Biosafety

OSHA Violations and the Bloodborne Pathogens Standard

Did you know that the most frequent cause of OSHA violations related to the Bloodborne Pathogens Standard is outdated, or otherwise non-compliant, Exposure Control Plans?

It is generally known in the biotech community that Exposure Control Plans are required to be in place for any facility working with blood or other potentially infectious material (OPIM). What is often overlooked is that there is a specific regulatory requirement to update the Plan.

The Bloodborne Pathogens Standard (in section 1910.1030(c)(1)(iv) ) specifies that the Exposure Control Plan must be reviewed and updated at least annually and whenever necessary to include new or modified tasks and procedures which affect occupational exposure and to address new or revised employee positions with occupational exposure.

The review and update of the Exposure Control Plan must also reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and document annually consideration and implementation of appropriate commercially available and effective safer medical […]

Remember to Post OSHA Form 300A!

OSHA Form 300A, Summary of Work-Related Injuries and Illnesses, is used to summarize the recordable injuries and illnesses for the previous year and includes the number of days work was lost or restricted, and the types of injuries and illnesses that occurred.

Information about the company, including the average number of employees and total hours worked by all employees, must also be recorded.

Form 300A must be posted from February 1 through April 30 each year.  If no recordable incidents or illnesses occurred during the previous year, the form must still be completed and posted reflecting zero recordable cases. The information in Form 300A is based on information recorded in OSHA Form 300, Log of Work-Related Injuries and Illnesses. However, certain employers are exempt from these reporting requirements.

Employers with 10 or fewer employees are not required to prepare Form 300 or Form 300A. In addition, only industries within certain North American Industrial Classification (NAICS) codes are […]

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 […]

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) […]

The 6th Edition of the BMBL Has Been Published!

In a November 17th, 2020 Lab Advisory, the CDC announced the release of the 6th Edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL)! The BMBL has become the foundation of biosafety practice since it was first published in 1984. Historically, the information in this publication has been advisory in nature although some legislation and regulations, in particular local recombinant DNA ordinances, have made compliance with the guidance provided mandatory. The previous version of the BMBL (5th Edition) was published in December 2009.

So what’s different about the 6th Edition? The updated BMBL is more detailed in many sections and has increased in length by ~160 pages! For example, the section describing Standard Microbiological Practices (Section IV) for BL1 and BL2 labs now includes a detailed description of content requirements for a written Biosafety Manual.

In addition, there is a new requirement that long hair be restrained so that it cannot contact hands, specimens, containers, or […]

The Bloodborne Pathogens Standard and the Needlestick Safety & Prevention Act: Not Just for OSHA Compliance

Often companies seek to check off all of the regulatory boxes so non-compliance doesn’t interfere with their work and timelines. While this may be reasonable, regulations can be general and do not always achieve safety standards that appropriately address workplace hazards.

The OSHA Bloodborne Pathogens Standard went into effect in 1991 and was updated in 2001 to incorporate the requirements of The Needlestick Safety and Prevention Act.

This Standard is an example of a sweeping and effective regulation that has significantly reduced the risk of occupational transmission of bloodborne viruses.

In this post, we’re going to focus on the Needlestick Safety and Prevention Act and the changes that have been made to reduce sharps injuries. The Act itself is only four pages and lays out the problem (occupational exposure to contaminated sharps), the empirical evidence for the need to resolve it, and specifies the requirements related to sharps with engineered sharps injury protections that were added to […]

Guest Blog from CRB: Biologics Facility Considerations

Safety Partners welcomes the chance to share information from other companies serving the life science industry in MA and NY.

Today we’re proud to share our first guest blog, from CRB! CRB is a leading provider of sustainable engineering, architecture, construction, and consulting solutions to the global life sciences and advanced technology industries.

Moving to the Suburbs

Seems everyone is talking about how the coronavirus pandemic is contributing to an already growing life science industry in the Boston area. With this growth, life science firms and particularly those in biologics, are looking towards the suburbs both as a place to spread out and expand their operations and as a cost-saving alternative to the overheated Cambridge and Boston markets.

Good access to regional transit for talent and materials along with new suburban amenities of restaurants, retail, and hotels make this an attractive option.

Biotech companies planning operations in the suburbs can focus on some key considerations.

Start with a robust programming process that […]

Is Your Facility Prepared for an Emergency?

September is National Preparedness Month (NPM)! NPM is recognized each September to promote family and community disaster planning now and throughout the year.

The 2020 theme is Disasters Don’t Wait- Make your Plan Today.

The same principles promoted for NPM apply to prepare for workplace emergencies. Specifically, starting with an up-to-date Emergency Action Plan!

Emergency Action Plans and Contingency Plans are required by various regulations, including  OSHA 29 CFR 1910.38 and 157, Massachusetts Comprehensive Fire Safety Code 527 CMR 1.0, and the Massachusetts Department of Environmental Protection 310 CMR 30.000.

It’s important to know if your facility is required to have an Emergency Action Plan or a Contingency Plan because regulators will look for the appropriate implementation during inspections.

All employees must have access to the written Plan and be trained on it. It’s critical that everyone be well-versed in proper response procedures should an incident occur! It’s good practice to hold drills for the […]

MassDEP Hazardous Waste Management Guidance During the COVID-19 Pandemic

The Massachusetts Department of Environmental Protection (MassDEP) recently amended its April 8, 2020 Hazardous Waste Management Guidance During the State of Emergency for the COVID-19 Pandemic.

Effective August 26, 2020, MassDEP is implementing the following amended guidance resulting from the COVID-19 pandemic for the items noted below related to hazardous waste management. Learn what you need to do in order to comply with the new regulation:

  • Compliance with hazardous waste container and tank inspection requirements for Small Quantity Generator (SQG) and Large Quantity Generator (LQG) facilities (described at 310 CMR 30.686 and 30.696, respectively) if the facility is closed during the State of Emergency- A facility that is normally subject to container and tank inspection requirements but is closed during the State of Emergency, should make every reasonable effort to do applicable daily/weekly inspections. If employers have concerns about having their employees onsite to do the inspections, then they should contact the DEP at […]

SARS-CoV-2: Determining Your Employees’ Exposure Risk Level

OSHA recently issued a guidance document on Preparing Workplaces for COVID-19 that focuses on determining employees’ risk of occupational exposure to SARS-CoV-2 in order to identify the appropriate control measures that can be put in place to protect employees from exposure.

OSHA has divided job tasks into four risk exposure levels:

Very high exposure risk

Jobs with high potential for exposure to known or suspected sources of COVID-19 during specific medical, postmortem, or laboratory procedures. Workers in this category include healthcare workers (e.g., doctors, nurses, EMTs) performing aerosol generating procedures (e.g., intubation, cough induction procedures, invasive specimen collection); healthcare or laboratory personnel collecting or handling specimens from known or suspected COVID-19 patients; and morgue workers performing autopsies on people known or suspected of having COVID-19.

 High exposure risk

Jobs with high potential for exposure to known or suspected sources of COVID-19. Workers in this category include healthcare and support staff (e.g., doctors, nurses, and other hospital staff who […]