Regulatory Compliance

Are You a Virtual Manufacturer?

Many of Safety Partners’ clients hold Controlled Substances Registrations (Researcher) for the research use of controlled substances.  In Massachusetts, a controlled substance includes all drugs regulated by the Drug Enforcement Agency (DEA) in schedules I through V as well as Schedule VI, which is defined as all prescription drugs, which are not included in any other schedule.  In addition to Researcher Registrations, the Massachusetts Department of Public health (DPH) has required registrations for controlled substances Manufacturers.

Did you know that the Mass DPH now requires registrations for Virtual Manufacturers?  A Virtual Manufacturer is defined as “a person in the business of manufacturing or distributing a controlled substance and who has a principal place of business located in the Commonwealth, but at no time takes physical possession of any controlled substance in the Commonwealth.”  Under this definition, you would be a virtual manufacturer if your company was using a contract manufacturing organization (CMO) for drug manufacturing.

This […]

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 […]

Proposed Changes to the MWRA Regulations

Proposed changes to the Massachusetts Water Resources Authority (MWRA) Sewer Use Regulations (360 CMR 10.000) were published in April 2019 and a public hearing on the changes was held this week on May 13. For those of you who didn’t get to participate in the public hearing and would still like to submit comments, the deadline for written comments to the MWRA is May 20th.

For most Safety Partners’ clients, the proposed changes are relatively minor. The most noticeable impact will likely be for those of you that hold Low Flow/Low Pollutant Permits. The fee for these permits will be increasing from an initial one-time fee of $244.00 for the 5-year duration of the permit to an annual fee starting in 2020 of $100.00/per year, increasing about 3% each year, for a total cost for the 5-year duration of the permit of $532.00.

Those clients holding Category 2 permits will also be seeing an increase in […]

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 […]

Reconcile Safety Data Sheets

Be sure to reconcile the Safety Data Sheets at your facility to verify that you have an SDS for all hazardous chemicals present on site.

29 CFR 1910.1200 Appendix D stipulates the minimum information required to be contained on a SDS, and specifies each section number and heading.  Hazard identification, first-aid measures, proper handling and storage requirements, appropriate personal protective equipment, exposure limits, and toxicological information are all covered on a SDS.  Information on the likely routes of exposure, symptoms of exposure, and immediate and delayed effects from short-term and long-term exposure are reported.  All of this information should be known by each individual working with a particular chemical.

It is the responsibility of the manufacturer, distributor, or importer to provide a SDS for each chemical.  It is the responsibility of the employer to make a SDS for each chemical in the workplace readily available to all employees.  And it is the responsibility of each individual […]

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.

 

 

Remember to Conduct Chemical Inventories

OSHA’s Hazard Communication Standard, 29 CFR 1910.1200 requires that employers maintain a list of the hazardous chemicals known to be present in the workplace.  While conducting chemical inventories, it is prudent to ensure that the SDS files are up to date for all chemicals found during the inventory.  The Lab Standard, 29 CFR 1910.1450, applies to laboratory scale use of hazardous chemicals, and requires the implementation of a Chemical Hygiene Plan.  The Chemical Hygiene Plan in place at your institution should specify how the chemical inventory will be maintained and how the SDS system works.

Safety Partners recommends conducting physical chemical inventories on an annual basis, at a minimum.  There are several chemical inventory barcode software systems available for companies choosing to maintain on-going chemical tracking.  These systems track chemicals from receipt to disposal, relying on the users to track their use using the barcoding system.  If a full bar coding system is not an […]

Be Sure to Submit Your LLRW Survey!

The Massachusetts Department of Public Health Radiation Control Program tracks the generation and disposal of low-level radioactive waste produced in Massachusetts every year. This is accomplished through requiring a completed LLRW survey from all licensed facilities every year.

Generally speaking, low level radioactive waste is waste generated from long-lived isotopes having a half-life greater than 120 days.  This waste must be shipped off-site for disposal at a facility licensed to handle this type of waste.  When shipping radioactive waste intended for disposal at a licensed facility, the information required on the Nuclear Regulatory Commission’s Uniform Low-Level Radioactive Waste Manifest must be documented.

Facilities licensed to work with radioactive material are able to decay in storage waste generated from isotopes with a short half-life.  This waste is stored on-site in a dedicated storage location for ten half-lives, and then surveyed to verify proper decay prior to disposal.  All disposal of radioactive waste must be done in strict conformance […]

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 […]