Hazardous Waste Management System: Identification and Listing of Hazardous Waste Solvents

There are no regulated entities as a result of this action. The index and the supporting materials are available on the Internet: Follow these instructions to access the information electronically:

WWW: www.epa.gov/epaoswer/hazwaste.htm#id FTP: ftp.epa.gov Login: anonymous Password: your Internet address Files are located in /pub/oswer

The contents of the preamble to this final rule are listed in the following outline:

I. Legal Authority and Background A. Statutory and Regulatory Authorities B. Existing Solvent Listings and the Regulatory Definition of Solvent II. Summary of Proposed Rule A. Determinations Not to List Solvent Wastes as Hazardous Waste B. Summary of Risk Assessment Supporting the Proposed Rule III. Peer Review of Calculated Toxicological Benchmarks IV. Summary of Response to Comments and Rationale for Final Rule A. Data Collection 1. Representativeness of Industry Characterization 2. Engineering Site Visit Reports B. Methodology 1. Definition of ``Solvent' 2. Lack of Sampling and Analysis 3. Consistency of Methodology With Other Listing Determinations 4. Plausible Mismanagement Scenarios C. Risk Assessment 1. Surface Impoundments 2. Tank-Based Management of Wastes 3. Multiple Solvents 4. Comparison with HWIR Exit Levels 5. Environmental Damage Incidents 6. Spills, Leaks, and Overflows 7. Non-Aqueous Phase Liquids 8. Risk Modeling Parameters 9. Comparison with Results of Air Characteristic Study D. Listing Determinations 1. General Comments 2. Sufficient Regulation of Solvents 3. Waste-Specific Rationales and Response to Specific Comments V. Regulatory Requirements A. Regulatory Impact Analysis Pursuant to Executive Order 12866 B. Regulatory Flexibility C. Unfunded Mandates Reform Act D. Executive Order 12875: Enhancing Intergovernmental Partnership E. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks F. Environmental Justice E.O. 12898 G. Paperwork Reduction Act H. National Technology Transfer and Advancement Act I. Executive Order 13084: Consultation and Coordination with Indian Tribal Governments J. Congressional Review Act

I. Legal Authority and Background

A. Statutory and Regulatory Authorities

The Environmental Protection Agency (EPA) conducted this investigation and listing determination under the authority of sections 2002(a), 3001(a), (b) and (e)(2) of the Solid Waste Disposal Act (42 U.S.C. 6912(a), and 6921(b) and (e)(2)), as amended by various other laws, the most comprehensive of which was the Hazardous and Solid Waste Amendments (HSWA) of 1984. These statutes are commonly referred to as the Resource Conservation and Recovery Act (RCRA) and are codified at Volume 42 of the United States Code (U.S.C.), sections 6901 to 6992(k). Section 3001(a) of RCRA, 42 U.S.C. 6921(a), requires EPA to promulgate criteria for identifying characteristics of hazardous wastes and for listing hazardous wastes. Section 3001(b) of RCRA requires EPA to promulgate regulations, based on these criteria, identifying and listing hazardous wastes which shall be subject to the requirements of the Act. Section 1004(5) of RCRA, 42 U.S.C. 6903(5), defines the term ``hazardous waste.'' There are two types of hazardous waste. First, hazardous wastes are those solid wastes which may cause or significantly contribute to an increase in mortality, serious irreversible illness, or incapacitating reversible illness. Second, hazardous wastes are those solid wastes which may pose a substantial present or potential hazard to human health or the environment when improperly managed. Id. EPA's regulations establishing criteria for listing hazardous wastes are codified at Title 40 of the Code of Federal Regulations (CFR) 261.11 (40 CFR 261.11). Section 261.11 presents three criteria by which EPA identifies wastes as hazardous. First, solid wastes may be classified as ``characteristic'' wastes if they exhibit any of the characteristics of hazardous waste identified at 40 CFR 261.21-24 (i.e., ignitability, corrosivity, reactivity, or toxicity). Second, solid wastes may be listed as acutely hazardous if they are fatal to humans at low doses, lethal in animal studies at particular doses designated in the regulation, or otherwise capable of causing or significantly contributing to an increase in serious illness. Third, solid wastes may be listed as hazardous if they contain any of the toxic constituents identified in Appendix VIII of 40 CFR part 261 and the Agency concludes, after considering the eleven factors enumerated in 40 CFR 261.11(a)(3), that the waste is capable of

posing a substantial present or potential hazard to human health or the environment when improperly managed. A substance is listed in Appendix VIII if it has been shown in scientific studies to have toxic, carcinogenic, mutagenic, or teratogenic effects on humans or other life forms. Today's listing determination has been made pursuant to this third set of criteria. As part of its regulations implementing section 3001(b) of RCRA, EPA published a list of hazardous wastes that includes hazardous wastes generated from nonspecific sources (F-wastes) and a list of hazardous wastes from specific sources (K-wastes). These lists, published at 40 CFR 261.31 and 261.32, respectively, have been amended several times. Persons who generate, transport, treat, store, or dispose of wastes listed as hazardous must do so subject to Federal requirements under RCRA. Facilities that must meet the hazardous waste management requirements, including the need to obtain permits to manage hazardous wastes, are commonly referred to as RCRA Subtitle C facilities. EPA standards and procedural regulations implementing Subtitle C are found generally at 40 CFR parts 260 through 279. Solid wastes that are not hazardous wastes may be disposed of at facilities that are overseen by State and local governments. These facilities are referred to as RCRA Subtitle D facilities. EPA regulations affecting Subtitle D facilities are found generally at 40 CFR parts 240 through 247, and parts 255 through 258. Section 3001(e)(2) of RCRA requires EPA to determine whether to list as hazardous several specified wastes, including solvent wastes. The Environmental Defense Fund (EDF) and EPA entered into a consent decree to resolve issues raised in a civil action brought by EDF (EDF v. Browner, Civ. No. 89-0598 (D.D.C.)) in which the Agency agreed, among other things, to a schedule for making a listing determination on spent solvents. This listing determination is to consider spent solvents, still bottoms from the recovery of these solvents, and spent solvent mixtures when the following chemicals are used as solvents: cumene, phenol, isophorone, acetonitrile, furfural, epichlorohydrin, methyl chloride, ethylene dibromide, benzyl chloride, p- dichlorobenzene, 2-methoxyethanol, 2-methoxyethanol acetate, 2- ethoxyethanol acetate, and cyclohexanol. For an additional set of seven solvents, EPA agreed to conduct a study and issue a final report by August 30, 1996. This study, which EPA completed on August 22, 1996, discusses the wastes associated with the use of the materials as solvents, the toxicity of the wastes, and a description of the management practices for the wastes. Solvent uses are found throughout various industries and, thus, would fall under the category of wastes from nonspecific sources (F- wastes) if listed in 40 CFR 261.31. In fact, wastes designated F001 through F005 are various wastes from solvent uses of a number of chemicals. In today's action, EPA has decided not to amend 40 CFR 261.31 to add wastes generated during the use of the 14 chemicals of concern as solvents. EPA emphasizes that the determination not to list these wastes only means that the Agency has found it is not appropriate to list as hazardous the wastes across broad industry categories that could result from solvent uses of the 14 chemicals. As will be more fully explained below, EPA did not find that solvent uses for these chemicals, in general, produce hazardous wastes that require listing. Many of the wastes examined are hazardous already because they are characteristic wastes under 40 CFR part 261, subpart C, or contain other solvent wastes currently listed as hazardous. In addition, some of the chemicals may produce wastes that are hazardous when used in ways other than as solvents, perhaps as catalysts, feedstocks or other uses in chemical manufacturing processes. Solvents use simply does not constitute an appropriate way to designate these chemicals as a hazardous waste category under RCRA for wastes from nonspecific sources. Particular industrial wastes from these chemicals might be hazardous, but such wastes were not examined in this determination.

B. Existing Solvent Listings and the Regulatory Definition of Solvent

Five hazardous waste listings for specific solvents have been promulgated to date: F001, F002, F003, F004, and F005. These are found at 40 CFR 261.31. Today's decision applies the same criteria for defining solvent wastes as are applied to these existing solvents listings. These criteria are explained in the Federal Register of December 31, 1985 (50 FR 53316) and are also consistent with the requirements of the EDF Consent Decree. The December 1985 document amended the solvent listings to include spent solvent mixtures when the solvent, before it is used, contains 10 percent or more of total listed solvents. The original listing included only the technical grade, practical grade or pure form of the solvents when used. This threshold level was considered by the Agency to be well below the minimum solvent concentration typically used in solvent formulations and was designed to bring the majority of listed solvent mixtures used in commerce into the hazardous waste management system, while excluding dilute mixtures or de minimis concentrations. In addition, the document issued several clarifications to the original listings. First, the listings apply to ``spent'' solvents-- those that are no longer fit for use without being regenerated, reclaimed, or otherwise processed. (See 40 CFR 261.1(c) (1) and (4); 261.2(c) (3) and (e)). Second, the listings cover only those solvents used for their solvent properties--``to solubilize (dissolve) or mobilize other constituents.'' These include solvents used in degreasing, cleaning, fabric scouring, as diluents, extractants, reaction and synthesis media. The document stated that the listings do not cover wastes from the processing of products where a chemical that might be used as a solvent is, instead, used as a reactant or where a chemical is used as a solvent only as an ingredient in the formulation of a commercial chemical. This latter category would include chemicals used as a solvent in paint formulations to dissolve the paint itself. These uses do not generate ``spent solvent'' wastes. The wastes of concern for these products would be the production process wastes or wastes from the use of the product, not the solvent itself. This approach is also consistent with the requirements of the EDF Consent Decree. This is because the consent decree identifies a subset of solvent wastes that are potential candidates for listing and specifies that the listing determination applies to ``spent solvents,'' a term that tracks the language of the existing listings. Moreover, this approach had been the longstanding approach of the Agency to dealing with solvent listings at the time the Consent Decree was negotiated and should be interpreted as representing the understanding of the parties. This approach, whereby EPA has limited the scope of this rulemaking through this focused definition of solvents subject to the listing, is a reasonable interpretation of RCRA and is consistent with EPA's historical treatment of solvent listing descriptions. Use of the definition has allowed the Agency to place reasonable limits on the scope of its listing investigation for this rulemaking. RCRA 3001(e)(2) directs

EPA to make a listing determination on ``solvents,'' but provides no further direction on the meaning of that term. EPA, therefore, has the discretion to reasonably define the scope of the listing determination. Given the ubiquity of solvents, the great variety of uses and the huge differences in the composition of the waste streams, EPA could not gather the evidence to list ``solvent wastes'' as a general category. Under the Agency's regulations at 40 CFR 261.11(b), wastes may be listed as a category if they are ``typically or frequently'' hazardous. EPA could make no such findings for ``solvent'' wastes in general and, therefore, has reasonably focused its investigation and listing decision. As noted above, the existing solvent listings are limited to spent solvent mixtures when the solvent, before it is used, contains 10 percent or more of total listed solvents. While wastes from this use threshold were the primary focus of today's listing determination, EPA also considered in its evaluations the few solvent uses that were reported to be below the 10 percent threshold. In a previous proposed hazardous waste listing for wastes from the production of dyes and pigments (59 FR 66072, December 22, 1994) EPA presented the general approach the Agency uses for determining whether to list a waste as hazardous pursuant to 40 CFR 261.11(a)(3). The discussion focused on the selection of waste management scenarios used in assessing risk and the use of information on risk levels in making listing determinations. This approach was further developed in EPA's listing for petroleum refining process wastes (proposed rule published at 60 FR 57747, November 20, 1995; final rule published at 63 FR 42110, August 6, 1988). EPA is employing the same general approach in this final rulemaking. Readers are referred to these documents for a description of EPA's listing policy. Also, section II.C.2. of the proposed rule, ``Risk Assessment,'' contains a discussion of how elements of EPA's listing policy were applied in today's listing determination. The following section contains a summary of the methodology used to arrive at the no-list determinations in today's document. For more details on this methodology, see the proposed rule, background document, and the response to comments document in the docket.

II. Summary of Proposed Rule

A. Determinations Not To List Solvent Wastes as Hazardous Waste

EPA proposed the decision not to list the spent solvent wastes from the 14 chemicals noted above on August 14, 1996 (61 FR 42318). The Agency determined that these wastes did not meet the criteria for listing set out in 40 CFR 261.11. The proposed rule presented the waste characterization, waste management, mobility, persistence, and risk assessment data that were the bases for the Agency's proposed decision not to list these wastes as hazardous. Further details of EPA's approach are presented in the Hazardous Waste Listing Determination Background Document for Solvents (hereafter known as ``Listing Background Document'') in the docket for the proposal to today's rule. As explained in section II.B of the proposed rule, spent solvents differ from other listed wastes among EPA's waste listings in that the solvents are used in manufacturing and allied processes rather than being the principal waste streams generated by manufacturing processes. In order to characterize industrial solvent use, the Agency sent out almost 1,500 preliminary questionnaires to cover the 21 total chemicals (14 from the listing determination and seven from the study). An additional 60 facilities were surveyed on their use of these chemicals as solvents through the chlorinated aliphatics industry survey. EPA then sent out a full RCRA section 3007 survey to facilities using greater than a combined total of 1,200 kilograms of all the chemicals of concern. The Agency consulted various literature and reference sources, such as Chemical Abstracts, general reference books, the Agency's Toxic Release Inventory (TRI) compiled under section 313 of the Emergency Planning and the Right-to-Know Act (EPCRA), databases compiled for various EPA programs dealing with air and water pollution, and information available from trade associations. Of the 14 chemicals involved in the listing determination, 11 were on the TRI. Use of the literature, Chemical Abstracts, TRI, and other EPA databases allowed the Agency to focus on the industries that actually use these chemicals as solvents. In addition, many of these sources gave strong indications as to when major uses of a chemical were not as a solvent. Once the Agency narrowed down the potential solvent-using industries, the Agency developed a list of facilities to survey about their solvent use. These facility names and addresses were obtained again from a variety of sources, including TRI, trade associations, and other Agency media program sources. The Agency sent a short (``preliminary'') questionnaire to approximately 1,500 facilities inquiring about uses of any of the 14 listing determination chemicals as solvents and the quantities used. The Agency used the preliminary questionnaire data to develop the large questionnaire mailing list and to organize site visits. The Agency also made several hundred confirmatory telephone calls to determine that reported information was correct. The data from the preliminary questionnaire showed the Agency several distinct patterns of solvent use: facilities that use large amounts of any of these chemicals as solvent, those that use small quantities as solvents, and those that use none of the chemicals as solvents. The Agency found that a solvent use quantity of 100 kg per month, or 1,200 kg per year, provided a mathematically convenient separation of those facilities who use large amounts of solvent and those who use very little and provided an indication as to which facilities were likely to be large quantity generators of hazardous waste based on use of these chemicals as solvents. Based on careful analysis of the data, the Agency identified likely large-scale users of these chemicals as solvents. The Agency then developed the large questionnaire. This questionnaire reconfirmed data on solvent use and requested detailed information on a facility's solvent-using processes, waste generation, waste management, and waste minimization activities. The Agency sent this questionnaire to approximately 150 facilities that indicated to the Agency through the preliminary questionnaire that significant solvent uses of these chemicals exist. The data obtained from the questionnaire were applied to the risk assessment process described in today's document as well as the preparation of the background document. To summarize the results, 4 of the 14 chemicals showed no use as a solvent. The remaining 10 chemicals were analyzed in the Agency's risk assessment based on solvent uses found by the Agency. For the 10 chemicals of the required listing determination for which there were solvent uses (acetonitrile, 2-ethoxyethanol acetate, 2-methoxyethanol, 2-methoxyethanol acetate, cyclohexanol, cumene, phenol, furfural, isophorone, and methyl chloride), EPA found that the management of residuals from the use of these chemicals as solvents did not pose a risk to human health or the

environment under the plausible management scenarios assessed. The data used as the bases for these determinations were presented in sections II.D through II.M of the proposed rule (61 FR 42327). Detailed information is also presented in the background documents supporting the proposed rule (RCRA Docket number F-96-SLDP-FFFFF). Specifically, none of the solvents satisfy the criteria for listing in 40 CFR 261.11 (a)(3). For acetonitrile, 2-methoxyethanol, and methyl chloride, while risk analyses indicated some potential risk from air releases of these chemicals from onsite accumulation in open tanks, EPA believes this risk would not be significant because most, or in some cases all, of the nonwastewater residuals are already regulated as hazardous waste. For phenol, 2-ethoxyethanol acetate, furfural, cumene, cyclohexanol, isophorone, and 2-methoxyethanol acetate, the risk estimates indicated that spent solvent residuals from the use of these chemicals as solvents do not pose a substantial risk or potential hazard to human health or the environment through the plausible management scenarios and pathways assessed. For the remaining four chemicals subject to the required listing determination in the EDF Consent Decree (1,4-dichlorobenzene, benzyl chloride, epichlorohydrin, and ethylene dibromide), EPA proposed not to list residuals from their use as solvents, because the data collected by EPA showed that these chemicals are extremely unlikely to be used as solvents. One of the chemicals (p-dichlorobenzene) is a solid at room temperature, and the other three (benzyl chloride, epichlorohydrin, and ethylene dibromide) are relatively reactive chemicals not well suited to solvent use. EPA's information showed that the very limited solvent use reported for these four chemicals is linked to bench-scale or experimental laboratory settings, and no significant solvent uses were found. For more detail see sections II.N through II.Q of the proposed rule (61 FR 42347) and background documents supporting the proposed rule (RCRA Docket number F-96-SLDP-FFFFF).

B. Summary of Risk Assessment Supporting the Proposed Rule

As described in detail in the proposed rule (see 61 FR 42322- 42327), EPA carried out various analyses to determine the potential risk that might arise from the disposal of the spent solvent wastes under study. In carrying out the modeling for these assessments, EPA used available data it collected from industries using these solvents. The Agency used information gathered in the RCRA 3007 Questionnaires and site visits related to the waste characteristics, waste management practices, and potential pathways for release and exposure. EPA used other generic input parameters to fate and transport models to estimate the risk a waste might present under management scenarios known to occur. The data used in the modeling efforts included the concentrations and toxicity of the solvent constituents in the waste, the mobility and fate of such constituents in different disposal scenarios, likely exposure routes under these scenarios, and the location of receptors that might be exposed. The levels of receptor exposure estimated from modeling were compared with toxicological benchmarks to evaluate the potential health impacts. For noncarcinogenic constituents, EPA used reference doses for ingestion exposure (RfDs) and reference concentrations for inhalation exposure (RfCs); these are measures of acceptable daily intakes for a specific chemical. To assess the hazard to a hypothetical individual, EPA used hazard quotients (HQs). An HQ is the ratio of the modeled exposure (or dose) received compared with the acceptable daily dose (the RfC or RfD). An HQ above one indicates that exposures may occur above acceptable levels. For carcinogenic constituents, EPA compared exposure levels to carcinogenic potency estimates (carcinogenic slope factors, or CSFs) to calculate specific risk levels. The carcinogenic risks results are expressed in terms of individual risk, reflecting the additional incidence of cancer that may occur in an exposed population. For example, a risk of 1 x 10-5 (which will be presented in this document as 1E-05) corresponds to a probability of one additional case of cancer for every 100,000 people exposed. EPA used verified RfDs, RfCs, or CSFs when available in EPA's Integrated Risk Assessment Information System (IRIS). IRIS, which represents a consensus opinion of EPA health scientists, is a database of human health effects that may result from exposure to various substances found in the environment. For the chemicals that did not have complete verified IRIS data available (2-methoxyethanol acetate, cyclohexanol, phenol, and isophorone), EPA calculated provisional values when needed for use in the listing determinations. EPA performed a number of different types of risk analyses. First the Agency completed a ``bounding analysis'' to screen out solvent wastes from further consideration. In this analysis, the key input parameters were set to their ``high-end'' values (typically the 90th percentile point on the distribution of values available for each parameter). For solvent wastes that did not ``bound out,'' EPA then ran a high-end ``deterministic'' sensitivity analysis to determine which high-end input parameters result in the greatest risk. EPA calculated risks for all combinations when the most sensitive parameters were set at high-end values and then used the highest ``high-end'' risk. In this way, EPA attempted to estimate ``high-end'' risks that were somewhere above the 90th percentile, i.e., the risks would be below this level for at least 90% of the population at risk. EPA also calculated ``central tendency'' risks, which correspond to the risk when all input parameters were set at their median value. Critical decisions for risk assessment include EPA's determination regarding which waste management scenarios to model and how to use the information on waste volumes and solvent concentrations disposed as modeling input. The Agency's modeling focused primarily on potential releases from wastes managed in aerated tanks, stored in open tanks, undergoing thermal treatment, and managed in surface impoundments. Modeling was based on the information EPA collected from facilities, including quantities of wastes managed. For each management scenario, EPA evaluated the full range of direct and indirect pathways through which the solvents could affect human health or the environment. Based on the physical and chemical properties of the constituents of concern and plausible management practices, certain routes of exposure for some scenarios were not considered to pose threats and were not further evaluated. In general, solvent wastes fell in several major categories. Wastewaters were typically diluted aqueous wastes that are managed in a biological treatment system (usually in tanks). Nonwastewaters includes two subcategories. These include: (1) wastes with high levels of solvents or other organic chemicals, which were sent for thermal treatment in incinerators, industrial boilers, or fuel blenders, and (2) treatment residuals, such as wastewater treatment sludges or incinerator ash, which contained negligible levels of solvents.

EPA modeled storage in an open tank and thermal treatment for nonwastewater spent solvent residuals from use of all of the ten solvents. EPA modeled wastewater treatment in

aerated tanks for wastewater residuals resulting from the use of acetonitrile, 2-methoxyethanol, 2-ethoxyethanol acetate, phenol, furfural, and cumene as solvents. The surface impoundment scenario was assessed for five of the solvents; acetonitrile, phenol, cumene, furfural, and methyl chloride. For acetonitrile and cumene, the headworks concentrations (i.e., the concentrations after the spent solvent was mixed with other wastewaters at the headworks of the wastewater treatment system) potentially discharged to surface impoundment were below the health-based levels for these constituents, and thus were not evaluated further. For phenol, three wastewaters with spent phenol were reported to be managed in surface impoundments that are part of a wastewater treatment train. In two of these cases, the phenol concentration was below the drinking water health-based level after mixing at the headworks, prior to reaching the surface impoundment. In the third case the stream had levels ranging above the health-based level; however this level is expected to be efficiently treated by the activated sludge, such that little phenol would be available for release to groundwater. For methyl chloride, EPA modeled air releases from treatment in a surface impoundment, but not the groundwater pathway because the impoundment was a permitted hazardous waste management unit. (As described below, the unit treating methyl chloride wastes was unique due to the highly specialized nature of this solvent use). EPA modeled treatment in a surface impoundment for furfural; however, bounding analyses showed no significant risks via air or groundwater pathways. The solvent use of the chemicals modeled in surface impoundments are very specialized. This means that they have properties that only allow very particular solvent uses in a very narrow set of circumstances and only for some industries, or even for only one. For example, methyl chloride is a gas at room temperature, which severely limits its utility as a solvent. The only significant solvent use for this chemical is as a solvent in the polymerization of butyl rubber, during which methyl chloride is passed through aluminum chloride to form and solubilize the catalyst used. The chemical's special ability to generate such a catalyst solution is why it is used. Similarly, by far the largest solvent uses of furfural and phenol are in the extraction of a high molecular weight oil (lubrication oil) during petroleum refining; these chemicals have very limited solvent uses outside the petroleum industry. Therefore, EPA has a high degree of confidence that the concentrations of chemicals in the streams flowing into surface impoundments studied in this listing determination are representative of the universe of such uses and possible exposure scenarios. The landfill scenario was initially assessed for acetonitrile, methyl chloride, cumene, and cyclohexanol, but not modeled for spent solvent residuals from any of these solvents because the concentrations in the wastes were ``trace'' or ``negligible.'' Further general background for the risk assessment is provided in the preamble to the proposed rule (see 61 FR 42318).

III. Peer Review of Calculated Toxicological Benchmarks

Standard inhalation toxicological benchmarks were not available to EPA for four of the solvents when the Agency was conducting the risk assessment for the proposed rule. The Agency therefore calculated values specifically for the rule. EPA has labeled these toxicological benchmarks ``provisional RfCs'' to clearly differentiate them from the Agency consensus values listed on IRIS. During the comment period, EPA solicited peer review of these calculated risk values. The peer review reports and the complete Agency response to the reports are in the docket for this rulemaking. In response to comments received in the peer review reports, EPA adjusted three of the provisional toxicological benchmarks used for this risk assessment. The changes are shown in Table 1.

Table 1.--Changes in Toxicological Benchmarks for Air Pathway ---------------------------------------------------------------------------------------------------------------- Previous New provisional provisional Solvent NOAEL \1\ (mg/m3) toxicological toxicological benchmark (mg/ benchmark (mg/ m3) m3) ---------------------------------------------------------------------------------------------------------------- Cyclohexanol............................ 0.06.................................. 0.00006 0.00002 Phenol.................................. 19.................................... 0.019 0.006 Isophorone.............................. 37 (LOAEL) \2\........................ 0.0037 0.012 ---------------------------------------------------------------------------------------------------------------- \1\ No observed adverse effect level. \2\ Lowest observed adverse effect level.

The new benchmarks for cyclohexanol and phenol reflect additional uncertainty factors to account for insufficient toxicity databases. The benchmark for isophorone reflects a reduction in overall uncertainty factors to reflect Agency guidance limiting such factors to a total of 3,000. Full documentation of the methodology for developing these benchmarks is in the docket for this rulemaking. In addition, the toxicological values for cumene were changed on IRIS during the comment period. The RfD (for noncancer ingestion risks) was changed from 0.04 mg/kg/day to 0.1 mg/kg/day. The RfC (for noncancer inhalation risks) was changed from 0.009 mg/m\3\ to 0.4 mg/ m\3\. These changes both reflect greater tolerance for cumene than the previous benchmarks and thus have no impact on EPA's decision not to list wastes derived from the use of this chemical as a solvent. The Agency has employed these revised ``provisional RfCs'' for all the updated risk assessments involving these solvents for the final rule. In addition, the Agency has re-estimated risks assessed for the proposed rule using these new benchmarks. Documentation of these re- estimations appears in the supplemental risk assessment background document to this final rule. The final risk estimates for all the solvents are shown in Table 3 of this preamble. In all cases the changes to the toxicological values do not have any significant impact on EPA's risk results, nor do the changes affect any listing decisions. The solvent wastes for the chemicals examined still do not pose significant risks, and thus, these analyses confirm the proposed decisions not to list these wastes.

IV. Summary of Response to Comments and Rationale for Final Rule

The Agency is responding in this preamble to the most significant comments received in response to the document of August 14, 1996, 61 FR 42318. Other comments received by the Agency are addressed in the document entitled Hazardous Waste Listing Determination: Spent Solvents, Response to Comments (hereafter known as Response to Comments Document) that is available in the docket associated with this rulemaking. The Agency is responding to a variety of comments concerning data collection, methodology, risk assessment scenarios, and issues specific to each chemical in this listing determination. The responses, while touching many specific aspects of the listing determination effort, involve three major themes: • The Agency used a very thorough survey, which characterized the risks of the spent solvents. The Agency researched various potential applications of these chemicals as solvents and found that solvent uses are confined to a limited set of industrial applications. Data collected from the questionnaires confirmed the general lack of wide solvent use, and are consistent with EPA's search of the literature. These findings allowed the Agency to consider the applicable waste generation and management practices, and define plausible management scenarios for use in evaluating potential risks associated with these solvent wastes. • Facilities use the solvents for specific purposes that vary by the desired process. Some of the solvents in this listing determination have different applications over certain industries (i.e., acetonitrile). Even within one industry, the primary commonality among the processes is the solvent constituent itself. Other solvents were used in very limited ways and their primary uses were highly specialized (e.g., furfural). However, even for solvents with specialized uses, other minor uses were typically reported for different industries and processes. The resulting potential variability in waste compositions led the Agency to focus its efforts on evaluating the solvent constituent itself. The Agency believes it has captured the risks that arise from the solvents themselves, and that this is a reasonable approach to fulfilling its listing determination obligations. • Little to no benefit would accrue from regulating these wastes because many are already regulated and treated as hazardous wastes. These solvent wastes, particularly nonwastewaters with a high organic content, are characteristically hazardous or mixed with other listed wastes, and are generally thermally treated. Other nonwastewaters, such as wastewater treatment sludges or filter media, do not contain measurable levels of the solvent constituents, and thus present no significant risks.

A. Data Collection

1. Representativeness of Industry Characterization One comment argues that EPA cannot fully characterize industry solvent management practices because the facilities that may be affected are too numerous to predict and specifically identify. Therefore, the Agency should project standard mismanagement scenarios in order to examine the full range of actual and potential waste management practices applicable to the wastes. This is the only way the Agency can discharge its mandate to protect human health and the environment. In response, EPA disagrees that it is not possible to predict and identify, as a practical matter, the facilities that may be affected. It is possible and appropriate to do so and EPA has, in fact, accomplished that purpose, as summarized below and explained more fully in the Response to Comments Document. The Agency outlined the general approach to the data collection process in the proposal (61 FR 42321- 42322). To summarize, the Agency began collecting data on all 14 chemicals involved in the listing determination (plus the seven in the Solvents Study) as a means of collecting background information on these chemicals. The Agency identified solvent uses through cross- referencing SIC codes in known and suspected process industries with data found in the TRI, Office of Water facility lists, and many other data sources. The Agency used many different facility address lists to create a list of potential solvent-using facilities. The sources used by the Agency provide a comprehensive view of the types of uses of these chemicals as solvents and the quantities used. The Agency identified industries using the 14 chemicals as solvents by conducting literature searches including Chemical Abstracts, the Chemical Engineering Handbook, the Industrial Solvents Handbook, and the SRI Chemical Economics Handbook. As today's document and the associated background documents explain, the process was a logical, iterative, step-by-step process. The chemicals in question are not likely to be widely used as solvents (with the exception of acetonitrile and, to a more limited extent, 2-methoxyethanol, which have significant solvent uses in some industries), because they have properties that limit their use to specific situations, and are generally noncompetitive in price. In addition, the Agency's data collection methodology combined a comprehensive view not only of the chemical's solvent use, but also of nonsolvent uses to confirm use data. The specificity of applications for these solvents, while sometimes cutting across more than one industry, is still limited enough that the listing determination could stay focused on the actual management scenarios found through questionnaires and site visits. The Agency is confident that the waste management practice data found in this investigation are adequate for risk assessment modeling, and that using other modeling practices not found would only lead to using hypothetical waste data that do not represent any activities that resemble reality. To engage in this kind of hypothesis would be likely to result in forcing significant additional costs on the public with no incremental risk reduction from regulating the wastes in question. The Agency notes that no commenter identified any specific solvent users of these chemicals not already found by the Agency. Also, the commenter could not suggest any alternative to the Agency's methodology other than a listing based on hypothetical uncertainties--an approach not justified by the data. The Agency sent almost 1,500 preliminary questionnaires asking facilities how much of each chemical was used as a solvent in 1991 and 1992. The data showed that the Agency was successful in identifying many solvent users, although more than 900 facilities were eliminated from further consideration because they did not use any of the chemicals as a solvent. The Agency was also able to eliminate another 400 facilities from consideration to receive the final questionnaires due to reporting errors, discontinued use, or reported use of small quantities of the solvents. The fact that the vast majority of facilities that received the preliminary questionnaire reported no solvent use supports EPA's view that many potential solvent users, in fact, do not use these chemicals this way. The Agency found that reported uses of very small quantities of the chemicals as solvents were often inaccurate, but facilities reported these quantities to err on the side of caution. The remaining

156 facilities received a large, detailed questionnaire requesting information on solvent uses and waste generation and management practices. The listing determination is based on these data. The details of the data collection effort also brought another point to the Agency's attention. While other solvents are used in countless industries and facilities and would be difficult to characterize, the particular set of solvents in this listing determination has much more limited applicability. EPA's literature search found these chemicals to have many and varied ``nonsolvent'' uses. Data collected from the questionnaires confirmed the general lack of wide solvent use, as discussed below. While reference sources (e.g., SRI Chemical Economics Handbook) indicated many of these chemicals are produced in fairly high quantities, these references reported significant quantities used as solvent for only four of the fourteen chemicals studied: acetonitrile, 2-methoxyethanol, furfural, and methyl chloride. This is consistent with what EPA found in its 3007 Survey for these four chemicals. Furthermore, as described in the Listing Background Document and the proposed rule, the solvent uses of furfural and methyl chloride were limited to a single specialized use in each case, and these users were fully surveyed. Solvent use quantities were not reported in reference sources for the other ten chemicals. Four of the ten were those for which EPA also found no solvent uses (benzyl chloride, epichlorohydrin, ethylene dibromide, and p-dichlorobenzene). For an additional four, EPA's Survey found that the amounts of the production quantities used as a solvent were small compared to total production (cumene-0.026%; cyclohexanol-99%) of the solvent use quantity found in the Survey was from one facility that produces phenol for its own captive use. This ``native'' phenol is produced as a byproduct of other processes, and would not be reported in production or use data in reference sources. Leaving out this volume from one facility, EPA's Survey shows that the fraction of phenol production that is used as a solvent is low (1,200 kg/yr), also used other solvents in lower volumes in some cases. Thus, the Agency has data on wastes from facilities that used small volumes of solvents, (see Listing Background Document, Appendix I). EPA reviewed the management practices for wastes generated by these smaller volume uses to see if any differences were evident. For all 10 solvents, EPA found a total of 73 wastes that were generated from solvent uses below 1,200 kg. The Survey data show that these were managed in ways that were very similar to practices reported for larger volume uses. Of these 73 wastes, 69 were incinerated or otherwise thermally treated (nearly all were classified as hazardous because they exhibited a hazardous Characteristic, or due to the presence of other listed hazardous waste), three wastewaters were treated in tanks, and one wastewater was treated in a surface impoundment (the chemical in the impoundment, acetonitrile, was evaluated through modeling). Furthermore, 67 of the 73 wastes reflected solvent use at concentrations of 50-100%, i.e., many of these wastes were generated from use of solvents at high concentration. None of these wastes from small volume users present any special risk, because risk analyses using larger loadings going to these management practices found no significant risks. Therefore, the existing data support EPA's belief that wastes from small volume users are not of any special concern. Furthermore, these wastes are nearly all handled as hazardous, which is also consistent with the general pattern found for other larger volume wastes. Two commenters stated that they agreed with EPA's decision to limit the solvents listing investigation to facilities that use a combined total of 1,200 kilograms or more per year of all chemicals of concern used as solvents because the commenters feel that this level represents a reasonable characterization of the universe of solvent users. One of these commenters requested clarification to ensure this approach would not be misconstrued by hazardous waste generators when determining their generator category. In response, the Agency is confirming that the cutoff categories used by the Agency in this listing determination are not to be construed by any actual or potential hazardous waste generators to be a means of determining waste generator categories. Furthermore, EPA did consider solvent uses below the 1,200 kg threshold as noted above, however, the Agency found that such small quantity use is highly unlikely to present risks of concern when compared to the risks from larger users. However, another commenter stated that EPA's rationale for deleting facilities using 1,200 kg or less of solvent in 1992 was that only large quantity solvent users could be expected to have treatment, storage, and disposal (TSD) units on-site, and that many of the solvent uses are peculiar to large companies. The commenter stated that this limitation in the data collection introduces bias against solvent generators relying upon commercial services, including offsite nonhazardous landfills, for their waste management needs. The commenter then argued that the Agency cannot assume offsite disposal in a nonhazardous waste landfill is rarely practiced when EPA intentionally excluded those facilities most likely to use such facilities by not surveying smaller volume users. The reasoning cited by the commenter is taken out of context and does not reflect EPA's rationale. EPA did not decide to eliminate small volume users because they would not have on-site treatment capabilities. Rather, EPA determined that the burden of completing a complex, 100-plus page questionnaire would not be commensurate with the value of the information EPA would receive. EPA would not gain useful information from small users because many of these facilities, if they use these chemicals as solvents at all, would present low risks compared to larger solvent users. Furthermore, as noted above, EPA did, in fact, capture small users of solvents in the full Survey, and found no special management or risk concerns that were not reflected in it evaluation of larger solvent users. Facilities are likely to use on-site as well as off-site waste management practices, and sometimes a combination of the two. This is evidenced in responses to the 3007 Survey, wherein respondents indicated that both on-site and off-site practices were employed. The 3007 Survey has captured numerous facilities that use commercial services. Based on the results of the Survey, 62 percent of the wastestreams are managed in commercial offsite treatment or disposal units. As such, the Agency does not believe there is any significant bias in its Survey. In addition, EPA points out that the vast majority of small solvent users eliminated by EPA reported using amounts well below the 1,200 kg threshold. In fact more than 90% of those eliminated reported used less than 120 kg total for all of the solvents studied. EPA found that uses of such small volumes typically were reported for laboratory uses, are difficult to verify, and may be reported as solvent use if laboratory uses are not known. The 1,200 kg/yr cutoff is an appropriate surrogate for identifying facilities that may potentially generate large amounts of hazardous waste or waste with high solvent loadings. EPA believes the facilities with larger solvent uses would be most likely to provide useful data through the questionnaire, i.e., data based on verifiable solvent use that could then be used in developing risk assessments. One commenter argued that solvent use fluctuates from year to year, thus uses below 1,200 kg could increase dramatically in the future due to process changes, increases in production, or solvent substitutions. The commenter went on to state that use volumes for some solvents reported in the final questionnaire for 1993 were higher than the rates reported for the same facilities in the preliminary questionnaire for the prior year. The commenter stated that EPA fails to appreciate the consequence of these fluctuations and substantial changes can be expected from year to year, e.g., a facility using less than 1,200 kg of solvent one year may use more than that amount the next year. The commenter concludes that EPA lacks an objective basis for simply assuming the data it collected is fully dispositive with

respect to future solvent uses and management practices. EPA believes that the data collected provides a reasonable bases for decision-making. The purpose of the preliminary questionnaire was to capture what occurs at the facilities surveyed during a typical year. As was expected, some facilities' solvent use consumption decreased between the two years and other facilities' solvent consumption increased between the two years. The Agency does not expect solvent consumptions to be identical from year-to-year, but has no data to indicate that 1993 is an atypical year. Even if the specific facilities meeting the cutoff varied from year to year, EPA believes the data gathered from facilities studied provide a representative database. The Agency used the most recent data when determining the 1,200 kg cutoff for those facilities receiving the full questionnaire. EPA considered whether or not solvent management practices were likely to change in the future from those reported in the 3007 Survey. The Agency determined that there was no reason to believe that they would, regardless of the volume fluctuation. In the case of wastewaters, EPA has no reason to believe that a facility would convert from a tank-based system to a surface impoundment given the capital investment and liability issues associated with land-based treatment, particularly when facilities do not have the physical space for a surface impoundment or have closed surface impoundments in favor of tank-based systems. For nonwastewaters, EPA has no reason to believe that a facility would switch from the thermal treatment of high organic wastes to disposal in a nonhazardous landfill due to the BTU value and the liability issues associated with land-based disposal. The Agency cannot accurately predict with specificity future uses of the fourteen chemicals, nor is it reasonable for EPA to regulate solvent waste based on some purely hypothetical future use. While the solvent consumption may change over time for some facilities, such fluctuations are unlikely to significantly affect EPA's current risk conclusions for several reasons. First, in its risk analyses EPA used high-end or maximum solvent loadings to project potential risks. Thus, EPA's evaluation is not likely to change due to some volume use fluctuations. In addition, for most of these solvents (and specifically for three noted by the commenter, acetonitrile, 2-methoxyethanol acetate, and isophorone), the vast majority of wastes are regulated as hazardous due to the hazardous waste characteristics (see 40 CFR 261.20-261.24) or mixing with other listed wastes. Thus, any increase in volume use would result perhaps in somewhat higher solvent quantities reaching wastes that would be already regulated and thus unlikely to pose significant risk. Therefore, while EPA agrees that its Survey is more-or-less a ``snapshot'' of waste generation data, the Agency continues to believe that such an approach has yielded data that are representative, and is a reasonable way to assess potential risks. The commenter also stated that EPA excluded any laboratory uses of the solvents from the universe of facilities receiving the preliminary questionnaire, notwithstanding the Agency's observation that ``lab use'' of chemicals was not restricted to small volumes. The Agency did not exclude laboratory uses of solvent from the universe of facilities. The Agency was precluded from sending a 3007 Survey to all laboratories due to the sheer number of labs that exist in the United States, approximately 183,000 according to an estimate by EPA. (For details please refer to the Response to Comments Document). Many of these laboratories are small, comprising research labs (12,500), medical laboratories (22,700), and university labs (108,000), as well as small analytical labs (40,000). The resources necessary to complete a RCRA 3007 questionnaire would be beyond the means of many of these small businesses as organizations. Nonetheless, the Agency captured the solvent uses and management practices of numerous (32) captive on-site laboratories of facilities who received the 3007 Survey. In doing so, the Agency captured large research, QA/QC, and analytical laboratories that operate at the same or larger scale as the small labs not surveyed. Approximately 38% of the laboratories captured were small laboratories (i.e., using 1) Thus, EPA believes that such wastes will be sent for thermal treatment under the current regulatory structure. The Agency decided, however, to examine the resulting risks if such disposal were to occur in an unlined Subtitle D landfill. As described in more detail in the Supplemental Risk Assessment, the resulting analysis suggested hazard quotients in the range of 11-22 for a high-end scenario. ---------------------------------------------------------------------------

\1\ See contact report dated June 10, 1998 documenting a telephone conversation with Dave Giffen, B.F. Goodrich, which is located in the docket accompanying today's rule. ---------------------------------------------------------------------------

EPA does not view these risks as significant, however, for several reasons. First, as noted above, landfill disposal is unlikely given the fuel value of the material, thus EPA does not view disposal in a D landfill plausible. In any event, the elevated HQs were projected for only one waste out of the 254 acetonitrile wastes identified in the 3007 Survey. Even if EPA found that the elevated HQs reflected a plausible management scenario, the Agency might well decide that the potential risk posed by this one waste does not merit listing of all acetonitrile residuals generated. Given the widely varying nature of the industries and wastes involved, and the very small percentage of management activities that even arguably could present a risk of concern, the Agency believes that a broad listing for solvent use would result in over regulation. In any case, EPA concludes that wastes such as these are not likely to be disposed in landfills, and are therefore unlikely to pose significant risks. Phenol. Decision. EPA is not listing wastes from the solvent use of phenol as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA finds no significant risks from treatment in aerated tanks, storage in tanks, or combustion in a boiler. Furthermore, EPA does not believe that potential risks from land-based management of phenol wastes are significant. None of the wastes containing phenol were reported to go to landfills. Wastes with high organic content that contain any appreciable levels of phenol were classified as hazardous waste, and were sent for fuel blending or incineration as hazardous. Wastewaters were generated from the specialized use of phenol as a solvent in the extraction of materials from crude oil, and the resulting spent phenol wastes were sent to wastewater treatment systems for treatment in tanks or surface impoundments. EPA found risks from impoundments would be low given the dilution and treatment that occurs in these wastewater treatment systems, and the specific facts associated with the impoundment of potential concern (see 61 FR 42337). In response to comments, EPA conducted further analyses of the potential risks that might arise from treatment of phenol wastewaters in a surface impoundment. In these analyses EPA also included consideration of any additional risk resulting from noningestion exposure from groundwater (e.g., inhalation), as well as codisposal with other solvent wastes under evaluation. As described in section IV.C, these analyses further confirmed this management practice presents no significant risks. EPA used the updated toxicological benchmark discussed in section III of today's rule for all additional analyses. The Agency also used the updated toxicological benchmark to revise the risk assessment results for other practices, i.e., storage and treatment in tanks, and found this

had no significant impact on the risks (see Table 3). Based the results of the risk analyses in the proposal, as well as the updated evaluations, these spent solvent residuals are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. Specific comments. One commenter supported EPA's decision not to list wastes from solvent uses of phenol as hazardous wastes. The commenter agrees with EPA that phenol does not satisfy the criteria for listing in 40 CFR 261.11(a)(3). However, another commenter stated that there are cases where phenol is currently used by itself (without being mixed with other F-listed wastes) as an industrial solvent and with this decision ``not to list'' phenol as a hazardous waste, EPA would seem to provide disposal option ``carte blanche'' for current users. Manufacturers can modify their processes to use these solvents, which would no longer be considered hazardous wastes, according to this commenter. In response, the Agency believes it unlikely that facilities would change their management practices based on the information collected in the Survey. The Survey indicated that all nonwastewater residuals containing phenol were managed as hazardous except one, which is managed by incineration. Thus, the solvent users managed their wastes as hazardous under the existing regulatory framework. There is no evidence that any facility that has not modified their process to use these solvents to date will do so after a no-list decision. Except for the facilities that use phenol for extracting lube oil, most facilities that use phenol as a solvent use it in laboratories or other specialty uses, and the waste solvents are sent for offsite treatment via incineration as hazardous waste. EPA has no indication that such generators could easily modify their use and accumulation practices in an attempt to generate nonhazardous material, nor is there any indication that facilities would do so. A third commenter stated that EPA's decisions regarding plausible mismanagement scenarios are especially suspect in the case of phenol, because phenol is the 33rd highest volume chemical produced in the United States, is already widely used, and its use is projected to increase. The commenter stated that EPA did not adequately evaluate groundwater risks posed by phenol. EPA disagrees with the commenter's inference that projected production increases in phenol are destined for solvent use. In fact, more than 96% of the phenol consumed in the U.S. is for nonsolvent uses (see SRI Chemical Economics Handbook, 1996). Increasing demand for products produced from phenol is due to increases for production of caprolactam, aniline, and bisphenol-A, (e.g., see https:// www.chemicalweek.com/marketplace/prod__focus.html). Nearly all of the solvent use of this chemical (>99.9%) was attributed to the petroleum industry, of which the Agency conducted a complete survey. Given that the major uses of this solvent were very specialized (i.e., extraction of lube oil), the Agency is confident that no other significant uses are likely to exist. Contrary to the comment, damage from groundwater contamination was evaluated for the proposed rule, and a refined assessment was conducted for the final rule, and noted in section IV.B. These analyses did not find significant groundwater risks (see Table 2), and details are given in the Supplemental Risk Assessment document in the docket. The commenter also noted that EPA's Hazardous Waste Characteristic Scoping Study (November 1996) showed that phenol releases originated from nonhazardous waste management units, principally landfills and surface impoundments. The Scoping Study, which expressly excluded product spills and accident releases, presents clear evidence of the potential risks posed by the improper management of phenol wastes, and the use of nonhazardous surface impoundments and landfills as plausible mismanagement scenarios for phenol and other solvent wastes. The commenter went on to state that EPA assumed tanks never leak, and landfills would never be used, because none were reported by the 31 facilities receiving the final questionnaire. The Agency disagrees that this aspect of the Characteristic Scoping Study is relevant to the Solvents Listing Determination. As EPA noted in the proposed rule, damage cases reviewed did not show evidence linking the phenol contamination at damage sites, including nonhazardous landfills and surface impoundments, to phenol use as a solvent. Without evidence that the mismanagement of phenol wastes resulting in contamination is linked to solvent use, the damage incidents are not an adequate basis for listing phenol as a spent solvent. As noted above, the vast majority of phenol is used for nonsolvent uses. Therefore simply pointing to damage case analyses is not compelling evidence for listing phenol wastes that result only from its use as a solvent. If EPA were to determine that certain industries that use phenol for nonsolvent uses are mismanaging wastes and causing significant environmental problems, then the Agency would consider other regulatory approaches. However, EPA's examination of the limited solvent use of this chemical indicates that such uses are not likely to generate wastes of concern. Thus, a listing of spent solvent wastes for this chemical would not be a practical way to address the types of environmental concerns raised by the commenter. EPA responded to the general issues of tanks and landfill disposal elsewhere in today's document. In the case of phenol, the Agency did not consider the disposal of phenol-containing wastestreams in a landfill to be a plausible management scenario for several reasons. None of the 38 wastestreams containing spent phenol reported in the 3007 Survey are managed in a landfill. One reason for this is that very few phenol wastes are solids (most are organic or aqueous liquids). Only one solid wastestream, spent carbon, contained significant levels of phenol. This was sent offsite for regeneration or incineration. EPA has no reason to conclude that the practice of landfilling will increase. Wastes with higher organic content are thermally treated, and 92% of the thermal treatment was conducted in hazardous waste units or through fuel blending for future burning. Therefore, EPA has no basis to project that wastes with significant phenol concentration are likely to be placed in a landfill. Methyl Chloride. Decision. EPA is not listing wastes from the solvent use of methyl chloride as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA finds treatment in aerated tanks and surface impoundments, storage in tanks, or combustion in a boiler do not present significant risk. The vast majority of methyl chloride produced is used as an intermediate in chemical manufacturing, and very few uses as a solvent were identified. Essentially all of the wastes reported from the solvent uses of methyl chloride were limited to two facilities that produce butyl rubber. While some of the updated lifetime individual excess cancer risks in Table 3 for storage in tanks and wastewater treatment in tanks/surface impoundments were above 1E- 06, the risks are below the 1E-05 level typically used by the Agency for identifying

candidate wastes for listing. Furthermore, as described below, the consideration of other factors indicate these risks are not significant. The high-end risks for storage tanks (4E-06 from the updated analysis and 2E-06 from the Air Characteristic approach) are highly likely to be overestimates, because the analyses assumed that all of the methyl chloride in the stored solvent waste would be released. This assumption is unlikely for materials being stored expressly to send for thermal treatment. Furthermore, these wastes were reported to be already regulated as hazardous, and would be subject to RCRA regulations limiting air releases under 40 CFR part 264, subpart CC. The risks found for wastewater treatment tanks (1E-06 from the updated analysis, and 1E-07 from the Air Characteristic approach) are at or below EPA's presumptive no-list level of 1E-06, and do not appear of concern. In addition, these are likely to be overestimates, because the concentration modeled for this scenario was 10 ppm, even though the value was actually reported as less than 10 ppm. EPA's updated assessment of the one wastewater reported to be treated in a surface impoundment showed a high-end risk of 4E-06. However the one impoundment that managed this waste is already a permitted Subtitle C hazardous waste unit, and is therefore subject to regulations limiting air releases (see 40 CFR part 264, subpart CC) and groundwater release ( 40 CFR part 264, subparts F and K,). In addition, potential air releases from this industry are being addressed by other regulations promulgated under the Clean Air Act (see 61 FR 46906, September 5, 1996). These regulations control releases of hazardous air pollutants from process units, storage tanks and wastewater treatment systems. EPA believes that these air regulations provide a more integrated approach to controlling air risks than would be possible under the limited controls available for air releases under the RCRA listing program. Based on the analysis in the proposal, the updated evaluations, and the other factors discussed in this document and the proposal, the methyl chloride solvent wastes are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. Specific Comments. One commenter supported the Agency's decision not to list methyl chloride. However, another commenter stated that the Agency left potential risks posed by the groundwater exposure pathway unevaluated by assuming methyl chloride was managed only in a permitted surface impoundment, that tanks never leak, and that landfills would never be used. As discussed more detail in the proposed rule (see 61 FR at 42334- 42335), the Agency did evaluate the groundwater exposure pathway through management scenarios where groundwater exposure was plausible. Wastes with high organic content were regulated as hazardous and incinerated. Waste solids were rarely sent to landfills, and in these cases the concentrations of methyl chloride were negligible. The only wastes sent to landfills were a small volume of spent desiccant that contained <5 kg of methyl chloride, and a larger volume sludge/ash from a sludge treatment unit which was reported to have a ``trace'' amount of methyl chloride. Given that this chemical is readily treated by biodegradation and volatilization in an aerated biological treatment system, it is unlikely that any significant levels of methyl chloride remain in this residual. EPA believes that these very low concentration wastes reflect the types of waste solids that are likely to be sent to landfills. EPA also notes that other nonwastewaters containing any reported levels of methyl chloride (a total loading of 1.6 kg) were regulated as hazardous waste, making disposal in an unlined Subtitle D landfill illegal. Thus, significant groundwater risks from landfills are unlikely to occur. The very limited solvent use of this chemical, and its unique characteristics (a gas at room temperature) lead EPA to conclude that it is unlikely that other solvent wastes would be generated that are managed in other surface impoundments beyond the example documented in the 3007 survey. As noted above, this impoundment is a hazardous waste unit, and is therefore subject to RCRA regulations limiting groundwater releases. Furthermore, as noted in the proposed rule, methyl chloride is readily treated by biodegradation and volatilization in waste water treatment systems, and thus is unlikely to migrate to the groundwater. Also, the tendency of methyl chloride to hydrolyze in water to methanol suggests that transport to receptors by groundwater is not likely to be significant. One commenter argued that EPA failed to adequately consider the formation of products of incomplete combustion (PICs) for methyl chloride. The commenter stated that EPA claimed PIC emissions were not cause for concern because the reported waste in question happened to be managed in a hazardous waste combustor, and disagreed with EPA's presumption that this one waste management practice reported represents current and future combustion activities. As noted above, the solvent uses of methyl chloride are very specialized, and the number of wastes sent for incineration are limited. The three wastes with reported concentrations that went to thermal treatment were all classified as hazardous waste and were treated as such under RCRA regulations. (Two wastes incinerated were treatment sludges that were reported to contain no significant levels of methyl chloride). Given these reported practices, and the very limited solvent uses for this chemical, EPA believes that combustion of solvent wastes with appreciable methyl chloride is likely to occur in RCRA regulated units. Therefore, the Agency believes its presumption for management is valid in this case. In addition, EPA is not aware of any precise way of predicting the kinds or levels of PICs that might be generated in a nonhazardous boiler, especially because the wastes in question would make up only a very small fraction of the wastes being treated. Nevertheless, EPA did consider the possibility of PIC formation for incineration of methyl chloride wastes. As discussed in the preamble to the proposed rule (61 FR 42334), the amount of methyl chloride in the wastes that are incinerated is extremely small (i.e., 2 kg). The loading of methyl chloride sent to a boiler or industrial furnace (BIF), although larger (i.e., at 2,250 kg) than the amount sent to an incinerator, is in a waste that is hazardous due to ignitability and toxicity characteristics, and therefore must be treated as hazardous wastes. This latter waste is generated from the use of methyl chloride in butyl rubber manufacturing, and it is unlikely that such a complex process could (or would) be modified to avoid generating waste methyl chloride in association with high levels of ignitable hydrocarbons. Thus, combustion in a RCRA-regulated unit seems likely to occur for this waste due to the specialized nature of this solvent use. These combustion units are operated according to stringent air emission standards that limit PIC formation (e.g., see 40 CFR part 264, subpart O, for incinerators and part 266, subpart H, for Boilers and Industrial Furnaces). EPA has also proposed revisions to these standards (see 61FR1538, April 19, 1996 and 62FR24212, May 2, 1997). Given these facts, as well as the results of the risk assessment for these wastes, EPA

does not believe that combustion of these wastes poses a significant risk. 2-Methoxyethanol (2-ME). Decision EPA is not listing wastes from the solvent use of 2-methoxyethanol (2-ME) as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from treatment in aerated tanks or combustion in a boiler. EPA also concluded that potential risks from air releases of 2-ME stored in open accumulation tanks are also not significant, because all of the nonwastewater residuals stored under this scenario are already regulated as hazardous waste, either because the wastes exhibit a characteristic, or because the 2-ME waste is commingled with listed wastes. EPA believes that regulatory controls afforded by the existing solvent listings and the characteristics (primarily ignitability) are sufficiently protective of human health and the environment. None of the wastes examined were sent to land disposal in a landfill or impoundment. Spent solvent solids are thermally treated, and wastewaters are all treated in tanks. In the face of the existing practices, EPA finds it implausible that high organic wastes currently sent to thermal treatment would be sent to landfills. Essentially all of the nonwastewater residuals that contain spent 2-ME are thermally treated or recovered, and nearly all (96%) are treated as hazardous waste. Because all wastewaters are treated in tanks, EPA also does not expect risks from surface impoundment management for these wastes. Given that nearly all of the nonwastewater 2-ME residuals are already being handled as hazardous, or contain negligible amounts of the solvent, these spent solvent residuals are not likely to pose a significant hazard to human health or the environment. Furthermore, treatment of wastewaters in tanks presents no significant risks. Therefore, the Agency continues to believe that a no-list decision is warranted. More general comments on EPA's methodology and approach that relate to 2-ME are discussed elsewhere in today's document. The few comments specific to 2-ME are discussed below. Specific comments. One commenter stated that EPA completely failed to evaluate potential risks from groundwater contamination, notwithstanding three groundwater contamination incidents involving this solvent identified by EPA from damage incidents. EPA described in the proposed rule why the damage cases cited by the commenter were not useful (see 61 FR at 42332). Of the three problem site identified, two were old landfills that received a wide variety of industrial and municipal wastes, and the use of 2-ME prior to disposal was impossible to ascertain. The chemical is widely used as a fuel additive and as a chemical intermediate. Thus, the damage could not be tied to wastes generated from the use of this chemical as a solvent. Damage at the third site also could not be linked to a specific use of 2-ME. However, this site was a used oil recycling site, and the contamination found may be related to the use of 2-ME as a fuel additive. Furthermore, none of the reports examined by the Agency provided any concentration of 2-ME in the groundwater. Thus, the limited data from the damage incidents provide no reliable support for listing wastes from the use of 2-ME as a solvent. In addition, the industries EPA identified as solvent users of 2-ME are not represented in the damage incidents. Finally, the vast majority of nonwastewater solvent wastes identified in the Survey were reported to be hazardous waste, and could not be placed in nonhazardous landfills. Thus, the damage incidents did not provide useful information on current or likely future waste management practices. One commenter argued that EPA's high-end risk analysis of onsite accumulation tank storage resulted in a HQ of 16, well above the HQ of 1 that typically warrants a hazardous waste listing. Only by performing the completely misguided Phase III assessment was EPA able to arguably rationalize a no-list decision. EPA's response to this comment is similar to the response above to essentially the same comment raised for acetonitrile. The apparent risks cited by the commenter were from an intermediate stage of the risk assessment, and did not reflect the fact that all nonwastewaters were managed as hazardous waste. EPA concluded that the management scenario referred to in the comment (on-site accumulation of nonwastewaters in unregulated tanks) does not apply to any 2- methoxyethanol waste streams. 2-Ethoxyethanol Acetate (2-EEA). Decision. EPA is not listing wastes from the solvent use of 2-ethoxyethanol acetate (2-EEA) as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from treatment in aerated tanks, storage in tanks, or combustion in a boiler. Furthermore, essentially all (99.8%) of the nonwastewaters were reported to be hazardous and were managed as hazardous waste through some form of thermal treatment. None of the wastes were reported to go to land disposal in landfills or impoundments, and these scenarios were not modeled. Given the existing waste management practices, EPA finds it implausible that high organic waste solids currently sent to thermal treatment would be sent to a landfill. The high percentage of wastes that are hazardous are precluded from disposal in an unlined Subtitle D landfill, and EPA has no evidence to indicate that spent 2-EEA wastes would be placed in a landfill. Due to the nature of the primary industries using 2-EEA as a solvent (e.g., the semiconductor and electronics industries), very few wastewaters are generated. Nearly all of the wastestreams generated are spent solvent wastes that undergo some type of thermal treatment. None of the wastestreams that were reported in the 3007 Survey go to a surface impoundment. Any change from the current treatment in tanks to treatment in impoundments seems unlikely given the capital investment associated with tanks and the liability issues associated with treatment in a surface impoundment. These facilities made an investment in tank-based systems in the absence of any listing, and EPA sees no reason why this would change if the status quo is not changed, i.e., if the wastes are not listed. In addition to cost considerations, some facilities may perceive other benefits from managing the waters in tanks, such as the current exemption from RCRA permitting requirement for such units (see 40 CFR 264.1(g)(6)). If hazardous waste were to be treated in a wastewater treatment system, impoundments in the system would require permitting as a Subtitle C unit. In addition, the use of 2-EEA has been decreasing in recent years, thus other new generators of this spent solvent are unlikely. Given that nearly all of the nonwastewater 2-EEA residuals are already being handled as hazardous, or contain negligible amounts of the solvent, these spent solvent residuals are not likely to pose a significant hazard to human health or the environment. Furthermore, treatment of wastewaters in tanks presents no significant risks. Therefore, the Agency continues to believe that a no-list decision is warranted. More general comments on EPA's methodology and approach that relate to 2-EEA are discussed elsewhere in today's document. The few comments

related specifically to 2-EEA are discussed below. Specific comments. Two commenters stated that EPA failed to consider in its risk assessment, that many of the generators manage 2- EEA with other solvents associated with this proposed rule. EPA calculated an HQ for 2-EEA for on-site accumulation of 0.7. Thus, additional risk from other solvents would cause the HQ level to exceed the threshold of one. One of the commenters went on to cite examples of facilities in several industries (e.g., printed circuit board manufacturers) at which multiple solvents were reported. EPA disagrees with the commenters' concerns about multiple solvent risks. First, the comment cited examples where the hazard quotient would exceed one at facilities that use more than one solvent in combination. However, the use of the chemicals at the facilities cited by the commenter are not solvent use, within the Agency's definition. These facilities used 2-EEA and other chemicals as components in formulations. Thus, no spent solvent is generated and was not included in the risk assessment. Furthermore, the HQ value of 0.7 cited by the commenter for on-site accumulation is likely to be unrealistically high for the reasons cited for the Phase II results for acetonitrile. The key reason is that essentially all residuals stored prior to thermal treatment were, in fact, already hazardous waste. Thus, air emissions from these wastes are already regulated under RCRA subpart CC to 40 CFR part 264, making the scenario of storage in an open tank unrealistic. EPA did not pursue a third phase of analysis for 2-EEA because the HQ was below one in the Phase II evaluation. Furthermore, the only wastes reported that were not hazardous consisted of one insignificant loading (<1 kg), and one waste characterized as ``containers/rags'' which contained very low levels of the solvent (<6 kg). Thus, EPA decided further analysis was not needed. As described in the Risk Assessment section, EPA addressed the general comment of the impact of multiple solvents in some wastes by conducting an assessment of the potential for cumulative risks. One commenter stated that the concentrations of 2-EEA in solvent nonwastewaters range from 0.1% to 100%. These ranges are not consistent with the Agency's position that nonwastewaters would always be managed as a hazardous waste due to ignitability, particularly where the solvent is not co-managed with listed solvent wastes. The commenter was also concerned because the concentration of 2-EEA in wastewaters ranges from 200-20,000 ppm. While the levels of 2-EEA in solvent nonwastewaters are variable, the reported data clearly indicate that essentially all 2-EEA solvent wastes generated were hazardous, and that these were all incinerated. Concerning the wastewaters, EPA believes the commenter's concern is unfounded. EPA's risk assessment included an analysis of potential risks from air releases from an aerated wastewater treatment tank, and found risks to be well below levels of concern. Furfural. Decision. EPA is not listing wastes from the solvent use of furfural as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from treatment in aerated tanks or surface impoundments, storage in tanks, or combustion in boilers. Essentially all of the solvent use of this chemical (greater than 99.99%) is in the petroleum industry as an extractant for lube oil. Thus, solvent use of furfural is limited, and the Agency identified only a handful of wastes derived from this use. The furfural solvent wastes are virtually all wastewaters (greater than 99.99%), which were managed in wastewater treatment systems. One of the three facility's wastewater treatment systems uses a surface impoundment, and EPA's bounding analysis for the proposed rule showed no risks of concern from ingestion of groundwater, or inhalation of possible air releases (HQ <1; see 61 FR at 42341). In response to comments, EPA conducted further analyses of the potential risks that might arise from treatment of furfural wastewaters in a surface impoundment. In these analyses EPA also included consideration of any additional risk resulting from non-ingestion exposure from groundwater (e.g., inhalation). As shown in Table 3, the high-end risk analyses showed that these wastewaters do not present significant risks via either groundwater releases (HQ = 0.46), or air releases (HQ = 0.11). Based the results of the risk analyses in the proposal, the updated evaluations, and the other factors discussed in this document and the proposal, the furfural solvent wastes are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. General comments on EPA's methodology and approach that relate to furfural are discussed elsewhere in today's document. EPA did not receive any other specific comments on EPA's decision not to list furfural solvent wastes. Cumene. Decision. EPA is not listing wastes from the solvent use of cumene as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from treatment in aerated tanks, storage in tanks, or combustion in boilers. While cumene is used in large volumes in the production of other chemicals, such as phenol, its use as a solvent is limited. Essentially all of the wastes containing cumene are thermally treated as hazardous or recovered. Small amounts of wastewaters are sent to treatment systems, and one resulting sludge was reported to be landfilled. However, the amount of cumene in this sludge would be well below the maximum of 28 kg that was used in the original solvent mixture (which contained only 1.7 % of cumene to start with). Thus, after treatment, any risks from cumene would be negligible. Similarly, one wastewater was reported to undergo treatment in a surface impoundment, however, as EPA noted in the proposal, the amount of cumene in the wastewater was small (<47 kg), and would be further reduced by treatment. In response to comments, EPA conducted further analyses of the potential risks that might arise from treatment of cumene wastewaters in a surface impoundment. In these analyses EPA also included consideration of any additional risk resulting from non-ingestion exposure from groundwater (e.g., inhalation during showering). As shown in Table 2, the revised bounding analyses showed that these wastewaters in impoundments do not present significant risks via either groundwater releases (HQ = 0.0001), or air releases (HQ = 0.003). As noted earlier in today's document, the toxicological values for cumene were updated during the comment period. The new benchmarks were used in the revised analyses, and were also used to recalculate risks derived in the proposed rule (see Table 1). The changes reflect greater tolerance for cumene than the previous benchmarks, and thus have no impact on EPA's decision not to list cumene solvent wastes. EPA also considered the potential for cumene to form NAPLs, which might present special problems in assessing potential risks. EPA noted in the proposed rule that cumene's water solubility is relatively low, such that NAPLs are theoretically possible.

However, EPA considered the potential risks from NAPLs to be very low, because cumene loading in wastes sent to land-based disposal was minimal. In response to comments, EPA provided further analysis showing that NAPL formation for these wastes is unlikely (see section IV.B). Based the results of the risk analyses in the proposal, the updated evaluations, and the other factors discussed in this document and the proposal, the cumene solvent wastes are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. General comments on EPA's methodology and approach that relate to cumene are discussed elsewhere in today's document. Cyclohexanol. Decision. EPA is not listing wastes from the solvent use of cyclohexanol as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from accumulation in storage in tanks or combustion in boilers. The solvent uses of cyclohexanol are limited, and few wastes containing cyclohexanol were reported. All wastes but one are hazardous waste due to other waste constituents or properties of the waste material. The incinerated material contains low levels of cyclohexanol (16 kg total loading per year). The one other waste generated was reported to go to a nonhazardous landfill, however, this waste is a small volume (750 kg) of filter material that contains negligible level of cyclohexanol. Given the limited solvent uses of this chemical, and the management practices reported, EPA believes other wastes or management practices are not likely to be significant. As noted earlier in today's document, the toxicological inhalation benchmark (``provisional RfC'') for cyclohexanol was adjusted somewhat based on peer review comments. Thus, EPA used the new benchmark to recalculate risks derived in the proposed rule (see Table 3). The revised HQs remain below one, and thus the updated health-based number has no material effect on EPA's decision not to list cyclohexanol solvent wastes. Based the results of the risk analyses in the proposal, the updated evaluations, and the other factors discussed in this document and the proposal, the cyclohexanol solvent wastes are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. More general comments on EPA's methodology and approach that relate to cyclohexanol are discussed elsewhere in today's document. Isophorone. Decision. EPA is not listing wastes from the solvent use of isophorone as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from accumulation in storage in tanks or combustion in boilers. The solvent uses of isophorone are limited, and few wastes containing isophorone were reported. All wastes but one were hazardous waste due to mixture with other listed wastes or the ignitability characteristic of the waste material. All wastes were reported to undergo some form of thermal treatment as a hazardous waste. Given the limited solvent uses of this chemical, and the management practices reported, EPA believes other wastes or management practices are likely to be significant. As noted earlier in today's document, the toxicological value (``provisional RfC'') for isophorone was adjusted somewhat based on peer review comments. Thus, EPA used the new benchmark to recalculate risks derived in the proposed rule (see Table 1). The revised HQs remain below one, and thus the updated health-based number has no material effect on EPA's decision not to list isophorone solvent wastes. Based on the results of the risk analyses in the proposal, the updated evaluations, and the other factors discussed in this document and the proposal, the isophorone solvent wastes are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. More general comments on EPA's methodology and approach that relate to isophorone are discussed elsewhere in today's document. 2-Methoxyethanol Acetate (2-MEA). Decision. EPA is not listing wastes from the solvent use of 2-methoxyethanol acetate (2-MEA) as hazardous waste under 40 CFR 261.31. As described in the proposed rule and as modified by subsequent analysis in response to comments, EPA found no significant risks from storage in tanks or combustion in a boiler. 2-MEA is reportedly no longer produced domestically, and solvent use of this chemical is limited. The few wastes generated were classified as hazardous and were all thermally treated as hazardous waste. Given the limited and decreasing use as a solvent, and the waste information reported, EPA believes that other wastes and management practices are unlikely. None of the wastes were reported to be disposed of in landfills or impoundments, and these scenarios were not modeled. Given the existing practice, EPA finds it implausible that high organic waste solids currently sent to thermal treatment would be sent to a landfill. The wastes are hazardous and thus precluded from disposal in an unlined Subtitle D landfill. EPA has no evidence to indicate that spent 2-MEA wastes would be placed in a landfill. Due to the nature of the solvent uses reported for 2-MEA (diluent in coating and reaction media), no wastewaters are generated, nor were they expected. Based on the results of the risk analyses in the proposal, the updated risk analysis, and other factors noted above and in the proposed rule, these spent solvent residuals are not likely to pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that a no-list decision is warranted. More general comments on EPA's methodology and approach that relate to isophorone are discussed elsewhere in today's document. EPA did not receive any specific comments on EPA's decision not to list 2-MEA solvent wastes. Chemicals with no significant solvent use. As described in the proposed rule and reaffirmed in this final decision, EPA did not find any significant solvent use for four chemicals: p-dichlorobenzene, benzyl chloride, epichlorohydrin, and ethylene dibromide. All but one are relatively reactive chemicals, which makes them unsuitable for most solvent applications. The other substance, p-dichlorobenzene, is a solid at room temperature, limiting its utility as a solvent. In all cases, the data collected by the Agency showed that any solvent use of these chemicals is extremely limited. Some may perhaps have specialty applications in laboratories, but no significant solvent uses were identified. Any residuals reported from the 3007 Survey were primarily from possible solvent use by laboratories and contain low levels of the chemicals under study. All were coded as hazardous, except one dilute wastewater, and were thermally treated as hazardous waste. The Agency received no new information during the comment period indicating that these four chemicals, (benzyl chloride, epichlorohydrin, ethylene dibromide, and p-

dichlorobenzene) were used as solvents. Comments received by EPA on this issue concurred with the Agency's decision that these four chemicals are not used as solvents, and that they would not fit the description for such a listing. Based on the analyses and factors noted above and in the proposed rule, these spent solvent residuals do not pose a significant hazard to human health or the environment. Therefore, the Agency continues to believe that no-list decisions for these four chemicals are warranted.

V. Regulatory Requirements

A. Regulatory Impact Analysis Pursuant to Executive Order 12866

Executive Order No. 12866 requires agencies to determine whether a regulatory action is ``significant.'' The Order defines a ``significant'' regulatory action as one that ``is likely to result in a rule that may: (1) have an annual effect on the economy of $100 million or more or adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.'' The Agency estimated the costs of today's final rule to determine if it is a significant regulation as defined by the Executive Order. Because the Agency has decided not to list as hazardous the wastes generated from the use of the solvents evaluated in this rulemaking, no specific action is required under this action. As a result, there are no costs associated with this final rule. This rule was deemed significant for novel policy reasons by the Office of Management and Budget (OMB) and was submitted to OMB for review.

B. Regulatory Flexibility Act

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996) whenever an agency is required to publish a document of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. The following discussion explains EPA's determination. This rule has no effect as the Agency is issuing this final decision not to list wastes generated from the use of 14 chemicals as solvents as hazardous under the Resource Conservation and Recovery Act (RCRA). The determinations in this rule are limited to specific solvent wastes. The rule does not impose new burdens on small entities. Therefore, I hereby certify that this rule will not have a significant economic impact on a substantial number of small entities. This rule, therefore, does not require a regulatory flexibility analysis.

C. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law No. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. EPA has determined that this rule does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate. The rule would not impose any federal intergovernmental mandate because it imposes no enforceable duty upon State, tribal or local governments. States, tribes and local governments have no compliance costs under this rule. For the same reasons, EPA also has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. In addition, as discussed above, the private sector is not expected to incur costs exceeding $100 million. By these findings, EPA has fulfilled the requirement for analysis under the Unfunded Mandates Reform Act.

D. Executive Order 12875: Enhancing the Intergovernmental Partnership

Under Executive Order 12875, EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 12875 requires EPA to provide to the Office of Management and Budget a description of the extent of EPA's prior consultation with representatives of affected State, local and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.'' Today's rule does not create a mandate on State, local or tribal governments. The rule does not impose any enforceable duties on these entities.

It issues a final decision not to list wastes generated from the use of 14 chemicals as solvents as hazardous under the Resource Conservation and Recovery Act (RCRA). Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

E. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

Executive Order 13045: ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies to any rule that: (1) is determined to be ``economically significant'' as defined under E.O. 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This final rule is not subject to the Executive Order because it is not economically significant as defined in E.O. 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The Agency performed a risk assessment to assist in its determination whether to list or not to list the solvent wastes in this final rule as hazardous waste. This risk assessment calculated the potential risk resulting from the current management of these wastes to individuals (including sensitive populations like children). The Agency has determined that management of these solvent wastes as hazardous is not required and that the environmental health risks or safety risks addressed by this action do not have a disproportionate effect on children.

F. Environmental Justice E.O. 12898

EPA is committed to addressing environmental justice concerns and is assuming a leadership role in environmental justice initiatives to enhance environmental quality for all residents of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, or income bears disproportionately high and adverse human health and environmental impacts as a result of EPA's policies, programs, and activities, and that all people live in clean and sustainable communities. In response to Executive Order 12898 and to concerns voiced by many groups outside the Agency, EPA's Office of Solid Waste and Emergency Response formed an Environmental Justice Task Force to analyze the array of environmental justice issues specific to waste programs and to develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3-17). The Agency has determined that a hazardous waste listing is not justified for the wastes examined in this rule. As a result, no specific action is required under this rule. It is, therefore, not expected to result in any disproportionately negative impacts on minority or low income communities relative to affluent or non-minority communities.

G. Paperwork Reduction Act

This rule does not contain any information collection requirements subject to OMB review under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.

H. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (``NTTAA''), Pub L. No. 104-113, Sec. 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involved technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

I. Executive Order 13084: Consultation and Coordination With Indian Tribal Governments

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.'' Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. As mentioned above, no specific action is required by this action. Today's rule does not create a mandate on State, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

J. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA has submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 261

Environmental protection, Hazardous materials, Waste treatment and disposal, Recycling.

Dated: October 30, 1998. Carol M. Browner, Administrator. [FR Doc. 98-30601 Filed 11-18-98; 8:45 am] BILLING CODE 6560-50-P