Help for thesis: american law regulating research

[Eni Idea]

Hey DIYers!

I really need your help. I'm studying in Austria/Europe and currently I'm writing my thesis for my studies. It's about the development of the DIY-community and I want to compare the American and Austrian DIY-Groups. One aspect is about the legislation concerning genetic engineering and research of each country because in the end the laws and regulations determine the possibilities to do research...
So, my question: Are there any regulations in America or do you have to abide by any law?
I suppose that it might be important if you want to establish a community lab or if you need materials for experiments. Or even if you tinker at home, isn't there any limiting rule??

I just found the NIH-guidelines and TSCA. But they apply to researchers supported by public institutions...

Maybe you can give me a hint, I'd be very thankful!

Best regards from Vienna!
E.

[Cathal Garvey]

When it comes time to discuss this with Europeans, you may want to try
the diybio.eu mailing list, too. :)

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[Mega [Andreas Stuermer]]

So, my question: Are there any regulations in America or do you have to abide by any law? 

I just know that S1 is unregulated. So it seems to be an absence of regulation in this particular case. Rüdiger from Berlin mentioned there even is a German law granting freedom of doing science, Recht auf freie Wissenschaft (or something like that). 

As you sure know, this right  stops with genetic modification here in Austria as well as in Germany. 

 suppose that it might be important if you want to establish a community lab or if you need materials for experiments. Or even if you tinker at home, isn't there any limiting rule??

AFAIK, you can do anything as long as it is not S2  regulated. 

The total American law system is totally diferent from ours. while we have the precautionary principle - everything is forbidden that is not allowed, in the US anything is allowed as long as not proven dangerous (evidence based) 

Greetings from Oberösterreich,

Andreas

[Cathal Garvey]

> anything is allowed as long as not proven dangerous (evidence based)

That might be taking the praise too far, because in *both* continents
there is sometimes a distinct *lack* of caution. I cite as evidence the
number of chemicals that are in use industrially for which little safety
information is available, and the number of chemicals whose regulatory
status remains very loose despite reams of evidence that they cause harm
(bisphenol A, I'm looking at you).

So, a little caution is OK. Technically speaking, the EU system is
superior, if it were honestly implemented. That is, in EU each GMO must
be independently considered for safety and responsibility, regardless of
the "source organisms". So, you could use a restriction enzyme from the
black death, and in principal nobody will bat an eyelid, because it's
*just a restriction enzyme dammit*.

On the other hand, the US system has a list of organisms that are
considered "baddies", and anything to do with them (the select list) is
essentially banned sans huge regulatory overhead. So your
yersinia-pestis restriction enzyme is out of the question. But this
system fails to account for potentially dangerous activities (few as
they are!) that fall outside the select list.

So EU need to stop being so stupid about issuing licenses, and the US
need to overhaul their system to make more sense. And both of them need
to get over this "BIO(T)ERROR!!!1" fearmongering and get back to science
and development.

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[kingjacob]

In the US BS levels are guidelines not specific regulations. 

So generally you can do anything, provided you don't fall afoul of another agencies specific regulations: 

• OSHA(if you have employees)
• EPA(environmental release)
• CDC(when dealing with select agents)
• NIH/NSF(only when receiving funding from those sources)
• City Laws(Zoning issues if you don't live in Houston).
  
• FDA/HHS(if you are doing something that requires an IRB ie human studies)

I much prefer this method, because adding a restriction across the board would just add a cost to independents and school labs, while not actually increasing safety. Since everyone mostly follows the CDCs guidelines even if they don't have to. And it's not the creation of a GMO in a lab that's potentially harmful but releasing said GMO which is already regulated by the EPA and/or the FDA.

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Cheers,
Jacob Shiach

founder: Brightwork CoResearch

program director: SynBio axlr8r

[Nathan McCorkle]

There are also regulations/recommendations for chem/bio/equipment
suppliers, such as requiring a purchaser to provide documentation on
legal business status and rental contract for the shipping address.
These help build a credibility profile of a person, since the multiple
items would be hard for a small-time crook to forge easily, it gives
them a coherent direction to point a finger towards if something goes
wrong. The rental agreement is considered their due diligence for
ensuring within reason that a purchaser is following zoning laws and
that their activities (lab/business) are consented by the property
owner (i.e. many apartment rental contracts state no business activity
allowed to transact). This makes sense to me, as evident in the poor
choice of residential-commercial zone buffers in a case like this:
http://www.itstactical.com/wp-content/uploads/2013/04/west_texas_fertilizer_plant_blast_map.jpg
http://en.wikipedia.org/wiki/West_Fertilizer_Company_explosion

"In addition to the obliterated plant, the damaged buildings included
the public West Middle School, which sits next to the facility.[23] A
neighboring 50-unit, two-story apartment building was destroyed."

People don't expect random chemical accidents in their neighborhoods.

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-Nathan

[Mega [Andreas Stuermer]]

That might be taking the praise too far, because in *both* continents 
there is sometimes a distinct *lack* of caution. I cite as evidence the 
number of chemicals that are in use industrially for which little safety 
information is available, and the number of chemicals whose regulatory 
status remains very loose despite reams of evidence that they cause harm 
(bisphenol A, I'm looking at you). 

So, a little caution is OK. Technically speaking, the EU system is 
superior, if it were honestly implemented. That is, in EU each GMO must 
be independently considered for safety and responsibility, regardless of 
the "source organisms". So, you could use a restriction enzyme from the 
black death, and in principal nobody will bat an eyelid, because it's 
*just a restriction enzyme dammit*. 

That is what I hate the most. Dishonesty. Dangerous chemicals in devices of everyday's use, even in baby-bottles bisphenol A. Nobody cares. But when it comes to GMO everything is totally bad, must be heavily regulated. 

[Eni Idea]

Okay, but still I don't really get it...;)
So, you say you can almost do anyhting you want ..you mean at home? One of the most important things is: is there, e. g., a special agency that really has control over your work?
And are all guidelines (NIH; CDC; BMBL;) only recommendet or required if you don't research at an institution?
So let's say you want to establish a community lab, can you open a BSL 1 - lab without any registration and expertise or is there an agency for the autorisation process?
Another question: you mentioned city laws, are there really special laws for each bigger city and if so, what are they mostly about?

Thanks again, it's not that easy to understand the American system, because in Austria, as already mentioned, you got really strict regulations. So here it's clear that you need to register somewhere if you want to organize community research...
Greetz, Eni

[Andreas Stuermer]

> So let's say you want to establish a community lab, can you open a BSL 1 - lab without any registration and expertise or is there an agency for the autorisation process?

As far as I understood, yes you can. S1 means "genes and organisms that do not pose a risk to human health and the environment". Thus, why should it be forbidden?

We sholud de-regulate S1 too here in Europe.

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[Nathan McCorkle]

See in-line responses below.

On Fri, Jan 31, 2014 at 2:26 PM, Eni Idea <eni....@gmail.com> wrote:
> Okay, but still I don't really get it...;)
> So, you say you can almost do anyhting you want ..you mean at home?

Yes, almost anything, except the exceptions. Because the government
has a strong State level presence, meaning sometimes State laws can
supersede Federal law, laws and their enforcement vary throughout the
country. Then there are counties, towns, villages, cities. All can
have laws, but generally these cannot supersede State or Federal (i.e.
reduce restrictions), only add restrictions.

This article looks pretty good upon first glance, zoning and
home-business are keywords here (just because :
"Is Your Home Zoned for Business?"
http://www.entrepreneur.com/article/68844

"Types of Zoning"
http://realestate.findlaw.com/land-use-laws/types-of-zoning.html

> One of
> the most important things is: is there, e. g., a special agency that really
> has control over your work?

Only if you start breaking laws do agencies get specific, or a certain
locality has a law saying you need to have permission. There are
Federal laws about Animal welfare, but even this depends on the
Zoning, i.e. if you're technically a farm things can be different.
This would be handled by the USDA, who also handles GMO plant stuff:
http://www.aphis.usda.gov/about_aphis/

> And are all guidelines (NIH; CDC; BMBL;) only recommendet or required if you
> don't research at an institution?

They are recommendations, period. Institutions follow them because
they're generally good recommendations, and they'll get sued for
negligence if something were to go wrong and they weren't following
industry-accepted best-practices that might have prevented the
accident.

The same would apply to an individual who was within their rights of
the law to perform experiments, if they screw up and were found to be
lazy with some safety mechanism, they'll likely be sued/jailed. Some
biotech/chemical companies break the law year after year, but simply
pay the fine since their profit is large enough. Sometimes these
companies eventually get taken to court to face shutdown if their
practices don't change, or they jail the CEO or whoever blame falls to
legally.

OSHA would also be a good research topic for you, but I think this
might only apply if you're paying someone to work:
https://en.wikipedia.org/wiki/Occupational_Safety_and_Health_Administration#Health_and_safety_standards

> So let's say you want to establish a community lab, can you open a BSL 1 -
> lab without any registration and expertise or is there an agency for the
> autorisation process?

Maybe, a knowledgeable 'Agent' could be a local lawyer, or as the
entrepreneur.com article says "The first step is to call or visit your
local municipal building and ask to see copies of the ordinances that
apply to home occupations". (or other home/residential ordinances)

> Another question: you mentioned city laws, are there really special laws for
> each bigger city and if so, what are they mostly about?

Yes, they vary by city and by region. The range of topics varies too,
anti-cloning, anti-guns, anti-explosives, anti-GMO, anti-nuclear. If
some group of people can convince the local population and achieve
majority vote, most anything can become a law. Some places pay you to
install rain-water capture barrels, others make it illegal, and it
depends on the property's zoning and extent of development:
http://blog.heritage.org/2012/08/07/when-it-rains-in-oregon-the-state-owns-the-raindrops/
www.naturalnews.com/029286_rainwater_collection_water.html

"Oregon graciously allows Oregonians to collect water from artificial
impervious surfaces (rooftops, parking lots, etc.) and feed it
directly into rain barrels."
"But if that water touches the ground, it is the property of the state
of Oregon, and you cannot collect it without a permit. Since Oregon
owns it, using it without permission would be a form of stealing."




See this *great* overview by Raymond:
http://chimera.labs.oreilly.com/books/1234000001995/ch07.html

"
Even in the US, there is a patchwork of regulations dependent on where
you live, although this is the exception rather than the rule. In
California, at the state level, human reproductive cloning is banned,
with a fine of $1 million levied for violations, making it
prohibitively expensive to raise a large clone army in the Golden
State. (Protip: Nevada does not even prohibit the use of state funds
for human cloning, borders California, and the available huge tracts
of desert land may be more suitable for a secret underground lair.)
Note that most of these laws have monetary fines rather than criminal
penalties. A few federal regulations exist, but most of these also
lack criminal teeth. They use the carrot of federal funding to enforce
experimental standards or restrictions. Bans on funding for
reproductive human cloning and the reversed ban on using particular
cell lines for stem cell research are good examples of using funding
carrots to enforce limits on research.
"

"
What will probably have more impact on you is where you interface with
your local utilities and services infrastructure. Most local
governments (at the city, county, or water district level) have
regulations about what's OK to dump down the sewer or throw in the
trash. What is hazardous, and how do you dispose of it? The short
answer is: if you'd be uncomfortable spilling it on your dining room
table, don't just flush it or throw it away. Check with your local
water and trash authorities about the best way to proceed. For
instance, most water authorities require that residential wastewater
result from basic activities like washing and not contain hazardous
waste. Specific restrictions may include things like allowable range
of pH, anything that can catch on fire, materials that might cause
obstructions, and even the color of the water.
"
"
Finally, in the US, the last resort when people are hurt or property
is damaged is often hiring a lawyer and suing someone. If you burn
down your apartment building, it really doesn't matter if it's from a
lamp you badly rewired or if you left an alcohol lamp
burning--something you could have prevented burnt several homes to the
ground, and you may be liable.
"