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Pharmaceuticals and Personal Care Products in the Canadian Environment: Research and Policy Directions

1.0 Workshop Summary

It has been known for over 20 years that pharmaceuticals and personal care products (PPCPs) are released into the environment, however only in the last 10 years have analytical methods become sufficiently sensitive to identify and quantify their presence in wastewater treatment plant (WWTP) effluents, surface waters, drinking water, ground water, biosolids, agricultural manures, and biota. The presence of PPCPs in the environment has emerged as a societal issue, but the science with respect to exposure and impacts is still rudimentary.

Environment Canada and Health Canada hosted a multi-stakeholder workshop in 2002, entitled ”Assessment and Management of PPCPs in the Canadian Environment”, to identify the major research and risk management needs. This workshop identified an initial set of research priorities as well as new policy thrusts, most notably the implementation of a ”National Science Agenda” focused on the emerging issue of PPCPs in the environment. A second multi-stakeholder workshop, sponsored by Environment Canada, Health Canada, the Ontario Ministry of Environment, Agriculture and Agri-Food Canada, and the Canadian Water Network, was convened in 2004. This workshop, entitled ”Toward a Monitoring Network: a Technical Workshop for PPCPs in the Environment”, examined in greater detail three areas of PPCPs research (analytical methods, sampling, and effects) and recommended strategies to achieve the 2002 research agenda. The recommendations from this workshop emphasized the importance of strengthening domestic and international partnerships and improving the transfer of knowledge as a whole.

These workshops catalyzed Canadian research on the occurrence and effects of PPCPs in the Canadian environment, and there has been considerable effort to determine whether PPCPs pose an ecological or human health risk. Little is known about the effects of these substances on nontarget organisms, many of which differ from mammals in their receptor sensitivity, and in the roles various metabolic pathways play in their development and reproduction. Endpoints, such as neurobehavioral changes, can be very subtle but nonetheless lead to unanticipated, profound outcomes on non-target populations. Research continues to demonstrate the effects of single compounds on various aquatic organisms under laboratory conditions at environmentally relevant concentrations; however it is not known how these results translate into the complexity of mixtures and environmental conditions. Analytical methods have been developed for a wide variety of compounds and labeled standards have become commercially available in the last 5 years; however large-scale method comparison and validation exercises to improve the accuracy and precision of quantitative measurements have not yet been conducted. Options to reduce environmental exposure to PPCPs, particularly through wastewater discharges and land application of biosolids and manures, are being examined; however risk management strategies and Best Management Practices (BMPs) are not fully developed. Environmental effects, accurate quantitation, and risk management alternatives are all necessary facets of a comprehensive ecological risk assessment.

The subject of the current report was based on a third National Workshop entitled ”Pharmaceuticals and Personal Care Products (PPCPs) in the Canadian Environment: Research and Policy Directions” took place March 5th to 7th, 2007 in Niagara-on-the-Lake, Ontario. The workshop was hosted by the Ontario Ministry of the Environment, Environment Canada, Health Canada, Agriculture and Agri-Food Canada, the Ontario Ministry of Agriculture, Food, and Rural Affairs, the Canadian Water Network, and the Walkerton Clean Water Centre, and was attended by over 150 scientists and regulators from across Canada. This workshop differed from the past two in that it was open to all those interested in PPCPs in the Canadian environment. Attendees represented a diverse group of interested parties, including municipalities, provincial regulators, federal risk assessors, pharmaceutical and fragrance industry associations, environmental consultants, United States Environmental Protection Agency and Non-Government Organizations, as well as government and university researchers.

This Workshop assessed the current state of Canada’s research on PPCPs in the environment in government, academia and industry sectors. Invited speakers provided overviews on environmental exposure and monitoring, effects of PPCPs on aquatic ecosystems, alternatives for Pharmaceuticals and Personal Care Products in the Canadian Environment: Research and Policy Directions 2 reduction of human and environmental exposure to PPCPs, risk assessment process and needs, international, industry activities, provincial and municipal activities.

A principal focus of the workshop was setting priorities for research, monitoring, and regulation of PPCPs. Facilitated discussion workgroups covered 5 topics:

  1. Effects of PPCPs on the Canadian Environment
  2. Risk Management Approaches
  3. Developing a Monitoring Network
  4. Developing an Inventory of Information and Activities
  5. Developing a Consistent Framework for Analysis

These workgroups created a list of priorities and key actions to guide future PPCPs research and Canada’s path forward in this emerging field, and a synopsis of the recurring themes is provided below. In addition the report provides an overview of policy and management issues.

This workshop report is intended to strengthen communication in this important field. The proceedings provide a common understanding of the state of the science, thereby helping researchers prioritize needs and better identify collaborative opportunities to address knowledge gaps. This report will also make funding organizations aware of the research priorities in this field, and give managers a better appreciation of existing research challenges and broader potential policy issues.

Recommendations and Priorities

1    Effects of PPCPs on the Canadian Environment

  • The use of more relevant (chronic) endpoints and exposure scenarios are required for impact assessment.
  • Consideration should be given to synergistic and cumulative effects including the evaluation of mode of action.
  • There is a need to evaluate potential effects at environmentally relevant concentrations.
  • There is a need to examine potential seasonal/reproductive cycle sensitivity of different species.
  • Expanded analytical capability in terms of both laboratory capacity and field studies for a wider variety of parent compounds and transformation products needs to be developed.
  • Prioritization needs to be given to substances to monitor in the environment and to the identification of sentinel species (e.g. mussels, bivalves, frogs, insects).
  • Further studies focusing on development of promising bioindicators of individual, population, and ecosystem effects.
  • There is a need to define impairment, adversity and impact.
  • Effects studies need to include terrestrial ecosystems.
  • There is a need to assess the uncertainty regarding the development of antibiotic microbial resistance in the environment.
  • Communication needs to be expanded to explain to the public what the environmental effects are and what it means to them. This involves improving the dissemination of information, especially the grey literature, such as regulatory and unpublished information.
  • Pharmaceutically active compounds and personal care products should be evaluated as independent groups of compounds due to their different chemical characteristics and use patterns.

2    Risk Management Approaches

  • There is a need for a nationally coordinated research program to support a regulated categorization program.
  • Quantifying loadings and concentrations of PPCPs to determine which sources are the most important.
  • Determining the cost-effectiveness of both conventional and advanced drinking water, wastewater, and sludge treatment technologies.
  • Developing BMPs for land application of manures and biosolids to mitigate off-site contamination and exposure to both aquatic and terrestrial ecosystems, including detailed dissipation information for the compounds.
  • Critical control points for environmental exposure should be evaluated and more efficient use of existing infrastructure for the collection of unwanted PPCPs needs to be investigated.
  • Education of the health care profession, and the public to encourage judicious use of PPCPs including the consideration of alternative formulations for pharmaceuticals.
  • Modifications to the current regulations so that PPCPs with low sales volumes must pass the risk assessment process.

3    Developing a Monitoring Network

A monitoring network should include a website sub-divided into the following subject areas; sources, loads and watershed mass balances; fate through WWTPs; fate through water treatment plants; concentrations in environmental matrices: sediment, groundwater, surface water, biota, etc.; ecological risk assessment and reports of field studies on effects; human health risk assessment; and analytical methods.

The purpose of the website would be to archive existing data, aid in the formation of hypotheses, support risk assessment exercises, and to help coordinate scientific research planning. Such an information source would identify collaboration opportunities, help to prevent duplication of efforts, and provide baseline data. The information generated from the monitoring should be available to scientists through portals on the website. Interpreted and peer reviewed results could be made available to the public. The next steps identified were:

  • Nominating champions from each region and investigate what networks currently exist and examine different website models.
  • Establishing a Technical Steering Committee to help guide the process (Federal lead).

4    Developing an Inventory of Information and Activities

An inventory would be useful to compile technical information (such as toxicological properties, compound fate, and Chemical Management Plan (CMP) and media specific information), assist in risk assessment, and identify knowledge gaps. Centralization of information could be accomplished by developing a specialized national database to capture: (1) transport and fate data (2) research projects, participants, and results (3) links to other PPCP groups and websites (4) all predicted no-effect concentrations (PNECs), and (5) publications. The next step would be to establish a Technical Steering Committee to guide the process (Provincial lead).

5    Developing a Consistent Framework for Chemical Analysis

The need for accurate, precise analytical methods that cover a wide range of PPCP parent compounds and metabolites in surface water, groundwater, wastewater, drinking water, sediment, sludge, biosolids, manures, and biota, and the need for increased laboratory capacity across Canada were identified in all discussions. Discussions at this workshop recommended a framework designed to accomplish the following:

  • A method compendium that is matrix dependent.
  • A mechanism to communicate methods with their respective method validation and QA/QC data.
  • A data quality objective statement to characterize the method of QA/QC and the validation data requirements.
  • Performance criteria to ensure consistent data quality for conducting routine sample analysis.

Conclusion

The National workshop on ”Pharmaceuticals and Personal Care Products in the Canadian Environment: Research and Policy Directions” was very successful based on the number and diversity of participants, the animated discussions, and the positive feedback. The common theme in all discussion areas was the importance of communication between researchers, risk assessors, regulators, wastewater managers, and the public. The formation of a central ”clearinghouse” for research and management data was recommended to enhance communication and exchange of information. To maintain momentum on this issue and strengthen relationships between interested parties, it is also recommended that a follow-up workshop be convened in February 2009.