Agency for Toxic Substances and Disease Registry
Board of Scientific Counselors
MINUTES of MEETING
(April 30 - May 1, 1998)
The Board of Scientific Counselors, Agency for Toxic Substances and Disease Registry (BSC, ATSDR) met in a public session at ATSDR, Building 35 Training Room on April 30 - May 1, 1998
TABLE OF CONTENTS
Opening Remarks.
ATSDR Update.
Hazardous Substances Emergency Events Surveillance ("HSEES").
Chemical Safety and Hazard Investigation Board ("CSHIB").
Child Health Initiative.
Environmental Cancer Registry.
Impact of Trichloroethylene ("TCE") Exposure in Children.
Historically Black Colleges and Universities ("HBCUs").
Community/Tribal Subcommittee.
ATSDR's Draft Response to the Subcommittee's Recommendations to the Board.
Great Lakes Health Effects Research Program.
ATSDR Office of Urban Affairs: Mississippi Delta Project.
Uncertainty in Health Guidance Values.
Comments from the Public.
Charge from the Acting Chair to the Board.
Closing Remarks.
Opening Remarks. Dr. Alice Stark, member of the Agency for Toxic Substances and
Disease Registry ("ATSDR" or the "Agency") Board of Scientific Counselors ("BSC"
or the "Board") called the meeting to order at 8:40 a.m. on April 30, 1998. The
meeting was held in the Training Room of ATSDR in Atlanta, Georgia. Dr. Stark
acted as chair due to the absence of Chair Dr. Eula Bingham.
ATSDR Update. Dr. Johnson noted that, by law, Superfund requires a
reauthorization every five years; Congress has debated the current reauthorization
since 1994. The House and Senate have drafted new versions and some portions of
Superfund may be set aside. Dr. Johnson felt that Superfund will not be reauthorized
by the current Congress. Three current bills will strengthen Superfund and provide
ATSDR the ability to work more closely with the Environmental Protection Agency
("EPA") and other organizations.
Dr. Johnson described some organizational changes that have occurred within the
Agency. Dr. David Satcher was confirmed as United States Surgeon General; Dr.
Claire Broome was appointed Acting Director of the Centers for Disease Control and
Prevention ("CDC") and Acting Administrator of ATSDR; Mr. Peter McCumiskey
was appointed Deputy Assistant Administrator; and Ms. Barbara Harris, Director of
the Office of Program Operations and Management.
Dr. Johnson mentioned a publication that he and Dr. Christopher DeRosa recently
co-authored. A copy of the paper was included in the BSC briefing document. He
noted that findings from a national database on NPL sites show approximately 40%
present
completed exposure pathways, though this figure rose to 80% in 1996. Data from
1992 through 1996 indicate 46% of sites are a hazard to public health. Thirty
substances are found at 6% or more of sites with completed pathways. Eighteen of
the substances are
known human carcinogens or reasonably anticipated to be carcinogenic. Many of the
30 substances also possess systemic toxicities. The high percentage of sites with
completed exposure pathways and the toxicity potential of substances in these
pathways show that
uncontrolled hazardous waste sites are a major environmental threat to human
health.
Dr. Johnson reported that at the November 1997 BSC meeting, the Hanford Health
Effects Subcommittee presented its medical monitoring program for thyroid cancer,
parathyroid cancer, and individuals exposed as children to iodine-131. The
Department of Energy ("DOE") requested that Congress fund a $5 million study of
the illegal use of methyl parathion. In a joint effort with EPA as part of the Child
Health Initiative, the Agency is examining Superfund sites where children have the
highest risk of exposure.
With respect to previous meetings, Dr. Johnson highlighted four requests from the
Board and the Agency's subsequent actions:
The BSC requested that "ATSDR form external evaluation panels to review and address issues of science in select ATSDR programs." The Agency formed external
work groups to evaluate the Historically Black Colleges and Universities, Great Lakes
Human Health Effects Research and Uncertainty in Health Guidance Values
programs.
The BSC "asked for an update of the environmental health profiles which were being prepared by Meharry Medical College under the Mississippi Delta Project." Dr.
Rueben Warren of the Office of Urban Affairs will provide an update on the four
needs assessment profiles.
The BSC stated "the Community/Tribal Subcommittee requested a status report on how the Agency has implemented suggestions and recommendations from the Houston meeting." ATSDR compiled and presented its responses to the Houston
meeting to the Subcommittee and is awaiting the Subcommittee's response.
The BSC requested "updates on the Child Health Initiative and Trichloroethylene Speech and Hearing Study." The Agency scheduled presentations for both of these
items on the agenda.
Hazardous Substances Emergency Events Surveillance ("HSEES")--Report of
Findings and Public Health Implications. Dr. Wendy Kaye reported that the data
collected for the surveillance are from 1993 to 1996. Dr. Kaye defined a hazardous
substance emergency event as a sudden or uncontrolled illegal or threatened release of
at least one hazardous substance or the by-product of a substance. She presented a
map illustrating the fourteen states included in the 1993 to 1996 surveillance system
in which 28% of the states were covered. HSEES is comprised of four components:
data collection, data management, data analysis and regular dissemination of reports.
HSEES has to determine victims' injuries, inclusion in a population group, medical
treatment received, and demographics and distance from the event for data collection
forms. The system also needs to ascertain the area, time, environmental sampling,
evacuations and response plan related to the release. A state's surveillance system
may include police and fire departments, hospitals or the media. Any or all of these
entities can notify the state health department, which in turn provides data to
HSEES. HSEES then collects data for quarterly and annual reports and distributes
this information to the general public.
Approximately 80% of events occur in fixed facilities; the remaining 20% occur in
transportation events, i.e., air or water. Although most events only have one
chemical, Dr. Kaye differentiated between the distribution of chemical releases in all
events compared with HSEES events involving victims. In chemical events,
approximately 7,800 victims had more than 13,000 injuries. The three most
commonly reported injuries were respiratory irritation, eye irritation and nausea. In
fixed facility events, employees receive the majority of injuries; in transportation
events, responders receive the most injuries.
Dr. Kaye cited additional statistics regarding victims' injuries: 14% were treated on
the scene; 68% were treated at a hospital but not admitted; 6% were admitted to a
hospital; 7% were observed at a hospital and 5% presented to a physician within 24
hours of the event. The mean age of the victims was 32 years with males constituting
62%. Evacuations were ordered in 11.5% of all events and of those, 68% occurred in
buildings and 17% were based on a circular area surrounding the event. With
multichemical releases, Dr. Kaye reported an evacuation is twice as likely to be
ordered and the likelihood of an individual sustaining injuries is doubled as well. In
all events, 6.8% involve multiple chemicals. Of the ten most frequently released
chemicals involving injuries, multichemical releases occurred most often.
Dr. Kaye recounted some of the lessons learned since the creation of HSEES in 1993.
Most events occur at fixed facilities, do not involve victims, and involve only one
chemical. Events involving chlorine, acids, ammonia and pesticides are more likely to
result in injuries compared to other substances. HSEES data will be used to enhance
the training and relocation of Hazardous Materials Teams, enhance emergency
preparedness among Local Emergency Planning Committees, and perform chemical-specific analyses.
Dr. Kaye proposed future directions of HSEES, including collaborating with the BSC
and the Chemical Safety and Hazard Investigation Board; working with ATSDR's
Division of Toxicology to create additional chemical categories; adding a Department
of Transportation Hazard Team; developing a queriable data set of HSEES events on
the Internet; and expanding HSEES by adding states to ensure sufficient
representation.
Chemical Safety and Hazard Investigation Board ("CSHIB"). Dr. Gerald Poje
explained that CSHIB, a new Board interested in collaborating with ATSDR, was
authorized on November 15, 1990 when the United States enacted the Clean Air
Act. CSHIB was modeled by Congress after the National Transportation Safety
Board ("NTSB") and is an independent federal agency consisting of a chairman and
four board members. The board members are appointed on the basis of technical
qualifications and professional standing in toxicology and air pollution regulation.
Each board member serves for five years and is shielded from civil litigation.
In 1990, the President and Congress acknowledged the growing risk chemicals
present and the need to reduce the likelihood and effects of incidents related to
chemicals. In response to these concerns, CSHIB's mission is to promote safety and
prevent incidents of chemical release. CSHIB is also required to conduct special
studies; advise Congress on the effectiveness of preventing chemical incidents;
establish requirements for reporting chemical incidents; and develop and
communicate recommended actions to improve safety in the production,
transportation, handling, use and disposal of chemicals. More than 278,755 facilities
generate, treat, store or dispose of hazardous materials.
When a chemical incident occurs, CSHIB provides 24-hour communication coverage
and coordinates investigative efforts with appropriate federal, state and local
enforcement and investigative agencies, including the Occupational Safety and
Health Administration ("OSHA"), the Bureau of Tobacco and Firearms, the
Department of Defense ("DoD"), and the National Institute for Occupational Safety
and Health ("NIOSH"). CSHIB typically deploys a team to conduct an on-site
investigation of a chemical incident and may deploy a board member for enhanced
coordination.
CSHIB investigates and analyzes chemical releases by gathering documentary and
physical evidence, interviewing witnesses and holding public hearings to determine
direct and contributing causes of an accident and identify prevention and mitigation
opportunities. For example, CSHIB may examine the integrity and frequency of the
equipment used and recommend changes in equipment, procedures, training,
regulations, oversight or law. CSHIB may formally convene a Board of Inquiry to
review preliminary facts, findings and recommendations. Because CSHIB is required
to have a memorandum of understanding with NTSB and OSHA, it may also utilize
the expertise and experience of other federal agencies. A high expectation of
coordination with other agencies is implied in the statute.
Dr. Poje concluded by asking for the Board's guidance and input on three issues of
collaboration with ATSDR: (1) research, i.e., hazardous events surveillance, a risk
management planning database, and issues of prevention and toxicology; (2)
investigation support, i.e., provision of investigators, toxicologists, medical personnel
and occupational hygienists; and (3) linkage to other partners due to CSHIB's broad
interest in labor and environmental safety. Dr. Poje reiterated CSHIB's strong desire
for collaboration with ATSDR to maximize the knowledge base of all partners.
Discussion and Recommendations. Ms. Linda Price-King expressed concern about the
dissemination of data as presented by Dr. Kaye. She believed the Agency should
issue a disclaimer stating this information is not necessarily accurate. Because acute
injuries occur at sites, Ms. Price-King felt that oftentimes doctors have no knowledge
of what symptoms to look for when examining victims of chemical releases, and as a
result, overlook the actual cause of an event at a site. Although ATSDR should assist
community residents, Ms. Price-King saw no evidence that the Agency incorporated a
public health emergency clause in the Comprehensive Environmental Response,
Compensation and Liability Act of 1980 ("CERCLA") related to sites. Dr. Kaye
replied that HSEES has specifically analyzed acute injuries related to the
consequences of spills. While investigations of acute events have been conducted, no
projections of occurrences have been made. Since HSEES encompasses an 80% to
90% state-based coverage, the number of individuals who do not present to a doctor
should be minimal. Dr. Kaye reminded Ms. Price-King of the 14% of victims who
receive treatment at the sites. In addition, HSEES obtains hospital data.
Dr. Johnson reported that in 1980 when Congress enacted CERCLA, there were a
number of revisions which related to the incident at Love Canal in New York. Of the
three provisions in CERCLA related to health care and testing, ATSDR has had great
difficulty implementing one provision located in Section D. Because no legislative
history exists as to what constitutes a public health emergency, the Agency has
defined such an occurrence as an event declared by the President, i.e., hurricanes or
other natural disasters. Although Section E in CERCLA addresses public health
emergencies, no support exists for ATSDR to provide medical care and treatment. As
of 1981, public health hospitals were no longer in existence. Congress asserted in
Section E that ATSDR can serve as a referral for medical care and treatment; Section
104(i)(9) addresses medical monitoring, periodic medical testing and a referral
mechanism for treatment. Dr. Johnson acknowledged that this language has not been
the subject of debate for any change by Congress.
Dr. Robin Leonard inquired about the inclusion of the incidence of "near misses" in
Dr. Kaye's data, as well as the consistency of the states' reports. Dr. Kaye replied
that although "near misses" are a new addition, these data are being collected on a
chemical-by-chemical basis. Additionally, checking the consistency of states' reports
is not possible due to the diversity of states; however, HSEES obtains quarterly
information from the databases of EPA, DOT and other federal agencies, conducts
case evaluations, disseminates quarterly updates to states, holds meetings with states
to discuss these issues, and has staff in place to answer any questions states may have.
Dr. Maria Morandi suggested that HSEES incorporate mortality data which may be
due to trauma or chemicals. Dr. Kaye cited 56 deaths from trauma and 22 deaths
related to explosions. Approximately 40% of trauma deaths were directly related to
chemicals. Dr. Morandi asked for a clear delineation of the relationship between
CSHIB and OSHA in the absence of a memorandum of understanding. Although
there have been joint investigations with OSHA in an attempt to collaborate with
other agencies, Dr. Poje stated CSHIB wants to become more experienced before
signing a memorandum of understanding.
Dr. Gershon Bergeisen added the investigation of threats is a worthwhile endeavor
and should be included in HSEES' data as evidenced by Washington, D.C. regularly
receiving seven to ten threats a week. He suggested that CSHIB involve community
members at the inception of this initiative and include community investigations as a
source of input. Dr. Poje replied that CSHIB plans to operate in a fashion similar to
the NTSB, which conducts community investigations. Open comment periods will be
a component in this effort as well. Dr. Luz Claudio stressed the need for a
mechanism to disseminate this information to affected communities. Dr. Poje agreed
and cited affected communities as a workforce.
Dr. Stark framed the first question for the Board's consideration. Should ATSDR
seek to expand the reporting area or does the map illustrating the fourteen
HSEES participating states represent a broad enough spectrum of the United
States that is reporting? The BSC had further discussion regarding this issue.
Dr. Jeffrey Roseman questioned the cost to ATSDR and states to collect this
information. According to Dr. Kaye, the annual cost to operate HSEES is $1.2
million. States incur 100% of this cost and the cost per state varies between the
fourteen participating states. Dr. Stark wondered whether the adequacy of the
current coverage was a fair representation of the remainder of the country. Dr. Kaye
speculated that the current coverage reasonably represents the rest of the country.
Dr. Claudio countered that Puerto Rico would not be represented by any other state
because of its differences. Dr. Stark inquired about the usefulness of including
petroleum spills. Dr. Kaye disclosed that petroleum spills are legally excluded from
the statutory authority. If included, the cost of the system would double because
states would be unable to track these spills due to the frequency of occurrences.
Dr. Stark posed the second question to the Board. How can ATSDR increase the
use of the large amount of information collected and expand the use of these
data to other areas? Dr. White suggested that the dissemination of this
information to health care providers would be useful. Medical personnel and
emergency rooms are unprepared because no infrastructure exists to handle an event.
Health care providers are overwhelmed with the large amount of patients resulting
from a chemical release, while at the same time must make attempts to determine the
chemicals that caused the injuries.
Dr. Roseman noted that the HSEES data did not specifically address efforts to
minimize risk factors or training. To fill these data gaps, Dr. Roseman recommended
that case control studies be conducted. As HSEES has no personal or industry
identifiers, Dr. Kaye stated that case control studies were not an option. Dr.
Bergeisen cited the National Institute for Environmental Health and Safety
("NIEHS") as a good source for worker data. Dr. White agreed NIEHS would be an
excellent interface as this agency provides a large part of training.
Child Health Initiative (the "Initiative"). Dr. Robert Amler stated that the three
purposes for this presentation were to (1) report recommendations of the Child
Health Work Group; (2) present a proposal for a national environmental childhood
cancer registry; and (3) discuss ATSDR's strategy for 1999 and 2000. The Child
Health Work Group sought the Board's continued support and recommendations.
There was much progress in the Initiative as evidenced by the active year for
children's health. Although the Initiative was mandated by the President and
Congress, 1998 appropriations did not earmark funds specifically for child health.
Secretary Shalala appointed Dr. Johnson to implement the Work Group's program,
which endorsed four areas of priorities: all childhood asthma, unintentional injuries,
cancer and developmental disorders.
Dr. Lorne Garrettson, Chair of the Child Health Work Group, reported that the
group met in February 1997 to review the Agency's progress as a result of the
recommendations made in the original report. The Work Group was delighted by the
activities and accomplishments of all four divisions involved in the Initiative: the
Division of Health Assessment and Consultation ("DHAC"), the Division of
Toxicology, the Division of Health, Education and Promotion ("DHEP"), and the
Division of Health Studies. The Work Group ensured that children were the clear
focus of the activities.
Dr. Garrettson stated that the Work Group included child health in its health
assessor training and commented on the remarkable work done in connection with
establishing the national cancer registry. The Division of Toxicology wrote a
children's health section in all of its toxicology profiles. The most significant
outcome from this division will be listing children's issues in data needs. The most
important result from DHEP will be the development of a group of child health
clinics to address the needs of environmental exposures to children. Three clinics
have been started in New York, Boston and Seattle; activities are ongoing under this
funding mechanism. The clinics will have a major impact to provide consultative care
to the respective regions and the Work Group applauded this creative move.
One notable issue for the Work Group was to ascertain exactly what is a child health
study. As the Agency reviewed this concern, it became clear that adult studies
addressing exposures in childhood should be considered in child health studies, and
the proposed study of toxins in and around schools should receive priority.
Unfortunately, this topic has several ramifications because oftentimes federal agencies
neglect the needs of schools. On the other hand, ATSDR has identified schools as
worthy of further study. Dr. Garrettson concluded that the Work Group's report is
in draft and is still being reviewed.
Discussion and Recommendations. Dr. Stark requested additional information on the
three clinics, such as the funding source, the function of the facilities, i.e., hands-on
clinics or referral centers, and methods to disseminate information to physicians. Dr.
Garrettson replied that funding is via a cooperative agreement with the Association of
Occupational Environmental Clinics. Each clinic will define its respective patient
population; will primarily be a referral center advertising to very broad centers; and
will be perceived as a tertiary care center. Dr. Garrettson confirmed that physicians
will be referred to the centers.
Dr. Lichtveld made the important distinction that the centers are not clinics, but
rather pediatric referral units. The primary goals and objectives of the units will be to
cross-fertilize environmental and pediatric medicine, provide education, and function
as referral units by working with pediatricians to develop clinical practice guidelines.
Dr. Amler added that ATSDR chose to fund these pediatric referral units given that
the units will immediately be in a position to serve children. Other major activities
under the Initiative are the creation of an expert work group on pediatric assessments
and a children's environmental health and safety task force, the design of an award-winning WEB site, and collaboration with non-government partners. Dr. Amler gave
recognition to the members of ATSDR's Agency Roundtable on Child Health as a
major force in developing the Initiative. The most ambitious component of the
1999-2000 proposal is the childhood cancer registry. Dr. Amler emphasized that the
design of the registry will not be the exclusive domain of ATSDR or scientists, but
will involve collaboration with families and communities.
Dr. Johnson informed the Board of the significant accomplishments in developing the
Initiative. ATSDR has made a major commitment to address exposure of children.
Five years of research demonstrated that the ingestion of contaminated fish by high
consuming populations will lead to problems in children. He recognized the
significance of approximately 1.4 million children residing within a mile of a
hazardous waste site. The Agency firmly believes risk and public health assessments
may not be incorporating young children's behavior in these studies, such as ingesting
soil. Because children have historically been under-appreciated in terms of an at-risk
population, Dr. Johnson expressed ATSDR's commitment to its childhood autism
and cancer studies. The Agency also has completed a number of studies examining
childhood exposure to lead. EPA, NIEHS and ATSDR will work in concert to present
a larger database.
Environmental Cancer Registry. Dr. Je Anne Burg updated the Board on the
National Environmental Childhood Cancer Registry ("NECCR"), which is part of
Superfund's mandate. NECCR requires the Agency to establish registries of
individuals with known exposure and disease, and its first basic concept was to create
a national registry of children with cancer. Dr. Burg approximated 8,700 new cases
of childhood cancer, including leukemia and lymphoma. The second basic concept
was to use this information to assess the relationship between the occurrence of
cancer and environmental exposures to ascertain the relationship between
environmental factors and childhood cancer.
A national law was passed in 1992 designating the CDC as the lead agency in
establishing cancer registries in every state. Dr. Burg stressed the absolute necessity
of obtaining cooperation from a number of agencies. NECCR has a three-phased
action plan: (1) implement the feasibility study in FY'98 through FY'99; (2) write a
report to Congress including recommendations; and (3) request funding to conduct a
pilot project based on the success of the recommendation. During the feasibility
study, the need for the registry and the probability of identifying childhood cancer
cases will be assessed and included in the report to Congress. The purpose of the
registry has been defined as serving the public's need for information by assessing the
association between the occurrence of childhood cancer and exposure to
environmental hazardous agents. NECCR expects to ascertain whether a problem
exists and the reason for increased rates in childhood cancers. State cancer registries
will be used as sources of cancer rate data.
Cancer registries are representative of the environmental information presently
available and the National Cancer Institute currently sponsors two clinical groups.
Dr. Burg cited cancer mortality rates as decreasing, while cancer survival rates are
increasing. Of the 8,700 expected new cancer cases, 1,700 will become mortality
cases. Dr. Burg described Phase I activities NECCR expects to accomplish this fiscal
year: developing a draft policies and procedures manual, conducting technical and
planning meetings, drafting the final manual, holding informational meetings,
reviewing the manual, and providing comments. Phase II activities in FY'2000
include implementing the pilot project, assessing the success of the pilot project and
making recommendations, and requesting funding for the expanded project based on
the success of the pilot project. The proposed Phase III activity in FY'2001 will be to
implement the expanded project.
Discussion and Recommendations. Dr. Stark asked for clarification of whether
comments were being solicited from the BSC. Dr. Burg stated she was seeking
volunteers from the Board to assist with focus groups. Dr. Johnson added that a great
benefit to ATSDR would be for the BSC to comment on the worthiness of the
Initiative as it will need to be marketed to Congress and will require extensive
collaboration. He noted that cancer should replace asthma as the first priority.
Dr. Stark proposed the following recommendation.
The BSC strongly supports Phase I efforts to develop recommendations for
Congress for the purpose of exploring whether the childhood cancer registry
can proceed. Dr. White moved to accept the recommendation; the motion was
seconded by several BSC members; the Board unanimously approved
proceeding with the Child Health Initiative Phase I activities.
Dr. Amler posed the following question for the BSC's consideration.
Does the Board endorse the recommendation of the Child Health Work
Group, which is that ATSDR should focus its resources on key program
elements, such as the pediatric referral units? Although Dr. Collins made a
motion to endorse these activities, which was seconded by several Board members,
the vote did not reach consensus as the BSC had further discussion regarding this
issue.
Dr. Roseman noted the difficulty of reviewing the Initiative in light of the Agency's
other resources, and theorized that ATSDR would ultimately "rob Peter to pay Paul."
Dr. Johnson explained that in its appropriations language, Congress endorsed a
children's health initiative from ATSDR and earmarked new monies for such an
effort; therefore, ongoing programs would not be impacted. The Board's endorsement
would be most helpful in showing the productivity and impact of the Initiative to
Congress during budget discussions. He added that the Agency expects a modest
increase in this effort for the next two fiscal years. Dr. Stark clarified that the BSC
was being asked to support the concept that children will become a facet of existing
programs, such as toxicology profiles.
Dr. Claudio recognized the usefulness of developing a mechanism to link pediatric
referral units and academic research centers. Dr. Amler was uncertain of any link at
this time because the application process for the academic research centers was
incomplete. Nevertheless, the referral units are expected to become self-supporting
facilities in the future. Dr. Lichtveld verified that ATSDR is, in fact, working to
develop this mechanism. EPA, which is convening in the summer to discuss this
issue, has expressed a strong interest in working with the Agency. The management
of EPA firmly believes the referral units and academic research centers will be
connected.
With no further comment or discussion on this issue, the Board unanimously
supported the endorsement proposed by Dr. Amler. Dr. Leonard made a
motion that ATSDR report to the BSC the outcome of the semi-annual
meeting with EPA. The motion was seconded by Dr. Claudio and
unanimously approved by the Board.
Impact of Trichloroethylene ("TCE") Exposure on Oral Motor, Speech and Hearing
in Children. Dr. Ginger Gist introduced the members of the TCE Speech and
Hearing Study, which was conducted at the University of South Carolina School of
Public Health: Team Leader Dr. Eugene Feigley, Dr. Elaine Frank, Dr. William
Cooper and Dr. Yu Huang. The TCE registry was implemented in 1990 and was the
first existing registry. The outcome of the data analysis found that children ages ten
and younger had excess speech and hearing problems. Since that time, however,
more in-depth testing has been conducted on these children. The purpose of this
presentation was to report preliminary findings of the study. Cranial nerves V, VII
and VIII are affected by TCE exposure. The 390 children who participated in the
study were less than age ten at baseline survey. The ages of the children matched the
comparison group which was not exposed to TCE based on drinking water analyses
and residential history.
Dr. Frank explained the three steps of the study. First, participants were recruited.
The team enlisted the children by identifying an unexposed control group, contacting
the subregistrants in the exposed group and providing incentives to the participants.
Second, procedures were tested. The mobile unit and field testers were speech
language pathologists and audiologists who had training sessions in specific
procedures and oral motor screens, including a hearing screening and the Fisher-Logemann test of articulation. Third, in-depth testing of oral motor, speech and
hearing skills were conducted.
After a determination of the children's skills was made, Dr. Feigley described how
exposure was measured, which was principally via ingestion and inhalation routes.
The team used a tap water TCE concentration as a surrogate for the multi-path
absorption rate. The Geographic Information System was used to estimate a subject's
exposure in all subregistry water analyses; the Lagrangian mathematical interpolation
was employed to give a time profile.
Dr. Feigley recalled quite a bit of variability in the means of the different
communities participating in the registry. For the years 1984, 1985, 1989 and 1990
in Rockford, Illinois, the concentration seemed to have increased. Dr. Huang
reported the data used in the analysis were collected from exposure data, speech tests
and hearing tests. Disease history data were gathered as well. The team also utilized
T-Tests, Chi-square tests, a general linear model, a linear regression model and a
logistic regression model in the data analysis.
Dr. Frank mentioned the numerous telephone calls and contact made in both the
subregistry and control groups. Although a maximum effort was made to have every
child participate in the study, some individuals were reported as "no-shows." The
participants in the subregistry resided in Elkhard, Indiana, Battle Creek, Michigan
and Rockford, Illinois; the controls lived in St. Joseph, Michigan and Oregon and
Mount Morris, Illinois. The results of the study demonstrated a percentage of the
participants with structural differences in their palate; however, upon examination of
the children's functions, the differences were insignificant.
Another outcome of the study revealed craniofacial and dental function differences.
Of the children analyzed by exposure level, those with a greater exposure did not
present any differences. It was concluded that these differences did not appear to be
linked to a dose exposure. The dental screening tested for gross abnormalities and the
data found that children with high palatial arches presented with the most dental
abnormalities. Although the results of the dental screening showed no differences in
speech error rates between the subregistry and control groups, Dr. Frank
acknowledged the continuation of the analysis for error types and comparisons to
national data.
Dr. Feigley reported that the percentage of children who failed the hearing screening
was statistically insignificant between the control and exposed groups, the right and
left ears, or between the sexes. The TCE study utilized higher frequency thresholds
than other studies. Frequencies were measured at 8,000, 10,000, 12,500 and 16,000
kilohertz in children, which is comparable to the norm when conducting hearing
screenings in adults. The team also implemented filtered words tests, auditory
filtered group tests, competing words tests and competing sentences test. Again, no
statistically significant differences were found in these combined tests. Dr. Feigley
reiterated the vast amount of work remaining in the TCE study. The team intends to
determine if the exposure group is too large. Future results will be correlated to the
children who failed tests. Another important finding in the study was that children
were exposed to more than TCE.
Historically Black Colleges and Universities ("HBCUs")--ATSDR Program of
Research. Dr. Christopher DeRosa stated that the purpose of this presentation was
to focus on the report by the National Advisory Board ("NAB"), which oversees the
research of the HBCU Research Program (the "Program"). As the NAB's report
addressed the quality, impact and future impact of the Program, Dr. DeRosa asked
for the Board's response to the report. The NAB also intended to solicit the Board's
input and recommendations for the future direction of the Program.
Dr. DeRosa introduced members of the NAB. Dr. Marcellus Grace, Dean of the
College of Pharmacy at Xavier University of Louisiana and Principal Investigator of
the Program would provide an overview. Dr. Gary Wolfe of R.O.W. Sciences and
NAB member would outline the quality of the science of the Program. Dr. James Bus
of Dow Chemical and past President of the Society of Toxicology would present
information related to the toxicology component of the Program. Dr. Bailus Walker
of Howard University, past Chair of the BSC and NAB member would present the
future direction of the Program.
Dr. DeRosa also recognized Dr. Magdi Soliman of Florida A&M University and the
Program's Director; Dr. Basil McKenzie, past Vice President of the Robert Wood
Johnson Pharmaceutical Research Institute and NAB member; Mrs. Carol Lewis,
Executive Director of the Minority Health Professions Foundation (the
"Foundation"); and Foundation staff Dr. Annette Ellis and Mr. Anthony Winn. Dr.
DeRosa commended the invaluable efforts of Dr. William Cibulas and Dr. Mildred
Williams-Johnson of ATSDR in this initiative.
Dr. DeRosa defined the role of toxicology in public health as the information that
supports optimal decisions. The Program collaborates with colleagues at NIEHS and
EPA to find fundamental quantitative and qualitative conclusions about toxicology.
One significant outcome of this applied research has been the expansion of the
information base to include exposure pathways, body burdens, toxicity, target organs,
biomarkers and mechanisms. The utilization of these data will lead to improved
public health assessments at sites. The Program, which is in its sixth year of research,
is designed to address the needs of the population exposed to hazardous substances
and is a critical mechanism for filling priority data needs.
Report of the External Evaluation Panel. Dr. Grace explained that the Association of
Minority Health Professions Schools ("AMHPS") is a subset of the HBCUs. AMHPS
represent nine of the 110 HBCUs in the sciences of dentistry, medicine, pharmacy
and veterinary medicine. In 1986, the Foundation was created as a mechanism to
obtain federal grants for the HBCUs. At that time, a plan was presented to partner
with ATSDR for the Substance Specific Applied Research Program to focus primarily
on capacity building and infrastructure.
In the third year of the Program, significant experiments were being conducted at the
HBCUs. A cooperative agreement differing from other traditional grants was
awarded to fund the Program, but the relationship was indeed a true partnership.
The cooperative agreement provided an opportunity for the HBCUs to significantly
contribute to science. As a stipulation to the cooperative agreement, the Foundation
instituted mandatory site visits to the schools. Other serious measures were taken to
protect the Program's integrity, such as recommending that an institution's project
not be funded. To further ensure the quality of the Program, manuscripts,
publications and abstracts were reviewed both internally and by ATSDR. At the
conclusion of the first five-year cycle of the cooperative agreement, the Foundation
hosted its Biomedical Symposium in April 1998. Dr. Grace referred the Board to the
Environmental Health & Toxicology Research Program brochure, one of the Foundation's
major accomplishments from the first five-year cycle.
Dr. Wolfe recognized two NAB members who were unable to attend the Board
meeting: Dr. Frank Greene of Pennsylvania State College of Medicine and Dr. Judith
Weis of Rutgers University. The primary objective of the Program is to conduct
research for ATSDR's identified data needs for priority hazardous substances and
enhance existing capabilities. The nine hazardous substances investigated were
benzene, benzo(a)pyrene, cadmium, fluoranthene, lead, mercury, toluene,
trichloroethylene and zinc. Dr. Wolfe delineated the five HBCUs involved in the
Program along with their projects:
Charles R. Drew University of Medicine and Science--Inner City Environmental Lead
Exposure and Hypertension;
Florida A&M University, College of Pharmacy and Pharmaceutical
Sciences--Mechanisms of Lead and Cadmium Toxicity;
Meharry Medical College, School of Medicine--Acute and Subchronic Inhalation and
Oral Toxicity of Benzo(a)pyrene and Fluoranthene;
Morehouse School of Medicine--A Longitudinal Study of Lead Poisoning From Maternal-Infant Relationship Through Early Childhood; and
Xavier University of Louisiana, College of Pharmacy--Multimedia Study of Lead,
Cadmium, Zinc and Benzene in an Urban Environment; Developmental Toxicity of Benzene in
Two Species of Fish; Developmental Toxicology of Benzene in Rats and Mice; and Neurotoxicity
of Subchronically Administered Zinc in Rats.
The functions of the NAB are to review progress reports, provide expert scientific
support and guidance to funded investigators, review continued applications, meet
with funded researchers and their teams to discuss projects' progress, and make
necessary recommendations. Dr. Wolfe concluded that the highlights of the Program
are the publications and presentations, and confirmed that infrastructure
enhancement has indeed occurred at all of the member institutions. The universities
have obtained funding sources in addition to the cooperative agreement with
ATSDR.
Dr. Bus' review of the Program was from the perspective of an outside scientist. The
Program has been and is an important stimulus for the inclusion of minority
institutions in science. The basis for the rationale of the Program was due to the
extensive explosion in environmental sciences and toxicology, but an under-representation of minority scientists. Scientific judgments regarding the health and
environmental effects of chemicals must be supported by scientific talent and data of
the highest caliber.
Dr. Bus recognized the Program as an essential element supporting the growth and
maintenance of minority-focused research and training. Some benefits obtained by
this collaborative effort have resulted in an increase of research and training
opportunities for minorities; improvements in the quantity and quality of research
facilities capable of addressing research questions of interest to minority communities;
expanded opportunities for technology transfer; improved interaction of minority
scientists with the health and environmental research community at large; outreach
programs that have credibility within minority communities; and broad support and a
funding base for research from NIEHS, industry or other organizations.
While evaluating the Program's research, Dr. Bus discovered clear and convincing
evidence that the projects were focused on research questions of concern to minority
communities, and also confirmed a high level of research productivity in a relatively
short period of time, including journals and publications peer reviewed by ATSDR
appearing in high quality research journals, contributions made to minority scientists
in need of training, and increased interaction with the environmental research
community, such as presentations to and active participation in annual Society of
Toxicology meetings. Dr. Bus impressed upon the Board that the quality of scientists
and facilities of the Program are attracting funding in general; in particular, he touted
Xavier University's state-of-the-art environmental aquatic toxicology facility as a
prime example of the success of the Program. He firmly stated his belief that the
Program will continue in both its effectiveness and impact.
Dr. Bailus Walker commended Dr. Johnson for his support of the Program. Because
the issue of children and lead is a major topic of debate, Dr. Walker foresaw the
establishment of centers for children as an excellent opportunity for the Program to
become more actively involved in childhood studies. However, current data gaps will
need to be filled, such as obtaining further information about the relationship
between exposure and dose, as well as securing the foundation on which science is
based.
Dr. Walker proposed other future activities of the Program, including marketing
capabilities; obtaining additional capacity to strengthen Foundation schools as
national environmental resources; continuing to establish partners and other
collaborative relationships; developing a clear research program designed to assess
children's exposure to environmental toxicants and health outcomes; developing
research and training programs to enhance the cross-training of epidemiologists and
toxicologists; developing an agenda to address gaps in research on endocrine
disrupters, i.e., pesticides and immunotoxicology issues; and quantifying multiple
routes of urban environmental exposure including household dust.
Discussion and Recommendations. Dr. Stark asked for the Board's comments related
to the quality of the science of the HBCU Program. Due to previous associations
with the Program, Dr. White attested to its high quality, as well as enthusiasm by its
participants. Dr. Stark concurred that the rate of publications documents the success
of the Program. Additionally, Dr. Stark applauded how the Program was planned and
established.
Dr. Leonard requested information on the number of graduate students in the
Program, and inquired about the percentage of these students who enroll in medical,
pharmacy or dentistry schools. Dr. Soliman replied that thirty students participate in
the Program each year and stated the impact on students' training is excellent. Dr.
Walker added that Florida A&M University recently opened a graduate program in
public health and admitted 19 students.
Dr. Stark wondered whether faculty were attracted to the HBCUs because of the
Program. Dr. Soliman described the unique expertise of faculty at the institutions,
such as Morehouse's psychometrician. Dr. Claudio asked whether any expansion
programs were planned for the future. Dr. Soliman reported that the Program has
instituted an exchange program pairing majority and minority institutions, i.e.,
Tulane University with Xavier and Emory University with Morehouse School of
Medicine. Dr. Walker added that the National Library of Medicine has created an
initiative for the institutions to have access to toxicology and environmental health
data.
Dr. Collins questioned what tools were used to recruit students. Dr. DeRosa
admitted difficulty in recruiting students in environmental health and toxicology;
however, NIEHS has tracked the success of former students in this discipline to
present to potential students. Ms. Doris Bradshaw noted that the Program did not
include multiple chemical studies. Dr. Walker clarified that these studies will be in
the Program's future agenda.
Dr. Johnson saw the HBCU Program as a marvelous success story and in line with Dr.
Satcher's first priority as Surgeon General of eliminating disparity in health status
across racial lines. Of all at-risk children, two-thirds are African American and
Hispanic. The HBCU Program has the potential for ascertaining whether mortality
data are related to the environment, as well as answering a number of other health-related questions. Dr. Johnson asked for the Board's endorsement of the Program,
which would be solid ammunition during budget discussions before Congress. Dr.
Leonard commented that the Program is in concert with the agenda of other health
agencies and science agencies. Dr. Stark was pleased that the Program does not have
a cancer study and is focused on other issues. Historically, cancer has been the
subject of much medical attention, which has caused scientists to neglect identifying
the role the environment plays in health effects.
Dr. Roberts advised the Foundation of the extreme importance in documenting the
Program's activities to educate other scientists and the general public. He urged the
Foundation to apprise Congress and politicians about its mentor program by inviting
Congressmen to meetings to engage in dialogue with the students. Since it appears
the Foundation has the formula for a successful research program, Dr. Roberts
challenged the member institutions to instruct other schools. He requested that the
Foundation provide a one-page fact sheet about the Program and recommended that
each Board member disseminate this information to their respective institutions.
Dr. Stark moved for the Board to strongly encourage its partnership with the
Foundation, and to commend and recognize the accomplishments of the
HBCU Program. The motion was seconded by Dr. Claudio and unanimously
approved by the BSC.
Community/Tribal Subcommittee--Charge from the BSC Chair. Dr. Morandi
emphasized that the Subcommittee's summary report which had been distributed to
the Board was in draft form. The objective of the presentation was to respond to Dr.
Bingham's formal charges to the Subcommittee of providing the BSC with advice and
citizen input, and making recommendations on community/tribal programs, practices
and policies. The Subcommittee was also charged to provide a report to the BSC,
select three individuals to attend BSC meetings, and institute a rotation system for
the Special Consultants.
Subcommittee's Report to the BSC. The Subcommittee's first meeting was held on
February 6, 1998 during which a number of topics were discussed, including
operational issues. The Subcommittee designated four questions related to this
subject to Dr. Xintaras to which he responded during the Subcommittee's April
meeting. The remaining issues established a framework for future discussion of
recommendations for the Board's approval.
Section I. The Subcommittee's recommendations to the BSC were categorized as (i)
operational procedures, (ii) issues for the Board's consideration, and (iii) future
agenda items. The following topics are the Subcommittee's requests and ATSDR's
subsequent responses to operational procedures.
1. The Subcommittee requested that ATSDR clearly delineate the process for lines of
communication as it relates to the Special Consultants. ATSDR's Office of the
Assistant Administrator has implemented the following methods for the Agency to
receive community reaction to its programs, activities and policies: (i) Special
Consultants shall communicate any formal issues to the BSC via the Subcommittee's
Chair; and (ii) Special Consultants shall communicate any informal issues directly to
ATSDR personnel.
2. The Subcommittee requested that ATSDR provide more information on the Federal
Advisory Committee Act ("FACA"). ATSDR distributed Executive Order 12838 to
the Special Consultants. Both President Clinton and Vice President Gore have stated
their positions that too many advisory committees exist. The number of these
advisory groups should be reduced by one-third; the cost to operate advisory
committees should be reduced by 5%. The Division of Health and Human Services
has a ceiling of 169 advisory committees, and to date, DHHS has 169 advisory
committees. Dr. Xintaras urged the Special Consultants to thoroughly review
Executive Order 12838 because it provides more detail about how a group or
subcommittee can become a federal advisory committee. He informed the Special
Consultants that in order to make the Subcommittee a FAC, the BSC would have to
be eliminated.
3. The Subcommittee requested that ATSDR provide mechanisms for consultant
outreach activities and financial support of same. ATSDR has implemented a toll-free number for Special Consultants to contact the Agency; a toll-free number for
Special Consultants to communicate with each other; and a toll-free bridge for all
official and formal conference calls of the Subcommittee that are required to be
announced in the Federal Register.
4. The Subcommittee requested that ATSDR develop an expedited method for
reimbursement of travel expenses and payment of consulting fees. The Agency is
attempting to develop procedures that will facilitate payment, including advancing
80% of travel expenses if legally possible.
5. The Subcommittee requested that ATSDR provide a court reporter at its meetings.
ATSDR has contracted a rapporteur to provide detailed minutes of Subcommittee
meetings. Since the Committee Management Secretary has determined that the
Agency is only required to produce detailed minutes, the meetings will no longer be
audio taped nor will a verbatim transcript be provided. ATSDR will initially send the
detailed meeting minutes in draft form to the Special Consultants to provide them an
opportunity to make any necessary revisions on the material presented at the
meeting.
6. The Subcommittee requested information on tribal/ATSDR relations. The Agency
has a permanent liaison to tribal governments and expects to hire an additional
environmental health scientist to work with tribal communities by June 1998. A
relevant policy guideline--Policy on Government-to-Government Relations With Native
American Tribal Governments--has been developed to address the public health
concerns of the tribes.
7. The Subcommittee requested that ATSDR use the same criteria to select new
consultants as are used to choose charter members, i.e., national recruitment,
application process, and selection of consultants by the BSC.
Section II. The following recommendations are issues proposed by the Subcommittee
for the Board's consideration. These recommendations derived from a table which
summarized ATSDR's responses to the Community/Tribal Forum as a result of a
September 1996 meeting in Houston, Texas.
The Subcommittee shall (i) meet before the BSC meeting in November 1998; (ii)
meet face-to-face four times a year; and (iii) hold conference calls to address specific
issues.
The Subcommittee shall obtain confirmation to obtain Dr. Morandi and Dr. Roberts
as Co-Chairs for an additional year. Although both Drs. Morandi and Roberts
declined this proposal because of other commitments, they agreed to avail themselves
to the incoming Chair via conference calls. In the future, Dr. Morandi suggested that
the Subcommittee have a single chair as opposed to two Co-Chairs.
The Subcommittee shall utilize Dr. Henry Cole as an information resource during its
deliberations.
The Special Consultants shall serve as follows: (i) the membership terms of Ms.
Bradshaw, Ms. Grandpre and Mr. Matheny will expire after two years; (ii) the
membership terms of Ms. Jim, Mr. Lorrigan and Mr. Sanchez will expire after three
years; and (iii) the membership terms of Mr. Crafter, Ms. Moses and Ms. Price-King
will expire after four years.
The Subcommittee recommended that ATSDR develop a mechanism to address
exposure of small populations and explore alternatives to the standard methodology.
The Subcommittee recommended that ATSDR seek funding and statutory authority
to develop health clinics in communities to serve as emergency response centers,
which could be mobile centers.
The Subcommittee recommended that ATSDR make health-related services equally
available to all communities.
The Subcommittee recommended that ATSDR explore funding mechanisms to
extend technical assistance grants ("TAGs") to include health, although the Special
Consultants acknowledged these grants are under the purview of EPA. ATSDR
cannot give local groups money, but there should be a method devised to allocate
funds for community groups to hire technical people when health becomes an issue.
The Subcommittee recommended that ATSDR develop a glossary of terms. A
representative or working group from the Subcommittee should review the glossary to
determine its appropriateness for a particular community. If documentation exists
regarding procedural steps or health associated activities when visiting a site, this
material should be provided to the Subcommittee. This process must also include an
evaluation component.
The Subcommittee recommended that ATSDR disseminate any available information
about its findings of affected neighborhoods through schools, churches, local
repositories or other areas easily accessible to the impacted community, and make
this information immediately available to residents. ATSDR should post signs in
public places of affected areas to make its presence visible to all residents. The Subcommittee recommended that ATSDR utilize the Subcommittee as an external sounding board to provide input in the evaluation of ATSDR's policies and
procedures. The Subcommittee shall develop an outreach mechanism to solicit input
and feedback from affected communities throughout the country in order to serve as
a conduit for community input to ATSDR and the BSC. The Subcommittee is able
to provide input on the following issues:
sensitivity, cultural and competence training of ATSDR staff;
ATSDR's draft policies and operating procedures on ongoing activities, community
entry, needs assessment and community involvement; and
ATSDR's site-specific evaluations. If this recommendation is approved by the BSC
and ATSDR, the Subcommittee shall create a working group charged to develop an
information packet for the Agency's site team visiting communities; however,
administrative support for this effort was requested. The packet would include the
Subcommittee's role, membership, telephone numbers and an evaluation form, and
would be used to provide input to the Agency's community activities.
The Subcommittee recommended that ATSDR send staff to community sites in
advance of any activities to understand the socioeconomic context of the community
and include this component in its action plans.
The Subcommittee recommended that ATSDR inform the Special Consultants of the
calendar of working groups and committee meetings.
Section III. The Subcommittee proposed the following requests as future agenda
items.
Presentations by the (1) Community Involvement Branch, (2) Office of the
Ombudsman and (3) Office of Urban Affairs as to their functions, the relationship
between these offices, and their roles related to the Subcommittee. The Special
Consultants also requested presentations related to the Agency's community entry
process, and an orientation of ATSDR's staff, programs and policies.
Discussion of the need and purpose for a biennial meeting of the Community/ Tribal
Forum.
Presentations by Frank Bove and other health experts on the limitations, study
design, protocol and site suitability methods of health studies.Discussion of the portions in the Superfund Reauthorization that address public
health emergencies and provision of testing and medical records.
Presentation and discussion of ATSDR's budget.
Presentation and discussion of ATSDR's structural changes and mandates.
Presentation and discussion of ATSDR's methods in deciding how communities are
selected. The Subcommittee wants to be a part of this process to ensure the highest
needs are addressed first.
Presentation and discussion of morbidity and mortality issues.
Discussion of ATSDR being the lead agency at Superfund, federal and NPL sites
when adverse health effects are identified.
Additionally, the Agency submitted items to the Subcommittee for inclusion on a
future agenda. DHAC requested that (1) site entry guidance, (2) site inactivation
and (3) participation in a proposed DHAC Child Assessment Workshop be
incorporated at a future Subcommittee meeting. The Special Consultants moved to
include these items on the agenda of their next meeting. DHEP requested a
collaborative effort with the Subcommittee to develop risk assessment
communication training programs designed to enhance the sensitivity and skills of
ATSDR staff working with tribes and communities. As the Special Consultants
unanimously supported this request, Mr. Sanchez and Ms. Bradshaw volunteered to
collaborate with the evaluation team's project. Additionally, Dr. Morandi asked that
the evaluation team present its overall plan at the next Subcommittee meeting.
Discussion and Recommendations. Due to the vast amount of information presented
by the Subcommittee, Dr. Stark suggested a telephone consultation with the Board
members in the future. The BSC unanimously agreed to officially revisit operational
issues before taking a vote. As ATSDR was anxious to progress to the next level of
the Subcommittee initiative, Dr. Johnson committed to responding to the issues
listed under the remaining two sections the following day.
Dr. Bergeisen informed the Special Consultants that the current law would have to be
changed in order to make another agency the lead agency. Mr. Marvin Crafter
replied that ATSDR should have the authority to stop activities at a site until an
assessment has been made. Ms. Bradshaw agreed by citing the Memphis, Tennessee
situation wherein DoD was the lead agency and caused many problems to the
community, which was attempting to obtain assistance from other federal agencies.
Mr. Sanchez clarified that the Subcommittee was not asking the federal agencies to
break the law, but rather to find methods to protect residents' health. At Dr.
Claudio's request, Dr. Roberts asked that the Special Consultants consider individuals
from the University of Puerto Rico as co-chairs during the next Subcommittee
rotation.
Dr. Johnson stated that the Chair, Dr. Bingham formally appoints subcommittee
chairpersons.
Ms. Price-King asked that the Board seriously consider the mechanisms by which the
Special Consultants meet. Mr. Richard Matheny agreed by stating the unfairness of
allowing the Subcommittee two days to meet, review material, develop
recommendations and present a report to the BSC. Dr. Roberts reminded the Board
that this initiative was ATSDR's first major foray to obtaining citizen input using
community residents. The effort was designed to communicate and express
frustrations, concerns and requests in an administrative regard.
There being no further comments or discussion, Dr. Stark adjourned the BSC
meeting at 4:50 p.m. on April 30, 1998.
Dr. Stark reconvened the BSC meeting on May 1, 1998 at 8:45 a.m., and reminded
the Board of the change in the agenda to allow Dr. Johnson to respond to the
Subcommittee's report.
ATSDR's Draft Response to the Subcommittee's Recommendations to the Board.At Dr. Johnson's request, ATSDR's draft responses were duly recorded and incorporated
into the record of the Board's April/May 1998 meeting.
Agency staff met after the adjournment of the BSC meeting the previous day, and
reviewed each of the recommendations made by the Subcommittee. Dr. Johnson
prefaced his comments by stating the Subcommittee's recommendations were positive
and made in the spirit of partnership. ATSDR looked forward to working with the
Subcommittee and responded as follows:
Responses to Section II--Issues for the Board's Consideration.
Item 1--ATSDR concurred with this recommendation and looks forward to working
with the Subcommittee to identify a facilitator to manage meetings and conference
calls; however, Dr. Johnson emphasized that the Agency should not be burdened by
this request. Additionally, an e-mail system will be created for the Subcommittee.
Item 2--This recommendation is not possible due to ATSDR's policy of rotating
chairs.
Item 3--ATSDR concurred with this recommendation.
Item 5--ATSDR requested clarification on this recommendation and suggested
combining this topic with Section III, Item 2 as a future agenda item.
Item 6--ATSDR is not prepared to go forward with this recommendation at this
time, but is willing to discuss this matter with the Subcommittee. The Agency
acknowledged that such discussion should include communities' access to local health
care, and suggested combining this topic with Section III, Item 4 as a future agenda
item.
Item 7--ATSDR requested clarification on this recommendation and suggested
combining this topic with Section III, Item 7 as a future agenda item.
Item 8--ATSDR committed to exploring this possibility with EPA, which has the
only designated authority under Superfund to award TAGs. Dr. Johnson noted that
the Agency has testified before Congress advocating for TAGs for health
professionals.
Item 9--ATSDR committed to working with the Subcommittee to develop a glossary
of terms; however, the Agency requested clarification of "to determine its appropriateness for a particular community." ATSDR will provide the Subcommittee
with its procedural steps for community site visits. The evaluation component will
require further discussion with the Special Consultants.
Item 10--ATSDR concurred with this recommendation and looks forward to further
guidance from the Subcommittee. Dr. Johnson added that the Community
Involvement Branch will also be included in this effort.
Item 11--ATSDR concurred with the spirit of the recommendation by accepting the
Subcommittee's invitation to discuss various policies and procedures. ATSDR
recognized the need for the Special Consultants to outreach to communities and
Tribal Nations, but the mechanism and purpose for the outreach will have to reach
consensus.
ATSDR looks forward to working with the Subcommittee on issues of sensitivity,
cultural and competency training of Agency staff.
ATSDR welcomed dialogue on draft policies, operating procedures and other items,
but advised the Subcommittee to determine what constitutes the policies and
procedures it wishes to discuss. The Agency needs to move quickly on some policies;
therefore, the Subcommittee cannot be made aware of each policy and procedure.
ATSDR understood the importance of having evaluation independent of the Agency;
however, Dr. Johnson foresaw major problems and several concerns with the
evaluation form due to Office of Management and Budget clearance. ATSDR
suggested a demonstration project and further discussion on this issue.
Item 12--ATSDR concurred with this recommendation and offered the Community
Involvement Branch's participation in this effort.
Item 13--ATSDR concurred with this recommendation, but requested clarification.
Dr. Johnson suggested that the Subcommittee consider outreach to EPA as well.
Section III--Future Agenda Items. ATSDR accepts these recommendations in
general; in particular, will need clarification on the following items:
Item 5-- ATSDR committed to sharing any budget information available to the
public and describing the budget process; however, the Agency views the
Subcommittee making budget recommendations as inappropriate. Dr. Johnson firmly
held that advisory boards to the government are off limits in some areas, and the
budget is not within the province of the Subcommittee.
Items 6 and 7--ATSDR needs further clarification.
BSC Discussion and Recommendations. Dr. Leonard noted that the topics related to
TAGs and lead agencies were also EPA issues, and wondered if anything could be
gained from the Subcommittee presenting these topics to EPA. Dr. Johnson replied
that the BSC and Subcommittee are working in an open and candor manner for the
sake of public health. Since obtaining the involvement of EPA is certainly consistent
with this philosophy, Dr. Johnson recommended that the Special Consultants
consider meeting with EPA, beginning with EPA Superfund leadership. Dr. Bergeisen
committed to distributing the Subcommittee's recommendations to EPA executive
leadership and senior managers, and reporting any determinations made by EPA to
the Board.
Dr. Cole urged that caution be taken when meeting with EPA due to the relationship
being new. The most important factor in this initiative is building a relationship of
trust between the BSC and Special Consultants. A history of collaboration between
the Board and Subcommittee should be established before other agencies are involved
in this effort. Before meeting with EPA, Dr. Cole believed the Subcommittee should
be consulted to determine which issues should and should not be discussed.
Dr. Stark commented that the Subcommittee's report was a new, original and
extraordinary occurrence, and the first formal exchange between the Board and the
Special Consultants. Both the BSC and Subcommittee should take time to reflect on
the background material provided by Dr. Morandi, the Subcommittee's report, and
ATSDR's responses to the report. At that time, Dr. Stark felt that methods could be
developed on how best to proceed. Dr. Roberts challenged the BSC to continue the
Community/Tribal process, and urged the Board to continue to nurture this unique
opportunity of getting to know the community residents first-hand. He opined that
the Board has become more responsive as a result of listening to citizens' input.
Dr. Morandi requested a mechanism to provide clarifications due to the vagueness of
some of the Subcommittee's recommendations. Dr. Johnson preferred that the
Subcommittee add a page of clarification, which would become a part of the record
for the Board's meeting. Dr. Stark informed that Board that initial steps were taken
by Drs. Morandi and Roberts to transition the new chairs into the Subcommittee.
Dr. Leonard made a motion to support the continuation and discussion of the
Subcommittee's activities. Dr. Morandi seconded the motion, which was
unanimously approved by the Board.
Great Lakes Health Effects Research Program ("GLHHERP"). Dr. DeRosa reported
that the synthesis paper which was distributed derived from 32 recommendations as a
result of a treaty between the United States and Canada at a meeting held in
Montreal. The focus of this presentation was two-fold: evaluate the quality of the
science and assess the impact and future directions of GLHHERP. Dr. DeRosa
intended to solicit the Board's input and recommendations after presenting an
evaluation report.
The strategy of GLHHERP was built upon five elements of disease prevention:
identification, evaluation, control, dissemination and infrastructure, including state
and local levels. CDC established a tissue bank to conduct additional evaluation.
Two new cohorts were established in GLHHERP and attempts were made to build on
existing expertise. Dr. DeRosa described the at-risk populations as Native Americans,
sport anglers, elderly people, pregnant women, fetuses, nursing infants, women and
men in reproductive years, and immunologically compromised individuals.
GLHHERP is in its sixth year and is administered through grants to states and
academic institutions. Exposure pathways and body burdens have been identified in
at-risk populations, and persistent toxic substances in the Great Lakes Basin have
been discovered, including polychlorinated biphenyls ("PCBs"), dioxins, heavy metals
and benzo(a)pyrene. A potential association between exposure and adverse health
effects is currently being evaluated.
Report of the BSC Evaluation Work Group. Dr. Stark thanked the GLHHERP
Subcommittee which assisted in developing the report: Drs. Bingham, Brix,
Fitzgerald, Mattison, Minear and Needham. She summarized the quality of the
research grants and reports, as well as the impact and future directions of GLHHERP.
To evaluate the quality of research grants and reports, a three-tiered peer review
process is initially implemented involving reviews from an internal technical panel, an
external panel and an ATSDR/CDC objective panel. The consultants and partner
agencies then score the grants and rank the final selections based on this scoring
system. Dr. Stark informed the Board that of the grants funded in 1995, eight were
scored "very good" and two were scored "fair." The review criteria of the grants
include scientific merit, study design, QA/QC procedures, the adequacy of the study
population, and the time frame for completing the study.
The review mechanism for manuscripts includes an internal panel and at least three
outside reviewers. Dr. Stark emphasized that all comments made by the reviewers are
addressed by the manuscripts' authors; however, final approval is given by the Office
of the Associate Administrator for Science at ATSDR. Dr. Stark described some of
the indicators of scientific quality that are external to ATSDR and used to judge the
quality of the science, i.e., if the manuscripts were published, and could the published
manuscripts be presented at a conference or symposium.
The conclusions Dr. Stark reached were that GLHHERP-supported studies have high
scientific quality and GLHHERP has had major impact, such as briefing Congress and
contacting affected communities and other individuals by distributing fish advisories.
Dr. Stark noted that ATSDR has distributed over one million fish advisories to health
care providers. Developing consistent fish advisories has been a major effort by EPA
within the last ten years. The two major functions of fish advisories are to describe
what types of fish are edible for human consumption and what methods should be
taken to reduce the level of exposure to contaminated fish. In addition to
distributing fish advisories, ATSDR also has disseminated reports and publications
related to GLHHERP.
Dr. Stark touted behavioral changes by breast-feeding mothers as one success of the
program. Although these women continued to breast-feed, they ate less fish as a
direct consequence of participating in and receiving information from GLHHERP. It
was discovered that fish contaminants were being passed through breast milk, which
resulted in higher levels of these contaminants in nursing infants. Other significant
accomplishments of GLHHERP have been partnerships with national and
international agencies, extensive media coverage to inform the public of the
correlation between health and fish, and a positive and substantial impact on the
scientific knowledge of government officials and the scientific community.
Conversely, Dr. Stark noted that improvements need to be made in disseminating
information to health care providers. The general public was well served overall, but
large fish eaters need to be more specifically addressed.
Dr. Stark recalled a literature search wherein methyl mercury, PCBs and other
persistent toxic substances were found to be neurotoxic and developmental disruptors.
Four ATSDR studies identified the existence of impacts on reproductive health,
although these studies are incomplete and the data are inconclusive. GLHHERP also
cannot conclude other adverse impacts, such as immune disruption, thyroid
malfunction and diabetes. Dr. Stark recommended studying these toxic substances
and filling these data gaps as future activities of GLHHERP, and provided additional
suggestions to the Agency as follows:
1. Use already established cohorts to monitor changes in the tissue levels of persistent
toxic substances and specified health and disease states.
2. Develop and evaluate new health promotion and risk communication tools. For
example, several large industries depend on fishing and fishing boats for economy and
tourism.
3. Evaluate time trends relating the Great Lakes contamination to human tissue levels,
i.e., analyze archived specimens and correlate to the changes in water and fish.
4. Explore opportunities to apply knowledge gained about the Great Lakes basin
ecosystem to other challenged ecosystems, i.e., Chesapeake Bay, Puget Sound and the
Gulf of Mexico. Dr. Stark foresaw this concept as a great opportunity to use and
generalize existing work to another part of the United States.
5. Develop new and maintain existing cross-agency opportunities to maximize data
exchange, research collaboration and risk communication.
6. Develop a national clearinghouse for the collection, review and dissemination of
human health information. Dr. Stark referred the Agency to EPA's similar model for
ecosystems.
Dr. Stark proposed that ATSDR review the scientific credibility and value of
GLHHERP to determine whether the program should continue with broad-based
activities or focus on specific activities. The continuation of GLHHERP will, of
course, depend on the Agency's budget. Dr. DeRosa added that ATSDR has had
discussions with EPA and the Office of Minority Health to collaborate in this effort.
BSC Discussion and Recommendations. Regarding the timeliness of GLHHERP's
activities, Dr. Roseman inquired about the median turnaround time between a grant's
proposal and review. Dr. Stark replied that this procedure is faster and more
responsive than applying for an R01 grant. As an example, Dr. DeRosa stated that
the Agency received funds for GLHHERP in 1992 and began the program in FY'93.
Dr. Heraline Hicks agreed with Dr. Stark's recommendations and confirmed that
some of these suggestions have been implemented. She advised the Board that as a
result of the efforts from ATSDR and EPA, Michigan now has a fish advisory uniform
to other states. Because this information can address numerous health issues, Dr.
Morandi encouraged the Agency to expand the distribution of these data.
Dr. Roberts expressed concern that GLHHERP urges some individuals to eliminate
fish from their diets, which is very significant given that fish is a major source of their
food intake. Dr. Hicks clarified that GLHHERP does not advocate for the non-consumption of fish, but rather provides education on what species are appropriate to
eat and offers alternative methods to prepare and cook fish.
Dr. Hicks described some methods utilized by the Agency to have communities
actively participate in GLHHERP. Residents assisted in developing proposals for
grantees of the program, and participated in sessions, forums and classes held in their
communities. Dr. Johnson acknowledged the significance of ATSDR's activities, but
believed the Agency has not done enough in this effort. He asserted that the body of
knowledge collected from five years of research should now be applied. Dr. Johnson
regarded GLHHERP as good in terms of a public health advancement, and solid in
terms of a scientific return based on the funds spent. He reminded the BSC that the
Agency will have to justify continuing this program.
The Board was unable to reach a consensus at this point due to weaknesses identified
in GLHHERP: (1) risk communication and health promotion issues were not
sufficiently addressed; (2) partnerships with other agencies were not implemented;
and (3) adverse health impacts, with the exceptions of methyl mercury and PCBs,
were not firmly established. Dr. Roberts asked that the BSC consider another
limitation. Although the local health education efforts are supported, this component
involves state institutions only, which may be problematic when private institutions
wish to be included in the program in the future.
Dr. Roseman was troubled that the cost of the long-term cohort study may be
unbalanced with the data produced by these studies. Dr. Stark replied that the
cohorts are already established; nevertheless, she agreed this issue needs further
examination. On the one hand, Dr. DeRosa saw the findings on neurobehavioral
development compelling enough to provide a substantive base; on the other hand, he
believed some findings were tenuous. Overall, Dr. DeRosa thought an opportunity
existed to continue with the studies.
Dr. Stark moved that GLHHERP either continue with the new direction
proposed or maintain the existing direction. Dr. Roberts made a motion for
the Board to accept the recommendations and charge ATSDR to move forward
with the program, but be mindful of the fact that the health aspects are paying
dividends. The motion was seconded by Dr. Claudio and unanimously
approved by the BSC.
ATSDR Office of Urban Affairs ("OUA"): Mississippi Delta Project. Dr. Rueben
Warren introduced family physician, Dr. Jewel Crawford to the Board. Although Dr.
Crawford was a recent addition to the Agency, she had already visited communities.
The OUA was established in March 1997 and was currently in the process of
completing a five-year strategic plan. Dr. Warren assured the Board that the progress
of the plan would be measurable. The plan is presently in the formulation stage to
address the needs of all concerned parties. As the Delta is perceived to be the worst
place in the nation, the context of the Delta project was conceived as a true
partnership. Dr. Warren recognized the public as the most important partner in this
effort.
The OUA is charged to provide leadership for minority health, Brownfields and
environmental justice, and hopefully, the Agency will benefit from the overlap of
these three areas. Dr. Warren defined health as a "dynamic relationship focused on the physical, social, psychological and spiritual well being of the individual and/or group and their interaction with the physical and social environment." The Office of
Management and Budget has defined minority groups as African Americans, Asian
Americans, Pacific Islanders/Native Hawaiians, American Indians/ Native Americans,
Alaskan Natives, and Hispanic Americans. Dr. Warren reminded the Board that
these individuals are suffering; therefore, the data should drive the efforts of this
initiative. Additionally, "low income" will broaden the definition of minority groups.
Dr. Warren defined environmental justice as "sites where there is a perceived or real concern by a minority and/or low income population that feel they have not been appropriately involved in matters concerning planning, implementing and evaluating activities related to the environment or environmental health." Communities view
Brownfields as a reaction and not a proaction. Although residents have voiced strong
opposition to the Agency turning Brownfields sites into NPL or Superfund sites on
paper, communities firmly believe that ATSDR is still responsible for Brownfields
sites.
Dr. Warren asked Ms. Charlotte Keys to share her perspectives and assess the Delta
project. Ms. Keys is founder of Jesus People Against Pollution ("JPAP"), an
environmental justice group in Columbia, Mississippi. She resides in the Delta, is a
member of the Delta project's Steering Committee, and has been with the project
since its inception. Ms. Keys has also been nationally recognized by Vice President
Gore for her work.
Community Update. Ms. Keys stressed the great need for community residents to
participate in and become involved with decisions regarding their health and well-being. The residents feel that the federal agencies have been collecting data far too
long and do not have sufficient hands-on experience in the communities' activities.
In a collaborative effort with the Highlander Project, JPAP obtained funds to
incorporate other communities in the Delta project. Although the Delta project was
developed to meet the communities' needs, Ms. Keys noted there is presently little or
no funding for this initiative.
Since many federal agencies may not be sensitive to residents' needs, the
communities' input is invaluable. Ms. Keys requested that Phase II of the Delta
project be funded to focus on the environmental health needs of the community. The
government has previously stated its commitment to the project; however, there has
been little to no assistance from the federal agencies to underserved and under-represented communities. She urged the government to be truthful in this regard
because the promises made thus far have not amounted to any action. In this
environmental health crisis, Ms. Keys saw no evidence of sufficient collaboration or
partnership to implement a problem-solving plan of action. Although federal agencies
fund several small projects, there is no large initiative to properly address these
environmental crises which are plaguing communities. Because residents are unable
to conquer these problems alone, she implored the government to support
communities by offering funding and professional skills.
Ms. Keys recalled that in February 1994, a symposium held in Arlington, Virginia
resulted in the active participation of academia, private sector industry and
communities to prevent environmental hazards from impacting residents' health.
Individuals were unaware that contaminants and other toxic substances had been
dumped and buried underneath the areas in which they lived. She concluded that if
the government is indeed sincere about correcting environmental health justices, now
would be the time for such action.
BSC Discussion. In response to Dr. Roseman's question of what priorities were
considered highest, Ms. Keys replied that assistance from officials with (i) suitable
skills to render needed environmental health services, (ii) appropriate knowledge of
adverse health effects resulting from toxic exposure, and (iii) access to communities
with a hands-on action approach ranked high. Dr. Johnson informed the Board of a
recent occurrence that was both significant and remarkable. The State of Mississippi
passed visionary legislation related to the development of the Brownfields initiative.
Dr. Johnson cited the valuable leadership of Ms. Keys in getting the legislation
passed.
Update on Needs Assessment Profiles. Dr. Warren acknowledged that the profiles
would not have been developed without the assistance of many partners: Ms.
Marilyn DiSioro of CDC; Dr. Vincent Nathan, an environmental health scientist
formerly at Meharry Medical College and presently a NIOSH Fellow; Dr. Bergeisen
for reviewing the proposals and profiles; Dr. Walter Williams, CDC Associate
Director for Minority Health; the Foundation for its sustained commitment to and
coordination of the projects; Meharry Medical College for its leadership in developing
the profiles; Public Health Service Regional Offices; and Dr. Greg Christenson, Ms.
Sandee Coulberson and Dr. Maureen Lichtveld for their invaluable support and
assistance. Dr. Warren mentioned that CDC will remain a full partner in the Delta
project.
The Lower Mississippi Delta Development Commission defined this region as 220
counties in the states of Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri
and Tennessee. The project began because the Delta was identified as a geographic
region of high need; however, Dr. Warren firmly stated his belief that the impact of
this area affects communities throughout the country. Although the project has
demand, intervention and resolution, the resolution has not surfaced but is underway.
ATSDR conducts good science as part of its public health responsibility and not on
the basis of intention. The responsibility to use the best science available takes time
and is one of the reasons for the project's slow pace. Dr. Warren reported that the
collection of secondary data is behind schedule due to an under-estimation of
available information. Additionally, difficulties arose in accessing, formulating and
analyzing data.
An effort that is both problem-solving and solution-finding needs to be organized to
further develop the four profiles: social demographics and health, environmental
hazards, health provider, and educational resources. Dr. Warren conceded there were
difficulties in creating the profiles. The social demographics and health profile was
the most problematic due to outdated, inaccurate and unorganized data; the
environmental hazards profile was vague; and the health provider profile was not
properly defined to include dentists, nurse practitioners, nurse midwives and
physician assistants. Notwithstanding these initial hurdles, the social demographics
and health profile is now complete, and recommendations support that the number
and quantity of health providers be expanded and improved.
Phase II of the Delta project will be to translate the needs assessment into
demonstration projects. Demonstration projects have been developed for the profiles
related to health services, research and education. Dr. Warren described the Head
Start program that was created in Mississippi. To achieve the goal of a data-driven
curriculum to provide environmental health education, parents of the Headstart
children were asked questions. In this random sample, 97% of the parents returned
the completed questionnaire. Dr. Warren cited some findings of the studies: 79%
were African American, 23% were Caucasian; 60% were either high school graduates
or attended college; 37% lived in homes that were at least ten to fifteen years old;
11% used unmonitored well water as a primary source of drinking water, 12% used
this water for cooking and bathing; 5% used cotton poison as a primary pesticide; and
59% kept unused pesticides in a store room, while 30% maintained these substances
inside the home.
Head Start is viewed as an enduring success of Lyndon Johnson's War on Poverty. In
1965, 1.4 million children were beneficiaries of Headstart activities. Indeed, every
president since Jimmy Carter has supported Headstart. Another result of this
initiative was the funding of the Mississippi Action for Progress Program in
collaboration with Meharry Medical College. Dr. Warren concluded by seeking the
Board's guidance in three areas of the Delta project: methods to re-engage partners in
the demonstration projects; mechanisms to encourage both public and private funders
to contribute to the demonstration projects; and a decision-making process to
determine the appropriate groups to include in the effort of educating the public
about the project.
BSC Discussion and Recommendation. Dr. Johnson reported that the Delta project
was started as one part of an environmental public health challenge which included
the mismanagement of hazardous wastes and uncontrolled releases into the
environment. The central idea behind the project was to create partnerships between
federal and state agencies, communities, and academia to focus on environmental
problems and solutions. Dr. Johnson conveyed the challenge of maintaining these
partners in this effort; however, these partners should now make the Delta project an
initiative.
Dr. Johnson provided data related to the Delta project. Infant mortality rates for
African American infants are 50% higher than for Caucasian infants. Within the past
five years, there have been 17 programs within the Delta project, such as a nursing
project at Howard University, the Columbia Mississippi project, and a needs
assessment project in counties in the geographic area of the Delta. These projects
have been funded by the respective partners, including the National Library of
Medicine. Dr. Johnson emphasized that the continuation of the Delta project is a
social obligation.
Dr. Roseman noted that one significant issue of the Delta project was the medical
testing, and felt that the government should disclose its intentions to community
residents. He also saw the paperwork generated by federal agencies as problematic
because this "paper-pushing" process prohibits officials from entering communities.
Dr. Roseman suggested that optometrists, who are expressing interest in
environmental health issues and can detect diseases such as diabetes, be included in
the health care provider profile. Dr. Johnson reiterated that the Agency has the
authority to conduct testing under the Superfund statute, but it cannot provide
medical care and treatment. In an attempt to be responsive, however, ATSDR has
established pediatric referral units as a mechanism in this regard.
In order to alleviate some confusion with respect to the function of the Agency and
its sister organizations in this initiative, Dr. Bergeisen suggested that the BSC
consider inviting HRSA to make a presentation to the Board and Subcommittee
about its roles and mission related medical care access. The Board unanimously
agreed on this recommendation. In response to communities' collective requests for a
health clinic and access to health services, Dr. Warren added that a model is currently
being implemented in Mississippi to evaluate whether a demonstration project will be
feasible.
Dr. Morandi questioned how well the Agency's findings were disseminated
throughout communities. Dr. Warren reported that the profiles are extremely
successful because ATSDR can now locate communities and apply its findings
elsewhere. Because of the undertakings by ATSDR and EPA, Ms. Bradshaw stated
that funding is currently being implemented for health services in the Memphis,
Tennessee Depot community. Specifically, she acknowledged Dr. Warren as being
instrumental in assembling the agencies and ensuring each organization was
responsive to its respective charge. Dr. Morandi advocated for the Board to support
the continued effort by the Delta project.
Uncertainty in Health Guidance Values. Dr. DeRosa reminded the BSC that this
program resulted from a previous request by ATSDR. The Agency sought the Board's
assistance in devising a plan to change the current state of the use of uncertainty
factors to reduce scientific uncertainty in the process of calculating health guidance
levels. To formally answer this charge, a workgroup consisting of Drs. DeRosa, Hugh
Hansen, Dennis Jones and Robin Leonard was formed.
Dr. DeRosa cited the program as an example of a much greater need in environmental
health due to four broad areas of uncertainty: (1) uncertainty factors used for the
derivation of health guidance values, i.e., extrapolation from animals to humans,
human variables and the extrapolation from a low-effect-level to a no-effect-level; (2)
the validity of the toxic equivalency approach; (3) the evaluation of fractional
exposure from different pathways; and (4) the use of body burdens in the absence of
multimedia and multi-route exposure data associated with body burdens.
After much discussion between the Work Group and the Board of the need to address
all four areas, Dr. DeRosa stated an agreement was reached that it would be more
realistic to focus on only the first area of uncertainty at this time. The minimal risk
level ("MRL") is defined as an estimate of the daily human exposure to a substance
that is likely to be without an appreciable risk of non-cancerous adverse health effects
over a specific duration of exposure. Although a modifying factor ranging from 3 to
10 is sometimes invoked in the MRL to account for limitations in the database, Dr.
DeRosa clarified there is an opportunity for public comment and extensive peer
review of the data.
Report of the BSC Evaluation Work Group. Dr. Leonard reported that the Work
Group considered the broad area of scientific uncertainty and the more specific area
of uncertainty factors. Sources of concern related to these topics were uncertainty
factors that were not based on a complete knowledge of substance-specific chemistry
or toxicology. These concerns were valid based on the discernment that "real" threats
to public health exist when uncertainty is high, as well as the significant social and
financial costs in attempting to solve every perceived problem.
The Work Group defined the scope of this task to be constrained by a consideration
of the uncertainty factors used for the derivation of health guidance values; however,
in defining the status quo, Dr. Leonard recalled differences within the Work Group as
to what constituted uncertainties. The Work Group began with some fundamental
assumptions, but was not in a position to totally eliminate these paradigms. Efforts
were made to identify a new approach to decrease the reliance on default values by
incorporating tools such as human and epidemiology data, as well as a Monte Carlo
model.
The Work Group proposed a four-step work plan designed to reduce the scientific
uncertainty of the current approach by systematically addressing the uncertainty
factors presently being used: (1) develop a list of analytical tools that refine the
uncertainty factors and have adequately described methods of scientific and
mathematical bases; (2) construct case studies of examples of the calculation of health
guidance levels; (3) define criteria that can be used to select the most appropriate and
effective tools; and (4) use these criteria as a non-prescriptive framework for
exploring new approaches in other areas of scientific uncertainty.
Dr. Leonard cautioned that ATSDR should not spend a large amount of time, money
or resources on literature reviews, but rather should make use of existing efforts in
this regard. When criteria are developed for the case studies, Dr. Leonard urged the
Agency to iterate around each criterion. She recommended that ATSDR conduct a
workshop between steps (2) and (3) of the plan to facilitate consensus. In order to
appropriately judge the criteria, input from the scientific and regulatory communities
will be needed.
Dr. Leonard concluded by citing three concepts she learned from the American
Industrial Health Council: use sound science in decision-making, reduce the
uncertainty in risk assessments, and employ previous knowledge gained to analyze the
risk assessment methodology. Because the information learned from human
variability data will direct new thought processes, Dr. Leonard asserted that ATSDR
should be on the cutting edge of this scientific approach. Depending on the number
of factors impacted by this program, the Agency may require additional guidance and
should develop a problem-solving mechanism for these issues.
BSC Discussion and Recommendations. Dr. Roseman noted the significant
variability throughout the government as problematic, and recognized the need for
standardization between the federal agencies. Dr. Leonard agreed that the agencies
should work in concert, which is one of primary reasons the Work Group
recommended conducting a workshop. Because there is a heated debate within EPA
regarding the additional uncertainty factor of 10 for children, Dr. Bergeisen wondered
whether the Work Group planned on incorporating this element. In order to have
corresponding representation and harmonization among the various work groups, Dr.
DeRosa responded that this issue would be examined in concert with the Child
Health Initiative.
Overall, Dr. Morandi saw the program heading in a positive direction, but specifically
had a number of concerns. For example, risk assessments appear scientific, but
contain a large amount of uncertainty. Dr. White added that uncertainty factors are
supposed to provide a degree of confidence, and are intended to be used as guidance
in decision-making processes--not predictors. Dr. Leonard conceded that complex
methods have the potential for obfuscating the degree of uncertainty that remains
after use, which is why the Work Group attempted to refine methodologies and
uncertainty factors.
Dr. Stark advised that the Board cautiously make a recommendation because this
area was one of the most difficult and possibly most important areas in the entire
scientific arena. To conduct further study of this issue could cause ATSDR an
enormous amount of resources and time. If the BSC was in a position to make a
recommendation related to the four-step plan, Dr. Stark asked whether the time
frame of the plan should be the Agency's responsibility.
Dr. Roberts recommended that the BSC encourage ATSDR to continue its
involvement in this effort as the Agency is more experienced than other
organizations in human health effects. Dr. Leonard added that ATSDR should
thoroughly review the four-step plan. The next phase will be to develop four
additional steps for a more specific and detailed work plan, and encourage
harmonization between the activities of other agencies. Dr. Leonard moved for the
continued involvement of ATSDR in this important effort. The motion was
seconded by Dr. White and unanimously approved by the Board.
Comments from the Public. There were no responses to Dr. Stark's solicitation for
public comments.
Charge from the Acting Chair to the Board. Dr. Stark charged the BSC to propose
items for possible discussion at the next meeting of the BSC..
1. Program review of the Minority Health Professions Foundation.
2. Provision of additional scientific advice, i.e., discuss exposure assessments, develop
methods to address disease clusters, and examine the methyl mercury risk assessment.
3. Report from the Subcommittee on Community/Tribal affairs.
4. Presentations by HRSA and NIEHS regarding medical care provision at sites. NIEHS
should present the basic research program as this organization has outreach and
health education activities.
5. Presentation on uncertainty in health guidance values in relation to children's health.
Dr. Johnson cautioned that including all of these items on the next agenda would be
contingent upon having sufficient time and locating appropriate presenters.
Closing Remarks. Dr. Johnson thanked the BSC, Subcommittee and EPA for their
participation. The Board was significantly instrumental in establishing the research
programs of both Minority Health Professions Foundation and Great Lakes.
Dr.Johnson acknowleged Dr. Stark, who chaired the BSC meeting in the absence of
Dr. Eula Bingham; Dr. Xintaras, who served as Executive Secretary for the BSC; Ms.
Sandra Malcom, who facilitated the Subcommittee's logistical needs; Ms. Lynn
Atmiller for general meeting support; and Ms. Nadine Rivera, who served as
rapporteur for the Board and the Community/Tribal Subcommittee.
Dr. Johnson recognized Dr. John Andrews, who is retiring from the Public Health
Service after 20 years of service, and will be joining the University of Cincinnati in
approximately two months. Although he was unable to attend the BSC meeting, Dr.
Johnson went on record in appreciation of Dr. Andrews' significant leadership in
science and contributions to ATSDR.
There being no further comments or discussion, Dr. Stark adjourned the BSC
meeting at 2:00 p.m. on May 1, 1998.
I hereby certify that to the best of my knowledge, the foregoing summary of the
minutes is accurate and complete.
Date: 6/4/98
________/s/__________
Alice D. Stark, Dr.P.H.
Acting Chair
Board of Scientific Counselors
Coded by Charles Xintaras
This page last updated on July 1, 2001
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