Hi Reader, chances are you have encountered this issue too.
You want to drive change, but regulations and laws make it impossible.
Or do they?
Here’s what you should know about “impossible changes” and how you might get around them:
Today's Lesson: Handling Guidelines Well
Why a direct look at the paperwork makes sense
Number of the Day
There are several dozen guidelines for proper scientific conduct and manufacturing practices. For example, the ICH Q guidelines are a family of internationally harmonized guidelines focusing on medicines. Taken together, they amount to 922 pages, without counting all annexes and supplementary information. However, if you focus only on those most likely to be relevant to sustainability-related changes, that number drops to about 50 pages. And here is why this matters:
922
Consulting Regulations and Guidelines
The key when it comes to regulations is to understand where the limits really are.
I’ve seen many times that people set unnecessary limits for themselves.
The ICH has 14 guidelines, and with other regulations, such as those from the Food and Drug Administration (FDA) or EudraLex (the body of EU pharmaceutical law), there is quite a bit of literature to go through. However, the key is realizing that you only need to know where to look rather than reading it all. Most people are intimidated by the tone and sheer number of pages and therefore too often claim that change is impossible.
While there are sometimes real limitations, in many (if not the majority of cases) the limitation is based on false assumptions.
It’s often hearsay or doubts expressed by higher-ups that falsely shape the culture.
Here’s an example from my own work that illustrates this perfectly:
Beliefs and Assumptions
Is all waste that is created in safety level 2 environments to be considered contaminated?
I have been asked this question in many presentations and workshops, as well as in my work as an advisor.
A big topic of debate is also whether items that were inside a biosafety cabinet count as contaminated? And what if, for example, you use serological pipettes and remove the plastic/paper wrapper right at the airflow border? Instructions such as those provided by Labkafe also mention that you have to consult your own SOPs. So, what is your take?
Of course, I thought, there must be a regulation on this. And since I had heard other people say that anything that enters a safety level 2 environment should be treated as contaminated, I assumed that this was how things had to be handled.
However, being somewhat unhappy with that answer, I eventually decided to look into the regulations myself.
And then came the surprise: I found that the opposite was true.
When Regulation Becomes Your Friend
Of course, you must consult the guidelines that apply to you.
However, I was recently advising a German institution, so I was going through the local texts of more than five different legal frameworks.
Even in Germany, it was literally stated that non-contaminated items could be separated and discarded as non-contaminated waste.
As I found out later, the advice that anything entering a safety level 2 environment is contaminated was simply based on the idea that this was probably the safer approach. It was not based on someone having read the guidelines or on an institution-specific policy. It was simply based on the belief that being cautious is always the best option. This is why I do advise that, insofar as local guidelines allow for it, placing plastic and paper bins even close to biosafety cabinets is a good idea.
Beyond that, the guidelines on waste handling went a step further, essentially outlining that this practice is obligatory.
For example, if you treat non-hazardous waste as hazardous and thereby increase the likelihood of ignition, you are breaking regulations.
Why You Should Engage Yourself
Taken together, my main advice is to consult your actual legal frameworks yourself! Why? Three reasons:
The first is hearsay. In other words, somebody might originally have read the text, but over time, the message gets diluted.
Secondly, there is authority bias. If a group leader says that change is probably not possible, many people interpret that as meaning that change is not possible.
Finally, there are our own assumptions. Too often, we believe we know something, or we believe something to be impossible, even though the actual guidelines are often much more pragmatic and sensible than we might think.
We all have a distaste for long, stale, and restrictive legal texts, but in my experience, they are often less restrictive than people make them out to be.
Applying the Knowledge
So whenever you think there is a regulation, or somebody tells you that there is, have a look yourself.
For workflows, regulations often prescribe the factors that need to be controlled and documented but allow practitioners to determine how to design their processes.
However, these texts are often pages long. Still, as mentioned, the key is to start selectively with those sections that truly matter.
In essence, there are several guidelines, from international ones (here shown for international, EU, and Chinese contexts) to those of your own institution. I would start with the most local guidelines, as they align with the broader ones while being tailored more specifically to your processes. When you want to drive change and are uncertain, you can check whether it aligns with the broader guidelines.
So here are three tools I use to make my work much more manageable.
First, selectivity is key. You don’t need to read the entire framework. Look at the table of contents and read it from top to bottom.
Then, Ctrl+F is going to be your best friend. Search for the keywords that are relevant to you and start your reading there. If something is restricted, you will realize it fairly quickly.
Additionally, I think you can feed the framework into an AI, use moderate or high reasoning, and then ask it to find an answer to your question. Pro Tip: ask it to include quotes and extracts. Once it has done this, ask whether there are other parts of the document or other frameworks you should be aware of.
If you and the AI agree, you have what you need to approach the legal, quality, and safety teams at your institution.
In essence, there are far fewer limitations than we might think.
We must simply not be intimidated by the reputation of regulations.
How We Feel Today
If you have a wish or a question, feel free to reply to this Email. Otherwise, wish you a beautiful week! See you again on the 20th : )
Edited by Patrick Penndorf Connection@ReAdvance.com Lutherstraße 159, 07743, Jena, Thuringia, Germany Data Protection & Impressum If you think we do a bad job: Unsubscribe
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