[Federal Register Volume 59, Number 174 (Friday, September 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22228]


[[Page Unknown]]

[Federal Register: September 9, 1994]


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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