Permits and Licenses

New Watertown Regulation: Biotechnology and the Use of Recombinant DNA Molecule Technology

Watertown announced yesterday that due to the COVID-19 emergency they will be ​postponing the effective date of their new regulation (Biotechnology and the Use of Recombinant DNA Molecule Technology) from May 1 until July 1, 2020. Existing facilities located in Watertown​ will have one year from the effective date to come into compliance.

Overall, the new regulation is similar to other cities and towns in the area. One difference is that Watertown will be regulating non-recombinant DNA (rDNA) research involving biologic agents at Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3). (BSL-4 work is prohibited in Watertown.) Examples of agents at BSL-2 include non-recombinant work with Salmonella entericaStaphylococcus aureus, Hepatitis B, and Herpes Simplex Virus. BSL-2 agents can also include toxins of biological origin requiring BSL-2.  In comparison, Cambridge, Lexington, and Boston only regulate biologic agents at BSL-3.

The Watertown regulations do not apply to finished products which contain rDNA molecules and which have been approved by other government regulatory […]

Evaluate USDA Permitting Applicability

The United States Department of Agriculture (USDA) regulates the transport of potentially invasive species, pests, and/or agricultural threats through their Animal and Plant Health Inspection Service (APHIS). Permits are required for importation, interstate transit, or release of regulated animals, animal products, veterinary biologics, plants, plant products, pests, organisms, soil, and genetically engineered organisms.

The type of material being imported or transported will dictate the type of permit that needs to be in place prior to the movement of the material. As part of the permitting process, security for the building and specific lab, storage plans, work practices, and decontamination methods all need to be considered and appropriate plans put into place.   This process can take several months, so it is ideal to begin the process as soon as you know you will be needing these materials. Fixed, autoclaved, and irradiated samples may be exempt so be sure to verify the applicability before you begin the […]

Review Permit and License Conditions

conditionAs EHS permits and licenses are received, amended, and renewed, be sure to review the conditions stipulated in the permit or license upon receipt. Avoid the temptation to be happy that the final document has been received, and just file it away in your central recordkeeping location. It is important that everyone involved in the application process is aware of this requirement to avoid potential issues of non-compliance.

If permits and licenses are issued to different individuals within the company, be sure that one person is responsible for ensuring that all permits and licenses are received and current. This will avoid the potential for renewals falling through the cracks, or confusion around the permits and licenses held. This point person should also be responsible for verifying that the conditions of issued permits and licenses have been reviewed, and a plan is in place to ensure compliance with those conditions. There may be sampling requirements, record […]

Reference NUREG-1556, Volume 7, for Radiation License Applications

NUREGWhen submitting applications to MA Department of Public Health Radiation Control Program to request permission to possess and use radioactive material in a research and development laboratory, be sure to reference U.S. Nuclear Regulatory Commission’s NUREG-1556, Volume 7. The Consolidated Guidance About Materials Licenses; Program Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope must be used as general guidance when drafting permit applications.

All applicants are required to carefully evaluate their proposed use of radioactive materials and ensure that appropriate radiation safety procedures will be established. These procedures need to include how to receive radioactive materials, work with radioactive materials while keeping exposures as low as reasonably achievable, respond to emergency situations involving radioactive materials, and dispose of waste. Appropriate implementation of these procedures and other radiation safety practices must be part of the radioactive material use program at any licensed facility.

It is important to take the time to carefully […]

Flammable Permit vs. Flammable License

Fire truckBe careful not to confuse a flammable permit with a flammable license. These are two very different regulatory processes stipulated in 527 CMR 1.00, Massachusetts Comprehensive Fire Safety Code. When discussing flammable permitting, the terms permit and license should not be used interchangeably.

In accordance with the Massachusetts Comprehensive Fire Safety Code, companies using and storing flammable materials are required to hold a flammable storage permit with the local fire department.  The town Fire Department issues flammable permits through their established process, and a permit is required to store and use any amount of flammable material. When licensing thresholds stipulated in Table of 527 CMR 1.00 are exceeded, a flammable license must be obtained in addition to the flammable permit.  Obtaining a flammable license is a much more complicated process, which involves going before the local licensing commission.  Even when a flammable license is held, a flammable permit must still be obtained and […]

Environmental, Health, and Safety Permits and Licenses

EHS permitting and licensing in compliance with Federal, State, and Local regulations is a crucial item to address for all companies.

EHS Permits and Licenses

Many cities and towns have local ordinances that establish requirements for recombinant DNA permits and hazardous material storage permits.   Wastewater discharge typically needs to be permitted through the regulatory agency having jurisdiction, which is commonly the Massachusetts Water Resources Authority in eastern Massachusetts.  Any facility generating hazardous waste must be appropriately registered as a Very Small Quantity Generator, Small Quantity Generator, or Large Quantity Generator.  The use of radioactive material requires a license from the MA Department of Public Health Radiation Control Program.  From the basic permits and licenses that most companies need to the specific import/export permits or DOT registration, it is critical that your company holds the appropriate permits and licenses.

Many permit/license applications require detailed information that is not always easily accessi

Import and Export Permitting Can Be Complicated

Biological materials imported into the US or exported out of the US may be subject to permitting requirements through various agencies, including the Centers for Disease Control (CDC), United States Department of Agriculture (USDA), and US Fish and Wildlife (FWS). Common permits required by these regulatory agencies include CITES permits, APHIS permits, EAIPP permits, and export licenses.  For example, the USDA Animal and Plant Health Inspection Service’s Biotechnology Regulatory Services (BRS) requires a notification or permit for the importation of certain genetically engineered organisms. 

Biological materials are not the only materials subject to import/export regulation.  The EPA regulates the importation of new chemicals through the Toxic Substances Control Act (TSCA).  There are extensive regulations surrounding this topic, but a […]