RokStories EPA Proposes RCRA Rules Easing Standards for Pharmaceutical Wastes and Revising Generator Standards
By Chris Bryant
Senior Regulatory Analyst
Bergeson & Campbell, P.C.

EPA on August 31, 2015, proposed two rules under the Resource Conservation and Recovery Act (RCRA) that would alter fundamentally the hazardous waste regulatory program.

One rule eases the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals, while the other proposes some three score of revisions to the requirements for generators of hazardous waste. The rules will be published in the Federal Register shortly, and EPA will take public comment on them for 60 days. Both rules are less stringent than the existing hazardous waste regulations. If promulgated in final, RCRA-authorized states thus would not be required to adopt the rules. Pre-publication copies of the rules are available online.

The rules are EPA’s first attempts in 35 years to tailor the one-size-fits-all RCRA hazardous waste program generator requirements to specific industry sectors. The proposed hazardous waste pharmaceuticals rule is intended to reduce the burden on healthcare workers and pharmacists working in healthcare facilities by creating a specific set of regulations for hospitals, clinics, and retail stores with pharmacies and reverse distributors that generate hazardous waste. Some pharmaceuticals are regulated as hazardous waste under RCRA when discarded. Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the RCRA Subtitle C hazardous waste regulations for a number of reasons. First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but are often involved in the implementation of the regulations. Second, a healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in small amounts.

To facilitate compliance and to respond to these concerns, EPA proposes to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals.

EPA is specifically proposing to add a new Subpart P under 40 C.F.R. Part 266. This new subpart is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. If promulgated in final, healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all pharmaceutical reverse distributors, regardless of their RCRA generator category, will be required to manage their hazardous waste pharmaceuticals under Subpart P of 40 C.F.R. Part 266, instead of 40 C.F.R. Part 262. That is, the proposed standards are not an optional alternative to managing hazardous waste pharmaceuticals under 40 C.F.R. Part 262; they are mandatory standards. Under the proposal, healthcare facilities will have different management standards for their non-creditable and creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals (those that are not expected to be eligible to receive manufacturer’s credit) will be managed on-site similar to how they would have been under a previous proposal for managing these wastes: the 2008 Universal Waste proposal for pharmaceutical waste (73 Fed. Reg. 73520; December 2, 2008). When shipped off-site, they must be transported as hazardous wastes, including the use of the hazardous waste manifest, and sent to a RCRA hazardous waste treatment, storage and disposal facility (TSDF). Healthcare facilities will be allowed, however, to send potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors for processing manufacturers’ credit. In response to comments received on the Universal Waste proposal, EPA is proposing standards to ensure the safe and secure delivery of the creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors.

EPA is also proposing standards for the accumulation of the creditable hazardous waste pharmaceuticals at pharmaceutical reverse distributors. Like healthcare facilities, pharmaceutical reverse distributors will not be regulated under 40 C.F.R. Part 262 as hazardous waste generators, nor will they be regulated under as TSDFs. Rather, the proposal establishes a new category of hazardous waste entity, called pharmaceutical reverse distributors. The proposed standards for pharmaceutical reverse distributors are, in many respects, similar to the LQGs standards, with supplementary standards added to respond to commenters’ concerns. For both healthcare facilities and reverse distributors, EPA is proposing to prohibit facilities from disposing of hazardous waste pharmaceuticals down the toilet or drain (flushed or sewered). According to EPA, the proposal is projected to prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually. Further, EPA proposes that hazardous waste pharmaceuticals managed under Subpart P will not be counted toward calculating the site’s generator category. Additionally, EPA is proposing a conditional exemption for hazardous waste pharmaceuticals that are also controlled substances under Drug Enforcement Administration regulations. Finally, EPA is proposing management standards for hazardous waste pharmaceutical residues remaining in containers.

The second rule proposed by EPA on August 31, 2015, is the Hazardous Waste Generator Improvements Rule. This rule proposes “a much-needed update to the hazardous waste generator regulations to make the rules easier to understand, facilitate better compliance, provide greater flexibility in how hazardous waste is managed, and close important gaps in the regulations,” according to EPA.

Two key provisions where EPA is proposing flexibility are allowing a hazardous waste generator to avoid increased burden of a higher generator status when generating episodic waste provided the episodic waste is properly managed and allowing a conditionally exempt small quantity generator (CESQG) to send its hazardous waste to a large quantity generator under control of the same person. EPA also proposes to revise certain components of the hazardous waste generator regulatory program; address gaps in the regulations; provide greater flexibility for hazardous waste generators to manage their hazardous waste in a cost-effective and protective manner; reorganize the hazardous waste generator regulations to make them more user-friendly and thus improve their usability by the regulated community; and make technical corrections and conforming changes to address inadvertent errors, remove obsolete references to programs that no longer exist, and improve the readability of the regulations.

EPA states that these proposed changes are both a result of EPA’s experience in implementing and evaluating the hazardous waste generator program over the last 30 years, as well as a response to concerns and issues identified by the states and regulated community. In addition to these two changes, EPA is proposing to revise about 60 provisions in the RCRA hazardous waste regulatory program applicable to generators.

Many of the changes proposed by EPA alter long-entrenched regulatory requirements. EPA is proposing to revise the definition of “small quantity generator” and add definitions for the other two generator categories as well as a definition for “central accumulation area.” In addition, EPA proposes to change the name of the “conditionally exempt small quantity generator” category to “very small quantity generator” or VSQG.

EPA is also proposing four changes to the hazardous waste identification regulations. First, EPA is proposing to add a new provision that would explain what generator category would apply to a generator that generates both acute and non-acute hazardous waste in the same calendar month. Second, EPA would revise the regulations at 40 C.F.R. Sections 261.5(h) and (i) and 261.3 that address the mixing of a non-hazardous waste with a hazardous waste. Third, EPA is proposing to amend 40 C.F.R. Sections 261.5(f)(3) and (g)(3) to allow CES QGs to send their hazardous waste to LQGs that are operated under control of the same person. Under this proposal, a CESQG that wants to take advantage of this provision would need to comply with the proposed requirements. Finally, EPA is proposing to amend 40 C.F.R. Section 261.6(c) to require biennial reporting for owners or operators of facilities that recycle but do not store hazardous waste before the recycling.

EPA is proposing a number of changes to the regulations for generators of hazardous waste at 40 C.F.R. Part 262 to improve the understanding of the RCRA generator regulations to encourage increased compliance by the regulated community. These proposed changes include the following:

  • Revising the scope and applicability section to distinguish between independent requirements and conditions for exemption for generators of hazardous waste;
  • Revising the regulations for making hazardous waste determinations;
  • Requiring re-notification by SQGs and LQGs;
  • Revising the regulations for labeling and marking of containers, tanks, drip pads, and containment buildings when accumulating hazardous wastes;
  • Revising the closure provisions for LQGs;
  • Updating the preparedness, prevention, planning and emergency procedures provisions for SQGs and LQGs;
  • Revising the provisions for satellite accumulation areas (SAA) for SQGs and LQGs;
  • Revising the SQG regulations for accumulating hazardous waste on drip pads;
  • Deleting obsolete regulations that refer to the Performance Track program;
  • Revising the biennial reporting provisions for LQGs;
  • Adding a provision that hazardous waste generators are prohibited from disposing liquid hazardous waste in landfills.
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