Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine
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.
iJuly 1st is right around the corner. We hope most of you are either done or well on your way to completing your TRI number crunching. While there is still plenty of time to get the TRI reports completed, keep in mind there are some potential pitfalls that can stop you in your tracks:
Due Diligence - TRI Applicability Determination
If you are a small but growing company, don’t ignore the TRI reporting again this year because you have never had to report in the past. Do your annual Due Diligence and prepare some calculations and analysis that you can place in a compliance folder for when MDEQ or USEPA come to visit. This way you can easily demonstrate that your facility in not required to report. Your facility is required to report if it meets ALL three of these threshold criteria:
SRM can help you with your TRI determination. USEPA also has resources to help you at their website.
TRI-Me Web Access
USEPA requires companies to update their passwords. If you are running short on time or the certifying official is going out of town on a long business trip in two days, updating crucial information can pose a problem. What if you need to change the certifying official due to corporate reorganization? Changing information in the TRI-ME system can take a week or two to complete and can be disruptive. So you shouldn’t wait until the last minute to update your information. A good rule of thumb is to get onto the CDX system sooner rather than later and make sure you and your certifying official can access the CDX system and your TRI forms. Update your passwords as necessary.
Check Your Formulas
If you are like many TRI preparers, you use spreadsheets to estimate chemical usage and emissions. As we enter or remove data from year to year we can move linked data cells around the worksheet causing errors in the calculations. In addition, “Fat-Finger Syndrome” is still incurable and people often delete or move links without even knowing it. So, take some time every year to examine your formulas and links between worksheets to ensure data integrity.
Contact SRM if you have questions about TRI applicability or reporting.
Chemical Accident Prevention is high on everyone’s priority list. The EPA even has a rule for it. The Risk Management Plan (RMP) Rule (40 CFR Part 68) governs accident prevention under Section 112(r) of the Clean Air Act Amendments. The “RMP Rule” established regulations that facilitate accident prevention at facilities that use certain highly hazardous chemicals listed in the regulation. For example, many facilities that use anhydrous ammonia are required to prepare and implement an RMP at their location, and must submit the RMP to the EPA every 5 years. Whoa, you say. What’s in an RMP?
An RMP is a set of documents and procedures that govern the following actions at a facility when that facility has the highly hazardous chemicals in a process in quantities above a Threshold Quantity. For ammonia refrigeration the threshold is 10,000 pounds.
Why would a facility want to prepare an RMP? First of all, because these plans provide your local police, fire and emergency response personnel with information needed so that they can respond to an incident at your facility in the most effective way possible. And, Secondly, because these plans must be submitted to EPA. They must also be resubmitted every five years.
Did you know that the Environmental Protection Agency implements the Risk Management Plan (RMP) Rule in Michigan – not the Michigan Department of Environmental Quality?
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:
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.
Once again SRM is attending and hosting a booth at the semi-annual Michigan Environmental Compliance Conference (MECC) located at the Lansing Center on June 12 and 13, 2018. There will be over 70 educational sessions, 38 exhibitors, and 18 DEQ program exhibitors. Click here for more information.
Come visit SRM at Booth 35. We hope to see you there!!
The next Hazardous Waste Biennial Report deadline is March 1, 2018 and covers activities during calendar year 2017. The Michigan DEQ will not be sending biennial packets to waste generators. Instead, Large Quantity Generators and TSDFs will be required to report using the federal forms and instructions.
While the MDEQ will accept paper copies, it is encouraging facilities to submit their Biennial Report data electronically through the Biennial Report component of the USEPA RCRAInfo Industry Application (RIA).
The RCRAInfo login page can be used to set up a RCRAInfo account and login. The web site provides guidance and information to be followed to prepare and submit the report. Additional information for submitting Biennial Reports to the MDEQ either electronically or on paper can be found at the MDEQ web site for Biennial Reporting.
I have less than the threshold quantity of Anhydrous Ammonia. What does the EPA Enforcement Alert mean for me?
Vicki Schneider, Principal Consultant at Schneider Risk Management
As we shared with you in a previous article, the U.S. EPA (EPA) issued an Enforcement Alert (February 2015) describing how facilities using anhydrous ammonia are under scrutiny by EPA. The Alert primarily addressed facilities that contain anhydrous ammonia above the threshold quantity (TQ) of 10,000 lbs.; however, these warnings should not be ignored by those companies with systems under the TQ.
EPA Issues Enforcement Alert associated with Anyhdrous Ammonia at Refrigeration Facilities, February 2015
The U.S. EPA (EPA) issued an Enforcement Alert in February 2015 entitled “Anhydrous Ammonia at Refrigeration Facilities Under Scrutiny by U.S. EPA.” This Enforcement Alert notes that the EPA has gathered evidence that suggests refrigeration facilities may not be properly managing their ammonia. It states that the “Alert is intended to inform industry that companies must take responsibility to prevent accidental releases of dangerous chemicals like anhydrous ammonia through compliance with CAA’s Chemical Accident Prevention Program (40 CFR 68).”
Ohio EPA issued the new Industrial Storm Water General Permit (OHR000005) on December 15, 2011. The effective date of the new permit was January 1, 2012.
Existing facilities were required to submit a Notice of Intent (NOI) within 90 days of receiving Ohio’s written instruction to re-notify, and are required to update their Storm Water Pollution Prevention Plan within 180 days of the effective date of the permit. New facilities must submit the NOI within 180 days of commencing operations and must complete their SWPPP prior to submitting the NOI.