United States ^2-506-0556
Environmental
Protection Agency
Project Work Plan for
Revised Air Quality Criteria
for Lead
Notice
This document is a preliminary draft.
It has not been formally released by EPA
and should not at this stage be construed
to represent Agency policy. It is being
circulated for comment on its technical
accuracy and policy implications.
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NCEA-R-1465
January 2005
CASAC Review Draft
Project Work Plan for
Revised Air Quality Criteria
For Lead
National Center for Environment Assessment
Office of Research and Development
U. S. Environmental Protection Agency
Research Triangle Park, NC 27711
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DISCLAIMER
This document is an external draft for review purposes only and does not constitute U.S. Environmental
Protection Agency policy. Mention of trade names or commercial products does not constitute endorsement
or recommendation for use.
PREFACE
This project work plan has been prepared as a managerial and management information tool for the
U.S. Environmental Protection Agency's National Center for Environmental Assessment Division in Research
Triangle Park, NC. It may be modified and amended from time to time, as necessary, to reflect actual project
requirements and progress. As a result, any proposed schedules and outlines, or any lists of technical
coordinator assignments, authors, or reviewers are subject to change.
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TABLE OF CONTENTS,
DISCLAIMER i
PREFACE i
TABLE OF CONTENTS ii
I. INTRODUCTION 1
A. LEGISLATIVE BACKGROUND 1
B. REGULATORY BACKGROUND 2
C. PROJECTED SCHEDULE 4
II. SCIENTIFIC BACKGROUND AND KEY ISSUES 6
A. LEAD AS A MULTIMEDIA ENVIRONMENTAL CONTAMINANT 6
B. HEALTH EFFECTS OF EXPOSURE TO LEAD 8
C. ECOLOGICAL EFFECTS OF EXPOSURE TO LEAD 10
III. ORGANIZATIONAL STRUCTURE AND PREPARATION/REVIEW
PROCESS 14
A. ORGANIZATION AND CONTENT OF REVISED LEAD DOCUMENT 14
B. METHODS AND PROCEDURES FOR DOCUMENT PREPARATION 15
C. PERSONNEL 16
D. APPROACH 17
E. PUBLIC AND SCIENTIFIC REVIEW 18
REFERENCES 19
APPENDIX A: Proposed Contents of Revised Air Quality Criteria for Lead A-l
APPENDIX B: EPA Work Group for Air Quality Criteria for Lead B-l
APPENDIX C: NCEA-RTP Project Team and Other Technical Consultants C-l
APPENDIX D: Science Advisory Board Clean Air Scientific Advisory
Committee Members D-l
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I. INTRODUCTION
A. LEGISLATIVE BACKGROUND
Two sections of the Clean Air Act (CAA) govern the establishment, review, and revision of
National Ambient Air Quality Standards (NAAQS). Section 108 (42 U.S.C. 7408) directs the
Administrator of the U.S. Environmental Protection Agency (EPA) to list certain air pollutants that may
be reasonably anticipated to endanger public health or welfare and to issue air quality criteria for them.
These air quality criteria (scientific bases for NAAQS) are to reflect the latest scientific information
useful in indicating the kind and extent of all identifiable effects on public health or welfare that may be
expected from the presence of a given "criteria" pollutant in ambient air.
Section 109(a) of the CAA (42 U.S.C. 7409) directs the Administrator of EPA to propose and
promulgate primary and secondary NAAQS for pollutants identified under Section 108. Section
109(b)(l) defines a primary standard as one that, in the judgment of the Administrator, is requisite to
protect the public health (see inset) based on the criteria and allowing for an adequate margin of safety.
The secondary standard, as defined in Section 109(b)(2), must specify a level of air quality that, in the
judgment of the Administrator, is requisite to protect the public welfare (see inset) from any known
or anticipated adverse effects associated with the presence of the pollutant in ambient air, based on
the criteria.
PUBLIC HEALTH EFFECTS
Effects on the health of the general population,
or identifiable groups within the population,
who are exposed to pollutants in ambient air:
Effects on mortality
Effects on morbidity
Effects on other health conditions including
indicators of:
:.::.:. pre-morbid processes,
v ; : «;risk factors, and
'': :; :»-dise&se
PUBLIC WELFARE EFFECTS
Effects on personal comfort and well-being
Effects on economic values
Deterioration of property
Hazards to transportation
Effects on the: environment, including:
> animals
climate
crops
' materials
' soils
:« vegetation
visibility
«water
weather
wildlife
Section l()9(d) of the CAA (42 U.S.C. 7409) requires periodic review and, if appropriate, revision
of existing criteria and standards. If, in the Administrator's judgment, the Agency's review and revision
of criteria make appropriate the proposal of new or revised standards, such standards are to be revised and
promulgated in accordance with Section 109(b). Alternatively, the Administrator may find that revision
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of the standards is inappropriate and conclude the review by leaving the existing standards unchanged.
Section 109 of the Clean Air Act (42 U.S.C. 7409) also requires that the criteria and NAAQS be reviewed
by an independent scientific review group, those review responsibilities being met by the Clean Air
Scientific Advisory Committee (CAS AC) of EPA's Science Advisory Board (SAB).
B. REGULATORY BACKGROUND
On October 5, 1978 the EPA promulgated primary and secondary NAAQS for lead, under
Section 109 of the CAA (43 FR 45258). The primary standard and the secondary standard are the same:
1.5 ug/m3 as a quarterly average (maximum arithmetic mean averaged over a calendar quarter). The
standards were based on the EPA:s 1977 Air Quality Criteria for lead. Subsequent regulations reducing
the use oflead additives in gasoline were promulgated in 1985 (50 FR 9386), leading to substantial
reductions in ambient air lead concentrations.
In 1986, the EPA published a revised Air Quality Criteria Document for Lead (Lead AQCD). The
1986 AQCD assessed newly available scientific information on the health and welfare effects associated
with exposure to various concentrations oflead in ambient air. The 1986 AQCD reviewed literature
through 1985 for information relevant to derivation of air quality criteria for lead. The document was
principally concerned with the health and welfare effects of lead, but other scientific data were also
discussed in order to provide a berter understanding of the pollutant in the environment. Thus, the 1986
document included chapters that discussed the atmospheric chemistry and physics of the pollutant;
analytical approaches; environmental concentrations; human exposure and dosimetry; physiological,
lexicological, clinical and epidemiological aspects oflead health effects; and lead effects on ecosystems.
An Addendum to the 1986 Lead AQCD was also published along with it in 1986 (U.S. Environmental
Protection Agency, 1986). Subsequently, a supplement to the 1986 Lead AQCD/Addendum was
published by EPA in 1990 (U.S. Environmental Protection Agency, 1990). That 1990 supplement
evaluated still newer information emerging in the published literature concerning (1) lead effects on blood
pressure and other cardiovascular endpoints and (2) the effects of lead exposure during pregnancy or early
postnatally on birth outcomes and/or on the neonatal physical and neuropsychological development of
affected children.
The evaluations contained in the 1986 Lead AQCD/Addendum and the 1990 Supplement provided
scientific inputs to support decision-making with regard to review and, as appropriate, revision of the
Lead NAAQS and they were drawn upon by EPA's Office of Air Quality Planning and Standards
(OAQPS) in preparation of an associated Lead Staff Paper. After consideration of evaluations contained
in these documents, EPA chose not to propose revision of the Lead NAAQS.
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Changes in relative contributions of various lead sources and exposure pathways to human
exposures in the United States, and EPA actions to reduce such exposures also provide important
background for this review. Since 1978, the amount of lead emitted into the air nationally has markedly
declined. From 1982 to 2002, for example, lead emissions into the air decreased by 93 percent, and the
average air quality concentration of lead decreased by 94 percent from 1983 to 2002
(http://www.epa.gov/airtrends/lead2.html). Total lead emissions into the air decreased from about
220,000 tons in 1970 to less than 4,000 in 1999. This decline is mainly attributable to EPA's regulatory
efforts to reduce the content of lead in gasoline (http://www.epa.gov/airtrends/lead2.html), which has
substantially altered basic patterns of air lead emissions in the United States. Emissions from stationary
sources have also been greatly reduced (http://www.epa.gov/airtrends/lead2.html, Fig. 2-11); however,
given the even greater reductions in emissions from transportation sources, industrial processes (including
smelters and battery manufacturers) now constitute a larger percentage of remaining lead emissions to the
atmosphere (i'rf., Fig. 2-12). (See generally (http://www.epa.gov/airtrends/lead2.html). In short, lead
emissions into the atmosphere decreased greatly in the 1980's and 199()'s, a trend that has continued to the
present. As a consequence, airborne lead now represents only a relatively small component of total
exposure to lead, such that the principal sources of U.S. lead exposure in the most sensitive population
(young children) are through non-inhalation pathways (such as lead in deteriorating paint, food, drinking
water, dust, and historically contaminated soil).
Since the 1980's, EPA has played a major role in working to reduce the main sources of lead
exposure for most children, including deteriorating lead-based paint, lead contaminated dust, and lead
contaminated residential soil (http://www.epa.gov/lead/). For example, EPA has established standards
for lead-based paint hazards and lead dust cleanup levels in most pre-1978 housing and child-
occupied facilities, and is now developing standards for those conducting renovation activities that
create lead-based paint hazards and for the management and disposal of lead-based debris
(http://www.epa.gov/lead/regulation.htm). Also, EPA has developed standards for management of
lead in solid and hazardous waste, oversees the cleanup of lead contamination at Superfund facilities,
and has issued regulations to reduce lead in drinking water (http://www.epa.gov/lead/sources.htm).
Beyond specific regulatory actions, the Agency's Lead Awareness Program continues to work to
protect human health and the environment against the dangers of lead by conducting research and
designing educational outreach efforts and materials (http://www.epa.gov/lead/).
Since the 1980's, EPA has also promulgated regulations under section 112 of the Act,
42 U.S.C, § 7412, to address emissions of lead components and other toxic pollutants from both primary
lead smelters and secondary lead smelters (40 CFR Subparts X and TTT). Under section 112(d), these
emission standards are to require "the maximum degree of reduction in emissions" that are "achievable."
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EPA promulgated section 112(d) standards for secondary lead smelters on June 23,1995 (60 Fed. Reg.
3587) and revised them on June 13, 1997 (62 Fed. Reg. 32209) followed by promulgation of section
112(d) standards for primary lead smelters on June 4,1999 (64 Fed. Reg. 30194).
C. PROJECTED SCHEDULE
On November 9, 2004, EPA's National Center for Environmental Assessment Division in Research
Triangle Park, NC (NCEA-RTP) announced official initiation of the current periodic review of air quality
criteria for lead. More specifically, under processes established in Sections 108 and 109 of the CAA, the
EPA began by announcing in the Federal Register (69 FR 64,926) the formal commencement of the
review with a call for information. In addition, EPA has prepared this Lead AQCD Work Plan, a draft of
which is now being made available for review by CASAC and the public, to communicate the process and
timeline for development of a revised Lead AQCD. After carefully assessing and evaluating pertinent
new studies, the EPA will first prepare preliminary draft chapters for a revised criteria document and
subject them to expert review at public workshops. After consideration of comments received at the
workshops, appropriate revisions will be made in ihe draft materials and a First External Review Draft of
the entire revised document will be made available for review and comment by CASAC and the public.
EPA expects that, after consideration of CASAC and public comments, it will be necessary to prepare a
Second External Review Draft of the revised Lead AQCD for further review by CASAC and the public
before EPA completes the final version of the Lead AQCD. Publication of the final document and its
availability to the public will be announced in the Federal Register. Table 1 shows the projected schedule
for the criteria document revision process.
Drawing upon evaluations in the Lead AQCD and other lead exposure/risk analyses, the EPA's
Office of Air Quality Planning and Standards (OAQPS) staff will prepare a draft Lead Staff Paper
assessing policy implications of key information in the Lead AQCD and posing possible options for the
EPA Administrator to consider regarding whether to retain or, if appropriate, revise the Lead NAAQS.
The draft Staff Paper and analyses will also be made available for review by CASAC and the public.
Taking into account CASAC and public comments, final revisions will be made in the Lead Staff Paper,
and it will provide information for decisions to be made by the EPA Administrator regarding possible
retention or revision of the Lead NAAQS.
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Table 1. Proposed Schedule for Development of Revised Lead Air Quality Criteria
Document (Pb AQCD)'
Major Milestones Target Dates
1. Literature Search Ongoing
2. Federal Register Call for Information November 2004
3. Prepare Draft Pb AQCD Project Work Plan Nov-Dec 2004
4. Release Draft Project Plan for Public Comment/CASAC Review January 2005
5. Public Comment Period Jan/Feb 2005
6. CASAC/SAB Public Meeting to Review Proj ect Work Plan March 2005
7. Workshop Drafts of Pb AQCD Chapters May/June 2005
8. Peer Consultative-Review Workshop(s) July/August 2005
9. Release First External Review Draft January 2006
10. Public Comment Period (90 days) Feb-April 2006
11. CASAC/SAB Public Review Meeting (First Ext. Rev. Draft) April 2006
12. Release Second External Review Draft September 2006
13. Public Comment Period (60 days) Oct-Nov 2006
14. CASAC/SAB Public Review Meeting (Second Ext. Rev. Draft) December 2006
15. Final Lead AQCD February 2007
1 Proposed schedule may be modified from time to time, as necessary, to reflect actual project requirements and progress.
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II. SCIENTIFIC BACKGROUND AND KEY ISSUES
Numerous issues were identified by authors and reviewers of the 1986 Lead AQCD/Addendum
and the 1990 Supplement (U.S. Environmental Protection Agency, 1986, 1990) as being relevant to the
development of lead criteria. Additional issues were identified in the course of public discussion and
CAS AC review of draft versions of those earlier AQCD materials and/or the associated Lead Staff Paper,
and some further issues have begun to emerge since then as being of potential public health concern.
By way of introduction to the types of issues anticipated to be considered in the current lead criteria
review, the next several sections each open with concise presentation of some pertinent background
information on a given general category or topic, followed by listing of a number of the more important
issues as illustrative of the types of questions to be considered in the current review of lead criteria.
Many of these issues were addressed by previous reviews. This review will consider any newly available
evidence as it may pertain to potential affirmation or revision of previous ly-stated key findings or
conclusions.
A. LEAD AS A MULTIMEDIA ENVIRONMENTAL CONTAMINANT
Lead is a toxic metal that can produce a variety of physiological and, ultimately, pathological
effects in humans and can also have adverse effects on the environment. As illustrated in Figure 1,
human exposure occurs through multiple pathways, including primarily ingestion of lead in media such as
food, water, soil, and dust, as well as inhalation of airborne lead. Because health effects in humans are
associated with varying levels of lead in the blood and because all exposure pathways contribute to blood
lead levels, health risks are a function of total exposure. Thus, the evaluation of potential health risks
associated with exposures to concentrations of lead in the air must also take into account estimated
exposures and blood lead impacts of lead derived from other media (e.g., food, water, etc.). As a result,
considerable attention will be accorded in the revised Lead AQCD to delineation of information useful in
facilitating understanding of lead as a multimedia environmental contaminant, including characterization
of relative contributions of various exposure pathways to lead burdens in humans and ecosystems and
relationships of such lead burdens to consequent human health and environmental effects.
Examples of important key issues related to delineation of lead as a multimedia environmental
contaminant are provided below.
1. Physical and Chemical Properties of Lead and Measurement Methods
What are important chemical and physical features of inorganic lead and organic lead compounds
encountered in the environment?
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AUTO 1 / INDUSTRIAL \ I CKUSTAL
EMISSIONS J V EMISSIONS / I WEATHERING
Figure 1. Principal pathways of lead from the environment to human consumption. Heavy arrows
are those pathways discussed in greatest detail in the 1986 Lead AQCD.
Source: U.S. Environmental Protection Agency, Air Quality Criteria for Lead, Volume II of IV,
EPA/600/8-83/028bF (June 1986).
What are key features of sampling and analytic methods employed for measurement oflead in
environmental and biological media?
What are appropriate quality assurance/quality control approaches to help ensure reliability of
such measurements?
2. Sources, Emissions, Transport, and Environmental Fate of Atmospheric Lead
Long-Term Historic Trends in Atmospheric Lead Emissions and Environmental Contamination.
» What are more recent trends in atmospheric emissions in the United States since the 1970's?
How important is the downward deposition oflead onto surfaces accessible by humans?
What are the spatial concentration patterns of anthropogenic lead emissions and how do these
differ from natural emissions?
What fraction of observed U.S. ambient air lead concentrations can be attributed to anthropogenic
emission sources?
To what extent does long-range transport oflead emitted in other countries contribute to U.S.
ambient air lead levels?
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3. Mttltimedia Human Exposure and Dosimetry
What are the main multimedia/exposure pathways accounting for human environmental lead
exposures in the United States since the 1970's?
What are current typical lead concentrations currently encountered by sensitive U.S. populations
via different major exposure pathways, e.g., air, food, water, etc.?
What is the current status of population-based information on total human lead exposure and
spatial and temporal patterns of exposures of sensitive population groups?
What tissue or fluid lead concentrations can serve as useful biomarkers of short- or long-term
lead exposure?
What other types of biomarkers are useful as indices of short- or long-term lead exposures?
How do social factors (e.g., human activity patterns and variable avoidance behaviors) affect lead
exposures of sensitive population groups?
What genetic/physiologic factors influence lead exposure and the magnitude of lead
uptake/biological retention?
What are features of currently available biokinetic models that are useful for projecting likely
impacts of multimedia human lead exposures (via air, food, water, etc.) on internal body burdens
as indexed by blood lead levels, etc?
B. HEALTH EFFECTS OF EXPOSURE TO LEAD
Decision-making underlying establishment of the 1978 primary Lead NAAQS took into account
consideration of the following key issues:
(1) Determination of blood lead (PbB) concentrations associated with unacceptable risk of adverse
health effects, especially in infants and young children as key sensitive population;
(2) Characterization of PbB distributions typical of U.S. pediatric populations;
(3) Determination of target level for average PbB concentration to keep PbB levels of given
percentage of sensitive population group below concentrations associated with unacceptable health risks;
(4) Characterization of typical relative contributions of different multimedia lead exposure
pathways (food, water, air, soil, etc.) to U.S. pediatric PbB levels; and
(5) Determination of allowable air lead concentrations (i.e., the NAAQS), taking into account
average contributions from other multimedia lead exposure pathways (e.g., via food, water, etc.).
One of the most controversial and intensely debated issues was the first listed above, i.e., the
determination of blood lead levels associated with unacceptable risk of adverse health effects. This
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determination was based on the 1977 Pb AQCD characterization of health effects associated with acute
and more chronic exposure to lead resulting in internal lead body burdens indexed across a wide range of
blood lead levels in adults and, of most concern, in young children, infants, and the unborn (in-utero)
fetus. This included qualitative delineation of types of lead effects documented by clinical and
epidemiological observations (as also supported by experimental animal studies) and characterization of
quantitative dose-response relationships. The latter included estimation of lowest-observed effect levels
for induction of: (a) clearly adverse, clinically evident classical signs and symptoms of acute lead
poisoning, such as (1) indications of life-threatening lead encephalopathy (serious central nervous system
damage most often seen in infants and young children and often leading to permanent severe mental
retardation and learning disabilities among survivors) documented to be associated with acute high-level
lead exposures resulting in very high blood-lead levels or (2) other signs of peripheral nerve damage
(as indexed, for example, by slowed nerve conduction velocities), anemia, indications of renal damage
and/or gastrointestinal symptoms (e.g., colic) observed in young children at somewhat lower blood lead
levels (the occurrence of a sufficiently severe constellation of the above types of acute lead poisoning
signs and symptoms typically warranting chelation and other types of immediate medical treatment).
It also included (b) much more subtle and difficult to detect indications in asymptomatic infants and
children of less severe but still serious nervous system impacts (as indexed by IQ decrements or various
other types of sensitive tests of neurobehavioral or psychomotor functions) and/or more moderate red
blood cell impacts reported to occur at still lower blood lead levels but seen as likely collectively
constituting adverse health effects; and (c) much smaller magnitude biological or pathophysiological
effects of lead unlikely to be of medical concern (e.g., initial biochemical impacts on heme synthesis that
occur starting at very low blood lead levels and increase in magnitude as blood lead levels become more
elevated). Subsequent studies assessed in the 1986 Lead AQCD/Addendum and the 1990 Supplement
provided further evidence substantiating the above types of findings and reported observed effect levels
for neurobehavioral impacts that extended to still lower PbB values than previously reported.
Among the more important health-related issues that are anticipated to be considered in the current
Lead NAAQS review as part of the basis for decisions on the primary Lead NAAQS are those listed
below.
1. Biological Mechanisms of Action
What are mechanisms and time-courses associated with lead-induced subcellular, cellular, and
tissue injury, repair, and/or remodeling?
What are the effects of age, gender, and pre-existing disease on cellular and tissue responses to
lead-induced injury?
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In particular, to what extent does lead affect heme synthesis at varying lead exposure levels and
what are consequent impacts on various tissue or organ system functions?
2, Effects of Repeated Short-term, Prolonged, or Long-term Lead Exposure on Potential
Histopathologic, Pathophysiologic and Clinical Sequelae of Disease
What levels and/or patterns of lead exposure are associated with retardation of growth rate in
fetuses, infants, and children?
What levels of exposure (indexed by blood, bone, teeth lead levels) early in development are
associated with induction of neurological/neurobehavioral deficits?
To what extent do lead-induced neurobehavioral/growth effects early in development persist and
have long-term sequelae?
To what extent does long-term lead exposure contribute to postmenopausal osteoporosis,
formation of cataracts, or other health problems encountered most typically in older population
groups?
What evidence exists for genotoxic, carcinogenic, and/or co-carcinogenic effects of lead?
3. Sensitive Populations and factors that Enhance Susceptibility
What environmental and host factors (e.g., demographic, socioeconomic, genetic) are associated
with increased vulnerability or susceptibility to short- and long-term exposure to lead?
Does lead exposure exacerbate pre-existing health conditions? If so, what is the nature of
enhanced health effects in persons with pre-existing health conditions who are exposed to lead?
What are the quantitative relationships between ambient lead exposures and the frequencies of
occurrence of these effects?
C. ECOLOGICAL EFFECTS OF EXPOSURE TO LEAD
Lead occurs in various forms in the environment. Ionic lead (Pb:;+), lead oxides and hydroxides,
and lead-metal oxyanion complexes are the general forms of lead released into soil, groundwater, and
surface waters. Pb2+ is the most common and reactive form of lead, forming mononuclear and
polynuclear oxides and hydroxides. The form of lead in the environment greatly influences the
bioavailability and toxicity to various biota.
Lead can accumulate in the terrestrial environment in soils, microorganisms, and plants. The forest
canopy is the functional interface between 90 percent of the Earth's biomass and the atmosphere.
Scavenging of atmospheric lead by foliage is a significant entry route of Pb into terrestrial ecosystems.
Soil-borne lead can be directly toxic to soil microorganisms and disrupt decomposition and mycorrhizal
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processes. Once captured, lead persists within terrestrial ecosystems for decades, if not centuries. Lead
can enter adjacent aquatic systems by interactions between the terrestrial and aquatic environment.
Lead can also accumulate in sediments of aquatic ecosystems and serve as a source of
contamination to benthic organisms over long periods of time. Aquatic macrophytes can accumulate lead
from sediments and introduce lead into the aquatic food chain through the activities of plant grazers.
Uptake of lead directly from the water column can also contribute to total lead body burdens in pelagic
aquatic species. Lead can move up the food chain and ultimately impact human health through
consumption of lead-tainted fish and shellfish.
The previous review (U.S. Environmental Protection Agency, 1986) indicated that remaining
uncertainties in available data for a number of environmental effects categories increased the difficulties
associated with characterizing qualitative or quantifiable risks to various components of agronomic,
forested, and natural ecosystems. The following issues tend to center around addressing such
uncertainties and provide an overall framework for assessing new scientific information that should likely
be considered to support selection of an appropriate secondary lead NAAQS protective of crops, natural
vegetation, and ecosystem components and processes.
1. Exposure Dynamics: monitoring to determine ambient lead concentrations encountered in urban
and rural farm/forest areas, exposure patterns (episodes), concentrations vs flux, relationship between
chamber and field exposure data, plant uptake;
a. Modeling
What is the state of the science in modeling lead concentration gradients and deposition velocities
across plant canopies, plant communities, or multiple ecological resource landscapes?
How precise and accurate are these models?
How well can these models be extrapolated temporally and spatially within or across different
forest types, crops, watersheds, basins, ecophysiographic regions, the urban-rural interface, etc.?
« Can passive samplers be useful to "fill in the gaps" in model-derived lead concentrations at remote
areas where continuous lead monitoring is not routinely performed?
b. Exposure Regimes
How do episodic exposures (predisposition) alter plant or animal responses to chronic, cumulative
lead exposures?
How do we translate results from controlled exposure studies which are typically conducted with
single species/organisms (e.g., tree seedlings or crops) to whole trees, forest stands, farm land,
lakes, estuaries, ecosystems, watersheds, airsheds, or ecophysiographic regions?
Can data from remote sensing platforms be useful in understanding local, regional, national,
and global lead transport and deposition?
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2. Plant/Animal Response and Mode of Action: biological, chemical and physical responses,
especially cellular biochemical/physiological mechanisms; individual plant sensitivity/ genetic
composition; site/habitat influences; pest, disease, and abiotic stress interactions;
a. Plants
Is there new information regarding the mode of action of lead once it enters a plant?
Are there genetic markers that can be identified using state-of-the-art molecular biological
methodologies that differentiate lead tolerant and intolerant cultivars and species?
What is known about lead's effects on ecosystem components singly and in combination with other
air pollutants?
How does lead, both singly and in combination with other air pollutants, influence plant-pathogen
and plant-pest interactions?
b. Wildlife
Are lead exposure effects on wildlife similar to human exposure effects?
Has lead altered the nutritional content of forage for domestic animals or wildlife populations?
What is known about lead's effects on faunal ecosystem components singly and in combination
with other air pollutants?
c. Aquatic organisms
« How important is lead uptake from sediments in lead accumulation in aquatic plants and animals?
How important is methylation in lead mobility and bioavailability in aquatic systems?
« To what extend is lead biomagnified up the food chain?
3. Ecosystems: exposure/response relationships of sensitive individual plant species and forest trees to
lead under ambient conditions; impact of lead exposure on interspecific competition on both above-
and below-ground interactions and on ecosystem products and services.
a. Biodiversity
* Does lead influence the biodiversity of ecological systems?
6. Terrestrial-Aquatic Interface
* Have terrestrial ecosystem effects of lead exposure affected aquatic ecosystems?
Has lead altered the nutrient cycling in forested catchments that may manifest themselves as
changes in water chemistry at the stream and watershed levels?
4. Assessment: assessment of economic impacts on products (crops, forests, fish, shellfish, etc.) and
ecosystem services, benefits derived from control of lead exposures.
a. Economics
« Have new and innovative methods evolved since the last criteria document for monetizing
ecosystem services and non-consumptive use products (e.g., aesthetics, recreation, plant nutritional
quality for wildlife)?
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To what extent can credible estimates be derived for economic impacts of lead on consumptive-use
ecosystem products (e.g., crop yields, fish yields, shell fisheries, and timber)?
b. Scaling Up
What recent advances, if any, now allow for localized or spatiotemporally disparate data sets to be
aggregated for regional ecological effects assessments?
Can critical loads be determined for sensitive ecosystem components?
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III. ORGANIZATIONAL STRUCTURE AND
PREPARATION/REVIEW PROCESS
A. ORGANIZATION AND CONTENT OF REVISED LEAD DOCUMENT
The updated Lead AQCD will critically evaluate and assess scientific information on the health and
welfare effects associated with exposure to the concentrations of this pollutant in ambient air. The
revised document is not intended to be an exhaustive review of the literature. Rather, the cited references
will reflect the current state of knowledge on the most relevant issues pertinent to decisions on possible
Lead NAAQS revision. Although emphasis will be placed on the presentation of health and welfare
effects data, other scientific data will also be presented and evaluated in order to provide a better
understanding of the nature, sources, distribution, measurement, and concentrations of lead in ambient air,
as well as the measurement of population exposure to lead.
The focus of the selected scientific information in the text will be on literature published since the
previous review of the air quality criteria for lead. Emphasis will be placed on studies conducted at or
near lead concentrations found in ambient air. Other studies may be included if they contain unique data,
such as the documentation of a previously unreported effect or of a mechanism for an observed effect; or
if they were multiple-concentration studies designed to provide exposure-response relationships.
Key findings and conclusions from the 1986 Lead AQCD/Addendum and 1990 Supplement will
briefly be summarized at the outset of discussion of a given topic, with appropriate reference back to the
previous materials. Important prior studies will be more specifically discussed if they are open to
reinterpretation in light of newer data and are judged to be potentially useful in decisions on revision of
the standards for lead. Generally, only information that has undergone scientific peer review and has
been published (or accepted for publication) in the open literature will be considered in the criteria
document. Exceptions may be made depending on the importance of the subject information and its
pertinence to criteria development for Lead NAAQS, as determined in consultation with CASAC.
The proposed structure of ihe document will begin with an Executive Summary and Conclusions.
Chapter 1 (Introduction) will present information on the legislative background and purpose of the
document, provide a brief introduction to key issues to be addressed, and present an overview of the
organization of the document. Chapter 2 will provide information on the physics and chemistry of lead,
as well as sampling and analytic methods for measurement of lead concentrations in various
environmental and biological media. Chapter 3 will cover sources, emissions, transport, and
deposition/fate; and Chapter 4 will cover environmental concentrations, patterns, and multimedia
exposure pathways. Chapter 5 will discuss dosimetric issues, focused mainly on modeling of multimedia
exposure impacts on human internal lead burdens, as indexed by blood or bone lead concentrations.
Chapters 6 and 7 will discuss toicologic studies of lead health effects in humans and laboratory animals,
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as well as clinical and epidemiologic studies. Chapter 8 will then provide an integrative synthesis of key
information regarding human lead exposures and health effects. Chapter 9 will deal with ecological and
other environmental effects of lead. The proposed chapter topics are provided in the inset below. See
Appendix A for a more detailed outline of proposed contents to be included in the revised Lead AQCD.
Chapter Topics for Revised Air Quality Criteria for Lead
Executive Summary
Chapter 1 Introduction
Chapter 2 Chemical and Physical Properties and Measurement
Chapter 3 Sources, Emissions, Transport, and Deposition
Chapter 4 Environmental Concentrations and Pathways to Human Exposure
Chapter 5 Models of Human Exposure, Uptake, and Biokinetic Distribution of Lead
Chapter 6 Toxicologic Effects of Lead in Laboratory Animals
Chapter 7 EpidemiologicaJ and Clinical Studies of Lead Effects in Humans
Chapter 8 Integrative Synthesis of Human Exposure and Health Risks
Chapter 9 Environmental Effects of Lead
B. METHODS AND PROCEDURES FOR DOCUMENT PREPARATION
Responsibilities for developing the revised Lead AQCD will be essentially the same as those used
for recent criteria documents, with additional emphasis being placed on more extensive coordination and
collaborative inputs from various participating EPA units. Briefly, the respective responsibilities are as
follows. The Research Triangle Park Division of EPA's National Center for Environmental Assessment
(NCEA-RTP) will have lead responsibility for preparation of the updated Lead AQCD. The Director of
NCEA-RTP has appointed a project manager and team with responsibility for developing the present
project work plan for preparation of the document. Development of the plan has been facilitated by input
from other EPA program and policy office staff among those listed on the EPA Lead Criteria Work
Group (see Appendix B). This resulting draft project plan is being made available for CASAC and public
review and will then be revised, as appropriate. It will also be further updated, as appropriate, to reflect
any major future changes and/or progress in its implementation.
A literature search has been ongoing to collect references on the health and ecological effects of
lead. Additional literature searches are also underway for other respective areas to be covered in the
criteria document; and NCEA-RTP has developed an information base to access the references and
provide quality assurance and quality control functions. Specific chapter or section authors are being
selected on the basis of their expertise in the subject areas and their familiarity with the relevant literature.
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Both EPA and non-EPA scientific: experts will be involved in this effort. The main focus of the revised
criteria document will be on evaluation and interpretation of data that deal with the effects of airborne
lead on human health and welfare. One or more peer consultation workshops will be convened to discuss
draft criteria document chapters and will focus on the selection of studies included in the chapters, the
potential need for additional information to be added to the chapters, and the quality of the summarization
and interpretation of the literature. The respective authors of the draft chapters will revise them on the
basis of the workshop discussions. After resolution of outstanding issues and comments derived from the
workshops, NCEA-RTP will release the First External Review Draft of the revised Lead AQCD for
public comment and CASAC review. Then, revisions will be made on the basis of the public comments
and CASAC review. EPA expects that it will be necessary to make a Second External Review Draft
available for further CASAC and public review before EPA completes and releases the final version of
the revised Lead AQCD. Preparation of an updated Lead Staff Paper, drawing upon key findings and
conclusions from the Lead AQCD and other related exposure/risk analyses, will be carried out by EPA's
Office of Air Quality Planning and Standards (OAQPS).
C PERSONNEL
Dr. Robert W. Elias will serve as the NCEA-RTP project manager responsible for overall
coordination of the Lead AQCD preparation effort. Drs. Lester D. Grant and J. Michael Davis will
provide overall technical guidance for the health effects aspects and Dr. Timothy Lewis for the ecological
effects aspects of the document. Other NCEA-RTP project team members who are to provide overall
coordination and technical inputs for individual chapters are as follows: Dr. Joseph Pinto for the chapter
on lead chemistry and measurement methodologies; Dr. Robert Elias, Dr. Joseph Pinto, Ms. Beverly
Comfort, and Mr. William Ewald for the chapter on environmental concentrations, patterns, and potential
exposures; Dr. Robert Elias for the chapter on lead biokinetic modeling: Drs. Lori White, James Brown,
Srikanth Nadadur, and J. Michael Davis for the chapter materials dealing with toxicological effects in
laboratory animals and humans; Drs. Dennis Kotchmar and Ji Young Kim for review and evaluation of
epidemiological studies; and Dr. Timothy Lewis for the chapter on environmental effects. Additional
technical assistance on air quality, health effects, and ecological effects will be obtained from EPA
scientists in EPA's National Exposure Research Laboratory (NERL), National Health and Environmental
Effects Research Laboratory (N HEERL), and the Office of Air Quality Planning and Standards
(OAQPS), as appropriate and needed. As needed, scientific expertise will also be obtained from outside
EPA, utilizing contractual arrangements with non-EPA experts. Members of NCEA-RTP's project team
and other EPA and non-EPA personnel expected to contribute to the document are listed in Appendix C;
examples of the pool of experts that EPA expects to tap to assist in development of the Lead AQCD as
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potential authors or contributors of written materials or serving in peer consultative or reviewer roles for
review of workshop draft or external reviews draft materials are also listed in Appendix C.
D. APPROACH
Discussions will be held between NCEA/RTP staff and EPA workgroup members to help identify
key issues and approaches to addressing them. Non-EPA experts will also be consulted to help identify
and refine key issues to be addressed and pertinent new literature to be considered. Discussions will also
be held with the authors at the initial stages of document development to acquaint them with detailed
guidelines and specifications. Subsequent meetings with authors may be conducted to facilitate
continuity within and between chapters. Periodic coordination meetings will be held to facilitate flow of
information on document preparation progress, to obtain feedback on evolving draft materials, and to
determine any needed modifications in planned actions.
The authors will be provided copies of the previous 1986 Lead AQCD/Addendum and the 1990
Supplement (U.S. Environmental Protection Agency, 1986). New sections for the updated document will
each first summarize key findings and conclusions from those prior document materials, including
reference to "key" studies. Once this background information is presented, the remainder of the given
section will be updated with discussion and interpretative evaluation of the newer literature. In cases
where no new information is available, the summarization of key findings from the previous criteria
document will suffice. The primary focus in the main Lead AQCD chapters will be on interpretive
evaluation of the most pertinent evidence with reference being made to more descriptive summarization
of details of particular studies provided in separate annexes to be appended to the main Lead AQCD.
A list of references published since the last review of lead criteria (mainly after completion of the
1986 Lead AQCD/Addendum and 1990 Supplement) will be made available to the authors. The
references will be selected from information data base searches conducted by EPA and from any materials
submitted in response to the November 2004 call for information. Hard copies of these references will be
supplied upon request. Additional references may need to be added to the list (e.g., missed or recently
published papers or "in press" publications). As an aid in selecting pertinent new literature, the authors
will also be provided with a summary of issues that need to be addressed in the preparation of the revised
Lead AQCD. These will include issues identified by authors and reviewers of the previous lead
document materials, raised in public discussions, workshops, or CASAC comments received by EPA
and/or raised via interactions involving EPA Lead Workgroup members. The list of issues may be further
augmented in the course of preparation or review of draft materials for the revised Lead AQCD.
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E. PUBLIC AND SCIENTIFIC REVIEW
1. Review and Revision of Consultative Review Workshop Draft
When working drafts of the main chapters (other than the Executive Summary) of the document
have been completed by the authors, one or more workshops will be convened by the NCEA-RTP Project
Team. The workshops will include the document authors, EPA Work Group participants, and external
reviewers chosen on the basis of scientific expertise within specific areas covered. The workshops will be
open to the public, as announced in a Federal Register Notice.
2. Public Review of External Review Drafts
After the workshop consultative review process is completed, the authors, contributing reviewers,
and NCEA-RTP Project Team will resolve how to address comments received and will revise the draft
chapters in preparation for their inclusion in the First External Review Draft (ERD) of the Lead AQCD.
After clearance by the U.S. EPA, the draft document will be released for public comment as announced in
a Federal Register Notice. Electronic and printed copies of the ERD will be made available for review
during a specified time period, usually of 60 to 90 days; written comments are solicited during this time.
A similar procedure will be followed for public and CAS AC review of a Second External Review Draft
that EPA expects to be necessary before completion of the Final Lead AQCD.
3. Review by Clean Air Scientific Advisory Committee
At the time the First External Review Draft is released to the public, that draft document will also
be sent to the Clean Air Scientific Advisory Committee (CASAC) of EPA's Science Advisory Board
(SAB). CASAC members and consultants (see Appendix D) will review the draft document and discuss
their comments in a public meeting announced in the Federal Register. At the meeting, the NCEA-RTP
Project Team plans to present an overview of the main features of the document, a summary of key issues
raised by public comments received on the document, and the charge to the committee, as well as being
prepared to discuss proposed revisions, if indicated. Based on CAS AC's past practice, EPA expects that
key CASAC advice and recommendations for revision of the document will be summarized by the
CASAC Chair in a letter to the E!PA Administrator. EPA will take into account any such
recommendations, as well as CASAC and public comments at the meeting and any written comments
received, in revising the draft Lead AQCD. As noted earlier, EPA expects that it will be necessary to
prepare a Second External Review Draft for further CASAC review and public comment. After
appropriate revision, the final document will be made available on an EPA website and subsequently
printed, with its public availability being announced in the Federal Register.
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References
Federal Register. (2004) Air quality Criteria Document for Lead: Call for Information. F. R.
(November 9) 69: 64926-64928.
Federal Register. (1979) National primary- and secondary ambient air quality standards: revisions to
the National Ambient Air Quality Standards for lead. F. R. (February' 8) 44: 8202-8237.
U.S. Environmental Protection Agency. (1986) Air quality criteria for lead. Research Triangle Park, NC:
Office of Health and Environmental Assessment, Environmental Criteria and Assessment Office;
EPA report nos. EPA/600/8-83/028A-F. Available from NTIS, Springfield, VA; PB87-142949.
U.S. Environmental Protection-Agency. (1990) Summary of selected new information on effects of lead
on health and supplement to 1986 air quality criteria for lead. Research Triangle Park, NC: Office
of Health and Environmental Assessment, Environmental Criteria and Assessment Office; EPA
report no. EPA/600/8-89. Available from NTIS, Springfield, VA; PB92-235670.
U.S. Environmental Protection Agency. (2000) Science policy council peer review handbook. 2nd ed.
Washington, DC: Science Policy Council: report; EPA no. EPA-100-B-00-001.
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APPENDIX A
PROPOSED CONTENTS OF REVISED AIR QUALITY CRITERIA FOR LEAD
Page
LIST OF TABLES
LIST OF FIGURES
AUTHORS, CONTRIBUTORS, AND REVIEWERS
EXECUTIVE SUMMARY AND CONCLUSIONS
1. INTRODUCTION
1.1 LEGISLATIVE BACKGROUND
1.2 REGULATORY BACKGROUND
1.3 DOCUMENT PREPARATION AND REVIEW PROCESS
1.4 ORGANIZATION AND CONTENT OF THE DOCUMENT
2. CHEMISTRY/PHYSICAL PROPERTIES OF LEAD AND MEASUREMENT METHODS .
2.1 GENERAL CHEMISTRY OF LEAD
2.2 ORGANOMETALL1C CHEMISTRY OF LEAD
2.3 STABLE ISOTOPE METHODOLOGIES
2.4 CONTAMINATION CONTROL METHODS
2.5 AIR SAMPLING MEASUREMENT/METHODOLOGIES
2.6 PARTICLE DEPOSITION MEASUREMENTS
2.7 DUST SAMPLING METHODS FOR HUMAN EXPOSURE
2.8 BIOLOGICAL TISSUE MEASUREMENT METHODS
3. SOURCES, EMISSIONS, TRANSPORT, AND DEPOSITION
3.1 SOURCES AND EMISSIONS OF ATMOSPHERIC LEAD
3.2 ATMOSPHERIC TRANSPORT AND DEPOSITION OF LEAD
3.3 OTHER SOURCES OF LEAD IN DUST
4. ENVIRONMENTAL CONCENTRATIONS AND PATHWAYS TO HUMAN EXPOSURE
4.1 LEAD [N INHALED AIR
4.2 LEAD IN INGESTED DUST
4.3 LEAD IN FOOD
4.4 LEAD IN DRINKING WATER
4.5 OTHER MISCELLANEOUS EXPOSURE PATHWAYS
5. MODELS OF HUMAN EXPOSURE THAT PREDICT TISSUE DISTRIBUTION OF LEAD
5.1 HISTORIC LEAD MODELS
5.2 INTEGRATIVE EXPOSURE UPTAKE BIOKINETIC (IEUBK) MODEL
FOR LEAD IN CHILDREN
5.3 ALL AGES LEAD MODEL (AALM)
5.4 OTHER MODELING APPROACHES
6. TOXICOLOGICAL EFFECTS OF LEAD IN LABORATORY ANIMALS
6.1 INTRODUCTION
6.2 EFFECTS ON HEME SYNTHESIS
6.3 NEUROLOGICAL/NEUROBEHAVIORAL EFFECTS
6.4 REPRODUCTIVE AND DEVELOPMENTAL EFFECTS
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PROPOSED CONTENTS
(cont'd)
fas
6.5 CARDIOVASCULAR EFFECTS
6.6 GENOTOXIC/CARCINOGENIC EFFECTS
6.7 SUMMARY AND CONCLUSIONS
REFERENCES
7. EPIDEMIOLOGIC STUDIES OF AMBIENT LEAD EXPOSURE EFFECTS
7.1 INTRODUCTION
7.2 EFFECTS OF SHORT-TERM AMBIENT LEAD EXPOSURE
7.3 EFFECTS OF LONG-TERM AMBIENT LEAD EXPOSURE
7.4 SUMMARY AND CONCLUSIONS
REFERENCES
8. INTEGRATIVE SYNTHESIS OF HUMAN LEAD EXPOSURE PATHWAYS AND
HEALTH RISKS
8.1 INTRODUCTION
8.2 SOURCES, CONCENTRATIONS, AND EXPOSURE PATHWAYS
8.3 EVALUATION OF HEALTH RISKS FROM SHORT-TERM OR EPISODIC
LEAD EXPOSURE
8.3.1 Health Effects in the General Human Population
8.3.2 Health Effects in Susceptible Population Groups
8.4 HEALTH RISKS FROM LONG-TERM LEAD EXPOSURE
8.4.1 Effects Associated With Chronic Exposures in Human Populations . .
8.4.2 Extrapolation of Effects Observed in Laboratory Animals to
Human Populations
8.5 SUMMARY OF KEY FINDINGS AND CONCLUSIONS
REFERENCES
9. ENVIRONMENTAL EFFECTS OF LEAD
9.1 TERRESTRIAL ECOSYSTEMS
9.1.1 Introduction
9.1.2 Methodologies Used in Terrestrial Ecosystems Research
9.1.3 Species Response/Mode of Action
9.1.4 Factors that Modify- Organisms Response to Lead
9.1.5 Exposure/Response of Terrestrial Species
9.1.6 Effects of Lead on Natural Terrestrial Ecosystems
9.1.7 Economic Effects of Lead on Agriculture, Forestry, and other
Terrestrial Ecosystems
9.2 AQUATIC ECOSYSTEMS
9.2.1 Introduction
9.2.2 Methodologies Used in Aquatic Ecosystems Research
9.2.3 Species Response/Mode of Action
9.2.4 Factors that Modify Organisms Response to Lead
9.2.5 Exposure/Response of Aquatic Species
9.2.6 Effects of Lead on Natural Aquatic Ecosystems
9.2.7 Economic Effects of Lead on Aquaculture, Shellfishery, and Fishery Systems
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PROPOSED CONTENTS
(cont'd)
9.3 EFFECTS OF LEAD ON NONBIOLOGICAL MATERIALS
9.4 EFFECTS OF LEAD ON GLOBAL CLIMATE CHANGE PROCESSES
9.5 SUMMARY AND CONCLUSIONS
REFERENCES
APPENDIX: GLOSSARY OF TERMS AND SYMBOLS
Page
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APPENDIX B
EPA WORK GROUP FOR AIR QUALITY CRITERIA FOR LEAD
Dr. William K. Boyes
National Health and Environmental Effects Research Laboratory (B-105-05)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Ms. Beverly M. Comfort
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. J. Michael Davis
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Robin L. Dennis
National Exposure Research Laboratory (E-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. Ronald Evans
Office of Air Quality Planning and Standards (C-339-01)
U.S. Environmental Protection Agency
Research Triangle Park, N.C. 27711
Mr. William G. Ewald
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. Tyler Fox
Office of Air Quality Planning and Standards (D-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Mary E. Gilbert
National Health and Environmental Effects Research Laboratory (B-105-05)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Ian Gilmour
National Health and Environmental
Effects Research Laboratory (MD-92)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Toxicology
Indoor air quality
Toxicology
Atmospheric modeling
Economic assessment
consultation
Environmental
concentrations
Atmospheric modeling
consultation
Toxicology
Immunotoxicology
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EPA WORK GROUP
(confd)
Gerald Gleason
Office of General Counsel (2344A)
U.S. Environmental Protection Agency
Washington, DC 20460
Dr. Lester D. Grant, Director
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Sharon Harper
National Exposure Research Laboratory (D-205-5)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. James B. Hemby
Office of Air Quality Planning and Standards (C-304-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Brooke Hemming
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Lee Hofmann
Office of Solid Waste and Emergency Response
Office of Solid Waste (5103-T)
U.S. Environmental Protection Agency
EPA West Building
1200 Pennsylvania Avenue, N.W
Washington, DC 20460
Dr. Ji Young Kim
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Dennis Kotchmar
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 277] 1
Dr. Charles W. Lewis
National Exposure Research Laboratory (E-205-03)
U.S. Environmental Protection Agency
Research Triangle Park, NC 277:. 1
Consultation
Executive and
technical oversight
Analytical methods
Exposure aspects
Air quality
consultation
Atmospheric science
Soil/Dust Pb
consultation
Epidemiology
Epidemiology
Source apportionment
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EPA WORK GROUP
(cont'd)
Dr. Timothy E. Lewis
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Deborah J. Luecken
National Exposure Research Laboratory (E-205-02)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Deborah Mangis
National Exposure Research Laboratory (D-305-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Karen M. Martin
Office of Air Quality Planning and Standards (C-539-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. Thomas R. McCurdy
National Exposure Research Laboratory (E-205-02)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. David C. Misenheimer
Office of Air Quality Planning and Standards (D-205-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Srikanth Nadadur
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency-
Research Triangle Park, NC 27711
Dr. Lucas Neas
National Health and Environmental
Effects Research Laboratory (MD-58)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Ms. Sharon V. Nizich
Office of Air Quality Planning and Standards (C-339-02)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Terrestrial and aquatic
ecosystem effects
Atmospheric chemistry
Ecosystems; Exposure
Consultation
Exposure;
Activity patterns
Air emissions
consultation
Toxicology
Epidemiology;
Children's health
Air quality/trends
consultation
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EPA WORK GROUP
(cont'd)
Dr. Edward Ohanian
Office of Water (4304-T)
U.S. Environmental Protection Agency
EPA West Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Dr. David Olszyk
National Health and Environmental
Effects Research Laboratory
U.S. Environmental Protection Agency
200 S.W. 35th Street
Corvallis, OR 97333
David Orlin
Air and Radiation Office of General Counsel (2344A)
U.S. Environmental Protection Agency
Washington, DC 20460
Dr. Zackary Pekar
Office of Air Quality and Standards (6-339-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Joseph P. Pinto
National Center for Environmental Assessment (B-243-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. Harvey M. Richmond
Office of Air Quality Planning and Standards (C-539-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27'H 1
Dr. Mary Ross
Office of Air Quality Planning and Standards (C-539-01)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27 711
Mr. William E. Russo
National Health and Environmental
Effects Research Laboratory (B-305-02)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Water Pb consultation
Crops
Consultation
Exposure/dosimetry
consultation
Air chemistry;
Global effects
Exposure modeling
consultation
Human health
consultation
Consultation
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EPA WORK GROUP
(cont'd)
Ms. Victoria A. Sandiford Ecosystems
Office of Air Quality Planning and Standards (C-539-01) consultation
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Mr. Kenneth L. Schere Atmospheric modeling
National Exposure Research Laboratory (E-243-03)
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Dr. Dave Topping Pb-based paint
Office of Prevention, Pesticides, and Toxic Substances (7404-T) consultation
U.S. Environmental Protection Agency
EPA West Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
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APPENDIX C
NCEA-RTP PROJECT TEAM AND OTHER TECHNICAL CONSULTANTS
NCEA-RTP Project Team
Scientific Staff
Dr. James Brown Health Scientist, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Ms. Beverly M. Comfort Health Scientist, National Center for Environmental Assessment
(B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. J. Michael Davis Senior Health Science Advisor, National Center for Environmental Assessment
(B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Robert W. Elias Senior Health Scientist, National Center for Environmental Assessment
(B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Mr. William G. Ewald Health Scientist, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Brooke Hemming Atmospheric Scientist, National Center for Environmental Assessment
(B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Ji Young Kim Epidemiologist, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Timothy E. Lewis Ecologist, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Shrikanth Nadadur Health Scientist, National Center for Environmental Assessment (B-243 01),
U.S. Environmental Protection Agency, Research Triangle Park,NC 27711
Dr. Joseph P. Pinto Physical Scientist, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Lori White Health Scientist, National Center for Environmental Assessment
(B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Technical Support Staff
Mr. Douglas B. Fennell Technical Information Specialist, National Center for Environmental
Assessment (B-243-01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Ms. Emily R. Lee Management Analyst, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park,
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NCEA-RTP PROJECT TEAM AND OTHER TECHNICAL CONSULTANTS
(cont'd)
Technical Support Staff (cont'd)
Ms. Diane H. Ray Program Specialist, National Center for Environmental Assessment (B-243-01),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Ms. Donna Wicker Management Analyst, National Center for Environmental Assessment (B-243-
01), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Other EPA Contributors
Dr. William K. Boycs National Health and Environmental Effects Research Laboratory (B-105-05),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Ian Gilmour National Health and Environmental Effects Research Laboratory (B-143-04),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Mary E. Gilbert National Health and Environmental Effects Research Laboratory (B-105-05),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. Charles W. Lewis National Exposure Research Laboratory (E-205-03), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711
Dr. Sharon Harper National Exposure Research Laboratory (D-205-05), U.S. Environmental
Protection Agency, Research Triangle Park, NC 27711
Dr. Lucas Neas National Health and Environmental Effects Research Laboratory (MD-82),
U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
Dr. David Olszyk National Health and Environmental Effects Research Laboratory,
U.S. Environmental Protection Agency, 200 SW 35th Street, Corvallis, OR 97333
Dr. MaryJane K. Selgrade National Health and Environmental Effects Research Laboratory
(B-143-04), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711
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NCEA-RTP PROJECT TEAM AND OTHER TECHNICAL CONSULTANTS
(cont'd)
Non-EPA Consultants (Potential Sources1)
Dr. Carol Angle Toxicology /Epidemiology, University of Nebraska Medical Center
Dr. Ann Aschengrau Toxicology/Epidemiology, Boston University
Dr. Gerald Audesirk Toxicology/Epidemiology, University of Colorado
Dr. Donald Barltrop Toxicology/Epidemiology, Westminister Children's Hospital
Dr. Barbara Beck Health Scientist, Gradient Corp
Dr. Mike Bolger Health Scientist, FDA
Mr. Craig Borieko Environmental Scientist, ILZRO
Dr. Robert Bornschein Toxicology/Epidemiology, University of Cincinnati
Dr. Mary Jean Brown Health Scientist, CDC
Dr. Ian Calder Health Scientist, South Australian Health Commission
Dr. Rufus Chancy Environmental Scientist, USDA
Dr. Deborah Cory-Slechta Toxicology/Epidemiology, Rutgers
Dr. Anita Curren Toxicology/Epidemiology, Westchester County Health Department
Dr. Cliff Davidson Environmental Scientist, Carnegie-Mellon University
Dr. Gary Diamond Statistician, Syracuse Research Corp
Dr. Kim Dietrich Health Scientist, University of Cincinnati
Dr. Mark Farfel Toxicology /Epidemiology, Kennedy-Krieger Institute
Dr. Russ Flegal Environmental Scientist, University of California, Santa Cruz
Dr. Bruce Fowler Toxicology/Epidemiology, University of Maryland
Dr. Don Fox Toxicology /Epidemiology, University of Houston
Dr. Tom Goehl Toxicology/Epidemiology, NIEHS
'This list ofnon-EPA scientists is proposed on the basis of published, peer-reviewed scientific publications on topic areas that are
likely to be included in the revised crite.-ia document or on the basis of previous involvement as an author, contributor, or
reviewer of the I986 Lead AQCD/Addendum. Contractual agreements for professional services would be the likely mechanism
for obtaining their contributions to the revised Air Quality Criteria Document for Lead and/or their participation in workshops.
January 2005
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NCEA-RTP PROJECT TEAM AND OTHER TECHNICAL CONSULTANTS
(cont'd)
Non-EPA Consultants (Potential Sources1) (cont'd)
Dr. Phil Goodrum Statistician, Syracuse Research Corporation
Dr. Robert Goyer Toxicology/Epidemiology, Retired, Chapel Hill, NC
Dr. Brian Gulson Health Scientist, Macquarie University, Sidney Australia
Dr. Vic Hasselblad Statistician, Duke University
Dr. Derek Hodgson Toxicology/Epidemiology, University of North Carolina
Mr. Dave Jacobs Environmental Engineer, HUD
Dr. Richard Kaufman Health Scientist, ATSDR
Dr. David Koeppe Texas Tech University
Dr. Phil Landrigan Toxicology/Epidemiology
Dr. Bruce Lanphear Toxicology/Epidemiology, Children's Hospital Medical Center, Cincinnati, OH
Dr. Stephen Lasley Toxicology/Epidemiology, University of Illinois
Dr. Samuel Lestz Pennsylvania State University
Dr. Morton Lippmann Toxicology /Epidemiology, New York University Medical Center
Dr. Ben Liu Atmospheric Scientist, University of Minnesota
Dr. Paul Mushak Toxicology/Epidemiology, PB Associates, Durham, NC
Dr. Herbert Needleman Toxicology/Epidemiology, Children's Hospital of Pittsburgh
Dr. Jerome Nriagu Environmental Scientist, University of Michigan
Dr. Ellen O'Flaherty Toxicology/Epidemiology, Retired
Dr. Anna Orlova Toxicology /Epidemiology, John Hopkins School of Hygiene & Public Health
Dr. Dan Paschal Environmental Chemist, CDC
Dr. Joel Pounds Toxicology/Epidemiology, Battelle Pacific Northwest
Dr. Michael Rabinowitz Environmental Scientist, Children's Hospital Medical Center
Dr. Deborah Rice Toxicology/Epidemiology, State of Maine
January 2005 C-4 DRAFT - DO NOT QUOTE OR CITE
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NCEA-RTP PROJECT TEAM AND OTHER TECHNICAL CONSULTANTS
(cont'd)
Non-EPA Consultants (Potential Sources1) (cont'd)
Dr. John Rosen Toxicology /Epidemiology, Albert Einstein College of Medicine
Dr. Glen Sanderson Environmental Scientist, Illinois Natural History Survey
Dr. Ellen Silbergeld Toxicology/Epidemiology, University of Maryland
Dr. Don Smith Environmental Scientist, University of California, Santa Cruz
Dr. William Smith Ecologist. Yale University, School of Forestry
Dr. Paul Succop Statistician, University of Cincinnati Medical Center
Mr. Ian von Lindern Environmental Scientist, TerraGraphics
Mr. Brian Wilson Environmental Scientist, ILZRO
Dr. Nasser Zawia Toxicology /Epidemiology. University of Rhode Island
January 2005
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APPENDIX D
U.S. EPA SCIENCE ADVISORY BOARD
CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE MEMBERS
Fiscal Year 2005
The Clean Air Scientific Advisory Committee (CASAC) has a statutorily mandated responsibility
to review and offer scientific and technical advice to the Administrator on the air quality criteria and
regulatory documents that form the basis for the national ambient air quality standards (NAAQS), which
currently include standards for lead (Pb), paniculate matter (PM), ozone (O3), and other photochemical
oxidants, carbon monoxide (CO), nitrogen oxides (NOJ and sulfur oxides (SO^. To perform such
reviews, in each case the Committee forms a review panel consisting of CASAC members and augmented
by selected consultants with expertise in scientific or technical areas pertinent to the given pollutant or
pollutant class under review.
CHAIR
Dr. Rogene Henderson
Lovelace Respiratory Symposium
Lovelace Respiratory Research Institute
Albequerque, NM 87185
PAST CHAIR
Dr. Philip Hopke
Robert A. Plane Professor
Department of Chemical Engineering
Clarkson University
Potsdam, NY 13699
MEMBERS
Dr. Frederick Miller
Director of Respiratory Toxicology Research
Chemical Industry Institute of Toxicology
Research Triangle Park, NC 27709
Mr, Richard Poirot
Environmental Analyst
Department of Environmental Conservation
Vermont Agency of Natural Resources
Waterbury, VT 05671
Dr. Frank Speizer
Edward Kass Professor of Medicine
Channing Laboratory
Harvard Medical School
Boston, MA 02115
January 2005 D-l DRAFF - DO NOT QUOTE OR CITE
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SCIENCE ADVISORY BOARD
(cont'd)
MEMBERS
(cont'd)
Dr. Ellis B, Cowling
University Distinguished Professor
North Carolina State University
Raleigh NC
Dr. James Crapo
Chairman, Dept. of Medicine
National Jewish Medical and Research Center
Denver, CO
Dr. Barbara Zielinska
Research Professor
Atmospheric Sciences Division
Desert Research Institute
Reno, NV 89512
SCIENCE ADVISORY BOARD STAFF
Mr. Fred A. Butterfield, III
Designated Federal Officer
Clean Air Scientific Advisory Committee
Science Advisory Board (1400A)
US Environmental Protection Agency
Washington, DC 20460
Ms. Zisa Lubarov-Walton
Management Assistant
Science Advisory Board (1400A)
US Environmental Protection Agency
Washington, DC 20460
January 2005
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Unifcxi Steles
EnvirorsmenJa!
Protection Agency
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detach copy or copy, and return to the address in the upper
left-hand corner.
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detach copy or copy, and return to the address in the
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January 2005
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