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Mr. 0. R. Smith Special Studies Staff Environmental Protection Agency
National Environmental Research Center Research Triangle Park* North Carolina 27711
APR vWfc -
g.Riwuw,*
Dear Mr. Smith:
This will furnish you further Information on the subject of reported non polymerization worker cases of angiosarcoma which we discussed by telephone on March 31 and April 2.
Some confusion seems to have arisen over the nomenclature applied to the reported cases of angiosarcoma In Connecticut. They have been variously called "community cases" or "neighborhood cases" in the media, In EPA documents (STAR Document, p. 1), and In the EPA hearing (cross-examination of Barry Castleman by Dr. William Marcus, hearing transcript p. 42, copy attached), "non-polymerization cases" by NI05H, and "non-occupational cases" by CDC and in other places. Unfortunately, we seem to have added to the confusion by using both "non-occupational" and "non-polymerization" on page 19 of the Air Products' submittal to Dr. Goodwin, dated February 23, 1976.
I will hereinafter use the NIOSH designation of "non-polymerization" for employees not workinq in PVC plants and "non-occupational" for persons not employed In any part of the PVC Industry.
The cases with which we are concerned are therefore "non-polymerization" cases. NIOSH does list these In "Table II" which they maintain. The latest listing of these cases is dated September 12, 1976, and 'is attached. It has not been distributed routinely with Table I over the last few months, and Drs. Adams and Smith of this company were informed earlier this year by Dr. Lloyd that it had been discontinued. This led to the statement in the submittals by Air Products and the Society for the Plastics Industry that these cases had been dropped. In a conversa tion today with Dr. Pierre Decaufle of NIOSH, he confirmed that this list is not normally distributed now, but that It is still In existance and will be maintained.
The burden of proof is on NIOSH to substantiate their listing of these cases, arid to show their relationship to vinyl chloride. No one presently exercises this responsibility. Angiosarcomas do occur in populations not exoosed to vinyl chloride. The CDC has recently published a survey of ten cases in Wisconsin which have no
vinyl chloride relationship whatsoever (copy attached). The Connecticut cases would seem to fall into a similar classification except for the very casual relation
ship to fabrication operations. This type of correspondence is expected to occur on a statistical basis from time to time.
AP00011368
Mr. J. R. Smith
-2-
April 6, 1976
Regarding the foreign cases listed in NIOSH Table II, Germany 03 filled aerosol cans where the exposure from leakage was reported to be high. We have no more information than NIOSH on Germany 07, or Great Brltian 02. Italy 01 did not have primary liver angiosarcoma. Sweden 02 worked in an obsolete acetylene-process vinyl chloride plant where the exposure was high.
The two U. S. (Connecticut) cases are discussed by you in the footnotes to Table 6-19 of the STAR Document, where you quote Dr. L. B. Thomas of the National Cancer Institute. ' He states that both cases are uncertain. Furthermore, EPA has stated that their measurements of vinyl chloride around fabrication plants show it to be "almost negligible" (Preamble to Standard 40 FR 59534). The highest found was 6 ppb, and none was found at 3 of the 5 plants tested. Thus, these "non polymerization" cases are doubtful in relationship to vinyl chloride, and do not support any concern for harm at "levels of exposure as low as 1-10 ppm" (STAR Document, p. 1
The exchange between Mr. Castleman and Dr. Marcus at the EPA hearing Indicates that the EPA has reached the same conclusion. This is supported -by-the statement fn Appendix E, page 5, of the Risk Assessment Document by A. M. Kusmak and R. E. McGaughy that, "This survey has produced no evidence that living around vinyl chloride plants is a risk.factor In the occurrence of liver angiosarcoma."
Thus, we.stand on our position that there is no demonstrated risk to persons not exposed to high concentrations of vinyl chloride for long periods of time, and therefore, the proposed standard is unnecessary.
I hope that this clarification is of help to you, and apologize for any confusion to which we may have contributed. We will be happy to discuss any other part. of. our. comments.with you. whenever you may wish.
Very truly yours,
Attachments,. ,
.
Vc; ;Mr. G._ Baise/llucVelshVus, Beveridge, Fairbanks & Diamond, Wash., DC
0. R._ Goodwin, EPA, Research Triangle Park, NC ' : -Mr* 0* Hadley, Keller V Heckman, Wash, DC
Mr. R. Harding, SPT," New York, NY
bcc:" A.' R. Adams'
R. Fleming R* H. Schenck W. M. Smith L. B. Tepoer
AP000U369
TRANSCRIPT OF EPA HEARING ON vinyl chloride:, February 3, 1976
DR. MARCUS: po you know of any evidence of the
increased rink in the general population, Dthor than the
studies that have been done in work?
MR. CA?TT.r?-tAtt: Aside from the fact that there
were apparently two neighborhood canes with no known
occupational e>rposure, no X don*rt.
PR. MARCUS: I would like to say that EPA
investigated very carefully those cases, and we consulted
with our expert doctor, Hans Popper of Mount Sinai, and
it was his expert opinion that these people did have
* * ' r
angiosarcoma.- that was of a different type then that caused
by vinyl chloride monomer, and I must cay, to date va
do not have any evidence that angiosarcoma has been produced by vinyl chloride monomer in the general population.
MR. -CASTLEMATT: I think it is important, to realize that only about one-fourth of the present WC
plants were operating 20 years ago. The latency .of this
disease is 20 years or more, and of these ten plants,
at least one-fourth of the present level of plants, which
is about ten, the total production rate is one-tenth of the
rate it is today. The population nay also have boon thinner
around the plants than it is todays -
. !*;
' Sc?, If you look at the present situation in terms
of how many people lived near the plants of a certain
sire, it boars little rcscmblencc to the situation 20
vJicm % /.V*i ' *li
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na
AP00011370
ysjars ago.
The mortality experience that wo obssrvo today
started 20 years ago, I don't think the absence o
eases is any proof of anything. Wouldn't you agree with
that?
i
DR* MARCUS: In general I would say that is a
very cogent comment. The only thing here is that vinyl chloride happens to offer us a unique opportunity to
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see an extremely rare cancer, which wo can cay is maybe
due to the substance in question, rather than an increased
rate of cancer, which la a very difficult thing to assess.
That is why I say, I was hoping somebody would
have some information about VCM induced angiosarcoma in
`the general public, because we have not been able to find
it as yet..
. . * '
j
MR* CASTLEMAM: I talk to the came people you do
y
CllAIRMAN DENNEY: Dr. McGaughy.
DR. MC GAUGHY: I just have cno short question.
* Re are interested in getting as accurate a
picture as we can as to 'what the risk is to the population
due to vinyl chloride exposure. You mentioned there
were two or three factors that ve have not considered.
Mainly the carcinogieity of vinyl chloride and
other chemicals and the transplancental effects that might
*3
caused to expectant mothers.
AP0001)371
Vo!. 25, No. 0
WEEKLY UEruTT
For Week Ending February 28, 137G
U.S.DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE PUDUC HEALTH SERVICE
DATE OF RELEASE: MARCH S. 1976 - ATLANTA. GEORGIA 30333
EPIDEMIOLOGIC .VOTES AND REPORTS ANGIOSARCOMA OF THE LIVER - Wisconsin
In the period June 1973-Novcmbcr 1975, 4 esses of ngiosircoma Of the liver (ASL) were diagnosed at the Marsh field Clinic, Marshfield. Wisconsin. One wm based on hepatic Arteriography and 3 on tissue findings later confirmed by pathologic review at the National Cancer Institute (NCI).
An additional 6 cases, confirmed on pathologic review at NCI and identified through a national ASL case surveil lance project initiated at CDC in 1974, have been diagnosed since 1904 in Wisconsin residents. This total of JO cases is foughly twice as large as might be expected (5.5 cases), based on CDC surveillance estimates of erode ASL incidence for the entire United States. (Five additional cases had been re
CONTENTS
Epidemiologic Norn and Reports
Angiosarcoma of the Liver -- Wisconsin........................... 67
Possible Lasu Fever - Washington, D.C..................... ...... 6A
Current Trends
Influent* -- Worldwide ....................................... ..
S3
Interactional Notes
Solmanttti typhimurkm -- Canary Islands,
Finland, and the Federal Republic of Germany .... 64
ported for Wisconsin; 4 were not confirmed, and I was in a resident fanolhersuic.)
In view of this relative frequency of cases, together with the recent succession of cases at the Marshfield Clinic, epi
demiologic information concerning each of these 10 caves
-.
TABLE 1. CASES OF Sl'ECli-TLl) NOTIFIABLE DISEASES: UNITED STATES (Cumulative totals include revised and delayed reports through previous weeks!
DISEASE
WEEK ENDING
February 38 1976
February 23 1975
MEDIAN 1971*1975
CUMULATIVE. FIRST &
February 23 1976
February 22 1975'
WEEKS
MEDIAN 1971-1475 .
Encephalitis Hepatitis, Viral
Type U ................................ ..
Henififococctl infections total..............................
28
5,764 A
13 A
242 12 6 133
3 405 - 53
53
2
Tbbrrculosis . * ( 1 aa aa^at aa** t - -570
Tvhremi* .... aa<4e*4*idd4
r *
IVphtu, (tclt-barne (Ricy. Mt. spotted fever)....
Venerea! Diseases:
ll.M)
562
. SypWlb, primary and secondary
. * *'
52 B .
Rabies ia inimafs ......................................................
31
35
4,311 14 IT 7
210 707 150
6 578
41 41
1*425
285
*05 12
33
6 15
5 172 [ 690
6 622
41 40
1 1,892
445
.2 4
17,273 419
S31 1
4$
'
56
307
39 ,268
62
129
32
1,935
5*409
1*365
*3 4,316
284
261
3
9,366 194
1 *670
6
4,572
-
21
* 56
3
''151,748
4,708 4,132
-64 . ,249
292
29,493 64 96 33
1 *566 $.426 1,123
42 2*668
270 263
7 11*136
201 1*937
9 4,105
8 29 10
141,258 4 *776 3*936 52 284
292 15
23 120
33 1*314
42 4,167.
270 263
9 14,241
3*534 6
13 31
9
448
TABLEil. NOTIFIABLE DISEASES OF LOW FREQUENCY Cum.
Cum.
2
Poliomyelitis, total: ............ e
2 2
19
Hague:................................ .........................................................
fKrpuH l<>
,,
Trirltinosiv. NJ. 1 , . ....................... ....................................
33 2
*t ...
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58
MorlntUly ou<l Mortality Weekly Report
FEBRUARY IS. 1976
ANCIOSARCOMA - Continued his been BiiwmbleJ tltrour.lt medical record review and family interview (l.-tble !). Farneiihr attention bat bet'!) given to potential occupational or environmental exposure to chemicals known to induce ASL (vinyl chloride, arsenic, and
thorium dioxide). Most cases (7 of I0)were diagnosed since 1970, prob
ably reflecting better ease ascertainment in recent years. Ages ranged from 36-71 (mean age 58 years). All but 1 pa tient were male, and all but 1 were white. Places of usual residence for all cases were widely scattered across the state, roughly corresponding with the state's population (figure 1).
One patient had a history of prior thorium dioxide ex posure. For none of the remaining cases was tumor etiology obvious. Occupations and histories of exposure to potential environmental toxins differed widely, with no more than 1 case associated with any particular industry or mode of exposure. In several instances, however, individual patient occupations or exposures were suggestive of possible onco genic*ly (Table I). Patient 10 had had exposure to a vinyl
compound; he had worked in paper and plywood products with potential contact with various chemicals, including poly vinyl acetate. Two other patients gave histories of possible exposure to arsenic: patient 9. who had exposure to insecti tides while farming,, and patient 8, who worked with wood probably treated with arsenic preservatives in the manu facture.of bleachers. AM.but 3 of the 10 patients were known to have lived on farms during their lifetimes, 2 Tot all of their
Jives (Table 1).. (Reported by J Fiechtner, .1/0, C Reyes. MD, Marshfield Clinic; K Retumcssisr, MPli, JIG Skinner, MD, State Epi demiologist, Wisconsin State Dept of Health and Social Serv ices; Office of Cxtramural Coordination end Special ProfcctS, National Institute of Safety and Health; and the Cancer and
Birth Defects Div. Bur of Epidemiology, CDCJ
Editorial Note These data indicate no obvious common-source origins
among recent cases of ASL in Wisconsin. The marked male preponderance among cases, however, suggests occupational
Figure I
GEOGRAPHIC tStSTTtl NUT t ON Of CONFlUMm CASES Of ANGJOSAKCUMA titHit. l.l\ fit IN WIMONMSl 111 MIM.NIS.
1904-1975. HY PLACE OF USUAL KCSTUCM.C
exposure as the potential origin for at least some of the eases. Anecdotal histories of occupational and environmental exposures in several of the eases may warrant further tttvcjtigation. particularly in relation to contact wirh arsenic. Al though at present only vinyl chloride monomer (/). thorium dioxide (J). and arsenic (S.S) are clearly implicated as causes of ASL. Investigations such as the one described here may well provide useful leads in defining further causes. 'References ). Creech JL, Johnson MN: Angioureeraa of liver in the manufacture Of polyvinyl chloride. J Oecup Med 16:1 J0-J3J, 1974 2. MacMahon HE. Murphy AS. Bites Ml: Endothelial-Cell sarcoma of liver following ThorottJSl injection. Am J Pathol 23:SS5-59S, 19J7 3. Leader Si, Stanly RJ, Sumner HW, <t s[: Angiosarcoma of she liver associated with Fowier'i solution (potaicium irunue). Gastroenterology 69:I5S2-15S6,1975 4. Roth F: The sequels of chronic irsenie poisoning in Moselle vinsers. Ger Med Mon 2:172-175,19S7
_______
.
Table 1 Ow of ASL In SVjtcomin Resident* 1964--1975
6k Month and Year L'sttji Town Age at Number Diagnosis Death Of Residence Diagnosis Race Sex
Occupation
Comments
Farm Residence
1 4/64 2/65 Sheybogan 71
W
3 5/67 2/67 Oshkosh
.
3 6/67 6167 Necedah
61 W 36 W
4 7/71 7/71 Milwaukee 68 * ^ B
:j
4/72 4/72 Milwaukee
64 1 "V
6 4/74 6/74 Drown Deer 46
W
7 ' 1/74 7/74 Wausau
57 W
-9/74- -9/74 --Wjupon------ ---46-- w
T' " 9
10
5/74 S/74 SlratM ` * C6 * w
11/75 11/75 Marshfield
65
w
-- ----- ------- ---1 -----
- 7 -------- * -- . .
4
M University Teacher Lived near a chemical company
Youth
M Foundry Welder
which made plastics ud resin Exposure to welding materials
None
F Secretary
and resins Infectious hepatitis in childhood.
Youth
mother and sister had liver disease
M HogScatder
None
91 Unknown
Exposure to tlrorium dioxide
Unknown
M Lutheran Pastor
Lived near a paper mill. 1955-1959 Youth
M Rock OushvrjGhie- Exposure to silica dust, rubber
Youth
Liner for rubber
cement
raincoats, 1940s
M Postal Mail Carrier Contact with lumber, paints, wood Lifetime
formerly employed preservatives, lanttnoniacal-coppcr-
by company that arsenate wood prcscrvaiiveM?)
made Mv.ulicrs
M Retired farmer
No tissue diagnosis; ARLdiapnowd Lilciime by hepatic artcno|tr.tftsy
M Press operator for Contact with wood, plywood.
Youth
paper and pfywtoJ t;luv, polyvinyl acetate, others
company (23 years)
'
j
AP00011373
TABLE II
i | REPORTED CASES OT ANGIOSARCOMA OF THE LIVER AMONG ........ | NON-POLYMERIZATION WORKERS EXPOSED TO VINYL CHLORIDE
i'
,r '
COUj NTRY
i
Fed. Rep. Germany Fed. Rep. Germany Great;Britain Italy
Sweden United States United States
-
CASS
j
BIRTH
#; DATE ; i1
03* 07-16-30
07* 05-09-36
02* 09-08-14
01 ' 06-15-34
02* 11-27-11
14 00-00-13
15* 00-00-25
1st VC or PVC EXPOSURE
06-09-52 00-00-60 00-00-46* 00-00-65 , 00-00-45 08-18-38 i00-00-00
DX ANGI0 SARCOMA
03-00-73 00-00-74 02-00-70 04-19-71 05-15-72 06-00-73 07-00-72
AGE YRS
TOT
AT 1st EXP YRS
DX TO DX
EXP
43 21 38 14 55 24 36 6 61 27 60 36 47 00
14 03 . 11
3
23 00* 00
DATE OF DEATH
*
10-10-73 Note 6 12-16-74 Note 9
12-00-70 Note 1 04-16-71 Note 2 & 7
08-16-72 Note 3 07-03-73 Note 4&8 02-15--73 Note 5
Note L Note 2 'Note 3 Note 4 Note 5 'Note 6
Note 7
Note 8
Kota 9
Pouring PVC oil mixture j onto fabric bases
Production of PVC sacks
Production of Vinyl Chloride
...
Machine operator covering electrical vlre vith PVC plastic Insulation
--
Accountant at plant making PVC fabric
Loading pesticide cans with VC propellant i
1
Angiosarcoma Involving live^, lung, and pericardium. Although difficult to determine, primary
site seems to be pericardium. Diagnosis: Sarcoma (possibly "angiosarcoma")* liver. Possibility of generalised neoplasm of
the reticuloendothelial cell system cannot be ruled out.
Assistant Factory Chemist
t
* Indicates microscopically confirmed! angiosarcoma of the liver.
"00" Indicates unknown data.
|
AP00011374