Text

Findings of Fact & Conclusions of Law on Contentions 8/9 & 17/26.Certificate of Svc Encl.Two Oversize Brochures Encl. Aperture Cards Available in PDR
	ML20054H772
Person / Time
Site:	Waterford
Issue date:	06/21/1982
From:	Duncan C, Groesch G; JOINT INTERVENORS - WATERFORD
To:	;
References
	ISSUANCES-OL, NUDOCS 8206240415
	Download: ML20054H772 (110)
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e UNITED STATES 01 AMI.R i t ' A NUCl !;AR Rt.Gl'I A IORY COMISSION v.o.,*

Ill: FORE Tile ATOMIC SAFE 1T AN!1 ^ LICENSING tOARD In the Matter of Diuket No.

50 - 18 ]

or, l.0UISI ANA POWl:R AND l.1U111' COMPANY (Waterford Steam Elec t ric St.i t l on,

l'n i t 3) a llEARING MEMORANDUM ON CONTENTION 8/9 foini !ntervenors' pioposed Finding, of Fact.md Conc l us i on r ol I.. t w discuss the evidente pre;ented and.ipplicablo conclu. ion.

TI e re f o re,

.loint Intervenors will not re i t e rat e m.it e r i.il cont a ined in it l'ri po wd l'in d in g.; o f F.ic t and Conclusions on law.

(in i s uittet not eli. c osst d t her ein wilI le dealt wit h in.lo i n t Inteivenor-.' IrioI Mea ir. nlu m l'NDI SPI'Tl:D F I ND I NGS OF FACT \\NH CONT l US li'N S O!- I A',l

.!aint Intervenor-ha ve no d i sput e wit h Ap; l ic.in t 's Findinos ut I n-t No.

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All other pr opowd Findiin. ol I.n f

.n ol C..in lusion, ol I.a w hv App!icant a re contest ed.ts st.i t ed.

IllE RECORD The Iloa rd ruy c on s i de r a l l p.ipers l i st eil o r identilled in.loint

'ntervenors' Pleading >. 10 C.F.H. J.7J0(a). (b),.i l l doctown t a ry evident e 4

"as cuy be required for full and t rue d i '.c l o s n i e of the tacts," 10 C.F.R. 2.743(a) of fic ial records of a goveranco1 rnev, 10 C.F.R.

2. 74 3(b),

and all rutters or tacts which fall wit hin the lio.i rd 's expe rt i se or brought to t he lioa r d 's attention, 10 C.I.c J. 7 /. l ( i ) ;.nni all tacts ctillla ine d ill Qllesljti n t-t ct'lll ' t! it e ' \\ !

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raised durinr lin.ited appearer's appearar. cec. 10 C.F.R. Fart 2, App.A V sd )(1) ar.d all other matters within the Ecard's discre-ticnary authority, 10 C.F.R. 2 760(a).

L Joint intervences, in proposed 1indinga of Fact and Co.clu-sions of Law, have cited pertinent scien'ific papers and covern-ment stucies wh;ch the Board may concider ir. makinc its recom-mendations an d;ccurred previously.

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after a ** f u l, a:J trae c loclosure of tb factc," 10 C.F.h. 2.74)(a),

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and to core:cer v. : ether the issuance 0; tr e licence will te in-laical to tne health anc safety of the putlic." 10 C.F.R. Fart 2 App. A VI!I(Lj(b).

Many ofthe papers and studies referred to are contained in Joint intervenort ' '"xhibits 1-27,cNEL:ns of which were furnished to the Boar' and all counsel.

The boa rd can and chould concider all cuch exm tite at part of the evidentiary record of the hearings.

Althoufh Joi-t ~. n t e rven c rc ' counsel arre( d to the withdrawl of sottw exhititz, re acted with?ut authority, and in disrecard of his client inrtructiorc.

(See Affidavit attached hereto.)

While ordinar g, an atttrney has discretion in such mattere, it ic clear from the record that Sr. Jones dig not have such authority, k

7 Mr. Jones was instructed that he could stipulate with all other the Board's ruling o bon-vitness-authored hC6. d r..d counsel that e

would apply to all document s in the course of the hearings. Jongswas not given authority to withdraw without roling Joint I n t e r veno r s '

a non-witness-authored doc u wn t s.

While dec i.sions rude on the pa rt of an at torney regarding the admission of docunente, or e.hibit s are norma lly within counsel's purview, under these c ircumstances, to allow Mr. Jones' unilateral decision without a u t ho r i za t i on to prejudice the case of Joint Intervenors and the people of Louisiana whose interests Joint Intervenors are protecting would be a grave injustice and would i

deprive the court of probat ive scientif ic evidence which represents the i

vanguard of scientific research in this area.

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Joint Intervenors' counsel at no tice during the course of the hearings informed his cFients that he had disregarded their instructions.

This f ailure on counsel's part prevented Joint Intervenors f rom introducing such documents later on in the hearing because Joint Intervenors ' had been led to believe that their exhibits had been excluded by a ruling of the court, thereby protecting their right to appeal on this ground.

Joint Intervenors' understanding of their counsel's actions is confirmed by their repeated objections to "non-witness-authored documents" later in the hearings and acting counsel Groesch's objection to the double standard employed by the Board in excluding non-witness-authored exhibits offered by Joint Intervenors while allowing into evidence such documents offered by Staff and Applicant.

L'nder these circumstances Joint Intervenors are entitled to withdraw f rom counsel's stipulation and Joint Intervenors exhibits should be considered by the Board.

Staf f and Appiicant were informed of said exhibits well before trial and therefore would suffer no prejudice.

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the event that the Board does not consider. aid exhibits part of the evidentiary record and the test imny of I)r. Samuel Epstein, Joint Intervenors move to reopen the synergi sm he t rine,s and/or hold new hearings on synergism issues in order t o bring all probative evidene before the lloa rd, which was exc ludeD!F.NDATIONS Joint Intervenors have shown that the operation of Waterford 3 will have disastrous health consequences for the people of Louisiana, but, in the alternative only, if the Board recomrends granting the Waterford 3 operating license Joint Intervenors urge that any Waterford 3 operating license issued to applicant not permit radioactive emissions in each of the following categories: liquid, gaseous, iodine and particulate, to exceed 1/100 of the radioactive emission levels currently allowed by Nuclear Regulatory Commission Regulations contained in 10 C.F.R. 50 App. I.

J

ATOMIC ENERGY COMMISSION DECISIONS A.E.C. decisions cited by applicant have no precedential or persuasive value in N.

R. C. hearings. The A.E.C. was abolished because it perceived its role as promoting nuclear energy and prbtecting the nuclear industry rather than protecting the interests of the public.

The abuses of public trust and lack of concern for public safety are too well known to require citation.

It is inappropriate for the N.R.C. and its licensing boards to consider A.E.C. decisions.

POLITICS AND SCIENCE - THE RAalAT10N PROTECTION CO.91 UNITY Joint Intervenors bring to the Board'+ attention material pertinent to the above issue recently d iscovered in Shutdown, The Book Publisning Company (1979) containing transcripts of testimony in lionicker v. Joseph P. Hendrie et. al., No. 78-3371, (M.D. Tenn. Oct. 2, 1978) at which hearing the Nuclear Regulatory Commission had the opportunity to cross-examine said witnesses and the issues involved were similar to those in this hearing. Accordingly, Joint Intervenors move to introduce said testimony of Dr. John Gofman and Dr. Ernest Sternglass at this time as mterial contained in government records.

10 C.F.R. 2. 74 3(h)

Dr. Gof mn one of the fathers of the atomic bonb, author of 150 scientific articles concerning inter alla the medical effects of ionizing radiation chromosomes and cancer and the hazards of plutonium and other sources of ionizing radiation, test ified inter alla that the A.E.C did not look f avorably upon scientest s whose work showed that radiation was harmful because the thrust of their position was that there is a safe dose of radiation.

Dr. Gofman testified that Dr. Arthur Tamplin, his colleague had twelve of his thirteen staf f members

taken away from him afte: publishing a papet showing that radiation would produce twenty times as many cancers per unit of radiation per unit of radiation as had been previously thought.

Dr. Gofman testified that he lost two hundred fif ty thousand dollars a year f rom his cance ch romo some work as a result of his position on the health hazards of ionizing radiation.

Dr. Gofman also cited Dr. Thomas Mancuso as an example of the retribution visited by the go'edrnnent on those who expose the dangers of ionizing radiation and nuclear power plants. A former colleague of Cofman's, Dr. Donald Geesamen, who was one of the few persons doing work on the lung cancer hazards of plutonium for the A.E.C. and who felt that plutonium was mre hazardous than was commnly accepted by the A.E.C.

lost his position All of the above cases were cases in which Gofman had personal experience and knowledge of.

Dr. Ernest Sternglass, professor and director of Radiological Physics at the University of Pittsburgh since 1967 and author of more than 100 scientific papers in the literature in the field of nuclear physics, radiological sciences, nuclear instrumentation, and biological ef fects of radiation on man inter alia, testified that Marvin Goldman, who testified before this Board, attempted to di scredit his findings appearing in a 1963 edition of Science.

In response to questions by l

l N.R.C.

counsel Dr. Steinglass testified that Dr. Goldman testified on bahalf of utilities at various hearings at shich Dr. Sternglass qualified as an expert on behalf of citizens' groups and intervenors. When asked l

whether he was aware that Goldmn received an award f rom the A.E.C. Dr.

Sternglass replied:

"That is right, and the Atomic Energy Co : mission l

always awards these grants to the people who do it s bidding."

l Joint Intervenors upon request wilI supply the Board a copy of l

l Shutdown containing such information and a re atterrpting to secure copies i

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of said court proceed inm, t or considerat 109 by the lloard and other counsel. Joint Intervenors have no objection to the Board or other counsel requesting that said transcript in No. 78-3371 being sent to a district court in Washington D.C.

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l. uke 'ontana Gary Groesch l'or Joint Intervenors I hereby certify that a copy of the foregoing pleading was served by deposit in the United States Mail, first class, postage prepaid, this 21st day of June, 1982 to the Atomic Safety and Licensing Board and all counsel of record.
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27. 5 7.3 6'J[ 21,1982 UNITED STATES OF AMERICA f
NUCLEAR REGULATORY COMMISSION I
DEFORE TIIE ATOMIC SAFETY AND LICENSING BOARD In the Matter of
)
LOUISIANA POWER AND LIGHT
)
Docket No. 50-3820L' (Waterford Steam Electric Station, )
Unit 3)
)
CERTIFICATE OF SERVICE I hereby certify that copies of the following documents:
(1) JOINT INTERVENORS FINDINGS OF FACT AND CONCLUSIONS OF LAW ON CONTENTION 8/9 INCLUDING APPENDICES 1 THROUGII 7 (2) JOINT INTERVENORS FINDINGS OF FACT AND CONCLUSIONS OF LAW ON CONTENTION 17/26, (3)
MEMO ON JOINT INTERVENORS EXHIBITS WITH AFFIDAVITS were served by deposit in the United States mail, first class, postage prepaid, this 21st day of June, to parties identified on the attached service list.
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i Luke-Fontana and Gary L. Groesch Counsel for Joint Intervenors Dated: June 20,.1982 1
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June 21, 1982 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE ATOMIC SAFETY AND LICENSING BOARD In the Matter of
)
)
Louisiana Power & Light
)
)
Docket No. 50-382 OL (Waterford Steam Electric Station, )
)
Unit 3)
)
MEMO ON JOINT INTERVENORS EXHIBITS Joint Intervenors, Oystershell Alliance and Save Our Wetlands, Inc., as part of the operating license hearings on Waterford 3 did proffer as Exhibits 29 scientific papers and documents relating to the Synergism contention 8/9 of said hearings.
Joint Intervonors also did produce 4 live experts. These experts did author some of these documents and scientific papers.
The remainder were non-witness authored documents.
All of these documents were considered important toward the Synergism question which is a scientific question.
On March 27, 1982 Joint Intervenors did meet with their principal attorney, Lyman Jones, of the firm Gillespie and Jones.
I The purpose of the meeting was to decide the fate of the documents, especially the non-witness authored documents since it was felt they would be challenged by the Applicant and Staf f on the following Monday, March 29, 1982, during said hearings.
There was considerable controversy on whether to argue each non-witness authored document onits merit. AHoweveg, a compromise Jones did not want to argue on a case-by-case basis.
position was reached. Counsel Jones would seek a ruling on the non-witness authored document, Joint Intervenors Proposed Exhibit
1, Surveillance, Epidemiology, and End Results. Joint Intervenors would agree to apply this ruling to all other non-witness authored documents.
On March 29 Counsel Jones did enter into stipulation with Applicant Counsel Blake only to surrender all non-witness authored documents if he would agree to withdraw objections to all witness
l authored documents.
4 Staff counsel Turk reserved'his right to question the admissibil-ity 'of the witness authored documents. Regardless, Counse1 Jones -
perai ' ed in agreeing to the half-stipulation with Counsel Blake and agreed to surrender said documents.
Counsel Jones did not inform co-counsel Fontana or other members of the Joint Intervenors that no ruling had been made on non-witness authored documents as per the March 27, understanding.
Joint Intervonors were unaware that no ruling had been made on the admissibility of non-witness authored documents until they reviewed the transcripts of the Hearings (Tr. 1103-1108).
Respectfully Submitted, f
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i GaryI. Groesch Acting Counsel for Joint Intervenors I
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Christine Duncan Research Coordinator Joint Intervenors 3
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W AFFIDAVIT OF CHRISTINE DUNCAN BEFORE ME, the undersigned, there did appear, Christine
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Duncan, who daly being placed on oath deposes and says:
1. That she is a research coordinator for Joint Intervenors.
2. That she resides in Orleans parish in the state of Louisiana.
3. That she is aware of the contents of the ' Memo on Joint Intervenors Exhibits' and attests the information contained therein i
is true and correct to the best of her personal knowledge and belief.
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Christine Duncan i
i SUBSCRIDED AND SWORN to before me, this 21st day of June, 1982.
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NOTARY PUBLIC MY COMMISSION IS FOR LIFE l
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d AFFIDAVIT OF GARY L. GROESCH BEFORE ME, the undersigned, there did appear, Gary L. Groesch, who ciuly being placed on oath deposes and says:
1. That he is the research coordinator and acting counsel for Joint Intervenors.
2. That he resides in Orleans Parish in the State of Louisiana.
3. That he is aware of the contents of the' Memo on Joint Intervenors Fxhibits' and attests the information contained therin is true and correct to the best of his personal knowledge and belief.
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Gary [L. Groesch
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J SUBSCRIBED AND SWORN to before me, this 21 st day of June, 1982.
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NOTARY PUBLIC MY COMMISSION IS FOR LIFE f
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION BEFORE THE ATOMIC SAFETY AND LICENSING BOARD
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m In the Matter of LOUISIANA POWER AND LIGHT COMPANY Docket No.'50-382 OL (Waterford Steam Electric Station, Unit 3) i Statement of the Case e $ ne m,,,
3 Joint intervenors-allege that Applicant has not taken into account the synergistic and/or cumulative effects of ionizing radiation and the multitudes of carcinogens that already exist in the area around Applicants Waterford 3, a 1165 megawatt nuclear power plant located in Taft, Louisiana. This failure will result in excess mortalities and morbidi ties.
Hearings were held in New Orleans, Louisiana from March 23 through May 12, 1982. TFe evidence, the testimony, and arguments of counsel, now make the following:
Findings of Fact eg Ce,,L,nben 8/9 l
1.
The Waterford 3 site is located 25 miles upriver from New Orleans 1
at Taft, Louisiana, next to the bank of the Mississippi River.
It is 127 miles i
from the Gulf of Mexico (see Map, Appendix I).
This site is surrounded by petro-chemical industries, chemical manufacturing plants and petroleum refineries.
l Liquid and airborne effluents from these industries are routinely discharged into the Mississippi River, whose water is used as a water source for over a l
million and a half people living in parishes along it.
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2.
The Harris report (see Appendix II), submitted to New Orleans councilmen in November,1974, clearly stated that persistent carcinogens (cancer-causing substances) are discharged into the Mississippi River, from the industries that border the river, nd also from municipal discharges, accidental spills, and run-off from agricultural and urban areas.
3.
From a 1972 study (sce Appendix III), forty-eight (48) organic compounds were identified in raw or treated water supplies at Carville, New Orleans (Carrollton Water Treatment Plant), and Marrero, Louisiana.
Included were chloroform, hexachlorobenzene, zylene, ethyl benzene, dimethylsulfoxide, benzene, carbon tetrachloride, and chloromethyl ether.
Although some of these chemicals are relatively low levels of exposure, preliminary epidemiologic studies of aggregate populations in Louisiana, Ohio, and New Jersey support the hypothesis that carcinogens in drinking water are related to human cancer. ($ee abc, ScaMalemed d bn s. 5 Epdeln, Ques.132ud 14, Gubmdled.h lim dal ttggearamee) 4.
Dr. Velma Canpbell, in sworn testimony, question 9, cited data taken from the SEER Program (National Cancer Institute), that is, " Cancer Incidence and Mortality in the United States, 1973-77," show high mortality rates for the New Orleans area, compared to the rest of the nation:
(a)
Incidence rates (i.e.,' new cases of a disease in a population over a period of time), show that the average annual age-adjusted incidence-
rates in the New Orleans area for the respiratory system (including lung) is 71.1/100,000, while nation-wide it is 52.6/100,000 - the highest in the nation!. Females had an incidence-rate for respiratory cancer of 30.0/100,000 compared to 24.4/100,000 for the United States.
For bladder cancer the incidence rate for males is 27.7/100,000 compared to 25.8/100,000 for the United States.
Incidence rates for blacks showed -
the highest rates in New Orleans for buccal cavity and pharynx (16.3/100,000), the digestive system (95.6/100,000), and the respiratory system (80.1/100,000) than other areas in the study. Black males had the highest rates for stomach cancer (29.0/100',000), and also black females for stomach cancer (13.3/100,000).
(b)
Cancer mortality rates (i.e., the number of persons in a given population who die of given cause) also are very high in the New Orleans area compared to the rest of the national; the SEER Report shows these results for average annual age-adjusted mortality rates:
For all races, both sexes, New Orleans had the highest rate for all cancer sites combined (201.1/100,000), compared to the United States (166.5/100,000). Also, New Orleans had the highest rate for the respiratory system (50.8/100,000) compared to 39.7/100,000 nationwide; the highest for breast cancer (16.7/100,000) compared to 15.1/100,000 in the United States, and the highest in the urinary system (8.6/100,000) compared to 7.5/100,000 for. the United States. New Orleans tied for highest with Connecticut for rectal cancer (5.4/100,000). Males are
highest in the New Orleans area for respiratory cancer at 94.0/100,000 and second only to Connecticut for colon cancer at 23.3/100,000.
Males are also highest in the U.S. for liver cancer at 4.5/100,000.
Average annual age-adjusted mortality rates for females, all races, also show the highest rates, for all sites combined (152.3/100,000),
compared to the other United States areas in the report.
Females are second highest (to San Francisco) in pancreatic cancer,. second highest (to San Francisco) in lung cancer, and second highest in rectal cancer, next to Connecticut. For Whites overall, both sexes, the New Orleans area is the highest in bladder cancer (5.3/100,000) and in lung cancer (46.1/100,000), and second highest in colon (19.5/100,000) and in rectal cancer (4.9/100,000). Blacks, overall, both sexes, are highest in the New Orleans area in all sites combined (243.9/100,000), in stomach cancer (15.4/100,000), in rectal cancer (6.9/100,000), and in respiratory cancer (58.5/100,000) than the rest of the United States.
5.
Several cancer studies have been published with regard-to the southeastern Louisiana ' area, including the New Orleans metropolitan area, and also parishes bordering the Mississippi River. A study done on lung cancer in Louisiana through death certificate analysis (Gottlieb, Pickle, et.al., JNCl, November,1979) revealed approximately a two-fold excess risk of lung cancer associated with certain types of industries. Lung cancer
risk was also found among older men who had been employed in the petroleum industry and among male and female residents of towns where the petroleum industry was a major employer.
In a study on pancreatic cancer mortality in Louisiana (Pickle, Gottlieb, AJPH, March,1980), high pancreatic cancer
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mortality among white males in a clus'hr of Louisiana pariches was t
investigated. Excess risk was seen-for workers in the oil refining and paper manufacturing industries, and for residents living near refineries.
The latest Louisiana study, " Cancer and Drinking Water in Louisiana: Colon and Rectum" was published this. year (Gottlieb, Carr, Morris,'IJ of E,1981).
This study found a significant risk for rectal cancer associated with drinking water derived from the Mississippi River. A multi-dimensional contingency table analysis found the association between rectal cancer and surface water (Mississippi River water used for drinking water) significant at the 0.0001 level and not dependent on age, race, sex, and diet. Chlorination also associated significantly with rectal cancer.
Among those who used river water, the risk increased inversely as the distance from the mouth, with greater risk downstream from the many industries which line the river.
6.
p Dr. Velma Campbell in sworn testimony before the Atomic Safety I
and Licensing Board, did state, (Q.9), that along the Mississippi River 1.
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corridor between Baton Rouge and flew Orleans, Louisiana, there is a larger burden of chemical expcsures through air, drinking riater, and occupation than in many other areas of the country. She also stated that rates of cancer for people who live along the,Jower Mississippi River in Southeast Louisiana are significantly higher than the natinnal average, expecially for respiratory, urinary tract, and pancreatic cancers, and that epidemiologic studies have linked these high cancer rates to such exposures as use of the Mississippi River for drinking water, employment in shipbuilding and chemical industries, and residence near petroleum refineries.
Dr. Campbell stated (in the same answer) that the people of this area (i.e., along the flississippi River " corridor") face a potentially serious public health problem; that they are exposed to a vast array of chemicals from a variety of sources and that they also suffer a burden of cancer incidence greater than the national average, which is demonstrably related to those environmental exposures.
7.
l Dr. Campbell, in her sworn testimony, Q.8, defined synergism as l
"the capacity of tw6 (or more) substances when combined to cause more effect than either would cause acting alone." h.h wel 6 hdeia, A has tdd s3 en}%, g)W5 A simIhst fttutshei scNetM page, dadig3 h
i ddw&n in h is sen Shfenient (Otics.g, la) subm;Ifud as a bHed appearance. The &aed og %suegu3e da{enx3t ok DF. b SNi h fetwAnb t o 10 C fir. Part a,il p./1,IC b)(4h f
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8.
Dr. Campbell stated in Q.9 that chemicals, radiation, and other agents, when found together in the general environment, may behave in ways not predictable by laboratory experiments in which these agents are isolated from each other. She stated that certain chemicals, particularly halogenated hydrocarbons, accumulate in animal and human tissues over time, prolonging and increasing the exposure of body tissues to the offending chemicals, thus increasing the possibility of ill effects, including cancer.
Then Dr. Campbell stated (same Q.9) that it is now proposed to' add another increment of risk to the already higher than average burden (of cancer incidence). She cited references from the medical literature that. include sienificant research which supports the premise that small doses of radiation increase the development of cancer from exposure to some chemicals.
She stated that the logical conclusion is that, to knowingly add radiation, even at low levels, to the chemical exposures confronting the presumably limited capacity of the human inn 1une system is to greatly increase the risk of cancer for. each individual who lives in the area, and (Q.12) that small childrer. (less than seven years old) and older people (sixty years and older) are particularly vulnerable to this type of risk.%h dAkmed 'ss spydd b %t& De 65.EpdeinCaucc.9, Fi-J/)submilld es IbnM appataue.
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g, Dr. Carl Johnson, in his sworn testimony, Q.ll, defined the term synergism as the action of'two or more substances, chemicals, or agents to v-w
achieve an effect of which each is incividually incapable. He said that in the general population, one could expect to see this effect after exposure both to carcinogens in drinking water and to low levels of radiation emitted by a nuclear installation, in the exhaust from its smoke stacks and in its liquid effluents.
10.
In Q.13 Dr. Johnson said that exposure to external radiation will be the least important consideration. He stated that inhalation and ingestion of radioactive gases, vapors, and particulates in the air, in the water, or buil t' up in the food chain, i.e., milk, meat, other produce, and grai.ns, will be the most important source of exposure to the plant, and these sources of exposure have been very poorly evaluated.
11.
In Q.14 Dr. Johnson stated that in his study of cancer incidence around the Rocky Flats nuclear plant, he found an excess of leukemia, lymphoma, and myaloma, and cancer of the lungs, thyroid, breast, esophagus, stomach, and colon.
12.
l In Q.15 Dr. Johnson said that, in regard to special segments of the l
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population more likely to demonstrate-health effects from living in proximity to a nuclear installation, the fetus is considered about twenty times more sensitive to radiation than the adult, a child about ten times more sensitive to radiation than the adult, and in addition, people with defects in their immune system are conhidered to be much more prone to injuries from radiation.
13.
Dr. Johnson stated (Q.16) that the effects of radiation are considered to be cumulative. That is, one rem over thirty years will have about the same effect as a single exposure to thirty rems. He said that this has been fairly well demonstrated and accepted in many studies of radiatior; workers.
14.
Dr. Johnson, in Q.19, when asked about the special' risks associated with ground water radionucleide contamination, given the special geographic circumstances of Louisiana, stated that there are special risks associated in ground water contamination with radionucleides, because of the high water table in Louisiana. He also state (Q.20). that we could expect to see a synergistic effect ii. Louisiana, where people may be exposed to high levels of chemical contamination in the water, along with normal exposure to radionucleides from nuclear plants in the air, water, or food. Dr. Johnson stated (Q.22) that he thinks that the introduction
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of ' additional radiation in South Louisiana resulting from plant operations j
is unacceptable.
Further, he doubts very much that actual exposures i
will be as small as this, especially considering the biological effects of the 240 radionucleides of importance released by nuclear power plants l
such as that proposed (see also pp. 1868 of Docket No. 50-382, the Cross-Examination of Dr. Carl Johnson, April 1,1982).
Dr. Johnson stated that many of these radionucleides are isotopes of trace elements and other elements important in nutrition; that they will be concentrated and stored in the body in places where they can do much harm. He said that no one has really done an adequate study of the molecular, cellular, and develop-j mental effects of these 240 radionucleides; that no one really knows what the long-term effects of these radionucleides on the reproduction of man, animals, and plants will be.
1 15.
i Dr. Johnson stated (Cross-Examination, pp. 1902, 1903, 1907, April 1,1982) that he has seen records of very large releases of radioactive gases and radionucleides in exhaust plumes and liquid emissions from operating nuclear power plants, that releases of five reactors were reported i
l-l in papers sent to him by the NRC, and in EPA reports. These published releases are considerably higher than the proposed releases of the Waterford 3 plant.
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16.
Dr. Hemchandra Pandit, in his sworn testimony, (Q.9), defined synergism as a cooperative action of discrete agents resulting in a total effect which is greater than the sum of effects taken independently.
He stated that it is known that synergism operates between chemical agents, such as drugs or environmental pollutants, and physical agents, such as ionizing radiation.
17.
In Q.14, Dr. Fandit stated that the damage due to elements of low-level radiation which get incorporated into the drinking water, the food, and ultimately into the body tissues is slow and cumulative and more dangerous than damage caused by external skin surface exposure, because the skin is much more resistant to the radiation. He stated that since the first phase of respiration is the exchange of gases between the atmosphere and the lungs, the gaseous radioactive materials present in the atmosphere get into the lung very quickly and cause more damage there than they do on the skin.
From his studies of the urinary tract, he could say that the bladder would l
be at high risk for cancer too, since it endures prolonged exposure to carcinogens, including radioactive elements, concentrated in the urine.
l
18.
In Q.15 Dr. Pandit likened southern Louisiana's environment to the " Love Canal" because both ground water and the major river water are contaminated with chemicals such that all drinking water for the area populations contain some carcinogens. He said that the special risk posed by radionucleide contamination of Louisiana's water is that synergism could cause another Love Canal here.
19.
Dr. Pandit, in Q.17, stated that there was no question in his mind that the addition of nuclear power plant emissions to the Louisiana environment will greatly canplicate the existing health problems due to chemical contaminants.
dL o,
Synergism is defined as "a more-than-additive effect" by Dr. Bross (sworn statement, Q.14).
"When two factors jointly have an effect which is greater than additive, that is to say, greater than the sum of the-effects of each factor acting separately, the relationship of the two factors is generally considered to be synergistic," (K.J. Rothman, p. 347, Vol.108, No. 5, AJ of E,1978).
" Synergism has been most frequently regarded as a public health concept reflecting the situation in which joint exposure to two or more factors results in a greater. number of cases of disease than exposure to the sum of the separate factors," according to W.S. Blot and N.E. Day, of the National Cancer Institute, in letter to the editor of the American Journal g Epidemiology (p. 99, Vol.110, No. l ~,1979).
cTI.
Dr. Bross explicates in detail the mechanism by which radiation and chemicals cause cancer. "The first event in the long evolutionary biological process that ends with death from leukemia or other cancer is the occurrence of a bi,ochemical lesion or break-point in the complex chemical structure of the DNA in. the genetic material of a human cell...
(6h;b;F a6)
We know that this genetic degredation is the cause of cancer," A This mechanism is also describd in response 'to Questions 20,_43, 44, 45, and 46 of Dr. Bross's sworn statement and in Exhibit 22. Neither Applicant nor NRC Staff witnesses refute or deny Dr. Bross's explanation of the ultimate
~
cause of cancer as a genetic break-point which can be caused by radiation and chemical agents.
C.L. Greenstock and G.W. Ruddock support Bross's explanation of the initiation of cancer with chemical experiments which demonstrate "a mechanistic basis for shnergistic effects between toxic chemicals and radiation." See attached AppendixT, " Radiation Activation of Carcinogens and the Role of OH and 0," for a detailed explanation on 2
the molecular level of how synergism initiates genetic damage.
M.
In response to question 48 of his sworn statement,.Dr. Bross states,
" Synergism operates at low levels of exposure (and possibly more efficiently-at these levels)." Allen Brodsky, in the NRC'c Office of Standards Development, strongly supports Dr. Bross's observations with his most significant preliminary studies of which the Board takes notice pursuant to 50 CFR 2. 743 (h), (i). Brodsky on p. 425 of his presentation, writes "The present stochastic two-sequential stage model does contain features, however, that could account for the sometimes greater carcinogenic-response observed for the same dose given at lower dose rates (within a certain range) - both for radiation as.well as chemical carcinogens.
Lower dose-rates and extended durations of irradiation, would particularly be more effective in situations where radiation was acting primarily as a promoter in the presence of active chemical initiators in the environment." See attached Appendix 1
J3.
The earliest adverse effect; upon a population exposed to low levels of radiation and chemical agents are manifested upon young children, infants, and fetuses.
Effects evident in the two fonner groups can be due either to direct exposure, or to in_ utero exposure, or to preconception parental exposure. Effects on the fetus, obviously, are due either to exposure of the pregnant mother or to exposure of either or both parents prior to conception.
Children, infants, and fetuse s, being the first affected by cumulative and/or synergistic risk factors is due to the fact that they are among the most sensitive members of any population in tenus of inuune defense systems and genetic vulnerability.
"The studies c/
childhood cancers caused by X-rays during pregnancy suggest that the infant is 5 to 10 times as sensitive as an adult," (R. Wilson, p. 47, Vol. 51 of Yale Journal g Biology and Medicine,1978).
" Radiation received in utero is probably about five times as likely to produce leukemia per rad as in the adult," (N. Stannard, p. 98, Nuclear Power and the Public, ed.' H. Foreman, 1971).
"The absolute excess of leukemia and other cancers per rad is higher following prenatal irradiation than following postnatal irradiation...
susceptibility to the induction of thyroid cancer is higher in those irradiated during childhood than in those irradiated during adult life,"
( A.C. Upton, p. 484, Origins g Human Cancer, Boaii A, Incidence, of Cancer JJn llumans, ed. by lif att, Watson, Winston,1977).
Excessive ~ sensitivity to drugs and environmental chemicals is well established in the medical literature 9
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4
^
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on children, infants, and fetuses.
It should be noted that adult men.bers of the population, being less sensitive to genetic damage, may exhibit either similar or different health effects and may exhibit effects only af ter a longer exposure than younger popula' ion n. embers.
(Bross sworn statement, Q38).
M.
Dr. Bross provides evidence for synergistic radiation effects which do not involve joint chemical exposure. Low level radiation to both parents produces health effects on offspring which exceed control group effects by individudly a factor which is lanser than the sum of factors by whichAexposed parent groups exceed the control group effects.
(Bross sworn stater. ant, Q. 35, 36,37).
.2 5.
It is an established fact, known to and relied upon by the scientific conmunity, that fractionation of radiation dose does not diminish the carcinogenic effect.which would result from a single exposure to the same total dose of radiation. This was documented by the BEIR I Report in 1972 and is supported throughout the independent scientific literature.
This observation strongly supports the contention that radiation health effects are cumulative over time in a given population. To the extent
i 1
that radiation and chemical carcinogens operate by similar mechanisms upon the genetic material, the observation concerning fractionation of-radiation dose indicates that chemical agents and radiation can have a j
cumulative health effect over time on a given population where chemical'
" fractions" and radiation " fractions" act interchangeably and thus cumulatively. Dr. Goldman and Dr. llamilton clearly subscribe to L.J. Cole's j
and W.A. Foley's conclusions about radiation dose fractionation in the i
presence of carcinogens which are the "Fractionated X-radiation (50R X 6 given daily) plus urethan (0.2 mg/9) elicited a higher lung tumor frequency than observed in several appropriate control groups... fractionated j
X-rays yield an over two-fold increase in tumor multiplicity per mouse."
l This paper is cited as Reference 8 by Dr. llamilton and as Reference 11 by l
Dr. Goldman in their Direct Testimonies.
4 s
i 4.
The Board finds that it is well established in the scientific literature that health effects and/or genetic effects caused by exposure to chemicals and radiation are cumulative or additive in an exposed population over time. This is established in Dr. Bross's sworn statement:
i Q. 17, 23, 24, 25; and in his published report, " Cumulative Damage in i
Children Exposed to Preconception and Intrauterine Radiation," (Investigative Radiology,, Vol.15, No.1, p. 52,1980).
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29 Despite the lack of direct experimental evidence (in human populations) l of synergism at low or environmental levels of radiation and chemical agents, circumstances in the U.S.S.R. duplicate those which would be created in South Louisiana, should Waterford 3 operate for 30 - 40 years.
(Bross, sworn statement, 0.29 and 30).
The health effects experienced by populations in the U.S.S.R. exposed to heavy chemical pollution and at the same time to routine releases from nuclear power plants can reasonably be expected to parallel health effects South Louisianians will experience under the same circumstances (Bross, sworn Statement, Q.31, 33, 34, 47). This observation, which is discussed at length in Dr. Bross's cross-examination, is not refuted by either Applicant's or NRC Staff's witnesses, and is nibstantiated in tir U.P.Dert, of Cor:cterce 19c0 rublication " Rising hfant Mortality in the U.P.D.P. in the 1970's" (C3.1r6:t95/74) written by C. Davis and h.Fesbbach.
J8.
The population in the Love Canal region is and has been exposed simultaneously to radioactive wastes and to hazardous chemical wastes.
l This population exhibits high incidence rates for certain types of cancer in adults as well as above nonnal rates for miscarriages and infant health e f fects.
Dr. Bross and Dr. Pandit both express the view that, given the numerous chemical pollutants and resulting high cancer rate in South Louisiana, the simultaneous exposure of this burdened population to radiation in its food, air, and water can be expected to result in health effects in this population similar to those in the Love Canal population.
l These views were not refuted or denied by witnesses for the Applicant and NRC Staff.
l l
l
49, in so far as the NRC functions as a management agency for implementation of peaceful nuclear technology, the adverse health consequences observed as a result of management's (in Russia, the government's) siting policy in the U.S.S.R. serve as a clear example to the Board of what not to do.
As a nuclear management agency and as a final decision-making body, the Board can be expected to take notice of and draw conclusions applicable to siting policy from management decisions made by similar decision-making bodies in other nations. As an expert in "metatechnology" and in biomedical technology and as President of the Biomedical Technology Corporation, the Board finds persuasive Dr. Bross's testimony that the U.S.S.R. siting policy is an error and that to site a nuclear power plant on the lower Mississippi River would be duplicating the U.S.S.R. management error - much to the detriment of the public health (Bross, Hearing Transcript, pp. 1366 - 1368, sworn statement, Q.51).
30 The same logic which is applied to radiation risks in the BEIR I Report (and in FDA evaluations) is applicable to synergism risks; M., in the absence of specific data in the lowest dose ranges (for both chemical and radiation doses and/or for any combination of high and low doses of each agent), regulatory agencies must extrapolate from available infonnation in higher dose ranges to risks at lower doses. The absence of specific data
at low chemical dose levels with low radiation dose levels does not preclude a detennination that synergism can be expected to operate at these low dose levels.
This is logical because synergism is known to operate at higher dose levels of eithe,r and both chemical and radioactive agents. Not only do Joint Intervenors' witnesses Drs. Pandit, Johnson, and Bross agree that synergism is a significant biological / medical phenomenon, but also Applicant's and NRC Staff's witnesses do not dispute or refute the fact that synergism is a known phenomenon at certain chemical-plus-radiation dose levels where it can practicably be tested and even quantified.
See
!!utchison on llearing Transcript, p. 3437, lines 23-25; Goldman on p.943, line 19, and p. 945 of Hearing Transcript as well as p.10 of his Direct Testimony; Hamilton, Direct Testimony, pp.13-14; finally see Exhibit 27.
31, Research data, statistics, and all other information identified by Joint Intervenors since the initiation of this intervention represent "the state-of-the-art" for the study of synergism between radiation and chemicals at extremely low dose rates in large human populations over extended periods of time. Besides the ethical and complex logistical obstacles to populations at multiple risk, excessive costs and times required for observation of synergism at work among ultra-low levels of various chemical agents in conjunction with low level radiation severely limit the state-of-the-art for synergism research in human populations.
(llowever, data
i is available for occupational and accidental exposures to carcinogens at
. higher levels over relatively short time periods).
Similar constraints of time and money limit synergism and ultra-low level exposure studies even in laboratory animals, as noted by Dr. Goldman on p. 988, lines 11 and 18 of the Hearing Transcript. Any uncertainties as to the exact risk factor (s) attributable to introducing additional radiation to an already chemically burdened and cancer prone population represent the limits of current scientific knowledge, rather than any proof that no risk exists.
Given the great weight of indirect evidence that synergism between low levels of radiation and chemicals can adversely affect the public health, and given the unlikelihood of any direct experimental evidence becoming available in the foreseeable future, it is reasonable to expect that regulatory decisions will be made based upon the state-of-the-art information and the implications thereof.
Especially considering the intractable, painful and most often fatal nature of cancer and other diseases which can result from the synergistic effects under consideration, the limits of scientific knowledge indicate not thet "what we don't know won't hurt us," but rather that, like an untested drug, synergistic health effects have not been adequately researched to say that they cannot cause adverse health effects (Bross, sworn statement, Q.51).
3e2, Applicant fails to evaluate the health consequences of any synergistic effect operative between existing chemical agents in the south Louisiana envimnment and routine radioactive releases from Waterford 3 to the extent that Applicant relies on BE'IR Committee reports and NRC regulations.
This is so because ilRC regulations and guidelines (and BEIR reports upon which they are based) do not explicitly and quantitatively account for synergistic, multiplicative, or more-than-additive effects in their risk factor calculations, nor do they in any way account for chemical agents which may enhance the effects of radiation within 50 miles of Waterford 3.
This fact is made clear in Dr. Bross's sworn statement in answer to Q.18 and in the Hearing Transcript, p.1351, lines 10-16, and p.1448, line 14 through p.1451, line 7, and p.1524, lines 20-23, and in Exhibit 25.
Exhibit 23 further indicates why Applicant's reliance on federal guidelines does not in any way represent an actual evaluation of health consequences-of synergism.
H.F. Kraybill of the flational Cancer Institute provides supporting evidence of this fact on p. 44 of Environmental Cancer, edited by himself and published by Hemisphere Publishing Corp. in 1977: " Qui te frequently, scientific and regulatory decisions are made on the basis of exposure-response relationships relevant to a single stress agent or one route of exposure.
In the environment, both humans and animals are exposed to multiple stresses via contaminants or additives in the air, water, and diet in addition to the insults received from drugs, biological agents (viruses, pathogens, parasites), and physical agents (radiation from
ganna rays, X-rays, or ultraviolet rays).
The multiple factors involved in human exposures may play either a synergistic or an inhibitory role.
Test systems, on the other hand, are developed to detect the responses of specific agents. The role of combined, factors in the induction of carcinogenic effects has been studied in too limited a number of cases."
33, Applicant fails to evaluate the cumulative health effects due to population exposure to both chemical agents existing in the south Louisiana environment and radioactive releases from Waterford 3 to the extent that Applicant relies on NRC regulations and BEIR Commi ttee reports. This is true because the NRC regulations and the BEIR Committee reports in no way evaluate health effects due to chemical agents nor do they evaluate in any way the mechanisms by which chemical risk factors can be cumulative with radiation risk factors in a population over time. This fact is highlighted in the following:
Dr. Bross's sworn statement, Q.18; Hearing Transcript, p.1375, lines 23-25; p.1524, lines 20-23, Exhibits 25 and 23; 10 CFR, 50 et. seq.
34.
Applicant fails to identify, much less evaluate, chemical agents within 50 miles of Waterford 3 which can interact cumulatively and/or synergistically with radioactive releases from the plant. Neither Applicant's
witnesses Kenninc nor Mauro (the only witnesses presented who were familiar
'th the actual plant site and environment) offer evaluations of such chee.ical agents or related factors.
(a) Applicant's witness Kenning ackowledges that in his calculations of background radiation he omits existing radiation exposure from Mississippi River water and from sources in the food chain. He further acknowledges that he has no information about other environmental pollutants in the food, water, and air in the Waterford 3 area which he evaluated.
(Hearing Transcript, p. 478, lin 16 through p. 479, line 10).
(b) Applicant's witness Mauro admits that he does not account for environmental chemical pollutants nor for existing cancer rates in South Louisiana in his risk assessment (Hearing Transcript, p. 530, lines 13-24).
5, Dr. Branagan's response to the line of questioning which begins on Hearing Transcript, p. 879, states that the annual radiation exposure to the maximally exposed individual from Waterford 3 is 23 millirems. He further calculates that this exposure is equal to 27% of background radiation (p. 880, lines 15-20). Since these figures are arrived at by simple addition of exposures estimated for various pathways and nucleides, a similar addition process for exposure estimates of other individuals in the unrestricted area must yield higher doses than generally cited by the Applicant.
I
___i
3 tc.
Dr. Bross points out that actual exposures are likely to exceed
" average" estimated exposures in some individuals because of the methods by which " averages" are derived and because of concentrating and dissipating factors in the environment (Bross, sworn statement, Q.40, Hearing Testimony, pp. 1372-1375). This observation is supported by the Argonne National Laboratory Report, " Plutonium in Drinking Water: Effects of Chlorination on Its Maximum Pennissible Concentration" (Science, Vol. 201, p.1008, 1978) and by J.R. Watts and C.E. Murphy, Jr., who close their abstract with the following statement: "These potential doses show the necessity of considering the interaction of radioactive material with the ecosystem for dose calculation," (Heal th Physics, Vol. 35, p. 287).
M.
NRC Staff and Applicant proffer Dr. Branagan's testimony as evidence that Staff and Applicant have adequately considered cumulative and/or synergistic effects of routine emissions from Waterford 3 on the Louisiana environment. Their assertions are entirely misplaced.
Dr. Branagan's calculations concern only the amount of planned radioactive emissions that Staff estimates Louisianians will be exposed to.
Dr. Branagan admits that he knows nothing about chemical carcinogens in the Louisiana environment (Branagan,pp. 844,846). His calculations (and those of Staff) do not take into account the massive quantity of chemical carcinogens in the Louisiana environment and its high cancer rate (Branagan, pp. 844,846).
Moreover, the competence and credibility of Dr. Branagan and Staff is severely
..ws.
1, i
discredited by Dr. Branagan's numerous and material changes to his suorn testimony (f/a.trin3 swrecipl,g. 707d.sg.) an't the ILS subui tteil in 'ieptenter T
1981.
The Board does not need to decide the truthfulness of I)r. Branagan's explanations for these untimely changes occnrring at the inoment Dr. Branagan took the witness stand and why all significant changes in calculations favored positions advanced by Applicant and Staff to observe that the emissions calculations testified to by Dr. Branagan are contradicted by his I0are.bla,RE; statement under oath. Whether these eleventh hour changes were the result of fraud or gross incompetence on the part of Staff is immaterial.
The erroneous emission estimates (whether in the sworn statement or testimony before the Board) are not trivial errors, especially those pertaining to Neptunium, which decays.in a short amount of time into plutonium, the deadliest element known to man, and those involving lodine 131 which concentrates in the thyroid gland. But for these hearings, Dr. Branagan, Staff, and Staff Attorneys may never have " corrected" what they now allege to be false statements in the sworn testimony of Dr. Branagan and the Staff's FES. Under these circumstances, the Board does not find the testimony of Dr. Branagan or the Staff's FES Appendix J estimates credible or reliable, therefore it does not reach the issue whether the Staff's calculations are " Mickey Mouse arithmetic" (Bross Transcript, p.1372) or whether the NRC estimates are unreliable because of the Nuclear Regulatory Connission's " notorious industry bias" (Direct Testimony of Dr. Johnson, p.10).
i 36.
Dr. Hamilton makes repeated references in this Direct Testimony to the estimated amount of additional radiation from Waterford 3 as
" smaller even than the existing variations in natural background radiation"
~
(p.10) and as "being a tiny fraction of the doses the population already receives annually from natural background radiation" (p.10) and again as "the tiny incremental addition of low-level doses of radiation" (p.15).
He apparently does not know the exact figures to which he refers as " tiny" and nowhere in his testimony offers a specific amount in rems or a percentage of background radiation. Nevertheless, his defense of Waterford 3 hinges on the assumptions quoted above which are at serious variance with Dr. Branagan's estimation that certain individuals can be exposed to 23 millirems
~
annually or 27% above the natural background radiation level, hardly a " tiny frac tion. " The vagueness of Dr. Hamilton's assumptions and the fact that they contradict Dr. Branagan's explicit statements call the validity of his argument and even his familiarity with Waterford 3 into such serious question as to make his testimony unmliable.
39.
Dr. Hamilton misses the point of J.A. DiPaolo's report which he cites as Reference 6 on p.13 of his Direct Testimony.
"The lack of transformation by X-irradiation alone" means that, regardless of the actual number of rads used (which Dr. Hamilton sees as the significant point), the DiPaolo experiments constitute a viable model for the environmental situation
at hand. This model is entirely analogous to the situation in which a dose of radiation which alone causes no affects is then shown to significantly enhance the effects of polycyclic hydrocarbon carcinogens.
As a model, DiPaolo's experiments fulfil the requirement that circumstances
,[
of observed effects parallel those of. the greater human environment; 13., a non-carcinogenic (or non-transfonning) dose of radiation, which is no hazard alone, beconus a hazard by causing more cancers (or transfonnations) than would be expected from a given dose of chemical carcinogen alone.
These expariments represent a more-than-additive effect because the radiation effect alone is zero. What Dr. flamilton overlooks is that it is the experimental respon_s_e to the radiation dose which makes DiPaolo's work relevant, not the magnitude of the dose.
YO.
Dr. llamilton fails to consider the difference in biological effect between external radiation exposure (" natural background radiation") and internal radiation exposure (such as that of the thyroid gland having concentrated I-131). Ilis position that "... environmental pollutants in the absence of Waterford 3 would already be interacting with natural background radiation to produce the postulated cumulative and/or synergistic effects," (p.10, Direct Testimony) does not account for the fact that radiation exposure pathways from Waterford 3 include eating, drinking, breathing, and metabolizing into the cell structure radioactive elements.
Dr. Carl Johnson stat a that internal r etiat ion exp;r.ure iu imre !:. c.:ran and damacing to tissues than external expocure (nworn clitenant Q. 1"; r.
1F69,1! caring Transcript).
Dr. Pandit confirms
t. hic view, W ich in r.ot dir< et.ly refuted by Applicant or I. TIC fitaff (swcrn otntemnt, O.
11. ).
Therefore his comparison of synergistic and/or cumulative effects operating in the presence of background radiation with those which will come into play as a result of Waterford 3 emissions is inappropriate and partial at best. The same is true of this unsupported argo: mat iepeated at the bottom l
l of p.14 in his Direct Testimony.
41 Dr. Ita tlil ton's re ference to various e xpe r.mnt.s m o
itorts on synergism (pp.13-14 of his Direct Testimony) indi:: ate his knowledqo of synergism as an accepted medical phenomenon.
lie o f fe rs no di r ec t statement or conclusions on the possibility of. n iple addi t ive or cunulative health ef fects.
He indicates ne knowleSp whatsoever of tLe types, sources, or tuncentrations of chemical agents to which the population is exposed which can act cumulatively and/or synergistically with Waterford 3's radioactive emissions.
'lc1 Dr. llanilton's objectivity in advocating lippiicatit 's posi tion on the plant licensing is called into question by the fact that he testifies regularly for utility companies and has never testified at the request of the NRC, and ASLil, or any Congressional Committee Ilis selectively bad memory in recalling just whom he had testified on behalf of at various NRC hearings had to be prompted by the Board before these facts were acknowledged (Hearing Transcript, pp. 540-544).
i-r U 3.
Applicant relies entirely on Dr. Hamilton's assumptions concernh)g linear dose-effect curves for the ultimate satisfac-tion of issues raised in centent,Lon 8/9. af ter acknowledging tha t "neither Applicant nor N.R.C. Staf f explicitly took synergism into account" (Applicant's Findings of Fact, pg. 65).
Dr. Hamilton makes three basic assumptions which are in no way supported and which the Board questions as sufficient scientific support for Applicant's position.
The first assumption is that the linear-linear dose-effect curve derived from scientific observation of responses to radiation alone will automatically reflect multipli-cative effects in responses to radiation-plus-chemicals.
The re is no evidence for this assumption whatsoever, as pointed out in the exchange between Judge Foreman and Dr. Hamilton (Hearing Transcript, pg. 717 top).
It is reasonable to assume that synergistic effects observed at relatively hich levels of ex-posure will continue to occur at lower levels.
However, it is not reasonable to assume that effects which are multiplicative in nature and which are dependant upon doses of two or more agents (as well as time intervals between administration of the agents in some experiments cited) will be simply linear over a range of radiation doses.
Despite evidence in the medical literature that synergism is optimized at certain doses of
e radiation and even disappears at higher or lower doses, Dr. Hamil-ton's seomd unsupported assumption is that "I would expect, the results of addition to be directly proportional to the additional dose of radiation" (Hearing Transceipt, pg. 717, lines 18-19).
And further based on his assertion "the dose we're talking about is zero, less than 0.01 millirem a year" (pg. 716), Dr. Hamilton concludes that the synergistic effects " proportional" (calculated presumably usin6 some constant factor, as yet unknown) to such a small additional dose above background radiation will be negligi-bly small.
However, if the Board applie s Dr. Hamilton's assump-tion to Dr. Branagan's calculated total annual radiation dose to the maximally exposed individual of 23 millirems, or 27% of the background radiation dose (Hearing Transcript, pg. 880, lines 15-20), the resulting anticipated health effect of 27% more cancer deaths is absolutely unacceptable, and,it is hoped, unreliable ar.d inaccurate.
The third unsupported basic assumption upon which Applicant's presumed compliance with Contention 8/9 hinges is that "the ability to place an upper bound on the effect"
)
(Applicant's Opinion, pg. 24) is bestowed by the linear-linear l
l dose-effect curve developed in the B.E.I.R. I Report for radi-i ation doses alone.
However, even the B.E.I.R. Committee makes no assertion that the linear curve represents an upper limit of risk, but frankly states that "because there la greater killing' of susceptible cells at high doses and hiEh dose rates,
t extrapolation based on effects observed under these exposure conditions may be postulated to underestimate the risks of irradi-ation at low doses and dose rates,"-(B.E.I.R.
I, Chapt. VIII, Sec.
Iv).
The B.E.I.R. I Report goes on to define the linear hypoth-
.esis as "the only workable approach to numerical risk estimation
...since there is no means at present of determining the value of the dose-effect slope in the low-dose region" (same as above, Sec. VI) and to emphasize that "it is clear that these estimates are subject to great uncertainty" (B.E.I.R. I, Chapt. V. Sec. I).
These statements clearly contradict Dr. Hamilton's declaration, "But as we use only the linear-linear relationship.- and as I know tha t exaggerates or gives an upper limit to risk, I f eel confident..." (Hearting Transcript, pg. 719, lines 14-16).
tio-wherein his testimony does Dr. Hamilton, or Dr. Hutchinson, who was a member of the B.E.I.R. Committee, of fer evidence or support for this upper limit definition within Une linear hypothesis, or even make reference to it.
Furtaermore, it is not common practice, nor is it logical to draw a straight line through mean points defined by two axes, where the actual points occurs both above and below the line, and then to conclude that the line represents an upper limit in areas where there are nonpoints.
Dr. Hamilton's basic assumptions simply assume too much to provide meaningful evidence that synergistic and/or cummulative effects are properly evaluated by Applicant.
I
Dr. Hamilton's claim to have published "150 scientific papers, including many assessing the hazards of various energy sources" (p. 5, Personal Qualifications) is not substantiated by an attached bibiliography such as is submitted by each of the o'ther witnesses whose works are published. Over the last ten years the Index Medicus cites only one scientific paper under the name Leonard D. Hamilton (as second author) and There is no the topic is not remotely related to energy or public safety.
evidence that Dr. Hamilton's scientific papers are published in the general medical literature nor that they have been subject to peer review.
N.
Dr. Goldman agreet that synergism is a valid medical principle (Hearing Testimony, p. 943, line 19, and p. 945, and p.10 of Direct Tes timony). He also cites in his Direct Testimony References 7, 8, and 10 which demonstrate greater than additive effects in vivo and h vitro.
Dr. Goldman acknowledges and discusses additive or cumulative effects of radiation with various chemical agents in his Direct Testimony and gives supporting References 9,11 and 12. The latter Reference also cites "more lymphatic disorders... than expected from the sum of the effects of the two agents separately in Collip rats" in its abstract. Dr. Goldman's reference 11, in addition to demonstrating simple additive effects, also proves that several small radiation doses in conjunction with a chemical agent have "an over two-fold increase in tumor multiplicity" above that produced by a single radiation exposure delivering the same total dose.
These observations on fractionation of radiation dose along with those stated in the Discussion of Dr. Goldman's Reference, indicate not only that multiple low doses of radiation over a period of time may represent a greater health hazard than a single large dose (same total dose), but that the two types of dose delivery, or dosage rates, are not comparable.
Dr. Goldman's Direct Testimony, pp.10-13 and his choice of References 7-12 not only do not refute contention 8/9, but in principle support the underlying concepts of synergistic and cumulative, or additive effects from radiation and chemical agents.
Indeed, his choice of references indicates that no published medical reports clearly refute or disprove these principles, b.
In his discussion of "quantification of the effects of mixtures of radiation with chemicals" (p.11, Direct Testimony), Dr. Goldman explains that due to cell killing, experimental results probably indicate less transformation / neoplasia than would result at lower doses; 13, lower doses would produce more cancers and fewer individual cell deaths. Ilis quotation from Cole and Foley (Reference ll) supports this position, as do his References 8, 9, an[f 12 relevant to fractionation of dose where a large single dose kills cells which othenvise would/do transform.
Dr. Goldman's Reference 7 (also cited by Dr. IIamilton) states on p. 441, "TPA most effectively enhanced transformation at low doses of X-Radiation." Therefore, it is clear that the difficulty in quantification of synergistic and additive n
effects remarked upon by Dr. Goldman [pp.11 and 12 (bottom), Direct Testimony]
lie chiefly in determining how much greater the effects will be at lower levels and dosage rates than have been experimentally practicable.
A conservative public health decision would anticipate more neoplasia at lower doses and dosage rates than at those presently reported on.
kb Dr. Goldman's credibility and his ability to interpret scientific reports are severely compromised by his gross misrepresentation of the A.R. Kennedy, et.al., (Reference 7) studies. On p.10 of his Direct Testimony, Dr. Goldman attempts to minimize the magnitude of the observed enhancement: "However, under the most ideal of conditions, using relatively high radiation doses (20 mrem or more) the maximum enhancement was a factor of about eight or nine" (p.10, Direct Testimony). Nowhere in the Kennedy report are the factors "eight or nine" mentioned. The report actually states (on p. 440): "X-irradiation (100 rads) with subsequent TPA treatment resulted in a transfonnation frequency of about 1.410.1 (S.E.) X 10-3 (average of Groups 3 to 5 in Table 1), a 19-fold enhancement in transfonnation over 100 rads alone... TPA worked most effectively in enhancing X-ray transformation at doses of radiation that yielded very low levels of transfonnation by themselves." When confronted with this serious discrepancy under cross-examination, Dr. Goldman was unable to explain his interpretation of the Kennedy data, nor did he indicate that an error was made in his original testimony offered under oath (Hearing Transcript, pp. 946, line 19, through i
l l
949, line 18).
Further evidence of Dr. Goldman's incompetence in interpreting and drawing conclusions from the scientific literature - even those he relies on in his testimony - lies in his discussion of the DiPaolo studies, one of which he cites as Reference 8 (as "DiPaoli, J.A.").
He mistakenly focuses on the quantity of enhancement or the size of the enhance-ment factor as the significnat point in DiPaolo's work. The real relevance of these experiments to low-level radiation-mediated synergism is that a non-transforming dose level of radiation enhances " transformation ordinarily associated with the chemical" and that "the lack of transformation with irradiation alone argues against the selection of a special radiation-sensitive cell." (Goldman's Reference 8, Abstract)
Despite this and the introductory statement in this paper, "Under the conditions of these experiments, no_ transfonnation was identified as a result of the X-irradiation in tha wM of only," Dr. Goldnan insists under cross-examination that "littleAtransformation" occurred with radiation alone (Hearing Transcript, p. 970). Any as tute expert cannot miss the consistent feature of DiPaolo's often described experimental model: the radiation dose utilized is a sub-effective dose level when used alone, thus presenting a valid model for low dose or other sub-effective dose, situations.
Dr. Goldman's inexplicable misrepresentation of the Kennedy studies and his failure to note the conspicuous feature of the DiPaolo model - both being references with which he claims familiarity -
make it impossible for the Board to accept' his interpretations of and conclusions from his reading of the literature on the topic of synergism.
J
___________---________.--.-_1
Despite any other expertise Dr. Goldman might have, his highly questionable credibility and competance, as well as his mistaken observations on synergism disqualify him in the Board's eyes as an expert on this subject. Thus, his assessments of the health risk due to synergism and the adequacy of Applicant's consideration thereof are given little weight by the Board, furthermore, Dr. Goldman acknowledges that he has no knowledge of the environmental carcinogens or the cancer incidence rate in Louisiana and that he did not address genetic damage as a possible health effect from operation of Waterford 3 (Hearing Transcript, p. 980, lines 1-12).
9 ff-The fact that carcinogens acting alone (i.e. without being enhanced by radiation cause concern in the South Louisiana popu-lation is irrefutable evidence that cancer causing chemicals (pollutants) exist "in quantities sufficient to support syncrcism with radiation from Waterford 3" (Applicant Findings of Fact, pg. 63: Opinion, pg. 23).
Since the definition of synergism presupposes that relatively ineffective levels of carcinogens (physical or chemical types) become more effective due to inter-action, any lack of quantitative evidence of specific carcinogens is adequately compcnsated for by the self-evident fact that exis-ting carcinor, ens are present in quanties great enough to cause cancer alone and thus also to interact with radiation from Waterford 3
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49.
Drs. Fabrikant and Hutchison express a certain optimism concerning the peer review process in their statements that Dr. Bross is wrong in his estimation of the " radiation protec-tion community" and its role in the peer review process. (bross, Hearing Transcript pgs. 1632-56 1405 line 21-1406: 1613-19)
Dr. Fabrikant says, "Neither situation exists:
the ' radiation protection community'that Bross describen does not exiet" (pgs 13-14, Rebuttal Testimony).
Dr. Hutchinson finds it "hard for me to conceive of a system that would effectively block publi-cation of scientific work because of undesired findings" (pg.
28. Rebuttal Testimony).
But on cross examination, Dr. Hutchinson acknowledges participation in a Congressional Committee Hearing on a-matter of peer review which resulted in Committee Hearing Chair-man Representative Paul G. Rogers' conclusion, It's the most disordered, unstructured mess that I have looked into in some time.
If our research programs are being carried on in this manner
...we may also ask the Department of Justice to look into the whole matter." (Hedring Transcript specifically 3391-2, also 3352-3398 Hutchinson.)
Dr. Bross' position tha t the peer review process as applied to research Ginding is subject to pressure is confirmed in the New York Times, June 13, 1982, edition which re-ports, "What worries scientists is political intrusion into deci-sions on what constitutes good and bad science and on which pro-l jects should be funded."
Cases of outside pressure being applied l
l
to individuals and peer review panel choices include the National Bureau of Standards, the U. S. Department of Agriculture, and the U. S. Foo'd and Drug Administ, ration.
National Academy of Science friends hint that "the Administration nicht be unhappy with the scientific truth about a politically volatile subject."
And the Director of A.A. A.S., which published a related article in Science, on May 7,1982, calla for a halt to the " spread of the infection of political interference."
Clearly. Dr. Bross and Dr. Johnson are not alone in their critical views of certain private and government peer review processes and panels.
The Board acknowledges that the highly controversial nature of nuclear power well might focus certain pressures on those iden-tified as the "radioation protection community" and that Dr.
Bross' observations reflect a valuable insicht into come non-scientific nethods and sources which give rise to certain types of data on one cide of a controversial topic and tend to under-state the importance of conflicting data.
See attached Appen-dises2E[ and3EE.
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f3C).
Joint Intervenors' Contention 8/9 nimply states tha t Appli-cant fails to properly evaluate synergistic and/or cummulative effects oflow level radiation with environmental pollutants known or suspected to be carcinogens.
At every opportunity darough-out the hearing, Joint Intervenors clarify two basic points in the contentions (1) the " low level" of radiation refers to the doses and amounts of radiation specified in 10 C.F.R. 50 App. 1, and under no circumstances does it refer to any estimated or calculated doses or amounts formulated by Applicant or N.R.C.
Staff (2) by " properly evaluate," Joint Intervenors intend that all available evidence and data on existing carcinogens, low level radiation, and synergism be evaluated by Applicant, and under no circumstances do Joint Intervenors recognize com-pliance with N.R.C., A.E.C., N.E.P.A. or E.P.A.-regulations or design objectives as proper evaluation.
The reason for the latter stipulation is that none of the above guidelines explicitly account for risk factors due to synergism.
Joint Intervenors' position on these two points was not specifically agreed to by Applicant and N.R.C. Staff, but neither was it debated, refuted or denied by these parties.
It is significant that the board at no time ruled against Joint Intervenors' interpretation of these basic points in Contention 8/9 and so Joint Intervenors' inter-pretation of meaning for terms in their contention is considered to be the interpretation and definition in force.
The Board finds that accordinE to these definitions of the terms of Contention 8/9, Applicant han in fact failed to deal with the provisions set forth in the contention.
O CchCLUS10NS OF LAW 05 C0h?3 TION 8/9 L
42 U.S. C.
2222 (a) require s that, in connection with applica-tions to operate nuclear power plants, applicant must demonstrate tha t the use and specific characteristicu of Ole nuclear facility meet Nuclear Regulatory Commission regulations and that the tanner the nuclear faclLity is operated will provide adequate protection to the health and safety of the public.
Congress ' command tha t applicant meet the double burden of showing compliance with N.R.C.
rules and that granting U;e license will not endanger the public health reste upon the sound premise tha t regulatory agencies too frequently perceive their role as protecting the industry from the public.
(The N. R.C.
itself was criticized by members of the public on these r, rounds in the limit,cd appearance portion of the hearin63.)
This Congressional instruction is reflected in 50 C.F.R. 2.732 and 50 C.F.R. Fart 2. App. A (V)(d)(1) which place the burden of proof upon the applicant in licensing hearings.
i
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Applicant' and S taff have attempted to show that their pre-dicted estimates of radioactive emissions from saterford 3 fall within radioactive effluent emissions standards promulgated by
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the N.R.C.
Their-efforts are misdirected.
They have missed the point of these hearings.
Applicant and Staff have failed to counter the probative, reliable, and convincing evidence pre-cented by Joint Intervenors that synergism between pre-existing carcinorens in the Waterford 3 area and allowable releases of a,d4,c7lnted vik W,
radioactive ef fluents under N.R.C. r,egula tionsowill create a serious threat to the health and lives of thousands of Louisi-n..ians living in the cancer corridor stretching from Baton Rouge to the mouth of the iiississippi.
Conformance to N.E.F.A., E.F.A.,
N.R.C. and/or A.E.C. standards will not prevent the cancer deaths of Louisianians who will be killed by the synergistic and/or cumulative interaction of radiation and pre-existing carcinogens in the Lcuisiana environment because none of the above agencies l
consider the synergistic and/or cumulative interaction of radi-atioh and other carcinogens, but consider only the effects of Individual agents, acting separately.
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As the operating license sou,ht tyApplicantwillper{it
- i the exposure of an individual intan unrestricted area to a dose St of approximately 10 millirems totah body dose from all pathways R
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figure rather than the sericusly flktwe;l estimated emissions cal-culations presented by Appliennt and Staff to be applicable to this proceeding.
This conc;.usion on our part, of course, would be altered if Applicant were to seek an operating 1.Neense allow-
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a Accord hcly the Board finds ar'a mattgr of law that applicant has failed to show tha' 102 ( 2 ) ( C'), ( E ) cf the National Environmen-l tal Policy Act of 1969 and 10 C.F.R. 51 tave ter.n complied with in acccordance with 10 C.F.R. Fart 2 App. A f( d. 10 C.F.K. Fart 2 s
App A VIII(0)(7) ~ applicable to operating _lteenses by operation of 10 C.F.R. Fart 2 App. A VIII (a)]thav it is necissar~y to de'ny m
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applicants licence in order to protect envirnmental values, i.e.
preventing an aceravation of Louisiana'r cnneer epidemic, 10 C. F.R.
iart 2 App. A (f)(3).
The Ecard further findu tha t the iscuance L
of applicant's license wil. be inimical to the health and safety of the public.
0 C.F.R.
Fart 2 App. A 1.
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(3), (6), (7).
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5 Accordingly, the Board recommends that applicante licence application be denied.
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T. uke Fontana Gary Croesch FOR JOINT INTERVENORS L.. ;
I hereby certify that a copy of the foregoing pleading was served by deposit in the United States Mail, first class, postage prepaid, this 21st day of June 1982 to the Atomic Safety and Licensing Board and all counsel of record and all others on the service list of said hearing.
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June 19, 1982 r m fl 1
D;11 ED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION HEFORE THl: Al OM IC SAFETY AND LICFNS ING BOARD In the Matter of
)
LOUISIANA POWER & LIGHT
)
Docket No. 50-382 OL (Waterford Steam Electric st ation. )
Unit 3)
)
I.
STATEMENT OF Tile CASE Joint Intervenors allege that evacuation planning around the Waterford Steam Electric Station Unit 3 is inadequate in two major subparts of one contention 17/26. The first subpart has six sub-categories, A through F, which alleges inadequacies in: notifying residents, roads and highways, warning systems, command structure, evacuation drills, and evacuating people in six special categories.
The second major subpart alleges inadequacies in the distribution of potassium iodide.
Testimony was heard at the Fifth Circuit Court of Appeals from May 3, 1982 through May 12, 1982.
II. MEMORANDUM ON CONTENTION 17/26(1) & (2) 1.
Emergency Planning: Education Emergency planning around Waterford 3 is ostensibly based on two general principles according to the Applicant. If it is true that " education of those who may be involved in emergency response" and " anticipating events and problems" is one aspect of the first principle, the emergency response personnel-civil defense directors, state and local-should be knowledgeable of the consequences of the severe accidents at nuclear power stations. The President's Commi%sion on the accident at Three Mile Island (The Kemeny Commis-sion) is very clear on this aspect of ' education' in assigning responsibility to the accident at Three Mile Island: (p. 17 of the Kemeny report) "The farl that too many individuals and organizations were not aware of the dimensions of serious accidents at nuclear
1 power stations accounts for a great deal of the lack of preparedness and the poor-quality of the response."
Both NUREG-0654, " Criteria for Preparation and Evaluation of Radiological-Emergency Response Plans and Preparedness in Support of Nuclear Power Plants," and NUREG-0396, " Planning Basis for the Development of State and ' Local Government Radiologica1' Emergency Responso Plans in Support of Light Water Nuclear-Power' Plant,"
specifically includes core melts in their scenarios of concern. The more important guidance document. NUR EG- 0654, states: (pp.6-7)
...a planning basis is very large...[ including]... the worst possible accident" and (p.7)
...a number of. accident descriptions were considered in the development of the guidance, including the core melt accident release category."
Further, (p.6) " FEMA has also concluded that the guidance in NUREG-0396 should be used as the planning basis for emergency pre-paredness around nuclear power facilities."
NUREG-0396 has numerous-graphs and extensive texts describing severe accident sequences -
including the core molt.
Joint Intervenors were repeatedly denied the right to question key personnel --Azzarello (LP&L), Myers (Louisiana), Madere (St. John)-
Lucas - (St. Charles) -- about their' knowledge of the critical end points in the consequences of serious nuclear accidents -- including core melts.
f NUREG-0654 (pp. 7-8) also sets down several areas it considers l
to le of utmost importance to planning officials. The most important of these is the " definition of the area" over which planning is-e 1
necessary. This.is followed by information on " time frames" of accidents. The third category, " knowledge of the kinds of. radio-active materials potentially released," was specifically excluded from the cross-examination of Joint Intervenors by ASLB rulings. The 4
l key civil defense officials -- Azzarello, Myers, Madero and Lucas --
agairf were excluded f rom any testing of their knowledge of the j
{'
radioactive materials that were released from nuclear power plants during accidents, even though NUREG-0654 considers it important l
for planning officials to know this material. The Board can now see its error. PF 1
2.
Emergency Planning: Paper Plans The second priciple holds that emergency plans are a continuous activity, a so-called "living document." The Joint Intervonors contend that as no exhaustive plans are available for specific review, the principle is little more t-han a convenient device to hide oversights, frustrate judicial review and deprive intervenors of their right of due process under the 5th Amendment of the United States Constitution.
More correctly, the "living document" could be seen as a " dead document." A thin skeleton of generalized statements, the emergency plans do not begin to deal adequately with those problems reasonably associated with an orderly evacuation. The plans includes no brochure, no agreements with surrounding parishes for buses, vans or ambulances, no communication systems installed or tested, no implementing procedur no sirens and no evacuation tests.
The Applicant has had nearly 12 years in which to prepare emergency plans (LP&L applied for a construction permit on December 28, 1970) and the result of its work in this regard has produced what can at best be described as a minimal plan.
The Board agrees with Judge Jordan's statement that "there has to be more than paper plans." (tr. 2275-11). This is in response to the suggestion of Staff cousel Turk that "(a)l1 that has been raised until now is the adquacy of the emergency plan on paper" (tr.
2273-17&l8). Joint Intervenors allege they are interested in more than paper plans. The leard agrees. PF 2 3.
Regulations and People No operating licenso can be issued unless the staff can make a favorable finding that the integration of offsite and onsite emergency planning "provides reasonable assurance that adequate protective measure can and will be taken in the event of a radio-logical emergency"(10 CFR 50.<17 (a) (1).
The key words, the verbs "can and will" refer to the elements of the plan itself. In essense, the regulations ask "is it possible to implement listed protective actions effectively?"
The second standard [ reasonable assurance that protective action
'will be taken'] implies looking at the individuals involved. There is reasonable doubt that the individuals in key positions 'will'
perform their functions ef fectively. Joint Intervenors were blocked by ASLB from probinq possible conflicts of interest among those officials in the correnand decision structure. The Parish president in St. Charles parish has potentially severe conflicts of interest with rega rd to the Applicant -- conflicts that are both familial and financial. Similarly, the civil defense director of St. John the Baptist parish, Dort ram Madere, is a full time employee of the E.I.
Dupont du Namours in St. John the Baptist Parish. Dupont is the owner of the Savannah River Nuclear Power Station in South Carolina. Madere, as eivil defense director, is the chief of staff for the parish president during emergency situations. Thus the health and safety of residents in both parishes is possible threatened by potentially severe questions of conflict of interest.
People - real people - are the essential ingredient in the emergency plans. The NRC Lakes this into consideration in onsite plans. NRC expert Perrotti:
...I cannot at this time state whether the people are adequate or not, because I have not had a chance to evaluate the individuals involved." (tr. 3920). This conflicts sharply with the Board's rulings against questioning and evaluating the key individual in the offsite plans -- the Parish President:
"We're not going to get into incumbents in office. We're talking about command structure." (tr. 2966-15&l6). The apex of the command structure is the parish president. Aznarello, et al.,
at 12-13; Benton and Lookabaugh at 7-8. Thus the Board can question whether there is reasonable assurance that the of f site emergency decisionmaker.
will respond correctly. PF 3 4.
Predictive Findings and Post-IIcaring Verification The concepts of predictive findings or post-hearing verification as a decision-making device in a judicatory hearings involving members of the public is contrary to the 5th Amendment right of due process under the Constitution of the United States, the Administrative Pro-1 cedures Act and The Atomic Energy Act. These " verifications" or
" findings
are simply convenient devices to deprive legal intervenors the right to question the basis or facts involved in them.
It creates an "old boy" netwo rk where the real decisions are made between bureaucrats who are out of sight and earshot of the public.
Any predictive findings or post-hearing verification by the NRC l
or FEMA on subjects delineated in the contentions of Joint Intervenors are illegal. Joint Intervonors contend that their rights can only be t
protected by reconvening this tribunal af ter the substantive parts 1
of the emergency plans have been finalized. The Board agrees. PF 4 i
5. The Contentions a
Joint Intervenors' Contention 17/26(1) (a) asserted that:
l Applicant has f a iled to. adequately make provi-i sion, according to the Emergency Plan contained in Chapter 13.3 of the FSAR, for evacuation of individuals located within the 10-mile plume exposure pathway e"ergency planning zone for the Waterford 3 site in the event of a serious reactor incident, as required by applicable NRC L
regulations, in that:
j A.
the provisions.for notifying residents of evacuation procedures are inadequate.
The notification of residents is clearly. inadequate because no brochure was available to critique (Tr. 2889). The, brochure distributed around the Grand Gulf nuclear power plant was produced j
by Joint Intervonors, but they were barred questioning Azzarello on the general format or nuclear terminology contained therein.
(Tr. 2202) It is inconceivable that the key element of the notification system -- the brochure -- was not available for ' Joint Intervenors to critique. Azzarello testified that plans for notification'of the public do not take population increases into account (Tr. 2289&2290).
l Joint Intervenors object to the post-hearing verification now being l
planned for the brochure as a violation of their right of due process 1
(
and of the Administrative Procedures Act; The Board ' agrees. PF 5 Contention 17/26(1)(b) asserted that:
B.
the roads and highways necessary for such evacuation are inadequate.
{tadoretestifiedat length about the need for increased roads and highway in his parish. He said-that they were needed to hasten evacuation. Although he has been promised additional roads.since 1972, none has been built. (Tr. 2783&2795).
I Lucas also testified that he would like to have additional raods built ~ to speed up the evacuatin process. However,- neither of these men mentioned the need of prior requests for additional roads to FEMA. As local officials experienced in evacuating their' respective parishes, Lucas and Madere_should have indicated Lto FEMA officials their reservations about the existing number of l
roads and highways (2875-2877).
The evacuation time estimate (ETE) sponsored by applicant has expert Twine also severe problems. Important categories of indi-viduals were completely excluded. The computer code, GPSS, has never been used at a licensing hearing. The ETE also does not factor the impact of theomission categories under contention F:
(a) refusal to evacuate, (b) additional collisions, (c) hystpria, and.(d) single modo evacuation.
The Board is aware that NRC and FEMA regulations on the adequacy of the road and highway network are generally weak and vague. In order to protect the health and safety of the people of Louisiana, however, our conclusions can be none other than that Joint Intervenors' contention is correct. PF 6 Contention 17/26(1)(c) asserted that:
C.
the evacuation warning system is is inadequate.
The siren system is not in place and, therefore, not tested.
Further, no experts were~available on the panel to answer questions about the evacuation warning system (Tr. 2341-5). Although FEMA witnesses testified that the warning system was adequate, it was-shown that they never visited the proposed siren locations (Tr.-2879).
Madere testified that the outdoor warning system would warn 10Qt of the population. This would indicate that the hearing impaired of the parish have not been considered (Tr. 2698).
The siren warning system would certainly-not contact this population segment. In-this case, phone calls to the neighbors of the hearing impaired would allegedly be made.
Joint Intervenors were prevented by Board ruling from questioning the adequacy of the phone system in a time of crisis. (Tr. 2820).
Because of the overload and breakdown of the phone system aronnd the Three Mile Island facility during the accident, Joint Intervenors believe the phone system around Waterf(rd 3 is inadequate, ' and therefore provisions for contacting the hearing impai. red are also inadequate.
When the public is notified, pre-prepared messages will be used by radio stations to transmit information. The stations will " fill in the blanks" with information supplied by officials at the time of the accident. None of the messages were completed or available, and it is uncertain whether they will provide adequate information to the;public.
l
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The Board concludes that-Joint Intervenors contentions concerning the inadequacy of the evacuation warning system is valid. PF 7 4
Contention 17/26(1)(d) asserted that:
D.
there is not an adequate command decision j
structure, including appropriate guidance, l
for commencing evacuation.
+
Parts #1 and #3 of this section address some of the weaknesses in the offsite command decision structure. These weaknesses dealt primarily with the lack of specific knowledge of the consequences i
q of serious accidents at Waterford 3 -- including core melts. They l
also addresse5the lack of knowledge of the radiological consequences of serious reactor accidents.
Part 3 dealt with the conflicts of interest of the key decision makers in the offsite plan. This incluiu the parish president of j
St. Chnries parish and the civil defense director of St. John the Baptist parish. There are other, more specific areas on concern which I
will now be addressed.
Lucas says he will recommend an evacuation order be given by the parish president if the Applicant tells him to evacuate. He says he would so recommend without first contacting the state for an independent accident assessment. (Tr. 2954) FEMA expert Benton.
says the state can act immediately on information from the licensee,-
without an independent assessment from other state agencies. (tr.2910-t i
23). Therefore both the parish and FEMA explicitly state that on j
some occassions, the protective action recommendation of the j
utility will be all that is necessary to begin an evacuation.
Yet FEMA expert Benton states elsewhere in testimony that no confidence can be given to the utility's ability to recommend protective actions, i
He said the utility has no knowledge of traffic conditions or l
resoupces available (Tr. 2913-8).
p Independent information aVailable at all times is essential for offective and trustworthy protective action decisionmaking.
i l
The fact that the State does not have instant, independently verifiable information on accident parameters to add to parish
)
information on traffic condictions and general state of readiness puts a large cloud over the decisions that might have to be make
~
very quickly. NUREG-0654 guidelines state that a radioactive could i
have an impact on the surrounding population in one-half hour.
Madere is so unfamiliar with NUREG-0654 that he believes that the people in his parish would get exposure 45 minutes to one hour af ter a radioactive release because they are five miles away (assuming a three mile per hour wind) (Tr.2676-18ff). Madere apparently does not understnad that the guidance document has subsumed all variables into its calculations. Madere should be planning for a possible exposure to his population in one-half hour. (NUREG-0654 - Table 2).
Madere also indicated grave misgivings about the adequacy of NUREG-0654 (Tr.2570-3&4) thus putting in doubt his use of this guidance document in preparation of plans or in recommending pro-tective actions to the parish president in an emergency. Joint Intervenors were prevented by ASLB ruling from questioning Madere's reservations about NUREG-0654 (Tr. 2572-2).
To allow a utility to offer protective action guides based on data not independently verifiable to a parish constitutes a risky practice, Joint Intervenors showed by cross-examination that the protective action guides that are in the utility and state plans are substantially different concerning specific, high-risk portions of the population -- pregnant women and children. The utility plan offers no special consideration whatsoever to this high-risk group in the categories of whole body dose, one to five rems, and thyroid dose, 5 to 25 rems. It simply uses a child thyroid dose as a category without mentioning pregnant women (Tr. 3107 -- 11 through 13). The state plan, however, does have an option in that dosage category for evacuating pregnant women and children when constraints make general evacuation impossible (Tr. 3141-14).
The Board finds that because of the possible conflicts of interet of the key decisionmakers, the lack of independent accident assessment-and the general unfamiliarity of the parish officials with the guiddhce documents, there is grave doubt that the proper emergency response would be formulated in case of the most severe accidents. PF Contention 17/26(1)(e) asserted that:
E.
the Emergency Plan lails to provide for realistic and comprehensive evacuation drills, in that the provisions for moving individuals are not actually tested.
In their attempt to show that evacuation drill are not necessary, FEMA witnesses testified that they have " observed (evacuation) exercise-
in which the public did not choose to participate (Tr. 2883). This conclusion was shown to be misleading because, in fact, they had only observed one exercise.
When the applicant does conduct a drill to test the commitments from resources" and " officials" (Tr. 2614), all but one of these will be announced ahead of time. The only unannounced drill will be con-ducted after the plant is in operation (Tr. 3097). This schedule does not adequately test the evacuation plans because (a) prior announcement allovs time for people to prepare themselves and the resources needed -- 1.ime that would not be available in the case of a real accident, and ( b), the unannounced drill, as it is schedulec to take place after the beginning of plant operation, will not be of any benefit in the case where an accident were to occur af ter the opening of the plant and before the scheduled unannounced ' drill.
These common sense observations were accepted by the Board -
which concluded that this segment of the plan was inadequate. PF 9 Contention 17/26(1)(f) asserted that:
F.
procedures are inadequate for evacuating people who ares (i) without vehicles; (ii) school children; (iii) aged or crippled; (iv) sick and hospitalized; (v) imprisonned; (vi) transient workers.
Part F deals with a number of specific categories of individuals which would be affected by an accident at Waterford 3. Four general considerations were overlooked in the preparation of evacuation plans.
These omissions would effect all of the categories listed above in part r; They deal with unforseen drains on resources and poor evacu d ion routing that could lead to unnecessary 'and excess doses of radiation. " Dose savings" are the' primary consideration for the genedb1 population and especially for the population about which Joint Intervenors have raised contentions -- the sick, hospitalized, aged and children.
Omission 1 - Refusal to Evacuate Lucas testified that at a recent chemical spill in St. Charles parish that affected nine homes, three of those homes refused to evacuate. Many resources -- human and material -- were used to
extricate these people. Resources were also expended to impound these people's animals (Tr. 2917-19ff). Lucas said that the parish presi-dont declared an emergency situation, and then officials physically removed.them. (Tr. 2718-6) Joint Intervenors attempted to question Lucas on the amount of resources used~to extricate the people --
one-third ~of the affected population -- but were stopped by ruling of the ASLB (Tr. 2724-18) on objection from Applicant's counsel.
This came af ter the Board had allowed a question concerning the type of police van that would be used to evacuate the people who refused orders to evacuate (Tr. 2723-16). Lucas stated that people who refuse to evacuate during an accident. at Waterford 3 could be forcibly evacuated (Tr. 2710-13). This would appear to be logical, as the same emergency situation would doubtlessly be declared by the parish president.
On cross-examiniaion by the Applicant, the Board sustained a reexamination of the question of people who refuse to evacuate (Tr.
3037-3). The Board allowed questions pertaining to resource commit-t ent.
Since the subject of people who refuse to evacuate was not addressed by the Board, Joint Intervenors had no opportunity.to re-direct questions at Lucas.
Lucas' assertion that people who refuse to evacuate would -
not divert resources is without legal basis. If the people threatened.
by the chemical spill had to be forcibly evacuated because of an executive order by the parish president of a general emergency, people threatened by a serious accident at Waterford 3 deserve the same consideration. They certainly did not create the hazard and therefore do not deserve to be unnucessarily exposed to radiation.
Millions of dollars have been spent by the atomic industry on television, radio, and newspaper advertisements which have had the affecpofdownplaying the hazards of adiation. In all likelihood, the brochuro to be distributed by th 2 utility will contain charts and text stressing the ' extremely 1r.w likelihood' of a serious accident. The brochure distributed arc und the Grand Gulf station contained these leements. It is no' unreasonable to assume that the cumulative effect of this infocmat.on would result in one-third, or more, of the population refusir.g to evacuate.
The neighboring population should be aware of the massive mortality and morbidity possibilities from a serious nuclear accide t They should not n
be unduly swayed by hours of television advertise-ments reassuring them of the safety of the plant and then one day hear sirens go off and be told to run for their lives. Joint Inter-venors have been repeatedly stopped from questioning even the evacuation officials on the hazards of a serious accident.
Even attempts by Lucas to downplay the phenomenon of people refusing to evacuate raises many questions. Lucas said:
...threugh
)
manay, many months that we've had emissions in St. Charles Parish, it (the phenomenon) hasn't been to that extreme. No haven't had that ruch of it." ('I r. 3036 - 19&20). If one-third of the population refusing to evacuate is considered " extreme", what is the usual percentage? Joint Intervenors were prevented from finding out due to rulings from the Board. PF 10 Omission 2 - Additional Collisions:
Lucas testified that because people would be " enthusiastic" to leave the contaminated area, there would be an increased number of accidents on the evacuation route. Madere concurred. Twine tes that he did not agree, but that he did not want to contradict their experience (Tr. 2840-2843). Twine also testified that when developing ETE, he assumed there would be enough rescue vehicles to clear accidents (Tr. 3003) However, since he did not count on an increased any number of accidents, and in fact, the number of assumed a reduction in accidents, rescue vehicles he assumed would be needed would be below the actual number needed given a greater number of accidents as indicated by Lucas and Madere. This could impede the evacuation by slowing vehicles used on roads and highways. PF 11 Omission 3 - Hysteria:
The question of hysteria as a factor in the emergency plans has hgl a complex history. The original question on the possibility of hysteria was posed by Joint Intervenors to FEMA expert Benton (Tr.
2886-19f f). Over objection by the Staf f, FEMA and Applicant, Benton was instructed to answer. His response was an unequivocal 'no'.
On Boa rd examination, Denton said he " personally" did not take it into account -
NUREG-0654 does (Tr. 2914).
{
On further inquiry, Benton said a section in Planning Basis part of NUREG-OG54 ' implied' hysteria was considered (Tr. 2915-19).
l
)
Joint Intervenors, on redirect, again affirmed that i
l L_ _..
FEMA witnesses
P i
(Lookabaugh and Benton)'did not take hysteria'into account (Tr.2918 3) 4 (Tr. 2918-6) nor did hysteria appear in any manner directly in NUREG-0654 (Tr. 2918-16&l7).
Then Joint Intervenors attempted to question the witnesses on the relationship of hysteria to the ' evacuation shadow-phenomenon",
a documented phenomenon related to hysteria seen'at Tree Mile Island.
Staff, FEMA, and the Applicant objected and the Board sustained. This potentially fruitful line of questioning was ' ended over objections l
of Joint Intervenors (Tr. 2920-9).
The vast numbers of people at Three Mile Island who evacuated (nearly 144,000) because of their anxiety contrasts sharply with the actual number (5000) of pregnant women and children who 'were
' advised' to leave. PF 12
.I f
Omission 4 - Single Mode Evacuation:
The relationship between the two parish evacuation plans is strange. In both parishes the plan is to move in a single direction -
each opposite from the other - at the same time, with St. John moving 1
west and St. Charles moving east (Tr. 267- - 8&9). Even though there l
are reasonable mehhods of evacuating St. John parish eastward (Tr. 267 westward is the only alternative now incorporated into the plans.
Similarly, despite good methods of evacuating St. Charles parish westaward, the only alternative now available is eastward. This l
is planned allegedly to "stop the confusion of both parishes evacuating in the same direction." This is'in complete noncompliance with NUREG-0654 which says: "(T)he overall objective of emergency response planning is to provide dose savings (and in some cases immediate life saving) for a spectrum of accidents that could provide offsite doese." [ Read into the record by Judge Wolfe at Tr. 2360ff].
-NUREG-0654 also states: "No single specific accident sequ9nce should be isolated as the one for which to plan..." (Tr.
2360-19).
Clearly, flexibility is the key to the NRC/ FEMA guidelines.
This flexibility of response has been made brittle by the arbitrary nature of the selection of only one nothod of evacuation when per-fectly good alternative routes wre available. This single path was i
chosen to " avoid confusion" and not for " dose saving." This is un-acceptable under NRC/ FEMA guidelines.
If confusion is possible because
the residents of one parish would have to cross parish lines, then more practice and fuller integration of plans and resources is called for -- not arbitrary segregation of evacuation routes without regard to changing accident circumstances or maximizing dose savings.
This single mode evacuation conce pt that " avoids confusion" by not crossing parish lines make nonsense of the supposedly longstandinc mutual aid agreements between the two parishes which allow them to share resources during times of emergency (Tr. 2989-91). In reality, they appear willing to expose their people to higher doses of radiation than share their resources with people of the other parish.
PF 13 F.
procedures are inadequate for evacuating people who are:
(i) without vehicles; (ii) school children; The primary reality in the p1rns for evacuating school children and persons without private transportation is the. omplete c
lack of agreements to provide for those people in need of evacuation after the parish resources are exhausted.
143 buses are needed for evacuation of residents without vehicles in both parishes (Tr. 2413-20). This is for 5,777 persons without transportation in both risk parishes (Perry, at 3). There are 16,951 students in both parishes requiring 290 buses to evacuate. (Perry at 4 There is a need for 429 buses for total evacuation of both parishes. St. John and St. Charles parish have 138 buses. This leaves a 291 bus shortfall that will, of necessity, have to be obtained f rom neighboring parishes (Tr. 2545).
No agreements with any neighboring parishes have been reached to provide for this shortfall (Tr. 2536). Madere admits implementing procqdures are inadequate and not complete (Tr. 2537). Madere says implementing procedures are never finalized (Tr. 2591).
Madere affirms there is reasonable doubt that bus drivers would drive into St. John and St. Charles parishes from outside the 10 mile EPZ during a major radiological accident at Waterford 3. Somehow volunteer bus drivers would be transported beyond the 10 mile EPZ and, allowed to use out-of-parish buses to drive into the contaminated zone (Tr. 2619).
There is no documentation whatsoever that a significant portion
of people without transportation would be given rides by other people during an emergency (Tr. 2755) (Urbanik).
The Board finds that taking into consideration the four omissions listed at the beginning of this section and the massive uncertainties that permeate this plan, it must withhold approval.
PF 14 h
F.
procedures are inadequate for evacuating people who are:
(iii) aged and crippled; (iv) sick and hospitalized; There are no agreements whatsoever to provide the aged, crippled sick and hospitalized with transportation - buses, vans or ambulances -
from surrounding parishes after the parish resources are exhausted (Tr. 2614).
Lucas says that they cannot get people and wheelchairs into vans (Tr. 2501). Madere says that they do not have sufficient vans and ambulances and that they are in talking stages with support parishes (Tr. 2507).
To evacuate the home bound aged and handicapped calls for 25 vans and 25 ambulances in both parishes (Tr. 2504)(Tr. 2524).
To evacuate the sick and hospitalized in both parishes requires 37 ambulances, 10 buses, and 3 vans. Perry, at 11.
This ia a total number of 62 ambulances, 28 vans and 10 buses to evacuate the aged and crippled needing transportation and the sick and hospitalized in both parishes. T*.e two parishes presently list resources of 11 vans and 7 ambulances. Lookabaugh and Denton, 14 and 16. Thus there is a shortfall of 55 ambulances, 17 vans, and 10 buses needed to evacuate the home bound, infirm and aged needing transportation and the sick and hospitalized.
No arrangements with neighboring parishes to provide for this shortfall have been made in the 12 years that have elapsed since Waterford 3 applied for a construction permit.
The Board finds that the great uncertainties and omissions listed previously leaves no alternative but to withhold approval of the plan to evacuate these population groups. PF 15 (v) imprisoned Joint Intervenors feel that the four general categories listed under contention F do not result in dose savings to the prison popula-
tion.
The already great strain on resources - policemen, police cars and police vans - during an emergency would make it highly unlikely that sufficient resources would be available to transport prisoners.
The prison population is given low priority.
The Board feels that the four omission of contention F are sufficient to withhold approval of the plan toevacuatethebrison population. PF 16 (vi) transient workers The Board feels that the transient worker population will be inadeg aately protected because of the concerns raised in the four omissions enumerated under Contention F. As noteo earlier,' the strain on resources, the hysteria., the poor evacuation routing will combine to jeopardize the safety of the transient worker population.
For these reasons the Board withholds its approval. PF 17 Joint Intervenors' Contention 17/26 (2) asserted that Applicant has failed to adequately make provision, according to the Emergency Plan contained in Chapter 13.3 of the FSAR, for distribution and /or storage of potassium lodide in accordance with accepted public health practice in locations which are readily accessible to affected individuals as protected against thyroid irradiation.
The predistribution of Potassium Iodide (KI) is not included in present NRC or FEMA regulations except for certain restrictive categories (prisons, hospitals etc.). This is not in compliance with NUREG-0654 guidance which specifically lists ' dose savings' as the guiding principle of action.
i Joint Intervenors have shown that predistribution of KI reduces of chance of excessive thyroid doses without placing the general population at risk.
1 The Board concludes that the Atomic Energy Act which places the health and safety of the public as its primary concern must l
supercede present inadequate regulations. The Board agrees that predistribution of KI to the general population is warranted. PF 18-25 s
III. PROPOSED FINDINGS 1.
Emergency planning around Waterford 3 has been gu'ided by.twc general principles.'The first recognizes that effective planning is largely an educational activity. This includes educating themselves and others idio may be involved in emergency response and anticipating -
events and problems (Azzarello et al, pp.1&2). The Kemeny Commission (The President's Commission *on the Accident at Three Mile Island) is very clear on this aspect of ' education' in assigning responsibility in the accident at Three Mile Island: "The fact that too many individuals and organizations were not aware of the dimensions of serious accidents at nuclear power stations accounts for a great deal of the lack of preparedness and the poor quality of the response"(p. 17 of Kemeny report read into transcripts at 3130) NRC expert Grimes confirms that individuals involved in emergency planning should be aware of the consequences of a serious nuclear accident (3760-20).
NUREG-0654 includes the most serious reactor accidents in its
' Planning Basis' section. FEMA has:also concluded that NUREG-0396-should be used as a ' Planning Basis'(pp. 6&7 of NUREG-0654).
Joint Intervenors were repeatedly denied the right by Board ruling to question the key evacuation officials--Azzarello (LP&L)
Myers (State of Louisiana), Madere (St. John the Baptist), and Lucas (St. Charles)-- about their knowledge of the consequences of severe accidents at nuclear power plants and-specifically Waterford 3(Tr. 2190-17)(Tr. 2236-15)(Tr.2253-14)(Tr.2253-18)(Tr. 2276-9)
(2279-14)(Tr.2279-25) (22-79-10) ( Tr. 2280-15 ) ( Tr. 2280-25 ) (T r. 2710-12 )
NUREG-0654 (pp.7-8) also sets down several areas it considers to be of utmost importance to planning officials. " Knowledge of the kinds of radioactive materials potentially released" is one area in this category. Joint Intervenors were repeatedly denied the right to question the key evacuation officials--Azzarello, Myers, Madere,-
and Lucas--on their knowledge in this category (all transcript numbers in the preceding paragraph apply and including 2282-16,2237-20, 2237-22).
2 The second principle that the Applicant has used in draf ting emergency plans holds that emergency plans are a continuous activity,
a so-called "living document"(Azzarello et al. pp.1&2). In fact, the plans as reviewed by Joint Intervenors have no brochure, no agreements with surrounding parishes for buses, vans, or ambulances, no com-munication systems installed or tested, no implementing procedures, no sirens, and no evacuation tests. This is after nearly 12 years of preparation. (FEMA "l?AC" Review on Waterford Nuclear Power Plank, (Tr. 2537)(2536)(2591)(3955-2&4)(2507-9)(3074).
Joint Intervenors agr.ee with the observation of Judge Jordan:
"There has to be more than paper plans"(2275-11).
3 The Board is limited in its power to give approval under 10CFR 50.47(a)(1) which states that onsite and offsite planning "provides reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency".
The 'can and will' section is the most important. It implies two standards must be met. The first test (whether adequate protective measures 'can' be taken) is the theoretical plans themselves. Their failures are examined elsewhere in these findings.
The second test (whether adequate protective measures 'will' be taken) denotes examining-the individuals in key positions.
Joint Intervenors attempted to delineate possible conflicts of interest of individuals in key positions in the offsite planning.
The parish president of St. Charles parish has both familial and financial interest in the well-being of the corporation of Louisiana Power & Light. (Tr. 2962-66). The civil defense director of St. John the Baptist Parish, Bertram Madere, is a full time employee of E.I.
Dupont. Dupont has a tremendous financial interest in nuclear power in the Savanah River Nuclear Power Plant in South Carolina.
(Tr. 2234). The Board prevented Joint Intervenors from pursuing this line of questioning by adverse rulings.
Evaluating personnel involved with onsite planning is a concern of the NRC. NRC expert Perotti:
...I cannot at this time state whether the people are adequate or not, because I have not had a chance to evaluate the individuals involved."(Tr. 3920).
This contrasts sharply with the Board"s ruling on questioning the adequacy of the key individual-the parish president-in the off-site plan:"We're not going to get into incumbents in office. We're talking about command structure."(Tr. 2966-15&l6)
4 The concepts of predictive findings and post-hearing ver-ification as a decision-making device in ajudicatory hearings involving members of the public is contrary to the 5th Amendment right of due process under the Constitution of the United States, the Administrative procedures Act, and the Atomic Energy Act. Any predictive findings or post hearing verification by the NRC or PEMA in subjects delineated' in the contentions of the Joint' Inter-venors is clearly illegal. Joint Intervenors contend that their rights can nnly be protected ay reconvening this tribunal af ter the substantive parts of the emergency plan have been finalized. Joint Intervenors reserved this right in the record. (Tr. 3989-90). However, this right was denied by ruling from the'Doard.
5 l
The notification of residents was clearly inadequate because no brochure was available to critique (Tr. 2889). Joint Intervenors were prevented from questioning even a similar brochure (Grand Gulf) on its general foremat or nuclear terminology (Tr. 2202) 6 Madere testified at length about the need for increased roads and highways in his parish. These roads are needed to hasten evacuation from chemical spills. Although he has been promised additional roads since 1972, none has been built (Tr. 2783-2795)
Lucas also testified that additional roads built to speed up the evacuation process. However,-neither of these men mentioned the prior requests for additional roads to the FEMA experts. (Tr. 2875-77) 7 The siren system is not in place and therefore not tested.
(Lookabaugh and Benton, p.
7). Further, no witnesses were present t'o answer questions about the siren system as an expert (Tr. 2345-5).
Although FEMA witnesses testified that the warning system was adequate, they never visited the siren locations (Tr. 2879).
The siren system would not contact the hearing impaired pop-ulation (lookaba. ugh and Denton, p.
7). The siren system would also not contact those individuals who work in an area with high ambient noise (Lookabaugh and Benton, p.6). In the case of the hearing-imp-aired, officials would attempt to contact the neighbors of these individuals by phone to relay the message..
Joint Intervenors were prevented by Board ruling from quest-ioning the adequacy of the phone system in a time of crisis (Tr. 2820).
The pre-prepared messages that are to be transmitted over the radio are' fill in the blanks' type. No messages were completed or available and it is uncertain whether they will provide adequate information to the public (Tr. 3092).
l 8
Findings of Fact #1 and #3 deal with command decision structure and they should be subsumed'in toto in this finding of fact as written.
41 deals with lack of knowledge of serious nuclear accidents that could contribute to poor response. #3 deals with conflicts of interest and its possible ef fect on proper response.
Lucas says he would immediately recommend evacuation to the parish president if the utility tells him to evacuate. He would do this without requesting an independent accident assessment from the state (Tr. 2954). FEMA expert Benton says the state can act immediately on information from the licensee without independent assessment from other state agencies (Tr. 2910-23). FEMA expert Benton states elsewhere in his testimony that no confidence can be given to the utility's ability to give protective actions because the utility has no knowledge of traf fic conditions or resources (Tr. 2318-8).
Madere shows little knowledge of NUREG-0654 in not knowing that windspeed and distance are all subsumed in guidance calculations that appear in Table 2 of that documents.
-He does not believe that radiation could reach his populated areas in one-half hour (Tr. 2676-18ff).
Madere also had grave misgiving concerning the NUREG-06S4 (Tr. 2570-3&4). Joint Intervenors were prevented by Board ruling from probing Madere's doubts about the document (Tr.2572-2).
The utility and the state have substantial differences in their protective action recommendations concerning pregnant women and children (Tr. 3107--11 thru 13)(3141-14).
9 FEMA witnesses said that evacuation drills are not likely to be well attended if the public was allowed to participate because they had " observed exercises" in which people did not
t participate. In fact, they had observed only one exercise (Tr. 2883).
When the Applicant does conduct a drill to test the commitments of resources and officials, all but one will be announced ahead of time. The only unannounced drill will be conducted after the plant will be in operation (Tr. 2614)(Tr. 3097).
10 Lucas testified that at a recent chemical spill in St. Cha rles parish that affected nine himes, three of those homes refused to
, evacuate. Many resources--human and material-- were used to extricate these people. Resources were also expended to impound these people's animals (Tr. 2917-19ff). Lucas said-that the parish president declared an emergency situation, and then officials physically removed them. (Tr. 2718-6). Joint Intervenors attempted to question
-Lucas on the amount of resources used to extricate the people--
one third of the affected population-- but were stopped by ruling of the ASLB on objection from Applicant's counsel (Tr. 2724-18).
11 Lucas testified that because people would be' enthusiastic' to leave the contaminated area, there would be an increased njmber of accidents on the evacuation route. Madere concurred. Twine testified that he did not agree, but that he'did not want to contradict their experience (Tr. 2840-2843). Twine testified that when developing the ETE, he assumed there would be enough rescue vehicles to clear any accident (Tr. 3003).
12 FEMA expert Benton said he personally did not take hysteria into account (Tr. 2914) but NUREG-0654 does. On further inquiry, Benton said a section in the ' Planning Basis' part of NUREG-0654
' implied' hysteria was considered (Tr. 2915-19). Joint Intervenors,
-on redirect, again affirmed that FEMA witnesses (Lookabaugh and Benton) did not take hysteria into account (Tr. 2918-3)(Tr. 2918-6) nor did hysteria appear in any manner directly in NUREG-0654(Tr. 2918-16&l7).
Then Joint Intervenors attempted to question tee witnesses on the relationship of hysteria to the' evacuation shadow phenomenon',
a documented phenomenon related to hysteria seen at Three Mile Island.
Staff, FEMA, and the Applicant objected and the Board sustained.
This potentially fruitful line of questioning was ended over objections of Joint Intervenors (Tr. 2920-9)
13 The relationship between the two parish evacuation plans is strange. In both parishes the plan is to move in a single direction -
each opposite from the other - at the same time, with St. John moving west and St. Charles moving east (Tr. 2671-8&9). Even though there are reasonable methods of evacuating St. Charles Parish eastward (Tr. 2673-2), westward is the only alternative now incorporated into the plans. Similarly, despite good methods of evacuating St. Charles parish westward, the only alternative now available is eastward. This is plat.nea' allegedly to "stop the confusion of both parishes evacuating in the same direction".
NUREG-0654 says this about the primary objective of emergency planning: "The overall objective of nmergency response planning is to provide dose savings (and in some cases immediate life saving) for a spectrum of accidents that could provide offsite doses"...
No single specific accident sequence should be isolated as the one for which to plan..." [ Read into the record by Judge Wolfe at Tr. 2360ff]
14 The primary reality in the plans for evacuating school children and persons without private transportation is the complete lack of agreements to provide for those people in need of evacuation after the parish resources are exhausted.
143 buses are needed for evacuation of residents without vehicles in both parishes (Tr. 2413-20). This is for 5,777 persons without transportation in both parishes. St. John and St. Charles parish have 138 buses. This leaves a 291 bus shortfall that will, of necessity, have to be obtained from neighboring parishes (Tr. 2545).
No agreements with any neighboring parishes have been reached to provide for this shortfall (Tr. 2536).
Madere admits implementing procedures are inadequate and not complete (Tr. 2537). Madere says implementing procedures are never finalized (Tr. 2591).
Madere af firms there is reasonable doubt that bus drivers would drive into St. John and St. Charles parishes from outside the 10 mile EPZ during a major radiological accident at Waterford 3.
Somehow volunteer bus drivers would be transported beyoun the 10 mile
EPZ and allowed to use out-of-parish buses to drive into the contamin-ated zone (Tr. 2619).
15 There are no agreements whatsoever to provide the aged, crippled sick and hospitalized with transportation - buses, vans or ambulances - from surrounding parishes after the parish resources are exhausted (Tr. 2614).
Lucas says that they cannot get people and wheelchairs into vans (Tr. 2501). Madere says that they do not have sufficient vans and ambulances and that they are in talking stages with support parishes (Tr. 2507).
To evacuate the gome bound aged and handicapped calls for 25 vans and 25 ambulances in both parishes (Tr. 2504)(Tr. 2524).
To evacuate the sick and hospitalized in both parishes requires 37 ambulances, 10 buses, and 3 vans. Perry, at 11.
This is a total number of 62 ambulances, 28 vans, and 10 buses to evacuate the aged anl crippled needing transportation and the sick and hospitalized in both parishes. The two parishes presently list resources of 11 vans and 7 ambulances. Lookabaugh and Benton, 14 & 16. Thus there is a shortfall of 55 ambulances, 17 vans, and 10 buses needed to evacuate the home bound, infirm and aged needing transportation and the sick and hospitalized.
16 Findings of facts 10, 11, 12, and 13 are all that is necessary to demonstrate bad planning and unexpected drains on resources.
Great strains on resources - policemen, police cars, and police vans -
during a crisis makes it unlikely that the prison population would receive high priority.
The prison population would receive unnecessary and excess doses of radiation during an evacuation because of this bad planning and unexpected resource drains. Therefore Joint Intervenors believe the plan is inadequate.
17 The bad planning and unexpected resource drains listed in Findings of Fact 10, 11, 12, and 13 will result in unnecessary and excess doses of radiation to the transient worker population i
during an evacuation.
18.
The human thyroid gland has an active iodide transport system which 4
enables it to concentrate iodide so that the ratio of thyroid to plasma (blood) iodide concentrations is usually between 20-to-1 and 50-to-l.
Iodine is essential for the production of thyroid hormones which regulate the me$abolic rate of the body and are necessary for full body growth and normal function.
(Mauro, ff. Tr. 3138; U.S. Food and Drug Administration, Bureau of Radiological Health Background Material for the Development of the Food and Drug Administration's Recommendations on Thyroid-Blocking with Potassium Iodide.
HHS Publication FDA 81-8158,p.1) 19.
The ability to concentrate iodide is not limited to the thyroid gland but is found to a lesser degree in other organs, including the salivary glands, parts of the gastrointestinal tract, mammary glands, and t
placenta. The latter two have special significance for pregnant women, the fetus, and nursing infants.
(HHS Publication FDA 81-8158, p.1 and p.ll)-
20.
A significant percentage of the long-lived radioactivity in the core of an operating nuclear reactor is radioactive iodine. These radiciodides would make up an even larger percentage of the radioactive gases driven l
off by an overheated reactor core, because the chemical forms of the radiciodides in a reactor core are relatively volatile.
(VonHipple, statement
on March 5,1982 before the Subcommittee on Oversight and Investigations of the House Committee on Interior and Insular Affairs) 4 21.
The principal radioactive isotope released in a reactor accidenk is Iodine-131 along with other radiciodines.
The primary route of exposure is inhalation of contaminated air Ingestion of contaminated foods, water, and milk can persist as a means of exposure for days, weeks, or months after an accident.
These radioiodines tend to accumulate and concentrate in the thyroid where they cause radiation damage which results in many thyroid disorders including benign tumors and malignant cancers. (Mauro at 2; Mauro t
ff. Tr. 3141; Van Hipple, March 5,1982, Statenent before the Subcommittee on Oversight and Investigations of the House Committee on Interior and Insular Affairs. HHS Publication FDA 81-8158, p. 7) 22.
While only some persons may actually die as a result of thyroid cancers induced by radiciodines many will require surgery, experience pain and suffering, and be forced to take thyroid hormones for the rest of their lives if a major accident occurs at a nuclear reactor.
(Mauro, ff. Tr. 3141-42; Von Hipple, March 5,1982, Statement before the Subcommittee on Oversight and Investigations of the House Committee on Interior and Insular Affairs)
23.
It is possible to achieve up to 90% blockage of absorption of radiofodines into the thyroid by administering 130 mg of. potassium iodide to an adult (65 mg to a child one year or less) prior to exposure.
The benefit drops to 50% blockage if potassium iodide is administered three to four hours after a release and 'ittle benefit can be expected after 10 to 12 ho. 's for a single exposure.
In case of prolonged exposure to radioiodines potassium iodide will be of some benefit because it will reduce further accumulation. Howdver the most efficient'use of potassium iodide can only be achieved if it is administered prior to exposure.
(Mauro,
at 2; Myers, ff. Tr. 3198; HHS Publication FDA 81-8158, pp. 2-4) 24.
Due to the airborne nature of radioiodine releases, and the inhalation pathway of exposures to the thyroid a number of analyses have concluded that, out to a distance of ten miles from a release point at least, the-i only way to ensure that potassium iodide would be available to the population in time would be to predistribute it.
It is difficult to discern how the l
drug can be made available to persons in the "high risk" area soon enough to allow for effective thyroid blocking unless each household is provided in advance with a supply sufficient for all residents of the household.
(Myers ff. Tr. 3191-94; Von Hipple and Galwin, March 5, 1982, Statement to the Subcommittee on Oversight and Investigations of the House Committee on Interior and Insular Affairs; HHS Publication FDA 81-8158,p.13)
/
r 25.
Potassium iodide in dosage levels sufficient to provide protection to the thyroid gland (130 mg for adults and children over one year and 65 mg for children less than 1 year) has been found so safe by the U.S. Food and Drug Administration that the Federal legend has been removed and i, may be sold without a prescription. Potassium iodide in large doses (300-1200 mg daily) and on a long-term basis has been widely used for years in the management of bronchial asthma and other pulmonary disorders.
In eleven years (1969-1980) the Division of Drug Experience of the FDA has only 160 adverse reaction reported.
Known allergy to iodide would appear to be the only contraindication to its use in a radiation emergency.
(Mauro, ff. Tr.
3156; HHS Publication FDA 81-8158, p.4; Vil'1forth, March 15, 1982, Statement before the Subcommittee on Oversight and Investigations of the House Connittee on Interior and Insular Affairs) 26.
Potassium Iodide U.S.P. is an inorganic chemical that is readily.
available in any pharmacy in small quantities for compounding in whatever dose is necessary either as a liquid or capsule by a pharmacist or physician.
It is a common practice for pharmaceutical manufacturers to temporarily.
cease production of their products until current supplies are depleted to minimum levels before producing additional supplies.
(Perratti ff. Tr. 3260; Perrotti, ff. Tr. 3891-93, Perrotti ff. Tr. 3923)
IV. CONCLUSIONS OF LAW The Board has considered all of the ovidence submitted by the parties and the entire record of this proceeding. based on the Findings of Fact set forth herin, which are supported by reliible, probative and substantial evidence in the record, this Board, having dedided all matters in controverny, concludes that, pursuant to 10 CFR 2.760a, the Director of Nuclear Reactor Regulation sho tid be authorized to deny to the Applicant a license authorizing' operation of the Waterford Steam Electric
.otion, Unit 3.
c V. ORDER IT IS IIERERY ORDERED, pursuant to t'he Atomic Energy Ad t f
i 1954 and the Commission's rules and requiations,1;ased on the Findings of Fact and Conclusions of Law set forth.in thin Initial Decision, the Director of Nuclear Reactor Regulati6n is, author.ized under 10 CFR 2.760a to deny to the Applicant Louisiana Power &
Light Company a license to operate ac any temperature.
Respect' fully-submitted '
Luke;Fontana and Gary Groesch' Counsel for Joint Intervenors s
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A Report Sulamitted To J (ilne G A.
M') :' t'N di Councili:ia n-at -..i rty-New Orleattu, 1.ouiniana 1
liy 11obe r t it, ll a t r i c, l'h.11 l
linvi l.ont:ien t.a l l>u fe rine l'ut <l t
Wi L h isnois t.aitet-Fi:otu The Ecology Conter 01 1.uuinian.t 1: li t it Vme i i, l'h.18 F.nvi s:anrmittal W.* fuose Fund Samuel G.
Up:: Ln i n, M. I).
Caue U: *:t orn Itener ve Uniw iuiLy Schoul of R:dicilie
1ovenLe r 6,
J974
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3. 6 ca rcinogen i c.i t y na t-i on 1:ul :.t.uice.
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e Ti!C I!4 PLICATION OF CAI.CER-CAUSIIlG SUliSTANCES
]Il MISSISSIPPI RIVUl! WATER Abutract The !!inuinnippi River rinus in Mirnianota and flown southward 2350 mi.len to the Gulf of Mexico, draining over 40?, of the United States and part of Canada.
Including its numeroun tributarien, nuch an the Ohio River, it is the receptacle for a wide variety of municipal and industrial unntes.
Many of the indun-tries, including the petroleum, organic chemical, and coal-producta industrien, are known to discharge persist ent carcinogenn into the Minninnippi River.
In addition, chlorination of water during treatment increauen the carcinogenic burden.
Connequently, theno carcinogens are imbibed by millions of Ameri-cans, as has bocn documented t'ocently by the Environ-mental Protection Agency during nLudien on eight cition that receivo drinking water from the Minnis-sippi River system.
In Louiniana alone, over one million people are nerved water from the Jower Mic-sinnippi River or it.n distributarien.
Presumptive epidemio]ogical evidence accumulated by the Environ-rnental Defence Fund with the aid of a computer-assisted ntatiutical model cuggentn a significant relationship between cancer nortalit.y among white males and drinking water obtained from the Minnin-sippi River.
Neither the Environme'ntal Protecti.on Agency nor ntate and local regulaLory agencien have to dato developed adequato programn of pollution abatement or drinking unter treatment to addrenn these problemn, despite the Environmental ProLection Agency's strong recommandati ona to the contrary in 1972, and despite the. availability of inexpensive and effective reuedial measuren.
/
Prenonce of Cancer-Causino Chemical:. in Waler There in little quention t. hat industrial wantou contain
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a variety of potentially toxic cubutance:, which are routine 3y e
e
~2-discharged into our nation's watern despite the recent enact-ment of laws (e.g., Federal Water Pollution Control Act Amend-monts of 1972, PL 92-500) which are supponed to prevent thene discharges.
Over a decage ago, Dr.
W.
C.
lieupe r, of the National Cancer Institute, outlined the nources of certain of thene chemical substances (carcinogenu) which can cause cancer (1).
Some of these are as follows:
1.
Petroleum Products -- Petroleum refinery wastes con-Laining polycyclic aromatic hydrocatbonc, fuel oil, lubricating oils and cutting oiln are being intro-duced into lakes and rivern from garages, service stationn, potrochemical pl :m 8 c,
el' - " t ;_ r,; p l ;: n t c,
'+8-and ships.
Contamination of public water supplien may alno renult from the une of keroneno, methylated naphthalenes and similar petroleum products used as vehicles,of insecticide sprays, or enter water from rain contaminated with air pollutants or from tarred or asphalted roads.
2.
Coal Tar - -
Effluents f rola gan planLn, coke oven operations, tar distillerien, Lar paper planta, and wood pickling planta all contain carcinogeno.
Coal tar, pitch, creosote, and anthrocune oil are kno./n human carcinogens.
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'3.
Aromatic taino-and Ni t ro-Cotapu nc h.
-- Amino com-
<i poundu nuch an beta-naphthylamine, benzidino, and-
~
% * #f 4-aminodiphenyl are known to be human carcinogenc
[P. a,,'
from results of occupational exposure of workers in dye and rubber industrieu.
These compounds along with their nitro-analogues are released by dye and rubber manufacturintj, pharmac. alcul factories, textile dying plants, plantic production, and othern.
4.
Pe n t i. c i d e, lie rb i.ci de, and 3o11 Sterilantu -- Compounds such au DDT, D.i e ld ri n, Aramite, carbon tetrachlorido, acetamide, thionce tami de, thiourea, thiouracil, amino-
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4-s.;. v e,1 <., r e. 'e r.1 u r'; O *' ; ' r n..t. ;. c :, 1:.;p;c /,-l i
.fi chlorophenyl carbamate, and beta propiolactone are kP' J'f\\
capable of eli7it.ing benign and/at r.a lign a n L tu:aoru in various or.Jann of experimental cutimalt..
In addition to induutrial uustun, dic.chargen itom domestic sewage treatment planta may also be recponuible for a variety of carcinogenic nubatances found in water.
in-a rcuent utudy by Jolley (2), f or extuaple, over 50 ch]orinated hydrocarbons were identified in chlorinated doisentic nuvage ef f luento.
Con-nequently, Jolley estimated that over 1,000 ton:. of ';h lo ri n a ted organic compountis ato discharged by ;ewage treat.menL plantu into the nation's waterways annually.
4 I
.9-(l;PA) laboratorien in Cincinnati 1uu. con!irond 1in":e ren u t t.:..
I' rom analyses of five concuunitieu r eceivi ng wa ter e.i ther f r'om the Ohio or Minninsippi Rivers, chloroform concent.rationn were observed to range from 3~/ to 152 ppb (parLn per billion parta of water).
Communities receiving well walt:r, which in gener-ally less polluted with organic matter than in surface water, were observed to have less than 1/10th the concentration of chloroform in their drinking water when compared to communitien receiving polluted Ohio or Missiculppi Itiver water.
From these studies, therefore, it can be concluded that public drinking water nupplica are rou t i nol.v. _c.on ti:mi n a ted viit h..
... ~
carcinogeni_c,,,rd!)2pt ances from induutrial intd municipal diu-
- - - - - ~ ~
charges, accidental upills, runof f I rota agricultural and urban
arean, and from the chlor.ination proccan at water treatment planto.
From analyses of tap water campleu at Nitro, Went Virginia (5), 1:vannville, Ind. (6), Aides, Iowa (7), and several Nebrauka communities (8),' it is evident that carc.inogena and other potentially toxic organic chemicals are not removud by standard wat.or treatment processes and are continual contami-nants of tap water.
The 1972 EPA Study of t.he Lower Minn.inaipti Iti v e r In 1967, the Federal government init.inted field nLudien to l
investigate the causen for the neve re Liu Le and odor probican present in the municipal drinking water supplies and the off-
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flavors of fich caught in the love r liian i un i pp i P.iver Jn Louisiana.
Much of this problem was asnumed to be due to the rapid growth of the petrochemical industry nince the mi.d-1950's.
The survey included analycin of river wa t er, treated drinhing water, industrial wastes, and Lich exposed to the river f rce.
St. Franciaville.to Venice, approximately 250 river milen.
In 1972, the Environmental Protection Agency relcaned the results of this survey.
IIcavy no talu such tu; mercury, a ra c n i. c,
lead, copper, chromiun, cadmiutu, and c.ine were found in waste discharges in addition to pheliolu, cyaniden, and a vide array of organic compounds.
Although time did not permit identifi-9 s%
cation of all chemicals, 48 organic chemicals were identitled g M
in the raw or treated water supplies from three plants --
the U.
S.
Public IIcalth Service llonpital at CarviJ3c, the Carroll-ton Watgr Treatment Plant of the city of I;ow Or.leanu, and the
~
Jefferson Parish No. 2 Water Plant at Rtrrero.
Five of these Cl chemicals found in finished water nupplie:, (al;ilo ro f o rn., hn':a-i chlorobenzene, zv3ene, ethyl benzene, diin : t hs/ luulfoxi.de) were listed as having induced histopathological changes during chronic toxicity studien,on animalu.
Three compoundu (chloro-form, b e n ;: e n e, and carbon tetrachloride) were listed au carcin-ogens.
I' rom the results of th i.a nurvey, the EPA cuncluded that the industrial discharges were the principal cause of the persintent " ally petrochemical" odor.i n the public vater e.
r i
_.g supplien downstream f rou 11at.on Rouge.
And on a more ominous note, the EPA concluded that:
The trace organics in the Minninsippi River drinking unter supp]ien are a potential th rea l.
to the health of the 1.5 million paople who connume thin water, particularly the olderly, those that are ill, and children. (9)
In addition, the EPA of fered rather ut.rong recommendations for corrective action and for epidemiological investigations to determine the long-term effects on humana of ingen ti ng contiuni-nated water from the Mionicuippi River:
It in clear that society must volgh caref ully the expendituren for corrective action, both industrial and municipal, against the costs it'may have to pay in terms of prenent or future health impairmont of its people stemming f rom man-made hazard:,. (9)
A * *
1.
A I t is mandatory to ningle out potentially harmf ul nub-stancen and prevent them from entiering those bodica of waters that will be used for drinking or food nourceu until it in clearly demonstrated that they pose no
, threat to human health or aquatid life. (9)
** * * * :k
Municipal water treatment plantn (ahould) install treatment facilitics designed to (a) obtain optimum removal of organic contaminants and heavy nota 1n and to (b) prov de increased protection of the wa te r supplico from accidental spilln of chemical:. and oil upstream from the municipality's raw water supply intake structure. (9)
Although the EPA did not elaborate further on corrective actions, they did suggest that "continuoun une of activated carbon would probably be required t o remove the trace organien in the water supplien" '(9).
Despite these warnings and k,:
t recommendations, there han in general been no effort by communities along the lo',ter Minnisnippi River to take cor-rective action and relatively little effort by the industrial dicchargers to abate pollution from toxic and carcinogenic substances.
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9._
The New Orle: inn Ca r t o l l t on Ua t < r T r i.i t iu n t Plant f
The Carrollton Mater Treatr.^.cnt PlanL in Ne'./ Orleans in facilition in the typical of most municipal water trea tire nt United States.
It was designed and countrucLtd in the early 1900's, employing latter 19 t.h Cen tury and ea r ly 20th Century tecluiology.
At the time of i tn count.ruction, the najor problems diseases f acing the water treatment industry were wa terborne such as typhoid fever and cholera.
Consequently, a treat-ment objective was developed that has remai ned et son tiitily unchanged over the pant nix decades; carrollton remainn today a facility uhone primary f unction in tc pre wnt the spread of waterborne dineanen.
The t rea t n ont pr w es.nc, at Carrollton were not designed to remove ca rcincipen i c and other toxic subatances.
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~
The present treatment proces at Carrollton includeu per-l manganate treatment for partial tante and odor control,. lime addi ti on for nofteni.ng, coagul a ti on/nedi nan t a tion / fil t ra ti on l
for removal of suspended particles, and chlorination for dio-infection.
Although the average water qualit.y leaving the plant i
technically rnects the U.
S. PilS 1962 drinking water ntandards j.
ca r r i.o r c up;)1y, the L
and is approved by the EPA an an interntate PilS standards can only be enforced to protect against the spread of con'municable dineaces, and not to protect against toxic chemicaln.
l'or these reanons, the t!n i t ed St.. Lou Congress is e
considering corrective leginlation and the El'n i n currently re-vining the standards to eliminate the inadequacies of the 1962 1
(
Pub'lic IIealth Service n tandards.
Therefore, compliance vith the 1962 Public licalth Service ntandards can in no sense b_e taken an a gua rantee o f saf e ty_.
From an exci:tination of the operation of the Carrollton the following can be concluded:
plant and its operating records, Current treatment practices are inadequate for the (1) proper control of toxic organic compounds which 1
f enter the water through municipal and industrial runoff from agricultural regions, discharges, j
and chemical spil'ls and accidents on the river.
(2)
Despite E?A recommendations to the contrary made
'~'
for toxic in 1972, monitoring is still inadequate noth :Ould l
oufudc c' e. icals c..d hca.f act:12.
l be expected to vary daily, and samples should be 1
I least weekly at the consumer's tap.
taken at
,1 The nodiura concentration in the fininhed water (3) frequently exceeds the recorraended levels set by the American IIcart Association for patients on a l
y restricted-salt diet.
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The present practice of reducing hardness is prob-
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M.
(4)
- Q ably not beneficial, and,in fact there is strong 4,.-
s that it may be detrimental to the con-
,.e Q'
evidence l
A number of studies in Canada, e
sumer's health.
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Sweden, The Ne therlands, South America c
k creat aritain,
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Japcn,
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in t h i s, c<.unte-I m.<e
'myyt..1 < d that the r.o ! t e r t1
.tter the h i '!.
t t.hu i n e i.d en ce of elin-e n n e:. of the heart and ciiculatory.:ynten.
(5)
Ity reducing hardner.: vi ! i. 1 i i: e.uldit ion, the p!! of the valer delivereit tu tin ei,. ni i. 1 generidlyexceeda f.
.Qle O.
Thin ;,h i n excep t i < n..< 1 l y n'i gh co..pa red t.o
.ocL connuni t.y drin';ing uale: ';oppli' in the Un i. t.ed S t:a t es, al t hi u,Jh t he t. - at.
av i u, ;n hea l th ell ec tn nuncelated u.ith th i s c' >;ai t t. i on.
Ilowever, a p!!-value as high as 10.co u hi lo.c r 'he <-l1iciency of the t matrent
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t e r i e.1 pa ' hr e n n a.
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( N. ; i e i. [ y 3.'. I 1:
()) !~t ' r Iilt: ) i.O ! l U;i i
in fire
u t,t e t i e;n i '.1 t,
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.e sp; } ]: in : ;u ri: :ir i; pi se a.: !.
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the by p.,
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I n con e l u:. i on, Ihere *:ee
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cit- :t;on t h. i '-
Ca rro.1 i t un.i t
.in a n t s i n.. l. i! vf a t, i
( :,.it..
n: pl.ui t a l t. a ;, ( i n g i
ta cope.ti th.' tith cen i tiry problern. i s u t.
h.:uiicapped vith 191.h-ce:i t.u ry tecluic>luey.
Jn the ah*.
n-of procedure. to r etc.o v e toxic chenicale.. n d.i n the o!.:. a r.:
<>l eli nin fect ion
't practice.. which do not l'ivduce toxic ib
.itatn, tht c.itirot
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of NOW Orl ealt., can l>e...
Ured oj thi j1v-a..te O l' carcinogt:: ale
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.1 11 l h e 5 l' d! 1 i d.11 DJ U.11 t ' f' 1 I6+1! I la1 t ) y, ol Unl11 [ 8 ro'
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llit-r I 'J. ' E ttad 10 T ei.io Vs* like T el:la Ili n t] L O X.k C c!le M'l t l l !.
al t n, s Vi. s ! t ' r tI.' ' t !.M 'n l [al1 nl.
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l 1.ikely Pluctua t ioru, a n Ty:,e. arul Ouanti t ies.
Of Carcinogen:. in it.u.u i r u iij>T 1:iver Ma t u r l
l It can be expected thal both the typer, and qui.n ti Li e:.
of carcinogens in the flinniusippi. River would vary, probably on a daily basin.
For example, many inductrial proconnen are scaccinal, others are batch operations, and both practiceo would lead to intermittent waste discharges.
Coupled with
- seasonal variations in river flow, runori from urban areas, runoff from agricultural regions during the growing season, and spillu and indus trial accidenLn on the r.i v e r, these intermittent operations practically guarantee that there will be vide variation in the concentration of chemical con-taminan ts in the river at New Orleans.
Inadequacies of Current EPA Testing Progrou In the 1972 EPA tes ting program, the proceduren nued to meanu2:e organic chc micalu in the drinking water cir. ployed the "mega" nampler, which unen activated carbon to remove and concentrate t.he organien, followed by extraction and analynis using GLC-Mann spectroscopy.
Th t' New Orleinu. drinking wa ter supply was fi rs t nantpled in January' of 1970.
The current l
EPA tes ting program uarapled in July-Augus t of 1974.
In addi-tion to uning the "m.cga" saapler for thin mont recrnt canpling program, the 1;PIs has indicated (10) that addi tional cumples will be obtained and analyzed usinq both a Jiquid/]iquid s
9
e x t rne t i.,nn,J>rocede:en. n.d.a ur omnon i n extraction pro-a ri"/e i ne N
cedure.
The several shortconings of both OE t hene EPA testing programa can be summarined an follown:
(1)
They reprc nent encentially a " grab sample" and therefore are not indicative of the long-teru exposure of concua.orn to careinogens in their drinking water.
Va ri a tions in the Lind:. and quan ti tie:. (discunned above) of carcinogens in the river will not. be treasured.
The r e '?o r e,
it will be impossible frou the resultn of those testing programs to determine an average body i
burden of these carcinogens for New Orleans residents.
IIoueve r, even if precise quantitative and titre-dependent data vero n:ade available by these l
testing programu, it in unlikely that defini ti.ve conclusions could be reached regarding the cancer k
hazard (this will be dincut.:ed further in later sections).
(2)
The activated carbon (moga s ample r) p ro ce d u rer.
have been outdated and should not lee used an un analytical procedure for determining c;ircinogenc in wa ter.
Activated carbon may not trap every carcinogen that is present and those carcinor; ens 1
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h. !
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which are trapped may not be removed and ana-e t
lyzed during the extractio:
procedurcu which follow.
Therefore, although activated carbon proceduren will measure many compoundo, 4
they are likely to miss others.
(3)
There is incomplete information on the nennitivity and extraction ef fic.ioncy for all of the compounds that are likely to be present in Mississippi Rive r
?:
9 water.
i i
(4)
Certain classes of carcinog.:ns, in particular poly-l nuclear aroma tic hydrocarbon:,
(Pall) will probably be minuud by the analytical procedures employed by the EPA.
Pall are poten t ciarcinoaorm a ml + 1 " i >-
i ubiquitous presence in polluted drinking water supplies has lead the Ucrld llealth Organization to octablish standards on 6 of these compounda (11).
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_. _,. _., - - - - - - - ' - ' - - ' - - - - ' ' ' - " - * ~ '
~ uhen administered to animals or imm mn, incroano the piobability of tumor induction.
Carcinogun:. may arL at tho site of initial I
contact, at the site of selective organ localization or acctuaula-tion, at the site of excretion, or at the site of metabolism.
\\
j Some carcinogens act at single sites only; olhorn act at multiple sites.
I I
Low Levels of Carcinogens in the U n v i. r o n m.2 n L l
There is now growing recogni.t. ion that the majority of u
I huuan cancers are due t.o chemical ca rc i. n ocytnu in the environ-ment, and, there fore, as concluded by LI.e World IIcal th Organi-
"... p,o t e n t i a l.l y_ prevent.able."
Estimate: by zation (WHO) are the WilO, the National Cancer Ins t it ule (UCI) an-
~lous concer skiocialistssuggest that somewhere between 60 and 9". of human
['cancersareenvironmentalinorigin.
The basin for these t
estimates largely deri.ves f rom ep.i demi'ological s tudies, in large 9
f community popula ti.ons over extended periods, which have revealed vide geographic variations in the inci.dence of cancer oE various rgans (Appendix B).
Although less certain t.y e::i.s ts of the 1: ole of most environmental contaminants in human cancer th.ut say cigarette smoking, drugs, and occupational airborne particles, a recent presidential panel concluded that:
Cancer incitements by no far unrecogni.ned ehenical:.
combine to form a t h rea t.
to health, that 1.uy we l l be j
of at least the same.jeni ra l ;i ze as the t bree :wjor a
threats juct des c ri bed
[i.e.,
c.i q a re t. t r :a..ok i n g,
alcohol abuse and choice of dietary composition).
l
These chemicals may be natural or.iyntheLic.
m:
un a.l.
l Although most of the evidence,for the effect. of environ-mental carcinogens on man has come ui.th industrial exposu$c to high levels of these carcinogens, most cancer experts insist
)
the low levels of carcinogens to which the general popula-g}
that
/
7 4
tion is exposed are responsible for the majority of human cancers /.
7_-
Although others would argue that the levels of these chemi. cal in the environment are too small to be of significance to the the scientific evidence simply does not general population, support this viewpoint.
For example, the chemical " aflatoxin" s,'.
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is known to cause cancer in man, and in experiments on trout, it was shown to produce liver tumors'whei present in feed in -
me__ w ne__.enn n,rs. mer _ trillion ;
even at this 1
w..
u.,,,,
low level, its carcinogenic ef fect was enhanced by addition of various non-carcinogenic oils to the diet (Appendix B).
Similarly, dieldrin (a chlorinated hydrocarbon) has been found 100 parts to be carcinogcnic in the lowest concentrations tested, per billion.
Therefore, lacking scientific evidence that a the ad hoc threshold existed for any, chemical carcinogen,
t. ;..
Committee on the Evaluation of Low Levels of Environmental
bN7
' Chemical Carcinogens reporting to the Surgeon General in 1970 iNP y
7 '.'
concluded that:
.n t ;
No level of exposure to a chemical carcinogen should y
(12)
, (,
be considered toxicologically insignificant for man.
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.18-Carcinogenicity Data on Substances Found in New Orleans Drinking G
Water Among those compounds found in the 19721:PA study on treated l
drinking uater supplies in communities in the lower Mississippi River, carbon tetrachloride, chloroform, his (2-chloroethyl) ether have been shown to be carcinogenic in oral feeding studies using animals.
Although bis (chloromethyl) ether, a known human carcinogen, was also listed, it is suspect since this compound
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~
is extremely volatile and it is doubtful whether it could be stable
',.t A fif th compound, benzene, lias been shown tio increase
'in water.
the incidence of leukemia and lymphoma among occupationally c::pec ~.8 t.'O.9 e r e, hne han hnen inadeauntely tested in ora.L feeding studies.
Five additional compounds afe 1nmpee-teda(,
being carcinogens and have been included in the.on going large-scale carcinogenicity testing programs sponsored by the National Cancer Institute (Appendix C).
Therefore, except for benzene and 'possible bis (chloromethyl)
~,
cther, human carcinogenicity data does not exist for the
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compounds found in New Orleans drinking water, and it is there-
' Jy t fore logical to question'the appropriateness of applying data i '.
7, obtained from animal experiments to expected human response.
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In casen like this, determining whether a carcinogen causes y:'
k.
cancer to humans in difficult, since the lag time between y;,
exposure and onset of malignance is usually measured in~ decades.
~g.
4 ey 3
).
F.
[ <,
1 1
(
not possible to predict safe levels of carcinogens based on data from animal experiments.
As !!EW Secretary Fleming I
stated some 14 years ago, " Scientifically, there is no way to Q r}'
d determine a safe level for a substance known to produce L
L, cancer in animals" (Appendix B).
a ':
Cancer Mortality in Louisiana' and Its Relation to Drinking Water
. c.,g.
+ 'dn
/,:
Considering the incidence of human cancer in the United I' #
there ic'little question that wide geographical varia-
States, tions exist as well as variations among othnic and socio-economic groups.
For example, bladder cancer mortality rates f,
are higher in the northeast and lower in the south (Louisiana is a notable exception).
Bladder cancer death rates are also higher in Protestants and in lower or middle socio--economic groups and there is an increased risk in cigaretto smokers.
f':
Using data collected for the period 1949-51, the U.
S.
47 o R 7, Public Healtli Service Report on " Comparative Mortality Among Metropolitan Areas of the United States" listed New Orleann as 1
[.
.g
,T,-
.the third highest of 163 metropolitan areas for mortality from Xh
/g kidney cancer, Gth. highest for cancer of the bladder and urinary u,
Y' organs, 9th highest for cancer of unupecified digesti.ve organs,
.x-t
~6, '
and lith highest for benign and unspecified other kinds of
9 * ~,
cancer.
New Orleans was also listed a:, having 2.6 ti mes the
n. c.'. ~.
1D, pt-c M
c.V
.{ '
M.
(
a.
a. -
national average mortality rate for tongue cancer and 3.5
< times the national average of cancer of other parts of the mouth.
V The last comprehensive survey of cancer incidence in 4
New Orleans and other major cities in the Uni.ted States was t
prepared from data collected for the period 1948-49 (14).
s Compared with 9 other major cities in the' United States, New ty.
M, Orleans ranked second in incidence of all cancers, 25% higher d.!G:
7 than the average for the 10 cities studied.. Dallas had the
. v:
highest incidence of cancer, largely due to the extremely n
/
high incidence of skin cancer.
Compared with the three t
[
other southern cities (Atlanta, Birmingham and Dallas) inclucca in.tnis survey, tiie lucIdenou vf unuovi. vf U.u dige.s 4
, 4 j -
tive system uns 42% higher in New Orleans, while the incidence of cancer of the urinary organs was over twice as high in o
New Orleans (bladder cancer rate was I times higher in How s
Orleans).
Compared to the other 9 cities, New Orleans had
,c
'a higher incidence of practically every type of cancer except 7..-
cancer of the digestive system and cancer of the brain and nf.i -
N, nervous system, as well as a few rare cancers.
-.i
?>
y:7 Recently, the U.
S. Department of, IIoalth, Education and
[0
Welfare has published a comprehensive study on cancer mortality 3
3G titled "U.
S. Cancer Mnrt ality by County:
1950-1969"-(13).
~
h(?[q, i, jL As can be seen in _ Table 2. ranking counties by cancer mortality y,
ij.3:
among white males, nine Louisiana counties are among the top o
I.M r
. }yY l\\a x
.: (
N j
45 counties in the United Staten.
Comparing Louisiana i
and New Orleans with average U.
S. mortality rates (Table 3) it can be seen that New Orleans, the third highest county for
(
cancer raortality in the United States (230/100,000), has a I
321 higher total cancer mortality rate than the national
~
average (174/100,000).
Similarly, New Orleans is seen to have a 69% higher respiratory cancer rate, a 351 higher rate I
of cancer of the urinary organs, a 322 higher rate for cancer (t.
of the pattercari, and a 53% higher rate of cancer at unspecified
~
W qlz sites.
The average cancer mortality for Louisiana as a state
.b is also significantly higher than the U.
S.
average.
i i Considering the earlier data on the incidence of cancer i
in New Orleans, and the mo):o recent data on cancer mortality n
by parish (county) in Louisiana, there seems to be little question but that certain locations in Louisiana represent
" hot spots" for cancer mortality.
In view of the debate over whether or not carcinogens in Mississippi 11iver water I
are contributing to this high cancer rate among Louisiana re siden ts, the Environmental Defense I'und, in cooperation with Dr. Talbot Page of llosources for the Future, Inc. (a Washington-i
e. '
based non-profit research organization) has conducted an c
epidemiological investigation of the causes of cancer nortality Y'
n i
in Louisiana, with particular attention to the importance of
(
4 b
drinking water an a causative factor.
i; I(f q^k.
/ -
Tc 1.'iY I +
1.
7,(,
1',
, b $'
p
It has long been recognized by epidemiologists that cancer rates vary according to social, racial, and economic considera-to
'tions, which undoubtedly reflect differential exposures i :
carcinogens caused by difforences in dietary habits, smoking and drinking habits, occupational exposure to carcinogens, urban air pollution, and others.
Provided that there are clear differentials in exposure of the general population to specific h
s N.3.
chemicals, epidemiologic techniques may then be abic to correlate certain cancers with certain chemicals or groups of
, a chemicals.
With regard to carcinogens in drinking water, this condition appears to be satisfied in Louisiana (Fig.'l).
For residente, c,f 11 pc.rishc.c cut of a t tal the puol duvude or more, of 64 parishes in Louisiana have been receiving part or all
$[c of their drinking water from the Mississippi River (Table 4).
) e -
This represents approximately one-third- (over one million people)
f. a,'f '
g, i i Q,l -
Table 4 -- Louisiana Parishes and Their Approximate
[jff 3G Population Drinking Water from the Mississippi River l{., s,!?. ~
k h
,' Parish Population Population Served Percent of in 1960 Water from Miss.
R.
Pop. in 196
'(hy-t L Served Wate in 1960 7 'r from Miss._
jN[(f, (W)
W Ascension 27,927 7,750
287, p((h.
Assumption 17,991 15,000 83
.. f.
Jefferson 200,769 208,769 100 Lafourche 55,381 53,135 96 4
f I.yF v Orleans 627,525 627,525 100 i Yi Plaquemines 22,545 22,545 100
MI> ' s
.St.
Bernard 32,186 32,186 100 7'@
St. Charler 21,219 21,219 100
$ ' 6
St. James 18,369 14,220 77 81 St. John Baptist 18,439 14,930
$[fk't St. Mary 48,833 29 850 61
%p@T;(
1 Total 1,047,129
[.
g(f-1 A.;.
.. ~.,
fv bhN than mortality data as more sensitive indicators of the possible v'! A.
ffYb effects of drinking water, if such data could be obtained or r
4: #E M)/-
developed in the future, yi, -
i. c Py,
Ny '
Ituferences 1.
7[r ([,
l.
Mason, T.
J.
and F. W. McKay, "U.
S. Cancer Mortality by 0-County: 1950-1969."
Di!EU Publication !!o. (MIII)74-615, n.3.h.
National Cancer Institute, Bethenda, Maryland, 1974.
f n'"'.
2.
Goldberger, A.,
Econometric Analysin.
John Wiley, New York,
. s.
}J, 1964.
gyy,
'A,%,.
3.
Malinvaud, E., Statintical Methods of,Econometrica. Rand gy McNa.1,1y and Co., Chicago, 1966.
d..U
' j'.
4.
" Inventory of Municipal Water Facilities," Environmental V'
Proteutivu Lu envy, iiuohingtvu, L.C., 1963.
5,
'[d..! -
5.
" Waterworks Warning Network Plan: Lower Minninnippi River,"
Division of Public Ilealth Engineering, Louiniana Stato
' /,,
Board of Ilealth, June 8, 1960.
6.
" Social Characteristics of the Poliulation, Louisiana," 1960, j
Table 82, Bureau of the Census.
'W 7.
"1972 County and City Data Book," U.
S.
Dept. of Commerce.
.y.h 8.
" County Business Patterns," U.
S.
Dept. of Conauerce, 1962, g.
pp.67-115.
4 s
,.=g
~.
l
'n;l;.
9.
Schneiderman, M.,
Personal Communication, Oct. 24, 1974.
l
(
i
,(d'
/
0,.
')
h!-
l
?
.8 e #-
's.
9
[ ',.
9 i
q':.,t_
s
,e
.s *+.
kY l
([N c
.1
.s,.
/ (e For example, a nyni ficant relationship van found over the 64 parichen in Louisiana between total cancer mortality and urbanization, income and drinking water from the Minciunippi
/
Iliver.
An interpretation of the results would suggent, for example, that if New Orleann, which obtaina all of i en
[,
drinking water from the Minuinnippi lliver, were to either treat
.t.
'lM its water to remove the carcinogens or suitch to local ground water free of carcinogens, in the long run over 50 premature l 5 '.
deaths from cancer among white malen alone would be averted I
L' annually.
Thin vould represent a reduction of approximately e
15% in the cancer mortality rate among white males in New Orleanu.
Simi. la rly, extending this analynin to consideration of cancer mortality raten by, nite, significani. rela tionnhips uere found in the following:
k f
l (1) between nortality from cancer of the urinary organs r
(bladder, kidney, etc.) and drinking water from the j
a
.s.'
Minnissippi River, urbanization, and occupation in 7.,y[7 the organic and inorganic chemicals industry.
t
,3
-. b.,',+. '
(2) between mortality from cancer of the gantro-i b.'.>
. ^L, l intentinal tract (stomach, lItrge i nten tine and rectum)
..L '
and drinking water from the Minninnippi 1:iver,
dpi, urbanization, income, and employnent in the organic
[tk.
and inorganic chemicaln induntry.
y%...
l
,f ~.
m p ;'.
9' th
' er.. 'r,i i t e(.'[
m.s l
1
a
(
,?
y o
y.;,
(3) between mortality from cancer of the respiratory
.a
.M system (lung, e tc. ). and urbanization, but not for
.ro N. -
drinking unter from'the Mississippi River or occupational,
rn
~'
,['f exposures (although the petroleum and coal products industry variables were almost significant).
(4) but not between mortality f rom cancer of the liver and any of the exposure variables, including drinking
'E water from the Mississippi River.
In conclusion, although EDF's statistical analysis is a e
Y = h,
.9 modest, small-scale study, its results raise serious questions
, v,
P ~ '-
about the safety of drinking water.
It is known that there are
'
iY carcinogens and suspected carcinoc' ens in drinking water; it is
';.?
known that most of those substances slip through the treatment !
s process unaffected; it has recently bacn learned that some of
)
them react with chlorine in the treatment process to become
]
.N more toxic.
The remaining question is whether or not these l '.
-t[W substances, singly or in combination, are in sufficient con-w; ayC contration to produce a detectable increase in the risk of.
W
'y+p G,.$l,y U
cancer.
It would hardly be surprising to find that the answer f?
is yes.
The EDF study does not prove that even the most
[$R,'
industrialized water is carcinogenic to humans--not even the
$'i
$.: f d
raost massive statistical studies could do that.
What statiutical, kQ[u.'
//I$ '
cpidemiological studies can do is becomo more convincing as
$QN yg?f
!,&.R *.*
Y
?.
gg
. m.
e ima ei
- _ _ _ _ _ _ ~ _ _ _ - _ _. _ _ _ _ _.
(
1
'[
they pile up.
It is nunpected that furt.her studies will bc able to refine the data, modify the interpretations, and add to the evidence one way.or another.
0; hat scens to have been clearly demonntrated, however, is that it in no longer possible,to take for granted the safety of 1rinking water which has been obtained f rom polluted sourcen.
' E g.
af.'
{..
l1,$ -.
6 4 4 f
4 gf 1
e 0
O e
J N
(4 4e 9
'F
1-.
r
+
1.'
.2-e t
t
t
. J n.
t I.,
\\
v procedures (accidental spille, ugricultural runof f, etc.
will still threaten uater supplied, municipal drinking unter
..~
' '.k '.,
treatment plants in Louisiana musi:5 instalJ techno. logy de-signed to remove carcinogeh's.
Cer tain trea'tmen t proce'aures, through activated calbon have been Uemon-such as filtration in ro. oving a wide variety strated to be effective (17-21) s 1!
of potentially toxic chemicals and hava 6een shown to be
' r inexpensive in the more than 40 municipal water supplyD>1dnts i h.,
w....
ir 5
)
(including the City of Ilouma, La. ) that have adopted this M
procedure.
These general principals have been endorsed 1.
$=
rec'ently by Frank M. Middleton, Deputy Director,. National p y,v.
Environmental 1:esearch center, Environmental Protection Agency,
.n i
f Cincinnati, Ohio.
Speaking before the 15th Unter Quality Conference at the University of Illinois (22), Mr. Middleton suggested that:
While identifying and assessing the heal th e f f ec ts of organics must be continued and accelerated 'our treatment and control procedures for organics should be the best possible.
The municipa) water M?-
treatment plant is the last barrier between the consuner and pollution and every possible maans must 7,
be taken to assure a safe and palatable water 4 "l Considering the quality of unters in,use for drinking y'
water sources, one can be uneasy about.the safety of M
the final product One can wcl1 ask1the question:
Should any public water supply derived from polluted
,b,*,
sources be vended without being treated' wi th activated carbon?
Although carbon is not a universal panagia, it does have a high capability for adcorbing.those 1
.p organics that are of greatest concern.
The' tbken
~
1 application of a feu parts per million c>f carbon is 3
d,e.;
not necessarily suf ficient.
Cood technology exisLG
~
r for the use of carbon in beds and columns along wi'th If,[\\
reactivation and reuse.
^n; f
j 69,
/
7 73 i '.
un
l-
In view of the health hazards which exist from present levels of carcinogens in Mississippi River water, and con-
~
sidering the availability of incxpensive and relatively f
'[ s ef fect.tvo procedures of reducing the levels of hazardouc chemicals at indust. rial out,f alls and at municipal water a
the following are recommended as a prudent i
treatment plants,
action program:
Public 11ealth of ficials in Louisiana should inuae-
.s 1) 1 f,h diately issue a warning io every conuaunity re-ceiving its drinking water supply from the
~:, "
Mississippi River or its distributaries that a health hazard exists from,the chemical carcin-t.
ogens present in the River and f rom chlorination addit.ional carcinogenic procedures which produce compounds.
Con:aunities receiving drinking water f rota the (2) j y Mississippi River should determine the availability i j 4,
of and monitor for the quality of alternative e,
cources of drinking water (including comnercial I
r" ::
bottled water) and report these results to the M d....
3
. :1 public.
W['
These communities should further institut' rrograms
'( 3 )
hs,: '
to ancist lower socio-economic groups in obtain-2 h?*
ing water f rom higher quality alternative sources v7 W p
e. g installed or a ;,a '
until treatment procedures are i
t KQ '
D$(,.
. s,:
wo
/ -
n
(
alternative sources of water are found for the community at large.
(4)
The state of Louisiana in cooperation with the Unvironmental Protection Agency should initiate an if, l accelerated program (less than a year) to dator-mine the best available treittment technology econom-L ically achievable for reducing the levels of s [x.
cancor-causing organic chemicals found in the s
, s.
Mississippi River or formed during treatment.
Since it is not possible to determine threshold s
i levels for carcinogens, the principle of "wro I
toleranze" should be adopted, and treatment i [
processes should be prescribed that reduce the l
levels of carcinogens to the maximuu exten t feasible.
The State of Louisiana in cooperation with the I
((5)
Environmental Protection Agency shr.uld review State and Federal Water Quality Criteria in order
f. r. ',, '
to determine their adequacy in light of this new
+1
,7:p.
s,,t. j.- '
information, and they should review discharge J ' ! '.
v. t.
permits for all industries in t lower Mississippi p,e. ;
I' ' $ ' '
Itiver systela for purposes of determining compliance with EPA policies and regulations for itaplementation l,7,[,.
i 3 q.>.
., Nl of S307 of the Federal Water Pollution Control Act i t *p5:.
y g: ty j*%
.N,C-f1[!.
g. v
( ;;. %. f,-
Y 8
b
,s
>~,.
- 1. j pl..
M h
eli e Anondinent of 1972 (Toxic Pollutant Section).
r;.). ~ d
. N..
the EPA should develop a list Furthermore, Gy -:(
',( 5 '
of carcinogens and suspected carc.inogens under
)
f;307, and establish zero tolerances tor their discharge to water.
- s.
y h,.
,6)
The EPA must begin developing a regulatory strategy for the control of industrial and
~.
7:;i.7.'
municipal discharges of carcinogens to water c;t. }'[>
that places the burden of proof on the pollutcr,
}$;/'.,
^
.. yN."
rather than on the EPA.
Otherwise, it will bc
p..v/
impossible for the EPA to keep track of the
' s n t ;. -
hundreds of new chemicals developed annually
f. ',*. '
u ine alnno Hin thousands already D I,
...,., _.i...
3 !.' ', ',
in production.
. ^4.t '.
r.,
'S.,
r' g
-i _ q
.I '
,9_
.2 k,.] 4,
.... +
b & '
3
. y..
d.,,
s b + $..
3 y
e Ih a
d.h Ttt,.'.g
1. *' ;
sG,
'tv <
. g,YO..h..%'?,{
E$ h
?.
., o D 1..
, 9' 5 ' * -.
d am -
g-
.h,.4_~
p
/4, *
.s APPENDIX A s
i
i..
(#
l ',.
Statistical Analysis of
.n; *
(,-
Cancer Mortality
.1 In
.:t;' t.
9 1;f,',.,
Louisiana
,,, n,
,' (f.b',e
J. :; n.
~4.43
.% h [$... '
...y.~
v. r.,..
2.s c
'u.
..f:
N.'.,
> r,.
.g ' +
g4
,i.
7 o
Y(~,'f '
Dy S.M h *;
' r.'s '
X.M... J' Talbot Page, Ph.D.
L b:,
Itosources for the Future, Inc.
( b,. '.
3(.
And
??. M -
td3 Itobert H.
liarris, Ph.D.
's 3; i' i '
Environmental Defense Fund
,qq,e
u., ) ~
fh.,.
november 6, 1974
's. 3
+
Y
!.i 4 '.
g
'. c s. -
ee I f.
4 g
,o m17
q h
', i.'i.
,~U.
q.. s,
ej 4
r
\\ ;.., ;
/ re ;-
)ff
. 1;
,; rg APPENDIX C e,...
Carcinogenic 1ty I...,t ':4 :
0t f ', a*9.*
'Vf,,V.
Organic Compounds
,a
[.[a. e. <,.
f'[ ~
Identificd in Mississippi River Water 5
T
.c.4 -
a
4 I,
's Y,,~
Y-f.
t *
.4' Tinc.'-
1 oe O
?
\\O,.
8 s
9 b
h"m., *
c w.
,-q [,,
p. t - 9
( ' rA
~
s
.?
ofty;
! ',5
a
'[-j 'a[ <
>..?;.
t ny
..s, naiu1 zipser vermeij, Ph.D.
bDV UCUMcN O O *
,,~..
y :' $;, > > -
i 4 + 4 r.,
de,4 7,' 'r,
n ;
.(h s s N'%.,
.s.
f, f. 4..
[ * '
..fY.!.
.h b :
g
g i
m._
f J
J 2
1,,
4".'
Cornpounds Investigated for Carcinogenicity With At Least I.
One Positive Result _
r 6,
w BENZENC
. e i
^,
Carcinogenicity of Ben".one.i,n Humanc 2,
.e The evidence for benzene as a hum?in. carcinogen consists and of retrospective epidemi.ological reports of leukemia
o s.
[.
lymphoma, incidence among patients previously exposed to ben-
.m
P,I zene at work, or of reports of leukemia cases in individuals
-y
d =
exposed to benzene.
Most of these reports do not involve either a'large number of unbjects or a carefully matched control o*
I
"~'o-an incidence of leukemia and lymphoma among group.
workers exposed to benzene appcars to be unusually high.
t t, Epideniological Investigations Cases of leukemia associated with benzene exposure in l
l l
two Italian provinces have been revicued by Vigliani and Saita (1964).
In the period between 1942 - 1963, 47 patients with j...q, blood disorders attributed to benzene were seen in the Clinica
' 'T
,[-
de Lavoro of Milan, and 6 of the 47 developed similar hemo-cytoblastic, undifforentiated stem cell leukemi.ac.
concentration of benzer.o in air to which the patients The
.s.
0.60-2.10 mg/1.
tY;,'.
were exposed was reported only for one patient at I,
l ', jl Pigures were also g,iven from the Institute of Occupational
.e
[(/
IIcalth in Pavia.
Porty-one cases identified as chronic benzene p.
\\if
m,
.tp.,,
m-
.g,.
n.'.s
, n. P u, -
4.s ; ;,
-(.
][s.Vii '
g: 1,h g 3 -
') e..
.l BIS (2-CllLOROETIIYL) ETilER p
'a I.h; '; ",
g.4.
o..
. Bis (%--chloroethyl) ether,(also known as 2,2-dichloroethyl e,."
E Q
~~
Q(,
other) belongs to'a family of compounds, the chloro-ethers, The which includes several alkylating agent carcinogens.
W//
4 chlorine atoms in bis (2--chloroct'hyl) cther are situated 2 carbon
. g< ;p h,.b atoms distant from the ethe~r-group, in the 2-or " beta" posi-
-e Related 1-chloro or. alpha-chloro ethers', which have Q:-..h~5. tion.
i
$ 3 Sfk
...chlorino atoms on the carbon adjacent to the other group, are Tyb: '. sthe most chemically-reactive and. carcinogenic compoun s d
in the WW Q;fjNf:
I.
.. ?
L qg )
family.
Bis (chloromethyl) ether is carcinogenic to mice. and y 1, ~
Uf 9 -
rats (Van.Duuren, et al. 1972, 1969) and probably to humans-m
+
, -(.,"...
(ICAR Monographs on the Evaluation of Carcinogen.tc luss or
.. j-Jy '
Chemicals to Man, Vol. 4).- Ilowever, the relatively-high chemical
?
r ~
reactivity of 1-chloro others loads them to decompose rapidly
'C I; h sN f
in water.
The 2-chloro compound-bis (2-chloroethyl)cther,
(v s although h wecker alkylating agent and possibly a weaker car-d$
w
,8 $v -
'cinogen than its relatives, persists in water and has been n&
m ?{ y reported to be present in finished water from several commu-p?!h Q
i.?
nitics in this country and abroad.
Epp %
ig,WFI,P W if Ey.porimentalCarcinohenicity, b
.lf.y[!%,
}j.if 99,g$ j Oral Administration NMf81 h.
A survey of the oral' carcinogenicity of 120 posticidos and t wu.
f E;I 4
4. b,,M industrial chemicals in mico found bis (2-chloroethyl)cther to
.(.
I I
6
% w.-.
hD c,j[+ *[
um.w
a *
.:m -
_C ll L O R O F Olh'_!
In Lhe opinion of Ihe ICAR work ing group on the evaluation of the carcinogenic rink of chemicals to man (LCAR Ilonogipaphs, Vol.
I, 1972), the c.tecinogenic potential of chloroform has been inadequately ov.tluated and no extrapolation of the carcino-genic risk poned by chloroform to man could be made in 1970.
The carci.nogenicity of chloroform has been intestigated only in mice, in experiments involving a small number of animals
~
Neverthe,less among these the frequency of liver tumors was high, in one cane wil.h all nurviving animals affected.
p:<oe rire n ta) Carcinogenicil.y of Ohloroform Oral Adminin teation The only two papers located which denct.ile the offects of orally adminintered chloroform report the forn.ation of liver tumorn or hepatoraan in mice.
In a dose-reuporne study by Eschen-brenner and Mi.ller (1945), groups of 10 mice woro given 30 oral doses of 0.1, 0.2, 0.4, 0.8 and 1.6 ml/kg of body wt. of chloro-form at 4-day intervals.
All mico receivi.ng the highest done died before termination of the experiment 150 days af ter first injection, but all the rai.ce nurviving t:he next highest donos of 0.8 and 0.4 mis /kg (4 and 3 femalen re::pectively) develope'd hepaloman.
I!o hepatomas were observed at the two lowest doce levels or in the controln.
I
~
mentioned here; at the time of writing either no ci.Lations had yet been found for theni in the parver vo:'umes, or, only rather inadequat.e studies (e.g., expel:iments with very few animals or lasting only a few months) had yet bgen found cited.
This does not mean that no other work han been donc on these compounds.
The following compounds have been contr.tcted out for large-scale carcinogenicity testing, according to Dr.
S.
Siegel of the National Cancer Institute.
No resultu were available to us in the form of " final reports."
Compound Project;od Dates of Study Blu (2-chloroe thyl) c ther 2/4/69 2/4/71 (?)
Din (chlo rome thyl) o ther 3/72 Chloroforn 3/72 2/74-1-2-Dichloroethane 4/72 5/74 Tetrachloroethyleno 6/72 9/74 Toluene 1,1,2-Trichloroethane 5/72 9/74 Styrene 1/73 3/75 ACETOMM Consultation of the ;)urvey of Cogyninds ylhich Itavo noen Tes ted for Carcinogeniqi.ty through 1971 ceveulu that acetone id
,o.
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& : DC\\(dNS DE WW %9CLR -l 9 N ll carsonm e 9-A6twoa1C Carcinogenic Hazards of Organic Chemicals in Drinking Water q
R. H. Harris Environmental Defense Fund Washington, D.C. 20036 T.Page Resources for the Future Washington, D.C. 20036 N. A. Reiches
-f r
Department of Preventive Medleine Ohio State Univeralty, Columbus, Ohio 43210 o
=l Although there has been considerable interest in the roles of air and food in environmental carcinogenesis, relatively little attention has been directed i
to carcinogens in drinking water. Recent concern stems from discoveries of
_.j widespread contamination of drinking water by chemical carcinogens. Pre-i q liminary epidemiologic studies have also suggested that polluted water may be associated with elevated cancer mortality rates. In an effort to review these I"
studies and to assess the'ir implications, the following will be discussed: (1) the occurrence of organic carcinogens in drinking water; (2) approaches to assessing the potential health consequences of these chemicals; (3) recent
- i epidemiologic studies in Ohio and Louisiar:n; (4) statistical problems in re-
- ]
lating exposure to water pollutants to cancer mortality; and (5) the implica \\'
a tions of these epidemiologic studies of drinking water in relation to the general problem of assessing the importance of low-level exposure to carcinogens in q
the environment.
o 1
Carcinogens in Drinking Water Although most of the scientific studies of organic chemicals in drinking water j
have been conducted over only the last 5 years, the presence of organic
- l chemical carcinogens in river water and in industrial wastes discharged to j
water supplies has been known for decades (Middleton and Rosen 1956, Hucper and Conway 1964). In addition to industrial sources of these chemi-cals, domestic sewage-treatment-plant effluents may also be responsible for a
~- q variety of carcinogenic substances found in drinking-water supt lies. In a !
recent study (Jolley 1973), over 50 chlorinated hydrocarbons were identified in chlorinated domestic sewage e!!!uents. The study estimated that over 1000 3
tens of chlorinated organic compounds are discharged by sewage-t eatment 1
plants into the nation's waterways annually.
Discharges from industry and municipal waste-treatment plants represent 1
more or less continuous sources of pollu' tion, but spills and accidents result-soe e
l ft..
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i'
-310 II. H. Harris. T. Pap mi N. A. n iches i
+
3 6j i
K ing from industrial operations, barge trallic, or tran<portation accidents near - ~
M.
, M1 F
bodies of water may aho contribute signifkantly to the lescis of hazardous 3
]i$ Jf'[J jl substances i,n public water supplies (llanis 1971).1: is therefore not sur.
piising thal Nume ous studies have demonstrated the piesence of chem
$$}.Iqff; f
,;f, carcinodens in aiser water (Dosted et al.1%5; Anon,1970; Fident 1971; I 7
/
C
!!!tes and Iliemann 1972; Svce et al.1913) and in ticated municipal drink-f
'.hjg; ing water (llueper and Payne 1963; Schafer et al.1969;'Andicinan and Suess 1970; liPA 1912; K!copfer and Fair! css 1912; Scheim.m et al.197 8:
i')c4n.eg
..,?.Mk I
Dein/cr et al.1974; Junk and Stanley 1975). Recent studies have aba y E %([
demonstrated that chlorination of diinking water, pastitularly if the source is heavily polluted with organic chtmicals, icwits in the production of a y
,T,,,, g)y t
j variety of chlorinated hydrocarbons, some of which are carcinogenic (Rook I
1974; Ilciar et al.1974; Dowty et al.1975; liPA.1975b). Furthermore, yQQ f
drinking water may be contaminated by org mie c'iemicals migrating from
' qQAd F materials used in'conselance systems. For crunple, the linvimnmental Pro-i.
[%,q$p@ I:,'.f tection Agency (l!PA) has recently obsened that sinyl chloside mntamin-k[
r water carsicd by polyvinyl chloride piping at wnscntrations up to 5 pg/l i
{
when water stands in the piping for long periods of time (Dressman nd # p IQMJ 4.gf.K g McFarren 1976).
Wg 'n e {[
Additional studies documenting the chemical contamination of diinking-h,-I@kk* [Q;-
water supplies include a 1970 U. S. Public Ileahh Service survey which p"rI; g ; y(
,g found that the Icvels of organic chemicals in many water supplies,cxceeded the Public lieahh Senice's recommcoded limit (WCabe et al.1970). A
?}%g.p) f 1972 liPA report identified 46 potentially carcinogen;c or otherwise toxic h,
organic chemicals in the drinking water of three communities along the lower Sfississippi River in I.ouisiana (l?PA 1972). A sewnd !!PA study in 1974
%r/9 d,,.
identified 66 organic themicals in the New Oileans thinking water (liPA
'NMh 1974). These and other similar studies were i.ited by the lip A as the reasons ME{I[ k for initiating the National Organics Reconnaissance Survey (NORS) in
, f Q fi'
November,1974, to clarify to what extent organics are present in the nation's
.g y% i f drinking water (EPA 1975b).
J
,4gg gk One of the objectives of the NORS study, which included 80 cities repre-ggy Joh sentative of the drinking-water quality throughout the United States, was to jdgM determine the extent to which chlorination resulted in the formation of 3.,/.~t f[l / ]
chlorinated hydrocarbons. In addition, a more comprehensive analysis was
~
Ofe@J", 3h conducted to identify a broad spectrum of organic chemicals present in the f.
4I drinkinS water of 10 of the 80 cities.
.rgy hr, Results of the NORS study indicated that the paesence of four trihalometh-
@O f.v t.; i({
l) g anes (chforoform, bromodichloromethane, dibromochloromethane, and bro-moform) was due largely to chfosination of the water. In addition, the study i
O,dMt h
showed that the concentration of total organic chernicals which serve as the i
[,),
precursors to the tiihalomethanes was positively mrielated with the resultant 343 concentration of tribalomethanes. Atcordingly, the 16 groundwater sup-k b p!ies studied, which in general contained considerably lower concentrations dr h,f ;
'.,pgr e, g;
cf total organic chemicals than did surface supplies, had lower conecntrations QQ j
of trihalomethanes (Miami was a notable exception). Chloroform, a known RD 4
carcinogen (NCI 1976), was found in the drinking water of all h0 cities. Two l
\\.
additional chemicals, carbon tetrachloride (aho a known carcinogen) and
0.L'4W,./ '
t 1,2.dichloroethane, which were found in 10 and 26 cities, respectisely, were 2
l a.
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Carcinogens in Ddcaing V/ater 311 t
3 Table t
,[
l j
EPA Analysis of Representative Cont.uninants in an 30 City
?'
Suncy
+
I NamGr vi e isies Rangeal l
Jerected wneco.tradon
{(
Compour.d in (n/I)
I, l t,
Chlorofor m
$0
<n 1 -)i I firomo f;chformacthane 78 03116 i
Y Oibromochtur omethane 72
<0,1 100
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-(08 92 i
Casten tetrachlorkfe 10
< 2 -3 J,
1.2 Dichtoioethane 26
<0. 2 -6 p
.i, 1
I apparently contributed by industrial sources rather than by the chlorina-
[ II tion process and were generally absent from groundwater supplies. A sum-p 4
l mary of the results of the analyses for these six chemicals in the diinking
,g water of the 80 citics surveyed is presented in Tabic 1.
p i
The more comprehensive analysis of the organic chemical content of the 43'
{
8 drinking water of 10 of the 80 cities identified a total of 127 organic chemi-j cals (EPA 1975b). Although less than 10% of these chemicals have been I
adequately tested for carcinogenicity, a list of those chemicals either known M.
l or suspected of being carcinogenie was included in a recent report from the
i; iJ International Agency for Research on Cancer to the National Academy of w
Sciences (IARC 1976). The frequency of occurrente of these known or sus-l b pected carcinogens in the 10 cities of the NORS study and in New one.ms j,'
is presented in Table 2.
A survey similar to the NORS study and with simihir resnits was conducted by the Region-V o!! ice of the EPA (1975b). Collectisely, these surveys demonstrate that contamination of the nation's drinking water by organic carcinogens and other potentially toxic organic chemicals is widespread and extensive. A recent summary compiled from 94 technical reports in the scientific literature listed 423 organic chemicals as basing been reported in various waters (Junk and Stanley 1975). Of this total, 325 were identified in treated drinking water.
4 Assossment of ifcalth Risk Alethods for assessing the health risk of low-lesel exposure to chemical car-t cinogens in drinking water are not yet fully deseloped. At least four ap-
[!
proaches are possible: (1) bioassay using whole extracts; (2) estrapolation
(
of dose-response data on indisidual compounds; (3) aggregate population
[
, studies; and (4) disaggregate population studies.
[
('
Bicassays Using IVisole Ertracts l
9 Studies on the drinking water from the Kanawha Riser in West Virginia i
(liucper and Payne 1963) and from the hiississippi River in I.ouisiana q,
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s 0.1 0.2 0.4 0.3
<0.01 0.5 0.G7 0.2 h,/.;
4 2,4,6-Trichlorophenot x
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x x
i i
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li l
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x x
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A Compounds whose structures sug-4 %, c'.
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. x x
x x
x x
x x
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- X indicates reported presence; numbers are reported concer.trations in gg/1.
a Vinyl chloride, a known human carcinogen, was not included in the IARC study.
. "{ i -
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a (Dunham et al.1967) have attempted to assess the carcinogenicity of or-
[r h
ganic extracts from such water. llowever, these studies were inconclusive (2i;) h I[b.[
,i
'l primarily because components of the organic cxtracts were highly toxic, thus limiting the dose that couhl be administered to animals without result-
].
it ing in an acutely tosic c!Icet. Despite this limitation, using whole extracts M yff g
does otter the possible advantage of as<.cssing additive and synergistie effects.
D'p3 MJI.
'3.
.7% f Recently, ciforts (Tardi!! et al.1976) hase been made to detamine the 6g-J,3ip mutagenicity of organic extracts from drinking water, although no extrapola-tion of these data has been cariied out to predict carcinogenicity.
yg
'i
.d
,h!59 L,i E.1tropolation of Dose-Response Dara on Indiviatual Comporurds lluman health risk for individual chemical carcinogens can also be predicted
.p' 7
'.%g,,,d'l;-
'f by extrapolating dose. response data from animal experiments. The limita-
./
ID !I tions of this a'pproach are discussed by Rall and by lloci elsewhere in this volume. As applied to drinking water, the most obvious limitation is that l
q q, i
hn,/h y a polluted water supply may contain literally hundreds of organic chemicals, t
l
],,
most of which hase prebably never been tested for carcinogenicity and even
+.
fewer have probably ever been tested adc'quately at varying doses. Extrapola-1h h;E tion techniques also fail to predict interactive effects, which are likely to be g,'
substantial.
7R p*y A recent ctfort (EPA 1975a) to extrapolate dose. response data from ani-2.*b, g, f',p mal experiments to humans was made by the Ad lloe Study, Group of the EPA's liazardous Materials Advisory Conunittee, which was estabfished to Q - QM assess 1.calth risks from selected organic chemicals in drinking water. A f,'Q comprehensive assessment of health risks was not made, however, since Q['y%g[W:(Q'g d.
tertain contaminants such as pesticides, ashestos, and inorganic chemicals
.lyft k,'
were explicitly excluded from the charge to the study group. I~urthermore, as
(i.l noted in the study group's final report, the chemicals that have been mea-sured in drinking water " account for only a few percent of the total organic F,
} p "N
.'.s content of drinking water." This indicates that other potentially toxic organic h,$,,
compounds may have gone undetected.
Although numerous caseinugens have been identified in drinking water, 2
y j'I with the exception of chloroform, the dose-response data have been insuffi-f
. **')"
cient to permit extrapolation to predict lannan risk, in the case of chloroform, dg-
. t.
3 %,,I although the tenuous nature of the techniques for extrapolating from animal 1
p O I,0 experiments to man was recognized, the study group estimated the risk in 5
g 4
the fo!!owing terms:
'g $y The lesel of risk, estimated from consideration of the worst case
. g[j?
4 y
[ Miami,311 ppb) and for the expected cancer site for ehtoroform (the
'f[
liver), might be extrapolated to account for up to 40% of the observed g,,
g liver cancer incidence rate.
g f) l Aggregate l'opulation Studies Scattered European studies (Stocks 1947; Tromp 1955) hase suggested a
{?fyy,.
possible association between drinking polluted riser water and cancer mor.
eil' t.',q W-tality, although the results were inconclusive. Similar studies (Cook and Watson 1966) in the United States have observed that counties in Missouri p
with high multiple cancer incidence are clustered around the Missouri River.
.y.
f ph.
j f (l ;
Despite the suggestion that carcinogens in drinking water might hase been a n
t.)
'j 3
l.c.
. s r
t w*%g.m,
. ~ _ _ _
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m.,_
'""';~I L.,j ~,. -~
l..
Ca rd.4 ; as in Orid h.g '.,< t :r 311
[ pmshic explan dion for 11 se el,esutions, this hypothesis was f-
ated fur ther.
j 9*
Uccause of the histo:ical esiince of high cancer rates in New Ortcans and the results of liPA test; demomtrating the piesence of numerous car-cinogens in New Orleans drinting water, two recent studies (Itarris 1974; Page et al.1976), using motiuriate seges, ion techniques, have investigated e
\\ p,)
l ', j the relationship between drinkin;;~ water quality and c meer mortality rates J
for the period 1950-1969 by ;urish in I.cukiana. Ihrosnre variables were kI
[
[
chosen from the epidemiologie lifeiatme to reticct 'hme environmental, t
t,
[
social, and demographic sariables generally anotiated with buinan cancer.
included were urbanization, f.nnity income, occupation. ropulation density, hs and source of drinking water. The results of these studies indicated a statisti-
'(
cally signiGcant association between cancer rnortality rp and populations which receised drinking water from the Nfiwiwippi River In a similar an d> sis in New Jersey (P. Vasitenko and I.. Stagno, unpubb),
a statistically significant relitionship was ebsened bi. tween drinking water obtained from smface supplies and cancer muitality rates. A subsequent study (Buncher 1975) investigated counties boidering the Ohio River in Ohio and Kentucky. Although the statistical methods ddiered fiom those used in the I_ouisiana analysis, the findings were suggestise of a water cliect. Comparisons of persons in counties along the Ohio Riser who drank from that source with persons who receised other water yielded statistically significant results for white females. For white males, the statistical re<ults were borderline, although in the predicted direction. It is possible, howeser, that this investiga-tion failed to obtain consistently significant results because of the method employed. The implications of this are distussed below.
Other studies have obsened a statistical rela:ioa3 hip between chloroform contentrations in diinking water an,I cancer mortality rates. For c.xample, one study (5f tCabe 1975) of 50 cities in the 80-city NORS study found a statistically significant correlation between the chloroform concentration in drinking water and the age, sex, and race-adjusted cancer mortality rates by city for all cancers combined. The 50 cities chosen all had populations greater than 25.000 in 1950, and 70% or more of the populations received water comparable to that saanpled by the I!PA.
I
'lhese relatienships were confirmed by another study (Buncher 1975),
which obsened a similar correlation between the chloroform concentrations 3
in 23 cities with populations of 25,000 or rnore in 1970 and the total can-ccr mertality rates for white rnales. This study also reported a statistically d(M E significant correlation between t osofoim concentrations in 77 cities with (
hi
[
glhiata and panercatic caneer death rates for white males. This cor-
.c g g y 3
relation was shown primarily for the 59 surface water supplies and for P cities that accounted for more than 30% of the county population. For cities y that accounted for more than 70% of the county population, there was a f.g p d.),
I significant cortehnion between chloroform concentrations a_n._d bla.dd.er can ~
~
~ cer mo_rt_ality rates for bot _h white maics_an__d. white fcmales.
n.,,m 3
~ _ _ __.
d Diseggresare l'opulation Stw!!es g
Disaggregate, case-centrol, or cohort epidemiologic studies are ;,resumably r.
more precise than aggregate populatien studies. IJnfortunately, it appears a
T
.-.~
~
u
+
. % n. m;. e. x.
, ~,.,. 7 +
pNrf. ;,;
4'.4 n *M I. w}.-'4 /
31s
n. H. Itaois, r. Pa.y an.f 9. A. nnkha
h. U..i,d.;;, )
h- )'
3..y
>f, t'iat such samlics have yet to be initiated to insestigate the role of drinking-
[M.'s.
w ater centaminants in Imm.m cancer.
ff
m..N?w'3,@
4
?
i.
6 Aggregato Population Studies in Ohio and 1.ouisiana 1
fb Aggregate population studies, which weie dF twed ahose, have relied on two t
h N statistical mutisariate approaches. The f.ouisiana study (Page et d.1976) h,k.h,h Y
.h employed multiple regresdon, in which the esplanatory sariables were en-l,gy [
tered symmetsically in each cignation. I?or all the ops.nions, ikinling water,
' 'M,;M
't.%
urbaniiation, income, and, in addition, three ouupational variabics were
', M u y l1.
as the percentage of the parish (county) consuming Miwiwippi Riser water,
[.
included in the ciguations for males. The thinking water vasiable was defined r
y% w
.h
,h!g.9 -k (Iluncher l')75), a twootage analysis.as used on Ohio Itiser ountics in as opposed to other surface water or groundwater. In a sccond approath M M,, U' '{](.
confounding or contributing tuiables such as imputation density, propor-which cancer mmtality was Grst regicwed up m one or more potentially i
.1 %.1 f('. J (q W'Q tion rural, :md ociupation. The ecsiduals were then divided into two groups
'g)N1:p'y/,di depending on the water source of each county. At the second stage, t. tests were performed on the two groups of iesiduals to determine if the means of Q
},,I the residuals were statistically different, kii Q{:$ C,
As discussed above, it is powihte that the Ohio Itiser study did not obtain
.h consistently signiGeant results (some t. tests wtre igmficant, hot others were y;p$$ Q not) because of the method emptoyed. possible limitations in this method M *,'C' T t.e include:
'kg{ dj f;I
i. P N-
l. The sample site w..s small for the d inking water variable. Although mor-e,$p ',
tality was regicssed on the potentially confounding variables for all S8 h,?,T'p. M{h '
h ;Vh, Ohio counties, a drinking water classification was defined for only 14 counties. At the seconti stage, only the 14 counties in Ohio bordering the St iji y,f,
Ohio River were investigited for the c!Tect of their drinking water. Of M YM these, only seven were estimated to receive water from the Ohio River, the-4 l
gj D[8 others receiving groundwater.
M[MD,$*W'dff Jy.
2. 'lle drinking-water variabic was treated discontinuously. All sesen Ohio h
Riser drinking water counties were treated identically, esen though one countv-had only 13% u age of the Ohio itiser and another had 9M I
usage of the Ohio River. It is likely, howeser, that the.tfect of the sur-
< (g' Q l i h
face / ground drinking-water dithotomy saries linearly whh the peicentage
[
of the population utilising surface water. This is because the percentage g{IM nth i exposure to the probable higher levels of carcinogens. In contrast, urban-receiving surface water is a measure of the rclatisc number at' risk from dy.,
ization was treated as the percentage of the county population in one
[9[,h.J :9
j$iQ Lj category (towns over 2500) as compared with a <econd category (towns fess than 2500). It is not clear, therefore, why drinking water shoald he Mike l
treated as a n:c ene discontinuous sariabie and urbaniertion as a
[h' continuons sariab!c. Moreover, with only sett n Ohio Riser dririking-water 3.d k counties in the uimple, it wu!d api ear om!~irable to discard iaroima-
[%, rM f<'
iji tion, w!.ich is li(cly to oscur when a continuous vasiable is treated as a P '
i' 9
.I 7ero -one tariable.
f b.3 J
3. 'lle Ohio study was litniud to an anc. lysis of total aegregated cancer rates
$5-d and did not iavestigate mortality by site or by other groups of sites.
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Cartinorns in Ori Aing Water 319
~
4. There are unknown statistical properties of the two4tage method. This method is cquivalent to stancwise linear regrewion, whereby the residuals of the first regression are regrewed on a zero one dununy variabic for drinking water. Stagewise regression is hiased in both cocilicients and in the estimated standard urors. Thus a test for drinking water is of un-known power and imknown sire, both depending on the correlations of l
the entire list of explanatory variables. Iloweser, the two4tage method v
l may be more powciful than direct regressions for a given size and main-tained hypothesis, depemling on the attual values of the explanatory vaiiables. This question deserses more attention.
t To gain a more direct aunparison of the pouible etiologic factors in Ohio and I.ouisiana cancer sates and to see in what ways differences in method-clogy influence the analysis, a direct regression analysis was applied to Ohio. First, a drinking 4ater varithie was constincted for all X.3 counties in Ohio. Then the same equations were estimated as in the I.ouisicna analysis (page et al.1976). Finally, a stepwke approath was followed in which drink-ing water was forced into the equation and other variables were introduced in the onfer of their contribution. In addition, direct regressions were per-e formed analogous to the 1.ouisiana studies. These results are presented here for comparatise purposes. ~lhe results were similar for both methods.
a Six independent variables were entered in the regrenion equations: the-3 g
percentage of persons in each county living in rural (R) areas, as defined by the U. S.11 ore:m of the Census (1960); median family income (Inc) ( Anon.
1960); popu!ation density (D) (Anon.1960); an indes of industrialization (Ind), which was ilefined as the pescentage of persons in a county employed in mining, constinction, or manufacturing ( Anon.1960); the percentage of persons in a county who receised smface. water (S), which was derived 8
from the 1963 public Ifeahh Service sursey of 11. S. Water Supidies (I)liliW l
1964); and the percentage of persons in a county whose water is treated for control of taste and odor (T/0) (I)liliW 196 %).
Tables 3 and 4 present the regression findings for white males and white females, respectisely. Since S was generally a better predictor of cancer mor-tality than T/0, the equations that include 5 are reported. For males, the coefficient for the water variabic is uniformly in the anticipated direction.
For females, the sign is negalise for kidney, esophagus, and uriaary cancer rates. Ifowever, the F ratios, which test for the significance of the entire rerression equations, are insignifkant, and the cocilicients of detennination (R2) are estremely low.
For both seses, S was significant for total canter and stomach cancer rates.
Significant water cliccts for males were also obtained for pancreas, bladder, esophagus, gastrointestinal, and urinary tract cancers. R was a enoderately strong predictor in the equations for males, and the in'lustrialization index w as significa'nt for several sites among females.
Particularly striking is the differential effect of water on male and femate cancer mortality. For all sites cwept p:mercas and liser, the coc!Iicient of determination (R2) was substantially higher for ma'es. The difference in R2 was most pronounced for total cancer, stomach, large intestine, rectum, bladder, and lung cancer. The male. female difference is particularly interest-ing because of the " relative protection'* of white fenn!cs found in the 1
T
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Tabla 3
.!s Regression Coemeients for White Males in Ohio
. {
z.
3' N.
h! ort.2!ity
{
(" ~ ;' '
rate iper p.Q 'p%
p Sat 100.000)
R*
F,,,
Sark R a r.:J ine Ind a $b 4
' +
7 e,
m_
Total cancer 17S.41 0.4S 19.44*
1S.57*
- 39.66*
- 0.002 94.29 r
Stomach 15.10 0.31 9.51*
S oca 1.77 0.0003 26.50 l
h
[j Colon 18.63 0.23 7.85*
-3.S7 0.0002 12.15 l
,,4.{.>
Pancreas S.94 0.03 1.70 1.866 0.73 0.0003
-5.05 Lung 38.06 0.60 30.69*
3.95
- 17.59' O.001 24.41
.:<,, [
l Kidney 4.03 0.09 2.05 0.45
-0.76 0.0U01
-1.20 9 f,5
{
Bladder 6.85 0.40 13.74*
1.89
- 0 25 0.000Sa 1.79
,..,i Liver 5.62 0.07 1.50 09.s
- 0.62
- 0.0004
-5.09 j
Rectum S.31 0.2S 7.S S*
2.48
-3.d7 0.0002 12.15 U
l Esophagus 4.51 0.55 25.74*
. a o*
-1.93*
0.0005*
-4.70 GI 42.04 0.37 12.43*
10.94*
-5.96 0.0007 50.79 j
i
.]...Cl)
Urinary 10.88 0.34 10.48*
2.346
-1.01 0.00096 0.59 ij Prostate
'18.d5 0.11 2.49 1.74 1.08 0.0004 17.42 jj l
j
p < 0 01.
b p < 0.05.
i
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6 6 a
5 6 55 4 9 0 sP 85 5 4 1
1 727 4 05 2 2 ;2 97 n
3 9266 408 204 40 I
71 3 - -
3 6
6 7 4 3
5 5 5 00
06 1
201 0 0001 1 03 02 c
00000 00000000 n
000000000000.0 i
0000000000000 6
55 725 h S 3 96 3 65 91 91 25 6 2 971 27 R
9001 0001 0021 1 0.306 6
6 5
1 3 5 2
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000 S
1 920 0000 00202 1
e
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6 4 779 3 2 4 973 1
4 8 io 83 1 45 3 9 3 8 05 3 774 1 21 1 041 221 3 h
F 1
O in slea 8 47 O9 0 467023 9 e
m R
2 1 0.'. 0 0 0.i.01 1 03 e
0000000000000 F
te i
h W
tyr) e0 5 227 63 1 9771 4 3 i
'a.
p0 2 47 4 4 062 1 83 6 8 ro f
t i 0
6 775 62265004 6 r
s ote0 3
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tn A r1 1
e ic i
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00 4 i e
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t c c r
a nd e tuh a
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TSCPLKBLREGUB
~
~
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4t-.fI 5
, i ll ' i j '
.}
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.I
)1,,
,..,,-. e,.,w -,..:.. v.
~ i. ~. w e.~ s -. ~.~...
-.. - ~. -.. -
, w v.;
4. e.g'k. /,.l h.s
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wr@' g'E.;y *s; 322 H. it. itmis. r. r.c m s tu. Nctes gj
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!.onisiana study. Ilowever, it wonhl be inap;nopriate to minimite the pos-2 fy M sible role of drinking water sonstituents in the etiology of cancer simply 9
4,#y %.9/
hecause the findings are not consistent between sexes. I?sposure to c:acinogens fif.fh*
in water and to relevant cocarcinogens may vary 1 etween sexes. Also, males f
((('*I'h
..nd females may not be equally sensitise to the agent (s) present in water.
n'
'f;,;
The model tested may be inappropriately specified for females, thereby mask-
'lgMY3 ing a true c!Icet.
gr/pF.b ;
1 Compared to the f.ouisiana study, the pattern of significance fnr the if8Dd;'
drinking-water variable is less strong in the Ohio regressions. Nevertheless,
'p.hf hk.f2p;;
-a pattern of sign _ificance esists for the Ohio study as well as for the 1.ouisiana W' %
study, and, taken together, the two reinfmce one another. In both studies, gastrointestinal and urinary tract caneers appear prominently in relation to I, # " D the drinking-water cliect.
L.91gy Moreover, the Ohio and I.ouisi.ma regressinns taken togcihcr shed further v
e y.W[,h,, l light on the role of diet. It 'was suggested previously (llettouca.md Diem
},ffh5yf 1975) that there are important noith south differentes in iliet in I.ouisiana '
1AN. g:
,f' and that these ihticiences might he the true esphmation for the observed
h/f,fhM(*
drinking-water effect in the I.ouisiana regressions. The suggested dichotomy MN%g~.1,/; g$ h *,
was between north and south, without gradations in diet within each' region.
- g:
To test whether or not drinking water is a proxy for diet (all the surface-
[M[g,S,hdf*
fQ p..
diinking-water parishes happen to he in the south), the regressions were (in dict. In the restricted regressions. the drinking-water (ITect was s restricted to the 29 southern parishes in I ouisiana alleged to be homogeneous
$g,g% [/,".:
served, thus showing that diet is unfitely to be the esplanation for the drink-M...f T. h :
ing-water c!Tect)This does nca mean that diet may not be an important fac-
[ Qty y@,.4 v. ug }(
tor in cancer moitality in I ouisiana. l'here appears to be a north-south p,
Z h.$h,Y,,,,,,
effect (po',ssly diet) as wc!! as a ibinking-water c!Tect. It shouhl also bc
'N.-g..;h noted th:u in Deltonen's nonparametiic, imivariate test for gntrointestinal N.y S
<k.
cancer i the southern parishes, drinking water was significant at the 0 001
,; %gt;P/ W *'
level (DeRouen and Diem 1W'5). I?mtheimore, if liet weie the true e.tplana-p%p[d,h.,
K tion for the drinking-water c!Iect, the water variabic wouhl not be expected to i
-f he significant in Ohio, where there are no clear-cut regional differences in dict that correlate with the smface water-groundwater dichotomy. Thus a
(;
{dg/ pj
[
positive finding of the drinking-water cffect in Ohio strengthens the con-
? ;@
l clusion from the regressions of the 29 southern parishes in f.ouisiana-dict I
.M
. [
is not likely to be the explanation for the observed ihinking water efTect.
t Aj((* 4
?
There remains the difference in the positive finding of a drinking water effect
9M 2 In the Ohio study reported here and the inconclusise one reported by Buncher 4 Q. [jM ;f.
{ [j.
(1975). The difference appears to be methodological. Ituncher et al. (this i
4.U.W l'i volume) have performed a second Ohio study with a drinking-water variable defined for a larger number of counties for which the distinction is between i
l
-? Djh I surface water and groundwater rather than between Ohio Riser water and l
l
'[.3d?.2 : i groundwater supply. Siteopecific cancer mortality rates were tested in addi.
l
' 'Y.
$P tion to total cancer mortahty. Thus lluncher's second Ohio study is closer to h,w)s !,h our methodology than his first, although it stdl differs from direct regreuion.
-f % %*
I h.
The second Buncher study is an analpis of covariance with a dichoto nous l
,49 O, sariable for drinking water, and the iesults do not appear to inifer gic.tly
!; 1 'M fj fro.n ours.
l M. {.
A ;.,regate statistical analysis, as dinuwed abuse, is to a great extent pre-l
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Carcinogens in Orinking Water 323 l
liminary and descriptive; however, it can be mcful in specifying more pre-cisc ctiologic hypotheses. Specifically, the comistent findings with respect to gastrointestinal and urinary sites in the two Ohio studies reported in this volun e and in the !.ouisiana study suggest that the water effect, though modest,is probably not the result of spurious cm rclation.
l Low Numbers and Statistical Power Results of the regression analyses in 1.ouisiana and Ohio suggest that if there is a drinking-water effect, it is likely to be a modest one, perhaps EB to 20c5 of the background cancer rate.The question immediately arises: If there was in fact such a relatively modest effect, to what extent would these statistical tests detect it? As a general rule, statistical power is a function of the size of the c!Tect; the smaller the clicct, the Icss the power. In addition, a given cancer occurring in a given year is a rare event with a probability of the order of 10-' tu 'O 5. Thus a second question emerges: Ifow does the l
rarity of a particular s,,ncer alTect statistical power? Ily means of a simpic model, this section discusses how rarity and relative site of c!Tect interact to aficct the power of statistical testing.
To focus on the role of rarity, a simple model can be constructed in which the only source of variance is from the low numbers typical of cancer rates. In reality, of course, there is considerable variation within each county with respect to urbanization, income, water quality, and other potentiaily im-portant variables. Ilowever, the interaction of rarity and modest effect can be i!!ustrated in a model where all the variation is between countics and none within. This yictds a straightforwart! generalization to take into account l
variation within counlics.
To construct the model for a state with I countics, suppose that the prob-ability of a person in county i dying of a particular cancer in a given year is a linear function of a background clicet, determined by both urbanization and income, and a drinking-water cliect:
1-A R + A:1 + A31V,
(1) p3== A 3
3 3
'-y '
l back ground drink.
clicct ing.
water effect where R is urbanisation,1 is income, and W is the percentage of the county l
3 3
3 I
drinking surf ace w ater, here 0 or 100.
For a county population at risk of N, we add up N 11ernoulli trials into a 3
3 total number of deaths, this number being a binomial random variable. We can espress this binomial random sariable. deaths 31. as the sum of a mean a.nl a c- :: u::: c l'...
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d* i.9..e ' - *>. -- - - * *" ~ * ' ~ - *. p. *. :-d **.. -g p.., - - C'; g t-
"----- L r,
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124
' R. H. HarrM. T. P.wp cud N. A. n.d. tws
'Q plus its drinking-water (Irect), or signal, and ihlferent valia:Re of the error bg}g'.;
term, or noise. It is well known that the signal to-nni c ratio of a binomial f
Ny tandom variable declines as p declines. I hus for 1.uge N, the sinaller the p, the
,[,%
harder it is to detect a small change in the signal coming from a drinking-j.
$gf water effect.
g 9
To convert deaths to mmtality rates per hundred thousand, both sides of f
g,7.)*
Equation 2 are multiplied by 105/N. The resulting equation is estimable but 3
@y,t;,ff z
-heteroskedastic; that is, the vasiance of the error term (10'apj (1 - p,)/N,)
I varies from county to county. The most obvious correction is to weigh the re-
{p,g i
gressions by county population. Ilowever,in the 1.ouisiana regrev. ion analysis (Page et al.1976), various heteroskedastic corrections, beyond weighting by 1
Lgj0(. ll parish population, made relatisely little difference in the coelScients and jg,gh t-values for drinking water. Unlike the empirital regression analysis, herc
~'
i there are clearly otl.ier sonrecs of error; in this simple binomial model, the g,[g
' ' rg g
error variance is completely specified in terms of the coelGeients.f, and the g
M,3,7[J,*'*
county characteristics R, I;, and IV.
3 3
i; In the binomial model, the error variance arises entirely from " inherent gf,[.,g[,*
binomial variance." To the extent that this variance is not too heteroskedas.
,i!,}%
tie, we can use a nonnal test on the segicssion coelDcient to derise statistical
,,Mf,h,f,3..: -
'3 power functions. For this approximate nonnal test we use u? w 105"p(1 - p),
g.
where p is the statewide aserage mmtality sate for a particular cancer. For f"d.d, pd :
a two tailed test of si/c 5%, an eficct will be observed if T.
,*,4 w j,,' s;,i.M.. h, :
-- > 1.96,
-(3) b
i, 8.(.
b-
.'m u y }y.
where b is the regression coctEcient for IV and.<i,is the <tandard enor of b.
I 7/g}g, a
g If the drinking-water effect is actually g, the power of the test can be com-puted as a function of B. In this case, (b - 0)/.,i,is a standard normal vari-
",:y g,,
able, and the test indicates a drinking-water clicct w hen
>. e, f,,
y, P*1d,h,,,
..o :j o
-b - p > 1.96
g..
(4)
~
y,)
b 4
a
* ;, [.N..,y.v (if (b - g)/b.< l.96 -- g/oi., a positise drinking-water effect is not in-r dicated.) By substitution, the test condition becomes Ii W. x.,.
37,
? ;{s !
b.g Q
J U
- > 1.9 6 -
4
.'g c h 4
g/(X'X)n. _
(5) e
,~
T' l
[Nj where (X'X). ' is the diagonal element corresponding to IV on the (X'X) -8 d
matrix of county characteristics R,1, and IV.
3 3 3
g!
4 rhree types of effects on the power of the test can be co,sidered. First, for Q(
a gisen site of background etfect and.i ;,isen g, there may be more or less l!
multicolinearity among R, /, and IV. The greater the colinearity, the greater -
) [,
(X'X)M, and I:ence the smaller the site and the m. re nearly the power t
4
}
approaches the size, hete 5%. Secend, for a gisen background effect, the jp ;
u cgnitude of the drinking-water clicct may vary. An explicit pow'er fune-
. 2,. yg l
'f l
-. 'I i l o, t
'.*.=..;.'t b.
1 d
ee-=eww= * *=*
,=..e.-
ew.
mi.
w.-...
.r..,,.w~+.
p-
_ g.g _...
+-
r
, c *=.,, a* N, -* *wed.r t
4 s. 5 v M ** * **-- %.
'" ?*
1 ' ~
'*#*m+t-a.
="
s L
.._Q;.s. pna ~ -= 35 WX.X.
QI i ~;WXa~.M EX..;. W..;.a,.r=~
m.. p.
',reem p
g at. ~.. ~. ~,
L
- s, Carcinogens in Drinking Water 32s I
se.hai.einty or t.
itna 1.0
- esteen with only (e) binastan vsslowe to) t
.)
.s 6
.r
.6
.5 6
.1
.2 4
4 I
2 4
6 s
to tz 16 16 is m
nortality per M3.3.10 associated with detnatra.*ter errect 'p) r Figure 1 Statistical power at a function of the backgroimd c.mccr rate and the drink.
s ing4ater clicct relative to background. tu) Background held to a constant 8
30 per 100,000; only # varies. (b) Background varies with #; background is
~
always five times greater than #.
tion depends upon specific values for A, Rj, l, and IV. For illustrative pur-i j
3 poses, the weighted regression equation for gastrointestinal cancers for white males (GlWMj) in I.ouisiana can be considered as I
t i
GIWM = 49 - 12.15R, - 1.83/ + 6.24W (6) 3 3
3 (9.9) (-4.4)
(-3.8)
(5.0)
(t-values in 3
parentheses)
For the transformed variables, s/lX'X)?! = 1.77 x 10-3 For gastroin-cstinal cancers, the average 20-year (1950-1969) age-adjusted rate is ap-proximately 30 x 10-5 cancer deaths per person for the state of Louisiana.
/ ssuming a' background rate of 30 x 10-5 together with the drinking. water I
et*cet, the test cutoff point becomes 1.96 -
1.77s/3 + 0.1#_-
(7)
For a constant background effect of 30 x 10.s, # can be varied from I x 30-5 to 20 x 10-8 and the power of the test determined as a function of
(Fig.1, curse a).
Third, the power of the test can be determined when drinking water is a small effect compared to the background and both move up and dawn to-gether in proportion. For exampic, suppose'that-drinking water is a 20%
cffect compared with the background and that the power is determined for more-or-less rare cancers. Suppose # = 0.2 (background effect), then the total effect is 6# and.,2 = 6# x 105. In this case, the cutoli point is 1.96 - N #7
/
1.77vU6, and the power of the test is represented by curve b in Figure 1.
Y er.
b#
Y g
g.
Iy w,;$::&- Dh$W',Q&'&_'h~~~&&%;-.n~ ~.w-&~ T&~A' -
A S
{
- g4 q,
i
.e s L.-
. -.w
,i....T
~
J
_....~...
"*7
- :j i t,'
=
g l'
e 326
n. it. Ifao k, T. i'e ge.md 14. A. ti ktms
, i:
Although the drinking. water ctreet is a constant.'0% of the baelground
i cifcer, the drinking water tifcet is harder to distoser for raser cancers. This (j ^
l decrease in power with saier canter, may be called a pure binomial varianec r,l c!!eet.
At first glance, the power amo<iated with the numbers of the GlWhl l3l
!I.
equation (# = 6. GlWS! mean
30) seems seiy low, a mere !0%; and this is without any other somces of caror in the model. Iloweser, the model 1
was constincted for illustr dive p'u;w.cs coly.md is too simple to fit the as-f sumptions of the actual estimated npotions. Nescithc! css, the umdct saqcsts 4
certain questions about the rmity of cancer and the.ncraging proccucs un-h dcrlymg the cancer mortality data (',f ason and NicKay 1974). If the icgres-
'p sion andysis is to predict the long.:un aseiage imp; ct of enviionmental fac-fors, c:n.ccr rates per decade may be a better detinition of varity than rates per 3 car. The normalization is iirportant becanse probabilities are piae nom-l'els wilhCU! dimension. NIoreo'.er, the c.inces lates cally luole infoilnalitol th m single-bar obseivations, since the sates.ne 'O year asciages flow the I'*
aseraging proce s is taken into acwunt thanges the istimated power of the k,.
sta tistical test.
f*
The purpose of deve!oping this simpic ruoilel was to demonsaate that y:
modest lesc!s of effect and can. er i.nity, althench repicsenting ddicient con-b:
cepts, can interact in impmtant ways and may, under ccitain ciremnstani cs, severely restrict the statistical power of a test to detect cifcets. In certain Q : I cases, combining sites may increase the statistical power, and the cfore snett
j aggregation may be justified for statistical if not for etiolo;;ical reasons. In-2*'
E,. [
sesrigation of the power characteristics of various models is important in order to d.aelop espectations as to the consistency of pattern which may be obsersed in a set of regressions or other tests. Fin.,Ily, when dealing with
[l'
[
modest c!! cots and raie events, the methodology may be close' to the edge of strtistical capability in finding potentially esisting effects. This suegests.that in h[
ihe commonmense dictum of scaiching for the most poweiful tests is especially hg important in the area of assessing modest ensironmental clietts. He process j'y of descloping the statistical propert;es of sarious c'timators and tests in the d;~]
specific setting of diinking-water re;earch has b.ucly begun.
i f:
l i
Hl,n CONCLtJSION Y@
Nfmt of the information that has been accumulated to date on the risk to hu-c l.
mans fltlin Cs{osiirC Io (bCmWal c.lle filh[, ens !!.ls
!),,*/ n.it tl1lilet! If tst Wyh
]Q, qidemielegic studies'in the work ensino.unent. In general, occupational i
cspounes to c!.cmical t arcino.;ns.ae far grr.uct th m esposnics to c ar-I y
tira; ens thiench air, water..rul f.uil wniaminat:. n lloweser, it is esi.! cot h
that the general public is esposed to a wide variety of chemical e:acinogens i
in casimm :nts cther l'i m that of work. For this rea -on, it is impeiatise th it P
epidemiologic studies b: undeitaken to assess the impact of thoe general 9'l n ; w ures.
if In the e.ne of drinking uter, cont.unination fio:n indmiriil, m-ni. ipal, :.nd l
agricultural sources, as wc!! as ficm th!orination at water-treatment p'mts, results in the public's e.spure to a w:de sariety of demical carcino; ens. Al-l l,
t1 4
14 If 4
,d t
' ^ -. - -
b 1
p
,__..._._....s
t' c :. a,..r n,.., o,,m.y w.4, e
i 34 n
e.
s -
he
.E 28
?$
=
l 4
24 e;
2s e
~
4 3
s so a
o 3
a,,
.s*
a
... a,.
v 3
,e u
e 4
. e4 he
,9 o
a
..c.,
s o.
e,
...c-.....
j 1; ic e
.y....
p y
8
' tuo,[
i eo 6
,',,' f u
3; 4
.o.
..s.,
o
,/
.'/
i 2
.=
/
...'s *..
/
' ~ ~ ' Yio iA'o
.Ao ifro iOo'~ ~
i Figuro 2
/
Cancer moital;ty rates and shenikal podaction as a fi nstion of time.
. I though the number of gmtential carcinogens is large, th ir concen rations are sma!! in compari on with tho e typically enwuni: red in the york c.miren.
j j
e
(
..icntguniongn snew a., iclothcly low lesch of esposure preliminary epi-demiofogie studies of.irpet;a:; populations in 1.ouisiana, Ohio, and Niw y
Jency support the hypothesi, that carcinogens in drinking, n.Ar are retmied to
\\
human rance) Although similar orr,an secs were obsc4 sed to be atitcted by drinking water contamin:. don in thesc <'udies, the iMts are not comp'etely consktent among states. 'lliis may N due b+f r at to t!.e to.v ninnb.rs of caaeers and the sciathcly sm 'll e:Tett i!rintin.j water ; f in in il cir etiofogy.
~, -
Ikth rarity.ind ulithe me i f etT t : yo itt c'.2 p! :e ; 6. tr.t cc. trah.ts lI
',/., 1 oil the power of st.itistical f e%%%.
+
~
It is afsa impoitant to tomidct tis ue Gek and non. bets i i chemkal car..
i
' ' / 3 ~
e e
1 i
P e
f
{*
o
/
..s
- t n m
_g h
a
.n.,~..u
-w..~o...se-*~.
s
...... ~..-
- y -.
./
s y
p' t
_j
dl ?'.b,9 e.
p.
q,.. p.,y.l p
t, ~$'. '$,e.~.
MS it.If.ff rii.. T. P ;,. " I f t. A. r'rir hi s
+,, '......'
u.
g %..'O A
g g jp g' @,
[
j
f 4.l}rl )(
t.inogctn pic" nt HI 'Itr.n, on; water f.ulay.ite hkly to be far {;te att r than
.D'
%erc pre cht ?O or 30 )c.its ap. Therefore, the in.o ft't sifet ts <.1% x!t d by m
i
, u f,.rp y
,W th; ephlen,. b g.e tmfoa ifn. i m cil in Il m p.ijvt. %Ito.h s edet t ( Tir.uict u
4 l@h'.
/,..
i
'D, 30, or 10. f e je u s ido, f at t fog,it al!) I.c f t.msla rc ! to laster clIct f s in the h
(
future. t his is opp.1h d by the if at i pic cntn! in 17igure 2, u tih.! xon.
g' ' [*.g.;
sie ale that the fes tl i4 ini'u.! i il as t hily entido:tiop, atuiy i f th.:. !r sai. als 17
{.. ; 'i.V IdJohSed in drisding s., der Ius sp. ne c. d II..ia afi ally mcr !!.c p.v t f # ) cats f I.e c!fcct of this ( ht r. sal "m.ht.ai" m !d n..t p t ! : eq
.1 d to ?
re-
,g',;
l'n led in os t rall i a n c r r des, a i.nd.'. ii.. '.a j uil t.Ie
'O-to
'O-o';
%y l,' ' ', '. r -
l f or t.p t < !n ni. al. o in.mcos. Il n j i..o d y i. it :!as o.u oi. i c, l'..
q id i
,' 0. A V.;b$'.
si e in t!.c loc! of ( !n n k il r.ir, iug-, at t'.e miri mo at in t t 9.
p n t.'O
( *.p: n.%
i
i*
.t
s i ;u t, that i.. of;;.ihfe c fos t sha in!d
!...f s eitc,f f fler d.iqq. n. ].. nh ct e.:^
,4 t
'{ l j [y.[{)g 7,
e4 cphicn:. h qic :.tudh ti anew the ctIcs t inf thsu h..d t ardmg;ns in <!rine n-
,3 *,,
in j miter.
P,a. y r,o
e
(. : *il.y...4
.e..
.t.
.M i ' ',..,.
,s#
s os
,.O,. > f
HIJEH ENCf.S
>F ?l"(,*N ' h
. <.n r'
k ['!h}{ ;
A n.!efin a n.1 11 a nd \\1 1. En s. 19 io l'of > o n ' ar o.on o.c hpf r. cart ons ia the water environrmnt # dl. W//O U: 4 79.
,= ? N.S. f 4..
iM f.d *.
P !.r T A.,1 J. I.it hrenberg and R C. K r< ver. 1974 Ibe oact, ente nf er.
g omb dides in c!.forinated dr;nling orcr.1.. fin. W..Irr We, A s,f noc vi:103.
,,' A.'.'fi? l1 '
Pt.acher, C R.1975. Ci scinnati. hinting n uva r-a n. ro '...nvlo;rc stual; of..au er
,. i.t['.Y. ' 40,,$,
rates. Unher4ty of Findenats \\fc.In al rcneer, rint n n io. Ohio.
M,,, e,,...
Cook. O n. and F R. Watm,.1%6 rhe3,eegryhicto.to m of E. orim A dh j'r,
,Q.
n1of ti t " *,%,Q {4 f
t f etancer.Tto 1f.,I M:9') 7 Dein/er, M.,
R. *.f c!!on, D '.th !.t ll. F. K' A r u ni F. f 51. o m 1971 Te a r r.
4,l[,k;,;,
nr;:nic. onwai+:nts in ! odin >< at. r Tiz, t
ur:va iy r e cr e o.w.ais, a r o ~.. nto r. [;,** i t'.nsironme ntal Protction Acc m.), Chewti, Oluo.
.'*.$ t ! ',, 2. ','
Dqartu.ent of !!c.hh, f.!+ ti o.ani m lf.oc t aillLW) 1% 8. l'M 1/"s u nrory of
...'g..[.s e'
.e' ina nie lpal u. ter f.a.lirin PuHie i f. a't h "t s s.t e Pahlitation '.'o. 7 M, sol. 5,
5. %, n h,,,,
Dif fiW, Wa shington, D C
"- 9,./g; p DeRouen, T A. and J E D~e.n.19 K ILe New Orleasa if rkking w..ter u.or.neny:
'N [ ;r...
. p';h*f,' y A st.athlical peryectae.,f ns.1. /*ollac //culth (J:1 r)f.it Dmtal, K. A., R C. PMnon D C. !!ager md G R Pol a k. 1%5. rn:mn '.ed
. ' ].'/ ',q 'l J"6 t r 'eri i steh it Nif ro. West Vir gi,o o /..f,n. War. r W.., A r,t u.u S 7d. fil.
. c a,On' [1 De s ty, H J D R. C.ul d and J J. f..cr. 19 7 5. N 4 04 an.hirt og 4..tcr M';r,'t.d,,
< arco rce d by gas t'.ro n.rogra; h> -m m gettrom try Fo o. n Sci. T, c!-ol.
.~.,.
'.b 9:762.
~\\ ',Nisi Di e u.nu n. R t ' a n <! F F. 9.f.-! S t ren !"76 D, ter"r."a'a m of wol i /Jori !r iv,ra-
' 0.43; t:an from
..!>.n> t Alorv!r ri, e m s arer uine inut 'aml um < w"'!%'arh!
. '~. g i[s' I t m r t '. v.lo lo g y. Water Sog fy Ro ush I b roon. !M it o. n oe n t.d Prolut'un s
.fo*.
t A ge ncy, Cincirmti, Ohio.
t'% $g nu ham. I J., R W. O' Gar i and F H I olor V"i 7. St ole, on po'!o' ant s fr em 2,s.% y, pimcmd water. Co;tection Itom there staticos and hol.we h sri nj for towly
^
.und casesnou:veds. Aire 1. I'u!.hc fl.vith S h.'l :8.
' ( " '. j
' I Fadronmental PnstectMn A.;rucy (I P %) 191? In /,arral rollation of ilo-In <r i 'I,
\\fini:ri;'; s Ris er irs i v:dd.n a t PA. t) 'l a <, Ve ' as.
. r
- ~ 19 7L nr Jt.
.!p...I re;.a t Nc m b ; s.m a. :'r r sur;ly s:~ly L PA,
.- i,*'.*. -
Cin. ie n.ti. OS;o.
' \\':.M. ?
i-Q.-
197$a. A re;wr:.t u cuv: at of 1.cdth ritt fro.us aqanics in J&.Un
,p' :.'v'p).,r*,
h.H e.
u m
.,'.'d*Y',UI' l [l r
s 'ya *d, f,(
s a:
L I
.:,,..,, sw
' d. $ ', g p
y~ ~.(Q e
f l'
JW,*
++=...,p.,r.----<.e.3..e-.--.,,g---,,..,,....
,,.s
~., w.2......
~
... +...,
,e+
Cc.rc* nog < ns in Oslaning Water 321 water. Ilatardous $latcrials Adsimsy Conunittee, Science Adviwry Board. liPA, Washington, D C.
, l9756. Prelianinary cuessenent of suspen ted earninogrns in drinting mater.
Report to Congress. I:PA, Wuhington, D C.
ftdout, l. 197 l. retruchconical wantes as a pollutlon endlen in the loser MIisdraippilliver. Envisonmental Protetrion Agen6y, Dall.a, l'esas.
Ifarris, R.ll.1974. Irnetications of canser caning substa sces in Sfississippi River w ater. Envisonmental Defense Fund, Washington, D C.
Ilites, R.A. and K. Hicmann.1972. Water pollution: Organic campounds in the Charles Riser. Science 17N:158.
Ilueper, W.C. and W.D. Canaay.196 8. Chcmiral s areinogenesis and cancert.
Charles C 't homas, Springfield, Illinois, llucper, W.C. and W.W. Payne.1963. Carcinogenic effects of adsorbates of raw and linished water supplies. Am.1. Clin. Pathol. 39:475.
International A ency for Research on Cancer (IARC).1976. Rcport of an assess.
C nient of the carcinogenic potential of s ontananaras Jetected in drinking uater in the U.S., including reconunendations for further study. IARC, f. yon, France.
l Solfcy, R.I 1973. Chlorination efects on organic sonstituents in effluents from Jamestic sanitary sewage treatment plants. Publication No. 565. Environmental i
Science Division, Oak Ridge National I.aboratory, Oak Ridge, Tennessee.
lunk, G.A. and S R. Stanley.1975. Organics in drinting m ater. Part I: Listing of IJenti/!cd chemicals. National
.chnical Information Servlee, Springfield, V;rginia.
Kfeepfer, R.D. and il J. Faittess.1972. Characterisation of organic components in a municipal water wpply. Environ. Sci. Technol. fi:1036 Sf ason, T.I. and F,W. 51cKay. I974. U. S. cancer mortality by county: 1950-1969 DilEW Publication No. (Nill)74-615. National C.meer institute, T!cthesda,
$f aryland.
htcCahe, l ).
1975. Asweiatlon letween trihalomethanes in drinting sater (NORS data) and smurality (Draft Repost). Enviromnental Protection Agency, Cincinnati, Ohio.
AtcCabe, l..J., J.ht. Symons, R D. I.ec and G.G. Robeck 1970. Survey of com.
munity water supply systems.1. Arn. Ivater IVorks Assoc. 62:670.
Sfiddicion, F.M. and A.A. Rosen.1956. Organic contaminants affecting the quality of satcr. Public flealth Rep. 7IslI25.
National Cancer Institute (NCI).1976. Report on the carcinogenesis bioassay of chloroform. Division of Cancer Cause and Prevention NCI, Dethesda, Sf ary.
Mage.d.
lan T., R.ll. Ilarris and S 5. Ppstein.1976. Drinking water and cancer mortality in Louisiana. Science 193:55.
Rook, J.J.,1974. Formation of haloforms during chlorination of natural waters.1.
Soc sVater Treat. Eraun. 23:234 Sehafer, M.E J.'T. Peeler, W.S. Gardner and J.E. Campbell.1969. Ensiron. Sci.
T, ehnot. 3:1261.
Scheiman, AIA., R.A. Saunders and F.E. Salleid.1974. Organic contaminants in the District of Columbia w ater wpply. Bio. Afan. Spec. I:209 Stocks, P.1947. Regional and.*ocal Joferences in concer death rates: Stu< lies on enedical and population subjats. General Registry othe, No.1, l.ondon, Eng.
hnd.
S'.ec,11.3.1.S. Fritt and G.V. Calder.1973. Trace soluble organic sompounds in potable water suppIIer. Depattment of Inte ior, Washington, D.C.
Tardiff, R.G., G.P. Carlson and V. Simmon,1976. llafogenated organics in tap t
__p_.
..- -.. _...~.~. -... - - -,
rs 7.Q,t.
s t
i 3 ;3 e t
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S 1,,,_, 4,7 g,
A-__
... -..... ' - " -~'~~** ' '* * *'~ ~
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+-
y
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W...-....,
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l 9 '. -
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'I #
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g
, ri g gr a nts ps6, y f,J[ g,,4 g, a I (8f
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e
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f g ?s for /nnitive#. N -6f tou nl l'i s ! ni '.al lit fe.i t u ef p *o S'I s ia
/q Ts oniiji, S.W. 19 'ii leo Jfe II.iis of i. m q.to-il ioni if o. In.o.. - d f n tois on i
l
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(feu!.ipoi nt.in.1 p ogi.ip ne.'r ti d uti. n.<i..in t r. L o.n.
i
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o s. nu,cau a o e nusnt n,i u.,,,....a...c.i....... o s i:,.u,,,:....a n,us,,e Otr.cc. Wahington, O C.
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1, l9 lb,
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i i
e
i t,. I,. s :. s t..m.s. c. s.a :. er oe...
.w, a s.,a v.,.
,,sn..,
g r.>
l
... a.... t..
l-TEA % k h h ot Ni I
j ltADIATION ACTIVATION OF CAltCINOGl!NS AND w o.
"8"'
hy d.
Tilli ItOI.E OF 'Oli AND Of
'd8Cd Cetse L Gnossten and Groma W. Rt'osm
>ccies N 'O' Medical fhophysks fir.mch. Atornie I nitry of Canait.e f.imiscd.
WhiscshcIl Nuclear Rcse. arch I~siabbshment. Panama. M.initoba. Can. eda ROr' ILO I
t sys.
abste g,,,.u,j yy 3f,,,3,973,,,,7,,,f4,4,,,g97,,,
7 oper.
e) t o-A hlrect - R adiation induce d cosalen1 bmdeng of tabc1d caronopns to DNA has been intesterated under a seriety of camd,hons uung ultrafsitraison or miti,porc filtration of ICA ptcop. table comptenes
.c o m.
o be High ykids of caronopn binding at high DNA conct ntrations are atm obscried for a tarkly of small mnicsules and are not carcmogen-specif.c At h8th caronogen conctntrations, r.idution in f ogd I*
unstable clatrophd c caronogenic species arefro.foted, and underpo frer:s.uf. cal rcacteEn[yhqh
~~ ~
<om-i g;ETaicTITufar r~cdos rexteons miohed art mct.abotec c. ronorm.n h* ation. Is.nhne to the foonahon thcir i
ilHei.iMt'fb~ourid caronogn adducts to DN A as a potential targer rIucrom<.lciule
~
lhe yufds robic d '*""" Ten-DNA adducts enucase hncarly with dose and stcpend upon carcineren u.ncentration.
The results of scatenger studies indicate that the onidning spcors Oj and Oli ere the prenopal activating species Rate constants for the selectisc rade.dion-induced unidation reactions of sanous
{mme chemical carcmogens with superoside have pesn measured by a cornpctition &mcik method udng inter.
pulse radiolysis. The relatively long hsed superoside radical reacts with caror ngens at a rate which h
is tuo ordcre of magnitude sinwer aban the d,ffusion contro!!cd rate for the hydrosyl radical, thus aftaming a measure of Of specificity in the presence of competing reactants withen the cell I
art by l
,rtnts
'a ncer IsistooUctioN which are pencrally thought to be insolved in aryla-mine carcinogen activation ire tiro (Mi!!ct, 1970, g,nans are be.mg espo ed to escr. increasing lesels
. ja.ide sariety of physical and chemical pollutants Weisburger and Weisburger,197JL We have med
, p.c ensitonment. including ionisinE and non.ioniz. pulse and steady. state radiolysis studies of model
. g radiation and chemical carcinogens. Chronic chemical sysicms in agorous sointion to generate free g
l pg term exposure to these po!!utants may lead to radical species as selectise redox reagents to simulate.
I metabolic pr oduction of electrophilic carcinogen 3 #.:er ( Arcos er al.,1968; Pochm.1969. Scarle,1976L Species including hydroxylation products, and to goegh the latent period m. both chenu. cal carcino.
p.esis and radiation carcinogenesis is long. neser* probe the mechanisms of the underlying chemical gss. these biclogical effects are predeterrnmed by reactions involved in cartinogen activation and in the i
I pical events initiated at the time of esposure subsequent inscrxtion of carcinogens and their radia-
! per.1970, hidict and Efiller,1966; IIcidelberger, tion-chemically actisated metahahtes with potential ce!! alar target nucleophiles (Greenstoc'i and Rud.
91R gi us first pom.ted out by J. A. and E. C. Maler dock.1976a; Grecnstock and Weibe,1977). according gjj that chemical carcinogens must be metaboh. to the hypothesis of Afiller and Afilier (1953) ne Ig4 actisated"in siro before they can react to form role of OJ in carcinogen actisation and its imp!ica-plcnt bonds with such critical cc!! components as tion in biochemistry and radiation biology is dis.
I d.
i p and proteins it has been shown that a principal l g or this activation is in hver microsomes (Gelboin, u
g g, Wang et af,1975) presumably by inducible
'8 4 D M
l ^
N D '" I"U M
' -.wt function onidases and hydrosylases. In addi-The chcmkal caronogns benei.bne, benio[a] pyrene.
ectitation can be achieved themic.il!) (lloffman Anicthykholenthis ne and p n.I;JWI.IiTUne (p NAl were h
obtained frorn Sigma Chemical Company, and,C labelled A 8b 1970. Menger et of,1976), electrochemical!y 2 acetyla-minofluorene from pfalti anA flaucr, Inc. The gicand Adams,1970)or radiation chemr. ally (Car
p naphth 1 amine was obiained from Sc hw a r to Mann.
3
. p,, af.,1975; Greenstock and Ruddock,1976a; padiation indumf bind;ng to highly polymerited calf p and 1.u.19Mk 11 is interesting to note that in thymus DNA (Sigma Chemical Co) was determined by
[ gese methods of activation. free radical inter.
Pd i di'*
dh C"Id E h MI"""Cic d'id (I##I 8"d P!
e
Aates such as 5:speroxide radical anions (O[) and collection by high pressure f.Itration (00psil on gf.o fibre faters The f.tters were digested with Nuc! car Cb:
,a tis-g.py! radical ('Oll)are important in initiating free sue solubiliier and counted in a Nxlar Chic.go Mark giredos reactions to simulate metabolic oxida. II scmtalation counter. The assay for cosaient b, ding is glisation DCSC SPCdC1 Of the pI0dOCI5 OI thC5f based upon copreoritation of radioactise carcir ogen and j.4f4uent reactions in irradiated solution take part DNA. and upon the snabihty of carcinogen DNA adducis to pass through these fillcrs which can only retain macro.
" gaation, epoirdation (fiuston ct al.,1976) and rna.! cules whose mol wt escreds 10#n b 3)lation K sein and Fridosich,1972) reactions The puhe radio!)6s studecs were performed with the 811 t
1i
. %W:-e-a-
- 4i.M p.~&'2WMWu ym MBQfAWMa'iM6.fiS JPGbisbMMMMiM'~v2@2VW' N'*
3
.o o
e u
o uo s,
2 -..
.; - p.. ;.... w
..o...
A73 CIIse i r ins e..s t e s a.e rnt Ge os s a W P t one s a utV Van de Gruff ar n huot.cli Nck r Rcscarth roan e
i e
'O fuhmene Det,oh of the irr.utsation con.tloons, an4n of
%'3 " "
It e esp 6timtnts and the amtirrd a yoig nunt fer the
'***'8" sfetcreion of face rad <als and their tenrtic an.efWs hate
~
e*-
lun riestidsd gneiously (Gn cantod and R mt.fm k.1976 e,
Hunt er ul.,194
,,,,a
]
<v e
o lI sd M it.I5 5
We base uudicJ the radiation-indoted int or por.
}', 4.[
-y~ ~ ~ '
..p... a
e r<
ation of radioactisely labelicd carcinogens (C*) into highly polymcrifcd DNA (whcme 1):
A 2-
. *;:L~.
...a W Figure 3 Raic of ai Ed D "
c hcme I. Rad,atum indo(ed carcinogen binding hpun I aht binduq uf Me c.ounopn (nn@
inine to DNA as a functnin of r.ntation dme, follo*#I When high concentrations of DNA are irradiated in radiation induico carcinegen acenanon by she caiWI acrated aspreous solution in the presente of low con.
Sl*'i Ii 03 ' '"o Oi.
tion of 0; with the
<cntrations of the "C labe!!cd precarcinogen ANa; filot is shown for the primary water r.nfiofysis species. principally 'Oli nantly with the highly molute c.ininoren anotecuks of the line, a wmp and Of and the wcondary products of their scif-scac.
arnt these reactions can Icad to osi tatise atiisation of 0 with fNA 3
tions react predominantly with the DNA. ligure I by generating clettrophibe intermediates 'which sabe.
Supermide is react shows how the yield of covalcntly bound carcinogen quenity bind to DNA (wherne 11 Unifer these condi-einogens Some of' incorporated inlo DNA saries with radiation dose.
Imns, the b;ghest yicld of caninogen binding is 10' - 10' Af ' 's ' '.
under a variety of radiation chemical conditions. In, achiesed in the escsente of the rnost selectise oxidant.
all cases, carcinogen binding _i_ncreases liu._carly_w_ith liti. The w. iter :nfio!) sis species Oi and 'Oli are rai satmn dose Afaumum bindmg is obsc. sed in aho potent initiators, whereas the reducing radical Ilitrous oxide (N 0) saturated solutions where a!! r,; CllgilOli produces sirtually no bindmg.
Dese emperimer 2
are conserted to the o6firirig species 011. In the liasing establahed that niidizing free rajical tise spaies forenei picscnee of ethanol. Oli is scascnged to form a species are capahic of actisating caninogens in a radiation on aques mihfly midizing akohol eadwal CligilOll, whereas siinple DNA s aninogen binding auay. the kinetics chcrn: cal cardnor in the presence of bromide ions, a, scry selectise of the proposed actisation step were uudied using 11 0 -
r#
weakly oxiditing species liti is formed In both these puhe ra.fio!) sis. In siew of the importance of Of as 2
cases. Oli scascnging results in a decrease of DNA-an intcrmnfiate in rnany r.nfuimn t hemical.md bio-In ouygen usura' caninogen binding In osygen uturated solution wn.
themical pr = cues (Ilors cr af 19711. capab!c of enhi-species, formed m taining r. butanol, where Of which (foes not react biting more scic tisc reactaily than 'Oll a kinetic Of and in pure s appreciably with DNA is the major species. DNA-rnethod (Gacnstock and Ruddock,1976), was used flaO,. These ihn carcinogen bir. ding is sery low. This type of radiation. to study the rate constants for the reaction of Of actisate pre-carci induced binding. insohes 'Oli induced DNA radicals with various carcinegens. Since neither Oi, nor the reaction to gem and is found for a wide sariety of mganic molecules artisated puwfucts in reaction 1. hase any appretiable (inogens" (r eactic
(!!) field et al.,1970) absorption in the wasdlength region amenable to used to simulat.
The results obtained when carcinogen is present in puhe radiolysis study, an indirect competition Linetic initiate the met.
high concentration are shown in Fig 2. Under these method was used:
cinogens.
conditions, the water radiofysis species react piedomi.
Oi & C + non absorbing prawfuct (I) i-i-
i
,g
, ei,o Oi + pilQ.pflQ ' + 0, Gl Prc<aninogen -
oss e=a
=
b.= c o m eer.
A/Ao, I + 1,[C]([r!!QJ (3) re-Superoside radicals, generated in oisgen uturated so-
~
Pr es m.us studies g
aqueous solution tonta..mmg 0 l Af t butanol as a by-radicah react at No, su r o drosyl radical seascnger, arc reatied with a fised con-
{+o-a centration of p ben /oquinone (rllQ) to form the radi-i Tabte 3. R cat anion pitQ which absmbs strongly at 410ntn mth ca a
{
y, the rate of build up of pIlQ absorption as a function The rate constant 1, obtained by measuring directly cardnege
/
%-.-s cm,f: r-MA iw er g,, g,,
o,i
...o of time after the puhe using puhe radiolysis, is nenrotain 0 95 = 10' Af -'s-' If the absorbante of the f )Q~
Weth> h
.i.
i-a e
a e
io ec g i,,,,,
species fonned after a fised dose is measured in the bPW ih h
f fienndine ab nee (Ao) and presence (A) of dMerent concen-Figuse 1. Cosalent binJ4ng of the c.minogen f naphthyla-mme to DNA as a fun (1 ion of radatis doc. under conds-trations of cartinogen C. then Fq 3 can be used to
. sohid tion. where the carcinogen reacts with DNA radicaIL estimJte ibC Unknown rate Wnstant l for the read ammonou g
9 l
~
it.idunon.nId. Hum Of 4afunopens t
..,,_m_.,.~
879 t i:
j(
g
, g p.
197'l lhese shess umfirm that Oi, while not as
'*r
/.,
re.sctne n Ull. std! veasts u ry rapidly with a wafe
/
,s*
s.n ct, of themwal carunopens.
./ y ucady u.de radiehm studies.11 n I rom puhe and l#
f[
reactmns are oudatmn sea tens appuent that the In presious studies
j s
i
"/,.~
.S. * " *.. n. s., J with rutro wnyuunik Ilhaglow it uf.1977) it was f'"'nd 'b' 'hme <""'P""nd'
c'e 'ouc fono*ing rcitadne metaboinm whnh tould be simulated by V
_g
_._g g
_. ga c, attack m puhe urathat.d :.queous solution Some ef the reihetrae metabstes. the rutroso and hydron. le p
I ^ ' W
.g*
Rare 4 a,nonon of fi ngabylamme tu lamme dernatnes are belicsed to be carcinogeme hpe,1 i
s. Jcrernoned in empttian Onuws uung puhe r nholWcaburyr anit Wenhmger.1971) Ihese ume me o.
9 mediates are forinot following oudatne atthalmn of Im er-y c.ncmogen c ammo In bght of the urong csidense not. of 0; w uh the caronogen A 13 p. sal sompetamn that the hydrmslahd denut ses of many poin plot n shown for M \\ m I w bydrocar bons c
3 i rom the sl.yv and at Amm.n are the.n tiw of the late, a compermg raR coneam for the reastion unogens m e no (\\lAr. PDO. Wenburger ;md W cm of t( 'blth /bbA tif l 2b
tO' \\l hurrer.197.t i
n s'br.i!Hrd 4 H n mtcmu ig to noe flut both (til
's I
.wperoude t, rea ti.e w dh a und3 of thenucal car-altd ();
.HC peitent sintiats>rs of aroin flic h}dioylation emovern Some of the tale constants rangmg heturen readions diosun and I ndouth.1972; Jenna 19 10' 10'.if
's
8. are shown m lab:
1.
.n wc!! as eguu.laimn reaumns tituuon a 4.1974
'Ibe 0 -mduced hydioniations are probably indnect 3
prmessn either inwhmg catalywd Oj mduced Oil g,,,
i productmn, uccondary reactions of unstable or Thew espenments miheate that mme of the reae-products of O, attask j
me species formed by the mdnect action of ionumg In this and prenom work (Cardona rt 4,1975;
}I t
radution on aqueous solutiorn (reaction 41 react with in'o and Lu. lWL it h.n been confirmed that radra-
{
shemwal caremogen teort-mduced adnation leads to the formation ild 5 - c".117011.Oi. II 0
11. H 0.
coulently bound chemical adduds between transient of 3
1 3
(41 " ' ""E#"
T E
(
bi oupen saturated solution, the pnncipal reactne centres in DNA in the presence of high concen.
l specin. formcJ m roughly equal yickh. are Oil and trations of caremoren to scascnge the mater radeoly O,. and in pure water they can further react to form secdes (seaetmn 5L the yield of carcinogen DNA l
ss H D; these ihree raduitmn-mduced reactants may bmdmg mcreases bncarly with radiatmn dose and is
3. maic pre.caremogem m solution m an oudation highest in mlution sontainmg radiation-induced oxi-'!
dants such as 'Oli and 0 rcA non to generate electrophibe " actuated car.
3 and n lowest where these uegni rcattmm $t and such reactions are bemg species are scavcogcd. Although hydro 91 radicah are t
rcJ to sn;mlare those chemical reactions more reacthe towards caremorem arkt are therefore
~[
?
which
,mn.ae the metabohe actnation of chemical car. better activatmg agents m a simple model system in f'
the ccH they read indhcommately and would h f
aopm a sery low probaNhty of sesking out and actisating a ve j
on o, n o, t.
precarcinogem On the other hand. Oj j
- -. oudged artmogen is a very P c iaronogen -
omadm vm A tb meg d wHh w s.,...
ponents films ie of.1974; t ircenstock md Ruddock m
,7-redused carcmogen
!97M Nmg only w!ectncly reaune woh protein and li l
nomprotem wifhydryh (Armureng and llahanan t
heuom studws hase estabinhed that h dront frec thn conferencel and gulpmodarated fats (Greenst.
}'
3 t.sdieah text at ditTuuon controHed rates woh som and Ruddo k.197N t.
ock s
I ensquenth m the ce!L O e
I law I Raic tomt.nn to:
ycncrateil bnw henuath g
O.
r or radunon
( Lem na Hy.
1 i
em non anh aremogens 4 U %'m nncht eduNI a lagh probah.hty of attnatme car-i t
3
~
cu.open,. csen tho u pecw r.t m loa i
Inuasellul.ir supetoudc thunmer may wncentranon I morWrcn e be.ible to n
pmm thew dehnous &m of nontbologid r
1- %:hsl holanthr rie rundmn a w bu -ns a iw 6
c tl*
p NapMhdamme mmeamom compcres for thew supciou& radwah with the cellu-1i Hcnnanc Lir targettu for caronogenna P
lN r 4
%IAlacJ woh ool V scMtictct!al
%-* *c.! rt prescrit a umple tev of a
.commum Nonn&
P'"P d f#d"' '* M I"' ' k"""I "d"9 #"CO 4
die 45 m whkh precartmorcin are actiuted to clee-4 1
l
.~
-~.
6
~
~.. -...:.
o
. n0 C,. s < m..... m na C....., W,,..., _
~.--.r-u......r......
fe t DOE MOLIL iOH CHf MICAL C A R C INO c t re f T.15
...c.........
c.. e......
u
..................... -.r..................
r....
,r.....
Ca..,
x
x.......
~
......o.
.n.._...................
A lwl. act -
d u..
s.,,
l.cen shm jpD; Figure 4. A trdlas model for chemical cartinogenesis ihatcan R esult trophibc free radical inicsmediales. These actisated These studies implicate actiuted oi> gen in the to le ac carcinogens can subcquently scact with target nuc.
form of Of and '011. not only in radiation c.ersino-icophiles to produce a chemical change. as in the gert. genesis (Pochin.1969; Yuhas er af.1976: Kh.in and etic material of the cell, whith ultimately may triggur Kasha.1970). but also in carcinogen actisation there-the~cc11 lo~lGTne _ncoplauic._ We are presently by estahtishing a enechania. tic b. isis for, synergistic cniendmg our DNA. carcinogen binding studies to cifqts [Cansa and !!alny'.1971)_between toujeJhemi, desclop and test the efTects of selectise scasengers on cals (Scarle 1976) and radiation, and suggest the im-carcinogen activation in model systems, in order to portant pouibihtes of carcinogen deactivation or of Ik work of G culuate the relative efficiencies of the actisation step supprewing (aronogen actisation by radiation chcrne-in detail the p and the target.actisated carcinogen interaction step cal rncans.
ti M the of the propo<cd model (Fig 4) under chemically g
g defined conihtions.
phenomenon i oxigen cfTect, s so n, n.q,y, ecular lesci O.
Asmstrong. D A and 1 D. Duchanan (1978) Phor.= Arm Pharuhmt 2M. 743 755.
"circtron.alTmn Ascos. L C'. M. F. Angus and G. Wolf (1965) Chemical Indutrum of Cancrr. Au.fcmic Preu. New
O York and London.
tron, on) gen at Diaglow.1 E., D. Jacobson. C. L Gicenuock and 1 A. Raleigh (1977) Mol. Pl.a.mac. 13. 269-282.
04) radicals at Hors. W., M. Saran. E l engfelder. R. Spotti rnd C. Mechel (1974) Curr. Top. Ra!.or Res. Quart.
the superonide 9, 247-309.
11uuon. G. V 1 C. Green. R. Ili rins and S Kanji (1976)
1. Chem. Soc. Chrn C<wnmun.15P-159.
rnutase (SODI t
Byfield. J E Y. C. l.cc and L R Itcnnet t!970) Nature 225.859 86a f dou. h (1969)I c
Cansa. L 1 and C. Dalny (1971) Inr. J. RaJiot. Th s Chem. 3. 458-455.
ide radicals to i
Cardona. R A, C. M. King and 1 L Redpath (1975) Conccr Res. 35. 2007-2014.
Gelboin. II. V.
(1969) Cancer Res. 29. 1272-1276.
Ox) gen. Recen Goscin S. A. and A. I'ridosich (1972),4rch. Ri.. chem. Biof,s s. 153. 778-783.
(1974) on Ach.
A Greenstock C. L and G. W. Ruddock (1976) Int. J. Rad,ar. Phj s Chem. A. 367 369.
(197Q on E co Greenuock. C. L and G. W. Ruddock (1976a) Radiot. R.s 6?. 531.
pmtecsc crc Grecanoch. C. L cad R. A. W,ebe (1977) Al siracts 5th Mcc ng Am. Soc. Photobiol., p. 48.
oA) gen enhan lleidefberger. C.
(1973) Adr Cancer Res. 10. 317-3 4 lloffman,11 D, S. A I esko and P. O P. Ts'o (1970) Rim h. mistry 9. 2594 2tos taken as eside llunt.1 W. C.1. G,cenurwk and M.1 Ilionstill (1972) Int. J. Radiar. Phj s Chem 4.87-101 and Fridosici 3 chic. L and R. N. Adams (1770)
1. Am. Chem. Soc. 97, I U32-13337 3esina. D. M.
(197)) Chrmrec h 120 127.
tions might a-Khan. A. U. anJ M. Kasha (1970) Ann N.Y AcaJ Sir 171.24 13.
the chemical Menger. E. M. R D SpAane and P. D Suffiun (1976)
Rm.h. m. Rieph) s Rn Commun. 78.610 616.
Miller. L A. and E. C. Mdler (1953) AJr. Cancer Res I. 339 396.
been shown l Miller 1 A.
(1970) Cancer Res 30.539-5 4 mycn in the Miller. E. C. and 1 A. Miller (1966) Pharmac. Rrr. 18. 605 838.
tise with a u Pochin. E. E.
1969) R..liation.indurrJ Cancer. International Atomic l'ncegy Agency. Virnna be unequisoc Searle. C. E.
(1976)
Chemical Carci.rog.ni. American Chemical Sosiet) Wo.hington. D C.
Ts'o. P. O. P. and P. Lu logic 2il caper (1964) Proc. Karl Acad. Sn U S. St. 171-279.
Wang C. Y, C. W. Chiu and G. T. Bryan (1975) Riochem. Pharmac. 24. 1563-1563.
This work Wang. I. Y., R. E. Rasmussen and T T. Crocker 18975a) lafe sci. 15. 1291-1300, I
d 1*Md Weisburger 111, anJ E. K. Weisbuiger (1973) Pharmac. Err. 25.1 &
has been sho Yuhas.1 M, R. W. Tennant and 1 D. Regan (1976) Riology of Radiation Ca.cinogensis.- Raven
- be a '03 que l
Press. Ne= YorL
~
D.
./.&,
$m f
n.. ;
Y f &m rF COMT&T100$f & LOA f I
l NO l l.'S 421
'l l."' I I
"Ddfusion from a Stream l'!owing through a terastions in esperiments at the animal r.cl. ~Ihe w ere Cylindrical Tube", l' roc. R. fr. Arad., Sa t. A52 e
tw be-i 163.
purpine of thh note is to introduce a stochasue model of caninogenmh that incorporates i.crtam t) be.
lii63 Ilillary J. J. and Ta> lor J. G.,19M, 't he phenimieni scranting ihr scipiential mter.o.finen of he Civil AGR Ifighly Gn Treatment Test,(!K Al:A of so t.oiinort nw and to t
Report No. NhM(WI.
present some pri. h.
Tah!c Kr78 minary evidence of the conshtenc> of this rudel 1%ec.
Kric(niak J. W. and Porstenddrfer J.,1978, with obser v ed ipu ntilat h e dose-response
" Selection of Some i dter Matetiah Used in relationshipt
Iant C and Sampling of Airborne Radioacthe lodine and Meth>l lodide", In preparation.
Certain espenmens with chcmie.d carcinogens j have shown that relathcly stable first tranutions Trees Po68 Porstenddrfer 1, 196M, " Die Diffusion-can be mdmed by low les ch of sertain I or of skoeffizienten und mittleren freien Wegl.ingen carcinogens, in such a way that later applications ii der geladenen und n' utralen Radon-e Folgeprodukte in Luft",2. l'hys. 213,3H4-396 of sometimes the une, or sometimes different.
usion hion substantes can produte simdar tumor appearance Tc73 Technical Repoit Series No. I 4R, 1973, time distnbutions th s3; Po59; lle49). ihese time
~
ds Control of Iodine in the NucIcar Indu stry dhtribmions wcm to be relatisely independent of of
[
(Vienna: I A E A).
.d h the time bctween the brst and second series of Tw62 Twomey S.
1962, "Eiputicra for the idon Decay by Diffusion of Particles in an Aerosol treatmenh. Aho, in some esperiments a resersal
[
f the
'Y of the order of application of two substances that Howing through Circular and Rectar. gular
- io n.
Channels", Ilull. l'Ohiere. I'uy de Ihme A,173.
piesiously acted as co carcinogens wouhl fail to
['
'^c 4
i produce an> tumort
~I hese obsenations tHror,6a, b; ilro67) led to the
.t to i
the moibneation of an earlier stochastic model of L
01) t hemie.d carcinogenesh th 50; Ar641 to mo oansw i mms'e m awume mt>
He Phsus VW M 4 4ugL pp 4?id.'8 that a specific second transition was necewary
[1%'"/, 'd["
""*d '""" """
he{pgg a ggjgp[ar, %sthe) d couM arrhe at ett the " tumor state", where it we aid then grow by a
,h specihed stothastic rrowth precen to a clinically in lN observab'e rumor. Moreover, since the second T
ggg.njgjpg gangpg, aggogding jo geggain egpegjmen-tal obsersations, be an esent independent of the A Stochastic Model of Carcinor,enesis in.
first transition, a cond tional probability for the d
6 corporating Certain Obwrs ations l' rom I"' ' d "I d "C "" ' " d "" 8 5""
Chemical And Radiation Ihne-Response Data' postulated. rhen a cell preu!he tunior state was ously mduced to the g
g;g g gggg g.Ihe use of a conditional 7
af (Receited 14 July 1977; arrepted 21 NoirmNr probabihty for the second transition in derhing k
t 1977) thh model will be seen to provide a number of qualitathe as well as quantitathe umilarities of jf i
A Ntmut u of quantitathe modch postulating two the model with obscased data. These simdarities 4M or more stages of ce!! transformation before the base been observed for a broad clan of earcino-
' tumor state k reached have been proposed to genie phenomena, includmg cumulati e tumor in-D describe claues of Jose-response data in chemical cidence vs dose, average tumor appearance time i
and radiation carcinogenesh (Hru$8; Hu65; Ke71; ss dose, and eff ects of changing dose-rate-but so
?}
F Hau73; Sh74; Ro74; Wal75; Ho76; Itrow76; Je76).
far in a limited number of experimer.ts involving
~3 e
3 However, although these modek hase been useful carcinogenic chemicals and/or radiation.
A in clucidating certain aspects of carcinogenesis, 11 will be useful here to summarire some basic l
stages in the derivation and mathematical forms of they do not take into account, nor pros ide theoretical descriptions and adpatab!c parameters the model, both to dhcuu ways in which the T
for. ecrtain obsersed sariables and stosh.ntie in, model can be adapted to radiation carcinogenesis
~
and to indicate some stochastic properties of a m > del that are neccuary in order to be conshtent
'This note i a preliminar> presentation of some with currently known sperimental phenomena.
flowever, before attempting to use or estend the of the author's s iew s and obsers ations on carcinogenesis, and is not intended to represent model, the reader should refer to the detailed Wcial views or policies of the NRC.
presemation of the awumptions and limitations of the model(llrotAb).
+
a
Y:n 422 NOTES The conditional probability of a hrst "es.
citation" (or transition) of the " cancer control where K,is the probabihty that a center in the hru l r"i D ss C. althoug center" withm a cell
m (t. t + dt) g ven it was stdl enited stj. te at tinic i will change to the second I
the log. normal fu, unexcited at time i was taken fre.n Isersen and state withm (t. t + dt). per umt concentration C(t).
rn,n
,,enseniently) as a strai Atle) (lv50) to be of the ume carcmogen. and the mathematical"
~
- per (Fin 62) for a w symbok for condition;d probabih. ties are dehned as.
in Parten (Pa62). Ily m, tegration of equation (q,.. l Y,. K.. and A, with the p,(t) = K,C c"' dt.
(1)
.,ne being adjustable I the conditional density function 4:n(t[t') wu
\\
l where K, is the probability of the first transition obtained in cimed form (Ilro66b). and used to birameters. Experimenta mber of single chemi.
ebrain the the probabihty that a given cance,
'I per unit concentration of carcinogen in tinue for
,.und to approsimate 1 control center will be escited to State 2 in the rirne at the appropriate site in the cell) at t = 0, C(t) is interval (f. t + di) ghen that the center was in the !
7,,p,bihty paper plot o'
ew duo 66a. b; ilro67; the concentration of a given carcinogen, and A h normal st ite at t c 0

the rate constant for removal of the carcinogen j
,i.iany cases by the the from the tinue. Thus, the probability that a cancer
%:!icient data are now l
ber of eitperiment5 control center, unescited at t = 0. makes its first g g
)
transition within (t. t + dt)is nber of animah) to int j
.a a mnships for radiat d F - F,( t + dt ) - F,( t ) = [ I - F,( t )l A. Cc *' dt.
't he consolution integral of equation (4 represents jien ht the log normal 5 the sum m er l' of the products of the probahhty l
h,e,,t al stage model (
(2) that the hrst citeiration occurred m (t' i' + dt'l and the conditional probability that the second occur.
l a normal shape is sorr where Fdt) is the cumulative time Jntribution of m., sed dme plotted in the hrst ciicitation the factor in brackets is the red in (f. t + dt) given that the first occurred in it.
l
,3,mmtered dme in pC t' + dt'). This type of integration is a necewary probability that the center has not i een cuited by step in the desetopment of any quantitative mood l
'....Juce variable absorbi time t, and the remaining factor is the condition.d that can be espetted to adequately represene i,,ran,e times or deat probability of cincitation p,(t) (som equation (1).
esperimental observations reg.uding the necewiv
,t. c a. 70; Sa76).
Integration of equation (2) followed by differen-of two sequential transitions to form a tumor Mt.
t he two sequential sta tiation of Fdt) )ields the probability density
'Ihe consolution of equation (5) was aho i+
wh in log. normal d(
function for escitation of a cancer control center mulving either nes to the fint citeited state tegrable in cimed form (ilro66b), and gase ske
.uterm application of ik following mathematical form for the probabhiy wlish might abo ma density 4At) for citciling a cancer con!rol (enter hat i a stmn, with long ter dt c it p (1 - e ) )K Ce state,y) in (t. t + di): normal at t = 0 to State 2 (the " tumor 6,( t ) :
=.
4, k
..bahht) of) conce i
A (h
.. holy is products at p'
. f the dose-respome d' Up to this point, the dern.ahon n eqm. valent to 6At)dt = A. - A exp KrC/A - At*
-c
.h ire mso s e shorter e 7
A
,.I some in olve lon that in the Iversen-Arley model tis 30).
Now, a specific second transition, conditioned
..t.imns mer a longer i on a specific first transition hasing already occur-
. egp (. K,C/A - At + K'Ce ).
dt.
A red, is introduced to take into account obsena-n
[ 1' h,, n,
"o tions indicating the importance of the sequence of application of two different co-carcinogens, as well when K. / Kr. and A / 0. Equation (6) was foed as the stability of the first transition (llro66a) The by me of 1/Ilmpital's Rule to appropriately com yy[
conditional probability that a cant er control center serge to the clmed forms obtained by ducst pe_
will be escited to State 2 in time interval (f. t + di),
deris ation for the cases K = K, and A-O g 3a given that it was previously escited to State I in ( th o66b).
time interval (t', t' t dt'). for t' < t. is Convolutmn by numerical computer integration l
6o of 4At) with the Gaussian tumor growth-inc F>ntt + Jtlt')- Fmujr') = 11 - F,nt tjr')]K,C e
dt.
dhtribution of Iversen and Arley (1950) then wn p
s o
(.1) used to obtain the tumor appearance time on-pya tributiom d w (t) (llro66b). Double integratwn
We are considermg probabihties here with gase the cumulathe dhtribution F. u) of numer u
respect to a particular, semith e cel!; i e. the appearance over time, as a function of ton e>
probabihty of changing thk cell to a single cancer tration C. as well as the (meaningful) parameten cell may twome large at certain carcinogen K, K, and A. For sulheiently long, or close fd uj _
concentration, but the probabihty that any cell in the anim.d lifetime l', F.,.,(l') s s C rerresenh IM the entire sotume of tinue espmed will be dose-response relationship in terms of perter.t d o'
affected aill sti:1 be estremely sm di animah with tumars s s concentra ion.
I
.. o.
l c.
f. ' '.j ' N I.-
(
'J
[
o.'< - 3 p, s
n y y.;v:., ;. w,
m.mp;; 7
.s,s e
g-
- y
~.
~
~ r3. o, y,3,v.
ew 1,
. ~..-
,t... '
4; g u rg a% x[...
.'. %[$
'N
(( h h,y R,w ~. n
,,s,.f.8Nb.? t..m J
%~
y,b,
(', P
{
M
,sr
.r.
--u ".. '
~
o a.4 y. hk
'.,R )
[
. ).
4' d
~ ; i '
. s.
gl _.,
y a
A s
.t
h c.
.V af
...g 3
^
s r.=--
-i, "G eh ; ~
,.. h ;i t.
> ~,
J.
- g;.y
. p g.s,\\
' 6-
.s s
+.
.A.
N O ll.S 423 er in the fn a
[
h,,(T) ss C, although ddierent mathematically result in dose-response lines of lower slope (larger a the werd imm the log-normal function, was found to plot standard geometrie desiation) other factors being ntration ( u.
(conseniently) as a straight line on log-probability similar (see l'igs. 1-3). Single doses of euernal na t he mati...!
pner (Fin 62) for a wide range of parameters radiation of low I.l?.I' produce sharply rising dose-
.re <fehned,
l K,, Kr. and A, with the slope and position of the response curses. (See, e g. Fi;t. 5 and Shci! barger equation ::.
line being adjustable by adjustment of these rt al, IW4, which also illustrate the competing risk irid tlr's w.n i parameters. Experimental dose-response data for a of animal or cell killing, or other competing ynd uwd n,
,, umber of single chemical carcinogens w n aho ctrects, at higher dose leveh. Any stoc hastic IVen (an.cr found to approsimate a straight.line on a log-moilel dewribing dose-response relationships in 2,n the imk pmbability paper plot oser a wide concentration the lower range of dose would require the i
r was in ite unge (llro66a, b; ilro67; Dr65) and could be fitted subtraction or multiplication of an appropriate t in rnany cases by the theoretical F.,,(t) vs C.
term that l>ecomes effective only at the higher Surlicient data are now available (from a limited dose lesels, as indicated, e g. by the data in Figs. I, 9
rumber of experiments with a sutliciently large 1 and 51 l'i dt' 6,
cumber of animah) to indicate that dose-response in the plot of l'ig. 4, lung tumor incidence relationships for radiation carcinogenesis may produced by intsatrm. heat adtninistration of Cc.144
5) represem' dien fit the log-normal shape, or that of this two n beta dose (('c64), two points are plotted to a prob.dula' sequential stage model (see I is;s.1-4). Aho, the show the agreement of the Ce 148 data with that
, t' + del and bg-normal shape is sometimes obsersed for ab-from beta irradiation hv ""Ru "Rh implanted in i
sond ou u sorbed dose plotted in rad, and sometimes for pellets II.a64. Itic pellets were implanted in such tunedinu 1
.Jministered dose in pCi or pCi kg-whish could a wa> that the beta dose to sensitise target celk of pmduce variable absorbed doses up to tumor ap-biont hial mucosa could be acc urately calculated.
4 "cC C " " '
rearance times or deaths in indisidual arimals (l.a64. l'ortherrnore. I_askin et al. showed in this tatise moat IY ' ' P ' N "'
l ' (IA3,64,70; Sa76).
paper (l a64 that their dose-response curse fitted he nesewan lhe two sequential stage model also happens to the log normal shape all the way to 1.6 x 10* rad.'
a tumor seit result in log-normal dose-response shapes for
'd5 d I'"
cases invohing either short-teim (A large) or -
nd gne ite longterm application of the carcinogen ( A close to
Of course, calculated doses to certain target probabih" rero, which might aho simulate continuous ir-celh serse here only as a relative index of dose.
.ntrol tenn '
i rahtion, with long. term maintenance of Ohe 1 rom any such conditions of irradiation from a Ohc
t""*'
probability of) concentrations of particular thed beta source, it should be obvious that there
\\
radiolysis products at particular cell sites). Some are celh exposed oser a wide range of doses and of the dose-response data fitting the log-normal that this situation implies some comptes depen-t + bb, e I
shape involve shorter effectise half-life nuclides dence of the parameters of this paper on the A
and some invohe longer term irradiation. fr.
probability distribution of " hits" on the a p-radiations over a longer time span often appear to propriate positions of certain cell.
dt.
(
i i i r : iisy
-T T7 TT T T]
i t
t i T TTT' 90 iTg y 1 g
.o _
U i) w as f outtd 70-0-
priately 6on e So l 40-se d by doc r and A 0 g
3n o, i20 =
y
(
integratton
%n gr ow th-time so 501 then w 3 _o t e time stas inteflalid o p, M. g,,,, we m an rm A 'M ' N - i q ters,n rotg (t) of rumol p
of (onten' s
(
f.m %u,n on,
s,,p., w,n a~ 'e n,, no e paramen t-
. or close to 7
7
A-1
A
'd -
' '),
g
'1'N presents the i
g if percent el
% a m,eqn,,y, ycfg i
)
Fm.1.
1
%i n w n p s
!I
rF M4 NEI !3 derD aN 3
00
,,,t-T-- TvT T T TTi Po
.Ml gqoJtion% I oc
(
I
.D. I g qeriments w 6,
- k
,,. r.ediation in S
]
p
({
-.b g
..hemical pre r_
7
{
r, 7' a
d.
orgte I)pe were
,0.
5, ~j l
. [i. t
.n> gisen doW s
E 8:
o C*l *4
l44 (4 gg,q y
,4 t
sti g
y hsq correr e spn g,,,,p ms
',n,e tMo75; I, s-o g
a R,*i w to u. wi.,.w,.
"[
m t** r"ima * =.
esen with tadiat5 a
hess % -v.,-o p a.k-rw riswn tor, i.suno oner%--
l 5c molecular la i
6 e,.c== wis.as n w ni j
1-a J A L11tg _ L 1-L LA.ua,
..caly by radi apma 4r em,, or s,1w,,a os woe.n r t *9 " 'a 'o'$ w tea eaw=..
,.w rusm m9 ve a rusws esosed e-en l
IM Iocations+
Sime ionj ge,,go,ri,sontraman2o,.
g:,g, 4, g
,;,,n,
+cir ow n right. (
i..
.1
,,,...i t
m.tesular radica W
Amroge tuse dse frwer Pij, rod
- --- g -- g y v t T T T f T~T~T T p
g n w((h 14 0. 2, kw
.iuon with cons
.,e. ihen K a t
["
i 2te constants !
T T TTf[
T T Tai T T T~
^
~
['
arektuce the firs M
f]p;.
^1
'o at,o. A may tw f-
{
f.., pulses of lr
,,,9,,g-E, so
,.nt,nu m W v
/
E-1.J n,t nis prod 4 ws.ui emww, '.""w=*w' aew **,,,,ne,..
a
entration (j o
/,. #f d no a va 5 'or'.o" a (a " <6 i
\\ sequeriec '
s A
r 9
(MJ'03) g 9 O
g g"j,cg wpuld, l
E ok
" ' ' * ' 1,7 _4 _ _ 2. t_ i. m m.innsofthe,
..t hem it n.al 1,
a m c.a
~,,~,m.,x..,..,,,
a o. w.o, m.,,a e na 'ro llo.5.
P"""""E g'1 w..n,o m.,.
.au. w ce...
g ON ratrote-ev9mt oocyrear. saurrm e rys.
u t g an gtion reato.itm ob '70 nt gv n ei in 94) a orum,t.cwz.,, coin,w.,0.a,v'_M'4' Although the model as presented in this ruse A
I it e ' hemical t_ i_a_ut u.4__
_n _n a 22.u i. =
deals only w. h the probabilities of induction of e
m ir uw, w w"W.
transitions in a single " cancer control center" hv r i.,
I'io. 3.
single cell?), the model may be easily estended
""S#"'
' ' " ' b" #
logically to any number of postulated cells or s.tes
"""I#
(Note that only a small solume of tiwue w as when a large solume of tissue is exposed ta the
'"I' irradiated.)
carcinogen (llroub). Flowever, since the neces-I t.c uos h.n Data on tumor appearance time vs radiation sary specific interactions between carcinogens ara I
dose or administered actisity are also presented in the susceptible tissue sites have been shown to be e a number of the references cited. Fumor ap.
cxtremely rare events (Mo75, War 74). the rnudel
^ "]"" " #
pearance time in radiation carcinogenesis generally established on the basis of the first tramformed 'k decreases with increasing radiation dose and in-tumor cell. or not more than a few. may st.ffice for creasing tumor incidence in a manner similar to purposes of setting radiation protection standarJs l that predicted by the model(llro66b).and also that at low doses and dose rates.
.,,'.[",", g obsers ed for applications of sing!c chemical Although the model has been derised for only a caremogens (llro%b). The shape of the tumor single carcinogen applied in concentration C 8 appearance time distribution depends of couse on t = 0. it may be noted from the form of equa:. a
],
. s; g,
the grow t h-time parameters anumed for the (6) that terms containing C within the bradets ae
',,, q particular tumor-type and species, although the either of the products K.C or K,C. Thus M
.,,. bi cumu'ative lifetime tumor incidence u dose adjustment of K and K,, it may be powiWe fa
,'g.,,jolo corses are generally not sery sensitive to ominion empirically simulate experiments where a secorst ;
or inclusion of the growth-time distribution in the co-carcinogen is added in concentration C: 28 i
,c integration (llro66b). particularly for animals times on the order of those required for rnost d esposed early in life the first transitions to occur. Neverthelew. a r.c=
0 m [',
s
.'s
,e e.p,5m-
iph
,A %
g, -'..
(
y Nr.
.t
t
f. 4, }*c'.y; % <..
r...y. ' (g.g...
4 ll>
e
-L yn 4,
j..n.,
4
.O..,3 q 7
.. *v,
9 g e
e
. 4 6 & h; v',
g
>;g
' N
-l)
[*f
' @.t w; l
~*
s
~.,,
a n
..s
, pg%g m..'9
,1 i Mlt
]Gj j,}N$,
h W
f..; L t
\\
N O I'liS m
425 r
derisation incorporating steps similar to those o cau,tions (lH6) would be needed to reprcsent i encre.y., independent of dme les el, w ith the esperiments with two dsfferent co+arcinogens, assumption that cash type of radiath'n rroduces
[
' e C. radiation in sub-optimal amounts enhant ed by lethabt> by the s.sme set of rnethanisms t ut with
, a chemical " promoter." llow es er, if radiation of a ddiering potent y. Ihus, the Iwo stare sequential I
d single t>pe were to be administered continuously # unchastic model may proside in alternati,e model I
a.u..u cd,. $1,,ol at any gisen dose. rate, the single carcinogen model to the log normal for interpreting a broad range c
W <m - e
" h '*
rnay still turn out to be applicable. Recent esi-radiobiological and tosicological effects. The log.
Q*A"D.$, i Jence (Mo75; Tr76; Se75; War 74) in.ficates that normal model in toxicology has al
%s esen with radiation, the carcinogenic transitions at completely empirical mom, and can be derhed r ' ' ' - ' ' ' '
the molecular level are more likely initiated in-theoretically only under ihe auumption that the n
o u te mww,,
arectly by radiolysis products near the specific biological end result is produced by a large number DNA locations, particularly for low I.ET radia-of multiplicative factors and events, each differing
,w
.8 only slightly from unity (Fin 62L Esidence is their own right,it is pouible that the same induced ' ihastic deposition olp.
,I noiccular radicals ultimately produce both the tint of 5ariable quantities of energy transition with constant K, and the second tran.
at microscopie utes (on ilE order of nanometen in sition with constant Kr. If this turns out to be the difiiension) can induce nonearcinogenic mutations o
that case, then K, and K, may be derivable from the may result in biological effects other than d
ancer (flail 75; Ke71; lle76; War 74).
d raic constants for the chemical reactions that groduce the first and second transitions in DNA.
Data on human carcinogenesis by radiation, al.
j Aho. A may be adjusted to specific linite values though adequate to establish reasonably safe for puhes of radiation, or set equal to standards for protection of radiation workers (due 7
o for to early epidemiological initiathe (Ev74; Row?5; y
sr.tmuous preJuction (and replenkmenti of thow?Ml. is (fortunately) in the author's opinion
,y,y,
%. e.
r del > sis products to maintain a continuous wncentration C.
not plentiful enough to dhciiminate between the
.a
' ' "M y o%. ]
A sequence of protracted multiple irradiation shapn of sarious modek (llrow76) estendmg into u
"'I pubes would, howeser, require some additional the towt r dose rances. Ihe present stochastic two.
N * * % i. ce mathematical analpis to represent competing sequential str.ge model does contain features,*
reactions of the active molecular species in cither however, that could account for the sometimes
' promoting" to the second stage (tumor state) a greater carcinogenie response obsersed for the trst transition aheady produced by a presious same dose gnen at lower dose rates (within a esented in this nett puhe. or initiating a first transition. Radiation, and s ertain iange) both for radiation (llrow7N as wc!I 8t'c5 of induction a
'"Sc 'hemical carcinogens (llro66b);a're known to chemical carcinogens (llro66b). l.ower dose-as r control eenter" hir N able to act as promoton alone, as well as rates and euended durations of uradiation, would be casily estendrJ rarcinogens particularly he more effeitise in situations were or initiators, in appropriate dose stulated cells or sitr,
' W es (in exception to the statement that
=
radiahon was atting piimarify as a promoter in the se h exposed to ih, pmm ters are not generally earcinogens or in-presense of acthe chemical initiaton in the en-
r,smcc the neces malon (Tr7N].
sironment. Since Ib(r) n C approximates very een carcinogens arv lhe stochastic model presented here rnay notclosely the hhaped cunes of the loenormal e been shou n to tw N
War 74), the mode'
'I "". be ujeful for understanding and piedicting ~ fannly, the model could aho account for the sopra-se first transformed
8'"'e effects, but may aho turn out to be linearity in the leukemia incidence n Jose data of (Al phenomena invohing two seque ti le to other radiobiological and toxicologi-Iliro few. may suffice for as observed by Itaum (llau?3)-particularly in consideration of the rotection standard, na stages of yteenesis. The log normal dose-response shape k tho been obsened in esperiments on 30 day
~
derh ed for only.i It "the proper convolution of the conditional oneentration r j M. ty of mice, produced b) 44041eV and 730-protons and by X-rays tilra63; lira 64). Aho.
probabihty of the sceor d transition 4.n(tlt') with form of equanon the dose.tesponse lines on a log nor mal pl t 4,(r') as in equauon (5), builds into the resulting m the bracken are o of the feV and 730-McV experiments were each formula of equation (6) a probability of fero of r K:C. Thus,tu 8"allel to the respective X-ray response lines but reaching state 2 before state 1; thus events that in o be possibfc r) 45 Ebiological variabihty") were characteristic other modek would allow the second " hit" to be s w here a second
( the mouse strain used at each laborator c!fes the at any time, are " wasted"in this modelif centration c.
a, imhw
y. This A enperiments (Fin 62) as allowing a single relaould be interpreted in ordinary sired for rnost cf more striking if the model is extended for ap-
< crtheless, a r:c.
8"e potency (Rile) to be assigned to each plisation of 2 ditierent co-carcinogens ating in proton concentrations C and Cr.
(
.Y n j,v L WJ ' +4 '
h v.
+
~ ':
(
ra 426 NOTES p-J.
competing risks that obviously were elTestise at titatise dme-rc<.ponse relationships is among the higher dose levels.
objectives, a sulheient number of animals g I g.,a
.% rh% N l#
d"d M"O Relatively little additonal human data on radia-be insluded in each dose group of interest so ig, '
sf <do me t o.rtand J-) ( Mdd'*
tion carcinogenesis will appear (hopefully) in the the variabihty in estimating the "true" expegg,q near futurr, under present and evolving standards proportion of tumors p is not greater than 3
}
an onsin Pscssb of radiation protection, particularly with sufficient desired s,. on the sertical probability scale; e g
,s Dailey N A-I hc R"d "b'"t"E"
statntical precision and accuracy in case should be large enough so that V(P<d N N r.,
t identification and dose estimation to improse where q - I - o Preliminar> cstimates of p %
sariita.ns in lineri understanding of earcinogenic mechanium. Ihus.
be made from plots similar to thme of I;g M q e,Jiations". m: Adi rnore immediate progress in understandmr the appropri.ite published data, from esperiments th.w sd sp I ti dited
'c* Yo'k AC"d#"
quantitative nature of dose-tesponse relationships might be e spected to proside similar dow c
it.or W.
J..
at the mammalian level will depend on animal response relationships. Also when the study c4 e perirnents. Some suggestions to make these dose-response shape is important, at least 3 ci,.
cenn" in-Adra-experiments more helpful in developing "rnacros-mal groups vatisf >ing the preceding inequahr, l
s. '.t. p 242 t Edite wpic" theories useful in clucidating dose-response should be included. It is suggested that salues og i,
.Me M iINc* "h H e' e'd'lu m L" '
Ildt"" I U phenomena are:
not greater than about 0.02 would be helpful 4N 4
(1) More experiments should be carried out to improsing cmrent dose-response inform ition.
acu examine the potential for radiation to act as a (4) When an e speriment is complete cdl amma,s a..n..r3. W h
~ d/or promoter) with hase died and autopsy results are evaluated,, a
.A Honadi P'lh.e co. carcinogen (initiator an other known chemical agents. Such esperiments quantitative data on all animah should f.e pe.
l gw!d J. and I
~
should include esposmes with single doses of hshed along with the analyw. of resulb. Iha data L ' # "I (,"I""E radiation. accurately measurable. both before and should include: estimated appearance time of nru L8 "" " I" #
Hradfe> IE J-after application of chemicals know n to be tomor in each animal; number of tumors of en s.
carcinogens by themsches as well as thme that tspe in cach animal at autopsy; times of auters, w
on J A and S att only as initiaturs or promoters (llro66b.1.a6L and/or death; timeh) and age (s) of administrano.
C'-
II C' "
1.a70). Also, time intervah between applications of each carcinogen; the dose level and man od "OP L R"D I' should be varied for pairs of espmures where tissue esposed for each carcinogen apphcanon..
't b" l' M N" sufficient numbers of tumors appear, to test the appropriate units; the cumulatise fraction of re.
H'*UO E stability of the initial transition as well as the time mais with one or more tumors integrated a.e, i H'od,h A. and
" M P'"I""
independence of the postulated growth-time die lifespan for each dose troup; and estimates.1 E"1n h
\\ P tribution. Ihperimech shou!J aho be carried oct a.crage radiation absorbed dose in rad recened h where a chemical known to act only as an initiator tinues of interest within each dose group up o
'N 10 N ' l
' ' ' tuods4 A at specific concentrations is applied first and then (linical obsersation of the first tumor, and up to graded single doses of gannna radution are applied time of death or sacrifice. In this wa). ipunntan.c at a specific time inters al te g. one monthi follom data of interest on indisidual animah rnas N Re'P""'C P'
'k d' Ph"k' N ing the initiator, ic_ radiation dose groups lower pooled appropriatelv b futme researchers or re-
, t m Hcolth h than tumon would be obsersed b) radunon alone siewers to obtain better statistical power for,
H'"Ab I and estending to a 'ose range where up to 50'f s estigating sarious apuntitatis e aspech
"' I " d "' U "" '
tumon or more would be obsersed Repeatcd c ar cinogent sis M
U ^ '"' " I '
esperiments of this kind, sar>ing the time inten al paA Wahl between treatments, could help characterite the
" * 'u s of M tumor growth time distnbution for a particular A ArmwicJurments Jihe esecilent work of Georce
' ' ' " ' I h ' 3 " 3 species; present esperimental methods would not Elt hin in designing and producing the figure la> out 's
^
otherwise allow the obsersation of the moment of appreciated. Eileen llayeraf t's e xcellent anistanse H'"W A transition of a cell to the tumor state in riio in with manuscripts and correspondence is aho e
"'h*'n.
Model order to obtain direct measurement of growth preciated. Charles A. Willis kindly re-programmeJ
";# ' "I I time distributions.
the modeh for use in this paper.
(2) In addition to other plots that may be of "d
'*3
' " ' ~ '
interest, the hfetime incidence of animah with
"'"""I tumon at each dose lesel should be plotted on a At iI N HFooW "I ?
log probabihty scale, with probabiht) on the th < upational licutth Standards Ilranr h sertical scale as in Figs.1-5. for ease in inter-Dirnion of Sitine. Henith, and comparing data of different esperiments and for Na/cgucrd Standards
"{
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consenience in weighted-regrewiun analph. of the Ofn r "f Standards Dei clopment g,
probit sersus dose Ime t Fin 62r U.S Nm icar Regulatory Comminion
' ' ' N
0) in esperiments where informanon on quan-Wa shington. D. C. 20s55
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N o rliS 427 lionships is among th M m nces ment of Cancer-Associated Dose to the 1.ung nhet of animals shou)t.
e4 Ar'ey N.,1964, in: Sim hustic.ifoJcis in from "'Ce", itcalth Phys. lo, 1177-1180.
roup of interest so th Aftditinc and Hiology pp. 3-39 (tidited by Dr65 Druckery 11.,1965, "Quantitathe Aspects
.g the "true" espe tcj Gurland J.) (Madison, Wl: The Unisersity of in Chemical Carcinogent sis" U.l C.C.
s not greater than ani Wisconsin Preuk Syn:posmm on the Risk of C.reino.:enis Et'eet s
.robability scale; e y g gui;$ liailey N. A. and Steigerwalt J. E.1975 Due to Administration of Sorae Medi:al Drugs, so that v'(pq/N i.,
"The Radiobiological Implications of Statistical Paris, 3 6 Novemt er 19M.
r) estimates of p m.[.
Vanations in Energy Deposition by Ionizing liv 75 th ans R.
D.,
1974, "!:ad.um in Man",
to those of Fig. Is..g ud,ations", in: AJcan es in Radiation Hialogy.
ficahh Phys. 27. 497-510.
from esperiments :h4-Vol. 5 p.1 (Edited by 1.ett J. T. and Adler 11.)
Fin 62 Finney D. J., 1962. Prchibit Analysis,
'roside simdat do c INew York: Academic Press).
(l.ondon: Cambridge Unis ersity Press).
o. when the simh,-
16ar74 Dair W.
J., 1974, "Tosicology of Plu.
Fink 69 I mkci M.. Itiskis II. O. and Jinkins P. II.,
mrtant, at leau i aru tonium", in: Advances in Radiarisn liiology, 1%9
l'osicity of Radium.226 in Mice", in:
preceding inequalu, Vol. 4. p. 242 (Edited by 1.ett J. T., Adler 11. and Radiation.Induccd Canccr. Proceedings of a cested that salues of,
ZeHe M )(New York: Academic Press).
Sy mposmm. Athens STl/PilH/22M pp. 369-191
' would be helpful i.
tout 3 llaum J. W.,1971, IIcolth Phys. 25. 97.
IVicnna: I A E A ).
'onse information be49 I erenblum I. and Shubik P.1949 Hr. I Ile76 Ilenfelberger C.
1976 " Chemically and
, complete tall anunah Carrar 3.384-386.
Metabobcally Induced DNA Adducts:
des are es aluated t.."
1976 lionaiti.Pellie C.
Ilriard Guillemot M. l.
Relationship to Chemical Uminogenesis" in imsk shouh1 he p,a.
Vemgvid J. and Yrcial J..
1976 "M uta tion Agine, Carcinm;cnesis and Radiation Biology-a of results. 'I ha a e Tbcory of Carcinogenesis in Retinoblastoma",I the Role of Nucleic Arid Addhion Reactions
'ecarance time of I.
6atn. Cancer Inst. 57, No. 2,269-276.
pp. 341 160 (Edited by Smith K. Ca (New York:
'er of tumors of c.J I4ra63 Dradley F. J.. Hrodsky A., Doolittle D. P.,
Plenum Press).
09. times of antern W.ason J. A. and Sutton R. II.,
1%3, "Relatis e Iv50 hersen S. and Arley N.,1950, Acta. path.
chl of adminiorau -
healogie EITects of 440 MeV Prutons and microbiol. scand. 27, 773 -80 t se lesel and man 125 kVp X. Rays for Acute i.ethality of Miec",
h53 Iversen S., Ergelbreth-liolm J. and Noring
inogen apphcatwn,
hil Ant. Phys. Soc. ljunck 0.,195 L acta. path. microbiol. scand. 32, 218.
lathe fraction of.c.
Bre4 liradicy F. J., Watson J. A., Doolittle D.
Je76 Jee W. S. S.. (Fdd.1976, rhe lfcahh Efects integr.ned,,, c P., Hrodsky A. and Sutton R. 11.,1964, " Rile of of Photonium, (Salt I.ake City. J. W. Pressh mors sp: and c timates,t m.M eV Proton Radiation Compared to I.a61 1.askin S., Kuschner M.. Nelson N., Al-me in rad recchcJ t.
125 kVp X. Rap for 1 D50(30) of Mice". IIcalth bhuler II., liarley J. and Daniels M.,
196 3 t h dose group up Phn 10,71-74.
" Carcinoma of the 1.ung in Rats thposed to the est tumor and op ismr.6a llrothky A.,1%6, "A Stothastie Model lleta Radiation of Intrabronchial Ruthenium 106 thh was, quanta.a.u of Carcinogenesis and its Implications in the Pelleh:
1.
Dose-Response Relationship", 1 ad animah m a r.
Ibe-Response Plane" presented at Ihe annual natn Cum er lent. 31, 219.
re sescar6 hces or <<
Health I'hpies Society meeting, June 1966, ab.
I.a64 I.askin S., Kuschner M., Alahuler II. and krical poucr toe uract n Hcalth Phys. 8,1176.
Nchon N.,1%4, "Tiwue Reactions and Dose itathe aspes -..
Isrt*b Hmdsky.,1966,"A Stochastie Model for Relationships in Rats Following Intrapulmonary lumor Induction as Applied to Skin Tumors in lieta Radiation", ifcalth Phys. 10. 1229.
Mke" Doctoral diwertation, Graduate Sshool I a70 1.askin S, Kuschner M. and Drew R. T.,
of Pubbe IIcahh, Unhersity of Pittsburgh 1970," Studies in Pulmonary Carcinogsnesis,"in lient work of Georrr IUnhersay of Microfilms,1966), 136 pp, ah-Inhalation Carrinogenesis, pp. 321-351 (EJited mg e he figure lawut o uract in Dhsertation Abstracts V2710. p 3413H, by llanna, M. G., Jr.. Nettesheim, P. and Gil-
, e scellent auw.,n s Bro 67 1%7L bert. J. R.), U.S. Atomic Energy Commission,
.ondence is abo e Brodsky A. and Thompson D. J.,1%7, " A available as CON F-691001 from National ndly re programr,r
Stochastic Model of Carcinogenesis Insohing Tec hnical Inf. Services. U.S. Dept. of Com-l Two stages of Escitation", presented at the merce, Springfield, Va. 22151.
er.
Annual Meeting of the American Statistical Mal 69 Maldague P.,1969, " Comparative Study
^"n. 27-30 December 1%7, Washington, D C.
of ihrer: mentally Induced Cancer of the Kid-Bros 76 A s i e s, ilun *
Brown J. M.
1976 "I.inearity vs Non-ney in Mice and Rats with X-Rays", in: Radia-
's Hram 4 IJncarity of Dose-Response for Radiation tion.Indm ed Cam cr. I AEA. ST!/PUH/228. op.
Casemogenesis", llcahh Phys. 31, 231-245.
it., p. 442.
s
), hmsh Hrues A. M.,1958 Science 128,693.
May75 Mays C. W.
Spies 11, Taylor G.
N.,
but5 n,
Hursh P. R. J,, px,5, Proc. R. Soc. Iluh.,
Q',C64' 30,22L239,240-262 and 263-287.
I.loy d R. D., Jee W. S. S., McFarland S. S.,
m u ron Tapuma D.11., Ilsammer T. W lirammer D.
lh e.
g Cember 11.,1864. " Empirical Estabbsh-and Pollard F. A.,1975, " Estimated Risk to W~C e
tT
'[
4 428 NOI ES A
iluman Bone from '"Pu",in: ficafth Egrcts of av wom;mo m so%
,, em l
""*'"'*v cwo M, @,*,',','d w "e veC""""""""'"'"*
j Plutonium and Radium, p. 351 (Edited by Jee, W. S. S.) lSalt Lake City, UT. J. W. Pren).
Mo75 Mole R.11., " Carcinogenesis by lonizing g".da' Radiation and Lessons for Other Pollutants",in:
l w,uw Radiation Research-liiomedical. Chemical.
W',',$"
and Physical Perspectices, pp. 860-868 (Edited l
g'L,,,,
by N>gaard O. F., Adict 11. I. and Sinclair W.
Comparison of Relatise Risk from Radiation w "5 K.),(New York: Academic Preuk Faposure and Other Common llazarde NI'5' Pa62 Parien E.,1%2, Stochastic Processes,ISan
[,3',Z""
Francisco: IIolden Day).
s a*8 "'
Yo39 Poel W. E.,1959, J. natn. Cancer Inst 22, (R'"Id 1' N"r ember 1977; accepted 30 Januar 19-43.
3978)
Con Ros74 Rossi 11. II. and Kellerer A. M.,1974, l
l he llEIR rc Radiat. Res. 58,131.
Introduction death rate due t Row?5 Howland R.
E.,
1975, "'i he Risk of M ANY occupationally exposed radiation workers do l
per million pe' Malignancy from Internally. Deposited not have adequate training in the fundamentah of g
deaths due to ni Radioisotopes", in: Radiation Research-health physics to understand or interpret the meau.
approximately i
Biomedical, Chemical, and Physical Persper-ing of monthly personnel dosimeter reports. One of I
mterpreted to tires pp.14bl49 (Edited by Ny gaard O.
F.,
the most frequently asked questions fr.!!owing a esposed to I r Adler 11. I. and Sinclair W. KJ (New York: discussion of radiation safety with such workers is l
l his assumes 1 Academic Pren).
"I receised 240 (or 60, or 500 etc.); what does this same distribut Sa76 Sanders C, L., Dag!c G. E., Cannon W. C.,
number mean?"It has prosen helpful to relate the
{
population oo Craig D.
K., Powers G. J. and Meier D. M.,
risk due to health (somatic injury) due to the
(
l's death rat-1976, " Inhalation Carcinogenesis of liigh.I' ired radiation exposure with other common risks faced mahon popula
'"PuO, in Rats", Radiat. Res. 68, 349-360.
by woikers today. Statistics are available both for i
Table I cor.
Se75 Setlow R.11. and Ilart R. W.,1975, " Direct the risk for health from radiation (NAS72) and foi
,anses of dear Esidence that Damaged DN A Results in Neo-the risk from other common hatards (!!C76).
rn e an individ plastic Transformation-A Fish Story", in:
It is auumed that there is no recovery from a radiation in Nygaard et al., op. cit.
radiation injury and that the clicet of I rem is the anon of the re Sh74 Shellabarger C. J., llrown R. D., Rao A. R.,
same w hether delivered oser 1 month, I yr or 5 yr. it e s pected deat Shantcy J. P., llond V. P., Kellerer A. M., Rowi is aho auumed that the latent period for the l
can be easil)
11. II., Goodman I.. J. and Milk R. E.,1974. Rat radiation injury has paued. These simphfying an-g.hcation by Mammary Carcinogenesis, in: I AEA Document proximations do not alter the basic conclusions and 4
merease in <
I AEA.SM 179/18, p. 391 make presentation of the resuits to untrained groups esposure is b Tr76 Trosko J. E. and Chang C.,1976, " Role of much more stiaight forward. Three comparisons I he seton, DN A Repair in Mutation and Canser Produe-have prosen incful in placing radiation effects in ehuh preser tion", in: Aging, Carcinogenesis, and Radiation perspectise and in auisting radiation workers in the t.'nited S' niology, Srmth K. C., op. cit., p. 40L evaluating the relative risk due to radiation dn ahng the <
Wal75 Wabh P. J.,1975. "A 'l hcoretical Cctl esposure. 't he first is a comparison of the hazard 5 related accid Alterati,n Model in the Contest of Carcino from radiation exposure with hatards from ac
.ncrage of,
gence', in: W. S. S. Jee. Editor, op. cit.. p.
cidents in the United States. 'i he second is a imm wc 657wM.
comparison of relative accident rates for variom one would ir War 7 6 Ward J. F.,1474," Molecular Mechannms occupations in the linited States and the third is a accidental dt c'l Radiation.Indused D anage to Nucleic comparison of the health hatards awociated with appropriate c Acids", in-Illogical F#ct is of Neutron fr-eig:irette smoking and radiation. These comparhow due to the radiation. Pros eedings of a 9 mposium in are picscored in the twlief that others will find them matenah. la Munich. October 1973. IEAE.
usefulin discuuions of radiation safety to radiation studes fatah workers and the general public. The results are
( ons ersely i reported in terms of hatard per one rem exposure, wakers hat which is taken as a conservative aserage of oc-r.nh stion is cupational esposure (N RC 76) t sposure an I
tion injury )
'Suppoited in part by Grant CA 16127 and CA w m k related 14052 and CA 21074 from the National Institute of ra.hation ef7 Ilealth.
Il<e third BERiiEBREN
cmcwpm XL Can Science anc Politics Safely Mix?
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' comes to evafuitq:, say, birth con.
By ROBERT REINH01.D
ject, trol nucarch, antwoortson activists In other anatters, the Reagan Ad.
should be considered WASHINGTON - Remember ministrata m appears to have re.
Asked if a pohtical loyalues test ADen V. Asun? He h==== the Eisen.
spected the independece and integ.
would be used in replacing Dr. John hower Administration's first big rtty of octance. It appears not to have Slaughter, who announced that he bombehell back in 1953. As director of interfered, for example, with the two would leave this summer as director
the Nauonal Bureau of Standards, largest Federal science agencies, the of the Nauunal Science roundation,
, Dr. Astia tan afoul of the pohttcal Neuenal Science Foundatson and the leadershap because his agency - Nanonal Instatutes of Health. The in.
widch jealously guarded its reputa.
sututes' new darector, Dr. James Dr. Keyworth saHI a scientist of "ex.
tion as a setentihc boeuan impregna.
Wyngaarden, is a rvepected profen.
ceDesce" would be chosen, but "ulti.
ble to polnacal and crunmerdal pres-sional, nomina!!y a Democrat, and mately we wiu choose a person whose streg - had declared a chemical has expressed views on abortion in.
philosophy is compatible with the called ADwX2, than sold as a rejuve.
consistent with the Admuustrauan's.
Premdent."
nator of tired car batterise, usaless.
So,it remams to be seen whether a Clearty, there are posts in govern.
The uct's preenoter however, consistent partern is emerging Reac.
ment where science and medscine was a of Dr. Asun's boss, Sirk Gonin the scientihe commuroty, how.
merge mte policy and poh*ics, partse.
clair Weeks, the Secretary of Com.
ever, is clear: There is widespread ularly m regulatory agencies. Whale merce, who prtunptly fired the Bu.
unease. "With each pohtacal era of many may disagree, for example, reau of Standards director. The rw find examples where the sensativity with the strong views of Surgem Gen.
sult was a storm of preenst from the of the scientific eystem is tested by eral C.Everett Kaip on family hfe scientific comumanity, Mr. Weeks's abusee," said Dr. Donald Fredrtch.
and abortaon - he's pro family and recanung and Dr. Asun's rehMng.
son, who served under three Presi.
anti-abortion - few would disagree AD-X2 was not heard frorn agam.
dents and five department secre-that the President has the right to ap As that trarsd=d suggests, science tartes as director cf the Nauonal In.
pomt a doctor who shares tus views car:not always be emparttad from statutes of Health "There is always on such matters, parucularly since politics. And as recent eviets indl.
someone who ese:ts more seal than the Surgeon General has httle to du cate, the fallout is not always so is justined in appostments. Pohtical with research. He as mainly the Gov.
humorous Last month,9ar example, peuple come in not understanding ernment's spokesman on heahh.
Science, the jaarnal of the American scientific method They must learn "
What worries ac6entists is pohucal Ammartatice for the Advancamset of Dr. Fredrickson thes not perretve intrusaan into dects6ans on what con.
te'a==, *=rw that the Depart.
an organtand effort to sutwert the in.
aututes good and bad science and on ment of Agricuhure was ustag a poht.
tegrity of sc$eece. Neither does Wil.
which projects should be funded.
Icallitsam test ha afana=*== tts peer llam D. Carey, amerutive director of TraditionaHy, these chtsces have rewtew peamis, which judge the qual.
the A.A.A.S. But Mr. Carey does been gedeal by nunpartisan panels of sty of basic rummerch proposals. De-argue that Government *. w-a working scienusts frorn =meda gov.
partammt etncials said that to chone.
ased more Pdda-freen the White ernment Ing among actemuses with compara.
Ilouse science advtser to prevent i Even pohticaDy cumserveuve the profematonal a=d==eale, prsfer.
spread of the "hdection" of poHtica' scsantists, such as Herbert I. Fiasfeld, esco was given to thsee "philenophs.
tuserference a physacast and head of New York cally <===pantha=" week the Reagan Dare seems lieue hope in that di.
Universety's Center for $<4==w and I
.e In the puhuctry that recuan. Whom asked about the prot >
Tarh=ainey Pobey, are worrted. "It's l
Sailowed. Secretary Jaim R. Banck lees, the metamam adviser, Dr. George plain stupid to use pahucal criteria in reversed the pohey.
A. Esyworth 28, easd h was "end.
stafnag thsee gro qu," Dr. Fusfeld I
ne Washingte Pet last west tw amatly reasonable" for um Pres 6 dent said. "from tune to thne, and for l
perted that petit $ cal redstrals were to want actamatne pensis that share certain purpoems, a government rep l
heing used so flB vacancies to the his pohtical pbstammity. "There are resentadve usan sumeschnical crt.
I Food and Drug Administrauen's ad.
met very assey panels that look at teria. But in ahncat every case, they vtsory panois of emperts. AMus to tasume that are 131 percent edenunc distgrg the purpose of the panel and l
- Bealth and Husman Services Secre.
ang e-ca nangnent " Dr. Keyworth they spess up the progra m."
tary Richard S. Schwether said they said, cittag herth cuatret, abertson, in-I were trytng to broadse panel awm.
distrial tempvation, ag'tcuNure and tership. Meanwtue, the Neustal-arsas centrol. What is wanted, he Academy of Sciencue has beso frasen said, are "compotrd scienusts who cut of Government.. 64 ro.
meterstand what President Reagan search on acto rain, wtth the Admin.
porretwee as the role of govern istretton suggesting that academy ment."If a panelis to evaluate bask studies are biased and the acadercy's research proposals, he said, no pets frtends hinting the Admirustration cat conskjeranons sWd emer Bus might be unhappy with the scientific accordmg to Dr Keyworth, when it
w -n.
_g-- _n
(
control by the mahtary. Ihese. accordm:: rcrant l'eihaps more impor t.o : i te W h.i n ec
,c'm
a ns om m %
i ta the GAO, for the mmt part us!! be the ohl aunpn'ers will allow t he a u:..
arpro ich o
.i...i h ienss as s u j
large rnainfr anin Itom !ntern.stional to use wfi u.u c t hat aircaJ s inns
..n r a, s.o h u i e sp c t.\\nd taLuis
. i Businen Mas hines tillMI known as comre'er..c lobnson, a p car sa. m3 the hc..alon< apn o is h..ne sicp lun ber.
3033's, which were descloped around she iteuh pmg software n of ten i nuc the \\u I...i ocnee a u nt:.nI w ah 1977. Thew alreath are two pnerations esptnme thaa bupng the iinne.ncrs lit \\1 so th..: u.
uentn ral s6 tup.c H.e old, hning been superseded b5 IllNI tla m ch t s l he probicin n ih..i ihc wit for. indica \\lo h i.. i 1 e s. t h ilu rh model.W1 anil the sceently.tnnounced w.u c too n i o from statt el the ait catid m tohnei o :he imht.ay,an l
IBM.W Marn of i'n.ntr ophnisal.dn tit t nn co farther s.n.
.r.
,, c.mnbr o. n,c What n to be e.nned in the ine os tw L to ih
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m, i. % e+h, w hi, sm.u. ~ o one r in. t o. # e....i c,.. s in well, and IllM scsenth.mnounced a a p. o l 3 oo s c cut to upgr.ntr i.i.'.s order to $c.d.
cibe t. ihe n er price sui oa some moilets of op so l' co. n or.: na, s our soltu.o i.e s - d u h.n '. hn or.n io.
..c n m e CouT6WrW f 9cAPP6No_/X _Wl -
Security ' hecks on USDA Peer Reviewers ihe e s ~ mee,e e, A - n m e - m a -.h.
m..< ~_,~_,a..
m to a u cli enb uins d \\Jminntration elbs tal b becn wicen-and e rn i. n o< c pl. hworhic dh "E nt n
L'
\\ttoon-mg weet Inh to securits lisks and pohtn.d omi ed rats ntrahon a c.a c. w to t hoo, t si ll u ter w !c o{c Ins disl [ !beni !o si! i'n pe'c esik '.
l'.% i' I k. M Unn! 4 af
'If,[t' Is th l (ll: y [
[..{.<l'.
g s4g.s g
panch, t oinpg sed of perple suppinedl, linen t..
I! s al Afn t 4F > lio s ' ces -t - i d h.
u;u. '.. i O !-
u..i N it s mc i
espertne alons. will deade w hh h scscar h r ori -d, i to em" its i
..Los v.I
..,icesJ serve to be f unde.1 by the t15D \\N sempetdo..md spes i d about th e grafits o!! ice < hp.,k es mt'r1 for IIIe b.it u tti.d '% teih r I *I'H1 l ht te o:c t u
't i s 4n li' Nli.
4
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! R 'm
pett dation and the National Institutes of lic.Wh sa.
t hs
.t panel s N P,
is aith p s een io t o
.wk procedures.uc imusu.d. then ageshics do noi snFn s i l% cl I hic n il it il. '. w.. n. o t t.
. ei
'. oi J(
reglew ers to I rderal lluteau of ins c tigain'n ti ll!' or adordm/ t
'I t s ti - al * !. I t A s.'
n.!.
o..
i pohtscal s heck s.
At t stus s
.o n 1 ti c to st timi l h,
.. ab.
utomi lhe pr.htice of scicenmg sesentnh f oi ths n i ota n d tu. Neuu d. iht m mmanons..a n, o i o.
><sa.
stthe
. iew s n niegular in itself flut, acun dme to stscial cini of i cFlur t o nis
..ns ths 1 I?!
n.n c <.uw obserser s. it has aho caused sestre piobls nn in s. hcanhne thinoch n to S u cck s Ian s.ont ih i ' la.
"o pic h o
bMIL rCscat s h aV af ds lhn ) ear. II.th kground 6 bes k s
.a t the department s m house 'ior s.ir. cL k aetwIdo, time consummg At present. nommahons ar e nw me hm t il the 2~0 nonno.a.o.n f or t he s ai n w pct e a,.mch
1) through the bureaneratic mate. and the ecs te s o sts m ha had beco Jc.ccJ la 21 \\pt d ui n!me m r ovic a\\
seems tbre.oceed with delay.
spokesman tet the l ill s.n s it tat-to 14 das-te in the case of the 4 s ear-old compctHn e giann pr ota.un pro.ess a v oulme n ene il<cs k i ( n i ' > <
i has oes a names et I40 potenhal lessewers wole submdtcd foi ap-w or k nig taths la ct.shh " to t es u. o ' i.t at twi proval carh thn. car As of 23 Apid. onh is of the '2 bs the I lti !!c hopes 1o hau all the n m s
na d n, 'he needed to condust businew had been deared h ine mght of 2r, acid Secretart of' Agrhuhure. T hese reuew ers.ac sorpou d to l hcie w at low es ci. no de.a c s r'. te.

i iN dela,
meet and gn e the ir hnal decnions on grant apphcanons on m home il.c ntm u ho w.n icsimred
."nren i.
3 M.i). Alans has e been readmg appheahons to w ecks m inc gnmts pr ori.un. D.n id Ar ogtn.m o m te i of bio-j prep.mu.on.
chem nim.o em dee i une, sus iiciae,s m c oe,. n.
The persori respotisible anost dires th to wiet nm the w hde rabnv a s c.a 's le.n c liom PmJo m Dno I tu s s e.o nominations. Charles Grinle, confidenhal assnt.mt to Nes he has b. en.nked to mn o ag.nn. sphus w r in<
bcnu en retary of Agriculture John lilock wa s thcie has been no l'urdue..o I the i Ti > i lle rcu nced oo
' wush a.
improprkis m selecting members of pect sedew connu t-in c static.n h ihn s e.u ai the t SI) \\ s
- ma e of 2-tecs ihn > car. Il n true that nonunees for poha or Aprd, he and hn s ca mts so!l h.nl u m o n.1 r. tor me advhor) cornmittees are checked for their pohuc.d solor-appros al to take sonho! of the pim a'n l' n ida. of atton. "If two na nes are subnutted to us.md onc n a mon'in m vet ony s r.o t ed. k r oen.a.m s.o s ia sci a nc e Demomo and one o a Repubhcan, w e u d' t h+ ne the record tor the der.u tn>cnt Repubhean." he sa) s. Candidates hir the saennhc pans k
'I be tu si do e nu 01 ihe s ompttonc u cu >. c..n m to are not scr atmiled as carefulh.n those for the pohs s Kc). now a pi m e
o. in the na no Js n.
t e tbr i
committed. but they are sercened.
Unn er.aa of ( ecoi ~a teu~indsonh I M i \\ o 's i d, m n Ctiule s iis that nominatiorn to the pet t pant h.ui vcnt be pras ti. ing i h u m ol mahen n. ch.
11.
.mpt hin e t
to the l'HI tot a rootme name cheek. Iht n thes underga a grann pmeran tw ne m teen hLcd te m J.sh ai "ser) cursert the,L' at the \\erkultme Depat tmt nt "to l i S D -\\. ke s - n, 11 ihe ace u tmem s r.o n-
.n noueh make sure th.d weTe eot people in the riytt dor md tb a to h.mdh an opw ben ic c.o s b 4
i tu they basen i gotten nused up somewhere a'one the hoc.
shon!d conuJer o.m on a somew h<
Gnnie u)s '1ho pimespal cruerion n went.hc quahtaa
!io itsusosii i
l e.s1 on :,. iiii 's 1
n: o.i' eir..i c i., r i,3 s ura n.: ssi
. ii-.
s u ss in
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ML20054H772

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