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Prepared by the Staff of the Air Resources Board
and the Office of Environmental Health Hazard Assessment As
approved by the Air Resources Board on: April 24, 1997
In accordance with California Health and Safety
Code sections 39660-39662, the Air Resources Board staff is
recommending that the Board consider the identification of inorganic
lead as a toxic air contaminant. The draft report, Proposed
Identification of Inorganic Lead as a Toxic Air Contaminant,
was written and revised numerous times as a result of public
comments received during several public comment periods, and
public workshops conducted on April 21, 1993, May 20, 1994,
and March 7, 1996. This current version is being made available
to the public for a seventh comment period. No control measures
are being proposed in this report. The Scientific Review Panel
has approved the report and prepared Findings which are included
in the Staff Report/Executive Summary. The report will be presented
to the Air Resources Board at a public hearing on April 24,
1997. If the Air Resources Board approves the report
and identifies inorganic lead as a toxic air contaminant, the
information in the report may become part of an evaluation to
determine the potential need for and the development of control
measures. Any consideration of potential control measures will
be conducted through a full public participatory process, including
public comment periods and workshops. In preparing this report,
we reviewed pertinent literature through May 1996.
Preface*
The Air Resources Board (ARB) has reviewed the Staff Report
and the Scientific Review Panel's (SRP) Findings in the matter
of the Proposed Identification of Inorganic Lead as a Toxic
Air Contaminant. On this review, the ARB acknowledges and
agrees with the SRP and the ARB and Office of Environmental
Health Hazard Assessment staff that uncertainty exists when
dealing with the quantitative correlation of potential health
effects (neurodevelopmental effects in children, cardiovascular
effects in adults, and potential carcinogenicity) at exposure
to low levels of air concentrations of inorganic lead.**
The information contained in this report form the basis for
the identification of inorganic lead as a Toxic Air Contaminant.
No controls or risk management decisions are made in this report.
As risk management guidelines are developed, the uncertainties
will be taken into account and the science updated as appropriate.
Further, given the complexity of the models and the limitations
of interpretation of the tests of Intelligence Quotient (IQ)
used to correlate the neurodevelopmental effects to low air
concentrations of air lead, the reader needs to be aware that
the fractional (IQ) measurements related to the low statewide
ambient air lead concentrations are given as an example of directional
effects and involves uncertainty and should not be viewed as
definitive.
This preface is not intended in any way to modify the SRP's
Findings on the inorganic lead report. In addition, this preface
was not reviewed or accepted by the SRP.
* Added by the Air Resources
Board at its April 24, 1997 hearing in response to public comment.
** Low levels of air concentrations
of inorganic lead means average ambient air measurements. The
statewide population-weighted average is estimated to be 0.02
micrograms per cubic meter based n data collected in 1994-95.
INITIAL STATEMENT OF REASONS FOR RULEMAKING
STAFF REPORT/EXECUTIVE SUMMARY
What is the Initial Statement
of Reasons for Rulemaking?
This report is a summary of the information used by the members
of the Air Resources Board (ARB or Board) to determine if inorganic
lead should be listed as a toxic air contaminant (TAC). The
Board will consider the identification of inorganic lead as
a TAC at a public hearing in April 1997, in accordance with
California Health and Safety Code section 39662.
What is Contained in the Initial
Statement of Reasons for Rulemaking?
The Initial Statement of Reasons for Rulemaking for the Proposed
Identification of Inorganic Lead as a TAC consists of a Staff
Report/Executive Summary (which summarizes the scientific basis
for the proposed regulation), a discussion of the environmental
and economic impacts of the proposal, the Findings of the Scientific
Review Panel (SRP), and the Proposed Regulation Order.
What is Contained in This Report?
This report consists of a Staff Report/Executive Summary which
summarizes the scientific basis for the proposed regulation
to identify inorganic lead as a TAC, and Parts A, B, and C of
the Technical Support Document. Inorganic lead consists of lead
compounds that do not contain carbon and includes metallic or
elemental lead. Part A, prepared by the ARB staff, is an evaluation
of emissions of inorganic lead, ambient and indoor concentrations,
statewide population exposure, and atmospheric persistence and
fate. Part B, prepared by the Office of Environmental Health
Hazard Assessment (OEHHA) staff, assesses the health effects
of inorganic lead. Part C consists of copies of the public comments
received on the previous draft versions of the report, and the
ARB/OEHHA staff responses.
What is a Toxic Air Contaminant (TAC)?
According to section 39655 of the California Health and Safety
Code, a toxic air contaminant is "an air pollutant which
may cause or contribute to an increase in mortality or an increase
in serious illness, or which may pose a present or potential
hazard to human health." In addition, substances which
have been listed as federal hazardous air pollutants (HAPs)
pursuant to section 7412 of Title 42 of the United States
Code are TACs under the state's air toxics program pursuant
to section 39657 (b) of the California Health and Safety Code.
The Board formally made this identification on April 8, 1993
(Title 17, California Code of Regulations, section 93001).
Lead compounds (which include organic and inorganic lead compounds)
are listed as HAPs and, therefore, were identified as TACs on
April 8, 1993. However, the federal HAPs list does not include
elemental lead in the definition of lead compounds. Elemental
lead is included in the ARB/OEHHA definition of inorganic lead
and is therefore being considered for identification under the
state's air toxics identification program.
What is the California Program for Identification and Control of TACs?
This program is required by a California law which took effect
in 1984 (AB 1807, Tanner, Chapter 1047, statutes of 1983, Health
and Safety Code sections 39650-39674). This statute created
a comprehensive program administered by the ARB to address the
adverse public health impacts caused by emissions of toxic substances
to the ambient air.
The program consists of a two-phase process which separates
risk assessment (identification) from risk management (control).
During the identification phase, a report is developed which
determines whether there are potential adverse health effects
from substances in consideration of the quantities of their
emissions and human exposure in California. If the Board formally
identifies a substance as a toxic air contaminant, it enters
the risk management phase. In the risk management phase, the
ARB staff determines the need for and appropriate degree of
controls in consideration of cost and potential health benefits.
Both the identification phase and control phase are open public
processes in which the ARB staff actively seeks industry and
public participation.
What are the Requirements of
the Health and Safety Code Sections 39660 - 39662 for Identification
of Substances as TACs?
Health and Safety Code section 39660 (f) requires that the
following criteria to prioritize compounds for evaluation as
possible TACs: 1) risk of harm to public health, 2) amount or
potential amount of emissions, 3) manner of, and exposure to,
usage of the substance in California, 4) persistence in the
atmosphere, and 5) ambient concentrations in the community.
In consultation with the OEHHA staff, the ARB staff prepares
a report that serves as the basis for regulatory action. Health
and Safety Code section 39660 requires that, upon the request
of the ARB, the OEHHA evaluates the health effects of a potential
toxic air contaminant while the ARB evaluates the exposure data
associated with it.
The ARB's exposure assessment is based, to the extent available,
upon research and monitoring data, emissions inventory data,
toxic chemical release data, and information on estimated actual
exposures from data on ambient and indoor air environments [Health
and Safety Code section 39660(f)].
The OEHHA's health evaluation includes an assessment of the
availability and quality of data on health effects, including
potency and mode of action. Where it can be established that
a threshold of adverse health effects exists, the estimate must
include a safe exposure level and an explanation of the uncertainties
of the data. If there is no threshold of significant adverse
health effects, a range of risk for exposure is determined.
The report, together with the scientific data on which the
report is based, is made available to the public and is formally
reviewed by the Scientific Review Panel (SRP or Panel) pursuant
to Health and Safety Code section 39661. The SRP reviews scientific
procedures and methods used to support the data, the data itself,
and the conclusions and assessments on which the report is based.
The SRP submits its findings on the report, and may reject the
report if the SRP finds it to be seriously deficient. If so,
the report is revised by the staff and again reviewed by the
Panel. Subsequent to the SRP review, the Board conducts a public
hearing to determine, based on the staff's report and the SRP
findings, if a substance should be listed as a TAC. If the Board
decides to list the substance as a TAC, it is added to section
93000 of the California Code of Regulations.
What is Inorganic Lead?
Lead (Pb) is a bluish gray metal that occurs naturally in various
mineral forms in the earth's crust. It has been widely used
for hundreds of years because it is readily shaped and molded,
and is resistant to corrosion. "Organic lead" refers
to lead compounds which contain carbon; "inorganic lead"
refers to those substances that do not contain carbon and includes
metallic lead. This report focuses on inorganic lead compounds
because the most significant outdoor exposure in California
is from inorganic lead particulate matter. For the purposes
of this report, inorganic lead and lead are used interchangeably.
Is There a Concern for Exposure to Inorganic Lead in California?
Yes. California is in attainment (average ambient air measurements
are well below the federal and state ambient air quality standards)
for lead. However, new information has been reported on the
health effects of lead since the adoption of the ambient air
quality standards approximately 20 years ago. Lead is now
considered a potential human carcinogen. However, neurodevelopmental
effects in children and increases in blood pressure and related
cardiovascular conditions in adults are more significant health
concerns from ambient air lead exposure than cancer. Furthermore,
it is now known that these effects can occur from exposures
below the ambient air quality standard. Therefore, although
at current average ambient levels, air lead is a minor contributor
to children's exposure,ambient and near-source exposures
may still present a potential public health concern. This report
contains the technical information which serves as the basis
for consideration of inorganic lead as a TAC under state law.
What are the Sources of Inorganic Lead Emissions?
The major sources of outdoor emissions in California include:
stationary point and area source fuel combustion, aircraft fuel
combustion, industrial metal melting, autobody refinishing,
cement manufacturing, and incineration. Also, inorganic lead
emissions may deposit and accumulate in soil for many years.
These lead-contaminated particles including dust particles can
be re-entrained (resuspended) by wind and agricultural activities.
How Much Inorganic Lead is Released into California's Air?
Based on information from local air pollution control districts
and surveys conducted by the ARB staff, an estimated 175 to
182 tons of inorganic lead are directly emitted to California's
atmosphere each year. We estimate that sources of aircraft fuel
combustion emit 149 tons per year, and non-ferrous and
ferrous metal melting facilities emit approximately 6 tons per year.
The ARB staff estimates that re-entrained
lead contributes approximately 390 tons of lead per year to
California's atmosphere. Most of the lead emitted into ambient
air is expected to be associated with particles smaller than
10 micrometers in size; however, resuspended dust may also have
particles greater than 10 micrometers. Particles less than 10
micrometers in size are of health concern because of their ability
to bypass the body's natural defense systems and their potential
for long residence time in the lung. Although particles greater
than 10 micrometers may not be respirable, they are also of
health concern because they may be inhaled and swallowed or
can deposit on food or water which could ultimately lead to
ingestion.
Are Emissions of Inorganic Lead
Expected to Change in the State?
At this time, the ARB staff do not have sufficient information
to determine whether overall emissions in California will increase
or decrease. Emissions from nonferrous metal melting facilities
have decreased (as demonstrated by near source ambient air monitoring)
since the adoption of an air toxic control measure (ATCM)
adopted by the Board in January 1993. Re-entrainment of lead
from soil dust is expected to decrease because of the removal
of lead from fuel. Emissions from cement manufacturing may increase
because manufacturers may use tires which contain lead, as a
new source of fuel for cement kilns.
In January 1992, remaining lead additives used in fuels were
banned for use in on-road vehicles in California. Consequently,
emissions of lead from this source category will be virtually
eliminated. Nationally, the federal Clean Air Act prohibited
the use of leaded fuel in on-road vehicles after December 31,
1995. However, both in California and nationally, leaded fuel
may still be used in aircraft. In addition, off-road vehicles
such as pleasure-craft and farm implements may also use leaded
fuel; however, these vehicles are expected to obtain fuel from
the same fuel distribution system as on-road vehicles.
What are the Ambient Outdoor
Air Concentrations of Inorganic Lead?
The ARB staff's detailed analysis of the ambient outdoor concentrations
of inorganic lead are based on data collected in 1990-91 from
the ARB's criteria pollutant monitoring network. Mean annual
concentrations ranged from a minimum of 0.02 micrograms per
cubic meter to 0.12 micrograms per cubic meter. The statewide
population-weighted exposure is estimated to be 0.06 micrograms
per cubic meter. The ARB staff also reviewed ambient monitoring
data immediately after the January 1992 full ban (January to
June 1992) of lead in automobile fuel. It shows a range of mean
concentrations from 0.01 to 0.08 micrograms per cubic meter.
It is expected that more recent measurements of ambient
concentrations of lead are lower. Further updates of ambient
concentrations will be conducted after inorganic lead is identified
as a toxic air contaminant by the Board.
Are There Near-Source Exposures
to Inorganic Lead in California?
Yes. Measurements made by the South Coast Air Quality Management
District (SCAQMD or District) of ambient air concentrations
of lead near two secondary lead recycling facilities were used
to assess the potential impact of emissions on the nearby populated
areas in the South Coast Air Basin. In 1992, measurements taken
less than two kilometers from these facilities have shown average,
monthly ambient lead concentrations as much as 52-fold higher
near one of the facilities than the South Coast Air Basin mean
annual ambient lead concentration of 0.07 micrograms per cubic
meter. This 52-fold value is the highest average monthly ambient
lead concentration and was measured at a monitoring site located
in a local railroad yard, approximately one mile away from a
residential area, during a period of construction at the facility.
This measurement downwind of the facility was more than double
the state standard of 1.5 micrograms per cubic meter averaged
over 30 days.
In 1992, the District adopted a rule to reduce emissions of
lead from stationary sources, Rule 1420 - Emission Standards
for Lead. Using a conservative modeling approach, the SCAQMD
estimated that a facility which emits 0.5 pounds per day of
inorganic lead has the potential to exceed the state's ambient
air quality standard for lead of 1.5 micrograms per cubic meter
for a 30-day period. Rule 1420 requires facilities that use
or process more than two tons of lead per year, and have maximum
daily lead emissions of 0.5 pounds per day or more, to install
or upgrade emission controls on equipment and processes to certain
specifications. The District estimated that approximately 125
facilities have emissions at this rate or greater, and it requires
these facilities to conduct modeling or monitoring to ensure
that the remaining emissions do not exceed the state ambient
air quality standard. The rule also requires facilities to practice
good housekeeping to minimize lead emissions from fugitive dust
sources. As a result of SCAQMD's monitoring, these two secondary
lead recycling facilities have taken steps to reduce emissions
and significant reductions in ambient air concentrations have
been observed. Recent data taken near the facilities have shown
annual average concentrations on the order of 0.24 micrograms
per cubic meter.
The ambient measurements reflect the following: emissions from
the secondary lead recycling facilities including the construction
activities at one of the facilities, lead contributed from other
sources, and re-entrained lead from surface deposition. The
SCAQMD samplers were placed as near as possible to the expected
site of maximum ground level concentration. Monthly means were
measured. The results do not represent maximum annual concentrations
because of frequent variations in local meteorology and because
samples were not collected daily.
Is There Evidence of Indoor
Air Exposure to Inorganic Lead?
Yes. However, indoor concentrations of airborne lead are typically
lower than outdoor concentrations. Most of the lead present
in the indoor air of non-occupational environments appears to
result from the infiltration of lead particles from outdoor
air. However, certain activities that disturb lead-based paint,
such as remodeling or paint removal, can release large amounts
of lead-bearing particles into the air. Lead was a major ingredient
in many types of house paint prior to the 1950s. In the early
1950s, other pigment materials gained popularity, but lead compounds
were still used in some pigments and as drying agents. Lead
has been banned for use in residential paint since 1978 but
remains on interior and exterior surfaces of an estimated 8.6 million
housing units in California. Of the 8.6 million housing units
built before 1978 in California, 2.2 million homes were built
before 1950 and are likely to contain lead-based paint. Lead-based
paint, however, is still allowed to be used in industrial, military,
and marine applications. Other potential sources of lead in
indoor air are re-suspension of lead-bearing dusts, second-hand
smoke, and certain hobbies that use melted lead or lead
glazes.
Are There Other Routes of Exposure
to Inorganic Lead?
Yes. Inorganic lead may be present in air, water, soil, foods,
consumer products, dust and lead-based paint chips. While this
document is especially concerned with the impact of airborne
inorganic lead, at current ambient concentrations, air lead,
on average, is a minor contributor to a child's overall lead
exposure. People may be exposed to particulate lead emissions
when the lead settles onto water, soil, vegetation, and other
surfaces which are ingested or upon contact, absorbed through
the skin. Lead particulate matter is the primary form of lead
present in the air. Once absorbed, lead is distributed throughout
the body.
The greatest source of waterborne human exposure is drinking
water contaminated with lead which is leached from plumbing.
Currently, the national action level for lead in drinking water
is 15 parts per billion. Nationwide, public water agencies are
required to evaluate households with tapwater concentrations
exceeding 15 parts per billion of lead for repair. People may
also be exposed to lead when plants that take up lead from the
soil are consumed. The United States Environmental Protection
Agency (U.S. EPA) reports that the typical soil lead "background"
concentration is about 15 milligrams per kilogram or parts per million (ppm);
however, soils near emissions
sources may have concentrations 100-fold higher or more. In
1982, soil samples collected throughout the San Joaquin Valley
had lead concentrations ranging from 3 to 99 milligrams
per kilogram or ppm with a mean of 17 milligrams per kilogram
or ppm. The U.S. EPA has also reported that livestock forage
located 25 meters from roads with high-traffic density have
shown lead concentrations ranging from 20 to 950 milligrams
per kilogram or ppm. Lead solder in food containers can be another
source of exposure to lead. However, only approximately one
percent of canned goods currently use lead solder.
Most cases of chronic lead poisoning in children result
from the ingestion of lead-based paint and contaminated soil.
Lead poisoning can also occur in some ethnic cultures as the
result of the use of traditional medicines containing high concentrations
of lead. The greatest opportunity for lead-based paint exposure
occurs when painted surfaces are refinished or remodeled. The
federal Department of Housing and Urban Development initiates
lead abatement in public housing where lead concentrations are
above 5,000 milligrams per kilogram or ppm in the paint.
In a study of about 1,000 homes in Oakland, Sacramento, and
Los Angeles, approximately 25 percent of the households had
lead concentrations of 5,000 milligrams per kilogram or ppm
or above in the paint. Homes built prior to 1950 may contain
paint with lead concentrations as high as 500,000 milligrams
per kilogram or ppm (50 percent lead). In 1978, the Consumer
Products Safety Commission limited the manufacture of lead-based
paint.
What is the Persistence of Inorganic
Lead in the Atmosphere?
Particles which contain inorganic lead are expected to have
an atmospheric lifetime of up to 30 days. As mentioned previously,
inorganic lead is emitted and atmospherically transported in
the form of small particulate matter (less than 10 micrometers
in diameter). Many factors, such as physical characteristics
and meteorological conditions, affect the lifetime of lead in
the atmosphere. The primary mechanisms for removal of inorganic
lead particulate matter from the atmosphere are wet and dry
deposition. After removal from the atmosphere and being deposited
on the ground and soil, inorganic lead may be re-entrained into
the atmosphere by wind and traffic.
What are the Health Effects
of Inorganic Lead Exposure?
The health effects of inorganic lead have been reviewed and
evaluated to determine whether inorganic lead may cause or contribute
to an increase in mortality or serious illness. Based on current
knowledge, adverse health effects that may occur at relatively
low blood lead concentrations include: (1) neurodevelopmental
effects in children, (2) increased blood pressure
and related cardiovascular conditions in adults,
and possibly (3) cancer. Of these three outcomes,
the neurodevelopmental effects may be of greatest public health
significance since a large number of children could be affected,
no threshold has been clearly identified, and the effects may
be irreversible.
Neurodevelopmental Effects of Lead Exposure in Children
At very high blood lead concentrations (80 micrograms per deciliter
and above in children), lead causes encephalopathy (brain damage)
and an associated high risk of death. Many children with blood
lead levels in this range, with or without evidence of encephalopathy,
experience permanent neurological damage such as severe mental
retardation and recurrent convulsions.
At low blood lead concentrations, several carefully conducted
prospective human epidemiological studies have shown an association
between general measures of intelligence and both pre-
or post-natal blood lead concentrations. Studies of effects
at earlier ages appear stronger and more consistent than effects
from pre-natal exposures. Based on these studies, a blood lead
level of 10 micrograms per deciliter has been identified by
the U.S. Centers for Disease Control (CDC) as the level
of concern for children.
Based on these findings, the OEHHA staff concurs with the U.S.
EPA, the CDC, and the National Academy of Sciences that 10 micrograms
per deciliter should be regarded as the level of concern for
children. A no observed adverse effect level (NOAEL) has not
yet been clearly identified, and an analysis, specifically focusing
on the determination of a threshold, was unable to detect one.
Increase in Blood Pressure and Related Cardiovascular Conditions
in Adults
Lead in the environment, including the occupation setting,
has also been correlated with increased blood pressure and related
cardiovascular effects in adults. Several large population-based
studies have examined the relationship between blood lead and
either systolic or diastolic blood pressure. A relationship
between systolic and diastolic blood pressure and blood lead
has been reported over a wide range of blood lead levels as
low as 4 micrograms per deciliter for middle-aged Caucasian
men, with some studies reporting evidence of effects in women,
other races, and other age groups.
Cancer
Lead can cause gene mutations and cell transformation in mammalian
cells in culture. Lead also interferes with DNA synthesis in
mammalian cell in culture. Many studies have shown that feeding
lead compounds to rodents induces kidney tumors. Available epidemiologic
studies of people occupationally exposed to lead give some indication
that occupational exposure to lead may cause cancer. However,
in these studies, lead was only one of several known or putative
carcinogens present in the occupation environment.
The International Agency for Research on Cancer (IARC) has
placed lead in Class 2B, possibly carcinogenic to humans, based
on sufficient evidence of carcinogenicity from oral exposure
studies in animals and inadequate evidence of carcinogenicity
in humans. Likewise, the U.S. EPA has placed lead in Group B2,
probable human carcinogen, based on sufficient evidence of carcinogenicity
from oral exposure studies in animals and inadequate or no data
from epidemiological studies.
What is the Risk Assessment
for Exposure to Inorganic Lead?
The OEHHA has conducted a risk assessment for the three adverse
health effects that may occur at relatively low blood lead concentrations:
neurodevelopmental effects in children, increased blood pressure
and related effects in adults, and possibly cancer. Since our
understanding of lead's toxicity is based on blood lead levels,
OEHHA also examined the relationship between lead in air and
lead in blood.
Evaluation of Blood Lead/Air Lead Slope
Existing studies indicate a consistent association between
ambient concentrations of lead in the air and subsequently measured
blood lead levels in children and adults. The OEHHA used these
studies as the basis for an "aggregate" model which
quantitatively relates exposures from ambient air lead concentrations
to blood lead levels, both directly through inhalation and indirectly
through other media impacted by airborne lead, such as soil
and household dust. With this aggregate model, risks could be
estimated that relate different levels of ambient air lead to
potential adverse neurodevelopmental outcomes. Current evidence
suggests that the blood lead to air lead relationship for adults
is approximately 1.8 micrograms per deciliter per 1 microgram
per cubic meter, while the relationship for children is approximately
4.2 micrograms per deciliter per 1 microgram per cubic meter
with a reasonable range of 3.3 to 5.2 micrograms per deciliter
per 1 microgram per cubic meter. These slopes are assumed to
be linear within the range of blood and air concentrations currently
experienced in California.
Impact of Air Lead on Distribution of Blood Lead Levels
The health impacts of airborne lead were evaluated in two ways.
First, OEHHA used the aggregate model discussed above to relate
changes in air lead to changes in blood lead. Second, OEHHA
used a model developed by the U.S. EPA called the Integrated
Exposure Uptake Biokinetic (IEUBK) model. The IEUBK can incorporate
both direct and indirect pathways of exposure. Model outputs
from the IEUBK vary with initial air concentration and baseline
levels of dust and soil lead.
Data from the third National Health and Nutrition Examination
Survey (NHANES III), representative of the U.S. population,
were used to estimate the current blood lead distributions for
residents of California. The effects of changes in air lead
on the distribution of blood lead for the subgroup of children
with the highest mean blood lead levels, one and two year old
children, were determined. Using both the aggregate and IEUBK
models, OEHHA estimates that exposure to the 1990-91 ambient
airborne lead concentration of 0.06 micrograms per cubic meter may
elevate between 0.6 percent and 2.3 percent of the population
of one- and two-year-old children above the 10 micrograms per
deciliter level of concern. With an estimated 1.2 million
one and two year old children in California, this represents
between 7,200 and 27,600 children that are predicted to
be above the 10 micrograms per deciliter blood lead level of
concern. In addition, based on current estimates on the distribution
of blood lead levels, 131,000 one- and two-year-old children
who are estimated to already be at or above 10 micrograms
per deciliter (even at zero air lead) could be additionally
impacted. At a hypothetical elevated exposure, an air lead concentration
of 0.20 micrograms per cubic meter could cause an additional
3 percent of the children exposed on average to this air lead
level, to exceed the level of concern in a localized area.
Neurodevelopmental Effects Risk Assessment
For neurodevelopmental effects of lead, the results of the
prospective cohort studies indicate a potential mean decrease
of 1.39 IQ points per microgram per cubic meter of air lead.
Applying this mean change to the cohort of 4.73 million children
in California below the age of 7 suggests that the 1990-91 ambient
lead concentration of 0.06 micrograms per cubic meter is associated
with a potential decrease of 392,000 IQ points or, a mean decrease
of 0.08 IQ points per child. A small difference in a mean score
between two groups can result in large differences in the proportion
of the population at extreme values, since the entire distribution
is shifting. The percentage of children with IQ scores equal
to or less than 80 is predicted to increase from 10.56 percent,
at a zero air lead concentration, to 10.66 percent at an air
lead concentration of 0.06 micrograms per cubic meter. This
represents a relative increase in the number of such children
of approximately one percent (i.e., (10.66-10.56)/10.56 x 100).
Based on a cohort of 4.73 million children in California
below age 7, the 0.06 micrograms per cubic meter average air
lead concentration relates to approximately 4,700 additional
children that would be predicted to have IQ levels below 80,
relative to a zero air lead level. Each subsequent year, the
model estimates an additional 780 children to have IQ levels
below 80. At a hypothetical elevated concentration of
0.20 micrograms per cubic meter, above the current ambient average,
would theoretically result in an average decrease of 0.28 IQ
points in exposed children. A 0.28-point shift in mean IQ would
correspond to a relative increase of approximately three percent
in the number of children with scores below 80 (i.e., (10.97-10.66)/10.66
x 100).
Increase in Blood Pressure and Related Cardiovascular Effects
Risk Assessment
Exposure to air lead has been associated with an increase in
blood pressure and related cardiovascular effects, including
hypertension. The document quantifies the risks for blood pressure
changes in adults associated with changes in ambient air lead
concentrations. Our model estimates increases in the diastolic
blood pressure and how the increases may result in hypertension
(increase in the diastolic blood pressure greater than or equal
to 90 millimeters of mercury), heart attacks, or mortality.
These effects are based on epidemiologic studies from which
it is generally difficult to prove causality. Therefore, controversy
remains about the precise magnitude of the effect of blood lead
on cardiovascular disease.
The estimates from our model indicate that the 1990-91 average
ambient air lead concentration of 0.06 micrograms per cubic
meter may account for 26,000 cases of hypertension (95 percent
confidence interval is 6,100 to 60,800) among 3.96 million California
adults aged 40 to 59. In addition, the 1990-91 ambient
air lead levels may result in 72 additional fatal and
non-fatal heart attacks and coronary heart disease deaths (95
percent confidence interval is 12 to 164) and 74 additional
deaths (95 percent confidence interval is 9 to 218) per year
among 7.92 million adults in California aged 40 to 59
(See Table 1 of the attached SRP Findings). Although some
of the health outcomes are derived from nonlinear models, linear
approximations fit the data reasonably well over ranges seen
in California, and can be used to estimate the impacts of changes
in air lead concentrations or diastolic blood pressure.
Cancer Risk Assessment
The OEHHA staff performed a quantitative estimate of unit cancer
risk from inorganic lead. This estimate of unit cancer risk
was based on data from oral exposure studies in rodents because
there are inadequate data in humans. By extrapolation of rodent
data (from animals to humans and from ingestion to inhalation),
the OEHHA determined a range of unit cancer risk values for
humans and also a best value of unit cancer risk. From the available
studies on inorganic lead, the range of unit cancer risk is
1.2 x 10-5 to 6.5 x 10-5 per microgram
per cubic meter for a lifetime exposure to 1 microgram per cubic
meter of lead based on the no identifiable threshold assumption
for lead-induced carcinogenicity and using the linearized multistage
model. The best value of 1.2 x 10-5 per microgram
per cubic meter, based upon the latest and best animal study
data set, can be used for quantitative cancer risk assessment.
Using the OEHHA staff's range of risk values and the 1990-1991
statewide mean annual population-weighted exposure of 0.06 micrograms
per cubic meter, exposure to this level of inorganic lead could
result in 0.7 to 4 potential cancer cases per 1 million people
exposed by direct inhalation for a 70-year lifetime. Based on
a population of 34 million, it is estimated that the cancer
burden for California residents may be approximately 24 to 136
potential excess cancer cases statewide (assuming a lifetime
of exposure) from direct inhalation only. Using the OEHHA staff's
best value of 1.2 x 10-5 per microgram per cubic
meter, exposure to ambient inorganic lead may result in 0.7
potential cancer cases per 1 million, with a cancer burden of
24 among the 34 million residents of California. This estimate
represents the upper range of plausible excess cancer risk and
the potential number may be significantly lower and possibly
zero if a threshold mechanism exists for lead-induced carcinogenicity.
A multipathway risk assessment which includes risk impacts from
dust and soil contamination would increase the risk estimate.
Table 2 of the attached SRP Findings shows a comparison of the
inorganic lead cancer potency with other compounds the Board
has identified as TACs.
What are the Uncertainties Associated
with the Risk Assessments?
Unlike most toxicological
risk assessments and previous assessment of TACs, most of our
conclusions are based on human studies except those for cancer.
The uncertainties in the risk assessments for adverse neurodevelopmental
effects and increased blood pressure are considered to be much
less than those for the cancer endpoint. Four major uncertainties,
usually encountered in cancer risk assessments, are those due
to (1) animal-to-human extrapolation, (2) high-to-low dose extrapolation,
(3) accounting for sensitive members in the human population,
and (4) small numbers of subjects. Regarding animal-to-human
extrapolation, the cancer effect results from oral exposure
studies in animals are extrapolated to derive an inhalation
unit risk for humans.
For the noncancer endpoints from lead exposure, the data used
were obtained in humans so that uncertainty introduced by extrapolation
is not an issue. The second concern, the degree of uncertainty
introduced by extrapolation from high to low doses, is small
for the noncancer endpoints and several orders of magnitude
for the cancer effects. Only limited extrapolation is necessary
for the noncancer effects, since most results have been obtained
at blood lead levels within a factor of two to five of the current
estimated mean blood lead levels in California.
The third source of uncertainty, differential sensitivity in
the population, is relativity small for adverse neurodevelopmental
effects and increased blood pressure, since sensitive individuals
were considered within the studies evaluated. The fourth source
of uncertainty, arising from the small numbers of subjects evaluated
in the animal cancer studies, is relatively insignificant for
the noncancer health effects. For the noncancer health effects
of lead, there are multiple studies on neurodevelopmental effects
and more than 10,000 adults in the blood pressure studies. Consequently,
the uncertainty in the noncancer risk assessment for lead is
small relative to that usually encountered in risk assessments
for toxic chemicals including the lead cancer risk assessment
for this document.
The risk and potential health impact calculations should not
be interpreted as precise measurements or probabilities of mortality
or morbidity associated with exposure to inorganic lead. Although
based upon the best available scientific data, the calculations
are derived from models which contain many assumptions and uncertainties.
Uncertainty is inherent in the application of relatively small
changes in the blood lead levels and associated physiological
or neurological effects to large populations assumed to be exposed
on average to the California's average ambient air lead level.
The risk estimates are useful in providing a perspective and
appreciation for the potential magnitude and severity of individual
health threats and populations impacts.
Is There a Threshold Level for Inorganic Lead?
Based on information available, there is no clearly established
threshold level for lead-induced toxicity. Therefore, should
inorganic lead be identified as a TAC, it is recommended that
a qualifying statement be included which indicates there currently
is no evidence of an identified threshold for neurotoxicity,
increased blood pressure and related cardiovascular effects,
or possible carcinogenicity.
What has been Done to Reduce
Exposure to Inorganic Lead?
The state has taken a number of actions to reduce exposure
to lead in California. In November of 1970, California adopted
an ambient air quality standard for lead based on a 30-day running
average of 1.5 micrograms per cubic meter. The state standard
is a monthly average as contrasted to the 1978 federal standard
of 1.5 micrograms per cubic meter averaged over a calendar quarter.
The 1978 federal standard of 1.5 micrograms per cubic meter
is based on preventing children from exceeding a blood lead
level of 30 micrograms per deciliter of blood.
In the early 1970's, this standard was exceeded in many areas
of the state. However, emissions of lead into ambient air from
mobile sources have decreased significantly since 1975 because
of regulations phasing out the use of lead in fuel with the
introduction of catalyst-equipped vehicles. Between 1978 and
1987, the consumption of leaded-gas decreased by 90 percent
and total lead emissions were reduced by 94 percent. As a result
of these regulatory efforts, the state is now in attainment
of the state and federal ambient lead standards at all of our
ambient monitoring locations. In January 1992, the ARB regulation
prohibiting the sale of leaded fuel for on-road motor vehicle
use went into effect. These regulations are estimated
to have virtually eliminated statewide lead emissions from on-road
motor vehicles.
In January 1993,
the Board also adopted an air toxic control measure that reduces
emissions of toxic metals from nonferrous metal melting
facilities such as smelters, foundries, die casters, and galvanizing
operations. As a side benefit, emissions of lead from nonferrous
metal melting operations is expected to have been reduced
by 45 percent. The control measure was written specifically
to address emissions of arsenic, cadmium, and nickel which all
have previously been identified as TACs in California. This
control measure is expected to have reduced emissions of lead
from nonferrous metal melting facilities in the South Coast
Air Basin and should reduce ambient air lead levels in the immediate
vicinity of the facilities implementing the required controls.
The emission reductions have been achieved by collecting emissions
from furnace and casting operations and ducting them to best
available equipment for control of particulate emissions, and
by requiring control of fugitive emissions.
Further, as discussed on page 5, in 1992 the SCAQMD adopted
Rule 1420 to require that facilities do not release emissions
beyond the property line of the facility which cause ambient
concentrations of lead to exceed the state ambient lead standard.
According to the SCAQMD staff, this rule is expected to reduce
lead emissions by nearly 80 percent, which corresponds to 10.5
tons.
In addition to the air toxic control measure and Rule 1420,
several other programs may have contributed to emission reductions
of inorganic lead. As part of the Air Toxics "Hot Spots"
Information and Assessment Act (AB 2588), the ARB staff is aware
that a number of facilities have taken voluntary steps to reduce
emissions of air toxics. This may also be the case for facilities
subject to Proposition 65 (California's Safe Drinking Water
and Toxic Enforcement Act of 1986), and Superfund Amendments
and Reauthorization Act of 1986 (SARA) Title III requirements
(Emergency Planning and Community Right-to-Know Act). However,
comprehensive information on voluntary emission reductions as
a result of these other programs is not available.
Also, the ARB and the OEHHA staff have participated in the
Environmental and Consumers Sources Workgroup for the development
of the Strategic Plan to Eliminate Lead Poisoning in California
which is being lead by the California Department of Health Services.
The purpose of the workgroup was to develop goals, problem statements,
and strategies for the elimination of lead poisoning in waste
disposal, air, water, and consumer products. The plan is nearing
completion of public comment and is expected to be implemented
in the future.
How Does This Information Affect
Proposition 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition
65) differs and is separate from the toxic air contaminant program.
Proposition 65 requires a person to warn if he/she cannot show
that exposures caused in the course of doing business, (1) by
carcinogens on the Proposition 65 list pose no significant cancer
risk or (2) by male and female reproductive toxicants or developmental
toxicants on the Proposition 65 list have no observable effect
assuming exposure at one thousand times the level in question.
A specific reference
exposure level for reproductive effects has not been developed
in the toxic air contaminant program. The Proposition 65 safe
harbor level for the reproductive effects of lead is not affected
by this review.
The range of cancer unit risk developed for the toxic air contaminant
program is for inhalation of inorganic lead (Title 22, California
Code of Regulations, Section 12705). Under Proposition 65 no
significant risk levels (for cancer) have been adopted for lead
acetate and lead subacetate. These values, which currently apply
to both inhalation and ingestion, will be reconsidered and modified
as appropriate should inorganic lead, under this program, be
identified as a toxic air contaminant.
How May Risk Managers Use This
Information?
The aggregate model presented in the document is a useful tool
to determine the potential impact of an airborne lead concentration
on the population percentage or number of children that may
exceed the CDC guidelines of 10 micrograms per deciliter. However,
due to the multiple sources of lead exposure and the inter-relationship
of the various media, risk managers may need to examine all
sources of lead to determine the most effective manner to reduce
childhood blood lead levels for a given community. The IEUBK
model, which can incorporate local inputs from field measurements,
may provide useful information when considering various mitigation
strategies. Further risk management guidance in this area is
recommended to be developed by ARB staff, with the assistance
of OEHHA staff. This guidance would contain any updated statewide
population-weighted concentrations.
Has the Staff Conducted an Assessment of the Economic Impacts?
Based on the evidence available, the identification of inorganic
lead as a TAC will not require any private person or business,
including any small business, to incur any cost in reasonable
compliance with the proposed action. If, and when, the need
and appropriate degree of control for inorganic lead are considered
by the ARB during the risk management process, all costs of
compliance will be described and considered. The reasons that
the identification of inorganic lead as a TAC is not anticipated
to have any adverse economic impacts on businesses are discussed
below.
The recommended OEHHA cancer risk number for inorganic lead
is approximately seven times lower than the cancer risk
number that has been used historically by the local air pollution
control districts and the California Environmental Protection
Agency for cancer risk assessments. Therefore, the ARB does
not anticipate any adverse economic impacts on businesses. For
noncancer, the ARB and the OEHHA staff propose to develop, in
a full open public process, further risk management guidance
in this area.
Why Does the Staff Recommend Inorganic Lead be Identified
as a TAC?
The staff of the ARB and the OEHHA have reviewed the available scientific evidence
on the presence of inorganic lead in the atmosphere of California
and its potential adverse effect on public health. The staff
has found that lead is emitted from a variety of sources, is
found throughout California in ambient air, is persistent in
the environment, and may be re-entrained in the atmosphere.
Inorganic lead has been associated with many different health
effects which include neurodevelopmental effects in children,
increases in blood pressure and related cardiovascular conditions
in adults, and possibly cancer. Both the U.S. EPA and IARC have
concluded that, based on oral exposure studies in laboratory
animals, inorganic lead is a potential carcinogen. Based on
neurotoxicity, increases in blood pressure and related cardiovascular
effects, and potential human carcinogenicity, the OEHHA staff
has found that, inorganic lead has the potential to be an air
pollutant that may cause or contribute to an increase in mortality
or an increase in serious illness, or that may pose a present
or potential hazard to human health. Therefore, the OEHHA staff
and the ARB staff conclude that inorganic lead meets the definition
of a TAC supported by the findings of neurotoxicity, increases
in blood pressure and related cardiovascular effects (increased
risk for fatal and nonfatal myocardial infarction, death from
coronary heart disease), carcinogenicity, and direct human exposure.
Commencing in the late 1970's, there has been substantial reduction
in exposure to lead from environmental sources. On a nationwide
basis, from 1976 to 1990, the amount of lead used in gasoline
decreased 99.8 percent. The use of lead soldered food and drink
cans has declined substantially from nearly 50 percent in 1980
to approximately 1 percent today. The manufacture of lead-based
paint was limited by the Consumer Products Safety Commission
in 1978. In California, the annual average ambient air lead
levels have declined approximately 30-fold from the mid-1970's.
Similarly, cross section national surveys conducted by the CDC
indicate a dramatic decline in blood lead levels from NHANES
II (1976 to 1980) to NHANES III (1988 to 1991). NHANES II (1976
to 1980) estimated 88.2 percent of 1 to 5 year old children
in the United States exhibited blood lead levels greater than
or equal to 10 micrograms per deciliter. A decrease in
mean blood lead levels of greater than 70 percent was observed
for all subgroups stratified by age, race/ethnicity, gender,
urban status and income levels, in comparing NHANES III to NHANES
II.
Despite the dramatic reduction in environmental lead levels,
and the concomitant decrease in blood lead levels in the population
as a whole, there remains concern for populations who may experience
disproportionately higher lead exposures. For example, blood
lead level surveys conducted by the California Department of
Health Services indicate there are communities within urban
areas of California with a disproportionate percentage of children
with blood lead levels greater than 10 micrograms per deciliter.
Similarly, NHANES III indicates that the percentage of children
aged 1 to 5 with blood lead levels greater than, or equal to,
10 micrograms per deciliter is disproportionately higher, on
a nationwide basis, for non-Hispanic African-American children.
The major remaining sources of environmental lead that may pose
a public health threat appear to be localized sources of lead,
including, but not limited to, continued deterioration of lead-based
painted surfaces in older buildings, lead that has already accumulated
in dust and soil, and near sources of air lead emissions.
What are the Findings of the
Scientific Review Panel?
Findings of the Scientific Review
Panel on
THE REPORT ON INORGANIC LEAD
as Adopted at the Panel's October 31, 1996 Meeting
Pursuant to Health ant Safety Code section
39661, the Scientific Review Panel (SRP/Panel) has reviewed
the report Proposed Identification of Inorganic Lead as a Toxic
Air Contaminant by the staffs of the California Air Resources
Board (ARB or Board) and the Office of Environmental Health
Hazard Assessment (OEHHA) on the public exposure to, and health
effects of, inorganic lead. The Panel members also reviewed
the public comments received on this report. Based on this review,
the SRP makes the following findings pursuant to Health and
Safety Code section 39661:
1. Lead is known to cause significant noncancer
health effects. The two noncancer health effects of most concern
at low blood pressure and related cardiovascular effects in
adults. The neurodevelopmental and cardiovascular effects likely
have the most public health significance.
2. There is relatively little uncertainty
in the risk assessments for the noncancer endpoints for lead,
including neurodevelopmental and blood pressure effects compared
to the cancer endpoint. Four major uncertainties associated
with most risk assessments are animal to human extrapolation,
high to low dose extrapolation, full consideration of sensitive
members of the human population, and studies with small numbers
of subjects. The uncertainty for the noncancer risk assessment
for lead is small because it includes human and low dosage data,
full consideration of sensitive members of the human population,
and studies that contain numerous subjects.
3. Scientific studies have indicated that,
at low to moderate blood lead levels, neurodevelopmental effects
include: decreased intelligence, short term memory loss, reading and
spelling underachievement, impairment of visual motor functioning,
poor perception integration, disruptive classroom behavior,
and impaired reaction time.
4. The data on the effects of lead on measures
of intelligence are particularly compelling. Evidence from three
prospective cohort studies show a relationship between blood
lead levels and intelligence in children up to 10 years of age.
The effects on intelligence appear to occur above and possibly below the
10 micrograms per deciliter "level of concern" identified by the Centers
for Disease Control (CDC) and the National Academy of Sciences.
A threshold for neurodevelopmental effects from lead exposure
has not been identified.
Based on scientific evidence for neurodevelopmental effects, and increase
of 1 microgram per cubic meter of lead in ambient air inhaled would, on average,
lead to a decrease of approximately 1.32 intelligence quotient
(IQ) points for children below the age of 10. Based on an evaluation
of peer-reviewed evidence, it is estimated that there would
be a mean decrease of 0.08 IQ points for children below the
age of 10 exposed to the mean annual 1990-91 population-weighted
exposure of 0.06 micrograms per cubic meter of airborne lead.
While this effect may seem insignificant at the individual level,
it would result in a downward shift in the distribution in IQ
points for children in an exposed community. For example, at
the ambient average air lead concentration of 0.06 micrograms
per cubic meter, the models predict that 4,700 additional children
in California have IQ levels below 80 relative to a zero air
lead level.
5. Based on current scientific evidence and
using blood lead data provided by the recent National Health
and Nutrition Examination Survey (NHANES III), the percent of
children that would move above the 10 micrograms per deciliter
blood level of concern established by the CDC and accepted
by OEHHA, can be calculated. The evidence suggests that at the mean
annual 1990-91 statewide population-weighted lead level, an
additional 0.6 to 2.3 percent of children between the ages
of 1 and 2 could move above 10 micrograms per deciliter.
The amounts to between 7,200 and 27,600 children in California. At an air lead
concentration of 0.25 micrograms per cubic meter, the models indicate that
an additional 5 to 13 percent of the children in this
age group would move above 10 micrograms per deciliter.
6. Increases in both systolic and diastolic
blood pressure and cardiovascular effects have been correlated
with lead exposure. There are many large population-based studies
that examine the relationship between blood lead levels and
hypertension (diastolic blood pressure greater that or equal
to 90 millimeters of mercury). In addition, scientific evidence
indicates a consistent association between increases in blood
pressure and increases in more serious cardiovascular outcomes.
7. Based on this evidence, exposure to the
mean annual 1990-91 statewide population-weighted airborne lead
exposure of 0.06 micrograms per cubic meter is estimated to
lead to 26,000 (with a 95 percent confidence interval of 6,100
to 60,800) additional cases of hypertension (diastolic blood
pressure greater than or equal to 90 millimeters of mercury)
among the 7.92 million adults in California between the
ages of 40 and 59. In addition, the exposure to 0.06 micrograms
per cubic meter of air lead is estimated to result in 72 (with
95 percent confidence interval of 9 to 218) deaths from all
cardiovascular related disease per year among the 8 million
adults between the ages of 40 and 59. These values equate to
a unit risk for mortality from cardiovascular disease of 4.6
x 10-4 per microgram per cubic meter (Table 1).
8. The risk assessment for potential near
source exposure to inorganic lead at the annual average ambient
concentration of 0.24 micrograms per cubic meter could result
in a 4-fold increase in risk for neurodevelopmental effects,
increased blood pressure and related cardiovascular effects,
and cancer.
9. The current federal ambient air quality
standard for lead developed by the United States Environmental
Protection Agency (U.S. EPA) is 1.5 micrograms per cubic meter.
This standard was based on preventing blood lead levels in 99.5
percent of children from exceeding 30 micrograms per deciliter,
a level of concern that dates from 1978. The CDC has established
a level of concern for children at blood lead levels of 10 micrograms
per deciliter. At an air lead level of 1.5 micrograms per cubic
meter, approximately one-half of California children would be
expected to exceed the CDC guideline of 10 micrograms per deciliter.
With current air lead levels (0.06 micrograms per cubic meter),
the percentage of children exceeding the CDC guideline of 10
micrograms per deciliter is anticipated to be 11.5 percent,
0.6 percent more children than it there were not lead in the
air.
10. Lead compounds (which include organic and inorganic
lead compounds) are listed as federal hazardous air pollutants
(HAPs) and, therefore, were identified as toxic air contaminants
(TACs) by the Board on April 8, 1993. However, the federal HAPs
list does not include elemental lead in the definition of lead
compounds. For this process, elemental lead is included in the
ARB/OEHHA definition of inorganic lead and is, therefore, being
considered for identification under the state's air toxics program.
11. The major source of inorganic lead in ambient outdoor
air are estimated to emit approximately 180 tons per year. Aircraft
fuel combustion is the primary source of emissions at 149 tons
per year. Other sources include autobody refinishing, battery
manufacturing facilities, cement manufacturing, cogeneration,
sawmills, paperboard mills, foundries and steel mills, stationary
source fuel combustion, incineration, paint and coatings manufacturer's,
sand and gravel facilities, and secondary lead recycling facilities.
Inorganic lead previously emitted from such sources may be re-entrained
as windblown dust; it is expected to contribute 390 tons per
year into the atmosphere. Ambient levels of inorganic lead can
be much higher near sources which emit lead such as those listed
above.
12. Based on air monitoring data collected by the ARB's
criteria pollutant monitoring network, the 1990-91 statewide
population-weighted exposure is estimated to be 0.06 micrograms
per cubic meter. Current statewide population-weighted
exposure is expected to be lower due to the ban on the use of
leaded fuel for on-road vehicles in California effected January
1992, the implementation of a South Coast Air Quality Management
District emission standard on lead (Rule 1420), and an air toxic
control measure limiting lead emissions from stationary
sources. The 1992-93 near-source annual average ambient
concentration is 0.24 micrograms per cubic meter taken one third
of a mile away from a specific secondary lead recycling
facility.
13. Lead associated with particles may remain suspended
in the atmosphere for up to 30 days. These particles
are removed by wet and dry deposition.
14. Indoor concentrations are generally lower than outdoor
concentrations; indoor/outdoor ratios range from
0.3:1 to 1:1.
15. Inhalation is not the only route of exposure to lead.
Airborne lead that deposits on soil, water, and food can be
ingested.
16. Most cases of lead poisoning in children are caused
by ingestion of lead-based paint. Lead poisoning
is also caused by the use of lead-containing traditional medicines
from different cultures.
17. Scientific evidence suggests that a 1 microgram per
cubic meter increase in atmospheric lead corresponds
to 4.2 micrograms per deciliter (with a 95 percent
confidence interval of 3.3 - 5.2 micrograms per deciliter)
increase of blood lead over time for children and a 2 microgram
per deciliter increase of blood lead for adults. The estimates
have been developed using both an aggregate model and the
U.S. EPA's Integrated Exposure Uptake Biokinetic Model
(IEUBK) which incorporate the impacts of air lead emissions
through all potential pathways.
18. California ambient air monitoring data from the mid
1970's to 1991 show a substantial decrease in ambient
lead concentrations. This is primarily due to leaded fuel
regulations that have eliminated the use of lead in automobile
fuels and the introduction of catalyst equipped vehicles.
19. The International Agency for Research on Cancer (IARC)
has listed lead and Inorganic lead compounds in class 2B
(1980), possibly carcinogenic to humans, based on
sufficient animal carcinogenicity and inadequate human carcinogenicity
data. The United States Environmental Protection Agency (U.S.
EPA) has placed lead compounds in category B2(1986), probable
human carcinogen, on the basis of sufficient evidence
of carcinogenicity in animals, but inadequate or not data
form human epidemiological studies.
20. Scientific studies show that lead can cause gene
mutation and cell transformation in culture, and
can interfere with DNA synthesis. Rodents that have ingested
high doses of lead show increased occurrences of kidney tumors.
21. Based on a health protective interpretation of the
available scientific information, the upper-bound
of the lifetime excess unit cancer risk resulting from
inorganic lead exposure ranges from 1.2 x 10-5 to
6.5 X 10-5 per microgram per cubic meter. This
estimate of unit cancer risk was based on rodent
data because there are inadequate data in humans. The best value
for unit cancer risk is 1.2 x 10-5 per
microgram per cubic meter, and is based on the largest
data set available for quantitative assessment.
22. Based on the best value for potential unit cancer
risk of 1.2 x 10-5 per microgram per cubic meter
and the mean annual 1990-91 statewide population-weighted
average of 0.06 micrograms per cubic meter, there could be
0.7 potential cancer cases per million people over a 70-year
lifetime. Based on a population of 34 million California
residents, the cancer burden is estimated to be 24
potential cancer cases.
23. Table 2 , attached to these Findings, compares the
best value of upper-bound unit cancer risk for inorganic
lead with those of other compounds reviewed by the
SRP. These 95 percent upper-bound lifetime risk estimates are
health-protective estimates; the actual risk may be much lower.
24. Based on available information, there is no evidence
for a threshold for neurotoxicity, increased blood pressure
and related cardiovascular effects, or cancer.
25. Based on available scientific evidence, we conclude
that inorganic lead should be identified as a
toxic air contaminant.
After careful review of the September 1996 draft SRP version
of the ARB report, "Inorganic Lead as a Toxic Air Contaminant,"
we find this report with the changes specified in our October 31,
1996 meeting as representing a complete and balanced assessment
of our current scientific understanding.
For these reasons, we agree with the science presented in Part
A by ARB and Part B by OEHHA in the report on inorganic lead and
the ARB staff recommendation to its Board that inorganic lead be
listed by the ARB as a toxic air contaminant.
I certify that the above is true and correct copy
of the findings adopted by the Scientific Review Panel on October
31, 1996.
//s//
James N. Pitts Jr., Ph.D.
Chairman, Scientific Review Panel
TABLE 1
NONCANCER POTENCIES APPROVED
BY THE SCIENTIFIC REVIEW PANEL 1996
|
Compound
|
Unit Risk (ug/m3)-1
|
Endpoint
|
|
Inorganic Lead
|
4.6 x 10-4*
|
Cardiovascular Mortality
|
ug/m3: microgram per cubic meter
* The noncancer risk is based on the predicted number
of cardiovascular deaths for adults age 40 to
59. The estimate indicates an expected 74 deaths per year per
7.92 million California adults exposed to the 0.06 ug/m3
airborne lead concentration. Therefore, the risk per ug/m3
would be (74/7.92 million) x (1/0.06) = 1.56 x 10-4.
Using the upper 95 percent confidence estimate of 218 annual
deaths for the 7.92 million California adults 40
to 59 generates a unit risk of 4.6 x 10-4. These
95 percent upper-bound lifetime risk estimates are
health-protective estimates; the actual risk may be much lower.
(See Findings No.7)
TABLE 2
CANCER POTENCIES APPROVED BY THE
SCIENTIFIC REVIEW PANEL FROM 1984 TO 1996
(in order of cancer potency)
|
Compound
|
Unit Risk (ug/m3)-1
|
Unit Risk (ppbv)
|
| Dioxins |
3.8 x 101
|
Particulate Matter
|
| Chromium |
1.5 x 10-1
|
Particulate Matter
|
| Cadmium |
4.2 x 10-3
|
Particulate Matter
|
| Inorganic Arsenic |
3.3 x 10-3
|
Particulate Matter
|
| Benzo[a]pyrene |
1.1 x 10-3
|
Particulate Matter
|
| Nickel |
2.6 x 10-4
|
Particulate Matter
|
| 1,3-Butadiene |
1.7 x 10-4
|
3.7 x 10-4
|
| Ethylene Oxide |
8.8 x 10-5
|
1.6 x 10-4
|
| Vinyl Chloride |
7.8 x 10-5
|
2.0 x 10-4
|
| Ethylene Dibromide |
7.1 x 10-5
|
5.5 x 10-4
|
| Carbon Tetrachloride |
4.2 x 10-5
|
2.6 x 10-4
|
| Benzene |
2.9 x 10-5
|
9.3 x 10-5
|
| Ethylene Dichloride |
2.2 x 10-5
|
8.9 x 10-5
|
| *Inorganic
Lead |
1.2 x 10-5
|
Particulate Matter
|
| Perchloroethylene |
5.9 x 10-6
|
4.0 x 10-5
|
| Formaldehyde |
6.0 x 10-6
|
7.0 x 10-6
|
| Chloroform |
5.3 x 10-6
|
2.6 x 10-5
|
| Acetaldehyde |
2.7 x 10-6
|
4.8 x 10-6
|
| Trichloroethylene |
2.0 x 10-6
|
1.1 x 10-5
|
| Methylene Chloride |
1.0 x 10-6
|
3.5 x 10-6
|
| Asbestos |
1.9 x 10-4 (per 100 fiber/m3)
|
---
|
ug/m3: microgram per cubic meter
ppbv: part per billion volume
* Noncancer deaths from exposure to Inorganic Lead are
more significant than cancer effects (See Table 1).
PROPOSED REGULATION ORDER
Amend Titles 17 and 26, California Code of Regulations, Section
93000 to read as follows:
93000. Substances Identified as Toxic Air Contaminants.
Each substance identified in this section has been determined
by the State Board to be a toxic air contaminant as defined
in Health and Safety Code Section 39655. If the State Board
has found there to be a threshold exposure level below which
no significant adverse health effects are anticipated from exposure
to the identified substance, that level is specified as the
threshold determination. If the Board has found there to be
no threshold exposure level below which no significant adverse
health effects are anticipated from exposure to the identified
substance, a determination of "no threshold" is specified.
If the Board has found that there is not sufficient available
scientific evidence to support the identification of a threshold
exposure level, the "Threshold" column specifies "None
identified."
|
Substance
|
Threshold Determination
|
| Benzene (C6H6) |
None Identified |
| Ethylene Dibromide (BrCH2CH2Br) |
None Identified |
| Ethylene Dichloride (ClCH2CH2Cl;
1,2-dichloroethane) |
None Identified |
| Hexavalent Chromium [Cr(VI)] |
None Identified |
| Asbestos [asbestiform varieties
of serpentine (chrysotile) riebeckite (crocidolite) cummingtonite-grunerite
(amosite), tremolite, actinolite, and anthophyllite] |
None Identified |
| Dibenzo-p-dioxins and Dibenzofurans
chlorinated in the 2,3,7 and 8 positions and containing
4, 5, 6, or 7 chlorine atoms |
None Identified |
| Cadmium (metallic cadmium
and cadmium compounds) |
None Identified |
| Carbon Tetrachloride (CCl4;
tetrachloromethane) |
None Identified |
| Ethylene Oxide (1,2-epoxyethane) |
None Identified |
| Methylene Chloride (CH2Cl2;
Dichloromethane) |
None Identified |
| Trichloroethylene |
None Identified |
| Chloroform (CHCl3) |
None Identified |
| Vinyl Chloride (C2H3Cl;
Chloroethylene) |
None Identified |
| Inorganic Arsenic |
None Identified |
| Nickel |
None Identified |
| Perchloroethylene (C2Cl4;
Tetrachloroethylene) |
None Identified |
| Formaldehyde (HCHO) |
None Identified |
| 1,3-Butadiene (C4H6) |
None Identified |
| Inorganic Lead |
None
Identified |
NOTE: Authority cited: Sections 39600, 39601,
and 39662, Health and Safety Code.
Reference: Sections 39650, 39660, 39661, and 39662,
Health and Safety Code.
TABLE 1
CANCER POTENCIES APPROVED BY THE
SCIENTIFIC REVIEW PANEL FROM 1984 TO 1994
(in order of cancer potency)
| Compound |
Unit
Risk (ug/m3)-1 |
Unit
Risk (ppbv) |
| Dioxins |
3.8
x 101 |
Particulate
Matter |
| Chromium VI |
1.5
x 10-1 |
Particulate
Matter |
| Cadmium |
4.2
x 10-3 |
Particulate
Matter |
| Inorganic Arsenic |
3.3
x 10-3 |
Particulate
Matter |
| Benzo[a]pyrene |
1.1
x 10-3 |
Particulate
Matter |
| Nickel |
2.6
x 10-4 |
Particulate
Matter |
| 1,3-Butadiene |
1.7
x 10-4 |
3.7
x 10-4 |
| Ethylene Oxide |
8.8
x 10-5 |
1.6
x 10-4 |
| Vinyl Chloride |
7.8
x 10-5 |
2.0
x 10-4 |
| Ethylene Dibromide |
7.1
x 10-5 |
5.5
x 10-4 |
| Carbon Tetrachloride |
4.2
x 10-5 |
2.6
x 10-4 |
| Benzene |
2.9
x 10-5 |
9.3
x 10-5 |
| Ethylene Dichloride |
2.2
x 10-5 |
8.9
x 10-5 |
| Perchloroethylene |
5.9
x 10-6 |
4.0
x 10-5 |
| Formaldehyde |
6.0
x 10-6 |
7.0
x 10-6 |
| Chloroform |
5.3
x 10-6 |
2.6
x 10-5 |
| Acetaldehyde |
2.7
x 10-6 |
4.8
x 10-6 |
| Trichloroethylene |
2.0
x 10-6 |
1.1
x 10-5 |
| Methylene Chloride |
1.0
x 10-6 |
3.5
x 10-6 |
| Asbestos |
1.9
x 10-4 (per 100 fiber/m3) |
--- |
ug/m3: microgram per cubic meter
ppbv: part per billion volume
|