Federal Register Hazardous Waste Management System: Identification and Listing of Hazardous Waste; Treatability Studies Sample Exclusion Vol. 59, No. 034 Part VII 59 FR 8362 Friday, February 18, 1994 AGENCY: ENVIRONMENTAL PROTECTION AGENCY (EPA) DOC TYPE: Rules and Regulations CFR: 40 CFR Part 261 NUMBER: FRL-4838-5 EFFECTIVE DATE: This rule becomes effective on February 18, 1994. CONTACT: FOR FURTHER INFORMATION CONTACT: Questions relating to the technical content of this rule should be directed to Jim Cummings or John Kingscott, Technology Innovation Office (5102W), U.S. Environmental Protection Agency at (703) 308-8796 or (703) 308-8749. Other inquiries should be directed to the RCRA/Superfund Hotline at (800) 424-9346 or (703) 920-9810. ADDRESSES: The public docket for this rulemaking is located in the RCRA docket, located in room M2427 at the U.S. Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. The telephone number for the docket is (202) 260-9327. The record is available for inspection by appointment only, between the hours of 9 a.m. and 4 p.m., Monday through Friday, excluding legal holidays. Viewers may copy up to 100 pages free of charge, after which copies cost $0.15 per page. ACTION: Final rule. SUMMARY: On July 7, 1993, the Environmental Protection Agency (EPA) proposed revisions to the Treatability Studies Sample Exemption Rule. The rule conditionally exempts small scale treatability studies from Subtitle C regulation. EPA is today issuing a final rule. The principal change to the existing rule is to increase the quantity of contaminated media which are conditionally exempt from Subtitle C regulation when used in conducting treatability studies. WORD COUNT: 5,592 TEXT: SUPPLEMENTARY INFORMATION: Outline I. Background II. Discussion A. Summary of Existing Treatability Sample Exclusion Rule B. Need and Rationale for This Rulemaking C. Response to Major Comments 1. Quantity Limits 2. Scope of the Exemption 3. Time Limits for Sample Retention 4. Variances for Processing Additional Quantities and Extended Time Limits 5. Treatability Studies at Federal Facilities 6. Promulgation/State Adoption III. State Authority IV. Effective Date V. Regulatory Analyses A. Executive Order 12866 B. Regulatory Flexibility Act C. Paperwork Reduction Act I. Background On July 19, 1988 (52 FR 27290), EPA issued a rule that conditionally exempted from Subtitle C hazardous waste regulation waste samples collected for purposes of conducting small-scale treatability studies. 40 CFR 261.4 (e)-(f). This rule was promulgated in recognition of the inhibiting effect of the stringent Resource Conservation and Recovery Act (RCRA) Subtitle C requirements on the development of new treatment capacity, and the minimal public health and environmental risks involved in conducting small-scale treatability studies. The rule identified specific quantities of various types of wastes which could be transported, stored and used in treatability studies without the need for RCRA Subtitle C regulation. On July 7, 1993 (58 FR 36367), EPA proposed amendments to the existing rule which would increase the quantity limits for major classes of contaminated media (specifically soil and debris) which could be employed in treatability studies without triggering RCRA Subtitle C requirements. The proposal was based in part on the recognition that larger quantities of soil and debris were often needed for treatability testing by technology developers. Larger-scale testing also greatly increases the confidence with which remedial action decision-makers make remedy selection decisions, thus improving CERCLA response activities and RCRA corrective actions, see 58 FR 36367, 36370. EPA also requested comment on the desirability of an amendment to increase the quantity limits for other forms of remediation waste in addition to soil and debris. The proposal also included an amendment which would allow longer time frames for conducting treatability studies involving bioremediation, and solicited comment on appropriate time limits for other technologies. EPA did not request comment on, or reopen the comment period on, the propriety of the existing exemption. Twenty- seven comments were received in response to the proposed rule. The comments were universally favorable regarding the need for and desirability of increasing the treatability study quantity limits. A substantial majority of the comments favored extending the scope beyond soil and debris to other forms of remediation and/or hazardous waste. General reasons offered by commenters mirror those stated in the proposed rule, e.g., assisting technology development and increasing confidence in remedy selection. EPA is today issuing a final rule which increases the quantity and time limits for contaminated media to be used in treatability studies. The rule would increase the exempt amounts from 1000 kg up to 10,000 kg of media contaminated with non-acute hazardous waste and from 250 kg to 2500 kg of media contaminated with acute hazardous, when used in treatability studies. The existing case-by-case variance provision (40 CFR 261.4(e)(3)) is increased from 500 kg to 5000 kg for media contaminated with non-acute hazardous waste and from 250 kg to 2500 kg for media contaminated with acute hazardous waste. The existing variance provision focuses on allowing limited additional quantities after the initial increment of material is processed. EPA is adding criteria to the variance provision to allow the additional quantity to be requested in advance. EPA is also increasing the time limits for treatability studies involving bioremediation. Treatability studies involving bioremediation have an initial period of two years to complete testing, and under the case-by-case variance provisions discussed below, may request up to an additional two years. The remainder of the preamble discusses the major comments received on the proposed rule and EPA's response to them. All other comments are discussed in a background document that is available in the RCRA docket. II. Discussion A. Summary of the Existing Treatability Sample Exclusion Rule The existing Treatability Sample Exclusion rule imposes limits on the quantity of material which may be shipped, stored or treated under the exemption. In order to qualify for the conditional exclusion, laboratory and test facilities must comply with the following quantity and time limitations as well as notification, reporting and record-keeping requirements: Shipment- The mass of each sample shipment may not exceed 1000 kg of "as received" hazardous waste, 1 kg of acute hazardous waste, or 250 kg soils, water, or debris contaminated with acute hazardous waste. 40 CFR 261.4(e)(2)(ii). "As received" refers to the waste {pg 8363} shipped by the generator or sample collector as it arrives at the laboratory or testing facility. 40 CFR 261.4(f)(3). Storage-The laboratory or testing facility may store up to 1000 kg of non-acute hazardous waste. This limitation can include 500 kg of soils, water, or debris contaminated with acute hazardous waste or 1 kg of acute hazardous waste. 40 CFR 261.4(f)(4). Treatment-The laboratory or testing facility, on a per waste stream per treatment process basis, may conduct treatability tests on up to 1000 kg of non-acute hazardous waste, 250 kg of soils, water, or debris contaminated with acute hazardous waste, or 1 kg of acute hazardous waste. 40 CFR 261.4(e)(2)(i). The rule imposes a treatment initiation rate limit of 250 kg per day of "as received" waste for the entire laboratory or testing facility. Time Limits-The existing exclusion requires that the laboratory or testing facility return the sample to the generator or sample collector, or send it to a designated facility within 90 days of completion of the treatability study, or no more than one year from the time the generator or sample collector shipped the sample to the laboratory or testing facility, whichever date first occurs. 40 CFR 261.4(f)(5). EPA did not seek comment on the propriety of these exemption levels or criteria, but merely sought comment on amendments that would expand the scope of the existing rule. B. Need and Rationale for Amendments to the Existing Rule The preamble to the proposed rule contained an extensive discussion of the reasons the Agency felt that amendments to the existing rule were desirable. 58 FR 36367 (July 7, 1993). Interested readers are referred to that document for further information. C. Response to Major Comments 1. Quantity Limits All commenters supported an amendment to increase the quantity limits in the exemption for soil and debris samples by at least the quantities proposed. Almost 50% of the comments suggested adopting higher exemption limits on either an across-the-board or a case-by-case basis. Commenters noted the significant challenges posed in designing and verifying the operational performance of treatment processes. Commenters also noted the challenges encountered in designing and testing ancillary system components-e.g., material handling equipment (getting the waste material into the treatment unit in an appropriate physical state and condition), and emission control equipment. Smaller-scale tests conducted at the laboratory or bench scale often do not involve ancillary system components, or may not utilize sufficient throughput to adequately test these components. Suggestions to further increase the quantity limits ranged as high as 25,000 kg. Other comments suggested that quantity limits higher than those proposed be set on a case-by-case basis. These comments identified site size, the nature of the waste and/or the remediation technology, the concentration of hazardous constituents in the waste matrix, and the intent of the study as possible factors to be considered in these case-by-case determinations. EPA is aware that the larger the scale of the technology development or remedy selection treatability study, the more likely the results will represent the performance of full-scale remedial equipment. Furthermore, EPA's proposal identified the need to address materials handling problems as a major basis for the proposed revision. The data adduced by EPA in the proposed rule support the conclusion that many of the technologies can be tested within the limits proposed. Nevertheless, EPA's own data also confirm that there are situations where additional quantities may be necessary in order to conduct treatability studies at an appropriate scale. The existing rule has a provision for case-by-case approval of additional quantities. 40 CFR 261.4(e)(3). As discussed further below, EPA is modifying the variance provision to allow advance approval, on a case-by-case basis, of conducting studies on additional quantities of contaminated media. Due to the potential for delay in processing case-by-case applications, laboratory and testing facilities should carefully consider the tradeoffs in seeking advance approval of additional quantities. 2. Scope of the Exemption All comments supported the basic proposal to increase the quantity limits for soil and debris. In response to EPA's solicitation of comment on increasing the scope of the revision beyond soil and debris, a substantial majority of the comments recommended extending the quantity increases to various other forms of hazardous waste. Comments differed on the exact scope beyond soil and debris-e.g., all hazardous waste, "remediation waste", wastewater and/or groundwater. Reasons suggested for increasing the scope beyond soil and debris included the difficulty of determining the boundary between sludge and media in, for example, unlined lagoons; the low concentration of contaminants in groundwater; the need for longer-duration continuous flow tests; and the need to develop integrated, optimized remediation approaches in the case of "remediation waste" in general. A number of commenters also suggested extending the increases to all forms of hazardous waste, which would include newly-generated industrial hazardous wastes. In response to these comments, and in light of EPA's own experience regarding the variety of contaminated media encountered in cleanup efforts, EPA is at this time modifying the scope of the exemption to reach contaminated media, including groundwater, surface water, soils, sediment and debris that contain listed hazardous waste or that themselves exhibit a characteristic. However, the proposal did not focus on samples of newly-generated waste or waste sludges, and the Agency is not taking final action of those materials at this time. EPA is considering additional rulemaking to address larger scale treatability studies on other forms of hazardous waste. fn 1 fn 1 As noted by several commenters, sludges will have often become commingled with underlying media, and present difficulty for those attempting to collect media samples for shipment. EPA agrees that it may be difficult to distinguish sludges from underlying media. Where uncontainerized sludges have come into contact with underlying media, EPA does not expect sample collectors to undertake extraordinary efforts to assure that samples consist only of contaminated media. 3. Time Limits for Sample Retention As discussed above, EPA proposed to allow up to two years for treatability studies involving bioremediation. EPA solicited comment on whether these time frames were sufficient, and whether testing involving other technologies also required longer time frames. No negative comments were received on this proposal. Comments included suggestions that the allowable time period be even longer and/or that additional technologies (e.g., phytoremediation and solidification/stabilization) be eligible for longer duration studies. With regard to the time limits, EPA believes that two years should be adequate for most treatability testing involving bioremediation. fn 2 Nevertheless, as discussed below, EPA is modifying the case-by-case variance provisions to allow up to an additional {pg 8364} two years for completion of such studies. fn 2 As a point of clarification, for purposes of this rule, EPA considers phytoremediation to be a form of bioremediation. EPA expects that this provision will be used judiciously. Laboratory and testing facilities cannot exceed the limits in the rule on the amount of material which may be stored and treated. (e.g., 10,000 kg of media contaminated with non-acute hazardous waste plus 5000 kg if a full variance quantity request is granted). On-going studies reduce the quantity of materials which may be stored for use in new studies. With regard to stabilization/solidification, EPA's experience in the Superfund Innovative Technology Evaluation (S.I.T.E.) program indicates that a one-year time frame is generally adequate. Modifications discussed below which allow retaining small samples of treated materials should address some of the concerns underlying suggestions for allowing longer duration studies for this technology (e.g., to ensure the long-term efficacy of the stabilization). Several comments addressed the desirability of retaining samples of treated material for future analysis. EPA understands that such a provision may be useful for technologies such as solidification/stabilization where the attributes of treated material such as compressive strength and leachability of contaminants may change over time, or solvent extraction where there may be issues of the long-term biodegradability of residual solvent in treated soil. In response to these comments, EPA is promulgating a provision allowing up to 500 kg of treated material from a particular wastestream from treatability studies to be stored by the laboratory or testing facility for up to 5 years. Material archived for future analysis must be included in the storage quantity limit for the facility-e.g., a facility which archives two 500 kg samples from separate waste streams may only store up to 9,000 kg (plus 5000 kg if a variance is granted) of additional material, and must be identified as such in facility records and reports. 4. Variances for Requesting Additional Quantities and Extended Time Limits Several commenters suggested that the variance provisions in the existing rule (40 CFR 261.4(e)(3)) be increased by the same factor applied to the base quantity allowed. For example, under the existing rule laboratories or testing facilities could request approval for further testing on up to an additional 500 kg from a particular wastestream. Comments included raising the variance limit for contaminated media by the same amount as the basic proposal. The variance provisions allow additional quantities of materials to be used in treatability studies on a case-by-case basis if specified conditions are met-e.g., mechanical failure during the initial treatability study or need to verify the results of a previously conducted study. As with the comments relating to quantity limits in general, commenters suggested across-the-board and case-by-case approaches to variances. EPA finds the suggestion to allow increased quantities of contaminated media to a set maximum on a case-by-case basis to be reasonable. EPA is modifying the variance quantity by the same factor by which it is increasing the basic quantity limit. Thus, laboratory and testing facilities may request up to an additional 5000 kg of media contaminated with non-acute hazardous waste, or 2500 kg of media contaminated with acute hazardous waste. The Agency considers this to be a conforming change to the general concept of allowing larger quantity studies, and views it as a logical outgrowth of the proposed rule. Furthermore, as discussed above, in response to comments that quantities beyond those proposed be allowed on a case-by-case basis, EPA is also adding a provision that will allow laboratory and testing facilities to apply for advance authorization for variances. Factors to be considered in reviewing advance requests for additional quantities include the nature of the technology, the type of process (e.g., batch versus continuous), size of the unit undergoing testing (particularly in relation to scale-up considerations), time/quantity of material required to reach steady-state operating conditions, and test design considerations such as mass balance calculations. Finally, the case-by-case variance provision has been modified to allow laboratory and testing facilities conducting bioremediation treatability studies to request a variance of up to two additional years to complete their studies. 5. Treatability Studies at Federal Facilities Several comments requested clarification of the status of federal facilities for purposes of eligibility for the treatability study sample exclusion. Federal facilities are often large in size, with numerous different contamination problems for which solutions must be developed and applied. EPA notes that the rule identifies "laboratory or test facilities" as the entities which may take advantage of the conditional exclusion. The Agency would not consider a large federal installation with numerous laboratories or testing sites to be a single "laboratory or test facility" for purposes of this rule. Distinguishing attributes include the requirement to obtain an EPA Identification number for each laboratory or test facility. 40 CFR 261.4(f)(2). 6. Promulgation/State Adoption Comments on State Authorities are addressed below in the "State Authority" section. III. State Authority A number of comments indicated that the efficacy of this rule depends to a considerable extent on the availability of the exclusion at the State level. Since the original treatability sample exclusion rule was promulgated under RCRA and not the Hazardous and Solid Waste Act Amendments of 1984 (HSWA), this revision is also promulgated pursuant to RCRA. As with the existing rule, the revisions promulgated today are not immediately effective in authorized States, since this rulemaking does not impose requirements or prohibitions contained in HSWA. Thus this regulation will be applicable only in those States that do not have final authorization for the non-HSWA base RCRA program. In a State authorized to implement the base RCRA program, the proposed regulation would not be applicable until the State revises its program to adopt equivalent regulations under State law. However, as with the original rule these proposed changes are less stringent or reduce the scope of the Federal program. Therefore, although EPA strongly encourages timely adoption, authorized States are not required to modify their programs to adopt regulations consistent with and equivalent to this rulemaking. The Agency plans to work with States to encourage timely adoption of this rule because of its benefits to the development of treatment capacity. IV. Effective Date This rule is effective immediately upon publication. HSWA amended section 3010 of RCRA to allow rules to become effective in less than 6 months when the regulated community does not need the 6- month period to come into compliance. This is the case here, because this rule reduces the existing requirements for laboratories and test facilities conducting treatability studies on contaminated media. An effective date 6 months after publication would impose unnecessary expense and regulatory burden upon those persons the rule is designed to benefit, and {pg 8365} might delay the achievement of the rule's objective of improving CERCLA response activities and RCRA corrective actions by facilitating treatability studies. These reasons also provide a basis for making this rule effective immediately upon final promulgation under the Administrative Procedures Act, 5 U.S.C. 553(d). V. Regulatory Analyses A. Executive Order 12866 OMB has determined that this rule is not a significant rule within the meaning of Executive Order 12866. B. Regulatory Flexibility Act Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., whenever an Agency is required to publish general notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the impact of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). The purpose of the original rule was to eliminate time-consuming and costly permitting requirements. This revision extends the scope of activities which may be conducted without requirements to obtain permits, and will thus have additional positive effects on small entities. This amendment will have no adverse economic impact on small entities. In fact, it should reduce the burden imposed on small entities that conduct treatability studies and comply with the provisions of this rulemaking. Accordingly, I hereby certify that this rule will not have a significant economic impact on a substantial number of small entities. This regulation therefore does not require a regulatory flexibility analysis. C. Paperwork Reduction Act This rule does not contain any new information collection requirements subject to OMB review under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. To the extent that this rule discusses information collection requirements imposed under existing regulations, these requirements have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and have been assigned OMB control number 2050-0053. List of Subjects in 40 CFR Part 261 Hazardous waste, Recycling. Dated: February 9, 1994. Carol M. Browner, Administrator. For the reasons set out in the preamble, title 40 of the Code of Federal Regulations is amended to read as follows: PART 261-IDENTIFICATION AND LISTING OF HAZARDOUS WASTE 1. The authority citation for part 261 continues to read as follows: Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938. 2. Section 261.4 is amended by revising paragraphs (e)(2)(i) and (e)(2)(ii), (e)(3), (f)(3), (f)(4), and (f)(5) to read as follows: Sec. 261.4 -- Exclusions. * * * * * (e) * * * (2) * * * (i) The generator or sample collector uses (in "treatability studies") no more than 10,000 kg of media contaminated with non- acute hazardous waste, 1000 kg of non-acute hazardous waste other than contaminated media, 1 kg of acute hazardous waste, 2500 {pg 8366} kg of media contaminated with acute hazardous waste for each process being evaluated for each generated waste stream; and (ii) The mass of each sample shipment does not exceed 10,000 kg; the 10,000 kg quantity may be all media contaminated with non-acute hazardous waste, or may include 2500 kg of media contaminated with acute hazardous waste, 1000 kg of hazardous waste, and 1 kg of acute hazardous waste; and * * * * * (3) The Regional Administrator may grant requests on a case-by-case basis for up to an additional two years for treatability studies involving bioremediation. The Regional Administrator may grant requests on a case-by-case basis for quantity limits in excess of those specified in paragraphs (e)(2) (i) and (ii) and (f)(4) of this section, for up to an additional 5000 kg of media contaminated with non-acute hazardous waste, 500 kg of non-acute hazardous waste, 2500 kg of media contaminated with acute hazardous waste and 1 kg of acute hazardous waste: (i) In response to requests for authorization to ship, store and conduct treatabilty studies on additional quantities in advance of commencing treatability studies. Factors to be considered in reviewing such requests include the nature of the technology, the type of process (e.g., batch versus continuous), size of the unit undergoing testing (particularly in relation to scale-up considerations), the time/quantity of material required to reach steady state operating conditions, or test design considerations such as mass balance calculations. (ii) In response to requests for authorization to ship, store and conduct treatability studies on additional quantities after initiation or completion of initial treatability studies, when: There has been an equipment or mechanical failure during the conduct of a treatability study; there is a need to verify the results of a previously conducted treatability study; there is a need to study and analyze alternative techniques within a previously evaluated treatment process; or there is a need to do further evaluation of an ongoing treatability study to determine final specifications for treatment. (iii) The additional quantities and timeframes allowed in paragraph (e)(3) (i) and (ii) of this section are subject to all the provisions in paragraphs (e) (1) and (e)(2) (iii) through (vi) of this section. The generator or sample collector must apply to the Regional Administrator in the Region where the sample is collected and provide in writing the following information: (A) The reason why the generator or sample collector requires additional time or quantity of sample for treatability study evaluation and the additional time or quantity needed; (B) Documentation accounting for all samples of hazardous waste from the waste stream which have been sent for or undergone treatability studies including the date each previous sample from the waste stream was shipped, the quantity of each previous shipment, the laboratory or testing facility to which it was shipped, what treatability study processes were conducted on each sample shipped, and the available results on each treatability study; (C) A description of the technical modifications or change in specifications which will be evaluated and the expected results; (D) If such further study is being required due to equipment or mechanical failure, the applicant must include information regarding the reason for the failure or breakdown and also include what procedures or equipment improvements have been made to protect against further breakdowns; and (E) Such other information that the Regional Administrator considers necessary. (f) * * * (3) No more than a total of 10,000 kg of "as received" media contaminated with non-acute hazardous waste, 2500 kg of media contaminated with acute hazardous waste or 250 kg of other "as received" hazardous waste is subject to initiation of treatment in all treatability studies in any single day. "As received" waste refers to the waste as received in the shipment from the generator or sample collector. (4) The quantity of "as received" hazardous waste stored at the facility for the purpose of evaluation in treatability studies does not exceed 10,000 kg, the total of which can include 10,000 kg of media contaminated with non-acute hazardous waste, 2500 kg of media contaminated with acute hazardous waste, 1000 kg of non-acute hazardous wastes other than contaminated media, and 1 kg of acute hazardous waste. This quantity limitation does not include treatment materials (including nonhazardous solid waste) added to "as received" hazardous waste. (5) No more than 90 days have elapsed since the treatability study for the sample was completed, or no more than one year (two years for treatability studies involving bioremediation) have elapsed since the generator or sample collector shipped the sample to the laboratory or testing facility, whichever date first occurs. Up to 500 kg of treated material from a particular waste stream from treatability studies may be archived for future evaluation up to five years from the date of initial receipt. Quantities of materials archived are counted against the total storage limit for the facility.