Regulatory Compliance

Massachusetts Safety Standards for Office Spaces During the COVID-19 Reopening Period

On May 18, Governor Baker announced the State’s Plan to safely reopen the Massachusetts economy, while minimizing the health impacts of COVID-19. The guidance includes mandatory sector-specific standards and recommended best practices for sectors that are eligible to open in Phase 1. In my May 20th blog, I discussed the Safety Standards for Laboratories. Since that blog was posted, the State has clarified that offices associated with laboratories must comply with The Safety Standards for Office Spaces. Like the Safety Standards for Laboratories, these standards are organized around four categories: social distancing, hygiene protocols, cleaning and disinfecting, and staffing and operations.

Social Distancing

Social distancing requirements for offices include limiting occupancy within the office space to no more than 25% of the maximum occupancy limit specified in the certificate of occupancy, or the typical occupancy as of March 1, 2020. Any business or other organization that has been operating as a “COVID-19 Essential […]

Are Workplace-Related COVID-19 Cases Recordable and Reportable?

On April 10, 2020, OSHA published interim guidance regarding the enforcement of employers’ obligation to record and report employees’ COVID-19 cases.

The OSHA guidance recognizes that determining whether an employee contracted COVID-19 at work will often be difficult, and because of this, relaxed COVID-19-related recordkeeping obligations for many employers.

However, for employers of workers in the healthcare industry, emergency response organizations (e.g., emergency medical, firefighting, law enforcement services), and correctional institutions, COVID-19 is a recordable illness.

These employers are responsible for recording cases of COVID-19, if:

  • The case is a confirmed case of COVID-19, as defined by theCDC
  • The case is work-related as defined by the OSHA standard on recording and reporting occupational injuries and illnesses 29 CFR 1904.5 and
  • The case involves one or more of the general recording criteria: death, days away from work, restricted work or transfer to another job, medical treatment beyond first aid, or loss of consciousness.

For other employers, including […]

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 […]

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 […]

Hazard and Risk Analysis

The terms risk and hazard are used often in the safety world, many times interchangeably. They have very different meanings, however, and when using these terms, care should be taken to use them appropriately. When evaluating a process or procedure, assigning these terms appropriately can help simplify the safety assessment process.

What is a hazard?

A hazard refers to a potential source of harm. Examples can include chemical, biological, radiological, and physical hazards. Toxic chemicals, infectious biologics, and moving mechanical parts are all different types of hazards. The hazard level of a particular item or condition is static, meaning it does not vary. However, it can be evaluated relative to other hazards. Simply put, a hazard is a material or condition that can have an adverse effect on a person’s health or physical property.

What is risk?

Risk is the potential for interaction with a hazard. Generally speaking, risk is referenced in relative […]

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 […]

Did You Know About Planned Changes to the OSHA Hazard Communication Standard?

OSHA has been involved with a long-term project to be aligned with the Globally Harmonized System (GHS) of classifying chemical hazards and providing labels and safety data sheets for hazardous chemicals. OSHA incorporated the GHS system into the Hazard Communication Standard (HCS) in March 2012 to specify requirements for hazard classification and to standardize label components and information on safety data sheets, in an effort to enhance both employer and worker comprehension of hazards and facilitate international compliance.

The GHS has been updated several times since OSHA’s 2012 rulemaking which was based on the third edition of the GHS and the United Nations recently completed the seventh edition. OSHA is now in the process of conducting rulemaking to harmonize the Hazard Communication Standard (HCS) to the latest edition of the GHS and to codify a number of enforcement policies that have been issued since the 2012 standard. OSHA has recently published a new Proposed Rule “Update […]

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 […]