Regarding junk science. I would suspect that the toxicity studies carried
out on glyphosate are in that league. Here is what professional
toxicologists reported after reveiwing the raw toxicity data on glyphosate
which Monsanto submitted as required under the US FIFRA. It is note worthy
that under the Federal Fungicide, Insecticide and Rodenticide Act of the US
that companies are only required to submit summaries of the toxicity
studies. These studies were completed by Monsanto and their contractors
after fraud was uncovered earlier by Industrial Biotest Laboratories which
did the original acute and chronic toxicity studies on glyphosate [active
ingredient in Roundup].
This is from my own publication "Silvicides: a literature review", 1988,
which were reviewed the California Department of Food and Agriculture.
Glyphosate is sprayed on many forests and agriculture sites, and is the
largest volume and sales of any pesticide. Recently glyphosate was banned
from areas in or near water in Australia. Up to 1600 commercial formulations
were banned.
"The state of California requires that toxicity data be reviewed and
information on the health hazards associated with the use of pesticides be
made available to workers who may become occupationally exposed (Frey 1985).
Evaluation of pesticides by the CDFA may take place when a pesticide poses a
significant risk to public and environmental health. The raw data on
glyphosate was re-eveluated by the CDFA in 1985 and 1986. Of the toxicity
data re-evaluated, only 1 mutagenicity test met the USEPA protocol
guidelines for an acceptable study (Christopher 1986). Many of the required
toxicity tests were judged to be inadequate by the CDFA (1986). Table 26
reports the data gaps found by the CDFA."
page. 95
"A comparison of the summaries on the toxicity of glyphosate in background
statements of the USDA Forest Service show that many of these studies are
reporteded to be adequate. In a chronic toxicity study (Biodynamics 1981)
with rats, the toxicologists for the CDFA noted a siqnificant 12 % incidence
in testicular cancer in rats fed 300 ppm in their diet for 2 years
(Christopher 1986). There was up to 70 % mortality in some groups, and
mortality was not dose related. Data was missing for: individual body
weights, fat content, stability of test substance, analysis of dose
solution, diet analysis, and clinical observations. No clinical observations
were presented in the report and no statistical measure was given of the
ranges, despite a statement that observations were in the normal range.
A chronic toxicity study on mice was found inadequate because of major
variations (Biodynamics 1983). This study found a 2 fold increase in
lymphoreticular tumours in females receiving the highest dose, but there was
no overt toxicity reported, nor was there a consistent statistical pattern
in any of the losses in body weights. Males suffered from an increase in
renal tubular neoplasms (kidney cancer), however no historical data was
presented. Increased chronic interstitial nephritis was observed. No
clinical observations were presented in the report.
A teratology study (International Research and Development Corp. 1980) on
the rat was also inadequate. Data were absent on clinical observations,
individual animal records, and on litters. No data was presented on
histopathology. Excessive mortality occurred in the high dose group, since
28 % died. Pregnant rats
Page 96
were given 10 seperate doses during gestation of 500 to 3500 ppm in the
diet. Fetotoxicity was observed at 1000 ppm bwd. Symptoms in surviving rats
included diarrhea and other signs, however no data was presented. One litter
had multiple malformations at 3500 ppm. There was a significant decrease in
fetal body weight. One dam resorbed her entire litter at the high dose. The
ratio of viable fetuses to total implants per dam was highly variable. Each
group contained 25 females. Only 17 were pregnant at the time of sacrifice
in the high dose group. The high dose group had increased resorptions, and
post implantation losses as well as an increase in unossified sternebrae.
The toxicologist concluded that glyphosate is fetotoxic and teratogenic when
given to rats at ten seperate doses of 1000 ppm.
A reproductive study on the rat done by Biodynamics Inc. for Monsanto in
1981 was found unacceptable, but contained useful data indicating renal
tubular dilation and pancreatic atrophy. However, individual pathological
data were missing except for one male kidney for which the kidney lesions
were observed. There were no individual body weights, fat content, organ
weights or pathology reported. No analysis of dose solution was presented.
Too few animals were used and methods of statistical treatment of data were
not presented or were missing. Gross examination of animals was not even
carried out. Despite the missing data, a no observable effect level of 10
ppm bwd was derived from the data in this 3 generation study on reproductive
toxicity.
A dominant lethal bioassay on the mouse conducted by the International
Research Development Company was found unacceptable because of insufficent
information. No data on individual mice and no clinical observations were
presented. Nevertheless, this study is cited by the USDA Forest Service in
support of its use of glyphosate in the National Forests.
A teratologic study on the rabbit was also found unacceptable, however the
data was useful. At the highest dose, one fetus had multiple malformations.
This dose was at 350 ppm bwd. No malformations were observed in the
controls. The total number of fetuses, however, over all the treated groups
were comparable. High mortality occurred in the high dose group, since 10
females died, but the cause of death was not determined other than pneumonia
enteritis. Major variances discussed were the lack of analysis of the dose
solution, lack of clinical observations, summary and individual data.
Findinqs from necropsy were not presented. The only indication given of
maternal toxicity was death and from evidence observed in clinical
observations, which was not presented. From the available evidence it was
difficult to acertain whether maternal toxicity was disease related or
chemical related. The toxicologist believed that the dose selection needed
to be justified. Despite the missing data, maternal toxicity was observed at
175 ppm bwd when the feeding regime was 21 days. Developmental toxicity was
observed at the hiqhest dose of 350 ppm.
Another rat teratology study was judged to be unacceptable because of
missinq data. This study was conducted by IRDC and completed in 1980.
Clinical observations were not presented, nor were an analysis of the dosing
solution or observations from the necropsy. Maternal toxicity was based on
missing clinical observations and necropsy data. Major malformations were
not discussed in the text. The reviewer's discussion ends: "if these fetuses
are classified as multiple malformations and compared to historical controls
with 2 fetuses/9660 (2 litters/726), then this study with 1 litter/16 and 6
fetuses/196 is markedly different. Table 5 denominator in the report
representing the percentage of fetuses with skeletal or visceral
malformations is incorrect". The pesticide background statements of the USDA
Forest Service refer only to summary data only, therefore the summary is
based on missing data required by FIFRA.
A chronic feeding study of glyphosate in mice was found unacceptable because
two entire volumes of data were missing from the report. This 2 year study
reported kidney tumours at the highest dose tested. The final report was
completed in 1985 and was done by the Biodynamics Corporation for Monsanto.
Of the studies evaluated by the state of California, only one study reviewed
met the guidelines set by the USEPA. The acceptable study found no mutagenic
activity at the doses selected, however, no analysis of dose solution or
technical description of the test article was presented.
Summaries on the surfactants in Roundup indicate that "severe local skin
reactions and testicular effects" were observed in rabbits exposed at use
level and five times use level (Sandquist 1979). Increased mortality and
body weight loses were also noted.
Reports of harmful exposure to glyphosate have been numerous (USEPA 1980;
CDFA 1987). Following registration in 1978 and prior to October 1980, 109
incidents were reported following exposure to lyphosate in the United States
Symptoms of injury included conjunctivitis, dizziness, headache, nausea,
contact dermatitis, erythema of the skin, keratitis associated with a
corneal ulcer and blurred vision. Other symptoms reported were irritability,
excessive sweating, congestion, itching, diarrhea, and abdominal pain. One
man spilling herbicide on his feet and legs while cleaning out a tank,
suffered many symptoms such as loss of vision and weakness. Two college
students studying a pond were dermally exposed to drift from a nearby road
side spray operation. The female was situated 50-60 feet from the rig and
noted that spray blew into her eyes and caused her pain in the eye and eye
area as well as dizziness and nausea. The spray nozzle was only two feet
from the ground and there was no wind."
copyright 1988.
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