Monday, August 23, 2004

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; Final Rule

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ENVIRONMENTAL PROTECTION and standards for wastewater discharges i.e., confidential business information or AGENCY from new and existing concentrated other information whose disclosure is aquatic animal production facilities that restricted by statute. Certain other 40 CFR Part 451 discharge directly to U.S. waters. EPA material, such as copyrighted material, [OW–2002–0026; FRL–7783–6] estimates that compliance with this is not placed on the Internet and will be regulation will affect 242 facilities. The publicly available only in hard copy RIN 2040–AD55 rule is projected to reduce the discharge form. Publicly available docket of total suspended solids by about 0.5 materials are available either Effluent Limitations Guidelines and million pounds per year and reduce the electronically in EDOCKET or in hard New Source Performance Standards discharge of biochemical oxygen copy at the Water docket in the EPA for the Concentrated Aquatic Animal demand (BOD) and nutrients by about Docket Center (EPA/DC) EPA West, Production Point Source Category 0.3 million pounds per year. The Room B102, 1301 Constitution Ave., AGENCY: Environmental Protection estimated annual cost for commercial NW., Washington, DC. The EPA Docket Agency. facilities is $0.3 million. The estimated Center Public Reading Room is open ACTION: Final rule. annual cost to Federal and State from 8:30 a.m. to 4:30 p.m., Monday hatcheries is $1.1 million. EPA through Friday, excluding legal SUMMARY: Today’s final rule establishes estimates that the annual monetized holidays. The telephone number for the Clean Water Act effluent limitations environmental benefits of the rule will Public Reading Room is (202) 566–1744, guidelines and new source performance be in the range of $66,000 to $99,000. and the telephone number for the Water standards for concentrated aquatic Docket is (202) 566–2426. animal production facilities. The DATES: This regulation is effective animals produced range from species September 22, 2004. For judicial review FOR FURTHER INFORMATION CONTACT: For produced for human consumption as purposes, this final rule is promulgated additional information contact Marta food to species raised to stock streams as of 1 p.m. (Eastern time) on September Jordan at (202) 566–1049. 7, 2004 as provided at 40 CFR 23.2. for fishing. The animals are raised in a SUPPLEMENTARY INFORMATION: variety of production systems. The ADDRESSES: EPA has established a production of aquatic animals docket for this action under Docket ID I. General Information contributes pollutants such as No. OW–2002–0026. All documents in A. Does This Action Apply To Me? suspended solids, biochemical oxygen the docket are listed in the EDOCKET demand, and nutrients to the aquatic index at http://www.epa.gov/edocket. Entities that directly discharge to environment. The regulation establishes Although not listed in the index, some waters of the U.S. potentially regulated technology-based narrative limitations information is not publicly available, by this action include:

Examples of regulated enti- Examples of regulated enti- Category ties and SIC Codes ties and NAICS codes

Facilities engaged in concentrated aquatic animal production, which may include the 0273—Animal Aquaculture. 112511—Finfish Farming following sectors: Commercial (for profit) and Non-commercial (public) facilities. 0921—Fish Hatcheries and and Fish Hatcheries. Preserves. 112519—Other Animal Aquaculture.

This table is not intended to be this action, any public comments electronically through the EPA Internet exhaustive, but rather provides a guide received, and other information related under the ‘‘Federal Register’’ listings at for readers regarding entities likely to be to this action. Although a part of the http://www.epa.gov/fedrgstr/. regulated by this action. This table lists official docket, the public docket does An electronic version of the public the types of entities that EPA is now not include Confidential Business docket is available through EPA’s aware could potentially be regulated by Information (CBI) or other information electronic public docket and comment this action. Other types of entities not whose disclosure is restricted by statute. system, EPA Dockets. You may use EPA listed in the table could also be The official public docket is the Dockets at http://www.epa.gov/edocket/ regulated. To determine whether your collection of materials that is available to view public comments, access the facility is regulated by this action, you for public viewing at the Water Docket index listing of the contents of the should carefully examine the in the EPA Docket Center (EPA/DC), applicability criteria listed at 40 CFR EPA West, Room B102, 1301 official public docket, and to access part 451 of today’s rule. If you have Constitution Ave., NW., Washington, those documents in the public docket questions regarding the applicability of DC. The EPA Docket Center Public that are available electronically. Once in this action to a particular entity, consult Reading Room is open from 8:30 a.m. to the system, select ‘‘search,’’ then key in the person listed for information in the 4:30 p.m., Monday through Friday, the appropriate docket identification preceding FOR FURTHER INFORMATION excluding legal holidays. The telephone number. Although not all docket CONTACT section. number for the Public Reading Room is materials may be available (202) 566–1744, and the telephone electronically, you may still access any B. How Can I Get Copies of This number for the Water Docket is (202) of the publicly available docket Document and Other Related 566–2426. Every user is entitled to copy materials through the docket facility Information? 266 pages per day before incurring a identified in section B.1. 1. Docket. EPA has established an charge. The Docket may charge 15 cents C. What Other Information Is Available official public docket for this action a page for each page over the page limit To Support This Final Rule? under Docket ID No. OW–2002–0026. plus an administrative fee of $25.00. The official public docket consists of the 2. Electronic Access. You may access The major documents supporting the documents specifically referenced in this Federal Register document final regulations are the following:

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• ‘‘Technical Development Document for the best conventional pollutant control F. Economic Impacts the Final Effluent Limitations Guidelines and technology (BCT), and the best available G. Loadings New Source Performance Standards for the technology economically achievable H. Environmental Assessment and Benefits Concentrated Aquatic Animal Production (BAT) as soon as their National Analysis Point Source Category’’ [EPA–821–R–04–012] VII. Who Is Subject to This Rule? referred to in the preamble as the Technical Pollutant Discharge Elimination System A. Who Is Subject to This Rule? Development Document (TDD). The TDD (NPDES) permits include such B. What if a facility uses more than one presents the technical information that limitations. Generally, this occurs when production system? formed the basis for EPA’s decisions in existing permits are reissued. New C. What Wastewater Discharges Are today’s final rule. The TDD describes, among direct discharging sources must obtain Covered? other things, the data collection activities, the an NPDES permit for the discharge and VIII. What Are the Requirements of the Final wastewater treatment technology options comply with applicable new source Rule and the Basis for These considered by the Agency as the basis for performance standards (NSPS) on the Requirements? effluent limitations guidelines and standards, A. What Technology Options Did EPA the pollutants found in wastewaters from date the new sources begin discharging. Consider for the Final Rule? concentrated aquatic animal production For purposes of NSPS, a source is a new B. What Are the Requirements for the facilities, the estimates of pollutant removals source if it commences construction Flow-Through and Recirculating associated with certain pollutant control after September 22, 2004. Systems Subcategory? options, and the cost estimates related to C. What Are the Requirements for the Net reducing the pollutants with those F. How Does EPA Protect Confidential Pen Subcategory? technology options. Business Information (CBI)? D. What Monitoring Does the Final Rule • ‘‘Economic and Environmental Benefit Certain information and data in the Require? Analysis of the Final Effluent Limitations record supporting the final rule have E. What Are the Final Rule’s Notification, Guidelines and Standards for the been claimed as CBI and, therefore, EPA Recordkeeping, and Reporting Concentrated Aquatic Animal Production Requirements? Point Source Category [EPA–821–R–04–013] has not included these materials in the IX. What Are the Costs and Economic referred to in this preamble as the Economic record that is available to the public in Impacts Associated With This Rule? and Environmental Benefit Analysis or the Water Docket. Further, the Agency A. Compliance Costs EEBA. This document presents the has withheld from disclosure some data B. Economic Impacts methodology used to assess economic not claimed as CBI because release of C. What Do the Cost-Reasonableness impacts, environmental impacts and benefits this information could indirectly reveal Analyses Show? of the final rule. The document also provides information claimed to be confidential. X. What Are the Environmental Benefits for the results of the analyses conducted to To support the rulemaking while This Rule? estimate the projected impacts and benefits. A. Summary of the Environmental Benefits preserving confidentiality claims, EPA Major supporting documents are B. Non-Monetized Benefits is presenting in the public record C. Monetized Benefits available in hard copy from the National certain information in aggregated form, XI. What Are the Non-Water Quality Service Center for Environmental masking facility identities, or using Environmental Impacts of This Rule? Publications (NSCEP), U.S. EPA/NSCEP, other strategies. A. Air Emissions P.O. Box 42419, Cincinnati, Ohio, USA B. Energy Consumption 45242–2419, (800) 490–9198, Table of Contents C. Solid Waste Generation www.epa.gov/ncepihom. You can obtain I. General Information XII. How Will This Rule Be Implemented? electronic copies of this preamble and A. Does This Action Apply to Me? A. Implementation of Limitations and rule as well as major supporting B. How Can I Get Copies of This Document Standards for Direct Dischargers and Other Related Information? B. Upset and Bypass Provisions documents at EPA Dockets at C. What Other Information Is Available To C. Variances and Modifications www.epa.gov/edocket and at Support This Final Rule? D. Best Management Practices www.epa.gov/guide/aquaculture. D. What Process Governs Judicial Review E. Potential Tools To Assist With the for Today’s Final Rule? D. What Process Governs Judicial Remediation of Aquaculture Effluents E. What Are the Compliance Dates for XIII. Statutory and Executive Order Reviews Review for Today’s Final Rule? Today’s Final Rule? A. Executive Order 12866: Regulatory Under Section 509(b)(1) of the Clean F. How Does EPA Protect CBI? Planning and Review Water Act (CWA), judicial review of II. Definitions, Acronyms, and Abbreviations B. Paperwork Reduction Act Used in This Document C. Regulatory Flexibility Act today’s effluent limitations guidelines III. Under What Legal Authority Is This Final and standards may be obtained by filing D. Unfunded Mandates Reform Act Rule Issued? E. Executive Order 13132: Federalism a petition for review in the United IV. What Is the Statutory and Regulatory F. Executive Order 13175: Consultation States Circuit Court of Appeals within Background to This Rule? and Coordination With Indian Tribal 120 days from the date of promulgation A. Clean Water Act Governments of these guidelines and standards. For B. Section 304(m) Consent Decree G. Executive Order 13045: Protection of judicial review purposes, this final rule C. Clean Water Act Requirements Children From Environmental Health is promulgated as of 1 pm (Eastern time) Applicable to CAAP Facilities and Safety Risks V. How Was This Final Rule Developed? H. Executive Order 13211: Actions That on September 7, 2004 as provided at 40 A. September 2002 Proposed Rule CFR 23.2. Under section 509(b)(2) of the Significantly Affect Energy Supply, B. December 2003 Notice of Data Distribution, or Use CWA, the requirements of this Availability I. National Technology Transfer and C. Public Comments regulation may not be challenged later Advancement Act D. Public Outreach in civil or criminal proceedings brought J. Executive Order 12898: Federal Actions VI. What Are Some of the Significant by EPA to enforce these requirements. To Address Environmental Justice in Changes in the Content of the Final Rule E. What Are the Compliance Dates for and the Methodology Used To Develop Minority Populations and Low-Income Populations Today’s Final Rule? it? A. Subcategorization K. Congressional Review Act Existing direct dischargers must B. Regulated Pollutants comply with today’s limitations based II. Definitions, Acronyms, and C. Treatment Options Considered Abbreviations Used in This Document on the best practicable control D. Reporting Requirements technology currently available (BPT), E. Costs Act—The Clean Water Act.

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Agency—U.S. Environmental Protection FCR—Feed conversion ratio. pollutants are or may be discharged. See Agency. FDF—Fundamentally different factor. CWA Section 502(14). AWQC—Ambient water quality criteria. FFDCA—Federal Food, Drug, and Cosmetic POTW(s)—Publicly owned treatment BAT—Best available technology Act, 21 U.S.C. 301, et seq., as amended. works. It is a treatment works as defined by economically achievable, as defined by FIFRA—Federal Insecticide, Fungicide and Section 212 of the Clean Water Act that is section 304(b)(2)(B) of the Act. Rodenticide Act. owned by a State or municipality (as defined BCT—Best conventional pollutant control FR—Federal Register. by Section 502(4) of the Clean Water Act). technology, as defined by section 304(b)(4) of FTE—Full Time Equivalent Employee. This definition includes any devices and the Act. FWS—U.S. Fish and Wildlife Service. systems used in the storage, treatment, BMP—Best management practice, as INAD—Investigational new animal drug. A recycling and reclamation of municipal defined by section 304(e) of the Act. new animal drug (or animal feed containing sewage or industrial wastes of a liquid BOD5—Biochemical oxygen demand a new animal drug) intended for testing or nature. It also includes sewers, pipes and measured over a five day period. clinical investigational use in animals. Food other conveyances only if they convey BPJ—Best professional judgment. and Drug Administration regulations limit wastewater to a POTW Treatment Plant. The BPT—Best practicable control technology the conditions under which such drugs may term also means the municipality as defined currently available, as defined by section be used. 21 CFR 511, 514. in Section 502(4) of the Clean Water Act, 304(b)(1) of the Act. Indirect Discharger-A facility that which has jurisdiction over the Indirect CAAP—Concentrated aquatic animal discharges or may discharge wastewaters into Discharges to and the discharges from such production. a publicly-owned treatment works. a treatment works. CBI—Confidential business information. JSA/AETF—Joint Subcommittee on Priority Pollutant—One hundred twenty- CFR—Code of Federal Regulations. Aquaculture, Aquaculture Effluents Task six compounds that are a subset of the 65 CWA—33 U.S.C. §§ 1251 et seq., as Force. toxic pollutants and classes of pollutants amended. lb(s)/yr—pound(s) per year. outlined pursuant to Section 307 of the CWA. Conventional Pollutants—Constituents of NAICS—North American Industry 40 CFR Part 423, Appendix A. wastewater as determined by Section Classification System. NAICS was developed PSES—Pretreatment standards for existing 304(a)(4) of the CWA (and EPA regulations), jointly by the U.S., Canada, and Mexico to sources of indirect discharges, under Section i.e., pollutants classified as biochemical provide new comparability in statistics about 307(b) of the CWA, applicable to indirect oxygen demand, total suspended solids, oil business activity across North America. dischargers that commenced construction and grease, fecal coliform, and pH. NEPA—National Environmental Policy prior to the effective date of a final rule. Daily Discharge—The discharge of a Act, 33 U.S.C. 4321, et seq. PSNS—Pretreatment standards for new pollutant measured during any calendar day NMFS—National Marine Fisheries Service. sources under Section 307(c) of the CWA. NPDES Permit—A permit to discharge or any 24-hour period that reasonably QUAL2E—Enhanced Stream Water Quality wastewater into waters of the United States represents a calendar day. Model. issued under the National Pollutant Daily Maximum Limit—the highest RFA—Regulatory Flexibility Act, 5 U.S.C. Discharge Elimination System, authorized by allowable ‘‘daily discharge’’. 601, et. seq. Section 402 of the CWA. Direct Discharger—A facility that SBREFA—Small Business Regulatory NRCS—Natural Resources Conservation Enforcement Fairness Act of 1996, Public discharges or may discharge treated or Service. Law 104–121. untreated wastewaters into waters of the Nonconventional Pollutants—Pollutants SIC—Standard Industrial Classification, a United States. that are neither conventional pollutants numerical categorization system used by the DMR—Discharge monitoring report; listed at 40 CFR 401 nor toxic pollutants consists of the reports filed with the listed at 40 CFR 401.15 and Part 423 U.S. Department of Commerce to catalogue permitting authority by permitted dischargers Appendix A. economic activity. SIC codes refer to the to demonstrate compliance with permit Non-water quality environmental impact— products or groups of products that are limits. Deleterious aspects of control and treatment produced or distributed, or to services that DO—Dissolved oxygen. technologies applicable to point source are provided, by an operating establishment. ELG—Effluent limitations guidelines. category wastes, including, but not limited to SIC codes are used to group establishments EQIP—Environmental Quality Incentives air pollution, noise, radiation, sludge and by the economic activities in which they are Program. solid waste generation, and energy used. engaged. SIC codes often denote a facility’s Existing source—For this rule, any facility NRDC—Natural Resources Defense primary, secondary, tertiary, etc. economic from which there is or may be a discharge of Council. activities. pollutants, the construction of which is NSPS—New Source Performance TDD—Technical Development Document. commenced before September 22, 2004. Standards. TSS—Total Suspended Solids. Extralabel drug use—Actual use or NTTAA—National Technology Transfer U.S.C.—United States Code. intended use of a drug in an animal in a and Advancement Act, 15 U.S.C. 272 note. UMRA—Unfunded Mandates Reform Act manner that is not in accordance with the OMB—Office of Management and Budget of 1995, 2 U.S.C. 1501. approved label. The Federal Food, Drug, and Outfall—The mouth of conduit drains and USDA—United States Department of Cosmetic Act allows veterinarians to other conduits from which a facility Agriculture. prescribe extralabel uses of certain approved discharges effluent into receiving waters. III. Under What Legal Authority Is This animal drugs and approved human drugs for Pass through—a discharge that exits a animals under certain conditions. These POTW into waters of the United States in Final Rule Issued? conditions are spelled out in Food and Drug quantities or concentrations that alone or in The U.S. Environmental Protection Administration regulations at 21 CFR Part conjunction with discharges from other Agency is promulgating these 530. Among these requirements are that any sources, causes a violation of any regulations under the authority of extralabel use must be by or on the order of requirement of the POTW’s NPDES permit Sections 301, 304, 306, 307, 308, 402, a veterinarian within the context of a (including an increase in the magnitude or veterinarian-client-patient relationship, must duration of a violation). and 501 of the Clean Water Act, 33 not result in violative residues in food- PCB—Polychlorinated biphenyls. U.S.C. 1311, 1314, 1316, 1318, 1342, producing animals, and the use must be in POC—Pollutants of Concern. Pollutants and 1361. conformance with the regulations. A list of commonly found in aquatic animal IV. What Is the Statutory and drugs specifically prohibited from extralabel production wastewaters. Generally, a use appears at 21 CFR 530.41. chemical is considered as a POC if it was Regulatory Background to This Rule? Facility—All contiguous property and detected in untreated process wastewater at A. Clean Water Act equipment owned, operated, leased, or under 5 times a baseline value in more than 10% the control of the same person or entity. of the samples. Congress passed the Federal Water FAO—United Nations Food and Point Source—Any discernable, confined, Pollution Control Act (1972), also Agriculture Organization. and discrete conveyance from which known as the Clean Water Act (CWA),

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to ‘‘restore and maintain the chemical, discharged from CAAP facilities are in nonconventional pollutants. For toxic physical, and biological integrity of the concentrations lower, in full flow pollutants, EPA typically regulates Nation’s waters.’’ (33 U.S.C. 1251(a)). discharges, and similar in off-line priority pollutants, which consist of a The CWA establishes a comprehensive settling basin discharges, to nutrient specified list of toxic pollutants. In program for protecting our nation’s concentrations in human wastes specifying BPT, EPA looks at a number waters. Among its core provisions, the discharged to POTWs. The options EPA of factors. EPA first considers the cost CWA prohibits the discharge of considered do not directly treat of achieving effluent reductions in pollutants from a point source to waters nutrients, but some nutrient removal is relation to the effluent reduction of the U.S. except as authorized by a achieved incidentally through the benefits. The Agency also considers the National Pollutant Discharge control of TSS. EPA concluded POTWs age of the equipment and facilities, the Elimination System (NPDES) permit. would achieve removals of TSS and processes employed, engineering The CWA also requires EPA to establish associated nutrients equivalent to those aspects of the control technologies, any national technology-based effluent achievable by the options considered for required process changes, non-water limitations guidelines and standards this rulemaking and therefore there quality environmental impacts (effluent guidelines or ELG) for different would be no pass through of pollutants (including energy requirements), and categories of sources, such as industrial, in amounts needing regulation. In the such other factors as the Administrator commercial and public sources of event of pass through that causes a deems appropriate. (See CWA waters. Effluent guidelines are violation of a POTW’s NPDES limit, the 304(b)(1)(B)). Traditionally, EPA implemented when incorporated into an POTW must develop local limits for its establishes BPT effluent limitations NPDES permit. Effluent guidelines can users to ensure compliance with its based on the average of the best include numeric and narrative permit. performance of facilities within the limitations, including Best Management Direct dischargers must comply with industry, grouped to reflect various Practices, to control the discharge of effluent limitations in NPDES permits. ages, sizes, processes, or other common pollutants from categories of point Technology-based effluent limitations in characteristics. Where existing sources. NPDES permits are derived from performance is uniformly inadequate, effluent limitations guidelines and new EPA may establish limitations based on Congress recognized that regulating source performance standards higher levels of control than currently in only those sources that discharge promulgated by EPA, as well as place in an industrial category, if the effluent directly into the nation’s waters occasionally from best professional Agency determines that the technology may not be sufficient to achieve the judgment analyses. Effluent limitations is available in another category or CWA’s goals. Consequently, the CWA are also derived from water quality subcategory and can be practically requires EPA to promulgate nationally standards. The effluent limitations applied. applicable pretreatment standards that guidelines and standards are established restrict pollutant discharges from by regulation for categories of industrial 2. Best Conventional Pollutant Control facilities that discharge wastewater dischargers and are based on the degree Technology (BCT)—Section 304(b)(4) of indirectly through sewers flowing to of control that can be achieved using the CWA publicly-owned treatment works various levels of pollution control The 1977 amendments to the CWA (POTWs). (See Section 307(b) and (c), 33 technology. required EPA to identify additional U.S.C. 1317(b) & (c)). National EPA promulgates national effluent levels of effluent reduction for pretreatment standards are established limitations guidelines and standards for conventional pollutants associated with only for those pollutants in wastewater major industrial categories generally for BCT technology for discharges from from indirect dischargers that may pass three classes of pollutants: (1) existing industrial point sources. In through, interfere with, or are otherwise Conventional pollutants (i.e., total addition to other factors specified in incompatible with POTW operations. suspended solids, oil and grease, Section 304(b)(4)(B), the CWA requires Generally, pretreatment standards are biochemical oxygen demand, fecal that EPA establish BCT limitations after designed to ensure that wastewaters coliform, and pH); (2) toxic pollutants consideration of a two-part ‘‘cost- from direct and indirect industrial (e.g., toxic metals such as chromium, reasonableness’’ test. EPA explained its dischargers are subject to similar levels lead, nickel, and zinc; toxic organic methodology for the development of of treatment. In addition, POTWs must pollutants such as benzene, benzo-a- BCT limitations in July 1986 (51 FR develop local treatment limits pyrene, phenol, and naphthalene); and 24974). applicable to their industrial indirect (3) Nonconventional pollutants (e.g., Section 304(a)(4) designates the dischargers. Any POTWs required to ammonia-N, formaldehyde, and following as conventional pollutants: develop a pretreatment program must phosphorus). EPA considered the Biochemical oxygen demand measured develop local limits to implement the discharge of these classes of pollutants over five days (BOD5), total suspended general and specific national in the development of this rule. EPA is solids (TSS), fecal coliform, pH, and any pretreatment standards. Other POTWs establishing BMP requirements for the additional pollutants defined by the must develop local limits to ensure control of conventional, toxic and Administrator as conventional. The compliance with their NPDES permit for Nonconventional pollutants. EPA Administrator designated oil and grease pollutants that result in pass through or considers development of four types of as an additional conventional pollutant interference at the POTW. (See 40 CFR effluent limitations guidelines and on July 30, 1979 (44 FR 44501). 403.5). Today’s rule does not establish standards for direct dischargers. The 3. Best Available Technology national pretreatment standards for this paragraphs below describe those Economically Achievable (BAT)— category, which contains very few pertinent to today’s rule. indirect dischargers, because the Section 304(b)(2) of the CWA indirect dischargers would be 1. Best Practicable Control Technology In general, BAT effluent limitations discharging mainly TSS and BOD, Currently Available (BPT)—Section guidelines represent the best which the POTWs are designed to treat 304(b)(1) of the CWA economically achievable performance of and which consequently, do not pass EPA may promulgate BPT effluent facilities in the industrial subcategory or through. In addition, nutrients limits for conventional, toxic, and category. The CWA establishes BAT as

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a principal national means of of Columbia, (NRDC et al v. Leavitt, Civ. more per year as defined in 40 CFR part controlling the direct discharge of toxic No. 89–2980). On January 31, 1992, the 122 and are subject to permitting and nonconventional pollutants. The court entered a consent decree which, depending on the production level at factors considered in assessing BAT among other things, established the facility. Most pond facilities do not include the cost of achieving BAT schedules for EPA to propose and take require permits because ponds generally effluent reductions, the age of final action on effluent limitations discharge fewer than 30 days per year equipment and facilities involved, the guidelines and standards for several and therefore generally are not CAAP process employed, potential process point source categories. The amended facilities unless designated by the changes, non-water quality consent decree requires EPA to take NPDES program director. The NPDES environmental impacts including energy final action on the Concentrated Aquatic program director can designate a facility requirements, economic achievability, Animal Production (CAAP) effluent on a case-by-case basis if the director and such other factors as the guidelines by June 30, 2004. determines that the facility is a Administrator deems appropriate. The significant contributor of pollution to C. Clean Water Act Requirements Agency retains considerable discretion waters of the U.S. Applicable to CAAP Facilities in assigning the weight to be accorded V. How Was This Final Rule these factors. Generally, EPA determines EPA’s existing National Pollutant Developed? economic achievability on the basis of Discharge Elimination System (NPDES) total costs to the industry and the effect regulations define when a hatchery, fish This section describes the background of compliance with BAT limitations on farm, or other facility is a concentrated to development of the proposal, the overall industry and subcategory aquatic animal production facility and, proposed rule, EPA’s data collection financial conditions. As with BPT, therefore, a point source subject to the effort, and changes to the proposal EPA where existing performance is NPDES permit program. See 40 CFR considered based on new information uniformly inadequate, BAT may reflect 122.24. In defining ‘‘concentrated and comments on the proposal. aquatic animal production (CAAP) a higher level of performance than is A. September 2002 Proposed Rule currently being achieved based on facility,’’ the NPDES regulations technology transferred from a different distinguish between warmwater and EPA started work on these effluent subcategory or category. BAT may be coldwater species of fish and define a guidelines in January 2000. EPA relied based upon process changes or internal CAAP facility by, among other things, on a federal interagency group known as controls, even when these technologies the size of the operation and frequency the Joint Subcommittee on Aquaculture are not common industry practice. of discharge. as a primary contact for information A facility is a CAAP facility if it meets about the industry. The Joint 4. New Source Performance Standards the criteria in 40 CFR 122 appendix C Subcommittee on Aquaculture, (NSPS)—Section 306 of the CWA or if it is designated as a CAAP facility authorized by the National Aquaculture New Source Performance Standards by the NPDES program director on a Act of 1980, 94 Stat. 1198, 16 U.S.C. reflect effluent reductions that are case-by-case basis. The criteria 2801, et seq, operates under the achievable based on the best available described in appendix C are as follows. National Science and Technology demonstrated control technology. New A hatchery, fish farm, or other facility Council of the Office of Science and facilities have the opportunity to install is a concentrated aquatic animal Technology in the Office of the Science the best and most efficient production production facility if it grows, contains, Advisor to the President. The National processes and wastewater treatment or holds aquatic animals in either of two Aquaculture Act’s purpose is to promote technologies. As a result, NSPS should categories: cold water species or warm aquaculture in the United States to help represent the most stringent controls water species. The cold water species meet its future food needs and attainable through the application of the category includes facilities where contribute to solving world resource best available demonstrated control animals are produced in ponds, problems. The Act provides for the technology for all pollutants (i.e., raceways, or other similar structures identification of regulatory constraints conventional, nonconventional, and that discharge at least 30 days per year on the development of commercial priority pollutants). In establishing but does not include facilities that aquaculture, and for development of a NSPS, EPA is directed to take into produce less than approximately 20,000 plan identifying specific steps the consideration the cost of achieving the pounds per year or facilities that feed Federal Government can take to remove effluent reduction, any non-water less than approximately 5,000 pounds unnecessarily burdensome regulatory quality environmental impacts, and during the calendar month of maximum barriers to the initiation and operation energy requirements. feeding. The warm water species of commercial aquaculture ventures. It category includes facilities where also directs Federal agencies with B. Section 304(m) Consent Decree animals are produced in ponds, functions or responsibilities that may Section 304(m) of the CWA requires raceways, or other similar structures affect aquaculture to perform such EPA every two years to publish a plan that discharge at least 30 days per year, functions or responsibilities, to the for reviewing and revising existing but does not include closed ponds that maximum extent practicable, in a effluent limitations guidelines and discharge only during periods of excess manner that is consistent with the standards and for promulgating new runoff or facilities that produce less purpose and policy of the Act. The Joint effluent guidelines. On January 2, 1990, than approximately 100,000 pounds per Subcommittee on Aquaculture EPA published an Effluent Guidelines year. 40 CFR part 122, appendix C. established the Aquaculture Effluents Plan (see 55 FR 80) in which the Agency Today’s action does not revise the Task Force (AETF) to work with EPA to established schedules for developing NPDES regulation that defines CAAP provide information and expertise for new and revised effluent guidelines for facilities. the development of this rule. The AETF several industry categories. Natural Most facilities falling under the became an instrumental group Resources Defense Council, Inc., and definition of CAAP are either flow- providing input and comments to EPA. Public Citizen, Inc., challenged the through, recirculating or net pen The AETF consists of members from Effluent Guidelines Plan in a suit filed systems. These systems discharge various Federal agencies, State in the U.S. District Court for the District continuously or discharge 30 days or governments, industry, academia, and

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non-governmental (environmental) application of the national limitations chemicals. In addition, EPA proposed organizations. and standards by size of production. that net pen facilities prevent the EPA used the information provided On September 12, 2002, EPA discharge of solid wastes such as feed by the AETF and conducted its own published the proposed rule (see 67 FR bags, trash, net cleaning debris, and research for this rulemaking effort. EPA 57872). The proposed limitations and dead fish; chemicals used to clean the also relied on the 1998 Census of standards applied only to new and nets, boats or gear; and materials Aquaculture conducted by the existing CAAP facilities that discharge containing or treated with tributyltin Department of Agriculture (USDA) to directly to waters of the United States. compounds. Further requirements were provide information on the size and EPA proposed requirements for three designed to minimize the discharge of distribution of facilities in the industry. subcategories for this industry: flow- blood, viscera, fish carcasses or The Census also provided some basic through, recirculating, and net pen transport water containing blood information on the revenues and prices systems. Flow-through and recirculating associated with the transport or realized by aquatic animal producers. production systems are land-based. Net harvesting of fish. This information became a primary pens, by contrast, are located in open water. B. December 2003 Notice of Data resource for describing the industry. Availability Because of limitations in the Census EPA based the proposed requirements data, EPA conducted its own survey of for the recirculating and flow-through On December 29, 2003, EPA the aquatic animal production industry. subcategories on effluent control published a Notice of Data Availability (NODA) at 68 FR 75068. In the NODA, EPA adopted a two-phase approach to technologies that remove suspended EPA summarized the data received collecting data from aquatic animal solids from the animal production water since the proposed rule and described producers. In the first phase, EPA prior to discharge. The technologies considered include quiescent zones, how the Agency might use the data for distributed a ‘‘screener’’ survey. EPA settling basins (including off-line the final rule. The NODA also discussed designed this survey to collect very settling basins, full flow settling basins, the second phase of data collection, a basic information from all known and polishing settling basins) and detailed survey, which EPA conducted aquatic animal producers including filtration technology. EPA proposed to in 2002. The detailed survey was mailed public facilities regardless of size, establish limitations on the to a stratified sample population of ownership, or production system. EPA concentration of Total Suspended facilities identified from the screener mailed the survey to approximately Solids (TSS) in the discharges from survey. EPA received responses from 6,000 potential aquatic animal these facilities based on its preliminary 203 facilities. The surveyed population producers in August 2001. The survey assessment of the performance achieved included a statistically representative consisted of 11 questions asking for by the various control technologies. In sample of facilities that reported general facility information. EPA used the case of recirculating systems, EPA producing aquatic animals with flow- the information collected to refine the based the proposed TSS limitations on through, recirculating and net pen profiles of the industry with respect to solids polishing or secondary solids systems. EPA also surveyed a small the production systems in use and the removal technology. For flow-through number of facilities that would not have type of effluent controls in use. The systems, EPA based the proposed TSS been subject to the proposed screener survey, AETF information, and limitations on primary or secondary requirements. EPA’s objective was to Census data became the primary sources solids settling technologies depending further verify the assumptions on which for the proposed rule. on the production level of the facility it had based its preliminary decision to EPA based the limitations and (i.e., primary for 100,000–475,000 lbs/yr exclude these facilities from the scope standards for the proposed rule on the and secondary for >475,000 lbs/yr). In of the final rule. analysis of technologies to achieve addition to numeric limits, EPA also The detailed data collected through effluent reductions using model aquatic proposed to require these facilities to this survey allowed EPA to revise the animal production facilities. Each of implement operational measures so- methods used for the proposed rule to these model facilities represented a called—Best Management Practices estimate costs and economic impacts. different segment of the population (BMPs)—to reduce the discharge of EPA developed facility-specific costs corresponding to a particular pollutants and develop a BMP plan to and economic impact assessments for production system type, size range (in document these practices. Depending on each surveyed facility based on the terms of annual pounds of aquatic the type and size of the facility, the plan detailed information provided in the animals produced), and species would have required a facility to survey responses. The detailed produced. identify and implement practices that information included production EPA evaluated the economic impact controlled, for example, the discharge of systems, annual production, and control of each regulatory option it considered solids and ensured the proper storage practices and technologies in place at for the proposed effluent limitations and and disposal of drugs and chemicals. the facility. new source performance standards EPA based the proposed requirements The detailed responses to the second based on the revenues and production for net pen facilities on requirements to survey provided EPA with better cost information available from the reduce the amount of solids, mainly information on the baseline level of USDA Census of Aquaculture along feed, being added directly into waters of control technologies and operational with EPA’s own engineering cost the U.S. The proposal required net pen measures in use at CAAP facilities. estimates for the pollution control facilities to develop and implement Based on this understanding, EPA technologies being considered. After BMPs to address the discharge of solids described two modified options in the determining revenues and compliance including the requirement to conduct NODA that EPA was considering for the costs for each model facility, EPA used active feed monitoring to minimize the final rule. These options reflected the a compliance cost-to-revenue ratio as a amount of feed not eaten and thus same technologies and practices predictor of potential economic impacts discharged to the aquatic environment. considered for the proposed regulation, for the different model facilities. EPA Other proposed requirements included but reconfigured the combinations of used this economic analysis in its adoption of practices to ensure proper treatment technologies and practices evaluation of whether it should limit the storage and disposal of drugs and into revised regulatory options.

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EPA visited 17 additional sites and Reducing the Discharge of Pollutants, that there is no clear dividing line sampled at one facility in response to and the Economic and Environmental between the hydraulic retention time in issues raised in the comments. The Impact Analysis. These documents used a system that was considered a NODA discussed the post-proposal data to support the proposed rule and the recirculating system and one that was including site visits and additional final supporting documents are considered a flow-through system. EPA sampling. The results of EPA’s analyses available at www.epa.gov/guide/ examined the aquatic animal production of the data were also presented in the aquaculture. literature for alternatives for NODA. EPA solicited comment on the distinguishing recirculating systems and VI. What Are Some of the Significant new data and the conclusions being flow-through systems. Given the Changes in the Content of the Final drawn from them. difficulty in distinguishing certain flow- Rule and the Methodology Used To through facilities from recirculating C. Public Comments Develop It? ones, EPA considered whether it should EPA has prepared a ‘‘Comment This section describes some of the combine the two subcategories into one Response Document’’ that includes the major changes that EPA made to the subcategory. EPA discussed this in the Agency’s responses to comments final rule from that it proposed. This NODA and solicited comment on this submitted on the proposed rule and the section also describes differences in the option. notice of data availability. All of the methodology EPA used in evaluating its While some commenters opposed public comments, including supporting options for the final rule. combining these two subcategories, EPA documents, are available for public A. Subcategorization has decided to combine flow-through review in the administrative record for and recirculating systems for the this final rule, filed under docket The proposed regulation included purpose of establishing effluent number OW–2002–0026. limitations and standards for three limitations guidelines for the following The comment period on the proposed subcategories: Flow-through systems, reasons. First, as some commenters rule closed on January 27, 2003. EPA recirculating systems and net pens. The recognized, both flow-through and received approximately 300 comments, final rule establishes limitations and recirculating systems may reuse water including form letters. EPA received standards for the same systems but for and employ similar measures to comments from sources including the only two subcategories: A flow-through maintain water quality including Joint Subcommittee on Aquaculture— and recirculating systems subcategory mechanical filtration. Second, the Aquaculture Effluents Task Force (JSA/ and a net pens subcategory. The characteristic of wastewater discharged AETF), industry trade associations, recirculating and flow-through systems from facilities that are identified as Federal and State agencies, are combined into one subcategory recirculating systems that are similar to environmental organizations, and instead of two separate subcategories. the wastewater from the off-line or private citizens. For the NODA, EPA As previously noted, flow-through solids treatment units at flow-through received 20 comments between and recirculating systems are both land systems. Both waste streams are December 29, 2003 and February 12, based systems that typically discharge characterized by high levels of 2004. continuously, but can occasionally suspended solids, which can be discontinue discharges for short periods effectively treated through properly D. Public Outreach of time. The principal distinguishing designed and operated treatment As part of the development of the characteristic between these two systems employing either settling proposed rule and today’s final rule, systems is the degree to which water is technology combined with effective feed EPA has conducted outreach activities. reused prior to its discharge, with management or a carefully controlled EPA met with affected and interested recirculating systems typically feed management system alone. stakeholders through site visits and discharging lower volumes of Therefore, EPA decided that the same sampling trips to obtain information on wastewater. In the proposal, EPA requirements should apply both to operating and waste management distinguished recirculating systems wastewater discharged from practices at CAAP facilities. EPA met from flow-through systems by recirculating production systems and numerous times with members of the describing a recirculating system as one wastewater discharged from off-line JSA/AETF and conducted outreach with that typically filters with biological or solids treatment units at flow-through small businesses during the SBREFA mechanically supported filtration and facilities. Moreover, EPA had based the process. reuses the water in which the aquatic proposed limits for both of these waste EPA conducted three public meetings animals are raised. Net pen systems, by streams on the same data set. For the to discuss the proposed rule during the contrast, are located in open water and foregoing reasons, EPA has concluded public comment period for the proposed have distinctly different characteristics that this change in the organization of rule. EPA has participated in the from either recirculating or flow- the final rule does not substantively industry’s conferences to update through systems. change the requirements. participants on the progress and status EPA received a number of comments Commenters also pointed to of the rule. EPA also held several on the distinction between flow-through differences in BMPs employed at the meetings with other federal agencies to and recirculating systems described in different production systems. EPA discuss issues that potentially affect the proposed rule. Because some flow- recognizes that there are differences their mission, programs, or through systems also reuse their between recirculating systems and flow- responsibilities. production water, commenters did not through systems. EPA has concluded, Moreover, EPA maintains a website believe EPA had adequately however, that the control technology that posts information relating to the distinguished recirculating systems selected as the basis for the final regulation. EPA provided supporting from flow-through systems. Some narrative limitations will effectively documents for the proposed rule on the commenters encouraged EPA to use remove pollutants from both systems to site. The documents included the hydraulic retention time as a basis for the same degree. Further, the BMP Technical Development Document, the distinguishing between flow-through requirements in the final rule for this Draft Guidance for Aquatic Animal and recirculating systems. However, subcategory are flexible enough to Production Facilities to Assist in EPA’s review of available data showed accommodate differences in the specific

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practices appropriate for the two types single pollutant—total suspended solids In the final rule, EPA is also not of production systems. Finally, (TSS)—while controlling the discharge establishing numeric limits for any drug commenters were concerned that of other pollutants through narrative or pesticide, but is requiring CAAP collapsing these two systems into one requirements. Following proposal, EPA facilities to ensure proper storage of subcategory could be interpreted as reevaluated the technological basis for drugs, pesticides and feed to prevent indicating that EPA favors recirculating the numerical limits for TSS and spills and any resulting discharges of systems over flow-through systems and determined that it would be more drugs and pesticides. EPA is also implying that flow-through systems appropriate to promulgate qualitative establishing a requirement to implement should be modified to become TSS limits, in the form of solids control procedures for responding to spills of recirculating systems. This certainly is BMP requirements, that could better these materials to minimize their not EPA’s intention and the Agency is respond to regional and site-specific discharge from the facility. EPA’s survey not suggesting that recirculating systems conditions and accommodate existing of this industry indicated that many should replace existing flow-through state programs in cases where these CAAP facilities currently employ a systems or be given a preference in the appear to be working well (see Section number of different measures to prevent construction of new systems. The VIII.B. for further discussion). EPA is spills and have established in-place primary reason to collapse these two thus not promulgating numerical systems to address spills in the event systems into one subcategory is to limitations for TSS or other pollutants. they occur. EPA is thus establishing a eliminate redundancy in the CFR. EPA is instead establishing narrative requirement for all facilities to develop effluent limitations requiring and implement BMPs that avoid B. Regulated Pollutants implementation of effective operational inadvertent spills of drugs, pesticides, There are a number of pollutants measures to achieve reduced discharges and feed and to implement procedures associated with discharges from CAAP of solids and other materials. For the for properly containing, cleaning and facilities. CAAP facilities can have high final rule, as it did at proposal, EPA has disposing of any spilled materials to concentrations of suspended solids and also developed narrative limitations that minimize their discharge from the nutrients, high BOD and low dissolved will address a number of other facility. The effect of these requirements oxygen levels. Organic matter is pollutants potentially present in CAAP will be to promote increased care in the discharged primarily from feces and wastewater. These narrative limitations handling of these materials. uneaten feed. Metals, present in feed address spilled materials (drugs, Some commenters suggested that EPA additives or from the deterioration of pesticides and feed), fish carcasses, regulate certain other pollutants or production equipment, may also be viscera and other waste, excess feed, substances that may be discharged from present in CAAP wastewater. Effluents feed bags, packaging material and these production systems. For this rule, with high levels of suspended solids, netting. EPA evaluated control of some of these. when discharged into receiving waters, EPA’s decision to not establish For example, EPA evaluated the can have a detrimental effect on the national numeric limits for TSS will not application of activated carbon environment. Suspended solids can restrict a permit writer’s authority to treatment to remove compounds such as degrade aquatic ecosystems by impose site-specific permit numeric antibiotic active ingredients from increasing turbidity and reducing the effluent limits on the discharge of TSS wastewater prior to discharge. For the depth to which sunlight can penetrate, or other pollutants in appropriate reasons discussed in Section IX.A, thus reducing photosynthetic activity. circumstances. For example, a permit however, EPA is not basing any Suspended particles can damage fish writer may establish water quality-based pollutant limitations on the application gills, increasing the risk of infection and effluent limits for TSS (see 40 CFR of this technology. disease. Nutrients are discharged mainly 122.44(d) or regulate TSS (by in the form of nitrate, ammonia and establishing numeric limits) as a C. Treatment Options Considered organic nitrogen. Ammonia causes two surrogate for the control of toxic EPA evaluated three treatment main problems in water. First, it is toxic pollutants (see 40 CFR 122.44(e)(2)(ii)) options as the basis for BPT/BCT/BAT to aquatic life. Second, it is easily where site-specific circumstances proposed limitations for the flow- converted to nitrate which may increase warrant. The permit writer may also through and recirculating subcategories plant and algae growth. issue numeric limits in general permits and three options for the net pen Some substances, like drugs and applicable to classes of facilities. In fact, subcategory. For flow-through and pesticides, that may be present in the one of the bases for EPA’s decision not recirculating systems, EPA proposed a wastewater may be introduced directly to establish uniform national TSS limits numeric limitation for TSS. For Option as part of the aquatic animal production is the recognition that a number of 1, the least stringent option, EPA process. An important source of the states, particularly those with considered TSS limitations based on pollutants potentially present in CAAP significant numbers of CAAP facilities, primary settling as well as the use of wastewater is, as the above discussion already have general permits with BMPs to control the discharge of solids suggests, the feed used in aquatic numeric limits tailored to the specific from the production system. The second animal production. Feed used at CAAP production systems, species raised, and treatment option (Option 2) considered facilities contributes to pollutant environmental conditions in the state, by EPA for establishing TSS limitations discharges in a number of ways: by- and these permits seem to be working was based on Option 1 technologies product feces, ammonia excretions and, well to minimize discharges of plus the addition of reporting most directly, as uneaten feed (in suspended solids (see DCN 63056). EPA requirements if INAD or extralabel drug dissolved and particulate forms). believes there would be minimal use were used in the production Moreover, the feed may be the vehicle environmental gain from requiring these systems, plus the implementation of for introducing other substances into the states to redo their General Permits to BMPs to ensure proper storage, handling wastewater, like drugs. For example, conform to a set of uniform national and disposal of drugs and chemicals medicated feed may introduce concentration-based limits that in most and the prevention of escapes when antibiotics into the wastewater. cases would not produce significant non-native species are produced. EPA In the proposed rule, EPA proposed to changes in control technologies and based limitations for the most stringent establish numeric limitations for only a practices at CAAP facilities. option (Option 3) on primary settling

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and the addition of secondary solids discharge of solids. It also requires pesticide use as part of the application settling, in conjunction with BMPs, to facilities to develop and implement for the permit or exemption. Also in control the discharge of solids from the practices designed to prevent the both cases the permittee or the State or production system. This option also discharge of spilled drugs and Federal authority must report included BMPs to control drugs, pesticides, inspection and maintenance immediately to EPA any adverse effects chemicals and non-native species and protocols designed to prevent the from the use. Prior to issuing an the reporting of drugs. For New Source discharge of pollutants as a result of emergency exemption, EPA is required Performance Standards (NSPS), EPA structural failure, training of personnel, to determine that the exemption will not considered the same three options. various recordkeeping requirements, cause unreasonable adverse effects on EPA evaluated three treatment and documentation of the the environment (see 40 CFR options for the net pen subcategory. The implementation of these requirements 166.25(b)(1)(ii)) and that the pesticide is least stringent option, Option 1, in a BMP plan which is maintained on likely to be used in compliance with the required feed management and site and available to the permitting requirements imposed under the operational BMPs for solids control. authority upon request. exemption (see 40 CFR 166.25(b)(1)(iii)). Option 2 consisted of the same practices For net pens, the final rule establishes EPA’s regulation further specifies that and technology as Option 1 plus a BMP non-numeric, narrative limitations that the applicant for an emergency plan to address drugs, chemicals, are similar to those adopted for flow- exemption must coordinate with other pathogens, and non-native species and through and recirculating systems. affected State or Federal agencies to general reporting requirements for the Thus, the limitations require which the requested exemption is likely use of certain drugs and chemicals. minimization of feed input, proper to be of concern. The application must Option 3, the most stringent option, storage of drugs, pesticides and feed, indicate that the coordination has included the requirements of the first routine inspection and maintenance of occurred, and any comments provided two options as well as active feed the production and wastewater by the other agencies must be submitted monitoring to control the supply of feed treatment systems, training of to EPA with the application (see 40 CFR in the production units. Many existing personnel, and appropriate 166.20(a)(8)). facilities use active feed or real time recordkeeping. Compliance with these In contrast, the FDA’s regulations for monitoring to track the rate of feed requirements must be documented in a Investigative New Animal Drugs consumption and detect uneaten feed BMP plan which describes how the (INADs) exempt INADs from the passing through the nets. These systems facility is minimizing solids discharges requirement to conduct an may include the use of devices such as through feed management and how it is Environmental Assessment (see 21 CFR video cameras, digital scanning sonar complying with prohibitions on the 25.20 and 25.33). As a policy matter, detection, or upwellers, in addition to discharge of feed bags and other solid FDA encourages INAD sponsors to good husbandry and feed management waste materials. Further, net pens must notify permitting authorities of the use practices. These systems and practices minimize the accumulation of uneaten of an INAD. There is, however, no allow facilities to cease feeding the feed beneath the pens through active requirement that the sponsors comply. aquatic animals when a build-up of feed feed monitoring and management Therefore, EPA considers the reporting or over-feeding is observed. EPA strategies. of INADs in today’s regulation necessary considered the same treatment options to ensure that permit writers are aware D. Reporting Requirements for NSPS. of the potential for discharge of the The NODA described two additional EPA’s proposed rule would have INAD and can take action as necessary options that EPA was considering for required permittees to report the use of in authorized circumstances. flow-through and recirculating systems, INADs and extralabel use of both drugs EPA is providing an exception to the but did not identify any new options for and chemicals. In the final rule, EPA is requirement to report INAD use. When net pens. These two options contained modifying the proposed requirement, by an INAD has already been approved for the same treatment technologies and deleting the reporting requirements for use in another species or to treat another practices described in the three options chemicals, including pesticides, and by disease and is applied at a dosage that considered for the proposed rule but in further limiting the reporting does not exceed the approved dosage, slightly different combinations. requirement for drugs, as described reporting is not required if it will be The NODA Option A included below. EPA used the term ‘‘chemicals’’ used under similar conditions. The primary solids treatment, a reporting in the proposed rule to refer to requirement that the use be under requirement for the INAD and extralabel registered pesticides. similar conditions is intended to limit drug uses, and the implementation of EPA’s decision not to include the exception to cases where the INAD BMPs to control drugs and chemicals. In pesticides in the final reporting use would not be expected to produce addition to Option A requirements, requirements is based on the language significantly different environmental Option B included secondary solids in the Federal Insecticide, Fungicide impacts from the previously approved removal treatment or, alternatively, the and Rodenticide Act (FIFRA) and the use. For example, use of a drug that had implementation of BMPs for feed regulations that implement the statute. been previously approved for a management, and solids handling to FIFRA Section 5 authorizes EPA to freshwater application as an INAD in a control the discharge of solids. allow field testing of pesticides under marine setting would not be considered As previously explained, for flow- development through the issuance of a similar condition of use, since marine through or recirculating systems, today’s Experimental Use Permits. Further, ecosystems may have markedly different final rule does not establish numeric FIFRA Section 18 authorizes EPA to vulnerabilities than freshwater limitations for total suspended solids allow States to use a pesticide for an ecosystems. Similarly, the use of a drug (TSS) but does include narrative unregistered use for a limited time if approved to treat terrestrial animals as limitations requiring the solids control EPA determines that emergency an INAD to treat aquatic animals would measures and operational practices conditions exist. Under both of these not be considered a similar condition of described as part of Option B for BPT/ provisions the applicant is required to use. In contrast, the use of a drug to treat BCT/BAT limitations and NSPS. These submit information concerning the fish in a freshwater system that was include requirements to minimize the environmental risk associated with the previously approved for a different

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freshwater species would be considered potential impacts in the receiving in the regulation. EPA continues to view use under similar conditions. EPA has stream. Facilities are expected to make BMPs as effective tools to control the concluded that when a drug is used an oral report to the permitting discharge of pollutants from CAAP under similar conditions it is unlikely authority within 24 hours of the spill’s facilities and is establishing narrative that the environmental impacts would occurrence followed by a written report requirements based on the use of BMPs be different than those that were already within 7 days. The report shall include as the basis of today’s regulation. EPA considered in the prior approval of the the identity of the material spilled and has also retained the requirement for a drug. an estimated amount. BMP plan. The BMP plan is a tool in CAAP facilities must also report the EPA has concluded that today’s which the facility must describe the use of extralabel drugs. However, as reporting requirements are appropriate operational measures it will use to meet with INADs, reporting is not required if because they make it easier for the the non-numeric effluent limitations in the extralabel use does not exceed the permitting authority to evaluate what the regulation. Upon incorporation of approved dosage and is used under additional control measures on INADs today’s requirements into an NPDES similar conditions. EPA anticipates that and extralabel drug use may be permit, the CAAP facility owner or most extralabel drug use will not require necessary to prevent or minimize harm operator will be expected to develop reporting, but wants to ensure that to waters of the U.S. and to respond site-specific operational measures that permitting authorities are aware of more effectively to any unanticipated satisfy the requirements. The final rule situations in which a higher dose of a environmental impacts that may occur. requires CAAP facilities to develop a drug is used or the drug is used under Because neither of these classes of drugs BMP plan that describes how the CAAP significantly different conditions from has undergone an environmental facility will comply with the narrative the approved use. It is also possible that assessment for the use being made of requirements and that is maintained at drugs approved for terrestrial animals them, EPA is ensuring that the the CAAP facility. The CAAP facility could be used to treat aquatic animals permitting authority is aware of their owner or operator must certify in as extralabel use drugs. use and if warranted can take site writing to the permitting authority that For the final rule, the timing and specific action. the plan has been developed. In EPA’s content of reporting requirements Today’s reporting requirements are view, a BMP plan, as a practical matter, related to the use of INADs and authorized under several sections of the can assist facilities in achieving extralabel drugs are similar to the CWA. Section 308 of the CWA compliance with the non-numeric proposed requirements. EPA requires authorizes EPA to require point sources limitations. It can also assist regulatory both oral and written reporting. The to make such reports and ‘‘provide such authorities in verifying compliance with final rule has an added requirement that other information as [the Administrator] the requirements and modifying specific the CAAP facility report the method of may reasonably require.’’ 33 U.S.C. permit conditions where warranted. As drug application in both the oral report 1318(a)(A). Section 402(a) of the Act explained earlier in this section, EPA and the written report. EPA has authorizes EPA to impose permit has concluded Section 308 clearly concluded that both oral and written conditions as to ‘‘data and information authorizes it to require this information. reports are reasonable requirements collection, reporting and such other Of course, irrespective of the content of because the oral report lets the requirements as [the Administrator] the plan, a facility must still comply permitting authority know of the drug deems appropriate.’’ 33 U.S.C. with the narrative limitations. use sooner than the written report, thus 1342(a)(2). It is well established that facilitating site-specific action if these provisions justify EPA’s In conjunction with the requirement warranted. The written report provides establishing a range of information to inspect and provide regular confirmation of the use of the drug and disclosure requirements. Thus, for maintenance of CAAP production and more complete information for future example, the United States Court of treatment systems to prevent structural data analysis and control measures. Appeals for the District of Columbia damage, EPA is including a reporting Today’s regulation also adds a Circuit concluded that the Agency’s requirement associated with failure of requirement that CAAP facilities notify data gathering authority was not limited the CAAP containment structure and the permitting authority in writing to information on toxic pollutants any resulting discharges. EPA is within seven days after signing up to already identified by the Agency in a requiring CAAP facilities to report any participate in INAD testing. Advance permittee’s discharge. EPA regulations failure of or damage to the structural notice prior to the use of the INAD required permit applications to include integrity of the containment system that allows the permitting authority to information on toxic pollutants that an results in a material discharge of determine whether additional controls applicant used or manufactured as an pollutants to waters of the U.S. For net on the discharge of the INAD during its intermediate or final product or pen systems, for example, failures might use may be warranted. byproduct. In the court’s view, EPA include physical damage to the predator Finally, today’s regulation includes a could reasonably determine that it could control nets or the nets containing the requirement to report any spill of drugs, not regulate effectively without aquatic animals, that may result in a pesticides or feed that results in a information on such pollutants because discharge of the contents of the nets. discharge to waters of the U.S. Facilities they could end up present in the Physical damage might include are expected to implement proper permittee’s discharge. Natural abrasion, cutting or tearing of the nets storage for these products and Resources Defense Council, Inc. v. U.S. and breakdown of the netting due to rot implement procedures for the Environmental Protection Agency, 822 or ultra violet exposure. For flow- containing, cleaning and disposing of F.2d 104, 119 (DC Cir. 1987). The same through and recirculating systems, a spilled material. If the spilled material is true for certain INADs and extralabel failure might include the collapse of, or enters the production system or drug use that may end up as pollutants damage to, a rearing unit or wastewater wastewater treatment system it can be discharged to waters of the U.S. treatment structure; damage to pipes, assumed that the material will reach Under the proposed rule, the valves, and other plumbing fixtures; and waters of the U.S. EPA considers operators of facilities subject to the rule damage or malfunction to screens or reporting of these events necessary to were to certify that they had developed physical barriers in the system, which alert the permitting authority to a BMP plan that met the requirements would prevent the unit from containing

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water, sediment, and the aquatic the facility and other site-specific facilities currently had at least primary animals. The permitting authority may information (such as labor rates). EPA settling technologies in-place. EPA further specify in the permit what obtained additional cost information performed a cost analysis for the constitutes a material discharge of from data supplied from public facilities without primary settling using pollutants that would trigger the comments and site visits. With the new the facility-specific configuration reporting requirements. The permittee data, EPA revised the method to information provided in the detailed must report the failure of the estimate compliance costs. Instead of a survey. EPA also evaluated facilities containment system within 24 hours of model facility approach, EPA used a with primary settling in-place by discovery of the failure. The permittee facility-level cost analysis based on the comparing actual (i.e., DMR data) or must notify the permitting authority available facility-specific data contained estimated TSS effluent concentrations to orally and describe the cause of the in the detailed survey responses. We the proposed limits. For those facilities failure in the containment system and applied statistically-derived survey not meeting the proposed TSS limits, identify materials that were discharged weights instead of the frequency factors EPA also evaluated the implementation as a result of this failure. Further, the used at proposal to estimate costs to the of additional solids controls, including facility must provide a written report CAAP industry as a whole. secondary solids polishing and feed within seven days of discovery of the For proposal, EPA used national management. failure documenting the cause, the averages for many of the cost elements, For facilities with no solids control estimated time elapsed until the failure such as labor rates and land costs. In its equipment, we estimated the costs for was repaired, an estimate of the material analysis for the final regulation, EPA primary solids control. EPA evaluated released as a result of the failure, and used facility specific cost information, each facility to identify the steps being taken to prevent a such as labor rates, to determine the configuration of the existing treatment reoccurrence. costs associated with implementing the units and what upgrades would be regulatory options. When facility required. E. Costs specific rates were not available, EPA EPA also used industry cost At proposal, EPA used a model used national averages for similar information provided through public facility approach to estimate the cost of ownership types of facilities (i.e., non- comment and the detailed survey to installing or upgrading wastewater commercial and commercial ownership) estimate costs for design and treatment to achieve the proposed to determine managerial and staff labor installation of primary settling requirements. As described in the rates. EPA revised estimates for all labor equipment for effective settling of preamble to the proposed regulation (67 costs using the employee and wage suspended solids. For example, we used FR 57872), EPA developed 21 model information supplied in the detailed the facility-level data included in the facilities (based on the USDA’s Census surveys. For those facilities indicating detailed survey responses to place and of Aquaculture and EPA’s screener they use unpaid labor for part of the size the off-line settling basins on the survey) characterized by different facility operation, we used wages for facility site. combinations of production systems, similar categories (i.e., managerial or EPA classified each facility’s size categories, species and ownership staff) supplied by that facility to wastewater treatment system based on types. EPA developed regulatory estimate costs associated with the description provided in its survey technology options based on screener implementing the regulatory options. response and available monitoring data, survey responses, site visits, industry Comments also suggested that EPA’s including DMR data. We assumed that and other stakeholder input, and assumed land costs were too low at treatment technologies indicated by a existing permit requirements. proposal; EPA assumed national average facility on the detailed survey are EPA estimated the cost for each land values for agricultural land. EPA properly sized, installed, and option component for each model revised its estimates for land costs when maintained. EPA estimated facility- facility. We then calculated costs for determining the opportunity costs of specific costs for each of the responding each regulatory option at each model using land at a facility if structural direct dischargers and used these facility based on model facility improvements were evaluated that estimates as the basis for national characteristics and the costs of the required use of facility land that was not estimates. Because the survey did not option’s technologies or practices currently in use by the CAAP collect information about many specific corresponding to the option. operation’s infrastructure (e.g., occupied parameters used in individual facilities’ EPA estimated frequency factors for by tanks, raceways, buildings, settling production processes and treatment treatment technologies and existing basins, etc.). When evaluating the cost systems, EPA supplemented the facility- BMPs based on screener survey of land for the revised analyses, EPA specific information with typical responses, site visits, and sampling used land costs of $5,000/acre, which is specifications or parameters from visits. Baseline frequency factors twice the median value for land literature, survey results, and industry represented the portion of the facilities associated with aquaculture facilities comments. For example, EPA assumed represented by a particular model surveyed in the U.S. (see DCN 63066). that facilities have pipes of typical sizes facility that would not incur costs to EPA used this conservative estimate for their operations. comply with the proposed requirements because the only facilities that required As a consequence of such because they were already using the structural improvements in the options assumptions, a particular facility might technology or practice. EPA adjusted the evaluated were non-commercial need a different engineering component cost for each model facility facilities, for which land value estimates configuration from those modeled if it to account for those facilities that were not available. installed equipment that varies from the already have the component in-place. EPA considered several technology- equipment or specifications we used to Subsequently, EPA derived national based options to determine the technical estimate costs. EPA nonetheless estimates of costs by aggregating the and economic feasibility of requiring considers that costs for these facilities component costs applicable to each numeric TSS limits for in-scope CAAP are generally accurate and model facility across all model facilities. facilities. EPA’s analysis of the detailed representative, especially industry- EPA’s detailed surveys captured survey revealed that over 90% of the wide. EPA applied typical specifications information on the treatment in-place at flow-through and recirculating system and parameters representative of the

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industry to a range of processes and than facilities with constant water practices at facilities where (1) the treatment systems. We contacted temperatures. We did not apply costs for cultured species was not commonly facilities to get site-specific solids control BMPs for facilities with produced or regarded as native in the configuration information where reasonable explanations for the higher State, (2) the facility was a direct possible. FCRs. We evaluated facilities that did discharger, and (3) the species was In revising cost estimates, EPA paid not report FCRs or provide enough data expected to survive if released. (In particular attention to: for an estimate by using a randomly contrast, producers of a warm water 1. Size of tanks, raceways, and culture selected FCR, which is described in species in a cold climate, such as tilapia units; Chapter 10 of the Technical producers in Minnesota or Idaho, would 2. Labor rates; Development Document (DCN 63009). not incur costs for this practice.) Costs 3. Treatment components in place; For those facilities that required for escape prevention include staff time 4. BMPs and plans in place; additional solids controls, EPA for production unit and discharge point 5. Daily operations at the facility. evaluated both feed management and inspections and maintenance of escape Site visits and analysis of the detailed the installation of secondary solids prevention devices. We applied these surveys indicated that raceways and polishing technologies. EPA received costs to facilities that installed quiescent zones are cleaned as comments on the use of microscreen equipment conforming with State necessary to maintain system process filters and EPA agrees with concerns requirements for facilities producing water quality. raised in comments that the cost non-native species (identified by the In evaluating facilities for the need to associated with enclosing the filter in a State). Management time includes use additional solids controls, EPA first heated structure would be prohibitive. quarterly production unit and discharge checked for evidence of a good feed EPA found that the effective operation point inspections, eight hours a year to management program. If the facility of microscreen filters requires that they review applicable State and Federal reported they practice feed be enclosed in heated buildings to regulations, and quarterly staff management, EPA looked for evidence prevent freezing when located in cold consultations. of solids management and good climates. EPA’s revised estimates of operation of the physical plant, costs for secondary solids polishing are F. Economic Impacts including regular cleaning and not based on the application of There are a number of changes made maintenance of feed equipment and microscreen filters unless the detailed to the costing and economic impact solids collection devices (e.g., quiescent survey response indicated that such a methods used for the final rule. EPA zones, sedimentation basins, screens, structure existed at the site. When the used data from the detailed survey to etc.). To evaluate the effectiveness of a detailed survey did not indicate a project economic impacts for the final facility’s solids control practices, we structure at the site, EPA estimated costs rule, in contrast to the screener data and calculated feed conversion ratios (FCRs) for a second stage settling structure frequency factors used for the proposed using pounds of feed per pound of live rather than a microscreen filter. Based rule. For existing commercial product (as reported in the detailed on data from two of EPA’s sampling operations, EPA assessed the number of survey) and considered existing solids episodes at CAAP facilities, this business closures among regulated control equipment. We assumed technology will achieve the proposed enterprises, facilities, and companies by facilities lacking evidence of good feed limits for TSS. applying market forecasts and using a management or solids control programs We also considered the use of closure methodology that compares would incur additional costs to improve activated carbon filtration to treat projected earnings with and without or establish them. effluent containing drug or pesticide incremental compliance costs for the EPA estimated FCRs from data in the active ingredients from wastewater, but period 2005 to 2015. Other additional detailed survey and follow-up with rejected controls for these materials. analyses include an analysis of some facilities and compared FCRs for Research indicates that this technology moderate impacts by comparing annual groups of facilities (i.e., combinations of is effective at treating these compounds, compliance costs to sales, an evaluation ownership, species and production and at least one aquatic animal of financial health using a modified U.S. system types such as commercial trout production facility installed this Department of Agriculture’s four- flow-through facilities or government technology for water quality reasons. category (2 × 2) matrix approach, and an salmon flow-through facilities). We EPA estimated the costs for activated assessment of possible impacts on found a wide range of FCRs (reported by carbon treatment as a stand-alone borrowing capacity. For new facilities in their detailed surveys, technology. We estimated costs on a commercial operations, EPA evaluates which were validated by call backs to site-specific basis for facilities which whether the regulatory costs will result the facility) among apparently similar reported using drugs and then added in a barrier to entry among new facilities within ownership-species- these costs for the different regulatory businesses. For noncommercial production system groupings. options considered to assess the operations, EPA evaluated impacts For example, we had good data for 24 economic achievability of this using a budget test that compares of 60 government trout producers using technology. A detailed discussion of incurred compliance costs to facility flow-through systems. They reported a how EPA estimated costs is available operating budgets. Additional analyses range of FCRs of 0.79 to 1.80 with a from the public record (DCN 62451). investigate whether a facility could median FCR of 1.30. If an individual EPA considers these costs to be recoup increased compliance costs facility’s reported FCR was significantly economically unachievable or not through user fees and estimated the greater than the median, EPA further affordable on a national scale. However, associated increase. evaluated the facility to ascertain the EPA is aware of at least one facility For today’s final regulation, EPA reason for the higher FCR. Facilities that currently using this technology, and modified its forecasting models to produce larger fish, such as broodstock, notes that it is an effective technology include certain data for recent years that might have higher FCRs because the for removing drug compounds from became available after the Agency larger fish produce less flesh per unit of wastewater. published its NODA (see 68 FR 75068– food. Facilities with fluctuating water EPA estimated the costs to develop 75105). This and other details about temperatures could also be less efficient and implement escape management how EPA developed its economic

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impact methodologies is presented in pollutant loads to estimate the baseline goals may not place as great an this preamble and in the Economic and loads. EPA validated the baseline load emphasis on maximum growth. Environmental Benefit Analysis of the estimates with effluent monitoring data However, EPA expects that all facilities, Final Effluent Limitations Guidelines (DCN 63061). regardless of production goals, can and Standards for the Concentrated For today’s regulation, EPA evaluated achieve substantial reductions in Aquatic Animal Production Industry secondary solids removal technologies pollutant discharges over uncontrolled (‘‘Economic and Environmental Benefit and feed management. EPA assessed levels by designing and implementing Analysis’’), available in the rulemaking whether improved feed management in an optimal feed input management record. addition to primary solids settling might strategy, including appropriate be as effective at reducing solids in the recordkeeping and documentation of G. Loadings effluent as secondary settling. EPA FCRs. To estimate the baseline discharge found that feed management was the The process for the random loadings and load reductions for the lower cost option compared to assignment of FCRs to facilities with proposed rule, EPA used the same secondary solids removal technology. incomplete information included: model facility approach as used to (As discussed in more detail below at • EPA grouped facilities by estimate the compliance costs. Briefly, VIII.B., EPA has now concluded that a ownership, species, and production EPA first estimated pollutant loadings rigorous feed management program • FCRs were estimated for each for untreated wastewater based on alone will achieve significant reductions facility with sufficient data within a several factors for each model facility. in solids at CAAP facilities.) group As previously noted, feed used at CAAP Pollutant removals associated with • The distributions of grouped data facilities contributes to pollutant feed management result from more were examined for possible outliers, discharges in three ways: By-product efficient feed use and less wasted feed. which were defined as FCRs less than feces, dissolved ammonia excretions, For its evaluation, EPA used feed 0.75 or greater than 3.0. When extreme and uneaten feed (in dissolved and conversion rates as a surrogate for values were found and validated, they particulate forms). These byproducts of estimating potential load reductions were removed from the grouping. feed contribute to the pollutant load in resulting from feed management Although these extremes may be the untreated culture water. EPA then activities. Note, EPA used FCR values as possible and a function of production used typical efficiency rates of removing a means to estimate potential load goals, water temperature, etc., EPA was specific pollutants from water to reductions, not as a target to set absolute not able to validate and model all of the estimate load reductions for the FCR limits for a facility or industry factors contributing to the extreme FCR treatment options and BMPs. EPA segment. rates. Facilities excluded because of estimated frequency factors for Based on the information in the extreme values were not assigned a treatment technologies and existing detailed surveys, EPA calculated FCRs random FCR, but were found to have a BMPs based on screener survey for 69 flow-through and recirculating documented reason for the extreme responses, site visits, and sampling system facilities. EPA validated the value. For example, one facility visits. The occurrence frequency of feeding, production and estimated FCRs produced broodstock for stock practices or technologies was used to by contacting each facility. For those enhancement purposes. Some extreme estimate the portion of the operations facilities that were not able to supply values were updated based on that would incur costs. Using the same accurate feed and/or production validating information from the facility, frequency factors for technologies in information, to enable EPA to estimate and the updates were found to be within place that were used to estimate costs, a FCR, EPA randomly assigned a FCR. the range used for analysis. EPA estimated the baseline pollutant EPA attempted to capture and account • After removing outliers, the first loads discharged, then calculated load for as much of the variation as possible and third quartiles were calculated for reductions for the options. when analyzing FCRs and in the each grouping. The first quartile of a As described in the NODA, EPA random assignment process. For group of values is the value such that revised the loadings approach to example, the production system, 25% of the values fall at or below this incorporate facility-level information species, and system ownership (which value. The third quartile of a group of using data primarily from the detailed are all known from the detailed surveys) values is the value such that 75% of the surveys. EPA also incorporated were expected to influence feeding values fall at or below this value. information included in comments practices, so facilities were grouped • For each grouping, the target FCR concerning appropriate feed conversion according to these parameters. EPA was assumed to be the first quartile ratios (FCRs). included ownership as a grouping value. EPA based its estimates of pollutant variable to account for some of the • For the facilities with no FCR loads on the reported feed inputs variation in production goals. Most information, a random FCR between the included in the detailed surveys. EPA commercial facilities that were first and third quartiles was assigned. used the annual feed input and feed-to- evaluated are producing food-sized fish • To account for variation in FCRs pollutant conversion factors described and generally are trying to maintain based on factors such as water in the TDD and DCN 63026 to calculate constant production levels at the temperature, EPA only costed additional raw pollutant loads. EPA then analyzed facility; commercial facilities would feed management practices at a facility each facility’s detailed survey response tend to target maximum weight gain when the reported or randomly assigned to determine the treatment-in-place at over a low FCR in determining their FCR was within the upper 25% of the the facility. Using published literature optimal feeding strategy. Non- inter-quartile range. This was values to determine the pollutant commercial facilities are generally considered to be an indication of removal efficiencies for the types of government facilities that are producing potential improvement in feed wastewater treatment systems used at for stock enhancement purposes. management. CAAP facilities, EPA calculated a Production goals are driven by the • For some combinations of baseline pollutant load discharged from desire to produce a target size (length ownership, species, and production, each surveyed facility. EPA used these and weight) at a certain time of year for there was not sufficient data to do the pollutant removal efficiencies and raw release. Non-commercial facility feeding quartile analysis. In these cases, data

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from a similar grouping of ownership, concentrations at different points in the develop a method to measure species, and production was used. facilities. EPA then calculated metal to oxytetracycline in effluent from CAAP If a facility’s FCR was in the upper TSS ratios (in mg of metal per kg of facilities. EPA took samples to analyze 25% of the inter-quartile range or did TSS) based on the calculated net the effluent from a CAAP facility that not currently have secondary settling concentrations. EPA removed negative produces trout during a time period in technologies in place, EPA assumed the and zero ratios from the samples. which oxytetracycline, in medicated facility would need to improve feed Finally, basic sample distribution feed, was being used to treat a bacterial management practices. The statistics were calculated to derive the infection in some of the animals at the improvement in feed management relationship between TSS and each facility. Results of the study indicate practices would result in increased costs metal. that oxytetracycline can be stabilized in due to increased observations and EPA calculated estimated load samples when preserved with recordkeeping and in pollutant load reductions of PCBs from regulated phosphoric acid and maintained below reductions resulting from less wasted facilities as a percentage of TSS load ° feed. reductions. Since the main source of 4 C prior to analysis. The method The approach for estimating the found levels of oxytetracycline to range PCBs at CAAP facilities is through fish µ loadings for the final rule has not feed, a conversion factor was calculated from <0.2 g/L (which was the method changed significantly from the approach to estimate the amount of PCBs detection limit) in the supply and µ taken in the NODA. In estimating the discharged per pound of TSS. EPA hatchery effluent to 110 g/L in the loadings and removals for the final rule, assumed that 90% of the feed was eaten, influent to the offline settling basin. The EPA considered incidental removals or and that 90% of the feed eaten would level detected in the combined raceway removals gained from the control of be assimilated by the fish. By combining effluent was 0.95 µg/L. See the analysis solids through narrative limitations. As the amount of food materials excreted report (DCN 63011) for additional part of the loadings analysis, EPA by fish (10% of feed consumed) with the information. considered incidental removals of 10% of food uneaten, EPA was able to H. Environmental Assessment and metals, PCBs and one drug, partition the PCBs among fish flesh and oxytetracycline. aqueous and solid fractions. Due to a Benefits Analysis Metals may be present in CAAP lack of sampling data, EPA used a EPA’s environmental assessment and effluents from a variety of sources. Some µ maximum level of 2 g/g, the FDA limit benefits analysis for the proposed rule metals are present in feed (as federally on PCB concentrations in fish feed, to consisted of two efforts. First, EPA approved feed additives), occur in estimate the maximum amount of PCBs sanitation products, or may result from reviewed and summarized literature it that could possibly be in the TSS. This had obtained regarding environmental deterioration of CAAP machinery and maximum possible discharge load in the impacts of the aquaculture industry, equipment. EPA has observed that many TSS was estimated to be 21% of the focusing particularly on segments of the of the treatment measures used in the PCBs in the feed. EPA considers this CAAP industry provide substantial estimate to provide an upper bound on industry in the scope of the proposed reductions of most metals. The metals the amount of PCBs discharged from rule. Second, EPA used estimates of present are generally readily adsorbed to CAAP facilities, and the amount pollutant loading reductions associated solids and can be adequately controlled potentially removed by the rule. Even with the proposed requirements to by controlling solids. so, the estimates are quite low (0.52 assess improvements to water quality Most of the metals appear to be pounds of PCBs discharged in the that might arise from the proposed originating from the feed ingredients. baseline). CAAP facilities are not a requirements, and monetized benefits Trace amounts of metals at federally significant source of PCB discharges to from these water quality improvements. approved concentrations are added to waters of the U.S. (see DCN 63011). EPA’s approach to the environmental feed in the form of mineral packs to EPA estimated the pollutant load of assessment and benefits analysis for the ensure that the essential dietary oxytetracycline discharged from in- final rule is similar to the approach for nutrients are provided for the cultured scope CAAP facilities using data from the proposed rule, except that EPA has aquatic animals. Examples of metals EPA’s detailed survey of the CAAP incorporated new data, information, and added as feed supplements include Industry. EPA first determined facility methods that were not available at the copper, zinc, manganese, and iron specific amounts of oxytetracycline time of proposal, particularly those (Snowden, 2003). used by each CAAP facility. For those sources described in Section V of this EPA estimated metals load reductions facilities that reported using medicated Preamble. For example, literature, from facilities that are subject to the feed containing oxytetracycline, EPA discussions, and data submitted by final rule (see DCN 63011). The metals evaluated their responses to the detailed for which load reductions are analyzed survey to determine the amount, by stakeholders both through the public are those which were present above the weight, of medicated feed containing comment process on the proposed rule detection levels in the wastewater oxytetracycline and the concentration of as well as at other forums were samples collected from CAAP facilities the drug in the feed. EPA then estimated considered. EPA also used facility- during EPA’s sampling for this the amount of oxytetracycline that was specific data provided by or developed rulemaking. EPA used the net reduced at facilities in which feed from the detailed survey responses. EPA concentrations of the metal in the management practices were applied in has updated and revised its summary of wastewater to estimate these loads. EPA the cost and loadings analyses. The material relating to environmental estimated these load reductions as a facility level estimates were then impacts of CAAP facilities in Chapter 7 function of TSS loads using data multiplied by the appropriate weighting of the Economic and Environmental obtained from the four sampling factors and summed across all facilities Benefit Analysis for today’s final rule episodes. For this analysis, EPA first to determine the national estimate of (DCN 63010). EPA’s revised benefits assumed that non-detected samples had pounds of oxytetracycline reduced from analysis are described in both Section X the concentration of half the detection discharges as a result of the regulation. of this Preamble as well as in Chapter limit. From the sampling data, EPA As part of a sampling episode, EPA 8 of the Economic and Environmental calculated net TSS and metals also performed a preliminary study to Impact Analysis (DCN 63010).

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VII. Who Is Subject to This Rule? generate minimal pollutant discharges relatively large volumes of water into This section discusses the scope of in the baseline or that available and out of the rearing units. Some flow- the final rule and explains what pollutant control technologies will through systems discharge a single, wastewaters are subject to the final reduce pollutant loadings from these combined effluent stream with large limitations and standards. operations by only minimal amounts. water volumes and dilute pollutant For further explanation, see the concentrations. Other flow-through A. Who Is Subject to This Rule? proposal at 67 FR 57572, 57885–86. systems have two or more discharge Today’s rule applies to commercial Facilities that indirectly discharge streams, with the process water in (for-profit) and non-commercial their process wastewater (i.e., facilities which the fish are raised as the primary (generally, publicly-owned) facilities that discharge to POTWs) are also not discharge. This discharge, referred to as that produce, hold or contain 100,000 subject to today’s rule. EPA did not raceway effluent or bulk flow, is pounds or more of aquatic animals per propose and is not establishing characterized by a large water volume year. Any 12 month period would be pretreatment standards for existing or and dilute pollutant concentrations. The considered a year for the purposes of new indirect sources. As explained secondary discharges from flow-through above, the bulk of pollutant discharges establishing coverage under this rule. systems with multiple discharges result While facilities producing fewer than from CAAP facilities consists of TSS typically from some form of solids and BOD. POTWs are designed to treat 100,000 pounds of aquatic animals per settling through an off-line settling basin these conventional pollutants. year are not subject to this rule, in (OLSB) or other solids removal devices. Moreover, CAAP facilities discharge specific circumstances they may require The discharges from off-line settling nutrients in concentrations lower in NPDES permits that include limitations basins or solids removal devices have full-flow discharges, and similar in off- developed on a BPJ basis. An aquatic low water volumes and more line settling basin discharges, to animal production facility producing concentrated pollutants. The nutrient concentrations found in human fewer than 100,000 pounds of aquatic supernatant from the OLSB may be wastes discharged to POTWs. EPA has discharged through a separate outfall or animals per year will be subject to the concluded that the POTW removals of may be recombined prior to discharge NPDES permit program if it is a CAAP TSS would achieve equivalent nutrient with the raceway effluent. as defined in 40 CFR 122.24. As removals to those obtained by the Recirculating systems may also have explained in the proposed rule, EPA options considered for this rulemaking two waste streams: Overtopping limited the scope of the regulation it for direct dischargers. EPA, therefore, wastewater and filter backwash. was considering to facilities that are concluded that there would be no pass Overtopping is a continuous blowdown CAAPs above this production threshold. through of TSS or nutrients needing from the production system to avoid the The Agency concluded that facilities regulation. Indirect discharging facilities buildup of dissolved solids in the below the threshold would likely are still subject to the General production system, and filter backwash experience significant adverse economic Pretreatment Standards (40 CFR 403) is generated by cleaning the filter used impacts if required to comply with the and any applicable local limitations. to treat the water that is being proposed limitations. EPA concluded EPA has also determined that there are recirculated back to the production that these smaller CAAP facilities would few indirect dischargers in this system. Overtopping wastewater is have compliance costs in excess of 3 industry. usually small in volume (a fraction of percent of revenues. Further, smaller the total system volume on a daily basis) CAAP facilities account for a smaller B. What If a Facility Uses More Than and has higher TSS concentrations than relative percentage of total CAAP TSS One Production System? a full flow discharge. Filter backwash discharges and only limited removals EPA has found that several detailed wastewater is typically low in volume would be obtained from the proposed survey respondents are operating more and is as concentrated as wastewater BPT/BCT/BAT control. 67 FR 57872, than one type of production system. A from similar devices at flow-through 57884. Other types of facilities also not facility is subject to the rule if the total systems. covered by today’s action include closed production from any of the regulated Net pen systems are located in open pond systems (most of which do not production systems meets the waters and thus are characterized by the meet the regulatory definition of a production threshold. The facility flow and characteristics of the CAAP facility), molluscan shellfish would need to demonstrate compliance surrounding water body and by the operations, including nurseries, with the management practices required addition of raw materials to the pens crawfish production, alligator for each of the regulated production including feed, drugs and the excretions production, and aquaria and net pens systems it is operating. from the confined aquatic animals. rearing native species released after a growing period of no longer than 4 C. What Wastewater Discharges Are VIII. What Are the Requirements of the months to supplement commercial and Covered? Final Regulation and the Basis for sport fisheries. This last exclusion This rule covers wastewaters These Requirements? applies primarily to Alaskan non-profit generated by the following operations/ This section describes, by facilities which raise native salmon for processes: Effluent from flow-through, subcategory, the options EPA release into the wild in flow-through recirculating and net pen facilities. The considered and selected as a basis for systems and then hold them for a short flow-through and recirculating today’s rule. For each subcategory, EPA time in net pens preceding their release. subcategory (Subpart A) applies to provides a discussion, as applicable, for The flow-through portions of these wastewaters discharged from these the options considered for each of the facilities are within the scope of the systems. regulatory levels identified in the CWA rule, if they produce 100,000 pounds or The type of production system (i.e., BPT, BCT, BAT, NSPS). For a more per year, but the net pen portions determines the nature, quantity, and detailed discussion of all technology would be excluded from regulation. quality of effluents from CAAP options considered in the development EPA determined for the types of facilities. Flow-through systems of today’s final rule, see the proposal excluded systems or production commonly use raceways or tanks and (see 67 FR 57872), the NODA (see 68 FR operations listed above either that they are characterized by continual flows of 75068) or Chapter 9 of the Technical

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Development (TDD) for today’s final subcategories constitute the best Based on its review of the data and rule. available demonstrated control information it obtained during this Based on the information in the technology. For a discussion on the rulemaking, EPA has concluded that the record for the final CAAP rule, EPA has compliance date for new sources, see key element in achieving effective determined that the selected technology section I.E. of today’s final rule. pollution control at CAAP facilities is a for the flow-through and recirculating well-operated program to manage A. What Technology Options Did EPA systems subcategory and the net pens feeding, in addition to good solids Consider for the Final Rule? subcategory are technically available. management. Feed is the primary source EPA has also determined that the Among the options EPA considered of TSS (and associated pollutants) in technology it selected as the basis for for the final rule for flow-through and CAAP systems, and feed management the final limitations or standards has recirculating systems in addition to the plans are the principal tool for effluent reductions commensurate with options presented in the proposed rule minimizing accumulation of uneaten compliance costs and is economically were (i) establishing no national effluent feed in CAAP wastewater. Excess feed achievable for the applicable limitations (ii) establishing limitations in the production system increases the subcategory. EPA also considered the and BMPs based on technology options oxygen demand of the culture water and age, size, processes, and other A and B, and (iii) establishing narrative increases solids loadings. In addition, engineering factors pertinent to facilities limitations based on BMPs only. Based solids from the excess feed usually in the scope of the final regulation for on analysis presented in the NODA, settle and are naturally processed with the purpose of evaluating the EPA focused it analysis on these latter the feces from the fish. Excess feed and technology options. None of these three options. For net pens, EPA feces accumulate in the bottom of flow- factors provides a basis for selecting considered three options: no national through and recirculating systems or different technologies from those EPA requirements, requirements equivalent below net pens. Ensuring that the has selected as its technology options to those proposed but for new sources aquatic animal species being raised for today’s rule (see Chapter 5 of the only, and essentially the same receive the quantity of feed necessary TDD for the final rule for further requirements for existing and new for proper growth without overfeeding, discussion of EPA’s analyses of these sources as those in the proposed rule. and the resulting accumulation of factors). B. What Are the Requirements for the uneaten feed, is a challenging task. As previously explained, EPA Achieving the optimal feed input adopted a production threshold cutoff Flow-Through and Recirculating Systems Subcategory? requires properly designing a site- as the principal means of reducing specific feeding regimen that considers economic impacts on small businesses The following discussion explains the production goals, species, rearing unit and administrative burden for control BPT/BCT/BAT limitations and NSPS water quality and other relevant factors. authorities associated with the EPA is promulgating for flow-through It also requires careful observation of treatment technologies it considered. and recirculating system facilities. actual feeding behavior, good record EPA notes that certain direct dischargers 1. BPT keeping, and on-going reassessment. that are not subject to today’s effluent After full examination of the data limitations or standards will still require After considering the technology supporting EPA’s model technology, a NPDES discharge permit developed on options described in the previous EPA has decided not to establish a case-by-case basis if they are CAAPs section and the factors specified in numerical TSS limitations. While the as defined in 40 CFR 122.24. section 304(b)(1)(B) of the CWA, EPA is model technology will effectively The new source performance establishing nationally applicable remove solids to a very low level, EPA’s standards (NSPS) EPA is today effluent limitations guidelines for flow- data show wide variability, both establishing represent the greatest through and recirculating system CAAP temporally and across facilities, in the degree of effluent reduction achievable facilities producing 100,000 pounds or actual TSS levels achieved. EPA thus through the best available demonstrated more of aquatic animals per year for the does not have a record basis for control technology. In selecting its reasons noted above at VIII.A. establishing numeric TSS limitations technology basis for today’s new source EPA based the final requirements on derived from its data set that are performance standards (NSPS), EPA production and operational controls that appropriate for all sites under all considered all of the factors specified in include a rigorously implemented feed conditions. EPA believes that CWA section 306, including the cost of management program. Programs of establishing a uniform numeric TSS achieving effluent reductions. EPA used production and operational controls that limitation would result in requirements the appropriate technology option for include feed management systems, that are too stringent at some sites and developing today’s standards for new proper storage of material and adequate not stringent enough at others. This is direct dischargers. The new source solids controls, and proper operation because feed management, while an technology basis for both subcategories and maintenance are in wide use at effective pollution reduction technology is equivalent to the technology bases existing flow-through and recirculating for this industry, is not amenable to the upon which EPA is setting BPT/BCT/ system facilities. Based on the detailed same level of engineering process BAT (see Chapter 9 of the EEBA). EPA survey results, EPA estimates that such control as traditional treatment has thoroughly reviewed the costs of programs are currently used at 61 flow- technologies used in other effluent such technologies and has concluded through and recirculating facilities out guidelines. The basis for this conclusion that such costs do not present a barrier of 242 total facilities. The costs of is further explained below. to entry. The Agency also considered effluent removals associated with the Clean Water Act sections 301(b)(1)(A) energy requirements and other non- evaluated practices are reasonable. The and 301(b)(2) require point sources to water quality environmental impacts for cost per pound of pollutant removed is achieve effluent limitations that require the new source technology basis and $2.77 as measured using the higher of the application of the BPT/BCT/BAT found no basis for any different the removals for either BOD or TSS at selected by the Administrator under standards from those selected for NSPS. each facility. (The removals for these section 304(b). Customarily, EPA Therefore, EPA concluded that the parameters are not summed because of implements this requirement through NSPS technology basis chosen for both possible overlap and double counting.) the establishment of numeric effluent

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limitations calculated to reflect the EPA’s decision not to set uniform could provide an incentive for facilities levels of pollutant removals that numeric TSS limitations based on to achieve the limit through dilution facilities employing those technologies rigorous feed management and good and would not reduce the pollutant can consistently achieve. EPA solids management is further supported loads discharged to receiving streams. traditionally uses a combination of by its analysis of measured or predicted While dilution is generally prohibited as sampling data and data reported in TSS concentrations at facilities a means of achieving effluent discharge monitoring reports from well- employing this technology. EPA’s limitations, this prohibition is harder to operated systems employing the model effluent monitoring data show enforce at CAAP facilities than in most technology to calculate numeric effluent differences in the measured TSS other systems because the flow of limitations. concentration in discharges at facilities culture water is dependent on a wide In the proposed rule and the NODA, employing feed management programs range of factors and is highly variable EPA used a similar approach to from the predicted TSS concentration from one facility to another. Thus it calculate numeric effluent limitations levels derived using EPA’s calculation would be impossible for regulatory for TSS from a partial data set composed from the data on feed used at BPT/BAT authorities to determine if water use of well operated CAAP facilities facilities. For this comparison, EPA was being manipulated to dilute TSS employing a combination of wastewater calculated a TSS concentration that concentration. Due to variations in treatment and management practices to could be achieved through feed water use from facility to facility, EPA reduce TSS concentrations in the management plans using the data on also decided not to establish mass-based discharged effluent. To reduce TSS feed and fish production at surveyed numeric TSS limitations on a national discharge levels, the facilities examined facilities. EPA then compared these basis. Solids control operational by EPA used settling ponds and a concentrations, where available, with measures such as feed management and number of different techniques, the actual TSS levels reported by those the requirement to focus on the proper including feed management programs facilities in their discharge monitoring operation of existing solids control and periodic solids removal from both reports. The differences between the structures are expected to achieve the culture water and settling ponds. calculated TSS levels and reported reductions in the TSS concentrations EPA’s examination of well-operated levels may result from differences in and at the same time reduce the TSS facilities also identified several facilities application of feed management loadings being discharged. This using feed management and other practices, variation in the flows or approach is supported by DMR data operational and management controls dilution of the effluent. from facilities in Idaho which have had alone that were achieving the same low EPA recognizes that it would be to comply with feed management BMP levels of TSS discharge as facilities feasible to calculate numeric effluent requirements in their general permit. using settling ponds in combination limitations for TSS based on treatment This data demonstrates that improved with good feed management. technologies alone, i.e., eliminating best performance can be achieved through Based on EPA’s examination of the management practices from the BMPs (DCN 63012). A comparison of data in its record, the Agency has technology basis for today’s rule. EPA DMR data from Idaho prior to the concluded that a combination of settling did not employ this approach for three technology and feed management issuance of a general permit in calendar reasons. First, EPA has determined that year 1999 with data following control practices or rigorous feed primary treatment in the form of management control and proper solids compliance with the general permit quiescent zones in the culture water indicates that 64 percent of the facilities handling practices alone will achieve tanks and settling ponds by themselves have reduced the TSS loads discharged low levels of TSS. Operational measures are not the best technology available for from the facility with an average TSS like a feed management system, treating TSS. Instead, rigorous feed reduction of 75 percent. however, are not technologies that management in conjunction with good reflect the same degree of predictability solids handling practices constitutes a For these reasons, EPA has expressed as can be expected from wastewater better technology for controlling this effluent limitations in this rule in the treatment technology based on chemical pollutant. Second, EPA is concerned form of narrative standards, rather than or other physical treatment. While EPA that establishing numeric limitations for as numeric values. EPA has a legal is confident that its chosen technology TSS based on primary and secondary authority to do so. The CWA defines can consistently achieve BPT treatment settling may not be a practicable ‘‘effluent limitation’’ broadly, and EPA’s levels of solids removal, the Agency technology. Commenters pointed out regulations reflect this as well. Each recognizes that feed management that site and land availability provides that an effluent limitation is systems may not have the precision or constraints might limit their ability to ‘‘any restriction’’ imposed by the consistently predictable performance install the additional treatment needed permitting authority on quantities, from site to site that come with the to achieve TSS limitations. Third, EPA discharge rates and concentrations of a traditional wastewater treatment believes based on its analysis of the pollutant discharged into a water of the technologies. The record confirms that data, that comparable discharge levels United States. CWA section 502(11) there is variability in results associated can be achieved using feed management (emphasis supplied); 40 CFR 122.2 with the use of feed management and other management practices alone (emphasis supplied). Neither definition systems and other operational measures as can be achieved using these practices requires an effluent limitation to be to control solids. Thus, EPA determined in combination with settling expressed as a numeric limit. The DC that it should not establish specific technologies. Thus, while settling Circuit observed, ‘‘Section 502(11) numeric TSS limitations based on the technology may be amenable to more defines ‘effluent limitation’ as ‘any model technology. This conclusion is precise control, EPA believes that the restriction’ on the amounts of supported by a number of commenters overall environmental benefits of this pollutants, not just a numerical who maintained that consistently technology relative to rigorous feed and restriction.’’ NRDC v. EPA, 673 F.2d achieving the proposed TSS levels solids handling management alone are 400, 403 (DC Cir.) (emphasis in would require installation of additional negligible. original), cert. denied sub nom. settling treatment structures, with little EPA is further concerned that Chemical Mfrs. Ass’n v. EPA, 459 U.S. additional environmental benefit. establishing a numeric limit for TSS 879 (1982). In short, the definition of

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‘‘effluent limitation’’ is not limited to a discharge of solids from the facility and that facilities repair this damage single type of restriction, but rather during these activities. promptly. EPA has not specified any contemplates a range of restrictions that The final rule also provides that design requirement for structural may be used as appropriate. EPA has facilities must remove dead fish and fish components of the CAAP facility. concluded that it is appropriate to carcasses from the production system on Rather, it has adopted the requirement express today’s BPT/BCT/BAT a regular basis and dispose of them to that facilities identify practices that will limitations in non-numeric form. These avoid the discharge to waters of the U.S. ensure existing structures are narrative limitations reflect a technology § 451.11(a)(3). EPA is establishing an maintained in good working order. demonstrated to achieve effective solids exception to this requirement when the Flow-through and recirculating facilities removals while still giving facilities permit writer authorizes a discharge to are also required to keep records as flexibility in determining how to meet benefit the aquatic environment. The described previously and to conduct them. following example explains one routine training for facility staff on spill Today’s BPT regulation requires circumstance in which a permit writer prevention and response. CAAP facilities to comply with could authorize such a discharge. There As discussed further below, in the specified operational and management are a number of federal, state, and tribal final rule, EPA is not establishing requirements—best management hatcheries that are raising fish for numeric limits for any drug or pesticide practices (BMPs)—that will minimize stocking or mitigation purposes. In some but is requiring CAAP facilities to the generation and discharge of solids cases, these facilities have been ensure proper storage of drugs, from the facility. These requirements are approved to discharge fish carcasses pesticides and feed to prevent spills and non-numeric effluent limitations based along with the live fish that are being any resulting discharge of spilled drugs on the technologies EPA has determined stocked. In these situations, the and pesticides. EPA is also establishing are BPT. carcasses are serving as a source of a requirement to implement procedures The final regulation requires adoption nutrients and food to the fish being for responding to spills of these of specified solids control practices. stocked in these waters. The exception materials to minimize their discharge would apply in these circumstances if from the facility. See§ 451.11(c)(2) of See, e.g., § 451.11(a) and § 451.21(a). the permitting authority determines that this rule. Facilities must also train their Thus, to control the discharge of solids the addition of fish carcasses to surface staff in spill prevention and proper from flow-through and recirculating water will improve water quality. operation and cleaning of production system facilities, the final rule requires Facilities must also implement systems and equipment. See § 451.11(e) minimizing the discharge of uneaten measures that address material storage of this rule. The detailed survey did not feed through a feed management and structural maintenance. In the case provide information about spill program. See § 451.11(a) of this rule. of material storage, EPA is requiring prevention, but during site visits and Complying with this limitation will facilities to identify and develop sampling visits EPA identified require a CAAP facility to identify practices to prevent inadvertent spillage containment systems and practices. feeding practices which optimize the of drugs, pesticides, and feed from the EPA’s site visit information indicated addition of feed to achieve production facility. § 451.11 (b). This would include that CAAP facilities currently employ a goals while minimizing the amount of proper storage of these materials. EPA is number of different measures to prevent uneaten feed leaving the rearing unit. also requiring facilities to identify spills and some have established in- Such a program should include proper procedures for cleaning, place systems to address spills in the practices such as periodic calibration of containing and disposing of any spilled event they occur. The effect of this automatic feeders, visual observation of material. EPA’s assessment, based on narrative limitation will be to promote feeding activity and discontinuation of site visits and sampling visits, indicates increased care in the handling of these feeding when the animals stop eating. that facilities may have varying degrees materials. Its adoption as a regulatory The rule also requires that CAAPs of spill prevention procedures and requirement provides an additional maintain records of feed inputs and containment and structural maintenance incentive for facility operators currently estimates of the numbers and weight of practices to address these requirements. employing effective spill control aquatic animals in order to calculate The final rule also includes a measures to continue such practices representative feed conversion ratios. requirement that facilities inspect and when handling drugs and pesticides. See § 451.11(a)(1) of this rule. provide regular maintenance of the Moreover, because EPA has adopted the Development of feed conversion ratios production system and the wastewater same requirements for existing and new is a key component in a properly treatment system to ensure that they are sources (see discussion below), this will functioning feed management system properly functioning. § 451.11(c). One ensure that new sources employ the because it allows the facility to calibrate area of concern addressed by this same highly protective measures as more accurately the feeding needs of the requirement is the potential existing sources have employed species being raised. This, in turn, will accumulation of solids (especially large successfully to protect against spills. result in further improvement in control solids such as carcasses and leaves) that Today’s regulation does not include of solids at the operation. could clog screens that separate the any requirements specifically In addition to feed management, EPA raceway from the quiescent zone. These addressing the release of non-native also requires flow-through and solids could prevent the flow of water species. The final regulation, however, recirculating system facilities to identify through the screen causing water to includes a narrative effluent limitation and implement procedures for routine instead flow over the screen and impair that requires facilities to implement cleaning. See § 451.11(a)(2). This will the passage of solids into the quiescent operational controls that will ensure the ensure that CAAP facilities develop zone. Proper maintenance should production facilities and wastewater practices to minimize the build-up and ensure that screens are regularly treatment structures are being properly subsequent discharge of solids from the inspected and cleaned. maintained. Facilities must conduct rearing units. The facility must also The final rule also requires that routine inspections and promptly repair identify procedures with respect to facilities conduct routine inspections to damage to the production systems or harvesting, inventorying and grading of identify any damage to the production wastewater treatment units. This fish so as to minimize disturbance and system or wastewater treatment system requirement, described in more detail in

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Section VI.D., will aid in preventing the those faced by existing sources. It is of water. Development of a system to release of various materials, including generally less expensive to incorporate capture the water and treat the water live fish. pollution control equipment into the within the pen would be prohibitively design at a new facility than it would be expensive. EPA, therefore, rejected 2. BAT to retrofit the same pollution control physical treatment systems as the basis EPA is establishing BAT at a level equipment in an existing plant. At a for BPT limitations. Instead, EPA is equal to BPT for the flow-through and new facility, no demolition is required promulgating narrative effluent recirculating system discharge and space constraints (which can add to limitations. subcategory. For this subcategory, EPA retrofitting costs if specifically designed As was the case with flow-through did not identify any available equipment must be ordered) may be less and recirculating systems, feed technologies that are economically of an issue. management programs are a key element achievable for the subcategory that of the promulgated requirements for the would achieve more stringent effluent C. What Are the Requirement for the Net reasons explained above and in the limitations than those considered for Pen Subcategory? proposal at 67 FR 57872, 57887. BPT. Because of the nature of the wastes The following discussion explains the Consequently, for the control of solids, generated from CAAP facilities, BPT/BAT/BCT limitations and NSPS the final regulation requires that net pen advanced treatment technologies or EPA is promulgating for Net Pen CAAP facilities minimize the practices to remove additional toxic or Systems. accumulation of uneaten feed beneath nonconventional pollutants that would 1. BPT the pen through the use of active feed be economically achievable on a monitoring and management practices. national basis do not exist beyond those After considering the technology § 451.21(a). These strategies may already considered. options described in the proposal and include either real-time monitoring (e.g., the factors specified in Section the use of video monitoring, digital 3. BCT 304(b)(1)(B) of the Clean Water Act, EPA scanning sonar, or upweller systems); EPA evaluated conventional pollutant is establishing nationally applicable monitoring of sediment quality beneath control technologies and did not effluent limitations for net pen facilities the pens; monitoring of the benthic identify a more stringent technology for producing 100,000 pounds or more of community beneath the pens; capture of the control of conventional pollutants aquatic animals per year. Today’s BPT waste feed and feces; or the adoption of for BCT limitations that would be regulations requires CAAP net pen other good husbandry practices, subject affordable than the final requirements systems, like CAAP flow-through and to the permitting authority’s approval. considered. Other technologies for the recirculating systems, to comply with As noted, feed management systems control of conventional pollutants specified operational practices and are effective in reducing the quantity of include biological treatment, but this management requirements. These uneaten feed. Facilities should limit the technology is not affordable for the requirements are non-numeric effluent feed added to the pens to the amount subcategory as a whole. Consequently, limitations based on technologies EPA reasonably necessary to sustain an EPA has not promulgated BCT has evaluated and determined are cost- optimal rate of fish growth. In limitations or standards based on a reasonable, available technologies. determining what quantity of feed will different technology from that used as Based on the detailed survey results, result in minimizing the discharge of the basis for BPT limitations and EPA estimates that such programs are uneaten feed while at the same time standards. currently in use at most or all the net sustaining optimal growth, a facility pen systems. As a result, the cost to should consider, among others, the 4. NSPS facilities of meeting the BPT following factors: The types of aquatic After considering the technology requirements is very low. To EPA’s animals raised, the method used to feed options described in the proposal and knowledge, all existing net pen facilities the aquatic animals, the facility’s NODA and evaluating the factors that are currently covered by NPDES production and aquatic animal size specified in section 306 of the CWA, permits are subject to permit goals, the species, tides and currents, EPA is promulgating standards of requirements comparable to today’s the sensitivity of the benthic community performance for new sources equal to limitations. Therefore, EPA concludes in the vicinity of the pens, and other BPT, BAT, and BCT. There are no more that the BPT limits are both technically relevant factors. In some areas, deep stringent technologies available for available and cost reasonable for the net water and/or strong tides or currents NSPS that would not represent a barrier pen subcategory. may prevent significant accumulation of to entry for new facilities, see Section IX EPA rejected the establishment of uneaten feed such that active feed for more discussion of the barrier to numeric effluent limitations for net pens monitoring is not needed. Several states entry analysis. Because of the nature of for obvious reasons. Because of the with significant numbers of net pens the wastes generated in CAAP facilities, nature of the facilities, net pens cannot (e.g., Washington, Maine) already EPA has not identified advanced use physical wastewater control systems require feed management practices, treatment technologies or practices to except at great cost. Located in open which may include active feed remove additional solids (e.g., smaller waters, nets are suspended from a monitoring, to minimize accumulation particle sizes) in TSS or other pollutants floating structure to contain the crop of of feed beneath the pens. Facilities will that would be generally affordable aquatic animals. Nets are periodically need to ensure that whatever practices beyond those already considered. changed to increase the mesh size as the they adopt are consistent with the EPA determined that NSPS equal to fish grow in order to provide more water requirements of their state NPDES BAT will not present a barrier to entry. circulating inside the pen. The pens are program. The overall impacts from the effluent anchored to the water body floor and In order to implement a feed limitations guidelines on new sources sited to benefit from tidal and current management system, the facility must would not be any more severe than action to move wastes away from, and also track feed inputs by maintaining those on existing sources. This is bring oxygenated water to, the pen. As records documenting feed and estimates because the costs faced by new sources a result, these CAAP facilities of the numbers and weight of aquatic are generally the same as, or lower than, experience a constant in- and out-flow animals in order to calculate

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representative feed conversion ratios. limitation, similar to that for CAAP pollutants that would be economically § 451.21(g). As previously explained, flow-through and recirculating systems, achievable on a national basis beyond development of feed conversion ratios requiring that net pen facilities those already considered. are a necessary element in any effective adequately train facility personnel in 3. BCT feed management system. how to respond to spills and proper Real-time monitoring represents a clean-up and disposal of spilled EPA evaluated conventional pollutant widely-used business practice that is material. See § 451.21(h) of this rule. control technologies and did not employed by many salmonid net pen Next, the final regulation requires identify a more stringent technology for facilities to reduce feed costs. Net pen regular inspection and maintenance of the control of conventional pollutants systems do not present the same the net pen § 451.21(f). This would for BCT limitations than the final opportunities for solids control as do include any system to prevent predators requirements considered. Consequently, flow-through or recirculating systems from entering the pen. Net pens are EPA has not promulgated BCT for the obvious reason that ocean water vulnerable to damage from predator limitations or standards based on a is continuously flowing in and out of attack or accidents that result in the different technology from that used as the net pens. Therefore, in EPA’s view, release of the contents of the nets, the basis for BPT limitations and feed monitoring, including real time including fish and fish carcasses. Given standards. monitoring and other practices is an the economic incentive to prevent the important and cost reasonable practice loss of production, EPA assumes 4. NSPS to control solids discharges. facilities will conduct routine After considering the technology The final rule includes a narrative inspections of the nets to ensure they requirements described previously limitation requiring CAAP net pen are not damaged and make repairs as under BPT, and the factors specified in facilities to collect, return to shore, and soon as any damage is identified. Most section 306 of the CWA, EPA is properly dispose of all feed bags, net pen facilities are already doing these promulgating standards of performance packaging materials, waste rope and inspections. However, in evaluating this for new sources equal to BPT, BAT, and netting. § 451.21(b). This will require technology option, EPA estimated costs BCT. There are no more stringent best that net pen facilities have the for increased inspections at every net demonstrated technologies available. equipment (e.g., trash receptacles) to pen facility in order to ensure that costs Because of the nature of the wastes store empty feed bags, packaging are not underestimated. generated and the production system materials, waste rope and netting until Like the final BPT limitations for used, EPA has not identified advanced they can be transported for disposal. flow-through and recirculating systems, treatment technologies or practices that EPA is also requiring that net pens the BPT limitations for net pens do not would be generally affordable beyond minimize any discharges associated include any requirements specifically those already considered. with the transporting or harvesting of addressing the release of non-native fish, including the discharge of blood, species. The final regulation, however, Although siting is not specifically viscera, fish carcasses or transport water includes a narrative effluent limitation addressed with today’s standards, containing blood. § 451.21(c). During that requires facilities to implement proper siting of new facilities is one stocking or harvesting of fish, some may operational controls that will ensure the component of feed management die. The final limitations require production facilities and wastewater strategies designed to minimize the facilities to remove and dispose of dead treatment structures are being properly accumulation of uneaten feed beneath fish properly on a regular basis to maintained. Facilities must conduct the pens and any associated adverse prevent discharge. Discharge of dead routine inspections and promptly repair environmental effects. When fish represents an environmental damage to the production systems or establishing new net pen CAAP concern because they may spread wastewater treatment units. EPA facilities, consideration of location is disease and attract predators, which included this requirement to ensure critical in predicting the potential could imperil the structural integrity of achievement of the other BPT impact the net pen will have on the the containment system. The wastes and limitations for net pens such as the environment. Net pens are usually wastewater associated with the prohibition on the discharge of feed situated in areas which have good water transport or harvest of fish have high bags, packaging materials, waste rope exchange through tidal fluctuations or BOD and nutrient concentrations and and netting at net pens, and the currents. Good water exchange ensures should be disposed of at a location requirement to minimize release of good water quality for the animals in the where they may be properly treated. solids, fish carcasses and viscera. This nets. It also minimizes the concentration The final regulations also require net requirement will also aid in preventing of pollutants below the nets. In pen facilities to ensure the proper the release of other materials including implementing today’s rule for new net storage of drugs, pesticides, and feed to live fish. pen operations, facilities and permit avoid spilling these materials and authorities should give careful subsequent discharge. See § 451.21(e)(1) 2. BAT consideration to siting prior to of this rule. Facilities must also EPA is establishing BAT at a level establishing a new net pen facility. implement procedures for properly equal to BPT for the net pen EPA has concluded that NSPS equal containing, cleaning and disposing of subcategory. For this subcategory, EPA to BAT does not present a barrier to any spilled material. See § 451.21(e)(2) did not identify any available entry. The overall impacts from the of this rule. As previously discussed, technologies that are economically effluent limitations guidelines on new excess feed may present a number of achievable that would achieve more source net pens are no more severe than different environmental problems. stringent effluent limitations than those those on existing net pens. The costs Preventing spills of feed is consequently considered for BPT. Because of the faced by new sources generally should important. Additionally, net pens may nature of the wastes generated from be the same as, or lower than, those use different pesticides and drugs in CAAP net pen facilities, EPA did not faced by existing sources. It is generally fish production. Preventing their release identify any advanced treatment less expensive to incorporate pollution is similarly important. The final technologies or practices to remove control equipment into the design at a regulation also includes a narrative additional toxic and nonconventional new facility than it is to retrofit the

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same pollution control equipment in an good husbandry practices that are prescribe extralabel drugs to treat existing facility. approved by the permitting authority. aquatic animals or other animals in accordance with FFCDA and 40 CFR Although EPA is not establishing E. What Are the Final Rule’s Part 530. This reporting requirement is standards of performance for new Notification, Recordkeeping, and promulgated to ensure that permitting sources for small cold water facilities Reporting Requirements? (i.e., those producing between 20,000 authorities are aware of the use at and 100,000 pounds of aquatic animals The final rule establishes CAAPs of extralabel drugs when such per year), such facilities would be requirements for reporting the use of use may result in the release of the drug subject to existing NPDES regulations spilled drugs, pesticides or feed that to waters of the U.S. Because the use is and BPT/BAT/BCT permit limits result in a discharge to waters of the likely to involve adding the drug developed using the permit writer’s U.S. by CAAP facilities. This provision directly to the rearing unit, EPA believes ‘‘best professional judgment’’ (BPJ). ensures that, any release of spilled there is a probability that these drugs EPA, based on its analysis of existing drugs, pesticides and feed to waters of may be released to waters of the U.S.. data, determined that new facilities the U.S. are reported to the permitting The regulation requires that a would most often produce 100,000 authorities to provide them with permittee must provide a written report pounds of aquatic animals or more per necessary information for any to the permitting authority within seven year because of the expense of responsive action that may be days of agreeing to participate in an producing the aquatic animals. warranted. This will allow regulatory INAD study and an oral report authorities to reduce or avoid adverse Generally, the species produced are preferably in advance of use, but in no impacts to receiving waters associated considered of high value and are event later than seven days after starting with these spills. EPA is requiring that produced in such quantities to to use the INAD. The first written report any spill of material that results in a economically justify the production. For must identify the drug, method of discharge to waters of the U.S. be example, one net pen typically holds application, the dosage and what it is reported orally to the permitting 100,000 pounds of aquatic animals or intended to treat. The oral report must authority within 24 hours of its more. In reviewing USDA’s Census of also identify the drug, method of occurrence. A written report shall be Aquaculture and EPA’s detailed application, and the reason for its use. submitted within 7 days. Facilities are surveys, EPA has not identified any Within 30 days after the use of the drug required to report the identity of the existing commercial net pen facilities at the facility, the permittee must material spilled and an estimated provide another written report to the producing fewer than 100,000 pounds of amount. permitting authority describing the aquatic animals per year. EPA is retaining for the final rule the drug, reason for treatment, date and Offshore aquatic animal production is proposed requirement that CAAP time of addition, method of addition an area of potential future growth. As facilities report to the Permitting and total amount added. these types of facilities start to produce Authority whenever they apply certain EPA has similar reporting aquatic animals, those with 100,000 types of drugs under the following requirements for extralabel drug use pounds or more per year will be subject conditions. First, the permittee must except that EPA is not requiring a to the new source requirements report drugs prescribed by a written report in advance of use. established for net pens as well as veterinarian to treat a species or a The reporting requirement applies NPDES permitting. disease when prescribed for a use which only to those drugs that have not been D. What Monitoring Does the Final Rule is not an FDA-approved use (referred to previously approved for their intended Require? as ‘‘extralabel drug use’’) as described use. Reporting would not be required for further below. Second, the permittee EPA registered pesticides and FDA The final rule does not require any must report drugs being used in an approved drugs for aquatic animal uses effluent monitoring. In the case of net experimental mode under controlled when used according to label pen facilities, however, it does require conditions, known as Investigative New instructions. Reporting would only be CAAPs to adopt active feed monitoring Animal Drugs (INADs). In EPA’s view, required for INAD drugs and drugs and management practices that will notifying the Permitting Authority is prescribed by a veterinarian for most often include measures to observe necessary to ensure that any potential extralabel uses. Because these classes of the addition of feed to the pen. Net pen risk to the environment resulting from drugs have not been fully evaluated by facilities subject to today’s rule must the use of these drugs can be addressed FDA for the potential environmental develop and implement active feed with site-specific remedies where consequences of the use being made of monitoring and management strategies appropriate. EPA strongly encourages them EPA considers reporting ensures to minimize the discharge of solids and reporting prior to use where feasible, as the permitting authority has enough the accumulation of uneaten feed this provides the Permitting Authority information to make an informed beneath the pen. Many existing net pen with the opportunity to monitor or response if environmental problems do facilities use a real-time monitoring control the discharge of the drugs while occur. EPA has included an exception to system such as video cameras, digital the drugs are being applied. EPA has not the reporting requirement for cases scanning sonar, or upweller systems to made this an absolute requirement, where the INAD or extralabel drug has accomplish this. With a real-time however, in recognition of the fact that already been approved under similar monitoring system, when uneaten feed swift action on the part of veterinarians conditions for use in another species or is observed falling beneath the pen and operators is sometimes necessary to to treat another disease and is applied feeding should stop. Depending on the respond to and contain disease at a dosage that does not exceed the location and other site-specific factors at outbreaks. approved dosage. The requirement that the facility, a facility may adopt other The reporting requirement applies to the use be under similar conditions is measures in lieu of real time the permittee and imposes no obligation intended to limit the exception to cases monitoring. These may include on the prescribing veterinarian. The where the INAD or extralabel drug use monitoring of sediment or the benthic reporting requirement for extralabel would be expected to produce community quality beneath the pens, drug use is not in any way intended to significantly different environmental capture of waste feed and feces or other interfere with veterinarians’ authority to impacts from the previously approved

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use. For example, use of a drug that had Today’s regulation does not include the time elapsed until the failure was been previously approved for a any requirements specifically repaired, an estimate of the types and freshwater application, as an INAD in a addressing the release of non-native amounts of materials released and the marine setting would not be considered species. The regulation, however, steps that will be taken to prevent a a similar condition of use, since marine includes a requirement for facilities to recurrence. Because the determination ecosystems may have markedly different develop and implement BMPs to ensure of what constitutes damage resulting in vulnerabilities than freshwater the production and wastewater a ‘‘material’’ discharge varies from one ecosystems. Similarly, the use of a drug treatment systems are regularly facility to the next, EPA encourages approved to treat terrestrial animals inspected and maintained. Facilities are permitting authorities to include more used as an INAD or extralabel drug to required to conduct routine inspections specific reporting requirements defining treat aquatic animals would not be and perform repairs to ensure proper these terms in the permit. Such considered a similar condition of use. In functioning of the structures. EPA conditions might recognize variations in contrast, the use of a drug to treat fish included this requirement to promote production system type and in a freshwater system that was achievement of BPT/BAT limitations on environmental vulnerability of the previously approved for a different the discharge of feed bags, packaging receiving waters. freshwater species would be considered materials, waste rope and netting at net Today’s regulation requires record- use under similar conditions. EPA has pens, and on the discharge of solids, keeping in conjunction with concluded that when a drug is used including fish carcasses and viscera at implementation of a feed management under similar conditions it is unlikely all facilities. This requirement, system. As previously explained, EPA is that the environmental impacts would described in more detail in Section requiring flow-through, recirculating be different than those that were already VI.D, will also aid in preventing the and net pen CAAP facilities subject to considered in the prior approval of the release of other materials, including live today’s regulation to keep records on drug. fish. feed amounts and estimates of the The reporting requirements with The final regulation also includes a numbers and weight of aquatic animals respect to INADs are not burdensome. requirement for facilities to report in order to calculate representative feed FDA regulations require that the failures and damage to the structure of conversion ratios. The feed amounts sponsor of a clinical investigation of a the aquatic animal containment system should be measured at a frequency that new animal drug submit to the Food leading to a material discharge of enables the facility to estimate daily and Drug Administration certain pollutants. EPA realizes that most CAAP feed rates. The number and weight of information concerning the intended facilities take extensive measures to animals contained in the rearing unit use prior to its use. Therefore, this ensure structural integrity is may be recorded less frequently as information will be readily available to maintained. Nonetheless, failures do appropriate. any CAAP facility that participates in an occur with potentially serious Flow-through and recirculating INAD investigation. Having advance consequences to the environment. The facilities subject to today’s requirements information will enable the permitting failure of the containment system can must record the dates and brief authority to determine whether result in the release of sediment, fish descriptions of rearing unit cleaning, restrictions should be imposed on the and fish carcasses which, depending on inspections, maintenance and repair. release of such drugs. the magnitude of the release, can have Net pen facilities must keep the same EPA is also requiring all CAAP significant impacts on the environment. types of feeding records as described facilities subject to today’s regulation to For net pen systems, failures include above and record the dates and brief develop and maintain a Best physical damage to the predator control descriptions of net changes, inspections, Management Practices plan on site. This nets or the nets containing the aquatic maintenance and repairs to the net pens. plan must describe how the permittee animals, which result in a discharge of IX. What Are the Costs and Economic will achieve the required narrative the contents of the nets. Damage Impacts Associated With This Rule? limitations. The plan must be available includes abrasion, cutting or tearing of This section discusses the costs and to the permitting authority upon the nets and breakdown of the netting economic impact of the rule request. Upon completion of the plan, due to rot or ultra-violet exposure. For promulgated today. the permittee must certify to the flow-through and recirculating systems, permitting authority that a plan has a failure includes a collapse or damage A. Compliance Costs been developed. of a rearing unit or wastewater treatment The information below describes the The proposal included a requirement structure; damage to pipes, valves, and rule’s costs and how EPA determined to implement escape prevention other plumbing fixtures; and damage or these costs. A more detailed discussion practices at facilities where non-native malfunction to screens or physical of how EPA estimated compliance costs species are being produced. EPA barriers in the system, which would is included in the Technical received comments supporting such prevent the unit from containing water, Development Document (EPA–821–R– controls to prevent the release of non- sediment, and the aquatic animals. In 04–012) and the discussion of the native species. EPA also received the event of a reportable failure as economic impacts is included in the comments arguing against controls in defined in the NPDES permit, EPA is Economic and Environmental Benefits this regulation because other authorities requiring CAAP facilities to report to the Analysis report (EPA–821–R–04–013). are already dealing with non-native permit authority orally within 24 hours Both of these documents can be found species, and because of the complexities of discovering a failure and to follow the on EPA’s Web site, www.epa.gov/ost/ of determining what is a non-native oral report with a written report no later guide/aquaculture. species and when such species may than seven days after the discovery of become invasive. For example, species the failure. The oral report must include 1. How Did EPA Estimate the Costs of raised by Federal and State authorities the cause of the failure and the materials Compliance With the Final Rule? for stocking may not be ‘‘native,’’ but that have likely been released. The EPA estimated costs associated with would not generally impose a threat if written report must include a regulatory compliance for the options it escapes occurred. description of the cause of the failure, considered to determine the economic

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impact of the effluent limitations feed management, materials storage (i.e., reported a range of FCRs of 0.79 to 1.80 guidelines and standards on the spill containment), structural with a median FCR of 1.30. If an aquaculture industry. The economic maintenance, recordkeeping, and individual facility’s reported FCR was impact is a function of the estimated training. For net pen facilities, the BMP significantly greater than the median, costs of compliance to achieve the plan must also document provisions for EPA further evaluated the facility to requirements. These costs may include complying with narrative limitations ascertain the reason for the higher FCR. initial fixed and capital costs, as well as related to waste collection and disposal, Facilities that produce larger fish, such annual operating and maintenance minimization of discharges associated as broodstock, might have higher FCRs (O&M) costs. Estimation of these costs with transport or harvest, and carcass because the larger fish produce less began by identifying the practices and removal. EPA found that the net pen flesh per unit of food. Facilities with technologies that could be used as a facilities responding to the detailed fluctuating water temperatures could basis to meet particular requirements. survey generally have operational also be less efficient than facilities with EPA estimated compliance costs for measures in place that address these constant water temperatures. EPA each facility, based on the specific requirements. assumed facilities lacking evidence of configuration of the facility as provided The costs associated with BMP plan good feed management practices (based in the detailed survey and the development include a one-time labor on the calculated FCR) would incur implementation of the practices or cost of 40 hours for management staff additional costs to improve or establish technologies to meet particular training and time to develop and write them. However, EPA did not apply costs requirements. the plan. The plan that EPA costed for feed management BMPs for facilities EPA developed cost estimates for included time for the manager to (1) with reasonable explanations for the capital, land, annual O&M, and one- identify all waste streams, wastewater higher FCRs because EPA assumed such time fixed costs for the implementation structures, and wastewater and manure facilities were already optimizing feed of the different best management treatment structures at the site, (2) input or would be able to do so at practices and treatment technologies identify and document standard reasonable cost. targeted under the regulatory options. operating procedures for all BMPs used EPA evaluated facilities that did not EPA developed the cost estimates from at the facility, and (3) define report FCRs or provide enough data for information collected from the detailed management and staff responsibilities an estimate by assigning each facility a survey, site visits, sampling events, for implementing the plan. EPA random FCR between the first and third published information, vendor contacts, assumed that each employee at a facility quartiles of the FCR distribution of the industry comments, and engineering would incur a one time cost of 4 hours group of facilities (i.e., combinations of judgment. EPA estimates compliance for initial BMP plan review. EPA ownership, species, and production costs in 2001 dollars that it converted to included an annual cost for four hours systems) where it was classified. For its 2003 dollars using the Engineering of management labor to maintain the analysis, EPA estimated target FCRs for News Record construction cost index. plan and eight hours of management each group as the 25th percentile value All costs presented in this section are labor and 4 hours for each employee for of the category. EPA used these target reported in pre-tax 2003 dollars, unless training and an annual review of BMP FCRs in its costing and loadings otherwise indicated. performance. EPA included the cost of analyses, but does not intend to set any The final regulation requires facilities developing solids control, spill specific FCR targets at facilities (see to adopt various management practices prevention, and structural maintenance DCN 62467). These facilities were to control pollutant discharges and components of the BMP plan in the assigned costs associated with feed incorporate these practices in a BMP estimates for all appropriate facilities. management BMPs in the same manner plan. The detailed survey provided EPA also included recordkeeping and as facilities with calculated FCRs. information on the use of BMPs at each training costs as a part of annual Costs for the feed management BMP surveyed facility. In its analyses, EPA operation and maintenance activities for component include staff time for estimated the costs associated with the BMP components. recordkeeping for feed delivery and implementing various types of BMPs. One part of the solids control daily feeding observations. Management As explained above, EPA has concluded component of the BMP plan is feed activities associated with the feed that BMPs are an effective tool for management. Based on feed and management practices were weekly data controlling pollutant discharges. EPA production data reported in the surveys, reviews of feeding records, regular assumed no additional costs for EPA evaluated the effectiveness of a estimates of changes to feeding regimes compliance for a facility for particular facility’s feed management programs. for each group of aquatic animals, and BMPs when the facility indicated that it EPA calculated feed conversion ratios staff consultations about feeding. For had comparable BMPs in place, or EPA (FCRs) using pounds of feed per pound facilities that reported using drugs or found strong evidence that such BMPs of live product. These calculated FCRs pesticides, EPA evaluated costs for (1) were already being implemented at the were compared for groups of facilities storage containment, (2) spill prevention facility. For example, facilities reporting (i.e., combinations of ownership, planning and training, and (3) reporting the use of drugs and pesticides that are species and production system types of INAD and extralabel drug uses. For located in Washington or Idaho were such as commercial trout flow-through storage containment, EPA evaluated the not costed for drug and pesticide BMPs facilities or government salmon flow- amount of product stored onsite and because the general permits in these through facilities). EPA found a wide estimated containment structure costs states require facilities to implement range of FCRs (reported by facilities in specifically for the facility. This capital BMPs related to drugs and pesticides their detailed surveys, which were cost was for the purchase of that are at least as stringent as these validated by call backs to the facility) commercially available drum storage required by today’s rule. among apparently similar facilities units and pesticide cabinets that will EPA is requiring each facility to within ownership-species-production contain spills in the event of leakage or develop a BMP plan that describes the system groupings. accidental spills. EPA also estimated the practices and strategies it is using to For example, EPA had good data for costs for management to develop a spill comply with narrative limitations 24 of 60 government trout producers prevention plan, which is included in addressing solids control, including using flow-through systems. They the facility BMP plan, and annual staff

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training at the facility (8 hours/year for a failure includes a collapse or damage regulation. EPA estimates that a total of managers and 4 hours/year for each of a rearing unit or wastewater treatment 242 facilities will be affected by today’s employee). EPA assumed that reporting structure; damage to pipes, valves, and final regulation. These counts include to the appropriate regulatory authority other plumbing fixtures; and damage or two non-profit flow-through facilities in would occur 6 times per year for malfunction to screens or physical Alaska producing 100,000 lb/year or facilities reporting using INAD or barriers in the system, which would more that did not receive a detailed extralabel drug uses. The reporting for prevent the unit from containing water, questionnaire. More information is each occurrence includes 20 minutes for sediment, and the aquatic animals. The provided in the rulemaking record (DCN an oral report and 1 hour for a written rule provides the permitting authorities 63065). Table IX–1 summarizes the report. EPA considers these costing may specify what constitutes damage estimated number and type of facilities assumptions to be conservative and may and/or a material discharge on a site- affected by the rule, based on the overstate actual reporting frequency. specific basis for the purposes of production threshold of 100,000 lb/year. In addition, EPA estimated costs for triggering the reporting requirement. These 242 facilities consists of 101 inspections in order to maintain the Based on available information related commercial facilities and 141 structural integrity of the aquatic animal to containment system failures in the noncommercial facilities; containment system. The costs include past, flow-through and recirculating noncommercial facilities include regular inspections of rearing units, facilities have had less incidences of Federal, state, Alaskan non-profit, and solids storage units, and drug/pesticide failures than net pen facilities. Tribal hatcheries. Of the 101 storage units. EPA considers the aquatic Therefore, EPA estimated that 10 commercial facilities, 32 are projected to animal containment system to include percent of the flow-through and be unprofitable prior to the final rule any physical barriers and practices used recirculating facilities would incur a (i.e., baseline closures) under cash flow to prevent the release of materials from cost associated with the reporting of the analysis. EPA did not identify any the containment system. For flow- failure whereas, for costing purposes, all academic/research facilities in the through and recirculating facilities, the net pen facilities were assumed to detailed questionnaire that produced containment system includes experience a failure. Again, EPA 100,000 lbs/yr or more. wastewater treatment, for example, believes these assumptions are quiescent zones or settling basins, in conservative and may overestimate the The estimated cost for this rule is $1.4 addition to the rearing units and storage frequency of reportable failures. million per year (pre-tax, 2003 dollars). units. For net pens, the containment EPA revised estimates for all labor Noncommercial facilities account for system includes the use of double nets costs using the employee and wage about 81 percent of the total cost of the or other techniques that may be used to information supplied in the detailed rule. These estimated total costs reflect deter predators. EPA also included costs surveys. For those facilities indicating aggregate compliance costs incurred by for reporting of structural failure or they use unpaid labor for all or part of facilities that produce 100,000 lb/year or damage to the containment system that the facility operation, or that did not more and will be affected by today’s results in a material discharge of supply useable wage information, EPA final regulation. EPA’s total cost pollutants to waters of the U.S. used average State or regional wages for estimates do not include costs that are For net pen systems, failures include both staff and management labor. incurred by the 32 commercial facilities physical damage to the predator control Separate estimates were used for that are considered baseline closures. To nets or the nets containing the aquatic commercial and non-commercial the extent that some projected baseline animals, which result in a discharge of facilities. closures remain open and incur costs the contents of the nets. Damage under this rule, despite analysis includes abrasion, cutting or tearing of 2. What Are the Total National Costs? showing unprofitability in the baseline, the nets and breakdown of the netting Tables IX–1 and IX–2 summarize national compliance costs, pollutant due to rot or ultra violet exposure. For numbers of affected facilities and total load reductions and potential benefits flow-through and recirculating systems, annualized costs for today’s final would be higher than projected.

TABLE IX–1.—ESTIMATED NUMBER OF AFFECTED FACILITIES WITH PRODUCTION 100,000 LBS/YR OR MORE

Estimated number of facilities (see note) Organization Baseline clo- Not baseline Total sures 1 closures 2

Commercial ...... 32 (28) 69 4 (69) 101 (97) Noncommercial 3 ...... NA (NA) 141 (141) 141 (141)

Total ...... 32 (28) 210 (210) 242 (238) Note: Numbers in (parentheses) are facilities that are determined not to be in compliance with final rule requirements at the time this final rule is signed by the EPA Administrator. NA: EPA does not determine closures for noncommercial facilities. 1 Projected baseline closures are estimated using cash flow analysis. When net income analysis is assumed for earnings, the number of com- mercial baseline closures increases to 43. Baseline closures would not be projected to incur costs for a new rule in accordance with EPA’s Guidelines for Preparing Economic Analyses (USEPA, EPA 240–R–00–003). Baseline closures (based on cash flow) are therefore not included in estimates of costs for this rule. 2 Total costs and economic impacts for this rule are estimated using incremental compliance costs incurred by the facilities that are not base- line closures and not in compliance with the rule at time of final signature (i.e., 210 facilities are expected to incur costs under this rule: 69 com- mercial and 141 noncommercial facilities). 3 Noncommercial facilities include those operated by States, Tribes, the Federal Government, and Alaskan Non-Profits. 4 Includes two facilities that are projected to be baseline closures using discounted cash flow analysis but are characterized by EPA as ‘‘Not Baseline Closures’’ due to unique facility-specific evidence associated with production, fish type, scale, and financial data (as outlined in DCN 20500 in the confidential record for this rule).

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TABLE IX–2.—NATIONAL COSTS: TOTAL BY SUBCATEGORY

Pre-tax annualized costs ($000, Production system Owner 2003 dollars) Final option

Flow-through and Recirculating Systems ...... Commercial ...... $256 Noncommercial 2 ...... $1,149 Net Pen ...... Commercial ...... $36 Noncommercial 2 ...... $0 Total pre-tax 1 ...... $1,442 Note: Totals may not sum due to rounding. 1 Total annual post-tax cost for the final option is $1,362. 2 Noncommercial facilities include those operated by State, Federal, Alaska nonprofit, and Tribal facilities.

B. Economic Impacts assuming a 7 percent real discount rate commercial facilities are baseline This section discusses the economic to account for the time value of money closures, assuming discounted cash effects associated with the final rule. and place earnings and costs on a flow for earnings. When EPA adopts net comparable basis. EPA considers that income as the basis for earnings, 1. How did EPA Estimate Economic the rule will result in a facility closure baseline closures are projected to be 43. Effects? if a facility shows (1) positive When EPA projects closures based on Existing Commercial Facilities. EPA discounted cash flow (or net income) negative earnings in one out of three uses several measures to evaluate without the rule and (2) negative forecasts, baseline closures are projected possible impacts on existing commercial discounted cash flow (or net income) to be 34. EPA notes that this type of facilities. These measures examine the with the rule for two out of three analysis identifies candidates for possibility of business closure and forecasting scenarios. The forecasting closure; information on facility-level corresponding direct impacts on methods give a range of trends: (1) costs and earnings may be too uncertain employment and communities and Optimistic or upward (USDA CPI Food to allow precise prediction of which indirect and national impacts associated at Home, Fish and Seafood Sector), (2) operations will actually close, in the with closures. EPA also evaluates pessimistic or downward (weighted absence of the rule. potential moderate impacts short of average, based on facility production, of In addition to its closure analysis, closure, as well as changes in financial USDA trout price data or U.S. EPA also prepared additional analyses health and borrowing capacity. Department of Labor, Bureau of Labor to assess potential effects, short of To evaluate impacts to commercial Statistics, Fish PPI, Producer Price closure, on existing businesses, facilities, EPA conducts a closure Index—Unprocessed and packaged fish, including an analysis of additional analysis that compares projected not seasonally adjusted), and (3) neutral moderate impacts using a sales test, an earnings, with and without cost of or no change (average of 1999–2001 evaluation of financial health using an compliance with the final regulation for earnings collected in the detailed approach similar to that used by USDA, the period 2005 to 2015. For this rule, questionnaire). In an effort to evaluate and an assessment of possible impacts EPA used discounted cash flow and net the effects of relying on two out of three on borrowing capacity. Use of these income to estimate earnings for closure forecasts to define closures, EPA also measures has the advantage that they analysis. The difference between cash analyzed closures using a more mirror analyses that investment and flow and net income is depreciation conservative assumption whereby lending institutions perform to evaluate (cash flow equals net income plus closures are defined as occurring when industries and businesses. depreciation). Analysis using net negative earnings are projected under First, to assess whether there are income is more likely to identify only one of three forecast scenarios. additional moderate impacts to baseline closures and could demonstrate EPA does not assess potential for facilities, EPA uses a sales test to additional regulatory closures closure under the rule if a facility is compare the pre-tax annualized cost of associated with the rule. Table IX–3.5 projected to have negative earnings the final rule to the revenues reported presents closure results obtained using under baseline conditions (i.e., baseline for facilities that passed the baseline both discounted cash flow and net closure). Baseline closures are defined closure analysis. EPA considers that income. All other analytical results (for as facilities that are projected to have facilities show additional moderate example, other measures of economic negative earnings under 2 or 3 of the impacts if they are not projected to close impacts, costs and benefits) presented in forecasting methods before they incur but incur compliance costs in excess of this final action reflect discounted cash pollution control costs (i.e., baseline 5 percent of facility revenue; this flow as the basis for earnings. EPA also closures). EPA’s standard methodology threshold is consistent with threshold examines the effects of attributing a when using forecasts in closure models values established by EPA in previous wage rate to unpaid labor and found is to use a ‘‘weight of evidence’’ regulations and is determined to be that imputing costs for unpaid labor and approach across a set of reasonable appropriate for this rulemaking. management would not change the assumptions regarding future industry Second, EPA calculates impacts on projected economic impacts of the rule. behavior. This allows EPA to recognize financial health at the company level Closure analysis assumes that (1) uncertainty in the forecasts without using USDA’s 2 × 2 matrix (i.e., four- producers are unable to pass on the placing undue emphasis on any one set level) categorization of financial health costs of incremental pollution control to of ‘‘timing and initial conditions’’. based on a combination of net cash consumer through higher prices and (2) Using this methodology, EPA income and debt/asset ratios. The costs and earnings are discounted determined that 32 out of 101 categories are favorable, marginal

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solvency, marginal income, and percent are assumed to signal potential commercial facilities that incur no land vulnerable. EPA considers any change ‘‘moderate’’ and ‘‘adverse’’ impacts, or capital costs, and (3) ratio of in financial health category as an impact respectively. EPA examines the ability incremental land and capital costs to of the rule. of State-owned hatcheries to recoup total company assets. The cost to asset Finally, EPA performs a credit test by compliance costs through increases in ratio is calculated using company data calculating the ratio of the pre-tax funding derived solely from user fees. because asset data were collected only annualized cost of an option and the All States and the District of Columbia at the company level; company impacts after-tax Maximum Feasible Loan have fishing license fees for residents. cannot be extrapolated to the national- Payment (MFLP) (i.e., 80 percent of The license fees are not raised every level because sampling weights are after-tax cash flow). EPA identified year even though costs increase through based on facilities, not companies. EPA companies with a ratio exceeding 80 inflation. Instead, when fees are raised calculates the ratio for each company percent of MFLP as being impacted by or a fish stamp instituted, the and uses the average of the ratios. More this rule (i.e., the test threshold is incremental or new fee is usually a information is provided in the therefore actually 64 percent of the round number such as $3, $5, or $10. A Economic and Environmental Impact after-tax cash flow). $3 to $5 hike in State fishing license Analysis available in the rulemaking For the purposes of EPA’s analysis, fees translates into an increase in fees of record. the Agency assumes (1) no growth in about 20 percent to 35 percent. 2. What Are the Results of the Economic production to offset incremental costs Although all States report having fishing Analysis? and (2) that the costs of the rule are not license fees, if a state hatchery reports passed on to consumers. The facility no funding from user fee sources, EPA Existing Commercial Facilities. Table must absorb all increased costs. If it considers that facility to be unable to IX–3 shows the impacts on commercial cannot do so and remain in operation, recoup increased costs through operations from today’s regulation. As all production is assumed lost. EPA’s increased funding from user fees. shown, EPA projects no facility closures assumption of no cost pass through is a More detailed information is provided as a result of the final rule under the conservative approach to evaluating in the Economic and Environmental cash flow analysis. No closures are economic achievability among regulated Benefit Analysis and the rulemaking projected for enterprises or companies. entities. To evaluate market and trade record. Correspondingly, there are no level impacts, EPA assumes all costs are New Commercial Facilities. To assess employment and other direct and shifted onto the broader market level as effects on new businesses, EPA’s indirect impacts estimated for this rule a way of assessing the upper bound of analysis considers the barrier that as a consequence of closures using cash potential impacts. compliance costs due to the effluent flow analysis and negative earnings in The Economic and Environmental guidelines regulation may pose to entry two of three forecast scenarios. When Benefit Analysis, available in the into the industry. In general, it is less the closure analysis is conducted using rulemaking record, provides more detail costly to incorporate waste water net income as a basis for earnings, EPA on EPA’s analysis (DCN 63010). treatment technologies as a facility is projects two closures out of 58 Noncommercial Facilities. For today’s built than it is to retrofit existing commercial facilities (see Table IX–3.5). final rule, EPA collected information on facilities. Therefore, where a rule is When the closure analysis is conducted how U.S. Fish and Wildlife Service and economically achievable for existing using only one of three forecast State agencies make decisions about facilities, it will also be economically scenarios, EPA also identifies two operating or closing public hatcheries. achievable for new facilities that can closures out of 67 commercial facilities EPA confirmed that public hatcheries meet the same guidelines at lower cost. (see Section IX.B.1 for discussion of close; the U.S. Fish and Wildlife Service Similarly, even where the cost of forecast methods). Based on these hatchery system once had as many as compliance with a given technology is results, EPA concludes that the final 250 hatcheries and it now operates not economically achievable for an rule option is economically achievable. fewer than 90 facilities. Closures may existing source, such technology may be EPA notes that all other analytical result from funding cuts (e.g., Mitchell less costly for new sources and thus results (for example other measures of Act Funds and the Willard National have economically sustainable costs. It economic impacts, costs) presented in Fish Hatchery or General Funds for is possible, on the other hand, that to this final action reflect discounted cash State Hatcheries) or revision of a the extent the up-front costs of building flow as the basis for earnings; EPA’s program’s mission and goals (e.g., a new facility are significantly increased analyses indicate that use of net income increase focus on endangered species as a result of the rule, prospective will not materially change results. versus provision of recreational builders may face difficulties in raising EPA expects some operations will services). Closures may also result from additional capital. This could present a incur moderate impacts, short of water quality impacts associated with barrier to entry. Therefore, as part of its closure, based on an analysis that shows aquaculture activities. The costs of analysis of new source standards, EPA that some operations will incur upgrading pollution control at public evaluates barriers to entry. If the compliance costs in excess of 5 percent hatcheries are not generally the primary requirements promulgated in the final of annual revenue. For the final reason for closure, but costs may tip the regulation do not give existing operators regulation, 4 of 69 commercial facilities balance of a particular hatchery toward a cost advantage over new source incur costs greater than 5 percent of a closure decision. See the Economic operators, then EPA assumes new sales, affecting about 5 percent of and Environmental Benefits Analysis source performance standards do not regulated facilities in the flow-through (DCN 63010) for more details. present a barrier to entry for new and recirculating subcategory; no In the absence of well defined tests for facilities. additional facilities have costs projecting public facility closures, EPA EPA’s analysis includes all exceeding 3 percent of revenues. No compares pre-tax annualized commercial facilities within scope of commercial facilities have costs that compliance costs to 2001 operating the rule, including those that are exceed 10 percent of annual revenue. budgets for public facilities (‘‘Budget baseline closures. EPA examines the (1) EPA’s analysis shows no expected Test’’). For the purposes of this analysis, proportion of commercial facilities that change in financial health. One costs exceeding 5 percent and 10 incur no costs, (2) proportion of company fails the USDA credit test as

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a result of the final regulation. These the final option. Under EPA’s assumed facility is projected to incur costs greater results are based on data from criteria for determining economic than 3 percent of revenues. companies represented in the Agency’s achievability, these operations may be Given that the results of EPA’s detailed questionnaire. These results vulnerable to closure. analysis project that a small share of further support EPA’s conclusion that Twelve facilities incur costs regulated noncommercial facilities may the final options are economically exceeding 5 percent of annual budgets incur costs exceeding 10 percent of achievable for commercial facilities (and under the final rule. These results budget, estimated at 3 percent of companies). More information is indicate that an additional 6 percent of facilities, the Agency has determined provided in the Economic and that these final technology options to be all non-commercial operations (not Environmental Benefit Analysis economically achievable for counting those adversely affected) available in the rulemaking record (DCN noncommercial facilities. For more would experience some moderate 63010) information, see the Economic and impact, short of closure, associated Noncommercial Facilities. Table IX–3 Environmental Benefit Analysis under this final rule. Some of these also shows the impacts on available in the rulemaking record. noncommercial operations from today’s facilities report the use of user fees New Commercial Facilities. EPA regulation. Four facilities incur costs revenues, implying potential flexibility estimated that about 4 percent of exceeding 10 percent of budget. EPA in meeting the incremental costs. regulated facilities do not incur any assumes that those facilities that face No in-scope Alaskan nonprofit costs under the final regulation, and costs exceeding 10 percent of their facilities responded to EPA’s detailed about 76 percent of facilities incur no budget would be adversely affected by questionnaire, but EPA did identify two land or capital costs. The incremental the final regulation. None of these in-scope facilities based on screener land and capital costs, where they were facilities report the use of user fee data. These facilities were costed using incurred, represented less than 0.2 funds. These results indicate that 3 screener data and economic impacts percent of total assets. This final percent of all non-commercial were projected based on publicly regulation should therefore not present operations may be adversely affected by available revenue data for 2001. Neither barriers to entry for new businesses.

TABLE IX–3.—ECONOMIC IMPACTS: EXISTING COMMERCIAL & NONCOMMERCIAL OPERATIONS

Number of in- Impacts pro- Threshold test scope facilities jected under in the final option Analysis 1

Commercial Operations

Closure Analysis (discounted cash flow) 2 ...... 69 0 Sales test >3% (facility level) ...... 69 4 Sales test >5% (facility level) ...... 69 4 Sales test >10% (facility level) ...... 69 0 Change in Financial Health (Company level) 3 ...... 34 0 Credit test >80% (Company level) 3 ...... 34 1

Noncommercial Facilities 6

Budget test >3% (all facilities) ...... 141 19 State owned only (# with user fees) 5 ...... 106 12 (8) Federal owned only ...... 33 7 Alaskan Non-Profit 4 ...... 2 0 Budget test >5% (all facilities) ...... 141 12 State owned only (# with user fees) 5 ...... 106 8 (8) Federal owned only ...... 33 4 Alaskan Non-Profit 4 ...... 2 0 Budget test >10% (all facilities) ...... 141 4 State owned only (# with user fees)5 ...... 106 0 (0) Federal owned only ...... 33 4 Alaskan Non-Profit 4 ...... 2 0 Source: Estimated by USEPA using results from facility-specific detailed questionnaire responses, see Chapter 3. 1 There are 101 in-scope commercial facilities, represented by 34 unweighted companies. Of the 101 facilities, 32 are baseline closures, as- suming cash flow analysis, leaving 69 commercial facilities that can be analyzed. Closure analysis and sales test are performed at facility level; financial health and credit tests performed at company level; and all noncommercial tests performed at facility level. 2 Closure analysis results obtained using discounted cash flow and closure defined as negative earnings in two of three forecast scenarios. See Table IX–3.5 for results under different assumptions. 3 Analysis performed at the company level. The statistical weights, however, are developed on the basis of facility characteristics and therefore cannot be used for estimating the number of companies. 4 Two Alaska non-profit organizations are within the scope of this rule, but did not receive a detailed survey. They were costed using screener survey data. Economic impacts were calculated using publically available information. 5 Some State-owned facilities reported that they relied, in part, on funds from State user fee operations. These numbers are reported in paren- thesis and are included in the overall numbers as well. 6 There is a potential for a small number of Tribal facilities to be present within the population of non-commercial facilities, despite the absence of a line item for Tribal facilities above. In its screener survey which was a census of the industry, EPA identified a number of Tribal facilities that might be subject to the proposed rule for the CAAP category (DCN 51401). However, all of the tribal facilities represented by the detailed survey were determined to not be in scope.

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Because the detailed survey is a that have not been analyzed. As part of costly than the final option). These sample, there is uncertainty associated the analyses conducted prior to the results are for facilities that are not with the conclusion that there are no NODA, based on the screener data, EPA within the scope of the final rule, but tribal facilities in scope for the final estimated impacts for tribal facilities they provide evidence that the final rule rule. For this reason, EPA believes there producing between 20,000 and 100,000 is expected to be economically may be a few in-scope tribal facilities pounds per year for Option B (more achievable for tribal facilities.

TABLE IX–3.5.—CLOSURE ANALYSIS FOR COMMERCIAL FACILITIES UNDER DIFFERENT ASSUMPTIONS

Number of in- Closures pro- scope facilities jected under in the final option analysis 1

Closure Analysis (discounted cash flow) 2 ...... 69 0 Closure Analysis (Net Income) 2 ...... 58 2 Closure Analysis (one out of three forecasts) 3 ...... 67 2 1 There are 32, 43, and 34 baseline closures projected under discounted cash flow, net income and one out of three forecasts respectively. Baseline closures are not analyzed for regulatory closure and therefore subtracted from the 101 in-scope facilities. 2 Discounted cash flow and net income are two different assumptions used to estimate earnings under closure analysis (see Section IX.B.1 for details). Closures defined as occurring when negative earnings are projected under at least two of three forecast methods. 3 Analysis assumes earnings estimated using cash flow and closure defined, more conservatively, as occurring when negative earnings are projected under only one of three forecast methods.

3. What Are the Projected Market Level 4. What Are the Potential Impacts on of this rule, assuming discounted cash Impacts? Foreign Trade? flow (two closures are projected using Foreign trade impacts are difficult to net income as shown in Table IX–3.5), EPA was not able to prepare a market indicating minimal likelihood of predict, since agricultural exports are model analysis for this rule because of measurable impacts on (1) direct losses determined by economic conditions in the complex interaction between in commercial production, revenue, or foreign markets and changes in the commercial and non-commercial employment; and (2) local economies international exchange rate for the U.S. operations (e.g., trout are raised and employment rates. Should some dollar. In addition, for today’s final rule, commercially, but also for restoration facilities cut back operations as a result EPA was not able to perform a market of this final regulation, EPA cannot and recreation), wild catch accounts for model analysis for this rule and did not project how great these impacts would a large share of the market for some obtain quantitative estimates of changes be as it cannot identify the communities species, and USDA Census data indicate in overall supply and demand for that there is a high degree of where impacts might occur. Under a aquaculture products and changes in scenario that assumes the total costs of concentration of specific species, such market prices, as well as changes in as trout and some other food fish. the rule are absorbed by the domestic traded volumes including imports and market, EPA estimates that U.S. Literature on estimated measures of exports. elasticity of supply and demand is aquaculture prices would rise by Nevertheless, EPA believes that the slightly more than 1 cent per pound. limited and exist for only a few species, impact of this final rule on U.S. (See EPA’s Economic and such as catfish which are not covered by aquaculture trade will not be significant. Environmental Benefit Analysis.) this regulation. The Agency does Because of the relatively small market Closures of non-commercial facilities therefore not report quantitative share of U.S. aquaculture producers in could also result in employment estimates of changes in overall supply world markets, EPA believes that long- impacts on communities. EPA projects and demand for aquaculture products term shifts in supply associated with four noncommercial facilities, with a and changes in market prices. For more this rule are unlikely given expected total employment of 16 employees information, see Chapter 3.6 of the continued competition from domestic could experience impacts such that they Economic and Environmental Benefit wild harvesters and already lower-cost would be vulnerable to closure (i.e., Analysis for the proposed rulemaking foreign suppliers in China and other costs exceed 10 percent of annual available in the docket (DCN 63010). Asian nations. Under a scenario that budget). The communities in which However, EPA does not expect assumes the total costs of the rule are these facilities are located could significant market impacts as a result of absorbed by the domestic market, EPA experience moderate impacts, but, as today’s final rule because economic estimates that U.S. aquaculture prices noted in Section IX.B.2, environmental impacts are expected to be low (see would rise by slightly more than 1 cent compliance costs are generally a per pound. Under the alternative discussion above) and the overall cost of contributing rather than the deciding assumption that all costs are born by the rule is low, as compared to the total factor in closure decisions. EPA facility operators, impacts are projected value of the U.S. aquaculture industry. therefore does not expect significant to be small and would not significantly impacts on communities as a result of Long-term shifts in supply associated affect production (see Section IX.B.2). today’s final rule. with this rule are unlikely given expected continued competition from 5. What Are the Potential Impacts on C. What Do the Cost-Reasonableness domestic wild harvesters and low-cost Communities? Analyses Show? foreign suppliers. For additional The communities where aquaculture EPA performed an assessment of the information, see the Economic and facilities are located may be affected by total cost of the final rule relative to the Environmental Impact Analysis the final regulation if facilities cut back expected effluent reductions. EPA based available in the rulemaking record. operations. However, EPA projects no its ‘‘cost reasonableness’’ (CR) analysis commercial facility closures as a result on estimated costs, loadings, and

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removals. See EPA’s Development option. Because BOD can be correlated reasonableness is undefined for the Net Document in the rulemaking record for with TSS, EPA selected the higher of the Pen Subcategory systems because these additional details. two values (not the sum) to avoid facilities have adequate treatment to Table IX.4 shows the cost- possible double-counting of removals. achieve requirements for pollutants (i.e., reasonableness values for conventional For the Flow-through and Recirculating no incremental removals are estimated pollutants. EPA estimates BOD and TSS Systems Subcategory, cost- for these facilities). removals for each facility for each reasonableness is $2.77/lb. Cost-

TABLE IX–4.—COST-REASONABLENESS: BOD OR TSS

Pre-tax BOD or TSS Cost-reason- annualized ableness Subcategory costs removals 1 ($2003/pound) ($2003) (lb)

Flow-through and Recirculating Systems ...... $1,405,866 506,839 $2.77 Net pen ...... $35,640 0 Undefined 1 EPA determines the higher of BOD or TSS mass removal for each facility and then aggregates pounds across facilities. Undefined: Facilities in this group are not projected to achieve incremental removals of the pollutants in this table (i.e., no incremental remov- als are estimated).

X. What Are the Environmental metals and some feed contaminants as B. Non-Monetized Benefits Benefits for This Rule? a result of these final requirements. EPA 1. Metals and Other Additives and A. Summary of Environmental Benefits could not quantify baseline or regulated Contaminants loads for drugs and pesticides. Today’s final action does not establish CAAP facilities may release metals numeric limits for total suspended These requirements and loading and other feed additives and solids (TSS) or other pollutants from reductions (TSS, TN, TP, BOD, metals, contaminants to the environment in flow-through and recirculating systems. and feed contaminants) could affect limited quantities; proper management It establishes BMPs for solids control, water quality, the uses supported by of solids and other management materials storage, structural varying levels of water quality, and practices may reduce environmental maintenance, recordkeeping, and other aquatic environmental variables risk from these releases. Trace amounts training. The final rule also requires the (e.g., primary production and of metals are added to feed in the form permittee to develop a BMP plan on-site populations or assemblages of native of mineral packs to ensure that the describing how the permittee will organisms in the receiving waters of essential dietary nutrients are provided. achieve the BMP requirements and regulated facilities). These impacts may In general, FDA establishes safety limits make the plan available to the result in environmental benefits, some for feed additives and must address permitting authority upon request. The of which have quantifiable, monetizable environmental safety concerns facilities are also to maintain the value to society. For today’s final action, associated with such additives under structural integrity of the aquatic animal EPA has only monetized benefits from the requirements of the Federal Food, containment system. The final rule also water quality improvements resulting Drug, and Cosmetic Act (FFD&CA) and establishes BMP requirements for net from reductions in TSS, TN, TP, and National Environmental Policy Act pen systems that address feed BOD. (NEPA). Trace amounts of metals may management, waste collection and also be present as feed contaminants. disposal, discharges associated with TABLE 1.—SUMMARY OF ENVIRON- Metals may also be introduced into the transport and harvest, carcass removal, MENTAL BENEFITS OF FINAL RULE environment from CAAP machinery, materials storage, structural equipment, and structures (e.g., net pens maintenance, recordkeeping, and treated with antifouling copper Type of benefit Monetized value training. Net pen facilities are to ($2003) compounds). Other feed additives may develop and maintain a BMP plan on- include FDA-approved compounds used site describing how the permittee is to Improved water qual- $66,000–$99,000 to improve the coloring of fish flesh. achieve the BMP requirements. The ity from reduced Organochlorine contaminants such as permittee must make the plan available TSS, TN, TP, and polychlorinated biphenyls (PCBs) also to the permitting authority upon BOD loadings due may be present as trace residues request. Both the flow-through and to improved solids regulated by FDA in some fish feeds. control, including recirculating and net pen subcategories feed management EPA estimates that today’s final rule have reporting requirements for (1) the Reduced inputs to re- not monetized will reduce total suspended solids (TSS) use of INADs and extralabel drugs use, ceiving water of released by CAAP facilities by about (2) failure or damage to the structural metals and feed half a million pounds per year. Metals integrity of the aquatic animal contaminants and other feed contaminants that may containment system, and (3) spills of Reduced inputs of not monetized be released to the environment from drugs, pesticides and feed which result drugs and pes- CAAP facilities are in large part in discharge of pollutants to waters of ticides associated with waste solids. EPA the U.S. The requirements, according to Reduced inputs of not monetized estimates that reductions in TSS will be EPA loadings estimates, will reduce materials as a re- accompanied by incidental removals of facility discharges of TSS, total nitrogen sult of structural metals and PCBs. EPA estimated metal (TN), total phosphorus (TP), and maintenance and reductions of approximately 2,700 material storage re- biochemical oxygen demand (BOD). quirements pounds per year nationally and a EPA has also estimated reductions for maximum of PCB reductions of 0.04 lbs

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per year. For further discussion of C. Monetized Benefits categories for which case studies were metals and other feed additives and not developed. Benefits for these 1. Case Study Framework contaminants, see the Economic and categories are expected to be small Environmental Impact Analysis and As was done for EPA’s proposed rule, relative to those included in the Technical Development Document for EPA estimated monetized benefits of the analysis. The total national benefit this final rule (DCNs 63010 and 63009). regulation based on predicted estimate was estimated as the sum of improvements in water quality in the benefits for all categories. 2. Drugs and Pesticides receiving waters of facilities that were CAAP facilities employ drugs and expected to have load reductions as a 2. Economic Valuation Method pesticides for a variety of therapeutic result of the rule. EPA’s water quality Economic research indicates that the and water treatment purposes. Facilities modeling for today’s final action differs public is willing to pay for release treated waters that may contain from the proposal modeling, however, improvements in water quality and residual amounts of drugs, pesticides, in that for the final rule, more detailed, several methods have been developed to and their byproducts directly to the facility-specific operational and translate changes in water quality to environment. Drugs used for therapeutic environmental data were obtained, both monetized values, as noted in EPA’s purposes are regulated by FDA. Prior to from information provided by facilities ‘‘Guidelines for Preparing Economic approving drugs for use, FDA must on the detailed surveys as well as other Analyses (EPA–240–R–00–003, 2003;). evaluate the environmental safety of sources. This more detailed data At proposal, EPA based the water animal drugs as required by FFDCA and provided EPA with a better basis for quality benefits monetization on results NEPA. While FDA is required to developing representative case studies from a stated-preference survey consider environmental impacts of on which to perform water quality conducted by Carson and Mitchell approved and investigational drugs modeling and valuation and for (1993) (DCN 20157). We divided under these authorities, the extrapolating from case studies to a household willingness-to-pay (WTP) environmental safety of drugs used national benefit estimate. values for changes in recreational water under FDA’s ‘‘investigational new To select a set of representative case ‘‘use classes’’ by the number of ‘‘water animal drug’’ (INAD) program may not studies from among the facilities for quality index’’ points (an index based be fully characterized. The INAD which EPA had detailed data, EPA on water quality variables; see below) in program is an important mechanism assumed that three factors primarily each use class. We assigned a portion of that enables the collection of data that drive water quality improvements at any the value for each unit change to can be used to characterize and given facility: (1) The magnitude of achieving the whole step. Recently, EPA establish the environmental safety of pollutant load reductions under the developed an alternative approach, also new drugs. For compilations of final rule, (2) effluent pollutant based on Mitchell and Carson’s work. technical literature supporting FDA’s concentrations at baseline (prior to Mitchell and Carson also expressed environmental assessments of regulatory reductions), and (3) the ratio their results as an equation relating a therapeutants used at CAAP facilities, of facility effluent flow to receiving household’s WTP for improved water see the FDA’s Center for Veterinary water streamflow (‘‘dilution ratio’’). EPA quality to the change in the water Medicine (CVM) Web site then created categories based on quality index and household income. (www.fda.gov/cvm). It should be noted combinations of values (low and high) An important feature of this approach is that FDA environmental assessments are for each of these factors. For example, that it is less sensitive to the baseline not site-specific and may not cover all the ‘‘LLL’’ category means facilities with use of the water body. This approach is discharge scenarios (e.g., multiple ‘‘low’’ pollutant reductions under the also consistent with economic theory in dischargers to a single receiving water) final rule, ‘‘low’’ baseline effluent that it exhibits a declining marginal or applications (e.g., extralabel concentrations, and ‘‘low’’ dilution WTP for water quality (see more applications of drugs). For additional ratios; this category is expected to information on this approach in DCNS discussion of this topic, see Chapter 7 experience the smallest benefits of the 40138 and 40595). While caution must of EPA’s Environmental Impact final regulation. In this manner, eight be used in manipulating valuations Analysis for this final rule. categories were created (LLL, LLH, LHL, derived from stated preference surveys, Today’s final rule requires the proper LHH, HLL, HLH, HHL, HHH; see Table this valuation function approach helps storage of drugs, pesticides, and feed to 2). EPA then assigned all detailed address some concerns about earlier prevent spills that may result in a survey facilities with non-zero load applications of the water quality discharge from CAAP facilities. For reductions in the scope of the final rule benefits monetization method. (See DCN reasons explained in Section VI.G to an appropriate category based on the 40595 for a more detailed discussion). (Loadings) of this Preamble, EPA has three factors described above. For more not quantified expected reductions in details on the categorization procedure, 3. Water Quality Modeling the release of drugs and pesticides to the see Chapter 8 of the Economic and As was done for the proposed rule, environment nor environmental benefits Environmental Impact Analysis for EPA applied the Enhanced Stream that might result. Today’s final rule also today’s final action [DCN 63010]. Water Quality Model (QUAL2E, http:// requires CAAP facilities to report to EPA then developed a ‘‘case study’’ www.epa.gov/waterscience/wqm/) to permitting authorities whenever an for one facility in each of the five simulate changes in receiving water investigative drug or an extralabel drug categories expected to experience the quality resulting from reductions in is used in amounts exceeding a greatest water quality improvement TSS, BOD, total nitrogen, and total previously approved dosage, as (EPA did not develop case studies for all phosphorus estimated by EPA to result described above in Section VIII.E. This categories partly because of resource from the regulatory requirements of this requirement is expected to better enable constraints). EPA multiplied the final rule. QUAL2E is a one- permitting authorities to monitor the estimated benefits for each case study dimensional water quality model that potential for environmental risks that by the total number of facilities assigned assumes steady state flow but allows could result from such uses. EPA has to that category to estimate a total simulation of diurnal variations in not quantified benefits that might arise national benefit for that category. No temperature, algal photosynthesis, and as a result of this requirement. benefits were estimated for the three respiration. The model projects water

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quality by solving an advective- dimensions of water quality. Analysis presently estimated for the industry. For dispersive mass transport equation. using monetization methods that fully additional details about air emissions Water quality constituents simulated captures non-use values could increase from CAAP facilities, see Chapter 11 of include conservative substances, the estimated benefits for this rule if it the TDD. temperature, bacteria, BOD , DO, significantly affects these dimensions. 5 B. Energy Consumption ammonia, nitrate and organic nitrogen, EPA does not have enough information phosphate and organic phosphorus, and to determine if this is the case. EPA estimates that implementation of algae. • Other receiving water impacts are today’s rule would result in a net Resource and data limitations not captured in the QUAL2E modeling, decrease in energy consumption for constrained the number of QUAL2E such as build-up of organic sediments in aquaculture facilities. The decrease applications that could be performed. stream channels. Research included in would be based on electricity used EPA developed a QUAL2E case study the administrative record for today’s today to pump solids from raceways to for the following categories: LHL, LHH, final action documents that such solids settling ponds, which will no HLH, HHL, and HHH. EPA did not accumulations can impair aquatic longer be generated, from wastewater prepare case studies for the LLL, LLH, ecosystems. Benefits from reducing treatment equipment. EPA determined and HLL categories because (a) no these effects are not captured in EPA’s that the decrease in energy consumption facilities were in the HLL category and analysis of water quality-based benefits for flow-through and recirculating (b) EPA focused modeling resources on of today’s final action. systems is estimated at 4,900 kilowatt- categories expected to represent a larger hour (kW-h). This represents about 1.3 proportion of benefits. Water quality TABLE 2.—EXTRAPOLATED TOTAL NA- × 10¥7 percent of the national generated improvements for facilities in the LLL TIONAL WATER QUALITY BENEFIT energy. and LLH categories were expected to be ESTIMATE, FINAL OPTION smaller than the improvements for the C. Solid Waste Generation facilities in the other categories. B EPA estimates that implementation of Total national today’s rule would result in an 4. Calculation of ‘‘Water Quality Index’’ A benefit for ex- estimated reduction of 2.3 million Extrapolation category trapolation cat- Simulated water quality changes for egory pounds of sludge, on a wet basis each case study must be translated into ($2003) (assuming 12 percent solids) for flow- a composite ‘‘index’’ value for the through and recirculating facilities. This monetization method described in LLL–LLH ...... not estimated reduction is due to feed management Section X.B.2 above. EPA more recently LHL–LHH ...... $2,126–$5,330 that results in less solid waste developed a six-parameter WQI (‘‘WQI– HLL–HLH ...... $6,591–$12,031 generated. 6’’) based on TSS, BOD, DO, FC, plus HHL–HHH ...... $57,497–$81,255 XII. How Will This Rule Be nitrate (NO3) and phosphate (PO4). The Total ...... $66,214–$98,616 new index more completely reflects the Implemented? type of water quality changes that will In general, however, the relatively This section helps permit writers and result from loading reductions for TSS, small recreational benefits projected for CAAP facilities implement this total nitrogen (TN), total phosphorus the rule suggest that non-monetized regulation. This section also discusses (TP), and BOD. Final rule benefits benefits categories are likely to be small the relationship of upset and bypass presented here were estimated on the as well. provisions, variances, and modifications basis of WQI–6. to the final limitations and standards. XI. What Are the Non-Water Quality For additional implementation 5. Estimated National Water Quality Environmental Impacts of This Rule? information, see Chapter 2 of the Benefits Under Sections 304(b) and 306 of the Technical Development Document for EPA monetized water quality benefits Clean Water Act, EPA may consider today’s rule. for each of the 5 QUAL2E case studies non-water quality environmental A. Implementation of Limitations and performed (Table 2). Using the methods impacts (including energy requirements) Standards for Direct Dischargers described above, the Agency estimates when developing effluent limitations that the total national benefit from water guidelines and standards. Accordingly, Effluent limitations guidelines and quality improvements arising from TSS, EPA has considered the potential new source performance standards act BOD, TN, and TP reductions from this impact of today’s final regulation on air as important mechanisms to control the rule are $66,000—$99,000. This range emissions, energy consumption, and discharges of pollutants to waters of the reflects varying assumptions that the solid waste generation. United States. These limitations and Agency implemented to reflect some standards are applied to individual A. Air Emissions sources of uncertainty. Furthermore, facilities through NPDES permits issued this range of water quality-based With the implementation of feed by the EPA or authorized States under benefits of this regulation may be management, the final rule decreases Section 402 of the Act. uncertain for several reasons including: the amount of solid waste generated and In specific cases, the NPDES • EPA did not estimate benefits for land applied from CAAP facilities. Land permitting authority may elect to the facilities in the LLL and LLH application is a common waste disposal establish technology-based permit limits extrapolation categories. However, it is method in the CAAP industry; therefore, for pollutants not covered by this not expected that inclusion of these the amount of ammonia released as air regulation. In addition, where State facilities would greatly increase emissions would be expected to water quality standards or other monetized water quality benefits. decrease as the quantity of waste provisions of State or Federal law • EPA’s monetization method mainly applied to cropland decreases. EPA require limits on pollutants not covered captures benefits for recreational uses of estimates the decrease in ammonia by this regulation (or require more the streams. Economic research emissions to be 8,182 pounds of stringent limits or standards on covered indicates that there are significant ‘‘non- ammonia per year. This is a decrease of pollutants in order to attain and use’’ values associated with some about 8 % over the ammonia emissions maintain water quality standards), the

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permitting authority must apply those or more of aquatic animals per year in fundamentally different with respect to limitations or standards. See CWA flow-through, recirculating, and net pen the factors specified in Section 304 Section 301(b)(1)(C). systems. There is an exception for net (other than costs) from those considered The final regulation establishing pen systems rearing native species by EPA in establishing the effluent narrative limitations for the flow- released after a growing period of no limitations or pretreatment standard. through and recirculating system and longer than 4 months to supplement Section 301(n) also defined the net pen subcategories requires that a commercial and sport fisheries. conditions under which EPA may point source must meet the prescribed establish alternative requirements. B. Upset and Bypass Provisions limitations expressed as operational Under Section 301(n), an application for practices or ‘‘any modification to these A ‘‘bypass’’ is an intentional diversion approval of a FDF variance must be requirements as determined by the of the streams from any portion of a based solely on (1) information permitting authority based on its treatment facility. An ‘‘upset’’ is an submitted during rulemaking raising the exercise of its best professional exceptional incident in which there is factors that are fundamentally different judgment.’’ Sections 451.11 and 451.21. unintentional and temporary or (2) information the applicant did not This provision authorizes the permitting noncompliance with technology-based have an opportunity to submit. The authority to tailor the specific NPDES permit effluent limitations because of alternate limitation or standard must be permit limits that implement the factors beyond the reasonable control of no less stringent than justified by the guideline limitations to individual sites. the permittee. EPA’s regulations difference and must not result in As previously explained, the final concerning bypasses and upsets for markedly more adverse non-water narrative requirements, in many cases, direct dischargers are set forth at 40 CFR quality environmental impacts than the require achievement of environmental 122.41(m) and (n) and for indirect national limitation or standard. end points. There may be circumstances dischargers at 40 CFR 403.16 and EPA regulations at 40 CFR Part 125, which require some modification to 403.17. Subpart D, authorizing the Regional these requirements to best accomplish Administrators to establish alternative C. Variances and Modifications these environmental end points, or to limitations and standards, further detail accommodate specific circumstances at While the CWA requires application the substantive criteria used to evaluate a particular site. The provision allows of effluent limitations established FDF variance requests for direct the permitting authority to address such pursuant to section 301 to all direct dischargers. Thus, 40 CFR 125.31(d) situations by incorporating in the dischargers, the statute also provides for identifies six factors (e.g., volume of NPDES permit specific tailored the modification of these national process wastewater, age and size of a conditions that accomplish the intent of requirements in a limited number of discharger’s facility) that may be the narrative limitations. The CWA circumstances. Moreover, the Agency considered in determining if a facility is recognizes that it should provide established administrative mechanisms fundamentally different. The Agency mechanisms for addressing certain to provide an opportunity for relief from must determine whether, on the basis of unique, site-specific situations in the the application of the national effluent one or more of these factors, the facility guidelines regulation. Here, EPA has limitations guidelines for categories of in question is fundamentally different provided upfront in this rule such a existing sources for toxic, conventional, from the facilities and factors mechanism. and nonconventional pollutants. considered by EPA in developing the nationally applicable effluent 1. Fundamentally Different Factors 1. What Are the Compliance Dates for guidelines. The regulation also lists four Variances Existing and New Sources? other factors (e.g., infeasibility of New and reissued NPDES permits to EPA will develop effluent limitations installation within the time allowed or direct dischargers must include these or standards different from the a discharger’s ability to pay) that may effluent limitations unless water quality otherwise applicable requirements if an not provide a basis for an FDF variance. considerations require more stringent individual discharging facility is In addition, under 40 CFR 125.31(b) (3), limits, and the permits must require fundamentally different with respect to a request for limitations less stringent immediate compliance with such factors considered in establishing the than the national limitation may be limitations. If the permitting authority limitation of standards applicable to the approved only if compliance with the wishes to provide a compliance individual facility. Such a modification national limitations would result in schedule, it must do so through an is known as a ‘‘fundamentally different either (a) a removal cost wholly out of enforcement mechanism. factors’’ (FDF) variance. proportion to the removal cost New sources must comply with the Early on, EPA, by regulation provided considered during development of the new source standards (NSPS) of this for the FDF modifications from the BPT national limitations, or (b) a non-water rule when they commence discharging effluent limitations, BAT limitations for quality environmental impact CAAP wastewater. Because the final toxic and nonconventional pollutants (including energy requirements) rule was not promulgated within 120 and BCT limitations for conventional fundamentally more adverse than the days of the proposed rule, the Agency pollutants for direct dischargers. FDF impact considered during development considers a discharger to be a new variances for toxic pollutants were of the national limits. source if its construction commences challenged judicially and ultimately The legislative history of Section after September 22, 2004. sustained by the Supreme Court. 301(n) underscores the necessity for the (Chemical Manufacturers Assn v. FDF variance applicant to establish 2. Who Does Part 451 Apply To? NRDC, 479 U.S. 116 (1985)). eligibility for the variance. EPA’s In Section VI.A. of this preamble and Subsequently, in the Water Quality regulations at 40 CFR 125.32(b)(1) are Chapter 2 of the TDD, EPA provides Act of 1987, Congress added new explicit in imposing this burden upon detailed information on the Section 301(n) of the Act explicitly to the applicant. The applicant must show applicability of this rule. 40 CFR part authorize modifications of the otherwise that the factors relating to the discharge 451 will apply to existing and new applicable BAT effluent limitations or controlled by the applicant’s permit concentrated aquatic animal production categorical pretreatment standards for which are claimed to be fundamentally facilities that produce 100,000 pounds existing sources if a facility is different are, in fact, fundamentally

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different from those factors considered limitations and standards and such (2) Create a serious inconsistency or by EPA in establishing the applicable other requirements as the Administrator otherwise interfere with an action taken guidelines. In practice, very few FDF deems appropriate. or planned by another agency; variances have been granted for past (3) Materially alter the budgetary E. Potential Tools To Assist With the ELGs. An FDF variance is not available impact of entitlements, grants, user fees, Remediation of Aquaculture Effluents to a new source subject to NSPS or or loan programs or the rights and PSNS. A potential option to assist land obligations of recipients thereof; or Facilities must submit all FDF owners with aquaculture effluent (4) Raise novel legal or policy issues variance applications to the appropriate quality is the Environmental Quality arising out of legal mandates, the Director (defined at 40 CFR 122.2) no Incentives Program (EQIP). This is a President’s priorities, or the principles later than 180 days from the date the voluntary USDA conservation program. set forth in the Executive Order. Pursuant to the terms of Executive limitations or standards are established EQIP was reauthorized in the Farm Order 12866, it has been determined or revised (see CWA section 301(n)(2) Security and Rural Investment Act of that this rule is a ‘‘significant regulatory and 40 CFR 122.21(m)(1)(i)(B)(2)). EPA 2002 (Farm Bill 2002). The Natural action.’’ As such, this action was regulations clarify that effluent Resources Conservation Service (NRCS) submitted to OMB for review. Changes limitations guidelines are ‘‘established’’ administers EQIP funds. or ‘‘revised’’ on the date those effluent made in response to OMB suggestions or limitations guidelines are published in EQIP applications are accepted recommendations will be documented the Federal Register (see 40 CFR 122.21 throughout the year. NRCS evaluates in the public record. each application using a state and (m)(1)(i)(B)(2)). Therefore, all facilities B. Paperwork Reduction Act requesting FDF variances from the locally developed evaluation process. effluent limitations guidelines in today’s Incentive payments may be made to The information collection final rule must submit FDF variance encourage a producer to adopt land requirements in this rule have been applications to their Director (as defined management, manure management, submitted for approval to the Office of at 40 CFR 122.2) no later than February integrated pest management, irrigation Management and Budget (OMB) under 21, 2005. water management and wildlife habitat the Paperwork Reduction Act, 44 U.S.C. management practices or to develop a 3501 et seq. The information collection 2. Economic Variances Comprehensive Nutrient Management requirements are not enforceable until Section 301(c) of the CWA authorizes Plan (CNMP). These practices would OMB approves them. a variance from the otherwise applicable provide beneficial effects on reducing EPA has several special reporting and BAT effluent guidelines for sediment and nutrient loads to those monitoring provisions in this regulation nonconventional pollutants due to aquaculture operations dependent on as previously explained. The provisions economic factors. The request for a surface water flows. In addition, include reporting requirements (1) for variance from effluent limitations opportunities exist to provide EQIP the use of INAD or extralabel drug uses; developed from BAT guidelines must funds to foster the adoption of (2) for failure or damage to the normally be filed by the discharger innovative cost effective approaches to containment system (including the during the public notice period for the address a broad base of conservation production system(s) and all the draft permit. Other filing time periods needs, including aquaculture effluent associated storage and water treatment may apply, as specified in 40 CFR remediation. NRCS does not at present systems) that results in a material 122.21(1)(2). Specific guidance for this have standards that apply specifically to discharge of pollutants to waters of the type of variance is available from EPA’s waste handling at aquaculture facilities, U.S; and (3) for spills of drugs, Office of Wastewater Management. thus EQIP funds for aquaculture projects pesticides or feed. Section 308(a) of the would only apply to practices related to CWA authorizes the Administrator to D. Best Management Practices other agricultural aspects of a facility require the owner or operator of any Sections 304(e), 308(a), 402(a), and such as CNMPs for the land application point source to file reports as required 501(a) of the CWA authorize the of solids. to carry out the objectives of the Act. Administrator to prescribe BMPs as part This ELG requires reporting in the event of effluent limitations guidelines and XIII. Statutory and Executive Order that drugs are used which are either standards or as part of a permit. EPA’s Reviews under a conditional approval as an BMP regulations are found at 40 CFR A. Executive Order 12866: Regulatory Investigative New Animal Drugs 122.44(k). Section 304(e) of the CWA Planning and Review (INADs) or are prescribed by a licensed authorizes EPA to include BMPs in veterinarian for treatment of a disease or effluent limitations guidelines for Under Executive Order 12866, [58 FR a species that is outside the approved certain toxic or hazardous pollutants for 51,735 (October 4, 1993)] the Agency use of the specific drug, referred to as the purpose of controlling ‘‘plant site must determine whether the regulatory extralabel drug use, unless the INAD or runoff, spillage or leaks, sludge or waste action is ‘‘significant’’ and therefore extralabel drug use is under similar disposal, and drainage from raw subject to OMB review and the conditions and dosages as a previously material storage.’’ Section 402(a)(1) and requirements of the Executive Order. approved use. EPA believes this NPDES regulations [40 CFR 122.44(k)] The Order defines ‘‘significant reporting requirement is appropriate for also provide for best management regulatory action’’ as one that is likely these classes of drugs, because they practices to control or abate the to result in a rule that may: have not undergone the same degree of discharge of pollutants when numeric (1) Have an annual effect on the review with respect to their limitations and standards are infeasible. economy of $100 million or more or environmental effects as approved In addition, Section 402(a)(2), read in adversely affect in a material way the drugs. The final regulation also requires concert with Section 501(a), authorizes economy, a sector of the economy, reporting when the facility has a failure EPA to prescribe as wide a range of productivity, competition, jobs, the in the structural integrity of the aquatic permit conditions as the Administrator environment, public health or safety, or animal containment systems that results deems appropriate in order to ensure State, local or tribal governments or in a material discharge of pollutants. compliance with applicable effluent communities; EPA believes this reporting is necessary

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to alert the permitting authority to the population of less than 50,000; and (3) facilities, EPA identifies 38 facilities (37 release of large quantities of material a small organization that is any not-for- percent of in-scope facilities) as small from these facilities. The rule also profit enterprise which is independently businesses using SBA’s definition. allows the permitting authority to owned and operated and is not Finally, EPA based the final rule on a specify in the permit what constitutes dominant in its field. technology option that has lower costs damage and/or material discharge of After considering the economic and fewer impacts (including impacts pollutants for particular facilities based impacts of today’s final rule on small on small businesses) than several other on consideration of relevant site-specific entities, I certify that this action will not technology options that were considered factors. have a significant economic impact on as possible bases for the final rule. Burden means the total time, effort, or a substantial number of small entities. EPA conducted outreach to small financial resources expended by persons The small entities directly regulated by entities and convened a Small Business to generate, maintain retain, or disclose the final rule are primarily commercial Advocacy Review Panel prior to or provide information to or for a businesses that fall within the NAIC proposal to obtain the advice and Federal agency. This includes the time codes for finfish farming, fish recommendations of representatives of needed to review instructions; develop, hatcheries, and other aquaculture. The the small entities that potentially would acquire, install, and utilize technology Small Business Administration size be subject to the rule’s requirements. and systems for the purposes of standard for these codes is $0.75 million The Agency convened the Small collecting, validating, and verifying in annual revenues. Among the costed Business Advocacy Review Panel on information, processing and facilities, EPA identified 38 facilities January 22, 2002. Members of the Panel maintaining information, and disclosing belonging to small businesses or represented the Office of Management and providing information; search data organizations. Of the 38, 37 facilities are and Budget, the Small Business sources; complete and review the owned by small businesses and 1 is an Administration, and EPA. The Panel collection of information; and transmit Alaskan facility operated by a small met with small entity representatives or otherwise disclose the information. non-profit organization that is not (SERs) to discuss the potential effluent EPA estimates that the reporting and dominant in its field. For the purposes guidelines and, in addition to the oral recordkeeping requirements included in of the RFA, Federal, and State comments from SERs, the Panel today’s regulation will result in a total governments are not considered small solicited written input. In the months annual burden of 45,000 hours and cost governmental jurisdictions, as preceding the Panel, EPA conducted $808,000. documented in the rulemaking record outreach with small entities that would An agency may not conduct or (DCN 20121). Thus, facilities owned by potentially be affected by this sponsor, and a person is not required to these governments are not considered regulation. On January 25, 2002, the respond to a collection of information small entities, regardless of their SBAR Panel sent some initial unless it displays a currently valid OMB production levels. EPA identified no information for the SERs to review and control number. The OMB control public facilities owned by small local provide comment on. On February 6, numbers for EPA’s regulations in 40 governments. No small organization is 2002, the Panel distributed additional CFR are listed in 40 CFR part 9. When projected to incur impacts. Of the 101 information to the SERs for their review. this ICR is approved by OMB, the commercial facilities, 37 (37 percent) On February 12 and 13, the Panel met Agency will publish a technical are owned by small businesses. Under with SERs to hear their comments on amendment to 40 CFR part 9 in the EPA’s closure analyses no small the information distributed in these Federal Register to display the OMB business is projected to close as a result mailings. The Panel also received control number for the approved of the final rule, assuming discounted written comments from the SERs in information collection requirements cash flow (two small business closures response to the discussions at this contained in this final rule. are projected using net income). In meeting and the outreach materials. The addition to considering the potential for Panel asked SERs to evaluate how they C. Regulatory Flexibility Act adverse economic impacts, EPA also would be affected and to provide advice The RFA generally requires an agency evaluated the possibility of other, more and recommendations regarding early to prepare a regulatory flexibility moderate financial impacts. Expressed ideas to provide flexibility. See Section analysis of any rule subject to notice as a comparison of compliance costs to 8 of the Panel’s Report (DCN 31019) for and comment rulemaking requirements sales, only 4 facilities belonging to small a complete discussion of SER under the Administrative Procedure Act businesses (11 percent of small comments. The Panel evaluated the or any other statute unless the agency businesses, and 4 percent of commercial assembled materials and small-entity certifies that the rule will not have a facilities) are likely to incur costs that comments on issues related to the significant economic impact on a exceed 3 percent of sales. One small elements of an Initial Regulatory substantial number of small entities. business fails the USDA credit test. Flexibility Analysis. A copy of the Small entities include small businesses, Although this final rule will not have Panel’s report is included in the small organizations, and small a significant economic impact on a rulemaking docket. EPA provided governmental jurisdictions. substantial number of small entities, responses to the Panel’s most significant For purposes of assessing the impacts EPA nonetheless designed the rule to findings in the Notice of Proposal of today’s rule on small entities, small reduce the impact on small entities. The Rulemaking (67 FR 57918–57920). In entity is defined as: (1) A small business scope of the final rule is restricted to general, the requirements of this final that is primarily engaged in CAAP facilities that produce 100,000 rule address the concerns raised by concentrated aquatic animal production, lbs/year or more. This means that of the SERs and are consistent with the Panel’s as defined by North American Industry approximately 4,000 aquaculture recommendations. Classification (NAIC) codes 112511 and facilities nationwide, as identified by 112519, with no more than $0.75 USDA’s Census of Aquaculture, EPA’s D. Unfunded Mandates Reform Act million in annual revenues; (2) a small final regulation applies to an estimated Title II of the Unfunded Mandates governmental jurisdiction that is a 101 commercial facilities or Reform Act of 1995 (UMRA), Public government of a city, county, town, approximately 2.6 percent of all Law 104–4, establishes requirements for school district or special district with a operations. Among commercial Federal agencies to assess the effects of

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their regulatory actions on State, local, the States, or on the distribution of rulemaking for CAAPs in September and tribal governments and the private power and responsibilities among the 2002, requesting comment on the sector. Under section 202 of the UMRA, various levels of government.’’ proposal. In December 2003, EPA issued EPA generally must prepare a written This rule does not have Federalism a Notice of Data Availability describing statement, including a cost-benefit implications. It will not have substantial options for changes to the proposed analysis, for proposed and final rules direct effects on the States, on the rule. As noted, EPA identified a number with ‘‘Federal mandates’’ that may relationship between the national of tribal facilities in its screener survey, result in expenditures to State, local, government and the States, or on the however further evaluation did not and tribal governments, in the aggregate, distribution of power and identify any in-scope tribal facilities or to the private sector, of $100 million responsibilities among the various based on subsequent evaluation of the or more in any one year. Before levels of government, as specified in detailed survey information from a promulgating an EPA rule for which a Executive Order 13132. EPA estimates sample of these facilities. Thus EPA has written statement is needed, section 205 that, when promulgated, these revised not had a basis to have any formal of the UMRA generally requires EPA to effluent guidelines and standards will consultation with Tribal officials. EPA identify and consider a reasonable be incorporated into NPDES permits has however concluded that the final number of regulatory alternatives and without significant additional costs to rule will not have a substantial direct adopt the least costly, most cost- authorized States. effect on one or more Indian Tribes, will effective or least burdensome alternative Further, the revised regulations would not impose substantial direct that achieves the objectives of the rule. not alter the basic State-Federal scheme compliance costs on Indian tribal The provisions of section 205 do not established in the Clean Water Act governments, nor pre-empt tribal law. apply when they are inconsistent with under which EPA authorizes States to G. Executive Order 13045: Protection of applicable law. Moreover, section 205 carry out the NPDES permitting Children From Environmental Health allows EPA to adopt an alternative other program. EPA expects the revised and Safety Risks than the least costly, most cost-effective regulations to have little effect, if any, or least burdensome alternative if the on the relationship between, or the Executive Order 13045 (62 FR 19885, Administrator publishes with the final distribution of power and April 23, 1997) applies to any rule that: rule an explanation why that alternative responsibilities among, the Federal, (1) Is determined to be ‘‘economically was not adopted. Before EPA establishes State and local governments. Thus, significant’’ as defined under Executive any regulatory requirements that may Executive Order 13132 does not apply Order 12866, and (2) concerns an significantly or uniquely affect small to this rule. environmental health or safety risk that EPA has reason to believe may have a governments, including tribal F. Executive Order 13175: Consultation disproportionate effect on children. If governments, it must have developed and Coordination With Indian Tribal the regulatory action meets both criteria, under section 203 of the UMRA a small Governments government agency plan. The plan must the Agency must evaluate the provide for notifying potentially Executive Order 13175, entitled environmental health and safety effects affected small governments, enabling ‘‘Consultation and Coordination with of the planned rule on children, and officials of affected small governments Indian Tribal Governments’’ (65 FR explain why the planned regulation is to have meaningful and timely input in 67249, November 9, 2000), requires EPA preferable to other potentially effective the development of EPA regulatory to develop an accountable process to and reasonably feasible alternatives proposals with significant Federal ensure ‘‘meaningful and timely input by considered by the Agency. intergovernmental mandates, and tribal officials in the development of This rule is not subject to Executive informing, educating, and advising regulatory policies that have tribal Order 13045 because it is not an small governments on compliance with implications.’’ ‘‘Policies that have tribal economically significant rule under E.O. the regulatory requirements. implications’’ is defined in the 12866. Executive Order to include regulations EPA has determined that this rule H. Executive Order 13211: Actions That does not contain a Federal mandate that that have substantial direct effects on one or more Indian tribes, on the Significantly Affect Energy Supply, may result in expenditures of $100 Distribution, or Use million or more for State, local, and relationship between the Federal tribal governments, in the aggregate, or government and the Indian tribes, or on This rule is not a ‘‘significant energy the private sector in any one year. The this distribution of power and action’’ as defined in Executive Order total annual cost of this rule is estimated responsibilities between the Federal 13211, ‘‘actions concerning Regulations to be $1.4 million. Thus, today’s rule is government and Indian tribes.’’ that Significantly Affect Energy Supply, not subject to the requirements of The final rule does not have tribal Distribution, or Use’’ (66 FR 28355 (May Sections 202 and 205 of UMRA. implications. It will not have substantial 22, 2001)) because it is not likely to direct effects on tribal governments, on have a significant adverse effect on the E. Executive Order 13132: Federalism the relationship between the Federal supply, distribution, or use of energy. Executive Order 13132, entitled government and Indian tribes, or on the As part of the Agency’s consideration of ‘‘Federalism’’ (64 FR 43255, August 10, distribution of power and non-water quality impacts, EPA has 1999), requires EPA to develop an responsibilities between the Federal estimated the energy consumption accountable process to ensure government and Indian tribes, as associated with today’s requirements. ‘‘meaningful and timely input by State specified in Executive Order 13175. The The rule will result in a net decrease in and local officials in the development of Executive Order provides that EPA must energy consumption for flow-through regulatory policies that have federalism ensure meaningful and timely input by and recirculating systems. The decrease implications.’’ ‘‘Policies that have tribal officials in the development of would be based on electricity used federalism implications’’ is defined in regulatory policies that have tribal today to pump solids from raceways to the Executive Order to include implications. EPA’s rulemaking process solids settling ponds, which will no regulations that have ‘‘substantial direct has provided that opportunity for longer be generated, from wastewater effects on the States, on the relationship meaningful and timely input. EPA first treatment equipment. EPA estimated the between the national government and published a notice of proposed decrease in energy consumption for

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flow-through and recirculating systems communities given the relatively low 451.22 Effluent limitations attainable by the at 4,900 kilowatt-hour (kW-h). economic impacts of today’s final rule. application of the best available Comparing the annual decrease in technology economically achievable K. Congressional Review Act electric use resulting from the final (BAT). 451.23 Effluent limitations attainable by the requirements to national annual energy The Congressional Review Act, 5 application of the best conventional use, EPA estimates the decrease to be U.S.C. 801 et seq., as added by the Small ¥ technology (BCT). 1.3 × 10 7 percent of national energy Business Regulatory Enforcement 451.24 New source performance standards use. Therefore, we conclude that this Fairness Act of 1996, generally provides (NSPS). rule is not likely to have any adverse that before a rule may take effect, the Authority: 7 U.S.C. 135 et seq., 136–136y; energy effects. agency promulgating the rule must 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671, submit a rule report, which includes a I. National Technology Transfer and 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 Advancement Act copy of the rule, to each House of the U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, Congress and to the Comptroller General 1321, 1326, 1330, 1342, 1344, 1345(d) and As noted in the proposed rule, of the United States. EPA will submit a (e), 1361; 42 U.S.C. 241, 242b, 243, 246, 300f, Section 12(d) of the National report containing this rule and other 300g, 300g–1, 300g–2, 300g–3, 300g–4, 300g– Technology Transfer and Advancement required information to the U.S. Senate, 5, 300g–6, 300j–2, 300j–3, 300j–4, 300j–9, Act of 1995 (‘‘NTTAA’’), Public Law the U.S. House of Representatives, and 1857 et seq., 6901–6992k, 7401–7671q, 7542, 104–113, 12(d) (15 U.S.C. 272 note) 9601–9657, 11023, 11048; E.O. 11735, 38 FR the Comptroller General of the United 21243, 3 CFR, 1971–1975 Comp., 973. directs EPA to use voluntary consensus States prior to publication of the rule in standards in its regulatory activities the Federal Register. A major rule § 451.1 General applicability. unless to do so would be inconsistent cannot take effect until 60 days after it As defined more specifically in each with applicable law or otherwise is published in the Federal Register. subpart, this Part applies to discharges impractical. Voluntary consensus This action is not a ‘‘major rule’’ as from concentrated aquatic animal standards are technical standards (e.g., defined by 5 U.S.C. 804(2). This rule production facilities as defined at 40 materials specifications, test methods, will be effective September 22, 2004. CFR 122.24 and Appendix C of 40 CFR sampling procedures, and business Part 122. This Part applies to the practices) that are developed or adopted List of Subjects in 40 CFR Part 451 discharges of pollutants from facilities by voluntary consensus standards Environmental protection, that produce 100,000 pounds or more of bodies. The NTTAA directs EPA to Concentrated aquatic animal aquatic animals per year in a flow- provide Congress, through OMB, production, Waste treatment and through, recirculating, net pen or explanations when the Agency decides disposal, Water pollution control. submerged cage system. not to use available and applicable Dated: June 30, 2004. voluntary consensus standards. § 451.2 General definitions. Stephen L. Johnson, Today’s rule does not establish any As used in this part: technical standards, thus NTTAA does Acting Deputy Administrator. (a) The general definitions and not apply to this rule. I For the reasons set forth in the abbreviations in 40 CFR part 401 apply. J. Executive Order 12898: Federal preamble, chapter I of title 40 of the Code (b) Approved dosage means the dose Actions To Address Environmental of Federal Regulations is amended by of a drug that has been found to be safe Justice in Minority Populations and adding part 451 to read as follows: and effective under the conditions of a Low-Income Populations new animal drug application. PART 451—CONCENTRATED (c) Aquatic animal containment The requirements of the AQUATIC ANIMAL PRODUCTION system means a culture or rearing unit Environmental Justice Executive Order POINT SOURCE CATEGORY such as a raceway, pond, tank, net or are that EPA will review the other structure used to contain, hold or environmental effects of major Federal Sec. produce aquatic animals. The 451.1 General applicability. actions significantly affecting the containment system includes structures quality of the human environment. For 451.2 General definitions. 451.3 General reporting requirements. designed to hold sediments and other such actions, EPA reviewers will focus materials that are part of a wastewater on the spatial distribution of human Subpart A—Flow-Through and treatment system. health, social and economic effects to Recirculating Systems Subcategory (d) Concentrated aquatic animal ensure that agency decision makers are 451.10 Applicability. production facility is defined at 40 CFR aware of the extent to which those 451.11 Effluent limitations attainable by the 122.24 and Appendix C of 40 CFR Part impacts fall disproportionately on application of the best practicable 122. covered communities. This is not a control technology currently available (e) Drug means any substance defined major action. Further, EPA does not (BPT). as a drug in section 201(g)(1) of the believe this rulemaking will have a 451.12 Effluent limitations attainable by the application of the best available Federal Food, Drug and Cosmetic Act disproportionate effect on minority or technology economically achievable (21 U.S.C. 321). low income communities because the (BAT). (f) Extralabel drug use means a drug technology-based effluent limitations 451.13 Effluent limitations attainable by the approved under the Federal Food, Drug guidelines are uniformly applied application of the best conventional and Cosmetic Act that is not used in nationally irrespective of geographic technology (BCT). accordance with the approved label location. The final regulation will 451.14 New source performance standards directions, see 21 CFR part 530. reduce the negative effects of (NSPS). (g) Flow-through system means a concentrated aquatic animal production Subpart B—Net Pen Subcategory system designed to provide a industry waste in our nation’s waters to 451.20 Applicability. continuous water flow to waters of the benefit all of society, including minority 451.21 Effluent limitations attainable by the United States through chambers used to and low-income communities. The cost application of the best practicable produce aquatic animals. Flow-through impacts of the rule should likewise not control technology currently available systems typically use rearing units that disproportionately affect low-income (BPT). are either raceways or tank systems.

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Rearing units referred to as raceways are use in a concentrated aquatic animal documenting the cause, the estimated typically long, rectangular chambers at production facility subject to this Part of time elapsed until the failure or damage or below grade, constructed of earth, any investigational new animal drug was repaired, an estimate of the material concrete, plastic, or metal to which (INAD) or any extralabel drug use where released as a result of the failure or water is supplied by nearby rivers or such a use may lead to a discharge of damage, and steps being taken to springs. Rearing units comprised of tank the drug to waters of the U.S. Reporting prevent a reccurrence. systems use circular or rectangular tanks is not required for an INAD or extralabel (c) In the event a spill of drugs, and are similarly supplied with water to drug use that has been previously pesticides or feed occurs that results in raise aquatic animals. The term does not approved by FDA for a different species a discharge to waters of the U.S., the include net pens. or disease if the INAD or extralabel use permittee must provide an oral report of (h) Investigational new animal drug is at or below the approved dosage and the spill to the permitting authority (INAD) means a drug for which there is involves similar conditions of use. within 24 hours of its occurrence and a a valid exemption in effect under (1) The permittee must provide a written report within 7 days. The report section 512(j) of the Federal Food, Drug, written report to the permitting shall include the identity and quantity and Cosmetic Act, 21 U.S.C. 360b(j), to authority of an INAD’s impending use of the material spilled. conduct experiments. within 7 days of agreeing or signing up (d) Best management practices (BMP) (i) New animal drug application is to participate in an INAD study. The plan. The permittee subject to this Part defined in 512(b)(1) of the Federal Food, written report must identify the INAD to must: Drug, and Cosmetic Act (21 U.S.C be used, method of use, the dosage, and (1) Develop and maintain a plan on 360b(b)(1)). the disease or condition the INAD is site describing how the permittee will (j) Net pen system means a stationary, intended to treat. achieve the requirements of § 451.11(a) suspended or floating system of nets, (2) For INADs and extralabel drug through (e) or § 451.21(a) through (h), as screens, or cages in open waters of the uses, the permittee must provide an oral applicable. United States. Net pen systems typically report to the permitting authority as (2) Make the plan available to the are located along a shore or pier or may soon as possible, preferably in advance permitting authority upon request. be anchored and floating offshore. Net of use, but no later than 7 days after (3) The permittee subject to this Part pens and submerged cages rely on tides initiating use of that drug. The oral must certify in writing to the permitting and currents to provide a continual report must identify the drugs used, authority that a BMP plan has been supply of high-quality water to the method of application, and the reason developed. animals in production. for using that drug. (k) Permitting authority means EPA or (3) For INADs and extralabel drug Subpart A—Flow-Through and the State agency authorized to uses, the permittee must provide a Recirculating Systems Subcategory administer the National Pollutant written report to the permitting § 451.10 Applicability. authority within 30 days after initiating Discharge Elimination System This subpart applies to the discharge use of that drug. The written report permitting program for the receiving of pollutants from a concentrated must identify the drug used and waters into which a facility subject to aquatic animal production facility that include: the reason for treatment, date(s) this Part discharges. produces 100,000 pounds or more per and time(s) of the addition (including (l) Pesticide means any substance year of aquatic animals in a flow- duration), method of application; and defined as a ‘‘pesticide’’ in section 2(u) through or recirculating system. of the Federal Insecticide, Fungicide, the amount added. and Rodenticide Act (7 U.S.C. 136(u)). (b) Failure in, or damage to, the § 451.11 Effluent limitations attainable by (m) Real-time feed monitoring means structure of an aquatic animal the application of the best practicable a system designed to track the rate of containment system resulting in an control technology currently available feed consumption and to detect uneaten unanticipated material discharge of (BPT). feed passing through the nets at a net pollutants to waters of the U.S. In Except as provided in 40 CFR 125.30 pen facility. These systems may rely on accordance with the following through 125.32, any existing point a combination of visual observation and procedures, any permittee subject to this source subject to this subpart must meet hardware, including, but not limited to, Part must notify the permitting the following requirements, expressed devices such as video cameras, digital authority when there is a reportable as practices (or any modification to scanning sonar, or upweller systems failure. these requirements as determined by the that allow facilities to determine when (1) The permitting authority may permitting authority based on its to cease feeding the aquatic animals. specify in the permit what constitutes exercise of its best professional Visual observation alone from above the reportable damage and/or a material judgment) representing the application pens does not constitute real-time discharge of pollutants, based on a of BPT: monitoring. consideration of production system (a) Solids control. The permittee must: (n) Recirculating system means a type, sensitivity of the receiving waters (1) Employ efficient feed management system that filters and reuses water in and other relevant factors. and feeding strategies that limit feed which the aquatic animals are produced (2) The permittee must provide an input to the minimum amount prior to discharge. Recirculating systems oral report within 24 hours of discovery reasonably necessary to achieve typically use tanks, biological or of any reportable failure or damage that production goals and sustain targeted mechanical filtration, and mechanical results in a material discharge of rates of aquatic animal growth in order support equipment to maintain high pollutants, describing the cause of the to minimize potential discharges of quality water to produce aquatic failure or damage in the containment uneaten feed and waste products to animals. system and identifying materials that waters of the U.S. have been released to the environment (2) In order to minimize the discharge § 451.3 General reporting requirements. as a result of this failure. of accumulated solids from settling (a) Drugs. Except as noted below, a (3) The permittee must provide a ponds and basins and production permittee subject to this Part must written report within 7 days of systems, identify and implement notify the permitting authority of the discovery of the failure or damage procedures for routine cleaning of

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rearing units and off-line settling basins, § 451.13 Effluent limitations attainable by (b) Waste collection and disposal. and procedures to minimize any the application of the best conventional Collect, return to shore, and properly discharge of accumulated solids during technology (BCT). dispose of all feed bags, packaging the inventorying, grading and harvesting Except as provided in 40 CFR 125.30 materials, waste rope and netting. aquatic animals in the production through 125.32, any existing point (c) Transport or harvest discharge. system. source subject to this subpart must meet Minimize any discharge associated with (3) Remove and dispose of aquatic the following requirements representing the transport or harvesting of aquatic animal mortalities properly on a regular the application of BCT: The limitations animals including blood, viscera, basis to prevent discharge to waters of are the same as the corresponding aquatic animal carcasses, or transport the U.S., except in cases where the limitations specified in § 451.11. water containing blood. permitting authority authorizes such (d) Carcass removal. Remove and § 451.14 New source performance dispose of aquatic animal mortalities discharge in order to benefit the aquatic standards (NSPS). environment. properly on a regular basis to prevent (b) Materials storage. The permittee Any point source subject to this discharge to waters of the U.S. must: subpart that is a new source must meet (e) Materials storage. (1) Ensure proper storage of drugs, the following requirements: The (1) Ensure proper storage of drugs, pesticides, and feed in a manner standards are the same as the pesticides and feed in a manner designed to prevent spills that may corresponding limitations specified in designed to prevent spills that may result in the discharge of drugs, § 451.11. result in the discharge of drugs, pesticides or feed to waters of the U.S. pesticides or feed to waters of the U.S. Subpart B—Net Pen Subcategory (2) Implement procedures for properly (2) Implement procedures for properly containing, cleaning, and disposing of § 451.20 Applicability. containing, cleaning, and disposing of any spilled material. any spilled material. This subpart applies to the discharge (f) Maintenance. (c) Structural maintenance. The of pollutants from a concentrated (1) Inspect the production system on permittee must: aquatic animal production facility that a routine basis in order to identify and (1) Inspect the production system and produces 100,000 pounds or more per promptly repair any damage. the wastewater treatment system on a year of aquatic animals in net pen or (2) Conduct regular maintenance of routine basis in order to identify and submerged cage systems, except for net the production system in order to promptly repair any damage. pen facilities rearing native species ensure that it is properly functioning. (2) Conduct regular maintenance of released after a growing period of no (g) Recordkeeping. the production system and the longer than 4 months to supplement (1) In order to calculate representative wastewater treatment system in order to commercial and sport fisheries. ensure that they are properly feed conversion ratios, maintain records functioning. § 451.21 Effluent limitations attainable by for aquatic animal net pens (d) Recordkeeping. The permittee the application of the best practicable documenting the feed amounts and control technology currently available estimates of the numbers and weight of must: (BPT). (1) In order to calculate representative aquatic animals. feed conversion ratios, maintain records Except as provided in 40 CFR 125.30 (2) Keep records of the net changes, for aquatic animal rearing units through 125.32, any existing point inspections and repairs. documenting the feed amounts and source subject to this subpart must meet (h) Training. The permittee must: estimates of the numbers and weight of the following requirements, expressed (1) In order to ensure the proper aquatic animals. as practices (or any modification to clean-up and disposal of spilled (2) Keep records documenting the these requirements as determined by the material adequately train all relevant frequency of cleaning, inspections, permitting authority based on its facility personnel in spill prevention maintenance and repairs. exercise of its best professional and how to respond in the event of a spill. (e) Training. The permittee must: judgment) representing the application (2) Train staff on the proper operation (1) In order to ensure the proper of BPT: and cleaning of production systems clean-up and disposal of spilled (a) Feed management. Employ including training in feeding procedures material adequately train all relevant efficient feed management and feeding and proper use of equipment. facility personnel in spill prevention strategies that limit feed input to the and how to respond in the event of a minimum amount reasonably necessary § 451.22 Effluent limitations attainable by spill. to achieve production goals and sustain the application of the best available (2) Train staff on the proper operation targeted rates of aquatic animal growth. technology economically achievable (BAT). and cleaning of production and These strategies must minimize the Except as provided in 40 CFR 125.30 wastewater treatment systems including accumulation of uneaten food beneath through 125.32, any existing point training in feeding procedures and the pens through the use of active feed source subject to this subpart must proper use of equipment. monitoring and management practices. achieve the following effluent These practices may include one or limitations representing the application § 451.12 Effluent limitations attainable by more of the following: Use of real-time the application of the best available of BAT: The limitations are the same as feed monitoring, including devices such the limitations specified in § 451.21. technology economically achievable (BAT). as video cameras, digital scanning Except as provided in 40 CFR 125.30 sonar, and upweller systems; § 451.23 Effluent limitations attainable by through 125.32, any existing point monitoring of sediment quality beneath the application of the best conventional source subject to this subpart must meet the pens; monitoring of benthic technology (BCT). the following requirements representing community quality beneath the pens; Except as provided in 40 CFR 125.30 the application of BAT: The limitations capture of waste feed and feces; or other through 125.32, any existing point are the same as the corresponding good husbandry practices approved by source subject to this subpart must limitations specified in § 451.11. the permitting authority. achieve the following effluent

VerDate jul<14>2003 14:39 Aug 20, 2004 Jkt 203001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 E:\FR\FM\23AUR2.SGM 23AUR2 51930 Federal Register / Vol. 69, No. 162 / Monday, August 23, 2004 / Rules and Regulations

limitations representing the application § 451.24 New source performance standard is the same as the limitations of BCT: The limitations are the same as standards (NSPS). specified in § 451.21. the limitations specified in § 451.21. Any point source subject to this subpart that is a new source must meet [FR Doc. 04–15530 Filed 8–20–04; 8:45 am] the following requirements: The BILLING CODE 6560–50–U

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