Turn Regulatory Chaos into Strategic Leadership Opportunity

If you work in a role responsible for managing compliance and safety in the manufacturing or handling of hazardous substances, you have likely encountered this scenario: Your company is suddenly facing an industry-altering regulatory change that targets a class of widely adopted chemicals.

While these moments can initially feel overwhelming, they may also present an opportunity to step up. With a strategic approach that integrates regulatory affairs with the core ideas behind management of change (MoC), you can not only navigate the risks associated with the change but also emerge as a leader in the industry. 

Anyone who’s been on the receiving end of a compliance issue knows this: Effective MoC isn’t just baked into frameworks like EPA’s Risk Management Program (RMP) and OSHA’s Process Safety Management (PSM); it’s a pillar of keeping the business running. When MoC works, it protects your operations and your reputation. When it doesn’t, work grinds to a halt, reputations take a hit and fines pile up. A formal MoC isn’t a “nice to have”; it’s essential for safety and compliance. And even the best plan can wobble if communication is fuzzy. Success isn’t just about the plan on paper; it’s about how clearly it is shared and executed across teams and levels of the business.

Know your Catalysts of Change

When initiating change for regulated substances, start by documenting your known change-control triggers. Keep this documentation clear and consistent so that actions are repeatable and reproducible, regardless of the change's size or risk. Keep in mind that consistency is what keeps compliance tight as you move through MoC. Here are some standard change drivers that hit regulated chemical substances.

The Formulation Change

Formulations (aka product “recipes”) are dynamic, meaning ingredients can be added, removed, or swapped. In response to these fluctuations, concentration limits can exceed reportable thresholds, new impurity profiles can be introduced, and, as technology evolves, antiquated chemistries are replaced by more effective or cost-efficient alternatives. All good — but this means you need sharp oversight and solid documentation throughout change control, so nothing will slip through a gap in the process.

Changes in Raw Materials or Suppliers

When looking for additional raw materials or suppliers, a perfect one-to-one substitute for substances sounds great in theory. However, identifying a perfect replacement, or the so-called "magic bullet," can be tough. In many cases, reformulating with something close that still meets performance, safety and regulatory needs is the practical route. Moderate design tweaks can have significant ripple effects if you do not thoroughly evaluate the risks associated with the change.

A simple “grade change” in a commodity chemical, for example, might unintentionally introduce new impurities, and suddenly you are in reporting territory and hitting more red tape. Considering sourcing that raw material from a new supplier? That can also bring about surprises — process shifts, added complexity and new risks to assess during MoC. Bottom line: build a process that leans on thorough impact assessments, cross-functional input and a risk-based mindset.

Regulatory Reclassification or New Reporting Requirements

One of the overlooked and often most disruptive drivers of change arises when a substance is reclassified or subject to regulatory oversight changes. There are countless triggers to these types of updates, such as EPA rules, new state-level chemical restrictions, global actions like changes to EU CLP (classification, labeling and packaging), or additions to lists such as TRI, Toxic Substance Control Act or hazardous air pollutants; hence, any one of these shifts in regulation can instantly alter your obligations. A material that was previously unregulated may suddenly need extensive hazard communication updates, new exposure controls, additional reporting or even phase out planning.

These demands of the ever-changing regulatory landscape require rapid cross-functional MoC; specialized teams will interact throughout to interpret the new rule, reassess product viability, evaluate on-site impacts and determine whether alternative resources are required. Without a structured MoC process, companies risk missing deadlines, underestimating operational impacts or communicating outdated information to customers and downstream users. With strong change control, however, regulatory reclassifications become predictable, controlled transitions rather than fire drills.

Changes to Hazard Communication 

Management of change in hazard communication can vary depending on where you operate, what products you sell and even your company’s culture. Whatever the setup, some MoC mechanism will be present. Without solid hazard communication, which includes MoC, moving products both legally and safely would be essentially impossible.  

As science, technology and our understanding of the impact of substances deepen, hazard communication must keep pace with these advancements. Think of hazard communication like a warning system: if the alarms aren't updated when conditions change, they can't protect anyone. If your hazard communication system is designed to protect human health and the environment but fails to account for changes, safety becomes more illusion than reality. Simply put, uncommunicated changes are just as dangerous as unrecognized ones.

Operational Changes

The U.S. Chemical Safety Board (CSB) emphasizes the importance of maintaining safety when modifying chemical processes. It emphasized the need for a robust MoC system for planned and unplanned changes across technology, equipment and processes.

Unfortunately, uncontrolled change too often becomes a cautionary tale, as in incidents described in the CSB safety bulletin, published in 2001. The CSB bulletin examines two fatal 1998 incidents—an oil refinery fire killing six and a chemical plant explosion injuring four—emphasizing that systematic MoC systems must cover operational deviations and abnormal situations, not just physical changes. Both accidents could have been prevented through multidisciplinary hazard analysis and written procedures.

The bulletin also outlines the following best practices for implementing a sound MoC:

1. Define safe limits for process conditions, variables and activities, as well as train personnel to recognize significant changes. Combined with knowledge of established operating procedures, this additional training will enable personnel to activate the MoC system when appropriate.  
2. Apply cross functional approach with the help of people involved in the process when analyzing changes. 
3. Use appropriate hazard analysis techniques. 
4. Change should be authorized at a level that is proportionate to the risk.
5. Communication of the essential elements of the change, including new standard operating procedures.
6. Identify and share potential hazards and safe operating limits during process changes.

Embed Change Control

Safer processes lead to safer workplaces and safer communities. A detailed approach to managing change can prevent the worst-case outcomes from becoming reality — no matter the level of risk.  

The most resilient organizations don’t just meet regulatory expectations; they embed change control into their everyday culture. Now is the time to move beyond reactive checklists and build proactive systems that flag, evaluate and communicate risk before it spreads.

Whether you're working in formulation, procurement or regulatory affairs, ask: “Does our MoC process still match the speed and complexity of today’s chemical landscape?”  If not, it’s time to revisit your playbook. Start small by clarifying roles, standardizing impact assessments and opening cross-functional lines of communication. Because in this evolving era of chemical regulation, your change-control program isn’t just a compliance tool; it’s your frontline defense.