Experts participate in a Q&A on the EPA’s proposed hazardous waste regulations.
- Management Standards for Hazardous Waste Pharmaceuticals
- Hazardous Waste Generator Improvements
Elise Paeffgen, a senior associate in the Environment, Land Use, & Natural Resources Group, has a focus in pharmaceutical waste. She counsels companies regulated by the EPA and state authorities. Below is her comment on the first proposed regulation:
“It is a tailored, sector-specific set of regulations for the management of hazardous waste pharmaceuticals (HWPs) by healthcare facilities (including pharmacies) and reverse distributors. The intent is to make drinking and surface water safer and healthier by reducing the amount of pharmaceuticals entering our waterways by banning healthcare facilities from flushing hazardous waste pharmaceuticals down the sink and toilet.”
Jonathan Wells is a partner in the Alston & Bird’s Environment, Land Use, & Natural Resources and Toxic Tort Groups, with a focus on environmental regulatory matters and compliance counseling. In regards to the second proposed regulation, Wells had this to say:
“Wide-ranging changes to a host of RCRA regulations that has the potential to affect tens of thousands of hazardous waste generators across every sector of the economy. For large quantity and small quantity generators the rules have the potential to substantially increase the workload related to non-pharmaceutical hazardous waste, particularly in the areas of recordkeeping, labelling, training, and contingency plans.”
Paeffgen and Wells discussed the future and implications of these proposed regulation changes:
Q: How does this differ from previous/current practices? How has hazardous waste been managed in the past?
PAEFFGEN: RCRA regulations are designed for manufacturing, and do not translate well to healthcare facilities and to healthcare workers—whose focus is patient care, not waste management. For many healthcare facilities, the amount of HWPs generated puts them in the large quantity generator (LQG) category, triggering onerous hazardous waste management requirements better suited for manufacturers. Under the proposed regulations, small quantity generators (SQGs) and LQGs no longer need to count HWPs towards the facility’s hazardous waste generator calculations. Removing HWPs may enable healthcare facilities to more easily shift generator categories and be subject to generator requirements under RCRA that are more appropriate for healthcare facilities.
HWPs, which will be outside of the traditional hazardous waste count at SQGs and LQGs, will be subject to management standards in an entirely new subpart in the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations—Subpart P of 40 CFR Part 266. These sector-specific regulations will significantly ease the compliance burden for healthcare facilities and will include reduced storage and labeling requirements for HWPs.
WELLS: For the hazardous waste generator rules, the proposed changes primarily have to do with increased recordkeeping requirements, more specific labelling, the potential for expanded employee training, and updates to contingency plans. In addition, two proposals for conditionally exempt small quantity generators (CESQGs) have the potential for easing regulatory burdens for those generators under two circumstances:
- First, the proposed rules create an episodic event exemption, which allows a company to maintain its generator status even if a one-time event causes it to exceed the quantity thresholds. This would allow a company to respond to an accidental spill or have a one-time laboratory clean-out without having to create and develop more procedures that are now required for higher quantity generators.
- The second proposed change would allow a CESQG to send its waste to a large quantity generator under the control of the same entity as the CESQG. This has the potential to be very beneficial to companies that have one central location that generates large quantities of waste along with satellite locations generating minor quantities because waste can be more efficiently accumulated and disposed of from the central location.
Q: How would these proposed regulations impact how companies in the healthcare sector—including pharmaceutical manufacturers, hospitals, retail pharmacies, veterinary clinics, reverse distributors, and more—identify and manage waste?
WELLS: Under the proposed regulations, there would be no accumulation time limits, container requirements, or labeling for potentially creditable HWPs generated at healthcare facilities. Healthcare facilities can ship these items via common carrier in compliance with Department of Transportation requirements to a pharmaceutical reverse distributor so long as advance notice is provided and a delivery confirmation mechanism is used.
Healthcare facilities will be subject to more rigorous requirements for the management of non-creditable HWPs, yet these are still far less onerous than current regulation under 40 CFR Part 262. This waste can be accumulated in containers in a convenient manner and merely labeled as “hazardous pharmaceutical waste.” This eases the burden on healthcare workers managing waste from formularies with thousands of items. Such waste can accumulate onsite for up to a year, without quantity restrictions, so that healthcare facilities can focus on providing healthcare to patients and schedule pickups when the load size is large enough to be cost-effective. Such pharmaceuticals must still be transported as hazardous waste and sent to a hazardous waste RCRA interim status or permitted facility. In other words, they cannot be sent to a pharmaceutical reverse distributor.
Further, the rule—if finalized—would enable pharmaceutical reverse distributors to manage HWPs under reduced accumulation, storage, and labeling requirements. However, new inventory and 21-day processing requirements are triggered in this proposed rule, which may require significant procedural and technological updates at some pharmaceutical reverse distributors.
Q: How will proposed regulations affect compliance burdens?
PAEFFGEN: The proposed HWP rule is a welcomed relief to much of the industry. In particular, hospitals and similar healthcare facilities are likely to eagerly embrace this proposed approach to disposal of waste pharmaceuticals, as it will significantly ease compliance burdens. It also creates a clearer regulatory scheme for reverse distributors to follow. By creating this new, separate category and applying clear procedures tailored for their operations, the proposed rule provides needed certainty for this industry.
WELLS: As explained above, the proposed hazardous waste generator rules have the potential to increase the regulatory compliance burdens for health care sector companies who generate non-pharmaceutical hazardous waste above the level of a CESQG. For those operating as a CESQG (or those who will be a CESQG once the HWP regulations are effective), these rules are likely to ease their burdens.
Q: How will proposed regulations affect state-by-state regulations, if at all?
WELLS: When a state adopts the new Subpart P or the hazardous waste generator rules, if elements of the state program are more stringent, the state will have the option of retaining those more stringent elements. States also have the option of adding elements to their programs that are more stringent or broader in scope than the new subpart or the hazardous waste generator rules.
Q: What is the approval process of proposed changes to regulation? More specifically—how soon could these proposed regulations be approved and how soon could they be implemented?
WELLS: The proposed rules were published in the Federal Register on September 25, 2015, and an extended public comment period will follow. Comments are due to EPA by December 24, 2015. It will take EPA some time to review the comments received and draft the final rules. It will likely be well into 2016 until the final rules are effective.
The sewer ban will take effect immediately after the final rule is published. The sector specific standards in Subpart P will also take effect in states with unauthorized RCRA programs (Alaska and Iowa) immediately after the final rule is published. The other states, with authorized RCRA programs, will be required to modify their programs to adopt the amendments, a process which may take a year or more after the federal rules are finalized.
PAEFFGEN: The proposed HWP rule will directly impact manufacturers that reverse distribute pharmaceuticals. For example, manufacturers that receive pharmaceuticals from a reverse distributor for double-counting or credit verification will be regulated as reverse distributors and subject to the new subpart P management standards. Other requirements imposed on reverse distributors—such as the new 90-day maximum on-site accumulation limit—may impact manufacturer’s credit policies.
Although it will not be included in the final rule, through this rulemaking, EPA is soliciting comments on how to identify additional pharmaceuticals as hazardous, and the pharmaceutical industry should consider proposing a methodology based on sound science that is appropriately tailored for pharmaceuticals. A broaden definition of hazardous, as related to pharmaceuticals, will have major implications for the management of waste by manufacturers.
WELLS: For manufacturers who generate non-pharmaceutical hazardous waste, the proposed generator rule changes could substantially impact hazardous waste determination, accumulation, and recordkeeping processes. In addition, the potential changes to labelling requirements, where waste-specific labelling might be required, could be burdensome to environmental managers.
Q: What do you suspect the response of manufacturers and other affected parties will be? Do you think they will respond positively to this change?
PAEFFGEN: We expect most healthcare facilities to support the proposed HWP rule as it will ease their compliance burdens. Reverse distributors are likely to support most of the proposed changes, but raise concerns relating to additional compliance burdens, the broad definition of “pharmaceutical” (which includes dietary supplements), and point of generation issues.
WELLS: For those manufacturers who generate non-pharmaceutical hazardous waste, many of the proposed generator rule changes could be seen as unwelcome due to the increased regulatory compliance burdens.
Q: What are some of the steps companies can proactively take to prepare for changes proposed by this EPA action?
PAEFFGEN: The proposed rule indicates a renewed focus by EPA on its compliance monitoring and enforcement of the RCRA regulations relating to pharmaceuticals. Health care facilities should ensure that their current waste management practices are in compliance with existing regulations, and begin transitioning away from flushing pharmaceutical waste. The proposed ban on discharging hazardous waste pharmaceuticals to sewer systems is widely supported and will likely be included in the final rule without much change.
Pharmaceutical reverse distributors and pharmaceutical manufacturers need to carefully review whether the 90-day maximum on-site accumulation limit and three transfer limit of potentially creditable pharmaceuticals mesh with manufacturer return policies and industry practices, and consider commenting on the proposed rule.
WELLS: For the proposed hazardous waste generator rules, companies need to read the proposed changes carefully—with an eye towards how the changes could affect their current practices and procedures—and should comment on the proposed rule where the changes are unnecessary or unwarranted for their company or their industry.
Q: If the proposed regulation is finalized, do you have any recommendations as far as compliance strategies to these new regulations?
PAEFFGEN: Depending upon how quickly states move to implement the rules, the proposed rule could create a gap of up to a year or more between when the sewer ban becomes immediately effective and when hazardous waste pharmaceutical containers will become exempt from so-called RCRA-empty requirements, which often involve rinsing containers and pouring that rinsate down the drain. Healthcare facilities should make a compliance strategy for the sewer ban one of their top priorities.
For more information on these proposed rules, including how to submit comments, go to: http://www2.epa.gov/hwgenerators.
- Management Standards for Hazardous Waste Pharmaceuticals:
- Hazardous Waste Generator Improvements
This article can also be found in the November/December 2015 edition.