position Document
#4 affirms the Agency's decision to cancel the registra-
tion, the registrant may appeal to an Administrative Law
Judge. The Judge's decision can be appealed to the EPA
Administrator who makes the final decision.
5.2.4 Development of Test Methods
Test methods and protocols are developed primarily
within the science division responsible for a particular
type of test information. For example, tests aimed at
determining human health effects are developed by the
Health Effects Division. The activities involved in
developing a test method take place primarily within the
division.
When the Health Effects Division is authorized by the
Office Director to develop a new test method, a staff
person within the Health Effects Division is assigned to
manage the project. The project manager directs the
personnel and/or consultant resources used to develop
the test method and protocol. After receiving comments
from within the division, the proposed test method is
reviewed by the FIFRA Science Advisory Panel. Follow-
ing that review, the test method may be published for
comment in the Federal Register.
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5.3 Health Research Needs
5.3.1 Introduction
The registration, reregistration, and Special Review
processes require substantial health-related informa-
tion. In addition to evaluating ecotoxicology, fate, and
residue data, the program evaluates the toxicity of pes-
ticide products based on standard evaluation proce-
dures that have been formally developed, commented
on, and adopted as part of 40 CFR 158. The regulations
and associated guidance documents and protocols in-
clude requirements for study design and data reporting
and specify EPA standard procedures for evaluating the
results.
Since the pesticide program has the authority to require
industry to supply any information necessary to evaluate
a registration, its need for in-house testing is limited.
Program officials are reasonably satisfied with the cur-
rent testing protocols, and maintaining the same
protocols enables EPA to make historical comparisons.
However, OPP needs assistance in developing
guidelines for evaluating toxicity information prepared
under the existing testing protocols and for developing
new toxicity testing protocols for additional endpoints.
5.3.2 Major Research Categories
A. Hazard Identification
Hazard identification is a high priority for the pesticide
program. The Agency has already developed a number
of standard evaluation procedures for toxicity testing,
e.g., teratology studies, long-term rodent studies for
oncogenicity, subchronic and chronic exposure studies
for toxicity, etc. The program needs new methods to
assess immunotoxicology, mutagenicity for non-
genotoxic agents, reproductive and developmental
toxicity, endocrine effects, and neurotoxicity. In addition,
standard test batteries are needed for evaluating the
toxicity of genetically engineered microbes in human
populations as well as in the environment.
The program's greatest need is for shorter term, more
cost-effective methods, which are desirable because of
the large number of pesticides the program must
evaluate. Long testing periods extend the time that a
potentially hazardous pesticide stays on the market, or
delay the marketing of a safer substitute. Because ex-
posure to pesticides can be widespread, public and
occupational health impacts caused by such delays may
be significant.
In general, research on short-term in vivo and in vitro
methods for noncancer endpoints and better validation
of all methods require greater emphasis. Test batteries
should be developed utilizing a tiered approach, if pos-
sible: for example, a lower tier test for neurotoxicity
might be followed by a higher tier consisting of tests for
assessing developmental neurotoxicity, electrophysiologic
neurotoxic impacts, and operant behavior. Attempts should
be made to adapt or expand current and/or newly
developed protocols, so that they will have more wide-
ranging usefulness. For example, methods should be
incorporated into protocols for measuring biomarkers,
such as brain enzymes, to help refine dose-response
assessments at different levels. Finally, structure-activity
relationship (SAR) and metabolism information should
be developed. SAR methods would be useful for screen-
ing inert substances, and metabolism information is es-
sential for refining the toxicologic basis for developing
weight-of-evidence determinations.
B. Dose Response
Dose-response issues are a high priority for the pesticide
program because such a large number of tests are
required for registration of pesticides. While human data
are important in assessing the health effects of pes-
ticides, most regulatory decisions rely on whole animal
and short-term tests. This is particularly true of the
numerous evaluations that will be done as a result of the
reregistration program set up under the 1988 amend-
ments.
Dose-response assessment and risk extrapolation will
also be needed for new methods developed for various
toxicological endpoints, particularly immune system ef-
fects, behavioral teratology, and neurological and
reproductive endpoints. Risk extrapolation for results of
tests performed for limited duration and for tests at
critical stages of development (e.g., neonatal) is also
needed.
Health research on injury and repair mechanisms for
chronic and acute exposure should receive increased
emphasis. A greater knowledge of thresholds would help
the program in the tolerance-setting process. Better
dose-response information is needed for cancer
endpoints, in relation to thresholds, and for noncancer
endpoints, particularly the protectiveness of safety fac-
tors for developmental toxicology endpoints. Finally,
more information is needed on comparative metabolism
at different dose levels.
C. Exposure Assessment
Exposure assessment, as it relates to health research,
is currently of medium importance to the pesticide pro-
gram. Research to improve exposure assessment will
increase confidence in the program's exposure es-
timates. This research should focus on methods for
improving comprehensiveness, developing better sur-
rogates, and improving validation. The National
Academy of Sciences is currently evaluating specific
information on dietary exposure to pesticides in infants
and children; more studies are needed of nondietary
pesticide exposure in children and other critical groups
for home and garden use of pesticide products.
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D. Chemical-Specific Information
Research to increase chemical-specific data is a low
priority because the pesticide program has considerable
authority to require industry to test. HERL should, how-
ever, provide technical support to assist the program in
checking the results of toxicity tests done by industry.
There is also a sporadic need to fill specialized narrow
data gaps. For example, more information on dermal
toxicity would be useful since significant exposure to
pesticides occurs dermally.
5.3.3 Cross-Cutting Categories
A. Biological Markers
Development of biological markers is a relatively tow
research priority for the pesticide program. Biomarker
research should be designed to aid in deriving practical
guidance and standards. Biomarker research should
emphasize short-term regulatory needs, especially
biomarkers for dose and effects that are sentinel indicators
of toxicity. There is also interest in developing biomarkers
for immune system effects and improving biomaiker
methods for application to genetic/molecular/biochernical
epidemiology.
B. Pollutant Mixtures
The issue of pollutant mixtures is of medium priority to
the pesticide program. Research is needed in the area
of inert ingredients, particularly the bioavailability of oil-
based mixtures versus water-based mixtures.
C. Human Data
Research on human data is of medium priority for the
pesticide program. Most current health research needs
involve effects on children, e.g., developmental toxicity
and immune system effects. Better methods of assess-
ing indoor exposure to pesticides are important. Re-
search is needed both in measurement methods and
behavioral patterns. Human data are also being
gathered in occupational epidemiology studies currently
in progress, including a study incorporating biomarkers.
5.3.5 Summary
Table 5-1 summarizes the health research priorities of
the pesticide program. The highest priority needs for
health research are hazard identification and dose
response. Of medium priority are human data, particular-
ly for higher risk groups; exposure assessment; and
pollutant mixtures. The lowest research priorities are
biological markers and chemical-specific information.
Table 5-1 Important Health Research Needs and
Their Relative Priorities for the
Pesticide Program
Research Needs
Relative Priorities
1. Hazard Identification xxx
2. Dose Response xxx
3. Exposure Assessment xx
4. Chemical-Specific Information x
5. Biological Markers x
6. Pollutant Mixtures xx
7. Human Data xx
x - Low priority
xx - Medium priority
xxx - High priority
5.3.4 Emerging Research Needs
As test methods are developed and validated for a more
complete battery of toxicity endpoints, exposure assess-
ment is anticipated to emerge as a health research need
during the 1990s. Exposure assessment research
should incorporate metabolism and dose information
and biomarkers of exposure and effect.
The other currently emerging need is the study of infants
and children as a susceptible population. Particularly
needed are more complete batteries of toxicity tests to
predict health impacts of pesticides on children and
better characterization of exposure pathways for children
in diverse environments.
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SECTION SIX
THE TOXIC SUBSTANCES CONTROL PROGRAM
6.1 Program Description
6.1.1 Introduction to Statute and Overview of the
Program Area
The Toxic Substances Control Act (TSCA) of 1976 gives
EPA the authority to prohibit or restrict the manufacture,
distribution, use, and disposal of chemicals that present
"unreasonable" environmental or human health risks.
The Agency may require industry to generate and submit
extensive environmental and human health data to
facilitate the evaluation of a substance's risks. Upon
evaluation of the data, EPA may allow the substance to
be produced or to continue in production, publish ad-
visory information concerning the substance's risks,
negotiate voluntary limitations with affected businesses,
promulgate a regulation prohibiting or limiting use of the
substance, or refer the matter to another agency.
The TSCA program addresses the risks of both new and
existing chemicals. For new chemicals, manufacturers
must inform EPA of their intent to produce the substance
and submit data for EPA review prior to commercialization.
For existing chemicals, EPA and a statutorily established
Interagency Testing Committee identify priority substances
for testing. After review of these findings, the Agency
determines the need for chemical testing and regulation.
For both new and existing chemicals, EPA may require the
reporting of data concerning the manufacture, use, and
potential risks of substances in commerce.
Prior to the passage of TSCA, there were significant gaps
in the Federal government's authority to test and regulate
toxic chemicals. The Clean Air Act, the Clean Water Act,
and other laws regulated chemical substances entering the
environment (e.g., emissions to the air or discharges into
the water). Other statutes, such as the Occupational Safety
and Health Act and the Consumer Product Safety Act,
addressed only one phase of a chemical's existence (e.g.,
worker exposure or direct consumer exposure) and con-
tained no authority to address environmental hazards.
Throughout its life cycle, from production to ultimate
disposal, there are many opportunities for a chemical to
be released into the environment, resulting in human
exposure. The Toxic Substances Control Act was
designed to fill any potential gaps in coverage through
its broad authority to regulate chemicals throughout their
life cycle and to require testing of new and existing
chemicals.
EPA's toxic substances control program is described
below in seven sections:
Section 6.1.2 describes the scope and coverage of
TSCA.
Section 6.1.3 describes the premanufacturing
notification (PMN) process for new chemicals (Sec-
tion 5 of the act).
Section 6.1.4 explains the process of selecting and
evaluating chemicals under TSCA Section 4, and the
establishment of testing requirements for these sub-
stances.
Section 6.1.5 describes the reporting requirements
under TSCA and other sources of information which,
along with the testing results under Section 4, may
trigger the consideration of regulatory action.
Section 6.1.6 describes EPA's regulatory options
under TSCA Sections 6 and 7.
Section 6.1.7 explains the relationship between
TSCA and other Federal laws.
Section 6.1.8 describes special programs to control
asbestos hazards.
6.1.2 Scope and Coverage of the Toxic Substances
Control Act
Under TSCA, EPAhas broad authority to regulate chemical
substances or mixtures. A "chemical substance" is defined
as "any organic or inorganic substance of a particular
molecular identity" that occurs as a result of a chemical
reaction or occurs in nature. A "mixture" refers to a com-
bination of chemical substances that does not occur in
nature and is not the result of a chemical reaction. While
these definitions extend the coverage of the act to virtually
any substance, there are certain specified exclusions.
These exclusions include pesticides, tobacco, tobacco
products, nuclear material, firearms, ammunition, food and
food additives, drugs, cosmetics, and devices.
EPA can ban or restrict a wide range of activities related
to a covered substance, including manufacture, process-
ing, distribution, commercial use, ordisposal, if the Agen-
cy concludes that the substance presents "an unreasonable
risk of injury to health or the environment." In this context,
the term "manufacture" can mean to import, produce, or
49
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manufacture. The term "processor" refers to any person
who prepares a chemical substance or mixture for dis-
tribution in commerce, either in the same form or in a
different form from that in which it was received, or as
part of an article containing the chemical substance or
mixture. This definition includes any manufacturer of a
product, such as treated paper or coated fabric, that
incorporates a chemical. In determining whether a sub-
stance presents "an unreasonable risk of injury to health
or the environment," EPA takes into account a number
of specified factors, including the benefits of the sub-
stance for various uses; the availability of substitutes for
such uses; and the economic consequences of regula-
tion, including the effect on the national economy, small
business, technological innovation, the environment,
and public health.
The act provides broad authority for the Agency to collect
information on chemical risks. First, EPA may require
testing of any existing chemical substance or mixture
(Section 4). Second, prior notification and data submis-
sion are required before manufacture of any new chemi-
cal substance or manufacture or processing of an
existing chemical substance for a "significant new use"
(Section 5). Third, EPA may require recordkeeping and
the submission of health and safety studies and other
information on the substance, both published and un-
published (Section 8).
In summary, EPA's regulatory authority under TSCA
encompasses all types of chemicals and mixtures. The
Agency may require industry to submit extensive testing
information concerning the risks of particular substan-
ces. If, based on its evaluation, the Agency determines
that there are "unreasonable risks" associated with the
chemical, the Agency may regulate any or all phases of
the chemical's life cycle (Section 6).
6.1.3 Premanufacturlng Notification (PMN)
Under Section 5(a) of TSCA, businesses must notify EPA
at least 90 days before manufacturing or importing a new
chemical substance for commercial purposes. A new
chemical substance, as defined in Section 3 of the act,
is any chemical substance that is not included on the list,
or "Inventory," of existing chemical substances compiled
by EPA under TSCA Section 8(b). EPA first published the
TSCA Chemical Substance Inventory on June 1,1979.
The Agency periodically updates the inventory, which
now includes more than 70,000 substances, by adding
new chemicals that have undergone Section 5 review
and have entered commercial production.
Section 5(d)(1) of the act specifies information that sub-
mitters must provide in a premanufacturing notification
(PMN), including:
Test data in their possession or control.
Descriptions of health and environmental effects
data that they know of or can reasonably ascertain.
Known or reasonably ascertainable information on
chemical identity.
Proposed categories of use.
Proposed volume of production.
By-products resulting from manufacture, process-
ing, use, or disposal.
Workplace exposure.
Manner or method of disposal.
EPA Review of PMN Submissions
Once EPA receives a Section 5 notification, the Agency
has 90 days to review it, unless for good cause EPA
extends the review period under Section 5(c) for up to an
additional 90 days. During the review period, EPA may
act under Section 5(e) or 5(f) to regulate the production
or use of the new chemical substance.
Section 5(e) authorizes EPA to prohibit or limit the
manufacture (including import), processing, distribution
in commerce, use, or disposal of a new chemical sub-
stance until information sufficient to evaluate its health
and environmental effects is provided. EPA can take this
action if it determines that the available information is
insufficient for a reasoned evaluation and either (1) the
substance may present an unreasonable risk of injury to
health or the environment, or (2) the substance will be
produced in substantial quantities and there may be
significant or substantial human exposure to the sub-
stance or substantial release to the environment.
Under Section 5(e), EPA may issue either a unilateral
order or a consent order. A unilateral order prohibits the
manufacture, processing, distribution, use, or disposal of
a substance pending the submission and evaluation of
test data addressing the health or environmental con-
cern. This type of order may be implemented when EPA
identifies a potential unreasonable risk that can be
evaluated through testing the substance. In such cases,
the submitter may request a suspension of the notice
review period and voluntarily test the PMN substance
using a mutually agreed-upon protocol. EPA then
evaluates the test results to determine whether the data
confirm or refute the Agency's concerns.
A Section 5(e) consent order, mutually agreed to by the
PMN submitter and EPA, specifies requirements to
control exposures to the substance and to ensure that
persons who may be exposed are properly notified.
These requirements may include protective equipment
such as impervious gloves, safety goggles, or
respirators; worker training programs; warning labels;
customer notification letters; and disposal limitations.
In addition, some Section 5(e) consent orders include
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"testing triggers." These triggers require that upon
reaching a specified production volume, the submitter
must cease production of the PMN substance unless he
or she submits the results of a specified test that permits
a reasoned evaluation of the effects of exposure.
Under Section 5(f), EPA may regulate a new chemical
substance if it finds that the manufacture, processing,
distribution in commerce, use, or disposal of the sub-
stance will present an unreasonable risk of injury to
health or the environment. The EPA may issue either an
order prohibiting the activities described in the PMN or a
proposed rule limiting those activities.
A PMN submitter may withdraw a PMN from review at
any time. Submitters have chosen to do this when EPA
has identified potential unreasonable risks that might
need to be addressed by regulatory action. Once a PMN
is withdrawn, however, the manufacturer or importer
must submit another notice, which is subject to another
90-day review period, before manufacture or import can
3in.
If EPA has not prohibited manufacture or import of the
chemical substance, these activities may begin as soon
as the review period expires, subject to the restrictions
or testing requirements imposed during the review
period. When manufacture or import begins and the
PMN submitter provides a notice of commencement,
EPA adds the substance to the inventory.
Thereafter, any person may manufacture or import the
substance without submitting a Section 5 notice to EPA,
unless EPA has issued a significant new use rule (SNUR)
on the chemical under Section 5(a}(2) as described
below.
Exemptions
EPA may grant exemptions from PMN review or from the
full 90-day PMN review process. These include exemp-
tions for research and development, test marketing,
certain polymers, and low-volume substances. Manufac-
turers must apply for these exemptions in accordance
with EPA rules. Also, under Section 5(h)(4) EPA may,
upon application and by rule, exempt the manufacturer
or importer of any new chemical substance from all or
part of the Section 5 requirements, if the Agency deter-
mines that the substance under consideration will not
present an unreasonable risk of injury to health or the
environment. This could occur, for example, if a
manufacturer proposes to produce a new chemical vir-
tually identical to an existing substance that has already
been evaluated by EPA.
Significant New Use Rules (SNURs)
Businesses also must submit PMNs in order to manufac-
ture or process any chemical substance for a use that
EPA determines to be a "significant new use." In making
this determination, EPA must consider all relevant
factors, including:
The projected volume of manufacturing and
processing.
The extent to which a use changes the type or form
of exposure to humans or the environment.
The extent to which a use increases the magnitude
and duration of exposure to humans or the environ-
ment.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in com-
merce, and disposal.
A SNUR specifies the chemical (or group of chemicals)
and uses of concern. Once a final SNUR is promulgated
(and published in the Federal Register), any person who
intends to manufacture, import, or process the sub-
stance for a significant new use specified in the SNUR
is required to notify EPA at least 90 days before begin-
ning such activity. A substance listed in a SNUR is
generally subject to the same statutory procedures as
those required under TSCA's PMN rule for a new chemi-
cal substance.
The purpose of the SNUR notice requirement is to fur-
nish EPA with information necessary to evaluate the
intended use of the substance and, if necessary, give the
Agency enough time to prohibit or limit the use before its
inception. ASNUR may be issued for any TSCAchemical
substance, including individual substances and chemi-
cal categories, and for new or existing substances. A
SNUR may also be written in conjunction with a Section
5(e) order.
6.1.4 Chemical Testing Requirements
Section 4 of TSCA gives EPA the authority to require
testing of existing chemicals. To require testing of an
existing chemical, EPA must make the following find-
ings:
The chemical may pose an "unreasonable risk" to
health or the environment; or the chemical is
produced in "substantial" quantities, which could
result in substantial or significant human exposure
or substantial environmental release, and
Insufficient data or knowledge exist about the health
or environmental effects of the chemical to
reasonably determine or predict the impacts of its
manufacture, processing, distribution, use, and/or
disposal, and
Testing is needed to develop such data.
Additionally, EPA considers the potential economic im-
pacts of the required testing before issuing requirements
under Section 4.
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If EPA makes all of the above findings for a specific
chemical or category of chemicals, the Agency may issue
a rule requiring industry to test the substance(s). Alter-
natively, if EPA finds that affected manufacturers and
processors, and interested members of the public agree
with the Agency regarding the need for and scope of
testing requirements, EPA may issue an enforceable
consent order to expedite the testing.
Not all questionable chemicals need to be tested - only
those for which EPA specifically determines that addi-
tional data are necessary and issues a formal test rule.
This rule may prescribe the effects to be investigated, the
tests to be conducted, and the experimental test
guidelines to be used. The TSCA statute itself, in Section
4(b), details many of the studies that may be required,
including studies of carcinogenicity, mutagenicity,
teratogenicity, behavioral disorders, synergism, and
other types of toxicity. In addition, EPA has periodically
published (Federal Register, 9/27/85, 5/20/87, and
12/6/88) guidelines concerning acceptable testing
design and procedures. In promulgating test rules, EPA
must consider the relative costs and availability of
facilities and personnel, and the period within which tests
can reasonably be performed. Moreover, EPA must
review each test standard at least once a year and revise
it where warranted.
Selection of Chemicals for Testing
EPA may select chemicals for testing based on informa-
tion received on a chemical's adverse effects, concerns
raised by other EPA offices, or other sources. The
Agency's final decision on chemicals to be tested is
based, in part, on the recommendations of the Interagen-
cy Testing Committee (ITC). Section 4(e) of TSCAestab-
lished the ITC to recommend chemicals to EPA for
priority testing consideration. The ITC is composed of
appointed members from eight Federal agencies; repre-
sentatives from six additional Federal agencies serve as
liaisons. Members of the ITC review chemicals in com-
merce to establish for EPA consideration a "Priority List"
of chemical substances in need of testing. The chemicals
reviewed by the ITC may be nominated by government
agencies, industry, public interest groups, or private in-
dividuals. The ITC may designate up to 50 chemicals or
categories of chemicals on the Priority List; it must also
consider revising the list, and report to EPA at least every
6 months.
The Priority List of chemicals is divided into three parts:
(1) those designated for EPA response within 12 months;
(2) those recommended with intent-to-designate; and (3)
those recommended without being designated for
response within 12 months. (Chemicals in the first part
are referred to as designated chemicals; chemicals in the
second and third parts are referred to as nondesignated
chemicals.)
For ITC-designated chemicals, EPA must respond within
a 1 -year statutory deadline by either initiating rulemaking
or publishing in the Federal Register a notice that
describes why EPA has determined that further testing
is not required. The ITC recommends with intent-to-
designate chemical substances or mixtures those it
believes should receive expedited testing consideration.
The ITC may designate these chemicals later, after
EPA's review of the ITC's testing recommendations, and
after the ITC's own review of the data collected under
TSCA Sections 8(a) and 8(d) and other relevant informa-
tion. The intent-to-designate recommendation does not
require EPA to respond to the ITC by a certain deadline.
Should such chemicals be subsequently designated, a
1-year statutory deadline for EPA response would be
imposed at that time.
The third part of the Priority List includes chemical sub-
stances or mixtures that the ITC believes warrant testing
consideration, but not expedited review of testing needs.
The ITC adds these chemical substances or mixtures to
the Priority List, and recommends them for testing
without designating them for EPA review within any
statutory deadline. These chemicals may be evaluated
by EPA as time and resources permit.
For a nondesignated chemical (on the second and third
parts of the Priority List), EPA may evaluate the risks
posed by the chemical. However, in addition to the formal
rulemaking procedures required for designated chemi-
cals, EPA has the option of using a consent agreement.
To use the consent agreement process, EPA first deter-
mines whether a consensus exists among the Agency,
industry, and other interested individuals regarding the
need for and scope of testing. All parties then execute an
enforceable consent agreement that provides for the
completion of the agreed-upon testing.
Because lexicological testing is so expensive, TSCA
provides for the sharing of testing costs among all
manufacturers and processors of the regulated sub-
stance. If the test sponsors cannot decide a proper
allocation of costs among themselves, EPA is required
to adjudicate the dispute.
6.1.5 Reporting Requirements
TSCA Section 8 gives EPA the authority to require report-
ing and record-keeping relating to chemical substances
and mixtures.
Section 8(a) - Recordkeeping and Reporting
Section 8(a) allows EPA to promulgate rules that require
manufacturers, importers, and processors to maintain
records and report certain information to the Agency. The
Section 8(a) Preliminary Assessment Information Rule
(PAIR) requires manufacturers and importers of
specified chemicals to report general production, use,
and exposure information using a standard report form.
These data are used by the ITC in evaluating and estab-
lishing testing priorities.
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In 1986, under Section 8(a), EPA also promulgated the
Industry Update Rule, which required manufacturers and
importers to report current production volume and site
data on many of the approximately 70,000 chemicals in
the TSCA Chemical Substances Inventory. This rule rep-
resents the first inventory update since the original com-
pilation of the inventory in 1979. EPA will use the
information collected for chemical screening, priority set-
ting, exposure determination, risk assessment, and
development of TSCA regulations.
In late 1988, EPA promulgated a model information-
gathering rule under Section 8(a) called the Comprehen-
sive Assessment Information Rule (CAIR). CAIR
established uniform reporting and recordkeeping re-
quirements along with a list of questions from which
specific information requests can be assembled on a
chemical-by-chemical basis. EPA uses this rule to obtain
information needed by OSHA, NIOSH, CPSC, and the
Agency itself to support the assessment and regulation
of chemical substances and mixtures.
Section 8(c) - Significant Adverse Reactions
Under Section 8(c) of TSCA, any person who manufac-
tures, processes, imports, or distributes any chemical
substance or mixture must maintain records of "sig-
nificant adverse reactions" alleged to have been caused
by the chemical. Significant adverse reactions are "reac-
tions that may indicate a tendency of a chemical sub-
stance or mixture to cause long-lasting or irreversible
damage to health or the environment." Records relating
to possible health reactions of employees must be kept
for 30 years, during which time they may be inspected
or submitted to anyone designated by the EPA. All other
recorded allegations must be kept for only 5 years. In
1986, EPA required submission of these records for the
first time.
Section 8(d) - Reports of Health and Safety Studies
This rule requires past, current, or prospective manufac-
turers, importers, and processors of certain substances
(named periodically in the Federal Register) to submit
lists and copies of unpublished health and safety data to
EPA. EPA adds substances to the list of those covered
under the rule as the Agency identifies a need for health
and safety information. EPA uses this information to
support detailed assessment of the health and environ-
mental risks of these substances.
Section 8(e) - Substantial Risk
Under Section 8(e), persons who obtain new information
that reasonably supports the conclusion that a sub-
stance or mixture that they manufacture, import,
process, or distribute presents substantial risk of injury
to human health or the environment, must notify EPA
within 15 working days. A determination of "substantial
risk" does not include an evaluation of economic or social
benefits of the use of the chemical and, therefore, is not
synonymous with the term "unreasonable risk" which is
found in other sections of the act. Once received, the
notices are reviewed by EPA and an initial evaluation
(status report) is prepared containing, if appropriate,
follow-up questions to the submitter, referrals to other
agencies, and recommended EPA follow-up actions.
Voluntary Submissions
The Agency also receives a large number of voluntary
"For Your Information" (FYI) submissions on chemical
toxicity and/or exposure from chemical manufacturers,
processors and distributors, trade associations, labor
organizations, other government agencies, foreign
governments, academia, public interest and environ-
mental groups, as well as the general public. Another
source of data on existing chemical risks is the National
Toxicology Program, from which test data are routinely
received and reviewed.
Reporting Under SARA Title ill
Another source of information on toxic chemicals is the
data collected under the Emergency Planning and
Community Right-to-Know Act, or Title III, of the Su-
perfund Amendments and Reauthorization Act
(SARA). (This program is included in the TSCA section
of this document because it is managed by the Office
of Toxic Substances.) Under Section 313 of Title III,
businesses must submit annual reports to EPA and the
State in which they operate on certain specified toxic
chemicals manufactured, imported, processed, or
used at the facility. Facilities must account for the total
aggregate releases to the environment of each toxic
chemical listed under Section 313 for the calendar
year. These aggregate data are referred to as the Toxic
Release Inventory (TRI). The first annual report (for
the calendar year 1987) was due to EPA and the
designated State agencies on July 1, 1988. Those
businesses required to report under Title III are plants,
factories, or other facilities that are classified in the
Standard Industrial Classification (SIC) codes 20
through 39; employ the equivalent of 10 or more full-
time individuals; and manufacture, import, or process
any of the Section 313 chemicals in amounts greater
than 75,000 pounds in 1987, 50,000 pounds in 1988,
25,000 pounds in 1989 and subsequent years, or use
any listed chemical in any other way in amounts
greater than 10,000 pounds. Over 300 toxic chemicals
and chemical categories are subject to reporting.
6.1.6 Other Regulatory Options under Sections 6
and?
EPA has broad authority to take whatever regulatory
measures it deems necessary to ban or restrict chemi-
cals suspected of posing an unreasonable risk of injury
to health or the environment. The information used to
make such determinations comes from a variety of
sources including data submitted to EPA under Sec-
tions 4, 5, and 8. Private groups, citizens, and other
governmental agencies also provide information.
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In addition, EPA is authorized under TSCA to conduct
whatever research, development, and monitoring are
necessary to carry out the purposes of the act (Section 10).
In order to carry out its responsibilities, EPA has col-
laborated with other Federal agencies. For example, EPA
collaborated with the Veterans' Administration to study
dioxin and furan levels in the adipose tissue of Vietnam
Veterans. The Agency is collaborating with the Ecological
and lexicological Association of the Dyestuffs Manufactur-
ing Industry and the American Textile Manufacturers In-
stitute to assess the exposure to and associated risk from
the use of powdered dyes in the textile industry. In support
of the PMN program, EPA initiated a series of national
surveys to examine the frequency, duration, and amount of
use of certain products containing chemicals of interest.
Under Section 21, citizens may file petitions requesting
action (under specified sections), many of which also pro-
vide information.
EPA can regulate a broad range of activities involving
chemicals, including manufacturing, processing, labeling,
distribution, use, and disposal (Section 6). If EPA makes a
finding of "unreasonable risk," the Agency must promulgate
a rule to the extent necessary to protect against the risk.
The authority to regulate a substance includes:
Limiting the amount that can be produced.
Prohibiting or limiting specific uses (or a particular use
in a concentration in excess of a specified level).
Requiring instructions or warnings.
Mandating extensive manufacturing and monitoring
records.
Controlling disposal.
Requiring manufacturers to monitor or conduct tests.
Specifying quality controls in manufacturing or
processing (to address the problem of highly toxic
impurities).
Requiring the manufacturer or processor to inform
the public or distributors of the risk of injury.
Requiring the manufacturer or processor to replace or
repurchase products held to constitute a hazard.
"Otherwise regulate any manner or method of com-
mercial use of such substance or mixture."
Restrictions on a substance may be applied to some
geographical areas and not to others.
Section 7 gives EPA additional authority to regulate
imminent hazards. Under this section, EPA may go to
court and commence a civil action for seizure of any
imminently hazardous chemical substance or mixture
and/or for relief against any person who manufactures,
processes, distributes, uses, or disposes of an imminent-
ly hazardous substance. An "imminently hazardous
chemical substance or mixture" presents, by definition,
"an imminent and unreasonable risk of serious or
widespread injury to health or the environment." A risk
is considered imminent if it is likely to result in injury
"before a final rule under Section 6 can protect against
such risk." To date, Section 7 has never been invoked,
and no regulations have been promulgated.
6.1.7 Relationship to Other Federal Laws
Section 9 of TSCA directs the Administrator to consult
and coordinate with all relevant regulatory agencies for
"the purpose of achieving the maximum enforcement of
this act while imposing the least burdens of duplicative
requirements..." Thus, TSCA may serve as a backup
authority where other laws are inadequate. Under TSCA,
there are two procedures for EPA deference to other
Federal laws; the procedure used depends on whether
the other law is administered by EPA or by another
Federal agency. Where EPA determines that the risk
presented by a substance or mixture "may be prevented
or reduced to a sufficient extent" by action taken under
a Federal law administered by another agency, it must
submit a report to the other agency. Whether the other
agency issues an order declaring that the risk outlined in
the report does not exist or initiates proceedings under
its own authorities, EPA is precluded from further action.
With respect to risks that could be mitigated by other EPA
authorities, the test again is whether the risk "could be
eliminated or reduced to a sufficient extent by actions
taken under" the other law. However, even if this test is
satisfied, the EPA may still proceed under TSCA if it is
"in the public interest."
Section 9 requires EPA to defer to other Federal laws
only in connection with actions to restrict a chemical
under Sections 6 or 7. Thus EPA has the authority to
require recordkeeping, reporting, premarket notification,
and testing concerning risks regulated by other laws.
In 1986, TSCA authority was used for the first time to
address the chemical problems of other EPA programs
and other Federal agencies. In that year, EPA promul-
gated a rule under TSCA Section 8 (a) to consolidate
many information-gathering requirements. This rule may
be used to obtain information to support the assessment
and regulation of chemicals identified by EPA, Occupa-
tional Safety and Health Administration (OSHA), Nation-
al Institute of Occupational Safety and Health (NIOSH),
and Consumer Product Safety Commission (CPSC).
Additionally, the information collection authority of Sec-
tion 8(d) was used to obtain unpublished health and
safety studies on chemicals subject to the 1984 RCRA
amendments and other chemicals identified by multiple
users in EPA and CPSC. More recently, Section 4 has
been used to require testing on behalf of the Office of
Water for use under the Clean Water Act and for the
Office of Solid Waste for use under RCRA.
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Section 10 directs the Administrator to establish, ad-
minister, and coordinate an efficient and effective system
for the collection and dissemination of data to other
Federal departments and agencies. EPA has estab-
lished a comprehensive data management system that
is accessible to other EPA programs and Federal agen-
cies, as well as to Regions and States. This program has
resulted in resource savings for both industry and the
government by avoiding unnecessary or duplicative in-
formation gathering and dissemination efforts.
6.1.8 Asbestos Programs
On April 25,1986, EPA issued a final rule under TSCA
to protect State and local government employees from
the hazards of asbestos abatement work. This rule ef-
fectively extends OSH A worker-protection requirements
for asbestos abatement to State and local employees
who perform asbestos abatement work. (OSHA is nor-
mally responsible for the Federal regulations protecting
private sector workers, but OSHA does not have the
authority to cover those in the public sector [i.e., Federal,
State, and local government employees]).
In October 1986, Congress passed the Asbestos
Hazard Emergency Response Act (AHERA). This law
required local education agencies to identify friable
and nonfriable asbestos-containing material (ACM) in
public and private elementary and secondary schools
by visually inspecting school buildings, sampling
suspect materials (if they are not assumed to be ACM),
and analyzing the samples. The rule requires local
education agencies to submit management plans to
the Governor of their State by October 12, 1988, to
implement the plans by July 9,1989, and to complete
implementation of the plans in a timely fashion.
AHERA also contains provisions for the training and
accreditation of several types of asbestos profes-
sionals (e.g., inspectors, management planners,
abatement contractors, project designers, and
workers) and requires that accredited personnel be
used for certain AHERA-mandated activities.
Although AHERA's primary mission is to impose addition-
al inspection and management requirements on schools,
it also contains important amendments to the Asbestos
School Hazard Abatement Act (ASHAA). In 1984, Con-
gress enacted ASHAA to offer financial assistance to
needy schools so that they could abate asbestos
materials. AHERA amended ASHAA to prohibit financial
assistance from being awarded to any school that uses
persons who are not AHERA-accredited for asbestos
inspections, management planning, and abatement.
Thus, to qualify for an ASHAA award in 1989, a project
had to use accredited personnel. Congress appropriated
$47.5 million under ASHAA in 1989 to aid primary and
secondary schools with severe asbestos hazards.
On July 12,1989, EPA issued a final rule under Section 6
of TSCA to ban the manufacture, importation, and process-
ing of eight asbestos products: A/C corrugated and flat
sheet, roofing felt, flooring felt, vinyl asbestos floor tile,
pipeline wrap, clothing, and new uses of asbestos. The rule
goes into effect on August 27,1990. The Agency also banned
the manufacture, importation, or processing of additional
asbestos-containing products (i.e., disc brake pads, drum
brake linings, automatic transmission components, clutch
facings, commercial and industrial asbestos friction products,
and sheet and beater-add gaskets) as of August 25,1993.
The distribution of all of these banned products will be phased
out from August 25,1992 to August 25,1997. The rule also
requires the labeling of all asbestos-containing products
subject to the rules.
6.2 Program Organization
The Office of Toxic Substances (OTS), within the Office of
Pesticides and Toxic Substances (OPTS), manages the
toxic substances control program from EPA's Head-
quarters office in Washington, DC, where the major ac-
tivities of the program are conducted. OTS consists of a
Director and eight program divisions, as shown schemati-
cally in Figure 6-1. OTS is responsible for developing and
operating the Agency program and policies for new and
existing chemicals, including information collection and
coordination; data development; health, environmental,
and economic assessment; and control actions.
To carry out these responsibilities, OTS employs a matrix
management approach (i.e., several divisions work
together to carry out a given regulatory function). The
divisions of OTS are as follows:
Office of Program Management and Evaluation
Information Management Division (IMD)
Chemical Control Division (CCD)
Existing Chemical Assessment Division (ECAD)
Four divisions support the CCD and ECAD:
Health and Environmental Review Division (HERD)
Exposure Evaluation Division (EED)
Economics and Technology Division (ETD)
Environmental Assistance Division (EAD)
To illustrate the functioning of OTS, the role of each
division in the following two major program activities is
described below:
Existing Chemical Review Process.
Review of a Premanufacturing Notification (PMN).
Each of these program activities involves the use of
health effects information and is, therefore, of interest to
HERL
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Figure 6-1. Organizational Chart for Office of Toxic
Substances (OTS)
Office Director
Charles Elkins
(202)382-3810
Office of Program
Management
and Evaluation
Dwain Winters
(Acting)
(202) 382-3763
Information
Management
Division
Linda Travers
(202) 382-3938
Chemical Control
Division
John W.Melone
(202) 382-3749
Existing
Chemical
Assessment
Division
Charles M. Auer
(Acting)
(202) 382-3442
Health and
Environmental
Review Division
Joseph Cotruvo
(202) 382-4241
Exposure
Evaluation
Division
Joseph Merenda
(202) 382-3866
Economics and
Technology
Division
Susie Hazen
(Acting)
(202) 382-3667
Environmental
Assistance
Division
Michael Stahl
(202) 382-3949
Assists Director in program oversight
by providing administrative, personnel
management, financial management,
and program planning and evaluation
services.
Manages all information and security
services. Responsible for developing
and maintaining data bases and the
computer network and for collecting
and disseminating TSCA and SARA
Title III data.
Manages the PMN process; develops
generic and chemical-specific rules for
new chemicals under Section 5 and
existing chemicals under Sections 6
and 7; conducts risk management
studies for existing chemicals.
Manages the TSCA testing and exist-
ing chemicals program. Responsible
for identifying and evaluating the risks
to human health and the environment
posed by existing chemicals and for
implementing control measures, in-
cluding developing and implementing
test rules, significant new use rules,
and recording and recordkeeping
rules.
Responsible for assessing the hazards
posed by new chemicals, evaluating
new test data submitted by industry,
and developing testing requirements
for new and existing chemicals.
Provides guidance and rule develop-
ment support to CCD and ECAD in the
areas of field sampling, testing and
analytical methods, and epidemiology
studies for new and existing chemi-
cals.
Provides engineering, industrial
chemistry, and economic analyses as
part of the PMN review process and
conducts assessment of the overall
economic and technical impacts of
TSCA actions.
Provides professional assistance regard-
ing TSCA compliance, including provid-
ing speakers for groups, and provides
information on TSCA in the form of
Chemical Hazard Information Profiles
(CHIPs), quarterly reports, and chemi-
cal-in-progress bulletins.
6.2.1 Existing Chemical Review Process
ECAD and CCD are responsible for managing the
decision-making and review processes, and implement-
ing control actions for existing chemicals. They conduct
the existing chemicals review process with the support
of EED, ETD, HERD, and IMD. A description of the
decision-making process follows.
1. The chemical is brought to the attention of ECAD
through Section 4 test data, the ITC, Title III emission
data, Section 8(e) submissions, state referral, by acquir-
ing and evaluating the available literature, etc.
2. Based on this information, ECAD conducts an initial
screening of the data with assistance from HERD.
3. The chemical then enters the existing chemical
management process, a three-stage process in which
ECAD and CCD decide whether to regulate one or more
uses of a chemical and, if so, to what degree. As the
progression of regulatory options proceeds, more and
more comprehensive actions are considered. At all
stages of this process, ECAD and CCD can specify
additional information needed for the next risk manage-
ment decision step. Once regulation is satisfactory, the
decision-making process ends. If new information is
received that indicates additional regulation is needed,
however, the risk management process can be
reinitiated at the appropriate stage.
4. ECAD and CCD make three sequential decisions: "A,"
"B," and "C." The "A" decision is made at the Risk
Management Steering Decision Meeting, which is
chaired by ECAD with input from all participating
divisions. At this meeting, which is regularly scheduled
two to four times a month, chemicals coming out of the
screening process are reviewed. Decision "A" involves
initiating one or more of five alternative actions: to exer-
cise "non-regulatory" risk management options on one
or more uses of the chemical (e.g., voluntary cutback by
industry); to initiate regulatory actions on one or more
uses of the chemical (e.g., labeling, product
stewardship); to gather additional information and set an
appropriate timetable for gathering it in preparation for a
Decision Meeting on Limited Regulatory Action (Step
"B"); to list the chemical on a publicly available Risk
Reduction Candidate List (RRCL), which contains
chemicals for which EPA or some other agency should
initiate actions to reduce risk; or to exercise no risk
management options.
5. The "B" decision is made at the Decision Meeting on
Limited Regulatory Action, which is chaired by CCD with
input from all other participating divisions. Meetings
occur at least quarterly and discuss chemicals drawn
primarily from the Risk Reduction Candidate List. The
meeting is designed to resolve whether limited regulatory
actions (e.g., labeling, restricted use) are appropriate.
The "B" decision involves initiating one or more of five
alternative risk management options: to use additional
non-regulatory actions; to exercise limited regulatory
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action; to exercise comprehensive regulatory action; to
list a substance on the OTS management list (a subset
of the RRCL for which OTS assumes direct respon-
sibility) and gather additional information and set an
appropriate timetable for gathering it in preparation for a
Comprehensive Risk Management Decision Meeting
(Step "C"); or to exercise no additional risk management
or information-gathering activities.
6. The "C" decision, which is made at the Comprehensive
Risk Management Decision Meeting, reviews the results
of the previous actions and determines whether addition-
al comprehensive regulatory action is necessary. The
meeting is chaired by the Office Director and structured
by CCD with input from participating divisions. At the
meeting, three options are evaluated: to regulate a use
(or uses) of the chemical comprehensively, to remove
the substance from the OTS management list (which
means that no further actions are necessary), or to
require additional analysis for use in a subsequent Com-
prehensive Risk Management Decision Meeting.
6.2.2 Review of a Premanufacturing Notification
(PMN)
The PMN review process, described in Section 6.1.3, is
managed by CCD. CCD oversees the regulatory evalua-
tion, selects and implements appropriate control
measures, and initiates further control, particularly if
hazardous chemicals enter commercial production.
HERD, ETD, and EED assist in PMN evaluations. The
specific steps in the decision-making process are sum-
marized below:
1. The PMN is received and catalogued by IMD.
2. The PMN is initially reviewed by the Deputy Director
of HERD, who evaluates the chemical's structure and
physical and chemical characteristics.
3. EPA then makes three sequential decisions: "A," "B,"
and "C." Decision "A" either allows the chemical to be
manufactured or requires the Structure Activity Team
(SAT), which is a part of HERD, to evaluate the chemical.
SAT assesses the chemical's structure/activity and
categorizes its concern (as either low, medium, or high)
for two separate endpoints: health effects and economic
effects.
4. At the "B" decision point, chemicals with a "high
concern" ranking are referred to the Chemical Review
and Evaluation Branch, a branch of HERD, for a risk
assessment.
5. Based on the risk assessment, EPA makes one of the
following "C" decisions:
To issue a test rule under Section 5(e).
To issue a consent order under Section 5(e) allowing
the manufacture or processing of the chemical if
certain specified controls are instituted.
To issue an order under Section 5(f) prohibiting or
limiting the activities described in the PMN.
6.3 Health Research Needs
6.3.1 Introduction
The TSCA program needs health research information
for several program activities, including screening
chemicals prior to their manufacture, generating lists of
chemicals to be tested, developing test rules, and provid-
ing scientific support for regulatory action regarding ex-
isting chemicals.
The toxic substances control program has served as a
technical resource for other EPA programs concerning
SARA Section 313 and for ATSDR concerning SARA
Section 110. The toxic substances control program does
have the authority to require industry to test, but testing
requirements are usually limited to a few specific items.
Selection of chemicals for testing is usually justified by
exposure potential coupled with triggers from the health
information base and/or structure-activity relationships
(SARs). Testing requirements are usually limited to
standard toxicity endpoints and do not usually include
such information as immu no toxicology, human data,
comprehensive exposure studies, or environmental fate.
The program can ask industry to test prior to allowing a
compound to be manufactured or can allow a compound
to be manufactured while further testing is performed.
Industry can choose to perform testing required by the
program or to keep the substance off the market.
Whether industry invests in research depends on the
commercial importance of the product relative to the cost
of the testing requirements. Economically prohibitive
testing requirements may create disincentives for
developing new, possibly more environmentally sound,
products. HERL research can help the program define
economically reasonable testing requirements, and
HERL should take a lead role in establishing and coor-
dinating cooperative research studies among HERL,
industry, and academic laboratories.
6.3.2 Major Research Categories
A. Hazard Identification
Hazard identification is a high priority health research
need for the TSCA program because this program must
ensure the safety of large numbers of chemicals. There
is an acute need for improving test methods of all kinds
in order to screen and freely characterize risks for a
variety of poorly studied endpoints.
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In particular, new methods are needed for assessing
noncancer health effects in the areas of neurotoxicology,
immunotoxicology, and reproductive developmental
toxicology. Current methods are inadequate for measur-
ing certain effects, such as developmental neurotoxicity
resulting from lead exposure. Tiered approaches should
be developed, so that the initial tier is cost effective and
rapid, and has low false positive and false negative
detection rates. Initial tiers should detect major health
outcomes and subsequent tiers should refine the
toxicologic risks. Efforts such as those by the
halogenated solvents industry to develop electrophysiologi-
cal indicators for neurotoxicity should be encouraged.
Research is needed to validate immunotoxicology
methods and to develop data that are specific to effect.
The National Institute of Environmental Health Sciences
(NIEHS) should continue to develop and validate long-
term methods for immunotoxicology using tiered ap-
proaches.
Better short-term screening techniques are particularly
needed for evaluating teratogens. Standard teratogen
studies are currently very costly. While the Kavlock-
Chernoff assay is somewhat more rapid and less costly
than the standard teratogen assays required by OPTS
test rules, it is somewhat limited by its inability to screen
for skeletal abnormalities. A screening assay for
teratogens comparable to the Ames assay for
mutagenicity would be desirable.
Also, SAR techniques for reproductive and developmen-
tal endpoints should be developed and validated. In
general, research efforts to improve quantification of
SAR should be supported and expanded.
B. Dose-Response
This research area is a high priority for the TSCA pro-
gram, which relies on animal studies and short-term tests
to assess the large volumes of chemicals that must be
screened.
Mechanistic studies would contribute to better under-
standing of toxicity, and are important to the program for
improving interpretation of risks to humans. More re-
search on mechanisms by chemical class is needed. If
mechanisms are known, shorter term test methods may
be able to establish toxicity for specific endpoints. For
example, if skin cancer is shown to be caused by dermal
contact and the proposed mechanism is interaction with
an enzyme system, enzyme changes could be used to
screen for effect or risk. This mechanism could be com-
pared in a number of species.
More research is needed to understand mechanisms for
classes of compounds that are nongenotoxic car-
cinogens (e.g., dioxins, chlorinated solvents) and for
compounds that cause behavioral neurotoxicity, par-
ticularly for pre- and postnatal exposure. Research col-
laboration between industry, the TSCA program, and
HERL, such as occurred in studying the chemical 1-1-1
trichloroethane, should be encouraged. In addition, the
program would like to have health research support that
focuses on allergic responses and how the immune
system is modified during the infectious disease state.
Finally, there is a general need for research to develop
and improve quantitative mathematical modeling of
dose-response data for noncancer endpoints. Some
scientists suggested that the approach currently being
used, i.e., taking no effect levels, estimating uncertainty
and employing safety factors based on orders of mag-
nitude, is somewhat unscientific because it does not
consider detailed dose-response information. One ques-
tion is whether scientific refinements will lead to real
improvements in the current approach. Research is
needed to better evaluate whether the current approach
is sufficient. Compounds should be selected and tested
for a limited number of specific endpoints in the areas of
neurotoxicity, reproductive and developmental toxicity,
and immunotoxicity. A study design using more than two
doses needs to be built to yield a better curve. An uneven
distribution of doses should also be considered, with
greater clustering at low doses, to increase the statistical
power of the test in the low-dose region.
C. Exposure Assessment
Exposure assessment is currently a medium priority for
the toxics program, but it will become a more important
issue in the future. Better information should be collected
on adipose tissue levels of toxic substances. These
should be monitored and entered into a surveillance pool
that is statistically representative. Information on meta-
bolites is also needed.
D. Chemical-Specific Information
This is a low priority for the TSCA program since the
program can require industry to test chemicals. Any
HERL research in this area should focus on important
toxicologic endpoints for chemicals within a structural
chemical class. This was done with valproic acid, which
served as a prototype for other chemicals of the same
structure. The basic approach is to identify chemicals by
structural class and then predict what toxicological
endpoints might be expected. Thus, an SAR concept can
be used to generate chemical-specific information.
6.3.3 Cross-Cutting Categories
A. Biological Markers
Biological markers are a medium research priority for the
TSCA program. More research on biomarkers would be
helpful, particularly for estimating exposure to existing
chemicals. The hazard represented by the biomarker
should be taken into consideration. Research is needed
on physiological changes that indicate exposure after the
chemical itself is no longer present. Biomarkers for
neurophysiological changes that are predictive of
neurotoxic endpoints also should be developed.
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B. Pollutant Mixtures
Research on pollutant mixtures is a low priority for this
program. Most regulatory decisions are determined for
single chemicals; however, the law does consider mix-
tures. PCBs are currently the single most important
pollutant mixtures issue for the toxics program. A new
regulatory strategy for PCBs based on a toxicity
equivalent factor approach is under study.
Once in the environment, PCB mixtures age, leading to
changes in the percentage of chlorination. If the relative
amounts of various congeners are determined by chemi-
cal analysis, a toxicity equivalent factor can be calculated
to estimate the toxicity of that particular mixture. Health
research of PCB fractions is needed to provide stronger
scientific support for these estimates.
The TSCA program favors a research strategy that in-
cludes bioassay-directed fractionation and tiered ap-
proaches for the components. Research should identify
specific mixture components with sentinel toxicity char-
acteristics for all types of toxicity, and determine how to
extrapolate the data to more refined toxicity endpoints.
This approach would be more useful to the program than
screening whole mixtures.
C. Human Data
This is a low research priority for the toxics program
because chemicals reviewed for premanufacturing
notices may not have had any exposure prior to their
evaluation. The feasibility of generating epidemiologic
data for new chemicals once they are approved is also
questionable since patterns and extent of exposure are
uncertain. Human data are much more useful in evaluat-
ing existing chemicals, such as asbestos, and in helping
to support new regulatory actions.
6.3.4 Emerging Research Needs
Most of the near-term emerging health research needs
for the TSCA program are in test methods development.
Because the program must screen large quantities of
different chemicals, validated methods are needed for all
important toxicotogic endpoints, particularly neurotoxicol-
ogy, immunotoxicology, and reproductive and develop-
mental toxicity. Short-term screening methods are
needed for all endpoints.
Mechanistic studies that will help in developing short-
term tests for specific endpoints are needed. Such data
will also contribute to the development of more biologi-
cally plausible dose-response models for quantitative
risk assessment. Once methods have been sufficiently
developed and validated, biomarkers of effect, e.g.,
neurophysiologic changes that are predictive for
neurotoxic effects, should be identified and validated.
The longer term emerging health research needs will be
in exposure assessment for existing chemicals, par-
ticularly in monitoring trends using biomonitoring surveil-
lance systems and use of metabolite data. HERL could
play a major support role in developing biomarkers for
incorporation into health studies conducted by ATSDR
and other programs. This type of research could be used
in grouping exposed populations to examine dose-
response relationships, or in identifying and evaluating
effects for susceptible groups.
5.3.5 Summary
Table 6-1 summarizes the health research priorities of
the TSCA program. Hazard identification and dose-
response issues are high research priorities. Of medium
priority are exposure-related issues and biological
markers. Chemical-specific information, pollutant mix-
tures, and human data are low research priorities.
Table 6-1 Important Health Research Needs and Their
Relative Priorities for the Toxics Program
Research Needs
Relative Priorities
1. Hazard Identification xxx
2. Dose Response xxx
3. Exposure Assessment xx
4. Chemical-Specific Information x
5. Biological Markers xx
6. Pollutant Mixtures x
7. Human Data x
x - Low priority
xx - Medium priority
xxx - High priority
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SECTION SEVEN
HAZARDOUS AND SOLID WASTE PROGRAM
7.1 Program Description
7.1.1 Introduction to Statute and Overview of
Program Area
The Resource Conservation and Recovery Act (RCRA),
passed in 1976 and amended in 1980 and 1984, sets
forth the framework for EPA's comprehensive waste
management programs. The primary goals of RCRA
are:
To protect human health and the environment from
the potential hazards of mismanaged waste.
To conserve energy and natural resources.
To reduce the amount of waste generated, including
hazardous waste.
To ensure that wastes are managed in an environ-
mentally sound manner.
The 1984 amendments, referred to as the Hazardous
and Solid Waste Amendments (HSWA), significantly ex-
panded the scope of RCRA. HSWA was created, in
large part, in response to concerns that existing methods
of hazardous waste disposal, particularly land disposal,
were not safe. The Superfund program, described in
Section 8, is designed to clean up uncontrolled or aban-
doned waste sites, and to respond to spills and emer-
gency releases of hazardous substances.
RCRA, including its 1984 amendments, establishes major
regulatory programs under Subtitles C, D, and I. EPA's
Subtitle C program mandates a system for controlling
hazardous waste from generation through ultimate dis-
posal. EPA's Subtitle D program establishes a system
for controlling solid waste, such as municipal solid waste.
EPA's Subtitle I program, established by HSWA, regu-
lates toxic substances and petroleum products stored in
underground tanks.
Section 7.1.4 covers the nonhazardous waste pro-
gram.
Section 7.1.5 describes the program for regulating
underground storage tanks.
7.1.2 Waste Characterization
RCRAdef ines solid waste as "garbage, refuse, or sludge
or any other waste material." According to RCRA, a solid
waste can be a solid, a semisolid, a liquid, or a contained
gas. Hazardous waste is a subcategory of solid waste.
Under RCRA, a solid waste is a hazardous waste if it
meets the following criteria: "Because of its quantity,
concentration, or physical, chemical, or infectious char-
acteristics, [it] may cause, or significantly contribute to,
an increase in mortality, or an increase in serious irre-
versible, or incapacitating reversible, illness; or pose a
substantial present or potential hazard to human health
and the environment when improperly treated, stored,
transported, or disposed of, or otherwise managed."
EPA's Subtitle D program regulates nonhazardous solid
wastes, including municipal solid waste. Subtitle D solid
waste disposal facilities are subject to performance
standards established by the Agency to ensure that
human health and the environment are protected. EPA's
Subtitle C program regulates hazardous wastes and
includes comprehensive, stringent requirements, not
only for disposal facilities, but also for anyone who
generates, treats, transports and/or stores hazardous
waste.
The law requires EPA to specify the solid wastes that are
hazardous and must be managed under the Subtitle C
program. The Agency employs two separate mechanisms
for identifying hazardous wastes. Wastes may be
defined as hazardous based on their characteristics
("characteristic wastes") or be specifically designated in
lists published by the Agency ("listed wastes").
The RCRA program is described below in four sections: Characteristic Wastes
Section 7.1.2 describes EPA's procedure for defining
hazardous waste and thereby determining whether
a waste is covered under Subtitle C.
Section 7.1.3 describes EPA's program for regulat-
ing hazardous waste.
A waste is hazardous if it exhibits one or more of the
following characteristics:
Ignltabillty - Ignitable wastes can create fires under
certain conditions. Examples include liquids such
as solvents that readily catch fire, and friction-sensi-
tive substances.
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Corrositlvlty - Corrosive wastes include those that
are highly acidic or basic and those that are capable
of corroding metal (such as tanks, containers,
drums, and barrels).
Reactivity - Reactive wastes are those that are
unstable under normal conditions. They can create
explosions and/or toxic fumes, gases, and vapors
when mixed with water.
Toxicity - Toxic wastes are those that are harmful
or fatal when ingested or absorbed. When toxic
wastes are disposed of on land, contaminated liquid
may leach from the waste and pollute ground water.
Toxicity is identified through the extraction procedure
(EP) toxicity test. This test is designed to identify wastes
likely to leach hazardous concentrations of particular
toxic constituents (metals and pesticides) into ground
water. During the procedure, constituents are extracted
from the waste in a manner designed to simulate the
leaching actions that occur in landfills. The extract is
then analyzed to determine if it possesses any of 14 toxic
contaminants. If the concentration of any of the toxic
constituents exceeds specified levels (which are set at
levels 10 times more stringent than the National Interim
Primary Drinking Water Standards for those substan-
ces), the waste is classified as hazardous.
EPA regulations require that all waste generators
evaluate their wastes to determine if any of the four
hazardous characteristics are exhibited. Wastes exhibit-
ing these characteristics are subject to EPA's Subtitle C
hazardous waste regulations. The 1984 RCRA amend-
ments direct EPA to develop additional hazardous waste
characteristics, including measures of toxicity. They also
direct EPA to improve the EP toxicity test as a predictor
of the leachate potential of wastes.
The Agency finalized a rule in the spring of 1990 that
requires use of a new toxicity test. This test, called the
toxicity characteristic leaching procedure (TCLP), is
designed to analyze for an expanded list of constituents
compared to the EP toxicity test. EPA bases regulatory
levels for hazardous chemicals on health-based con-
centration thresholds and dilution factors. A concentra-
tion threshold indicates how much of the chemical
adversely affects human health, while the dilution factor
indicates how easily the chemical could seep into ground
water, possibly contaminating drinking water supplies.
The TCLP improves upon the manual leaching proce-
dure used in the EP test through the use of mathematical
modeling. It is more precise and easier to perform than
the EP test, and is, therefore, a more sensitive test for
some hazardous constituents of wastes.
Listed Wastes
EPA publishes lists of specific wastes determined by the
Agency to be hazardous. The lists are organized into
three categories:
Source-specific wastes - This list includes
wastes from specific industries such as petroleum
refining and wood preserving. Sludges and waste-
waters from treatment and production proces-
ses in these industries are examples of source-
specific wastes.
Non-source-specific wastes - This list identifies
wastes from common manufacturing and industrial
processes, such as solvents used in degreasing
operations in any industry.
Wastes from commercial chemical production -
This Ms includes specific discarded commercial
chemical products, off-specification species, con-
tainer residues, and spill residues, such as creosote
and some pesticides.
The 1984 RCRA amendments direct EPA to "list" addi-
tional wastes, including wastes containing chlorinated
dioxins and chlorinated dibenzofurans, other
halogenated dioxins and dibenzofurans, and to consider
listing a number of other specific substances. EPA indi-
cates the basis for listing a waste by employing one or
more of the following Hazard Codes:
Ignitable Waste
Corrosive Waste
Reactive Waste
EP Toxic Waste
Acute Hazardous Waste
Toxic Waste
I
C
R
E
H
T
The information upon which to base a listing is derived
from a variety of sources, including EPA criteria docu-
ments and standards. Currently 768 substances are
"listed" wastes.
All listed wastes are presumed to be hazardous regard-
less of their concentration and must be handled in ac-
cordance with EPA's Subtitle C hazardous waste
regulations. However, if a firm can demonstrate that its
specific waste is not as described in the listing document,
the waste can be "delisted" on a case-by-case basis and
is then no longer subject to Subtitle C requirements.
EPA's decision on listing or delisting of wastes is based
on an assessment of the impact of the substance on
human health and the environment, including analysis of
transport and fate, exposure, and health risks. The Health
Assessment Section in the Technical Evaluation Branch
of the Chemical Assessment Division evaluates the
health risks posed by chemicals and provides informa-
tion on levels considered to be safe and on levels that
pose health risks. A delisted waste is still covered by the
characteristic rules.
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Exclusions
Some wastes are specifically excluded from RCRA re-
quirements. These exclusions include:
Domestic sewage.
Irrigation waters or industrial discharges permitted
under the Federal Water Pollution Control Act.
Certain nuclear or nuclear by-product material as
defined by the Atomic Energy Act.
Mining overburden returned to the mine site.
Cement-kiln dust waste.
Fly ash, bottom ash waste, slag waste, and flue-gas
emission control waste from fossil fuel combustion.
Household wastes, including waste containing toxic
constituents.
Agricultural wastes, excluding some pesticides.
Small quantity wastes (that is, wastes from busi-
nesses generating less than 100 kg [220 Ib] of
hazardous waste per month).
The 1984 RCRA amendments mandate review of some
excluded categories. EPA is currently investigating a
number of potentially hazardous wastes to determine if
they should be regulated or regulated differently. These
include:
Medical wastes - These wastes consist of syringes,
needles, plastic tubing, and other medical debris
from hospitals, doctors' offices, clinics, and
laboratories. Congress has passed legislation re-
quiring EPA to set up a demonstration program for
tracking medical wastes from their generation to
disposal. Based on the results of the program, EPA
will develop regulations to ensure that medical wastes
are handled and disposed of properly.
OH and gas drilling wastes - These wastes consist
of water, mud, and brine contaminated with
petroleum and heavy metals. Although these wastes
are not now classified as hazardous, EPA will
develop regulations for these wastes and work with
States to improve their regulatory programs.
Hazardous waste fuels - EPA is developing rules
to control the burning of hazardous waste fuels in
boilers and industrial furnaces. The rules would apply
to all boilers and industrial furnaces except those
burning extremely small quantities of wastes.
Mining waste - This waste is produced by the smelt-
ing and refining of ores and minerals. EPA is con-
ducting a study to determine which wastes (if any)
should remain exempt from hazardous waste
regulation. The Agency also is developing regula-
tions for other mining wastes, including those from
the mining of metallic ores, asbestos, phosphate
rock, uranium, and oil shale.
Responsibilities of Hazardous Waste Generators
A generator is the facility owner, operator, or person who
first produces a waste or first causes a waste to become
subject to RCRA regulations (e.g., imports a hazardous
waste, initiates a shipment of hazardous wastes, or
mixes hazardous wastes with different Department of
Transportation [DOT] shipping descriptions by placing
them into a single container). Generators must deter-
mine if their waste is hazardous and must oversee the
ultimate fate of the waste, as explained in 7.1.3 below.
"Small quantity generators" are exempt from most of the
RCRA hazardous waste requirements. Prior to the 1984
RCRA amendments, only those generators of more than
1,000 kg (2,200 Ib) per month were subject to RCRA
regulations. EPA regulations effective in March 1986
changed the regulated minimum to 100 kg (220 Ib) per
month, equivalent to about one-half of a 55-gallon drum.
1PA is currently conducting an educational program to
inform businesses about these requirements.
7.1.3 The Hazardous Waste Program (Subtitle C)
RCRA Subtitle C regulations are designed to ensure
proper management of hazardous waste from "cradle to
grave" - from the moment waste is generated until its
ultimate disposal. This approach has three key ele-
ments:
A tracking system requiring that a uniform manifest
document accompany any transported hazardous
waste from the point of generation to the point of final
disposal.
An identification and permitting system that enables
EPA and the States to assure the safe operation of
all facilities involved in the treatment, storage, and
disposal of hazardous waste.
A system of restrictions and controls on the place-
ment of hazardous waste on or into the land.
Tracking System
Once a generator determines that a waste is hazardous,
he or she must obtain an EPA identification number for
each site at which the waste is generated. Generators
who dispose of hazardous waste off site must properly
package the waste to prevent leakage from containers
during transport, and must label the waste to enable
transporters, public officials, and emergency responders
to rapidly identify the waste and its hazards.
To track the approximately 12 million tons of hazardous
waste transported off site to treatment, storage, or dis-
posal facilities, EPA requires generators to prepare a
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Uniform Hazardous Waste Manifest. This form identifies
the type and quantity of waste, the generator, the
transporter, and the facility to which the waste is being
shipped.
The manifest is part of a controlled tracking system.
Each time the waste is transferred (e.g., from one
transporter to another transporter), the manifest must be
signed to acknowledge receipt of the waste. A copy of
the manifest is retained by each link in the transportation
chain. Once the waste is delivered to the designated
facility, the owner of that facility must return a copy of the
manifest to the generator to confirm that the waste
arrived.
If the waste does not arrive as scheduled, generators
must contact the transporter and/or the designated
facility to determine the whereabouts of the waste. If the
manifest is not received within 45 days, the generator
must submit an exception report to the EPA Regional
Administrator describing efforts taken to locate the wastes
and the results of these efforts.
Generators must retain copies of the manifest for 3 years
after shipment. Every other year generators must also
provide the EPA or their authorized State agency with
information on their activities during the previous year,
including:
EPA identification number and name of each
transporter used throughout the year.
EPA identification number, name, and address of
each offsite treatment, storage, or disposal facility to
which waste was sent during the year.
Quantities and nature of the hazardous wastes
generated.
Efforts taken to reduce the volume or toxicity of the
wastes generated.
Changes in volume or toxicity that were actually
achieved, as compared with those achieved in pre-
vious years.
Generators who treat, store, or dispose of their hazard-
ous waste on site also must submit a biennial report
describing the type and quantity of waste the facility
handled during the year and the method(s) of treatment,
storage, or disposal used.
Permitting System
The treatment, storage, and disposal facilities (TSDFs)
that receive hazardous waste from the transporter are
subject to an EPA permitting system to ensure their safe
operation. All treatment, storage, and disposal facilities
are part of this permitting system except:
Farmers disposing of pesticides from their own use.
Owners and operators of totally enclosed treatment
facilities.
Owners and operators of neutralization units or was-
tewater treatment plants.
Persons responding to emergency hazardous waste
spills or discharges.
Owners and operators of facilities that reuse,
recycle, or reclaim hazardous waste. (Wastes
generated during the recycling/reuse process must
be evaluated to determine whether they are hazard-
ous.)
Generators accumulating waste within certain
specified time periods.
Transporters storing manifested wastes for less than
10 days.
TSDFs must meet standards of performance (40 CFR
264 and 265) and permit requirements (40 CFR 270).
TSDFs must obtain a separate permit for each solid
waste management unit (SWMU) within the facility.
When applying for a permit, operators have to meet the
information requirements in 40 CFR 270.4, which require
that the owner/operator take soil and water samples in
SWMUs that are already in operation and analyze the
samples to determine whether they exceed the maxi-
mum soil concentration limits for water or the maximum
soil concentrations for soil. These concentration limits,
which are health based, are set by the Health Assess-
ment Section; the limits are codified in the Risk Facility
Investigation Guide, which is part of the Corrective Action
Rule. If exceeded, a facility investigation is triggered,
which could result in corrective action.
In addition, owners or operators of TSDFs must:
Verify identity of wastes prior to treatment, storage,
or disposal to ensure proper treatment. (The wastes
will have already been determined as hazardous by
the generator who would have consulted the hazard-
ous wastes list and the characteristic hazardous
waste definitions in order to make this determina-
tion.)
Prevent the entry of unauthorized personnel into the
facility by installing fences and surveillance systems
and by posting warning signs.
Periodically inspect the facility to determine if there
are any problems.
Adequately train employees.
Prepare a contingency plan for emergencies (i.e.,
any imminent or actual release, fire, or explosion)
and establish other emergency response proce-
dures.
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Comply with the manifest system and with reporting
and recordkeeping procedures.
Comply with performance-based, engineering re-
quirements that are established for each individual
facility by the Office of Solid Waste.
Comply with design and technology requirements,
such as installing double liners and leachate detec-
tion and collection systems.
Comply with location standards that include fkxxjplain,
earthquake, and hydrotogical considerations.
TSDFs must also comply with closure and post-closure
requirements, including:
Acquiring financial assurance mechanisms (such as
trust funds, surety bonds, or letters of credit) to pay
lor completion of all operations.
Demonstrating their ability to pay for 30 years of
ground-water monitoring, waste system main-
tenance, and security measures after the facility
closes. The TSDF must keep a record of the monitor-
ing data on site. The trigger levels can change if new
data become available.
Obtaining liability insurance to cover third-party
damages that may arise from accidents or waste
mismanagement.
In addition, to ensure clean closure, TSDFs must reach
cleanup levels specified by EPA. Based on the con-
centrations of contaminants at the site, and assuming
100 percent absorption of those chemicals, EPA deter-
mines the health risk posed by the site. This risk is then
compared to health-based standards, which are
developed by the Chemical Assessment Division, to
determine the cleanup levels. In the future, EPA hopes
to make cleanup levels more site specific based on
improved pharmacokinetic, bioavailability, and exposure
data that allow cleanup levels to reflect absorption more
accurately.
Under the RCRA statute, the TSDF cannot get a permit
without public hearings. At these hearings, the EPA
provides all necessary information.
Land Disposal Restrictions
One goal of the 1984 RCRA amendments was to tighten
restrictions on land disposal of hazardous waste and to
give impetus to the development of more environmental-
ly sound waste disposal methods. These amendments
mandated EPA to develop regulations to (1) minimize
wastes by reducing, recycling, and treating them; (2) ban
unsafe, untreated wastes from land disposal; (3) require
that land disposal facilities be designed, constructed,
and operated according to strict standards; and (4) re-
quire corrective action for releases of hazardous waste
into the environment.
Waste Reduction, Recycling, and Treatment
Hazardous waste generators must certify that they have
taken steps to reduce the volume of hazardous waste
they generate. Generators may reduce their waste
volume through manufacturing process changes, source
separation, recycling, raw material substitution, or
product substitution. Generators also may treat waste
prior to disposal to reduce the waste volume or eliminate
the waste's hazardous constituents. EPA is sponsoring
research on new treatment technologies to destroy,
detoxify, or incinerate hazardous waste; on ways to
recover and reuse hazardous waste; and on methods to
reduce the volume of hazardous waste requiring treat-
ment or disposal.
Banning Unsafe Wastes from Land Disposal
The 1984 RCRA amendments require EPA to examine
all hazardous wastes to determine if any should be
banned from land disposal. The amendments prohibit
the land disposal of untreated hazardous wastes unless
EPA finds that there will be "no migration of hazardous
constituents...for as long as the wastes remain hazard-
ous."
The RCRA amendments set strict deadlines for deter-
mining whether wastes should be restricted from land
disposal. They required EPA to complete its determina-
tion fordioxins and certain solvents by November 1986,
and for liquid hazardous wastes containing certain me-
tals, cyanides, polychlorinated biphenyls (PCBs),
halogenated organic compounds, or acid wastes by July
1987. EPA completed assessing all of the listed wastes
by May 1990.
If a waste is restricted from land disposal, it must be
treated and rendered less hazardous before it can be
disposed of on land. Thus, EPA's decision concerning
each group of wastes includes a "treatment standard"
for the restricted wastes. These treatment standards
specify a level or method of treatment (i.e., best
demonstrated available technology, BOAT), which
substantially reduces the toxicity or mobility of the
hazardous constituents so as to minimize long-term
threats to human health and the environment. The
Technology Branch in the Waste Management
Division selects the BOAT; they choose whatever
available technology reduces the toxicity and mobility
of the waste the most. Although health considerations
do not currently affect the choice of technology as it
has to be BOAT, in the future new regulations will allow
cleanup levels based on health criteria. These new
regulations may, in some cases, allow the use of
non-BDAT technology as long as it is capable of meet-
ing health-based levels. (At the present, the use of
some BOAT results in chemical concentrations that
are below health-based concentrations of the chemi-
cals, resulting in cleanup "over kill.")
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Standards for Land Disposal Facilities
The 1984 RCRA amendments provide several new
restrictions and standards for land disposal facilities to
ensure more thorough protection of the environment,
particularly ground water. These include:
Banning liquids from landfills.
Banning underground injection of hazardous waste
within 1/4 mile of a drinking water well.
Requiring more stringent structural and design con-
ditions for landfills and surface impoundments, in-
cluding two or more liners, leachate collection
systems above and between the liners, and ground-
water monitoring.
Requiring cleanup or corrective action if hazardous
waste leaks from a facility. The cleanup levels are
determined on a case-by-case basis.
Requiring location standards that protect human
health and the environment; for example, allowing
disposal facilities to be constructed only in suitable
hydrogeologic settings.
Corrective Action Requirements for Hazardous
Waste Releases
The 1984 RCRA amendments require that all Subtitle C
facilities take corrective action for any release of hazard-
ous waste or constituents into the environment. The
amendments provide an administrative order that
enables EPA or an authorized State to require corrective
action (such as repairing liners or pumping to remove a
plume of contamination) when there has been a release.
EPA or the State may require corrective action beyond
the facility boundary, and may require corrective action
regardless of when waste was placed at a facility. The
extent of cleanup required by the corrective action is
determined by EPA or the State on a case-by-case basis.
The amendments also require that Subtitle C facilities
provide financial assurance that they can complete the
corrective action.
The Role of the States In Hazardous Waste Management
RCRA encourages States to develop and run their own
hazardous waste programs as an alternative to direct
EPA management. For a State to have jurisdiction over
its hazardous waste program, it must receive approval
from EPA showing that its program is at least as stringent
as the EPA program. States that are authorized to
operate RCRA programs oversee the hazardous waste
tracking system, operate the permitting system for haz-
ardous waste facilities, and act as the enforcement arm
when an individual or company practices illegal waste
management. EPA may assist these States in enforcing
the law, and EPA acts directly to enforce RCRA in States
that do not have authorized programs.
7.1.4 The Nonhazardous Waste Program
Subtitle D wastes are solid wastes not subject to hazard-
ous waste regulations under Subtitle C. These include:
Municipal solid waste.
Industrial waste.
Small quantity generator hazardous waste.
Municipal sludge.
Construction and demolition waste.
Agricultural waste.
Oil and gas waste.
Mining waste.
Subtitle D of RCRA establishes a framework for coor-
dinating Federal, State, and local government manage-
ment of nonhazardous solid wastes. EPA establishes
the regulatory direction and provides technical assis-
tance to the States and Regions for planning and
developing environmentally sound waste management
practices. The actual planning, regulation, and im-
plementation of solid waste programs under Subtitle D
are State and local functions.
Guidelines for State Solid Waste Management Plans
(40 CFR Part 256)
On July 31, 1979, EPA promulgated guidelines under
RCRA for the development and implementation of State
solid waste management plans. These guidelines sug-
gest minimum requirements for State plans and describe
the procedures for State plan adoption, submission, and
approval by EPA. The guidelines set forth recommenda-
tions for solid waste disposal and resource conservation
and recovery programs, facility planning and implemen-
tation activities, and public participation. Through the
State solid waste management plan, the State:
Identifies an overall strategy for protecting public
health and the environment from potential adverse
effects of solid waste disposal.
Specifies efforts for encouraging resource recovery
and resource conservation.
Criteria for Sanitary Landfills (40 CFR Part 257)
On September 13,1979, EPA promulgated national per-
formance standards for the protection of public health
and the environment from solid waste disposal facilities.
These standards establish the level of protection neces-
sary to ensure that "no reasonable probability of adverse
effects on health or the environment" will result from
operation of the facility. A facility that meets the criteria
is classified as a "sanitary landfill"; a facility in violation
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is classified as an "open dump" and must be upgraded
or closed. The criteria include the following:
A facility or practice shall employ special controls for
location in floodplains.
A facility or practice shall not cause discharges to
surface waters or wetlands that are in violation of
Section 402 or 404 of the Clean Water Act.
A facility shall not cause ground-water contamina-
tion (particularly of underground drinking water sour-
ces). To "contaminate" means to introduce a
substance that would cause the concentration of that
substance in ground water to exceed the maximum
contaminant level (MCL) specified by EPA's drinking
water regulations, or to increase the concentration
of that substance in ground water where it already
exceeds the MCL.
A facility or practice shall have specific restrictions
on waste application to land used for food chain
crops. These restrictions are designed to safeguard
against possible health hazards from cadmium or
polychlorinated biphenyls (PCBs) entering the food
chain.
Afacility or practice shall meet specific requirements
for disease vector controls.
Afacility or practice shall not engage in open burning
of waste.
A facility or practice shall have specific requirements
for safety provisions to control explosive gases,
fires, bird hazards to aircraft, and public access to
the facility.
Implementation and enforcement of these criteria are
primarily the responsibility of State and local govern-
ments. In addition, private citizens may bring actions in
Federal court to enforce the criteria.
Inventory of Open Dumps
EPA has published a listing of facilities that States have
identified as failing to meet the criteria of 40 CFR Part
257. This inventory has two major functions:
To inform Congress and the public about the extent
of the problem presented by disposal facilities that
do not adequately protect public health and the
environment.
To provide an agenda for action by identifying prob-
lem facilities routinely used for disposal that should
be addressed by State solid waste management
plans.
1984 RCRA Amendments
The 1984 Hazardous and Solid Waste Amendments
modified Subtitle D in several ways. HSWA requires
EPA to conduct a study of the extent to which the existing
standards applicable to solid waste management and
disposal facilities are adequate to protect human health
and the environment from ground-water contamination.
The amendments also direct EPA to revise the Subtitle
D criteria by March 31, 1988, for facilities that receive
household hazardous waste or hazardous waste from
small quantity generators (effectively all municipal waste
disposal facilities).
EPA published its evaluation of existing Subtitle D facility
standards, and its proposed revisions to the standards, on
August 30, 1988. The proposal concluded that existing
criteria lacked several regulatory provisions necessary to
protect human health and the environment, including
ground-water monitoring, corrective action, methane
monitoring, location restrictions, closure and postclosure
care, and financial assurance. EPA proposed a perfor-
mance-based standard addressing these issues that would
effectively require additional controls to ensure the environ-
mental safety of Subtitle D facilities.
HSWA also required each State to establish (by November
1987) a permit program or other system of prior approval
for facilities receiving small amounts of hazardous waste.
(These permit programs do not require risk assessments.)
If a State fails to implement such a system by September
31, 1989, EPA is given authority to enforce the revised
criteria at facilities accepting household hazardous waste
or small quantity generator waste.
Encouraging Effective Waste Management
In addition to technical standards for solid waste facilities,
EPA's Subtitle D effort includes a number of programs to
reduce the quantity, cost, and environmental impact of
municipal solid waste. These programs include:
Establishing a national goal of a 25 percent reduc-
tion in the generation of municipal solid waste.
Encouraging waste reduction and recycling through
information programs and planning assistance aimed
at State and local governments, corporations, and
individuals.
Consideration of regulatory and nonregulatory op-
tions to reduce the toxicity of wastes.
Establishing procurement policies by government
agencies that emphasize the use of recycled products.
Evaluation of measures to stimulate demand for
recycled materials.
These programs, aimed at reducing the generation and
toxicity of wastes, will be a major focus of the Subtitle D
program in the future.
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7.1.5 Underground Storage Tanks Program
Subtitle I of HSWA directed EPA to develop a com-
prehensive program to protect public health and the
environment from leaking underground storage tanks
(USTs). The amendments required EPA to develop and
enforce regulations governing underground storage
tanks containing hazardous substances or petroleum
products. These regulations exclude:
Certain farm and residential motor fuel tanks.
Heating oil tanks for onsite use.
Septic tanks.
Stormwater or wastewater collection systems.
Pipeline facilities.
Flow-through process tanks.
Liquid traps or associated gathering lines directly
related to oil or gas production operations.
Storage tanks in an underground area such as a
basement, if the tank is on or above the floor surface.
HSWA set forth a rigid schedule for EPA to develop the
LIST program. EPA is currently implementing a program
that includes a massive tank notification program, a ban on
new unprotective tanks, and technical standards for new
and existing tanks. EPA also is assisting States in design-
ing their own LIST programs to operate in lieu of the Federal
program. Health data are not used in this program.
7.2 Program Organization
The Office of Solid Waste (OSW) within the Office of
Solid Waste and Emergency Response (OSWER)
manages EPA's hazardous and nonhazardous waste
programs. The Office of Waste Programs Enforcement,
also within OSWER, directs the enforcement of these
programs. Both these offices are located in EPA's
Washington, D.C., Headquarters. OSW consists of a
Director's Office, several offices and staffs, and three
operating divisions (Figure 7-1), as listed below:
Office Director
Office of Program Management and Support
Office of Policy, Planning, and Information
Municipal Solid Waste Task Force
Waste Minimization Staff
Permits and State Programs Division
Waste Management Division
Characterization and Assessment Division
Figure 7-1. Organizational Chart for Office of Solid
Waste (OSW)
Office Director
Sylvia K. Lowrance
(202) 382-4627
Office of Program
Management and
Support
Jim O'Leary
(202) 382-4697
Office of Policy,
Planning, and
Information
Loretta Marzetti
(202) 475-9391
Municipal Solid
Waste Task Force
Bruce Weddle
(Acting)
(202) 475-9872
Waste Minimization
Staff
Jim Lounsbury
(202) 382-4807
Permits and State
Programs Division
Devereaux Barnes
(202) 475-7276
Waste Management
Division
Russell H. Wyer
(202) 382-6972
Characterization
and Assessment
Divisbn
David Bussard
(202) 382-4637
Oversees alll OSW programs
including Subtitles C and D.
Assists Director in manage-
ment and oversight of OSW
programs; manages resouces,
communications, and training
functions.
Performs policy development
including economic analysis
and information management.
Develops municipal solid
waste policy including Subtitle
D regulations.
Directs activities for programs
designed to reduce waste
generation.
Oversees State solid waste
programs; develops and is-
sues regulations involving
facility permitting procedures.
Develops technical standards
for TSD facilities; develops
guidelines for corrective ac-
tion; assesses waste treatment
options; develops Agency
strategy for "special* waste
(e.g., oil and gas wastes).
Provides lexicological support
for all OSW programs; defines
and lists hazardous wastes;
and develops land disposal
restrictions.
The Health Assessment Section within the Charac-
terization and Assessment Division uses health data in
developing criteria and guidance for performing site risk
assessments. The site assessments are then conducted
by EPA Regional personnel and by State agencies. The
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risk assessments are performed both on a site- and
chemical-specific basis. (See Sections 7.1.2 and 7.1.3.)
The organization and functioning of OSW is illustrated
below for three program activities:
Development of technical standards for Subtitle C
facilities.
Development of Subtitle D criteria.
Development of medical waste tracking standards.
7.2.1 Development of Subtitle C Facility Standards
The Land Disposal Branch of the Waste Management
Division in OSW develops technical requirements for
Subtitle C facilities. Since these requirements are purely
technical, health information is not included in the
process. A number of technical standards have been or
will soon be developed, including:
Liner requirements.
Leak detection requirements.
Requirements for containerized liquids.
Location standards.
Ground-water monitoring and analysis require-
ments.
Closure requirements.
In general, standards development is directed by a staff
person within the branch under the guidance of a large
working group. For the double liner standard (proposed
in March 1986), for example, several other groups within
EPA provided substantial input:
Engineering studies of liner materials were con-
ducted at the Office of Research and Development's
(ORD's) Cincinnati facility. These included an
analysis of the probability of leaks using various liner
materials.
Accelerated testing of liner materials was also per-
formed at ORD Cincinnati.
Economic impact analysis was conducted by the
Office of Policy, Planning, and Information in OSW.
Additional technical advice and input was provided
by other working group members.
Using the above information sources, the Land Disposal
Branch prepared a draft rule and responded to EPA and
Office of Management and Budget (OMB) suggestions.
The branch then managed the response to public com-
ments and promulgation of the final rule.
7.2.2 Development of Subtitle D Criteria
The Municipal Solid Waste Task Force manages the
development of Subtitle D criteria. The Subtitle D rule,
proposed in 1988, included requirements for facility
design, ground-water monitoring, and financial as-
surance. Like the development of standards for Subtitle
C facilities, the development of these standards is ac-
complished with technical input from the ORD labs.
These standards are revisited as necessary.
The Municipal Solid Waste Task Force developed the
proposed rule with the extensive involvement of the
working group, which included representation from
throughout the Agency including the Office of General
Counsel, the Office of Policy Planning and Evaluation,
the Office of Research and Development, and the Office
of Waste Programs Enforcement. ORD's Cincinnati lab
was extensively involved in the design criteria, including
liner requirements. Some of the liner analyses con-
ducted in conjunction with the development of Subtitle C
regulations were relevant also to the Subtitle D rulemak-
ing. ORD's Las Vegas laboratory provided technical
support in developing the ground-water protection parts
of the regulation.
The draft rule received more than 350 public comments.
The task force is currently developing its response to
comments, again with the support of the working group
members.
7.2.3 Development of Medical Waste Tracking
Standards
The Waste Characterization Branch of the Charac-
terization and Assessment Division in OSW developed
EPA's medical waste tracking regulations, which were
promulgated on March 24, 1989. The waste tracking
regulations were atypical in that a final rule was promul-
gated without the normal proposal and public comment
period. This procedure was expressly allowed under the
Medical Waste Tracking Act of 1988.
Because the rule was promulgated directly, the Waste
Characterization Branch convened an interagency work-
ing group to provide extensive input during the rulemak-
ing process. This group included members of the
regulated community; representatives of trade associa-
tions including the American Medical Association and the
American Hospital Association; State government repre-
sentatives including public health officials; other Federal
agencies including the National Institute of Health and
the Centers for Disease Control; and other EPA offices
including the Office of General Counsel and the Office of
Waste Programs Enforcement.
In developing the regulations, the Waste Charac-
terization Branch obtained input from the working group,
and also conducted the following activities:
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Contacted virtually every State to get information on
their medical waste tracking programs.
Obtained detailed information and input from 10
States as specified in the statute.
Held two meetings with State officials to discuss
regulatory and implementation issues.
Held a meeting with government agency officials,
professional association representatives, and other
interested parties concerning waste definition and
segregation, packaging, and reporting require-
ments.
Discussed the proposed tracking program with the
government of Canada and the International Joint
Commission.
Based on the results of these meetings and analyses
conducted by the branch subsequent to the meetings,
the medical waste tracking and management standards
were prepared and promulgated.
7.3. Health Research Needs
7.3.1 Introduction
The Office of Solid Waste (OSW) establishes concentra-
tions of contaminants in certain wastes as hazardous;
these levels are health-based. Once a substance is
defined as a hazardous waste, it enters the regulatory
system. When establishing health-based standards
under RCRA, the Agency must use levels set in other
EPA programs, for example, the Maximum Contaminant
Level (MCL) set by the drinking water program. The
health-based standards from other program areas,
therefore, drive RCRA program decisions. The program
will soon propose a new rule for listing hazardous waste
based on health criteria and standards, e.g., an RfD that
can then be used as the starting point for a risk assess-
ment that is directly applicable to RCRA-related ex-
posure scenarios. This rule will be referred to as the
toxicity characteristic rule.
7.3.2 Major Research Categories
A. Hazard Identification
Hazard identification is currently a medium priority for
this program, largely because HERL has already made
significant contributions in this area. Additional efforts
should focus on validating existing methods. Better es-
timates of predictive value are needed, particularly for
serious effects. For example, there are many un-
answered questions relating to chronic toxicity testing:
Are limited time intervals, such as 90 days or 45 days,
sufficient for predicting all long-term damage? In what
time frame must tests be conducted to ensure that all
lexicological damage will be found? Health research
scientists should reexamine standard protocols, e.g.,
90-day tests, acute toxicity range-finding tests, etc., to
determine whether there are variations that could yield
more information and to identify sensitive endpoints that
could shorten tests.
The changing character of waste streams makes it dif-
ficult to sample and analyze for all chemical constituents
and for all temporal variations. New short-term tests are
needed to screen and routinely monitor waste streams
for compliance. These methods would be useful because
they could be applied in the field or in the laboratory and
would be direct, health-based indicators of risk. New
methods are particularly needed for noncancer
endpoints, such as birth defects, neurotoxicity, and hy-
persensitivity.
B. Dose Response
Dose response is a high research priority for the RCRA
program. To improve the validity of risk assumptions,
clearer rationale is needed for extrapolation from one
route or dose or duration to another. Information for
predicting inhalation risks from oral toxicity data is espe-
cially needed. Research is also needed on the scientific
basis for reference doses (RfDs) and potency values.
More data on bioavailability would be very useful in
establishing media-specific RfDs. Many compounds
present different hazards in different media because
absorption can vary considerably. The program has a
great need for more refined information on metal
bioavailability since metals are commonly encountered
pollutants in RCRA-regulated waste streams. At present,
metals are grouped together for risk assessment. This
does not take into account information on dose response
for industrial metals and/or species of metals by different
routes of exposure.
To improve methods for short-term bioassays, OSW
personnel suggested that HERL examine several repre-
sentative compounds in 90-day studies for inhalation and
ingestion, compare target tissue dose and other phar-
macokinetic data, and attempt to model these effects.
Data on ecotoxicology are also needed. These data may
be a more sensitive basis for regulation and, in combina-
tion with health information, would more completely char-
acterize the hazardous waste.
C. Exposure Assessment
Exposure assessment is a high research priority for the
RCRA program. Since RCRA regulatory requirements
rely heavily on technology-based standards, information
is needed on the extent to which these standards control
total exposure and their effect on different types of ex-
posure. For example, development of methods for as-
sessing the effects of short-term and intermittent
exposures would be useful. Surrogates for exposure
monitoring and surveillance systems for human popula-
tions should also be explored.
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D. Chemical-Specific Information
This area is a high research priority for the RCR A program.
Technical assistance from HERL is needed particularly in
obtaining health effects information for chemicals not in
IRIS. Research should be conducted to generate chemi-
cal-specific data for metals, especially thallium, nickel, and
vanadium. Additional needs include media-specific RfDs
and guidelines relating RfDs to concentrations at which
regulatory action should be considered. Chemical-specific
toxicologic information would be useful in the listing process,
cleanup criteria, and site risk assessment.
7.3.3 Cross-Cutting Categories
A. Biological Markers
Biomarkers are a medium research priority for this pro-
gram. Of greatest interest are biomarkers of exposure,
which would be useful in quantifying exposure, defining
exposed populations in the vicinity of RCRA-permitted
facilities, and reassuring enforcement staff that exposure
is within an acceptable range. Biomarkers of effect are
of less value to the program because their ability to
predict human health risk is still uncertain. HERL should
review the most fully developed biomarkers of exposure
for field studies and focus on the two or three that have
the greatest potential for improvement in the shortest
period of time.
B. Pollutant Mixtures
Research on pollutant mixtures is a high priority for the
RCRA program. The chemicals regulated are often
found in combinations that vary from relatively simple
mixtures such as metals or metal species, to complex
mixtures such as incinerator emissions. Information on
the bioavailability of mixtures in various media and by
various exposure routes is essential for refining the
standard risk assessment default, i.e., 100 percent ab-
sorption. Research should be conducted to address the
toxicity of truly complex mixtures, such as incinerator
emissions and landfill leachates, and to examine the
scientific validity of the additivity assumption in the mixtures
guidelines. Information on how environmental partitioning,
i.e., fate and transport, affect the ultimate human and
environmental risks of mixtures is also needed.
C. Human Data
Human data are needed to address siting issues for
RCRA-licensed facilities. Key needs are the develop-
ment of quality human data bases (e.g., epidemiological
data and disease and exposure registries) and
toxicologies! data to use in developing study protocols
that are sensitive to sentinel effects and relevant disease
outcomes. The Office of Emergency and Remedial
Response would use this information to develop records
of decision and to expedite site cleanup activities. Since
ATSDR's mandate includes forming exposure and dis-
ease registries, and performing epidemiological studies
around hazardous waste sites, the generation of human
data by HERL for the RCRA program is a low priority.
In addition, a national monitoring study similar to the
National Health and Nutrition Evaluation Survey
(NHANES) should be conducted for chemicals common
to incinerator and other emissions. Researchers should
choose chemicals for study for which biomarkers are
reliable. The program is also in need of studies that
address heightened susceptibility of the aged and the
very young.
7.3.4 Emerging Research Needs
The emerging or critical health research needs for the
RCRA program are substantial information on metal
toxicology, particularly as it relates to pharmacokinetics
and bioavailability, and the development of inhalation
reference doses (many RCRA-regulated facilities in-
volve exposure via ambient air). These needs continue
to be important because of key data gaps in existing
health research information.
7.3.5 Summary
Table 7-1 summarizes the research priorities of the
hazardous and solid waste program. The highest
priority topics for research focus include dose-response
issues, exposure assessment, pollutant mixtures, and
chemical-specific information. Of medium priority are
biological markers and hazard identification. Human
data is a low priority category.
Table 7-1 Important Health Research Needs and
Their Relative Priorities for the Hazardous
and Solid Waste Program
Research Needs
Relative Priorities
1. Hazard Identification
2. Dose Response
3. Exposure Assessment
4. Chemical-Specific Information
5. Biological Markers
6. Pollutant Mixtures
7. Human Data
xx
xxx
xxx
xxx
xx
xxx
x
x - Low priority
xx = Medium priority
xxx = High priority
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SECTION EIGHT
SUPERFUND PROGRAM
8.1 Program Description
8.1.1 Introduction to Statute and Overview of the
Program Area
EPA's program to clean up abandoned or uncontrolled
hazardous waste sites is authorized under the Com-
prehensive Environmental Response, Compensation,
and Liability Act (CERCLA) of 1980. This law, commonly
referred to as Superfund, provides broad Federal
authority and resources to respond directly to releases
or threats of releases of hazardous substances. The
Superfund program was reauthorized in 1986 by the
enactment of the Superfund Amendments and
Reauthorization Act (SARA).
The CERCLA statute and the SARA amendments estab-
lish a trust fund to pay for cleanup activities. The
CERCLA statute established the fund at $1.6 billion for
the first 5 years. The SARA amendments extended the
program for 5 years and increased funding to $8.5 billion.
As explained further below, cleanup actions may be paid
for out of the fund (i.e., fund-financed actions) or they
may be paid for directly by responsible parties.
Under the Superfund program, EPA identifies sites from
which releases of hazardous substances that could en-
danger human health or the environment might occur or
have occurred. Once a site is identified, EPA ensures
that the site is cleaned up by the responsible parties or
by the government. Depending on the circumstances of
the release, the site may require either a removal or a
remedial action. Removal actions tend to be short term
or temporary in nature and involve cleanup or other
actions to prevent immediate damage to public health
and the environment (e.g., an emergency response to a
hazardous materials spill). Remedial actions are usually
longer term in nature and are designed to provide a
permanent remedy for the release (e.g., the cleanup of
an abandoned hazardous waste site).
In implementing either removal or remedial actions, EPA
requires parties responsible for creating a hazardous
waste problem to pay for its cleanup. In general, EPA's
first course of action is to encourage those responsible
to undertake cleanup activities. However, if an immedi-
ate problem threatens human health, welfare, or the
environment, EPA will take action before responsibility is
determined. If EPA identifies the responsible parties but
is unable to persuade them to undertake the cleanup,
EPA may clean up the site with Superfund dollars and
then sue the responsible parties to recover the cleanup
costs; or EPA may issue an administrative order to
compel responsible parties to perform the cleanup with
their own funds.
EPA develops and publishes the National Oil and Haz-
ardous Substances Pollution Contingency Plan (NCP)
which guides the activities of the Agency and all other
parties involved in the Superfund program. The NCP is
currently being revised to incorporate changes resulting
from the SARA amendments. The next paragraph
describes the recently proposed NCP, which was pub-
lished in the Federal Register on December 21,1988.
The NCP identifies the responsibilities and authorities of
Federal, State, and local governments, private industry,
and citizens. States are substantially involved in the
selection, initiation, and development of remedial
responses. The roles of States and EPA are spelled out
in the EPA/State Superfund Memoranda of Agreement
(SMOA). Under these agreements, the "lead agency"
(either EPA or a State agency) for activities under Super-
fund is identified. State governments are not authorized
to take actions that involve expenditures of Superfund
monies unless a SMOA or other appropriate contract has
been executed between the State and EPA.
EPA's Superfund program is described in the following
four sections:
Section 8.1.2 describes the scope and coverage of
the Superfund program.
Section 8.1.3 describes the site evaluation actions
taken once a location is identified.
Section 8.1.4 describes removal actions under Su-
perfund.
Section 8.1.5 describes the procedures for remedial
actions.
8.1.2 Scope and Coverage of the Superfund
Program
Unlike other statutes directed at protecting a specific part
of the environment (e.g., Clean Air Act, Clean Water Act),
Superfund covers all environmental media: air, surface
water, ground water, and soil. Under the Superfund
program, EPA responds to actual or threats of releases
into any media of hazardous substances, pollutants, and
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contaminants. With only a few exceptions (e.g., environ-
mental releases permitted under other statutes), Super-
fund coverage extends to all sources of releases and all
means of entry of a substance into the environment.
Hazardous Substances
Under Superfund, a "reportable" hazardous substance is
any toxic substance or hazardous waste (excluding
petroleum and natural gas) designated under the Clean
Air Act, the Clean Water Act, the Toxic Substances
Control Act, and the Resource Conservation and
Recovery Act (RCRA). EPA must designate additional
substances as hazardous if they could present substan-
tial danger to health and the environment. EPA maintains
and updates the list of hazardous substances covered
under Superfund in 40 CFR Part 302. There are currently
715 substances on the list. Substances are automatically
added to the Superfund hazardous substances list when
they are added to any one of the statutes listed above.
Superfund also provides general authority to control any
release or threat of a release of any pollutant or con-
taminant that may adversely affect public health and
welfare. Pollutants or contaminants are defined as sub-
stances that, after release into the environment and upon
exposure, may cause death, disease, behavioral abnor-
malities, cancer, genetic mutation, physiological mal-
functions, or physical deformities in an organism.
In summary, EPA's authority to respond to releases or
threats of releases under Superfund covers (1) all en-
vironmental media, (2) all sources and means of entry
into the environment, (3) all toxic substances and haz-
ardous wastes designated under Superfund and four
other laws, and (4) any pollutant or contaminant that may
have adverse effects on human health and welfare.
8.1.3 Site Evaluation
The preremedial activities in the Superfund program
identify those sites that represent the highest priority for
further investigation and possible cleanup actions.
Discovery and Notification
Under Superfund, any person in charge of a facility must
immediately notify EPA of a release of a hazardous
substance (other than a Federally permitted release)
above certain specified levels (i.e., reportable quan-
tities). EPA has established reportable quantities for 442
of the 715 substances currently listed under Superfund
(40 CFR 302). For hazardous substances with no estab-
lished reportable quantity, there is a statutorily imposed
reportable quantity of 1 pound.
EPA must be notified also of any facilities where hazard-
ous wastes are or have been stored, treated, or disposed
of. Unlike release reporting, which applies to both haz-
ardous substances and wastes, the facility notice applies
only to hazardous wastes as defined under RCRA Sec-
tion 3001.
Releases also may be discovered through government
activities such as an investigation of hazardous waste
management facilities as authorized under Superfund,
notification of a release as required of a Federal or State
permit holder, inventory and survey efforts, or random or
incidental observation. The public may also initiate a
"discovery" through a citizens' petition, inventory and
survey efforts, or incidental and random observation.
EPA maintains a data base of current and historical
potential hazardous waste sites. The data base, known
as the Comprehensive Environmental Response, Com-
pensation, and Liability Information System or CERCLIS,
contains information on potential hazardous waste sites
as well as. sites undergoing removal and/or remedial
actions. There are currently over 30,000 sites in the
CERCLIS data base.
Under the NCP, facility managers are directed to report
releases to the National Response Center (NRC), the
national communications center for response activities.
Once it receives notice of a release, the NRC notifies the
on-scene coordinator (OSC) predesignated by the lead
agency. Upon receiving notification from the NRC, the
OSC notifies the Governor of the affected State.
Since State and local public safety organizations are nor-
mally the first government representatives at the scene of
a release, they are expected to initiate whatever measures
are necessary to protect public health prior to the arrival of
the OSC. Upon arriving at the scene of a release, the OSC
is responsible fordirecting response efforts. If a longer term
remedial action is warranted, a remedial project manager
(RPM), assigned by the lead agency, manages the
remedial activities at the site. The OSC and the RPM are
responsible for coordinating their efforts with Federal,
State, local, and private response agencies.
Preliminary Assessment
Upon notification or discovery, a preliminary assessment
is undertaken by the lead agency. The preliminary as-
sessment is a quick analysis of the situation based on
readily available information. The initial objective of the
preliminary assessment is to determine whether there is
an imminent threat requiring immediate action or
whether further investigation of the site is needed. If
response can be delayed without endangering public
health and the environment, additional time can be taken
to evaluate the site further and to identify appropriate
parties to undertake response actions.
The preliminary assessment may involve the collection
and review of data including photographs, information on
site management practices, information from gener-
ators, literature searches, and personal interviews. The
preliminary assessment may also include an evaluation
by the Agency for Toxic Substances and Disease
Registry (ATSDR) or by other appropriate parties (e.g.,
State public health agencies) to determine the threat to
public health. ATSDR health assessments are described
in more detail in Section 8.1.5.
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Preliminary assessments are conducted for all potential
hazardous waste sites, regardless of whether a removal or
remedial response is to be undertaken at the site. The
preliminary assessment for a removal response, especially
in an emergency, tends to be a quick assessment of the
situation. For sites identified for nonurgent removal or
remedial actions, the preliminary assessment is usually
more comprehensive. To date, preliminary assessments
have been conducted for nearly 27,000 of the 30,000 sites
identified as potential hazardous waste sites.
Site Inspection
In some cases, a site inspection is conducted as part of
the site evaluation. If a site appears to warrant further
investigation, based on the results of the preliminary
assessment, EPA will initiate a more detailed site inspec-
tion to evaluate whether the site poses an immediate
threat to people in the area or a potential threat to public
health or the environment. In the case of remedial site
inspections, inspectors collect sufficient information and
develop the data needed by EPA to evaluate the site's
hazard potential utilizing the Hazard Ranking System
(HRS). The HRS, discussed below, is the primary mechanism
for determining the eligibility of sites for longer term fund-
financed remedial action.
The site inspection usually involves both on- and offsite
field investigation and sampling. Prior to conducting field
sampling, the lead agency prepares a detailed site-
specific sampling plan which addresses the objectives
of the sampling effort and the quality of data needed to
fulfill those objectives. Upon completion of the site in-
spection, the lead agency prepares a report describing
the situation and presenting recommendations for fur-
ther action.
National Priorities List/Hazard Ranking System
Using data collected by or submitted to the Agency, EPA
prioritizes sites for cleanup. The National Priorities List
(NPL) is a list of those sites that appear to pose the most
serious threat to public health and the environment and
that appear to warrant remedial investigation and pos-
sible cleanup under Superfund. To date, 797 sites have
been listed on the NPL, with another 378 sites proposed
for addition. Only sites listed on the NPL are eligible for
fund-financed remedial actions. However, sites do not
have to be listed on the NPL to be eligible for short-
term fund-financed removal actions or enforcement
actions.
In most cases, EPA places a site on the NPL based on a
score calculated using the HRS. The HRS is designed to
assess the relative degree of risk to human health and the
environment posed by potential sites rather than to provide
quantitative risk assessments. As EPA explained in its
introduction to the HRS, "the HRS is a means for applying
uniform technical judgment regarding the potential hazards
presented by a facility relative to other facilities. It does not
address the feasibility, desirability, or degree of cleanup
required" (53 FR 52004, December 23,1988).
Because of the need to carry out initial studies in a timely
manner, EPA has elected to limit the complexity of the
HRS. For most sites, the data required for the HRS either
are already available or can be collected in a single site
visit.
Under the proposed NCP, EPA would calculate an HRS
score for a site by evaluating four possible migration
routes or "pathways": ground water, surface water, air,
and onsite exposure. The score for each pathway is
obtained by evaluating a set of factors (e.g., toxicity,
hazardous waste quantity, population) that characterize
the potential for the site to cause harm via the pathway.
The revised HRS would evaluate hazardous substances
and assign scores for three kinds of toxicity: acute
toxicity, carcinogenicity, and chronic noncarcinogenic
toxicity (53 FR 51968, December 23,1988). The path-
way scores are combined using a root-mean-square
approach to calculate the overall site HRS score.
The HRS system is designed so that, if all pathway
scores are low, the HRS score will be low. On the other
hand, if only one pathway score is high, the final score
will be relatively high. This is an important feature of the
ranking system since some extremely dangerous sites
pose threats through only one pathway.
Some sites are placed on the NPL for reasons other than
a HRS score. A site can be eligible for the NPL if a State
has designated it as its highest priority. In addition, a site
may be listed on the NPL if it meets all of the following
criteria: (1) the ATSDR has issued a Health Advisory
stating that individuals should be removed from ex-
posure to the release, (2) EPA determines the release
poses a significant threat to public health, and (3) EPA
anticipates it will be more cost effective to take remedial
instead of removal actions to respond to the release.
8.1.4 Removal Response Program
Removal Actions
EPA has broad authority to undertake whatever removal
actions are necessary to protect public health, welfare,
or the environment. Removal actions can be imple-
mented at any site, whether or not the site is listed on the
NPL. Compared to remedial actions, removals tend to
be shorter term and less expensive. Superfund imposes
a statutory time limit of 1 year and a dollar limit of $2
million on individual removals. However, these limits may
be waived if (1) there continues to be an immediate risk
to human health, welfare, or the environment; (2) con-
tinued response actions are necessary to prevent, limit,
or mitigate an emergency; or (3) continued response
actions will contribute to the performance of a long-term
remedial action. Actual or potential exposure of human
populations to hazardous substances, or to high levels
of hazardous substances in soils at or near the surface
that may migrate, might necessitate a removal action.
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EPA frequently undertakes removal actions in response
to an emergency situation such as a spill of hazardous
materials that threatens drinking water supplies.
Removal actions also may be undertaken if EPA deter-
mines that a removal is consistent with later remedial
work to be conducted at the site. Removal actions en-
compass a broad range of activities such as posting of
fences and warning signs, removal of drums or barrels
that contain hazardous wastes, and/or provision of an
alternative water supply. A list of possible removal ac-
tions is provided in section 300.415 of the NCP.
Cleanup Standards and Requirements
Both removal and remedial actions, to the extent pos-
sible, must attain or exceed applicable or relevant and
appropriate Federal and State requirements (ARARs).
Applicable requirements are those cleanup standards;
standards of control; and other substantive environmen-
tal protection requirements, criteria, or limitations
promulgated under Federal or State law that specifically
address a hazardous substance, pollutant, contaminant,
remedial action, location, or other circumstance at a
Superfund site. Relevant and appropriate requirements
are requirements that, while not applicable to a hazard-
ous substance, pollutant, contaminant, remedial action,
location, or other circumstance at a Superfund site,
address problems or situations sufficiently similar to
those encountered at the site that their use is well suited
to the particular site. An example of a relevant and
appropriate requirement is the use of Maximum Con-
taminant Levels from the Safe Drinking Water Act for
ground-water cleanup.
Identification of ARARs must be done on a site-specific
basis. To provide guidance in identifying ARARs, EPA
has classified the different types of requirements that
Superfund actions may have to comply with:
Ambient or Chemical-Specific ARARS establish
the acceptable amount or concentration of a chemi-
cal that may be found in, or discharged to, the
ambient environment.
Performance, Design, or other Action-Specific
ARARs are usually technology- or activity-based
requirements or limitations on actions taken with
respect to hazardous wastes.
Location-Specific ARARs are restrictions placed
on the concentration of hazardous substances or the
conduct of activities solely because they occur in
special locations.
State Role
Under Superfund, EPA is obligated to consult with a State
on all removal actions to be conducted in that State. In
addition, States may take the lead in fund-financed
removal actions if a cooperative agreement exists be-
tween the State and EPA. In most cases, States are not
required to share in the cost of a fund-financed removal.
However, States are required to cover 50 percent (or
more) of the cost of a fund-financed removal if the action
is being taken at an NPL site that was publicly operated
at the time of hazardous substances disposal.
States also are responsible for identifying to EPA, poten-
tial ARARs for all fund-financed removal actions in a
timely manner. With only a few exceptions, Superfund
removal actions must meet State ARARs if they are more
stringent than Federal requirements.
The exceptions to the ARAR requirements are as follows:
The selected action is only part of a remedial action
that will comply with the ARAR requirement upon
completion.
Compliance with the ARAR requirement would cre-
ate even greater health or environmental risks.
Compliance with the ARAR requirement is technical-
ly impractical from an engineering prospective.
The selected remedy will attain a standard of perfor-
mance equivalent to an ARAR required standard
through the use of another method or approach.
The State has not demonstrated consistent applica-
tion of the requirement in similar circumstances.
In cases where the remedy is fund-financed, meet-
ing the ARAR standard would not provide a balance
between the need for cleanup at a site and the
amount of funds needed to clean up other sites.
8.1.5 Remedial Response Program
Remedial Actions
Remedial actions are responses intended to provide a
permanent remedy at an NPL site. Under Superfund, the
remedy must be (1) protective of human health and the
environment, (2) cost effective, and (3) utilize permanent
solutions and alternative treatment technologies or
resource recovery technologies to the maximum extent
possible. In addition, Superfund establishes a strong
preference for remedial actions that utilize treatments
that permanently reduce the volume, toxicity, and
mobility of hazardous substances. Offsite transport and
disposal without treatment is the least preferred option
when other feasible treatment technologies are avail-
able. Potential remedial response actions include a wide
range of activities such as excavation, ground-water
pumping, incineration, and encapsulation.
Financing Options
Superfund creates two mechanisms for financing
remedial actions at sites where releases have occurred
or threaten to occur: (1) the "Superfund" and (2) direct
payment by responsible parties. EPA's approach is to
first negotiate with responsible parties to persuade them
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to voluntarily clean up the site. If this is unsuccessful,
EPA can sue or issue an administrative order to compel
those responsible to clean up sites where hazardous
releases have occurred. The enforcement authorities of
Superfund also allow EPA first to implement the cleanup
and later to sue potentially responsible parties to recover
the cleanup costs. Potentially responsible parties
(PRPs) include present and past owners of the site,
parties who transported wastes to the site, and parties
who arranged for wastes to be disposed of or treated at
the site.
State Involvement
States are expected to pay a portion of the cost of
remedial actions undertaken at sites within their borders.
States are required to cover 10 percent of the cleanup
costs at privately owned sites and at least 50 percent of
the costs at publicly operated sites. States also are
required to assume responsibility for operating and
maintaining the implemented remedial actions for the
expected life of the action. In addition, if the remedial
action requires offsite disposal or treatment of hazardous
substances, the State must provide assurances of the
availability of a facility in compliance with the require-
ments of Subtitle C of RCRA.
As mentioned previously, States also may assume the
lead in managing cleanup activities by entering into an
EPA/State Superfund Memorandum of Agreement
(SMOA) or they may provide support in an EPA-lead
response. Even in an EPA-lead response, States are
actively involved throughout the remedial process. As
with removal actions, States are responsible for identify-
ing to EPA potential ARARs for all fund-financed
remedial actions in a timely manner.
ATSDR Health Assessment
ATSDR develops a health assessment of Superfund
sites covered in the remedial response program. Under
SARA, ATSDR must conduct a health assessment for
each facility listed on or proposed for inclusion on the
NPL. Health assessments may also be performed in
response to petitions to ATSDR. The health assessment
is a qualitative evaluation used to assist in determining
whether steps should be taken to reduce human ex-
posure (e.g., relocation of the surrounding population,
provision of an alternative water supply) and to identify
the need for additional studies to assess the potential
human health effects associated with release. The health
assessment must be completed "to the maximum extent
practicable" before completion of the remedial investiga-
tion and feasibility study (described below).
The ATSDR health assessment bases its preliminary
analysis of the risk to human health on the following
factors:
Nature and extent of contamination.
Existence of potential pathways of human exposure.
Size and potential susceptibility of the community
within pathways of exposure.
Comparison of expected human exposure levels to
short- and long-term health effects associated with
the hazardous substance and available recom-
mended exposure limits.
Comparison of existing morbidity/mortality data on
diseases associated with observed levels of ex-
posure.
Remedial Investigation/Feasibility Study
The remedial investigation and feasibility study (RI/FS)
process is the framework used to determine the most
appropriate, cost-effective remedy for a site. The
remedial investigation (Rl) is conducted to obtain addi-
tional information needed to identify, evaluate, and select
cleanup alternatives. The Rl involves collecting exten-
sive data to fully characterize site conditions, determine
the nature of the waste, and assess risk to human health
and the environment; and testing to evaluate the poten-
tial performance and cost of treatment alternatives.
The feasibility study (FS) is the analysis of remedial
alternatives based on technological, public health, in-
stitutional, cost, and environmental factors. The FS in-
cludes the development, screening, and detailed
evaluation of alternative remedial actions. A risk assess-
ment is required for each alternative cleanup method.
The Rl and FS are conducted concurrently. Data col-
lected in the Rl influence the development of remedial
alternatives in the FS, which in turn affects the scope of
the later stages of the Rl.
The public health evaluation is an important component
of the RI/FS process. The public health evaluation com-
pares the potential hearth risks of inaction at the site with
the health risks of remedial alternatives. There are two
key elements to the public health evaluation: (1) the
baseline public health evaluation and (2) the public
health analysis of remedial alternatives.
A baseline public health evaluation is an analysis of the
health risks posed by site conditions in the absence of
remedial action. While the ATSDR health assessment is
a qualitative analysis of the risks to human health, the
public health evaluation is a quantitative risk assessment
of the health risks at the site. The objective of the risk
assessment is to identify and characterize the following:
Toxicity and quantity of hazardous substances
present in relevant media (e.g., air, ground water).
Environmental fate and transport mechanisms
within specific environmental media.
Potential exposure pathways and extent of actual or
expected exposure.
Potential human and environmental receptors.
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Extent of expected impact or threat and the
likelihood of such threat occurring.
"Acceptable" levels of exposure based on regulatory
and lexicological information.
The information developed in the baseline evaluation
provides input for setting cleanup goals and developing
and evaluating remedial alternatives.
Development of health-based performance goals and
analysis of risks for remedial alternatives are the next
key elements of the public health evaluation. Perfor-
mance goals are the chemical concentrations targeted
for the site that will protect public health; they are site
specific. Each goal is associated with a number of
remedial alternatives; they are evaluated by compar-
ing the public health risks associated with each alter-
native.
If available, ARARs are used as the basis for develop-
ing target concentration ranges for hazardous sub-
stances at the site. When ARARs are not available,
remedies being considered should reduce ambient
chemical concentrations to levels associated with a
carcinogenic risk of 10 to 10 . For noncarcinogenic
contaminants, exposure point concentrations should
be reduced to acceptable intake levels. Acceptable
intake levels are concentration levels to which the
human population, including sensitive subgroups, is
expected to be exposed without appreciable risk of
adverse effects during a lifetime.
Record of Decision
Upon the completion of the RI/FS, EPA must select the
appropriate cleanup option. Factors considered in deter-
mining the appropriate remedial action include:
Public health evaluation.
ATSDR health assessment.
Cost.
Technical feasibility.
Environmental issues.
Institutional issues.
The RI/FS report and a proposed plan for the site are
issued together for public comment. The proposed plan
describes the remedial alternatives analyzed and
proposes the preferred remedial action for the site. The
report also summarizes the information relied upon to
select the proposed action. All final decisions and
responses to public comments are entered in a legal
administrative record known as the Record of Decision
(ROD).
Remedial Design/Action and Operation and Main-
tenance
Following the decision concerning the remedial option,
the lead agency develops engineering designs incor-
porating site-specific factors. Once the design is com-
plete, the agency solicits bids for construction contracts.
The agency may award one or more contracts depending
on the scope of the project. To date, more than 140
long-term cleanups have been initiated at Superfund
sites across the nation. In addition to the initial construc-
tion to implement the remedial action, there is often a
long-term operation and maintenance phase. For ex-
ample, a site may require an extended program of
ground-water pumping and treatment.
Post-Closure Review
Whenever the remedial action will result in any hazard-
ous substances, pollutants, or contaminants remaining
at the site, EPA is required to review the site at least every
5 years. This review must assure that human health and
the environment are still being protected, and if they are
not, EPA must take additional action. EPA is also required
to report to Congress on the results of all reviews and
additional actions taken, including the location of remain-
ing hazardous substances.The actual procedures for the
5-year review are currently being developed by EPA.
Deletion from the NPL
EPA may delete sites from the NPL when no further
response action is necessary. The site cannot be deleted
from the NPL, however, until the State in which the release
was located concurs on the proposed deletion. Once the
State agrees to the deletion, EPA must publish a Notice of
Intent to Delete in the Federal Register and provide suffi-
cient opportunity for public comment. EPA must respond to
comments and any new data submitted during the com-
ment period before publishing the Final Notice of Deletion.
SITE Program
Because of the growing concern over the use of land-
based containment technologies at hazardous waste
sites, EPA has established a program to accelerate the
development of new treatment technologies, the Super-
fund Innovative Technology Evaluation Program (SITE).
The primary objective of SITE is to enhance the develop-
ment, demonstration, and commercial availability of in-
novative technologies at Superfund sites as alternatives
to the containment systems presently used.
Through SITE'S Emerging Technologies Program, EPA
provides funds to technology developers to assist in
taking a promising technology from the laboratory bench
to the pilot testing stage. A major part of SITE is the
demonstrations program under which EPA forms joint
ventures to use fully developed (but untested) tech-
nologies on real Superfund sites. Technologies sup-
ported by the program include recycling, separation,
detoxification, destruction, stabilization, and handling of
hazardous wastes.
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ATSDR Toxicological Profiles
Under SARA, ATSDR is responsible for developing
toxicologies! information on the hazardous substances
found at Superfund sites. ATSDR with input from EPA
has prepared a list of hazardous substances most com-
monly found at facilities on the NPL and which pose the
most significant potential threat to human health. As of
October 1988, ATSDR had identified 200 such hazard-
ous substances. ATSDR must prepare toxicological
profiles for each of the substances identified. To date,
ATSDR has completed 25 of these toxicological profiles.
The profiles provide a rapid index of up-to-date
toxicological information for parties involved in evaluat-
ing hazardous waste sites.
Each toxicological profile must include the following: (1)
a complete study and interpretation of the available
toxicological information and epidemiologic evaluation of
the hazardous substance; (2) a determination of whether
adequate information on the health effects of each sub-
stance exists or is being developed; (3) an identification,
where appropriate, of the type of toxicological testing
needed to determine the levels of exposure that pose the
greatest risk to human health.
8.2 Program Organization
The Superfund program is managed by EPA's Office of
Emergency and Remedial Response (OERR) located at
EPA Headquarters in Washington, D.C. OERR oversees
as well as supports the response and cleanup activities
directed and implemented by the Regional EPA offices
or the States. In addition, OERR develops policies and
guidances for the various Superfund programs. OERR
has three divisions and a program management office
that all report to the Director (Figure 8-1). The divisions
of each OERR division are as follows:
Office of Program Management
Hazard Site Evaluation Division
Hazardous Site Control Division
Emergency Response Division
For the most part, the evaluation of and response to a
site is handled by the Regional EPA offices. Depending
on who is appointed to the lead agency, the EPA
Regional office will either direct the response actions or
provide support to the State in responding to the site. For
removal actions, a predesignated on-scene coordinator
directs the response actions taken at a site. Remedial
activities are directed by a remedial project manager
(RPM) who is appointed by the lead agency.
To illustrate how the Regional EPA offices respond to a
hazardous waste site under Superfund, the following two
major program activities are described below:
Figure 8-1 Organizational Chart for the Office of
Emergency and Remedial Response.
(OERR)
Office Director
Henry Longest, II
(202) 382-2180
Office of Program
Management
Clem Rastatter
(202) 382-2441
Hazardous Site
Evaluation
Division
Larry Reed
(Acting)
(202) 475-8602
Hazardous Site
Control Division
Paul Nadeau
(Acting)
(202) 382-4632
Emergency
Response
Division
Stephen Luftig
(202) 475-8720
Provides support services to
the Director and the divisions
of OEER, including policy
analysis, information system
management, contracts ad-
ministration, and budget
management.
Develops Agency guidances
and policy for Superfund
response actions including
site assessment priorities,
data quality objectives, the
Hazard Ranking System, and
health effects assessment
methods.
Provides guidance to regions
and parties involved with
remedial actions to ensure
that the proper level of
cleanup is achieved.
Oversees the Superfund
removal program and
responds to emergency spills
of oil and hazardous substan-
ces.
Preremedial actions including how a site is ranked
using the Hazard Ranking System.
Conduct of a Remedial Investigation/Feasibility
Study including the public health evaluation.
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8.2.1 Preremedlal Actions
The management of preremedial actions, described
below, is an example of how response actions are
managed at the regional level. This example is based on
the approach to preremedial actions used in Region I and
should not be generalized to all regions. The organiza-
tional structure and approach varies from region to
region.
In Region I, all activities from discovery of a site through
listing the site on the NPL are managed by the Superfund
Support Section in the Waste Management Division. The
Waste Management Division is responsible for all
preremedial and remedial activities in Region I. The
steps taken during the preremedial phase can be sum-
marized as follows:
1. The EPA Regional office is notified of a hazardous
waste site.
2. The Superfund Support Section contacts their State
counterpart to advise of the discovery and to determine
whether the site is really a hazardous waste site.
3. If warranted, the site is referred to the Environmental
Services Division at the EPA Regional office for emer-
gency removal action. A site is referred to the Environ-
mental Services Division if there is a dangerous
concentration of the hazardous wastes or a threat of fire,
explosion, or direct contact with surrounding popula-
tions. The site will also be referred for emergency
removal if ATSDR gives an opinion that the site poses an
immediate threat to human health and welfare.
4. The site is entered into EPA's CERCLIS data base so
that it is eligible for Federal funding.
5. A Preliminary Assessment (PA) of the site is conducted
by either an EPA contractor or the State. The PA includes
a file search for data previously collected on the site.
6. A Site Inspection (SI) is then conducted by the EPA
contractor or the State to identify and characterize the
hazardous wastes found at the site.
7. Using the data collected during the PA and SI, a score
is calculated for the site using the Hazard Ranking
System (HRS). The Superfund Support Section feeds
the data collected during the PA and SI into a computer
model to generate the score. Data used in the HRS
include information on waste concentration, quantity,
and migration. If needed, additional data are collected by
either the EPA contractor, the State, or a PRP if one or
more has been identified.
8. If the score calculated for the site is above the cutoff
score, the site will be proposed for the National Priorities
List (NPL). If the score is below the cutoff, the Superfund
Support Section will refer the site back to the State.
8.2.2 Remedial Investigation/Feasibility Study
The Remedial Investigation/Feasibility Study (RI/FS),
described in Section 8.1.5, involves data collection to
fully characterize site conditions and a detailed evalua-
tion of treatment alternatives. The approach to the RI/FS
outlined below is also based on the experience of Region
I. For the most part, it follows the approach established
in the "Guidance for Conducting Remedial Investigations
and Feasibility Studies under CERCLA" prepared by
OERR.
In Region I, sites are prioritized for the RI/FS based on
their HRS score, the public health evaluation, enforce-
ment potential, internal EPA resources, and the available
budget. Once a site is selected for an RI/FS, a remedial
project manager (RPM) is assigned to the site. A review
team (see Table 8-1 for a list of the review team mem-
bers) is also assigned to the site to periodically review
the progress on the RI/FS and to provide expert consult-
ation during the different phases of the RI/FS. In addition,
higher level reviews are conducted by a management
review panel (see Table 8-2 for a list of the review panel
members). Region I is currently revising its RI/FS proce-
dures to incorporate additional meetings of the manage-
ment review panel earlier in the RI/FS process.
The remedial activities are managed by the Waste
Management Division. This division is divided into
geographic branches (e.g., the New Hampshire/Rhode
Island Branch) which are further divided into geographic
sections (e.g., the New Hampshire Section). The RPM
is usually a technical person who works in one of the
geographic sections.
The steps taken by the EPA Regional office in performing
an RI/FS are as follows:
1. The RPM and contractor prepare the scoping for the
RI/FS. Scoping the RI/FS includes developing a site
management strategy and preparing the RI/FS Work
Plan.
2. The RPM and contractor present a briefing, as neces-
sary, on the site history and proposed site strategy to
review team members. Key issues to be discussed in-
clude feasibility, division of site remediation into operable
units, potential for removal actions, preliminary iden-
tification of remedial alternatives, preliminary identifica-
tion of State and Federal ARARs and criteria, advisories
and guidances that should be considered, and identifica-
tion of initial data quality objectives.
3. The RPM notifies State and Federal trustees (i.e., the
U.S. Fish and Wildlife Service, the National Oceanographic
and Atmospheric Administration).
4. If potentially responsible parties (PRPs) have been
identified, notice is given that an RI/FS will be conducted
at the site.
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5. The contractor or PRP develops a draft RI/FS Work
Plan, which the RPM distributes to review team mem-
bers. RPMs are encouraged to meet with each review
team member and determine the key phases for their
involvement.
6. The RPM and the Community Relations Coordinator
from the Office of Public Affairs prepare a community
relations plan.
7. The RPM develops a calendar schedule for the RI/FS.
8. If necessary, a briefing is held on the Work Plan for
review team members and the Office of Public Affairs. A
site visit is held for interested team members.
9. The review team submits comments on the draft Work
Plan to the RPM. The RPM compiles comments and
submits them to the contractor or PRP. The final Work
Plan must be reviewed by the Office of Quality As-
surance in the Environmental Services Division prior to
approval by the RPM.
10. The final Work Plan is released to the public in
cooperation with the Community Relations Coordinator.
11. The RPM ensures that an administrative record file
has been compiled and is made available to the public
at the Regional offices and at a repository near the site.
12. The contractor or PRP performs Phase I of the Rl.
Once the data are collected under the Site Charac-
terization portion of Phase I, the contractor or PRP
prepares a Risk Assessment. The preparation of the Risk
Assessment is overseen by the RPM and the Regional
Risk Assessment Specialist. The Risk Assessment
Specialist is part of the Superfund Support Section and
provides expert advice on risk assessment to all the
geographic branches in Region I.
13. The RPM receives the draft Rl from the contractor or
PRP. Included with the draft Rl is a list of the chemical-
and location-specific ARARs that have been identified.
Both documents are distributed to the review team and
the State with a deadline for review and comment.
14. The review team provides comments on the draft Rl
to the RPM. The RPM compiles the comments and
forwards them to the contractor or PRP. The RPM en-
sures that the requested changes are made to the Rl.
15. The Site Characterization, part of the Rl, is submitted
to the Agency for Toxic Substances and Disease
Registry (ATSDR) to be used in the ATSDR health as-
sessment for the site.
16. The Site Characterization is submitted to the En-
vironmental Services Division for review and, if neces-
sary, emergency action. The RPM is contacted if
emergency action is required at the site.
Table 8-1 Review Team Members
RPM
Staff Attorney, Office of Regional Counsel
Geographic Section Chief
State Representatives
Trustees of Natural Resources (i.e., U.S. Fish and
Wildlife Service, National Oceanographic and Atmos-
pheric Administration)
Hydrologic Review Team from the Superfund Support
Section of the Waste Management Division
Risk Assessment Representative from the Superfund
Support Section of the Waste Management Division
RCRA Policy Representative within the Geographic
Branch
Water Division Review Team
Air Division Review Team
Air Section of the Environmental Services Division (Ex-
pertise in onsite monitoring)
Representatives from the Quality Assurance/Quality Con-
trol Office of the Environmental Services Division
ATSDR Regional Representative
Responsible Party Coordinator
Community Relations Coordinator from the Office of
Public Affairs
Table 8-2 Management Review Panel
Presenters:
RPM
Geographic Section Chief
Site Attorney
Review Panel:
Geographic Branch Chief
Superfund Remedial Lead Branch Chief
Waste Management Division Director
Deputy Division Director
Office of Regional Counsel Branch Chief
81
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17. The Site Characterization, Risk Assessment, and
ATSDR Health Assessment are released to the public in
cooperation with the Community Relations Coordinator.
18. Concurrently with Phase I of the Rl, the contractor
performs Phase I of the FS which involves developing
treatment alternatives.
19. The contractor or PRP develops a draft of the
proposed treatment alternatives. The draft is reviewed
by the RPM and appropriate team members. Team meet-
ings and briefings are held to ensure adequate identifica-
tion of ARARs and regulatory compliance.
20. The contractor or PRP conducts Phase II of the FS
during which the proposed treatment alternatives are
screened to reduce the number of alternatives that will
undergo a detailed analysis.
21. If necessary, the contractor or PRP conducts Phase
II of the Rl during which bench or pilot treatability tests
are performed.
22. The RPM distributes a draft Detailed Analysis of
Alternatives and the entire FS to the review team for
comment.
23. The management review panel (see Table 8-2 for list
of panel members) meets to discuss selection of the
preferred remedy, data gaps, and compliance with
SARA. The panel also reviews and discusses the
proposed plan that will be released to the public.
24. A briefing is held on the FS. Participants include the
RPM, the full review team, the Division and Office Direc-
tors, the Site Attorney, the Deputy Regional Ad-
ministrator, the Section Chief, the Geographic Branch
Chief, the Branch Chief of the Office of Regional Coun-
sel, the contractor, State, and the Office of Public Affairs.
25. The review team returns their comments to the RPM.
The RPM compiles the comments and forwards them to
the contractor or PRP.
26. The contractor or PRP prepares the final FS. The
RPM ensures that the requested changes were made to
the FS.
27. The RPM meets with the Community Relations Coor-
dinator at least 6 weeks before the expected release of
the RI/FS to plan community relations activities.
28. The RPM finalizes the proposed plan and submits it
to the State for comment on the preferred remedy and
identification of State ARARs.
29. The FS and proposed plan are released to the public.
8.3 Health Research Needs
8.3.1 Introduction
Health research information is used in several Superfund
program activities: initial site evaluation and emergency
removal actions in cases of immediate health threat,
long-term remedial actions at the sites, evaluation of
health risks of alternative cleanup technologies, verifica-
tion that a remediated site is clean and remains clean,
and evaluation of health risks of innovative technologies.
8.3.2 Major Research Categories
A. Hazard Identification
The Superfund program has relatively little need for new
hazard identification methods since the Health Effects
Research Laboratory (HERL) has already developed
methods that are generally sufficient for Superfund ac-
tivities. New tests for endpoints not yet covered would
ensure that the most sensitive health impacts have been
identified. Efforts to appropriately validate all tests will also
increase confidence that human health is being protected.
Additionally, EPA is still developing procedures for the
5-year site review. Tiered testing strategies could help the
program to determine whether sites have been sufficiently
cleaned up and whetherthey will remain ciean after 5 years.
Most current regulatory activity focuses on cleanup. Con-
sidering the large number of sites nationally at which
hazardous materials will have been secured or contained
on site, a very important future issue is whether hazard
identification strategies and methods are adequate to en-
sure continued protection of the public.
B. Dose Response
Dose-response issues are a high research priority for
Superfund. Health research support is needed to:
Develop a scientific rationale for default positions for
risk assessment assumptions. Site risk assess-
ments incorporate a number of standard assump-
tions that are described in various EPA policy
documents. These assumptions in many cases are
default positions that are necessary for assuring
public health protection when the scientific research
information is weak. An example from the Superfund
program is that 100 percent of metals ingested are
treated as absorbed. Scientific rationales are
needed to support these difficult positions.
Generate information on interspecies absorption
factors. Superfund-related risk assessments incor-
porate many assumptions relating to absorption.
Better information on how human absorption factors
vary by media, type of substance, and exposure
route and how these factors vary among animal
species will help to improve the quality of these
assessment documents, which drive regulatory ac-
tivities of enormous impact.
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Investigate how toxicity from short-term exposure
situations, such as removals or onsite incineration,
may be estimated from lifetime data. The Superfund
program encounters many situations involving short-
term exposure scenarios. Many questions need to
be answered regarding these exposures, e.g., Can
there be chronic damage from short-term exposure?
How do risks from short-term exposure to car-
cinogens compare with risks from the same ex-
posure received at tower levels over the course of a
lifetime? The data base concerning these issues is
currently very sparse.
Investigate how toxicity by oral route may be ex-
trapolated to inhalation. Most toxicology data for
animal species are for oral exposure. This
presents problems for Superfund risk assess-
ments, which typically concern exposure
scenarios involving inhalation and dermal absorp-
tion. Research is needed on how the phar-
macokinetics of a substance may vary by route;
whether this variation can be predicted; and, if so,
for which types of compounds.
Develop information on btoavailability for different
media. This will allow the program to more accurate-
ly determine absorbed dose from specific media.
Health risk estimates will then be more accurate and
realistic.
C. Exposure Assessment
Exposure assessment is a high priority for Superfund.
Estimation of exposures and control of exposures drive
cleanup activities. Health research is needed for:
Assessing exposure related to soil ingestion for
different age groups. Very few studies have
measured soil ingestion rates for children of dif-
ferent ages and adults. Many Superfund sites
have contaminated soil. The ingestion exposure
risk associated with this soil should be factored
into risk-based determinations about the level of
cleanup needed. However, while soil concentra-
tions of contaminants can be measured, the
amount of soil consumed cannot. The environ-
mental research information base needs to be
strengthened in this area.
Improving and developing methods (e.g.,
biomarkers) for identifying exposed populations. In
evaluating the impact of a site, biomarkers that
measure exposure may help in defining the extent
of the population at risk and in identifying pathways
of exposure. These biomarkers need to be reliable.
If the pharmacokinetics of the compound are known,
it might be possible to examine half-life and duration
of exposure using reliable biomarkers. Collaboration
with ATSDR in incorporating biomarkers into human
health studies would be desirable.
Generating scientifically well-developed methods for
incorporating background dose from multimedia ex-
posure into risk assessments. An understanding of
background dose is important in order to assess
whether the exposure from the site and background
may trigger lexicological effects that would not be
expected based on the site exposure alone.
In addition, better information is needed on fate (e.g.,
reaction products and decay rates) and transport (e.g.,
rates under different environmental conditions and in
different media). While these issues are not health re-
search issues per se, they directly impact health risk
assessment by providing information on duration and
intensity of exposure.
D. Chemical-Specific Information
While chemical-specific data are very important to the
program, HERL research to generate this information is
a tow priority, since ATSDR and NTP are currently iden-
tifying and filling chemical-specific data gaps. Regional
staff need basic health information, including reference
doses (particularly for metals), potency factors, and
structure-activity relationship information for the many
chemicals included in site risk assessments. In addition,
the scientific basis for chemical-specific information con-
tained in IRIS needs to be examined to determine chemi-
cal-specific research needs, since IRIS is a critical
information tool for regional staff.
8.3.3 Cross-Cutting Categories
A. Biological Markers
Biological markers are of medium research priority for
the Superfund program. While biomarkers of exposure
are very useful to the program (as discussed above),
biomarkers of effect are not. There are many complex
issues and problems in using effects biomarkers to
predict health risks. Most likely, long-term research and
development will be needed before such biomarkers can
be used, in part because their predictive value must be
clearly understood. Superfund remedial actions, how-
ever, need to proceed on expeditious regulatory enfor-
cement schedules that cannot wait for the results of
long-term research. In this research area, HERL should
focus on a very limited number of biomarkers that could
provide useful information in a reasonably short time.
B. Pollutant Mixtures
This is a high research priority for Superfund since
most sites are contaminated with chemical mixtures.
Research is needed to evaluate the additivity ap-
proach described in the mixtures guidelines. Also of
concern is the current approach of looking at exposure
only from the site itself. As discussed above, whether
or not to consider background exposures should be
investigated.
83
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C. Human Data
Epidemiologic data, which are a major force driving
cleanup, and expanded research involving small clinical
studies would both be useful. However, since ATSDR's
mandate includes developing exposure and disease
registries and performing epidemiological studies
around hazardous waste sites, research that generates
human data is a low priority lor HERL Because of the
complementary roles of EPA and ATSDR in relation to
Superfund activities, HERL could serve as a resource to
both agencies in developing methods (e.g., biomarkers
of exposure) which can be incorporated into both human
clinical studies as well as biological monitoring surveil-
lance systems.
8.3.4 Emerging Research Needs
One emerging research need for the Superfund program
is development of test methods for determining whether
sites are clean at various intervals after cleanup is com-
plete. Many Superfund sites will have contaminants
secured at the site itself and will need to be monitored.
As the number of investigations of human populations
around Superfund sites increase, growing collaborative
research activities with ATSDR will be desirable in
developing health surveillance systems for monitoring
these populations.
More information is needed on metal toxicology, par-
ticularly how exposure, pharmacokinetics, and dose to
target tissues varies with metal species.
Table 8-3 Important Health Research Needs and
Their Relative Priorities for the
Superfund Program
Research Needs
Relative Priorities
1. Hazard Identification x
2. Dose Response xxx
3. Exposure Assessment xxx
4. Chemical-Specific Information x
5. Biological Markers xx
6. Pollutant Mixtures xxx
7. Human Data x
x - Low priority
xx ğ Medium priority
xxx- High priority
8.3.5 Summary
Table 8-3 summarizes health research priorities for the
Superfund program. The highest research priorities are
dose-response issues, exposure assessment, and pol-
lutant mixtures. Of medium priority is biological marker
research. The lowest priority research needs are hazard
identification, chemical-specific information, and human
data.
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SECTION NINE
SUMMARY
Seven EPA program areas were described in Sections
Two through Eight. This section summarizes these dis-
cussions. Section 9.1 reviews the regulatory program
descriptions, comparing and contrasting the health-re-
lated features of each program. Section 9.2 summarizes
the discussions of program organization. Section 9.3
reviews the health research priorities of all the programs
in relation to the eight scientific categories.
9.1 EPA's Regulatory Programs
Each of the seven program areas include regulatory
programs designed to protect human health.
Air Quality - Air Standards are usually based on
human health endpoints. Federal emissions limits
and State programs are designed to achieve those
standards. Special emissions limits are established
for pollutants that are hazardous to human health.
Radiation standards and radon guidance are also
designed to protect human health.
Drinking Water - National drinking water standards
(MCLs) are based directly on human health
endpoints. Health Advisories present human health
recommendations for some pollutants not covered
under MCLs.
Water Quality - EPA develops criteria (i.e., ambient
pollutant limits) for surface waters based in part on
human health endpoints. States use the criteria to
set pollutant limits for their water bodies. In permit-
ting, States or EPA may require testing of effluent for
toxicity to prevent stream contamination. Regula-
tions for sludge disposal are based on health risks.
Pesticides - The pesticide registration, reregistra-
tion, and Special Review programs involve the
evaluation of toxicity and other health-related infor-
mation to assess the effects of pesticide products.
Toxic Substances - Health data collected on new
and existing chemicals are used to determine
whether to implement restrictions on the manufac-
ture, use, and/or disposal of these chemicals.
Hazardous and Nonhazardous Waste - Toxicity
characteristics are used to determine which wastes
are regulated as hazardous. Regulations for facilities
that accept waste and restrictions on land disposal
of waste are designed to protect the health of popu la-
ttons near disposal sites.
Superfund - Emergency response and cleanup ac-
tions are designed to protect the health of near-site
populations.
Table 9-1 summarizes the characteristics of the seven
program areas and of the health-related regulatory
programs within each program area. While all of the
programs are designed at least in part to protect public
health, the specifics of their authority to collect, monitor,
and track health-related data differ, as highlighted in
Table 9-1.
Authority to Request Toxlcologlcal Data from
Industry - The authority to request health-related data
from industry varies greatly from program to program.
The pesticide program routinely requires an extensive
battery of lexicological test data before approving a
registration. The TSCA program requires industry to
submit available lexicological data and evidence of ad-
verse effects of chemical substances. Although the
TSCA program can also require extensive lexicological
testing, this authority is only used in select circumstan-
ces. The authority of the remaining programs to require
industry to supply health-related data is more limited.
The water program may require effluent toxicity testing
in conjunction with permitting. The Superfund program
requires industry to conduct extensive health analyses
in remedial actions. For the hazardous and nonhazar-
dous waste, air, and drinking water programs, the
statutory authority to collect lexicological information
from industry (under RCRA, CAA, and CWA, respective-
ly) is negligible. These programs can, however, use the
information-gathering authority of other statutes, al-
though this is rarely done.
Pollutant Coverage - Each of the regulatory programs
within each major program area has unique require-
ments for pollutant coverage. For example, NAAQS
cover six classes of air pollutants, MCLs cover 83
specific drinking water contaminants, and water quality
criteria documents cover 126 toxic water pollutants. The
programs authorized under CERCLA/SARA, TSCA,
CAA, and FIFRA have an unlimited number of chemicals
over which they have authority. Virtually all statutes have
a process for adding or removing pollutants from the list
of regulated substances.
85
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Table 9-1 Regulatory Program Support
Principal
Authorizing Authority
Statute/Most to Request
Recent Health Data Regulatory
Program Area Amendments from Industry Program
Air Quality Clean Air No major data National Am-
Act/1977 from industry, bient Air Quality
Standards
National
Emission
Standards for
Hazardous Air
Pollutants
Radiation
Protection
Standards
Mobile Source
Emissions
Standards
Sludge Use
and Disposal
Regulations
Drinking Water Safe Drinking No major Maximum
Quality Water health data Contaminant
Act/1986 collection from Levels
industry
Health Ad-
visories
Regulatory Programs within Program Area
Pollutant
Coverage
Covers
concentration
of 'criteria'
pollutants in
ambient air.
EPA identifies
pollutants
based on
health and
production
volume or
emissions data.
Covers
radonuclides.
Covers primari-
ly hydrocar-
bons, carbon
monoxide, and
nitrogen
oxides in tail-
pipe and
evaporative
emissions.
Covers
pollutants
determined to
pose a poten-
tial risk.
Covers 83
specific
pollutants.
EPA must add
other
pollutants.
ODW selects
pollutants.
Protection
of Susceptible
Populations
Specifically
requires
consideration
of susceptible
populations.
Considers
susceptible
populations in
developing
NESHAPs.
Margin of
safety included
to protect
sensitive
populations.
High exposure
scenarios
expressly
included in
standard
setting.
Risk analysis
explicitly
addresses
most exposed
individuals.
Considers
susceptible
populations in
selecting
MCLQs and
Lifetime Health
Advisories.
Requirements)
for Pollutant
Testing or
Tracking
Requires states
to monitor their
compliance.
Monitoring re-
quirements vary
from rule to rule.
Margin of safety
included to
protect sensi-
tive populations.
EPA tests
vehicles.
States require
maintenance of
emissions con-
trol.
Requires
POTWs to test
for regulated
pollutants in
sludge to
comply with
standards.
Requires drink-
ing water sup-
pliers to monitor
their water
quality.
Not applicable.
Requirements
to Revisit
Standards
Statute requires
periodic review
and revision of
NAAQS.
Statutes
encourage
reviewing of
rules and
adding to
pollutant
coverages, but
does not require.
Requires
review every 2
years.
No statutory re-
quirements.
86
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Table 9-1 Regulatory Program Support (continued)
Regulatory Programs within Program Area
Principal
Authorizing Authority
Statute/Most to Request
Recent Health Data
Program Area Amendment from Industry
Water Quality Clean Water Provides
Act/1987 authority to
request
effluent char-
acteristics
data; authority
to require
toxicity testing
for NPDES
permitting.
Pesticides Federal Insec- Provides ex-
ticide, Fun- tensive
gicide, and authority to re-
Rodenticide quire toxicity
Act/1988 and other en-
viron mental
data.
Regulatory
Program
Water Quality
Criteria
Water Quality
Standards
National
Emissions
Limitations
NPDES
Permitting
Registration
Reregistration
Special Review
Pollutant
Coverage
Covers all
priority
pollutants.
Covers
pollutants
which could
affect a water
body's use.
Covers toxic,
conventional,
and non-
conventional
pollutants.
Covers all
pollutants
which could
affect a water
body's use.
Covers all pes-
ticides defined
by their func-
tion.
Covers
generally pes-
ticides with
active in-
gredients first
registered
prior to 11/84.
Covers all pes-
ticides cap-
tured by
registration or
reregistration
programs.
Protection
of Susceptible
Populations
Margins of
safety
incorporated to
protect sensi-
tive populations.
May protect
susceptible
populations
who use the
water body.
Not directly
applicable.
May protect
susceptible
populations
which use a
water body.
Uses sub-
mitted data to
assess risks to
susceptible
populations in
registration
and tolerance
decisions.
Requirements
for Pollutant
Testing or
Tracking
EPA conducts
tests to develop
criteria.
EPA or State
may conduct
tests to assess
a water body.
Not directly
applicable.
Permittees are
subject to self-
reporting and
Agency monitor-
ing and enforce-
ment.
Requires pes-
ticide com-
panies to
supply exten-
sive health and
environmental
data.
Requires pes-
ticide com-
panies to
supply exten-
sive health and
environmental
data.
Requires
review of health
and environ-
mental data.
Requirements
to Revisit
Standards
Requires States
to review stand-
ards every 3
years.
Requires EPA
to publish
schedule or
review and
revision of
guidelines
every 2 years.
Permits apply
for a maximum
of 5 years.
Requires
reregistration of
pesticides pre-
viously
registered
under less strin-
gent testing re-
quirements.
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Table 9-1 Regulatory Program Support (continued)
Regulatory Programs within Program Area
Program Area
Toxic
Substances
Hazardous
and Nonhazar-
dous Waste
Superfund
Principal
Authorizing
Statute/Most
Recent
Amendment
Toxic Substan-
ces Control
Act/1976
Resource
Conservation
and Recovery
Act/1984
Comprehen-
sive Environ-
mental
Response,
Compensa-
tion and
Liability Act
(CERCLA);
Superfund
Reauthoriza-
tion Act/1 986.
Authority
to Request Protection
Health Data Regulatory Pollutant of Susceptible
from Industry Program Coverage Populations
Can require in-
dustry to supp-
ly available
health-related
data and to
conduct
additional tests.
No major
health data
collection from
industry.
For enforce-
ment-led
response, in-
dustry may con-
duct the health
assessment,
subject to EPA
review.
Premanufactur-
ing Notification
Existing
Chemical
Assessment
SARA Title 3
Land Disposal
Restrictions
Technical
Standards for
Hazardous
Waste Facilities
Technical
Standards for
Non hazardous
Waste Facilities
Removal
Response
Program
Remedial
Response
Program
Covers broadly
defined chemi-
cal substances
and mixtures.
Covers broadly
defined chemi-
cal substances
and mixtures.
Covers more
than 300
chemicals.
Covers several
lists of hazard-
ous wastes.
Covers all
facilities that
treat, store, or
dispose of
Subtitle C
waste.
Covers
facilities that
dispose of non-
hazardous
waste.
Refers to pol-
lutants listed
under other
statutes.
Can be con-
sidered in
reviewing
PMNor
requesting
additional data.
Industry must
supply data on
adverse effects.
EPA may re-
quire health
effects testing
for susceptible
populations.
Not directly
applicable.
Explicitly con-
siders suscep-
tible near-site
populations.
Not directly
applicable.
Not directly
applicable.
Explicitly con-
siders health
impacts on
susceptible
near-site
populations.
Requirements
for Pollutant
Testing or
Tracking
Requires
notification prior
to manufactur-
ing a chemical
or when chemi-
cal use changes.
Requires
notification of
any new data
on adverse
health effects.
Requires
release report-
ing annually.
Requires
wastes contain-
ing some hazard-
ous substances
to be treated
prior to disposal.
Requires track-
ing of wastes
from cradle to
grave; requires
disposal
facilities to
monitor ground
water.
Requires
disposal
facilities to
monitor
pollutants in
ground water.
Wastes
removed be-
come subject to
RCRA manifest
and permitting
system; sites
must be
monitored for
10 years after
cleanup.
Requirements
to Revisit
Standards
Not directly
applicable.
Designates
certain chemi-
cals each year
for considera-
tion within 1
year deadline.
Not directly
applicable.
No periodic
revisions
required by
statute.
No periodic
revisions
required by
statute.
No periodic
revisions
required by
statute.
Requires EPA
to review sites
every 5 years if
any wastes are
left on site.
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Protection of Susceptible Populations. Most of the
regulatory programs explicitly address the health im-
pacts to the most susceptible populations. For example,
NAAQS are designed to protect those with respiratory
impairment, Superfund cleanup requirements are
designed to protect near-site populations, and sludge
rules are designed to protect pica children who may be
exposed to pollutants through ingestion. Frequently,
however, there is little health information available on
sensitive subpopulations.
Requirements for Pollutant Tracking or Testing. Most
regulatory programs require the testing or tracking of
pollutants once they are "listed" for inclusion in the
program. Firms must monitor and report their permitted
air and water emissions. Drinking water suppliers must
test for regulated contaminants. The RCRA program
includes cradle-to-grave tracking of hazardous waste;
wastes removed from Superfund sites become part of
the RCRA system. Under the SARA Title III, companies
must report releases into any media of any of more than
300 hazardous substances. Under TSCA, firms must
report any adverse effects or reactions to chemical sub-
stances.
Requirements to Revise Standards. Many of the
statutes include requirements to revisit standards peri-
odically. For example, States must review their water
quality standards every 3 years. Statutes that do not
require standards to be revisited generally expressly
allow and encourage this practice. Thus, the regulatory
process under most statutes has been designed to
evolve as better information becomes available. For
standards revisrtation to be fruitful, however, continued
improvement in both the quality and quantity of health
data is essential.
Authority to Conduct Health Research. The authority
of EPA to conduct health research for each program area
is summarized in Table 9-2. Significantly, all of the major
statutes expressly include health research authority.
9.2 Program Organization
The organization and management of approximately 20
regulatory programs that use health research informa-
tion were described in Sections Two through Eight. Table
9-3 presents summary information concerning the lead
offices, divisions, and branches for each of the programs.
The discussions within Sections Two through Eight pro-
vide a detailed description of each program's mode of
operation.
Most programs involve a lead office or division with
cooperative assistance from other divisions and
branches within the office and from ORD. Some
programs (e.g., pesticides) employ a matrix manage-
ment approach where one division has lead respon-
sibility for a decision (e.g., pesticide registration) and
other divisions provide discrete components of the
analysis (e.g., the Health Effects Division evaluates the
human health effects of the substance). Many of the
programs obtain hazard and risk assessment support
from ECAO or other parts of ORD.
Within the program offices, the lead responsibility for
health-related programs tends to be concentrated in a
particular division or branch. For example, the Criteria
and Standards Division, within the Office of Water
Regulations and Standards, develops water quality
criteria documents and sludge regulations, both of which
are based in part on human health risks. The discussions
of health research issues presented in Sections Two
through Eight and summarized in Section 9.3 below were
based, in part, on discussions with officials in the pro-
gram offices with lead health-related responsibilities.
9.3 Health Research Needs
9.3.1 Introduction
EPA's seven major regulatory programs all have
regulatory requirements based on health research infor-
mation. The health research information base is consid-
erable in some areas, and weak to nonexistent in others.
Review and discussion of each program's mandate and
scientific requirements identified four major research
categories - hazard identification, dose response, ex-
posure assessment, and chemical-specific information,
and three cross-cutting categories - biological markers,
pollutant mixtures, and human data. Research needs for
each of these topics are summarized below.
9.3.2 Major Research Categories
Hazard Identification
All programs that regulate chemicals rely on standard
lexicological tests to provide scientific support for their
decisions. Understanding the health risks for different
toxicologic endpoints depends on such tests, since
human data are not usually available, or cannot be
generated in the time frames dictated by the regulations.
Development of new test methods was a high priority for
three programs: the air program (hazardous pollutants
and mobile sources), the toxics program, and the water
program. In general, programs that must regulate large
numbers of chemicals would like to ensure that the
lexicological protocols cover all lexicological endpoints
and are validated. There is concern that human risk for
certain toxic endpoints, e.g., developmental neurotoxicity,
immunotoxicily, reproductive toxicity, endocrine system
loxicily, and cardiovascular loxicily, cannot be fully
evaluated because methods are not available, are not
specific or sensitive enough, or are not sufficiently
validated for predicting human effects. Serious con-
sideralion should be given to developing techniques that
would enable large numbers of chemicals to be screened
for potential hazard. The utility of struclure-aclivity
relalionship (SAR) melhods for assessing chemical
toxicity should also be further investigated. Also in need
of developmenl are shortened protocols and dosing pat-
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Table 9-2 Major Environmental Legislation Administered by the U.S. Environmental Protection Agency,
Specific Authorization for EPA to Conduct Health Research
Enabling
Legislation
Authorizing
Section
Language Authorizing EPA to Condi
ilth Research
Resource Conservation
and Recovery Act
(RCRA)
Comprehensive Environ-
mental Response,
Compensation and
Liability Act
(CERCLAor
Superfund)
Supertund Amendments
Reauthorization Act
Clean Air Act (CAA)
Safe Drinking Water
Act (SDWA)
Clean Water Act (CWA)
Toxic Substances
Control Act (TSCA)
Federal Insecticide,
Fungicide, and
Rodenticide ACT (FIFRA)
Subtitle H The Administrator shall conduct-research, investigations, experiments..
Sec. 8001 (A) and studies relating to an adverse health and welfare effects of the
release into the environment of material present in solid waste."
Sec. 311 (c) "The Administrator may conduct and support-research with respect to
the detection, assessment, and the evaluation of the effects and risk to
human health of hazardous substances...*
Sec. 209 The purposes of this section are to establish a comprehensive and
coordinated Federal (SARA) program of research...to improve the
scientific capability to assess, detect, and evaluate the effects on and
risks to human health from hazardous substances."
Title I. The Administrator is given broad authority to conduct research
Part A, relating to the tauses, effects, extent, prevention, and control of air pollution."
103 Special emphasis should be given to research on the short- and long-
term effects of air pollutants on public hearth and research to "improve our
knowledge of the contribution of air pollutants to the occurrence of
adverse effects on health, including, but not limited to, behavioral.
physiological, toxicological, and biochemical effects."
Part B, Sec. 153 The Administrator is given authority to conduct studies on "biomedical,
or other research and monrtoring...to ascertain any direct or indirect
effects upon the public health and welfare of changes in the stratosphere,
especially ozone..."
Part E. The Administrator may conduct research...of physical and mental
Sec. 1442 diseases and other impairments of man resulting directly or indirectly
from contaminants in water, or to...improve methods to identify and
measure the health effects of contaminants in drinking water."
Part 1254, "...the Administrator shall conduct research on the harmful effects on the
Sec. 104 health and welfare of persons caused by pollutants in water..."
Sec. 10 The Administrator is given authority to undertake research "directed
toward the development of rapid, reliable, and economical screening
techniques for carcinogenic, mutagenic, teratogenic, and ecological
effects of chemical substances and mixtures."
Sec. 20 The Administrator shall undertake research...to carry out the purposes
of this Act..."
terns that more closely reflect levels and patterns of real
life. In addition, test batteries are needed for evaluating
the toxicity of genetically engineered microbes for
human populations and for evaluating viable partrculates
in indoor environments.
Dose Response
Dose response is the single most important issue for
health research in all programs. Each program struggles
with the problem of trying to predict toxicity for conditions
different from those studied, e.g., different routes of
exposure, different exposure scenarios, populations, or
species, with limited scientific data.
The programs also need information that will allow them
to decide with confidence the target organ toxicity for a
given ambient exposure. To do this properly, the
programs need health research information for route-
specific absorption, distribution, and target organ effects.
Mechanistic studies to improve understanding of basic
biological mechanisms should be performed for pol-
lutants to which there is widespread exposure and which
must be regulated by several programs.
The programs mentioned the following specific research
areas: metal toxicology, especially involving extrapola-
tion issues; extrapolation from the oral to the inhalation
route and from animals to humans when routes differ;
extrapolation from one dosing pattern to another;
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Table 9-3
Lead Offices in EPA Regulatory Programs
Program Area/Lead Office
Regulatory Program/Lead Office/Division Branch
Air Quality/Office of Air and
Radiation
NAAQS
NESHAPS, NSPS
Radiation Standards
Ozone Protection
Regulations
Motor Vehicle/
Engine Standards
Ambient Standards Branch within the
Office of Air Quality Planning and Standards
Emission Standards Division within
the Office of Air Quality Planning
and Standards
Criteria and Standards Division
within the Office of Radiation Programs
Global Change Division within the
Office of Atmospheric and Indoor
Air Programs
Emission Control Technology
Division, Standards
Development and Support Branch
within the Office of Mobile Sources
Drinking Water/Office of Drinking
Water within the Office of Water
NCLGs
Health Advisories
MCLs
Health Effects Branch within
Criteria and Standards Division
Health Effects Branch within
Criteria and Standards Division
Drinking Water Regulations Branch
within the Criteria and Standards Division
Water Quality /Office of Water
Water Quality Criteria
Sludge Disposal Criteria
NPDES Permitting
Office of Water Regulations and Standards
Office of Water Regulations and Standards
Office of Water Enforcement and Permits
Pesticides/Office of Pesticide
Programs within the Office
of Pesticides and Toxic
Substances
New Product Registration
Reregistration
Special Review
Development of Test Methods
for Human Health Endpoints
Registration Division
Reregistration and Special Review Division
Reregistration and Special Review Division
Health Effects Division
Toxic Substances/Office of Toxic
Substances within Office of
Pesticides and Toxic Substances
Premanufacturing Notification
Existing Chemical Assessment
Chemical Control Division
Existing Chemical Assessment Division
Hazardous and Nonhazardous Waste/
Office of Solid Waste within
Office of Solid Waste and Emergency
Response
Subtitle C Facility Standards
Subtitle D Criteria
Municipal Waste Tracking
Land Disposal Branch within the
Waste Management Division
Municipal Solid Waste Task Force
Waste Characterization Branch
within the Characterization and
Assessment Division
Superfund/Office of Emergency
and Remedial Response within
Office of Solid Waste and
Emergency Response
Preremedial Actions Including Lead Agency: Eigher EPA Regional
Site Ranking Using the Hazard Office or State Agency
Ranking System
Remedial Investigation/
Feasibility Study
Lead Agency: Either EPA Regional
Office or State Agency
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mechanistic studies that will improve validation of
specific short-term test methods; extrapolation of effects
from lifetime exposure to those of critical developmental
periods; better information on injury and repair
mechanisms; methods for determining tissue sensitivity;
the shape of the dose-response curve for noncancer
endpoints; information on comparative metabolism and
population variability to improve extrapolation assump-
tions; and the sensitivity of one toxicologic endpoint with
respect to others.
Exposure Assessment
Most programs ranked exposure assessment as a high-to-
medium priority. The Superfund and hazardous waste
programs in particular would like to base much of their
regulatory rationale on exposure criteria. This topic is also
a high priority for the air program, since many air pollutants
have a ubiquitous exposure. The air program would benefit
from better characterization of exposure patterns, both
timing and duration, and from identification and toxicity of
reaction by-products of common toxic air pollutants, par-
ticularly those present in aged atmospheres.
Specific research subjects important to other programs
include better exposure characterization for infants and
children; dermal absorption for metals; soil ingestion
estimates; better estimation of background exposure
levels; bioavailability; and establishment of biomonitor-
ing surveillance systems for the types of exposures
encountered by the EPA regulatory programs. The latter
would be similar to the National Health and Nutrition
Evaluation Survey (NHANES) but would be designed to
track different compounds. The specimen banking pro-
gram, which monitors ambient media and human and
animal tissue for toxic compounds (e.g., lead and other
metals and selected pesticides), provides a critical data
base for tracking trends in the pollutant exposure burden.
This program could be expanded and used for studying
specific types of exposure scenarios, e.g., pesticides in
farming communities, metals in communities impacted
by municipal and hazardous waste incinerators, and
others; it could also be used to estimate the relative
contribution of the exposure dose to background levels.
Chemical-Specific Information
Health research needs for chemical-specific informa-
tion vary by program depending on the authority of the
program to require industry to test. Three programs
viewed this type of research as a high priority. Even
programs that ranked this area as a low research
priority still had critical information needs for certain
chemicals. In addition, the pesticide program
evaluates a lot of test data generated by industry, and
would like HERL to check the quality of these results
for some of the chemicals.
Chemicals selected for testing should have a good prob-
ability of yielding results that can be broadly applied.
Technical assistance is needed from HERL to fill gaps in
the IRIS data base, especially on dermal toxicity, and to
develop inhalation RfDs.
9.3.3 Cross-Cutting Categories
Biological Markers
While no program ranked biological markers as a high
priority, several programs indicated that biomarkers,
once developed, could prove valuable tools for risk as-
sessment. Biomarkers of exposure have more practical
value for programs than do biomarkers of effect, since
many of the latter are not specific. Exposure biomarkers
can help programs identify exposed populations and the
dose they have received. Research efforts should focus
on developing a limited number of well-defined
biomarkers of exposure, e.g., protein in urine (as an
indicator of exposure to environmental tobacco smoke)
or DNA adducts (as an indicator of carcinogen ex-
posure).
The challenge of using biomarkers of effect is determin-
ing their predictive value. Research on effects
biomarkers should focus on the development of sentinel
indicators of toxicity. These would be useful both in
monitoring human populations for physiological altera-
tions prior to the onset of actual biological damage and
possibly for shortening standard test protocols in the
event that biomarkers of effect are predictive of per-
manent toxicity endpoints. Specific endpoints for which
biomarkers of effect might be useful are neurophysiologi-
cal changes predictive of neurotoxic endpoints, develop-
mental neurotoxicity, immune system effects, pulmonary
toxicity, reproductive toxicity, and carcinogens.
Pollutant Mixtures
This topic was a high priority research area for four of the
programs. Programs confront a variety of mixtures, e.g.,
urban atmospheres, whole-vehicle exhaust, indoor air,
hazardous waste, drinking water disinfectants, effluents
to ambient water, active and inert ingredients in pesticide
products. The challenge in developing research plans for
chemical mixtures is that mixtures occur in many dif-
ferent combinations and relative proportions. They also
age differently once released into the environment.
Types of mixtures encountered may be simple binary
mixtures; complex mixtures representing a class ot
chemicals, e.g., polychlorinated biphenyls (PCBs),
polyaromatic hydrocarbons (PAHs); or those containing
many different classes of chemicals, e.g., hazardous
waste.
Much of the research needed to address pollutant mix-
tures problems is being conducted as part of other
research programs. For example, hazard identification
research programs are developing short-term tests for
field applications and new test methods to identify and
characterize all important toxic endpoints, and are im-
proving SAR techniques; these are all pollutant mixtures
research needs.
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Research should be undertaken to provide a firmer
scientific basis for assessing risk posed by exposure to
pollutant mixtures. Procedures for predicting interactions
between chemicals should be improved. In addition, the
validity of the additivity assumptions should be explored
with respect to dosing patterns for multiple toxicants in
cases where some exceed their Rf Ds and others do not.
A pollutant mixtures research program should also be
linked to a chemical-specific data program, since under
some circumstances it will be feasible and desirable to
evaluate specific mixtures or classes of mixtures.
Specific mixtures for which research support is needed
are disinfection by-products from ozonation, chloramina-
tion and chlorination, PCBs, aged atmospheres to deter-
mine cancer and noncancer endpoints, and
whole-vehicle exhaust. Also needed is research on the
effects of simultaneous exposure to chemicals and radia-
tion, and multichemical source category assessments for
NESHAPS. A stronger research base is needed to sup-
port bioassay-directed fractionation utilizing tiered ap-
proaches. This type of research focuses a lot of activity
and generates much information on a somewhat narrow
range of compounds. There is some question whether
other important groups may be deemphasized as a result
of this focus. If this type of focused approach is used to
evaluate health risks, a better understanding is needed
of the correlation between observed toxic effects and
other endpoints not actually tested.
Human Data
Two programs see the need for human data as a high
research priority. Human health research information,
when available, provides strong scientific support to
regulatory decisions and key validation of toxicologic
tests. Although most programs view human health data
as very important, primary reliance on animal toxicotogi-
cal data will continue, because it is often not practical to
wait for human data before issuing regulations.
The pesticide program is concerned about the effects of
exposure, what populations are susceptible, and how
this type of information should be factored into regulatory
decision-making. This program would like to ensure that
the registration process is adequately protective against
developmental and immunological effects.
The air program must consider effects on high-risk
groups as part of the development of the National Am-
bient Air Quality Standards. For this reason, quality
human data for answering specific research questions,
e.g., thresholds for lung disease from chronic exposure
to ozone, is not only a top priority, it is critical to this
program. The indoor air group is concerned about hyper-
sensitivity reactions among those exposed to indoor air
pollutants inside buildings.
A specific concern of the drinking water program was
heightened risk for persons with glucose-6-phosphate-
dehydrogenase (G6PD) deficiency from the disinfection
by-products of ozonation. This concern highlights the
fact that in general, the biological basis for toxicities
needs to be examined.
Health research should generally aim for small-scale
clinical and field studies, e.g., studies utilizing
biomarkers of exposure for Superfund sites, blood
chemistries in persons exposed to drinking water disin-
fectants, and clinical reactions to methanol and al-
dehydes from auto exhaust.
9.3.4 Emerging Research Needs
Emerging health research needs for the 1990s center
primarily on the health effects of various exposure
scenarios, exposure extrapolation, and development of
test methods for certain types of endpoints. There is a
great immediate need for the development of methods
for endpoints that are not currently covered sufficiently,
e.g., neurotoxicity, reproduction, developmental toxicity,
and others. Related needs are shorter term test methods
and validation. Extrapolation and exposure-related
health issues emerged as the next highest priority re-
search needs. This research should focus on improving
pur understanding of metabolism and dose (particularly
in extrapolating from one route of exposure to another),
and on biomarkers of dose and effect that can be used
in both human and animal studies.
Human studies for effects of chemicals on children will
continue as an important need, particularly for toxicologic
endpoints that are not now well understood and for which
adequate test methods may not yet be available. Better
understanding of the sensitivity of individuals in a popula-
tion, including hypersensitivity reactions, and sensitivity
of various tissues will also be needed. There will be a
continuing need for improvements to health surveillance
systems for toxic exposure to monitor long-term trends
and design human studies of effect. These systems
should incorporate new methods, e.g., biomarkers, as
they become available.
It is difficult to predict which specific chemicals will
emerge as problems. For this reason, each program
should continue to identify information needs for specific
chemicals on an ongoing basis. The air program will
need expanded health research information on acid
aerosols and methanol (including its aldehyde by-
products) if there is a new regulatory emphasis on
methanol as a component of alternative fuels. Stratos-
pheric ozone depletion is an emerging environmental
issue that may require important research on health
effects, such as immunological impacts (which may in-
crease risks from infectious diseases and cancer), and
visual impacts, including the risk of cataract formation in
sensitive individuals. The water programs need health
research on the potential cardiovascular toxicity of the
chemical by-products of water treatment methods. Pol-
lutant mixtures are currently of high concern and will
most likely remain so, particularly for programs con-
cerned with sources emitting variable, complex mixtures,
e.g., hazardous waste and municipal incinerator emis-
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sions, industrial effluents to water and air, auto exhaust,
and indoor air pollution.
9.3.5 Summary
Table 9-4 summarizes the health research priorities of
all seven major regulatory programs. Dose-response
issues were the only research area identified as a high
priority by every regulatory program; every program-
matic application of toxicology or human health data
requires some dose-response extrapolation from the
conditions under which the information was generated.
Another high priority area for most programs is pollutant
mixtures research, which was particularly important be-
cause most environmental exposures are to mixtures
rather than single chemicals. A better research base is
needed for the different types of mixtures, e.g., binary,
complex by class, complex by multiple classes. Also,
the scientific base for the assumptions in the chemical
mixtures guidelines should be strengthened.
Better methods are needed to assess important
toxicologic endpoints, especially those using testing
strategies that rely on multi-tiered, bioassay-directed
fractionation approaches.
Human health data, including information on the nature
of heightened susceptibility, is an important research
area in general because such data provide convincing
scientific support and validation for health risk assess-
ment. HERL should support health research activities by
developing tools, such as methods, biomarkers, etc.,
that can be incorporated into short-term clinical studies.
Research on susceptible human populations is impor-
tant for the ambient air, pesticides, and indoor air
programs, which must consider toxic impacts on high-
risk groups, e.g., children, fetuses, the very old, and
those with preexisting diseases or genetic suscep-
tibilities. Research in this area should focus on the
mechanisms of action and dose-response relation-
ships.
Generating chemical-specific information is a high
priority research need, particularly for programs without
the authority to ask industry to generate this information.
New test methods and extrapolation information as well
as the redesign of existing protocols or whole-animal
studies will be needed to help fill important data gaps in
the coming years.
Hazard identification and exposure assessment issues
were ranked as medium-to-high priority research needs
by most programs. These research areas are also im-
portant emerging needs for the 1990s. Presently, many
programs must regulate large numbers of chemicals to
meet Congressional mandates; regulation cannot wait
for the development of new test methods or refinement
of exposure estimates. Current bioassay methods for
many toxicologic endpoints, however, are not sufficiently
developed or validated. Research is needed to develop
and validate new methods, and to improve under-
Table 9-4 Research Needs for EPA Regulatory Programs
Regulatory Programs
Research Needs
1 . Hazard Identification
2. Dose Response
3. Exposure Assessment
4. Chemical-Specific
Information
5. Biological Markers
6. Pollutant Mixtures
7. Human Data
Drinking Water
Air Water Quality Pest Tox HW SF
XX X XXX XXX XXX XX X
XXX XXX XXX XXX XXX XXX XXX
XXX X XX XX XX XXX XXX
XXX XXX XXX XXX X
X X X X XX XX XX
XX XXX XXX XX X XXX XXX
XXX XXX XX XX X X X
x = Low priority
xx = Medium priority
xxx * High priority
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standing of different types of dose-response relation-
ships and mechanisms.
A research topic of somewhat lower priority is biological
markers, although specific programs identified high
priority needs. For example, research on a limited num-
ber of key exposure biomarkers was identified as a high
priority need. The development of biomarkers of effect is
seen as a long-term research goal because they must
be validated before they can be used in measuring health
effects. Long-term research on biomarkers that show
promise as early sentinels of serious lexicological effects
would also be worthwhile.
ft U.S. GOVERNMENT PWNTINC OFFICE: 199 o-7ğ Ğ 15ğ2
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