Tackling Chemical Safety Rules and Regulations
Article Jun 18, 2015
The number of chemical safety rules and regulations is staggering. In the US alone, there are hundreds of regulations from national initiatives such as the Toxic Substances Control Act (TSCA) to state and sometimes even local regulations, such as California’s HMBP Title 19 Hazardous Materials program. International chemical regulations are just as numerous and complex, if not more so since many of the Chemicals of Interest Lists disagree on what constitutes a hazardous material and what does not. The European Chemicals Association (ECHA) is tackling this arena by examining current challenges and issues each year during the annual Helsinki Chemical Forum (HCF).
HCF 2015 was held at the Helsinki Exhibition and Convention Centre from 28-29 May 2015. Each year, forum panels are defined concerning key areas of chemicals use and management, with an emphasis on new challenges. This year, a particular emphasis was given to ECHA’s upcoming REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging) and CLP (Classification, Labelling and Packaging) deadlines.
This year, HCF panels tackled SAICM (Strategic Approach to International Chemicals Management) and the future for global chemicals risk management; how to expedite adoption of the Globally Harmonized System (GHS) on chemical classification and labeling; improving communications about chemicals in products in the supply chain; avoiding regrettable chemical substitution; and, green chemistry challenges.
The Future of Global Chemicals Risk Management
One of the biggest challenges for all parties, from government to industry, is not just the identification of a hazardous material but also the management of that material throughout its lifecycle. Led by the European Commission’s Bjorn Hansen, the SAICM discussion panel zeroed in on issues surrounding the EU’s ban on certain chemicals, detection issues of those materials in products, and the inclusion of eWaste as a chemical management issue. Even with the small number of materials on the REACH Chemicals of Interest list, this is a huge challenge with huge costs that will make it very difficult to meet 2020 deadlines. SAICM was adopted in 2006 with the objective to share data internationally concerning exposure limits and safety data. However there is no requirement for the countries to agree upon what constitutes a hazardous material and thus discussions bog down over substances such as asbestos for which there is still not global acceptance of its dangers nor on how to manage it. Add to this the existence of pressures on less affluent countries to produce these chemicals and not implement chemical regulations, and the problem of global harmonization becomes very difficult indeed.
The next panel dived into GHS issues, specifically those surrounding the adoption of CLP and the difficulties meeting upcoming CLP deadlines. Currently some 67 countries worldwide are addressing GHS with the goal of making it simpler to create, use and understand chemical labels and safety data sheets. Unfortunately the actual chemical classification is not harmonized, nor is GHS legally binding. Even more confusing, not all of the GHS parameters are implemented by the adopting countries. In addition, different data sets, different test protocols and different interpretation of the same data set can and do cause differences in GHS interpretation. These are some of the key reasons why it has been so difficult to meet the GHS CLP deadlines. Another reason is that many countries already have numerous regulations in place with which GHS must segue. The United States, for instance, has implemented some aspects of GHS in its recent revisions to OSHA’s Hazardous Communications standard, but the US EPA has not yet implemented GHS programs concerning pesticides. Issues surrounding mixtures, which often have lower chemical concentrations, but cumulatively can exceed reporting limits, were also discussed. In general it was agreed by the panelists that there should be a global list of classified chemicals.
Improving Communications in the Supply Chain
Another aspect of chemical mixtures is chemicals in products, particularly when those products include hazardous materials. The controversy over lead in children’s toys is a case in point. This area is not covered by REACH but is very much a part of the right-to-know chemicals management dialogue and the growing demand for transparency from the public. A key difficulty identified by the panelists is understanding the entire supply chain and how actions taken by one supplier in the chain affect downstream users; in other words, ignorance of the final product is not acceptable when public health and safety are endangered. Safe alternatives to toxic chemicals were discussed as well as the benefits of moving from passive to active understanding of the chemicals in a manufacturer’s products. The growing role of consumers in deciding product viability was addressed, with an examination of the affects of large retailer bans on specific products. Understanding of the acute and chronic hazards associated with products is driving significant change throughout the supply chain.
Avoiding Regrettable Chemical Substitution
In the effort to use alternatives for toxic chemicals, substituting a less hazardous material is often the first choice. However, this is not always the best methodology as there are other aspects to consider along with product design, such as process change and exposure patterns. For instance, substituting Bisphenol S for Bisphenol A, an industrial chemical used primarily to make polycarbonate plastic and epoxy resins, does not solve the problem of toxicity. This panel expanded upon the supply chain challenges mentioned previously, with an emphasis on addressing the total lifecycle of a chemical, not just the section that applies at a single point. Part of the problem is that there often isn’t sufficient data on good alternatives. Again it was predicted that downstream users will continue to push for change, observing that the distinction between chemical hazard and chemical risk is not differentiated by these users.
Green Chemistry and Engineering
HCF wrapped up with a final panel on green chemistry. The panel pointed out that green chemistry is not the same as green chemicals, but encompasses a holistic process viewpoint that includes green manufacturing, green consumption and green waste. It is in essence a business strategy that drives sustainability. The twelve principles of green chemistry were examined as well as the components of successful green chemistry; e.g., that it be beneficial environmentally, societally and economically. Green chemistry is principally focused on manufacturing and engineering aspects, although the conversation is evolving to sustainable chemistry. The panelists agreed that green chemistry is a moving target and a never-ending journey.
Over the course of the two day forum, the growing awareness of the impact of chemicals on human health and the environment and the regulations to drive chemical safety were examined in depth with an eye to addressing not just current issues, but also emerging ones such as nano-substances, biocides, endocrine disruptors and more. ECHA’s HCF conferences seek to drive awareness of these challenges from a strategic level while enabling an open dialogue for all constituencies.
The Viral Genome: Moving Beyond Reading Code – Why Not Rewrite It?Article
Researchers have discovered how to read, decode, and manipulate previously ‘hidden’ viral code. This could open up new opportunities in drug delivery and gene therapy.READ MORE
The MAPK Pathway as a Therapeutic Target in Cancer ResearchArticle
Following the rapid and striking success of vemurafenib, a MAPK targeting drug used to treat melanoma, interest in this critical cell signalling pathway has exploded.READ MORE
Advancing Drug Discovery Through Academic–Industry CollaborationArticle
Genestack recently announced that they were joining the Milner Therapeutics Institute. In light of the announcement, we spoke to Prof. Tony Kouzarides, Director of the Milner Therapeutics Institute and Dr. Misha Kapushesky, Founder and CEO of Genestack, to learn more.READ MORE
Comments | 0 ADD COMMENT
Highly Potent Active Pharmaceutical Ingredients (HPAPI)
May 21 - May 22, 2018