[Federal Register: September 12, 2002 (Volume 67, Number 177)] [Proposed Rules] [Page 57871-57928] [[Page 57871]] ----------------------------------------------------------------------- Part II Environmental Protection Agency ----------------------------------------------------------------------- 40 CFR Part 451 Effluent Limitations Guidelines and New Source Performance Standards for the Concentrated Aquatic Animal Production Point Source Category; Proposed Rule [[Page 57872]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 451 [FRL--7263-2] RIN 2040-AD55 Effluent Limitations Guidelines and New Source Performance Standards for the Concentrated Aquatic Animal Production Point Source Category AGENCY: Environmental Protection Agency. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This action presents the U.S. Environmental Protection Agency's (EPA's) proposed effluent limitations guidelines and standards for wastewater discharges from the concentrated aquatic animal production (CAAP) industrial point source category. The proposed regulation proposes new technology-based effluent limitations guidelines and standards for wastewater discharges associated with the operation of new and existing concentrated aquatic animal production facilities. EPA estimates that compliance with this regulation, as proposed, would reduce the discharge of total suspended solids (TSS) by at least 4.1 million pounds per year and would cost industry an estimated $1.5 million and Federal and State permitting authorities an estimated $3,337 on an annual basis. EPA expects that the control of TSS would reduce the discharge of biochemical oxygen demand (BOD) and nutrients by at least 8.7 million pounds per year. EPA also believes that by implementing the best management practices (BMP) plans any toxic and non-conventional pollutants that may be discharged will be controlled. EPA estimates that the annual quantifiable benefits of the proposal would be approximately $22,000-$113,000. DATES: Comments on the proposal must be postmarked by December 11, 2002. EPA will conduct two or three public meetings to discuss the proposed rule. The information on dates, times and locations of the public meetings will be published in a subsequent Federal Register notice. ADDRESSES: Submit written comments to Ms. Marta Jordan, Office of Water, Engineering and Analysis Division (4303T), U.S. EPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. For hand-deliveries or Federal Express, please send comments to Ms. Marta Jordan, Office of Water, Engineering and Analysis Division, Room 6233M, 1201 Constitution Avenue, NW., 6th Floor, Connecting Wing, Washington, DC 20004. Comments may be sent by e-mail to the following e-mail address: aquaticanimals@epa.gov. For additional information on how to submit comments, see ``SUPPLEMENTARY INFORMATION, How to Submit Comments.'' The public record for this proposed rulemaking has been established under docket number W-02-01 and is located in the Water Docket, EPA West Room B135,1301 Constitution Ave. NW., Washington DC, 20004.The record is available for inspection from 9 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. For access to the docket materials, call (202) 566-2426 to schedule an appointment. You may have to pay a reasonable fee for copying. FOR FURTHER INFORMATION CONTACT: For technical information concerning today's proposed rule, contact Ms. Marta Jordan at (202) 566-1049. For economic information, contact Mr. Nicolaas Bouwes at (202) 566-1002. SUPPLEMENTARY INFORMATION: Regulated Entities Entities potentially regulated by this action include: ------------------------------------------------------------------------ Primary Category Examples of regulated NAICS entities codes ------------------------------------------------------------------------ Industry....................... Facilities engaged in concentrated aquatic animal production, which may include the following sectors:. Finfish Farming and Fish 112511 Hatcheries. Other Animal Aquaculture... 112519 ------------------------------------------------------------------------ The preceding table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility would be regulated by this action, you should carefully examine the applicability criteria in 40 CFR part 451.1, 451.10, 451.20, and 451.30. You should also examine the description of the proposed scope of each subpart in Section VI.B of this document. If you have questions regarding the applicability of this proposed action to a particular entity, contact the person listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section. How To Submit Comments EPA requests an original and three copies of your comments and enclosures (including references). Commenters who want EPA to acknowledge receipt of their comments should enclose a self-addressed, stamped envelope. No facsimiles (faxes) will be accepted. Please submit any copies of references cited in your comments. Comments may also be sent via e-mail, see ADDRESSES. Electronic comments must specify docket number W-02-01 and must be submitted as an ASCII, Word, or WordPerfect file avoiding the use of special characters and any form of encryption. Electronic comments on this proposal may be filed online at many Federal Depository Libraries. No confidential business information (CBI) should be sent via e-mail. Protection of Confidential Business Information (CBI) EPA notes that certain information and data in the record supporting the proposed rule have been claimed as CBI and, therefore, are not included in the record that is available to the public in the Water Docket. Pursuant to EPA regulations at 40 CFR 2.203 and 2.211, EPA treats all information for which a claim of confidentiality is made as confidential unless and until it makes a determination to the contrary under 40 CFR 2.205. Further, the Agency has not included in the docket some data not claimed as CBI because release of this information would indirectly reveal information claimed to be confidential. To provide the public with as much information as possible in support of the proposed rulemaking, EPA is presenting in the public record certain information in aggregated form or, alternatively, is masking facility identities or employing other strategies in order to preserve confidentiality claims. This approach ensures that the information in the public record both explains the basis for today's proposal and allows for a meaningful opportunity for public comment, without compromising CBI claims. Some tabulations and analyses of facility-specific data claimed as CBI are available to the company that submitted the information. To ensure that all data or information claimed as CBI is protected in accordance with EPA regulations, any requests for release of such company-specific data should be submitted to EPA on company letterhead and signed by a responsible official authorized to receive such data. [[Page 57873]] The request must list the specific data requested and include the following statement, ``I certify that EPA is authorized to transfer confidential business information submitted by my company, and that I am authorized to receive it.'' Supporting Documentation The rules proposed today are supported by several documents: 1. ``Economic and Environmental Impact Analysis of Proposed Effluent Limitations Guidelines and Standards for the Concentrated Aquatic Animal Production Industry Point Source Category'' (EPA-821-R- 02-015). Hereafter referred to as the CAAP Economic Analysis, this document presents the analysis of compliance costs; facility, firm, small business and market impacts; and water quality impacts and potential benefits. In addition, this document presents an analysis of cost-effectiveness. (DCN 20141) 2. ``Development Document for Proposed Effluent Limitations Guidelines and Standards for the Concentrated Aquatic Animal Production Industry Point Source Category'' (EPA-821-R-02-016). Hereafter referred to as the CAAP Development Document, the document presents EPA's technical conclusions concerning the CAAP proposal. This document describes, among other things, the data collection activities, the wastewater treatment technology options, effluent characterization, effluent reduction of the wastewater treatment technology options, estimate of costs to the industry, and estimate of effects on non-water quality environmental impacts. (DCN 61552) 3. ``Draft Guidance for Aquatic Animal Production Facilities to Assist in Reducing the Discharge of Pollutants'' (EPA-821-B-02-002). Hereafter referred to as the AAP Technical Guidance Manual, the document presents best management practices (BMPs) in use at concentrated aquatic animal facilities. The guidance manual presents general BMPs that can be applied throughout the industry and BMPs that apply to specific sectors of the industry. (DCN 61553) How To Obtain Supporting Documents All documents are available from the National Service Center for Environmental Publications, P.O. Box 42419, Cincinnati, OH 45242-2419, (800) 490-9198 and the EPA Water Resource Center. The supporting technical documentation (e.g., CAAP Development Document, Economic Analysis and AAP Technical Guidance Manual) can be obtained on the Internet, located at http://www.epa.gov/ost/guide/aquaculture/. This website is also linked to an electronic version of today's proposed rule. Overview The preamble describes the legal authority for the proposal, background information, the technical and economic methodologies used by the Agency to develop these proposed regulations and, in an appendix, the definitions, acronyms, and abbreviations used in this document. This preamble also solicits comment and data generally, and on specific areas of interest. Table of Contents I. Legal Authority II. Background A. Clean Water Act B. Section 304(m) Consent Decree III. Rulemaking History and Industry Profile A. Concentrated Aquatic Animal Production Effluent Guideline Rulemaking History B. Environmental and Human Health Impacts C. Industry Profile IV. Summary of Data Collection A. Primary and Secondary Sources of Data and Information B. Industry Surveys C. Site Visits and Wastewater Sampling D. Pollutants Sampled and Analytical Methods E. Other Data Collection F. Summary of Public Participation V. Scope/Applicability of Proposed Regulation A. Facilities to be Subject to 40 CFR Part 451 B. Facilities Not Subject to 40 CFR Part 451 VI. Subcategorization A. Factors Considered in Developing Proposed Subcategories B. Proposed Subcategories VII. Technology Options, Costs, Wastewater Characteristics, and Pollutant Reductions A. Description of Wastewater Treatment Technologies and Management Practices in the CAAP Industry B. Water Use and Wastewater Characteristics C. Pollutants of Concern D. Approach to Estimating Compliance Costs E. Approach to Estimating Pollutant Reductions VIII. Options Evaluated and Selected for Proposal A. Introduction B. Flow-through Systems C. Recirculating Systems D. Net Pen Systems E. Ponds F. No Regulation Option G. CAAP Pretreatment Standards IX. Economic Analysis A. Introduction B. Economic Data Collection Activities C. Economic Impact Methodologies D. Annualized Compliance Cost Estimates E. Model Facility Impacts F. Other Economic Impacts G. BPT Cost Comparison Test and Cost-Effectiveness Analysis H. Small Business Analysis I. Cost-Benefit Analysis X. Water Quality Analysis and Environmental Benefits A. CAAP Environmental Impacts B. Environmental Benefits Analysis XI. Non-Water Quality Environmental Impacts A. Energy Requirements B. Air Emissions Impacts C. Solid Waste Generation XII. Implementation A. Regulatory Implementation of Part 451 through the NPDES Permit Program and the National Pretreatment Program B. Upset and Bypass Provisions C. Variances and Modifications D. Best Management Practices E. Potential Tools to Assist with the Remediation of Aquaculture Effluents XIII. Administrative Requirements A. Executive Order 12866: ``Regulatory Planning and Review'' B. Regulatory Flexibility Act (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. C. Unfunded Mandates Reform Act D. Executive Order 13045: ``Protection of Children from Environmental Health Risks and Safety Risks'' E. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments F. Paperwork Reduction Act G. Executive Order 13132: ``Federalism'' H. Executive Order 12898: ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' I. National Technology Transfer and Advancement Act J. Executive Order 13211: ``Energy Effects'' K.Plain Language XIV. Solicitation of Data and Comments A. General and Specific Comment Solicitation XV. Guidelines for Submission of Analytical Data A. Types of Data Requested B. Analytes Requested C. Quality Assurance/Quality Control (QA/QC) Requirements Appendix A: Definitions, Acronyms, and Abbreviations Used in This Document I. Legal Authority These regulations are proposed under the authority of sections 301, 304, 306, 308, 402, and 501 of the Clean Water Act, 33 U.S.C. 1311, 1314, 1316, 1318, 1342, and 1361. II. Background A. Clean Water Act Congress passed the Federal Water Pollution Control Act (1972), also known as the Clean Water Act (CWA), to ``restore and maintain the chemical, physical, and biological integrity of the nation's waters.'' (33 U.S.C. 1251(a)). [[Page 57874]] The CWA establishes a comprehensive program for protecting our nation's waters. Among its core provisions, the CWA prohibits the discharge of pollutants from a point source to waters of the U.S. except as authorized by a National Pollutant Discharge Elimination System (NPDES) permit. The CWA also requires EPA to establish national technology based effluent limitation guidelines and standards (effluent guidelines or ELG) for discharges from different categories of point sources, such as industrial, commercial and public sources. Congress recognized that regulating only those sources that discharge effluent directly into the nation's waters would not be sufficient to achieve the CWA's goals. Consequently, the CWA requires EPA to promulgate nationally applicable pretreatment standards that restrict pollutant discharges from facilities that discharge wastewater indirectly through sewers flowing to publicly-owned treatment works (POTWs). See section 307(b) and (c), 33 U.S.C. 1317(b) & (c). National pretreatment standards are established for those pollutants in wastewater from indirect dischargers that may pass through, interfere with or are otherwise incompatible with POTW operations. Generally, pretreatment standards are designed to ensure that wastewaters from direct and indirect industrial dischargers are subject to similar levels of treatment. In addition, POTWs are required to implement local treatment limits applicable to their industrial indirect dischargers to satisfy any local requirements. See 40 CFR 403.5. Direct dischargers must comply with effluent limitations in National Pollutant Discharge Elimination System (NPDES) permits. Indirect dischargers, who discharge through POTWs, must comply with pretreatment standards. Effluent limitations in NPDES permits are derived from effluent limitations guidelines and new source performance standards promulgated by EPA, as well as from water quality standards. The effluent limitations guidelines and standards are established by regulation for categories of industrial dischargers and are based on the degree of control that can be achieved using various levels of pollution control technology. EPA promulgates national effluent limitations guidelines and standards of performance for major industrial categories for three classes of pollutants: (1) Conventional pollutants (i.e., total suspended solids, oil and grease, biochemical oxygen demand, fecal coliform, and pH); (2) toxic pollutants (e.g., toxic metals such as chromium, lead, nickel, and zinc; toxic organic pollutants such as benzene, benzo-a-pyrene, phenol, and naphthalene); and (3) non- conventional pollutants (e.g., ammonia-N, formaldehyde, and phosphorus). EPA considers development of six types of effluent limitations guidelines and standards for each major industrial category, as appropriate. 1. Best Practicable Control Technology Currently Available (BPT)-- Section 304(b)(1) of the CWA EPA may promulgate BPT effluent limits for conventional, toxic, and non-conventional pollutants. For toxic pollutants, EPA typically regulates priority pollutants which consist of a specified list of toxic pollutants. In specifying BPT, EPA looks at a number of factors. EPA first considers the cost of achieving effluent reductions in relation to the effluent reduction benefits. The Agency also considers the age of the equipment and facilities, the processes employed, engineering aspects of the control technologies, any required process changes, non-water quality environmental impacts (including energy requirements), and such other factors as the Administrator deems appropriate. See CWA 304(b)(1)(B). Traditionally, EPA establishes BPT effluent limitations based on the average of the best performances of facilities within the industry, grouped to reflect various ages, sizes, processes, or other common characteristics. If, however, existing performance is uniformly inadequate, EPA may establish limitations based on higher levels of control than currently in place in an industrial category when based on an Agency determination that the technology is available in another category or subcategory, and can be practically applied. 2. Best Control Technology for Conventional Pollutants (BCT)--Section 304(b)(4) of the CWA The 1977 amendments to the CWA required EPA to identify additional levels of effluent reduction for conventional pollutants associated with BCT technology for discharges from existing industrial point sources. In addition to other factors specified in section 304(b)(4)(B), the CWA requires that EPA establish BCT limitations after consideration of a two part ``cost-reasonableness'' test. EPA explained its methodology for the development of BCT limitations in July 1986 (51 FR 24974). Section 304(a)(4) designates the following as conventional pollutants: biochemical oxygen demand measured over five days (BOD5), total suspended solids (TSS), fecal coliform, pH, and any additional pollutants defined by the Administrator as conventional. The Administrator designated oil and grease as an additional conventional pollutant on July 30, 1979 (44 FR 44501). 3. Best Available Technology Economically Achievable (BAT)--Section 304(b)(2) of the CWA In general, BAT effluent limitations guidelines represent the best economically achievable performance of facilities in the industrial subcategory or category. The CWA establishes BAT as a principal national means of controlling the direct discharge of toxic and nonconventional pollutants. The factors considered in assessing BAT include the cost of achieving BAT effluent reductions, the age of equipment and facilities involved, the process employed, potential process changes, and non-water quality environmental impacts including energy requirements, and such other factors as the Administrator deems appropriate. The Agency retains considerable discretion in assigning the weight to be accorded these factors. An additional statutory factor considered in setting BAT is economic achievability. Generally, EPA determines economic achievability on the basis of total costs to the industry and the effect of compliance with BAT limitations on overall industry and subcategory financial conditions. As with BPT, where existing performance is uniformly inadequate, BAT may reflect a higher level of performance than is currently being achieved based on technology transferred from a different subcategory or category. BAT may be based upon process changes or internal controls, even when these technologies are not common industry practice. 4. New Source Performance Standards (NSPS)--Section 306 of the CWA New Source Performance Standards reflect effluent reductions that are achievable based on the best available demonstrated control technology. New facilities 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 (that is, conventional, nonconventional, and priority pollutants). In establishing NSPS, EPA is directed to take into consideration the cost of achieving the effluent reduction and any non-water quality environmental impacts and energy requirements. [[Page 57875]] 5. Pretreatment Standards for Existing Sources (PSES)--Section 307(b) of the CWA Pretreatment Standards for Existing Sources 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 (POTW). Categorical pretreatment standards are technology-based and are analogous to BAT effluent limitations guidelines. The General Pretreatment Regulations, which set forth the framework for the implementation of categorical pretreatment standards, are found at 40 CFR part 403. These regulations establish pretreatment standards that apply to all non-domestic dischargers. See 52 FR 1586 (Jan. 14, 1987). 6. Pretreatment Standards for New Sources (PSNS)--Section 307(c) of the CWA Section 307(c) of the Act requires EPA to promulgate pretreatment standards for new sources at the same time it promulgates new source performance standards. Such pretreatment standards must prevent the discharge of any pollutant into a POTW that may interfere with, pass through, or may otherwise be incompatible with the POTW. EPA promulgates categorical pretreatment standards for existing sources based principally on BAT technology for existing sources. EPA promulgates pretreatment standards for new sources based on best available demonstrated technology for new sources. 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. B. Section 304(m) Consent Decree Section 304(m) requires EPA to publish a plan every two years that consists of three elements. First, under section 304(m)(1)(A), EPA is required to establish a schedule for the annual review and revision of existing effluent guidelines in accordance with section 304(b). Section 304(b) applies to effluent limitations guidelines for direct dischargers and requires EPA to revise such regulations as appropriate. Second, under section 304(m)(1)(B), EPA must identify categories of sources discharging toxic or nonconventional pollutants for which EPA has not published BAT effluent limitations guidelines under 304(b)(2) or new source performance standards under section 306. Finally, under 304(m)(1)(C), EPA must establish a schedule for the promulgation of BAT and NSPS for the categories identified under subparagraph (B) not later than three years after being identified in the 304(m) plan. Section 304(m) does not apply to pretreatment standards for indirect dischargers, which EPA promulgates pursuant to sections 307(b) and 307(c) of the Clean Water Act. On October 30, 1989, Natural Resources Defense Council, Inc., and Public Citizen, Inc., filed an action against EPA in which they alleged, among other things, that EPA had failed to comply with CWA Section 304(m). Plaintiffs and EPA agreed to a settlement of that action in a consent decree entered on January 31, 1992. The consent decree, which has been modified several times, established a schedule by which EPA is to propose and take final action for four point source categories identified by name in the decree and for eight other point source categories identified only as new or revised rules, numbered 5 through 12. EPA selected the aquatic animal production industry as the subject for New or Revised Rule 12. Under the decree, as modified, the Administrator is required to sign a proposed rule for the aquatic animal production industry no later than August 14, 2002, and to take final action on that proposal no later than June 30, 2004. III. Rulemaking History and Industry Profile A. Concentrated Aquatic Animal Production Effluent Guideline Rulemaking History EPA actions to regulate aquatic animal production facilities under the National Pollutant Discharge Elimination System (NPDES) permitting program date back to 1973, when EPA proposed and promulgated NPDES permit application rules for concentrated aquatic animal production facilities. 38 FR 10960 (May 3, 1973)(proposed), 38 FR 18000 (July 5, 1973). After some litigation over the NPDES regulations, EPA proposed and took final action to re-establish the concentrated aquatic animal production facility requirements. NRDC v. Costle, 568 F.2d 1369 (D.C. Cir.1977); 43 FR 37078 (Aug. 21, 1978); 44 FR 32854 (June 7, 1979). The 1979 version of the regulations has not substantively changed since then. The NPDES regulations specify the applicability of the NPDES permit requirement to a concentrated aquatic animal production facility. 40 CFR 122.24 and appendix C to part 122. To be a concentrated aquatic animal production facility, the facility must either meet the criteria in 40 CFR appendix C or be designated on a case-by-case basis. 40 CFR 122.24(b). A hatchery, fish farm, or other facility is a concentrated aquatic animal production facility if it contains, grows, or holds, aquatic animals in either of two categories: cold water or warm water. The cold water species category includes ponds, raceways, or other similar structures which discharge at least 30 days per year but does not include: Facilities which produce less than 9,090 harvest weight kilograms (approximately 20,000 pounds) per year; and facilities which feed less than 2,272 kilograms (approximately 5,000 pounds) during the calendar month of maximum feeding. The warm water category includes ponds, raceways, or other similar structures which discharge at least 30 days per year but does not include: closed ponds which discharge only during periods of excess runoff; or facilities which produce less than 45,454 harvest weight kilograms (approximately 100,000 pounds) per year. 40 CFR part 122, appendix C. EPA does not propose to revise the NPDES regulation by today's action. Prior to today's proposal, EPA had not proposed effluent limitations guidelines and standards for the aquatic animal production industry. In the early 1970s, however, EPA staff did evaluate fish hatcheries and fish farms to develop recommendations on whether EPA should propose effluent guidelines. Ultimately, EPA did not propose any such regulations because the 1977 Clean Water Act amendments re-focused the Agency's attention on establishing effluent limitations guidelines for industry sectors with effluents containing toxic metals and organics. EPA's evaluation of fish hatcheries and fish farms did not reveal significant contributions of toxic metals or organic chemical compounds in the wastes discharged from those hatcheries and farms. That draft development document, however, did serve to assist NPDES permit writers in the exercise of their ``best professional judgment'' to develop permits for those fish hatcheries and fish farms that were considered ``concentrated aquatic animal production facilities,'' and thus required to apply for NPDES permits under EPA regulations. B. Environmental and Human Health Impacts The operation of CAAP facilities may introduce a variety of pollutants into receiving waters. Under some [[Page 57876]] conditions, these pollutants can be harmful to the environment. According to the 1998 USDA Census of Aquaculture (USDA, 2000, DCN 60605), there are approximately 4,200 commercial aquatic animal production (AAP) facilities in the United States. Aquaculture has been among the fastest-growing sectors of agriculture until a recent slowdown that began several years ago caused by declining or level growth among producers of several major species. EPA analysis indicates that many CAAP facilities have treatment technologies in place that greatly reduce pollutant loads. However, in the absence of treatment, pollutant loads from individual CAAP facilities such as those covered by today's proposed rule can contribute up to several thousand pounds of nitrogen and phosphorus per year, and tens to hundreds of thousands of pounds of TSS per year (see CAAP Economic Analysis). These pollutants, if discharged, can contribute to eutrophication and other aquatic ecosystem responses to excess nutrient loads and BOD effects. In recent years, Illinois, Louisiana, North Carolina, New Hampshire, New Mexico, Ohio and Virginia have cited the AAP industry as a potential or contributing source of impairment to water bodies (EPA, 2000, DCN 40319). State authorities in Idaho, Michigan, and Maine, for example, have set water quality based permit requirements for CAAP facilities in addition to technology based limits based on BPJ. Another area of potential concern relates to non-native species introductions from CAAP facilities, which may pose risks to native fishery resources and wild native aquatic species from the establishment of escaped individuals (Carlton, 2001, DCN 61434; Volpe et al., 2000, DCN 60611). Some CAAP facilities may also employ drugs, such as formalin, and chemicals, such as a variety of copper-containing pesticides, that may be released into receiving waters. For some applications of these drugs and chemicals, there is a belief that further information is needed to fully evaluate risks to ecosystems and human health associated with their use in some situations. Finally, CAAP facilities also may inadvertently introduce pathogens into receiving waters, with potential impacts on native biota. Today's proposed rule attempts to address a number of these environmental concerns. C. Industry Profile The concentrated aquatic animal production industry includes sites that fall within the North American Industry Classification System (NAICS) codes 112511 (finfish farming and fish hatcheries), 112512 (shellfish farming), 112519 (other animal aquaculture), and part of 712130 (aquariums, part of zoos and botanical gardens). SBA sets up standards to define whether an entity is small and eligible for Government programs and preferences reserved for ``small business'' concerns. Size standards have been established for types of economic activity, or industry, generally under the NAICS. See 13 CFR part 121 for more detailed information. The first three groups (NAICS 112511, 112512, and 112519) have Small Business Administration (SBA) annual revenue based size standards of $0.75 million while the SBA size standard for NAICS 712130 is $6.0 million. EPA uses these SBA size standards to conduct preliminary analyses to determine the number of small businesses in an industrial category and whether the proposed rule would have a significant impact on a substantial number of small entities. USDA reports that there were approximately 4,200 commercial aquaculture facilities in the 1998 Census of Aquaculture (DCN 60605). Based on revenues from aquaculture sales alone (not including other farm-related revenues from other agricultural crops at the facility), more than 90 percent of the facilities have revenues less than $0.75 million annually and thus may be considered small businesses. The Small Business Administration's size standard is based on annual revenue at the company level for all products, so using facility revenue from aquaculture sales reported in the 1998 Census of Aquaculture is likely to over-estimate the proportion of small businesses in the industry. Although aquaculture facilities exist in every State, there tends to be regional specialization by species as a result of local climate and the quality and quantity of water available for aquaculture (for example, catfish in the Southeast, salmon on the Northern coasts, and trout in Idaho). In 1999, commercial farm level aquatic animal sales totaled nearly $1 billion (842 million pounds). The range of products includes: Finfish raised for food and recreation (including food fish, sport or game fish, baitfish, or ornamental fish); crustaceans and molluscs raised for food; and other aquatic animals such as alligators, frogs, and turtles. Catfish and trout sales account for nearly fifty percent of the commercial market ($400 million and $64 million in production, respectively). The industry includes several types of ownership structures: (1) Commercial; (2) Federal and State; (3) Tribal; (4) academic and research; and (5) nonprofit. Within the private or commercial sector, ownership structures range from small family farms to large multinational firms. The non-commercial sector is also diverse. The U.S. Fish and Wildlife Service (FWS) operates 66 Federal hatcheries, six Fish Technology Centers, and nine Fish Health Centers. Its goals are to conserve, restore, enhance, and manage the Nation's fishery resources and ecosystems for the benefit of future generations. FWS distributes more than 50 aquatic species primarily to Federal, Tribal, State, and local governments. Many States operate fish hatcheries for stocking recreational fisheries, and EPA identified approximately 500 State hatchery facilities. As an approximate measure of the size of the governmental aquatic animal production, fish distributions from the FWS in 1999 totaled 5.5 million pounds. Fisheries magazine published an overview of State coldwater fishery programs that listed 23.7 million pounds of trout and salmon distributed from State hatcheries in 1996 (Epifanio, 2000, DCN 60851). EPA estimate that production from 17 Tribal programs is more than 1.3 million fish. EPA identified approximately 30 academic and research institutions that maintain facilities ranging from small research projects to full- scale systems for training the next generation of aquatic animal producers. Information on the magnitude of these operations nationwide is currently being sought by EPA through a detailed industry survey. Nonprofit organizations in the CAAP industry that were identified by EPA include Alaskan salmon hatcheries and non-taxable aquariums. Alaskan salmon hatcheries are different from salmon and finfish production facilities in the continental United States. Certain types of production activities related to the farming of salmon and other finfish in Alaska were outlawed in 1990 (ADFG, 2002, DCN 61556). Instead, Alaska permits nonprofit ``ocean ranching'', where native salmon species are reared from egg to fingerling (chum and pink salmon) or smolt (coho, chinook, or sockeye salmon) stage in hatcheries. The chum and pink salmon produced in the hatchery are then placed in pens in the ocean waters, and after a short additional growing period (approximately two months), are released into public waters to be available as adults for harvest by fishermen. Two types of nonprofit organizations exist--four regional aquaculture associations and eight private nonprofit corporations--with a [[Page 57877]] total permitted production of approximately 2 billion smolts for ocean release. EPA identified approximately 50 aquariums, some of which are non-taxable establishments. Aquatic animals raised for commercial purposes are very diverse, ranging from species produced for human consumption as food to species raised for their hides. As mentioned above, governments also produce aquatic animals, usually for recreational purposes. The animals may be raised in a variety of different production systems. The choice of a production system is influenced by a variety of factors including species, economics of production, markets, local water resources, land availability, and operator preference. Some production systems, especially those needed to produce species intended for release into the wild or other natural environments, are intended to provide a suitable environment that imitates the natural environment of the species. CAAP systems include ponds, flow-through systems, recirculating systems and open water systems. Each of these production systems is described below. 1. Pond Systems Pond systems are distinguished from other systems used to produce aquatic animals by the frequency of discharge. Typically, ponds do not have a continuous discharge. They will discharge water either as a result of a storm event or when the pond is drained for harvest or to make repairs. Aquatic animals produced in ponds include: catfish, shrimp, hybrid striped bass, tilapia, crawfish, baitfish and many ornamental and sport fish species. The largest species sector produced in ponds is catfish. Many pond producers must pump well water to fill their ponds and are constantly balancing the need to conserve water and reduce pumping costs with keeping ponds full. Most aquatic animal producers minimize the frequency or degree to which the ponds are drained because the water is a valuable asset. Some species require operators to drain the pond to allow for harvesting, while others can be harvested without draining by using seines (large nets) to capture the fish. Aquatic animals that are more difficult to capture in the seines, may require partial draining of the pond to harvest. Pond system operators must maintain a level of water quality that will support the aquatic animal population. In most cases, water quality maintenance requires that the pond be mechanically aerated to maintain sufficient oxygen levels. The growth of algae is promoted by the presence of nutrients made available either through excess feed or animal excretions. Planktonic algae (the desired form of algae) process these nutrients and improve water quality. Too much, or the wrong kinds of, algae can degrade water quality in ponds by contributing to excess turbidity and reduced oxygen levels. Producers monitor the dissolved oxygen and turbidity levels to evaluate pond water quality and protect their animal crops from rapid shifts in oxygen or other important water quality parameters. This monitoring also ensures that the pond is serving as an efficient waste treatment system. The pond system itself has the ability to decompose biological material and settle out solids such as fecal materials, sediment, and uneaten feed. Drugs, such as oxytetracycline (added in feed to treat certain diseases) and chemicals, such as copper sulfate and other aquatic herbicides (used to treat excessive aquatic vegetation or algae), readily bind to sediment and other particles in the pond system. Thus, pond systems are capable of treating and reducing the pollutants in the system. When the ponds are drained, the pollutant loads are likely to have been significantly reduced or contained within the sediment at the bottom of the pond. Draining practices that minimize disturbance of the sediments at the bottom of the pond will ensure that the water quality discharged is relatively high in quality. While most producers use drainage practices that minimize disturbance of the pond bottom (e.g., catfish, hybrid striped bass, and many sportfish), several species require specific drainage practices that have the potential to discharge higher levels of sediments in order to harvest. For example, shrimp require rapid draining. The shrimp are carried along with the drainage water and captured in external harvest structures. These harvest/draining practices are likely to result in the disturbance of the sediment on the bottom of the pond. To reduce pollutant loads and minimize escapement of the valuable animal crop, the water drained from shrimp ponds is typically routed through some type of sediment control structure (e.g., sedimentation basins, harvest boxes or vegetated ditches) prior to discharge. Most of the historical research on pond water quality and the various management practices to improve pond effluent quality was conducted in the catfish sector. Catfish production is the largest aquatic animal production sector in the United States, and the dominant species produced in ponds. Over the past few decades there has been considerable research leading to the improvement of management practices and the reduction of pollutants discharged from catfish ponds. One of the most significant changes has been the reduced drainage frequency in producing food sized catfish. Today, the predominant practice is to drain only to repair or rework the pond banks. Industry representatives indicate that ponds used to grow fish to food size are drained, on average, once every 5 to 7 years. Other practices that are being actively encouraged and promoted include water level management to maximize the capture of rainwater. Water level management minimizes the need for operators to pump well water to refill ponds, especially during the drier summer months, and also minimizes the occurrence of overflows (from precipitation). There are a number of other best management practices (BMPs) that have been or are being developed by various States to reduce pollutant discharges from pond systems. For example, BMPs to reduce the impacts from erosion in and around ponds include erosion control on pond banks through establishment of vegetative cover on all pond banks and rip rap where wave action is especially strong. Pond operators can also reduce erosion by the proper positioning of stationary and emergency aerators to prevent erosion during their operation, closing pond drains as soon as possible after draining, and quickly repairing any damaged areas of berms. Other BMPs include practices to reduce overflow and draining effluent volumes, feed management, proper use and storage of chemicals and therapeutic agents, and planning for emergencies. Pollutants discharged in overflow from catfish production ponds have been well studied in Mississippi and Alabama. The research shows variation in pollutant concentration by season, with the summer months having the highest levels of pollutants in effluent overflows and discharges. The measured pollutants and seasonal average ranges included settleable solids (0.01-0.2 mg/L), total suspended solids (29- 135 mg/L), total nitrogen (1.9-7.0 mg N/L), total ammonia (0.27-2.76 mg N/L), total phosphorus (0.09-0.54 mg P/L) and biochemical oxygen demand (5.3-26.1 mg O2/L) (Tucker et al., 2002, DCN 61555). Hybrid striped bass is another species that is often produced in pond systems. The body of knowledge needed for the culture of hybrid striped bass for foodfish production grew from the expanded efforts throughout the southeastern United States to provide [[Page 57878]] striped bass and hybrid Morone species for stocking public reservoirs for recreational fishing and fisheries management. Responses to EPA's screener survey indicates that 77% of striped bass/hybrid striped bass producers use earthen ponds, 17% use recirculating systems, and 6% use flow-through systems. Ponds used to raise food sized hybrid striped bass must be completely harvested before the pond can be restocked, otherwise the larger fish will feed on the smaller fish. Ponds are drained for harvest either annually or biennially, depending on stocking size. The ponds must be completely drained to ensure that all fish are captured. Some producers use an EPA registered pesticide to kill any remaining fish after harvest. If a pesticide is used, water conservation is the goal and the pond does not need to be drained. The most commonly used pesticide is rotenone, which degrades fairly quickly allowing the pond to be restocked within a short period of time. Other species that are raised in ponds that must be drained either partially or completely to be harvested include tilapia, baitfish, and sport fish. Tilapia can escape seines or nets by jumping over or swimming under them. Therefore, ponds are partially drained to make it more difficult for the tilapia to escape the nets. Most baitfish are harvested with seines, but ponds must be drained and all fish removed prior to starting a new crop. However, most baitfish producers conserve the water that is drained from a pond by moving it to another pond. 2. Flow-Through Systems The predominant form of flow-through systems, raceways, are constructed to mimic a stream, with fresh water continuously entering at the top of the system and discharging from the bottom (or downstream end) of the system. Between the top and the bottom of the raceway system are a series of production units, which can be either small ponds or raceways of earthen or concrete material. Smaller, younger fish are typically placed in the units at the top of the system near the water source, which is the highest quality water. As the fish grow they can tolerate lesser quality water and they are moved to downstream units. Flow-through systems are used to produce species that must have very high quality water. Trout and salmon are two examples of fish that require very high quality water with high dissolved oxygen levels and consistent cold temperatures. The predominant species raised in flow- through systems is trout. Salmon fry are also raised in flow-through systems until they are moved to a marine environment. The most significant pollutant discharged from flow-through systems is solids from uneaten feed and feces that settle to the bottom of the raceways. These solids are primarily composed of organic matter including BOD, organic nitrogen and organic phosphorus. Many flow- through systems have barriers in the lower portion of each raceway to create a quiescent zone. The quiescent zone allows the solids to settle and be collected. Restricting the fish from entering the quiescent zone keeps the solids from becoming resuspended. The captured solids are periodically transferred to an off-line settling basin for additional settling. Water is then typically decanted off and recombined with the rest of the water being discharged from the facility. Some facilities have installed additional solids polishing treatment, such as filtration or an additional settling basin. Facilities that do not use quiescent zones may treat the total flow-through a settling basin to remove solids. Older and smaller facilities that have earthen raceways or ponds generally use lower flow rates to prevent scouring and erosion of the production unit, allowing solids to accumulate and decompose by natural processes. Flow-through facilities typically are fed by wells, springs, or by diverting a portion of a stream. Springs and wells are preferred because they usually provide water that is of consistent temperature, high quality, and free from disease organisms. Free flowing springs also have the advantage of little or no pumping costs. Some flow- through system facilities require source waters to be pretreated to remove substances such as sediment or iron and to add oxygen. Fish in flow-through systems are fed on a scheduled basis, allowed to self feed by activating a feeding mechanism. or a combination of the two. Dead fish are removed from the raceways on a regular basis to prevent accumulation at the end of the raceway that impedes the flow of water from the facility. 3. Recirculating Systems Recirculating systems are used to raise fish in a controlled environment. The fish are raised in tanks with continuously flowing water that is recirculated through a water treatment system and returned to the production tanks. The treatment may include mechanical filters to remove solids and biological filters to degrade the BOD and nitrify the ammonia, and oxygenation. Most recirculating systems replace about 10% of the system water volume daily to make up for evaporation and water supply loss associated with solids filter backwash, and to compensate for inefficiencies in the filtration process. Several facilities reported treating their effluent with primary solids settling and solids polishing filtration. Because construction requires considerable capital investment, the fish produced in these systems are generally high valued species. Species produced include tilapia, hybrid striped bass, and ornamental fish species. Recirculating systems are well suited to maintaining water temperature and can be built almost anywhere. 4. Net Pen and Open Water Systems Net pens and open water systems take advantage of an existing water body's circulation to wash away wastes and bring fresh water to the animals. Presently, the most common species raised in open water systems are molluscan shellfish (oysters, clams, and mussels) that are primarily grown on floating rafts or prepared bottoms, and salmon that are grown to market size in net pens. Lobster pounds, found only in Maine, are placed in coves along the shoreline to hold lobsters for favorable markets. There is considerable interest and research being conducted to raise additional species of fish in net pen systems. In the case of molluscs, producers may plant the animals on the bottom of an intertidal area or suspend them above the bottom in racks or trays or on lines. The molluscs, which are filter feeders, reduce concentrations of nutrients through feeding. Molluscs do excrete wastes, but generally, this has a minimal impact on the environment. Net pen structures are mostly used to grow finfish to food size and are constructed in rectangular, octagonal or round shapes. Nets are suspended from a floating structure to contain the crop of fish. The mesh size of this net is usually increased as the fish grows to provide more water circulating inside the net. The net pen structures are designed to float at the surface and are constructed with ``jump nets'' that extend above the water line to prevent the fish from jumping out. There is another net, which surrounds the primary net in the pen to keep predators from reaching the confined fish. The pens are anchored to the sea floor, but are designed to have some movement with the tidal and wave action. These structures are often placed in bays and are sited to benefit from tidal and current action to move wastes away from the pens and bring oxygenated, high quality water to the net pen. Because these systems are placed in [[Page 57879]] open waters, anything that is added to the system may contribute to pollution. Feed and fish metabolic excretions will contribute solids, BOD and nutrients to the water column. Other potential pollutants include zinc, that is added in trace amounts to the feed as a mineral supplement and copper from an antifouling compound that is used on some of the nets. Pollutant discharges from some net pen operations have been found to cause impacts to the benthic community. Net pen facilities have also been linked to water circulation impacts and changes in the natural flushing around the facility that occurs from decreased tidal action when nets become fouled. 5. Feed, Diseases, and Non-Native Species Some concerns about certain aspects of producing aquatic animals have arisen. Among these are the feed (because of the nutrient content), diseases and possible ways of treating diseases when they occur through the use of drugs and chemicals, and escapement of non- native species. Each of these is summarized below. a. Feed. Most aquatic animal production requires active feeding of the animals being raised. A few species, such as molluscs, feed from naturally occurring sources. For some species, conditions are created to promote the growth of natural sources of feed (such as fertilizing ponds to stimulate the algae growth as the source of food). This is common practice in the production of baitfish, ornamental, and finfish fingerlings of many species. Commercial feed for the major species produced has undergone substantial improvements in recent years. The feed has been improved both in terms of its nutritional content (allowing for the reduction in some ingredients that are not processed by the fish, such as phosphorus), and its physical properties (a lower density and moisture rate allows the feed to float longer, increasing fish consumption and decreasing the amount of uneaten feed). Open water facilities offer little, if any, opportunity for treatment and removal of pollutants, such as excess feed, prior to discharge, thus feed management is a very important component of pollution control at net pen facilities. Pond facilities represent the other end of the spectrum. Ponds, as described above, act as a waste treatment system and have capacity to absorb pollutants resulting from uneaten feed and feces. Recirculating systems and flow-through systems perform better (i.e., discharge less waste) with the practice of proper feed management. These systems can remove some of the pollutants associated with uneaten feed, but most flow-through systems do not have the technology to treat excess feed as it breaks down and releases dissolved pollutants. The decomposition of uneaten feed will put a greater demand on the filtration system used by recirculating systems to clean the water as it is being recirculated. Feed is the most expensive production input for most CAAP facilities, so operators have a financial incentive to minimize excess feed, independent of concerns about water quality. b. Diseases. By providing food and oxygen, aquatic animal production facilities can produce fish and other aquatic animals in greater numbers than natural conditions would allow. This means that system management is important to ensure that the animals do not become overly stressed, making them more vulnerable to disease outbreaks. When diseases do occur, facilities may be able to treat diseased aquatic animals with drugs. Operators producing aquatic animals that are being produced for human consumption must comply with requirements established by the Food and Drug Administration (FDA) with respect to the drugs that can be used legally to treat their animals, the dose that can be used, and the withdrawal period that must be achieved before the animals can be processed for consumption. Drugs can be divided into four categories: approved drugs, investigational drugs, extra-label use drugs, and unapproved drugs. Approved drugs have already been screened by the FDA to determine whether they cause significant adverse public health or environmental impacts when used in accordance with label instructions. Currently, there are six approved drugs for selected CAAP species and disease conditions. The currently approved drugs are: (1) Chorionic gonadotropin (Chorulon[reg]) used for spawning, (2) oxytetracycline (Terramycin[reg]) which is an antibiotic, (3) Sulfadimethoxine, ormetoprim (Romet-30[reg]) which is an antibiotic, (4) tricaine methanesulfonate (Finquel[reg] and Tricaine-S) which is an anesthetic, (5) formalin (Formalin-F[reg], Paracide-F[reg] and PARASITE-S[reg]) used for fungus and parasite treatment, and (6) sulfamerazine which is an antibiotic. The FDA authorizes use of investigational drugs on a case-by-case basis to allow a way of gathering data for the approval process. 21 U.S.C. 360b(j). Study protocols establish quantities and conditions of use. NPDES permits sometimes have required reporting of the use of drugs and chemicals. To EPA's knowledge, very few permits have established limitations on the use of drugs and chemicals, probably due to their intermittent use and the lack of analytical methods to measure such drugs and chemicals in wastewater matrices. Extra-label drug use is restricted to use of approved animal and human drugs only by the order of a licensed veterinarian, and must be within the context of a valid veterinarian-client-patient relationship. New unapproved animal drugs are sometimes used in discrete cases where the FDA exercises its regulatory discretion. c. Non-Native Species. Many of the aquatic animal species in commercial production are ``non-native'' to the geographic area of production. These are species that have been brought into the United States from abroad or into a region of the United States where they would not occur naturally. When non-native species are introduced to an area, there may be a potential for these species to become invasive, out-competing and threatening the survival of the native species. There may also be the potential that the introduction of non-native species will introduce diseases against which native populations have no natural defenses. The Department of Interior's Fish and Wildlife Service along with the Department of Commerce's National Marine Fisheries Service oversee the introduction of non-native species into the United States. In addition, many State Departments of Fish and Wildlife have established programs to control the introduction and release of non-native species within their States. The United States, however, has banned the importation of very few non-native species. There are several examples of species becoming established in the wild, in part through aquatic animal production, that some States have defined as non-native to specific areas of the United States (e.g., Atlantic salmon--non-native to the Pacific Northwest, bighead and grass carp, and some ornamental species). It should be noted that aquatic animal production is one of several causes of non-native or invasive species introductions; ballast water, for example, has been associated with non-native or invasive species introductions. IV. Summary of Data Collection A. Primary and Secondary Sources of Data and Information The Agency evaluated the following databases to locate data and information to support regulatory development: the Agency's PCS database, the Aquatic Sciences and Fisheries Abstracts database, the USDA's AGRICOLA [[Page 57880]] database, the 1998 USDA Census of Aquaculture, the SEC's EDGAR Database, the Dun & Bradstreet Million Dollar Directory, and the Hoover's database. In addition, the Agency conducted a thorough collection and review of secondary sources, which include data, reports, and analyses published by government agencies; reports and analyses published by the aquatic animal production industry and its associated organizations; and publicly available financial information compiled by both government and private organizations. EPA used all of the documents cited above in developing the industry profile, a survey sampling frame, and for stratifying the survey sampling frame. In addition to these publications, EPA examined many other documents that provided useful overviews and analysis of the aquatic animal production industry. EPA also conducted general Internet searches by company name. B. Industry Surveys EPA developed a survey questionnaire because the existing primary and secondary sources of information available to EPA did not contain the information necessary to fully evaluate regulatory options. In particular, EPA evaluates facility/site specific technical and economic information to evaluate the costs and benefits of regulation. EPA made every reasonable attempt to ensure that the AAP industry Information Collection Request (ICR) did not request data and information currently available through less burdensome mechanisms. Prior to publishing a notice in the Federal Register on September 14, 2000(65 FR 55522), EPA met with and distributed draft copies of the survey questionnaires to the Joint Subcommittee on Aquaculture's Aquaculture Effluents Task Force (JSA/AETF), which includes representatives from various government agencies, industry and trade associations, academia, and other interested stakeholders. On September 14, 2000, EPA announced its intent to submit the Aquatic Animal Production Industry Survey Information Collection Request (ICR) to OMB (65 FR 55522). The September 14, 2000 notice requested comment on the draft ICR and the survey questionnaire. EPA received 44 sets of comments during the 60 day public comment period. Commentors on the ICR included: National Oceanic and Atmospheric Administration, U.S. Trout Farmers Association, American Farm Bureau Federation, North Carolina State University, Louisiana Rice Growers Association, Michigan Department of Natural Resources, Mississippi Farm Bureau Federation, Idaho Farm Bureau Federation, and the Freshwater Institute. EPA made significant revisions to the survey methodology and questionnaires as a result of these public comments. Based on the comments, EPA revised the questionnaire and divided it into two survey versions. The first version is the screener survey (short version) and the second version is the detailed survey (the longer version). The two primary reasons for the Agency splitting the survey were: (1) Comments to the effect that the Agency would not know how much emphasis to place on rarely occurring facility types without a census and (2) the need to target specific types of aquatic animal production facilities that could not be identified using information obtained from the databases available to the Agency at that time. After evaluating the comments received on the September 14, 2000 notice, EPA drafted a revised detailed survey, which was sent to the JSA/AETF for review and comment. EPA worked with the JSA/AETF via conference call and written comments to further refine the detailed survey. EPA also conducted two conference calls with the economic technical subgroup of the JSA/AETF to discuss the economic and financial questions in the survey. To the extent possible, EPA incorporated comments and suggestions from these reviews into the survey. EPA published a second notice in the Federal Register on June 8, 2001 (66 FR 30902), announcing the Agency's intent to submit another, revised aquatic animal production industry Survey Information Collection Request (ICR) to OMB. The June 8, 2001, notice requested comment on the draft ICR supporting statement, the short screener survey and the detailed survey questionnaire. EPA received 9 sets of comments during the 30 day public comment period. Commenters on the ICR included: North Carolina Department of Agriculture and Consumer Services, Ohio Aquaculture Association, Catfish Farmers of America, National Aquaculture Association, National Association of State Aquaculture Coordinators, U.S. Trout Farmers Association, American Farm Bureau Federation, and Florida Department of Agriculture and Consumer Services. EPA obtained approval from OMB for the use and distribution of the short screener survey on August 1, 2001 (66 FR 64817). EPA obtained approval from OMB for the use and distribution of the detailed survey on November 28, 2001 (67 FR 6519). 1. Description of the Surveys In August 2001, EPA mailed a short screener survey, entitled ``Screener Questionnaire for the Aquatic Animal Production Industry'' to approximately 6,000 potential Aquatic Animal Production facilities. A copy of the screener is included in the record (USEPA, 2001, DCN 10001). The screener survey consisted of eleven questions to solicit general facility information, including confirmation that the facility was engaged in aquatic animal production, species and size category produced, type of production system, wastewater disposal method, and the total production at the facility in the year 2000. EPA used the information collected from the screener survey to describe industry operations and wastewater disposal practices. EPA also used the responses to the facility production question to classify whether or not each facility is ``small'' according to the Small Business Administration regulations at 13 CFR part 121. EPA designed the second survey to collect detailed site-specific technical and financial information. A copy of the detailed survey is included in the record (USEPA, 2002e, DCN 10002). The detailed survey is divided into three parts. The first two parts collect general facility, technical, and cost data. The first set of questions in part A request general facility site information, including facility contact information, facility size, and NPDES permit information. The general facility information questions also ask the facility to identify species and production type and confirm that, in fact, it is engaged in aquatic animal production. The second set of questions in part A focused on system descriptions and wastewater control technologies. The wastewater control technology section is divided into six parts, one part for each type of production system (pond, flow-through, recirculating, net pens and cages, floating aquaculture and bottom culture, and other systems). The individual system sections have been tailored with specific questions and responses. Each of these sections asks the respondent to describe (1) the system, (2) water use, (3) pollutant control practices, and (4) discharge characteristics. The second part of the survey asks the respondent for facility cost information. The cost information is intended to provide EPA with a complete description of all cost elements associated with the pollution control practices and technologies used at the facility. Separate tables show the details [[Page 57881]] of capital and annual operating costs. The cost section also evaluates the current discharge monitoring practices, product losses, and feed information. The third part of the detailed survey elicits site-specific financial and economic data. EPA intends to use this information to characterize the economic status of the industry and to estimate potential economic impacts of wastewater regulations. The survey requests financial and economic information for the fiscal years ending 1999, 2000 and 2001--the most recent years for which data are available. The Agency intends to use this information to refine the regulation proposed today. The Agency also would use data that identifies treatment technologies in place to determine the feasibility of regulatory options, and to refine its estimates of compliance costs, pollutant loading and load reductions associated with the technology- based options, and potential environmental impacts associated with the regulatory options EPA considers for final rulemaking. The data gathered through this survey and any revisions to the proposed regulation that may result from this additional data would subsequently be published in a notice in the Federal Register to provide the public an opportunity to comment on this data. 2. Development of Survey Mailing List The mailing list (sample frame) for EPA's screener survey was developed by synthesizing facility information found in the Dunn and Bradstreet database, EPA's Permit Compliance System (PCS), contacts with EPA regional permit writers, EPA site visits, State aquaculture contacts, assistance from the Bureau of Indian Affairs on tribal facilities, universities, recent issues of Aquaculture Magazine, and an extensive collection of Web sites with aquaculture references. The mailing list EPA developed contained approximately 6,000 facilities. This number seemed to compare favorably with the roughly 4,000 commercial facilities found in the 1998 Census of Aquaculture and the additional Federal, State, Tribal, research, and non-profit facilities not found in the 1998 Census of Aquaculture (USDA, 2000, DCN 60605). EPA believes that this mailing population was as current as possible and reasonably complete. 3. Response to the Screener Survey EPA sent the screener survey to all 6,000 facilities on its mailing list. EPA received responses from 4,900 facilities, with about 2,300 facilities reporting that they do produce aquatic animals. The discrepancy between the number of surveys sent and the number of facilities reporting that they are aquatic animal producers is largely attributed to the fact that the list was compiled from general industry sources and included aquatic animal processors, retailers, etc. As described in Section V, EPA is proposing to establish effluent limitations guideline regulations for various segments of the concentrated aquatic animal production sector, thus, the Agency sent the detailed survey to a sample of 263 facilities. EPA used the results of the screener survey to ensure that the facilities that received the detailed questionnaire, in fact, produce aquatic animals and that a high percentage are conducting operations that would be included in the scope of today's proposal. 4. Sample Selection for the Detailed Survey Respondents to the detailed questionnaire were selected at random from within groups (stratified random selection) that were identified using results of the screener survey. The sample and the questionnaires described above are expected to provide EPA with the additional information that will be used to re-estimate the costs and benefits associated with the proposed regulatory options. These results along with results from any additional evaluations based on comments on the proposal will be published in the Notice of Data Availability (NODA) prior to final action. C. Site Visits and Wastewater Sampling During 2000 and 2001, EPA conducted site visits at more than 70 AAP facilities. EPA conducted some of these site visits as part of AAP conferences that EPA attended to better understand the industry. The purposes of these site visits were: (1) To collect information on aquatic animal operations; (2) to collect information on the generation of wastewater and waste management practices used by the AAP facilities; and (3) to evaluate each such facility as a candidate for multi-day sampling. In selecting candidates for site visits, EPA attempted to identify facilities that were representative of various CAAP operations, as well as both direct and indirect dischargers. EPA specifically considered the type of aquatic animal production operation (production method and species produced), geographical region, age of the facility, size of facility (in terms of production), wastewater treatment processes employed, and best management practices/pollution prevention techniques used. EPA also solicited recommendations for good-performing facilities (e.g., facilities with advanced wastewater treatment practices) from EPA Regional offices, State agencies, and members of the JSA/AETF. The site-specific selection criteria are discussed in site visit reports prepared for each site visited by EPA (DCN 30987-30998 and 61615-61652) and summarized in the CAAP Development Document. The sites visited reflect a cross section of the industry that is fairly complete and proportionally representative of the industry. During each site visit, EPA collected information on the facility and its operations, including: (1) General production data and information; (2) the types of aquatic animal production wastewaters generated and treated on-site; (3) water source and use; (4) wastewater treatment and disposal operations. EPA used the site visit reports to prepare multi-day sampling and analysis plans (SAPs) for each facility that would undergo multi-day sampling. For those facilities selected for sampling episodes, EPA also collected information on potential sampling locations for wastewater (raw influent, within the treatment system, and final effluent); and other information necessary for developing a sampling plan for possible multi-day sampling episodes. Based on data collected from the site visits, EPA selected three facilities for multi-day sampling (two flow-through systems and one recirculating system). The purpose of the multi-day sampling was to characterize pollutants in raw wastewaters prior to treatment as well as document wastewater treatment performance (including selected unit processes). Selection of facilities for multi-day sampling was based on an analysis of information collected during the site visits as well as the following criteria: (1) The facility activities and operations were representative of CAAP facilities and (2) the facility utilized in- process treatment and/or end-of-pipe treatment practices that EPA was considering for technology option selection. The Agency collected the following types of information during each sampling episode: (1) Dates and times of sample collection; (2) flow data corresponding to each sample; (3) production data corresponding to each sample; (4) design and operating parameters for source reduction, recycling, and treatment; technologies characterized during sampling; (5) information about site operations that had changed since the site visit or that [[Page 57882]] were not included in the site visit report; and (6) temperature, pH, and dissolved oxygen (DO) of the sampled waste streams. During each multi-day sampling episode, EPA sampled facility influent and effluent wastestreams over a 5-day period. Samples also were collected at intermediate points throughout the wastewater treatment system to assess the performance of individual treatment units. Samples were obtained using a combination of composite and grab samples, depending upon the pollutant parameter to be analyzed. EPA selected the duration for sampling the composites to reflect feeding and non-feeding conditions at the facilities and to minimize risk to sampling personnel. The composite time frames ranged from 12 hours to 24 hours. EPA had the samples analyzed for a variety of conventional (BOD, TSS, oil and grease, and pH), nonconventional (nutrients, microbiological, drugs and chemicals), and toxic (metals and organic compounds) pollutants. When possible for a given parameter, EPA collected 24-hour composite samples in order to capture the variability in the waste streams generated throughout the day (e.g., production wastewater during feeding and non-feeding periods.) Data collected from the sampling episodes contributed to characterization of the industry, development of the list of pollutants of concern, and development of raw wastewater characteristics. EPA used the data collected from the influent, intermediate, and effluent points to analyze the efficacy of treatment at the facilities, and to develop current discharge concentrations, loadings, and the treatment technology options for the Concentrated Aquatic Animal Production industry. EPA used effluent data to calculate the long-term averages (LTAs) and limitations for each of the proposed regulatory options. EPA intends to use industry-provided data from the CAAP detailed survey and other sources to complement the sampling data for these calculations in final rulemaking. During each sampling episode, EPA collected flow rate data corresponding to each sample collected and production information from each associated production system for use in calculating pollutant loadings. EPA has included in the public record all information collected for which a facility has not asserted a claim of Confidential Business Information (CBI) or which would indirectly reveal information claimed to be CBI. After conducting the sampling episodes, EPA prepared sampling episode reports for each facility and included descriptions of the wastewater treatment processes, sampling procedures, and analytical results. EPA documented all data collected during sampling episodes in the sampling episode report for each sampled site. Non-confidential business information from these reports is available in the public record for this proposal. For detailed information on sampling and preservation procedures, analytical methods, and quality assurance/ quality control procedures see the Quality Assurance Project Plan (QAPP) (DCN 61558) and SAPs (DCN 61557, DCN 61710, and DCN 61711) for today's proposed rule. D. Pollutants Sampled and Analytical Methods The Agency collected, preserved, and transported all samples according to EPA protocols as specified in the AAP QAPP. EPA collected composite samples for most parameters because the Agency expected the wastewater composition to vary over the course of a day. The Agency collected grab samples from unit operations for oil and grease and microbiologicals (e.g., total and fecal coliform, fecal streptoccocus, Aeromonas, Mycobacterium marinum, E. coli, and Enterococcus faecium). Composite samples were collected either manually or by using an automated sampler. Individual aliquots for the composite samples were collected at a minimum of once every four hours over each 12-hour period. Oil and grease samples were collected two or three times per composite time frame and microbiologicals were collected once a day. Table IV.D-1 lists the parameters sampled at the majority of the facilities, some of which have not been identified as pollutants of concern. Table IV.D-1: CAAP Sampled Parameters ------------------------------------------------------------------------ ------------------------------------------------------------------------ Settleable Solids Oil and grease pH Sulfate Biochemical oxygen demand (BOD\5\) Metals (e.g., arsenic, chromium, Chemical oxygen demand (COD) copper, mercury, zinc) Total organic carbon (TOC) Volatile Organics Total suspended solids (TSS) Semivolatile Organics Total dissolved solids (TDS) Total coliform Total volatile solids (TVS) Fecal coliform Chloride Escherichia coli Total Chlorine Fecal streptococci Ammonia as nitrogen Aeromonas Nitrate/nitrite Mycobacterium marinum Total Kjeldahl nitrogen (TKN) Enterococcus faecium Total phosphorus (TP) Oxytetracycline Total dissolved phosphorus (TDP) Toxicity: Orthophosphate Fathead Minnow, Pimephales promelas Temperature Cladoceran, Ceriodaphnia dubia Dissolved Oxygen Green Alga, Selenastrum capricornatum Turbidity Conductivity Salinity ------------------------------------------------------------------------ All wastewater sample analyses, except for the field measurements of temperature, turbidity, conductivity, salinity, total chlorine, dissolved oxygen, settleable solids, and pH were completed by EPA contract laboratories. EPA collected field measurements of temperature, dissolved oxygen, and pH at the sampling site. The analytical chemistry methods used, as well as the sample volume requirements, detection limits, and holding times, were consistent with the laboratory's quality assurance and quality control plan. Laboratories contracted for CAAP sample analysis followed EPA approved analysis methods for all parameters except some microbials and drugs (i.e., oxytetracycline) for which no current EPA approved method has been formally developed. The protocols used to measure those pollutants are available in the docket to today's proposal. The EPA contract laboratories reported data on their standard report sheet and submitted them to EPA's sample control center (SCC). The SCC reviewed the report sheets for completeness and reasonableness. EPA reviewed all reports from the laboratory to verify that the data were consistent with requirements, reported in the proper units, and complied with the applicable protocol. E. Other Data Collection EPA conducted a number of other data collection efforts to supplement information gathered through the survey process, facility sampling activities, site visits, meetings with industry experts, the general public, and government funded studies. The main purpose of these other data collection efforts was to obtain information on documented environmental impacts of aquatic animal production facilities, additional [[Page 57883]] data on aquatic animal production waste characteristics, pollution prevention practices, wastewater treatment technology innovation, and facility management practices. These other data collection activities included a literature search, a review of current NPDES permits, and a review of NPDES Discharge Monitoring Reports. 1. Literature Search on Environmental Impacts EPA conducted a literature search to obtain information on various aspects of the aquatic animal production industry, including pollutants causing environmental impacts, water quality and ecological impacts from these pollutants, non-native species impacts, and other potential impacts. EPA performed extensive Internet and library searches for applicable information. EPA has included a summary of the case studies in the public docket (DCN ) associated with today's proposal and in Chapter 9 of the CAAP Economic Analysis (DCN 20141). The primary sources for the case studies include technical journal articles, newspaper articles, industry experts, and government contacts for aquaculture. EPA also conducted a separate literature search for case studies that characterize the AAP industry, or more specifically the typical effluents associated with different production system types and species. The primary sources for the case studies were technical journal articles. 2. Current NPDES Permits EPA extracted information from the Agency's Permit Compliance System (PCS) to identify concentrated aquatic animal production industry point source dischargers with NPDES permits. This initial extraction was performed by searching the PCS using reported Standard Industrial Classification (SIC) codes used to describe the primary activities occurring at the site. Specifically, EPA used the following SIC Codes: 0273Animal Aquaculture and 0921 Fish Hatcheries and Preserves. EPA identified a total of 1,174 concentrated aquatic animal production facilities in the PCS database which does not include the number identified in the screener. Some of these facilities may have permits, but are not in the PCS database. Based on the NPDES permits found in the PCS database, EPA estimates that 377 facilities have active permits (i.e., facilities that are still in business and are required to be permitted). EPA selected a sample from this universe of dischargers. The Agency then reviewed NPDES permits and permit applications to obtain information on facility type, production methods and systems, species produced, and effluent treatment practices for each of the aquatic animal production sectors. EPA used this information as part of its initial screening process to identify the universe of AAP facilities that would be covered under the proposal. In addition, this information was used to better define the scope of the information collection requests and to supplement other information collected on waste management practices in the industry. EPA will continue to refine its estimates of direct dischargers to further incorporate information from the PCS database. 3. Discharge Monitoring Reports The Agency collected long-term effluent data from facility Discharge Monitoring Reports (DMRs) to supplement the PCS database in an effort to perform a check on the achievability of today's proposed requirements. DMRs summarize the quality and volume of wastewater discharged from a facility under a NPDES permit. DMRs are critical for monitoring compliance with NPDES permit provisions and for generating national trends on Clean Water Act compliance. DMRs may be submitted monthly, quarterly, or annually depending on the requirements of the NPDES permit. EPA extracted discharge data and permit limits from these DMRs to help identify regulated pollutants and to identify better performing facilities. EPA was able to collect DMR information on a total of 157 facilities. Of those 157 facilities, EPA was able to identify 57 flow- through and 2 recirculating systems for which basic facility characteristics are available. EPA does not have sufficient information on the facility characteristics for the remaining 98 facilities. EPA collected 38,096 data points on 126 separate pollutant parameters (including nitrogen, phosphorus, solids, flow, chemicals such as formalin, diquat, and copper). Indirect dischargers file compliance monitoring reports with their control authority (e.g., POTW) at least twice per year as required under the General Pretreatment Standards (40 CFR 403) while direct dischargers file discharge monitoring reports with their permitting authority at least once per year. EPA did not collect compliance monitoring reports for CAAP facilities that are indirect dischargers because: (1) A vast majority of CAAP indirect dischargers add only small volumes of wastewater to POTWs and typically do not discharge toxic compounds and (2) this information is less centralized and much harder to collect. F. Summary of Public Participation EPA encouraged the participation of all interested parties throughout the development of the proposed aquatic animal production effluent limitations guidelines and standards. EPA conducted outreach to the major trade associations via the JSA/AETF (participants include producers, trade associations, academics, federal and state agencies and environmental organizations). EPA also participated in several JSA/ AETF meetings and gave presentations on the status of the regulation development. EPA also met with environmental groups, including the Natural Resources Defense Council, concerning this proposal. In the development of the surveys, which were used to gather facility specific information on this industry, EPA consulted with the various JSA/AETF technical subgroups to ensure that the information being requested was asked for in such a way as to be understandable and that it would be available in the form requested. EPA also met with representatives from USDA, FDA, National Marine Fisheries Service (NMFS) of Department of Commerce and United States Fish and Wildlife Service (USFWS) of Department of Interior to discuss this regulation. EPA met with the Animal and Plant Health Inspection Service (APHIS) of USDA to discuss potential regulations related to aquatic pathogens. EPA met with FDA's Center of Veterinary Medicine to discuss the new drug approval process. EPA met with NMFS and USFWS representatives to discuss non-native species and the regulatory authority various agencies have over non-native species. EPA met with representatives from State and local governments to discuss their concerns with concentrated aquatic animal production facilities and how EPA should evaluate options to regulate discharges from these facilities. EPA learned about the regulatory framework that some of these agencies operate under. Specifically, EPA's discussion with USFWS focused on intentional and unintentional introductions and what authority USFWS has to control unintentional releases of non-native species. In discussions with FDA, the major concern raised was the use of investigational new animal drugs and extra label use of drugs. [[Page 57884]] V. Scope/Applicability of Proposed Regulation EPA solicits comments on various issues regarding applicability of today's proposed national effluent limitations guidelines and standards. The following discussion descibes the applicability for three subcategories of concentrated aquatic animal production facilities that would be subject to the regulations proposed today. A. Facilities To Be Subject to 40 CFR Part 451 EPA is proposing new effluent limitations guidelines and standards for three subcategories of the concentrated aquatic animal production industry: Flow-through systems, recirculating systems, and net pens. EPA does not propose to establish effluent limitations for CAAP facilities in any subcategory that produce cold water species with annual production between 20,000 pounds and 100,000 pounds annually. EPA also does not propose to establish effluent limitations guidelines for floating and bottom culture systems for molluscan shellfish (e.g., mussel rafts) or for ponds, but EPA does invite comment on whether EPA should regulate rapid drain discharges from such ponds. EPA does not propose categorical pretreatment standards for any production subcategory. B. Facilities Not Subject to 40 CFR Part 451 EPA developed the production rate thresholds based on 1998 Census of Aquaculture data and the AAP screener survey data, which was available prior to proposal. EPA used six production size categories that correspond with the revenue classifications used in the 1998 Census of Aquaculture (i.e., $1,000-$24,999; $25,000-$49,999; $50,000- $99,999; $100,000-$499,999; $500,000-$1,000,000; and $1,000,000) to develop model facilities representing these size ranges for each species evaluated. EPA also used these size ranges to group facility production data reported in the AAP screener surveys. EPA used national average product prices taken from the 1998 Census of Aquaculture to estimate the production (in pounds) for the dominant species that were reported grown in flow-through (e.g., trout, salmon, tilapia) recirculating (e.g., tilapia, hybrid striped bass) and net pen (e.g., salmon) systems. For alligator systems reported in the AAP screener survey, data from industry reports was used to estimate production value and create groupings of the facilities. EPA used these size classification groupings to more accurately estimate costs, loadings, non-water quality impacts (NWQIs), and economic impacts of the proposed limitations and standards for each of the size classifications within the various species (or aquatic animal types) cultured inthis industry. That is, rather than assume one model facility for each of the three regulatory subcategories, EPA used a minimum of 6 model facilities for each facility type (e.g., commercial, government, research) and species size combinations (e.g., fingerlings, stockers, food size) for better accuracy in its analyses (see also CAAP Development Document for further details on how these production based thresholds were developed). EPA applied these size classifications to the AAP screener survey data to derive the model facility characteristics that have been used to support this proposed regulation. In evaluating the AAP screener survey data related to facility annual production, EPA identified several variables distinguishing various types of facilities. Aquatic animal production facilities varied by type of facility operation (i.e., species and production method) and type of wastewater management (e.g., direct discharger, indirect discharger, no discharge/wastes applied to land on site). EPA identified annual production levels (by mass) at facilities and then identified the corresponding model facility. For the purposes of estimating costs, loads, economic impacts and Non Water Quality Impacts (NWQIs), EPA only considered the data for the model facilities that would meet the definition of a CAAP facility as defined in 40 CFR 122.24 and appendix C to part 122. EPA invites comments on the appropriateness of using this method of estimating production thresholds to characterize concentrated aquatic animal production facilities and to determine applicability of the proposed regulations. The production-based threshold in today's proposal were based on a determination that the facilities below this threshold would likely experience adverse economic impacts if they were subject to the proposed requirements. EPA made this determination based on the results of the model facility analysis and thus would likely find the regulations not economically achievable. As described above, the model facilities represent specific size ranges (in pounds) derived from annual revenue ranges from the 1998 Census of Aquaculture, using price data. Most of the impacts that EPA identified would adversely affect trout producers below the 94,000 pounds annual threshold. Therefore, the Agency proposes to establish the applicability threshold for this effluent guideline at 100,000 pounds annually based on the trout model facility. EPA believes it would needlessly complicate the regulation, with little corresponding environmental benefit, to try to establish different applicability thresholds for different species. EPA believes this applicability threshold is reasonable and will minimize the adverse economic impacts that would be imposed by this proposed regulation. See Section IX of this notice for a more detailed discussion of the economic impact analysis. EPA intends to conduct more detailed evaluations of potential thresholds using responses to the detailed survey. Further evaluation may warrant a change in the proposed production-based applicability threshold. Most smaller CAAP facilities (i.e., those producing below the applicability threshold) are not included within the scope of today's proposal for a number of reasons: (1) Small CAAP facilities, as a group, discharge less than 18% of the total suspended solids (or 1.1 million lbs/year) and less than 18% of the nutrients and BOD (or 1.1 million lbs/year) when compared to all discharges from the entire CAAP industry; (2) EPA determined that only a limited amount of loadings removal would be accomplished by improved treatment at the BPT/BAT level of control; and (3) EPA estimated that the small facilities would experience compliance costs that exceeded 5% of their revenues which is higher than for large facilities. Therefore, EPA is not proposing limitations and standards for discharges from the smallest facilities. Instead, an NPDES permit for such a smaller facility that is defined as a CAAP facility under the NPDES regulations would include limits based on the ``best professional judgment'' of the permit writer. As explained above, EPA's proposed applicability is based on the screener data available for this proposal. EPA invites comment on these estimates and conclusions based on modeled data, especially because EPA is aware that many permitted flow-through facilities producing less than 100,000 pounds of cold water species in Idaho, in fact, can achieve similar requirements that EPA is proposing for large facilities. EPA invites comment on the cost-reasonableness of lower cost BMP plans for smaller facilities (e.g., BMP option without numeric limits on TSS). EPA will re-evaluate this size threshold based on new data (i.e., the detailed survey responses) and intends to invite comment on that data in a notice in the Federal Register. EPA is also soliciting comment on alternative size thresholds [[Page 57885]] at different production levels. A supplemental analysis in the record (CAAP Economic Analysis ) compares the proposed size categories in terms of costs, pollutant removals, and economic impacts on the affected facilities. EPA specifically is requesting comment on how alternative thresholds might be justified using the factors discussed above (e.g. economic impact, small pollutant loadings, etc.) and/or other relevant factors. By today's action, EPA also does not propose effluent limitations guidelines and standards for certain species/production system combinations for reasons unrelated to economics, specifically, either because EPA does not believe the species/production system adds more than trivial amounts of pollutants or because no feasible pollutant control technologies are available to reduce pollutant loads in more than de minimis amounts. EPA is not proposing regulations for discharges from: --Ponds. The culture of aquatic animals in ponds requires high quality water to sustain and grow the aquatic animal crop. For many aquatic animals raised in ponds, the pond itself serves as a natural biological treatment system to reduce wastes generated by animals in the pond (including excess feed, manure, and dead aquatic animals). The NPDES regulations for warm water concentrated aquatic animal production facilities exclude discharges from ``closed ponds which discharge only during periods of excess runoff'' and does not apply to facilities that discharge less than 30 days per year. Given these circumstances, and given that overflow pipes in ponds tend to drain passively from the top surface of the pond, discharges due to excess runoff should be of comparatively high water quality. As such, EPA does not propose nationally-applicable effluent guidelines regulations for pond system discharges related to sediment, erosion, nutrients, or feeds. See section VIII for additional discussion on pond systems. EPA invites comment on its proposal not to adopt ELGs for ponds. In addition, EPA specifically invites comments on effluent limitations related to the use of drugs and chemicals in ponds should be considered, BMPs related to escapement of non-native aquatic animal species raised in ponds, and limits to control discharges from the technique of rapid pond drainage used in certain pond production systems, particularly shrimp, should be considered. --Lobster pounds. Intertidal impoundments are used for live storage of marine crustaceans (e.g., lobsters, crabs, etc.) to keep wild caught animals alive pending sale. EPA is not proposing nationally-applicable effluent limitations regulation at this time for lobster pounds because the Agency has not found any applicable pollutant control technologies to reduce discharges, EPA continues to evaluate BMPs that might apply for these types of facilities (see AAP Technical Guidance Manual). EPA invites comment, however, on whether controls and/or reporting of the use of drugs and chemicals that EPA is proposing for other production systems would be appropriate for intertidal pounds. --Crawfish. Crawfish are typically raised in conjunction with plant crops, as part of a rice, soybean, crawfish crop rotation because crawfish maintain aeration of the growing media. EPA is not proposing nationally-applicable effluent limitations guidelines regulation for discharges associated with crawfish operations because crawfish producers do not add feed, drugs, or chemicals to manage the crawfish operations and because any associated pollutants tend to be assimilated with the soils used to grow plant crops. EPA invites comment on not proposing regulations for discharges associated with production of crawfish. --Molluscan shellfish production in open waters. For large-scale production of molluscs for food, operators typically use bottom culture, bottom anchored racks, or floating (but tethered to the bottom) rafts in open waters. Because such operations do not typically add materials to waters of the United States, and because EPA has not found any generally-applicable pollutant control technologies to reduce any discharge, the Agency is not proposing effluent limitations guidelines and standards for discharges from open water mollusc culture. EPA notes that molluscs are filter feeders and, in some cases, are recommended not only as a food source, but also a pollution control technology in and of themselves. Molluscs remove pollutants from ambient waters via filtration. EPA also is aware that molluscs have been incorporated into polyculture aquatic animal production operations to minimize discharges of pollutants. EPA invites comment on not proposing regulations for open water molluscan production. --Aquariums. Public aquariums are AAP facilities that display a variety of aquatic animals to the general public and conduct research on many different threatened and endangered aquatic species. EPA has determined, through the AAP screener survey and site visits, that most aquariums are indirect dischargers and if these facilities discharge directly into waters of the U.S., it is only done in emergency situations requiring rapid dewatering of tanks. These systems maintain low stocking densities and very clean, clear water to enhance the visual display of the animals. Discharges from aquariums are likely to be low in TSS and nutrients because of the low stocking densities. Because most of the drugs used to treat stressed or ill animals are injected directly into the animal, EPA believes that discharges of drugs would be minimal. Few chemicals are used and include pH buffers and chemicals used to make artificial sea salt. Based on these preliminary evaluations, EPA proposes no regulation for discharges from these types of operations. EPA is exploring the potential releases of drugs and chemicals and technologies that can and are being used to remove drugs and chemicals through the detailed survey. Pending results from the detailed survey, EPA solicits comments on whether this regulatory approach is appropriate and also requests any data on the use of drugs and chemicals in public aquariums. --Alligators. EPA evaluated screener survey data to determine the scope of the alligator industry and the range of treatment technologies that are currently used. Alligator production facilities range in size from producers with less than 100 animals to some with many thousands of animals. As described through contacts with industry experts (Hochheimer 2002d DCN 61794), alligator production facilities do not discharge effluents from their alligator production systems. Instead, effluents are treated in one or two-stage lagoons and then land applied to crop or forested land. EPA intends to verify this through the collection of detailed survey information. Based on this information EPA believes alligator producers would not meet the definition of a CAAP because they would not exceed minimum threshold of discharging 30 days annually. [[Page 57886]] --Alaskan Net Pen Systems. In Alaska, salmon fry are raised for stocking under an arrangement that does not exist elsewhere in the United States. Non-profit, non-governmental salmon producers raise only native species for the purpose of supplementing natural populations and maintaining Alaska's fishing industry. Producers raise salmon in flow- through systems, which are transferred to net pen systems as they mature. Net pen rearing of salmon in Alaska occurs primarily for pink and chum salmon for two months of the year (mid-March to mid-May). Fish are placed in the pens weighing about 0.4 grams and reared until they reach about 2.0 grams. The industry reports achieving about a 1:1 feed conversion ratio since added feed is supplemented by naturally occurring zooplankton. Once the fish are released into the ocean the nets and pens are fallow until the following year. The Agency is not aware of any drug or chemical use in these non-profit Alaska net pen system operations. For these reasons the Agency proposes to exclude from today's proposed regulation discharges from the net pen phase of operations at non-profit Alaska salmon production based on the current provisions of Alaska law. The Agency solicits comments on any environmental impacts caused by these net pen facilities, in particular the use of drugs or chemicals such as anti-foulants. EPA may consider requiring these facilities to develop and implement BMP plans similar to the plans included in today's proposal for other net pen discharges in order to minimize the potential discharge of solids and other pollutants associated with net pen systems generally. EPA would consider the costs and economic impacts associated with the development and implementation of BMPs and would provide prior notice and opportunity for public comment on any such costs and impacts in a subsequent notice. The Agency solicits comments on this possible approach. VI. Subcategorization A. Factors Considered in Developing Proposed Subcategories The CWA requires EPA, when developing effluent limitations guidelines and pretreatment standards, to consider a number of different factors. For example, when developing limitations that represent the best available technology economically achievable for a particular industry category, EPA must consider, among other factors, the age of the equipment and facilities in the category, location, manufacturing processes employed, types of treatment technology to reduce effluent discharges, the cost of effluent reductions and non- water quality environmental impacts. See Section 304(b)(2)(B) of the CWA, 33 U.S.C. 1314(b)(2)(B). The statute also authorizes EPA to take into account other factors that the Administrator deems appropriate and requires the BAT model technology chosen by EPA to be economically achievable, which generally involves consideration of both compliance costs and the overall financial condition of the industry. EPA took these factors into account in considering whether to establish subcategories and found that dividing the industry into subcategories leads to better tailored regulatory standards, thereby increasing regulatory predictability and diminishing the need to address variations among facilities through a variance process. See Weyerhaeuser Co. v. Costle, 590 F. 2d 1011, 1053 (D.C. Cir. 1978). EPA used published literature, site visit data, industry screener survey data and EPA sampling data for the subcategorization analysis. Various subcategorization criteria were analyzed for trends in discharge flow rates, pollutant concentrations, and treatability to determine where subcategorization was warranted. Equipment and facility age and facility location were not found to impact wastewater generation or wastewater characteristics; therefore, age and location were not used as a basis for subcategorization. An analysis of non- water quality environmental characteristics (e.g., solid waste and air emission effects) showed that these characteristics also did not constitute a basis for subcategorization (see Section XI). Facility size (e.g., acreage, number of employees, production rates) directly affects the effluent quality, particularly the quantity of pollutants in the effluent and size was used as a basis for subcategorization because more stringent limitations would not be economically achievable for smaller aquatic animal production facilities (see Section V for definition of ``small'' and ``non-small'' facilities for each subcategory). See SectionV for a description on how and why EPA established production based thresholds for CAAP facilities. EPA also identified types of production system (e.g., pond, flow- through system, net pen, etc) as a determinative factor for subcategorization due to variations in operating practices, quality and quantity of effluent type and discharge frequency. Based on the results of an initial evaluation, EPA determined that using the production system employed at each facility most appropriately subcategorizes the CAAP industry. Additional subdivision was evaluated to better characterize the influence of water management strategies on discharge frequency, volume, and quality. When subcategorized by production system, the AAP industry consists of six major subcategories: Pond systems, flow-through systems, recirculating systems, net pens and cages, floating aquaculture and bottom culture, and alligator systems. AAP facilities can be characterized by the relative amount of water used to produce a unit of product, the general design of the facility, and the processes used to treat production water. Wastewater flow rates, water usage, and water requirements and characteristics are considered similar within each subcategory. EPA's analyses indicate that, in most cases, species is not a significant factor in determining differences in production system effluent characteristics. The management practices for a particular species dictate stocking densities, feed types, feeding rates and frequencies, and the overall management strategy. Species, however, does not appear to be a major determinant in the quality or quantity of effluent from the particular type of production system. The following section describes the proposed Concentrated Aquatic Animal Production industry subcategorization. B. Proposed Subcategories In today's notice, EPA proposes new limitations and standards for facilities in the following CAAP subcategories: flow-through systems, recirculating systems, and net pens. EPA developed the proposed limits based on the differences in quality and quantity of discharges from these types of facilities. Flow-through systems tend to have high effluent flows. Some facilities may treat two discharge points: a bulk discharge and a discharge from a settling basin referred to as off-line settling. The solids generated from the production process are collected and treated in the basin through settling. The discharge from the off-line settling basin is small in volume and more concentrated in pollutants such as TSS, BOD, or nutrients. Other facilities opt to treat their entire discharge (full flow settling) which includes the solids generated from the production process. Recirculating [[Page 57887]] systems have relatively small effluent volumes of treated effluents that are high in TSS, BOD and nutrients. Net pen systems discharge TSS, BOD and nutrients directly to receiving waters. See Section III. EPA chose to further segment the subcategories by facility size (i.e. by the amount of aquatic animals produced) because of economic considerations (see Section IX). VII. Control Technology Options, Costs, Wastewater Characteristics, and Pollutant Reductions A. Description of Wastewater Treatment Technologies and Management Practices in the CAAP Industry Most of the wastewater treatment technologies and management practices evaluated as options for AAP facilities are potentially applicable to all of the system subcategory types, including (1) feed management; (2) health management; (3) control of non-native species escapes; (4) drug and chemical use management; (5) water quality monitoring; (6) primary solids settling; (7) disinfection; and (8) additional solids removal. The following is a description of each of these treatment technologies and management practices as they apply to all systems followed by a description of any system-specific practices evaluated. The descriptions of the practices below, however, do not necessarily reflect what EPA proposes to require. 1. Treatment Technologies and Management Practices Considered for All Systems a. Feed Management. Feed management recognizes the importance of effective, environmentally sound use of feed. All AAP operators should continually evaluate feeding practices to ensure that feed placed in the production unit is consumed. It is important to eliminate excess feeding to reduce the input of solids and nutrients in the production unit. The goal of good feed management is to increase the ability of fish to efficiently convert food to flesh. By observing feeding behavior and noting the presence of excess feed, operators can adjust feeding rates to ensure minimal excess and waste. Use of high quality feed that meets the nutritional requirements of the species being cultured can also help to minimize excess feed. Proper storage and handling can be important for some types of feed in order to reduce the production of small feed particles (or fines) that most animals will not eat. Uniform feeding applications are another tool for achieving effective feed management. Feeding as much of the rearing unit (e.g., pond, raceway, or tank) surface as possible to ensure that all of the animals have feed available to consume prevents waste and improves the quality of fish production. Because feed is the most expensive production input for most facilities, operators have a strong financial incentive to minimize excess feed. b. Health Management. As a practice to promote health management, some operators have developed health management plans that include an assessment of the potential animal health problems that may be encountered at a facility and the environmental problems that may result from disease outbreaks. The plan outlines the actions needed to minimize the impacts of disease outbreaks, including the use of drugs and chemicals. As part of health management practices, AAP facility operators sometimes conduct health screenings by collecting samples of the cultured species and screening for diseases, parasites, and body weight. Health screening allows for the early detection of certain diseases and parasites, which would otherwise not be detected until the outbreak had spread through the cultured population. Most States have disease diagnostic services available to assist in screening aquatic animals and identifying potential problems. Measuring weight allows producers to evaluate general health, determine how well the crop is performing, and constantly update the feeding regimes so that the most efficient feed rates are used. Health screening can also reduce the need for medicated feeds by detecting the disease problems early. However, health screening can be expensive and its effectiveness is highly site- and species-specific. Operators have a strong financial incentive to conduct health screening to the extent that it is cost- effective at their facility. Mortality of the cultured species in small numbers is a common occurrence in aquaculture systems. Mortality removal is another health management practice that helps prevent the spread of disease and the introduction of excess pollutants into the system. Many of the mortalities float to the surface of the culture water and can be collected by hand or using nets. c. Control of Non-Native Species Escapes. When culturing non-native species, it is important to control escapes of the cultured animals if there is a potential for adverse impact on wild populations. Where this potential exists, it can be minimized by the preparation of a non- native species escapement plan to address control of escapes. This plan would include a mechanism to minimize or prevent the potential for escapement. Some examples in existing plans include screens or other barriers over discharge pipes to prevent escapement of aquatic animals, use of double nets in net pen operations, and training of employees to carefully transfer fish when moving or harvesting animals to prevent escapes. EPA is considering requiring CAAPs to report escapes of non-native species to the permitting authority. With this information, the permitting authority, in coordination with the state agency responsible for fisheries, the U.S. Fish and Wildlife Service (USFWS), and/or the National Marine Fisheries Service (NMFS) would evaluate the potential for the escaped fish to become established and cause ecological harm. Timely notification of any escapes would allow the State, USFWS, or NMFS to take measures to control the spread of the non-natives. EPA is also considering banning the intentional release of any non- native species with the potential to cause adverse impacts on wild species from CAAPs. EPA is aware of the possibility that non-native species may be intentionally released, especially from net pens, if they are not growing rapidly enough to justify continued feeding. States or USFWS would determine which species the ban would be applied to. EPA is soliciting comment on the appropriateness and efficacy of a ban on intentional releases, the appropriate entity to define which species the ban should be applied to, and the practicality of reporting requirements for escaped non-native species. EPA is aware of the concern that national ELGs under the CWA may not be an effective mechanism to address non-native species, since many facilities would be outside the scope of the ELGs. d. Drug and Chemical Use. Facility operators may develop drug and chemical plans that list all of the drugs and chemicals that will be used, the conditions for use, safe handling and storage practices, and actions being taken to minimize their use (e.g., maintaining water quality to minimize stress). EPA is evaluating whether to include a whole effluent toxicity (WET) test as a screening step for potential adverse environmental effects when a facility uses investigational new animal drugs or an extra label use drug. EPA solicits comment on: (1) The use of WET tests to determine any toxic effects that the addition of drugs could have on the receiving water body, (2) when such a test might be appropriate (e.g., to reflect [[Page 57888]] how the investigational drug use might otherwise impair local benthos) and (3) choice of test species. e. Production Unit Water Quality Monitoring. Water quality monitoring of the production unit water helps ensure that conditions are optimal for the species being cultured. Good water quality minimizes stress, which reduces the number of disease outbreaks. Routine monitoring, especially for dissolved oxygen, ammonia, nitrite, alkalinity, pH, and other key parameters will promote the health of the fish. For flow-through and net pen systems, the volume of water that flows through a system on a daily basis is quite large and the quality of the process water changes slowly, if at all. For these systems, once a baseline of water quality is determined, the operator rarely needs to monitor process water quality. Because pond and recirculating systems can have variable water quality, routine monitoring will also help system operators monitor the quality of potential effluent from the system. f. Primary Solids Control. Solids, which come from feces and uneaten feed, are the largest mass of pollutants generated in CAAP facilities. There are several technologies that can be used for primary solids removal from process waters, in addition to BMPs to control solids generated at CAAP facilities. The general strategy is to combine BMPs with the removal of solids from the bulk waste stream as efficiently as possible and to treat these solids in an environmentally sound way. Ponds continually process solids by a combination of physical (settling in pond) and biochemical (microbial decomposition of solids) processes. Since high production AAP pond facilities use additional aeration to keep the ponds well mixed and aerated, the processing of solids in ponds results in low organic content solids that accumulate on the pond bottom that can be periodically used to rebuild pond banks. As a result of the long residence times of water and the accumulating solids in a pond system, EPA believes in-pond solids settling to be an effective form of primary solids control. In flow-through systems, quiescent zones and other in-system solids collection practices help reduce TSS and associated pollutants in the effluent. The water velocities in most flow-through systems are rarely high enough to keep solids entrained in the water column. The swimming action of the cultured fish or the use of baffles to increase tank bottom water velocities, however, tend to keep most of the solids suspended in the effluent of the flow-through system. Quiescent zones are an effective way to enhance solids settling in flow-through systems, though they do reduce the production capacity of the system. Because flow-through system animal production capacity is governed by the flow rate of water into the rearing unit and species type and stage of growth, most raceway flow-through systems utilize excess tank volume for installing quiescent zones, which use approximately 10% of the bottom of the raceway as a settling area for solids (Hochheimer, 2002a, DCN 61791). Quiescent zones usually have a wire mesh screen, which extends from the bottom of the raceway to above the maximum water height to prohibit the cultured species from entering the quiescent zone. When the quiescent zones are cleaned, the solids collected in the system are moved to the sedimentation basin for solids holding and dewatering. This is called off-line settling. The goal of sedimentation basins (referred to as off-line settling basins or OLSBs) is to collect and store the solids captured in the quiescent zone. Some facilities use sedimentation basins which are larger than those designed for offline settling for treating all of the flow from the raceway. This is called full flow settling. EPA believes most flow-through systems collect solids in quiescent zones and remove this concentrated solids stream to a settling basin for further treatment. The water that is decanted off this settling basin at many facilities is commingled with the full flow discharge from the production system to be discharged through a single outfall. EPA is proposing to establish monthly average and daily maximum limits that would apply to the commingled effluent. EPA is also proposing to allow, at the permitting authority's discretion, facilities to comply with the TSS limits through development of a BMP plan designed to meet the limits without having to monitor discharges to demonstrate compliance. EPA solicits comment on this compliance alternative that would allow compliance with a BMP plan designed to minimize sediment discharges that was not explicitly tied to particular numeric limits. g. Disinfection. Another water treatment technology option is disinfection, which is used to remove most of the pathogens (both aquatic animal and human health) from the effluent stream. Disinfection is a process by which disease-causing organisms are destroyed or rendered inactive. EPA's sampling events found elevated levels of some indicator pathogens in effluents from sedimentation basins and solids storage facilities. Disinfection was evaluated as a way to reduce the discharge levels of these indicator organisms. Disinfection is most often accomplished using bactericidal agents. Three commonly used bactericidal agents are chlorine, ozone (O3), and ultraviolet (UV) radiation (disinfection with UV light). Chlorination, the use of chlorine, is the most commonly used method of disinfection in the United States. Chlorine and ozone function by being added at a concentration that effectively disinfects the discharge stream. UV radiation disinfects by penetrating the cell wall of pathogens with UV light and completely destroying the cell or rendering it unable to reproduce. h. Additional Solids Removal (Solids Polishing). Solids polishing is the use of a secondary wastewater treatment technology to further reduce solids discharged from flow-through and recirculating systems. Several technologies are available, including microscreen filters and polishing ponds. Microscreen filters are fine mesh filters with automatic backwash that collect solids. Polishing ponds are secondary sedimentation basins used to settle solids from the discharge of the primary sedimentation basin. Vegetated ditches are another effective means removing solids from effluent. A vegetated ditch is an excavated ditch that serves as a discharge conveyance, treatment, and storage system. The walls of the ditch are excavated at an angle that supports the growth of a dense vegetation layer. The vegetation layer aids in treating the discharge and reduces the susceptibility of the ditch banks and bottom to erosion. The length and width of the ditch are designed to allow for the slowing and temporary storage of the discharge as it flows toward the receiving water body. The vegetation layer increases the ability of the ditch to remove both coarse and fine particulate matter and the associated pollutants, such as BOD, settleable solids, and suspended solids. Constructed wetland treatment systems also promote solids removal from pond system discharges. These systems consist of shallow pools constructed on non-wetland sites with water at depths of usually less than 2 feet. Constructed wetlands provide substrate for specific emergent vegetation types such as cattail, bulrush, and reeds. Constructed wetlands are designed to treat discharges through physical, chemical, and biological processes. The vegetation causes the discharge to slow and flow in a more [[Page 57889]] serpentine manner, increasing the likelihood of solids settling. The vegetation also aids in the adsorption of potential pollutants through plant and bacterial uptake, and it increases the oxygen level in the discharge flowing through it. Constructed wetland treatment systems can be designed to provide several different benefits, including treatment of the discharge through biological and chemical processes, temporary storage of discharges, recharge of aquifers, and reduction in discharge volume to receiving water bodies. 2. Specific System Treatment Technologies and Practices In addition to the technologies and practices evaluated for all system types described in the previous section, EPA considered system specific technologies and practices. The technologies and practices that will be discussed in this next section apply to pond and net pen systems only because those practices applying to other systems are covered by the items in the previous section. a. Pond Systems. 1. In-pond treatment (including aeration). The objective of in-pond treatment is to use the natural carrying capacity of earthen ponds to process the solids, nutrients, and other compounds added to the pond water in the form of feed and chemicals for maintaining water quality or animal health. When operated within the limits of their carrying capacity, ponds can remove over 90% of solids, phosphorous, and BOD, and over 70% nitrogen. Mechanical aeration is used to enhance the natural assimilative processes of the pond by raising dissolved oxygen levels and provides mixing of the pond waters. Improving the quality of the water in the pond improves the quality of any discharge leaving the pond. 2. Water mana