NCD980602163_19821109_Warren County PCB Landfill_SERB C_Warren Co Environmental Health Surveillance Proposal - Collection and Storage of Human Sera-OCR

I •
DIVISION OF HEALTH SERVICES
P.O. Box 2091
Raleigh, N.C. 27602-2091
November 9, 1982
MEMORANDUM
TO: Ronald H. Levine, M.D., M.P.H.
State Health Director
THROUGH: Martin P. Hines, D.V.M., M.P.H.
FROM:
Chief, Epidemiology Section
John I. Freeman, D.V.M., M.P.H.
Head, Environmental Epidemiology Branch
C. Gregory Smith, M.D.
Environmental Epidemiologist
Ronald H. Levine, M.D., M.P.H.
ST ATE HEAL TH DIRECTOR
SUBJECT: Warren County Environmental Health Surveillance Proposal:
Collection and Storage of Human Sera
Rationale
In th~ unlikely event that PCB's escape from the Warre n County landfill
into the surface or groundwater adjacent to the landfill site, Warren County
residents living near the landfill site ma~ become concerned that they have
been inadvertently exposed to the PCB's despite the results of any water
samples analyzed for PCB contamination. If such a scenario were to evolve,
necessitating serum analysis for PCB's, it would be imperative to have as
many baseline PCB concentrations from the residents as possible.
Many problems currently exist with regard to analysis of blood for
PCB's and interpretation of the results. Among these are the following:
(1) suboptimal sensitivity and specificity in the analytical me thods ,
(2) significant intralab and interlab variability in results from split
sampling, (3) non-existence of a lab FDA-certified and licensed to analyze human
blood for PCB's and interpret the results, (4) absence of data on concentrations
of PCB's in the general population, and how t hes e concentrations vary with
age, sex, race, and physiologic factors, and (5) absence of adequate data on the
biologic and clinicopathologic importance of various concentrations of
PCB's in human tissue.
In light of these substantial problems, it is proposed that blood
be collected from the residents, and that the sera be frozen and stored,
should future analysis for PCB's become necessary.
ME'lliODOLOGY
Study Population
Residents of Warren County living within al½ mi le radius of the
James B Hunt, Jr/ Sarah T M MD MPH STATE OF NORTH CAROLINA DEPARTMENT OF HUMAN RE SOURC ES orrow, ' GOVERNOR SECRET ARY
MEMORANDUM to Dr. Levine from Dr. Smith
· Page 2
November 9, 1982
landfill between the ages of 12 and 60 will be eligible for blood donation.
A minimum of 50 residents will be needed to give credibility to any con-
clusions reached from future analyses of these baseline samples and subse-
quent samples.
Control Population
A minimum of 50 residents from Warren County, matched on age (within
3 years), sex, and race will be needed to control for potential confounding
by the above variables. This population should be selected from a different
township in Warren County remote from the landfill. Voting registers, tax
registers, and school registers are sources for obtaining the names of
potential controls.
Identification and Notification Suggestions
To be done by Warren County Health Department staff.
A. Cases:
1. Obtain an aerial photograph of the landfill site and
environs. Identify all houses within al½ mile radius
and number them in sequence along existing roads.
2. Identify the occupants in each house by age, sex, and
race.
3. Determine their receptivity to the proposed sampling and
their availability (morning, afternoon, or evening) to
donate blood.
4. Notify them of the date and time the North Carolina
Division of Health Services and the Warren County Health
Department staffs will be available to collect the blood.
5. Pretyped 5-x 8-inch cards denoting entries for name,
current address, phone number, age, sex, race, present
occupation, past occupation(s), length of residence at
the present address, length of residence in Warren
County, any known exposure to PCB's through electrical
work, road work, etc., will be needed.
B. Controls:
1. Obtain the names of 50 matched controls from voting
registers, tax registers, school or church registers in
a township remote from the landfill.
2. Match a control with each case.
3. Same as No. 3 above.
4. Same as No. 4 above. (Note: Control samples should be
collected within 3 or 4 weeks after the case samples are
collected.
5. Same as No. 5 above.
·MEMORANDUM to Dr. Levine from Dr. Smith
Page 3
Noveimber 9 r 1982
Collection and Storage Procedure
To be done by Division of Health Services staff with the assistance
of Warren County Heal th Department staff.
1. Apply a standard tourniquet to the mid-upper arm.
2. Prep the antecubital fossa with a standard alcohol swab
and dry with a 2x2 gauze pad.
3. Select an appropriate vein and obtain two full 20 cc vials
of blood, utilizing a plastic vacutainer vial holder and
two Royal Blue top Becton-Dickinson glass vials (these
should be chlorine-free, non-lubricated, non-anticoagulated
vials) .
4. Refrigerate the vials until centrifuging them within 12 hours
after collection.· Centrifugation in an ICE centrifuge at
high speed for one minute should be sufficient to separate
the sera from the cellular components.
5. Pipette 20 cc of sera from each sample using a standard
Fisher scientific (or equivalent) Pipette, into 20 cc black
screw-cap glass vials. It is imperative that these vials
have teflon inserts in the caps to prevent chemical contami-
nation of the vials. Screw the caps on tightly, label, and
store them upright in any standard household freezer.
Future Analysis Criteria
Analysis of these samples for PCB's shall take place under the
following circumstances:
1. Evidence that PCB's have leached Erom the landfill and
contamination of water supplies has occurred.
2. Determination by the State Health Director and Division of
Health Services staff that the results from analyses of
these samples would be helpful in interpreti ng the results
from analyses of subsequent samples.
3. Availability of a laboratory to reliably analyze the samples.
4. Availability of funds to pay for analysis of the samples.
(A baseline group of samples composed of 50 cases and 50
controls and a subsequent group of samples will require
200 analyses currently costing between $60 and $100 per
sample. This amounts to $12,000 to $20,000 .)
CGS/hk
cc: Mr. Joe Lennon, Warren County Health Director
Mrs. Mildred Kerbaugh, Chief, Laboratory Section, DHS