Has Bayer Bared It All?

Kudos to Bayer for committing to transparency at its recent community zoom meeting.

But how much transparency is that? Bayer doesn’t have a safety committee that seats members of the public. What we’ll know is what they’ll tell us. And there, the devil’s in the detail and in between the lines.

First off, reassuringly, Bayer won’t be studying how to genetically modify human beings, that is, they won’t be altering the human germline. This German owned company, unlike so many bioengineers these days, won’t be clearing the decks to make way for eugenic “designer baby” research. They are committed to finding treatments for people living today. Nice.

What about the local hot button issue of lab safety? Well, they have alarms and sirens that will alert people should one of their boilers burst or if there is an ammonia release. Residents don’t need to worry about it - unless they’re told to shelter in place. Then you must stay in your house. Hmm. Why is it OK for communities to live near industries where sirens and alarms are necessary? That dented-can of a question got kicked back to Berkeley’s city government doorstep: West Berkeley is zoned for it. Thank you, Berkeley City Council. Ahem.

Are these alarms and sirens capable of alerting residents about other sorts of hazards, e.g., lab mishaps, biohazardous spills, microorganism escape?

Evidently, this isn’t necessary because, we’re told, Bayer’s labs are very safe. Bayer follows all the protocols for biosafety level 1 and 2 (BSL-1 and -2) labs, the staff is well trained, and in any event, the kind of work that will go on in this new facility doesn’t (now) include working with dicey microorganisms. In fact, Bayer isn’t going to do research at all at their newly launched site, we’re told. They intend to take an “established potential manufacturing process,” one that has been researched elsewhere (where?) and develop it so they can supply larger populations with their product.

Let’s interrogate this.

The existing modified cells, as they describe them, don’t present much of a hazard. They seem to fall within the safer end of BSL-2 practices.

BUT:

Bayer is paying Berkeley $33 Million dollars over 30 years in exchange for building and operating a 1 million square ft. lab space facility on 46 acres. It has not finished its development. And when it does, its chief focus will be to research and manufacture new gene therapy agents for large scale phase I-III gene therapy and cell therapy trials and patient treatment. In other words, Bayer’s future activities in Berkeley could look quite different from their initial commercialization phase and, perhaps, more like the kind of research they reassuringly denied they would be conducting.

In fact, their research plans, as typically undertaken, involve using viruses.

Bayer dismisses biosafety concerns about viruses because, they say, viruses that they would use aren’t capable of replicating or escaping.

But would the scaling-up of virus culture for commercial use present special hazards? This is not something considered in primary research labs. It may seem like a concern for future activities, but it is one that will be baked into the plans and construction of the new facilities -- and this warrants public scrutiny.

For example, the National Institutes of Health guidelines for BSL-2-level research, strictly limit the volumes of cultures allowed to produce cell gene-modifying viruses. Will culture volumes in Bayer’s planned labs exceed those restrictions?

Does Bayer’s Development Agreement with the city preclude more exotic alterations of viruses? About that, they weren’t prepared to talk about “deep down specifics.”

That’s too bad. Why? Because, owing to the fact there are many more BSL-2 labs than there are BSL-3s or 4s (where protocols are stricter), there’s a lot of pressure on BSL-2 labs to stretch the limits of their constraints. And then, of course, there’s the problem that, as with all human activities, mistakes are inevitable – and, unfortunately, sometimes result in grave harm.

Bayer says their enterprise is highly regulated, “by everyone you can think of and then a few others.” But the patchwork of regulatory guidance, lax inspection, and haphazard enforcement is exactly part of the problem: so much falls through the cracks.

Bayer will hold another community meeting down the road, they’ll be sending postcards, mailings, placing fliers at residents’ homes, and they’ll secure more of the “sponsored” journalism in Berkeleyside that they’ve been doing. (Really? You can pay an “independent” news source to be your public relations platform? Who knew?)

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See: Hey, City Council: Do You Know What's Happening in Berkeley Biolabs?

Visit: Biolab Watch