Document yb9J15wDa7xBRYjyvRmXVL4GV
i lb:
Distribution
nmroviNv
Communication
From: Date:
Chris Bozraan, Public Relations August 24, 1989
if-NEEDED STATEMENT: BRAIN TUMORS
FINAL
VISTA
Attached is the final version of the if-needed statement concerning the occurrence of brain tumors at the VCM Plant.
No media inquiries on the situation have been received to date; however, it's possible the press might find out about our request for the NIOSH study.
Distribution: Jim DeBernardi Tom Huffman Dick Conrad John Friend Joe Ware Norm Frost Tom Grumbles Bill McClain Jack Drumwright Mike Reynolds Gretchen Weis
VVV 000002969
If-Needed Statement
Brain tumors VCM Plant, Westlake, Louisiana
8/24/89
An employee at our Vinyl Chloride Monomer (VCM) Plant underwent surgery to remove a brain tumor several months ago. This tumor was a fairly common type of brain tumor, and one which is not confirmed to be directly associated with employee populations working with vinyl chloride. This employee is currently recuperating from surgery.
A second employee at our plant underwent surgery July 11 to have a brain mass removed. Information we have received to date indicates the tumor was not of the same type as the first employee's, and not of a type associated with exposure to VCM.
We recognize and understand the concern felt by our employees and their families. We are working to provide information to our employees to deal with those concerns. While we don't believe the tumors are related to worker exposure to chemicals at our plant, the occurrence of two brain tumors in a short time has raised employee concerns regrading the relationship. For this reason, we believe an independent assessment of the situation would be beneficial. Therefore, Vista Chemical has requested that the National Institute for Occupational Safety and Health (NIOSH) independently investigate the recent tumor occurrences.
Our reading of the scientific literature shows conflicting evidence in regard to the association of brain tumors and vinyl chloride monomer. Some studies have indicated a possible association between brain tumors and VCM. Others have shown no association at all.
In the studies that indicate a possible association, the number of tumors occurring in workers was compared to the number of cases known to occur in the general population. While the number of tumors among the workers was higher than those occurring among the population at large, the difference was small and not considered statistically significant by the study group.
We will continue to evaluate the situation to determine any further actions that might be needed and will keep employees informed as the NIOSH investigation progresses.
VVV 000002970
To be used only if asked: Q. Isn't it true that you've had four or five (a number of) people come down with cancer at your plant? A. We've had approximately 175 employees at the VCM plant since we began operations in 1968. We are aware of seven present or previous employees who have had various forms of cancer over the last 17 years, none of which have been confirmed to be directly associated with employee populations working with vinyl chloride.
VVV 000002971
InfwefRn Communication
to:
vcm Plant Employees
FROM:
R. A. Conrad
DATE:
September 1, 1989
SUBJECT:
Medical Screening Program
VISTA
in response to the concerns expressed by some employees
over the need for additional company sponsored medical
screening for brain tumors, Vista Chemical Company will
cover the cost of a neurological evaluation/examination
for any LCVCM employee who has been employed at the plant
for at least 10 years or has worked in the vinyl industry
for at least 10 years.
This would include persons
currently employed at the plant or retirees who meet the
10 year criteria. These examinations are offered during
the next 90 days on a one-time basis, and of course,
participation is voluntary. The evaluation/examinations
would be conducted by Dr. Litel in Lake Charles. Each
employee is responsible for making their own appointment.
Upon completion of the neurological evaluation/ examination, a confidential report of the medical findings and the doctor's recommendations will be provided to Vista medical for review and filing in the appropriate employee's occupational health record.
Copies will also be provided to each employee upon written request to Vista Medical. (The same procedures used with the health van/hands on physical would apply,)
Additional tests, studies on further evaluations (including Cat Scans, MRI, dye studies, etc.) which may be recommended by the medical consultant will be handled as any other personal health problem and costs will be covered through Vista's group health insurance program.
Beginning September 8, 1989 for the next three months through December 8, 1989 you may schedule a neurosurgical consultation/evaluation directly with Dr. Gerald R. Litel at Vista's cost. His offices are located at 708 S. Ryan and his telephone number is 318-433-1927. Beginning September 2 through September 19, I will be away from the plant on vacation. If you have any questions concerning this program, please contact George Shirley (494-5039) who can direct your questions to Dr. Drumwright. Attached for your reference is a general description of a neurological evaluation/examination.
CrTM-6.^
R. A. Conrad Plant Manager
da
Distribution Dept. Heads, Supervisors, Bulletin Boards
VVV 000002972
Description of a Neurological Bvaluatlon/Examinatlon
Brain tumors present clinical signs and symptoms including hoadaaho, altered mental status, progressive loss of funotion or neurologic deficit and convulsions or seizures* These same signs and symptoms can also be produced by various degenerative diseases, chronic cardiovascular problems and various toxic states-lncluding medication.
A neurological evaluation/examination is performed to look for
specific objective signs or findings and to attempt to localize the
problem within the nervous system*
Symptoms of problems
experienced by the patient help the doctor to look at specific
areas and identify potential causes* The diagnostic evaluation of
a patient depends largely on his/her clinical history, cooperation,
and ability to provide useful information to the doctor.
In addition to the clinical history, the doctor conducts a
neurologic examination. This examination usually addresses five
major areas:
Mental status, Cranial nerves. Motor function.
Sensation, and Reflexes. Specific tests are used to determine
normal or abnormal functions of these areas.
Based on information obtained from the clinical history and neurological examination more specific tests may be requested including dye studies, Electroencephalograms (EEG), Skull X-rays,
CT Scans, or MRIs. These tests will help localize the problem and aid in determining treatment. Frequently, surgical procedures, biopsies, etc. are necessary to establish an absolute diagnosis.
VVV 00C002973
for employees of Vista Chemical Company's Lake Charles VCM Plant
in response to employee questions at the July 14 meetings
Q. What will Vista do if another brain tumor place in an accessible location at the plant. It is antic
is found?
A. We will continue to communicate with you re garding what we are currently doing in response to the recent employee health problems and concerns.
ipated this should be completed in early August with additions made as papers are received.
Dr. Drumwright is actively pursuing the issue of
medical screening for brain tumors.
We believe our cunent efforts are the right ones to ad
dress the present situation. Another brain tumor in
Q. Based on the potential inaccuracies of
the near term would certainly add emphasis to our ef death certificates, how can epidemiological
forts. However, it must be stressed that the recent
studies be accurate?
brain tumors are not known to be related in terms of type or origin.
A. Many epidemiological studies are based on mor tality (death rate) from a disease. This is done for
Q. Have we talked to other vinyl plants?
several reasons, but in general, deaths are well de fined, consistendy recorded, and the records are typi
A. Dr. Jack Drumwright, Vista Medical Manager, is cally available. In many cases, mortality studies are
discussing current health events with other chemical
the only feasible type of study to do, especially for
company medical directors to determine if other
chronic diseases with long latency periods, such as
chemical companies are experiencing any brain tumor cancer.
incidents, how they were discovered and what was
However, the cause of death on death certificates is
done to respond to them. Vista also belongs to the
indicative of a judgment on primary cause of death
Vinyl Institute and the Chemical Manufacturers Asso and may or may not list complicating factors at the
ciation. Those are industry groups that sponsor stud- time of death, such as brain tumors. This may result
of workers and promote safety and health practic- in an underestimation of a particular cause, or an
*n the industry. Any pertinent information
overestimation, such as a brain tumor that was due to
obtained will be shared with employees.
a lung cancer metastasizing (spreading) to the brain.
The result of any epidemiological study must be
Q. Will Vista study our group, the LCVCM
viewed with caution based on these potential prob
Plant?
A. We are currently attempting to review the medi
lems, and efforts made to be as thorough and accurate as possible when reviewing records.
cal and health records for employees and past em
ployees known or suspected to have had cancer. Em Q. We don't care about studies with thou
ployees at the plant are providing us names and Dr.
sands of workers. Why don't you study us?
Drumwright is attempting to find their records. This
A. A study of only the VCM plant, or even the
may be difficult because some records are with Cono VCM plant and our PVC plants, would involve a very
co and others may be held by private physicians. The small population and the results would probably not
matter of medical confidentiality and potential need
be conclusive. Studies done to determine the relation
for releases to obtain the information may slow the
ship of a disease or cause of death must have an ade
process.
quate sample size to assure that any differences, or
The plant population was included in the CMA
excess, seen in death rates or disease rates, are not
study, which is in the literature binder available at the random occurrences, but are truly different from what
plant. At this time, no decision has been made re
the normal, or unexposed population would have.
garding further studies.
The reason for this is explained by two fundamen
tal statistical concepts that define the needed sample
Q. How long will it take to answer our ques size (population studied) and power of the study,
tions?
which is the probability of detecting a real difference
A. We cannot tell you exactly how long it will take to address and resolve all of the issues raised by the recent employee health problems. Addressing your
in disease rates. The smaller the population studied,
the less chance you have of detecting truly different disease or death rates.
:ems and resolving the issues is a priority item
Wiin plant management and Houston staff. We have
ordered relevant scientific papers not in our files to 1
(more)
VVV 000002
Q. What do we know about EDC/TARS expo
sure effects?
A. Quite a lot is known about EDC short and long term exposure effects. Detailed information is availaw,e to you through your plants hazard communication
ogram and the Material Safety Data Sheets (MSDS). A summary follows.
EDC is a central nervous system depressant and causes damage to the liver and kidneys. Short-term exposure to high concentrations of EDC is character ized by anesthetic effects as well as by headaches, dizziness, nausea and vomiting, weakness, trembling and stomach cramps. Severe exposure causes coma and death from respiratory and circulatory failure. Animal studies, mostly in mice and rats, have estab lished carcinogenic effects in rodents. EDC may be absorbed through the lungs, skin and gastrointestinal tract with resulting liver and kidney damage.
Q. Can EDC and TARS be carried home on my clothes?
A. Yes, under some conditions. Avoid contact with EDC by wearing protective gear and remove soiled clothing that is contaminated with ethylene dichloride (EDC). EDC is volatile at room temperatures and will evaporate rapidly. EDC does not remain in the air for very long. There is, however, a higher poten tial for significant amounts of EDC to remain in im pregnable surfaces such as shoe leather. That is why only certain types of composition shoe soles are per
iled for plant workers. EDC has a very distinct jr at low levels. Many people smell it at 3 ppm or less. It's odor is a good warning property. Contami nated clothing should be properly stored until cleaned or destroyed, which will depend on the situation. Shoes with contaminated uppers should always be de stroyed. The danger with "TARS" is very similar although TARS are heavier in nature and may evaporate more slowly. The potential for TARS contaminated cloth ing to cause chemical bums or slowly release vapors into a storage area is even greater than that for EDC. Contaminated clothing should be professionally cleaned or destroyed, depending on the situation.
Q. Can't one molecule of a carcinogen cause cancer?
A. This question cannot be answered with a simple yes or no. There is much scientific debate over what level or dose of exposure to a carcinogen will result in cancer. Most toxic chemicals have a threshold level below which no effects are known to occur, or their effects are reversible. This is based on our knowl
edge of how the body "handles" the chemical and the way the toxic effect occurs.
However, we do not know as much about the way
`inogens cause cancer, and cannot say for sure if a threshold exists, or if one exposure can cause cancer.
There is clear evidence that the potential for cancer to occur is reduced when overall exposure is reduced.
Q. A film shown in 1972 said glioblastomas were a result of VCM exposure. Has this changed?
A. We cannot find the film mentioned in the em ployee meeting. Before 1974, there was little, if any, information available regarding the chronic human health effects of vinyl chloride. Even in the 1974-76 period, when VCM became strictly regulated, the in formation available was mostly about the incidence of liver cancers, specifically angiosarcomas.
Brain tumors, or glioblastomas, have been found in various studies of vinyl chloride exposed workers. The evidence showing the relationship between VCM and these tumors is conflicting.
Q. Haven't more than 100 angiosarcomas been found in workers exposed to PVC and VCM?
A. There is a worldwide angiosarcoma register kept. On this register there are currently 138 cases that have been reported. Thirty-eight of those are from the United States. Conoco Chemicals and Vista had none to report.
Q. What about HCI and chlorine effects?
A. Detailed information regarding the health effects of these chemicals can be found in your plant's hazard communication program.
In summary, both of these chemicals are severe ir ritants to the eyes, skin, and upper respiratory tract. Irreversible tissue damage can occur as a result of short exposure to high concentrations. The strong ir ritant properties serve as a good warning and, in gen eral, prevent long-term exposures. Many people can detect the odor of chlorine and HCI at levels below 0.5 ppm.
Long-term or repeated exposure to chlorine and HCI may cause corrosion of the teeth, chronic irrita tion of the skin, and chronic lung damage.
Q. Are EDC releases and exposures reported to OSHA?
A. No. There is no specific requirement to report EDC releases or exposures to OSHA. The VCM stan dard requires reporting "emergency exposures", under certain conditions, to OSHA but there is no such rule for EDC.
If five or more people are hospitalized as a result of EDC exposures during an emergency, a report to OSHA is required.
Q. Why don't you document high EDC expo sures like you do VCM exposures?
A. We do not document EDC exposures exceeding
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VVV 000002975
the permissible exposure limit with a letter to the em ployee as we do for VCM. However, it is routine for the plant to investigate over-exposures and emergen cy releases for all chemicals, including EDC. EDC exposure records are maintained in the same manner
/CM exposure records. As a result of the company's investigations, infor mation is developed and kept regarding those people that had high exposure during any emergency.
Q. Can different people get different can
cers from the same exposure to the same chemical due to Individual differences?
A. Yes. Every individual has a distinct biochemical make-up. These individual biochemical differences can result in different responses to toxic chemicals or other stresses. Individual susceptibility can also vary due to such things as generics, race, diet and age.
Q. Do studies look at the total number of employees exposed or total number of em ployees at the plant?
A. Each study is done differently. However, in gen eral epidemiological studies attempt to look at ex posed populations and not all employees at a plant site using that chemical. The vinyl chloride studies that are available have looked at various plant popula tions and generally attempted to include only exposed or potentially exposed workers.
Q. Do the chemicals here, VCM and EDC, have a cumulative effect?
A. VCM and EDC are metabolized by the body and eliminated through various routes. They are not known to accumulate in body tissues the way lead does, and exert effects as a result of remaining in the body.
Q. Since Ross & Fogleman are the reason this meeting will there be a study of their
work habits?
A. If we decide to do further studies of the LCVCM plant employees, this may be a part of the study. At this time that decision hasn't been made.
We do know that in the early 70's, the exposures at the plant due to general work practices were higher than they are today.
Q. Are two brain tumors in a short-time in a small group like ours indicative of a prob lem?
A. We don't believe so, especially not when they are of different types. Also, both are found in the general population and are a "common type".
Q. Did Mr. Fogleman have any apparent signs/symptoms from the van exam?
A. Several health problems were noted in the last exam, but were believed to be unrelated to his brain tumor. However, it is believed that his cancer was a rapidly growing one which developed since the last van exam.
Q. Is Vista looking at any other tests be sides Cat Scans?
A. Yes. However, there are no known direct screening methods to detect brain tumors. There are tests available that measure central nervous system dysfunction which may indirectly indicate a brain tu mor. We are evaluating the usefulness of the availa ble tests.
Q. Are there brain tumors at Oklahoma City and Aberdeen?
A. One has been seen at Aberdeen in the past. This tumor did not originate in the brain but spread from another site. This tumor occurred prior to 1984.
Q. What about the causes of death among children of employees? Will you look at those?
A. We will look at all data presented to us if appro priate releases are also provided for these family members.
Q. What are the types of cancer Ross & Fo gleman had?
A. According to the information available to us Ross' cancer was Glioblastoma Multiforme (astrocy toma) and Fogleman's was Adenocarcinoma (meta static).
Q. Would the problem Dan Ross had showup on the van chest X-Ray?
A. No.
Q. Will you get more info on Ross & Fogle man?
A. We hope to, but this depends on the employees'
Q. Did Dan Ross' cancer spread from anoth wishes and approval.
er site?
Q. Why isn't a Cat Scan part of a routine
A Medical information available to us does not indi physical for us?
cate any spreading.
A. The Cat Scan is not a routine screening test. It is
a very specific diagnostic test ordered after consulta
tion with the appropriate physician and based on
3 symptoms and medical findings.
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^o0?976
Q. What are possible signs and symptoms of a brain tumor?
A. The location of the tumor within the central ner vous system) and its biologic behavior determine the wav the patient's signs and symptoms are presented.
;n a tumor grows slowly in a "silent" area of the brain, it may first cause a headache, nausea, vomiting, alteration in personality or changes in the level of consciousness due to increased intracranial pressure.
A tumor within the speech or motor areas may cause general weakness, or dysphasia, long before other signs or symptoms are present.
Q. When used as a follow-up to signs and symptoms, can Cat Scans always detect tu mors?
A. CT scanning provides the ability to visualize the central nervous system and possibly the early di agnosis of tumors. The addition of IV or IT contrast material has increased the detection of hidden tumors. Tissue diagnosis of intracranial tumors is required before beginning therapy. Despite the increased sen sitivity of current imaging techniques, many diseases - including tumors - may not be detected by this meth od.
Q. Does cigarette smoking cause brain tu mors?
A. There is no confirmed link between cigarette smoking and primary brain tumors. However, cigare >moking is well known to contribute to lung canctx which can frequently spread to the brain. Also, cigarette smokers in general have a higher susceptibil ity to many diseases.
Q. Why do Vista blood results use higher normals for comparison?
A. Ranges used for comparison are guidelines only, and vary between laboratories due to different instru ments, methods, etc. It's important to remember that the normal ranges developed and reported by any la boratory are scientifically developed and reviewed by independent accrediting organizations. Also the nor mal ranges are based on data from different popula tions and regional differences may be seen.
Q. Why do the van testing results take so long to get?
A. Vista's medical department is notified immedi ately of any significant abnormalities found in the test results. Dr. Drumwright then notifies employees.
The full report is generally provided to the employ ee at the time of the hands-on portion of the exam. However, if an individual wants his prior to that time, he or she can be provided with the report when it is fit** available from Health Examinetics. This is usua i 4-6 week time-frame.
TO:
Distribution
Interoffice Communication
FROM: DATE:
SUBJ:
T. G. Grumbles August 3, 1989
LCVCM BRAIN TUMOR UPDATE MEETING
VISTA
The meeting is scheduled for 9:00-9:30 on Friday the 4th, in the Environmental Conference Room. There are two items on the agenda.
Obj ective:
1) Obtain consensus on asking NIOSH for a Health Hazard Evaluation
2) Review and agree on medical screening proposal
I) II) III)
Review discussions with NIOSH and Armco Review JRD medical testing proposal Decision time
TGG JRD/THH
ALL
' \ , -------------------
T. G. Grumbles
dlj .729
Distribution:
N. Frost, T. H. Huffman, J. A. DeBernardi, J. R. Drumwright, M. S. Reynolds, W. L. McClain
VVV 000002978
TO: VCM Plant Employees
FROM: DATE:
Interoffice
SUBJECT
Communication
R. A. Conrad July 12, 1989
Employee communication Meetings
VISTA
Because of the many concerns expressed recently by VCM Plant employees over two recent employee illnesses, we have scheduled three (3) employee question/answer meetings on Friday, July 14, 1989 in the Old Laboratory Conference Room.
Dr. Jack Drumwright, Vista's Medical Director and Tom Grumbles,
Vista's Environmental Quality Manager will attempt to answer
questions employees may have.
They will also bring some
material for discussion at the meetings.
The meetings are scheduled for 10 AM, 1 PM and 3 PM. Any
daylight workers who wishes to attend one of these meetings
should contact their supervisor. The supervisor will then
schedule interested employees to either the 10 AM or the 1 PM
meeting.
Shift workers may attend any of the three (3)
meetings depending upon their work schedule. Attached to the
bulletin board are some blank forms that you may fill out in
advance and give to your supervisor addressing questions you
would like to have discussed. Please turn your questions in
as early as possible so that the speakers will have some time
to research your question, if needed.
At various times during Friday*s visit, Dr. Drumwright will be
available to receive calls or to meet with individuals who may
wish to discuss their concerns privately. Please contact Betty
Rogers (494-5064) if you wish to make a telephone or in-person
appointment with Dr. Drumwright.
Dr. Drumwright is also
available in Houston to address your medical concerns. He can
be reached at 1-800-877-VIST-3044.
Again, if you have questions, please fill out the form provided and return to your supervisor or directly to Betty Rogers for prompt forwarding to Houston.
R. A. Conrad
br (2) Distribution Bulletin Boards Supervisors Dept. Heads
QOOOJ2979
EMPLOYEE QUESTIONS FOR MEDICAL CONCERNS FRIDAY'S MEETING 10 AM, 1 PM, 3 PM, JULY 14, 1989
OLD LABORATORY CONFERENCE ROOM l.
2.
3.
OPTIONAL - Employee's Name PLEASE GIVE TO YOUR SUPERVISOR OR SEND TO B. J. ROGERS PROMPTLY FOR FAXING TO HOUSTON.
VW 000002980
TO:
Distribution
Interoffice Communication
FROM: DATE:
SUBJ:
T. G. Grumbles August 14, 1989
NIOSH HEALTH HAZARD EVALUATION REQUEST
VISTA
Attached is the draft request letter.
I've also attached the
portion of the regulation detailing the suggested contents of a
request. Please get me any comments you have ASAP. I believe we
should target to get the request out by the end of this week.
Additional action items associated with the request are as follows:
1. Preparation of an if asked - I'll work with Gretchen Weis to draft and get out for comments.
2. Domini in j cat ion of Request - The plant will notify the employees. I sent factual information that can be used for this last Thursday.
We need the plant to determine what other groups or individuals
should be notified.
For example, LCCP, LCLAB, area Plant
Managers, etc.
T. G. Grumbles
dlj . 721
Distribution:
T. H. Huffman, J. A. DeBernardi, N. C. Frost, W. L. McClain, G. Weis, R. A. Conrad-LCVCM
VVV 000002981
August 14, 1989
Hazard Evaluations and Technical Assistance Branch
Division of Surveillance, Hazard Evaluations and Field Studies
NIOSH 4676 Columbia Parkway Cincinnati, Ohio 45226
Dear Sirs:
Vista Chemical is requesting a NIOSH Health Hazard Evaluation at
it's Vinyl Chloride Monomer production facility in Westlake,
Louisiana. This request is being made to investigate the incidence
of brain tumors at this manufacturing location. A plant profile is
attached that describes the plant operation and provides details the
plant size and history.
The evaluation is being requested as result of recent events in the
current employee population.
Two employees have recently been
diagnosed as having cancerous brain tumors.
According to the
information available to us, Uier one employee's tumor was a
Glioblastoma Multiforme (astrocytoma) and one was an Adenocarcinoma
(metastatic). Both employees have been employed at the plant for
more than 15 years. Based on the facts available to us at this
time, it appears the two tumors are of a different type and not
related in any way. However, the occurrence of two brain tumors in
a short time has raised concerns regarding the relationship of
VVV 0000029B2
chemical exposures and brain tumors at the plant. For this reason, we believe an independent assessment of the situation would be beneficial to further explore the potential work relatedness of the recent health events. Please contact the undersigned at 713-588-3445 to discuss the above or to determine the next step to be taken by NIOSH. Sincerely,
Thomas G. Grumbles, C.I.H. Environmental Quality Manager dlj Enclosures
VVV 000002983
jnment&l Investigations Branch, lion of Respiratory Disease Stud*
, niosh, $44 Chestnut Ridge Road, organtown, WV 36606, <b) Requests for health hazard evilu^ni shall be submitted In writing a igned by either: (1) The employer in -nose place of employment the sub* stance or physical agent Is normally found, or(2)an authorized represents* Uve of employees (see I 65.3-1(0) In the place of employment where the substance or physical agent la normal ly found.
149 FR 3993. Jan. 14.1990)
165.9-1 Contents of a r*quit for health hazard evaluation.
Each request for health hazard evil* uaWon shall contain:
u) The requester*! name, address, andtelephone number, If any.
(fc) The name and address of the place of employment where the sub> ^^jn^ce-.ir^fthyalcfcl-agent Is normally
KcJ The specific process or type of work which is the source of the sub stance or physical agent, or in which the substance or physical agent Is
l Details of the conditions or dr* istances which prompted the re-
.quest.
'/,()! A statement, if the requester la Hot/the employer, that the requester
1ST
(1) Aft authorized representative or an cer of the organization repre sen , the employees for purposes of collective bargaining: or
(2) An employee of the employer and Is authorized by two or more em*? ployees employed In the same place of employment to represent them for 1 purposes of these Acta (each such au thorizatlon shall be In writing and a oopy submitted with the request for health hazard evaluation >; or
(3> One of three or less employees employed in the place of employment where the substance or physical agent is normally found.
(f) A statement indicating whether or not the name(s) of the requester or those persons who have authorised the requester to represent them may be revealed to the employer by nkJsH. /7tg> ;The following supplementary in formation if known to the requester: MT>' Identity of each substance or physical agent Involved:
(3) The trade name, chemical name, and manufacturer of each substance involved;
(8) Whether the substance or Its container or the source of the physical agent has a warning label; and
(4) The physical form of the #ubstance or physical agent, number of
people exposed, length of exposure
ihours per day), end occupations of
exposed employees.
Non: NIOSK has developed two forms en titled "Request for Health Hazard Evalua tion" ana "Request ror Mining Health Huard Evaluation" to Mint persons m re questing evaluations. The forms are avaiiable upon request from the offices listed In I SS.S(a) (l) and (7) or from me Regional Consultant for Occupational Safety and Health In any Regional Office of the De partment of Health and Human Services-
(43 7R 2053. Jan. 14. 1890}
9 86,4 Acllng on requests.
(a) Upon receipt of a request for health hazard evaluation submitted under this part. NIOSH will determine whether or not there is reasonable cause to Justify conducting an investi gation.
(b) If NIOSH determines that an In vestigation Is Justified, a NIOSK offl* cer will Inspect the place of employ ment, collect sample! where approprtate, and perform tests necessary to the conduct of health hazard evaluation. Including medical examinations of em ployees,
(c) if NIOSH determines that an in vestigation is not Justified, the re quester will be notified In writing of the decision.
(49 FR 3693. Jan. 14, 1950)
lg 96,9 Authority for Investigation*.
(a) NIOSH officers who have been Issued official N106K credentials (Form No. CDC/NIOSH 2.05) are au thorized by the Director, NIOSH, under sections 20(a) (8) and 8 of the OSH Act and sections SOKaxll) and 103 of the rMSH Act: To enter with out delay any place of employment for the purpose of conducting investiga tion! of ail pertinent processes, condi tions, structures, machines, apparatus, devices, equipment, records, and mate rials within the place of employment; and to conduct medical examinations, anthropometric measurement!, and functional tU of employees within the place of employment as may be di rectly related to the specific health hazard evaluation being conducted. In vestigation* will be conducted In a rea sonable manner, during regular work ing hours or at other reasonable times and within reasonable limits. In con nection with any investigation, the NIOSH officers may question private ly any employer, owner, operator, agent, or employee from the place of employment; and review, ibetraot, and duplicate records required by the Acts and regulations and any other related records.
cb) Areas under Investigation which contain Information classified by any
agency of the United Bute* Govern ment in the interest of national secu rity will be investigated only by NIOSH officers who have obtained tht proper security clearance and authori zation.
(49 FR t695. Jan. 14.19901
6 59,6 Advance notice of vlilu,
(a) Advance notice of visits to the place of employment may be given to expedite a thorough and effective in vestigation. Advance notice will not be given when, in the judgment of the NIOSH officer, giving such notice would adversely affect the validity and effectiveness of the investigation.
(b) Where a request In accordance with this part has been made by an authorised representative of employ ees, advance notice In accordance with paragraph (a) of this section will be given by NIOSK to the requester, the representative of the employee! for purposes of collective bargaining if such representative Is other than the requester, and to the employer.
(c) Where a request in accordance with this part has been made by any employer, advance notice will be given* by NIOSH to the employer. Upon the request of the employer, NIOSH will inform the authorized representative of employees of the visit: provided, The employer furnishes NIOSH In writing with the identity of such rep- " resentative and with such information M Is necessary to enable NIOSH promptly to Inform such representa tive of the visit.
186.? Conduct of InvratlfsUona.
(a) Prior to beginning an Investiga tion. NIOSH officers shall present their credentials to the owner, opera tor, or agent In charge at the place of employment, explain the nature, pur pose, and scope of the investigation and the records specified in 189.6 which they wish to review, Where the investigation is the result of a request submitted by an authorized repre sentative of employees, a copy of the request shall be provided to the em ployer, except where the requester or any person authorizing the requester pursuant to I 66.3-lfek2) has indicat ed that NIOSH not reveal his name to the employer, In which cae a sum mary of the basla for the request shall be provided to the employer.
(b) At the commencement of an in vestigation, the employer should pre cisely identify Information which can be obtained In the workplace or work places to be inspected a* trade secrets. If the NIOSH officer has no clear reason to question such identification, such Information shall not be dis closed except in accordance with the provisions of section 20(a)(6) and sec-
VVV 000002984
Wii
ammsmmmmm
the
HEALTH HAZARD EVALUATION PROGRAM
of the NATIONAL INSTITUTE for OCCUPATIONAL SAFETY and HEALTH
U.S, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service Centers for Disease Control National Institute for Occupational Safety and Health Division of Surveillance, Hazard Evaluations and Field Studios
I
i
vvv Q
'
oog2985 --
!*
REQUESTS FOR HEALTH HAZARD EVALUATIONS
(Cod* of Federal Regulations, Title 42, Part 86, 37 FR 23640, November 7,1972; amended at 45 FR 2651, January 14, 1980)
TrAifnnr^SEQUK$T$ FOR HEALTH HAZARD EVALUATIONS
Sec. 85.1 Applicability. 85.2 Definition*. 85.5 Procedure* for requesting health
hazard evaluation*. 83.3-t Content* of a request for health
haaard evaluation*. 85.4 Acting on requeue, 86.8 Authority for investigation*. "3.9 Advance'notice of visit*.
> 7 Conduct of Investigation*. 45.9 Provision of suitable spaee for employ*
e interview* and examination*: identifi cation of employees. 85.9 Representative* of employer* and em ployees; employee request*. 88.10 imminent dangers. 85.11 Notification of determination to em ployers, affected employee*, and Depart ment of Labor. 95.12 Subsequent request* for health haaard evaluation*.
Authority: See. 8(g), 84 Stat, 1600: 39 U.8.C. 657(g) and sec. 608. 83 Stat. 90S: 30 U.S.C. 967.
Souacr 37 PR 33940. Nov, 7. 1972, unlete otherwise noted.
185.1 Applicability.
This part 60 applies to health hazard evaluation* requested by any employer or authorized representative of employees under section 20(a)(6) of the Occupational Safety and Health Act of 1670 or section 501<i)(ll) of the Federal Mine Safety and Health Act of 1077. Thi* part Is not intended to preclude the use of other channel! of communication with the National In stitute for Occupational Safety and Health to obtain information and technical assistance concerning toxic substances or physical agents.
*45 FR 3969, Jan. 14.1990]
5 65.2 Definition*.
.
Any term defined in the Occupation al Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1B7T and not defined below shall have the meaning given it in the respective Aot*. As used in this part:
OSH Act" means the Occupational Safety and Health Act of 1970 (39 U.6.C, 651. et seQ.).
"FMSH Act" mean* the Federal Mine Gaiety and Health Act of 197? <30 U.8.C. 601. et teq.).
"Authorised representative of em ployees'' means any person or organi zation meeting the conditions speci fied in I 85,3-KeMl). <2). or (3).
"employee" has the same meaning as stated in the OSK Act and for the purposes of this part Includes "miner" as defined in the FMSH Act.
'Employer1' has the same meaning as stated in the OGH Act and for the purposes of this part includes "Opera tor" as defined in the FMSH Act.
"Health hazard evaluation" means the Investigation and the determina tion of potentially toxic or hazardous effects of: (a) any substance normally used or found in any place of employ ment to which the OSH Act is applica ble, or (b) any substance or physical agent normally used or found in any pfaoe of employment to which the FM8H Act is applicable.
"Investigation" means a physical in spection of the place of employment under section 6 of the OSH Act or sec tion 103 of the FMSH Act and in cludes inspection, sampling, observa tions, review of pertinent records, and other measurements reasonably neces sary to determine whether any sub stance or physical agent found in the place of employment has potentially toxlo or hazardous effects in the con
centrations or levels used or found. "NIOSH" means the National Insti
tute for Occupational 8afety and Health, Center for Disease Control. Public Health Service, Department of Health and Human Services.
"NI08H officer" means a NIOSH employee who has been authorized by the Director, NIOSH, to conduct inveatigations according to this part.
"Physical agent" means any condi tion produced by the environment1 and/or work processes that can result in hazardous effects as defined in this section. Examples of physical agents art noise, temperature, illumination, vibration, radiation, and pressure.
"Place of employment" mesne any cctl or other mine, factory, plant, es tablishment, construction site, or other area, workplace, or environment where work Is performed by any em ployee of an employer.
"Substance" means any chemical or biological agent or dust which has the potential to produce toxic effects.
"Toxic effects" or "haeardous ef fects" are those effects which result in short, or long-term disease, bodily injury, affect health adversely, or en danger human life.
(45 FR 3653. Jan. 14.1990)
9 S6.S Procedure* for requesting hnhh hasard evaluattona
(a) Requests for health haaard eval uations should be addressed to the Na tional Institute for Occupational Safety and Health as follows:
(1) Requests from general industry. Hazard Evaluations and Technical As sistance Branch, Division of Surveil lance, Hazard Evaluation!, and Field Studies, NiOSH. 4676 Columbia Parkway, Cincinnati, OH 46326.
(3) Bequest* from mining industry.
[42 CFH tgJ% l
VVV 000002986
Environmental Investigations Branch. Division of Respiratory Disease Studlet. NiOSH, 944 Chestnut Ridge Road. Morgantown. WV 38506.
) Requests for health hazard eval.on* shall be submitted In writing and signed by either: (1) The employer
in whose place of employment the sub stance or physical agent Is normally found, or (2) an authorized representa tive of employees (see |85.3-l(e in the place of employment where the substance or physical agent is normal ly found.
people exposed, length of exposure ihouri per day), and occupations of exposed employees.
Sort: NIOSH has developed two forms en titled -Request for Health Hazard Evalua tion" and Request for Mining Health Hazard Evaluation" to assist persona in re queuing evaluations The forma are availa ble upon request from me offices lifted in I Sft.3(t) ti> and :a> or from the Regional Consultant for occupational Safety and Health in any Regional Office of the De partment of Health and Human Services
[45 PR 3853. Jan. 14. I860]
146 FR 3666. Jan. 14. i860]
9 96.4 Acting on requests.
9 85.3-1 Contents of a request for health haaard evaluation.
(a) Upon receipt of a request for health hazard evaluation submitted under this part, NIOSH will determine
Each request for health hazard eval* whether or not there is reasonable
uatton shall contain;
cause to Justify conducting an investl*
The requester'! name, address, gation.
and telephone number, if any.
(b) Zf NIOSH determines that an In
o) The name and address of the vestigation is Justified, a NIOSH offi
place of employment where the sub* cer will inspect the place of employ*
''TlWrce-.irj^iyjUcaJ'-egent is normally i ment, collect samples where^gppropri-
i I ate, and perform tests necessary to the
\ (ic> The specific process or type of t conduct of a health hazard evaluation,
work which is the source of the sub* | including medical examinations of em*
stance or physical agent, or in which the substance or physical agent is used.
i-tdi Details of the conditions or cir cumstances which prompted the re quest.
! ployees. j <c> If NIOSH determines that an inI vesttgatlon is not Justified, the reI quester will be notified in writing of
the decision.
va A statement, if the requester is (46 FR 3653, Jan. 14. 1960]
hot/the employer, that the requester ' 916,8 Authority for investigations.
IAh authorixea representative or
a*, officer of the organization repre senting the employees for purposes of collective bargaining; or
(2) An employee of the employer and Is authorized by two or more em ployees employed in the same place of employment to represent them for purposes of these Acta (each such au
(a) NIOSH officers who have been
issued official N108K credentials (Form No. CDC/NIOSH 2 03) are au thorized by the Director, NIOSH, under sections 20(a) (8) and 8 of the OSH Act and factions SOl(axil) and 108 of the FMSH Act; To enter with out delay any place of employment for
the purpoee of conducting investiga
thorization shall be in writing and a tions of all pertinent processes, condi
copy submitted with the request for tions, structures, machines, apparatus,
health hazard evaluation); or
devices, equipment, records, and mate
(3> One of three or less employees rials within the place of employment;
employed In the place of employment and to conduct medical examinations,
where the substance or physical agent is normally found.
(f) A statement Indicating whether or not the name(s) of the requester or those persons who have authorized the requester to represent them may be revealed to the employer by
NJ0SH.
g) The following supplementary in* tlon If known to the requester:
> Identity of each substance or physical agent involved;
<2> The trade name, chemical name, and manufacturer of each substance involved:
(8) Whether the substance or its
anthropometric measurements, and functional tests of employees within the place of employment as may be dl* reetty related to the specific health hazard evaluation being conducted. In* veatlgations will be conducted In a rea sonable manner, during regular work ing hours or at other reasonable times and wtthln reasonable limits. In con nection with any investigation, the N108H officers may question private ly any employer, owner, operator, agent, or employee from the place of employment; and review, abatraot, and duplicate reoorda required by the Acts
container or the source of the physical and regulations and any other related
tgdnt has a warning label; and
record!.
(4) The physical form of the sub (b) Areas under investigation which
stance or physical agent, number of contain Information classified by any
agency of the United State* Govern ment in the Interest of national secu rity will be investigated only by NIOSH officers who have obtained the proper security clearance and authori zation.
(46 FR 3663. Jin. 14. 1910]
9 86.6 Advance notice of vltlu.
(a) Advance notice of visits to the place of employment may be given to expedite a thorough and effective in vestigation. Advance notice will not be given when, in the Judgment of the NIOSH officer, giving such notice would adversely affect the validity and effectiveness of the investigation.
tb) Where a request In accordance with this part has been made by an authorized representative of employ ee!, advance notice in accordance with paragraph <a> of this section will be given by NIOSH to the requester, the representative of the employees for purposes of collective bargaining if such representative is other than the requester, and to the employer.
(c) Where a request in accordance with this part has been made by any employer, advance notice will be given* by NIOSH to the employer. Upon the request Of the employer, NIOSH will inform the authorised representative of employees of the visit: Provided, The employer furnishes NIOSH in writing with the identity of such rep- " resentative and with such Information as is necessary to enable NIOSH promptly to inform such representa tive of the visit.
I 86.7 Conduct of investigations.
(a) Prior to beginning an Investiga tion. NIOSH officers shall present their credentials to the owner, opera, tor, or agent in charge at the place of employment, explain the nature, pur pose, and scope of the investigation and the records specified in 165.6 which they wish to review. Where the investigation la the result of a request submitted by an authorized repre sentative of employees, a copy of the request shall be provided to the em ployer, except where the requester or any person authorizing the requester pursuant to 186.3~He><2) has indicat ed that NIOSH not reveal hi# name to the employer, in which case a sum mary of the basis for the request shall be provided to the employer.
(b) At the commencement of an In vestigation. the employer should pre cisely identify information which can be obtained In the workplace or work places to be inspected a* trade secrets. If the NIOSH officer has no clear reason to question such identification, such information shall not be dis closed except in accordance with the provisions of section 20(a)(6) and see*
VVV 000002987
tion is of the OSH Act or section 501<a)(ll> of the FMSH Act. However,
11 NIOSH at any time question* such identification by an employer, not lea* .han 15 day*' notice to an employer shall be given of the intention to remove the trade secret designation from such Information. The employer may within that period submit a re quest to the Director, NIOSH, to re consider this intention and may pro* vide additional information In support of the trade secret designation. The Director. NIOSH. shall notify the em ployer In writing of the decision which will become effective no sooner than 15 days after the date of such notice.
(c) NIOSH officers are authorised to collect environmental samples and samples of substances, or meas urements of physical agents to take or obtain photographs related to the pur pose of the Investigation, employ other reasonable investigative tech*TH3uesw ..including ' medical exaroina"lions of employees with the consent of such employees, and to Question pri vately any employer, owner, operator, agent, or employee, The employer shall have the opportunity to review photographs taken or obtained for the purpose of identifying those which contain or might reveal a trade seoret.
(d> NIOSH officers shall comply with all safety and health rule* and practices at the place of employment being Investigated, and they shall pro-
ide and use appropriate protective clothing and equipment. In situation* requiring specialised or unique types of protective equipment, such equip ment shall be furnished by the em ployer.
(s) The conduct of Investigations shall be such as to preclude unreason able disruption ol the operations of the employer's establishment.
[31 fit 8**40, Nov. 7, 1971, U amended at 4* to aasa, Jan. u. issoi
I 85.8 Provision of suitable space for em ployee Interviews and examinational identification of employees.
An employer shall, In request of the NIOSH officer, provide suitable space, if such space is reasonably available, to NIOSH to conduct private Inter views with, and examinations of. em ployees, NIOSH officers shall consult with the employer as to the time and place of the medical examination and shall schedule such examinations so as to avoid undue disruption of the oper ation* of the employer'* establish ment, NIOSH shall conduct, and assume the medical coete of, examina tions conducted under this part
8 85.9 Representative* of employer! and employee*: employee request*.
(a) NIOSH officers shall be in charge of inveatlgatlona. Where the re quest for a health hazard evaluation has been made by an authorized repre sentative of employees, & representa tive of the employer and a representa tive authorised by his employees who is an employee of the employer shall be given an opportunity to accompany the NIOSH officer during the Initial physical inspection of any workplace for the purpose of aiding the Investi gation by Identifying the suspected haxard. The NIOSH officer may permit additional employer repre sentatives and such additional repre sentatives authorised by employees to accompany him where he determines that such additional representatives will further aid the investigation. However, if in the judgment of the NIOSH officer, good cause has been shown why accompaniment by a third party who Is not an-employee of the employer la reasonably necessary to the conduct of an effective and thor ough Investigation of the workplace, such third party may accompany the NIOSH officer during the Inspection: Provided, Aoioever, That access by such persons to areas described in paragraph (d> of this section shall be in acoordanoe with the requirements of such provision, and access to areas described in paragraph () of this sec tion shall be with the consent of the employer. A different employer and employee representative may accom
pany the officer during each different phase of an Inspection If this will not interfere with the conduct of the in vestigation.
(b) NIOSH officers are authorised to resolve all disputes as to who is the representative authorised by the em ployer and employees for the purpose of this section. If there Is no author ised representative of employees, or if the NIOSH officer is unable to deter mine with reasonable certainty who is such representative, he shall consult with a reasonable number of employ ees concerning matters directly related to the health hazard evaluation.
(c) NIOSH officers are authorised to deny the right of accompaniment under this section to any person whose conduct Interferes with a fair and or derly physical inspection.
cd) With regard to Information clas sified by an agency of the U.5. Gov ernment in the tntereet of national se curity, only persons authorised to havs access to such information may accompany an officer in areas contain ing such Information,
(e) Upon request of an employer, any representative authorized under this | 85.0 by employee# in aqy area containing trade secrets shall be an
employee in that ares or an employee authorised by the employer to enter that area.
9 85.10 Imminent danger*.
Whenever, during the course of, or fte a result of, an investigation under this part, the NIOSH officer believes that there Is a reasonable basis for an allegation of an imminent danger, NIOSH will Immediately advise the employer and those employees who appear to be in immediate danger of such allegation and will inform appro priate representatives of the Depart ment of Labor or the State agency des ignated under section 18(b) of the OSH Act.
(S7 TO 2*140. Nov. T, 1972, u intended St 48 TO 9881. Jan. 14, 1980]
I88.lt Notification of determination to employers, affected employee* and De partment of Labor.
(a) Upon conclusion of an investiga tion, NIOSH will make a determinetion concerning the potentially toxic or hazardous effects of each substance or physical agent investigated as a result of the request for health hazard evaluation. At a minimum, the deter mination will: (1) identify each sub stance or physical agent Involved and describe, where appropriate, the con centrations or levels of the substance or physical agent found in the place of employment and the conditions of use. and (9) state whether each substance or physical agent has potentially toxic or hazardous effects In the concentra tions or levels found, a* well as the bull for the judgment*.
cb) Copies of the determination will be mailed to the employer and to the authorized representatives of employ ees.
(c) Except u hereinafter provided, the employer shall post a copy of the determination for a period of Jo calen dar days at or near the workpiace(a) of affected employees. The employer shall take steps to insure that the posted determinations are not altered, defaced, or covered by other material during such period. The employer will not be required to post the determina tion if the employer requests that copiee of the determination be mailed to affected employees and furnishes NIOSH with a list of the names and mailing addresses of the employees employed in the workplace(s) desig nated by the NIOSH Officer. In the latter event, NIOSH will mall such copies to affected employees st the mailing addresses provided by the em ployer.
(d)-For purposes of this section, the term "affected employees" means those employees determined by NI08H to be exposed to the substance(s) or physical agenus)
VVV 0000029B6
which Is the subject of the health hazard evaluation.
,e> Copies of determinations made under the OSH Act will be forwarded to the Department of Labor and the appropriate State agency designated under section 18(b) of the OSH Act. Copies of determinations made under the FM6H Act will be forwarded to the Mine Safety and Health Admlnle* tratlon of the Department of Luon the Bureau of Mines. Department of the Interior, and Che State agency which. In the Judgment ol HIOSH.
would benefit the most from the infor mation. If NIOSK determines that any substance or physical agent has poten tially toxic or hazardous effects at the concentrations or levels at which It is used or found in a place of employ ment, and the substance or physical agent Is not covered by a safety or health .standard established under sec tion 6 of the 08K Act or section 101 of the FMSH Act. NIOSH will Immedi ately submit the determination to the Secretary of Labor, together with all pertinent criteria.
[37 FR 33640, Nov, 7,1973. as amended at 46 FR 3663, Jan. 14,19801
4 83.12 Subsequent requests for health
hssard evaluations.
If a request Is received for a health hazard evaluation in a place of em ployment in which an evaluation under this part was made previously, NIOSH may make another investiga tion If, as a result of the passage of time or additional information, an other Investigation would be consist ent with the purposes of the Acts.
[46 FR 3664. Jan. 14, 19601
> VAIMMlWriMIMMtt im . H.intoJJ
vvv 0000079B9
TO:
Dick Conrad-LCVCM
TGG: JCL: MMG: AJO: W
-------------------------------------------- -
Interoffice Communication
FROM: DATE:
SUBJ:
T. G. Grumbles
July 27, 1989
VISTA
LITERATURE RESULTS OF BRAIN TUMORS AND VCM EXPOSURE STUDIES
Attached is an example of what papers summarizing the literature say. In general, excesses have been seen but the excess is probably not significant, or in other words no more than the normal population.
These pages are from a I think we want to put attention to them.
"summary" paper that will go this type of paper first and
in the direct
book. their
T. G. Grumbles dlj Attachment
VVV 000002990
41
CONCLUSION Occupational exposure co concencrsclon* of VC of eh* order of 1,000
ppa haa closed th* classical 'vinyl chloride illness*. Exposure to such levels, or perhaps lover levels of ehe order of several hundred ppa, has caused angiosarcoma of ehe liver after a latent period that is seldom less chan IS years*
The evidence nov available froa following up aany thousands of sen occupationally exposed to vlnyl_ chloride. suggasts_ehat-a _s*ll risk. n_lung cancer aay jiao have been produced, which aust, however, have been substantially less (In absolute terms) than the risk of angiosarcoma of the liver. caused eancer in any other organ^ but le la impossible to state categoric ally that it has not. Clasrar avldenca, ona way or tha othar, could be obtained if the various investigators would praaent their results in comparable forms Chst would sllov them to be combined end subjected to the stsndard tests for an occupational hasard.
Thara Is no evldenea that exposura to VC has esusad any othar dlsaase*
Suggestive evidence hes been obtained that past levels of nvrt rnieemsl pollution with vinyl chloride aay have caused a few cases of cancer in tha general public.
VVV 000002991
28
German and eba Swedish studies dtrlved tha expected nuebers of deaths froe national eorcallty racaa for a single year towards tha and of the study period. Tha expected numbers of daatha ara likely, therefore, to have baan overestimated and tha SMts correspondingly uodaraaeinatad as tha mortality froa ions caaear had baan rising throughout tha parlod of obssrvaclon*
Tha Idas that VC night caosa brain caaear was suggastad by Honson at si* (1974), whan they reported 5 easas against 1.2 expected, in tha saaa papar in which they suggested that VC night eaosa lung caaear* Tha combined data that ara shown in Table 4 provide some support for this hypothesis* Monaon at al*'s cases ware, however, observed in US workers and mat be presuwd to be included in tha total raportad by Environmental Health Associates (1986), in wbieh caae they will have contributed a substantial proportion of tha total in Table 4* To test tha hypothesis we ought, tharafora, to subtract Monaoo at al**s data* Their study was not a cohort study and their expected deaths do oot correspond exactly to those in Table 4; wa can, however, only subtract both tha observed and tha expected cases from the present totals* This leaves 24 observed against approximately 18*3 expected, a difference which night easily oceur by chance <P, one-tailed, 0*1)**
Additional information from two other sources is given in Table 5* Tha snail excess raportad provides little further evidence of an occu pational hasard, as one of the two deaths obeerved in the Swedish study occurred in a young nan who had been employed for leee than a year when tha diagnosis wan made, while tha excess death rata for brain cancer observed
If wa regard Haxvellar at al *s (1976) study as tha origin of tha hypothesis we should be left with 26 deaths against 18*94 expected (P, one-tailed, 0*07).
VVV 000002992
29
la eh* Cernan study vat lass chan chat observed la ehemleal workers not exposed co vinyl chloride <2.9 deaths after allowance for deaths froa unknown eausee against 1.6 expected) and In workers la the PVC fabrication Industry (5.9 deaths after allowance for deaths froa unknown causes against 1.1 expeeced)
Cancers of Lyaphatlc and Haeaatopoletle Tissues The idea that VC night cause cancer of the lymphatic and haemato
poietic tissues - and nore specifically the lysphatlc tissue - was suggested by Tabershaw and Caffey (1974) and by Waxveller at al. (1976) when they found, respectively, in two cohort studies (1) 5 deaths fron lynphoaas in the nost heavily exposed workers against 2.54 expected, and (11) 4 deaths fron canears of the lymphatic and haeaatopoletle tissues against 2.5 expected* These snail excesses night have been Ignored If the laboratory findings had not been interpreted as suggesting that lynpbonas were produced experimentally la anInals exposed to vinyl chloride by inhalation (Kaltoni and Lefealna, 1975). On this basis, the idea that similar exposure night also cause lynphoaas In Man needed serious consider ation. The data fron the four principal studies that ere tuaaarlxed In Table 4 provide little support for the hypothesis when ell cancers of the lyaphatle end haematopoietic tissues ere considered together (57 deaths sgslnst 50.87 expected, SHE 112) end very little more Is obesloed fron the separate dees for cancers of the lymphatic system (using Tabershaw end Caffey*s definition of ICO Hat numbers, 8th revision, 200-203 and 205) that are shown in Table 1 (35 deaths against 29.40 expected). The position is, moreover, hardly altered by subtracting the data in Tabarsbaw and Caffey1s initial report (29 deaths sgslnst 23.36 expected, SMR 124).
Sons little additional information is provided by the results of the Carman study, some of which are shown In Table 5. This obtained an SHE of 214 for exposed workers (based on 15 observed deaths, increased to 16.5
coooo?-^3
36
absolutely almost as large ae the risk of developing the noraally very rare angiosarcoma.
One of the many hazard* that have been suggested can be dismissed, as there Is no evidence to eupporc it: namely, the idee that VC causes any cancer of Che digestive tract ocher than anglosercoaa of the liver. Two hazards (of melanoma and cancer of the thyroid) have been suggested only very recently end few of the available studies have provided information about thes. there le no good theoretical reaeon or laboratory evidence to suggest that alther should be produced by VC end, on present evidence, the staples* explanation la that the reported exeeeeee ere the ehance effects that oust be expeeted when aany different types of cancer ere atudled In several different populations. So far ae aelanoaa la concerned it has to be reaeabered that the disease has become such aore coaaon In recent years in Scandinavia (where the excess has been reported) due, it le believed, to the popularity of sunbathing and the increased opportunities for Scandinavians to travel to the warmer parts of Southern Europe end North Africa. The extent to which this aey have effected the observation la Norway needs to be examined.
Two other hazards (of lyaphoaa and ofkhrain.cancer}) were suggested by the early reeulta of eoae of the American studies. That VC might produce a hazard of lymphoma was initially supported by the preliminary reeulta of animal studies, but the coaiplete reeulta of the many studies chat have now been undertaken (see Haltoni and Lefealne, 19SA) do not suggest thee lyaphoaa or any other cancer of the haematopoietic system Is liable to be produced. There is, however, eoae evidence that brain tumours can be produced In rats (see Maltonl end Lefamine, 1964). The hypotheses that lymphomas end brain cancers might be produced by VC have been supported by the observation that both these types of cancer have caused death aore often then might be expected from national mortality rates, but the
000002994
VVV
37
sxcaoaee obfmd In the combined d*c from Che four principal studies are small and aoc statistically significant and the hypotheses remain unproven. The sawll excess of brain eancsr is particularly difficult to evaluate as mortality races from this disease have changed rapidly over time In company with Improved methods of diagnosis and the suspicion of an occupational haaard (uhlch was raisad In 1975) eould have influenced the findings. Vhat excess has occurred has been limited to the USA and Germany and the German findings carry little weight, as the excess was found in each of the three occupational groups studied. Irrespective of the chemicals to which they were exposed. The supplementary data from the German study showing an increased mortality from lymphatic and haematopoietic cancers are more impressive, particularly as the eseeea was moat marked for men who had been employed for st lesst 5 years* In these circumstances, we muse still suspend judgment until the daca for each study srs analysed for each specific type of cancer, by Intensity and duration of sxposura, and elms since expoeure began.
There remains ehe suggestion that VC night cause lung eancsr. At first sight, this Is ruled out by the SKR of 97 for the combined data for respiratory eanear for ehe four principal studies. Lung cancer is, however, normally eo enmos (accounting for about 8X of the expeceed deaths) that an increase In mortality that was half as important (numerically) as the mortality from angiosarcoma of the liver might easily be overlooked (95Z confidence limit of the SKR, 85*112). The incidence of che dlsesse is moreover very variable within a country and chare must be doubts whether the national experience provides e suitable control for men employed in planes that are not evenly distributed about the country. In these circwstances we cannot exclude sa occupational hatard unless it can ba shown that the mortality within the exposed men is Independent of the factors that might be expected to influence It, it some of it were
OOOo?995
TO:
Distribution
TGG XF:__
CONFIDENTIAL
\J0: RF
Interoffice Communication
FROM: DATE:
SUBJ:
T. G. Grumbles July 17, 1989
VCM PLANT EMPLOYEE MEETING ACTION ITEMS
Based on the feedback and discussions at the meetings held on Friday, July 14, below are the action items and proposed responsible parties.
1. Prepare a binder that contains copies of
the scientific literature referenced in the employ brochure.
TGG
2. Prepare a written Q & A document for the questions raised in the meetings.
3 . Prepare a list of suspected employee cancer cases.
4. Research cause of death for employees listed in #3.
TGG/JRD/Flant Plant
JRD
5. Continue to explore early screening tests for CNS dysfunction.
JRD
These 5 items were the ones that were raised in the meeting and the ones we have committed to for employee feedback.
I would add the following to the list:
6. Continue to discuss NIOSH Health Hazard Evaluation.
ALL
7. Consider medical screening steps for long term employees only (these are ones with highest risk.)
JRD/THH/ RAC
The general plan is to have further written feedback to the employees in a 2 week time frame. I believe Item 2 would be the major portion of this with any updates available on Items 1, 2, 5, and 6.
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T. G. Grumbles
dlj .715
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T. H. Huffman, J. A. DeBernardi, J. R. Drumwright, N. C. Frost, R. A. Conrad, M. Brady, G. Shirley-VCM
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