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state-by-state-biosafety




The Federal government covers guidelines on biological research through CDC and NIH guidelines on rDNA research and the Biosafety in Microbiological and Biomedical Laboratories (BMBL) guide from the NIH. These guides become more solid and turn into regulations when the Select Agents laws come into play.


These rules are fairly easy to come by on federal health institutes’ websites, but what isn’t so plain and simple is the network of regulations that traverse the country at the state level.  Here are the major biosafety laws and regulations for every state.

Before we dive in, it’s important to note that certain biosafety laws cover the entire United States. Some of these include regulations on radioactive materials, hazardous waste shipping and disposal, animal care and testing, and mandatory reportable disease reporting. Also, issues like stem cell research and GMO labeling are constantly in a state of flux, so these regulations have the potential to change in the coming months and years. Another often-changing facet of state regulations is the policy differences among states in regards to biosimilar medications and agents, which is a topic which exceeds the scope of this guide. An in-depth look at this issue can be found here.
 
This guide is in no way comprehensive, but should be used as a summary glance at the different ways in which biological research is regulated in individual states.

Some states do not have specific laws on biosafety aside from the federal standards. For those that do, you can find state-specific regulation in the links below:

Arkansas

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Arkansas keeps its own biological select agents and toxins registry, which makes it one of only a few states which do so. Any facility which possesses, ships, or works with biologic agents must register each with the state registry, or risk a $1000 fine per agent per day that’s out of compliance. In addition, each agent on the registry must be associated with a biosafety plan for the facility. You can find further details and a link to the Department of Health page on the matter here.

California

California lays out specific laws governing the ventilation and maintenance of biosafety cabinets. The Article in the California Code of Regulations which outlines these regulations is here.

Colorado

Colorado has extensive regulations on radioactive agents, summarized here, as well as specific communicable disease reporting requirements for laboratories.

Connecticut

Connecticut lacks hard and fast laws pertaining to biosafety and lab conduct, but they do provide a helpful checklist for labs that are preparing for an inspection from the Board of Health here. The standards which the checklist complies with are national, so this may be a helpful resource for labs in other areas, as well.

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Delaware

Delaware lacks specific laws regarding research, but does have a robust communicable disease reporting policy here.

Florida

Florida is one of a few states in the country to regulate biosimilars, so if this is your lab’s forte, then it might be worth it to get familiar with these regulations.

Illinois

Illinois has the Illinois Regenerative Medicine Institute Oversight Committee which oversees stem cell research operations in the state. Currently, this group acts more like a guidance agency than a regulatory body, but its influence and power could change in the coming years as biotech advances in the state. Learn more here.

Maryland

While the state of Maryland does not have biosafety laws which apply to the entire state, certain areas such as the city of Frederick have their own laws, due to the prolific nature of the biotech industry in this area. A link to the Containment Lab Community Advisory Committee is here.

Massachusetts

Like Maryland, Massachusetts has biosafety laws specific to areas of the state where there is a considerable amount of biotech activity, like Cambridge, which has the Cambridge Biosafety Committee (CBC), which set the standard for biosafety guidance in the 1970s and continues to operate today. Also, there are regulations which necessitate a Certificate of Registration for conducting stem cell research in the state. The complete regulations which pertain to clinical laboratories is here.

Nebraska

Nebraska is unique in that the state has certain requirements for the storage, dating, and disposal of certain specific biologic agents, as well as regulations for shipping microorganisms.

Nevada

Like Massachusetts and Maryland, Nevada has different laws for different areas of the state. In this case, Washoe County has specific laws on disposal of biohazardous waste, which also includes decontamination procedures and autoclaving requirements.

New York

The State of New York has fairly advanced regulations on some specifics of biological research, including dedicated policies on rDNA and dealing with live pathogenic microorganisms and viruses. These specific laws are part of New York State Code Public Health Article 32. The state also keeps a very detailed list of regulations regarding public health facilities and communicable diseases. You can find the link to this here. 

North Carolina

North Carolina has its very own select agents and toxins registry, which is used in conjunction with the federal version. A link to a Department of Health page with further information about this registry is here.

Pennsylvania

Clinical laboratories require both a Federal CLIA permit (as do clinical labs across the country) in addition to a Pennsylvania Clinical Laboratory Permit to operate in Pennsylvania.

Rhode Island

Rhode Island maintains certain communicable disease reporting requirements for lab workers which are stricter than requirements for other professionals.

South Carolina

South Carolina is unique in their easy-to-use Permit Central system, which shows you which permits your lab will need based on the specific types of research being conducted.

Tennessee

Tennessee requires a specific medical and microbiology lab permit, and there are three districts within the state which issue these permits. The complete list of state-specific permits and where to apply for them is below. 

Texas

Texas has specific laws regarding stem cell research as well as the privatization of research methods and findings unique to universities. If your lab is going to be working with a university, or if you see value in partnering with one, checking out these unique regulations is a must.

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