Permits and Licenses

New Watertown Regulation Biotechnology & the Use of rDNA Molecule Technology: Sharing Our Tips!

In my April 16th  2020 blog, I wrote about the new Watertown regulation Biotechnology and the Use of Recombinant DNA Molecule Technology which became effective July 1, 2020. Existing facilities located in Watertown​ will have one year from the effective date to come into compliance, but new companies moving to Watertown must comply before work covered by the regulation can begin.

The regulation covers recombinant DNA (rDNA) work as well as non-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.

Non-exempt rDNA work and work with regulated biologic agents requires a permit. However, low risk facilities may conduct rDNA work without a permit provided that they register with the Watertown Biosafety Committee (WBSC).  A low risk facility is one that creates, propagates, imports or uses rDNA […]

Safety Doesn’t Break for Parties: IANM V5

With the holidays, there’s a guarantee of rushing around which makes errors more likely to happen in the lab. Many people are typically off on vacation which adds another variable for accidents to happen.

Learn how to prevent accidents this season with this ‘near miss’ from our publication Incidents, Accidents, and Near Misses Volume 5:

It was the annual institute-wide holiday party and everyone in Charlie’s lab was excited to celebrate, relax, and have fun! It was the end of a long week and the weekend before many would be taking time off to go home for the holidays.

Charlie and most of his lab went just as the party was starting, but Ed stayed behind to finish up some of his work.

It wasn’t until Saturday morning that Charlie checked his email and noticed a flurry of messages from Ed the night before.

Ed is a graduate student in Dr. Brown’s lab and was finishing up some of […]

Have you Conducted Your Annual Fit Testing?

 Have you Conducted Your Annual Fit Testing?

The OSHA Respiratory Protection Standard requires that respirator fit testing be performed initially (before the employee is required to wear a respirator), and it must be repeated at least annually when respirator use is required.

Fit testing must also be conducted whenever respirator design or facial changes occur that could affect the proper fit of the respirator. Examples of conditions that would require additional fit testing include the use of a different size or make of respirator, weight loss, cosmetic surgery, facial scarring, the installation of dentures, or the absence of dentures that are normally worn by the individual.

What is the purpose of fit testing? Fit testing confirms the correct fit of any respirator that forms a tight seal on the user’s face. This ensures that users are receiving the expected level of protection by minimizing contaminant leakage into the facepiece.

When a respirator doesn’t fit properly, a portion […]

Have You Conducted Your MWRA Wastewater Sampling?

For Category 2 MWRA permit holders, semi-annual wastewater sampling results for the July through December sampling period must be conducted by December 31st.

Even though the sampling results are sent directly to the MWRA by the analytical testing laboratory using the MWRA’s electronic reporting system, permit holders are responsible for reviewing the results and notifying the MWRA of any issues of non-compliance.

If the sampling results show that any regulated chemicals are detected above the discharge limits specified in the facility’s permit or the Sewer Use Regulations (360 CMR 10), the MWRA must be notified within 24 hours of becoming aware of the violation. 360 CMR 10.024 specifies the specific daily maximum discharge limitations for regulated pollutants including formaldehyde, cyanide, phenol, specific metals, and listed toxic organics for both the Metropolitan Sewerage Service Area and the Clinton Sewerage Service Area.

If a violation is identified, the permit holder is responsible for repeating the sampling and submitting the […]

Have You Conducted Refresher Safety Training in 2020?

It’s not too late to conduct your annual refresher safety training! With all the COVID 19-related changes that everyone has had to make in the workplace this year, it’s easy to see how this requirement could slip through the cracks.

In light of the pandemic, OSHA is making some allowances for lapses in annual training requirements such as for companies that were required to close for a period of time.

That said, OSHA is requiring that companies demonstrate that they have made a good faith effort to comply with annual training requirements including the use of virtual training options and other means of remote communication. The use of virtual training has been a great option for many companies and has even proven to make annual refresher training easier to schedule!

Which OSHA standards specifically require refresher training?

  • The OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) requires that annual training be provided within one year (i.e., 12 months) […]

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 1.12.8.50 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 […]