0016-01 Microporous
Carcinogenic properties of Trichloroethylene (TRI) are known since a long time. In
1996 the Deutsche Forschungsgemeinschaft classified TRI as a proven carcinogen
to humans. This classification has been confirmed and supported with additional data
in 2010. In 2001, EU legislation (28. ATP to Directive 67/548/EEC) classified TRI as
“Carc.Cat. 2” (now “Carc 1B” according to CLP).
In 2007 REACH Regulation came into force, and in 2010 TRI was included into the
Candidate List with the clear expectance of incorporating TRI into REACH Annex
XIV. In 2010, the German AGS (committee on hazardous substances) published the
risk-based occupational exposure limit (3.3 mg/m³) associated with a low cancer risk
level, deemed as acceptable (work lifetime risk of 4 EE-05).
A standard “acceptable” work lifetime risk of 4:100,000 is consented, amongst others,
in Germany, the Netherlands and France. In the UK, there is an analogous basic
declaration from 2001 (“Reducing Risks, Protecting People. HSE’s decision-making
process”).
Therefore, for all downstream users of TRI it was obvious since 17 years, that there
is a need to substitute this carcinogenic substance. Since at least 7 years (since
inclusion into Candidate List) it was clear, that there is an urgent need for substitution
or – at least – for lowering occupational exposure below the risk based limit value of
3.3 mg/m³ (TWA).
In this context, it is not understandable that the company is planning a new (third)
production line using the same carcinogenic substance and process while other
factories successfully use alternative technology without carcinogenic substances.
Furthermore, it is neither understandable nor acceptable that in all these years no
R&D program was conducted (as stated in the AoA document) to identify and to test
alternative solvents and/or technologies. (Only a last-minute internet research has
been done to compile the AoA document.)
The obvious longstanding ignorance of the need to substitute the carcinogen cannot
be accepted as a reason or a justification for a prolonged review period.
Oftentimes the AoA and SEA documents presumes that the local authorities would
be accountable for the use of TRI in the plant.
In contrast to this attempt to shift the burden to local authorities, it is the job of the
company to manage substitution or, respectively, to guarantee worker’s exposure
below 3,3 mg TRI/m³.
As shown in the AoA, there are some reasonable alternatives using NONcarcinogenic substances. Among others, n-hexane is a feasible alternative. n-Hexane
is neither a proven carcinogen nor a suspected carcinogen.
Risks arising from the flammability of n-hexane can be mastered by technical means.
For n-hexane a health-based OEL exists, i.e. a workplace air concentration below of
which no adverse health effects occure. Due to current scientific knowledge this OEL
is 180 mg n-hexane/m³ as 8-hour-TWA with a short time (15 min.) value 1440 mg/m³
(MAK Deutsche Forschungsgemeinschaft). Even though the binding OEL in Austria
is lower (72 mg/m³; short time value 288 mg/m³), these limit values are more than 20
times higher than those for TRI. n-Hexane shows a vapour pressure not much higher
than that of TRI.
Therefore the use of n-hexane provides a large margin of flexibility in operating the
plant in different conditions compared with an air concentration restricted to 3.3
mg/m³.
The statement that ‘automobile sector (and the demand for battery foils) is steadily
growing’ seems to be over-optimistic in the own interest of the SEA document.
Worker contributing scenario 3: Mechanical processing of the separator sheet
(chapter 9.1.4):
Air concentration levels up to 44 mg/m³ had been measured. No measurement
showed a concentration below the permissible exposure limit (3.3 mg/m³).
All air concentrations, in the early shift as well as in the late shift, were at least 6.3times higher than the permissible exposure limit (3.3 mg/m³). A limit value of 3.3
mg/m³ is legally binding in Austria. It corresponds with an “acceptable” work lifetime
risk of 4:100,000.
It is estimated that 10% of exposure levels even lie ABOVE 36.9 mg TRI/m³! This
level is 11 times higher than the permissible exposure limit.
Even the mean exposure level (28 mg/m³) is more than 8 times above the exposure
limit.
Therefore, the workers underlying the Contributing Scenario 3 are subjected to a
cancer risk up to 13 times higher than the “acceptable” cancer risk. This is definitely
inacceptable.
The worker contributing scenario 3 (mechanical processing of the separator sheet)
only provides a basic general ventilation (2 air changes per hour) of the 45,000 m³
hall. No LEV is envisaged.
Improvement of general ventilation and implementation of LEV could reduce the
worker’s exposure to TRI to a considerable extent. These improvements are
indispensable, in particular to comply with EU legislation on Safety and Health at
Work [see Articles 5 and 6 of CAD (98/24/EC) and Articles 4 and 5 of CMD
(2004/37/EC)].
Suggested alternative:
If an authorisation should be granted for the use regarding “Worker contributing
scenario 3: Mechanical processing of the separator sheet” it is indispensable to
include ENHANCED GENERAL VENTILATION and LOCAL EXHAUST
VENTILATION of work zones in the conditions to be given in the authorisation
according to REACH Article 60/8.
“Human Biomonitoring” not suitable:
In Worker contributing scenarios 2, 3, 4 and 5 the following RMM is stated: “Human
biomonitoring of all workers takes place every 6 months. In case of increased
concentrations of TRI are found, the interval for the next check is only 3 months.”
1. This procedure is not in accordance with Austrian law any more. The determination
of a metabolite of TRI (trichloroacetic acid) in urine has been withdrawn because the
former metabolite guidance level was associated with the former, very high OEL (270
mg TRI/m³).
2. Instead of trichloroacetic acid determination now a general check of liver enzymes
in blood has to be made.
This parameter is quite unspecific. Determination of liver enzymes is NOT a measure
of Biomonitoring, but a measure of effect monitoring which allows only much less
conclusions than Biomonitoring data.
3. There is no biological parameter for “low” or “high” cancer risk due to workplace
TRI exposure. Enhanced trichloroacetic acid levels in urine as well as enhanced
levels of liver enzymes in blood are indications of possible ACUTE liver damage, in
particular of already severe liver damage. They do not provide any information on
liver cancer risk because hepatic tumors are long-term effects of TRI. The same is
true for renal cancer and non-hodgkin lymphomas.
In spite of the fact that the former OEL for TRI was associated with a very high
cancer risk of the exposed workers, the medical examinations (as quoted in SEA
document, chapter 2.3.7.5) did not show increased trichloroacetic acid levels. The
argumentation given in the SEA document that “therefore … the exposure of TRI …
is safe”, is without any reason and is unjustified.
4. The only way for risk control and risk surveillance referring to workplace TRI
exposure is recurrent air monitoring at the workplaces. Instead of medical
examination of the workers, monitoring (measurement) of workplace air concentration
levels is necessary as RMM.
5. Former monitoring of trichloroacetic acid levels in urine and future determination of
liver enzymes in blood does not allow any statement on the critical endpoint of TRI
exposure which is tumorigenic action. They are no risk management measures.
Suggested alternative:
If an authorisation should be granted for the referring uses, it is indispensable to
include REGULAR AIR MONITORING instead of “biomonitoring” in the conditions to
be given in the authorisation according to REACH Article 60/8. Only a short review
period seems to be justified in this authorisation.
Because the legal binding Austrian exposure limit for TRI is heavily exceeded in the
plant, any authorisation should NOT be granted without imposing conditions as
described above, including air monitoring, on the applicant.