Environmental Protection Agency (EPA).
Notice of Final 2008 Effluent Guidelines Program Plan.
EPA establishes national technology-based regulations known as effluent guidelines and pretreatment standards to reduce pollutant discharges from categories of industry discharging directly to waters of the United States or discharging indirectly through Publicly Owned Treatment Works (POTWs). The Clean Water Act (CWA) sections 301(d), 304(b), 304(g), and 307(b) require EPA to review these effluent guidelines and pretreatment standards. This notice presents EPA's 2008 review of existing effluent guidelines and pretreatment standards. It also presents EPA's evaluation of indirect dischargers without categorical pretreatment standards to identify potential new categories for pretreatment standards under CWA sections 304(g) and 307(b). This notice also presents the final 2008 Effluent Guidelines Program Plan (“final 2008 Plan”), which, as required under CWA section 304(m), identifies any new or existing industrial categories selected for effluent guidelines rulemaking and provides a schedule for such rulemaking. CWA section 304(m) requires EPA to biennially publish such a plan after public notice and comment. The Agency published the preliminary 2008 Plan on October 30, 2007 (72 FR 61335). This notice also provides EPA's preliminary thoughts concerning its 2009 annual reviews under CWA sections 304(b) and 304(g) as well as its reviews under 301(d) and 307(b) and solicits comments, data and information to assist EPA in performing these reviews. EPA intends to continue its detailed studies of the steam electric power generating industry, the health services industry, and the coalbed methane extraction industry, which is part of the oil and gas extraction industry. Finally, EPA is using this notice to solicit public comment to identify industry sectors and facilities that use water efficiency practices that promote water efficiency, re-use, and recycling because such practices can be related to reducing overall pollutant discharges.
Submit your comments, data and information for the 2009 annual review, identified by Docket ID No. EPA–HQ–OW–2008–0517, by one of the following methods:
(1)
(2)
(3)
(4)
Key documents providing additional information about EPA's annual reviews and the final 2008 Effluent Guidelines Program Plan include the following:
• Technical Support Document for the 2008 Effluent Guidelines Program Plan, EPA–821–R–08–015, DCN 05515;
• Steam Electric Power Generating Point Source Category: 2007/2008 Detailed Study Report, EPA–821–R–08–011, DCN 05516;
• Coal Mining Detailed Study, EPA–821–R–08–012, DCN 05517;
• Health Services Industry Detailed Study: Dental Amalgam, EPA–821–R–08–014, DCN 05518; and
• Health Services Industry Detailed Study: Management and Disposal of Unused Pharmaceuticals (Interim Technical Report), EPA–821–R–08–013, DCN 05519.
Mr. Carey A. Johnston at (202) 566–1014 or
The outline of this notice follows.
This notice simply provides a statement of the Agency's effluent guidelines review and planning processes and priorities at this time, and does not contain any regulatory requirements.
Do not submit this information to EPA through
When submitting comments, remember to:
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
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• Describe any assumptions and provide any technical information and/or data that you used.
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• Make sure to submit your comments by the comment period deadline identified.
This notice is published under the authority of the CWA, 33 U.S.C. 1251,
This notice presents EPA's 2008 review of existing effluent guidelines and pretreatment standards under CWA sections 301(d), 304(b), 304(g) and 307(b). It also presents EPA's evaluation of indirect dischargers without categorical pretreatment standards to identify potential new categories for pretreatment standards under CWA sections 304(g) and 307(b). This notice also presents the final 2008 Effluent Guidelines Program Plan (“final 2008 Plan”), which, as required under CWA section 304(m), identifies any new or existing industrial categories selected for effluent guidelines rulemaking and provides a schedule for such rulemaking. CWA section 304(m) requires EPA to biennially publish such a plan after public notice and comment. The Agency published the preliminary 2008 Plan on October 30, 2007 (72 FR 61335). This notice also provides EPA's preliminary thoughts concerning its 2009 annual reviews under CWA sections 301(d), 304(b), 304(g) and 307(b) and solicits comments, data and information to assist EPA in performing these reviews.
The CWA directs EPA to promulgate effluent limitations guidelines and standards (“effluent guidelines”) that reflect pollutant reductions that can be achieved by categories or subcategories of industrial point sources using technologies that represent the appropriate level of control. See CWA sections 301(b)(2), 304(b), 306, 307(b), and 307(c). For point sources that introduce pollutants directly into the waters of the United States (direct dischargers), the effluent limitations guidelines and standards promulgated by EPA are implemented through National Pollutant Discharge Elimination System (NPDES) permits. See CWA sections 301(a), 301(b), and 402. For sources that discharge to POTWs (indirect dischargers), EPA promulgates pretreatment standards that apply directly to those sources and are enforced by POTWs and State and Federal authorities. See CWA sections 307(b) and (c).
EPA defines Best Practicable Control Technology Currently Available (BPT) effluent limitations for conventional, toxic, and non-conventional pollutants. Section 304(a)(4) designates the following as conventional pollutants: Biochemical oxygen demand (BOD
In specifying BPT, EPA looks at a number of factors. EPA first considers the total cost of applying the control technology in relation to the effluent reduction benefits. The Agency also considers the age of the equipment and facilities, the processes employed, and any required process changes, engineering aspects of the control technologies, non-water quality environmental impacts (including energy requirements), and such other factors as the EPA Administrator deems appropriate. See CWA section 304(b)(1)(B). Traditionally, EPA establishes BPT effluent limitations based on the average of the best performances of facilities within the industry of various ages, sizes, processes, or other common characteristics. Where existing performance is uniformly inadequate, BPT may reflect higher levels of control than currently in place in an industrial category if the Agency determines that the technology can be practically applied.
The 1977 amendments to the CWA required EPA to identify effluent reduction levels for conventional pollutants associated with Best Conventional Pollutant Control Technology (BCT) for discharges from existing industrial point sources. In addition to considering the other factors specified in section 304(b)(4)(B) to establish BCT limitations, EPA also considers a two part “cost-reasonableness” test. EPA explained its methodology for the development of BCT limitations in 1986. See 51 FR 24974 (July 9, 1986).
For toxic pollutants and non-conventional pollutants, EPA promulgates effluent guidelines based on the Best Available Technology Economically Achievable (BAT). See CWA section 301(b)(2)(A), (C), (D) and
New Source Performance Standards (NSPS) reflect effluent reductions that are achievable based on the best available demonstrated control technology. New sources have the opportunity to install the best and most efficient production processes and wastewater treatment technologies. As a result, NSPS should represent the most stringent controls attainable through the application of the best available demonstrated control technology for all pollutants (
Pretreatment Standards for Existing Sources (PSES) are designed to prevent the discharge of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of publicly owned treatment works (POTWs), including sludge disposal methods at POTWs. Pretreatment standards for existing sources are technology-based and are analogous to BAT effluent limitations guidelines.
The General Pretreatment Regulations, which set forth the framework for the implementation of national pretreatment standards, are found at 40 CFR part 403.
Like PSES, Pretreatment Standards for New Sources (PSNS) are designed to prevent the discharges of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of POTWs. PSNS are to be issued at the same time as NSPS. New indirect dischargers have the opportunity to incorporate into their facilities the best available demonstrated technologies. The Agency considers the same factors in promulgating PSNS as it considers in promulgating NSPS.
Section 304(b) requires EPA to review its existing effluent guidelines for direct dischargers each year and to revise such regulations “if appropriate.” Section 304(m) supplements the core requirement of section 304(b) by requiring EPA to publish a plan every two years announcing its schedule for performing this annual review and its schedule for rulemaking for any effluent guidelines selected for possible revision as a result of that annual review. Section 304(m) also requires the plan to identify categories of sources discharging toxic or non-conventional pollutants for which EPA has not published effluent limitations guidelines under section 304(b)(2) or NSPS under section 306. See CWA section 304(m)(1)(B); S. Rep. No. 50, 99th Cong., 1st Sess. (1985); WQA87 Leg. Hist. 31 (indicating that section 304(m)(1)(B) applies to “non-trivial discharges.”). Finally, under section 304(m), the plan must present a schedule for promulgating effluent guidelines for industrial categories for which it has not already established such guidelines, providing for final action on such rulemaking not later than three years after the industrial category is identified in a final Plan.
In addition, CWA section 301(d) requires EPA to review every five years the effluent limitations required by CWA section 301(b)(2) and to revise them if appropriate pursuant to the procedures specified in that section. Section 301(b)(2), in turn, requires point sources to achieve effluent limitations reflecting the application of the best practicable control technology (all pollutants), best available technology economically achievable (for toxic pollutants and non-conventional pollutants) and the best conventional pollutant control technology (for conventional pollutants), as determined by EPA under sections 304(b)(1), 304(b)(2) and 304(b)(4), respectively. For over three decades, EPA has implemented sections 301 and 304 through the promulgation of effluent limitations guidelines, resulting in regulations for 56 industrial categories.
Section 307(b) requires EPA to revise its pretreatment standards for indirect dischargers “from time to time, as control technology, processes, operating methods, or other alternatives change.” See CWA section 307(b)(2). Section 304(g) requires EPA to annually review these pretreatment standards and revise them “if appropriate.” Although section 307(b) only requires EPA to revise existing pretreatment standards “from time to time,” section 304(g) requires an annual review. Therefore, EPA meets its 304(g) and 307(b) requirements by reviewing all industrial categories subject to existing categorical pretreatment standards on an annual basis to identify potential candidates for revision.
Section 307(b)(1) also requires EPA to promulgate pretreatment standards for pollutants not susceptible to treatment by POTWs or that would interfere with the operation of POTWs, although it does not provide a timing requirement for the promulgation of such new pretreatment standards. EPA, in its discretion, periodically evaluates indirect dischargers not subject to categorical pretreatment standards to identify potential candidates for new
EPA intends to repeat this publication schedule for future pretreatment standards reviews (
In its 2008 annual review, EPA reviewed all industrial categories subject to existing effluent limitations guidelines and pretreatment standards, representing a total of 56 point source categories and over 450 subcategories. EPA uses four factors in a phased approach to review existing effluent limitations guidelines and pretreatment standards: Pollutants discharged in an industrial category's discharge, current and potential pollution prevention and control technology options, category growth and economic considerations of technology options, and implementation and efficiency considerations of revising existing effluent guidelines or publishing new effluent guidelines (
EPA used this 2008 review to confirm the Agency's identification of industrial categories prioritized for further review in the preliminary 2008 Effluent Guidelines Program Plan (October 30, 2007; 72 FR 61335). EPA also continued work on four detailed studies as part of the 2008 annual review: Steam Electric Power Generating (Part 423), Coal Mining (Part 434), Oil and Gas Extraction (Part 435) (for the purpose of assessing whether to include coalbed methane extraction as a new subcategory), and Hospitals (Part 460).
Based on this review and prior annual reviews, and in light of the ongoing effluent guidelines rulemakings and detailed studies currently in progress, EPA is not identifying any existing categories for effluent guidelines rulemaking at this time, and is thus not establishing a schedule for further rulemaking at this time. EPA does, however, intend to continue its more focused detailed reviews in the 2009 and 2010 annual reviews of the effluent guidelines for the following categories: Steam Electric Power Generating (Part 423), Oil and Gas Extraction category (Part 435) (for the purpose of assessing whether to revise the limits to include Coalbed Methane extraction as a new subcategory), and Hospitals (Part 460) (which is part of the Health Services Industry detailed study). As part of its detailed study of the Coalbed Methane extraction industry, EPA is seeking approval from the Office of Management and Budget (OMB) for an Information Collection Request (ICR) to gather data from the industry (July 15, 2008; 73 FR 40575). EPA is also planning to submit a proposed ICR to OMB for the Health Services Industry; in particular, a study of unused pharmaceuticals from medical and veterinary facilities. This is a request for a new collection. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection (August 12, 2008; 73 FR 46903). See Sections V.B.2 and VII.D.
In view of the annual nature of its reviews of existing effluent guidelines and pretreatment standards, EPA believes that each annual review can and should influence succeeding annual reviews,
The first component of EPA's 2008 annual review consisted of a screening-level review of all industrial categories subject to existing effluent guidelines or pretreatment standards. As a starting point for this review, EPA examined screening-level data from its 2007 annual reviews. In its 2007 annual reviews, EPA focused its efforts on collecting and analyzing data to identify industrial categories whose pollutant discharges potentially are the most significant. EPA primarily uses TRI and PCS data to estimate the mass of pollutant discharges from different industrial facilities. Because pollutant toxicities are different, EPA converted the toxic and non-conventional pollutant discharges that are reported in a mass unit (pounds) into a measure of relative toxicity (toxic-weighted pound equivalent or TWPE). EPA calculated the TWPE for each pollutant discharged by multiplying the pollutant specific toxic weighting factor (TWF) and the mass of the pollutant discharge. Where data are available, these TWFs reflect both aquatic life and human health effects. EPA ranked point source categories according to their discharges of toxic and non-conventional pollutants (reported in units of TWPE) to assess the significance of these toxic and non-conventional pollutant discharges to human health or the environment. EPA repeated this process for the 2008 annual reviews using the most recent TRI data (2005).
Next, EPA considered the availability of technologies to reduce pollutant discharges. EPA does not have, for all of the 56 existing industrial categories, information about the availability of treatment or process technologies to reduce pollutant wastewater discharges beyond the performance of the technologies upon which existing effluent guidelines and standards were developed. At present 46 states and one U.S. territory are authorized to administer the CWA NPDES program. Under the CWA, permitting authorities must include water-quality based effluent limits where the technology-based effluent limits are not sufficient to meet applicable water quality standards. Therefore, dischargers may have already installed technologies that reduce pollutant discharges to a level below the original technology-based requirements in order to meet such water-quality based effluent limitations.
A commenter on the preliminary 2008 Plan argued that EPA should conduct rulemaking to amend its effluent guidelines even where water quality-based controls have already controlled pollutant discharges (
EPA also considered whether there was a way to develop a suitable tool for comprehensively evaluating the availability and affordability of treatment or process technologies, but determined that there is not, because the universe of facilities is too broad and complex. EPA could not find a reasonable way to prioritize the industrial categories based on readily available engineering and economic data. In the past, EPA has gathered information regarding technologies and economic achievability for one industrial category at a time through detailed questionnaires distributed to hundreds of facilities within a category or subcategory for which EPA has commenced rulemaking. Such information-gathering is subject to the requirements of the Paperwork Reduction Act (PRA), 33 U.S.C. 3501,
EPA is continuously investigating and solicits comment on how to improve its analyses. EPA made a few such improvements to the review methodology from the 2007 to the 2008 annual review. As part of the 2008 review, EPA corrected the PCSLoads2004 and TRIReleases2004 databases, by addressing issues raised in comments (
EPA also continued to use the quality assurance project plan (QAPP) developed for the 2007 annual review to document the type and quality of data needed to make the decisions in this 2008 annual review and to describe the methods for collecting and assessing those data (
Based on this methodology, EPA assigned those industrial categories with the lowest estimates of toxic-weighted
Because there are 56 point source categories (including over 450 subcategories) with existing effluent guidelines and pretreatment standards that must be reviewed annually, EPA believes it is important to prioritize its review so as to focus on industries where changes to the existing effluent guidelines or pretreatment standards are most likely to result in further pollutant discharge reduction. In general, industries for which effluent guidelines or pretreatment standards have recently been promulgated are less likely to warrant such changes. However, when EPA becomes aware of the growth of a new industrial activity within an existing category or where new concerns are identified for previously unevaluated pollutants discharged by facilities within an industrial category, EPA would apply more scrutiny to the category in a subsequent review. EPA identified no such instance during the 2008 annual review. In order to further focus its inquiry during the 2008 annual review, EPA assigned a lower priority for potential revision to categories for which effluent guidelines had been recently promulgated or revised, or for which effluent guidelines rulemaking was currently underway (
For industrial categories marked “(4)” in the “Findings” column in Table V–1 in section V.B.4 of today's notice, EPA had sufficient information on the toxic-weighted pollutant discharges associated with these categories to continue a detailed study of these industrial categories in the 2008 annual review. EPA intends to use the detailed study to obtain information on hazard, availability and cost of technology options, and other factors in order to determine if it would be appropriate to identify the category for possible effluent guidelines revision. EPA will continue three detailed studies in the 2009 annual review: Steam Electric Power Generating category, Oil and Gas Extraction category (only to assess whether to revise the limits to include Coalbed Methane extraction as a new subcategory), and unused pharmaceutical management for the Health Services Industry (which includes the Hospital category).
As part of its 2008 annual review, EPA also considered the number of facilities responsible for the majority of the estimated toxic-weighted pollutant discharges associated with an industrial activity. Where only a few facilities in a category accounted for the vast majority of toxic-weighted pollutant discharges (
EPA received comments in previous biennial planning cycles urging the Agency to encourage and recognize voluntary efforts by industry to reduce pollutant discharges, especially when the voluntary efforts have been widely adopted within an industry and the associated pollutant reductions have been significant. EPA agrees that industrial categories demonstrating significant progress through voluntary efforts to reduce hazard to human health or the environment associated with their effluent discharges would be a comparatively lower priority for effluent guidelines or pretreatment standards revision, particularly where such reductions are achieved by a significant majority of individual facilities in the industry. Although during this annual review EPA could not complete a systematic review of voluntary pollutant loading reductions, EPA's review did indirectly account for the effects of successful voluntary programs because any significant reductions in pollutant discharges should be reflected in TRI 2005 discharge data, as well as any data provided directly by commenters, that EPA used to assess the toxic-weighted pollutant discharges.
In summary, EPA's review enables EPA to concentrate its resources on conducting more in-depth reviews of certain industries, as discussed below.
In the publication of the preliminary 2008 Plan, EPA identified three categories with potentially high TWPE discharge estimates for further investigation (“preliminary category
EPA typically performs a further assessment of the pollutant discharges before starting a detailed study of an industrial category. In conducting these preliminary category reviews, EPA used the same types of data sources used for the detailed studies but in less depth. This assessment provides confirmation of the reported pollutant discharges and number of facilities that represent the majority of toxic-weighted pollutant discharges. EPA may also develop a preliminary list of potential wastewater pollutant control technologies before conducting a detailed study.
EPA continued detailed studies of four categories: Steam Electric Power Generating (Part 423), Coal Mining (Part 434), Oil and Gas Extraction (Part 435) (only to assess whether to include coalbed methane extraction as a new subcategory), and Hospitals (Part 460) (which is part of the Health Services Industry detailed study). For these industries, EPA gathered and analyzed additional data on pollutant discharges, economic factors, and technology issues. EPA examined: (1) Wastewater characteristics and pollutant sources; (2) the pollutants discharged from these sources and the toxic weights associated with these discharges; (3) treatment technology and pollution prevention information; (4) the geographic distribution of facilities in the industry; (5) any pollutant discharge trends within the industry; and (6) any relevant economic factors.
EPA's annual review process considers information provided by stakeholders regarding the need for new or revised effluent limitations guidelines and pretreatment standards. To that end, EPA established a docket at the time of publication of the final 2006 Plan to provide the public with an opportunity to submit additional information to assist the Agency in its 2007 and 2008 annual reviews. These public comments are in the supporting docket (EPA–HQ–OW–2006–0771,
In its 2008 screening level review, EPA considered significance of remaining pollutant discharges and the other factors described in section A.3.a. above in prioritizing effluent guidelines for potential revision. See Table V–1 in section V.B.4 of today's notice for a summary of EPA's findings with respect to each existing category; see also the TSD for the final 2008 Plan. Out of the categories subject only to the screening level review in 2008, EPA is not identifying any for effluent guidelines rulemaking at this time, based on the factors described in section A.3.a above and in light of the resources EPA is currently expending in effluent guidelines rulemakings and detailed studies. Specifically, EPA is engaged in rulemaking relating to the Construction and Development Point Source Category, the Airport De-icing Point Source Category; and the Concentrated Animal Feeding Operations Point Source Category.
In its 2008 annual review, EPA continued detailed studies of four industrial point source categories with existing effluent guidelines and pretreatment standards: Steam Electric Power Generating (Part 423), Coal Mining (Part 434), Oil and Gas Extraction (Part 435) (to assess whether to include coalbed methane extraction as a new subcategory), and Hospitals (Part 460) (which is part of the Health Services Industry detailed study). EPA is investigating whether the pollutant discharges reported to TRI and PCS for 2004 and 2005 accurately reflect the current discharges of the industry. EPA, through these detailed studies, analyzes the reported pollutant discharges, technology innovation, and process changes in these industrial categories. Additionally, EPA considers whether there are industrial activities not currently subject to effluent guidelines or pretreatment standards that should be included with these existing categories, either as part of existing subcategories or as potential new subcategories.
EPA completed the Coal Mining detailed study and the dental amalgam management detailed study for the Health Services Industry. As described below in more detail, EPA is not identifying either of these industries for an effluent guidelines rulemaking in this final 2008 Plan. EPA will continue the other detailed studies (
The Steam Electric Power Generating effluent guidelines (40 CFR 423) apply to a subset of the electric power industry, namely those facilities “primarily engaged in the generation of electricity for distribution and sale which results primarily from a process utilizing fossil-type fuel (coal, oil, or gas) or nuclear fuel in conjunction with
EPA has focused efforts for the 2007/2008 Detailed Study for the Steam Electric Power Generating point source category on certain discharges from coal-fired power plants. The study sought to: (1) characterize the mass and concentrations of pollutants in wastewater discharges from coal-fired steam electric facilities; and (2) identify the pollutants that comprise a significant portion of the category's TWPE discharge estimate and the corresponding industrial operation. EPA's previous annual reviews have indicated that the toxic-weighted loadings for this category are predominantly driven by the metals present in wastewater discharges, and that the waste streams contributing the majority of these metals are associated with ash handling and wet flue gas desulfurization (FGD) systems (
EPA's data collection efforts are primarily focused on coal-fired power plants, with particular interest in FGD wastewater treatment, the management of ash sluice water, and water reuse opportunities. EPA's site visit program gathers information on the types of wastewaters generated by coal-fired steam electric power plants, as well as the methods of managing these wastewaters to allow for recycle, reuse, or discharge. EPA conducted site visits at 16 coal-fired power plants and is continuing to identify potential site visit candidates to assess FGD systems using different scrubber designs or sorbents, and facilities operating or planning to install different types of treatment and water reuse options.
Between July and October of 2007, EPA conducted five sampling episodes to characterize untreated wastewaters generated by coal-fired power plants, including FGD scrubber purge, fly ash sluice, bottom ash sluice, and combined fly- and bottom ash sluice. EPA also collected samples to assess the effluent quality from different types of treatment systems currently in place at these operations. Samples collected during the five episodes were analyzed for metals and other pollutants, such as total suspended solids and nitrogen. Site-specific sampling episode reports are in the docket for the 2008 Plan (EPA–HQ–OW–2006–0771,
EPA is continuing to identify potential sampling candidates to evaluate additional types of FGD wastewater treatment systems, including advanced biological metals removal processes and chemical precipitation systems. EPA plans to conduct wastewater sampling at one or more additional plants in 2008 or early 2009.
EPA also collected facility-specific information using a data request conducted under authority of CWA section 308 (
The Utility Water Act Group (UWAG) provided EPA with a database that contains selected NPDES Form 2C data for 86 coal-fired plants operated by UWAG's member companies, namely those plants that operate wet FGD systems or wet fly ash sluice systems. The database provides facility information, data on facility outfalls, process flow diagrams, wastewater treatment information, and intake and effluent characteristics. Data are provided for the FGD, ash sluice, and coal pile runoff wastestreams.
EPA is also in the process of contacting vendors and conducting literature searches to collect additional information on wastewater treatment technology options and wastewater reuse opportunities for particular waste streams. The Electric Power Research Institute (EPRI) is conducting bench- and pilot-scale tests on FGD wastewater treatment technologies, including chemical precipitation, ion exchange, and biological metals removal.
EPA intends to continue its detailed review of the Steam Electric Power Generating point source category in the 2009 and 2010 annual reviews of effluent guidelines. Wastewater sampling at a facility operating a treatment system of interest was delayed by nearly one year due to operational conditions at the plant. In addition, several other plants recently began operating a new generation of FGD wastewater treatment technology that may achieve substantially better pollutant reductions of metals and nutrients than EPA has evaluated to date. EPA believes it is important to evaluate the performance of these technologies, as well as the processes being investigated by EPRI, prior to concluding the detailed study. As noted above, EPA has not yet completed its wastewater sampling activities. The UWAG Form 2C database was recently delivered to EPA; however, EPA has not had sufficient time to fully evaluate this data. The database provides substantial information on wastewater generation and wastewater management and treatment practices for a large number of plants. EPA believes it is important to take additional time to evaluate the Form 2C data, in concert with EPA's sampling data and the responses to EPA's data request. EPA also intends to continue investigating water reuse opportunities to assess the degree to which they may yield pollutant reductions for discharges of ash sluice and FGD wastewater.
As discussed in the final 2006 Plan and preliminary 2008 Plan, EPA conducted a detailed study during the 2007 and 2008 annual reviews to evaluate the merits of comments received from a public interest group and from states and industry urging revisions to pollutant limitations in the Coal Mining effluent guidelines (40 CFR Part 434) (
The public interest group, the Environmental Law and Policy Center, asked EPA to place more stringent controls on Total Dissolved Solids
The Interstate Mining Compact Commission, which represents mining regulatory agencies in 28 states, state mine permitting agencies in Pennsylvania and Virginia, and a few mining companies, asked EPA to remove the current manganese limitations.
EPA initiated the Coal Mining Detailed Study in January 2007. The study is consistent with the framework presented in the Detailed Study Plan, a draft of which the Agency placed into the docket (
As outlined in the Detailed Study Plan, EPA framed study questions based on public comment, identified data sources to help answer the study questions, developed a methodology for estimating treatment costs and discharge loads, and initiated data collection activities with the Interstate Mining Compact Commission, state agencies, and the Office of Surface Mining, Reclamation, and Enforcement within the U.S. Department of the Interior. In responding to these public comments the study used Part 434 definitions to describe the industry. In particular, proper understanding of the following terms is useful in understanding the following discussion and EPA's response to the public commenters:
• The term “acid or ferruginous mine drainage” means mine drainage which, before any treatment, either has a pH of less than 6.0 or a total iron concentration equal to or greater than 10 mg/l (
• The term “active mining area” means the area, on and beneath land, used or disturbed in activity related to the extraction, removal, or recovery of coal from its natural deposits. This term excludes coal preparation plants, coal preparation plant associated areas and post-mining areas (
• The term “alkaline mine drainage” means mine drainage which, before any treatment, has a pH equal to or greater than 6.0 and total iron concentration of less than 10 mg/l (
• The term “bond release” means the time at which the appropriate regulatory authority returns a reclamation or performance bond based upon its determination that reclamation work (including, in the case of underground mines, mine sealing and abandonment procedures) has been satisfactorily completed (
• The term “post-mining area” means: (1) A reclamation area or (2) the underground workings of an underground coal mine after the extraction, removal, or recovery of coal from its natural deposit has ceased and prior to bond release (
• The term “reclamation area” means the surface area of a coal mine which has been returned to required contour and on which re-vegetation (specifically, seeding or planting) work has commenced (
The study also notes that EPA has promulgated manganese effluent guidelines only for a subset of coal mining operations at Part 434: (1) Active surface and underground mining areas with acid mine drainage discharges (
EPA also reviewed scientific literature and conducted interviews with state regulatory personnel in order to assess comments concerning the toxic effects of manganese and whether coal mining discharges of other pollutants are of concern. EPA's review found that manganese discharges to surface water may have widely varying effects depending on water chemistry, and that manganese impacts are not well understood. Different aquatic species have a wide range of tolerance limits (
EPA clarified States' comments regarding the costs of EPA's coal mining manganese effluent guidelines. In their initial public comments, State commenters did not distinguish the costs of manganese removal among the three phases of coal mining: Active mining areas, post-mining areas, and post-bond release areas. This is important as EPA's manganese effluent guidelines only apply to a subset of coal mining areas. As documented in EPA's meetings and site visits, States indicated that they are most concerned about the cost of manganese treatment at
EPA reviewed the Technical Development Documents supporting the Coal Mining effluent guidelines and did not identify any discussion regarding promulgating manganese effluent guidelines to ensure surrogate removal of other metals (
EPA reviewed the cost and performance of passive treatment systems and concluded that they are less expensive than active treatment systems, but their effectiveness is generally limited to removal of manganese from alkaline discharges. As noted above, there are no manganese Coal Mining effluent guidelines for alkaline discharges for all three phases of coal mining. As for surface post-mining areas, EPA's review of State data indicates that manganese effluent limits for alkaline discharges are derived from State manganese water-quality standards or site specific BPJ technology-based effluent limits.
In conducting its study EPA also reviewed the costs of manganese treatment, which coal mining companies use to comply with manganese effluent limits derived from State manganese water-quality standards or site-specific BPJ technology-based effluent limits. Based on information received from the States of Pennsylvania and West Virginia, EPA concluded that only a small percentage of coal mine bond forfeitures are due to the cost of manganese treatment (
Overall, EPA found that there is little potential for future forfeiture of bonds on SMCRA permits that have been granted during the past five years or will be granted in the future. EPA's analysis indicates that forfeitures are largely a legacy of the first decade of SMCRA implementation during the 1980s and early 1990s. In particular, SMCRA requires an analysis of Probable Hydrologic Consequence (PHC) prior to approval of the SMCRA permit approval in order to identify regional hydrologic impacts associated with the coal mining and reclamation operation. The PHC is a determination of baseline ground water and surface water quality and quantity conditions and the impact the proposed mining will have on these baseline conditions. When potential adverse impacts are identified (
In response to comments from the Environmental Law and Policy Center, which asked EPA to place more stringent controls on manganese, TDS, selenium, mercury, and cadmium in coal mining discharges, EPA conducted a literature review regarding these pollutants in coal mining discharges. In particular, EPA reviewed recently initiated, long-term studies of coal mining discharges of TDS, being conducted by EPA Region 3 and Office of Research and Development (
EPA is not identifying its existing effluent guidelines for the Coal Mining point source category (Part 434) for an effluent guidelines rulemaking at this time. In response to State and industry comments, EPA's review indicated that manganese removal does double or triple treatment costs, but for active surface and underground mining areas with acid mine drainage discharges (regulated by Subpart C) and post-mining areas with underground acid mine drainage discharges (regulated by Subpart E) manganese treatment technology is available, economically achievable, and compliance rates with permit limits derived from the management effluent guidelines are high (
EPA identified the coalbed methane (CBM) sector as a candidate for a detailed study in the final 2006 Effluent Guidelines Program Plan (71 FR 76656; December 21, 2006). As part of that announcement EPA made it clear that it would conduct data collection through an information collection request (ICR) to support this detailed study. In accordance with the Paperwork Reduction Act (PRA) EPA must seek Office of Management and Budget (OMB) approval for an ICR. EPA also provided notice of this ICR in the preliminary 2008 Plan (72 FR 61343; October 30, 2007) and in two separate
CBM extraction requires removal of large amounts of water from underground coal seams before CBM can be released. CBM wells have a distinctive production history characterized by an early stage when large amounts of water are produced to reduce reservoir pressure which in turn encourages release of gas. This is followed by a stable stage when quantities of produced gas increase as the quantities of produced water decrease; and a late stage when the amount of gas produced declines and water production remains low (
Pollutants often found in these wastewaters include chloride, sodium, sulfate, bicarbonate, fluoride, iron, barium, magnesium, ammonia, and arsenic. Total dissolved solids (TDS) and electrical conductivity (EC) are bulk parameters that States typically use for quantifying and controlling the amount of pollutants in CBM produced waters.
Controlling the sodicity of the CBM produced waters is equally important in preventing environmental damage. Sodicity is often quantified as the sodium adsorption ratio (SAR), which is expressed as the ratio of sodium ions to calcium and magnesium ions. Sodicity is an important factor in controlling the produced water's suitability for irrigation as sodic soils are subject to severe structural degradation and restrict plant performance through poor soil-water and soil-air relations. All of these dissolved inorganic parameters can potentially affect environmental impacts as well as potential beneficial uses of CBM produced water.
Impacts to surface water from discharges of CBM produced waters can be severe depending upon the quality of the CBM produced waters. These discharges have variable effects depending on the biology of the receiving stream. Some waterbodies and watersheds may be able to absorb the discharged water while others are sensitive to CBM produced water discharges. For example, large lakes or rivers with sufficient dilution capacity or marine waters are less sensitive to saline discharges than smaller receiving water bodies. Discharge of these CBM produced waters may also cause erosion and in some cases irreversible soil damage from elevated TDS concentrations and SAR values. This may limit future agricultural and livestock uses of the water and watershed.
Currently, regulatory controls for CBM produced waters vary from State to State and permit to permit (
Coalbed methane (CBM) extraction activities accounted for about 10 percent of the total U.S. natural gas production in 2006 and are expanding in multiple basins across the U.S. Currently, the Department of Energy's Energy Information Administration (EIA) expects CBM production to remain an important source of domestic natural gas over the next few decades.
As discussed in section A.1, EPA's review of existing effluent guidelines considers four factors: pollutants discharged in an industrial category's effluent, current and potential pollution prevention and control technology options, category growth and economic considerations of technology options, and implementation and efficiency considerations of revising existing effluent guidelines or publishing new effluent guidelines. EPA will use the CBM ICR to collect technical and economic information from a wide range of CBM operations to address these factors in greater detail (
In 2007 and 2008, EPA worked with a range of stakeholders (
During the 2007 annual review, EPA identified three categories with potentially high TWPE discharge estimates (
For the Ore Mining and Dressing category (Part 440), EPA lacks sufficient information at this time on the magnitude of the toxic-weighted pollutant discharges. EPA will seek additional information on the discharges from this category in the next annual review in order to determine whether a detailed study is warranted. EPA typically performs a further assessment of the pollutant discharges before starting a detailed study of an industrial category. This assessment provides an additional level of quality assurance on the reported pollutant discharges and number of facilities that represent the majority of toxic-weighted pollutant discharges. EPA may also
For the Waste Combustors category (Part 444), EPA used information from TRI and PCS databases, as well as facility contacts, in its preliminary category review. TRI-reported discharges of pesticides accounted for the vast majority of the Waste Combustors category's TWPE identified in the 2008 preliminary plan. EPA contacted six waste combustor facilities to collect information on pesticides and received confirmation that pesticides were not detected in combustor wastewaters. Specifically, EPA determined that the TRI-reported pesticide releases from waste combustor facilities are generally estimated using characterization reports from clients and treatment efficiency data, rather than actual sampling data. Chapter 11 of the 2008 Technical Support Document for this Plan presents more details on EPA's findings on the Waste Combustors category (
For the Centralized Waste Treatment category (Part 437), EPA also used information from TRI and PCS databases, as well as facility contacts, in its preliminary category review. TRI-reported discharges of pesticides accounted for the vast majority of the Centralized Waste Treatment category's TWPE identified in the 2008 preliminary plan. EPA contacted five Centralized Waste Treatment facilities to collect information on pesticides and received confirmation that pesticides were not detected in four of the five facility wastewaters. Specifically, EPA determined that the TRI-reported pesticide releases from centralized waste treatment facilities are generally estimated using characterization reports from clients and treatment efficiency data, rather than actual sampling data. Only one of the five Centralized Waste Treatment facilities contacted detected pesticides; however, the amount reported to TRI was greater than the amount actually measured. This error will be corrected in future TRI reports from the facility. Chapter 6 of the 2008 Technical Support Document for this Plan presents more details on EPA's findings on the Centralized Waste Treatment Category (
EPA reviewed all categories subject to existing effluent guidelines and pretreatment standards in order to identify appropriate candidates for revision. Based on this review, and in light of effluent guidelines rulemakings and detailed studies currently in progress, EPA is not identifying any existing categories for effluent guidelines rulemaking. EPA is, however, conducting detailed studies for three existing categories: Steam Electric Power Generating category, Oil and Gas Extraction category (only to assess whether to revise the limits to include Coalbed Methane extraction as a new subcategory), and unused pharmaceutical management for the Health Services Industry (which includes the Hospital category).
A summary of the findings of the 2008 annual review is presented below in Table V–1. This table uses the following codes to describe the Agency's findings with respect to each existing industrial category.
(1) Effluent guidelines or pretreatment standards for this industrial category were recently revised or reviewed through an effluent guidelines rulemaking, or a rulemaking is currently underway.
(2) Revising the national effluent guidelines or pretreatment standards is not the best tool for this industrial category because most of the toxic and non-conventional pollutant discharges are from one or a few facilities in this industrial category. EPA will consider assisting permitting authorities in identifying pollutant control and pollution prevention technologies for the development of technology-based effluent limitations by best professional judgment (BPJ) on a facility-specific basis.
(3) Not identified as a priority based on data available at this time (
(4) EPA intends to continue a detailed study of this industry in its 2009 annual review to determine whether to identify the category for effluent guidelines rulemaking.
(5) EPA is continuing or initiating a preliminary category review because incomplete data are available to determine whether to conduct a detailed study or identify for possible revision. EPA typically performs a further assessment of the pollutant discharges before starting a detailed study of the industrial category. This assessment provides an additional level of quality assurance on the reported pollutant discharges and number of facilities that represent the majority of toxic-weighted pollutant discharges. EPA may also develop a preliminary list of potential wastewater pollutant control technologies before conducting a detailed study. See the appropriate section in the TSD (
As discussed in section V and further in section VIII, EPA is coordinating its annual and periodic reviews of existing effluent guidelines and pretreatment standards under CWA sections 301(d), 304(b), 307(b) and 304(g) with the publication of preliminary Plans and biennial Plans under section 304(m). Public comments received on EPA's prior reviews and Plans helped the Agency prioritize its analysis of existing effluent guidelines and pretreatment standards during the 2008 review. The information gathered during the 2008 annual review, including the identification of data gaps in the analysis of certain categories with existing regulations, in turn, provides a starting point for EPA's 2009 annual review. See Table V–1 above. In 2009, EPA intends to again conduct a screening-level analysis of all 56 categories and compare the results against those from previous years. EPA will also conduct more detailed analyses of those industries that rank high in terms of the significance of their toxic and non-conventional discharges among all point source categories. Additionally, EPA intends to continue its detailed studies of the following categories: Steam Electric Power Generating category, Oil and Gas Extraction category (only to assess whether to revise the limits to include
As part of the 2009 annual review EPA is also taking the opportunity to solicit information on industrial sectors that use water efficiency practices that promote water efficiency, re-use, or recycling. EPA is seeking this information to inform its evaluation of technology options across multiple industrial sectors.
Water efficiency practices can reduce the amount of pollutants discharged by industrial facilities, especially for those facilities that have on-site wastewater treatment systems, but also for those without them. EPA's effluent guidelines rulemakings and reviews have documented numerous examples of industrial facilities employing water conservation as a means to meet effluent limitations based on promulgated effluent guidelines (
In addition, reducing water use will also reduce associated costs (and energy requirements) for industry. As significant users of water, industry is becoming aware of the importance of measuring, managing, and controlling water use. Water scarcity can limit industrial growth and many industrial sectors have substantially increased water re-use in the past 15 years, through reclaiming industrial wastewater for non-potable applications (where reclaimed industrial wastewater is used for non-potable applications). Moreover, the cost savings of implementing water re-use and reduction technologies and pollution prevention practices can be significant, with payback periods often measured within a few months or years.
In addition, this data solicitation will also help implement EPA's National Water Program strategy for responding to climate change (
All indirect dischargers are subject to general pretreatment standards (40 CFR 403), including a prohibition on discharges causing “pass through” or “interference.” See 40 CFR 403.5. All POTWs with approved pretreatment programs must develop local limits to implement the general pretreatment standards. All other POTWs must develop such local limits where they have experienced “pass through” or “interference” and such a violation is likely to recur. There are approximately 1,500 POTWs with approved pretreatment programs and 13,500 small POTWs that are not required to develop and implement pretreatment programs.
In addition, EPA establishes technology-based national regulations, termed “categorical pretreatment standards,” for categories of industry discharging pollutants to POTWs that may pass through, interfere with or otherwise be incompatible with POTW operations. CWA section 307(b). Generally, categorical pretreatment standards are designed such that wastewaters from direct and indirect industrial dischargers are subject to similar levels of treatment. EPA has promulgated such pretreatment standards for 35 industrial categories.
One of the tools traditionally used by EPA in evaluating whether pollutants “pass through” a POTW, is a comparison of the percentage of a pollutant removed by POTWs with the percentage of the pollutant removed by discharging facilities applying BAT. Pretreatment standards for existing sources are technology based and are analogous to BAT effluent limitations guidelines. In most cases, EPA has concluded that a pollutant passes through the POTW when the median percentage removed nationwide by representative POTWs (those meeting secondary treatment requirements) is less than the median percentage removed by facilities complying with BAT effluent limitations guidelines for that pollutant. This approach to the definition of “pass through” satisfies two competing objectives set by Congress: (1) That standards for indirect dischargers be equivalent to standards for direct dischargers; and (2) that the treatment capability and performance of POTWs be recognized and taken into account in regulating the discharge of pollutants from indirect dischargers.
The term “interference” means a discharge which, alone or in conjunction with a discharge or discharges from other sources, both: (1) Inhibits or disrupts the POTW, its treatment processes or operations, or its sludge processes, use or disposal; and (2) therefore is a cause of a violation of any requirement of the POTW's NPDES permit (including an increase in the magnitude or duration of a violation) or of the prevention of sewage sludge use or disposal in compliance with applicable regulations or permits. See 40 CFR 403.3(i).
If EPA determines a category of indirect dischargers causes pass through or interference, EPA would then consider the BAT and BPT factors (including “such other factors as the Administrator deems appropriate”) specified in section 304(b) to determine whether to establish pretreatment standards for these activities. Examples of “such other factors” include a consideration of the magnitude of the hazard posed by the pollutants discharged as measured by: (1) The total annual TWPE discharged by the industrial sector; and (2) the average TWPE discharge among facilities that discharge to POTWs. Additionally, EPA would consider whether other regulatory tools (
EPA reviewed TRI 2005 discharge data in order to identify industry categories without categorical pretreatment standards that are discharging pollutants to POTWs that may pass through, interfere with or otherwise be incompatible with POTW operations (
In particular, commenters on the 2004 and 2006 annual reviews raised concerns about discharges of pollutants of emerging concern such as endocrine disruptors from health service facilities and mercury discharges from dentists and urged EPA to consider establishing effluent guidelines and pretreatment standards for such discharges. In response to these comments, EPA investigated the Health Services Industry in its 2005 and 2006 annual reviews and found that it did not have readily available information to make an informed decision on the potential for “pass through” or “interference.” Consequently, EPA identified this industrial category for detailed study in its preliminary 2006 Plan. EPA also received stakeholder comments on the issues of dental amalgam and unused pharmaceuticals management for the Health Services Industry in response to the 2007 annual review.
As discussed below EPA is not identifying dental facilities for an effluent guidelines rulemaking in this notice. However, EPA is continuing its study of unused pharmaceutical management for the Health Services Industry. EPA also solicits comment and data on all industrial sectors not currently subject to categorical pretreatment standards for its 2009 review. Finally, EPA solicits comment on methods for collecting and aggregating pollutant discharge data collected by pretreatment programs to further inform its future review of industry categories without categorical pretreatment standards.
EPA identified the Health Services Industry as a candidate for a detailed study in the final 2006 Effluent Guidelines Program Plan (
All these sectors require services to be delivered by trained professionals for the purpose of providing health care and social assistance for individuals or animals. These entities may be free standing or part of a hospital or health system and may be privately or publicly owned. The services can include diagnostic, preventative, cosmetic, and curative health services.
The vast majority of establishments in the health services industries are not subject to categorical limitations and standards. In 1976, EPA promulgated 40 CFR 460, which only applies to direct discharging hospitals. Part 460 did not establish pretreatment standards for indirect discharging facilities.
In evaluating the health services industries to date, EPA has found little readily available information from EPA databases. Both PCS and TRI contain sparse information on health care service establishments. For 2002, PCS only has data for two facilities that are considered “major” sources of pollutants, and only Federal facilities in the healthcare industry are required to report to TRI.
Based on preliminary information, major pollutants of concern in discharges from health care service establishments include solvents, mercury, pharmaceuticals, and biohazards (
As described above, the Health Services Industry is expansive and contains approximately half a million facilities. Because of the size and diversity of this category and other resource constraints, EPA decided to focus its detailed study on certain types of dischargers. EPA selected its focus areas, for the most part, to respond to stakeholder concerns. The focus areas are:
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The Agency notes that it has an overall interest in mercury reduction and on July 5, 2006, issued a report titled, “EPA's Roadmap for Mercury,” (
• What are current industry practices regarding the mercury disposal? To what extent are each of these practices applied? What factors drive current practices?
• Are there federal, state, or local requirements or guidance for disposal of mercury? What are these requirements?
• How are control authorities currently controlling (or not controlling) disposal of mercury via wastewater?
• To what extent do POTWs report pass through or interference problems related to mercury discharges?
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• What Best Management Practices (BMPs) are used as alternatives to wastewater disposal and/or to control discharges and is there any qualitative or quantitative information on their efficiency?
• Is there any quantitative or qualitative information on the costs associated with identified technologies and/or BMPs?
Across the United States, many States and municipal wastewater treatment plants (publicly owned treatment works—POTWs) are working toward the goal of reducing discharges of mercury into collection systems. Many studies have been conducted in an attempt to identify the sources of mercury entering these collection systems. According to the 2002 Mercury Source Control and Pollution Prevention Program Final Report prepared for the National Association of Clean Water Agencies (NACWA), dental clinics are the main source of mercury discharges to POTWs. The American Dental Association (ADA) estimated in 2003 that up to 50% of mercury entering POTWs was contributed by dental offices (
EPA estimates there are approximately 160,000 dentists working in 120,000 dental offices that use or remove amalgam in the United States—almost all of which discharge their wastewater exclusively to POTWs. Mercury in dental wastewater originates from waste particles associated with the placement and removal of amalgam fillings. Most dental offices currently use some type of basic filtration system to reduce the amount of mercury solids passing into the sewer system. However, best management practices and the installation of amalgam separators, which generally have a removal efficiency of 95%, have been shown to reduce discharges even further. A recent study funded by NACWA (
States, Regions, and localities have implemented mandatory and voluntary programs to reduce dental mercury discharges. Specifically, 11 states and at least 19 localities have mandatory pretreatment programs that require the use of dental mercury amalgam separators (
In 2007 and 2008, EPA focused its efforts on collecting and compiling information on current mercury discharges from dental offices, best management practices (BMPs), and amalgam separators. For amalgam separators, EPA looked at the frequency with which they are currently used; their effectiveness in reducing discharges to POTWs; and the capital and annual costs associated with their installation and operation (
EPA received comments from 32 stakeholders on the preliminary 2008 Plan. Most commenters were from pretreatment programs that provided useful information on their mandatory and voluntary pretreatment programs that include the use of amalgam separators. EPA used this information to update its final report on management and best practices for the control of dental mercury (
In response to mercury water quality and pollution prevention concerns, there is progress at the State and local level as amalgam separators and other BMPs are increasingly being mandated by States and local governments. ADA's recently revised BMPs will likely help in convincing dentists to install amalgam separators and employ other BMPs to recover dental amalgam and prevent the discharge of mercury to POTWs. This will help POTWs reduce the amount of mercury in their biosolids and the potential for mercury emissions when biosolids are incinerated. Additionally, due to mercury-free fillings and improved overall dental health, the use of mercury in dentistry is decreasing in the U.S. (
At this time EPA is not identifying this sector for an effluent guidelines rulemaking. As previously noted above, industrial categories demonstrating significant progress through voluntary efforts to reduce hazard to human health or the environment associated with their effluent discharges are a lower priority for effluent guidelines or pretreatment standards revision, particularly where such reductions are achieved by a significant majority of individual facilities in the industry. As an example, in the final 2006 Plan EPA relied on a national voluntary partnership program for the industrial laundries sector as a factor in not identifying the industrial laundries sector for an effluent guidelines rulemaking (
To date, scientists have identified more than 160 pharmaceutical compounds at discernable concentrations in our nation's rivers, lakes, and streams (
For many years, a standard practice at many health care facilities was to dispose of unused pharmaceuticals by flushing them down the toilet or drain. Through this study, EPA seeks to investigate the following questions:
• What are the current industry practices for disposing of unused pharmaceuticals?
• Which pharmaceuticals are being disposed of and at what quantities?
• What are the options for disposing of unused pharmaceuticals other than down the drain or toilet?
• What factors influence disposal decisions?
• Do disposal practices differ within industry sectors?
• What Best Management Practices (BMPs) could facilities implement to reduce the generation of unused pharmaceuticals?
• What reductions in the quantities of pharmaceuticals discharged to POTWs would be achieved by implementing BMPs or alternative disposal methods?
• What are the costs of current disposal practices compared to the costs of implementing BMPs or alternative disposal methods?
In a related effort, EPA also seeks to determine the effectiveness with which publicly-owned treatment works (POTWs) can remove pharmaceuticals from incoming sewage. Upon completion of the health services study, EPA hopes to understand what factors contribute to unused pharmaceutical disposal methods at health service facilities and which disposal methods represent best practices to minimize environmental impacts.
To date, EPA has completed an interim study of the health services industry (
The study focused on hospitals and long-term care facilities (LTCFs) because these facilities are likely responsible for the largest amounts of unused pharmaceuticals being disposed into sewage collection systems within this industry sector. In 2005, there were about 7,000 hospitals and 35,000 LTCFs in the United States (
EPA's four preliminary findings include:
(1) Federal, state, and local laws and regulations often require special handling of pharmaceutical waste. These laws and regulations can influence the options hospitals and long-term care facilities have for disposing of unused pharmaceuticals.
• Some federal regulations may inadvertently encourage disposal of unused pharmaceuticals via the sewer. The Controlled Substances Act (CSA), enforced by the Drug Enforcement Administration (DEA), establishes a closed distribution system for controlled substances. The CSA prohibits the return of controlled substances from end-users to any person except, in certain cases, a law-enforcement agent and CSA registrants. Disposal of controlled substances by CSA registrants is carefully regulated to ensure that the substance is destroyed or rendered unrecoverable. One acceptable method of destruction is witnessed disposal of controlled substances in a drain or toilet.
• Some unused pharmaceuticals are regulated as hazardous wastes and subject to the nation's hazardous waste disposal requirements. Pharmaceutical wastes may be hazardous waste (under the Resource Conservation and Recovery Act (RCRA)) if they are: (1) the pharmaceutical or its sole active ingredient is specifically listed in 40 CFR part 261.33(e) or (f) (commonly referred to as the P or U lists, respectively); and/or (2) the waste exhibits one or more characteristics of hazardous waste (ignitability, corrosivity, reactivity, or toxicity as defined in 40 CFR parts 261.21–24, respectively). Common pharmaceutical wastes that are RCRA hazardous waste when disposed of include epinephrine, nitroglycerin, warfarin, nicotine, and some chemotherapeutic agents.
• State regulations vary widely and influence disposal practices. State regulations of the disposal of unused pharmaceuticals and controlled substances vary widely (
• Medicare and Medicaid requirements also influence hospital disposal practices. The Centers for Medicare and Medicaid Services (CMS), the federal agency within the Department of Health and Human Services, administers the Medicare and Medicaid programs. Medicare provides health insurance to elderly and disabled Americans, while Medicaid provides health insurance for low income Americans, including long-term care coverage (
(2) Organization size, ease and access of disposal, and cost are also factors influencing the disposal of unused pharmaceuticals.
Some facilities use flushing to sewers as a primary means of disposal since it is both easy and complies with CSA requirements for destruction. Facilities are most likely to flush pharmaceuticals if they do not have an on-site pharmacy and/or do not have a pre-existing contract with a hazardous waste hauler to dispose of the pharmaceuticals. In the past, public health agencies and health-related non-government organizations guided the public to destroy unused medications by flushing them down the toilet. Many LTCFs have adopted this method for destruction of unused controlled substances. Many LTCFs have also extended this practice to include flushing all unused medications—controlled and non controlled substances (
(3) Fewer disposal opportunities exist for long-term care facilities because they are often not CSA registrants and cannot generally return pharmaceuticals to the manufacturer or use reverse distributors.
Hospitals typically have on-site pharmacies. It is common practice at hospitals to return some unused pharmaceuticals to the hospital pharmacy and then on to the manufacturer for credit or disposal. However, this option extends only to those pharmaceuticals for which the hospital can receive credit and does not include unused pharmaceuticals that are considered waste (
(4) Best management practices, if widely implemented, have the potential to reduce the amount of unused pharmaceuticals entering our nation's waters from disposal.
Three organizations provide guidance in the form of Best Management Practices (BMPs) to medical facilities on managing pharmaceutical waste: Hospitals for a Healthy Environment (H2E), Product Stewardship Institute (PSI), and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The guidelines provided by these organizations all aim to reduce health and environmental impacts due to current disposal practices of pharmaceutical waste, as discussed in Section 5.2 of the Interim Technical Report (
EPA is concerned about pharmaceuticals in the environment and is working on this issue in many different areas. Over the last few years, EPA has increased its work in a number of areas to better understand pharmaceuticals. EPA has an overall strategy to address the risks associated with emerging contaminants. This four-pronged strategy is aimed at improving science, improving public understanding, identifying partnership and stewardship opportunities, and taking regulatory action as appropriate. We are focused on learning more about the occurrence and health effects of pharmaceuticals in water. In addition, we are working to better understand what treatment technologies may remove them from wastewater and drinking water. We are developing analytical methods to improve detection capabilities. We are conducting national studies and surveys to help direct our course of action. We are also partnering with government agencies, stakeholders, and the private sector, and increasing public awareness about product stewardship and pollution prevention (
EPA continues to study the issue of how health care facilities are managing and disposing of unused pharmaceuticals and POTW treatment effectiveness in an effort to identify the root cause and potential solutions to address the issue of pharmaceuticals in our waterways. Over the coming year, EPA will need to gather more technical and economic information on unused pharmaceutical management in the Health Services Industry. To aid its decision-making, EPA intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for their review and approval under the Paperwork Reduction Act (PRA), 33 U.S.C. 3501, et seq., during the 2009 annual review. EPA will use this ICR to collect technical and economic information on unused pharmaceutical management and identify technologies and BMPs that reduce or eliminate the discharge of unused pharmaceuticals to POTWs. In designing this industry survey EPA
EPA also plans to conduct additional site visits to facilities to obtain more detailed information on how pharmaceuticals are managed, tracked, and disposed as well as influences on behavior. In addition, EPA is considering collecting data from other types of health care facilities (e.g., medical and dental offices, university and prison health clinics, and veterinary clinics). EPA is also reviewing studies on POTW effectiveness. EPA remains concerned about this issue and plans to expedite completion of this study.
In accordance with CWA section 304(m)(2), EPA published the preliminary 2008 Plan for public comment prior to this publication of the final 2008 Plan. See October 30, 2007 (72 FR 61335). The Agency received 32 comments from a variety of commenters including industry and industry trade associations, municipalities and sewerage agencies, environmental groups, and State government agencies. Many of these public comments are discussed in this notice. The Docket accompanying this notice includes a complete set of all of the comments submitted, as well as the Agency's responses (
As noted in section IV.B, CWA section 304(m)(1)(A) requires EPA to publish a Plan every two years that establishes a schedule for the annual review and revision, in accordance with section 304(b), of the effluent guidelines that EPA has promulgated under that section. This final 2008 Plan announces EPA's schedule for performing its section 304(b) reviews. The schedule is as follows: EPA will coordinate its annual review of existing effluent guidelines under section 304(b) with its publication of the preliminary and final Plans under CWA section 304(m). In other words, in odd-numbered years, EPA intends to complete its annual review upon publication of the preliminary Plan that EPA must publish for public review and comment under CWA section 304(m)(2). In even-numbered years, EPA intends to complete its annual review upon the publication of the final Plan. EPA's 2008 annual review is the review cycle ending upon the publication of this final 2008 Plan.
EPA is coordinating its annual reviews under section 304(b) with publication of Plans under section 304(m) for several reasons. First, the annual review is inextricably linked to the planning effort, because the results of each annual review can inform the content of the preliminary and final Plans, e.g., by identifying candidates for effluent guidelines revision for which EPA can schedule rulemaking in the Plan, or by calling to EPA's attention point source categories for which EPA has not promulgated effluent guidelines. Second, even though not required to do so under either section 304(b) or section 304(m), EPA believes that the public interest is served by periodically presenting to the public a description of each annual review (including the review process employed) and the results of the review. Doing so at the same time EPA publishes preliminary and final plans makes both processes more transparent. Third, by requiring EPA to review all existing effluent guidelines each year, Congress appears to have intended that each successive review would build upon the results of earlier reviews. Therefore, by describing the 2008 annual review along with the final 2008 Plan, EPA hopes to gather and receive data and information that will inform its reviews for 2009 and 2010 and the final 2010 Plan.
EPA is currently conducting rulemakings to potentially revise existing effluent guidelines and pretreatment standards for three categories. For the Organic Chemicals, Plastics and Synthetic Fibers (OCPSF) and Inorganic Chemicals categories, the effluent guidelines rulemaking is focused on discharges from Vinyl Chloride and Chlor-Alkali facilities. EPA first identified this effluent guidelines rulemaking in the final 2004 Plan and refers to it as the “Chlorine and Chlorinated Hydrocarbon (CCH) manufacturing” rulemaking. EPA emphasizes that identification of the rulemaking schedules for these effluent guidelines does not constitute a final decision to revise the guidelines. EPA may conclude at the end of the formal rulemaking process—supported by an administrative record and following an opportunity for public comment—that effluent guidelines revisions are not appropriate for these categories. EPA is not scheduling any other existing effluent guidelines for rulemaking at this time.
The final Plan must also identify categories of sources discharging toxic or non-conventional pollutants for which EPA has not published effluent limitations guidelines under section 304(b)(2) or new source performance standards (NSPS) under section 306. See CWA section 304(m)(1)(B). The final Plan must also establish a schedule for the promulgation of effluent guidelines for the categories identified under section 304(m)(1)(B), providing for final action on such rulemaking not later than three years after the identification of the category in a final Plan.
EPA is currently conducting effluent guidelines rulemakings for two potential new categories (
For the reasons discussed below, EPA is not identifying any potential new category for effluent guidelines rulemaking. Therefore, EPA is not scheduling effluent guidelines rulemaking for any category is this final Plan. In the 2004 Plan, EPA announced that it would begin development of a regulation to control the pollutants discharged from drinking water treatment plants. See 69 FR 53720 (September 2, 2004). Based on preliminary study and on public comments, EPA was interested in the potential volume of discharges associated with drinking water facilities. The preliminary data were not conclusive, and the Agency proceeded with additional study and analysis of treatability, including an industry survey. The additional analysis included extensive information about the industry, its treatment residuals, wastewater treatment options, and discharge characteristics. EPA is evaluating a range of effluent guidelines priorities, including court-mandated actions, and plans to make a decision shortly on whether to continue work on this rulemaking.
In order to identify industries not currently subject to effluent guidelines, EPA primarily used data from TRI and PCS. Facilities with data in TRI and PCS are identified by a four-digit SIC code (
The first criterion for identifying industries under section 304(m)(1)(B) is whether they are “categories of sources” for which EPA has not promulgated effluent guidelines. Because this section does not define the term “categories,” EPA interprets this term based on the use of the term in other sections of the Clean Water Act, legislative history, and Supreme Court case law, and in light of longstanding Agency practice. These sources indicate that the term “categories” refers to an industry as a whole based on similarity of product produced or service provided, and is not meant to refer to specific industrial activities or processes involved in generating the product or service. EPA therefore identifies in its biennial Plan only those new industries that it determines are properly considered stand-alone “categories” within the meaning of the Act—not those that are properly considered potential new subcategories of existing categories based on similarity of product or service.
EPA's interpretation of the term “categories” is consistent with longstanding Agency practice. Pursuant to CWA section 304(b), which requires EPA to establish effluent guidelines for “classes and categories of point sources,” EPA has promulgated effluent guidelines for 56 industrial “categories.” Each of these “categories” consists of a broad array of facilities that produce a similar product or perform a similar service—and is broken down into smaller subsets, termed “subcategories,” that reflect variations in the processes, treatment technologies, costs and other factors associated with the production of that product that EPA is required to consider in establishing effluent guidelines under section 304(b). For example, the “Pulp, Paper and Paperboard point source category” (40 CFR part 430) encompasses a diverse range of industrial facilities involved in the manufacture of a like product (paper); the facilities range from mills that produce the raw material (pulp) to facilities that manufacture end-products such as newsprint or tissue paper. EPA's classification of this “industry by major production processes used many of the statutory factors set forth in CWA Section 304(b), including manufacturing processes and equipment (
The second criterion EPA considers when implementing section 304(m)(1)(B) also derives from the plain text of that section. By its terms, CWA section 304(m)(1)(B) applies only to industrial categories to which effluent guidelines under section 304(b)(2) or section 306 would apply, if promulgated. Therefore, for purposes of section 304(m)(1)(B), EPA would not identify in the biennial Plan any industrial categories comprised exclusively or almost exclusively of indirect discharging facilities regulated under section 307.
Third, CWA section 304(m)(1)(B) applies only to industrial categories of sources that discharge toxic or non-conventional pollutants to waters of the United States. EPA therefore did not identify in the Plan industrial activities for which conventional pollutants, rather than toxic or non-conventional pollutants, are the pollutants of concern. In addition, even when toxic and non-conventional pollutants might be present in an industrial category's discharge, section 304(m)(1)(B) does not apply when those discharges occur in trivial amounts. This decision criterion leads EPA to focus on those remaining industrial categories where, based on currently available information, new effluent guidelines have the potential to address a non-trivial discharge of toxic or non-conventional pollutants.
Finally, EPA interprets section 304(m)(1)(B) to give EPA the discretion to identify in the Plan only those
EPA solicits public comments on the following areas of interest to support the Steam Electric Power Generating Detailed Study.
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EPA solicits data on pollutant removal performance of ash ponds. Such data should include influent and effluent concentration, mass and flow data. EPA solicits such data for total and dissolved metals, nitrogen compounds (ammonia, total Kjeldahl nitrogen, nitrates, nitrites, and total nitrogen), total dissolved solids, and effluent toxicity.
EPA also solicits information on seasonal effects on ash pond discharges, such as those resulting from seasonal turnover. EPA is particularly interested in the magnitude of the seasonal effects on the concentration and mass of pollutants discharged.
Finally, EPA solicits information that quantify how ash pond discharges have been affected by introducing FGD wastewater into ash ponds that previously did not receive this wastewater.
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EPA is researching the following questions and topics as they relate to the quantity and toxicity of pollutants discharged and the environmental impacts of these discharges to support the Oil and Gas Extraction/Coalbed Methane detailed study.
• What is the range of pollutant concentrations in CBM produced water?
• What is the toxicity of these pollutants to human health and the environment?
• What is the range of pollutant concentrations and what are the CBM produced water flow rates for the major CBM basins?
• What CBM produced water pollutants are typically controlled through permit limits and what is the range of these permit limits?
• What are the observed and potential impacts of CBM produced water discharges on aquatic environments and communities, riparian zones, and other wetlands?
• How does the composition of CBM produced water change when discharged to normally dry draws or ephemeral streams?
• To what extent do CBM produced water discharges mobilize metals, soil nutrients, pesticides and other organic contaminants present in soil and carry these constituents to surface waters?
• What are measures that can mitigate potential impacts to uses of surface waters that are used for irrigation?
EPA is researching the following questions and topics as they relate to the potential technology options and beneficial use practices for this industrial sector.
• What are the current industry treatment technologies for CBM produced water?
• What are the potential beneficial use applications of CBM produced water and what are the corresponding criteria for such uses?
• How effectively do these treatment technologies and beneficial use practices reduce the potential impacts of CBM produced water discharges?
• What is the range of incremental annualized compliance costs associated with these technologies and practices? How do these costs differ between existing and new sources?
• What is the demonstrated use and economic affordability (
• What are the types of non-water quality environmental impacts (including energy impacts) associated with the current industry treatment technologies and beneficial use practices for CBM produced water?
EPA is researching the following questions and topics as they relate to the expansion of CBM exploration and development and the affordability of potential technology options for this industrial sector.
• What is the near-term and long-term growth rate for this industry sector? Which CBM basins are likely to experience the most growth within the next ten years?
• What are the current industry drilling and infrastructure expansion plans for CBM exploration and development?
• What is the predicted range of CBM reserves across the different basins that would be economically recoverable at different natural gas prices?
• What are the potential impacts on developing CBM reserves and operator profitability and rates of return on investment of any increased costs associated with potential industry treatment technologies and beneficial use practices for CBM produced water discharges?
• What is the difference between potential impacts on existing sources versus new sources?
• What percentage of CBM operators are considered small entities?
EPA is researching the following questions and topics as they relate to current regulatory controls.
• How do NPDES permit programs regulate CBM produced water discharges (
• What is the BPJ basis for existing technology-based effluent limits for CBM produced water discharges?
• To what extent and how do current regulatory controls ensure the beneficial use of CBM produced water?
• What other statutes might affect the ability to discharge, treat, or beneficially use CBM produced water (
• EPA solicits identification of any policies, procedures or guidelines that govern the disposal of unused pharmaceuticals from hospitals and hospices; offices of doctors and mental health practitioners; nursing, long-term care, re-habilitation, and personal care facilities; medical laboratories and diagnostic service facilities; and veterinary care facilities.
• EPA solicits information on the most likely sub-sectors within the Health Service sector that would accumulate unused pharmaceuticals for management and disposal.
• When applicable, to what extent are unused pharmaceuticals disposed according to the Resource Conservation and Recovery Act (RCRA)?
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• EPA solicits quantitative information or tracking sheets for the past year on the disposal of unused pharmaceuticals via the toilet, drain, or sewer.
• EPA solicits data on how control authorities are currently controlling disposal of unused pharmaceuticals via wastewater.
• EPA solicits information on any technologies or BMPs that are available to control, reduce, or eliminate the disposal of unused pharmaceuticals to POTWs.
• EPA solicits qualitative and quantitative data on the effectiveness and annualized costs of the technologies or BMPs that health service facilities use to control or eliminate the discharge of unused pharmaceuticals from their wastewater. EPA is also interested in obtaining information on the current costs (including labor) associated with disposal of unused pharmaceuticals via the drain or toilet.
• EPA solicits any studies or information on the potential for unused pharmaceuticals that are disposed of in non-hazardous-waste landfills to contaminate underground resources of drinking water.
EPA will need to gather more technical and economic information on unused pharmaceutical management in the Health Services Industry. To aid its decision-making, EPA intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for their review and approval under the Paperwork Reduction Act (PRA), 33 U.S.C. 3501,
EPA requests information on the Ore Mining and Dressing category for which it is continuing a preliminary category review (
• What toxic pollutants are discharged from this industry in non-trivial amounts on an industry and per-facility basis?
• What raw material(s) or process(es) are the sources of these pollutants?
• What technologies or management practices are available (technically and economically) to control or prevent the generation and/or release of these pollutants.
EPA solicits comments on whether EPA used the correct evaluation factors, criteria, and data sources in conducting its annual review and developing this final Plan. EPA also solicits comment on other data sources EPA can use in its annual reviews and biennial planning process. Please see the docket for a more detailed discussion of EPA's analysis supporting the reviews in this notice (
EPA solicits comments on whether, and if so, how the Agency should provide EPA Regions and States with permit-based support instead of revising effluent guidelines (
As a factor in its decision-making, EPA considers opportunities to eliminate inefficiencies or impediments to pollution prevention or technological innovation, or opportunities to promote innovative approaches such as water quality trading, including within-plant trading. Consequently, EPA solicits comment on implementation issues related to existing effluent guidelines and pretreatment standards.
EPA solicits comments on its evaluation of categories of indirect dischargers without categorical pretreatment standards. Specifically, EPA solicits wastewater characterization data (
EPA requests data to evaluate the costs, benefits, and impacts of industrial water conservation practices. In particular, EPA solicits the following industrial sector or facility level data on water re-use and reduction technologies and pollution prevention practices:
• The main reasons why these technologies and practices were adopted (
• Descriptions of the water conservation technologies and practices employed at industrial unit operations; wastewater flow and pollutant data; and descriptions of the extent to which these water conservation technologies and practices reduce the amount of wastewater volume, the mass of wastewater pollutants resulting from an industrial unit operation, or both.
• Detailed descriptions of the wastewater treatment and the annual costs of operating wastewater treatment to maintain compliance with the facility's effluent limits.
• Detailed descriptions of the capital and annual costs associated with implementing water conservation technologies and practices and any cost savings resulting from water conservation technologies and practices.
Additionally, EPA solicits estimates of the amount of increased water conservation and the number of facilities that will likely adopt more advanced water conservation technologies and practices over the next five years as a result of limitations on water source availability or potential costs savings.