Long-Term legal consequences of EHS and management decisions

On 8 December 2020, 28 members of the Phylmar Regulatory Roundtable (PRR)and Phylmar’s BioPharma members’ group were joined by Michael Cooper. Cooper has developed and directed Environmental, Safety, and Health programs in the semiconductor, medical device, grocery, oil and gas, pharmaceutical, and foundry industries within the U.S. and abroad. Here is a summary of his comments:

There are core obligations that management has for the environmental, health and safety function; these obligations include:

• Identifying hazards in the business
• Assessing risks that arise from those hazard
• Developing controls designed to manage risks to “acceptable levels”
• Implementing controls (supervision by management)
• Periodically assessing the effectiveness of the controls
• Development of revised controls as needed including feedback

A safe and healthful workplace will have hazards and risks, however it will be a workplace where known hazards have been identified and assessed, a hierarchy of controls has been put into place and controls are reviewed often, and the review results in improving controls and assessing new hazards. For future EHS professionals and attorneys who will face standard of care litigation, these aspects should be considered:

• The time period in question can be decades in the past
• Records may be incomplete
• Companies may have changed hands, (mergers & acquisitions)
• Personnel are gone
• Gaps may exist in EHS programs
• IH monitoring may be desultory
• HS competence may be questioned
• Upset conditions (evacuations and maintenance procedures may be documented and need to be explained)
• PELs that were in place a decade ago may now be much lower based on new data and scientific review

Initial Lessons Learned:

• Recognize that the expense and steps taken to establish, document and maintain a defendable occupational safety program is worth it (even if not quantifiable at the time).
• Document all hazard assessments.
• Efforts to replace EHS personnel vacancies should begin immediately
• Join a trade group
• Establish and document and IH monitoring plan
• Reliance on third party pass/fail standards could be problematic
• Ensure EHS files document the closure of upset conditions, inspections, NOV’s etc.
• Consider development of a policy dealing with carcinogens