Tuesday, March 3, 2015

From Legislation to Lab Bench


I'm just a bill.
Yes, I'm only a bill.
And I'm sitting here on Capitol Hill
-Schoolhouse Rock (1975)
A few weeks ago I had the great privilege and pleasure of speaking to a group of students in the Biochemistry Department in historic Schweitzer Hall at the University of Missouri, here in Columbia.
The students are prospective interns for a successful and growing program here at ABC Labs, taking preparatory coursework before they begin their internship in earnest in the summer months.
My presentation was a “Regulatory Agency Overview.”

Minimally, I wanted to give the students a sense of the many agencies – local, state, federal, and global – under whose auspices our scientific work is regulated.  It’s a veritable “alphabet soup”: EPA, FDA, USDA, MDNR, EMA, OECD, and many more.
But that was just a start – Using relevant examples, I took them on a journey from public policy to legislation to regulation and rulemaking to guidelines to guidance.  I made the point that what starts out as evening news may well end up affecting activities at the laboratory bench, and that as scientists it behooves us to not only be aware of policy changes but also policy debates.
The students asked terrific questions, among the most important of which was how one keeps up-to-date with a dizzying array of changes.
It’s a great question in our business of providing contract research services to help our clients satisfy regulatory requirements for product development.
As interesting: they skipped the question of “Why stay up-to-date?” It’s intuitive that the costs of non-compliance – in time and money – are great.
The question of “How?” gets to the heart of one of our missions as subject matter experts – professional Reading, active participation in industry associations, travel to conferences, collaboration with consultants, and interaction with our clients, all in order to remain attuned to regulatory changes is part of the job.
But it’s not all soaking in information – we also endeavor to be the educators via webinars, whitepapers, this blog, and other venues. (As an example, I recently gave a webinar on new EPA guidance on “Strategies for Bound and Non-Extractable Residues in Laboratory Environmental Fate Studies").

How do you stay aware of regulatory changes? What can we do to help? Let us know!

No comments:

Post a Comment