-------
A-13
these effects than did the others. F was certain that
there is no IQ effect of lead up to at least 15 ng/dl.
At 25 ng/dl, the median judged IQ decrement is about a
0.25 point, and this increases to a median judged IQ
decrement of just under 2 points at 65 ng/dl.
According to F, at 25 |4.g/dl, the IQ decrement exceeds
approximately 0.5 point with probability 0.05, while at
65 M-g/dl, it exceeds 3.7 points with the same
probability.
There are overriding similarities in the judgments of
the other experts, although there are also small,
consistent differences among them. Thus, only G, H,
and J give any credibility to there being IQ effects as
low as 5 ng/dl, while I does so at 15 j^g/dl, and K does
at 25 M-g/dl. The judgments of H and J are consistently
very close, as are those of G, I, and K, which as a
group are somewhat lower than those of and H and J.
Considering the five sets of judgments, the median
judged IQ decrement at 5 ng/dl ranges from 0 to 2.4
points. The median judged IQ decrement at 55 ng/dl is
from about 7 to 11 points; According to the judgments
of G, H, and J, with probability 0.05, the IQ decrement
exceeds 1.8 to 4.5 points at 5 ng/dl, while according
to all 5 experts, it exceeds 9.9 to 15.1 points at 55
with the same probability.
Considering intermediate PbB levels, Expert F judged a
probability of 0.5 that the mean IQ decrement at a PbB level of
35 M-g/dl in low SES children would be 0.5 points. Corresponding
median judged IQ decrements at 35 ng/dl for the other experts
are: 1.5 (Expert G); 8.4 (Expert H); 3.6 (Expert I); 7.0 (Expert
J); 4.0 (Expert K). The median judged IQ decrements at 25 jxg/dl
for low SES children are: 0.25 (Expert F); 2.7 (Expert G); 4.9
(Expert H); 2.3 (Expert I); 4.8 (Expert J); 2.9(Expert K). At a
PbB level of 15 p.g/dl, the median judged IQ decrements for low
SES children are according to these experts: 0 (Expert F);
1.4 (Expert G); 3.5 (Expert H); 0.7 (Expert I); 3.5 (Expert J);
1.3 (Expert K).
As with hemoglobin, credible intervals were calculated for
each expert's judgments. For example, the 0.9 credible interval
is a set of mean IQ decrement values such that there is a 0.9
probability of the true value falling within it. The 0.9
-------
A-14
credible intervals concerning mean IQ decrements for the low SES
children for different PbB levels are as follows:
45 ng/dl: 0.45-2.07 (Expert F); 3.5-9.3 (Expert G); 6.4-
13.9 (Expert H);3.3-9.1 (Expert I); 6.3-11.4 (Expert J); 4.4-8.4
(Expert K) .
35 Jig/dl: 0.23-1.05 (Expert F); 2.1-7.3 (Expert G); 4.6-
12.7 (Expert H);2.2-6.5 (Expert I); 4.4-9.3 (Expert J); 2.0-5.5
(Expert K).
25 M-g/dl: 0.11-0.52 (Expert F); 1.1-6.3 (Expert G); 2.6-9.0
(Expert H);1.2-4.6 (Expert I); 2.3-7.2 (Expert J); 1.1-4.7
(Expert K).
15 ng/dl: 0 (Expert F); 0.6-3.5 (Expert G); 1.8-6.7 (Expert
H);0.3-1.7 (Expert I); 1.5-5.4 (Expert J); 0.5-1.8 (Expert K).
5 |ig/dl: 0 (Expert F); 0.2-1.8 (Expert G); 1.2-4.5 (Expert
H); 0 (Expert I); 0.9-3.9 (Expert J); 0 (Expert K).
Judgments about mean IQ decrement for the high SES group are
not displayed here, although all the experts, except F, felt that
the risks of lead effects on IQ would be smaller in the high SES
children. Also, as with the low SES population, F consistently
judged the IQ effect to be less than did the other experts. From
25 ng/dl on, the judgments of the others overlap, with, as
before, those of H and J being very similar and somewhat greater
than those of G, K, and I, which themselves are similar. Only H
gave any credibility to the existence of an IQ effect at 5 |ig/dl,
G, I,and J did so at 15 ng/dl, and F and K concur at 25 p.g/dl
(Wallsten and Whitfield, 1986).
Considering all the experts simultaneously, the median
judged IQ decrement at 15 ng/dl in the high SES group ranges from
0 to 2.4 points;at 55 p.g/dl, it ranges from 1.4 to 7.9 points.
-------
A-15
According to G, H, I, and J, with probability 0.05 it exceeds 1
to 7 points at 15 v.q/dl, while according to all the experts it
exceeds 4 to 11.5 points at 55 M-g/dl with probability 0.05.
C. DISCUSSION
Considering the scientific debate that has prevailed about
the IQ effects of lead, the degree of consensus reflected in the
results is notable. This is particularly so, since the experts
were selected so as to span the credible range of opinion. For
both health endpoints, encoding subjective probabilities from the
scientific experts about specific, well-defined scientific
outcomes eliminated or minimized disagreements about definitions,
policy, and other matters. The remaining differences, evidenced
in the preceding results, are mainly due to differing
interpretations of, and extrapolations from, the scientific
evidence.
As discussed previously, the health endpoints that were
assessed using probability encoding should not be considered the
individual effects most crucial to a determination of the
appropriate maximum acceptable PbB level. Further, the encodings
were conducted in 1985-86 prior to publication of several
important studies on IQ effects in children; these studies tend
to support earlier data. Several of the experts assigned fairly
high probabilities that potentially important hemoglobin and IQ
decrements could occur in children with PbB levels starting at 25
M-g/dl. Judgments of some of the experts suggest that effects on
IQ and hemoglobin could occur at and below 15 |o,g/dl. In general
the judgments tend to support that the range of 10-15 p-g/dl is
appropriate for evaluating in Section IV.C the health protection
provided by alternative lead NAAQS.
-------
APPENDIX B. EXPOSURE CASE STUDIES: SENSITIVITY ANALYSES
This appendix presents results of sensitivity analyses of
the three case studies on children described in Section IV.D.2.
Populations of children living near a Dallas secondary smelter,
the East Helena primary smelter, and a.secondary smelter and
battery plant in Tampa were modeled from birth up to their
seventh birthdays, 1990-1996. Blood lead distributions under
alternative lead NAAQS are estimated using the uptake/biokinetic
model which accounts for age-specific differences in exposure,
absorption, and physiological distribution of lead from food,
water, soil and housedusts, as well as air; behavioral and
biological variability not captured by the model parameters is
accounted for through use of empirically-derived measures of
blood lead variance (GSDs). Several parameters were assigned
lower and upper bound values that span the range of credible
estimates derived from available data. These include time spent
outdoors per day, volume of air respired per day, percent
absorption in the gastrointestinal tract of ingested lead in
diet, concentrations of lead in soil and housedust associated
with different air lead concentrations, the amount of dirt
typically ingested by children daily, and the GSD value that best
represents variability in childhood lead exposure around lead
point sources.
The results presented for children in Section IV.D.2
incorporate midpoint estimates of those parameter values with
lower and upper bounds. Tables B.I and B.2 summarize blood lead
distributions estimated by the uptake/biokinetic model using
either all lower bound values or all upper bound values. While
the staff believes that the results in Section IV.D.2 are better
representations of future scenarios, the results shown here
illustrate the extremes in possibilities. Sensitivity analyses
that focus on altering only one or two parameters at a time are
possible but are not shown here in the interest of space.
Results of any such analysis, using the same range of estimates,
would be intermediate to the results in the following two tables.
-------
B-2
TABLE B-l. LOWER BOUND SENSITIVITY ANALYSIS:
CHILDREN'S PbB LEVELS IN 3 CASE STUDIES*
Case Study
(# Children) /
PbB Level
Lead NAAQS Level (|j.g/m3)
1.5 Monthly0*
Baseline*3 Quarterly0 1.5 1.25 1.0
0.75
0.5
Dallas (241)
Mean PbB (ng/dl")
% > 10 M-g/dl
% > 15 M-g/dl
East Helena (217}
Mean PbB (ng/dl)
% > 10 M-g/dl
% > 15 ng/dl
Tampa (10)
Mean PbB (p.g/dl)
% > 10 M-g/dl
% > 15 M-g/dl
4
0
0
4
0
6
5
0
.9
.3
.001
.0
.03
0
.5
.3
.08
3.
0.
0
3.
0.
0
5.
1.
0.
8
01
6
004
6
4
009
3
0
3
0
5
0
0
.8
.01
0
.5
.003
0
.4
.9
.005
3.7
0.01
0
3.4
0.002
0
5.2
0.6
0.003
3.7
0.01
0
3.4
0.002
0
5.0
0.4
0.001
3
0
3
0
4
0
0
.6
.005
0
.3
.001
0
.8
.3
.001
•
3.6
0.004
0
3.2
0.001
0
4.7
0.2
0
* Assumes lower bound values for parameters specified in text.
a PbB distributions calculated by assuming GSD = 1.30.
13 Baseline scenario represents current conditions for air quality, as well
as soil and dust. Dietary intake assumed to be at 1990-1996 levels.
G Current NAAQS and averaging time (calendar quarter).
d Alternative NAAQS levels with monthly averaging time.
-------
B-3
TABLE B-2. UPPER BOUND SENSITIVITY ANALYSIS:
CHILDREN'S PbB LEVELS IN 3 CASE STUDIES*
Case Study
(# Children) /
PbB Level"
Lead NAAQS Level
1 . 5
Baseline*3 Quarterly" i . 5
Monthly*3
1 . 25 1.0
0.75
0.5
Dallas r24H
Mean PbB (ptg/dl)
% > 10 M-g/dl
% > 15 p-g/dl
East Helena (217)
Mean PbB (ng/dl)
% > 10 ng/dl
% > 15 ng/dl
Tampa (101
Mean PbB (p-g/dl)
% > 10 ng/dl
% > 15 ng/dl
8
38
10
8
32
8
13
76
41
.9
.8
.8
.3
.7
.1
.6
.6
.0
6
12
1
6
17
3
11
58
23
.1
.0
.7
.7
.7
.0
.0
.7
.1
5
10
"l
6
16
2
10
51
17
.9
.8
.4
.6
.6
.7
.1
.3
.9
5.8
10.1
1.3
6.4
14.5
2.2
9.6
46.1
14.7
5.7
9.3
1.1
6.1
12.6
1.8
9.0
40.3
11.6
5
8
1
5
10
1
8
34
8
.6
.6
.0
.9
.9
.4
.4
.4
.8
5.5
7.9
0.9
5.6
8.6
1.0
7.9
28.7
6.5
* Assumes upper bound values for parameters specified in text.
* PbB distributions calculated by assuming GSD = 1.53.
to Baseline scenario represents current conditions for. air quality, as well
as soil and dust. Dietary intake assumed to be at 1990-1996 levels.
G Current NAAQS and averaging time (calendar quarter).
<* Alternative NAAQS levels with monthly averaging time.
-------
APPENDIX C: CASAC CLOSURE REPORT
-------
pp A U-S. Environmental Washington, OC
fc* ** Protection Agency EPA-SA8-CASAC-90-002
Report of the Clean Air Scientific
Advisory Committee (CASAC)
Review of the OAQPS Lead Staff Paper
and the FCAO Air Quality Criteria
Document Supplement
A SCIENCE ADVISORY BOARD REPORT JANUARY 1990
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
THE ADMINISTRATOR
January 3, 1990
Honorable William K. Reilly
Administrator
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
RE: National Ambient Air
Quality Standards for Lead
Dear Mr. Reilly:
I am pleased to transmit the advice of the Clean Air
Scientific Advisory Committee (CASAC) concerning the National
Ambient Air Quality Standards (NAAQS) for Lead. The CASAC has
reviewed and offered comments directly to EPA Staff on the EPA Air
Criteria Document update, "Supplement to the 1986 EPA Air Quality
Criteria for Lead - Volume I Addendum (Pages Al - A67)w, and the
Office of Air Quality Planning and Standards (OAQPS) staff position
paper "Review of the National Ambient Air Quality Standards for
Lead: Assessment of Scientific and Technical Information", both
dated March 1989.
The Committee previously reached closure on the 1986 Air
Quality Criteria Document and Criteria Document Supplement. At a
meeting held on April 27, 1989, CASAC reviewed and was prepared to
close on the 1989 Criteria Document Addendum and the 1989 Staff
Position Paper, but withheld closure pending receipt and
consideration of additional public comments. The public comment
period, scheduled to close 30 days following the CASAC meeting, was
extended through June 12, 1989, providing the interested public
further time to prepare comments. The additional comments received
as a result of the extended comment period were provided to the
Committee and taken into consideration before reaching closure.
The Committee concludes that these EPA documents, along with the
1986 documents previously closed upon, provide a scientifically
balanced and defensible summary of our current knowledge of the
-------
effects of this pollutant, providing an adequate scientific basis
for EPA to retain or revise primary and secondary NAAQS for
airborne lead.
As part of this review process, the Committee considered and
approved the CASAC Exposure Subcommittee review of the August 1988
EPA document "Review of the National Ambient Air Quality Standards
for Lead: Exposure Analysis Methodology and Validation". That
approval is formally contained in the CASAC report transmitted to
you in April 1989 (EPA-SAB-CASAC-89-018, April 1989).
In November 1988, the CASAC formed an ad hoc Joint Study Group
with the Science Advisory Board (SAB). The broad charge to this
Study Group included assessment of the weight of. evidence
classification of lead and lead compounds as carcinogens; review
of lead-related health effects and exposure issues which cut across
EPA organizational lines; and an assessment of how the scientific
information concerning lead is applied to standard setting and
other regulatory decisions in the Agency. The report of that Joint
Study Group, based on their March 30, 1989 and April 28, 1989
meetings, is contained in their report (EPA-SAB-EC-90-001, December
1989), transmitted to you separately.
A key point of the Joint Study Group Report is the contrasting
nature of the data base for central nervous system versus
carcinogenic effects. The carcinogenic risk assessment is based
primarily on induction of kidney tumors in rodents administered
large quantities of lead. Use of these data for human risk
assessment involves two extrapolations: from rodents to people, and
from high doses to the low doses encountered in ambient exposures
of lead. In contrast, central nervous system effects are observed
directly in people and at exposures at or near the levels of
exposure relevant to setting the standard. Thus, and unless, more
quantifiable and relevant scientific evidence is available on the
carcinogenicity of lead, the Committee feels it appropriate to give
primary consideration to nervous system effects in setting the
national ambient air quality standard for lead.
During the course of the GASAC meeting several recommendations
were made to the EPA Staff as to actions that can be taken that
will provide an improved basis for setting the NAAQS for lead.
These include calculation of the distribution of blood lead levels
estimated to result from achieving an air lead concentration of
-------
0.25 ug/m3. In addition, it was suggested that it would be
appropriate to evaluate the estimated distribution of effects on
childrens intelligence at a given level of lead exposure.
While the Committee is willing to further advise you on the
lead standard, we see no need, in view of the extensive comments
provided, to review any proposed changes prior to their publication
in the Federal Register. The public comment period following
publication will provide sufficient opportunity for the Committee
to provide any additional comment or review, if needed.
The attached report contains the detailed analysis and
recommendations of the CASAC concerning its closure on the Criteria
Document Addendum and the EPA Staff Position Paper for airborne
lead. In considering the CASAC's recommendations for the lead
NAAQS it is important to recognize that air is just one source of
exposure to lead; reducing the total population risk from lead will
require a concerted effort to reduce lead intake from all sources'.
We appreciate the opportunity to provide advice on this
important issue and look forward to your response to our
recommendations.
Sincerely,
Roger O. McClellan, D.V.M.
Chairman, Clean Air Scientific
Advisory Committee
-------
U.S. Environmental Protection Agency
Science Advisory Board
Clean Air Scientific Advisory Committee Lead Review Committee
Chairman
Dr. Roger O. McClellan*, Chemical Industry Institute of Toxicology,
Research Triangle Park, North Carolina
Co-chairman
Dr. Arthur Upton, New York University Medical Center, Department
of Environmental Medicine, New York, New York
Members
Dr. Gary Carlson, Department of Pharmacology and Toxicology,
School of Pharmacy, Purdue University, West Lafayette,
Indiana
Dr. J. Julian Chisolm, Jr., Johns Hopkins School of Medicine,
Francis Scott Key Medical Center, Baltimore, Maryland
Dr. Robert Frank, The Johns Hopkins School of Hygiene and Public
Health, Baltimore, Maryland
Dr. Paul B. Hammond, Department of Environmental Health,
University of Cincinnati Medical Center, Kettering
Laboratory, Cincinnati, Ohio
Dr. Timothy Larson*, Environmental Engineering and Science
Program, Department of civil Engineering, University of
Washington, Seattle, Washington
Dr. Ian von Lindern, President, Terragrahics Environmental
Engineering, Moscow, Idaho
Dr. Morton Lippmann, Institute of Environmental Medicine, New
York University Medical Center, Tuxedo, New York
Dr. Kathryn R. Mahaffey, National Institute of Environmental
Health Sciences, University of Cincinnati Medical
Center, Cincinnati, Ohio
Dr. Paul Mushak, Consultant and Adjunct Professor, University
of North Carolina, Chapel Hill, North Carolina
Dr. Gilbert S. Omenn*, School of Public Health and Community
Medicine, University of Washington, Seattle, Washington
-------
Dr. Michael B. Rabinowitz, Marine Biological Laboratory, Wood's
Hole, Massachusetts
Dr. Marc B. Schenker*, Occupational and Environmental Health Unit,
University of California, Davis, California
Dr. Ellen Silbergeld, Environmental Defense Fund, Washington, DC
Dr. Mark J. Utell*, Pulmonary Disease Unit, University of Rochester
School of Medicine, Rochester, New York
Dr. Bernard Weiss, Division of Toxicology, Department of EHSC,
School of Medicine, University of Rochester, Rochester, New
York
Dr. Jerome J. Wesolowski*, Air and Industrial Hygiene Laboratory,
California Department of Health, Berkeley, California
Dr. George T. Wolff*, General Motors Research Laboratories,
Environmental Science Department, Warren, Michigan
* Statutory CASAC Members
Science Advisory Board Staff
Mr. A. Robert Flaak, Designated Federal Official, Science Advisory
Board (A-101F), U.S. Environmental Protection Agency,
Washington, D.C. 20460
Ms. Carolyn Osborne, Staff Secretary, Science Advisory Board
(A-101F), U.S. Environmental Protection Agency, Washington,
DC 20460
-------
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TECHNICAL REPORT DATA
(Please read Instructions on the reverse before completing)
1. REPORT NO.
EPA-A50/2-89-022
3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
Review of the National Ambient Air Quality Standards
for Lead: Assessment of Scientific and Technical
Information OAQPS Staff Paper
5. REPORT DATE
December 1990
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
8. PERFORMING ORGANIZATION REPORT NO.
9. PERFORMING ORGANIZATION NAME AND ADDRESS
Office of Air and Radiation
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
13. TYPE OF REPORT AND PERIOD COVERED
Final
14. SPONSORING AGENCY CODE
15. SUPPLEMENTARY NQTES
16. ABSTRACT
This paper evaluates and interprets the updated scientific and technical information
that EPA staff believes is most relevant to the review of the primary (health) and
secondary (welfare) national ambient air quality standards for lead. This assessment
is intended to bridge the gap between the scientific review in the EPA criteria docu-
ment and the judgements required of the Administrator in setting the ambient air
quality standards for lead.
The major recommendations of the staff paper are:
consideration should be from 0.5 to 1.5 ug/m
(1) the range of standards under
(2) a monthly averaging period would
better reflect children's responsiveness to lead exposures than a quarterly averaging
period; (3) the most appropriate form of the standard is the second highest monthly
average in a 3 year span; (4) with a monthly averaging period, more frequent sampling
is needed in areas with point sources; and (5) the hi-volume sampler should be re-
tained to monitor compliance with the lead NAAQS.
17.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.lOENTIFIERS/OPEN ENO'ED TERMS
c. COSATI Field/Group
Lead
Air Pollution
Air Quality Standards
18. DISTRIBUTION STATEMENT
Release to Public
19. SECURITY CLASS (This Report)
Unclassified
21. NO. OF PAGES
200
20. SECURITY CLASS (This page)
22. PRICE
EPA Form 2220-1 (R«y. 4-77) PREVIOUS EDITION is OBSOLETE
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