With Christmas and the end of 2016 approaching we are taking the opportunity to look back on a very busy year. We will report on some of the most important and interesting things that have happened in 2016:
2016 has been a year of refocusing for ECFIA. We have come a long way since our founding in 1979, and even though there have been a lot of changes with regard to the regulatory situation and associated requirements, our main focus is still the same: to develop safe working practices and good occupational health and safety standards in the production and use of HITWs. We took the time to summarise some basic information on ECFIA and our Product Stewardship Programme in two brochures that can be downloaded here:
Practical guidance document series
Now containing 21 documents, the ‘CARE Guidance’ series has reached a status where there is a document on every relevant exposure control element or exposure scenario. They are written by occupational hygienists for users and give helpful information on how to put in place effective controls to minimise exposure to airborne fibres. If you need advice on, for example, local exhaust ventilation systems or maintenance and repair operations, you will find a specific document in the CARE Guidance library.
Candidate Listing of ASW/RCF
The European Commission has proposed an amendment of REACH Annex XIV (authorisation). The latter does not include ASW/RCF any longer and suggests postponing the decision on ASW/RCF till the most relevant regulatory approach has been found. MS representatives forming the “Art. 133 Committee” will decide on the proposal. A decision is likely to come out in the first quarter of 2017”.
Revision of the Carcinogens Directive
On 13 October 2016 the European Council reached agreement on its position on a revision of the Carcinogens Directive. In addition to the substances covered by the existing 2004 directive, it proposes to set exposure limits for a further 11 carcinogens, including a BOELV for ASW of 0,3 f/ml. This now opens the way for discussions on the directive between the Council and the European Parliament.
Scientific paper comparing intrapleural, intraperitoneal and inhalation test results
The paper published by Drummond G, Bevan B & Harrison P in Regulatory Toxicology and Pharmacology compares results from inhalation studies with those from intraperitoneal/intrapleural (IP) tests for a number of fibrous and particulate test materials, including ASW/RCF, with the objective of establishing how well IP studies predict the pathological responses observed in standard inhalation studies. For many materials, positive results in the intraperitoneal test were not reflected by positive inhalation results. In addition, it was found that if a material tested negative in the intraperitoneal test it was never positive in inhalation tests. These findings led to the conclusion that the IP test can be used to exonerate a dust or fibre but should not be used to positively determine that a dust or fibre is carcinogenic by inhalation.
Scientific paper on threshold vs. non-threshold carcinogens
Recently, a paper on threshold vs. non-threshold carcinogens (co-authored by our consultant toxicologist, Professor Paul Harrison) was submitted for publication in Regulatory Toxicology and Pharmacology (expected to be published in early 2017). This paper explains the importance of determining the threshold or non-threshold nature of a carcinogen. At present, some regulatory bodies – including those that set occupational exposure limit values – do not make this distinction, resulting in inappropriate regulation of carcinogens that have a safe level of exposure. ASW/RCF is a prime example of such a substance.