-------
                           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.

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    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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                                34

Silbergeld, E.K.; Schwartz, J.; Mahaffey, K. (1988) Lead and
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                                35

Staessen, J.; Bulpitt, C.J.; Roels, H.; Bernard, A.; Fagard, A.;
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                                36

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     different biological indicators of lead exposure related to

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                                37

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                                38

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                                39

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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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