# Availability of ATSDR's Draft Criteria for Determining the Appropriateness of a Medical Monitoring Program Under CERCLA

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-22228

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** September 9, 1994

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-81]

Availability of ATSDR's Draft Criteria for Determining the
Appropriateness of a Medical Monitoring Program Under CERCLA

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Public Health Service (PHS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the availability of draft criteria for
determining the appropriateness of site-specific medical monitoring
programs under the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA). The public is invited to comment on these
draft criteria.

DATES: Comments must be received on or before October 24, 1994.

ADDRESSES: Submit written comments relating to the draft criteria to
Division of Health Studies, Agency for Toxic Substances and Disease
Registry, 1600 Clifton Road, NE., Mailstop E-31, Atlanta, Georgia
30333, telephone (404) 639-6200.

FOR FURTHER INFORMATION CONTACT: Dr. Wendy E. Kaye, Chief, Epidemiology
and Surveillance Branch, Division of Health Studies, ATSDR, telephone
(404) 639-6203.

SUPPLEMENTARY INFORMATION: Section 104(i)(9) of the CERCLA, as amended
[42 U.S.C. 9604(i)(9)], provides for the Administrator of ATSDR to
initiate a health surveillance program for populations at significant
increased risk of adverse health effects as a result of exposure to
hazardous substances released from a facility. A program included under
health surveillance is referred to as ``Medical Monitoring or
Screening'' by ATSDR and is defined in the legislation as ``the
periodic medical testing'' to screen people ``at significant increased
risk'' for diseases. The legislation states that a mechanism to refer
people who are screened positive for such diseases for treatment should
be included in the program. Statutory language only enables ATSDR to
provide medical care or treatment in cases of public health
emergencies. ATSDR has established criteria to determine when medical
monitoring is an appropriate health activity and the requirements for
establishing a medical monitoring program at a site.

Background

ATSDR is responsible for the public health related activities of
CERCLA. ATSDR's primary initial response at a hazardous substance
release or facility is the public health assessment, which is required
for every site on the National Priorities List (NPL). A public health
assessment can also be conducted in response to a petition from the
public. Other important components of ATSDR's initial response at sites
include health consultations and public health advisories. The public
health assessments, health consultations, and public health advisories
undergo review by ATSDR to determine if follow-up health activities are
needed at a site.
The types of follow-up health activities recommended for a site
will depend on the amount of information on the possible exposures and
their suspected pathways. In any case in which an association has not
been established between an exposure and a specific adverse health
outcome, several research and health education activities could be
considered. Those activities could include exposure assessment at the
site, epidemiologic studies, or professional education.
ATSDR's Division of Health Assessment and Consultation is
establishing a program for the investigation of exposures in
communities. That program will enable a more timely response to
questions on whether individuals in a community are being exposed. The
program will incorporate a variety of industrial hygiene techniques for
measuring chemicals in the environment, as well as selected biological
markers of exposure.
The Division of Health Education provides a wide variety of
services to educate health care professionals and communities on the
effects of exposures to hazardous substances. Activities in a community
around a hazardous substance release or facility may include conducting
grand rounds for health care providers on the effects of a specific
chemical, providing fact sheets on chemicals, conducting workshops on
clues to environmental disease, and producing case studies in
environmental medicine.
The Division of Health Studies (DHS) is responsible for conducting
epidemiologic research, including several types of studies,
surveillance programs, and exposure registries. Cluster investigations
and disease and symptom prevalence studies examine the occurrence of
disease in populations. Analytic epidemiology studies are conducted to
evaluate the causal nature of associations between exposure to
hazardous substances and disease outcomes.
DHS also has a surveillance program focusing on exposures to
substances at hazardous substance release or facility. The surveillance
program includes systems that follow populations exposed to hazardous
substances because of where they live or their occupation. It also
includes surveillance of emergency events in which hazardous substances
are released into the environment.
DHS is responsible for maintaining the National Exposure Registry,
a listing of people exposed to hazardous substances. The Registry is
composed of substance specific subregistries. The chemicals are
selected from the list designated by ATSDR as being of greatest threat
to health.
Medical monitoring is considered one of several follow-up health
activity options under the site-specific work conducted by ATSDR. A
medical monitoring program for the community exposed to hazardous
substances from a site will be considered with other health follow-up
activities when the information from ATSDR's initial response at the
site is reviewed. In cases in which there is no known association
between the exposure and specific adverse health effects (which could
include health outcomes, illnesses, or markers of effect), medical
monitoring is not an appropriate public health activity. In cases in
which there is limited information on a specific health effect's
relationship to an exposure, then options such as epidemiologic
surveillance, a disease and symptom prevalence study, or an
epidemiologic study are more appropriate. When adequate information
exists linking exposure to a hazardous substance with a specific
adverse health effect, further consideration will then be given to the
appropriateness of medical monitoring in that population.
Medical monitoring should be directed towards a target community
identified as being at ``significant increased risk for disease'' on
the basis of exposure. Significant increased risk will vary for
particular sites depending upon such factors as the underlying risk of
the outcome of concern, the risk attributable to the exposure, and the
presence of sensitive subpopulations. These factors will be considered
when evaluating the appropriateness of medical monitoring in a
community.
The CERCLA legislation also provides for a mechanism for referral
for treatment of those who are screened positive for the health
outcomes of concern; therefore, a mechanism to refer people for
diagnosis, interventions, or treatment should be in place prior to the
initiation of a medical monitoring program.
The primary purpose of a medical monitoring program is not
considered to be a research activity that further investigates the
cause-effect relationship between exposure and outcome. The primary
purpose of a medical monitoring program is case finding in order to
refer individuals for further evaluation and, as appropriate,
treatment. Within this framework, medical monitoring may include both
testing for early biological effect and an assessment of exposure using
biological specimens (for example, blood or urine), when appropriate.
This is provided as a service to individuals in communities where there
is believed to be significant increased risk of disease from exposure
to hazardous substances released into the environment.

Criteria for Considering Medical Monitoring

The criteria outlined below will be used to determine the
appropriateness of conducting medical monitoring in a community and
will be applied in a phased approach. Phase I, conducted by ATSDR,
consists of an evaluation of the exposure and outcome criteria. Phase
II consists of an evaluation of the system criteria. Phase II will be
conducted by a panel consisting of community, State and local health
officials, and ATSDR. At the end of Phase II, a detailed medical
monitoring plan for a community will be written. All of the criteria
must be met at a site in order for a medical monitoring program to be
established at that site.

Phase I

Exposure Criteria

A. There Should Be Evidence of Contaminant Levels in Environmental
Media That Would Suggest the High Likelihood of Environmental Exposure
to a Hazardous Substance and Subsequent Adverse Health Outcomes
The exposure must be to a hazardous substance as defined under
CERCLA, and the result of a release from a CERCLA covered facility. The
primary criteria for medical monitoring should be documented evidence
of exposure of a population to a hazardous substance in the
environment. An exposure will be considered to be at a sufficient level
if there is documentation of an increased opportunity for exposure to a
level that meets or exceeds some health-based comparison value or that
meets or exceeds a level reported in the peer-reviewed literature to
result in some adverse health effect. Documentation is considered
sufficient if it is from an exposure assessment, environmental exposure
modeling, or sampling from a general area (for example, water samples
from an aquifer or a town water supply). Documentation of individual
levels of exposure is not required. In cases in which exposures are
unknown or undocumented, environmental monitoring is a more appropriate
initial activity.
B. There Should Be a Well-Defined, Identifiable Target Population of
Concern in Which Exposure to a Hazardous Substance at a Sufficient
Level Has Occurred
Initially, the target population of concern will be defined
geographically on the basis of exposure. In addition, all populations
considered will be assessed for the presence of any sub-population at
increased risk of the adverse health effects associated with the
exposures. An example of a subpopulation at increased risk would be
preschool children in an area with soil lead contamination. The size of
the target population of concern is not a factor in the decision for
monitoring. In areas where biological markers of exposure have not been
collected, environmental sampling can be used to estimate exposure
levels. The target population of concern is the population in which
there is documented exposure at a sufficient level to place the
individuals in that population at significant increased risk for
developing some specific adverse health effect.

Outcome Criteria

A. There Should Be Documented Human Health Research That Demonstrates a
Scientific Basis for a Reasonable Association Between an Exposure to a
Hazardous Substance and a Specific Adverse Health Effect (Such As an
Illness or Change in a Biological Marker of Effect)
There must be previous studies on human populations which
demonstrate a reasonable association between a particular exposure and
an adverse health effect. In order to make that inference,
consideration should be given to the strength, specificity, and
consistency of the association among the identified studies. The period
of exposure (including its timing and duration) and its relationship to
the latency period for the disease or illness should also be examined
if information is available. Consideration should be given as to
whether the association has demonstrated a dose-response relationship
and whether the association is consistent with the existing body of
knowledge. This information could include a variety of occupational,
epidemiologic, or other studies involving human populations.
B. The Monitoring Should Be Directed at Detecting Adverse Health
Effects That Are Consistent With the Existing Body of Knowledge and
Amenable to Prevention or Intervention Measures
The monitoring should be established for specific adverse health
effects. The specific adverse health effect being monitored should be a
result of the possible exposure consistent with the existing body of
knowledge. An adverse health effect is consistent with the existing
body of knowledge if it has been described in the literature as caused
by that agent or by similar agents, taking into account structure-
activity relations.
In addition, the adverse health effects (disease process, illness,
or biomarkers of effect) should be such that early detection and
treatment or intervention interrupts the progress to symptomatic
disease, improves the prognosis of the disease, improves the quality of
life of the individual, or is amenable to primary prevention. If the
adverse health effects that are of concern in an individual or in a
community are not easily detectable and not medically treatable, then
medical monitoring would not be beneficial and would not be an
appropriate public health activity. An easily detectable effect is one
that can be found on clinical examination, or through the use of
simple, diagnostic tests in an outpatient setting. Also, the test
procedures must be acceptable to the patient and the community. The
diagnostic tests must be nonexperimental, relatively noninvasive (such
as the drawing of a tube of blood for laboratory tests), and simple to
administer.

Monitoring for Evidence of Continuing Exposure

In cases such as those at sites with lead exposure, the monitoring
program might include following biological markers of continuing
exposure. Those sites would be ones in which the exposure is known to
have a variety of adverse health effects, but for which no tests are
available to detect those effects at a time when intervention could
affect the course of the disease process. In those instances, the
primary intervention is to remove the individual from the exposure.
This allows the medical monitoring system to recommend referral for
intervention prior to the onset of detectable adverse health effects. A
monitoring system that includes biomarkers of continuing exposure is
similar to medical surveillance of hazardous waste workers where
changes indicative of increasing or continued exposures occur
sufficiently early that the exposure can be curtailed and the risk for
disease reduced (Gochfeld 1990).

Phase II

General Information

When ATSDR has determined that exposure from a site has met the
exposure and outcome criteria, a site panel will be formed to review
the system criteria and to develop a site-specific medical monitoring
plan.
The site panel will include representatives from the community,
State or local health departments, and local medical societies.

System Criteria

A. The General Requirements for a Medical Screening Program Should Be
Satisfied
The monitoring aspect of a health surveillance program consists of
the periodic medical testing to screen individuals who are at increased
risk of disease. Monitoring serves to identify those individuals with
an unrecognized adverse health effect. This is consistent with the
definition of screening as ``the presumptive identification of
unrecognized disease or defect by the application of tests,
examinations, or other procedures which can be applied rapidly.
Screening tests sort out apparently well persons who probably have a
disease from those who probably do not. A screening test is not
intended to be diagnostic. Persons with positive or suspicious findings
must be referred to their physicians for diagnosis and necessary
treatment.'' (Commission on Chronic Illness, 1957) In general, the
ability to predict the presence or absence of disease from test results
depends on the sensitivity and specificity of the test and the
prevalence of the disease in the population being tested. The higher
the prevalence, the more likely a positive test indicates disease
(Mausner & Kramer, 1985). In order for a screening program to be of
public health benefit, the population being screened should be at a
significantly high risk for the undiagnosed disease (i.e., the disease
should have a sufficiently high prevalence in the population).
Given that definition, there are certain requirements for screening
programs that should be considered when evaluating a possible medical
monitoring program for a site (adopted from Mausner & Kramer, 1985).
The natural history of the disease process should be
understood sufficiently for screening.
The early detection through screening should be known to
have an impact on the natural history of that disease process. For
example, the detection of breast cancer while it is localized has been
shown to increase the ten-year survival rate. For that reason, several
groups have made recommendations for the early detection of breast
cancer in asymptomatic women. Those recommendations include breast
self-examination, breast physical examination, and mammography (Mettlin
& Dodd, 1991; Kelsey & Gammon, 1991).
There should be an accepted screening test that meets the
requirements for validity, reliability, estimates of yield,
sensitivity, specificity, and acceptable cost. The purpose of ATSDR-
sponsored medical monitoring is not to develop new screening tests. The
medical monitoring program will use tests that have been recommended
and used for screening in other settings.
The screening program should be one that is feasible and
acceptable to individuals and the community. Therefore, plans for a
medical monitoring program will be presented to the community for input
prior to the initiation of any recommended program.
B. An Accepted Treatment, Intervention, or Both for the Condition
(Outcome or Marker of Exposure) Must Exist and a Referral System Should
Be in Place Prior to the Initiation of Medical Monitoring Program
There should be established criteria for determining who should
receive referral for intervention or treatment. These criteria will be
based on the selected effect being screened for and the screening test
being used. Results will be evaluated longitudinally and cross-
sectionally to identify changes in the system or screening tools that
require follow-up (Gochfeld 1990). A referral mechanism should exist so
that those who are eligible for the intervention can be referred to a
qualified health care provider for further diagnosis, treatment, or
intervention. The referral must be for treatment or intervention that
is standard practice and not experimental in nature. The medical
monitoring (screening) program is not responsible for the cost of the
referral, the intervention, or the treatment of individuals
participating in the program.
C. The Logistics of the System Must Be Resolved Before the Program Can
Be Initiated
After medical monitoring has been determinedappropriate for a site,
the specifics of the monitoring system will be detailed in a medical
monitoring plan. The site panel consisting of the community members and
appropriate health officials will develop the site- specific medical
monitoring plan. The specifics of the medical monitoring system
recommended can vary for each site. The monitoring plan is the protocol
for the specific program to be proposed in a community. The plan will
outline the target community, the types of outcomes to be screened for,
the participants in the referral system, and the program reports. The
plan will include a review of the latency period for the outcomes being
monitored and the duration of the exposure to define the period of time
that the program will operate in a specific site population. The target
population; the completeness with which the exposed population can be
identified, contacted, and followed; the screening tests; and the
selected health outcomes will all influence the specifics of the
system. Existing medical facilities and personnel will be used when
possible. The plan for a site might require review by an expert panel.
ATSDR's Division of Health Studies will work closely with the Division
of Health Education to provide for professional health education when
needed to enhance the medical monitoring program. Additionally, the
monitoring plan will be submitted for peer review prior to its
implementation at a site. The monitoring activity at each site will be
routinely evaluated for the effectiveness of the screening tests in
place and the types of effects being detected. Due to confidentiality
issues in dealing with small groups of people, the reporting from the
system will consist of annual reports noting the number of individuals
screened, the number of referrals made, and the number of conditions
diagnosed in the referral system.
The referral system will consist of the review of the screening
results and the referral to appropriate health care providers or
referral physicians. The specific mechanisms for determining who needs
referral and for selecting the health care providers in the referral
pool must be in place prior to the initiation of the medical
monitoring. Once the participant has been referred to the referral
providers, those providers will be responsible for the subsequent
diagnosis, treatment, or intervention.

Summary

Medical monitoring will be considered along with the other health
follow-up activities to be recommended for populations around specific
sites. The Division of Health Studies will make a determination on
whether a site meets the exposure and outcome criteria for medical
monitoring. If a site meets the previously discussed criteria and is
selected for further consideration of a medical monitoring program,
ATSDR will work with the community and other appropriate entities in
designing the specific monitoring and referral system for that site's
target population. ATSDR will notify, and where appropriate, will work
with the State health department to establish the program. The Division
of Health Studies will monitor the program and be responsible for
oversight on the annual reports.

References

Commission on Chronic Illness: Chronic Illness in the United
States, Vol. 1. Commonwealth Fund, Harvard University Press,
Cambridge, 1957, page 45.
Gochfeld M. Medical surveillance of hazardous waste workers. In
Principles and Problems in Occupational Medicine State of the Art
Reviews: Hazardous Waste Workers. Gochfeld M and EA Favata, editors.
Philadelphia: Hanley & Belfus, Inc., 1990;5(1):1-8.
Kelsey JL and MD Gammon. The epidemiology of breast cancer. CA-A
Cancer Journal for Clinicians 1991;41(3):146-165.
Mausner JS and S Kramer. Epidemiology--an introductory text.
Philadelphia: W.B. Saunders, 1985, pages 220-230.
Mettlin C and GD Dodd. The American Cancer Society guidelines
for the cancer-related checkup: An Update. CA-A Cancer Journal for
Clinicians 1991;41(5):279-282.

Dated: September 1, 1994.
Claire V. Broome,
Deputy Administrator, Agency for Toxic Substances and Disease Registry.
[FR Doc. 94-22228 Filed 9-8-94; 8:45 am]
BILLING CODE 4163-70-P

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-22228. Public record. Not legal advice.