Document kRX5Rr0eXX3ZY96BK0N7yMRn
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John H, Craddock
Monsanto Company
EXHIBIT MO--LX
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N. KUNCAITIS '
PCB's (polychlorinated biphenyls) have received considerable attention
over the past decade because of the public's concerns over their
possible effects on the environment and human health, These concerns
PCB'shave prompted a search for answers to many questions about
and
HOW THEIR EFFECTS CAN BE CONTROLLED,
PCB's PCB *This presentation will broadly discuss
and outline the
PCB'sproblem and issues in the United States, Hopefully, it will put
INTO PERSPECTIVE SO THAT YOU AS INDIVIDUALS CAN MAKE YOUR OWN INFORMED
JUDGEMENTS ON THESE ISSUES,
Chemistry and Structure
,,
First, what are PCB's?
PCB' ,The term polychlorinated biphenyls, or
s
REFERS TO A CLASS OF ORGANIC CHEMICALS INTRODUCED INTO UNITED STATES
INDUSTRY IN 1929, CHEMICALLY, THE COMPOUNDS ARE MADE UP OF CARBON,
HYDROGEN AND CHLORINE ATOMS, THESE ARE ESSENTIALLY ARRANGED AS 2-6
MEMBERED CARBON RINGS JOINED TOGETHER THROUGH 1 CARBON ATOM ON EACH
RING, I,E,, A SUBSTITUTED BIPHENYL MOLECULE, IN THE BIPHENYL MOLECULE
EACH REMAINING CARBON ATOM HAS ATTACHED TO IT ONE HYDROGEN ATOM, WHEN
THESE H ATOMS ARE CHEMICALLY REACTED WITH CHLORINE TO SUBSTITUTE A Cl
ATOM FOR A H ATOM, PCB'S RESULT,
__
.--
Thus, the biphenyl ring is composed ofs
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(a) 2-6 MEMBfcRED RINGS OF CARBON ATOMS,
(b) The two rings' are joined through one carbon atom on each ring,
(c) The remaining 10 carbon atoms have attached to each a hydrogen
ATOM CAPABLE OF UNDERGOING A CHEMICAL SUBSTITUTION REACTION BY
CHLORINE,
Because of the possible variations that can occur in substitution of
THESE 10 AVAILABLE H ATOMS BY Cl ATOMS,, l ,E,/ COMBINATIONS AND PER
MUTATIONS/ IT IS THEORETICALLY POSSIBLE TO FORM 209 DIFFERENT
CHLOROBI PHENYL MOLECULES,
,
Commercially produced PCB's consisted of mixtures of these 209 possible
INDIVIDUAL PCB MOLECULES; HOWEVER/ ONLY ABOUT H OF THE THEORETICALLY
POSSIBLE 209 ISOMERS ARE FORMED DURING COMMERCIAL PCB MANUFACTURE,
PCB 21X-60XCommercial
mixtures contained from
chlorine (an average of
3-5 CHLORINE ATOMS PER MOLECULE) ,
..
PCBCommercial
mixtures typically could contain various contaminants
depending upon the particular process used for manufacture, These
IMPURITIES INCLUDED VARIOUS POLYCHLORINATED DIBENZOFURANS (PCDF's)
AND CHLORINATED NAPHTHALENES/ WHICH HAVE BEEN IMPLICATED AS BEING AT
LEAST PARTLY RESPONSIBLE FOR SOME OF THE TOXICITY REPORTED FOR PCB'S,
I'll have more to say about these impurities later,
PROBEmiS^AMIL-USES.
The CHEMICAL AND PHYSICAL PROPERTIES OF PCB'S ARE VERY UNIQUE AND IT
IS THESE UNIQUE PROPERTIES THAT HAVE LED TO ITS WIDESPREAD USE,
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PCB'S ARE CHEMICALLY INERT/ STABLE AND FIRE RESISTANT, THEY HAVE A VERY LOW VAPOR PRESSURE (BP RANGES 2750-42500, THESE COMPOUNDS FUNC
TION UNIQUELY AS DIELECTRIC INSULATORS TO ACT AS NON-CONDUCTORS OF
DIRECT ELECTRIC CURRENT, THESE PARTICULAR PROPERTIES MADE THEM IDEALLY
SUITED FOR ELECTRICAL APPLICATIONS WHERE HIGH-VOLTAGE ARCING COULD
OCCUR/ AND RESULT IN FIRES AND/OR EXPLOSIONS/ DAMAGE TO EQUIPMENT AND
CREATE SIGNIFICANT HAZARDS TO HEALTH AND LIFE,
A$ THE UNIQUE PROPERTIES OF THIS MATERIAL BECAME MORE FULLY UNDERSTOOD/
MANY ADDITIONAL USES WERE FOUND, THEIR FIRE-RESISTANT NATURE MADE* THEM AN EXCELLENT CHOICE FOR USE IN HYDRAULIC AND HEAT TRANSFER
fluids, Their inertness imparted long-lasting qualities to lubricants,
They also improved the waterproofing"characteristics of surface coat
ings AND OFFERED SIMILAR AND OTHER BENEFITS TO THE MANUFACTURERS OF
CARBONLESS. COPY PAPER/ PRINTING INKS/ PLASTICIZERS AND SPECIAL
ADHESIVES,
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Distribution
PCB'Over four decades/
s evolved as a truly unique class of chemicals
WHICH MET BOTH IMPORTANT SOCIETAL AND INDUSTRY NEEDS, IT WAS WITHIN
THIS FRAMEWORK THAT MONSANTO AND OTHER PRODUCERS DEVELOPED A GROWING/
WORLDWIDE BUSINESS FOR THESE VERSATILE PRODUCTS, FROM 1930 TO 1977/
WHEN PCB MANUFACTURE CEASED IN THE U,S,/ ABOUT 1,4 BILLION POUNDS OF PCB'S WERE PRODUCED, IT IS ESTIMATED BY VARIOUS SOURCES THAT OVER
HALF OF THOSE ARE STILL IN USE TODAY IN ELECTRICAL TRANSFORMERS AND
CAPACITORS.
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A 1979 report by The National Academy.of Sciences Listed Monsanto
U.S.Industrial Chemicals Company as historically the only important
PRODUCER OF PCB'S. MONSANTO'S PLANTS WERE LOCATED AT ANNISTON/
PCB'Alabama^ and Sauget/ Illinois/ where production of
s ended in
1970 and 1977/ respectively,
PCB'S HAVE ALSO BEEN PRODUCED/ IMPORTED OR EXPORTED BY A NUMBER OF
OTHER COUNTRIES, OTHER PRODUCING COUNTRIES WERE ITALY/ FRANCE/ JAPAN/
Great Britain/ Austria/ Czechoslovakia/ West Germany/ Spain and the
U.S.S.R.
%
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4
U.S, PCB'According to the
Environmental Protection Agency/
s were
IMPORTED FOR USE BY FINLAND/ NEW ZEALAND/ CANADA/ FRANCE/ ITALY/
Norway/ Sweden and Great Britain, Countries which have exported
PCB's include France/'Italy and Great Britain.
Many European countries still allow/ and in some cases, require, use
PCBof equipment for certain applications. These requirements are
BASED UPON THEIR OWN RISK/BENEFIT ASSESSMENTS OF THESE COMPOUNDS,
Risk/Benefh
The risk/benefit issue with respect to PCB's is the
to the whole
PCB problem. Much soul-searching is being done to define these
PARAMETERS FOR PCB'S, THE BENEFIT SIDE OF THE EQUATION IS PERHAPS
THE EASIER OF THE TWO TO DEFINE.
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PCB'We know the; benefits of using non-flammable
s in certain key
and essential industries where technically suitable replacements are
not readily available. We CflN calculate the benefit of preventing
fires and saving lives1 in: 1i : |
high-rise buildings., hospitals, schools
1 U-
underground utility tunnels
UNDERGROUND TRANSPORTATION FACILITIES, E,G,, subways, trains, RIVER TUNNELS, PARKING GARAGES
HYDRAULIC SYSTEMS OF AIRPLANES AND OTHER PUBLIC TRANSPORTATION
UTILITY POWER TRANSMISSION AND DISTRIBUTION CENTERS
'
How DO WE QUANTITATIVELY MEASURE RISK --
RISK OF HUMAN HEALTH HAZARD RISK OF ENVIRONMENTAL DAMAGE, ETC,, And, compare them with benefits?
'
PCB' ,This risk/benefit problem is not unique to
s but confronts us
with many chemicals AND tJMX aspects of life, whether it's a new
medical/surgical procedure, a new (or old) chemical, a new toy or
automobile or a new gadget or work-saving appliance,
EMVIROHMENTAL AND UEAlIMJMEBaS In the late 1960's, some 40 years after PCB's were introduced, the
first signs of potential environmental problems turned up in two
SEPARATE EVENTS ~ ONE IN JAPAN, THE OTHER IN SWEDEN.
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SWEDlSlLEjimiltfiS
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The first sign of trouble was reported by a Swedish biologist. While USING A NEW AND THEN TOTALLY UNIQUE TECHNIQUE/ CHLORINATED PESTICIDE
ANALYSIS/ HE FOR THE FIRST TIME IDENTIFIED PCB'S IN THE BODIES OF FISH,
Monsanto and others began immediately to study the Swedish work, But/
BEFORE THESE FINDINGS COULD BE CONFIRMED OR DUPLICATED IN THE U.S./ .
ANALYTICAL METHODS HAD TO BE REFINED IN ORDER TO SEPARATE PCB'S FROM THE OTHER CHLORINATED HYDROCARBONS (LIKE DDT) THAT WERE KNOWN TO BE
PRESENT IN THE ENVIRONMENT, NEW TECHNIQUES ALSO HAD TO BE DEVELOPED TO ENABLE RESEARCHERS TO IDENTIFY THE CHEMICALS IN THE LOW PARTS PER BILLION RANGES BEING REPORTED,
In 1968, about 1,000 people in Japan became ill from eating rice oil HEAVILY CONTAMINATED WITH JAPANESE PRODUCED PCB'S AS A RESULT OF AN
UNFORTUNATE INDUSTRIAL ACCIDENT, THIS HAS COME TO BE KNOWN AS THE
PCB"Yusho Incident," The level of
contamination in the rice oil was
2,000-3,000 parts per million, extremely high concentrations, (For.
COMPARISON, LEVELS BEING REPORTED TODAY IN FISH AND WILDLIFE ARE IN
THE LOW PPM AND PPB RANGE,) (PPB EXAMPLE)
Some news accounts linked this incident with deaths, stillbirths and MISCARRIAGES, WHILE, IN FACT, NO SUCH CASES WERE ACTUALLY ATTRIBUTED
TO THE INCIDENT, PERSONS EXPOSED TO PCB CONTAMINATED RICE OIL DID
EXPERIENCE DIZZINESS, NAUSEA, LOSS OF APPETITE,WEAKNESS AND DERMATOLOGICAL SIDE EFEECTS, INFANTS, BORN TO MOTHERS WHO HAD BEEN EXPOSED DURING PREGNANCY, EXHIBITED DARKENED SKIN AT BIRTH; HOWEVER, IN EVERY CASE, THIS CONDITION CLEARED WITHIN THREE WEEKS
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The victims; of the Yusho Incident have been subjected to extensive FOLLOW-UP MEDICAL STUDIES SINCE THE EVENT TO EVALUATE POSSIBLE LONG TERM CHRONIC EFFECTS OF THE EXPOSURE, $OME LONG-TERM CHRONIC HEALTH EFFECTS WERE OBSERVED IN THE YUSHO PATIENTS, INCLUDING CANCER, HOWEVER,
RESULTS OF THESE INVESTIGATIONS INDICATE THAT PCB'S PER SE MAY Nfil HAVE
BEEN THE CULPRIT IN THE YUSHO INCIDENT, OTHER ORGANIC CONTAMINANTS
KNOWN TO BE SIGNIFICANTLY MORE TOXIC THAN PCB'S HAVE BEEN FOUND IN PATIENTS AT HIGH CONCENTRATIONS AND IN JAPANESE MANUFACTURED PCB's,
Some medical researchers and scientists are now unwilling,to blame
PCB's for chronic effects observed in the Yusho Incident, especially
IN LIGHT OF SEVERAL HUMAN EPIDEMIOLOGY STUDIES NOW AVAILABLE RELATED
TO PCB EXPOSURE,
Although conclusions About that incident have been clouded by the
UNKNOWN IMPACT OF IMPURITIES IN JAPANESE MADE PCB'S, THE INCIDENT
SOUNDED A CAUTIONARY SIGNAL,
."
In 1970, WHEN THESE SCIENTIFIC INVESTIGATIONS FIRST CONFIRMED THE PRESENCE OF PCB'$ IN THE ENVIRONMENT IN THE U,S, AND LONG BEFORE
INFORMATION REGARDING THE POTENTIAL IMPACT OF THIS CONTAMINATION WAS DETERMINED* MONSANTO, WORKING WITH VARIOUS AFFECTED INDUSTRY SEG MENTS AND GOVERNMENT AGENCIES, VQJLJJNTAR1LY, BEGAN ITS PROGRAM OF
TERMINATING SALES OF PCB'S FOR OPEN APPLICATIONS -- THOSE WHICH
COULD LIKELY RESULT IN UNCONTROLLABLE ENTRY INTO THE ENVIRONMENT,
However, termination of sales for dielectric uses would have resulted IN SEVERE ECONOMIC AND SOCIAL PROBLEMS FOR THE NATION, THIS WAS
RECOGNIZED BY THE FEDERAL INTERDEPARTMENTAL TASK FORCE ON PCB's WHICH
CONCLUDED IN 1972 THAT!
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"Their continued use for transformers and capacitors in the near FUTURE IS CONSIDERED NECESSARY BECAUSE OF THE SIGNIFICANTLY INCREASED RISK OF FIRE AND EXPLOSION AND THE DISRUPTION OF ELECTRICAL SERVICE
WHICH WOULD RESULT FROM A BAN ON PCB USE,"
At this time* Monsanto made the conscious decision to continue supply PCB'sing only to the electrical power distribution industry where they
WERE MARKETED AS DIELECTRIC FLUIDS IN "CLOSED." OR SEALED SYSTEMS SUCH
AS TRANSFORMERS AND CAPACITORS, IN CONTINUING THESE SALES *t MONSANTO
REQUIRED CUSTOMER ASSURANCES THAT THE MATERIALS WOULD BE SAFELY HANDLED
AND PROPERLY DISPOSED,
Monsanto* the government and the electrical industry together concluded
THAT THE BENEFITS TO SOCIETY OF CONTINUED PCB DIELECTRIC USE IN
ENCLOSED ELECTRICAL UNITS FAR OUTWEIGHED THE RISKS, THE KEY TO MANAG ING THE RISK WAS SOUND MAINTENANCE PRACTICE AND DISPOSAL CONTROL,
In 1977* Monsanto voluntarily ceased all production of PCB's once we
HAD BEEN ASSURED BY THE ELECTRICAL POWER INDUSTRY THAT SUITABLE SUBSTITUTES WERE AVAILABLE,
ENVIRONMENTAL EFFECTS
PCB's ARE STABLE; THEY RESIST DEGRADATION IN THE E_NVIRONMENT AND PERSIST FOR LONG PERIODS OF TIME, As THEY PERSIST* THEY TEND TO
ACCUMULATE IN ANIMALS AS THEY MOVE UP THE FOOD CHAIN, LOWER ANIMAL FORMS CONSUME THEM AND IN TURN ARE CONSUMED BY HIGHER FORMS AND* IN
SOME CASES* PCB'S MAY ULTIMATELY REACH HUMANS VIA THE FOOD CHAIN,
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PCBThe impact of
contamination on ecological systems is not fully
t ___
UNDERSTOOD, . HOWEVER, THERE HAVE BEEN A NUMBER OF ATTEMPTS TO SUM
MARIZE APPARENT EFFECTS AND TO ESTIMATE POSSIBLE FUTURE IMPACTS,
PCB'S HAVE BECOME WIDESPREAD THROUGH CERTAIN NATURAL AND MAN-MADE
MECHANISMS AND ARE OFTEN FOUND AT VARIOUS LEVELS AND LOCATIONS IN THE SOIL, AIR AND WATER,
PCB CONTAMINATION IN URBAN AIR HAS BEEN REPORTED, ALSO, SOME U,$.
WATERS AND SEDIMENTS SHOW PCB CONTAMINATION,
t
PCB'S ARE FOUND AT VARIOUS LEVELS IN ANIMAL AND AQUATIC SPECIES,
ONE
STUDY CONDUCTED BETWEEN 1970 AND 1974 BY THE U.S, FISH AND WlLDLIFE
PCBCommission showed
residues in various freshwater fish, waterfowl
AND STARLINGS, A 1972*1974 STUDY OF THREE LAKE MICHIGAN FISH SPECIES
TAKEN IN THE EASTERN PART OF THE LAKE SHOWED MEAN WHOLE FISH CONCEN
TRATIONS RANGING FROM 5,24 TO 22,9 PPM IN BLOATERS,.. SALMON AND LAKE
TROUT,
More recent studies in the Great Lakes (1979-1980) indicate that PCB
LEVELS IN FISH ARE NOW DECREASING, SIMILAR REPORTS HAVE BEEN MADE FOR FISH IN OTHER PARTS OF THE COUNTRY,
PCB'S HAVE BEEN FOUND IN THE GENERAL U.S. POPULATION, SAMPLES OF HUMAN ADIPOSE TISSUE AND MILK, COLLECTED IN 1973 AND 1974 IN A NATIONAL SURVEY, SHOWED THAT 35,11 AND 40,3S OF THE SAMPLES, RESPECTIVELY, CONTAINED 1 PPM OR MORE PCB'S ON A WETWEIGHT BASISj ABOUT 5,01 OF EACH STUDY SHOWED GREATER THAN 2 PPM PCB'S,
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mjMsmm
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Questions have been raised in four areas of possible health effects of PCB's?
(a) skin (reddening, rashes, chloracne) (b) systemic effects (liver damage, respiratory effects)
`
(c) WORKER EXPOSURE '
(d) carcinogenicity
In the classical short-term exposure_qr acute toxlcjty sense, PCB's
ARE CLASSIFIED AS "SLIGHTLY TOXIC" BY ORAL INGESTION, LD5Q MOO-8,000
OSHAmg/kg (similar to NaCl-salt), For inhalation,
has established
SAFE EXPOSURE LEVELS FOR WORKERS EXPOSED TO PCB'S, (THE EIGHT-HOUR
TIME-WEIGHTED AVERAGE THRESHOLD LIMIT VALUES (TLV) FOR WORKER EXPOSURE ARE 1,0 (42% CHLORINE) TO 0,5 (54% CHLORINE) MG/M^,)
Sm
Longer-term studies on skin effects using laboratory animals have SHOWN THE FOLLOWING? (a) Repeated and prolonged skin contact with the higher chlorinated
BIPHENYLS CAN PRODUCE SKIN IRRITATION. (b) Harmful amounts can be absorbed under repeated, prolonged
CONDITIONS, SUCH AS BY WEARING LEATHER GOODS THAT HAVE BECOME
SATURATED WITH PCB'S. (C) A SAFE EXPOSURE LEVEL DOES .EXIST FOR EACH PCB MATERIAL (l,E., A
NO-EFFECT LEVEL),
IN ADDITION, STUDIES IN 218 HUMAN VOLUNTEERS USING THE PATCH TEST TECHNIQUE OF THE U,S. PUBLIC HEALTH SERVICE CONCLUDED THAT AROCLOR
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(PCB) "...hAs no primary irritant eff-'ect nor is it a sensitizer of
HIGH POTENCY#. . . " (MONSANTO RECORDS SHOW THAT THIS STUDY USED
Aroclor 1254.)
Human exposure studies also indicate that skin effects are reversible
once the source is removed.
`
lilHALAIiflllZiteSPJLRA
Several animal tests have been performed to study the effects of
LONG-TERM INHALATION EXPOSURE TO PCB#S. In SOME CASES IT WAS NECESSARY TO HEAT THE PCB'$ IN ORDER TO OBTAIN THE HIGHER CONCENTRATIONS
NECESSARY TO CONDUCT THE EXPERIMENTS.
PCB 1-6Various
's were studied at test chamber concentrations of about
PPM. No INJURY WAS OBSERVED AFTER PROLONGED INTERMITTENT EXPOSURE OF
SEVERAL ANIMAL SPECIES AT THESE CHAMBER CONCENTRATIONS USING THE LOWER
CHLORINATED PCB'S ( I. E. > 422 Cl) . AT_.COMPARABLE _TS.T CHAMBER CONCEN TRATIONS OF THE HIGHER CHLORINATED PCB'S (e.G,, 542 Cl) SIGNS OF
REVERStBLE LIVER CELL INJURY WERE APPARENT.
Partly,, as a result of these studies the American Congress of Govern
(ACGIH) TLVment Industrial Hygienists
standards were established anh
WERE SUBSEQUENTLY INCORPORATED INTO CURRENT OSHA STANDARDS (1.0 AND
0.5 mg/m^).
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W0RKERJExE^R/1DEM10L0GY
:
PCB'The health effects of long-term human exposure to
s have been .
CAREFULLY REVIEWED BY SEVERAL RESEARCH GROUPS, MONSANTO IS AWARE OF
SEVEN EPIDEMIOLOGICAL STUDIES DONE IN THE U,S, OF GROUPS OF PEOPLE
PCB's,exposed to
These included persons with occupational, as well
AS COMMUNITY, EXPOSURE, THE POTENTIAL HEALTH EFFECTS STUDIES INCLUDED
DEVIATIONS IN BIOLOGICAL PARAMETERS (SUCH AS BLOOD AND TISSUE LEVELS)
AND REPORTED SYMPTOMS AND ILLNESSES, In ADDITION, THE CAUSES OF ANY
DEATHS OF ANY PERSONS FROM THE SAMPLE POPULATION WERE INVESTIGATED*,
The FOUR most recent studies appear'WCONSTITUTE the MOST EXTENSIVE
EPIDEMIOLOGICAL WORK YET DONE ON PCB'S,
In total, the human EPIDEMIOLOGY EXPERIENCE INDICATES AN ABSENCE OF
MORBIDITY ' (ILL HEALTH) ASSOCIATED WITH SIGNIFICANT EXPOSURE TO
PCB's,
PCB'More importantly, none of these studies found
s to cause
CANCER IN HUMANS,
Potential Carcinogenicity,-..Animal-Siueies
I 1975,What about cancer in animals? n
Dr, Renate Kimbrough reported
THE INDUCTION OF LIVER CARCINOMAS IN FEMALE RATS FED AROCLOR 1260, A
PCB, for two years.
Monsanto Company had sponsored previously three 2-year rat feeding
studies using three different Aroclor_mixtures, including the same
1260 D ,lot of Aroclor
used by r Kimbrough, The results from the
Monsanto studies showed that the test compounds produced liver injury
BUT NQ CANCER,
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An extensive re-evaluation by independent consultants was made of the
LIVER TISSUE-SPECIMENS FROM THE MONSANTO SPONSORED STUDIES. In
ADDITION, &JPEC1MEM OF LIVER TISSUE FROM Dr, KIMBROUGH'S STUDY WERE
ALSO EVALUATED BY INDEPENDENT CANCER RESEARCH EXPERTS. THAT REVIEW
FAILED TO CONFIRM THE KlMBROUGH FINDINGS. IN OTHER WORDS, IT SHOWED
4
NO.JICCiJ5REKCE-QE-Liyfi--CAMCR IN ANY OF THE FOUR STUDIES.
In 1977, the National Cancer Institute reported their results of yet
ANOTHER INDEPENDENT STUDY FOR POSSIBLE CARCINOGENICITY OF PCB'S
.NCI(Aroclor 125*0 using rats in a 2-year feeding study. The
report
STATED THAT AROCLOR 125*1 WAS NOT A CARCINOGEN UNDER THE TEST
'
CONDITIONS.
mm/jmimm
PCB'S HAVE BECOME AN INTENSELY EMOTIONAL ISSUE. IMPORTANT DECISIONS
AFFECTING THEIR USE, STORAGE AND ULTIMATE DISPOSAL ARE BEING MADE WITHOUT BENEFIT OF PROPER SCIENTIFIC ASSESSMENT.
PCB'S WERE USED AS THE SYMBOLIC EXAMPLE OF WHY THIS NATION NEEDED TOUGH, NEW REGULATIONS TO CONTROL TOXIC SUBSTANCES. IN THE PROCESS, THE HAZARDS OF PCB'S WERE GREATLY EXAGGERATED!
IN SOME CASES, THESE COMPOUNDS HAVE BEEN LABELLED BY REGULATORY AGEN CIES, LEGISLATIVE BODIES, THE POPULACE AND THE MEDIA AS HUMAN "CANCER-CAUSING AGENTS" AND "DEADLY TOXINS," HOWEVER, THE SCIENTIFIC EVIDENCE DOES NOT SUPPORT THESE CLAIMS.
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