• Overview
• Management of Pregnant Women with EBLLs
• Clinical Care
• Lead Exposure During Pregnancy Studies
• Panel Discussion
• Discussion on Forming an ACCLPP Lead and Pregnancy Workgroup

• What outcomes should be included in a cost-benefit analysis of window replacement in existing single and multi-family dwellings, such as energy savings and lead hazard reduction?
• What are reasonable estimates and ranges of costs that could be used in a decision analysis?
• What essential research should be conducted to capture the relationship between window replacement and each outcome, such as decreased asthma, lower blood lead levels (BLLs), lead poisoning prevention and energy efficiency?
• What are the barriers and incentives to participation for property owners and managers who are interested in participating in a window replacement program?
• What new legislative initiatives or modifications to existing legislation are needed to support this activity?
• What public monies or other funding could be mobilized for window replacement, particularly in distressed or subsidized housing?
• What types of work practices could be recommended?

The symposium participants raised several important points during the discussion. Window replacement can prevent or reduce a child’s BLL and also plays a role in asthma. Leaky, poorly maintained or improperly installed windows can cause moisture and may lead to mold-related asthma triggers. Windows serve as high-risk surfaces for childhood lead poisoning because window sills and a young child’s mouth are approximately at the same level and window troughs are highly leaded. Substantial evidence has been collected demonstrating that window replacement successfully reduces lead contamination.

For example, an evaluation of the U.S. Department of Housing and Urban Development (HUD) Lead Hazard Control Grant Program was published in 1999 and showed that dust lead levels (DLLs) on window sills and troughs significantly declined after replacement. Follow-up of the same houses until the present showed that the decrease in DLLs was persistent over time. No evidence has been collected demonstrating that DLLs in window sills or troughs substantially increased since window replacement. However, the impact of window replacement on BLLs and other health conditions is less clear and more difficult to capture, particularly the relationship among moisture, mold and asthma. Mold acts as a trigger for persons with asthma, but the role of exposure to mold in causing asthma in children is uncertain.

The symposium participants reached the following conclusions. Targeted window replacement in low-income homes that makes housing more energy-efficient and affordable is worthy of government support and incentives. Successful strategies include using tax incentives, blending existing federal funding, involving manufacturers and retailers in educational activities, and engaging the insurance industry. Window replacement can satisfy historic preservation concerns if these issues are identified early in the process. To advance this activity, LPPB and the National Center for Healthy Housing will jointly develop a white paper to describe the Window Symposium outcomes and outline responses of the expert panel to the questions. The white paper will serve as a reference document for health department and housing personnel who have an interest in pursuing window replacement.

LPPB will create an easy-to-read and short companion document to the white paper and will also develop a decision tool to assist contractors and others in determining whether window replacement is cost-efficient for a particular home. LPPB will design activities to address barriers that were identified by the participants. In particular, the U.S. weatherization program is well accepted by property owners of low-income units and other types of housing. However, consideration should be given to justifying the benefits of window replacement in an effort to raise the $2,500 cap per unit for weatherization activities. LPPB was pleased to convene a successful forum that allowed multi-disciplinary experts and representatives of disparate communities collectively address housing and health issues.

Two, CDC and HUD will jointly issue a letter to health and housing departments to confirm the authority of these agencies to share addresses where lead-poisoned children currently live or addresses where a series of lead-poisoned children lived in the past. The letter will contain the following language. The Privacy Rule authorizes local entities to release the information because CDC, HUD and the U.S. Environmental Protection Agency (EPA) are authorized by statute to conduct lead poisoning prevention activities. Release of the information is consistent with the missions and capabilities of the agencies and addresses the public health problem of lead poisoning. Programs may disclose to the Office of Healthy Housing and Lead Hazard Control, without parental authorization, the addresses of housing units that have a history of lead-based paint hazards or children with elevated BLLs (EBLLs). HUD will use the data to determine whether these properties are in compliance with the federal Lead Disclosure Rule.

EPA, HUD, the Department of Justice and local health programs have completed 34 enforcement settlements related to the failure of property owners to adhere to the disclosure rule. In these cases, large property owners did not inform tenants of potential lead-based paint hazards. To date, $561,000 in penalties has been collected and commitments were given to test and abate lead-based hazards in >166,000 high-risk rental units. An additional $421,750 has been made available to fund a series of projects, such as the purchase of portable blood lead testing devices, provision of lead hazard abatement training, and implementation of outreach programs.

Three, LPPB’s recent research and surveillance activities include the publication of several articles in the Morbidity and Mortality Weekly Report (MMWR). Ayurveda is a traditional system of medicine primarily practiced in India and South Asian countries; minerals, herbs, animal products or any combination of the three are used. LPPB’s MMWR article on this issue focused on lead poisoning in adults associated with the use of ayurvedic medications. A case was reported from New Hampshire with a BLL of 81 µg/dL. An analysis of the patient’s medications showed lead contents of 12,000 and 17,000 ppm. In addition to New Hampshire, the investigation led to the identification of 12 other ayurveda cases with exceptionally high BLLs in California, Massachusetts, New York and Texas. LPPB was particularly concerned because some of the highly leaded medications were being used to treat infertility in women. An ayurveda health alert will be released in the next two months.

A lead screening study was conducted among prenatal patients in two low-income clinics in Monterey County, California along the U.S./Mexico Border. Of 214 women tested, all with EBLLs were seen in one clinic, 27 had BLLs >10 µg/dL and 8 had BLLs >20 µg/dL. The women represented 13% of the prenatal population screened at the clinic and most were from Oaxaca, Mexico. Dried grasshoppers or “chapulines” with lead levels of 47,000 ppm were among the potential foods identified as sources of the EBLLs.

Four, LPPB is using geographic information systems (GIS) technology for program planning and evaluation of a study in Cleveland. The project will combine tax assessor, blood lead screening and Medicaid data to identify under-served areas of the city. The goal of the study is to present data in a meaningful, useful, simple and quick format to best serve the needs of pediatric healthcare providers. LPPB is preparing a manual to describe common data errors that prevent geocoding as well as techniques to avoid these errors. LPPB will also post GIS 2000 census data on its web site to allow childhood lead poisoning prevention programs (CLPPPs) to quickly collect census data on old housing, poverty, rental property and other issues.

LPPB used GIS to detect an unexpected number of EBLLs around the Charleston, South Carolina Naval Yard. This area did not have a large amount of old housing and would not have been routinely tested, but lead paint dust was distributed in local neighborhoods from shipyard work and by workers who brought paint home for residential use. LPPB is using GIS in conjunction with the Washington, DC health department to evaluate the impact of recent changes in water chemistry on BLLs of resident children.

Five, LPPB and CDC’s other communicable disease programs are adopting the National Electronic Disease Surveillance System (NEDSS). State health departments will use the electronic and laboratory-based reporting system to obtain data on STDs, tuberculosis, bacterial meningitis and other diseases from laboratories and forward the information to CDC. NEDSS will also maintain addresses, patient demographics and disease types. Release 1 of NEDSS is expected to be issued by the end of 2004, but lead will not be included in this version. However, Nebraska and South Carolina are currently deploying NEDSS to transmit data to CDC on vaccine preventable conditions, hepatitis and other diseases. To date, 29 other states have also expressed an interest in implementing NEDSS by the end of 2004. NEDSS will provide LPPB with a wealth of information and capacity to identify risk factors at geographic and population levels.

Six, LPPB is in the process of developing a lead program area module (PAM) that will be the first environmental health condition included in the NEDSS-based system. LPPB completed the prioritization of PAM features by convening meetings to obtain input from state and local partners that use other computerized database systems to manage cases. Joint application development sessions were also held with state and local program staff to discuss development of the lead PAM and usefulness of the system at state and local levels. Over the next 18 months, LPPB expects to migrate data from the Systematic Tracking of Elevated Lead Levels and Remediation system into the lead PAM.

Seven, LPPB is currently focusing on several electronic laboratory reporting issues. Most notably, efforts are being made for health departments to agree on using HL7 and other conventional techniques in submitting data to NEDSS. The overarching goal of these activities is to develop a rapid, common and less labor-intensive electronic laboratory reporting system.

Eight, LPPB is designing health education initiatives due to survey results that show 17 of 37 funded states have no laws to enforce remediation of homes with children who have EBLLs. LPPB is partnering with the Alliance for Healthy Homes (AHH) and the National Conference of State Legislators to compile health education information for state legislators. The materials will contain specific data for each state, including the total number and percentage of pre-1950 housing units; the total number of children <72 months of age and those in poverty; the total number of children tested in 2001 and those with confirmed BLLs >10 µg/dL; requirements for dust clearance testing; the proportion of lead paint abatement completed or ordered by the health department; and the existence of a local or state ordinance requiring home inspection and repair of lead hazards in the home of a child with an EBLL. LPPB acknowledges the importance of health education projects because capacity to enforce remediation in states with a significant amount of high-risk housing and large populations of lead-poisoned children will be critical in reaching Healthy People 2010 goals.

Nine, LPPB is engaging in efforts to improve its vocabulary because “EBLLs,” “undue lead absorption,” “lead poisoned” and similar terms may not be understood by parents and other care givers of children with EBLLs. LPPB will convene a series of focus groups to improve and obtain reactions to the current lead poisoning terminology. Input from the focus groups will be used as a basis in developing a new lead vocabulary that will be meaningful to LPPB’s target audience. One white, one Hispanic and two black focus groups with non-college educated mothers or female care givers of children <6 years of age who have an annual income <$35,000 will be conducted by telephone. Each of the U.S. regions in urban areas will be represented.

Ten, LPPB will release a videotape in May 2004 in an effort to improve blood lead sampling techniques. The videotape will illustrate errors that can cause contamination of capillary blood lead samples and preventive measures.

Eleven, LPPB taught a five-day classroom course and convened a five-day activity in the field to engage individuals in program evaluation. Harvard School of Public Health students collaborated with LPPB project officers to learn more about program evaluation, review the public health process, obtain practical skills and include this experience on resumes. The project officers and students conducted several field activities throughout the country.

In Alabama, case management was evaluated to determine the extent to which protocols are followed and whether case management contributes to decreased BLLs in referred children. In California, education of public health nurses who are not currently involved in lead was assessed to determine if nurses have time to inform families about lead poisoning prevention during home visits and whether changes in practice decreased lead exposure in high-risk families. Other program evaluations included a screening and outreach program by a community-based organization (CBO) in Connecticut; new abatement referral procedures in Detroit; case management in Indiana; an evaluation template for media campaigns in New York City; a housing-oriented primary prevention project in North Carolina; and the “Lead-Safe Baby Program” in Philadelphia. Over the next six to eight months, project officers will begin implementing project evaluations the students wrote in methodology papers. The course was extremely beneficial to project officers, students and lead programs.

Dr. Hoffman inquired about the role of LPPB’s GIS projects in improving screening of all Medicaid children. He also asked whether NEDSS will present confidentiality problems since the system will reveal the specific address of a child with lead poisoning, tuberculosis or another condition. Dr. Brown replied that LPPB will use GIS in the Cleveland study to pinpoint specific locations in communities where Medicaid children have or have not been screened. The initiative will be designed to result in active outreach. To the second question, she clarified that NEDSS will not raise confidentiality issues because state health departments are required to report these diseases. Data will be submitted to CDC through NEDSS with no identifiers.

Ms. Anne Evens, the Chicago Department of Public Health Lead Poisoning Prevention Program Director, described methods to assess BLLs and screening of high-risk children in Chicago. Based on 2001 data, Chicago had 308,415 children <6 years of age. Of those, 28% of children 1 year of age and 51% of children 2 years of age had received a BLL test; 12% of those tested had BLLs >10 µg/dL; and 45% of children born in Chicago each year are enrolled in Medicaid. Chicago has 660,000 pre-1950 housing units and 88,000 housing units that are hazardous to children. One in three children tested has an EBLL in some Chicago neighborhoods. However, childhood lead poisoning has been eliminated as a public health problem in 14 of 77 jurisdictions in Chicago.

The Chicago CLPPP is a multifaceted program with 72 staff who focus on surveillance, blood lead screening, medical case management, environmental inspections and enforcement, and the HUD abatement grant. The Chicago CLPPP incorporated four major strategies in its elimination plan. Additional funding is leveraged for abatements related to window replacement in a lead-safe manner, paint stabilization and other lead hazard interventions. Efforts are currently underway to enforce laws at federal, state and local levels to increase the interest of property owners in making properties lead safe and to provide financial incentives. Projects are designed to increase identification of young children with EBLLs and improve screening, particularly in high-risk neighborhoods. An evaluation component is incorporated into the plan to measure progress toward elimination.

The Chicago CLPPP implemented the first HITS in 2001 to determine the prevalence of children <6 years with EBLLs and to evaluate screening efforts. The activity was later expanded to collaborate with the immunization program and CBOs to assess other health indicators, to increase awareness of EBLLs in communities, and to improve screening of children enrolled in Medicaid. HITS has been conducted three times in six communities. These communities account for nearly 33% of BLLs >20 µg/dL in the city according to city surveillance data. The fourth HITS will be launched on April 3, 2004. The effectiveness of screening widely varies by neighborhood in Chicago.
Surveillance data shows a range of children < 6 years screened as low as 26% to a high of 47% in high-risk communities.

The HITS components include development of a protocol, review by an Institutional Review Board, staff training, blood lead testing, measles and rubella titers, informed consent, health data surveys, cleaning and hepa vacuum training, medical case management, home inspections, abatement, data analysis, evaluation, and recommendations for CLPPP screening initiatives. On the one hand, HITS validated prevalence estimates; gathered baseline data for sentinel surveillance of high-risk neighborhoods; identified 27% of children with BLLs >10 µg/dL who would have been missed by routine screening efforts; resulted in new and improved screening efforts; played a role in enrolling children into primary care and increasing measles and rubella immunization rates to 85%-90%; raised community awareness of EBLLs; strengthened knowledge of other health indicators; and served as an activity that was accepted by community groups and residents. The most significant outcome from HITS activities has been that 61% of children tested in these high-risk neighborhoods had not been previously screened. Of those, 70% were enrolled in Medicaid.

On the other hand, HITS is complex to manage, requires challenging work hours, and raises safety and security concerns. Moreover, the ability to generalize HITS to other settings is questionable. HITS is also costly and will be impractical for a citywide project. On average, $300 was required to screen each child, $320,840 was needed to implement the first three HITS, and $52 per child was allocated for fixed outreach. These costs were found to be much higher than those in pediatric offices or public clinics.

After gathering HITS data, the Chicago CLPPP focused on reasons why 61% of children tested had not been previously screened for blood lead. The analysis showed that children were not presenting for well child visits and physicians were failing to screen during well child visits. The Chicago CLPPP’s review of Medicaid billing records showed that 25%-33% of children <6 years of age had not had a well child visit in the previous 12 months. Since adherence to well child visits was found to be better among children 0-12 months of age, the Chicago CLPPP is partnering with the immunization program to increase well child visits among children 13-24 months of age.

The Chicago CLPPP also collaborated with the immunization program to audit >20,000 physician charts of lead screening and immunization rates in >300 clinical settings. Citywide results showed that 67% of providers in high-risk neighborhoods in Chicago are testing children according to the guidelines. However, physicians still cited several barriers to testing, including insufficient staff to draw blood on site, the cost to parents for off-site testing, the lack of free blood lead testing throughout the state, problems associated with drawing blood from young children, and insufficient time to test during well child visits. Surprisingly, providers did not perceive “lead poisoning is no longer a problem” as a barrier to testing.

Overall, HITS was found to be an effective educational tool because most providers have no lead poisoning data on their patients. As a result, the Chicago CLPPP implemented several activities that have resulted in improved screening rates. Recommendations are made and follow-up assessments are conducted for providers with the lowest screening rates. Healthcare providers are educated through conferences, data mailings and web-based classes with continuing medical education credits. Pediatric and family planning medical residents are invited to participate in the Chicago CLPPP for one day and conduct a site visit with an inspector.

Charts of blood lead testing, immunization rates and well child care visits will continue to be reviewed in providers' offices. Feedback and recommendations for improvement will be given based on these assessments. Educational activities will be specifically targeted to certified nursing assistants and medical technicians as well. The Chicago CLPPP also designed initiatives for parents to increase well child visits, including educational materials distributed through birth certificate inserts, mailings and community meetings; targeted outreach to untested children 13-24 months of age enrolled in Medicaid; free blood lead testing at Women, Infant and Children sites, day care centers and churches; and incentives for testing in certain settings.

Dr. Hoffman remarked that due to seasonality, April 3, 2004 may not be the best date to launch the fourth HITS. Children with EBLLs may not be identified at this time of the year and the overall EBLL rate may be affected. He noted that June-August are the optimal months to obtain EBLLs because windows are more likely to be open and children participate in more outdoor activities during this time of year. Dr. Hoffman also raised the possibility of the Chicago CLPPP using the second dose of measles, mumps, rubella immunization to measure adherence to well child visits since older children receive this dose.

Ms. Evens conveyed that the Chicago CLPPP selected April for the fourth HITS since children will be home for spring break. Based on the earlier HITS, late summer and early fall were not found to be optimal times due to a high refusal rate. Many children are tested during these seasons and most parents are reluctant to have their children undergo another blood draw. However, the Chicago CLPPP will be mindful of seasonality. Dr. Piomelli explained that blood drawn from a finger stick and placed onto filter paper is a successful method to test children and can be used by providers. This technique may address the issue of insufficient staff to draw blood onsite. He emphasized the need for CDC to educate providers in using this procedure. Dr. Piomelli also underscored the importance of the members collectively reviewing and commenting on the HITS results because the study is pertinent, relevant and germane to ACCLPP’s function. Dr. Campbell confirmed that ACCLPP will discuss outstanding issues related to HITS during the “unfinished business” agenda item on the following day.

• Design a conceptual framework for both documents that includes strategies for public health agencies, medical providers and follow-up testing.
• Use common and consistent language within and across both documents. For example, refer to “children with BLLs 5-9 µg/dL” as “the group targeted for primary prevention and screening.”
• Integrate the two documents as a comprehensive MMWR article or stand-alone publication and also publish both documents separately in the literature.
• Avoid combining the documents due to different audiences, topics, purposes and messages.
• Provide specific locations of ACCLPP’s case management and primary prevention reports in both documents.
• Present the policy, clinical and <10 Workgroup documents with a common linkage, unified message and internal agreement, particularly to address the disconnect between the policy and <10 Workgroup reports. For example, incorporate language to recommend that primary prevention be targeted to communities with high rates of children with BLLs >5 µg/dL. Cross-reference the three documents to ensure consistency.
• Consider whether the weight of evidence supports changing the term “managing elevated BLLs” to offer guidance to providers of high-risk populations or if the wording should remain the same as an option for clinicians.
• Develop an abstract or shorten the clinical document because busy clinicians will find the paper too long and difficult to read.
• Maintain the length of the clinical document because all of the issues raised are important for clinicians to know in interpreting BLLs.
• Maintain the user-friendly format of the clinical document because the numbered boxes quickly illustrate important points for busy clinicians.
• Include a statement in the clinical document to explain the lack of experience and evidence in treating children with BLLs 5-9 µg/dL as lead poisoned.
• Add bullet points in the policy document to advise clinicians in certain high-risk jurisdictions to consult with local health departments.
• Revise the tone of the policy and clinical documents to be more positive by highlighting DLL reduction, removal of deteriorated paint and other environmental interventions that are known to reduce BLLs and minimize exposure to lead in housing regardless of the child’s BLL.
• Emphasize in the beginning of the documents that communities with a high prevalence of BLLs 5-9 µg/dL are the same areas with BLLs >10 µg/dL.
• Ensure that screening recommendations, clinical management guidelines and policy implications are distinguished and not interchangeably used.
• Include text to strongly emphasize that Medicaid requires all children to be tested and CDC recommends state and local health departments develop screening guidelines for clinicians. Reference the HITS data and ACCLPP’s Medicaid screening paper that was published in the MMWR.
• Postpone further efforts to finalize the policy document until LPPB gathers and includes feedback from the lead poisoning vocabulary focus groups.
• Continue efforts to finalize both documents because the focus groups target parents and consumers, while the clinical and policy documents target clinicians and the public health community, respectively.
• Revise the policy document to include a table of bullet points that lists strategies to comply with the recommendations. Extract bullet points from ACCLPP’s case management and primary prevention reports in this effort.
• Include a diagram in the clinical document that clinicians can post in the office as a visual aid to assist in interpreting BLL results.
• Highlight the message in the clinical document that capillary blood samples are accepted by health departments and surveillance systems for screening, but appropriate measures must be taken to control contamination. Provide guidance to clinicians by referencing CDC’s established protocol for performing capillary blood draws, the videotape on improving blood lead sampling techniques and other available resources.
• Add a brief section in the clinical document to describe research needs in managing children with BLLs <10 µg/dL, such as a study to identify differences between capillary blood draws and vena-puncture in determining BLL prevalence.
• Ensure that messages in the clinical document are generally consistent with the lead statement on screening the American Academy of Pediatrics (AAP) Committee on Environmental Health is currently updating. However, be mindful that ACCLPP’s clinical document is targeted to a broad audience of providers who serve children, while the AAP statement specifically focuses on pediatricians.
• Replace “BLLs 5-9 µg/dL” with “BLLs <10 µg/dL” throughout the clinical document.

Dr. Brown made follow-up remarks to ACCLPP’s deliberations. First, CDC has discussed whether a fundamental recommendation should be made stating that screening children to identify those with BLLs 5-10 µg/dL will be beneficial to the individual child. CDC has not made this statement to date and agreement was reached during the previous ACCLPP meeting not to lower the BLL of concern from 10 µg/dL. However, CDC has no problem producing a document explaining that jurisdictions are using local data to monitor lower BLLs and determine if the Intervention will be effective. Second, CDC notes that efforts in 1991 to target primary prevention to communities with high rates of children with BLLs >10 µg/dL were unsuccessful.

Third, LPPB expects to complete the final report on the lead vocabulary in June 2004. The focus group data will inform the process of clinicians communicating with parents, but this activity should not delay efforts to finalize the policy or clinical documents. Fourth, the policy document does not describe strategies to comply with the recommendations because this guidance is available in existing well-written reports. Instead, the policy document references ACCLPP’s primary prevention and case management documents as well as CDC’s 1991 and 1997 statements on screening and follow-up of children with EBLLs.

Fifth, Dr. Brown was extremely concerned with ACCLPP’s focus on and use of the term “5-9” due to the danger of identifying a new group of children who need and can benefit from individual intervention. Since no evidence has been collected to date to support this statement, ACCLPP should use the terms “<10" or “>10.” To address the issue of BLLs 5-9 µg/dL, however, LPPB supports ACCLPP making the following research statement. Very young children with BLLs 5-9 µg/dL may actually be the same children whose BLLs are in the process of increasing. Efforts will be made to rigorously evaluate this trend and determine whether health education, DLL reduction and other interventions will interrupt the cycle. Lead is a poison that is not beneficial to the human body and a safe level of lead does not exist.

Sixth, ACCLPP’s letter to the Centers for Medicare and Medicaid Services (CMS) on screening waivers was distributed throughout CMS and reviewed, but new staffs are now involved with this process. Dr. Brown and the new CMS staff will meet on March 10, 2004 to discuss developing consistent guidance. However, CMS has already stated in writing its commitment to creating a waiver process and ensuring screening is performed by aggressively targeting states that do not submit waivers.

Dr. Hoffman placed the following motion on the floor. The <10 Workgroup report should be released in conjunction with the policy document as a collective body of evidence. The policy document should serve as ACCLPP’s official statement for the <10 Workgroup report. Relevant text from the clinical document should be incorporated into the policy document. The clinical document should remain as a separate paper to reach a specific audience. Dr. Lynn seconded the motion. With no further discussion, ACCLPP unanimously approved the motion.

Drs. Binns, Brown and Campbell described the process to continue developing the policy and clinical documents. Drafts will be distributed to ACCLPP for review by e-mail with a request to submit comments electronically rather than through conference calls. None of the revised versions will be labeled or referred to as “final;” instead, dates will be used to distinguish among drafts. A short abstract will be developed and incorporated into the clinical document. ACCLPP will submit comments on the policy document to Dr. Brown by April 15, 2004 and comments on the clinical document to Dr. Binns by May 15, 2004.

• What does the current evidence demonstrate regarding health effects of lead poisoning in pregnant or lactating women and neonates?
• At what BLL should education, follow-up testing or another intervention be initiated?
• What are appropriate interventions for healthcare providers treating lead-poisoned pregnant women, such as educational messages, coordination with the NYC CLPPP, frequent retesting, recommendations for nutritional counseling and calcium supplementation, and postpartum guidelines?
• What are appropriate public health department interventions for pregnant women and other family members, such as environmental assessment of the home or risk reduction?
• Which pregnant women should be screened for lead poisoning?
• What are barriers that prevent healthcare providers from risk assessment, delivery and coordination of care, testing and case management?
• What cultural, ethnic and linguistic issues should the NYC CLPPP and healthcare providers be aware of?
• What information on lead poisoning prevention should medical providers be giving all pregnant women?

Dr. Leighton announced that the expert panel has held two meetings, completed a draft of the literature review and expects to submit a report of its recommendations in Spring 2004.

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Clinical Care. Dr. Michael Shannon, of the Harvard Medical School, joined the meeting by conference call. He described efforts by the Boston Pediatric Environmental Health Specialty Unit (PEHSU) that resulted in publication of a paper in Ambulatory Pediatrics in 2003. Efforts to prevent childhood lead poisoning have historically targeted secondary prevention, such as screening at-risk children. However, the focus is now shifting to primary prevention to assess and abate hazardous environments. Less emphasis has been placed on lead exposure occurring in the fetus despite the fact that lead freely crosses the placenta; fetal brain development is potentially the most critical window of vulnerability; women of childbearing age may be increasingly exposed to lead as greater numbers join the workforce; and the growing number of immigrant populations brings objects and customs known to be associated with lead poisoning.

Although stable isotope studies show that all women mobilize lead from skeletal stores during pregnancy resulting in transmission of some lead to the fetus, less research has been conducted on the epidemiology of exposure to very large amounts of lead during pregnancy producing severe lead poisoning. The existing literature cites pica, occupations and home renovation as potential sources of exposure in pregnant women, but the mobilization of lead in a woman who was severely lead poisoned as a child is a research gap. Pica is defined as the repeated ingestion of non-nutritive objects, while polypica is the ingestion of more than one non-nutritive substance. In a recent study, 38% of ~100 pregnant women self-reported pica behavior with ice, freezer frost, laundry starch, cornstarch, clay dirt and baked clay dirt; 11 women in the study self-reported polypica.

The Boston PEHSU study was designed to determine the existence of identifiable patterns and the consequences of severe lead poisoning with BLLs >45 µg/dL during pregnancy. A case series was developed with two data sets and cases of severe lead poisoning that were treated in consultation with the Boston PEHSU were compiled and reviewed. The study represents numerator data, does not reflect incidence or prevalence, and also focuses on a specific population of women who became severely lead poisoned during pregnancy. Based on a systematic review of MedLine and the literature over the past 25 years, 15 cases of severe lead poisoning in pregnant women were identified. By race/ethnicity, seven women were Hispanic, two were Indian and one was white; race/ethnicity was unstated for five cases. At the time of diagnosis, the mean gestational age was 32 weeks and 13 of the 15 women were in the third trimester.

The pregnant women were identified with a mean initial BLL of 72 µg/dL and presented to obstetricians with malaise, fatigue and anemia. One of the 15 women had a BLL of 104 µg/dL and presented with a seizure; five were chelated. Of the 10 women who admitted to pica, a source was identified for 83%. Of these cases, the pica sources included clay, soil, pottery, other clay-based substances, home renovation, and lead-contaminated bone meal imported from India and used as calcium supplementation. At the time of birth, the mean maternal BLL was 55 µg/dL, the mean hematocrit was 29.5%, the mean neonatal BLL of 74 µg/dL broadly ranged from 26-206 µg/dL, and the correlation between maternal and neonatal BLL was highly significant at 0.72. The mean BLL of newborns was 32% higher than maternal BLLs and ranged from 99% higher to 112% lower. Although skeletal abnormalities are reported in some cases in the literature, no birth defects were identified in the Boston PEHSU series. Of the 15 newborns, 13 underwent chelation therapy.

The uptake of lead in the fetus is cumulative over time and suggests a net unidirectional flow. BLLs in newborns also appear to be higher in offspring of women with low calcium intake. The confounding nature of hematocrit is due to ~99% of circulating lead being bound to the erythrocyte. As a result, anemia, sickle cell disease and other syndromes of chronic anemia may significantly underestimate the overall lead burden. For example, the anemia of the women in the Boston PEHSU series most likely generated underestimates of their lead burden. Conversely, polycythemia may overestimate the lead burden, particularly among polycythemic newborns with a 50%-60% hematocrit at birth.

The Boston PEHSU series argues for targeted lead screening in pregnant women. Several resources are available to assist in this effort. Minnesota’s modified questionnaire has been shown to be useful in identifying lead-exposed women with a fair degree of accuracy. New York and other states have initiated prospective investigations to determine the scope of severe lead poisoning among women of childbearing age and pregnant women. The New York health department and American College of Obstetricians and Gynecologists (ACOG) have created guidelines for obstetricians to follow, such as Lead Poisoning Prevention Guidelines for Prenatal Care Providers. The Boston PEHSU data also suggest that a prenatal history of pica and use of a complementary/alternative medication or lead-based vocation or avocation may be useful predictors of lead exposure.

The study concluded as follows. The incidence of severe lead poisoning occurring in women during pregnancy is not fully known. Because in utero lead exposure produces a significant risk of adverse neurodevelopmental outcomes in children, close follow-up and early referral are extremely important. Consideration should be given to performing secondary prevention by screening pregnant women and conducting primary prevention by providing anticipatory guidance from obstetricians.

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Lead Exposure During Pregnancy Studies. Dr. Howard Hu, of the Harvard School of Public Health, summarized a series of studies that focused on the mobilization of maternal bone lead stores and its threat to the fetus. Although significant data gaps exist in this area, several outcomes are known. Lead substitutes for calcium in the hydroxy appetite of bone and causes bone lead stores to continually increase even as BLLs plateau. Lead stores remain in the body for decades and are not inert; most of lead that is absorbed through pulmonary or gastrointestinal routes is deposited in bone. Lead is continuously removed from the hydroxy appetite crystalline structure by passive diffusion. Bone is a dynamic organ that constantly undergoes deposition and resorption. Pregnancy and lactation are two physiologic stages in life when absorption is greatly heightened.

Study 1 focused on the contribution of maternal lead to maternal BLLs during pregnancy. The cohort was young women who had been raised in central Europe, exposed to lead with a particular isotopic signature and migrated to Australia with a different isotopic signature. The blood subsumed the isotopic signature of the host country, but the BLLs reverted back to the isotopic signature of the home country when the women became pregnant. The results clearly showed that stored lead in bone was the source of lead entering the blood. The proportion of circulating lead from bone ranged from 30%-70%. Because maternal BLLs may pose a threat to fetal development long after environmental lead exposure has actually occurred, focusing efforts on measuring BLLs in children 6 months to 5 years of age may present a missed opportunity to identify the major impact of lead exposure in utero.

Study 2 captured indirect evidence on the potential for lead health effects to transfer from mother to fetus. The cohort was women of similar ages and neighborhoods who survived lead poisoning as children; their children were matched with controls. Children of women who were lead poisoning survivors were found to be three times more likely to be learning disabled. In quantifying the relationship among bone lead levels, BLLs and bone lead outcomes, the amount of lead actually in a woman’s bones must be estimated. However, this information cannot be gathered through questionnaires because the sources of lead are too numerous and diverse.

Instead, bone lead levels should be directly measured by K-x-ray fluorescence (KXRF). This technique has been validated in several studies and serves as the basis of a series of investigations to compare bone and blood lead and determine its ability to predict adverse outcomes. KXRF showed that bone lead levels were better than BLLs in predicting hypertension. At this point, KXRF has not been used to measure bone lead levels in persons <11 years of age because children store 70%-80% of lead in bone and undergo much more active bone resorption and bone deposition than adults. Studies using KXRF in children 11-12 years of age produced imprecise measurements.

Study 3 analyzed the impact of maternal bone lead levels on fetal and infant development. KXRF was used to measure maternal bone lead levels in >600 women who gave birth in middle-class Mexico City hospitals. All of the women had high bone lead levels from past exposure to leaded gasoline in Mexico City. Although BLLs decreased due to the phase-out of leaded gasoline in the 1990s, bone lead levels of the women remained fairly high. The study triggered the question of whether bone lead levels are better predictors of toxicity than BLLs.

The results showed that maternal bone lead levels were better predictors than maternal BLLs of lower birth weight, lower head circumference at birth, shorter birth length and the growth trajectory from birth to one month of age. The findings remained the same after controlling for birth weight. The data indicate that lead crosses the placenta and affects fetal thyroid function and fetal osteocytes. The study also determined that maternal bone lead levels were independent predictors of cord BLLs in the performance of children at two years of age on the Bayley scales of mental development. The study findings served as a basis in epidemiologic analyses being conducted worldwide to determine the ability of BLLs to predict IQ in children.

Study 4 examined the impact of maternal bone lead levels on maternal health during birth. The cohort was pregnant women in Los Angeles with maternal bone lead levels measured by KXRF. The results showed that maternal bone lead levels predicted increased risk of pregnancy hypertension. Study 5 used animal data to determine risks to lactating infants due to lead mobilization from the maternal skeleton to maternal breast milk. The evidence indicated a potentially significant problem. Another study on this issue applied isotopic ratios to demonstrate contributions of bone lead levels to breast milk and breast milk to infant BLLs. Bone lead levels in the Mexico City cohort predicted higher BLLs in lactating mothers and lead levels in breast milk were found to heavily influence BLLs of lactating infants. However, the actual lead levels in breast milk were fairly low at <2 µg/dL.

Study 6 focused on whether dietary calcium supplementation can lower maternal bone lead mobilization and fetal lead exposure. This effort provides a persuasive argument to consider public health strategies to lower the amount of lead mobilized from the maternal skeleton during pregnancy and lactation. Most notably, an exogenous source of calcium should be provided to ensure that the mother’s physiology does not need to dissolve its own bones to meet the enormous demand for calcium in the growing fetal skeleton. Indirect evidence suggests that the strategy may be successful.

Study 7 was a randomized trial demonstrating that a nighttime calcium supplement will depress a specific biological marker of bone resorption. The data also showed that calcium supplements decreased BLLs in lactating women by 15%-20%. Study 8 is an ongoing randomized trial of nighttime calcium supplementation of 1200 mg during pregnancy. The placebo and supplement groups show similar results of a 15%-20% depression in maternal BLLs throughout all three trimesters.

Study 9 considered kinetics and biomarker issues in the context of maternal plasma lead levels. In all blood samples, >99% of lead is attached to the red blood cell and is not available to cross the placenta or other cell membranes. The body of evidence is building toward demonstrating that the amount of lead in plasma compared to whole BLLs can widely vary by factors of 3-5. Plasma lead levels cannot be simply measured because the process is difficult, technically challenging and requires extremely rigorous techniques to avoid contamination. However, a procedure has been developed to take direct measurements of plasma lead levels using specialized equipment to avoid hemolysis. The results showed variation in the ratio of plasma lead levels to whole BLLs by a factor of 3 in normal adults. Bone lead levels were found to contribute to this relationship. Based on the pregnancy data, plasma lead levels may have a separate ability to predict adverse outcomes that may be the mechanism for bone lead driving reproductive problems during pregnancy and lactation.

Study 10 is an ongoing effort to measure plasma lead at each trimester and identify effects on the infant. Preliminary data show that maternal plasma lead levels, particularly those in the first trimester, predict poor Bayley scores on mental development at two years of age. Although replication of all ten studies is a research need, several conclusions can be made at this point. Fetal lead exposure from maternal bone lead mobilization is problematic. The exposure is toxic, has an effect that is predicted by new biomarkers of dose and may be most damaging in the first trimester. Current data suggest that the mobilization of lead from bone occurs throughout the entire pregnancy, but the mobilization peaks during lactation. Calcium supplementation during pregnancy most likely decreases bone resorption, maternal BLLs and fetal lead exposure by 15%-25%. Other potential strategies may be available to reduce the mobilization of lead from bone during pregnancy, such as research focusing on diphosphanates.

Additional data are needed to determine the potential scope of the problem and the distribution of bone lead levels in women of reproductive age in the United States. Efforts should be made to identify other approaches in estimating bone lead levels without taking direct measurements of lead in bone. Most notably, only four centers have capacity to directly measure lead in bone, a national protocol has not been developed for this technique, and the technology will not be available to every hospital. However, research is currently being conducted to address this data need. The study is focusing on whether combined measurements of urine lead levels, BLLs, markers of bone resorption and environmental history can explain variance in bone lead levels and be used as an algorithm in predicting bone lead levels.

Better studies are needed to determine whether the bone lead level burden of girls who had high lead exposure persist into adulthood, particularly since the current data on this issue conflict. On the one hand, physiologic-based and pharmacokinetic models show that bone lead will “wash out” during adolescent bone growth. On the other hand, indirect evidence demonstrates that bone lead is retained. For example, a published case reported that a woman with a high bone lead level and childhood pica had no current exposure. An analysis showed a correlation between children who had shed primary teeth and their bone lead levels at 18 and 20 years of age. Consideration should be given to whether policy recommendations for pregnant women can now be made. At this point, ACOG has not released consensus guidelines for pregnant women on calcium intake. This approach should be explored for all women regardless of whether bone lead levels can be measured or if an extensive environmental history can be taken. Current data show that calcium supplementation during pregnancy has relatively few side effects.

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Panel Discussion. Dr. Hoffman proposed that NYC’s best practices on its high screening rate be compiled and widely shared because many other jurisdictions have poor screening rates. Dr. Brown clarified that Rhode Island and Massachusetts also have high screening rates of 80% and 70%, respectively, among children two years of age. The successes of both states are due to a mature lead poisoning prevention program, a state law requiring screening, active staff to periodically remind providers about the law, and dissemination of public information to educate consumers.

Dr. Stephens suggested that the NYC data on pregnant women with BLLs >20 µg/dL be analyzed to show birth outcomes, results of the home visits and BLLs of family members. He raised the possibility of recommending calcium supplementation for children with marginal BLLs. Dr. Bolger advised ACCLPP to take caution in making this recommendation. Although calcium supplementation may be effective for children with a sub-optimal calcium dietary status, current studies do not clearly indicate whether this strategy will be effective in reducing lead absorption of children with an optimal dietary calcium intake. He also underscored the need to gather additional information before making other dietary recommendations because current data are unclear about the effectiveness of calcium supplementation for women during pregnancy. Dr. Bolger acknowledged that the mobilization of bone depends on the calcium dietary status of the mother.

Ms. McLaine announced that ACCLPP’s case management document recommends assessing calcium status and encouraging adequate amounts of calcium in the diet. Dr. Banner remarked that a recommendation on calcium supplementation will be driven by non-lead issues beyond ACCLPP’s purview. For example, an article that was recently published in Pediatrics focused on bone density and the increasing incidence of fractures. He also noted additional research needs. The current literature minimizes the significant impact of smoking, alcohol and fluoride on maternal lead levels and bone lead deposition. In particular, fluoride affects long-term bone modeling and bone density and also alters the short-term kinetics of the amount of lead incorporated into bone. Dr. Banner proposed that ACCLPP and the Poison Control Center issue joint guidance in Spanish to publicize and discourage pica.

Dr. Binns conveyed that one of the studies Dr. Hu presented demonstrated an impact on fetal and infant development with the Bayley scales. However, these findings differ from the Bellinger data that showed prenatal lead measures were not significant when techniques other than the Bayley scales were applied. Dr. Lynn suggested that the public health community take proactive rather than reactive measures in using media contacts to more widely deliver educational messages and increase public knowledge of lead health effects during pregnancy. Dr. Towers added that communication campaigns to publicize this issue should include specific preventive messages to enhance cooperation with the recommendations among pregnant women.

The panel made follow-up remarks to ACCLPP’s deliberations. Dr. Leighton described some of NYC’s best practices for its high screening rate. Medical providers in NYC are generally not aware of the Medicaid screening requirement, but nearly all physicians are knowledgeable of and comply with the 1993 NYS law for lead screening and reporting. Medicaid managed care providers in NYC must submit information on lead testing indicators. NYC matches information with Medicaid databases to ensure screening is performed. NYC established primary prevention laws 20 years ago and created its lead poisoning prevention program 35 years ago. These actions have resulted in NYC having the lowest lead poisoning rates compared to six other large cities.

Dr. Hu explained that bone environmental exposures and lead in blood remaining from the in utero period contribute to adult lead levels. Additional studies will be needed to distinguish between these sources and also to determine whether dietary supplementation will have an impact in this area. With respect to calcium supplementation, two women in the Gulson study required to take calcium supplements had reduced lead mobilization. This finding led to a randomized trial of calcium intake that is currently underway. In terms of additional research needs, solid data are currently available on the impact of smoking on maternal lead levels. Alcohol consumption was not noted as a potential confounder in the studies because very few pregnant women drank.

Dr. Hu has not seen reports in the literature on adverse outcomes related to fluoride, but he is open to considering this issue. With respect to the impact of maternal bone lead levels on fetal and infant development, Dr. Hu reported that this study is still underway to obtain more data and follow children in the cohort as much as possible. McCarthy scales data at five years of age are currently being reviewed in the context of the growth trajectory and potential reversal of this trend.

The panel responded to Dr. Keyvan-Larijani’s question on whether ACCLPP should make recommendations on chelation during pregnancy. Dr. Hu pointed out that chelation has not been adequately studied to identify potential toxicity and teratogenicity on the fetus. Due to unknown risks, chelation during pregnancy is not recommended. Dr. Shannon confirmed that chelation of specific individuals continues to be a controversial issue in the internal medicine and adult occupational medicine literature. For example, chelation of asymptomatic pregnant women with BLLs 20-30 µg/dL is not recommended, but the health of the pregnant women in the Boston PEHSU series was in jeopardy without an acute reduction of their body lead burden. In deciding whether a pregnant woman should be chelated, Dr. Shannon mentioned that some studies recommend using an absolute number of a BLL, some research advises reviewing the entire clinical status of the individual woman, and some evidence suggests using significant symptoms and extremely high BLLs as criteria.

The panel responded to Dr. Binns’ question on whether current data are sufficient for ACCLPP to make solid recommendations or policy statements on the relationship between pregnant women and lead. Dr. Hu’s position was that providers of women who are contemplating pregnancy should note the nutritional intake of their patients and advise calcium supplementation for those who ingest dietary calcium below the recommended daily value. The current evidence is sufficient to provide this guidance. He hoped ACCLPP would take action because both CDC and NIH have reduced lead research projects. Since more data have been gathered for lead than any other toxin, a widely held belief is that additional research on lead is not needed. However, significant data gaps still exist at both population and mechanistic levels. Dr. Shannon agreed that CDC individually or jointly with ACOG should initiate a process to provide better education on lead poisoning during pregnancy and improve screening of women who are potentially at risk for significant lead exposure. The current evidence supports this effort.

The panel responded to Dr. Keyvan-Larijani’s question on whether ACCLPP should recommend that lead programs place more priority on screening girls than boys since bone grows faster and is more likely to absorb lead during childhood rather than teenage years. Dr. Shannon acknowledged that the medical community is more attentive to lead-poisoned females than males. The stronger emphasis results in providers seeing females more frequently and engaging females earlier in discussions about chelation.

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Discussion on Forming an ACCLPP Lead and Pregnancy Workgroup. Dr. Campbell pointed out that the draft charge for establishing the workgroup was distributed to ACCLPP. The activity is now being considered in response to previous suggestions by several members for ACCLPP to examine this issue in more detail. The draft charge proposes that ACCLPP will convene a lead and pregnancy workgroup to review the literature and other research findings on assessment and screening of pregnant women for lead exposure; evaluation of sources of lead exposure and lead poisoning; management of EBLLs in pregnant women; cultural and behavioral issues influencing lead poisoning and lead exposure in pregnant women; and recommendations for breast-feeding in the presence of elevated maternal lead levels.
The draft charge further notes that to date, neither ACOG nor any other group has issued national recommendations. New York is the only state with lead risk assessment and screening guidelines for prenatal care providers. The draft charge also proposes specific tasks the workgroup will perform. First, data will be evaluated and appropriate recommendations will be issued regarding lead exposure cautions for women of childbearing age and pregnant women, risk assessment and screening of pregnant women, and breast-feeding. Second, data gaps will be described and recommendations will be made for further research in this field. Third, a summary of the evidence and recommendations will be developed for publication in conjunction with ACCLPP. Health departments and practitioners would be the major audiences of the workgroup’s products.

Dr. Campbell asked ACCLPP to discuss whether a lead and pregnancy workgroup should be formed and take a vote to formalize the decision. Her position was that this topic is extremely timely, particularly since CLPPPs, heath departments and CDC grantees throughout the country confront lead and pregnancy issues on a daily basis. ACCLPP’s role in this effort would be to convene a workgroup with members and outside experts to examine these issues and make general recommendations to the public on pregnant women and lead exposures. Dr. Campbell opened the floor for ACCLPP to weigh in on this issue.

Dr. Brown confirmed that CDC’s state and local partners continually struggle with addressing lead and pregnancy issues. Moreover, CDC’s information hotline receives questions on a daily basis related to the implications of lead exposure during pregnancy, specific individuals to test and case management of pregnant women with EBLLs. Medical providers are taking actions in the absence of solid science and guidance. Similar to Dr. Campbell, Dr. Brown was also extremely supportive of ACCLPP forming the workgroup. She hoped the initiative would provide an opportunity to convene the best experts to identify current research conclusions, uncertainties in the available data and unknown areas. Dr. Binns was also in favor of ACCLPP establishing a lead and pregnancy workgroup due to the lack of political will and emphasis on this issue at the legislative level. She underscored that progress will not be made unless an authoritative body makes a definitive statement in this area.

Dr. Banner questioned the rationale for forming a workgroup because ACCLPP is now in a position to make a consensus statement about the need to fill current data gaps in lead and pregnancy related to pica, cultural issues, nutrition and the absence of state laws for lead risk assessment and reporting of pregnant women. He conveyed that the ACCLPP statement could also outline current knowledge, such as avoiding chelation of pregnant women with low BLLs due to unknown risks to the fetus.

Dr. Brown agreed that these issues are the primary focus of lead exposure during pregnancy, but she was uncomfortable with CDC or ACCLPP making a consensus statement or issuing guidance without input from outside experts. The process should be more inclusive because NIOSH, the NYC health department and other groups confront lead and pregnant issues on a daily basis. Dr. Campbell added that a lead and pregnancy workgroup with outside experts is needed to legitimize ACCLPP’s efforts and produce a more definitive product. From a logistical standpoint, a workgroup is also necessary to ensure that the literature is reviewed and draft reports are developed on a timely basis.

Assuming that a vote is taken to approve the formation of the lead and pregnancy workgroup, ACCLPP was divided on whether the draft charge should be shortened or expanded. On the one hand, Dr. Handy advised that the draft charge be narrowed to ensure meaningful information and useful products are generated. On the other hand, Dr. Leighton suggested that the draft charge be broadened to include making recommendations on medical management of pregnant women with EBLLs and advising providers to consult with a clinical center to obtain assistance in decision-making. Dr. Banner responded to this dilemma by describing the five key areas of the draft charge: appropriate individuals to screen, frequency of follow-up testing, actions to address environmental exposures, treatment strategies, and follow-up of the child. He added that the workgroup should not be charged with conducting a basic science review of low-level lead exposures in pregnant women

Dr. Binns remarked that to avoid duplicating efforts, activities of the ACCLPP workgroup should be based on those of the NYC expert panel. She also noted that the literature on spontaneous abortions and risks from a BLL of 5 µg/dL during pregnancy should not be ignored. Instead of solely focusing on studies of pregnant women with BLLs >45 µg/dL, the literature should be reviewed as a whole body of evidence. Ms. McLaine emphasized the need for the workgroup to use ACCLPP’s recommendations on case management of children as a primary data source. Dr. Towers cited additional data sources for the workgroup to use, including previous meta-analyses, Put Prevention Into Action recommendations sponsored by the Health Resources and Services and Administration, and documents describing the basis of these recommendations. Dr. Handy suggested that the workgroup consider patient education as a priority during its deliberations.

Dr. Stephens moved to form the ACCLPP Lead and Pregnancy Workgroup and accept the draft charge; Dr. Hoffman seconded the motion. Dr. Lynn amended the motion to formally add the following items to the draft charge: medical and environmental management of pregnant women, follow-up of infants and children with mothers who have EBLLs, and recommendations for health education needs in this field. With no further discussion, ACCLPP unanimously passed the motion as amended.

Drs. Brown and Campbell described next steps to advance the workgroup’s activities. The workgroup will consult with the NYC expert panel since this group has already completed a literature review of lead and pregnancy; assistance from Dr. Leighton will be solicited in this effort. An ACOG representative will be recruited to serve on the workgroup. Drs. Leighton and Stephens have volunteered to serve on the workgroup, but ACCLPP should submit additional names of potential workgroup members to Dr. Campbell. The following information will be distributed to ACCLPP by e-mail for review and comment: names of proposed workgroup members, slides of the lead and pregnancy presentations, and a draft outline or table of contents listing the major headings of issues the workgroup will address. The workgroup is expected to be convened and produce a progress report at the next ACCLPP meeting