WCA

Strategies for Sustainability

David Taylor — Wed, 21 Dec 2011 11:57:20 +0000

Strategies for Sustainability A further contribution of mine to the debate on moving towards a sustainable pharmaceutical industry has recently been published in European Pharmaceutical Contractor.

Quantitative risk assessment for contaminated land

Ed Stutt — Thu, 15 Dec 2011 15:44:13 +0000

The discipline of chemical risk assessment for contaminated land continues to be in a state of flux. Revised Statutory Guidance from Defra for the Contaminated Land Regime is due to go through Parliament in the coming months and this will contain new initiatives such as the “traffic light system” for assessment of Part 2A sites and incorporate the consideration of existing background concentrations (both rural and urban) for contaminants in soil.

Prior to these developments the Environment Agency published revised technical guidance and updated versions of the CLEA model in 2008 and 2009 but funding issues and re-organisations within the Agency left the job finished as updated guidance was not issued for some of the commonly occurring and ‘difficult’ contaminants. New Soil Guideline Value (SGV) reports were not produced for lead, polycyclic aromatic hydrocarbons (PAHs) and cyanides and recent developments in the toxicological understanding of these compounds mean that the TOX reports published in 2002 are now reasonably considered to be out of date. This leaves regulators and practitioners in a difficult position due to the absence of suitable technical guidance.

Assessments of lead toxicology by the European Food Standards Agency (EFSA) and Joint FAO/WHO Expert Committee on Food Additives (JECFA) have indicated that there are likely to be effects on the cognitive development of children (measured by loss of IQ) at much lower levels than previously thought. If used in CLEA to generate generic assessment criteria, the health criteria value derived by EFSA for dietary risk assessment of lead would result in the derivation of generic assessment criteria lower than the average value for lead in UK rural soils.

At the Society of Brownfield Risk Assessment (SoBRA) 2011 summer workshop on lead risk assessment for contaminated land I co-hosted a very lively debate on the toxicology of lead and attempts to select a health criteria value for use in human health risk assessment. The outcome of these disucssions will be contained in a SoBRA technical paper to assist practitioners in the risk assessment of this contaminant.

REACH support for catalyst industry

admin — Thu, 15 Dec 2011 14:53:57 +0000

wca environment has been lead consultant on REACH for Johnson Matthey’s catalyst division and the European Catalyst Manufacturers Association (ECMA). We have worked to demonstrate absence of risk for the manufacture and use of catalysts containing many different metals and metal compounds. Primary tasks for these projects were:

Compilation of emissions data and information on risk management measures from European catalyst sector.
Development of manufacturing and downstream user exposure scenarios.
Analysis of datasets to quantify catalyst sector-specific exposure scenarios for inclusion in the Chemical Safety Reports (CSRs) prepared by the major metals consortia such as nickel, copper and zinc.
Risk assessment to calculation RCRs.
Critical review and amendment of CSRs.
Development of SpERCs (industry specific environmental release categories) for the catalyst sector.
Registration dossier compilation.

wca environment support Movember

WCA Staff — Tue, 13 Dec 2011 12:17:04 +0000

Several of the more gullible (or brave??) male wca staff recently took part in this year’s Movember. For those who don’t know this is the month long moustache growing competition that takes place each year in November in aid of Men’s heath. A brief gallery of their “achievements” is shown below. So far the wca team has raised over £200.

Many thanks to all of our friends and colleagues who donated. If you’d like to donate there’s still time. Follow this link:

Graham

Mark

Pete

wca team - some imposters here I think!

Ecopharmacovigilance – An update

David Taylor — Wed, 09 Nov 2011 16:35:03 +0000

Interest in this subject has been given a boost by the appearance of a new EU Directive and associated regulation revising the law on pharmacovigilance. Recital 3 in the new regulation states:

“The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem. Member States should consider measures to monitor and evaluate the risk of environmental effects of such medicinal products for human use, including those which may have an impact on public health. The Commission should, based, inter alia, on data received from the Agency, the European Environment Agency, and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to Union legislation on medicinal products for human use or other relevant Union legislation are required.”

DG Sanco is currently seeking a contractor to help them to produce this report, but there is now a general view that some ecopharmacovigilance measures are likely to result. These issues were discussed at a recent meeting on the subject held in London at the Royal Society of Medicine. I co-chaired one of the sessions whilst my colleague John Fawell made a presentation on the recently published WHO Technical Report on the presence of Pharmaceuticals in Drinking Water. A review of the meeting has been already been published.

There is a clear view emerging from the industry that ecopharmacovigilance needs to be seen as a very specific activity not to be confused with the host of other issues that are encompassed by the term Sustainable Pharmacy. This latter term includes issues such as green process chemistry, water and energy conservation, minimisation of packaging etc. Gisela Holm from AstraZeneca was very clear that Ecopharmacovigilance was a process that started at the launch of the compound and she proposed a definition very closely related to the WHO Definition of pharmacovigilence:

“The science and activities associated with the detection, evaluation, understanding and prevention of adverse effects of pharmaceuticals in the environment”

How to undertake effective ecopharmacovigilance is a however a problem yet to find a solution.

COMING SOON: 2013 REACH Registration Deadline

simona — Wed, 12 Oct 2011 11:29:33 +0000

After the first REACH registration deadline in 2010, European industry now has to prepare for the second registration deadline of the 31st of May 2013. This deadline is for the registration of all phase-in substances manufactured or imported in the EU above 100 tonnes per year.

The lessons learned in 2010 tell us that all the companies involved in this phase have to be prepared and start work now to make sure that they have time to fulfill all the obligations required for the registration.

To remind everyone of this, ECHA is promoting its “REACH 2013 – Act Now!” campaign on its website. Here registrants will find all the information needed as well as the services and tools that the Agency provides to help companies to comply the REACH registration requirements.

Steps and timeline for submission

Here are the main steps and the suggested timeline for a successful submission:

SIEF work. Substance Information Exchange Fora help registrants of the same substances by facilitating data sharing, avoiding unnecessary studies and leading to agreed classification and labelling. A SIEF should be a shared effort: be active and communicate with other co-registrants.
Substance identification. Check with other SIEF members that you have the same substance.
Hazard data and data sharing. Collect all the available information on the intrinsic properties of the substance to be registered from published sources or within the SIEF. Avoid when possible new testing (consider the use of alternative methods, like QSARs, to fill data gaps) and agree on a transparent cost-sharing mechanism.
Chemical assessment. Carry out a Chemical Safety Assessment (CSA) of the substance to be registered and document it in a Chemical Safety Report (CSR). The CSA shall include all the information on the physico-chemical, human health and environmental hazard properties (hazard assessment), information on the uses (exposure assessment) and risk characterization.
Lead submission. The lead registrant of the SIEF has to submit the “joint submission dossier” via REACH-IT, which includes the joint information for the registration. The dossier should be submitted at least two months before the final deadline (31 May 2013) since it has to be accepted for processing before other SIEF-member’s submission can take place.
Member submission. Other co-registrants, once they have confirmed their membership of the joint submission, have to submit the member registration dossier through REACH-IT.

However, you may not need to undertake all these steps. As REACH is based on the principles of data sharing, if a dossier for the same substance has already been submitted in 2010, registration in 2013 can be completed by buying a letter of access (LOA) from the Lead Registrant in the Substance Information Exchange Fora (SIEF). The general process for registering as a co-registrant by buying a LOA is as follows:

Check that you have pre-registered. The first step is to check that a pre-registration was made for your substances by your company. If no pre-registration was made, you must cease manufacture (if > 1 tpa) and submit an inquiry to ECHA.
Identify the Lead Registrant for the dossier that has been submitted: It should be possible to identify the Lead Registrant or SIEF manager for the SIEF containing your substance within REACH IT.
Check that the current dossier completely covers your substance: In particular check that the substance composition and all your uses and your downstream users uses are covered.
Complete the company-specific sections of IUCLID: Specific details about your company and the substance to be registered need to be entered into IUCLID.
Check if any additional information is required: Some Lead Registrants will complete certain items that others will not. It is important to check that all of the required information is available and to complete it if it is not.
Submit the dossier using REACH-IT: Once complete, the IUCLID dataset will need to be submitted via REACH-IT.

How wca environment can help you

Need help? At wca environment REACH experts are ready to help and assist your company in the full registration process. We have experience in aspects of REACH registration from chemical safety assessment (CSA) to dossier submission. We can support you in different activities, such as:

Literature searches;
Data gap analysis and development of test strategies;
Data review and interpretation;
Preparation of IUCLID dossiers;
Hazard assessment and PBT/vPvB assessment;
PNEC and DNEL derivation;
Evaluation and application of in silico alternative methods (QSAR and read-across);
Classification and labeling;
Exposure assessments;
CSR preparation;
Assistance with dossier submission;
Strategic advice on cost-effective approaches to Registration.

We have been involved in hundreds of dossiers that have been successfully submitted to ECHA in 2010, and we are now ready to assist companies that are involved in 2013 deadlines.

Remember, companies that don’t register the substance they manufacture or import on time cannot place it on the EU market.

The 2013 Deadline is coming…

Environmental Effects of Nanoparticles and Nanomaterials

Rhiannon Smith — Fri, 30 Sep 2011 13:58:54 +0000

Pete and I attended the 6th International Meeting on the Environmental Effects of Nanoparticles and Nanomaterials in London last week. The meeting was organised by the Society for Experimental Biology (SEB) and the Society for Environmental Toxicology and Chemistry (SETAC). Plenary presentations were made across three days, with the first day focussing on chemistry, the second day on ecotoxicology and the third day on ecotoxicology and regulation. We were particularly interested in the presentations discussing registration and regulation of nanomaterials.

The meeting was well attended, with delegates mainly from academia, although government, military, industry and non-government organisations were also represented. We presented a poster: “Regulating nanomaterials to protect human health and the environment: progress and prospects” which you can download by clicking on the link.

Whilst many of the presentations discussed preliminary findings from on-going research, there appeared to be a general consensus throughout the posters and presentations that nanoparticular forms of substances are often no more toxic than their “bulk” or, in the case of metals, ionic, forms; this was particularly apparent for studies investigating the effects of nanosilver. Approximately 30% of the posters and plenary presentations related to nanosilver. Many of the presentations also discussed the impact of coatings and functionalisation on the fate and interactions of nanomaterials. As much of the research published to date on nanomaterials has focussed on “naked” (uncoated) forms of nanomaterials, rather than the functionalised forms of nanomaterials that are used predominatly by industry, the outcome of this ongoing research is likely to be increasingly relevant to the robust environmental risk assessment of nanomaterials.

OECD workshop on the environmental assessment of metals

Adam Peters — Fri, 30 Sep 2011 10:41:19 +0000

I recently contributed to a workshop organised by the OECD which was aimed at raising awareness of the various approaches that have been developed (mostly in Europe and North America) for performing hazard assessments for metals. The workshop covered a broad variety of issues such as how to deal with the very large datasets that are available for some metals, ensuring that data are both reliable and relevant to the assessment, combining data from multiple tests where appropriate, and normalising for bioavailability. The information presented was focused on the European assessments made under the Existing Substance Regulations (ESR) and, more recently, REACH. Although there were also presentations made on the approaches taken in both the US and Canada, and the development of the first EQS to be applied in Japan. The Metals Environmental Risk Assessment Guidance (MERAG) which was developed by the ICMM in collaboration with DEFRA also follows the same assessment principles.

Bioavailability was an important topic at the meeting, and issues such as whether or not a bioavailability correction should always be preferred, and if so how it should be implemented were discussed. Whilst there may have been the suggestion in the past that bioavailability is important for the assessment of all metals, a few examples were provided where bioavailability was either not important, was driven by factors other than those usually considered to be dominant, or where bioavailability correction was considered possible but not necessary due to low expected risks. The degree of complexity of different bioavailability models was discussed, as these may vary from simplistic corrections based on a single parameter to multiple models considering numerous parameters for different organisms. Ultimately, validation of which ever models are to be applied is likely to be the most important issue for the uptake of such methods by regulators

Bioaccumulation was another key area of discussion, although there was rather less consensus on how this should generally be addressed. Whilst metals can bioaccumulate in some cases this is due to biological requirements for them as micronutirents, although there are some cases where their accumulation can lead to problems. An important issue is the difference between the bioaccumulation of metals and organic compounds, and the use of bioaccumulation as an indicator of potential chronic toxicity in organic chemicals. It was also noted that whilst bioavailability is commonly considered to be critically important in assessing ecotoxicity it is rarely considered in assessments of bioaccumulation, although there is evidence to suggest that the bioavailability does affect bioaccumulation of metals.

Effects on iron on ecological communities

Adam Peters — Sun, 25 Sep 2011 22:45:41 +0000

Mark and I have been working with the Iron industry to try to understand the effects of iron on aquatic ecosystems. We have been analysing extensive field monitoring data on the quality of invertebrate communities in rivers and relating this to the levels of different forms of iron (total, dissolved, or particulate) that are present. Invertebrate communities do appear to be adversely affected when high levels of iron are present. This represents a possible approach towards deriving Environmental Quality Standards which are directly related to existing measures of ecological quality, therefore providing a better link between chemical and ecological quality in surface waters. It also avoids the need for laboratory test data, which can be especially difficult to interpret in the case of iron due to its precipitation behaviour. Some of the results of this work have recently been published in the Bulletin of Environmental Contamination and Toxicology (abstract).

Biotic Ligand Model for Manganese

Adam Peters — Wed, 14 Sep 2011 10:31:28 +0000

Biotic ligand models (BLMs) have become a very valuable aid to assessing the risks posed by metals in the aquatic environment, because they enable us to understand the effect of water quality on metal toxicity. Graham and I, along with Steve Lofts at the Centre for Ecology and Hydrology, have been working with the Environment Agency and the International Manganese Institute to develop and validate BLMs for manganese for a fish, an invertebrate, and an algal species. These models will enable future water quality standards for manganese to be adjusted to take account of the effects of differences in local water chemistry on the potential toxicity of manganese to aquatic organisms. The different effects of water quality on manganese toxicity to primary producers (e.g. algae) and higher aquatic organisms (fish and invertebrates) mean that different species are likely to be the most sensitive to manganese toxicity under different types of water chemistry conditions. The models include two novel approaches towards addressing the toxicity of metals to aquatic organisms. The BLM for fish considers two sites at which manganese uptake occurs, and a single model is used to address both biomass and growth related effects on algae. The models have been validated in a variety of different water chemistry conditions. A paper detailing the development and validation of the models has recently been accepted for publication in Environmental Toxicology and Chemistry (abstract).