Opinion on Cadmium - The Final Report by WS Atkins International Ltd based on : The Final Report (September 1998) and Additional Assessment (September 1998): "Assessment of the risks to health and to the environment of Cadmium contained in certain products and of the effects of further restrictions on their marketing and use". Expressed at the 7th CSTEE plenary meeting, Brussels, 18 January 1999.
Title of Opinion:
On the WS Atkins
"Assessment of the risks to
health and to the environment
of Cadmium contained in certain
products and of the effects of
further restrictions on their
marketing and use", Report
September 1998 and Additional
Assessment of the risks to
health and to the environment
of Cadmium contained in certain
products and of the effects of
further restrictions on their
marketing and use, Report
September 1998.
- The CSTEE has been
asked to express its opinion on
the adequacy of the above named
reports:
(1) Whether the degree
of risk to the environment and
man, as assessed by the WS
Atkins Reports, is sufficiently
justified?
(2) To comment on the
general quality of the Reports.
Executive Summary
Question: Whether the
assessment of the degree of
risk to the environment and
man, as assessed by the WS
Atkins Report "Assessment of
the risks to health and to the
environment of Cadmium
contained in certain products
and of the effects of further
restrictions on their marketing
and use" and the Report
"Additional Assessment of the
risks to health and to the
environment of Cadmium
contained in certain products
and of the effects of further
restrictions on their marketing
and use" are sufficiently
justified and to provide a
comment on the general quality
of the Reports.
-
Answer: The reports are
not of an acceptable quality.
The present reports have
inadequacies in that there are
some major areas in need of
further clarification or
amendment. These inadequacies
render parts of the reports
unacceptable. In particular,
some of the methodologies used
in the reports have been
incorrectly used and others
present difficulties for
interpretation. The opinion of
the CSTEE given below presents
the main criticisms of the
report.
- The main basis of the
scientific justification of the
Report's conclusions has been
the use of a wide range of
information from published
literature, industry and trade
associations, regulatory
authorities and member states
of the EU and on the
application of the principles
laid down in the Technical
Guidance Document (TGD) in
support of Directive 96/67/EEC
and Commission Regulation (EC)
No 1488/94. However, it is not
always clear which particular
source of information has been
used to provide specific data.
Conclusions of the WS Atkins
Reports, September 1998
1. Report Part 1, P6-1,
6.1 & 6.3
The report found that
the regional risks for man and
the environment arising from
all three products involving
cadmium as pigment in polymers,
as stabilisers in PVC and for
metal plating for the acidic
environment were acceptable.
2. Additional Assessment
P6-1, 6.3
The report found that
the regional risks to man and
the environment arising from
all three products for both the
generalised EU region and
acidic regions were acceptable.
3. Report Part 1, P6-1,
6.3
The report found that it
was not possible to provide the
risk characterisation for the
local risks from pigment
production because regional
PECs for the generalised EU
environment have not been
derived.
4. Additional Assessment
P6-1, 6.4
The risks to man and the
environment arising from one of
the three pigment production
facilities through the
atmosphere were considered
unacceptable.
5. Additional Assessment
P6-1, 6.4
The local risks to man
and the environment arising
through the environment in the
vicinity of facilities mixing
and using pigments were
considered to be acceptable.
6. Report Part 1, P6-1,
6.3
It was not possible to
provide the risk
characterisation for the local
risks from stabiliser
production because regional
PECs for the generalised EU
environment have not been
derived.
7. Additional Assessment
P6-1, 6.4
The local risks to man
and the environment arising
through the atmosphere in the
vicinity of two of the six
stabiliser production
facilities were considered to
be unacceptable.
8. Report Part 1, P6-2,
6.5 & Additional Assessment
P6-2, 6.6
Health risks in the
workplace associated with
pigment production, plating,
stabiliser mixing and use were
considered acceptable.
9. Report Part 1, P6-2,
6.5 & Additional Assessment
P6-2, 6.6
Stabiliser preparation
may present unacceptable health
risks in the workplace.
10. Report Part 1, P6-1,
6.3
For plating facilities
it was only possible to provide
risk characterisation for local
risks to the environment for
the acidic environment again
because regional PECs for the
generalised EU environment have
not been derived. These local
risks for the acidic regions
were considered acceptable.
11. Additional
Assessment P6-1, 6.4
The local risks to man
and the environment arising
from plating facilities for
both the generalised EU
environment and the acidic
environment were considered to
be acceptable.
12. Report Part 1, P6-2,
6.4
For incinerators it was
only possible to comment on the
local risks to man and the
environment for the acidic
environment again because
regional PECs for the
generalised EU environment have
not been derived. These local
risks for the acidic
environment were found to be
acceptable.
13. Additional
Assessment P6-2, 6.5
The local risks to man
and the environment arising
from incineration were
considered to be acceptable.
14. Report Part 1, P6-2,
6.4 & Additional Assessment
P6-2, 6.5
The risks from municipal
landfill sites were considered
to be potentially unacceptable.
It was not possible to
apportion the cadmium present
in a landfill or leachate from
such a site between cadmium
arising from components
associated with the products
and cadmium arising from other
sources.
15. Report Part 1, P6-2,
6.4 & Additional Assessment
P6-2, 6.5
The risks from hazardous
waste landfill sites in the
long term, assuming good
practice, were considered to be
small.
16. Report Part 1, P6-2,
6.4 & Additional Assessment
P6-2, 6.5
The risks and long term
risks from monofill landfill
sites, construction and
demolition waste landfill sites
were considered to be broadly
acceptable.
Opinion of the Scientific
Committee for Toxicity,
Ecotoxicity and the
Environment
The opinion of the CSTEE
is that the conclusions of the
Reports were not substantiated
and are doubtful.
(I) The derivation of
PEC values for the regional
environment is most likely
incorrect in terms of the
methodology used and probably
in terms of the data used in
the input.
Examples of this are:
a. The release
estimation of cadmium from
plastics and PVC does not
properly take account of
release during the entire
period in which the material is
used.
b. The emissions from
cadmium plated material are
averaged out over the
environment, both aquatic and
terrestrial. They do not take
account of the specific uses of
the plated materials and
emissions arising from these
uses.
c. PEC values are not
calculated for the steady-state
situation but for a specific
residence time in a
compartment, thereby ignoring
the potential long-term
accumulation of cadmium in soil
and sediment.
No clear distinction is
made in the report between the
concentrations arising from
anthropogenic sources and
natural sources, nor is it
always clear whether the values
used for the natural background
are in fact not also influenced
by anthropogenic emissions.
PEC values associated
with the three specific uses,
were derived by a fundamentally
incorrect procedure in that the
regional, continental and
background concentrations were
simply added together.
(II) The calculated
daily intakes of Cadmium, 110
µg d-1 for the acidic
environment and 114 µg d-1 for
the generalised environment,
are substituted by "measured
values", 15 µg d-1 for the
acidic and 45 µg d-1 for the
generalised environments, since
it was considered impossible
that the calculated intake
values could be higher than the
measured values. What the
measured values represent or
what they are based on, is not
clear. It seems likely that
they are population average
values.
The reported estimated average dietary intake of cadmium in European countries varies between 8 and about 50 µg d-1 (European Commission 1996; IPCS, 1992; Cuardo et al., 1995; Louekari et al., 1991; Buchet et al., 1983; Vahter et al., 1996; Berglund et al., 1994; Muller et al., 1993). Although it is known that there are great individual variations due to differences in dietary habits and energy intake, there is a lack of information on the distribution of the daily dietary intake of cadmium in the various European populations. Still it is obvious that the distribution often is very skewed and that a part of the population has an intake far exceeding the average. Thus even in a population having a fairly low average daily intake of cadmium, a fraction of the population is likely to exceed even the present PTWI of about 70 µg d-1. For example in Swedish studies of cadmium in collected duplicate diets, the individual daily intake of cadmium among 74 women varied from 5 to 70 µg d-1, Berglund et al. 1994; Vahter et al. 1996). In a Belgian duplicate diet study (21 hospital diets and three meals a day from 30 individuals from three areas) the total range of cadmium in the duplicate diets was 2 - 88 µg d-1, median 15 µg d-1 (Buchet et al, 1983).
In conclusion, the
values of daily intakes
employed in the risk
calculations are lower that
those found in the general
population. Thus, the PEC/TDI
ratios are in fact much higher.
(III) The TDI (PTWI in
the WHO document), like the WHO
water and air quality
guidelines, or the blood
cadmium concentration limit for
occupational exposed people,
represents the maximum
(tolerable) intake. Thus, the
dietary intake of all
individuals should be below
this value.
At the time when the present PTWI (WHO 1989) was evaluated, most dose- response relationships for cadmium were based on relatively crude methods to detect the renal damage or on studies of occupationally exposed male workers. During the last ten years much more sensitive methods, to detect renal damage, have become available. A number of recent studies of population groups, including elderly and individuals who are particularly susceptible to cadmium, exposed to relatively low levels of cadmium indicate that kidney tubular damage may develop at much lower levels than previously believed. Thus, most likely the true daily intake/TDI ratio is lower than that calculated based on a PTWI of 70 µg/d (Elinder et al 1985; Buchet et al, 1990; Bernard et al 1992; Chia et al 1992; Roels et al 1993; Fels et al 1994; Jarup et al 1995; Berglund et al, 1997; Jarup et al, 1998). In the risk assessment, it is also crucial to consider the individual variation in toxicokinetics and sensitivity.
(IV) The estimation of
the PNEC values is incorrect.
The use of probabilistic
approaches, although not yet
included in the TGD, is
considered valid and
scientifically sound. However,
there are some basic
requirements for probabilistic
methods that have not been
fulfilled in the report
calculations. Therefore the
values presented in the report
cannot be accepted.
Some major problems
observed in the PNEC
estimations are:
a. The toxicity data set
must be large enough (use of
probabilistic approach for n=5
is inappropriate).
b. Several NOEC and LOEC
values obtained for different
endpoints in a single study on
the same species have been
considered as individual data.
c. The probabilistic
curves and the statistical
values have not been included.
d. The taxonomic
distribution and
representativity of the data
set have not been presented.
e. The uncertainty of
the results and the need of
additional safety factors have
not been discussed.
(V) The effects of
environmental characteristics
on cadmium toxicity are not
addressed. This is a major
weakness, particularly for
local risk characterisation
which can be markedly
over-estimated if toxicity data
are not corrected for the real
bioavailability of cadmium in
the receiving environment.
In addition, regional
and continental risk
characterisations should be
improved by the inclusion of
PNEC values adapted to the
water/soil conditions using
probabilistic approaches for
European water/soil
characteristics.
(VI) The present report
does make the comparison
between exposure and effects
for individual uses but the
total picture of the risks of
cadmium is not given. Although
the summation of the risks from
the three uses is now given in
this report the implications of
the other sources of cadmium
are not addressed. For a
substance with a diffuse
emission pattern like cadmium,
this may lead to the conclusion
that the emissions from the
three use-types investigated
may not lead to unacceptable
levels but, if these are added
to the emissions from other
sources, the acceptable levels
may well be exceeded. This
remains a serious omission in
the report and is not in line
with common practice in
performing risk assessments for
substances. The present report
does not provide the means to
assess the relative risks from
these uses compared with the
other uses of cadmium.
References:
Bernard A, Roels H,
Thielemans N, Van Lierde M,
Lauwerys R:
Assessment of the
causality of the
cadmium--protein relationships
in the urine of the general
population with reference to
the Cadmibel study. IARC
Scientific Publications 1992;
118, 341-6
Berglund M, Åkesson A,
Nermell B, and Vahter M:
Intestinal absorption of
dietary cadmium in women is
dependent on body iron stores
and fibre intake. Environ.
Health Perspect. 1994; 102
(12), 1058-1067.
Buchet JP, Lauwerys R,
Roels H, Bernard A, Bruaux P,
Claeys F, Ducoffre G, De Plaen
P, Staessen J, Amery A, Lijnen
P, Thijs L, Rondia D, Sartor F,
Saint Remy A, Nick L:
Renal effects of cadmium
body burden of the general
population. Lancet 1990; 336,
699-702.
Buchet JP., Lauwerys R,
Vandevoorde A, Pycke J M:
Oral daily intake of
cadmium, lead, manganese,
copper, chromium, mercury,
calcium, zinc and arsenic in
Belgium: a duplicate meal
study. Food Chem. Toxicol 1983;
21, 19-24.
Chia KS, Tan AL, Chia
SE, Ong CN, Jeyaratnam J:
Renal tubular function
of cadmium exposed workers.
Annals of the Academy of
Medicine, Singapore 1992; 21,
756-9.
Cuadrado C, Kumpalainen
J, Moreiras O: Contaminants and
nutrients in total diets in
Spain. Eur. J. Clin. Nutr.
1995; 49, 767-778.
Elinder, C-G, Edling, C,
Lindberg, E, Kågedal B,
Vesterberg, O: Assessment of
renal function among workers
previously exposed to cadmium.
Brit J Ind Med. 1985;
42,754-60.
Fels LM, Bundschuh I,
Gwinner W, Jung K, Pergande M,
Graubaum HJ, Price RG, Taylor
SA, De Broe ME, Nuyts GD:
Early urinary markers of
target nephron segments as
studied in cadmium toxicity.
Kidney International. 1994; 46
(Suppl. 47), 81-8.
Jarup L, Carlsson MD,
Elinder CG, Hellstrom L,
Persson B, Schutz A:
Enzymuria in a
population living near a
cadmium battery plant.
Occupational &
Environmental Medicine 1995;
52, 770-2.
Louekari, K., Valkonen
S, Pousi S, Virtanen L:
Estimated dietary intake
of lead and cadmium and their
concentrations in blood.
Science Total. Environ. 1991;
105, 87-99.
Muller M, Thiel C, Anke
M, Harmann E., Arnold, W:
Cadmium intake of adults
in Germany. In Trace elements
in man and animals - TEMA 8,
1993 (M Anke, D Meissner, and
CF Mills, Eds.) pp. 211-215.
Verlag Media Touristik,
Gersdorf.
Nordberg GF, Jin T, Kong
Q, Ye T, Cai S, Wang Z, Zhuang
F, Wu X:
Biological monitoring of
cadmium exposure and renal
effects in a population group
residing in a polluted area of
China. Sci Total Environment
1997; 19, 111-114.
Roels H, Bernard AM,
Cardenas A, Buchet JP, Lauwerys
RR, Hotter G, Ramis I, Mutti A,
Franchini I, Bundschuh I:
Markers of early renal
changes induced by industrial
pollutants. III. Application to
workers exposed to cadmium.
British Journal of Industrial
Medicine. 1993; 50, 37-48.
Vahter M, Berglund M,
Nermell B, Åkesson A:
Bioavailability of
cadmium from shellfish and
mixed diet in women. Toxicol.
Appl. Pharmacol. 1996; 136,
332-341,.
WHO. 1992:
Cadmium. Environmental
Health Criteria. WHO, Geneva.
280 p