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Pharmaceuticals and Personal Care Products in the Canadian Environment: Research and Policy Directions
- Title Page
- List of Commonly Used Abbreviations
- 1.0 Workshop Summary
- 2.0 Introduction and Workshop Purpose
- 2.1 Workshop Objectives
- 2.2 Workshop Organization
- 3.0 Overview of the State of the Science
- 3.1 Environmental Exposure and Monitoring Activities
- 3.2 Effects of PPCPs on Aquatic Ecosystems
- 3.3 Reduction of Human and Environmental Exposure to PPCPs
- 3.4 Environmental Risk Assessment
- 3.5 International and Industry Activities
- 3.6 Provincial and Municipal Activities
- 4.0 Research and Policy Directions for PPCPs in the Canadian Environment
- 4.1 Effects of PPCPs on the Canadian Environment
- 4.2 Risk Management Approaches
- 4.3 Developing a Monitoring Network
- 4.4 Developing an Inventory of Information and Activities
- 4.5 Developing a Consistent Framework for Chemical Analysis
- 5.0 Overview of Policy and Management Issues
- 5.1 Wastewater Treatment
- 5.2 Drinking Water Treatment
- 5.3 Source Control, Prudent Use, and Source Separation
- 5.4 Biosolids Management and Agricultural Best Management Practices (BMPs)
- 6.0 Workshop Conclusions
- 7.0 References and Recommended Reading
- Appendix A: Workshop Agenda
- Appendix B: Participants List
- Appendix C: Poster Abstracts
4.1 Effects of PPCPs on the Canadian Environment
The primary driver for the issue of PPCPs in the Canadian environment is the concern that long-term exposure to low levels of PPCPs residues could have adverse effects on aquatic and terrestrial ecosystems and/or human health. Individual PPCPs have been associated with adverse effects on growth and reproduction of selected aquatic organisms under controlled laboratory conditions. However “effects research” still has many unexplored facets in terms of species to investigate, endpoints to elucidate, combinations of compounds, etc. Group discussions identified four areas of effects research that they considered to be the most pressing:
- Effects of PPCPs mixtures at the population and ecosystem levels;
- Standardization of effects research;
- Focusing on worst-case scenarios or model ecosystems; and
- Enhancing communication.
PPCPs in the environment are always present in mixtures, which include pharmaceutical parent compounds, metabolites, and transformation products in addition to the already present organic and metal compounds. Aquatic ecosystems are also mixtures of trophic levels in water and sediment matrices. Most laboratory studies to date have focused on one or two parent compounds and species of organisms at a time. New research from Europe, as presented by Dr. Karl Fent, has indicated the presence of synergistic or antagonistic effects with certain mixtures of PPCPs. There is a need to expand our capacity to characterize environmental mixtures and identify the effects of chronic exposure on populations; thus more accurately characterizing real environmental conditions at environmentally relevant concentrations.
The priority actions for improving our understanding of PPCPs in mixtures in ecosystems include:
- The use of Whole Effluent Toxicity (WET) studies, using more relevant (chronic) endpoints and exposure scenarios are required. Consideration should be given to synergistic and cumulative effects including the evaluation of a compounds mode of action;
- The use of both laboratory and field studies;
- Expanded analytical capability in terms of both laboratory capacity and methods for a wider variety of parent compounds and transformation products;
- Further studies on promising and developing bioindicators of population and ecosystem effects, particularly related to “genotoxicology” and metabolomics;
- Development of indicators of adversity and impairment to ecosystems;
- Improved (chronic) exposure scenarios;
- Multi-year funding to expand capabilities for long-term chronic effects studies at the ecosystem level.
These actions require the involvement of funding bodies, researchers, and municipalities to provide access to WWTP effluents.
Standardizing effects research would allow clearer comparison and confirmation of results between research laboratories. This type of research approach would require a consensus among researchers as to which substances should be tested on which organisms; the use of similar and environmentally-relevant end-points; the use of laboratory species rather than resident species; and the examination of multi-trophic effects.
The priority actions for standardizing effects research include:
- Determining those PPCPs that are most likely to be a problem and prioritizing substances to monitor (indicator compounds or mechanistic comparison;
- Determining which populations in an ecosystem most likely to be sensitive or vulnerable (e.g. mussels, bivalves, frogs, insects);
- Characterizing environmentally relevant exposure to chemicals;
- Evaluating potential effects at environmentally relevant concentrations and examining seasonal/reproductive cycle sensitivity of different species;
- Laboratory and field studies on chronic effects and Acute to Chronic Ratio (ACR) need to be considered;
- Effects studies need to include terrestrial ecosystems;
- Use of a top-down (directed by research consensus) rather than a bottom-up (directed by individuals) approach to drive additional research; and
- Ensuring that analytical methods are available for use on the selected priority substances.
Government and academic researchers, regulators, and funding bodies would need to be involved in decisions on research directions.
Focusing on the worst case scenarios, in terms of both ecosystem vulnerability and PPCPs potency, involves looking at chronic effects rather than acute effects; conducting field environmental effects monitoring in areas where the most serious problems have been observed to occur or would most likely occur; and accounting for complicating factors such as seasonality and reproductive status. This approach would encourage multi-faceted studies in the selected areas (e.g. watersheds), which could then serve as model ecosystems for prediction of effects in other areas.
The priority action for this “worst-case” or model approach include:
- Identification of high-risk Canadian sites/ecosystems through the use of a monitoring network;
- Development of field sites useable by a diverse group of researchers, that are monitored and that demonstrate a gradient of environmental degradation;
- Design of focused studies with multiple partners on the identified high-risk sites;
- Identification of those PPCPs with higher potency or persistence;
- Predictive models for fate and effects;
- Adequate long-term funding in order to design and operate a comprehensive research program.
This approach to PPCP effects research would need the involvement of government and university researchers, municipalities, and perhaps PPCP industries.
Enhancing communications regarding the issue of PPCPs in the Canadian environment includes:
- Communicating to the public the environmental effects and what it means for them;
- Improving the transfer of information among researchers and stakeholder organizations, and to decision-makers, to stay current on research activities and policy issues;
- Developing interactions between the scientists responsible for monitoring and assessment, and those with the opportunity to do research on biomarkers, bioindicators, and mechanisms;
- Improving communications across borders both within Canada and internationally; and
- Improving the dissemination of information, especially “Grey” literature, such as regulatory and unpublished information.
The priority action for enhancing communication would be the establishment of a coordinating network to monitor and disseminate PPCP research information. This could be done through one of the existing National Centres for Excellence, e.g. the Canadian Water Network. The federal government’s Domestic Substances List could be used as a starting point for cataloguing information.
Additional Concerns: Effects Research
In addition to the four priorities discussed above, workshop participants identified other concerns and needs in the area of effects research:
- Pharmaceutically active compounds and personal care products should be evaluated as independent groups of compounds due to their different chemical characteristics and use patterns. Pharmaceuticals are designed to have a biochemical effect on the target organism, and tend to be more water-soluble. Personal care products are designed for external use and tend to be more lipid-soluble. Restrictions on the use of problematic ingredients in personal care products are also easier to justify than restrictions on the use of pharmaceuticals.
- UV filters must be better analyzed for hormonal effects on fish and other aquatic organisms.
- Assessment of the potential for PPCPs to affect human health. PhRMA and the Dutch government have both issued statements that the presence of PPCPs in the environment does not pose a human health risk. PhRMA is working with the USEPA to issue a similar statement.
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