Biosafety

Biennial Reports Are Due March 1, 2020!

 

If your facility is registered with the MA DEP as a Large Quantity Generator (LQG) of hazardous waste, don’t forget that 2020 is a year when biennial reports must be filed.  Biennial reports are due by March 1st of even numbered years for any facility that exceeded the LQG threshold during the preceding odd numbered year, even if your facility is no longer registered as an LQG.  Treatment, Storage, and Disposal Facilities (TSDFs) are also required to report every two years.

Biennial reports provide the DEP with information on the quantity and nature of the hazardous waste that was generated in the previous year and whether the waste was sent for recycling, treatment, storage, or disposal. As of 2018, biennial reports need to be filed electronically using the RCRAInfo Industry Application. The electronic submission includes the following:

  • RCRA Subtitle C Site Identification Form
  • Waste Generation and Management (GM) Form
  • Waste Received From Off-Site (WR) Form, and […]

How to Protect Your Company From OSHA HazCom Violations

Did you know that violations related to the OSHA Hazard Communication standard ranked #2 in the OSHA top 10 list for most frequently cited violations in 2018? Common citations included not having a written program or safety data sheets (SDS) for all chemicals, lack of employee training, and deficiencies related to secondary container labels.

What can you do to protect your company from HazCom violations? Employers are responsible for ensuring that the labels and SDSs are readily available to all employees.  They are also responsible for training employees on how to properly recognize the hazards associated with chemicals and how to properly handle the chemicals based on the hazards conveyed.  For laboratories that use chemicals this specifically means that employers must ensure that:

  • Labels on incoming containers of hazardous chemicals are not removed or defaced. Incoming container labels must include the identity of the hazardous chemical(s), appropriate pictograms and signal word, and hazard and precautionary statements.
  • Labels […]

Is an In-House Blood Donation Program Necessary at Your Company?

The use of fresh blood drawn from company employees is sometimes required when timelines in experiments are too tight to use an outside blood supply vendor. That said, it is considered to be preferable from a safety standpoint, and often a logistical one as well, that an outside blood supply vendor be used rather than establishing an in-house program.

When research needs require establishing an in-house blood donation program, there are numerous considerations to take into account including:

  • Involvement of the legal department to develop an informed consent form for voluntary blood donation. This form should include an explanation of the risks associated with participating in the program, confidentiality concerns, and compensation for program participation, if any.
  • An evaluation of the need to establish an Institutional Review Board. If your company receives federal funding and/or the blood collected is being used to support an FDA submission, it’s very important to determine the need for […]

How Will the 2019 Changes to the NIH Guidelines Affect Your Company’s Research?

Local recombinant DNA ordinances, including those of Boston, Cambridge, and Lexington to name a few, require compliance with the NIH Guidelines for Recombinant DNA Molecules (originally published in1986) as well as revisions and amendments to the Guidelines.  As you may know, the scope of the Guidelines was updated in 2013 to include work with synthetic nucleic acid molecules, and the Guidelines were renamed accordingly and are now called the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.  Are you familiar with the more recent changes to the Guidelines that were published in April 2019?

The April 2019 changes streamline the oversight of human gene transfer (HGT) research.  Because of the FDA’s regulatory authority and oversight of gene therapy trials, NIH has removed the duplicative oversight of gene therapy research from the Guidelines.  The revised Guidelines eliminate the NIH Recombinant DNA Advisory Committee (RAC) review, protocol registration, and reporting requirements associated with gene […]

Responding to an Exposure Incident – The Steps to Take

Would you know what to do if an employee at your company had a needlestick injury or other exposure incident?  Other routes of exposure to biological material include accidents with other types of sharps as well as exposure to the mucous membranes of the eyes, nose, mouth, and non-intact skin.

Don’t be caught off guard! The last thing you want to be doing following an incident involving an exposure to potentially infectious material, or material known to be infectious, is figuring out the appropriate steps to take.  Proper incident response is critical to worker health and safety.  The Centers for Disease Control (CDC) recommends that these steps be followed after an exposure incident:

Step 1, provide immediate care to the exposure site: this includes washing the puncture area for 15 minutes with soap and water.  Remember, do not force bleed the wound!  Splashes to the mucous membranes (eyes, nose, mouth, or non-intact skin) should also be […]

OSHA Announces Safe + Sound Week 2019

OSHA has announced that Safe + Sound 2019 will be held August 12-18, 2019.  This national event is intended to promote the value of workplace health and safety programs.

OSHA is encouraging employers to share the safety successes they have enjoyed over the past year during this week.  Employers are encouraged to hold events and activities that highlight the elements of their health and safety program during this week.  Developing fun interactive activities can engage employees and remind them of the established policies in a creative way.  Even though it is a long way away, take advantage of the long lead time to develop daily activities to highlight the importance of your EHS program!  You have plenty of time to prepare and think about the daily themes to cover during this week.

Updated MA Law for Public Workplaces

The updated Law M.G.L. Chapter 149 § 6 ½ requiring public sector workplaces to comply with OSHA regulations went into effect on February 1, 2019.  While this is a significant change for public workplaces, OSHA does continue to have jurisdiction over private employers. The Massachusetts requirements found in this updated law are as strict as the OSHA regulations.

The update clarifies that the definition of public sector workplace includes counties, municipalities, all state agencies, quasi-public independent entities, courts, bureaus, commissions, divisions or authorities of the commonwealth, political subdivisions, and public colleges and universities.  The Massachusetts Department of Labor Standards is responsible for enforcing this law at public sector workplaces.

If you have not heard about this update, know that public workplaces are now responsible for complying with OSHA regulations.

 

 

Making Safety Training Fun

“I Love Safety Training!”

Wait…what?  Have you heard many people utter these words before?

It is easy to say that the importance of developing an effective safety training program should not be overlooked, but how do you put a fun and therefore effective safety training program into practice?

Developing a robust new employee safety orientation that encompasses a safety tour of the facility and interactive sessions to demonstrate the safety policies will likely improve material retention.  If new hires are forced to sit through hours of lectures to cover material that checks the boxes for various regulations, the details will be lost in the myriad of information given to them on their first day at a new job.  Encourage questions, ask questions, and get to know the new hires’ previous experiences with safety.  Start to build trust that a collaborative environment will be fostered from day one.

Even though annual refresher trainings are mandatory, this does not mean […]

Gap Analyses Benefit Everyone

If you have never conducted a gap analysis or if it has been some time since the last one, consider investing in this invaluable process.  Even if you have established a robust program, a gap analysis can provide input into what areas could use improvement or redefined focus.

A gap analysis should start with a thorough review of your EHS needs and an evaluation of the regulatory standards that are applicable to your site based on the work being conducted. This should include taking a deep dive into the hazardous materials present and how they are being stored, manipulated, and disposed of. When reviewing compliance with permit and license requirements, consider any permits or licenses that may have been overlooked due to changing needs or regulatory updates.

Gap analyses almost always produce a list of action items. Nice to have or do items that fell off the radar may be re-identified during the gap analysis and […]

Start Preparing OSHA Form 300A

All establishments covered by OSHA’s Part 1904 are required to complete Form 300A, Summary of Work-Related Injuries and Illnesses, on an annual basis.

This form summarizes the number of recordable work-related injury and illness cases, the number of days work was affected, and the types of injuries and illnesses.  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 of the year following the year covered by the OSHA 300 log.  Even if no recordable incidents or illnesses occurred during the previous year, the 300A form must be completed and posted reflecting zeros.  While going through this process, also take the time to review the incidents on the OSHA 300 log to ensure they have been recorded properly.

If you have not started completing this form already, be sure to get started so you […]