The German Environment Agency (UBA) and the Norwegian Geotechnical Institute (NGI) hosted a workshop on "PMT and vPvM substances under REACH” in Berlin, Germany on the 13-14th of March, 2018. Over 120 people from 16 countries attended.

The UBA has proposed criteria and an assessment procedure to identify Persistent, Mobile, Toxic and very Persistent, very Mobile substances that pose a hazard to the sources of drinking water, and invited the chemical industry, drinking water suppliers and regulatory bodies to participate in a discussion of voluntary measures and regulatory options to protect the sources of drinking water.

Prof. Dr. Eisenträger of the UBA introduced the topic with a brief history from the start of discussions in 2009 through the first round of workshops on how to improve drinking water protection in 2012 to the present time. The second draft of the UBA position paper published in October 2017 will be further refined based on the feedback of this workshop.

Benefits of PMT criteria for substances under REACH for drinking water company Oasen

The conference opened with the view of the water suppliers, represented by Dr. Harrie Timmer, of the Dutch water company Oasen drinkwater, and co-author of a recommended paper on the fate of organic micropollutants during long-term/long-distance river bank filtration. Dr. Timmer presented examples of the two-pronged approach used by the water companies: working to reduce the releases at the pollutant sources and continuously improving the treatments to ensure delivery of safe drinking water to the population that depends on supply from the downstream end of the heavily industrialized Rhine River.

The proposed PMT criteria: how many P, M, and T compounds are registered under REACH and are in drinking water?

Next, Prof. Dr. Hans-Peter Arp, from the co-host Norwegian Geotechnical Institute (NGI), presented research that NGI conducted as part of a research project commissioned the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety of Germany (BMUB). It is emphasized that the resulting list of REACH registered substances that could be considered PMT/vPvM substances represents a preliminary screening, not an official list of substances to be regulated by UBA or any other authority. That said, Dr. Arp achieved the purpose of showing a remarkable correlation between substances identified by screening of their REACH dossier data and substances that are above detection limits when analyzed in groundwater, even identifying novel targets for analysis.

The criteria proposed by UBA and applied by NGI in this assessment of REACH substances are:

• P/vP: Persistence is defined in REACH Annex XIII in the context of PBT/vPvB substances.
• M/vM: Mobile/(very mobile) substances are defined as having a lowest log Koc ≤ 4.0/(3.0) over the environmentally relevant pH range of 4-9; or in the absence of log Koc data, having a lowest log Dow ≤ 4.0/(3.0).
• Toxicity: the T criteria controversially does not correspond with the definition of T as defined in REACH Annex XIII in the context of PBT/vPvB substances. It starts with the NOEC/EC10, CMR, and STOT criteria laid out in Annex XIII, but extends the definition to also include: 
  • Carcinogenic category 2 and germ cell mutagenic category 2;
  • Additional category for effects on or via lactation;
  • Derived-No-Adverse-Effect-Level (DNEL) is ≤ 9 µg/kg/d (oral, long term, general population);
  • Endocrine disruptor criteria.

Based on the defined criteria, 240 substances are listed in the technical note on the NGI preliminary assessment: 

• vPvM and not T: 30 substances
• vPvM and PMT: 23 substances
• PMT (but not vPvM): 35 substances
• High Potential to be PMT/vPvM: 152 substances

“High potential” implies that no experimental half-life data is available so a weight-of-evidence approach applied.

The above information is detailed in the NGI Technical Note Preliminary assessment of substances registered under REACH that could fulfil the proposed PMT/vPvM criteria.

Dr. Arp drove the point home by continuing with a report on the next step, assessing whether the chemical identified by the PMT/vPvM screening approach are also found in groundwater. This phase of the project added screening of the ERC use descriptors and the overall volumes on the market, to identify the substances likely to have high release rates or wide dispersive uses, resulting in selection of 70 PM or vPvM substances for real-world analysis.

The results do give pause for thought:

• 45 of the 70 substances were detected in drinking water;
• 5 of the substances were detectable in all 14 samples;
• Over 50% of the samples had 28 of the identified substances

Some of these drinking water contaminants were the usual suspects but others were completely novel in the context of drinking water evaluation, never before having been targets of analysis in drinking water. Surveys of scientific literature produced similar support: two thirds of 77 substances were found to have good correlation between PMT screening criteria and detection in groundwater or drinking water.

Dr. Arp mentioned some examples, such as a novel substance identified by this investigation and detected in drinking water which has been attributed germ cell mutagenicity category 2 under the REACH joint notification. (Because this study has not quantified these contaminants nor established any risk assessment, and because mentioning specific examples too soon can reduce the attention on other unmentioned substances that perhaps deserve greater priority, the identities of the example substances discussed are not mentioned here.) Dr. Arp’s team is releasing the identities of these novel substances successively in scientific papers.

Subsequent discussion raised the easy criticisms: for example, melamine was mentioned as an example of a known drinking water contaminant found to be persistent, mobile and toxic. The NGI paper attributes Carc. 2 and STOT RE 2 categories to melamine, which is not supported by the scientific weight of evidence for the proper classification of this substance under REACH criteria. Lack of quantification also raises concern without perspective on the actual risks.

Participant comments reflected that it is important not to stoke unjustifiable fears but equally important not to dismiss the study due to the inevitable inclusion of some chemical substances that do not justify concern: an appropriate screening tool should lead to false positives if the intention is to ensure further data collection to correctly assess the potential for significant risks.

 
Discussion Café

This session was followed by a discussion session which broke the attendees into groups to give feedback on the criteria for persistence, mobility, and toxicity, as well as to comment on how the UBA should proceed to develop this PMT concept in the near- and long-terms.

Industrial point of view: Reflection on the PMT criteria and proposed tools to identify and regulate such chemicals

Dr. Ronald Bock of Chemours represented the CEFIC viewpoint on the UBA proposal for implementing PMT and vPvM criteria under REACH. CEFIC questions whether the approach offers the best tool for protecting water quality, mentioning especially the fact that agricultural, pharmaceutical, veterinary, and other sectors as well as metabolites are not covered under REACH. The timeliness of regulatory pathways must also be balanced against the risk of regrettable regulatory actions.

CEFIC’s position emphasizes that M ≠ B, that there is not an “equivalent level of concern” as required under REACH article 57(f) to act without amendment of the REACH regulation. The working group members also believe that the current PMT concern lists are overly conservative, questioning whether the program is manageable.

To illustrate industry’s concerns, Dr. Bock reviewed a number of specific examples where the data does not align with the attributes used in the PMT studies or where REACH exposure assessment has ruled out the possibility of risk. The underlying theme of the case studies supported the need for more and better scientific data before initiation of regulatory action.

Dr. Bock’s presentation met with the obvious question, put forth by a member of the audience: Since REACH reverses the burden of proof, what is CEFIC doing to prove the safe use of the chemicals identified as potentially of concern by this PMT screening method? Dr. Bock could not offer an official CEFIC position in response to the question.

Voluntary Groundwater Watch List: ongoing work coordinated by EU Common Implementation Strategy Working Group Groundwater

Dr. Ronald Kozel of the Swiss Bundesamt für Umwelt (BAFU) presented the Voluntary Groundwater Watch List (GWWL) created by the groundwater working group under the EU Common Implementation Strategy. The GWWL is voluntary, as compared to the Surface Water Watch List, which is a mandatory list.

The work on the GWWL further supported a good correlation between substances found in actual studies of groundwater with substances predicted by the BAFU method. The GWWL intends to

• Identify new/ emerging pollutants; 
• Create a candidate list of substances to be added to regulation as the evidence merits; 
• Assist the member states in selecting pollutants which should be monitored.

The target is to have the GWWL operational in 2019, after which it will be re-evaluated on the standard 6-year update cycle of the Common Implementation Strategy for Directive 2000/60/EC of the European Parliament and of the Council.

Discussion Café Feedback

The first day of the workshop concluded with a discussion of the feedback gathered during the break-out sessions. The range of comments will be taken into account by UBA in furthering their position on the PMT concept.

The way forward for the protection of the sources of our drinking water

Dr. Michael Neumann, of the German Environment Agency (UBA), introduce the second day of the workshop focusing on the future outlook, voluntary action, regulatory options, and mitigation measures by reminding the audience of the duty of industry to ensure safe use of chemicals. He highlighted the 3857 substances for which insufficient data was available to make any screening, and 2614 substances that raised potential for concern but lacked data for a definitive conclusion on P, M, and/or T – numbers which overshadow the 240 substances listed in the NGI report due to findings of potential concern.

Dr. Neumann reflected on an idea raised the prior day regarding the equivalency of mobility in PMT with bioaccumulation in PBT: the concentration of PB substances in the food chain or the concentration of PM substances in the environment from which we and other critical species get drinking water lead to the same result, exposure by the oral intake pathway to concentrations of chemicals that may pose a risk.

Dr. Neumann emphasized that regulatory options will be pursued only if voluntary actions are insufficient, but made clear that the conditions to apply article 57(f) on equivalent level of concern as a basis for authorization requirements under REACH appear to be met by the PMT and vPvM criteria. His position, and presumably that of UBA: “We really don’t need more monitoring to start acting.” His words emphasize the need to react on existing contamination presented by representatives of water suppliers and to prevent future contamination, because the PM properties make these chemicals difficult to clean up.

Experiences with managing industrial PMT chemicals in waste water in Germany from 1992-present

Prof. Thomas Knepper, of the Hochschule Fresenius Idstein, presented over a dozen cases of historically troublesome chemicals, demonstrating that the devil is in the details.
His examples included

• A 35% reduction in EDTA releases (compared with a 50% target);
• A continued rise in Atrazine concentrations after the ban in Germany, because farmers continued to source it in France where it had not been banned;
• A case which required interaction with the German revenue department to resolve, because tax incentives to denature alcohol introduced unintended by-products from reactions;
• Charts showing how the mosquito repellent DEET in water tracked the weather;
• The discovery of how chain length is critical in the degradation of PFOS and PFOA;
• And more.

From the development of analytical methods necessary to evaluate emerging issues to the treatments and regulations used to mitigate the risks, each case exemplified that problems can be solved only with reference to the unique circumstances of the specific contaminant.

1,4-Dioxane in Surface and Ground Water: Sources, Analysis and Reduction of Emissions

Dr. Wolfgang Körner, of the Bayerisches Landesamt für Umwelt, went into even more depth in the particular case of 1,4-dioxane, building on the sense established by Prof. Knepper that establishing controls requires targeted and multi-faceted efforts.

The view from the Chairman of the Member State Committee at ECHA

Dr. Watze de Wolf, Chairman of the Member State Committee at the European Chemicals Agency (ECHA), gave an informative overview of how the processes established under the REACH and CLP legislation can proceed.

He confirmed that if sufficient data supports a finding of equivalent level of concern for any PMT or vPvB substance, the identification as a substance of very high concern (SVHC) can proceed, potentially concluding in ECHA’s recommendation to add the substance to Annex XIV of REACH, subjecting it to authorization.

But he also pointed out that if there is not sufficient data, the CoRAP and substance evaluation process pathway can be used to generate further information to support the eventual control of a substance under REACH.

Furthermore, a legal analysis is needed to establish whether the PMT or vPvM cases meet the article 57(f) requirements for what constitutes an equivalent level of concern. In particular, is there sufficient “scientific evidence of probably serious effects to human health or the environment”? This legal analysis cannot be initiated until the 1st case is brought forward by a member state.

The timeline on the process is long. Substance evaluation can lead to various controls, with respective average timelines indicated:

• Harmonization of the classification and labelling: 3-4 years
• Identification as a candidate substance of very high concern (SVHC): only 6 months, but another 3 years for the candidate SVHC to be added to Annex XIV and another 2 years to Authorization
• Restrictions: 3 years

This overview resulted in good discussion, with two main conclusions: 1) it is unlikely that the Member State Committee will achieve the unanimity required to act on PMT/vPvB, so the issue will likely require policy discussion in Brussels before serious implementation can begin, an 2) Action is required to ensure that a persistent and toxic chemical cannot accumulate in water to concentrations exceeding the planetary boundary before the regulatory tools are in place.

Current and Future Regulatory approaches for PMT substances

Dr. Sylvain Bintein, Policy Coordinator for the European Commission Directorate General for the Environment, closed the presentation sessions with his personal views on the options available under current and potentially amended regulations. He emphasized that there is no official position on this issue yet, as there has been no petition from a Member State to consider it. He also suggested that the use of “M” for mobility should be reconsidered, since “M” is used widely already in REACH/CLP to refer to mutagens. So perhaps the next draft of PMT and vPvM policy will refer to PMoT and VpvMo instead.

With those caveats, Dr. Bintein proceeded to detail an extensive toolbox currently available to regulators:

• Recast of the Drinking Water Directive to include thresholds for groups of related compounds as well as for individual substances, and with the addition of criteria for PMT
• Options to facilitate access to data, including:
  • Information platform for chemical monitoring (IPCHEM)
  • A wikiREACH to reduce the burden of getting research data related to REACH substances
• Provision in REACH that could be applied without amendments:
  • Address drinking water contamination as “secondary poisoning” in dossiers
  • Improve evaluations of adequacy of screening data for persistence and mobility – section 0.10 of Annex I of REACH on particular effects such as ozone depletion or strong odors could be leveraged as it is mentioned in Annex XV
  • Case-by-case designation of SVHC: could the microplastics case become the 1st vPvM/PMT-based candidate?
  • As a last resort: the precautionary principle could be applied; it has not yet been used under REACH.
• Current regulations could be assessed for adequacy
  • Plant protection products and biocides are subject to groundwater assessments for all active substances and metabolites
  • Detergents are subject to a strong biodegradability criteria which may make the mobility criteria moot
  • Pharmaceuticals strategy is currently under review, with public consultation closed on 21 Feb 2018 and a target release date of May 2019 for the next step

Dr. Bintein also surveyed potential future regulatory approaches:

• Possible first step? Add a new hazard class to the UN GHS/CLP. This would
  • Trigger requirements to communicate the hazard as well as risk management measures, and specific use restrictions, such as in drilling or cosmetics
  • Initiate monitoring activity including self-classifications by industry, and
  • Subject all substances found to meet the new hazard class criteria to evaluation for substitution, a general aim of CLP
• Amendment of REACH
  • Add P, M, T criteria to article 57
  • Add Koc and simulation test, or half-life tests, at lower tonnage bands
  • Amend Annex I to assess PMT and vPvM in the dossier
  • Amend article 68(2) which fast tracks the restriction procedures
  • Apply PMT/vPvM criteria specifically for the identification of substances as SVHC candidates
  • Amend annex XIII criteria for vM (or vMo) and M (or Mo)
• Amendment of CLP
  • Amend annex I: this may be possible by comitology without the need for a more formal process
  • Add PMT classifications to the harmonized classification and labeling in Annex VI

He continued to review a wider range of options for consideration, including which other legislation (water directives, PPP/biocides, detergents, PoP, etc.) could more effectively and easily be leveraged to address potential PMT and vPvM risks. He raised questions on whether next steps need to address more powerful tools to screen for persistence, how to manage metabolites, and mobility in air, ending the discussion with a comment on the need to strengthen the “polluter pays” principle.

During the Q&A session, Dr. Bintein confirmed that there is no action yet at the UN level regarding the addition of a hazard class based on P, M, and/or T criteria. Dr. Neumann of UBA indicated that he is not sure Germany would be the one to bring such a proposal to the UN, so at this time there appears to be no imminent action to expand the globally harmonized system (GHS) with a PMT/vPvM class. Dr. Bintein took the opportunity to explain that the above are all the options that came to mind, not necessarily the good or probably options.

Conclusion

The session closed with a good discussion on the next steps. In the short term, expect to see a new revision of the UBA position paper on Protecting the sources of our drinking water. In the longer term, the list of options elaborated by Dr. Bintein can be expected to be put into use if voluntary action by industry cannot abate the growing concern by better identifying the potential risks, supporting the development of methods and standards to analyze the risks, and aggressively mitigating the risks where the persistence and accumulation threaten the planetary boundaries.

Follow-up and further resources

In subsequent discussion with Dr. Neumann, he commented that corrections have been made to typos for two of the four substances criticized by CEFIC, as presented by Dr. Bock. The updated document Assessment of persistence, mobility and toxicity (PMT) of 167 REACH registered substances, 2. revised edition, dated April 2018, has been published on the UBA website. UBA stands by the conclusions in the other two cases cited by CEFIC. 

The update for the UBA proposal on Protecting the sources of our drinking water from mobile chemicals is expected in late 2018.

Further information is available in English on the webpage of the Protecting Water Resources from Mobile Trace Chemicals (PROMOTE) project and in German at the UBA page on mobile chemicals. 

An excellent peer-reviewed paper on the topic by Thorsten Reemtsma et. al. appeared in the journal Environmental Science & Technology: Mind the Gap: Persistent and Mobile Organic Compounds - Water Contaminants That Slip Through