Regulatory Compliance

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 […]

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.