The three biggest EHS blind spots in pharma

In this week’s Expert View, Rich Hubner, managing principal at BSI Consulting, draws on decades of experience advising pharmaceutical manufacturers on environmental, health, and safety strategy.

I've worked with pharmaceutical companies for years, and one pattern keeps repeating: the most significant environmental, health, and safety (EHS) risks are rarely dramatic. They sit in routine practices, steadily increasing cost and exposure without drawing much attention.

Across facilities globally, three gaps come up again and again. None are new. All are manageable. Yet each can quietly erode margins and create avoidable risk.

Antimicrobial resistance (AMR): a self-defeating cycle

Pharma companies are in the business of combating infection, but some operational responses may unintentionally contribute to resistance pressures.

In biologically active manufacturing environments, the default reaction is often escalation: more disinfectants, higher concentrations, broader kill claims. The intent is understandable. If materials are biologically active, eliminate residual activity before discharge.

But escalation has consequences. Increased chemical loading can elevate occupational exposure risks, raise downstream treatment costs, and, paradoxically, contribute to selection pressures that drive resistance. Substituting one risk for another is rarely a durable solution.

More targeted sanitation strategies, tighter process controls, and risk-based chemical use can reduce both cost and exposure. The constraint is usually not willingness, but access to the right technical insight.

Waste characterization: misclassification as margin leakage

Waste management in pharma is complex, but the underlying issue is often basic: incomplete characterization.

When facilities lack a detailed understanding of inputs, reaction byproducts, and cross-contamination pathways, mixed waste streams become the default. From a compliance standpoint, the conservative choice is to classify broadly and dispose at the highest cost tier.

For biologically active waste, that frequently means incineration at a premium. Non-biological material entering the same stream inherits that cost profile.

The financial impact can be material. Over-classification, driven by uncertainty rather than regulation, can inflate annual disposal costs significantly. A disciplined chemical inventory review, coupled with accurate waste mapping, often reveals opportunities for compliant but lower-cost pathways.

This is less about cutting corners and more about eliminating unnecessary conservatism born from incomplete data.

The expertise gap: specialization without flexibility

Recruitment data tells a consistent story. EHS roles in pharma attract volume, but not always depth in microbiology, toxicology, or biochemistry.

Pharmaceutical manufacturing differs from many industrial settings because the materials are designed to be biologically active. That alters risk assessment, exposure modeling, and waste decisions. Generalist EHS frameworks do not always translate cleanly.

Yet maintaining a full bench of specialists internally is rarely efficient. The demand for niche expertise is intermittent but critical. The challenge is not headcount; it is access to fit-for-purpose expertise at the right moment.

Organizations that treat EHS capability as modular, rather than static, tend to navigate this tension more effectively.

The cost of inaction

Operational momentum can obscure latent risk. Product timelines dominate attention. EHS decisions become reactive rather than anticipatory.

Per- and polyfluoroalkyl substances (PFAS) illustrate the point. Companies that understood their chemical inventories and waste pathways could respond to regulatory scrutiny with data. Others have had to reconstruct exposure histories under pressure.

Regulatory classifications evolve. Enforcement priorities shift. Legacy assumptions are revisited.

Pharma is built on precision at the molecular level. Applying comparable rigor to EHS systems is not a marketing differentiator; it is a risk management imperative.