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October
14, 2003 |
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Opening
Session |
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Update
on CDC Activities |
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Update by Primary Prevention
Workgroup (PPW) |
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Review of Evidence
for Effects at BLLs <10 µg/dL |
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Building Blocks for
Primary Prevention |
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Public
Comment Period |
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October
15, 2003 |
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Discussion and Vote on the Primary
Prevention Document |
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National Academy of Sciences Study |
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Lead Exposure at Superfund Sites |
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Update on International Lead Issues |
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New ACCLPP Business |
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Public
Comment Period |
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Closing
Session |
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The
Department of Health and Human Services (HHS) and the Centers for
Disease Control and Prevention (CDC) convened a meeting of the Advisory
Committee on Childhood Lead Poisoning Prevention (ACCLPP). The
proceedings were held on October 14-15, 2003 at the Embassy Suites at
Olympic Centennial Park Hotel in Atlanta, Georgia. |
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Opening
Session |
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Dr. Carla Campbell, the ACCLPP Chair, called the meeting to order at
8:44 a.m. on October 14, 2003. She welcomed the attendees to the
proceedings and particularly recognized the diligent efforts and
valuable contributions of five ACCLPP members whose terms have expired:
Ms. Cushing Dolbeare, Ms. Anne Guthrie-Wengrovitz, Dr. Birt Harvey, Ms.
Amy Murphy and Dr. Michael Shannon. Dr. Campbell opened the floor for
introductions; the following individuals were present to contribute to
the discussion. |
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ACCLPP
Members
Dr. Carla Campbell, Chair
Dr. William Banner, Jr.
Dr. Helen Binns
Dr. Walter Handy, Jr.
Dr. Jessica Leighton
Dr. Tracey Lynn
Dr. Sergio Piomelli
Dr. Catherine Slota-Varma
Dr. Kevin Stephens, Sr.
Dr. Ezatollah Keyvan (CSTE)
Ms. Patricia McLaine (NCHH)
Mr. Ronald Morony (EPA)
Dr. Patricia Nolan (APHA)
Dr. Routt Reigart II (AAP)
Dr. George Rodgers (AAPC)
Dr. Walter Rogan (NIH)
Mr. Robert Roscoe (NIOSH)
Designated
Federal Official
Dr. Mary Jean Brown,
Executive Secretary
ACCLPP Ex-Officio/Liaison Members
Mr. Matt Ammon (HUD)
Mr. Byron Bailey (HRSA)
Mr. Steve Hays (AIHA)
Ms. Cathy Ramadei
Ms. Kathy Skipper |
CDC
Representatives
Dr. Henry Falk, NCEH/ATSDR Director
Ms. Crystal Gresham
Ms. Janet Henry
Dr. David Homa
Mr. Jeff Jarrett
Ms. Helen Kuykendall
Dr. Tom Matte
Ms. Susan McClure
Dr. Patrick Meehan
Dr. Pamela Meyer
Mr. Timothy Morta
Dr. Kimberly Thompson
Presenters and Guests
Dr. Craig Boreiko (International Lead
Zinc Research Organization, Inc.)
Estelina Dallett, Esq. (Dickstein,
Shapiro, Morin & Oshinsky)
Reuben Koolyk, Esq. (Arnold &
Porter)
Ms. Mary Ellen O’Connell
(National Academy of Sciences)
Jane Luxton, Esq. (King & Spalding)
Mr. Don Ryan
(Alliance for Healthy Homes)
Mr. Russell Riggs
(National
Association of Realtors)
Dr. Ian von Lindern (TerraGraphics
Environmental Engineering)
Dr. Michael Weitzman
(University of Rochester) |
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Update on CDC Activities |
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National Center for Environmental Health
(NCEH). Dr. Patrick Meehan
was recently appointed as the Deputy Director for Program of NCEH/Agency
for Toxic Substances and Disease Registry (ATSDR). He provided a status
report of the newly consolidated agency. This action was taken because
NCEH and ATSDR were two separate HHS agencies that conducted similar and
often overlapping environmental public health activities at state and
local levels. The consolidation will result in one federal
environmental public health agency that is more streamlined, effective
and efficient. However, the agencies’ programmatic functions have not
been merged and names have not been changed at this point. Only
Congress has the authority to remove legal restrictions to take these
actions.
On the one hand, NCEH has a broad
mandate that covers all aspects of environmental public health. On the
other hand, ATSDR is authorized and funded by the Superfund legislation
with a Congressional mandate that is limited to conducting Superfund
activities. To overcome legal barriers in the short term, the NCEH and
ATSDR Offices of the Directors and administrative functions were
formally integrated in August 2003. Dr. Henry Falk was appointed as the
NCEH/ATSDR Director; Mr. Robert Delaney and Mr. Peter McCumiskey were
appointed as the Deputy Director for Management for NCEH and ATSDR,
respectively.
In addition to merging leadership and
administrative functions, other changes will also be implemented to
consolidate the agencies. The transition team is represented by staff
from both agencies to ensure that the NCEH/ATSDR Office of the Director
is organized and structured in the most efficient manner. Many of the
~250 positions in the NCEH and ATSDR Offices of the Directors will be
reassigned to program areas within divisions. Financial, personnel,
information systems, global health and other infrastructures will be
consolidated into single offices. The Futures Initiative will be
replicated in the consolidated NCEH/ATSDR agency.
The Futures Initiative is a major
strategic planning activity currently underway throughout CDC to develop
innovative concepts and approaches in the areas of global health,
research, systems and customers. Strategies created for these four
domains will be used to guide CDC’s decision-making process over the
next few years. Overall, the NCEH/ ATSDR consolidated agency must
demonstrate success in integrating two Offices of the Directors,
streamlining administrative functions and effectively collaborating
while maintaining separate mandates and appropriations. This
accomplishment will generate strong political will for Congress to
examine the Superfund law and completely merge NCEH and ATSDR in the
future.
Dr. Meehan was pleased to report that
the HHS Secretary and CDC Director/ATSDR Administrator fully support the
consolidation. Most notably, NCEH and ATSDR have already built a solid
track record in successfully completing joint projects. With respect to
ACCLPP, the consolidated agency will not significantly impact the NCEH
Childhood Lead Poisoning Prevention Program because the activity has a
separate line item of ~$40 million. The consolidation will also have no
effect on the three NCEH divisions and four ATSDR divisions.
Lead Poisoning Prevention Branch (LPPB).
Dr. Mary Jean Brown is the new ACCLPP Executive Secretary. Her status
report covered the following areas. First, the case management document
developed by ACCLPP was published and is currently being evaluated. For
the pre-evaluation, state and local partners are attending training
sessions to describe the impact of the case management document and
training sessions on local practices. For the post-evaluation, training
session attendees will be contacted three to six months after
participation to determine whether changes in behavior persisted due to
the case management document and training sessions. Feedback about the
training sessions has been overwhelmingly positive to date. LPPB
expects to update ACCLPP on the evaluation outcomes during the next
meeting.
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top
Second, LPPB forwarded ACCLPP’s strategy
for targeted screening of Medicaid children to the Center for Medicare
and Medicaid Services (CMS) for review and comment. CMS has not yet
returned the revised document to LPPB; the strategy will be submitted to
the HHS Secretary after the CDC clearance process is complete. ACCLPP
focused on this issue in response to findings by the Government
Accounting Office. The data showed that <60% of children enrolled in
Medicaid were screened for blood lead levels (BLLs). However, >83% of
children with BLLs >20 µg/dL are enrolled in Medicaid. Third,
“Surveillance for Elevated Blood Lead Levels (EBLLs) Among Children in
the United States from 1997-2001” was published in the Morbidity and
Mortality Weekly Report (MMWR). The report represents a
monumental effort and is an essential step in LPPB’s ability to target
resources to areas most in need and evaluate progress.
The surveillance report reflects blood
lead tests reported to LPPB only; all children who were tested from
1997-2001 are not captured. Nevertheless, LPPB believes the states
reporting data represent 90%-95% of the child population in the United
States. Over this time period, the surveillance report shows that the
population of children 1-5 years of age increased from 20 million to 22
million; the number of BLL tests reported to LPPB increased from 1.7
million to 2.5 million; and the number of children confirmed with EBLLs
in all categories decreased from 130,000 to 75,000. LPPB will continue
to focus on this issue. CDC’s new electronic reporting system will
improve data reporting and strengthen LPPB’s capacity to develop and
distribute surveillance reports of BLL tests on a more routine basis.
Fourth, LPPB funded 42 new cooperative
agreements in July 2003 for childhood lead poisoning prevention programs
(CLPPPs) at state and local levels. The program announcement required
applicants to demonstrate capacity in several areas: identify and
provide services for children who are lead poisoned or at high risk for
lead poisoning; refocus some activities to primary prevention; develop
childhood lead poisoning elimination plans; create approaches to
evaluate childhood lead poisoning activities throughout the
jurisdiction; and establish strategic partnerships with agencies to
promote lead hazard reduction. LPPB has already met with nine grantees
to ensure that strong collaborations are developed with local and state
partners in housing, banking and finance, pediatrics and public health
to advance elimination plans.
LPPB has also asked grantees to consider
mechanisms to address lead exposure in pregnant women from a variety of
sources, such as renovation, occupation, traditional medicine and
ceramics. In addition to states, Chicago, Los Angeles, New York City,
Detroit, Philadelphia and Washington, DC were funded as well.
Applicants were selected based on need and expertise. Dr. Brown
concluded her update by emphasizing for the record LPPB’s deep
appreciation to the five ACCLPP members whose terms have expired.
Plaques will be distributed to Ms. Dolbeare, Ms. Guthrie-Wengrovitz, Dr.
Harvey, Ms. Murphy and Dr. Shannon. ACCLPP applauded the dedicated
service of the former members to the nation’s children and their
commitment to preventing childhood lead poisoning.
ACCLPP was extremely pleased that LPPB
has established a process to collect surveillance data of EBLLs on a
more consistent basis. The system is an excellent first step, but
several suggestions were made to improve future surveillance reports.
Dr. Campbell and Ms. McLaine encouraged LPPB to distinguish between
states with universal and targeted screening and also to focus on
screening of children 1-2 years of age. Dr. Banner stressed the need to
focus on children on the “tail” of the distribution of BLLs because
those children are disproportionately affected. He also urged NCEH/
ATSDR to encourage CLPPPs to collaborate with poison control centers.
Dr. Rodgers raised the possibility of making the surveillance database
of EBLLs available to the public.
Dr. Brown and Dr. Pamela Meyer of LPPB
followed up on ACCLPP’s comments. The surveillance report of EBLLs
serves as a baseline in collecting and analyzing data and strategically
using the information to evaluate and target programs. LPPB received
requests from Congress to produce the initial document, but future
surveillance reports will present more sophisticated analyses and there
should be more complete and comparable data. Significant progress has
already been made since the surveillance data were collected in 2001.
Most notably, many more states are now reporting all BLL tests instead
of EBLL tests only.
However, the surveillance report of
EBLLs should not be viewed as a state-based replication of the National
Health And Nutrition Examination Surveys (NHANES). NHANES is still the
best tool to analyze children’s BLLs at the national level. LPPB will
attempt to develop a surveillance database of EBLLs for public use in
the future, but CDC is developing a data release policy and eventually
would like to create a public use database. LPPB is already making
efforts to ensure that NCEH/ATSDR explores partnerships between CLPPPs
and poison control centers. |
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Update by Primary Prevention
Workgroup (PPW) |
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Ms. Patricia McLaine, the
PPW Chair, conveyed that most programs have been interested in primary
prevention for several years and have incorporated many elements of
primary prevention in local activities. Because the only effective
treatment of EBLLs is prevention, ACCLPP established a workgroup to
develop a primary prevention framework. This tool will be used to assist
in achieving the national goal to eliminate childhood lead poisoning by
2010. During the March 2003 meeting, ACCLPP conditionally approved the
primary prevention document pending refinement by a professional editor
and final approval by the full membership. ACCLPP agreed that the
primary prevention document would be a stand-alone report primarily
focused on housing and targeted to CLPPPs, state and local health
departments, and partner organizations. The document may serve as a
companion report to CDC’s 1997 screening guidelines. During previous
meetings, ACCLPP made several recommendations to PPW to strengthen the
document. The term “primary prevention” should be included and the
target audience should be identified at the beginning of the document.
The references should be improved and a glossary of terms should be
prepared. An appendix with a list of resources and links to other
sources should be added.
Comments made by Dr. David Jacobs of the U.S. Department of Housing
and Urban Development (HUD) should be incorporated in the preface.
“Lead-safe” should be clearly defined and the scope and breadth of the
role of CLPPPs should be characterized. PPW held a meeting on March 19,
2003 and took several actions to address ACCLPP's recommendations. The
document was thoroughly reviewed and edited by CDC and Mr. Ellis Goldman
of HUD. PPW dedicated the document to Mr. Goldman who recently passed
away. A glossary and appendix were developed with URLs, links to other
resources, and contact information for public and private agencies.
Comments made by Dr. Jacobs during the March 2003 meeting were
transcribed verbatim and included in the document.
Lead-safe was clearly defined as “units that were treated and cleared
at a point in time.” “Initiate,” “catalyze,” “orchestrate,”
“coordinate,” “collaborate,” “participate” and similar terms were
incorporated throughout the document to clarify the role of CLPPPS.
CLPPPS are expected to provide public health leadership in primary
prevention, but the programs will not always play a leading role in this
effort. The references were improved and will be reviewed again before
the document is finalized. The revised document was distributed for
review and comment to PPW members and CLPPPs in California, Minnesota,
North Carolina, Ohio, Oregon and Philadelphia.
Overall, the CLPPPs found the document to be very well written and
extremely useful in advancing toward primary prevention of childhood
lead poisoning. However, several CLPPPS recommended that concrete
examples of primary prevention strategies be included in the document;
additional program guidance be provided; and funding be increased at
state and local levels. Comments submitted by PPW members have been
incorporated and the document is nearly finished at this point. After
ACCLPP takes a vote, PPW will include additional comments submitted by
members and review the revised document with the ACCLPP Chair and LPPB
staff.
The document will then be submitted for CDC clearance, review and
approval of final changes. PPW will finalize the distribution strategy
for the document, but a tentative plan has already been developed. The
document will be immediately posted online after the CDC clearance
process is complete. Approximately 5,000 copies will be initially
printed and mailed to CLPPPs, state and local health departments, lead
programs funded by HUD and the U.S. Environmental Protection Agency
(EPA), and HUD and EPA regional offices. Information about the primary
prevention document will also be circulated by e-mail to raise awareness
and secure media coverage in the American Journal of Public Health and
similar publications.
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ACCLPP made several suggestions to strengthen the primary prevention
document.
- Hold a press conference to publicize the document and strongly
encourage legislators to allocate funding for primary prevention.
- Highlight research opportunities for primary prevention.
- Emphasize the need for programs to collect economic data on
primary prevention costs and cost savings.
- Make efforts to further clarify the roles of CLPPPs and health
departments in primary prevention. For example, recommend that an
interagency workgroup be established with leaders to designate
responsibilities.
- Replace “preventing lead poisoning” with “preventing lead
exposure” in the title.
- Explicitly state that secondary prevention is important; other
lead sources should be investigated for an individual child; and
population-based changes need to occur based on local conditions.
- List examples of best practices that could be formatted into a
“childhood lead poisoning prevention handout” and distributed to
expectant mothers at prenatal classes.
- Encourage CLPPPs to collaborate with non-traditional partners in
the primary prevention effort. For example, testing agencies could
incorporate language about lead poisoning into licensing examinations,
certification tests or continuing medical education courses for
contractors, physicians or medical students. Retail outlets could
distribute information to consumers about lead-based paint and other
hazards in the home.
- Add data about primary prevention cost savings to obtain support
from legislators.
Expanding the focus to include lead hazards not related to housing
was discussed, but it was agreed that primary prevention through housing
was to remain the primary focus of this document.
Dr. Lynn and several other members did not receive a copy of the
primary prevention document prior to the meeting and were unable to
provide PPW with meaningful input. ACCLPP agreed to table its vote until
the following day to give the members time to review the document
overnight. References for the document and the list of unsafe work
practices would be distributed for the members to review as well. ACCLPP
also agreed that the primary prevention document should maintain its
focus on housing; workgroups will be established in the future to
address other sources of lead exposure.
Ms. McLaine confirmed that efforts are underway to address many of
ACCLPP’s suggestions. For example, the Alliance for Healthy Homes is
currently conducting a project that contains several innovative
strategies and concrete examples of primary prevention. Retail outlets
throughout the country will soon begin putting labels on paint cans and
distributing pamphlets about lead-based paint to consumers. Several lead
programs have already established partnerships with local hardware
stores and home improvement chains. Ms. McLaine also acknowledged that
many of ACCLPP’s recommendations were made at previous meetings and are
captured in the current version of the document. During the overnight
review, she encouraged the members to ensure that PPW fully and
appropriately addressed these issues.
Dr. Campbell announced that in May 2003, she met with the Federal
Interagency Lead-Based Paint Task Force and summarized the primary
prevention document. ACCLPP will distribute the final document to
members of this group and request assistance in advancing the primary
prevention effort. Dr. Brown urged ACCLPP to feel free to take a vote on
the following day because the CDC clearance process will not
substantially change the document. However, ACCLPP will be notified if
CDC proposes major revisions. |
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Review of Evidence
for Effects at BLLs <10 µg/dL |
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Update by the Workgroup: Dr. Michael Weitzman is a former ACCLPP member
and the Workgroup Chair. The other workgroup members are Drs. David
Bellinger, Carla Campbell, Birt Harvey, Betsy Lozoff, Patrick Parsons,
David Savitz, Joel Schwartz and Kimberly Thompson. Drs. David Homa and
Tom Matte of CDC provide the workgroup with extensive technical support.
The members represent expertise in pediatrics, neuropsychological
assessment, lead and non-lead environmental epidemiology, biostatistics,
quantitative risk assessment and laboratory science. ACCLPP established
the workgroup in March 2002 with the following charge. The members were
asked to review existing evidence for adverse effects of lead exposure
and toxicity on children at levels below those currently defined as
“elevated” by CDC or at levels <10 µg/dL. The draft document of the
workgroup’s findings was distributed to ACCLPP prior to the meeting.
Dr. Weitzman reviewed the charge to the workgroup and its approach in
responding to the charge. The charge to the workgroup was to review the
existing evidence for adverse effects of lead exposure and toxicity on
children at very low BLLs and to focus on effects at BLLs of 10 µg/dL
and below. To fulfill the charge, the workgroup set out to answer two
questions: whether available evidence supports negative associations
between children's BLLs and health in the range of <10 µg/dL and whether
observed associations are likely to represent a causal effect of lead on
health.
Dr. Weitzman then summarized the background section of the workgroup
report, which discusses the context within which this review was
conducted. No threshold has been identified to date for harmful effects
of lead. A meta-analysis of cross-sectional studies conducted by the
World Health Organization (WHO) shows several wide confidence intervals
and a decrement of 2.5 IQ points when a BLL increases from 10 µg/dL to
20 µg/dL. Prospective cohort studies that examined the association
between change in IQ and a BLL increase from 10 µg/dL to 20 µg/dL showed
similar results as the WHO findings. At the same time that health
effects have been identified at lower BLLs, population BLLs have fallen.
The most recent estimates show that the median BLL for children <6 years
of age in the United States is ~2.2 µg/dL and 2.2% of children have BLLs
>10 µg/dL.
Despite the decrease in mean BLL and the percentage of children with
BLLs >10 µg/dL, large social and geographic disparities still persist.
In addition, the typical body burden of lead today is estimated to be
two orders of magnitude above estimated pre-industrial levels. To assess
whether associations between BLLs and health in the range of <10 µg/dL
are likely to represent causal relationships, the workgroup considered
criteria conventionally used by epidemiologists for this purpose, which
are stated in a 1964 Surgeon General’s report on smoking and health.
These criteria include consistency of findings across epidemiologic
studies; strength of the association defined by relative risk or odd
ratio; a temporal relationship; and coherence of the biological
plausibility and mechanism of action.
Dr. Weitzman noted that ACCLPP rather than the workgroup will
determine the impact the findings will have on policy and practice.
Thus, policy issues ACCLPP might consider, but which were not considered
by the workgroup, include the feasibility of measuring and classifying
BLLs in categories <10 µg/dL in the laboratory; the availability of
effective interventions for BLLs <10 µg/dL; the advantages and
disadvantages of lowering the BLL threshold below 10 µg/dL; the impact
of diverting resources currently targeted to children with BLLs >10 µg/dL;
and policy options at both individual and population levels.
The workgroup also established criteria to define and include
“relevant studies” in the review of evidence. Studies were required to
be published in English and measure BLLs with graphite furnace atomic
absorption spectrometry (GFAAS) or anodic stripping voltametry. Studies
that assessed IQ or general cognitive index (GCI) as an outcome had to
analyze the association between children's BLLs and IQ or GCI and were
included whether or not analyses specific to BLLs <10 µg/dL were
conducted. Studies that did not evaluate IQ or GCI as an outcome had to
analyze the association between children's BLL <10 µg/dL and another
health outcome. The workgroup also accepted studies with a formal or
informal assessment using non-linear modeling; linear modeling of >95%
of children with BLLs <10 µg/dL; a statistical comparison of >2
subgroups with BLLs <10 µg/dL; or a graphical display of results
permitting visual assessment of the relationship between outcome and
BLLs in the range of <10 µg/dL.
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Dr. Weitzman then noted that few studies had conducted analyses
specific to BLLs <10 µg/dL and health. The workgroup decided studies in
which IQ or GCI was the outcome would be included even if they did not
include such directly relevant analyses. This approach was taken to
determine whether slopes of the BLL-IQ relation became more horizontal
as the mean BLL of 10 µg/dL was approached. This finding would suggest a
no observed effect level. If slopes did not tend to diminish with mean
BLLs approaching 10 µg/dL and below or became steeper, a continuation of
the BLL-IQ association at lower BLLs would be supported.
ATSDR’s 1999 toxicological profile for lead served as the workgroup’s
initial data source to identify references. Several online searches of
data collected from 1990-2003 were also conducted to supplement and
update original references. Structured abstracts obtained from the
literature search were reviewed to locate relevant articles. The
workgroup identified 25 epidemiologic papers on IQ or proxy measures
involving 16 different populations. Most papers showed an association
consistent with an adverse effect on cognitive function and that
adjusting for potential confounders attenuated, but did not eliminate
the association. The exceptions to these results were a Kosovo study in
which adjusted findings were stronger than unadjusted findings and a
Cleveland study in which the association was eliminated at low BLLs with
adjustments for social class and other exposures.
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The workgroup
examined the relation of study population mean BLL to BLL-IQ slope in
two groups of published analyses: those in which BLL was measured at <24
months of age and those in which BLL was measured at age 4 years and
older. In neither group of results did regression slopes tend to
diminish as the mean BLL decreased. In two studies with sufficient power
to analyze the relationship between lower BLLs and cognition among
children whose BLLs never exceeded 10 µg/dL, the BLL-IQ slope was
greater than among all children enrolled. The workgroup reviewed
research that evaluated non-neurocognitive outcomes using the Wide
Ranging Achievement Test for math and reading scores; the WISC-R block
design and digit span subscales; tapping speed for sensorimotor
function; and visual function. The workgroup also reviewed studies
relating BLLs to growth, pubertal development and dental caries. Based
on its extensive and comprehensive review of the evidence, the workgroup
concluded that both direct and indirect data support a negative
association between children’s health, in particular cognitive function,
and BLLs in the range of <10 µg/dL. Dr. Weitzman then reviewed factors
the workgroup considered in judging whether the observed associations
are likely to be causal. Low BLLs affect fundamental biochemical
processes in animal and in vitro models unaffected by confounding
factors. Animal research demonstrates effects in experimental studies
that are consistent with those found in humans with BLLs of 10 µg/dL,
but primate data on BLLs <10 µg/dL are limited. The workgroup concluded
that effects at BLLs <10 µg/dL are plausible, but a mechanism of action
has not been clearly established, especially that would account for the
steeper slope at low BLLs.
The workgroup considered the impact that the age trend in BLLs, which
tend to peak between 15 months and 3 years of age in most populations
and the tendency of BLLs to correlate within individuals, might have on
observed results. The NHANES cross-sectional studies reviewed involved
school-aged children and did not measure BLLs at the peak point.
Therefore, effects associated with BLLs <10 µg/dL may be falsely
attributed to effects due to BLLs >10 µg/dL occurring at an earlier age.
However, the uncertainty with the NHANES study does not apply to the
2003 Bellinger or Canfield papers. In these two studies, multiple BLLs
were obtained at the point in which the highest BLLs were seen in
children. The workgroup concluded that neither the age trend in BLLs nor
errors in BLL measurement can fully explain observed associations
between BLL and adverse health indicators in children.
The workgroup considered what impact methods of neuropsychologic
assessment might have had on study results. The workgroup concluded that
because examiners were blinded to BLLs in neurobehavioral assessments of
cohorts in well-documented studies, biased neuropsychologic assessment
is unlikely to explain the observed results. The workgroup considered
whether confounding by unmeasured factors or factors measured with error
might explain the study results. Of particular concern is the potential
for residual confounding by social environment, which is strongly
related to IQ and lead exposure, but difficult to measure precisely. In
addition, some factors, such as maternal depression, were not measured
in any study. The workgroup concluded that some degree of residual
confounding cannot be ruled out and, if present, might explain the
troubling finding of the slope of the relationship between effects and
BLLs <10 µg/dL being steeper than at BLLs >10 µg/dL.
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The workgroup also considered other potential confounding factors.
Most studies the workgroup reviewed had limited or no gold standard
measures of iron deficiency to determine whether observed associations
were due to iron deficiency. However, the studies that controlled for
iron did not weaken the trend between lead and IQ. Measures used to
analyze the relationship between cognition and prenatal or passive
tobacco exposure were weak in most studies. The dose and critical period
when exposure occurred were not quantified. These limitations add
further to the uncertainty in estimating the impact of BLLs on
children’s health.
Another alternative explanation considered by the workgroup is that
mouthing behavior might be a cause of more lead ingestion and a marker
for delayed neurodevelopment. No direct evidence has been collected to
date to support the hypothesis. In the Port Pirie cohort, early measures
of cognitive function were not association with later BLL. The workgroup
concluded that other than cognition, sufficient data have not been
collected on any endpoint to make a definitive statement about a causal
relationship between an outcome and BLL. The overall weight of evidence
favors an inverse association between BLLs <10 µg/dL and children’s
health, particularly neurocognition.
The workgroup determined that the association between BLLs <10 µg/dL and
children’s cognitive function is more likely than not causal, at least
in part. However, limitations, especially residual confounding by
socioeconomic status (SES), cause uncertainties about the size and shape
of effects. Current data do not support labeling children with BLLs <10
µg/dL as “lead poisoned.” Specific research projects should be
undertaken to address gaps in the evidence base, such as analyses to
assess residual confounding factors in observational studies in
different settings; intervention trials to prevent, diminish or reduce
BLLs <10 µg/dL; and animal studies of mechanisms and dose-response. Dr.
Weitzman acknowledged the diligent efforts of Drs. Homa and Matte for
collecting, reviewing and compiling an enormous amount of data.
Dr. Campbell opened the floor for the members to weigh in on the
workgroup’s draft report. She explained that the input will be used to
refine the final document; the report will eventually be distributed as
an ACCLPP product. Dr. Piomelli pointed out that the workgroup relied on
the Bellinger and Canfield papers, but these studies use an unacceptable
methodology. For example, a child with a current BLL of 8 µg/dL who had
a BLL of 12 µg/dL two months ago would have the same health effects. As
a result, the exposure would be mis-classified. Moreover, the slope
being stronger at <10 µg/dL rather than at >10 µg/dL is absurd. Dr.
Piomelli wholeheartedly agreed with the workgroup’s conclusions, but the
findings should not be based on problematic data. He noted that he
outlined his concerns in a letter and distributed the document to
ACCLPP.
Dr. Banner was surprised that the workgroup included the Kosovo study in
its review because the exposure sources, cultures and ethnic backgrounds
of the cohorts were extremely different. He questioned the workgroup’s
approach in calculating power that is necessary to obtain and control
for adequate confounding factors. He cited two studies for the workgroup
to consider while revising the document. The Lozoff study in Costa Rica
should be reviewed to analyze the impact of paternal intelligence and
“iron insufficiency” on children’s outcomes. The Shannon paper published
in Clinical Toxicology should be reviewed to examine pervasive
developmental delay and persistent exposure to lead as a result of
mouthing behavior.
Dr. Banner also recommended that one reference in the workgroup report
be corrected. The 2003 Bellinger paper is actually a letter to the
editor that was not peer reviewed and is based on older published data.
He noted that some of the workgroup’s findings are different than the
conclusions outlined in the Bellinger manuscript. He advised the
workgroup to clearly explain the inconsistency in the report. Dr. Lynn
agreed that additional research is critically needed on effects at BLLs
<10 µg/dL to remove confounding SES variables. For example, nutritional
aspects directly related to brain development and learning ability were
not captured in the Canfield paper.
Dr. Binns advised ACCLPP to focus on next steps in this process. First,
a mechanism should be developed to widely distribute the report in an
appropriate venue. Information on current knowledge as well as
uncertainties about effects at BLLs <10 µg/dL is critically needed by
front-line providers. Second, the workgroup will soon finalize the
document and complete its charge. A new workgroup should be established
to explore policy implications that will be used to drive
decision-making. Dr. Rodgers questioned the workgroup’s rationale to not
use the term “lead poisoned.”
Dr. Reigart viewed the report as a useful synthesis of complex data that
should be published independent of ACCLPP. He encouraged the members to
refrain from significantly altering the document. The information in the
report should be separated from policy implications to prevent childhood
lead poisoning. The document will be extremely useful to pediatricians
who routinely advise parents about environmental hazards at relatively
low levels that may adversely affect children. Ms. McLaine was pleased
that the workgroup report emphasizes the importance of primary
prevention and risk assessment.
Back to top
Dr. Campbell reiterated the need to perform additional research on
effects from BLLs <10 µg/dL. The number of solid studies on this issue
is small and the number of children in the studies the workgroup
reviewed is limited. She raised the possibility of duplicating existing
studies to more closely examine residual confounding factors and other
research needs identified by the workgroup. Dr. Campbell conveyed that
solid data may provide more certainty about the association between
children’s health and BLLs <10 µg/dL. Dr. Stephens indicated that the
cost benefit of lowering BLLs <10 µg/dL is an additional research need.
These data would greatly improve the current medical literature.
Dr. Kevyan inquired whether the workgroup analyzed the original data in
an effort to minimize ambiguity in the studies. Dr. Leighton made
suggestions to refine the workgroup report. A discussion should be
included on the magnitude of effects compared to other potential
effects. The difference between individual effects on a child and
population effects should be more strongly emphasized. The conclusions
should be revised to match questions the workgroup attempted to answer
on the basis of its charge. Dr. Campbell directed ACCLPP to submit
written comments on the workgroup report to LPPB. After LPPB receives
marked-up drafts from members, the revisions will be forwarded to the
workgroup to review and address. The revised document will be discussed
at the next ACCLPP meeting before being finalized. ACCLPP commended the
workgroup for developing an excellent report.
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Drs. Matte and
Weitzman responded to several of ACCLPP’s questions and comments. The
workgroup will share and discuss Dr. Piomelli’s letter with other
epidemiologists to address his concerns. The multi-variate models in the
studies had adequate power to detect a statistical association based on
home score, maternal IQ and other covariates measured. However, the
workgroup plans to further refine the report to more accurately balance
the uncertainties and conclusions. The members realize that tobacco,
iron status and other residual confounding factors were not adequately
measured in the observational studies. Nevertheless, the workgroup is
fairly confident that major potential variables with an influence on
cognitive function and a strong relationship to lead were identified.
The available data did not allow the workgroup to reach definitive
conclusions for ACCLPP to address all policy issues.
ACCLPP will need to describe the cost benefit of lowering BLLs <10 µg/dL
because this issue is beyond the workgroup’s charge. The workgroup was
also not directed to analyze existing data. However, a consortium of
investigators that conducted the lead cohort studies is currently
performing a pooled re-analysis of the original data to more closely
examine the shape of the dose-response relationship. The workgroup
recommended that a statistical method used for air pollution studies be
applied to the pooled re-analysis of the lead cohort studies. This tool
is useful in addressing confounding factors in multi-center studies. The
workgroup agreed that applying the term “lead poisoned” is
inappropriate. Evidence has not been collected to date that every child
with a certain BLL will be adversely affected.
Policy Options: Dr. Brown conveyed that the <10 workgroup report and
policy options will be complimentary, but not necessarily linked. Both
sets of information will be useful to CDC’s state and local partners and
the broader public health community. LPPB has held several discussions
about policy options related to the <10 workgroup report and will
maintain its strong commitment to children with EBLLs. Most notably,
health effects ranging from reduced IQ to death become more pronounced
as lead exposure and BLLs increase. LPPB realizes that several important
issues must be addressed to provide services to children with EBLLs. For
example, ACCLPP’s guidelines for case management of children with EBLLs
can be accessed on the CDC web site.
Many studies have documented the failure of clinical or educational
interventions to either reduce BLLs in children with at least moderate
lead exposure or decrease developmental effects associated with EBLLs.
State-based data indicate that in many cases, several years are required
to reduce children’s BLLs after levels become elevated. In response to
this evidence, CDC lowered the level of concern from 40 µg/dL in the
1970s to 10 µg/dL in the 1990s. At this time, LPPB does not believe the
level of concern for an individual child should be lowered from 10 µg/dL.
Although compelling evidence has been produced demonstrating that
adverse health effects can occur at BLLs <10 µg/dL, several important
factors must also be considered.
No effective clinical or public health interventions have been
identified to lower BLLs. The unavoidable error associated with
laboratory testing is too great to ensure that children are properly
classified. No data have been collected demonstrating a threshold below
which no adverse effects are found. Children at highest risk are not
appropriately screened at the present time. While implementing the High
Intensity Targeted Screening (HITS) project in Chicago in 2001, for
example, LPPB learned that only 39% of young children in a low-income
neighborhood had ever received a blood lead test. Testing and providing
follow-up services to children with BLLs <10 µg/dL will deflect
resources from children living in high-risk communities.
Back to top
Communities with the largest percentage of children with BLLs >24 µg/dL
also have the greatest proportion of children with BLLs that are lower,
but still well above the national average. These reasons emphasize the
critical need to advance primary prevention and target communities where
the risk for exposure is highest. Primary prevention in these
communities will most likely benefit all high-risk children. In a
primary prevention strategy, the first essential element is to focus on
lead-based paint in housing as the most important source of lead for
young children. An intervention would be conducted before the child’s
BLL is elevated by identifying high-risk communities and incorporating
lead poisoning prevention activities into health and community services
that reach families at high risk for lead poisoning.
The infrastructure currently exists to identify high-risk housing. Most
notably, units built before 1950 have been located and specific
addresses of units that have repeatedly poisoned children are known to
local officials in many areas. In Detroit, Michigan, 657 addresses
accounted for nearly 1,500 children with BLLs >20 µg/dL identified in
the last ten years. In Louisville, Kentucky, <0.3% of all housing in the
community housed 35% of children with BLLs >10 µg/dL in the last five
years. The remediation of high-risk housing should be the highest
priority in primary prevention. Partners in housing, banking and code
enforcement should be strongly urged to become engaged in this effort.
Primary prevention can be linked to secondary prevention activities that
are currently being conducted by most state and local agencies.
For example, low-cost or free training sessions on lead-safe work
practices for workers are available. However, caution must be taken to
ensure that the necessary requirements and enforcement of lead-safe work
practices exist before paint in these units is disturbed. Making efforts
to advance primary prevention is also optimal at this time because more
federal support of housing remediation is now available than in the
past. Targeting resources to housing that is most likely to expose
children to lead paint and lead contaminated house dust or soil is
imperative. Another primary prevention strategy is to make a market for
housing that has been de-leaded.
Several approaches can also be taken for primary prevention of other
lead sources. Communities where cultural practices and traditional
medicines place families at risk can be identified. Current and new
non-essential uses of lead in toys, jewelry, food utensils, and
cosmetics can be controlled or eliminated. Lead poisoning prevention
activities can be incorporated into health and community services that
reach families at high risk for exposure. To meet the Healthy 2010
objective to eliminate childhood lead poisoning, the public/private
partnership must be strengthened among clinicians, public health
providers and housing agencies.
Private and public health care providers as well as environmental health
professionals can advocate for children and foster lead exposure
prevention by facilitating the implementation of primary prevention
recommendations in state and local communities. Active participation by
these groups will provide necessary expertise and leadership to
accomplish primary prevention goals. Pediatricians and other health care
providers should include education about measures to prevent or reduce
EBLLs as part of standard anticipatory guidance during routine well
child visits. Recommendations to assist providers in this area can be
found in Chapter 6 of the ACCLPP case management guidelines.
LPPB is already taking action in the primary prevention effort. The
focus of the CLPPP program announcement was changed to allocate funding
to areas with the highest risk children. Grantees are required to
improve data management and reporting and must also develop childhood
lead poisoning elimination plans at state and local levels. The plans
must focus on targeted screening to high-risk populations, primary
prevention, and community-based partnerships beyond the medical and
public health fields. LPPB is also strengthening strategic alliances
with existing partners, including the Women, Infants and Children (WIC)
program, HUD, immunization services, Medicaid and the Department of
Education.
LPPB has signed a memorandum of understanding with the Low Income Home
Energy Assistance Program. This agreement will ensure that the
weatherization community has knowledge of lead poisoning, is aware of
ongoing activities, and trains workers in lead-safe work practices. LPPB
plans to enhance partnerships with local housing code enforcement
agencies as well. LPPB acknowledges that elimination of lead exposure in
young children is the most important outcome of a successful primary
prevention strategy. This goal can be measured at both national and
local levels. NHANES data can be used to analyze BLLs of children based
on a national representative sample and demonstrate the nation’s
progress in meeting the 2010 objective. State-based surveillance data of
children’s EBLLs can be used to develop programs that identify and
respond to local areas with the highest need. CDC will continue to
conduct both activities. LPPB is confident that lead poisoning can be
resolved and the 2010 objective can be met.
Back to top
Some ACCLPP members were divided on LPPB’s approach to maintain the
focus on children with BLLs >10 µg/dL. On the one hand, Dr. Rodgers
clarified that interventions are currently available to lower a child’s
BLL to <10 µg/dL. The public will believe that BLLs <10 µg/dL are safe
if CDC takes no public health actions. The workgroup’s review of the
evidence demonstrates that BLLs <10 µg/dL are a concern. Dr. Rodgers
indicated that because the BLL standard of 10 µg/dL is global,
maintaining this threshold would be a disservice to the entire world. He
added that similar to 10 µg/dL being established as the standard in
1991, a goal for a lower BLL can be set as well. Mr. Hays also cautioned
LPPB against informing the public that BLLs <10 µg/dL are safe.
On the other hand, Drs. Thompson and Lynn completely agreed with LPPB’s
strategy to maintain the focus on children with BLLs >10 µg/dL. The
current evidence does not identify a “safe” threshold for a lower BLL.
Dr. Nolan clarified that the threshold can be addressed by reviewing the
health disparities elimination model and establishing a standard based
on success. For example, if 4 µg/dL was the lowest BLL achieved in a
community, this level could be established as the mean. Dr. Rogan raised
the possibility of changing the goal from eliminating childhood lead
poisoning to eliminating 26% of lead hazardous units in the United
States that house children <6 years of age.
Dr. Binns was in favor of lowering the standard of testing children’s
BLLs from 24 months to 18 months of age. This approach may allow
providers to detect peak BLLs earlier. Dr. Matte did not understand the
rationale for emphasizing blood lead tests at a certain age. Compelling
data have been collected during prenatal visits, children’s births and
high-risk pregnancies to show that housing is the most important factor
in EBLLs. This evidence should be utilized to bridge the gap between
housing-based strategies and blood lead tests. Dr. Matte added that a
true primary prevention strategy would focus on children at risk for
lead poisoning and their housing before the children are poisoned. As a
result, interventions should occur during pregnancy or at the child’s
birth rather than after a blood lead measurement is taken.
Dr. Stephens agreed with Dr. Matte’s suggestion to intervene at the
earliest possible time. Most notably, obstetricians could inform
expectant parents who plan to renovate a room for a new baby about the
need to examine other areas of the home and remove peeling paint or
other sources of lead. Dr. Slota-Varma also saw the need for LPPB to
develop partnerships with obstetricians. The success of the “Back to
Sleep” program to reduce sudden infant death syndrome and the car seat
campaign to decrease fatal automobile accidents involving infants is
largely due to informed parents. Obstetricians can replicate these
models by educating expectant and new parents about lead poisoning and
screening.
Mr. Morony expressed concern that CDC interprets the 2010 objective as
“virtual elimination of <1%.” Using this calculation, ~100,000 children
in the United States would still be lead poisoned. Because the vast
majority of these children will be in minority populations, EPA and
agencies at state and local levels will find the goal to be unacceptable
and withhold support for or investment in CDC’s elimination program. Dr.
Campbell was in favor of ACCLPP making recommendations to public health
providers and the general public about mechanisms to improve blood lead
screening. The need to continue case management interventions for
previously identified children should be strongly emphasized as well.
Ms. McLaine was pleased that LPPB’s strategy compliments primary
prevention activities currently underway throughout the country. Homes
with lead-poisoned children are being remediated and the public health
infrastructure is being used to target at-risk families living in older
housing. These models have been ongoing for quite some time in
Milwaukee, Rhode Island and other local programs. Dr. Leighton advised
LPPB to clearly define and explicitly state the <10 recommendations. For
example, primary prevention activities should be targeted to at-risk
children and the BLL should be set at a threshold to perform the best
interventions. She supported combining the CDC guidelines and primary
prevention document to provide a concise and conceptual framework.
Several members suggested additional partners LPPB should consider while
building strategic alliances: building code enforcement agencies,
building maintenance personnel, insurance agencies, realtors, testing
agencies and certification programs, the Consumer Product Safety
Commission, the Food and Drug Administration, and remediation workers.
Dr. Campbell proposed that ACCLPP formalize these deliberations in a
written draft. The document could then be distributed to members for
review and comment prior to the next meeting.
Dr. Meehan conveyed that an ad hoc group would serve as a better
mechanism to address policy and practice considerations and implications
of the < 10 workgroup report. The group could specifically focus on the
public health response to this issue and draft appropriate guidance to
provide to clinicians. LPPB staff could be designated to support the
group in developing a draft document. Dr. Thompson noted that in
addition to an ad hoc group, guidance to clinicians should also be
considered as a tremendous research opportunity. She made a motion for
ACCLPP to establish a Policy Options Ad Hoc Group; Dr. Banner seconded
the motion. The motion unanimously passed with no further discussion.
Dr. Campbell charged the group with formalizing ACCLPP’s comments about
policy options. LPPB staff will provide technical support in developing
a draft document. The group’s report will be presented to the full
ACCLPP for review and comment. Dr. Weitzman has already expressed an
interest in serving on the Policy Options Group. ACCLPP members who are
also willing to serve should inform Dr. Campbell.
Back to top
Drs. Brown and Meehan followed up on ACCLPP’s comments. LPPB’s targeted
strategy should not be misinterpreted to mean that BLLs <10 µg/dL are
safe. Instead, LPPB is taking a population-based approach and
recommending a public health action to target resources to entirely
remove lead from children’s environments through primary prevention.
This approach will be more effective in reaching the 2010 objective than
continuing to screen, identify children ages 0-6 years, and offer
interventions. Retesting children and educating parents are the only
interventions currently recommended for BLLs in the range of 10-14 µg/dL,
but only a minimal amount of evidence has been gathered to date
demonstrating that these actions make a difference.
The data reviewed by the workgroup provided no justification to
establish a new BLL threshold <10 µg/dL. Moreover, mistakes were made
when this standard was set in 1991. Nevertheless, LPPB realizes that
more explicit language should be included in the <10 workgroup report.
For example, the document should urge providers to perform follow-up
testing on children 24 months of age. The report should also
specifically point out that lead in the body at any level is not good.
LPPB also recognizes that collaborative efforts should be undertaken
with federal partners to establish health-based thresholds for lead in
dust, house paint and other media. LPPB will make strong efforts in the
future to build alliances with obstetricians to ensure that expectant
mothers are aware of the dangers of scraping old paint. |
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Building Blocks for Primary Prevention |
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Mr. Don Ryan,
Executive Director of the Alliance for Healthy Homes (Alliance),
announced that CDC awarded a two-year contract to the Alliance from
September 30, 2002-September 29, 2004 to develop building blocks for
primary prevention. The project is specifically focused on housing and
lead-based paint hazards in housing, but the model will be replicated
for other sources if the primary prevention building blocks demonstrate
success. The project can also compliment ACCLPP’s primary prevention
document by describing concrete examples. The Alliance realizes that the
effort for local and state departments to shift to primary prevent will
be tremendous.
Of the 98 million units in the U.S. housing stock, 60 million are
lead-free, 13 million with lead-based paint are in lead-safe condition,
25 million pose one or more lead hazards, and ~30,000 of these are home
to a child identified with a BLL >20 µg/dL. A “unit” is defined as a
single-dwelling home or apartment. Despite these challenges, however,
considerable progress has been made over the last five years in primary
prevention at state and local levels. Building blocks are structured to
identify successful strategies of individual programs and provide other
programs with an extensive list of specific primary prevention examples.
A building block serves as an innovative or promising strategy, tactic,
tool, resource or programmatic change to protect children prior to
exposure to lead and other environmental health hazards in the home.
State and local health officials and CLPPP directors serve as the
primary target audience for building blocks.
The Alliance selected seven areas for the initial building blocks:
financing and subsidies; lead safety and healthy homes standards; code
enforcement and other systems; capacity building for lead safety;
collaborations, partnerships and incentives; targeting strategies; and
mechanisms to build awareness and public support. Criteria the Alliance
established to select building blocks include consistency with the
principles of public health; sensitivity to the economics of affordable
housing; a potential for broad-scale impact; a reasonable possibility of
implementation; and a real promise for reducing hazards in high-risk
housing. The Alliance recently submitted to CDC a draft outline
summarizing the 75 most promising building blocks identified to date;
the document was distributed to ACCLPP as well. The building blocks will
eventually be expanded to a two-page template containing specific
information and will also be designed as an easily searchable web-based
system.
The Alliance took several actions to identify candidate building blocks.
Input was solicited from internal staff, CDC, ACCLPP, lead grantees, and
health departments at state and local levels. The published literature
and other data were reviewed. A call for nominations was widely
announced to health departments, housing agencies and community-based
organizations. Model building blocks are described as follows.
For financing and subsidies, Los Angeles tenants demanded a rent
increase of $1 per month to create a special fund for code enforcement.
Los Angeles County hired 70 additional code inspectors and committed to
inspecting all rental properties once every three years. New Jersey and
other jurisdictions are using the Community Reinvestment Act to
collaborate with banks that receive credit for conducting community
service activities.
For lead safety and healthy homes standards, New Orleans, San Francisco
and other cities have banned unsafe work practices, while California and
Rhode Island are making lead hazards a violation of the housing code.
For code enforcement and other systems, Illinois is training code
inspectors to identify lead hazards and pursue enforcement. Milwaukee,
Philadelphia and San Francisco are abating lead hazards when owners fail
to act and imposing a lien on the property to recover costs. For
capacity building for lead safety, Chicago is holding free lead-safe
work practice training sessions on a regular basis. This action is being
taken as part of an agreement between Attorney Generals and the National
Paint and Coding Association to sponsor 150 training sessions per year.
California and Indiana are adding lead safety to weatherization training
courses.
For collaborations, partnerships and incentives, Maine is partnering
with child care facilities to ensure lead safety for young children. For
targeting strategies, Ohio, Vermont and other states are capitalizing on
home nursing visits to target prevention services and make necessary
referrals to health or housing agencies.
For mechanisms to build awareness and public support, Philadelphia
analyzed and publicized data on EBLLs in the districts of city council
members to facilitate improved policies. This initiative resulted in the
establishment of a new lead court and a substantial reduction in the
backlog of lead cases. Community groups throughout the country are being
trained in the basics of lead hazard identification and screening to
document high-risk housing units.
Digital photographs of properties are being presented in court to
visually confirm the presence of lead hazards. Toxic tours have been
organized in several communities to raise public awareness of high-risk
housing units.Back to top
In addition to the building blocks project, the Alliance has also
developed the “primary prevention taste test.” Readers are asked to
review the alphabetized list and cross out all items that do not qualify
as primary prevention. The Alliance is requesting that ACCLPP review the
75 building blocks summarized in the draft outline and provide input to
LPPB by October 31, 2003. The Alliance will then revise the document
based on ACCLPP’s comments and resubmit the second draft to CDC by the
end of November 2003. The outline will be widely distributed to LPPB
grantees that are developing childhood lead poisoning elimination plans.
Dr. Campbell raised the possibility of extending the Alliance contract
beyond September 29, 2004 because other innovative building blocks may
be proposed after this time. Dr. Thompson was pleased that the Alliance
is collecting economic data to highlight the cost of the interventions.
This information will be extremely important when other programs are
making decisions to replicate a particular activity. Although the
project focuses on innovative and promising tools, Dr. Thompson urged
the Alliance to also gather information on building blocks that were not
selected. Distributing lessons learned will prevent other programs from
repeating previous errors.
Dr. Stephens added that specific categories of building blocks will also
assist programs in the decision-making process, such as projects in
urban versus rural areas and state versus local jurisdictions. He was
interested in ACCLPP making an effort to identify building blocks that
can be implemented at the national level. Ms. McLaine pointed out that
the primary prevention literature is minimal because <20% of programs
evaluate individual activities. She asked LPPB to engage research
organizations to ensure the building blocks are formally evaluated.
Dr. Leighton emphasized the need to coordinate ACCLPP’s primary
prevention document and the Alliance building blocks to ensure
consistent messages are being delivered. She added that the building
blocks document should explicitly inform programs about the need for
local data to drive interventions. Because many programs will be
overwhelmed by 75 building blocks, this guidance will assist in the
decision-making process. Dr. Binns mentioned that primary prevention
data should be incorporated in the building blocks document, such as
prenatal projects in St. Louis or home cleaning studies.
Mr. Ryan clarified that the Alliance reviewed the published literature,
but evaluating the data to identify successes and failures is beyond the
scope of the contact. However, the Alliance used the published
literature to establish criteria and select the building blocks. Dr.
Banner inquired about actions that will be taken for programs with no
interest in developing or implementing building blocks since the
previous primary prevention campaign failed. Dr. Brown replied that
additional funding, attention and other resources now being targeted to
primary prevention will most likely increase the interest of programs in
becoming actively engaged in this effort. Mr. Ammon underscored the need
for CDC and HUD to closely collaborate in developing primary prevention
strategic plans since many programs are grantees of both agencies. |
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Public
Comment Period |
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Ms. Estelina Dallett is an attorney at the law firm of Dickstein,
Shapiro, Morin & Oshinsky in Washington, DC. She was pleased about the
focus on primary prevention by LPPB, ACCLPP and the Alliance. She
viewed the building blocks document as an outstanding collection of
successful techniques and approaches. However, she recalled that a
“reasonable possibility of implementation” was one of the factors for
the Alliance to select a building block. In one model project
summarized in the draft outline, two lawsuits were filed against lead
pigment manufacturers. One trial resulted in a hung jury and the other
lawsuit was entirely dismissed with prejudice. This building block did
not demonstrate success and may be inappropriate to distribute to
programs.
Mr. Ryan urged LPPB to issue a cohesive public health response to
maintaining the focus on children with BLLs >10 µg/dL. This activity
should extend beyond primary prevention strategies, an ACCLPP
statement or the Alliance building blocks. Instead, strong public
health messages about lead should be delivered. “Level of concern”
should be refined because the term indicates that CDC is not concerned
about BLLs <10 µg/dL. The national goal of lowering children’s BLLs to
<10 µg/dL should be clarified since the geometric mean BLL of children
1-5 years of age is 2.2 µg/dL. The use of national averages in the
context of lead poisoning is no longer appropriate because some
communities have a lead poisoning prevalence rate of 30%. Overall, the
national goal for lead poisoning should be achieved by closing
disparities of race and income.
Mr. Ryan conveyed that the failure of secondary prevention is another
issue ACCLPP and LPPB should aggressively pursue. Lead hazards are not
remediated in at least 50% of units that are investigated and found to
have children with EBLLs. Screening children’s BLLs is pointless if
lead hazards in housing are not corrected. For units with lead hazards
that are remediated, lead-safe work practices and clearance dust
testing after paint repair are often not applied.
Mr. Ryan distributed to ACCLPP an informal survey the Alliance
administered to 42 health departments about lead dust testing
practices. The 40 respondents reported the following results: 32
health departments use lead dust testing; 8 states use dust testing as
a screening tool for both EBLLs and high-risk housing; and 9 states do
not conduct clearance dust testing. The Alliance has recommended that
a formal survey be administered with more precise questions to obtain
specific information about clearance dust testing practices. Mr. Ryan
encouraged ACCLPP to review the Rochester study on the failure of
programs to utilize clearance dust testing. The 31 units in the study
all had astronomical levels of lead dust on at least one surface, but
the units were soon enrolled in the HUD Lead Hazard Control Grants
Program.
Ms. Jane Luxton is an attorney at the law firm of King & Spalding in
Washington, DC. She received confirmation from Dr. Brown that the
public can send comments on the <10 workgroup report to LPPB. She
suggested that LPPB consider Dr. Kathleen White, the Designated
Federal Official of the EPA Science Advisory Board, as a resource in
convening advisory committee conference calls pursuant to the rules of
the Federal Advisory Committee Act (FACA). Ms. Luxton will send Dr.
White’s contact information to Dr. Brown by e-mail.
Dr. Campbell announced that the meeting would reconvene at 8:00 a.m.
on the following day instead of 8:30 a.m. as noted on the published
agenda. The extra time will be used for ACCLPP to further discuss and
vote on the primary prevention document. There being no further
business or discussion, Dr. Campbell recessed the ACCLPP meeting at
5:20 p.m. on October 14, 2003. |
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Discussion and Vote on the
Primary Prevention Document |
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Dr. Campbell reconvened the ACCLPP meeting at 8:05 a.m. on October 15,
2003 and opened the floor for the deliberations. Ms. McLaine announced
that Dr. Binns offered to assist PPW in adding numbers and making
other refinements to the primary prevention document references. She
asked the members to provide suggestions on improving the secondary
prevention language in the document because the text continues to be a
problem for PPW. ACCLPP members made comments on the document as
follows.
- Refine the “at-risk populations” definition in the glossary to
clearly place the focus on children. Residence in pre-1978 housing
that may contain lead-based paint hazards is defined as the risk to
women of child-bearing age, but actual risks to this population are
pica and immigrant status. Add “pregnant women” or “expectant
parents;” include “potential children of women;” and delete
“(especially those aged 1-2)" to ensure newborns are captured.
Alternatively, maintain the focus on pregnant women. [Dr. Binns will
rewrite the definition to reflect and clarify housing-based hazards
that need to be corrected before the child is exposed to lead.]
- Change the first sentence on page 15 to “Lead adversely affects
children’s cognitive and behavioral development.”
- Restructure Appendix 5 to be parallel to the “eight elements”
text box.
- Add “and potentially overall quality of life” to the last
sentence of the second paragraph on page 15.
- Change the first sentence of the executive summary to “Lead
continues to be one of the most significant environmental diseases
among young children in the United States.”
- Change the last sentence in the first paragraph of the executive
summary to “housing-associated lead hazards.” [Since “lead-based
paint hazards” is a federal definition used by EPA and HUD,
agreement was reached to add “in and around housing.”]
- Change the title to Preventing Lead Exposure in Young Children
or Preventing Lead Exposure and Lead Poisoning in Young Children.
- Incorporate language to emphasize the importance of lead
reduction.
- Add a sentence at the end of the second paragraph in the
executive summary stating that “targeted screening should remain a
priority to identify children with EBLLs.”
- Change the “risk assessment” definition in the glossary to “lead
risk assessment.”
- Incorporate a section on research needs to assist programs in
applying the primary prevention document to actual practice.
- Acknowledge economic issues that may be important in
implementing primary prevention strategies.
- Underscore the need to use local data in the executive summary.
- Provide guidance for programs to improve targeted and
cost-effective screening.
- Move Appendix 5 into the recommendations section to eliminate
redundancy and improve readability. [The text was moved from the
document and placed into a separate appendix in response to ACCLPP’s
previous suggestion.]
- Acknowledge the existence of other lead sources and additional
at-risk populations in the executive summary, but explicitly state
that the document is focused on housing-based prevention
interventions for children.
- Change “threshold” to “no observed effect level” on page 11.
- Delete the sentence “Reducing lead emissions...” on page 11.
- Change the first sentence of the second paragraph on page 20 to
“The goal of targeting housing for primary prevention...”
- Change the first sentence of the third paragraph in the
executive summary to “... for emphasizing primary prevention related
to housing...”
- Change the first sentence of the second paragraph on page 20 to
“...by removing lead exposure sources posed by lead-based paint...”
- Clarify secondary prevention by changing the sentence in the
second paragraph on page 17 to “...are subsequently employed to
prevent repeated exposures due to lead-based paint housing hazards.”
- Change the order of items in “a” and “b” in the first sentence
on page 21 under “Recommendations” to reflect the priority for
preventing future lead exposure.
ACCLPP was divided on whether a vote should now be taken on the
primary prevention document. On the one hand, Dr. Thompson requested
that PPW incorporate ACCLPP’s comments into the current version. The
final draft should then be presented to members before a vote is
taken. Dr. Lynn added that ACCLPP’s goal should be to produce and
distribute the best product possible. On the other hand, Dr. Binns
emphasized that the vote should not be tabled because state grantees
are supposed to be using the primary prevention document now to
develop elimination plans. She noted that ACCLPP’s suggestions are
fairly minor and can be addressed without further delays in finalizing
the document.
Drs. Brown and Campbell resolved this issue by directing ACCLPP to
submit comments to LPPB no later than October 22, 2003 to be forwarded
to Ms. McLaine. Comments submitted after this date will not be
entertained. After the revised version is distributed to ACCLPP, the
members will decide whether a conference call is needed to discuss the
document further. The members will then vote to approve the document
by either a conference call or e-mail. Dr. Banner made a motion to
conditionally approve the primary prevention document pending
incorporation of ACCLPP's comments; Dr. Handy seconded the motion. The
motion unanimously passed with no further discussion. |
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|
National
Academy of Sciences (NAS) Study |
|
Ms. Mary Ellen O'Connell of
NAS described an upcoming study entitled “Environmental Health Research
in Housing and the Built Environment: Ethical Issues Involving Children
and Families.” The study is primarily funded by HUD and will be
conducted in response to the Kennedy Krieger case in which researchers
involved three groups in housing intervention research. Two families in
the project filed a lawsuit because their children had EBLLs. The lower
court in Maryland ruled in favor of the researchers, but the state
appellate court stated that the lawsuit could be tried. The researchers
were eventually exonerated, but the case caused tremendous concern among
housing researchers and also raised awareness about the lack of guidance
related to housing intervention research.
The scope of the NAS study will compare issues related to housing
intervention research and biomedical research. Existing approaches to
interventions will be explored. Characteristics of therapeutic versus
non-therapeutic interventions will be defined to determine whether
parents can provide consent for children to participate in
non-therapeutic research if more than minimal risk is involved. Research
challenges and ethical issues will be characterized. Ethical obligations
to inform children and their parents will be analyzed. The process for
researchers to intervene in housing-related health hazard interventions
and protect study participants will be examined. The goals of the NAS
study are to advance housing research and provide guidance to
researchers conducting studies on housing-related health hazards.
Phase I of the project is underway. The scope of the NAS study is being
refined and potential committee members are being identified to provide
input on the study. Feedback will be solicited from the Institute of
Medicine, NAS, ACCLPP, the Board of Children, Youth and Families, and
other groups. Efforts will be made to ensure that input is balanced in
terms of geographic representation, age, gender and ethnicity. NA will
seek expertise in the areas of public policy, law, bioethics, child
development, Institutional Review Boards, housing intervention research,
environmental health, research involving children, community-based
research and environmental justice.
In Phase II, NAS will hold five or six committee meetings during a 15-
to 21-month period; obtain input from families, community activists and
similar groups; and convene a public workshop for commissioned papers to
be presented. The committee will then produce a consensus report
summarizing relevant research and outlining recommendations for research
and ethical guidance. The consensus report should be developed 21-24
months after the committee is formed. In Phase III, the committee report
will be disseminated to external experts for review and comment and then
repeatedly revised based on input. At this time, NAS is requesting
ACCLPP’s assistance in advancing the study. Ms. O’Connell distributed a
summary of the NAS study with her contact information. She encouraged
ACCLPP to forward to her the names of potential candidates who can serve
as committee members or reviewers as well as suggestions to improve the
study. She clarified that ACCLPP members are eligible to serve on the
NAS committee.
Dr. Banner reported that Oklahoma faced ethical barriers related to
conducting research on the impact of environmental exposures among
children in protective custody. He urged NAS to consider this issue
while refining the scope of the study. Dr. Thompson suggested that
experts in risk benefit analysis also be considered as NAS committee
members or reviewers. The Center on Bioethics in the National Institutes
of Health should be contacted since this agency is currently defining
“minimal risk.” She noted that the NAS study will be helpful to areas
beyond environmental issues related to housing. Dr. Binns recommended
that a staff member from the Office for Protection of Human Subjects
serve on the NAS committee. Ms. McLaine and Dr. Campbell were pleased
that NAS is undertaking the study. ACCLPP previously recommended that a
project on ethical issues related to housing research be conducted. |
|
Lead Exposure
at Superfund Sites |
|
Dr. Ian von
Lindern, of TerraGraphics Environmental Engineering (TGEE), described
lead cleanup activities at the Bunker Hill/Coeur d’Alene Basin Superfund
site in Idaho. In 1974, the lead smelter in this area operated without
pollution controls for six months and poisoned ~2,000 children who lived
within five miles of the facility. At that time, the average BLL for
preschool children in the area was nearly 70 µg/dL. The mean BLL for
children in the community was 40 µg/dL after the smelter ceased
operations 1981. ATSDR conducted research in 1983 demonstrating that
lead problems associated with residual soil and dust contamination
around the facility continued to persist. The study showed that 25% of
children in the area had BLLs >25 µg/dL.
In 2002, the mean BLL in the community significantly decreased to 2.5
µg/dL; only 2% of children had BLLs >10 µg/dL; and 85% of children had
BLLs <5 µg/dL. The Idaho Superfund site is 21 square miles and covers
five communities with 7,500 residents. The community was designated as
the nation’s second largest Superfund site until 2002. At one point
during its operations, the smelter produced 33% of lead, 25% of zinc and
50% of silver in the country. The goal of the cleanup activities at the
smelter is to transform the site into a world-class destination resort.
This objective would never have been considered without ACCLPP’s legacy
of solid public health contributions to the nation and CDC’s
implementation of the BLL standard of 10 µg/dL.Back to
top
The dramatic reduction in children’s BLLs in the area required a
comprehensive cleanup of the entire community by first demolishing the
365-acre industrial complex of buildings, machinery and waste piles. The
waste was then buried in a 40-acre landfill. Over the last few years, >2
million tons of material were removed and deposited in a large waste
repository at the complex. The original landfill was replaced with clean
soil and the old waste facility will eventually be remediated with
parking lots, golf courses and soccer fields. However, the residential
soil cleanup of 85% of homes within a 21-square mile radius had the most
significant impact on BLLs. One foot of topsoil was replaced with clean
material; this activity has been ongoing for 12 years.
In 1990, the Idaho Superfund site established a goal of lowering BLLs to
<10 µg/dL for 95% of children in each community and having no children
with BLLs >15 µg/dL. This objective would be accomplished by examining
site-specific dose-response relationships and identifying soil and dust
concentrations in the environment that would need to be achieved.
Residential and commercial soils with lead concentrations >1,000 mg/kg
were replaced with soils <100 mg/kg to achieve a mean level of <350
mg/kg throughout the community. Yard-wide averages were determined by
taking 24-inch random samples every 500 square feet in the yard.
The ultimate goal of the soil cleanup was to reduce house dust
concentrations to <500 mg/kg. The percentage of children with BLLs >10
µg/dL in the three major cities surrounding the community dramatically
decreased from 1988-2002. These data show a strong relationship between
EBLLs and contaminated yard soil. The Lead Health Intervention Program
was developed in the community to obtain BLLs of all children through
door-to-door surveys. Children with EBLLs received follow-up as
recommended by CDC. On an annual basis, 75% of children with EBLLs were
identified through school records. Of ~800 at-risk children in the
community 0-9 years of age, 400 participated each year in the program.
The 50% participation rate was largely due to the $20 incentive paid to
children. The program was discontinued in 2003 since community goals
were met in 2002.
ATSDR conducted three neurodevelopmental studies on the cohort of
children that had EBLLs in the 1970s. ATSDR recommended that a registry
be established because attention deficit hyperactivity disorder, renal
problems, hypertension and reproductive effects were detected. Due to
lack of political will by the state of Idaho, the registry was not
established. Montana gathered names of the impacted children in an
effort to develop the Idaho registry, but funding for the activity was
discontinued in the second year. Follow-up testing on the children was
also not performed. Although the victims were compensated through
settlements of private lawsuits, no government compensation was ever
offered. ATSDR’s data were published and are available to the public.
The high participation rate was not replicated in 1,000 children in the
1,500-square mile area surrounding the community. Only 25% of this
population was recruited for the BLL survey. Other activities were
targeted toward primary prevention. Under the High-Risk Residential
Program, units that housed a pregnant woman or children <9 years of age
were cleaned. This intervention resulted in ~200 homes per year being
cleaned. Because the cleaning intervention of individual houses was not
fully successful, geographic area cleanups were then performed to
eliminate lead sources in parks, playgrounds, roadsides, the smelter and
other common areas. Solid science was applied to implement these cleanup
activities.
Of all inorganic contaminants at Superfund sites, lead is found most
frequently. Unlike most contaminants, lead has no reference dose or
cancer slope values. A cleanup level of 500-1,000 ppm was established
for lead in 1989. The Integrated Exposure Uptake Biokinetic Model was
developed by EPA in 1994 and is required to be used at all sites to
assess the impact of lead on children. The current BLL of 10 µg/dL
should be considered as the gold standard when using formulas to
determine cleanup limits at sites. The threshold should be applied at
sites by examining all sources of lead to children, calculating the
bioavailability of each source, and analyzing the integrated combination
of intake to children. House dust is the source of most lead for young
children. Measurements of BLLs, house dust and soils can be used to
estimate a child’s intake of lead.
Data collected in the Idaho community showed a strong association
between BLLs and estimated intake. Undertaking cleanup actions at
Superfund sites is extremely expensive and can exceed tens of millions
of dollars. The federal government and the Coeur d’Alene tribe filed a
lawsuit against several mining companies to assess damages to natural
resources. On September 3, 2003, the presiding judge ruled that the
federal government and the mining companies shared responsibility for
depositing contaminated material at the site. The damages portion of the
trial will begin in May 2004.
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EPA funds were allocated for NAS to investigate the scientific aspects
of the Idaho community cleanup activities, particularly those
apportioning risks for multiple sources, analyzing risks other than
mining and smelting, and using the EPA model. The Coeur d’Alene tribe
asked about the feasibility of safely resuming aboriginal practices in
the Flood Plain River. The current lead level by ingestion is 25-30
µg/day, but some tribal practices will result in an ingestion level of
>1,000 µg/day. Approximately 400-900 years will be needed before lead
concentrations in the area will decrease to the point of supporting
aboriginal practices. To date, the federal government has allocated
~$150-200 million to the remediation of the Idaho Superfund site;
industry has spent $50-$100 million; and $359 million has been set aside
for the record of decision for the 1,500-square mile area.
Mr. Hays emphasized the need for TGEE to clearly document in writing
techniques that were used to clean up dust in houses. Dr. von Lindern
clarified that the long-term plan is to remove contaminated soil and
other sources which move lead into the home, but current efforts are
being directed toward house paint. Special studies on cleaning the home
interior have been conducted and are available to the public. TGEE
recently received a HUD Healthy Homes grant to analyze different
measurement techniques in both clean and unremediated areas in Idaho.
Ms. McLaine pointed out that high soil lead levels are not restricted to
Superfund sites. Contaminated soil levels of up to 5,000 ppm have been
detected in many urban areas. She hoped the TGEE data would be used to
more closely investigate the association between children’s BLLs and
soil lead levels on a wider basis. Dr. Banner suggested that a study of
an Oklahoma town serve as a control group to the Idaho Superfund site
for comparative purposes. The Oklahoma town is in the middle of the
mining activity and yards in the community have been remediated.
However, no contaminated piles of material have been moved to date. |
|
Update on
International Lead Issues |
|
Dr. Falk
reported that lead poisoning is a resurgent theme in discussions of
children’s environmental health issues. Various commissions, United
Nations groups and other committees continually emphasize the importance
of this topic. Lead is an area of interest internationally due to the
success of the United States in reducing childhood lead poisoning.
Average BLLs were previously between 20-25 µg/dL in the United States,
but the levels have dramatically decreased over time. Lead in gasoline
and other sources continue to affect children worldwide. Risk factors in
the developing world are very striking and multiple lead sources differ
from those in the United States.
For example, international industrial sites are frequently located near
or in residential areas. Hot climates lead to more intense exposures to
outdoor environments. Child labor is an important factor in lead
exposure in several countries, such as battery recycling by children in
India. Most countries have inadequate environmental and laboratory
monitoring capacity, a lack of data, and poor tracking systems of lead
use and consumption. Poor nutrition plays a significant role in
enhancing children’s lead toxicity. Knowledge and skills in toxic
chemicals are limited among international physicians and care givers.
Disease surveillance systems are typically non-existent or incomplete.
Chelating agents are frequently unavailable for children with EBLLs.
Protective safety equipment, technologies, industrial engineering
controls and hygiene programs are limited or entirely absent.
Regulations in many areas are inappropriate or have not been developed.
Implementation of standards are inconsistent; inspections are rarely
performed; and lengthy delays are usually associated with completing new
measures. The U.S. infrastructure to address lead problems is extremely
different than that of the developing world, but important advances have
been made internationally. The hand-held portable instrument is used to
immediately obtain BLL measurements in a community. This technology
allowed several international studies to be conducted.
Lead in gasoline continues to be a priority for the World Bank,
international non-governmental organizations and other groups.
Children’s BLLs are nearly three times higher in areas in Budapest with
heavy traffic and exposure to leaded gasoline versus less congested
areas in the suburbs. Improvements have been made in several countries
due to aggressive efforts by international programs to remove lead in
gasoline. Campaigns have been ongoing for the past 10-15 years in Asia,
Latin American and the Caribbean. Several studies have documented
considerable reductions in children’s BLLs in countries that have
removed lead from gasoline.
A CDC study in Bangladesh showed 87% of children had BLLs >10 µg/dL and
21% had BLLs >20 µg/dL. The most significant risk factor for EBLLs in
the study was living in housing adjacent to the highway. Research in
Indonesia showed that the mean air lead level of 0.35 along urban
highways was much higher than in rural areas. However, levels were much
greater in urban, commercial and industrial areas where products that
contained lead were used. Although removing lead in gasoline will reduce
mean levels, extremely high levels will still persist in areas of the
world where lead is used industrially or for other purposes due to poor
controls and weak infrastructures. Similar results were seen in a
Jamaican study that showed a mean BLL of 14 µg/dL in urban school
children versus 9 µg/dL in rural school children. In mining districts or
other contaminated areas, however, the median BLL was 35 µg/dL.
Back to top
CDC conducted a study of lead issues in Cairo to advise the Egyptian
government on establishing a central laboratory. During this time, CDC
also visited a village in Aswan, Egypt in response to abdominal
discomfort and other symptoms among residents. The mean BLL was 92.1 µg/dL
in the hospitalized group and 79.9 µg/dL in the non-hospitalized group.
Five family members had BLLs between 150-175 µg/dL. A flour mill was
identified as the source of EBLLs since lead in the grinding equipment
used at the facility could be ground into flour and consumed by
residents. Over the following year, BLLs in the Aswan village
significantly decreased to 30-40 µg/dL after use of the grinding tool
was discontinued. Rural Egypt contains ~8,000 similar flour mills.
In a study in Ecuador, lead glaze was used on roofing and other
construction materials. Because child labor was also used to build
homes, BLLs of children in the area ranged from 20-44 µg/dL. However,
several children had BLLs >70 µg/dL. Since pottery is still made with
lead glaze throughout Mexico, children in rural areas where ceramics are
used have much higher BLLs. Several studies have been conducted on EBLLs
as a result of battery recycling in Jamaica, the Dominican Republic,
Manila and Gaza. The year-round warm climate in these areas contribute
to prolonged and fairly extensive lead exposures to children. CDC
conducted a study in Lima, Peru due to the country’s effort to remove
lead from gasoline and obtain baseline BLLs. Peru was previously the six
largest exporter of lead ore.
Average BLLs in Lima were <10 µg/dL, but the mean was >20 µg/dL in the
suburb of Callao where mineral deposits were shipped. In areas closest
to the Callao port, average BLLs were even higher at >40 µg/dL. The
extremely dry climate and dirt roads were significant contributors to
EBLLs among local children.
CDC collaborated with a private foundation in India and other groups to
test 20,000 children in major cities in India. The percentage of
children with BLLs >10 µg/dL ranged from 40%-60%, while a smaller
proportion had BLLs >20 µg/dL. In New Delhi, contaminated air was
believed to be the cause of lead poisoning, but the sources were
probably unrelated to air. Lead in gasoline, battery recycling plants,
lead smelters, lead-based pigment in paint, printing presses, ceramic
pottery glazes, cosmetics containing lead and folk medicines were
identified as lead sources in India.
Efforts were made in New Delhi to duplicate EPA air regulations, but
this initiative was unsuccessful due to the infrastructure in India.
These projects have led to a joint binational program between India and
the United States to collaboratively address occupational and
environmental health hazards in India. Lead will be one of the focus
areas in the binational agreement.
Although efforts to prevent and eliminate childhood lead poisoning in
the United States should continue, significant problems in the
developing world must be addressed as well. The World Bank, WHO and
other international groups should broaden the focus from lead in
gasoline to other sources that can potentially result in much higher
BLLs.
Dr. Campbell pointed out that ACCLPP previously sent a letter to the HHS
Secretary recommending immigrant and foreign-born adopted children
receive BLL screening. Dr. Lynn emphasized the need for ACCLPP to
continue to outreach to international organizations that provide
services to immigrants and refugees who settle in the United States.
ACCLPP can play a significant role in educating these groups about lead
hazards. Dr. Nolan added that the American Public Health Association is
also focusing on global health. These issues include refugees and
immigrants who settle in the United States with a prior lead burden;
industrial and commercial strategies in the global economy; and the
impact of micro-environments on lead absorption among children and
adults. Duplicating U.S. interventions research in foreign countries is
an extremely important mission that should be remain on CDC’s agenda.
Dr. Rodgers inquired about ATSDR's formal charge for international
toxicology issues. Dr. Falk clarified that ATSDR has no mandate in this
area. The Superfund legislation provides ATSDR funding and authority to
conduct activities, but the program is completely domestic. ATSDR is
extremely interested in translating and sharing its toxicological
profiles, training materials and other documents with developing
countries to provide guidance in evaluating hazardous waste sites,
assessing toxic chemicals and addressing similar issues. Dr. Falk hopes
international collaborative efforts will be formalized now that the
U.S./India binational agreement has been signed. |
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|
New ACCLPP
Business |
|
Dr. Campbell
opened the floor for members to describe issues ACCLPP should consider
as new activities or future agenda items. For the first new business
item, Dr. Piomelli asked ACCLPP to consider door-to-door screening.
NHANES data show a decrease in the average BLL in the United States, but
EBLLs still persist in some areas of the country. This finding was
recently highlighted by the HITS project in Chicago. ACCLPP has a
responsibility to urge the HHS Secretary to allocate funding for
door-to-door blood lead testing. CDC and local health departments have a
responsibility to conduct door-to-door screening. ACCLPP cannot be an
advisory group for childhood lead poisoning prevention if the members
ignore children in high-risk communities and take no actions to conduct
door-to-door screening. The majority of lead intoxicated children are
poor, minority or immigrants who may never present to a health care
provider.
Dr. Brown was reluctant to return to the practice of door-to-door lead
screening program for children. Since many of these children have no
medical home, BLL testing will be virtually meaningless without
determining immunization status, enrollment in WIC or receipt of other
benefits. A holistic approach must be taken to identify children with
EBLLs. The American Academy of Pediatrics (AAP), practicing
pediatricians and the broader health care community should play a
leading role in high-risk areas. CDC’s responsibility would be to
educate clinicians about improving blood lead screening practices and
locating areas in need. ACCLPP’s role would be to partner with CDC to
inform providers about their obligation to screen patients.
Dr. Campbell mentioned that the primary prevention document will be
extremely helpful in addressing Dr. Piomelli’s concerns. The guidance is
focused on high-risk properties where children have been poisoned in the
past and also on low-income children, pregnant women and other high-risk
populations. ACCLPP previously developed and distributed a document with
recommendations for public health authorities and health care providers
to increase screening of Medicaid children. Dr. Banner cautioned CDC
against identifying AAP as the leader in the holistic approach for blood
lead screening. Of pediatricians in Oklahoma, <50% accept
Medicaid-insured patients. Pediatricians in many other states also have
no involvement in the care of high-risk children.
Dr. Nolan pointed out that many clinicians do not administer blood lead
tests because of poor information systems rather than a reluctance to
screen. Unlike immunizations, medical records do not contain a history
of lead tests performed on an individual child. Physicians throughout
the country have expressed a great deal of interest in improving
electronic information systems to strengthen quality of care. CDC should
partner with the Agency for Healthcare Research and Quality and other
agencies engaged in this effort. Reimbursement, policies to incorporate
blood lead test results into medical records and other critical issues
will need to be addressed at the federal level.
Dr. Binns agreed with Dr. Piomelli’s comments about the need to
highlight racial health disparities. ACCLPP should deliver messages to
providers that communities in greatest need are being ignored. Intense
efforts should be targeted to black and Hispanic children and old
housing or lead prevalence rates should be matched to census data.
However, Dr. Binns did not believe that door-to-door testing should be
widely replicated. The HITS program was successful in Chicago, but the
initiative will be expensive or inappropriate in other parts of the
country.
Dr. Slota-Varma noted that enrollment in WIC, Healthy Start, Head Start,
urban day care centers and similar programs presents excellent
opportunities for blood lead screening to capture more high-risk
children. Dr. Thompson advised CDC to examine the federal commitment to
children in the broader public health context. She also asked Dr.
Piomelli to clearly outline his concerns and ideas for action in a
proposal. The document can be used to facilitate ACCLPP’s continued
discussion on racial and economic health disparities.
ACCLPP agreed to take several actions in response to Dr. Piomelli’s
remarks. LPPB and CMS will present a status report at a future meeting
on changes that have been made in screening practices of Medicaid
children since ACCLPP’s guidance document was disseminated. An overview
of screening strategies in general and input from LPPB grantees will be
presented at a future meeting as well. Dr. Campbell and other interested
members will closely collaborate with LPPB and CMS to identify
mechanisms to improve medical services and other benefits for
Medicaid-eligible children. For example, a “lead checklist” for Medicaid
patients can be distributed to emergency room providers and CMS could
reimburse emergency room departments for providing these services.
For the second new business item, Dr. Thompson asked ACCLPP to consider
issues related to ACCLPP’s function, operation and process. One, an
extensive discussion on the <10 workgroup report should be scheduled on
the next meeting agenda. Two, draft documents should be distributed to
ACCLPP for review at least two weeks prior to meetings. For example,
many members were unable to provide PPW with meaningful input on the
previous day because the primary prevention document was distributed
during the meeting. Clear expectations and deadlines should also be
established for ACCLPP to submit comments on drafts.
Back to top
Three, ACCLPP documents should be available for the public to provide
feedback. Four, current ACCLPP documents should be reviewed to ensure
that the new federal requirements for the Information Quality Act are
being met. Five, a data set of raw data from CDC funded studies should
be accessible to the public after projects are completed. Six,
workgroups should be chaired by ACCLPP members who have attended at
least one meeting and will continue to serve through additional
meetings. Seven, research needs in general, LPPB’s research activities
in particular, and an ACCLPP discussion on research should be scheduled
on a future meeting agenda. For example, LPPB should consider funding
another long-term cohort study to better understand children’s BLLs <10
µg/dL. Dr. Campbell clarified that the CDC Committee Management Office (CMO)
does not require workgroups for any advisory committee to be chaired by
members. However, at least two members must serve on a workgroup.
For the third new business item, Dr. Binns asked ACCLPP to consider
follow-up actions to ongoing workgroup activities. First, LPPB should
develop measurable housing goals in accordance with Healthy People 2010.
This approach will provide primary prevention targets that can be
evaluated in the future. Second, ACCLPP should form a workgroup to
address the at-risk population of pregnant women. To facilitate this
discussion at the next meeting, Dr. Leighton could present a report on
New York City’s screening activities, findings and recommendations
related to pregnant women.
Third, ACCLPP should establish a clear process to address policy options
for the <10 workgroup report. Input from both pediatricians and the
public health community should be captured in ACCLPP’s response. Dr.
Binns is willing to chair the Ad Hoc Policy Options Group. For the
membership, she asked Dr. Slota-Varma to provide expertise as a
front-line clinician and Dr. Reigart to provide the AAP perspective. Dr.
Thompson’s position was that the charge of the new Ad Hoc Policy Options
Group established on the previous day should be limited to formalizing
ACCLPP’s deliberations in a draft report. The responsibility of
identifying appropriate policies for children’s BLLs <10 µg/dL should
remain with the full ACCLPP.
For the fourth new business item, Dr. Lynn asked ACCLPP to consider
developing formal written policies for its operation and function; the
document would then be circulated to all members. The guidelines should
clearly list specific deadlines for the following activities: LPPB to
distribute drafts to ACCLPP for review; ACCLPP to submit potential
agenda items to the Chair; ACCLPP to submit comments on documents; and
LPPB to provide members with travel arrangements for meetings. For the
current meeting, some members did not receive travel arrangements until
the day before they were scheduled to depart.
Convening conference calls between meetings to improve ACCLPP’s function
should be outlined in the policy document as well. LPPB should confer
with CMO to ensure that ACCLPP’s operational guidelines are consistent
with FACA. In response to Dr. Lynn’s final comment, Dr. Brown confirmed
that LPPB will renew ACCLPP’s charter which is scheduled to expire at
the end of October 2003. The new charter will be circulated to all
members. Dr. Campbell asked ACCLPP to submit suggestions for future
agenda items to her at least six weeks prior to a meeting. |
|
Public
Comment Period |
|
Dr. Craig
Boreiko, of the International Lead Zinc Research Organization (ILZRO),
was dismayed by several international lead issues he asked ACCLPP to
consider. Linguistically and culturally appropriate guidance materials
to diagnose and treat lead intoxicated children are minimal. Case
management strategies are not appreciated in the developing world and
access to chelating agents is extremely difficult. Lead is not a
priority at the international level because other issues are much more
important from economic, cultural and social perspectives.
ILZRO has been partnering with United Nations groups to address these
problems, but developing countries are currently not structured to
impact integrated solutions. Dr. Boreiko asked ACCLPP to identify other
groups with a strong interest in international lead issues. Dr. Banner
suggested that ILZRO contact the International Program on Chemical
Safety (IPCS) because this group produces a wealth of linguistically
appropriate information on lead chelators. Dr. Boreiko clarified that
IPCS materials are useful from an academic perspective, but the
documents are virtually useless in the field when efforts are being made
to communicate risk reduction and child intervention strategies. |
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Closing Session |
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Potential dates
for the 2004 ACCLPP meetings will be distributed to the members within
the next two weeks. There being no further business or discussion, Dr.
Campbell adjourned the ACCLPP meeting at 12:02 p.m. on October 15, 2003. |
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I hereby certify that to the best of
my knowledge, the foregoing Minutes of the proceedings are accurate
and complete. |
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Date
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Carla C. Campbell, M.D., M.S.
ACCLPP Chair |
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