Developing a Pathway to Regulatory Closure

Developing a Pathway to Regulatory Closure

Andrew Hart Member Name

Senior Environmental Scientist

Jonathan Medd Member Name

Principal, EPA Environmental Auditor

How often are you presented with proposals for investigation, monitoring and remediation programs that focus on generic criteria rather than on the risks posed to your site and surrounding environment? Do you question whether the additional work will help to achieve an outcome for your business?

When thinking about site closure, whether it be an operational manufacturing site or a legacy site where contamination can hinder divestment or redevelopment, success may be defined as achieving regulatory closure while also maximizing your return on investment. Throughout an investigation there are many opportunities to engage with regulators and explore options for approaches that bring more certainty to how the spend is programmed and reduce the burden and cost of future investigation or remediation. The challenge is to do this cost-effectively but without compromising the outcomes for the community or the environment.

Develop a strategy that begins with the end in mind

A site is an asset that has value and maximizing that value requires a vision for the future of the site. Operating a successful business requires a strategy that is built around a well-articulated destination as well as the tactics needed to reach the destination. When investigating or remediating contaminated sites, invest in such a strategy. A good strategy, built around the drivers for various stakeholders and the outcomes you want to achieve, articulates the processes and requirements for achieving your destination. Build this context for risk-based closure early.

To achieve a risk-based outcome, develop rational arguments based on scientific and engineering risk and clearly communicate these arguments to the regulator and other key stakeholders. As in any communication and engagement strategy, you need to understand your desired outcome and determine where in the journey you may be willing to compromise to achieve agreement. This will take time, so begin the process early in the project.

The investigation phase aims to fill in gaps and explore uncertainties to paint a fuller picture of the risk profile of the site. This clarifies the areas of real risk and how they can be quantified, remediated and/or managed. Focus on uncertainties that require more lines of evidence to support your risk-based argument.

In the investigation, consider whether innovations could be embraced to provide multiple lines of evidence to support your understanding of the site. You may benefit from exploring geophysics, use of tracers to understand contaminant movement in the environment, biomonitoring, direct measurement of indoor air and void spaces for vapor, bioavailability tests, or mass flux estimates to evaluate contaminant exposure for relevant receptors.

Communicate your information and arguments in ways that clearly present the value of the data you have collected and how that data supports your conclusion. Investing in visual aids such as graphics, innovative GIS plots and 3D diagrams will help to deliver critical messages and to encourage a focus on the desired outcomes rather than just the tables and graphs.

Using independent experts or respected reviewers throughout the process is likely to increase the confidence of the regulators in your investigation design and conclusions.

Engage early with the regulator

Engage the regulator early by developing a roadmap to regulatory closure to set, communicate and agree expectations. Use the process to articulate clear end goals, the steps you’ll take to reach your goals, and the risk-based strategies you propose to use. Consider the opportunity to integrate community expectations for sustainability-focused remediation goals and to encourage the regulator to focus on outcomes.

This approach will allow time for the regulator to accept your vision and will give you time to get feedback on areas of concern and adjust your approach where necessary. Allow enough time to let the story evolve.

When it comes to communicating your risk-based approach, put yourself in the position of the regulator and imagine the range of questions or concerns they may have. The regulator may be concerned about contamination and whether anyone’s health is at risk via water or vapors, and to what extent. They will be concerned about the community’s reaction to contamination in or from the site and will want to understand the extent and nature of community concern. They may be concerned about whether you are planning to sell the site, what you’re going to be leaving behind for them to deal with, and how the site risk can be managed into the future.

Central to this is the development of a clearly articulated conceptual site model to demonstrate a rigorous understanding of the pathways of contaminant movement from a source and the level to which receptors are exposed. A robust conceptual site model that uses multiple lines of evidence demonstrates that your approach is holistic and risk based.

To reach an outcome that is generally in line with where you want to be from the point of view of risk and asset value, start with a clear vision, back it up with strong science and engineering, and follow it through with a commitment to careful listening, communication, engagement and negotiation. This investment maximizes your chance of achieving regulatory closure in a timely, cost-effective, and sustainable manner – for the benefit of the community, the environment, and your business. Begin with the end in mind!

Andrew Hart Member Name

Senior Environmental Scientist

Jonathan Medd Member Name

Principal, EPA Environmental Auditor

About the Authors

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