After two decades of limited revisions to the hazardous waste generator standards, 2015 was a year of uncharacteristically vigorous cchanges, with five rule revisions either proposed, ppromulgated, or in process. The revised Definition of Solid Waste (DSW) regulations were finalized in January and became effective on July 13. EPA has made steady progress throughout the year towards developing its centralized Electronic Manifest system. EPA published two proposed regulations in September – the Hazardous Waste Generator Improvements Rule and the Hazardous Waste Pharmaceuticals Rule. Not finished yet, EPA proposed yet another rule in October, the Hazardous Waste Export-Import Revisions. Comments on the three proposed rules were all due in December. While most of these rules are considered by EPA to be "industry friendly," they all bring their own challenges.
With all the RCRA change comes the potential for confusion. While changes to the Definition of Solid Waste affected a limited number of facilities, the Electronic Manifest system affects everyone using a hazardous waste manifest, and the proposed Generator Improvements Rule affects every Large Quantity Generator (LQG), Small Quantity Generator (SQG), and Conditionally Exempt Small Quantity Generator (CESQG) in the U.S. as well as any person importing hazardous waste into the U.S. The Hazardous Waste Pharmaceuticals and Export Import Revisions are not as far-reaching, but the rules overlap and are being developed simultaneous to the Generator Improvements rule. Add in the effect of authorized states adopting all or portions of the various rules, and the result is several years of rapidly changing requirements for the RCRA regulated community.
Revised Definition of Solid Waste (DSW)
On January 13, 2015, EPA published the final DSW rulemaking changes to 40 CFR 260 and 261, affecting users of hazardous waste recycling exemptions, exclusions, and variances from the definition of solid waste.1 EPA made five major changes to the rule: (1) modifications to the legitimate recycling provisions and related recordkeeping and documentation; (2) revisions to the solid waste variance process and the non-waste determination process; (3) changes to the generator-controlled recycling exclusion; (4) replacement of the transfer-based exclusion with the new verified recycler exclusion; and (5) establishment of the new solvent remanufacturing exclusion.
Sham Recycling and Legitimacy
Sham recycling to escape RCRA regulation has been prohibited via EPA guidance and policy since 1983.2 The 2015 rule directly incorporates the policy into the regulations, specifically prohibiting DSW exclusion of "sham recycled" materials. Sham recycling is defined as "recycling that is not legitimate recycling."
EPA now requires legitimate recycling to meet all four legitimacy factors: (1) the recycled material must make a useful contribution to the process, product, or intermediate; (2) the recycling process must produce a valuable product or intermediate; (3) recycled materials and products must be managed as valuable commodities; and (4) the resulting product must be comparable to a legitimate product or intermediate.
The speculative accumulation provisions have also been strengthened, with EPA adding new recordkeeping requirements. To verify there is no speculative accumulation for hazardous secondary materials (HSM), facilities must label the date materials are first placed in the storage unit, and document at least 75 percent recycled per calendar year.
EPA added a "contained" standard to ensure proper HSM management prior to recycling. All HSM must be contained in a unit that is (1) in good condition, with no leaks or unpermitted releases; (2) properly labeled or logged; and (3) compatible with the materials of construction and materials stored within. Units that meet the tank or container standards are presumed to meet the contained standard, with specific documentation of such being required for other types of storage units.
New Requirements for Solid Waste Variances
Non-waste determinations and variances/exclusions that have been in place since 2008 will now be limited to a 10-year term, at the end of which facilities must re-apply. Initial notification to EPA or the state is required for each variance and non-waste determination. Facilities must re-notify, updating the original notification information every two years, and also when a change in circumstances affects how the criteria of the HSM variance or non-waste determination is met. EPA has not yet determined whether or when it will extend the new requirements to older variances and non-waste determinations.
Changes to the Exclusions
Three specific exclusions were added or modified in the 2015 DSW rule – the Generator Controlled Exclusion, the Verified Recycler Exclusion, and the Solvent Remanufacturing Exclusion. The Generator Controlled Exclusion for on-site HSM recycling, first promulgated in 2008, has been retained but modified in the 2015 rule. The newly added Verified Recycler Exclusion for HSM off-site third-party recycling replaced the 2008 Transfer Based Exclusion. The newly added Solvent Remanufacturing Exclusion addresses remanufacturing of 18 identified solvents from the pharmaceutical, organic chemical, plastics and resins, and paints and coatings industries.
A new suite of requirements applies to all categorical exclusions promulgated from 2008 onward, and including the following:
- Pre-operation notification;
- "Contained" standard;
- Documentation of legitimate recycling;
- Emergency preparedness and response provisions;
- Speculative accumulation recordkeeping; and
- Additional recordkeeping and reporting requirements.
The federal rule effective date, July 13, 2015, applies in all non-RCRA authorized states (currently only Iowa and Alaska). Other States must adopt the more stringent portions of the regulation by July 1, 2016 (or July 1, 2017, if a state statutory change is necessary). All states are required to adopt (1) the prohibition of sham recycling and the definition of legitimate recycling; (2) accumulation date tracking requirements for speculative accumulation provisions; and (3) changes to the standards and criteria for the solid waste variance and non-waste determinations. The four states (New Jersey, Pennsylvania, Illinois, and Idaho) that previously adopted the less stringent 2008 Definition of Solid Waste rule must modify their programs to be at least as stringent as the new Federal rule.
EPA has been developing a centralized system for electronic submittal, inspection, and records retention for hazardous waste manifests. This system is driven by the e-Manifest Act of 2012 and the Hazardous Waste Electronic Manifest System final rule (February 7, 2014). The Electronic Manifest final rule affects every user of the uniform hazardous waste manifest, and changes the regulatory language in 40 CFR Parts 260, 262, 263, 264, 265, and 271.
The centralized system, once available, must be used for any shipment on a hazardous waste manifest (including state-specific hazardous and special wastes requiring a manifest). Four data entry options are anticipated: internet; mobile app; system-to-system service; and paper. A valid electronic signature will be required. The centralized e-system will be used for all manifest tracking eliminating the need to mail or submit paper manifest copies directly to the states. Regulatory authorities will have access to the submitted data for compliance and documentation purposes. Electronic manifest copies stored in the centralized system will satisfy the manifest recordkeeping requirements, provided they are readily available for view/copy if requested by EPA or the state. EPA has specifically included protections against enforcement liability for legitimate e-system technical difficulties that prevent agency inspector access to the electronically stored data.
Notwithstanding the goal of replacing paper manifests to the extent possible, DOT HazMat regulations will still require that one paper copy of the manifest be carried with each shipment, at least until DOT’s electronic shipping program is more fully developed. In addition, EPA will require that a paper replacement be made available in the event that the e-manifest is interrupted.
EPA is working with the Government Services Administration (GSA) and various industry participants in development of the e-Manifest system. EPA is finalizing member selection for the e-Manifest Advisory Board established in August 2015. Testing of the preliminary e-Manifest system in September 2015 confirmed that the system can properly execute the end point chain-of-custody transaction – a key capability to overall system functionality. Full-scale system development will begin in early 2016, with iterative releases and testing occurring as the system progresses toward completion. EPA expects national rollout of the full system in Spring 2018.
A separate User Fee Rule is concurrently being established as EPA’s basis for determining and administering e-Manifest fees. The e-Manifest fees apply only to waste handlers (users of the manifest), and not to other users of the e-Manifest system. Although still under rule development, the manifest fee will likely be billed to facilities that terminate the manifest (TSDFs and some recyclers/reclaimers), with the expectation of cost sharing between the facilities and other manifest users. A surcharge is anticipated for use of a paper manifest.
The new e-Manifest system will supersede all less stringent and inconsistent requirements effective on the e-Manifest system roll out date. States cannot impose inconsistent requirements, and cannot establish their own system or require different formats. EPA will implement and enforce the program until state programs are revised.
RCRA Generator Improvements Rule
The long-awaited September 25, 2015 proposed rule includes over 60 substantive changes to the regulations at 40 CFR 260 through 279, plus another 30 corrections, clarifications, definitions, and deletions of outdated and obsolete information. These changes affect all hazardous waste generators – LQG, SQG, and CESQG – and any facility with related activities. EPA solicited comment on, in its words, "’practically every component of the generator regulatory program." The comment period closed on December 24, 2015.
EPA is proposing to reorganize the RCRA Subtitle C generator provisions, moving them into a consolidated set of requirements at 40 CFR 262.13 through 262.17 versus their historical locations in 40 CFR 261.5 and 262.34. The CESQG category is also being renamed to "Very Small Quantity Generator" (VSQG), with corresponding clarifications to generator categories for mixtures of acute and non-acute hazardous wastes, and mixtures of hazardous and non-hazardous wastes.
EPA is proposing numerous changes to generator recordkeeping and documentation requirements. Perhaps most significant is that facilities document all hazardous and non-hazardous solid waste determinations. Although generally a one-time requirement, an initial flurry of activity for generators to document compliance will ensue upon rule implementation. EPA is also proposing additional regulatory language to better explain waste evaluations and the use of generator knowledge, which is key to the RCRA rules. A few other proposed revisions, in addition to numerous changes to labeling, recordkeeping, reporting, and notification, include:
- All SQGs will be required to notify regarding their continuing SQG status every two years, to help EPA better understand the universe of SQG facility hazardous waste generation.
- The biennial reporting regulatory language is being clarified for consistency with existing reporting guidance.
- Satellite accumulation provisions are being clarified.
- LQG closure provisions are being revised to extend the existing LQG clean-closure requirements to LQG container accumulation areas, and adding notification requirements for all LQG unit closures (e.g., relocating or terminating container accumulation activities), as well as facility closure.
- New LQG Contingency Plans will include an executive summary identifying the most critical information needed for immediate response to an LQG facility event.
- Emergency response coordination requirements with local authorities are being strengthened to (1) require that the generator document arrangements have been made; and (2) prioritize LEPCs, where available, on the list of local authorities, in addition to several other miscellaneous changes to preparedness and prevention provisions.
EPA is proposing three "less stringent than" proposed provisions. The first is a waiver opportunity allowing storage of ignitable or reactive wastes within 50 feet of the property line, with approval from the local fire authority. The second is a contingent management scheme for companies with multiple facilities, where labeled hazardous wastes from a VSQG can be shipped and consolidated at an LQG facility under control of the same person. The receiving LQG does not require a TSDF permit, provided the LQG notifies the agency ("Site ID Form") and takes responsibility for the waste, including managing it as an LQG hazardous waste, maintaining proper recordkeeping, and including it in the LQG’s biennial report. Finally, EPA is also proposing a contingent management approach for episodic waste generators (no more than once per year, 45 days or less) to retain existing (VSQG, SQG) category while complying with streamlined requirements and subject to notification and recordkeeping, and management of the waste as an LQG waste.
EPA expects to finalize the Hazardous Waste Generator Improvements Rule in late 2016, with an early 2017 Federal effective date. The majority of the regulation is more stringent than current regulations, therefore will therefore need to be adopted into state programs. The three less stringent provisions (VSQG Consolidation, Episodic Generators, and 50-Foot Rule Waiver) are not required to be adopted by the states.
Hazardous Waste Pharmaceuticals Rule
The September 25, 2015 proposal affects healthcare facilities that generate hazardous waste pharmaceuticals, and replaces a 2008 proposal that categorized hazardous waste pharmaceuticals as Universal Waste. The comment period for this proposed regulation closed on December 24, 2015.
The far reaching definition of healthcare facility includes not just health care providers but also persons who sell or dispense over-the-counter or prescription pharmaceuticals. The complex definition of "pharmaceutical" can be summarized as anything requiring a Food and Drug Administration (FDA) drug facts label, in any dose form. This category of wastes is hugely variable, constantly changing, often acutely toxic, and generated in fairly small quantities but at a very large number of facilities. Furthermore, healthcare facilities utilize reverse distribution arrangements with pharmaceutical manufacturers, with credit given for some expired, unused, and un-administered pharmaceuticals prior to final disposition. Adding complexity, these wastes are regulated not just by EPA, but also by the Drug Enforcement Agency (DEA) and the FDA. Traditional RCRA simply does not effectively address the specific needs related to management of pharmaceuticals that are hazardous wastes.
EPA proposes a full prohibition on sewer disposal of hazardous waste pharmaceuticals, reflecting existing EPA policy plus recent efforts by DEA and other agencies to stop flushing of pharmaceuticals. This prohibition will affect ALL healthcare facilities and all reverse distributors, regardless of the generator category.
An alternate strategy for managing pharmaceutical hazardous wastes is being added via 40 CFR 266, new Subpart P, including sector-specific standards for waste pharmaceutical management by healthcare facilities/pharmacies and pharmaceutical reverse distributors. Subpart P will replace the SQG and LQG generator pharmaceutical waste requirements in 40 CFR 262. Accumulation periods of up to 365 days will be allowed without a permit, provided containers are clearly marked with "Hazardous Waste Pharmaceuticals." A basic level of training will be required for all personnel handling these wastes. The >1 kg LQG trigger for acutely hazardous wastes will be removed, with specific allowances for two different flows: "creditable," based on a reverse distribution to obtain manufacturer’s credit; and "non-creditable," with no reverse distribution.
EPA designed this regulation to encourage proper management of non-hazardous pharmaceuticals together with hazardous waste pharmaceuticals. Subpart P will require a hazardous/non-hazardous waste determination for each stream at the healthcare facility. Alternatively, all solid waste pharmaceuticals can be combined and managed as hazardous waste pharmaceuticals, without individual waste determinations. A biennial report will no longer be required for Subpart P-managed hazardous waste pharmaceuticals. EPA believes the relaxed labeling and reporting requirements for non-creditable Subpart P-managed hazardous waste pharmaceuticals will remove the primary barrier to co-managing non-hazardous and hazardous waste pharmaceuticals.
The Subpart P provisions will apply to all pharmaceutical reverse distributors and all SQG and LQG healthcare facilities. CESQG healthcare facilities will remain subject to the 40 CFR 261.5 requirements, plus the sewer disposal prohibition.
EPA expects a 2016 final rule date, with an effective date six months later. The sewer ban will become effective in all states on the final rule promulgation date. The rest of the rule is considered to be more stringent than existing regulations, so authorized states must adopt and be authorized for the final rule. States that incorporated hazardous waste pharmaceuticals into their universal waste rules (Florida and Michigan) must transition their program to the 40 CFR 266 Subpart P requirements.
Hazardous Waste Export-Import Revisions
The October 19, 2015 proposed rulemaking affects importers and exporters of hazardous wastes, and changes the regulations at 40 CFR 260 – 267, 271, and 273. The primary rulemaking purpose is to address issues raised in the 2013 Commission for Environmental Cooperation and the 2015 EPA Office of Inspector General reports. The comment period for this proposed regulation closed on December 18, 2015.
Similar to other proposed regulations, EPA is proposing to reorganize all exporter, importer, transporter, and receiving facility requirements into 40 CFR 262 Subpart H.
The proposed regulation now requires the use of international movement documents for each international shipment of hazardous wastes, including universal wastes and 40 CFR 266 Subpart G spent lead acid batteries. The regulation also requires mandatory electronic annual reporting of hazardous waste exports, and links the hazardous waste export consent with the U.S. Customs exporter declaration. Additional provisions address tracking individual shipments, requiring EPA ID numbers for all SQG and LQG hazardous waste exporters and importers, and matching consent numbers with manifest information.
The export-import revisions will be finalized in the fall of 2016, with an effective date no later than December 31, 2016, with the rules becoming effective in all states on the federal effective date.
With five different EPA rulemakings during 2015 affecting waste generators. There is much to pay attention to for U.S. facilities. There is overlap among all five rules with respect to affected waste categories, generator categories, industry categories, and rule sections, with each having a differing timeframe and implementation schedule. The content of each of the three proposed rules is affected by the content of the other two proposed rules, but the exact order of the rules being finalized is not yet known (although the Export-Import Revisions are expected first). All of the changes, plus the additional complexities brought about with state implementation specifics, promise to create a complicated implementation situation for hazardous waste generators. Maintaining compliance during the rapid changes over the next few years will require vigilance and close attention to detail.
1 A material must first be a solid waste to be a hazardous waste, so secondary materials exempt from the definition of solid waste are automatically exempt from the definition of hazardous waste. The 2015 DSW regulation addresses a specific subset of secondary materials: Hazardous Secondary Materials (HSM), which are conditionally exempt from the DSW, and which would be a hazardous waste if not otherwise exempted.
2 48 FR 1157 Enforcement Guidance, Environmental Protection Agency, March 16, 1983.