The USEPA published a final rule, entitled, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” in the Federal Register on February 22, 2019.  According to the USEPA announcement, the final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment. 
 
This final rule will help protect drinking and surface water reducing the amount of hazardous waste pharmaceuticals entering waterways by 1,644 to 2,300 tons on an annual basis.  To accomplish this the rule will prohibit disposal of pharmaceuticals in the sanitary sewer by all facilities subject to the rule.  This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.
 
In addition, FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded.  This will result in significant cost savings and burden reduction in the management of these types of nicotine wastes. 
 
Finally, the final rule reaffirms EPA’s long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste.  It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit.  Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.
 
SRM will keep you posted on this important development. 

​Did you think that once you “complete” your Risk Management   Planning   (RMP) and Process Safety Management (PSM) programs   there is no more   work to be done?  Often, regulatory requirements   are thought of as one and   done.  You prepare the document and its   done, you don’t have to look at it   again for five years.  Not in this   case.
 
These programs require vigilance, especially if the processes at your facility often change.  For starters, both PSM and RMP include periodic actions that must be completed regularly.  Here’s an abbreviated listing:

• Both programs require documentation reviews, some documentation must be reviewed on an annual basis and others on a less frequent basis.  For example, operating procedures must be reviewed annually.  They must also be certified as having been reviewed. 
• Frequency of inspections and tests of process equipment must be done regularly in accordance with manufacturer’s RAGAGEPs. …. Raga-what?  Recognized and Generally Accepted Good Engineering Practices.  RAGAGEPs are based on established industry codes, standards, recommended practices, technical reports, or similar documents.   
• Compliance audits must be conducted every 3 years, and a process hazard analysis (PHA) must be conducted or revalidated at least every 5 years.  A PHA may need to be conducted more often if there are changes to the process. 
• Process safety information must be updated whenever changes to the process occurs.  This includes a range of information including P&IDs, materials safety data sheets, block flow diagrams, operating limits, material and energy balances, to name a few.
• Emergency response information must also be updated regularly and training must be conducted annually for hazmat personnel and when job duties or procedures change for all other personnel. 
• RMP Submittals (or RMP eSubmit) may need to be updated more often than every five years if there are certain significant changes to your processes or regulated substances.   For example adding a hazardous substances to an existing process above threshold quantities.  Changes that trigger revisions to your PHA or off-site consequence analysis also require an update to your RMP eSubmit. 

 
So, as you can see with this truncated list of periodic requirements, there is a lot to do after the main part of the program is established.  I will say this, it gets a little easier as personnel understand what is expected of them and adopt a PSM/RMP safety culture. 
 
One final thought.  Remember to document all of your reviews and date all of your changes.  The old saying still holds true.  If it wasn’t documented and you can’t prove a review took place, it didn’t happen.

​  Beginning July 1, 2018, all hazardous waste shipments from
  small and large quantity hazardous waste generators, and all
  shipments of polychlorinated biphenyl (PCB) waste, requiring a
 uniform manifest, must be submitted to the U.S. EPA for
 tracking in the online e-Manifest system. 
 
The receiving TSDF is responsible for submitting the e-Manifest information it receives to the U.S. EPA.  It is also responsible for paying any e-Manifest processing fees due to the U.S. EPA following deployment.  To ensure a smooth transition, generators are encouraged to review e-Manifest resources shared with them by their TSDF and to review resources on the MDEQ and USEPA websites.
 
Highlights for Generators

• The e-Manifest launches nationwide on June 30, 2018. 
• Generators will have the option to create and submit manifests electronically in e-Manifest.
• If generators would like to submit electronically, they must register for e-Manifest within the USEPA CDX online system.
• Generators who wish to use electronic manifests will need an EPA Identification (ID) Number.  
• Generators may continue to use paper manifests after June 30, 2018; however, there is an extra charge for using paper manifests.  
• Existing 6-copy manifest form is being replaced with a new 5-copy form.  
• The system can also be used for shipments of Michigan liquid industrial by-products, but this is optional.

 
The eManifest online system is located in the USEPA CDX online system under RCRA Info and is currently available to explore.  You will need to open a CDX account if you don’t already have one.  There is a Youtube video from USEPA that walks you through a fictitious site and may be helpful. 
 
To get more information, check out the MDEQ and USEPA resource pages, or contact SRM for assistance.

​USEPA issued the TSCA Inventory Reset final rule On June 22, 2017 in pre-publication form.  The rule requires every chemical manufacturer and importer to notify USEPA of each chemical substance it manufactured or imported (for a non-exempt commercial purpose) in the US during the 10-year period ending June 21, 2016.  This 10-year period is referred to as the “Lookback Period.” 
 
Each chemical substance for which USEPA receives a notification will be designated as “active” on the TSCA Inventory.  Manufacturers and importers must provide this notification to USEPA within 180 days from the date on which the rule is formally published in the Federal Register.  However, USEPA has not yet published the final rule in the federal register.  If the rule is finalized as proposed it will require the following:

• Within 180 days of the date of publication of the final rule, manufacturers and importers must notify USEPA about all substances they manufactured or imported from June 2006 to June 21, 2016 unless the substance was already reported by another company or was otherwise exempt from reporting.  
• If a substance is not reported, it is considered "inactive" and a notification will need to be submitted 30 days before actual manufacturing or processing begins. 
• Chemicals added to the Inventory on or after June 22, 2016 are automatically designated "active" and are not subject to notification requirements.

 
For more information go to the USEPA TSCA inventory information page.