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In the United States, hazardous wastes are subject to regulations mandated by the Resource Conservation and Recovery Act (RCRA). Every month, we provide clear, in-depth guidance on a different aspect of the RCRA regulations. The information presented here is an excerpt from McCoy’s RCRA Unraveled, 2026 Edition.
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Treatability Study Exemption
The analytical sample exemption does not apply to large samples of hazardous waste, water, or soil used in treatability studies or other testing at pilot-scale or experimental facilities. Therefore, samples used in these activities were subject to the full Subtitle C program, necessitating RCRA permitting for pilot-scale experimentation and research required to evaluate hazardous waste treatment options. In response to petitions from industry, EPA established the treatability study exemption in §261.4(ef), and it works very much like the analytical sample exemption already discussed. [53 FR 27290] Large-size samples used in pilot-scale treatability studies are exempt from hazardous waste storage, manifesting, and treatment regulations (including permitting), when certain conditions are met.
What is a treatability study?
EPA defines a treatability study in §260.10 as a study in which a hazardous waste is subjected to a treatment process to determine:
- Whether the waste is amenable to the treatment process,
- What pretreatment (if any) is required,
- The optimal process conditions needed to achieve the desired treatment,
- The efficiency of a treatment process for a specific waste or wastes, or
- The characteristics and volume of residuals from a particular treatment process.
Examples of treatability studies typically conducted under the exemption are physical/chemical/biological treatment, thermal treatment (incineration, pyrolysis, oxidation, or other combustion), solidification, sludge dewatering, volume reduction, toxicity reduction, and recycling feasibility. However, EPA considers the following types of studies to also be exempt: 1) liner compatibility, corrosion, and other material compatibility studies (e.g., relating to leachate collection systems, geotextile materials, other land disposal unit requirements, pumps, and personal protective equipment); and 2) toxicological and health effects studies. [53 FR 27293, RO 11366]
EPA notes the exemption does not apply where the treatability study could result in a significant uncontrolled release of hazardous constituents to the environment. Therefore, it does not apply to open burning or to any type of treatment involving placement of hazardous waste on the land (e.g., in situ stabilization). [§261.4(f)(6)] The agency emphasizes the exemption is for the evaluation of a treatment process and is not to be used as a means to commercially treat or dispose of hazardous waste. [53 FR 27294]
Scope of the exemption
Treatability study samples or treatment residues are exempt from the hazardous waste program requirements while [§261.4(ef), RO 11366, 13334]:
- Samples are collected, prepared, and stored by the generator or sample collector prior to transport;
- Samples are shipped to a laboratory or testing facility to conduct the treatability study;
- Samples are stored at the laboratory or testing facility before testing;
- Samples are treated by the laboratory or testing facility during the study;
- Excess sample and treatment residues generated from the treatability study are stored temporarily after testing; and
- Excess sample and treatment residues generated from the treatability study are shipped from the laboratory or testing facility back to the generator or sample collector.
The primary advantages offered by this exemption are that 1) the actual testing or treatment of the samples does not require a RCRA permit, 2) such testing does not require prior EPA approval, and 3) the transportation to and from the laboratory or testing facility does not have to be manifested. As with the analytical sample exemption, however, DOT packaging, marking, labeling, and placarding requirements must be followed. At a minimum, the sample must be packaged so that it does not leak, spill, or vaporize from its packaging. [§261.4(e)(2)(iii)]
A number of sample quantity and time limits are specified in the treatability study sample exemption. If these parameters arent met, the affected sample and any treatment residues become subject to full RCRA regulation. Finally, once any unused sample or treatment residues are to be discarded, they are no longer exempt under §261.4(ef). Such solid wastes must be evaluated to determine if they are hazardous and managed under RCRA Subtitle C if so.
Treatability study sample quantity and time limits
EPA placed limits on the amount of waste that can be stored and then evaluated in a treatability study and the time frames under which such storage and treatment must occur. These limits, which were significantly revised on February 18, 1994 [59 FR 8362], are summarized in Table 1. For situations in which the quantities or time frames given in the regulations are inadequate, EPA may grant variances on a case-by-case basis to raise the treatability sample amounts or increase the available time.
Sample import/export for treatability studies
A laboratory inside the United States that imports samples for a treatability study qualifies for the treatability study exemption as long as it manages the samples under all §261.4(ef) requirements. The exemption extends to wastes originating from outside of the United States. Therefore, the laboratory would not have to comply with the hazardous waste import requirements in Part 262, Subpart H. [RO 14460]
Similarly, generators or sample collectors who comply with the exemption requirements are exempt from the Part 262, Subpart H requirements if they export samples for treatability studies. [53 FR 27293] However, sample mass exported to a foreign lab or testing facility or imported to a U.S. lab or testing facility from a foreign source must not exceed 25 kg. [§261.4(e)(4), 81 FR 85713] There are two provisions within the exemption, however, that seem to make it impossible for a generator or sample collector to satisfy the exemption requirements for a treatability study sample bound for a foreign facility. First, §261.4(e)(2)(iv) requires the sample to be shipped to a permitted TSDF or, alternatively, one that at least has an EPA ID number, as required in §261.4(f)(2). In addition, §261.4(e)(2)(v)(C)(2) requires the generator or sample collector to keep records of the facilities (and their corresponding EPA ID numbers) to which it sends samples for treatability studies. Laboratories or testing facilities outside the United States cannot be assigned an EPA ID number. However, EPA noted, persons who generate or collect samples for the purpose of conducting treatability studies outside the United States and who meet all of the requirements set forth in §261.4(e), except for §261.4(e)(2)(iv) and §261.4(e)(2)(v)(C)(2), meet the terms of the exemption. [RO 11667]
Laboratory/testing facility requirements
The exemption from RCRA storage requirements for laboratories or testing facilities conducting treatability studies does not apply to any intermediate storage that may occur between the generator or sample collector and the laboratory or testing facility. [RO 11366]
EPA has not limited the number of treatability studies that a laboratory or testing facility can perform per year. Typical hazardous waste treatment facility requirements, such as preparation of contingency plans and emergency procedures, are not necessary for laboratories or testing facilities conducting treatability studies. [53 FR 27298]
As mentioned previously, a laboratory or testing facility conducting treatability studies must have an EPA ID number. [§261.4(f)(2)] However, large facilities (including federal facilities) with numerous laboratories or testing facilities are not considered by EPA to be a single laboratory or testing facility for purposes of the treatability study exemption. Therefore, each laboratory or testing facility within a larger facility could conduct treatability studies utilizing the sample quantities and time frames specified in Table 1, as long as it has its own, unique EPA ID number. [59 FR 8364]
Mobile treatment units
Mobile treatment units (MTUs) conducting treatability studies qualify for the exemption. If more than one MTU is located at the same site, however, the group of MTUs is subject to the treatment rate, storage, time limits, notification, recordkeeping, and reporting requirements that are applicable to stationary laboratories or testing facilities. That is, a group of MTUs operating at one location will be treated as one MTU facility for purposes of §261.4(ef). [53 FR 27297, RO 11366]
Disposal of excess sample/analytical residues
The treatability study exemption ends if the laboratory or testing facility 1) does not return excess sample/treatment residues to the generator or sample collector within the time frames noted in Table 1, or 2) disposes of the excess sample/treatment residues instead of sending them back to the generator or sample collector. In either situation, the laboratory or testing facility must determine if the excess sample/treatment residues are hazardous and, if they are, manage the waste under all Part 262 generator requirements. However, some laboratories or testing facilities may qualify for VSQG status because of the relatively small amount of hazardous waste they generate. If the laboratory or testing facility decides to directly dispose of the excess sample/treatment residues instead of sending them back to the generator or sample collector, storage of the material before offsite shipment to the disposal facility remains exempt if such storage is within the time frames noted in Table 1. [53 FR 27292]
If the laboratory or testing facility returns excess sample/treatment residues, the treatability study exemption ends upon receipt by the generator or sample collector. At that point, excess sample/treatment residues that are hazardous must be managed under Subtitle C. Ultimately, all hazardous excess sample/treatment residues will be manifested to, treated, and/or disposed of in a RCRA-permitted facility.
Reporting and recordkeeping
Section 261.4(ef) specifies reporting and recordkeeping requirements to document compliance with the quantity and time limits of the treatability study exemption. The generator or sample collector and the laboratory or testing facility conducting the treatability study must keep copies of all contracts and shipping documents for a minimum of 3 years after the completion of each study.
A generator or sample collector must also maintain the following records (and include this information in its biennial reports):
- The amount of waste (per waste stream and treatment process) shipped under the exemption;
- The name, address, and EPA ID number of the laboratory or testing facility;
- Shipment dates; and
- Whether or not any excess sample/treatment residues generated from the treatability study were returned.
The owner/operator of a laboratory or testing facility must:
- At least 45 days prior to conducting a treatability study, provide written notification to EPA or the authorized state of its intent to do so. (This is a one-time notification; a notice does not have to be sent before each treatability study. [RO 11695]) When treatability studies are no longer planned at its facility, the laboratory or testing facility must notify EPA or the authorized state of this fact, in writing.
- By March 15 of each year, submit a comprehensive report to EPA or the authorized state that documents the pertinent information for all studies conducted during the previous calendar year.
- Maintain records documenting compliance with the specified treatment and storage quantity and time limits for 3 years after the completion of each treatability study.
Topic: Universal Waste Handler Requirements
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Disclaimer
Considerable care has been exercised in preparing this document; however, McCoy and Associates, Inc. makes no representation, warranty, or guarantee in connection with the publication of this information. McCoy and Associates, Inc. expressly disclaims any liability or responsibility for loss or damage resulting from its use or for the violation of any federal, state, or municipal law or regulation with which this information may conflict. McCoy and Associates, Inc. does not undertake any duty to ensure the continued accuracy of this information.
This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.