We received a note via email from our regular correspondent, 
Ferdinand Ebgelbeen, a chemical engineer working at plant in 
Belgium, who is also the spokesman for the Chlorine Chemistry Industry. 
The indented paragraphs are comments from a PVC opponent; Engelbeen's comments 
alternate. Bold typeface indicates editor's (E.L.) comments.
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Subj:	 Re: OEM: message on PVC toys (fwd)
Date:	98-08-29 16:45:17 EDT
From:	Ferdinand.Engelbeen@ping.be (Ferdinand Engelbeen)
To:	TurnerToys@aol.com

Dear OEM-ers,

Some reaction on the continuous story of phthalates...
The Weinberg Group, described in the ENDS report entitled "Scientists
criticise EU move to ban phthalates" is a third party consultancy hired
by industry to find uncertainties and questions in science regarding
product hazards and to keep restrictive action from occurring.  This
organization is by no means independent and unbiased and their
scientific integrity is questionable.
I do not know how questionable the Weinberg Group is, but the scientists
they asked to give their opinion in the phthalate question are not:

[Prominent among them is Rinus Rijk of the Dutch TNO Food and Nutrition
Research Institute, which is leading an international study to develop a
reliable method of testing phthalate migration from children's toys to
human saliva.][1]

TNO in The Netherlands is one of the most respected research institutes in
Europe. The named study is conducted for the consensus group, composed of
the Dutch government, the PVC and phthalate producers and the
Consumentenbond (Dutch consumers organisation heavily acting against PVC in
all its forms!).
Secondly, the efforts being undertaken by companies such as Mattel and
Exxon and the U.S. Department of Commerce to influence the European
Union scientific process are by no means scientific.  Documents obtained
from the Department of Commerce demonstrate clear political goals in
stopping EU action on phthalates in PVC toys.  Nonetheless, there is
absolutely no reason to believe that EU action on PVC toys would have
any effect on this $22 billion industry.  PVC toys make up less than 1%
of all plastic toys.
That is not the point. The point is that PVC toys (and medical devices),
containing phthalates, are safe or they are not. If they are not safe for
their purpose, they must be banned. But no safe product should be banned,
based on unscientific and only "political" motives.
PVC toys contain up to 50% by weight phthalate esters.
So do blood bags and other medical devices. There is as far as I know no
problem at all, even not for dialysis patients...
[See section on Phthalates on the PVC Home Page.  Studies referred to cite 
large daily intake of phthalates by dialysis patients]
Crystal glass contains up to 80% lead, that is no problem at all, as long
as it doesn't dissolve too much...  [Of course, lead content in crystal is a 
problem; pregnant women should not use such utensils. See section on lead toxicity 
on Home Page, especially cumulative effects]

At any rate, in the public health field we have
accepted results of animal testing to be applicable to humans for the
past 50 years.  Those who do not agree with this are often those who do
not like the results of the animal tests.

Based on lots of animal tests, all adverse effects of all phthalates tested
until now had NOAEL's. The lowest NOAEL's were for peroxisome
proliferation. That effect is not at all seen in primates, neither are
excess cancer cases, including liver cancer. [Precisely the opposite is true. 
See section on Phthalates on PVC Home Page.]   NOAEL's for other effects,
including liver cancer in rats and mice, were orders of magnitude higher.
Either one accepts scientific evidence, or one doesn't, but then we are
going into purely speculative politics, not science. [See quotation from cited study
regarding dosage of phthalates on PVC Home Page.]
These phthalate esters are not chemically bound to the polymer (even the
toy and chemical industries do not dispute that) so that they can leach
during normal toy use, even moreso when pressure, such as chewing is
applied.  The amounts of exposure have varied depending on the testing
protocol, however, all of the testing protocols to date have
demonstrated significant leaching of phthalates.
This is not true. Tests done in Germany for the Government (BGA) and by the
TÜV for the toy industry [2] with the standard protocol, had migrations
below TDI's or even below detection limits. So were the governmental tests
in Belgium and Italy. All tests in all countries, except in Denmark and The
Netherlands, were below TDI (TDI being 100-500 times below the lowest NOAEL
in rats). But even the highest level found in one toy (7 of 10 were below
TDI) in Denmark, was still 8.8 times below the NOAEL.
E.g. for DINP, levels found were from below detection limit (0.16 microg/kg
bw/day) up to 1,700 microg/kg bw/day) for the highest in the Danish test
[3]. As you can see the test method has definitely a large influence. That
means that you need a reliable test that accurately simulates what happens
in a child's mouth. That test will be ready within two months. So there is
no hurry to take any measure.  [We reprint that test in this website - see 
Dutch Government study attempts to replicate and quantify infant exposure to Phthalates from teething toys
The phthalate esters are the most abundant human made contaminants found
in the environment.  The U.S. Centers for Disease Control are in the
process of initiating a wide spread screening of the U.S. population for
phthalate levels (monoesters) as a result of finding high levels of
phthalates in blood when testing for DDT (DDE) and PCBs.   Even if the
phthalates are only weakly toxic, human exposure, especially to infants
who are ingesting phthalates in infant formula, could be great.
Daily ingestion of phthalates are partly measured and partly estimated from
average food intake [3]. Intake from air, food, water and soil for DEHP
(the most abundant man-made phthalate) is app. 10 microg/kg bw/day. Even
the highest amount of DEHP found in infant formulae wouldn't give more than
30% of the TDI which is 50 microg/kg bw/day. With that intake, 300 times
below the NOAEL for peroxisome proliferation in rats, tenthousands of times
below the NOAEL for all other effects, are phthalates still toxic???
Most importantly, there are alternative plastics and other materials
such as cloth and wood that can be used to replace PVC in toys.  Some of
these include polyethylene and ethylene vinyl acetate.
Cloth and wood, nice breeding grounds for bacteria and fungi, have to be
treated by nasty chemicals (pentachlorophenol...) to prevent them of being
biodegraded. [This is a clearly nonsensical statement!  Cloth or wood toys 
are not treated with preservatives - they are not used outdoors!  And, of 
course, they are washable.] Or you can paint wood (whith phthalate ester [!] 
based and sometimes lead coloured oilpaints...). Wood (dust) itself is a proven 
human carcinogen and contains natural chemicals that can leak from that toys
which induce sex changes in fish...[Really!! You don't get wood dust from wood toys.
And the cancer-causing effects of wood dust are associated ONLY with inhalation over 
a very long time, a situation occurring almot exclusively in wood-products manufacturing 
facilities.  The carcinogenic nature of wood is not chemical based, as with the substances 
used in plastics; it is due to the mechanical irritation of the dust collecting in the lungs.]

PE needs chemicals against oxydation
and sun-ray attack (nonylphenol...). Rubber (recommended by Greenpeace)
contains nitrosamines from the manufacturing process (and sometimes
phthalates!)... Which one do you like to give to your (grand)children?
A few months ago rubber baby soothers had to be withdrawn from the market
in Belgium because of too high nitrosamine content. I haven't heard of any
action of the EC to withdraw all rubber toys and other child care articles
from the market, neither of Greenpeace actions against rubber
manufacturers...[These statements are true, and have been overlooked in the 
present debate on PVC.  Most polymer substitutes have additives that will 
undoubtedly be found to be harmful, when finally they are investigated with 
the thoroughness with which we have examined PVC.]
These plastics are not only less polluting throughout their production, 
use and disposal,...
I do challenge you or anybody else to find ONE scientific report to prove
this. I am in the posession of more than ten realistic life cycle analyses,
not made for the PVC industry, where PVC is compared with alternatives,
including PE, PET, wood, steel, glass, aluminium,... for different
purposes, where it is always amongst, if not the least polluting
material(s) [4].
Meanwhile children continue to be exposed to phthalates, which could 
result in possible adverse health effects.
As far as I know, a NOAEL is a NO observed adverse effect level, in this
case for rats. That doesn't give a 100% safety for humans. There is still
maybe a 1% chance that some adverse effect was not detected. In the case of
phthalates the NOAEL gives already a >99.9% safety margin for
non-peroxisome endpoints, including oestrogenic, fertility, reproduction,
sperm count, carcinogenic, teratogenic,.... effects. The TDI gives a
99.999% probability that NO adverse effects will occur sooner or later.
And as far as I know, no adverse effects have been seen in children,
including dialysis patients, after more than 40 years of phthalate
intake... [Not true!  See PVC Home Page] What more proof of safety do you 
want?
In the case of DINP, this means that a range of
toxicological endpoints may have not even been examined yet.
Which one do you miss? And what endpoints have been tested yet for the
additives (or ingredients) of "safer" alternatives?
In the case of PVC toys and phthalate exposure, the debate needs to move
from one based on acceptable levels of risk or acceptable daily intakes,
which is uncertain, contentious, and based on limited knowledge to one
based on the availability of safer alternatives, which is much more
certain.
What makes you certain that the alternatives are safer? Testing for
acceptable daily intake of the migrating ingredients or just belief?
In the end, if this debate over an acceptable exposure level is to
continue, the toy industry could take on some responsibility by, at a
minimum, labelling their toys - that they contain a potentially toxic
chemical that can leach during use.
I could agree with the first point, if that wouldn't be abused by some
groups as a stigma to create fears amongst the public, just to reach their
target, which has nothing to do with public health. And for the second
point, do you label food and warn mothers also for salt, or worse, alcohol
before breast feeding, as potentially harmfull to fatal poisons, which they
are if taken in huge quantities?  [Yes! At least in the U.S., we do just that!]
Btw, Greenpeace was reprimanded by the Dutch Advertising Code Council for
their advert, calling PVC-toys toxic [5]. Even laymen do see the difference
between "toxic" and "maybe" (but probably not) harmfull...
As Alvin Weinberg (no relationship to the
other group, I believe) states, these are issues of "trans-science"
which must be resolved through public policy.
As you mean by "public policy" political decisions, even these must be
based on science, not the politics of the moment. That means that before
you switch from a known (extremely low) risk to any alternative with
unknown risk, that you should test the alternative as thoroughly as you
have done for the first one. I am pretty certain that you will find some
unpretty surprises...

Sincerely,

Ferdinand Engelbeen
Chairman Chlorophiles
Oude Ertbrandstraat 12
B-2940 Stabroek
Belgium
Tel.&fax: +32-3-664.46.63
if problems with faxes: call +32-3-664.46.63 - wait for beep - 48.
http://www.ping.be/chlorophiles/
Ferdinand.Engelbeen@ping.be

References:

[1] ENDS report June 16, 1998.

[2] Untersuchung von PVC-Spielzeugen auf Weichmacher (Investigation of PVC
toys on softeners), TÜV Rheinland, 22 December 1997.

[3] Phthalate migration from soft PVC toys and child-care articles, opinion
expressed at the CSTEE third plenary meeting, Brussels, 24 April 1998, EU
Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE).

[4] See: http://www.ping.be/chlorophiles/Eng/PVCLCAc.html

[5] See: http://www.ping.be/chlorophiles/Eng/ChlorineRCC2.html
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