[Federal Register Volume 69, Number 162 (Monday, August 23, 2004)]
[Rules and Regulations]
[Pages 51892-51930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-15530]



[[Page 51891]]

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Part II





Environmental Protection Agency





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40 CFR Part 451



Effluent Limitations Guidelines and New Source Performance Standards 
for the Concentrated Aquatic Animal Production Point Source Category; 
Final Rule

Federal Register / Vol. 69, No. 162 / Monday, August 23, 2004 / Rules 
and Regulations

[[Page 51892]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 451

[OW-2002-0026; FRL-7783-6]
RIN 2040-AD55


Effluent Limitations Guidelines and New Source Performance 
Standards for the Concentrated Aquatic Animal Production Point Source 
Category

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: Today's final rule establishes Clean Water Act effluent 
limitations guidelines and new source performance standards for 
concentrated aquatic animal production facilities. The animals produced 
range from species produced for human consumption as food to species 
raised to stock streams for fishing. The animals are raised in a 
variety of production systems. The production of aquatic animals 
contributes pollutants such as suspended solids, biochemical oxygen 
demand, and nutrients to the aquatic environment. The regulation 
establishes technology-based narrative limitations and standards for 
wastewater discharges from new and existing concentrated aquatic animal 
production facilities that discharge directly to U.S. waters. EPA 
estimates that compliance with this regulation will affect 242 
facilities. The rule is projected to reduce the discharge of total 
suspended solids by about 0.5 million pounds per year and reduce the 
discharge of biochemical oxygen demand (BOD) and nutrients by about 0.3 
million pounds per year. The estimated annual cost for commercial 
facilities is $0.3 million. The estimated annual cost to Federal and 
State hatcheries is $1.1 million. EPA estimates that the annual 
monetized environmental benefits of the rule will be in the range of 
$66,000 to $99,000.

DATES: This regulation is effective September 22, 2004. For judicial 
review purposes, this final rule is promulgated as of 1 p.m. (Eastern 
time) on September 7, 2004 as provided at 40 CFR 23.2.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. OW-2002-0026. All documents in the docket are listed in the EDOCKET 
index at http://www.epa.gov/edocket. Although not listed in the index, 
some information is not publicly available, i.e., confidential business 
information or other information whose disclosure is restricted by 
statute. Certain other material, such as copyrighted material, is not 
placed on the Internet and will be publicly available only in hard copy 
form. Publicly available docket materials are available either 
electronically in EDOCKET or in hard copy at the Water docket in the 
EPA Docket Center (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., 
NW., Washington, DC. The EPA Docket Center Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the Water Docket is (202) 566-
2426.

FOR FURTHER INFORMATION CONTACT: For additional information contact 
Marta Jordan at (202) 566-1049.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply To Me?

    Entities that directly discharge to waters of the U.S. potentially 
regulated by this action include:

------------------------------------------------------------------------
                                      Examples of         Examples of
            Category              regulated entities  regulated entities
                                     and SIC Codes      and NAICS codes
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Facilities engaged in             0273--Animal        112511--Finfish
 concentrated aquatic animal       Aquaculture.        Farming and Fish
 production, which may include    0921--Fish           Hatcheries.
 the following sectors:            Hatcheries and     112519--Other
 Commercial (for profit) and Non-  Preserves.          Animal
 commercial (public) facilities.                       Aquaculture.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be regulated by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be regulated by this action. Other types of entities 
not listed in the table could also be regulated. To determine whether 
your facility is regulated by this action, you should carefully examine 
the applicability criteria listed at 40 CFR part 451 of today's rule. 
If you have questions regarding the applicability of this action to a 
particular entity, consult the person listed for information in the 
preceding FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under Docket ID No. OW-2002-0026. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 
B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket 
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
Water Docket is (202) 566-2426. Every user is entitled to copy 266 
pages per day before incurring a charge. The Docket may charge 15 cents 
a page for each page over the page limit plus an administrative fee of 
$25.00.
    2. Electronic Access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, 
access the index listing of the contents of the official public docket, 
and to access those documents in the public docket that are available 
electronically. Once in the system, select ``search,'' then key in the 
appropriate docket identification number. Although not all docket 
materials may be available electronically, you may still access any of 
the publicly available docket materials through the docket facility 
identified in section B.1.

C. What Other Information Is Available To Support This Final Rule?

    The major documents supporting the final regulations are the 
following:


[[Page 51893]]


     ``Technical Development Document for the Final Effluent 
Limitations Guidelines and New Source Performance Standards for the 
Concentrated Aquatic Animal Production Point Source Category'' [EPA-
821-R-04-012] referred to in the preamble as the Technical 
Development Document (TDD). The TDD presents the technical 
information that formed the basis for EPA's decisions in today's 
final rule. The TDD describes, among other things, the data 
collection activities, the wastewater treatment technology options 
considered by the Agency as the basis for effluent limitations 
guidelines and standards, the pollutants found in wastewaters from 
concentrated aquatic animal production facilities, the estimates of 
pollutant removals associated with certain pollutant control 
options, and the cost estimates related to reducing the pollutants 
with those technology options.
     ``Economic and Environmental Benefit Analysis of the 
Final Effluent Limitations Guidelines and Standards for the 
Concentrated Aquatic Animal Production Point Source Category [EPA-
821-R-04-013] referred to in this preamble as the Economic and 
Environmental Benefit Analysis or EEBA. This document presents the 
methodology used to assess economic impacts, environmental impacts 
and benefits of the final rule. The document also provides the 
results of the analyses conducted to estimate the projected impacts 
and benefits.

    Major supporting documents are available in hard copy from the 
National Service Center for Environmental Publications (NSCEP), U.S. 
EPA/NSCEP, P.O. Box 42419, Cincinnati, Ohio, USA 45242-2419, (800) 490-
9198, www.epa.gov/ncepihom. You can obtain electronic copies of this 
preamble and rule as well as major supporting documents at EPA Dockets 
at www.epa.gov/edocket and at www.epa.gov/guide/aquaculture.

D. What Process Governs Judicial Review for Today's Final Rule?

    Under Section 509(b)(1) of the Clean Water Act (CWA), judicial 
review of today's effluent limitations guidelines and standards may be 
obtained by filing a petition for review in the United States Circuit 
Court of Appeals within 120 days from the date of promulgation of these 
guidelines and standards. For judicial review purposes, this final rule 
is promulgated as of 1 pm (Eastern time) on September 7, 2004 as 
provided at 40 CFR 23.2. Under section 509(b)(2) of the CWA, the 
requirements of this regulation may not be challenged later in civil or 
criminal proceedings brought by EPA to enforce these requirements.

E. What Are the Compliance Dates for Today's Final Rule?

    Existing direct dischargers must comply with today's limitations 
based on the best practicable control technology currently available 
(BPT), the best conventional pollutant control technology (BCT), and 
the best available technology economically achievable (BAT) as soon as 
their National Pollutant Discharge Elimination System (NPDES) permits 
include such limitations. Generally, this occurs when existing permits 
are reissued. New direct discharging sources must obtain an NPDES 
permit for the discharge and comply with applicable new source 
performance standards (NSPS) on the date the new sources begin 
discharging. For purposes of NSPS, a source is a new source if it 
commences construction after September 22, 2004.

F. How Does EPA Protect Confidential Business Information (CBI)?

    Certain information and data in the record supporting the final 
rule have been claimed as CBI and, therefore, EPA has not included 
these materials in the record that is available to the public in the 
Water Docket. Further, the Agency has withheld from disclosure some 
data not claimed as CBI because release of this information could 
indirectly reveal information claimed to be confidential. To support 
the rulemaking while preserving confidentiality claims, EPA is 
presenting in the public record certain information in aggregated form, 
masking facility identities, or using other strategies.

Table of Contents

I. General Information
    A. Does This Action Apply to Me?
    B. How Can I Get Copies of This Document and Other Related 
Information?
    C. What Other Information Is Available To Support This Final 
Rule?
    D. What Process Governs Judicial Review for Today's Final Rule?
    E. What Are the Compliance Dates for Today's Final Rule?
    F. How Does EPA Protect CBI?
II. Definitions, Acronyms, and Abbreviations Used in This Document
III. Under What Legal Authority Is This Final Rule Issued?
IV. What Is the Statutory and Regulatory Background to This Rule?
    A. Clean Water Act
    B. Section 304(m) Consent Decree
    C. Clean Water Act Requirements Applicable to CAAP Facilities
V. How Was This Final Rule Developed?
    A. September 2002 Proposed Rule
    B. December 2003 Notice of Data Availability
    C. Public Comments
    D. Public Outreach
VI. What Are Some of the Significant Changes in the Content of the 
Final Rule and the Methodology Used To Develop it?
    A. Subcategorization
    B. Regulated Pollutants
    C. Treatment Options Considered
    D. Reporting Requirements
    E. Costs
    F. Economic Impacts
    G. Loadings
    H. Environmental Assessment and Benefits Analysis
VII. Who Is Subject to This Rule?
    A. Who Is Subject to This Rule?
    B. What if a facility uses more than one production system?
    C. What Wastewater Discharges Are Covered?
VIII. What Are the Requirements of the Final Rule and the Basis for 
These Requirements?
    A. What Technology Options Did EPA Consider for the Final Rule?
    B. What Are the Requirements for the Flow-Through and 
Recirculating Systems Subcategory?
    C. What Are the Requirements for the Net Pen Subcategory?
    D. What Monitoring Does the Final Rule Require?
    E. What Are the Final Rule's Notification, Recordkeeping, and 
Reporting Requirements?
IX. What Are the Costs and Economic Impacts Associated With This 
Rule?
    A. Compliance Costs
    B. Economic Impacts
    C. What Do the Cost-Reasonableness Analyses Show?
X. What Are the Environmental Benefits for This Rule?
    A. Summary of the Environmental Benefits
    B. Non-Monetized Benefits
    C. Monetized Benefits
XI. What Are the Non-Water Quality Environmental Impacts of This 
Rule?
    A. Air Emissions
    B. Energy Consumption
    C. Solid Waste Generation
XII. How Will This Rule Be Implemented?
    A. Implementation of Limitations and Standards for Direct 
Dischargers
    B. Upset and Bypass Provisions
    C. Variances and Modifications
    D. Best Management Practices
    E. Potential Tools To Assist With the Remediation of Aquaculture 
Effluents
XIII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Congressional Review Act

II. Definitions, Acronyms, and Abbreviations Used in This Document

    Act--The Clean Water Act.

[[Page 51894]]

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

III. Under What Legal Authority Is This Final Rule Issued?

    The U.S. Environmental Protection Agency is promulgating these 
regulations under the authority of Sections 301, 304, 306, 307, 308, 
402, and 501 of the Clean Water Act, 33 U.S.C. 1311, 1314, 1316, 1318, 
1342, and 1361.

IV. What Is the Statutory and Regulatory Background to This Rule?

A. Clean Water Act

    Congress passed the Federal Water Pollution Control Act (1972), 
also known as the Clean Water Act (CWA),

[[Page 51895]]

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

[[Page 51896]]

a principal national means of controlling the direct discharge of toxic 
and nonconventional pollutants. The factors considered in assessing BAT 
include the cost of achieving BAT effluent reductions, the age of 
equipment and facilities involved, the process employed, potential 
process changes, non-water quality environmental impacts including 
energy requirements, economic achievability, and such other factors as 
the Administrator deems appropriate. The Agency retains considerable 
discretion in assigning the weight to be accorded these factors. 
Generally, EPA determines economic achievability on the basis of total 
costs to the industry and the effect of compliance with BAT limitations 
on overall industry and subcategory financial conditions. As with BPT, 
where existing performance is uniformly inadequate, BAT may reflect a 
higher level of performance than is currently being achieved based on 
technology transferred from a different subcategory or category. BAT 
may be based upon process changes or internal controls, even when these 
technologies are not common industry practice.
4. New Source Performance Standards (NSPS)--Section 306 of the CWA
    New Source Performance Standards reflect effluent reductions that 
are achievable based on the best available demonstrated control 
technology. New facilities have the opportunity to install the best and 
most efficient production processes and wastewater treatment 
technologies. As a result, NSPS should represent the most stringent 
controls attainable through the application of the best available 
demonstrated control technology for all pollutants (i.e., conventional, 
nonconventional, and priority pollutants). In establishing NSPS, EPA is 
directed to take into consideration the cost of achieving the effluent 
reduction, any non-water quality environmental impacts, and energy 
requirements.

B. Section 304(m) Consent Decree

    Section 304(m) of the CWA requires EPA every two years to publish a 
plan for reviewing and revising existing effluent limitations 
guidelines and standards and for promulgating new effluent guidelines. 
On January 2, 1990, EPA published an Effluent Guidelines Plan (see 55 
FR 80) in which the Agency established schedules for developing new and 
revised effluent guidelines for several industry categories. Natural 
Resources Defense Council, Inc., and Public Citizen, Inc., challenged 
the Effluent Guidelines Plan in a suit filed in the U.S. District Court 
for the District of Columbia, (NRDC et al v. Leavitt, Civ. No. 89-
2980). On January 31, 1992, the court entered a consent decree which, 
among other things, established schedules for EPA to propose and take 
final action on effluent limitations guidelines and standards for 
several point source categories. The amended consent decree requires 
EPA to take final action on the Concentrated Aquatic Animal Production 
(CAAP) effluent guidelines by June 30, 2004.

C. Clean Water Act Requirements Applicable to CAAP Facilities

    EPA's existing National Pollutant Discharge Elimination System 
(NPDES) regulations define when a hatchery, fish farm, or other 
facility is a concentrated aquatic animal production facility and, 
therefore, a point source subject to the NPDES permit program. See 40 
CFR 122.24. In defining ``concentrated aquatic animal production (CAAP) 
facility,'' the NPDES regulations distinguish between warmwater and 
coldwater species of fish and define a CAAP facility by, among other 
things, the size of the operation and frequency of discharge.
    A facility is a CAAP facility if it meets the criteria in 40 CFR 
122 appendix C or if it is designated as a CAAP facility by the NPDES 
program director on a case-by-case basis. The criteria described in 
appendix C are as follows. A hatchery, fish farm, or other facility is 
a concentrated aquatic animal production facility if it grows, 
contains, or holds aquatic animals in either of two categories: cold 
water species or warm water species. The cold water species category 
includes facilities where animals are produced in ponds, raceways, or 
other similar structures that discharge at least 30 days per year but 
does not include facilities that produce less than approximately 20,000 
pounds per year or facilities that feed less than approximately 5,000 
pounds during the calendar month of maximum feeding. The warm water 
species category includes facilities where animals are produced in 
ponds, raceways, or other similar structures that discharge at least 30 
days per year, but does not include closed ponds that discharge only 
during periods of excess runoff or facilities that produce less than 
approximately 100,000 pounds per year. 40 CFR part 122, appendix C. 
Today's action does not revise the NPDES regulation that defines CAAP 
facilities.
    Most facilities falling under the definition of CAAP are either 
flow-through, recirculating or net pen systems. These systems discharge 
continuously or discharge 30 days or more per year as defined in 40 CFR 
part 122 and are subject to permitting depending on the production 
level at the facility. Most pond facilities do not require permits 
because ponds generally discharge fewer than 30 days per year and 
therefore generally are not CAAP facilities unless designated by the 
NPDES program director. The NPDES program director can designate a 
facility on a case-by-case basis if the director determines that the 
facility is a significant contributor of pollution to waters of the 
U.S.

V. How Was This Final Rule Developed?

    This section describes the background to development of the 
proposal, the proposed rule, EPA's data collection effort, and changes 
to the proposal EPA considered based on new information and comments on 
the proposal.

A. September 2002 Proposed Rule

    EPA started work on these effluent guidelines in January 2000. EPA 
relied on a federal interagency group known as the Joint Subcommittee 
on Aquaculture as a primary contact for information about the industry. 
The Joint Subcommittee on Aquaculture, authorized by the National 
Aquaculture Act of 1980, 94 Stat. 1198, 16 U.S.C. 2801, et seq, 
operates under the National Science and Technology Council of the 
Office of Science and Technology in the Office of the Science Advisor 
to the President. The National Aquaculture Act's purpose is to promote 
aquaculture in the United States to help meet its future food needs and 
contribute to solving world resource problems. The Act provides for the 
identification of regulatory constraints on the development of 
commercial aquaculture, and for development of a plan identifying 
specific steps the Federal Government can take to remove unnecessarily 
burdensome regulatory barriers to the initiation and operation of 
commercial aquaculture ventures. It also directs Federal agencies with 
functions or responsibilities that may affect aquaculture to perform 
such functions or responsibilities, to the maximum extent practicable, 
in a manner that is consistent with the purpose and policy of the Act. 
The Joint Subcommittee on Aquaculture established the Aquaculture 
Effluents Task Force (AETF) to work with EPA to provide information and 
expertise for the development of this rule. The AETF became an 
instrumental group providing input and comments to EPA. The AETF 
consists of members from various Federal agencies, State governments, 
industry, academia, and

[[Page 51897]]

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

B. December 2003 Notice of Data Availability

    On December 29, 2003, EPA published a Notice of Data Availability 
(NODA) at 68 FR 75068. In the NODA, EPA summarized the data received 
since the proposed rule and described how the Agency might use the data 
for the final rule. The NODA also discussed the second phase of data 
collection, a detailed survey, which EPA conducted in 2002. The 
detailed survey was mailed to a stratified sample population of 
facilities identified from the screener survey. EPA received responses 
from 203 facilities. The surveyed population included a statistically 
representative sample of facilities that reported producing aquatic 
animals with flow-through, recirculating and net pen systems. EPA also 
surveyed a small number of facilities that would not have been subject 
to the proposed requirements. EPA's objective was to further verify the 
assumptions on which it had based its preliminary decision to exclude 
these facilities from the scope of the final rule.
    The detailed data collected through this survey allowed EPA to 
revise the methods used for the proposed rule to estimate costs and 
economic impacts. EPA developed facility-specific costs and economic 
impact assessments for each surveyed facility based on the detailed 
information provided in the survey responses. The detailed information 
included production systems, annual production, and control practices 
and technologies in place at the facility.
    The detailed responses to the second survey provided EPA with 
better information on the baseline level of control technologies and 
operational measures in use at CAAP facilities. Based on this 
understanding, EPA described two modified options in the NODA that EPA 
was considering for the final rule. These options reflected the same 
technologies and practices considered for the proposed regulation, but 
reconfigured the combinations of treatment technologies and practices 
into revised regulatory options.

[[Page 51898]]

    EPA visited 17 additional sites and sampled at one facility in 
response to issues raised in the comments. The NODA discussed the post-
proposal data including site visits and additional sampling. The 
results of EPA's analyses of the data were also presented in the NODA. 
EPA solicited comment on the new data and the conclusions being drawn 
from them.

C. Public Comments

    EPA has prepared a ``Comment Response Document'' that includes the 
Agency's responses to comments submitted on the proposed rule and the 
notice of data availability. All of the public comments, including 
supporting documents, are available for public review in the 
administrative record for this final rule, filed under docket number 
OW-2002-0026.
    The comment period on the proposed rule closed on January 27, 2003. 
EPA received approximately 300 comments, including form letters. EPA 
received comments from sources including the Joint Subcommittee on 
Aquaculture--Aquaculture Effluents Task Force (JSA/AETF), industry 
trade associations, Federal and State agencies, environmental 
organizations, and private citizens. For the NODA, EPA received 20 
comments between December 29, 2003 and February 12, 2004.

D. Public Outreach

    As part of the development of the proposed rule and today's final 
rule, EPA has conducted outreach activities. EPA met with affected and 
interested stakeholders through site visits and sampling trips to 
obtain information on operating and waste management practices at CAAP 
facilities. EPA met numerous times with members of the JSA/AETF and 
conducted outreach with small businesses during the SBREFA process.
    EPA conducted three public meetings to discuss the proposed rule 
during the public comment period for the proposed rule. EPA has 
participated in the industry's conferences to update participants on 
the progress and status of the rule. EPA also held several meetings 
with other federal agencies to discuss issues that potentially affect 
their mission, programs, or responsibilities.
    Moreover, EPA maintains a website that posts information relating 
to the regulation. EPA provided supporting documents for the proposed 
rule on the site. The documents included the Technical Development 
Document, the Draft Guidance for Aquatic Animal Production Facilities 
to Assist in Reducing the Discharge of Pollutants, and the Economic and 
Environmental Impact Analysis. These documents used to support the 
proposed rule and the final supporting documents are available at 
www.epa.gov/guide/aquaculture.

VI. What Are Some of the Significant Changes in the Content of the 
Final Rule and the Methodology Used To Develop It?

    This section describes some of the major changes that EPA made to 
the final rule from that it proposed. This section also describes 
differences in the methodology EPA used in evaluating its options for 
the final rule.

A. Subcategorization

    The proposed regulation included limitations and standards for 
three subcategories: Flow-through systems, recirculating systems and 
net pens. The final rule establishes limitations and standards for the 
same systems but for only two subcategories: A flow-through and 
recirculating systems subcategory and a net pens subcategory. The 
recirculating and flow-through systems are combined into one 
subcategory instead of two separate subcategories.
    As previously noted, flow-through and recirculating systems are 
both land based systems that typically discharge continuously, but can 
occasionally discontinue discharges for short periods of time. The 
principal distinguishing characteristic between these two systems is 
the degree to which water is reused prior to its discharge, with 
recirculating systems typically discharging lower volumes of 
wastewater. In the proposal, EPA distinguished recirculating systems 
from flow-through systems by describing a recirculating system as one 
that typically filters with biological or mechanically supported 
filtration and reuses the water in which the aquatic animals are 
raised. Net pen systems, by contrast, are located in open water and 
have distinctly different characteristics from either recirculating or 
flow-through systems.
    EPA received a number of comments on the distinction between flow-
through and recirculating systems described in the proposed rule. 
Because some flow-through systems also reuse their production water, 
commenters did not believe EPA had adequately distinguished 
recirculating systems from flow-through systems. Some commenters 
encouraged EPA to use hydraulic retention time as a basis for 
distinguishing between flow-through and recirculating systems. However, 
EPA's review of available data showed that there is no clear dividing 
line between the hydraulic retention time in a system that was 
considered a recirculating system and one that was considered a flow-
through system. EPA examined the aquatic animal production literature 
for alternatives for distinguishing recirculating systems and flow-
through systems. Given the difficulty in distinguishing certain flow-
through facilities from recirculating ones, EPA considered whether it 
should combine the two subcategories into one subcategory. EPA 
discussed this in the NODA and solicited comment on this option.
    While some commenters opposed combining these two subcategories, 
EPA has decided to combine flow-through and recirculating systems for 
the purpose of establishing effluent limitations guidelines for the 
following reasons. First, as some commenters recognized, both flow-
through and recirculating systems may reuse water and employ similar 
measures to maintain water quality including mechanical filtration. 
Second, the characteristic of wastewater discharged from facilities 
that are identified as recirculating systems that are similar to the 
wastewater from the off-line or solids treatment units at flow-through 
systems. Both waste streams are characterized by high levels of 
suspended solids, which can be effectively treated through properly 
designed and operated treatment systems employing either settling 
technology combined with effective feed management or a carefully 
controlled feed management system alone. Therefore, EPA decided that 
the same requirements should apply both to wastewater discharged from 
recirculating production systems and wastewater discharged from off-
line solids treatment units at flow-through facilities. Moreover, EPA 
had based the proposed limits for both of these waste streams on the 
same data set. For the foregoing reasons, EPA has concluded that this 
change in the organization of the final rule does not substantively 
change the requirements.
    Commenters also pointed to differences in BMPs employed at the 
different production systems. EPA recognizes that there are differences 
between recirculating systems and flow-through systems. EPA has 
concluded, however, that the control technology selected as the basis 
for the final narrative limitations will effectively remove pollutants 
from both systems to the same degree. Further, the BMP requirements in 
the final rule for this subcategory are flexible enough to accommodate 
differences in the specific

[[Page 51899]]

practices appropriate for the two types of production systems. Finally, 
commenters were concerned that collapsing these two systems into one 
subcategory could be interpreted as indicating that EPA favors 
recirculating systems over flow-through systems and implying that flow-
through systems should be modified to become recirculating systems. 
This certainly is not EPA's intention and the Agency is not suggesting 
that recirculating systems should replace existing flow-through systems 
or be given a preference in the construction of new systems. The 
primary reason to collapse these two systems into one subcategory is to 
eliminate redundancy in the CFR.

B. Regulated Pollutants

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

C. Treatment Options Considered

    EPA evaluated three treatment options as the basis for BPT/BCT/BAT 
proposed limitations for the flow-through and recirculating 
subcategories and three options for the net pen subcategory. For flow-
through and recirculating systems, EPA proposed a numeric limitation 
for TSS. For Option 1, the least stringent option, EPA considered TSS 
limitations based on primary settling as well as the use of BMPs to 
control the discharge of solids from the production system. The second 
treatment option (Option 2) considered by EPA for establishing TSS 
limitations was based on Option 1 technologies plus the addition of 
reporting requirements if INAD or extralabel drug use were used in the 
production systems, plus the implementation of BMPs to ensure proper 
storage, handling and disposal of drugs and chemicals and the 
prevention of escapes when non-native species are produced. EPA based 
limitations for the most stringent option (Option 3) on primary 
settling

[[Page 51900]]

and the addition of secondary solids settling, in conjunction with 
BMPs, to control the discharge of solids from the production system. 
This option also included BMPs to control drugs, chemicals and non-
native species and the reporting of drugs. For New Source Performance 
Standards (NSPS), EPA considered the same three options.
    EPA evaluated three treatment options for the net pen subcategory. 
The least stringent option, Option 1, required feed management and 
operational BMPs for solids control. Option 2 consisted of the same 
practices and technology as Option 1 plus a BMP plan to address drugs, 
chemicals, pathogens, and non-native species and general reporting 
requirements for the use of certain drugs and chemicals. Option 3, the 
most stringent option, included the requirements of the first two 
options as well as active feed monitoring to control the supply of feed 
in the production units. Many existing facilities use active feed or 
real time monitoring to track the rate of feed consumption and detect 
uneaten feed passing through the nets. These systems may include the 
use of devices such as video cameras, digital scanning sonar detection, 
or upwellers, in addition to good husbandry and feed management 
practices. These systems and practices allow facilities to cease 
feeding the aquatic animals when a build-up of feed or over-feeding is 
observed. EPA considered the same treatment options for NSPS.
    The NODA described two additional options that EPA was considering 
for flow-through and recirculating systems, but did not identify any 
new options for net pens. These two options contained the same 
treatment technologies and practices described in the three options 
considered for the proposed rule but in slightly different 
combinations.
    The NODA Option A included primary solids treatment, a reporting 
requirement for the INAD and extralabel drug uses, and the 
implementation of BMPs to control drugs and chemicals. In addition to 
Option A requirements, Option B included secondary solids removal 
treatment or, alternatively, the implementation of BMPs for feed 
management, and solids handling to control the discharge of solids.
    As previously explained, for flow-through or recirculating systems, 
today's final rule does not establish numeric limitations for total 
suspended solids (TSS) but does include narrative limitations requiring 
the solids control measures and operational practices described as part 
of Option B for BPT/BCT/BAT limitations and NSPS. These include 
requirements to minimize the discharge of solids. It also requires 
facilities to develop and implement practices designed to prevent the 
discharge of spilled drugs and pesticides, inspection and maintenance 
protocols designed to prevent the discharge of pollutants as a result 
of structural failure, training of personnel, various recordkeeping 
requirements, and documentation of the implementation of these 
requirements in a BMP plan which is maintained on site and available to 
the permitting authority upon request.
    For net pens, the final rule establishes non-numeric, narrative 
limitations that are similar to those adopted for flow-through and 
recirculating systems. Thus, the limitations require minimization of 
feed input, proper storage of drugs, pesticides and feed, routine 
inspection and maintenance of the production and wastewater treatment 
systems, training of personnel, and appropriate recordkeeping. 
Compliance with these requirements must be documented in a BMP plan 
which describes how the facility is minimizing solids discharges 
through feed management and how it is complying with prohibitions on 
the discharge of feed bags and other solid waste materials. Further, 
net pens must minimize the accumulation of uneaten feed beneath the 
pens through active feed monitoring and management strategies.

D. Reporting Requirements

    EPA's proposed rule would have required permittees to report the 
use of INADs and extralabel use of both drugs and chemicals. In the 
final rule, EPA is modifying the proposed requirement, by deleting the 
reporting requirements for chemicals, including pesticides, and by 
further limiting the reporting requirement for drugs, as described 
below. EPA used the term ``chemicals'' in the proposed rule to refer to 
registered pesticides.
    EPA's decision not to include pesticides in the final reporting 
requirements is based on the language in the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA) and the regulations that 
implement the statute. FIFRA Section 5 authorizes EPA to allow field 
testing of pesticides under development through the issuance of 
Experimental Use Permits. Further, FIFRA Section 18 authorizes EPA to 
allow States to use a pesticide for an unregistered use for a limited 
time if EPA determines that emergency conditions exist. Under both of 
these provisions the applicant is required to submit information 
concerning the environmental risk associated with the pesticide use as 
part of the application for the permit or exemption. Also in both cases 
the permittee or the State or Federal authority must report immediately 
to EPA any adverse effects from the use. Prior to issuing an emergency 
exemption, EPA is required to determine that the exemption will not 
cause unreasonable adverse effects on the environment (see 40 CFR 
166.25(b)(1)(ii)) and that the pesticide is likely to be used in 
compliance with the requirements imposed under the exemption (see 40 
CFR 166.25(b)(1)(iii)). EPA's regulation further specifies that the 
applicant for an emergency exemption must coordinate with other 
affected State or Federal agencies to which the requested exemption is 
likely to be of concern. The application must indicate that the 
coordination has occurred, and any comments provided by the other 
agencies must be submitted to EPA with the application (see 40 CFR 
166.20(a)(8)).
    In contrast, the FDA's regulations for Investigative New Animal 
Drugs (INADs) exempt INADs from the requirement to conduct an 
Environmental Assessment (see 21 CFR 25.20 and 25.33). As a policy 
matter, FDA encourages INAD sponsors to notify permitting authorities 
of the use of an INAD. There is, however, no requirement that the 
sponsors comply. Therefore, EPA considers the reporting of INADs in 
today's regulation necessary to ensure that permit writers are aware of 
the potential for discharge of the INAD and can take action as 
necessary in authorized circumstances.
    EPA is providing an exception to the requirement to report INAD 
use. When an INAD has already been approved for use in another species 
or to treat another disease and is applied at a dosage that does not 
exceed the approved dosage, reporting is not required if it will be 
used under similar conditions. The requirement that the use be under 
similar conditions is intended to limit the exception to cases where 
the INAD use would not be expected to produce significantly different 
environmental impacts from the previously approved use. For example, 
use of a drug that had been previously approved for a freshwater 
application as an INAD in a marine setting would not be considered a 
similar condition of use, since marine ecosystems may have markedly 
different vulnerabilities than freshwater ecosystems. Similarly, the 
use of a drug approved to treat terrestrial animals as an INAD to treat 
aquatic animals would not be considered a similar condition of use. In 
contrast, the use of a drug to treat fish in a freshwater system that 
was previously approved for a different

[[Page 51901]]

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

[[Page 51902]]

water, sediment, and the aquatic animals. The permitting authority may 
further specify in the permit what constitutes a material discharge of 
pollutants that would trigger the reporting requirements. The permittee 
must report the failure of the containment system within 24 hours of 
discovery of the failure. The permittee must notify the permitting 
authority orally and describe the cause of the failure in the 
containment system and identify materials that were discharged as a 
result of this failure. Further, the facility must provide a written 
report within seven days of discovery of the failure documenting the 
cause, the estimated time elapsed until the failure was repaired, an 
estimate of the material released as a result of the failure, and steps 
being taken to prevent a reoccurrence.

E. Costs

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

[[Page 51903]]

industry to a range of processes and treatment systems. We contacted 
facilities to get site-specific configuration information where 
possible.
    In revising cost estimates, EPA paid particular attention to:
    1. Size of tanks, raceways, and culture units;
    2. Labor rates;
    3. Treatment components in place;
    4. BMPs and plans in place;
    5. Daily operations at the facility.
    Site visits and analysis of the detailed surveys indicated that 
raceways and quiescent zones are cleaned as necessary to maintain 
system process water quality.
    In evaluating facilities for the need to use additional solids 
controls, EPA first checked for evidence of a good feed management 
program. If the facility reported they practice feed management, EPA 
looked for evidence of solids management and good operation of the 
physical plant, including regular cleaning and maintenance of feed 
equipment and solids collection devices (e.g., quiescent zones, 
sedimentation basins, screens, etc.). To evaluate the effectiveness of 
a facility's solids control practices, we calculated feed conversion 
ratios (FCRs) using pounds of feed per pound of live product (as 
reported in the detailed survey) and considered existing solids control 
equipment. We assumed facilities lacking evidence of good feed 
management or solids control programs would incur additional costs to 
improve or establish them.
    EPA estimated FCRs from data in the detailed survey and follow-up 
with some facilities and compared FCRs for groups of facilities (i.e., 
combinations of ownership, species and production system types such as 
commercial trout flow-through facilities or government salmon flow-
through facilities). We found a wide range of FCRs (reported by 
facilities in their detailed surveys, which were validated by call 
backs to the facility) among apparently similar facilities within 
ownership-species-production system groupings.
    For example, we had good data for 24 of 60 government trout 
producers using flow-through systems. They reported a range of FCRs of 
0.79 to 1.80 with a median FCR of 1.30. If an individual facility's 
reported FCR was significantly greater than the median, EPA further 
evaluated the facility to ascertain the reason for the higher FCR. 
Facilities that produce larger fish, such as broodstock, might have 
higher FCRs because the larger fish produce less flesh per unit of 
food. Facilities with fluctuating water temperatures could also be less 
efficient than facilities with constant water temperatures. We did not 
apply costs for solids control BMPs for facilities with reasonable 
explanations for the higher FCRs. We evaluated facilities that did not 
report FCRs or provide enough data for an estimate by using a randomly 
selected FCR, which is described in Chapter 10 of the Technical 
Development Document (DCN 63009).
    For those facilities that required additional solids controls, EPA 
evaluated both feed management and the installation of secondary solids 
polishing technologies. EPA received comments on the use of microscreen 
filters and EPA agrees with concerns raised in comments that the cost 
associated with enclosing the filter in a heated structure would be 
prohibitive. EPA found that the effective operation of microscreen 
filters requires that they be enclosed in heated buildings to prevent 
freezing when located in cold climates. EPA's revised estimates of 
costs for secondary solids polishing are not based on the application 
of microscreen filters unless the detailed survey response indicated 
that such a structure existed at the site. When the detailed survey did 
not indicate a structure at the site, EPA estimated costs for a second 
stage settling structure rather than a microscreen filter. Based on 
data from two of EPA's sampling episodes at CAAP facilities, this 
technology will achieve the proposed limits for TSS.
    We also considered the use of activated carbon filtration to treat 
effluent containing drug or pesticide active ingredients from 
wastewater, but rejected controls for these materials. Research 
indicates that this technology is effective at treating these 
compounds, and at least one aquatic animal production facility 
installed this technology for water quality reasons. EPA estimated the 
costs for activated carbon treatment as a stand-alone technology. We 
estimated costs on a site-specific basis for facilities which reported 
using drugs and then added these costs for the different regulatory 
options considered to assess the economic achievability of this 
technology. A detailed discussion of how EPA estimated costs is 
available from the public record (DCN 62451). EPA considers these costs 
to be economically unachievable or not affordable on a national scale. 
However, EPA is aware of at least one facility currently using this 
technology, and notes that it is an effective technology for removing 
drug compounds from wastewater.
    EPA estimated the costs to develop and implement escape management 
practices at facilities where (1) the cultured species was not commonly 
produced or regarded as native in the State, (2) the facility was a 
direct discharger, and (3) the species was expected to survive if 
released. (In contrast, producers of a warm water species in a cold 
climate, such as tilapia producers in Minnesota or Idaho, would not 
incur costs for this practice.) Costs for escape prevention include 
staff time for production unit and discharge point inspections and 
maintenance of escape prevention devices. We applied these costs to 
facilities that installed equipment conforming with State requirements 
for facilities producing non-native species (identified by the State). 
Management time includes quarterly production unit and discharge point 
inspections, eight hours a year to review applicable State and Federal 
regulations, and quarterly staff consultations.

F. Economic Impacts

    There are a number of changes made to the costing and economic 
impact methods used for the final rule. EPA used data from the detailed 
survey to project economic impacts for the final rule, in contrast to 
the screener data and frequency factors used for the proposed rule. For 
existing commercial operations, EPA assessed the number of business 
closures among regulated enterprises, facilities, and companies by 
applying market forecasts and using a closure methodology that compares 
projected earnings with and without incremental compliance costs for 
the period 2005 to 2015. Other additional analyses include an analysis 
of moderate impacts by comparing annual compliance costs to sales, an 
evaluation of financial health using a modified U.S. Department of 
Agriculture's four-category (2 x 2) matrix approach, and an assessment 
of possible impacts on borrowing capacity. For new commercial 
operations, EPA evaluates whether the regulatory costs will result in a 
barrier to entry among new businesses. For noncommercial operations, 
EPA evaluated impacts using a budget test that compares incurred 
compliance costs to facility operating budgets. Additional analyses 
investigate whether a facility could recoup increased compliance costs 
through user fees and estimated the associated increase.
    For today's final regulation, EPA modified its forecasting models 
to include certain data for recent years that became available after 
the Agency published its NODA (see 68 FR 75068-75105). This and other 
details about how EPA developed its economic

[[Page 51904]]

impact methodologies is presented in this preamble and in the Economic 
and Environmental Benefit Analysis of the Final Effluent Limitations 
Guidelines and Standards for the Concentrated Aquatic Animal Production 
Industry (``Economic and Environmental Benefit Analysis''), available 
in the rulemaking record.

G. Loadings

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

[[Page 51905]]

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

H. Environmental Assessment and Benefits Analysis

    EPA's environmental assessment and benefits analysis for the 
proposed rule consisted of two efforts. First, EPA reviewed and 
summarized literature it had obtained regarding environmental impacts 
of the aquaculture industry, focusing particularly on segments of the 
industry in the scope of the proposed rule. Second, EPA used estimates 
of pollutant loading reductions associated with the proposed 
requirements to assess improvements to water quality that might arise 
from the proposed requirements, and monetized benefits from these water 
quality improvements.
    EPA's approach to the environmental assessment and benefits 
analysis for the final rule is similar to the approach for the proposed 
rule, except that EPA has incorporated new data, information, and 
methods that were not available at the time of proposal, particularly 
those sources described in Section V of this Preamble. For example, 
literature, discussions, and data submitted by stakeholders both 
through the public comment process on the proposed rule as well as at 
other forums were considered. EPA also used facility-specific data 
provided by or developed from the detailed survey responses. EPA has 
updated and revised its summary of material relating to environmental 
impacts of CAAP facilities in Chapter 7 of the Economic and 
Environmental Benefit Analysis for today's final rule (DCN 63010). 
EPA's revised benefits analysis are described in both Section X of this 
Preamble as well as in Chapter 8 of the Economic and Environmental 
Impact Analysis (DCN 63010).

[[Page 51906]]

VII. Who Is Subject to This Rule?

    This section discusses the scope of the final rule and explains 
what wastewaters are subject to the final limitations and standards.

A. Who Is Subject to This Rule?

    Today's rule applies to commercial (for-profit) and non-commercial 
(generally, publicly-owned) facilities that produce, hold or contain 
100,000 pounds or more of aquatic animals per year. Any 12 month period 
would be considered a year for the purposes of establishing coverage 
under this rule.
    While facilities producing fewer than 100,000 pounds of aquatic 
animals per year are not subject to this rule, in specific 
circumstances they may require NPDES permits that include limitations 
developed on a BPJ basis. An aquatic animal production facility 
producing fewer than 100,000 pounds of aquatic animals per year will be 
subject to the NPDES permit program if it is a CAAP as defined in 40 
CFR 122.24. As explained in the proposed rule, EPA limited the scope of 
the regulation it was considering to facilities that are CAAPs above 
this production threshold.
    The Agency concluded that facilities below the threshold would 
likely experience significant adverse economic impacts if required to 
comply with the proposed limitations. EPA concluded that these smaller 
CAAP facilities would have compliance costs in excess of 3 percent of 
revenues. Further, smaller CAAP facilities account for a smaller 
relative percentage of total CAAP TSS discharges and only limited 
removals would be obtained from the proposed BPT/BCT/BAT control. 67 FR 
57872, 57884. Other types of facilities also not covered by today's 
action include closed pond systems (most of which do not meet the 
regulatory definition of a CAAP facility), molluscan shellfish 
operations, including nurseries, crawfish production, alligator 
production, and aquaria and net pens rearing native species released 
after a growing period of no longer than 4 months to supplement 
commercial and sport fisheries. This last exclusion applies primarily 
to Alaskan non-profit facilities which raise native salmon for release 
into the wild in flow-through systems and then hold them for a short 
time in net pens preceding their release. The flow-through portions of 
these facilities are within the scope of the rule, if they produce 
100,000 pounds or more per year, but the net pen portions would be 
excluded from regulation. EPA determined for the types of excluded 
systems or production operations listed above either that they generate 
minimal pollutant discharges in the baseline or that available 
pollutant control technologies will reduce pollutant loadings from 
these operations by only minimal amounts. For further explanation, see 
the proposal at 67 FR 57572, 57885-86.
    Facilities that indirectly discharge their process wastewater 
(i.e., facilities that discharge to POTWs) are also not subject to 
today's rule. EPA did not propose and is not establishing pretreatment 
standards for existing or new indirect sources. As explained above, the 
bulk of pollutant discharges from CAAP facilities consists of TSS and 
BOD. POTWs are designed to treat these conventional pollutants. 
Moreover, CAAP facilities discharge nutrients in concentrations lower 
in full-flow discharges, and similar in off-line settling basin 
discharges, to nutrient concentrations found in human wastes discharged 
to POTWs. EPA has concluded that the POTW removals of TSS would achieve 
equivalent nutrient removals to those obtained by the options 
considered for this rulemaking for direct dischargers. EPA, therefore, 
concluded that there would be no pass through of TSS or nutrients 
needing regulation. Indirect discharging facilities are still subject 
to the General Pretreatment Standards (40 CFR 403) and any applicable 
local limitations. EPA has also determined that there are few indirect 
dischargers in this industry.

B. What If a Facility Uses More Than One Production System?

    EPA has found that several detailed survey respondents are 
operating more than one type of production system. A facility is 
subject to the rule if the total production from any of the regulated 
production systems meets the production threshold. The facility would 
need to demonstrate compliance with the management practices required 
for each of the regulated production systems it is operating.

C. What Wastewater Discharges Are Covered?

    This rule covers wastewaters generated by the following operations/
processes: Effluent from flow-through, recirculating and net pen 
facilities. The flow-through and recirculating subcategory (Subpart A) 
applies to wastewaters discharged from these systems.
    The type of production system determines the nature, quantity, and 
quality of effluents from CAAP facilities. Flow-through systems 
commonly use raceways or tanks and are characterized by continual flows 
of relatively large volumes of water into and out of the rearing units. 
Some flow-through systems discharge a single, combined effluent stream 
with large water volumes and dilute pollutant concentrations. Other 
flow-through systems have two or more discharge streams, with the 
process water in which the fish are raised as the primary discharge. 
This discharge, referred to as raceway effluent or bulk flow, is 
characterized by a large water volume and dilute pollutant 
concentrations. The secondary discharges from flow-through systems with 
multiple discharges result typically from some form of solids settling 
through an off-line settling basin (OLSB) or other solids removal 
devices. The discharges from off-line settling basins or solids removal 
devices have low water volumes and more concentrated pollutants. The 
supernatant from the OLSB may be discharged through a separate outfall 
or may be recombined prior to discharge with the raceway effluent.
    Recirculating systems may also have two waste streams: Overtopping 
wastewater and filter backwash. Overtopping is a continuous blowdown 
from the production system to avoid the buildup of dissolved solids in 
the production system, and filter backwash is generated by cleaning the 
filter used to treat the water that is being recirculated back to the 
production system. Overtopping wastewater is usually small in volume (a 
fraction of the total system volume on a daily basis) and has higher 
TSS concentrations than a full flow discharge. Filter backwash 
wastewater is typically low in volume and is as concentrated as 
wastewater from similar devices at flow-through systems.
    Net pen systems are located in open waters and thus are 
characterized by the flow and characteristics of the surrounding water 
body and by the addition of raw materials to the pens including feed, 
drugs and the excretions from the confined aquatic animals.

VIII. What Are the Requirements of the Final Regulation and the Basis 
for These Requirements?

    This section describes, by subcategory, the options EPA considered 
and selected as a basis for today's rule. For each subcategory, EPA 
provides a discussion, as applicable, for the options considered for 
each of the regulatory levels identified in the CWA (i.e., BPT, BCT, 
BAT, NSPS). For a detailed discussion of all technology options 
considered in the development of today's final rule, see the proposal 
(see 67 FR 57872), the NODA (see 68 FR 75068) or Chapter 9 of the 
Technical

[[Page 51907]]

Development (TDD) for today's final rule.
    Based on the information in the record for the final CAAP rule, EPA 
has determined that the selected technology for the flow-through and 
recirculating systems subcategory and the net pens subcategory are 
technically available. EPA has also determined that the technology it 
selected as the basis for the final limitations or standards has 
effluent reductions commensurate with compliance costs and is 
economically achievable for the applicable subcategory. EPA also 
considered the age, size, processes, and other engineering factors 
pertinent to facilities in the scope of the final regulation for the 
purpose of evaluating the technology options. None of these factors 
provides a basis for selecting different technologies from those EPA 
has selected as its technology options for today's rule (see Chapter 5 
of the TDD for the final rule for further discussion of EPA's analyses 
of these factors).
    As previously explained, EPA adopted a production threshold cutoff 
as the principal means of reducing economic impacts on small businesses 
and administrative burden for control authorities associated with the 
treatment technologies it considered. EPA notes that certain direct 
dischargers that are not subject to today's effluent limitations or 
standards will still require a NPDES discharge permit developed on a 
case-by-case basis if they are CAAPs as defined in 40 CFR 122.24.
    The new source performance standards (NSPS) EPA is today 
establishing represent the greatest degree of effluent reduction 
achievable through the best available demonstrated control technology. 
In selecting its technology basis for today's new source performance 
standards (NSPS), EPA considered all of the factors specified in CWA 
section 306, including the cost of achieving effluent reductions. EPA 
used the appropriate technology option for developing today's standards 
for new direct dischargers. The new source technology basis for both 
subcategories is equivalent to the technology bases upon which EPA is 
setting BPT/BCT/BAT (see Chapter 9 of the EEBA). EPA has thoroughly 
reviewed the costs of such technologies and has concluded that such 
costs do not present a barrier to entry. The Agency also considered 
energy requirements and other non-water quality environmental impacts 
for the new source technology basis and found no basis for any 
different standards from those selected for NSPS. Therefore, EPA 
concluded that the NSPS technology basis chosen for both subcategories 
constitute the best available demonstrated control technology. For a 
discussion on the compliance date for new sources, see section I.E. of 
today's final rule.

A. What Technology Options Did EPA Consider for the Final Rule?

    Among the options EPA considered for the final rule for flow-
through and recirculating systems in addition to the options presented 
in the proposed rule were (i) establishing no national effluent 
limitations (ii) establishing limitations and BMPs based on technology 
options A and B, and (iii) establishing narrative limitations based on 
BMPs only. Based on analysis presented in the NODA, EPA focused it 
analysis on these latter three options. For net pens, EPA considered 
three options: no national requirements, requirements equivalent to 
those proposed but for new sources only, and essentially the same 
requirements for existing and new sources as those in the proposed 
rule.

B. What Are the Requirements for the Flow-Through and Recirculating 
Systems Subcategory?

    The following discussion explains the BPT/BCT/BAT limitations and 
NSPS EPA is promulgating for flow-through and recirculating system 
facilities.
1. BPT
    After considering the technology options described in the previous 
section and the factors specified in section 304(b)(1)(B) of the CWA, 
EPA is establishing nationally applicable effluent limitations 
guidelines for flow-through and recirculating system CAAP facilities 
producing 100,000 pounds or more of aquatic animals per year for the 
reasons noted above at VIII.A.
    EPA based the final requirements on production and operational 
controls that include a rigorously implemented feed management program. 
Programs of production and operational controls that include feed 
management systems, proper storage of material and adequate solids 
controls, and proper operation and maintenance are in wide use at 
existing flow-through and recirculating system facilities. Based on the 
detailed survey results, EPA estimates that such programs are currently 
used at 61 flow-through and recirculating facilities out of 242 total 
facilities. The costs of effluent removals associated with the 
evaluated practices are reasonable. The cost per pound of pollutant 
removed is $2.77 as measured using the higher of the removals for 
either BOD or TSS at each facility. (The removals for these parameters 
are not summed because of possible overlap and double counting.)
    Based on its review of the data and information it obtained during 
this rulemaking, EPA has concluded that the key element in achieving 
effective pollution control at CAAP facilities is a well-operated 
program to manage feeding, in addition to good solids management. Feed 
is the primary source of TSS (and associated pollutants) in CAAP 
systems, and feed management plans are the principal tool for 
minimizing accumulation of uneaten feed in CAAP wastewater. Excess feed 
in the production system increases the oxygen demand of the culture 
water and increases solids loadings. In addition, solids from the 
excess feed usually settle and are naturally processed with the feces 
from the fish. Excess feed and feces accumulate in the bottom of flow-
through and recirculating systems or below net pens. Ensuring that the 
aquatic animal species being raised receive the quantity of feed 
necessary for proper growth without overfeeding, and the resulting 
accumulation of uneaten feed, is a challenging task. Achieving the 
optimal feed input requires properly designing a site-specific feeding 
regimen that considers production goals, species, rearing unit water 
quality and other relevant factors. It also requires careful 
observation of actual feeding behavior, good record keeping, and on-
going reassessment.
    After full examination of the data supporting EPA's model 
technology, EPA has decided not to establish numerical TSS limitations. 
While the model technology will effectively remove solids to a very low 
level, EPA's data show wide variability, both temporally and across 
facilities, in the actual TSS levels achieved. EPA thus does not have a 
record basis for establishing numeric TSS limitations derived from its 
data set that are appropriate for all sites under all conditions. EPA 
believes that establishing a uniform numeric TSS limitation would 
result in requirements that are too stringent at some sites and not 
stringent enough at others. This is because feed management, while an 
effective pollution reduction technology for this industry, is not 
amenable to the same level of engineering process control as 
traditional treatment technologies used in other effluent guidelines. 
The basis for this conclusion is further explained below.
    Clean Water Act sections 301(b)(1)(A) and 301(b)(2) require point 
sources to achieve effluent limitations that require the application of 
the BPT/BCT/BAT selected by the Administrator under section 304(b). 
Customarily, EPA implements this requirement through the establishment 
of numeric effluent

[[Page 51908]]

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

[[Page 51909]]

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

[[Page 51910]]

Section VI.D., will aid in preventing the release of various materials, 
including live fish.
2. BAT
    EPA is establishing BAT at a level equal to BPT for the flow-
through and recirculating system discharge subcategory. For this 
subcategory, EPA did not identify any available technologies that are 
economically achievable for the subcategory that would achieve more 
stringent effluent limitations than those considered for BPT. Because 
of the nature of the wastes generated from CAAP facilities, advanced 
treatment technologies or practices to remove additional toxic or 
nonconventional pollutants that would be economically achievable on a 
national basis do not exist beyond those already considered.
3. BCT
    EPA evaluated conventional pollutant control technologies and did 
not identify a more stringent technology for the control of 
conventional pollutants for BCT limitations that would be affordable 
than the final requirements considered. Other technologies for the 
control of conventional pollutants include biological treatment, but 
this technology is not affordable for the subcategory as a whole. 
Consequently, EPA has not promulgated BCT limitations or standards 
based on a different technology from that used as the basis for BPT 
limitations and standards.
4. NSPS
    After considering the technology options described in the proposal 
and NODA and evaluating the factors specified in section 306 of the 
CWA, EPA is promulgating standards of performance for new sources equal 
to BPT, BAT, and BCT. There are no more stringent technologies 
available for NSPS that would not represent a barrier to entry for new 
facilities, see Section IX for more discussion of the barrier to entry 
analysis. Because of the nature of the wastes generated in CAAP 
facilities, EPA has not identified advanced treatment technologies or 
practices to remove additional solids (e.g., smaller particle sizes) in 
TSS or other pollutants that would be generally affordable beyond those 
already considered.
    EPA determined that NSPS equal to BAT will not present a barrier to 
entry. The overall impacts from the effluent limitations guidelines on 
new sources would not be any more severe than those on existing 
sources. This is because the costs faced by new sources are generally 
the same as, or lower than, those faced by existing sources. It is 
generally less expensive to incorporate pollution control equipment 
into the design at a new facility than it would be to retrofit the same 
pollution control equipment in an existing plant. At a new facility, no 
demolition is required and space constraints (which can add to 
retrofitting costs if specifically designed equipment must be ordered) 
may be less of an issue.

C. What Are the Requirement for the Net Pen Subcategory?

    The following discussion explains the BPT/BAT/BCT limitations and 
NSPS EPA is promulgating for Net Pen Systems.
1. BPT
    After considering the technology options described in the proposal 
and the factors specified in Section 304(b)(1)(B) of the Clean Water 
Act, EPA is establishing nationally applicable effluent limitations for 
net pen facilities producing 100,000 pounds or more of aquatic animals 
per year. Today's BPT regulations requires CAAP net pen systems, like 
CAAP flow-through and recirculating systems, to comply with specified 
operational practices and management requirements. These requirements 
are non-numeric effluent limitations based on technologies EPA has 
evaluated and determined are cost-reasonable, available technologies.
    Based on the detailed survey results, EPA estimates that such 
programs are currently in use at most or all the net pen systems. As a 
result, the cost to facilities of meeting the BPT requirements is very 
low. To EPA's knowledge, all existing net pen facilities that are 
currently covered by NPDES permits are subject to permit requirements 
comparable to today's limitations. Therefore, EPA concludes that the 
BPT limits are both technically available and cost reasonable for the 
net pen subcategory.
    EPA rejected the establishment of numeric effluent limitations for 
net pens for obvious reasons. Because of the nature of the facilities, 
net pens cannot use physical wastewater control systems except at great 
cost. Located in open waters, nets are suspended from a floating 
structure to contain the crop of aquatic animals. Nets are periodically 
changed to increase the mesh size as the fish grow in order to provide 
more water circulating inside the pen. The pens are anchored to the 
water body floor and sited to benefit from tidal and current action to 
move wastes away from, and bring oxygenated water to, the pen. As a 
result, these CAAP facilities experience a constant in- and out-flow of 
water. Development of a system to capture the water and treat the water 
within the pen would be prohibitively expensive. EPA, therefore, 
rejected physical treatment systems as the basis for BPT limitations. 
Instead, EPA is promulgating narrative effluent limitations.
    As was the case with flow-through and recirculating systems, feed 
management programs are a key element of the promulgated requirements 
for the reasons explained above and in the proposal at 67 FR 57872, 
57887. Consequently, for the control of solids, the final regulation 
requires that net pen CAAP facilities minimize the accumulation of 
uneaten feed beneath the pen through the use of active feed monitoring 
and management practices. Sec.  451.21(a). These strategies may include 
either real-time monitoring (e.g., the use of video monitoring, digital 
scanning sonar, or upweller systems); monitoring of sediment quality 
beneath the pens; monitoring of the benthic community beneath the pens; 
capture of waste feed and feces; or the adoption of other good 
husbandry practices, subject to the permitting authority's approval.
    As noted, feed management systems are effective in reducing the 
quantity of uneaten feed. Facilities should limit the feed added to the 
pens to the amount reasonably necessary to sustain an optimal rate of 
fish growth. In determining what quantity of feed will result in 
minimizing the discharge of uneaten feed while at the same time 
sustaining optimal growth, a facility should consider, among others, 
the following factors: The types of aquatic animals raised, the method 
used to feed the aquatic animals, the facility's production and aquatic 
animal size goals, the species, tides and currents, the sensitivity of 
the benthic community in the vicinity of the pens, and other relevant 
factors. In some areas, deep water and/or strong tides or currents may 
prevent significant accumulation of uneaten feed such that active feed 
monitoring is not needed. Several states with significant numbers of 
net pens (e.g., Washington, Maine) already require feed management 
practices, which may include active feed monitoring, to minimize 
accumulation of feed beneath the pens. Facilities will need to ensure 
that whatever practices they adopt are consistent with the requirements 
of their state NPDES program.
    In order to implement a feed management system, the facility must 
also track feed inputs by maintaining records documenting feed and 
estimates of the numbers and weight of aquatic animals in order to 
calculate

[[Page 51911]]

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

[[Page 51912]]

same pollution control equipment in an existing facility.
    Although EPA is not establishing standards of performance for new 
sources for small cold water facilities (i.e., those producing between 
20,000 and 100,000 pounds of aquatic animals per year), such facilities 
would be subject to existing NPDES regulations and BPT/BAT/BCT permit 
limits developed using the permit writer's ``best professional 
judgment'' (BPJ). EPA, based on its analysis of existing data, 
determined that new facilities would most often produce 100,000 pounds 
of aquatic animals or more per year because of the expense of producing 
the aquatic animals. Generally, the species produced are considered of 
high value and are produced in such quantities to economically justify 
the production. For example, one net pen typically holds 100,000 pounds 
of aquatic animals or more. In reviewing USDA's Census of Aquaculture 
and EPA's detailed surveys, EPA has not identified any existing 
commercial net pen facilities producing fewer than 100,000 pounds of 
aquatic animals per year.
    Offshore aquatic animal production is an area of potential future 
growth. As these types of facilities start to produce aquatic animals, 
those with 100,000 pounds or more per year will be subject to the new 
source requirements established for net pens as well as NPDES 
permitting.

D. What Monitoring Does the Final Rule Require?

    The final rule does not require any effluent monitoring. In the 
case of net pen facilities, however, it does require CAAPs to adopt 
active feed monitoring and management practices that will most often 
include measures to observe the addition of feed to the pen. Net pen 
facilities subject to today's rule must develop and implement active 
feed monitoring and management strategies to minimize the discharge of 
solids and the accumulation of uneaten feed beneath the pen. Many 
existing net pen facilities use a real-time monitoring system such as 
video cameras, digital scanning sonar, or upweller systems to 
accomplish this. With a real-time monitoring system, when uneaten feed 
is observed falling beneath the pen feeding should stop. Depending on 
the location and other site-specific factors at the facility, a 
facility may adopt other measures in lieu of real time monitoring. 
These may include monitoring of sediment or the benthic community 
quality beneath the pens, capture of waste feed and feces or other good 
husbandry practices that are approved by the permitting authority.

E. What Are the Final Rule's Notification, Recordkeeping, and Reporting 
Requirements?

    The final rule establishes requirements for reporting the use of 
spilled drugs, pesticides or feed that result in a discharge to waters 
of the U.S. by CAAP facilities. This provision ensures that, any 
release of spilled drugs, pesticides and feed to waters of the U.S. are 
reported to the permitting authorities to provide them with necessary 
information for any responsive action that may be warranted. This will 
allow regulatory authorities to reduce or avoid adverse impacts to 
receiving waters associated with these spills. EPA is requiring that 
any spill of material that results in a discharge to waters of the U.S. 
be reported orally to the permitting authority within 24 hours of its 
occurrence. A written report shall be submitted within 7 days. 
Facilities are required to report the identity of the material spilled 
and an estimated amount.
    EPA is retaining for the final rule the proposed requirement that 
CAAP facilities report to the Permitting Authority whenever they apply 
certain types of drugs under the following conditions. First, the 
permittee must report drugs prescribed by a veterinarian to treat a 
species or a disease when prescribed for a use which is not an FDA-
approved use (referred to as ``extralabel drug use'') as described 
further below. Second, the permittee must report drugs being used in an 
experimental mode under controlled conditions, known as Investigative 
New Animal Drugs (INADs). In EPA's view, notifying the Permitting 
Authority is necessary to ensure that any potential risk to the 
environment resulting from the use of these drugs can be addressed with 
site-specific remedies where appropriate. EPA strongly encourages 
reporting prior to use where feasible, as this provides the Permitting 
Authority with the opportunity to monitor or control the discharge of 
the drugs while the drugs are being applied. EPA has not made this an 
absolute requirement, however, in recognition of the fact that swift 
action on the part of veterinarians and operators is sometimes 
necessary to respond to and contain disease outbreaks.
    The reporting requirement applies to the permittee and imposes no 
obligation on the prescribing veterinarian. The reporting requirement 
for extralabel drug use is not in any way intended to interfere with 
veterinarians' authority to prescribe extralabel drugs to treat aquatic 
animals or other animals in accordance with FFCDA and 40 CFR Part 530. 
This reporting requirement is promulgated to ensure that permitting 
authorities are aware of the use at CAAPs of extralabel drugs when such 
use may result in the release of the drug to waters of the U.S. Because 
the use is likely to involve adding the drug directly to the rearing 
unit, EPA believes there is a probability that these drugs may be 
released to waters of the U.S..
    The regulation requires that a permittee must provide a written 
report to the permitting authority within seven days of agreeing to 
participate in an INAD study and an oral report preferably in advance 
of use, but in no event later than seven days after starting to use the 
INAD. The first written report must identify the drug, method of 
application, the dosage and what it is intended to treat. The oral 
report must also identify the drug, method of application, and the 
reason for its use. Within 30 days after the use of the drug at the 
facility, the permittee must provide another written report to the 
permitting authority describing the drug, reason for treatment, date 
and time of addition, method of addition and total amount added.
    EPA has similar reporting requirements for extralabel drug use 
except that EPA is not requiring a written report in advance of use.
    The reporting requirement applies only to those drugs that have not 
been previously approved for their intended use. Reporting would not be 
required for EPA registered pesticides and FDA approved drugs for 
aquatic animal uses when used according to label instructions. 
Reporting would only be required for INAD drugs and drugs prescribed by 
a veterinarian for extralabel uses. Because these classes of drugs have 
not been fully evaluated by FDA for the potential environmental 
consequences of the use being made of them EPA considers reporting 
ensures the permitting authority has enough information to make an 
informed response if environmental problems do occur. EPA has included 
an exception to the reporting requirement for cases where the INAD or 
extralabel drug has already been approved under similar conditions for 
use in another species or to treat another disease and is applied at a 
dosage that does not exceed the approved dosage. The requirement that 
the use be under similar conditions is intended to limit the exception 
to cases where the INAD or extralabel drug use would be expected to 
produce significantly different environmental impacts from the 
previously approved

[[Page 51913]]

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

IX. What Are the Costs and Economic Impacts Associated With This Rule?

    This section discusses the costs and economic impact of the rule 
promulgated today.

A. Compliance Costs

    The information below describes the rule's costs and how EPA 
determined these costs. A more detailed discussion of how EPA estimated 
compliance costs is included in the Technical Development Document 
(EPA-821-R-04-012) and the discussion of the economic impacts is 
included in the Economic and Environmental Benefits Analysis report 
(EPA-821-R-04-013). Both of these documents can be found on EPA's Web 
site, www.epa.gov/ost/guide/aquaculture.
1. How Did EPA Estimate the Costs of Compliance With the Final Rule?
    EPA estimated costs associated with regulatory compliance for the 
options it considered to determine the economic

[[Page 51914]]

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

[[Page 51915]]

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


[[Page 51916]]


            Table IX-2.--National Costs: Total by Subcategory
------------------------------------------------------------------------
                                                              Pre-tax
                                                            annualized
                                                           costs ($000,
       Production system                  Owner            2003 dollars)
                                                         ---------------
                                                           Final option
------------------------------------------------------------------------
Flow-through and Recirculating   Commercial.............            $256
 Systems.
                                 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

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

[[Page 51917]]

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

[[Page 51918]]

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

   Table IX-3.--Economic Impacts: Existing Commercial & Noncommercial
                               Operations
------------------------------------------------------------------------
                                           Number of in-
                                               scope          Impacts
             Threshold test                facilities in     projected
                                           the  Analysis    under final
                                                \1\           option
------------------------------------------------------------------------
                          Commercial Operations
------------------------------------------------------------------------
Closure Analysis (discounted cash flow)               69               0
 \2\....................................
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                   34               0
 level) \3\.............................
Credit test >80% (Company level) \3\....              34               1
-----------------------------------------
                      Noncommercial Facilities \6\
------------------------------------------------------------------------
Budget test >3% (all facilities)........             141              19
    State owned only ( with                 106          12 (8)
     user fees) \5\.....................
    Federal owned only..................              33               7
    Alaskan Non-Profit \4\..............               2               0
Budget test >5% (all facilities)........             141              12
    State owned only ( with                 106           8 (8)
     user fees) \5\.....................
    Federal owned only..................              33               4
    Alaskan Non-Profit \4\..............               2               0
Budget test >10% (all facilities).......             141               4
    State owned only ( with                 106           0 (0)
     user fees)\5\......................
    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,
  assuming 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
  parenthesis 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.
 


[[Page 51919]]

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

     Table IX-3.5.--Closure Analysis for Commercial Facilities Under
                          Different Assumptions
------------------------------------------------------------------------
                                           Number of in-
                                               scope         Closures
                                           facilities in     projected
                                           the  analysis    under final
                                                \1\           option
------------------------------------------------------------------------
Closure Analysis (discounted cash flow)               69               0
 \2\....................................
Closure Analysis (Net Income) \2\.......              58               2
Closure Analysis (one out of three                    67              2
 forecasts) \3\.........................
------------------------------------------------------------------------
\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 Impacts?
    EPA was not able to prepare a market model analysis for this rule 
because of the complex interaction between commercial and non-
commercial operations (e.g., trout are raised commercially, but also 
for restoration and recreation), wild catch accounts for a large share 
of the market for some species, and USDA Census data indicate that 
there is a high degree of concentration of specific species, such as 
trout and some other food fish. Literature on estimated measures of 
elasticity of supply and demand is limited and exist for only a few 
species, such as catfish which are not covered by this regulation. The 
Agency does therefore not report quantitative estimates of changes in 
overall supply and demand for aquaculture products and changes in 
market prices. For more information, see Chapter 3.6 of the Economic 
and Environmental Benefit Analysis for the proposed rulemaking 
available in the docket (DCN 63010). However, EPA does not expect 
significant market impacts as a result of today's final rule because 
economic impacts are expected to be low (see discussion above) and the 
overall cost of the rule is low, as compared to the total value of the 
U.S. aquaculture industry. Long-term shifts in supply associated with 
this rule are unlikely given expected continued competition from 
domestic wild harvesters and low-cost foreign suppliers. For additional 
information, see the Economic and Environmental Impact Analysis 
available in the rulemaking record.
4. What Are the Potential Impacts on Foreign Trade?
    Foreign trade impacts are difficult to predict, since agricultural 
exports are determined by economic conditions in foreign markets and 
changes in the international exchange rate for the U.S. dollar. In 
addition, for today's final rule, EPA was not able to perform a market 
model analysis for this rule and did not obtain quantitative estimates 
of changes in overall supply and demand for aquaculture products and 
changes in market prices, as well as changes in traded volumes 
including imports and exports.
    Nevertheless, EPA believes that the impact of this final rule on 
U.S. aquaculture trade will not be significant. Because of the 
relatively small market share of U.S. aquaculture producers in world 
markets, EPA believes that long-term shifts in supply associated with 
this rule are unlikely given expected continued competition from 
domestic wild harvesters and already lower-cost foreign suppliers in 
China and other Asian nations. Under a scenario that assumes the total 
costs of the rule are absorbed by the domestic market, EPA estimates 
that U.S. aquaculture prices would rise by slightly more than 1 cent 
per pound. Under the alternative assumption that all costs are born by 
facility operators, impacts are projected to be small and would not 
significantly affect production (see Section IX.B.2).
5. What Are the Potential Impacts on Communities?
    The communities where aquaculture facilities are located may be 
affected by the final regulation if facilities cut back operations. 
However, EPA projects no commercial facility closures as a result of 
this rule, assuming discounted cash flow (two closures are projected 
using net income as shown in Table IX-3.5), indicating minimal 
likelihood of measurable impacts on (1) direct losses in commercial 
production, revenue, or employment; and (2) local economies and 
employment rates. Should some facilities cut back operations as a 
result of this final regulation, EPA cannot project how great these 
impacts would be as it cannot identify the communities where impacts 
might occur. Under a scenario that assumes the total costs of the rule 
are absorbed by the domestic market, EPA estimates that U.S. 
aquaculture prices would rise by slightly more than 1 cent per pound. 
(See EPA's Economic and Environmental Benefit Analysis.)
    Closures of non-commercial facilities could also result in 
employment impacts on communities. EPA projects four noncommercial 
facilities, with a total employment of 16 employees could experience 
impacts such that they would be vulnerable to closure (i.e., costs 
exceed 10 percent of annual budget). The communities in which these 
facilities are located could experience moderate impacts, but, as noted 
in Section IX.B.2, environmental compliance costs are generally a 
contributing rather than the deciding factor in closure decisions. EPA 
therefore does not expect significant impacts on communities as a 
result of today's final rule.

C. What Do the Cost-Reasonableness Analyses Show?

    EPA performed an assessment of the total cost of the final rule 
relative to the expected effluent reductions. EPA based its ``cost 
reasonableness'' (CR) analysis on estimated costs, loadings, and

[[Page 51920]]

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

                                  Table IX-4.--Cost-Reasonableness: BOD or TSS
----------------------------------------------------------------------------------------------------------------
                                                                      Pre-tax       BOD or TSS         Cost-
                           Subcategory                              annualized     removals (lb)  reasonableness
                                                                   costs ($2003)        \1\        ($2003/pound)
----------------------------------------------------------------------------------------------------------------
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 removals are estimated).

X. What Are the Environmental Benefits for This Rule?

A. Summary of Environmental Benefits

    Today's final action does not establish numeric limits for total 
suspended solids (TSS) or other pollutants from flow-through and 
recirculating systems. It establishes BMPs for solids control, 
materials storage, structural maintenance, recordkeeping, and training. 
The final rule also requires the permittee to develop a BMP plan on-
site describing how the permittee will achieve the BMP requirements and 
make the plan available to the permitting authority upon request. The 
facilities are also to maintain the structural integrity of the aquatic 
animal containment system. The final rule also establishes BMP 
requirements for net pen systems that address feed management, waste 
collection and disposal, discharges associated with transport and 
harvest, carcass removal, materials storage, structural maintenance, 
recordkeeping, and training. Net pen facilities are to develop and 
maintain a BMP plan on-site describing how the permittee is to achieve 
the BMP requirements. The permittee must make the plan available to the 
permitting authority upon request. Both the flow-through and 
recirculating and net pen subcategories have reporting requirements for 
(1) the use of INADs and extralabel drugs use, (2) failure or damage to 
the structural integrity of the aquatic animal containment system, and 
(3) spills of drugs, pesticides and feed which result in discharge of 
pollutants to waters of the U.S. The requirements, according to EPA 
loadings estimates, will reduce facility discharges of TSS, total 
nitrogen (TN), total phosphorus (TP), and biochemical oxygen demand 
(BOD). EPA has also estimated reductions for metals and some feed 
contaminants as a result of these final requirements. EPA could not 
quantify baseline or regulated loads for drugs and pesticides.
    These requirements and loading reductions (TSS, TN, TP, BOD, 
metals, and feed contaminants) could affect water quality, the uses 
supported by varying levels of water quality, and other aquatic 
environmental variables (e.g., primary production and populations or 
assemblages of native organisms in the receiving waters of regulated 
facilities). These impacts may result in environmental benefits, some 
of which have quantifiable, monetizable value to society. For today's 
final action, EPA has only monetized benefits from water quality 
improvements resulting from reductions in TSS, TN, TP, and BOD.

        Table 1.--Summary of Environmental Benefits of Final Rule
------------------------------------------------------------------------
              Type of benefit                  Monetized value ($2003)
------------------------------------------------------------------------
Improved water quality from reduced TSS,    $66,000-$99,000
 TN, TP, and BOD loadings due to improved
 solids control, including feed management
Reduced inputs to receiving water of        not monetized
 metals and feed contaminants
Reduced inputs of drugs and pesticides      not monetized
Reduced inputs of materials as a result of  not monetized
 structural maintenance and material
 storage requirements
------------------------------------------------------------------------

B. Non-Monetized Benefits

1. Metals and Other Additives and Contaminants
    CAAP facilities may release metals and other feed additives and 
contaminants to the environment in limited quantities; proper 
management of solids and other management practices may reduce 
environmental risk from these releases. Trace amounts of metals are 
added to feed in the form of mineral packs to ensure that the essential 
dietary nutrients are provided. In general, FDA establishes safety 
limits for feed additives and must address environmental safety 
concerns associated with such additives under the requirements of the 
Federal Food, Drug, and Cosmetic Act (FFD&CA) and National 
Environmental Policy Act (NEPA). Trace amounts of metals may also be 
present as feed contaminants. Metals may also be introduced into the 
environment from CAAP machinery, equipment, and structures (e.g., net 
pens treated with antifouling copper compounds). Other feed additives 
may include FDA-approved compounds used to improve the coloring of fish 
flesh. Organochlorine contaminants such as polychlorinated biphenyls 
(PCBs) also may be present as trace residues regulated by FDA in some 
fish feeds.
    EPA estimates that today's final rule will reduce total suspended 
solids (TSS) released by CAAP facilities by about half a million pounds 
per year. Metals and other feed contaminants that may be released to 
the environment from CAAP facilities are in large part associated with 
waste solids. EPA estimates that reductions in TSS will be accompanied 
by incidental removals of metals and PCBs. EPA estimated metal 
reductions of approximately 2,700 pounds per year nationally and a 
maximum of PCB reductions of 0.04 lbs

[[Page 51921]]

per year. For further discussion of metals and other feed additives and 
contaminants, see the Economic and Environmental Impact Analysis and 
Technical Development Document for this final rule (DCNs 63010 and 
63009).
2. Drugs and Pesticides
    CAAP facilities employ drugs and pesticides for a variety of 
therapeutic and water treatment purposes. Facilities release treated 
waters that may contain residual amounts of drugs, pesticides, and 
their byproducts directly to the environment. Drugs used for 
therapeutic purposes are regulated by FDA. Prior to approving drugs for 
use, FDA must evaluate the environmental safety of animal drugs as 
required by FFDCA and NEPA. While FDA is required to consider 
environmental impacts of approved and investigational drugs under these 
authorities, the environmental safety of drugs used under FDA's 
``investigational new animal drug'' (INAD) program may not be fully 
characterized. The INAD program is an important mechanism that enables 
the collection of data that can be used to characterize and establish 
the environmental safety of new drugs. For compilations of technical 
literature supporting FDA's environmental assessments of therapeutants 
used at CAAP facilities, see the FDA's Center for Veterinary Medicine 
(CVM) Web site (www.fda.gov/cvm). It should be noted that FDA 
environmental assessments are not site-specific and may not cover all 
discharge scenarios (e.g., multiple dischargers to a single receiving 
water) or applications (e.g., extralabel applications of drugs). For 
additional discussion of this topic, see Chapter 7 of EPA's 
Environmental Impact Analysis for this final rule.
    Today's final rule requires the proper storage of drugs, 
pesticides, and feed to prevent spills that may result in a discharge 
from CAAP facilities. For reasons explained in Section VI.G (Loadings) 
of this Preamble, EPA has not quantified expected reductions in the 
release of drugs and pesticides to the environment nor environmental 
benefits that might result. Today's final rule also requires CAAP 
facilities to report to permitting authorities whenever an 
investigative drug or an extralabel drug is used in amounts exceeding a 
previously approved dosage, as described above in Section VIII.E. This 
requirement is expected to better enable permitting authorities to 
monitor the potential for environmental risks that could result from 
such uses. EPA has not quantified benefits that might arise as a result 
of this requirement.

C. Monetized Benefits

1. Case Study Framework
    As was done for EPA's proposed rule, EPA estimated monetized 
benefits of the regulation based on predicted improvements in water 
quality in the receiving waters of facilities that were expected to 
have load reductions as a result of the rule. EPA's water quality 
modeling for today's final action differs from the proposal modeling, 
however, in that for the final rule, more detailed, facility-specific 
operational and environmental data were obtained, both from information 
provided by facilities on the detailed surveys as well as other 
sources. This more detailed data provided EPA with a better basis for 
developing representative case studies on which to perform water 
quality modeling and valuation and for extrapolating from case studies 
to a national benefit estimate.
    To select a set of representative case studies from among the 
facilities for which EPA had detailed data, EPA assumed that three 
factors primarily drive water quality improvements at any given 
facility: (1) The magnitude of pollutant load reductions under the 
final rule, (2) effluent pollutant concentrations at baseline (prior to 
regulatory reductions), and (3) the ratio of facility effluent flow to 
receiving water streamflow (``dilution ratio''). EPA then created 
categories based on combinations of values (low and high) for each of 
these factors. For example, the ``LLL'' category means facilities with 
``low'' pollutant reductions under the final rule, ``low'' baseline 
effluent concentrations, and ``low'' dilution ratios; this category is 
expected to experience the smallest benefits of the final regulation. 
In this manner, eight categories were created (LLL, LLH, LHL, LHH, HLL, 
HLH, HHL, HHH; see Table 2). EPA then assigned all detailed survey 
facilities with non-zero load reductions in the scope of the final rule 
to an appropriate category based on the three factors described above. 
For more details on the categorization procedure, see Chapter 8 of the 
Economic and Environmental Impact Analysis for today's final action 
[DCN 63010].
    EPA then developed a ``case study'' for one facility in each of the 
five categories expected to experience the greatest water quality 
improvement (EPA did not develop case studies for all categories partly 
because of resource constraints). EPA multiplied the estimated benefits 
for each case study by the total number of facilities assigned to that 
category to estimate a total national benefit for that category. No 
benefits were estimated for the three categories for which case studies 
were not developed. Benefits for these categories are expected to be 
small relative to those included in the analysis. The total national 
benefit estimate was estimated as the sum of benefits for all 
categories.
2. Economic Valuation Method
    Economic research indicates that the public is willing to pay for 
improvements in water quality and several methods have been developed 
to translate changes in water quality to monetized values, as noted in 
EPA's ``Guidelines for Preparing Economic Analyses (EPA-240-R-00-003, 
2003;). At proposal, EPA based the water quality benefits monetization 
on results from a stated-preference survey conducted by Carson and 
Mitchell (1993) (DCN 20157). We divided household willingness-to-pay 
(WTP) values for changes in recreational water ``use classes'' by the 
number of ``water quality index'' points (an index based on water 
quality variables; see below) in each use class. We assigned a portion 
of the value for each unit change to achieving the whole step. 
Recently, EPA developed an alternative approach, also based on Mitchell 
and Carson's work. Mitchell and Carson also expressed their results as 
an equation relating a household's WTP for improved water quality to 
the change in the water quality index and household income. An 
important feature of this approach is that it is less sensitive to the 
baseline use of the water body. This approach is also consistent with 
economic theory in that it exhibits a declining marginal WTP for water 
quality (see more information on this approach in DCNS 40138 and 
40595). While caution must be used in manipulating valuations derived 
from stated preference surveys, this valuation function approach helps 
address some concerns about earlier applications of the water quality 
benefits monetization method. (See DCN 40595 for a more detailed 
discussion).
3. Water Quality Modeling
    As was done for the proposed rule, EPA applied the Enhanced Stream 
Water Quality Model (QUAL2E, http://www.epa.gov/waterscience/wqm/) to 
simulate changes in receiving water quality resulting from reductions 
in TSS, BOD, total nitrogen, and total phosphorus estimated by EPA to 
result from the regulatory requirements of this final rule. QUAL2E is a 
one-dimensional water quality model that assumes steady state flow but 
allows simulation of diurnal variations in temperature, algal 
photosynthesis, and respiration. The model projects water

[[Page 51922]]

quality by solving an advective-dispersive mass transport equation. 
Water quality constituents simulated include conservative substances, 
temperature, bacteria, BOD5, DO, ammonia, nitrate and 
organic nitrogen, phosphate and organic phosphorus, and algae.
    Resource and data limitations constrained the number of QUAL2E 
applications that could be performed. EPA developed a QUAL2E case study 
for the following categories: LHL, LHH, HLH, HHL, and HHH. EPA did not 
prepare case studies for the LLL, LLH, and HLL categories because (a) 
no facilities were in the HLL category and (b) EPA focused modeling 
resources on categories expected to represent a larger proportion of 
benefits. Water quality improvements for facilities in the LLL and LLH 
categories were expected to be smaller than the improvements for the 
facilities in the other categories.
4. Calculation of ``Water Quality Index''
    Simulated water quality changes for each case study must be 
translated into a composite ``index'' value for the monetization method 
described in Section X.B.2 above. EPA more recently developed a six-
parameter WQI (``WQI-6'') based on TSS, BOD, DO, FC, plus nitrate 
(NO3) and phosphate (PO4). The new index more 
completely reflects the type of water quality changes that will result 
from loading reductions for TSS, total nitrogen (TN), total phosphorus 
(TP), and BOD. Final rule benefits presented here were estimated on the 
basis of WQI-6.
5. Estimated National Water Quality Benefits
    EPA monetized water quality benefits for each of the 5 QUAL2E case 
studies performed (Table 2). Using the methods described above, the 
Agency estimates that the total national benefit from water quality 
improvements arising from TSS, BOD, TN, and TP reductions from this 
rule are $66,000--$99,000. This range reflects varying assumptions that 
the Agency implemented to reflect some sources of uncertainty. 
Furthermore, this range of water quality-based benefits of this 
regulation may be uncertain for several reasons including:
     EPA did not estimate benefits for the facilities in the 
LLL and LLH extrapolation categories. However, it is not expected that 
inclusion of these facilities would greatly increase monetized water 
quality benefits.
     EPA's monetization method mainly captures benefits for 
recreational uses of the streams. Economic research indicates that 
there are significant ``non-use'' values associated with some 
dimensions of water quality. Analysis using monetization methods that 
fully captures non-use values could increase the estimated benefits for 
this rule if it significantly affects these dimensions. EPA does not 
have enough information to determine if this is the case.
     Other receiving water impacts are not captured in the 
QUAL2E modeling, such as build-up of organic sediments in stream 
channels. Research included in the administrative record for today's 
final action documents that such accumulations can impair aquatic 
ecosystems. Benefits from reducing these effects are not captured in 
EPA's analysis of water quality-based benefits of today's final action.

  Table 2.--Extrapolated Total National Water Quality Benefit Estimate,
                              Final Option
------------------------------------------------------------------------
                                                            B  Total
                                                        national benefit
                                                               for
               A  Extrapolation category                  extrapolation
                                                            category
                                                             ($2003)
------------------------------------------------------------------------
LLL-LLH...............................................     not estimated
LHL-LHH...............................................     $2,126-$5,330
HLL-HLH...............................................    $6,591-$12,031
HHL-HHH...............................................   $57,497-$81,255
                                                       -----------------
    Total.............................................   $66,214-$98,616
------------------------------------------------------------------------

    In general, however, the relatively small recreational benefits 
projected for the rule suggest that non-monetized benefits categories 
are likely to be small as well.

XI. What Are the Non-Water Quality Environmental Impacts of This Rule?

    Under Sections 304(b) and 306 of the Clean Water Act, EPA may 
consider non-water quality environmental impacts (including energy 
requirements) when developing effluent limitations guidelines and 
standards. Accordingly, EPA has considered the potential impact of 
today's final regulation on air emissions, energy consumption, and 
solid waste generation.

A. Air Emissions

    With the implementation of feed management, the final rule 
decreases the amount of solid waste generated and land applied from 
CAAP facilities. Land application is a common waste disposal method in 
the CAAP industry; therefore, the amount of ammonia released as air 
emissions would be expected to decrease as the quantity of waste 
applied to cropland decreases. EPA estimates the decrease in ammonia 
emissions to be 8,182 pounds of ammonia per year. This is a decrease of 
about 8 % over the ammonia emissions presently estimated for the 
industry. For additional details about air emissions from CAAP 
facilities, see Chapter 11 of the TDD.

B. Energy Consumption

    EPA estimates that implementation of today's rule would result in a 
net decrease in energy consumption for aquaculture facilities. The 
decrease would be based on electricity used today to pump solids from 
raceways to solids settling ponds, which will no longer be generated, 
from wastewater treatment equipment. EPA determined that the decrease 
in energy consumption for flow-through and recirculating systems is 
estimated at 4,900 kilowatt-hour (kW-h). This represents about 1.3 x 
10-\7\ percent of the national generated energy.

C. Solid Waste Generation

    EPA estimates that implementation of today's rule would result in 
an estimated reduction of 2.3 million pounds of sludge, on a wet basis 
(assuming 12 percent solids) for flow-through and recirculating 
facilities. This reduction is due to feed management that results in 
less solid waste generated.

XII. How Will This Rule Be Implemented?

    This section helps permit writers and CAAP facilities implement 
this regulation. This section also discusses the relationship of upset 
and bypass provisions, variances, and modifications to the final 
limitations and standards. For additional implementation information, 
see Chapter 2 of the Technical Development Document for today's rule.

A. Implementation of Limitations and Standards for Direct Dischargers

    Effluent limitations guidelines and new source performance 
standards act as important mechanisms to control the discharges of 
pollutants to waters of the United States. These limitations and 
standards are applied to individual facilities through NPDES permits 
issued by the EPA or authorized States under Section 402 of the Act.
    In specific cases, the NPDES permitting authority may elect to 
establish technology-based permit limits for pollutants not covered by 
this regulation. In addition, where State water quality standards or 
other provisions of State or Federal law require limits on pollutants 
not covered by this regulation (or require more stringent limits or 
standards on covered pollutants in order to attain and maintain water 
quality standards), the

[[Page 51923]]

permitting authority must apply those limitations or standards. See CWA 
Section 301(b)(1)(C).
    The final regulation establishing narrative limitations for the 
flow-through and recirculating system and net pen subcategories 
requires that a point source must meet the prescribed limitations 
expressed as operational practices or ``any modification to these 
requirements as determined by the permitting authority based on its 
exercise of its best professional judgment.'' Sections 451.11 and 
451.21. This provision authorizes the permitting authority to tailor 
the specific NPDES permit limits that implement the guideline 
limitations to individual sites. As previously explained, the final 
narrative requirements, in many cases, require achievement of 
environmental end points. There may be circumstances which require some 
modification to these requirements to best accomplish these 
environmental end points, or to accommodate specific circumstances at a 
particular site. The provision allows the permitting authority to 
address such situations by incorporating in the NPDES permit specific 
tailored conditions that accomplish the intent of the narrative 
limitations. The CWA recognizes that it should provide mechanisms for 
addressing certain unique, site-specific situations in the guidelines 
regulation. Here, EPA has provided upfront in this rule such a 
mechanism.
1. What Are the Compliance Dates for Existing and New Sources?
    New and reissued NPDES permits to direct dischargers must include 
these effluent limitations unless water quality considerations require 
more stringent limits, and the permits must require immediate 
compliance with such limitations. If the permitting authority wishes to 
provide a compliance schedule, it must do so through an enforcement 
mechanism.
    New sources must comply with the new source standards (NSPS) of 
this rule when they commence discharging CAAP wastewater. Because the 
final rule was not promulgated within 120 days of the proposed rule, 
the Agency considers a discharger to be a new source if its 
construction commences after September 22, 2004.
2. Who Does Part 451 Apply To?
    In Section VI.A. of this preamble and Chapter 2 of the TDD, EPA 
provides detailed information on the applicability of this rule. 40 CFR 
part 451 will apply to existing and new concentrated aquatic animal 
production facilities that produce 100,000 pounds or more of aquatic 
animals per year in flow-through, recirculating, and net pen systems. 
There is an exception for net pen systems rearing native species 
released after a growing period of no longer than 4 months to 
supplement commercial and sport fisheries.

B. Upset and Bypass Provisions

    A ``bypass'' is an intentional diversion of the streams from any 
portion of a treatment facility. An ``upset'' is an exceptional 
incident in which there is unintentional and temporary noncompliance 
with technology-based permit effluent limitations because of factors 
beyond the reasonable control of the permittee. EPA's regulations 
concerning bypasses and upsets for direct dischargers are set forth at 
40 CFR 122.41(m) and (n) and for indirect dischargers at 40 CFR 403.16 
and 403.17.

C. Variances and Modifications

    While the CWA requires application of effluent limitations 
established pursuant to section 301 to all direct dischargers, the 
statute also provides for the modification of these national 
requirements in a limited number of circumstances. Moreover, the Agency 
established administrative mechanisms to provide an opportunity for 
relief from the application of the national effluent limitations 
guidelines for categories of existing sources for toxic, conventional, 
and nonconventional pollutants.
1. Fundamentally Different Factors Variances
    EPA will develop effluent limitations or standards different from 
the otherwise applicable requirements if an individual discharging 
facility is fundamentally different with respect to factors considered 
in establishing the limitation of standards applicable to the 
individual facility. Such a modification is known as a ``fundamentally 
different factors'' (FDF) variance.
    Early on, EPA, by regulation provided for the FDF modifications 
from the BPT effluent limitations, BAT limitations for toxic and 
nonconventional pollutants and BCT limitations for conventional 
pollutants for direct dischargers. FDF variances for toxic pollutants 
were challenged judicially and ultimately sustained by the Supreme 
Court. (Chemical Manufacturers Assn v. NRDC, 479 U.S. 116 (1985)).
    Subsequently, in the Water Quality Act of 1987, Congress added new 
Section 301(n) of the Act explicitly to authorize modifications of the 
otherwise applicable BAT effluent limitations or categorical 
pretreatment standards for existing sources if a facility is 
fundamentally different with respect to the factors specified in 
Section 304 (other than costs) from those considered by EPA in 
establishing the effluent limitations or pretreatment standard. Section 
301(n) also defined the conditions under which EPA may establish 
alternative requirements. Under Section 301(n), an application for 
approval of a FDF variance must be based solely on (1) information 
submitted during rulemaking raising the factors that are fundamentally 
different or (2) information the applicant did not have an opportunity 
to submit. The alternate limitation or standard must be no less 
stringent than justified by the difference and must not result in 
markedly more adverse non-water quality environmental impacts than the 
national limitation or standard.
    EPA regulations at 40 CFR Part 125, Subpart D, authorizing the 
Regional Administrators to establish alternative limitations and 
standards, further detail the substantive criteria used to evaluate FDF 
variance requests for direct dischargers. Thus, 40 CFR 125.31(d) 
identifies six factors (e.g., volume of process wastewater, age and 
size of a discharger's facility) that may be considered in determining 
if a facility is fundamentally different. The Agency must determine 
whether, on the basis of one or more of these factors, the facility in 
question is fundamentally different from the facilities and factors 
considered by EPA in developing the nationally applicable effluent 
guidelines. The regulation also lists four other factors (e.g., 
infeasibility of installation within the time allowed or a discharger's 
ability to pay) that may not provide a basis for an FDF variance. In 
addition, under 40 CFR 125.31(b) (3), a request for limitations less 
stringent than the national limitation may be approved only if 
compliance with the national limitations would result in either (a) a 
removal cost wholly out of proportion to the removal cost considered 
during development of the national limitations, or (b) a non-water 
quality environmental impact (including energy requirements) 
fundamentally more adverse than the impact considered during 
development of the national limits.
    The legislative history of Section 301(n) underscores the necessity 
for the FDF variance applicant to establish eligibility for the 
variance. EPA's regulations at 40 CFR 125.32(b)(1) are explicit in 
imposing this burden upon the applicant. The applicant must show that 
the factors relating to the discharge controlled by the applicant's 
permit which are claimed to be fundamentally different are, in fact, 
fundamentally

[[Page 51924]]

different from those factors considered by EPA in establishing the 
applicable guidelines. In practice, very few FDF variances have been 
granted for past ELGs. An FDF variance is not available to a new source 
subject to NSPS or PSNS.
    Facilities must submit all FDF variance applications to the 
appropriate Director (defined at 40 CFR 122.2) no later than 180 days 
from the date the limitations or standards are established or revised 
(see CWA section 301(n)(2) and 40 CFR 122.21(m)(1)(i)(B)(2)). EPA 
regulations clarify that effluent limitations guidelines are 
``established'' or ``revised'' on the date those effluent limitations 
guidelines are published in the Federal Register (see 40 CFR 122.21 
(m)(1)(i)(B)(2)). Therefore, all facilities requesting FDF variances 
from the effluent limitations guidelines in today's final rule must 
submit FDF variance applications to their Director (as defined at 40 
CFR 122.2) no later than February 21, 2005.
2. Economic Variances
    Section 301(c) of the CWA authorizes a variance from the otherwise 
applicable BAT effluent guidelines for nonconventional pollutants due 
to economic factors. The request for a variance from effluent 
limitations developed from BAT guidelines must normally be filed by the 
discharger during the public notice period for the draft permit. Other 
filing time periods may apply, as specified in 40 CFR 122.21(1)(2). 
Specific guidance for this type of variance is available from EPA's 
Office of Wastewater Management.

D. Best Management Practices

    Sections 304(e), 308(a), 402(a), and 501(a) of the CWA authorize 
the Administrator to prescribe BMPs as part of effluent limitations 
guidelines and standards or as part of a permit. EPA's BMP regulations 
are found at 40 CFR 122.44(k). Section 304(e) of the CWA authorizes EPA 
to include BMPs in effluent limitations guidelines for certain toxic or 
hazardous pollutants for the purpose of controlling ``plant site 
runoff, spillage or leaks, sludge or waste disposal, and drainage from 
raw material storage.'' Section 402(a)(1) and NPDES regulations [40 CFR 
122.44(k)] also provide for best management practices to control or 
abate the discharge of pollutants when numeric limitations and 
standards are infeasible. In addition, Section 402(a)(2), read in 
concert with Section 501(a), authorizes EPA to prescribe as wide a 
range of permit conditions as the Administrator deems appropriate in 
order to ensure compliance with applicable effluent limitations and 
standards and such other requirements as the Administrator deems 
appropriate.

E. Potential Tools To Assist With the Remediation of Aquaculture 
Effluents

    A potential option to assist land owners with aquaculture effluent 
quality is the Environmental Quality Incentives Program (EQIP). This is 
a voluntary USDA conservation program. EQIP was reauthorized in the 
Farm Security and Rural Investment Act of 2002 (Farm Bill 2002). The 
Natural Resources Conservation Service (NRCS) administers EQIP funds.
    EQIP applications are accepted throughout the year. NRCS evaluates 
each application using a state and locally developed evaluation 
process. Incentive payments may be made to encourage a producer to 
adopt land management, manure management, integrated pest management, 
irrigation water management and wildlife habitat management practices 
or to develop a Comprehensive Nutrient Management Plan (CNMP). These 
practices would provide beneficial effects on reducing sediment and 
nutrient loads to those aquaculture operations dependent on surface 
water flows. In addition, opportunities exist to provide EQIP funds to 
foster the adoption of innovative cost effective approaches to address 
a broad base of conservation needs, including aquaculture effluent 
remediation. NRCS does not at present have standards that apply 
specifically to waste handling at aquaculture facilities, thus EQIP 
funds for aquaculture projects would only apply to practices related to 
other agricultural aspects of a facility such as CNMPs for the land 
application of solids.

XIII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866, [58 FR 51,735 (October 4, 1993)] the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local or tribal governments or communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that this rule is a ``significant regulatory action.'' As 
such, this action was submitted to OMB for review. Changes made in 
response to OMB suggestions or recommendations will be documented in 
the public record.

B. Paperwork Reduction Act

    The information collection requirements in this rule have been 
submitted for approval to the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The 
information collection requirements are not enforceable until OMB 
approves them.
    EPA has several special reporting and monitoring provisions in this 
regulation as previously explained. The provisions include reporting 
requirements (1) for the use of INAD or extralabel drug uses; (2) for 
failure or damage to the containment system (including the production 
system(s) and all the associated storage and water treatment systems) 
that results in a material discharge of pollutants to waters of the 
U.S; and (3) for spills of drugs, pesticides or feed. Section 308(a) of 
the CWA authorizes the Administrator to require the owner or operator 
of any point source to file reports as required to carry out the 
objectives of the Act. This ELG requires reporting in the event that 
drugs are used which are either under a conditional approval as an 
Investigative New Animal Drugs (INADs) or are prescribed by a licensed 
veterinarian for treatment of a disease or a species that is outside 
the approved use of the specific drug, referred to as extralabel drug 
use, unless the INAD or extralabel drug use is under similar conditions 
and dosages as a previously approved use. EPA believes this reporting 
requirement is appropriate for these classes of drugs, because they 
have not undergone the same degree of review with respect to their 
environmental effects as approved drugs. The final regulation also 
requires reporting when the facility has a failure in the structural 
integrity of the aquatic animal containment systems that results in a 
material discharge of pollutants. EPA believes this reporting is 
necessary

[[Page 51925]]

to alert the permitting authority to the release of large quantities of 
material from these facilities. The rule also allows the permitting 
authority to specify in the permit what constitutes damage and/or 
material discharge of pollutants for particular facilities based on 
consideration of relevant site-specific factors.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; search data sources; complete and 
review the collection of information; and transmit or otherwise 
disclose the information. EPA estimates that the reporting and 
recordkeeping requirements included in today's regulation will result 
in a total annual burden of 45,000 hours and cost $808,000.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is 
approved by OMB, the Agency will publish a technical amendment to 40 
CFR part 9 in the Federal Register to display the OMB control number 
for the approved information collection requirements contained in this 
final rule.

C. Regulatory Flexibility Act

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small 
entities, small entity is defined as: (1) A small business that is 
primarily engaged in concentrated aquatic animal production, as defined 
by North American Industry Classification (NAIC) codes 112511 and 
112519, with no more than $0.75 million in annual revenues; (2) a small 
governmental jurisdiction that is a government of a city, county, town, 
school district or special district with a population of less than 
50,000; and (3) a small organization that is any not-for-profit 
enterprise which is independently owned and operated and is not 
dominant in its field.
    After considering the economic impacts of today's final rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The small 
entities directly regulated by the final rule are primarily commercial 
businesses that fall within the NAIC codes for finfish farming, fish 
hatcheries, and other aquaculture. The Small Business Administration 
size standard for these codes is $0.75 million in annual revenues. 
Among the costed facilities, EPA identified 38 facilities belonging to 
small businesses or organizations. Of the 38, 37 facilities are owned 
by small businesses and 1 is an Alaskan facility operated by a small 
non-profit organization that is not dominant in its field. For the 
purposes of the RFA, Federal, and State governments are not considered 
small governmental jurisdictions, as documented in the rulemaking 
record (DCN 20121). Thus, facilities owned by these governments are not 
considered small entities, regardless of their production levels. EPA 
identified no public facilities owned by small local governments. No 
small organization is projected to incur impacts. Of the 101 commercial 
facilities, 37 ( 37 percent) are owned by small businesses. Under EPA's 
closure analyses no small business is projected to close as a result of 
the final rule, assuming discounted cash flow (two small business 
closures are projected using net income). In addition to considering 
the potential for adverse economic impacts, EPA also evaluated the 
possibility of other, more moderate financial impacts. Expressed as a 
comparison of compliance costs to sales, only 4 facilities belonging to 
small businesses (11 percent of small businesses, and 4 percent of 
commercial facilities) are likely to incur costs that exceed 3 percent 
of sales. One small business fails the USDA credit test.
    Although this final rule will not have a significant economic 
impact on a substantial number of small entities, EPA nonetheless 
designed the rule to reduce the impact on small entities. The scope of 
the final rule is restricted to CAAP facilities that produce 100,000 
lbs/year or more. This means that of the approximately 4,000 
aquaculture facilities nationwide, as identified by USDA's Census of 
Aquaculture, EPA's final regulation applies to an estimated 101 
commercial facilities or approximately 2.6 percent of all operations. 
Among commercial facilities, EPA identifies 38 facilities (37 percent 
of in-scope facilities) as small businesses using SBA's definition. 
Finally, EPA based the final rule on a technology option that has lower 
costs and fewer impacts (including impacts on small businesses) than 
several other technology options that were considered as possible bases 
for the final rule.
    EPA conducted outreach to small entities and convened a Small 
Business Advocacy Review Panel prior to proposal to obtain the advice 
and recommendations of representatives of the small entities that 
potentially would be subject to the rule's requirements. The Agency 
convened the Small Business Advocacy Review Panel on January 22, 2002. 
Members of the Panel represented the Office of Management and Budget, 
the Small Business Administration, and EPA. The Panel met with small 
entity representatives (SERs) to discuss the potential effluent 
guidelines and, in addition to the oral comments from SERs, the Panel 
solicited written input. In the months preceding the Panel, EPA 
conducted outreach with small entities that would potentially be 
affected by this regulation. On January 25, 2002, the SBAR Panel sent 
some initial information for the SERs to review and provide comment on. 
On February 6, 2002, the Panel distributed additional information to 
the SERs for their review. On February 12 and 13, the Panel met with 
SERs to hear their comments on the information distributed in these 
mailings. The Panel also received written comments from the SERs in 
response to the discussions at this meeting and the outreach materials. 
The Panel asked SERs to evaluate how they would be affected and to 
provide advice and recommendations regarding early ideas to provide 
flexibility. See Section 8 of the Panel's Report (DCN 31019) for a 
complete discussion of SER comments. The Panel evaluated the assembled 
materials and small-entity comments on issues related to the elements 
of an Initial Regulatory Flexibility Analysis. A copy of the Panel's 
report is included in the rulemaking docket. EPA provided responses to 
the Panel's most significant findings in the Notice of Proposal 
Rulemaking (67 FR 57918-57920). In general, the requirements of this 
final rule address the concerns raised by SERs and are consistent with 
the Panel's recommendations.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of

[[Page 51926]]

their regulatory actions on State, local, and tribal governments and 
the private sector. Under section 202 of the UMRA, EPA generally must 
prepare a written statement, including a cost-benefit analysis, for 
proposed and final rules with ``Federal mandates'' that may result in 
expenditures to State, local, and tribal governments, in the aggregate, 
or to the private sector, of $100 million or more in any one year. 
Before promulgating an EPA rule for which a written statement is 
needed, section 205 of the UMRA generally requires EPA to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least costly, most cost-effective or least burdensome alternative that 
achieves the objectives of the rule. The provisions of section 205 do 
not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    EPA has determined that this rule does not contain a Federal 
mandate that may result in expenditures of $100 million or more for 
State, local, and tribal governments, in the aggregate, or the private 
sector in any one year. The total annual cost of this rule is estimated 
to be $1.4 million. Thus, today's rule is not subject to the 
requirements of Sections 202 and 205 of UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This rule does not have Federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132. EPA estimates that, when 
promulgated, these revised effluent guidelines and standards will be 
incorporated into NPDES permits without significant additional costs to 
authorized States.
    Further, the revised regulations would not alter the basic State-
Federal scheme established in the Clean Water Act under which EPA 
authorizes States to carry out the NPDES permitting program. EPA 
expects the revised regulations to have little effect, if any, on the 
relationship between, or the distribution of power and responsibilities 
among, the Federal, State and local governments. Thus, Executive Order 
13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on this distribution of power and responsibilities between the 
Federal government and Indian tribes.''
    The final rule does not have tribal implications. It will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
The Executive Order provides that EPA must ensure meaningful and timely 
input by tribal officials in the development of regulatory policies 
that have tribal implications. EPA's rulemaking process has provided 
that opportunity for meaningful and timely input. EPA first published a 
notice of proposed rulemaking for CAAPs in September 2002, requesting 
comment on the proposal. In December 2003, EPA issued a Notice of Data 
Availability describing options for changes to the proposed rule. As 
noted, EPA identified a number of tribal facilities in its screener 
survey, however further evaluation did not identify any in-scope tribal 
facilities based on subsequent evaluation of the detailed survey 
information from a sample of these facilities. Thus EPA has not had a 
basis to have any formal consultation with Tribal officials. EPA has 
however concluded that the final rule will not have a substantial 
direct effect on one or more Indian Tribes, will not impose substantial 
direct compliance costs on Indian tribal governments, nor pre-empt 
tribal law.

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

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that: (1) Is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health and 
safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    This rule is not subject to Executive Order 13045 because it is not 
an economically significant rule under E.O. 12866.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in 
Executive Order 13211, ``actions concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355 
(May 22, 2001)) because it is not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. As part of the 
Agency's consideration of non-water quality impacts, EPA has estimated 
the energy consumption associated with today's requirements. The rule 
will result in a net decrease in energy consumption for flow-through 
and recirculating systems. The decrease would be based on electricity 
used today to pump solids from raceways to solids settling ponds, which 
will no longer be generated, from wastewater treatment equipment. EPA 
estimated the decrease in energy consumption for

[[Page 51927]]

flow-through and recirculating systems at 4,900 kilowatt-hour (kW-h). 
Comparing the annual decrease in electric use resulting from the final 
requirements to national annual energy use, EPA estimates the decrease 
to be 1.3 x 10-\7\ percent of national energy use. 
Therefore, we conclude that this rule is not likely to have any adverse 
energy effects.

I. National Technology Transfer and Advancement Act

    As noted in the proposed rule, Section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (``NTTAA''), Public Law 
104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. The NTTAA directs EPA to provide Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.
    Today's rule does not establish any technical standards, thus NTTAA 
does not apply to this rule.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The requirements of the Environmental Justice Executive Order are 
that EPA will review the environmental effects of major Federal actions 
significantly affecting the quality of the human environment. For such 
actions, EPA reviewers will focus on the spatial distribution of human 
health, social and economic effects to ensure that agency decision 
makers are aware of the extent to which those impacts fall 
disproportionately on covered communities. This is not a major action. 
Further, EPA does not believe this rulemaking will have a 
disproportionate effect on minority or low income communities because 
the technology-based effluent limitations guidelines are uniformly 
applied nationally irrespective of geographic location. The final 
regulation will reduce the negative effects of concentrated aquatic 
animal production industry waste in our nation's waters to benefit all 
of society, including minority and low-income communities. The cost 
impacts of the rule should likewise not disproportionately affect low-
income communities given the relatively low economic impacts of today's 
final rule.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective September 22, 2004.

List of Subjects in 40 CFR Part 451

    Environmental protection, Concentrated aquatic animal production, 
Waste treatment and disposal, Water pollution control.

    Dated: June 30, 2004.
Stephen L. Johnson,
Acting Deputy Administrator.

0
For the reasons set forth in the preamble, chapter I of title 40 of the 
Code of Federal Regulations is amended by adding part 451 to read as 
follows:

PART 451--CONCENTRATED AQUATIC ANIMAL PRODUCTION POINT SOURCE 
CATEGORY

Sec.
451.1 General applicability.
451.2 General definitions.
451.3 General reporting requirements.
Subpart A--Flow-Through and Recirculating Systems Subcategory
451.10 Applicability.
451.11 Effluent limitations attainable by the application of the 
best practicable control technology currently available (BPT).
451.12 Effluent limitations attainable by the application of the 
best available technology economically achievable (BAT).
451.13 Effluent limitations attainable by the application of the 
best conventional technology (BCT).
451.14 New source performance standards (NSPS).
Subpart B--Net Pen Subcategory
451.20 Applicability.
451.21 Effluent limitations attainable by the application of the 
best practicable control technology currently available (BPT).
451.22 Effluent limitations attainable by the application of the 
best available technology economically achievable (BAT).
451.23 Effluent limitations attainable by the application of the 
best conventional technology (BCT).
451.24 New source performance standards (NSPS).

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345(d) and (e), 1361; 42 U.S.C. 241, 242b, 243, 246, 
300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 
Comp., 973.


Sec.  451.1  General applicability.

    As defined more specifically in each subpart, this Part applies to 
discharges from concentrated aquatic animal production facilities as 
defined at 40 CFR 122.24 and Appendix C of 40 CFR Part 122. This Part 
applies to the discharges of pollutants from facilities that produce 
100,000 pounds or more of aquatic animals per year in a flow-through, 
recirculating, net pen or submerged cage system.


Sec.  451.2  General definitions.

    As used in this part:
    (a) The general definitions and abbreviations in 40 CFR part 401 
apply.
    (b) Approved dosage means the dose of a drug that has been found to 
be safe and effective under the conditions of a new animal drug 
application.
    (c) Aquatic animal containment system means a culture or rearing 
unit such as a raceway, pond, tank, net or other structure used to 
contain, hold or produce aquatic animals. The containment system 
includes structures designed to hold sediments and other materials that 
are part of a wastewater treatment system.
    (d) Concentrated aquatic animal production facility is defined at 
40 CFR 122.24 and Appendix C of 40 CFR Part 122.
    (e) Drug means any substance defined as a drug in section 201(g)(1) 
of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321).
    (f) Extralabel drug use means a drug approved under the Federal 
Food, Drug and Cosmetic Act that is not used in accordance with the 
approved label directions, see 21 CFR part 530.
    (g) Flow-through system means a system designed to provide a 
continuous water flow to waters of the United States through chambers 
used to produce aquatic animals. Flow-through systems typically use 
rearing units that are either raceways or tank systems.

[[Page 51928]]

Rearing units referred to as raceways are typically long, rectangular 
chambers at or below grade, constructed of earth, concrete, plastic, or 
metal to which water is supplied by nearby rivers or springs. Rearing 
units comprised of tank systems use circular or rectangular tanks and 
are similarly supplied with water to raise aquatic animals. The term 
does not include net pens.
    (h) Investigational new animal drug (INAD) means a drug for which 
there is a valid exemption in effect under section 512(j) of the 
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360b(j), to conduct 
experiments.
    (i) New animal drug application is defined in 512(b)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C 360b(b)(1)).
    (j) Net pen system means a stationary, suspended or floating system 
of nets, screens, or cages in open waters of the United States. Net pen 
systems typically are located along a shore or pier or may be anchored 
and floating offshore. Net pens and submerged cages rely on tides and 
currents to provide a continual supply of high-quality water to the 
animals in production.
    (k) Permitting authority means EPA or the State agency authorized 
to administer the National Pollutant Discharge Elimination System 
permitting program for the receiving waters into which a facility 
subject to this Part discharges.
    (l) Pesticide means any substance defined as a ``pesticide'' in 
section 2(u) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. 136(u)).
    (m) Real-time feed monitoring means a system designed to track the 
rate of feed consumption and to detect uneaten feed passing through the 
nets at a net pen facility. These systems may rely on a combination of 
visual observation and hardware, including, but not limited to, devices 
such as video cameras, digital scanning sonar, or upweller systems that 
allow facilities to determine when to cease feeding the aquatic 
animals. Visual observation alone from above the pens does not 
constitute real-time monitoring.
    (n) Recirculating system means a system that filters and reuses 
water in which the aquatic animals are produced prior to discharge. 
Recirculating systems typically use tanks, biological or mechanical 
filtration, and mechanical support equipment to maintain high quality 
water to produce aquatic animals.


Sec.  451.3  General reporting requirements.

    (a) Drugs. Except as noted below, a permittee subject to this Part 
must notify the permitting authority of the use in a concentrated 
aquatic animal production facility subject to this Part of any 
investigational new animal drug (INAD) or any extralabel drug use where 
such a use may lead to a discharge of the drug to waters of the U.S. 
Reporting is not required for an INAD or extralabel drug use that has 
been previously approved by FDA for a different species or disease if 
the INAD or extralabel use is at or below the approved dosage and 
involves similar conditions of use.
    (1) The permittee must provide a written report to the permitting 
authority of an INAD's impending use within 7 days of agreeing or 
signing up to participate in an INAD study. The written report must 
identify the INAD to be used, method of use, the dosage, and the 
disease or condition the INAD is intended to treat.
    (2) For INADs and extralabel drug uses, the permittee must provide 
an oral report to the permitting authority as soon as possible, 
preferably in advance of use, but no later than 7 days after initiating 
use of that drug. The oral report must identify the drugs used, method 
of application, and the reason for using that drug.
    (3) For INADs and extralabel drug uses, the permittee must provide 
a written report to the permitting authority within 30 days after 
initiating use of that drug. The written report must identify the drug 
used and include: the reason for treatment, date(s) and time(s) of the 
addition (including duration), method of application; and the amount 
added.
    (b) Failure in, or damage to, the structure of an aquatic animal 
containment system resulting in an unanticipated material discharge of 
pollutants to waters of the U.S. In accordance with the following 
procedures, any permittee subject to this Part must notify the 
permitting authority when there is a reportable failure.
    (1) The permitting authority may specify in the permit what 
constitutes reportable damage and/or a material discharge of 
pollutants, based on a consideration of production system type, 
sensitivity of the receiving waters and other relevant factors.
    (2) The permittee must provide an oral report within 24 hours of 
discovery of any reportable failure or damage that results in a 
material discharge of pollutants, describing the cause of the failure 
or damage in the containment system and identifying materials that have 
been released to the environment as a result of this failure.
    (3) The permittee must provide a written report within 7 days of 
discovery of the failure or damage documenting the cause, the estimated 
time elapsed until the failure or damage was repaired, an estimate of 
the material released as a result of the failure or damage, and steps 
being taken to prevent a reccurrence.
    (c) In the event a spill of drugs, pesticides or feed occurs that 
results in a discharge to waters of the U.S., the permittee must 
provide an oral report of the spill to the permitting authority within 
24 hours of its occurrence and a written report within 7 days. The 
report shall include the identity and quantity of the material spilled.
    (d) Best management practices (BMP) plan. The permittee subject to 
this Part must:
    (1) Develop and maintain a plan on site describing how the 
permittee will achieve the requirements of Sec.  451.11(a) through (e) 
or Sec.  451.21(a) through (h), as applicable.
    (2) Make the plan available to the permitting authority upon 
request.
    (3) The permittee subject to this Part must certify in writing to 
the permitting authority that a BMP plan has been developed.

Subpart A--Flow-Through and Recirculating Systems Subcategory


Sec.  451.10  Applicability.

    This subpart applies to the discharge of pollutants from a 
concentrated aquatic animal production facility that produces 100,000 
pounds or more per year of aquatic animals in a flow-through or 
recirculating system.


Sec.  451.11  Effluent limitations attainable by the application of the 
best practicable control technology currently available (BPT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must meet the following 
requirements, expressed as practices (or any modification to these 
requirements as determined by the permitting authority based on its 
exercise of its best professional judgment) representing the 
application of BPT:
    (a) Solids control. The permittee must:
    (1) Employ efficient feed management and feeding strategies that 
limit feed input to the minimum amount reasonably necessary to achieve 
production goals and sustain targeted rates of aquatic animal growth in 
order to minimize potential discharges of uneaten feed and waste 
products to waters of the U.S.
    (2) In order to minimize the discharge of accumulated solids from 
settling ponds and basins and production systems, identify and 
implement procedures for routine cleaning of

[[Page 51929]]

rearing units and off-line settling basins, and procedures to minimize 
any discharge of accumulated solids during the inventorying, grading 
and harvesting aquatic animals in the production system.
    (3) Remove and dispose of aquatic animal mortalities properly on a 
regular basis to prevent discharge to waters of the U.S., except in 
cases where the permitting authority authorizes such discharge in order 
to benefit the aquatic environment.
    (b) Materials storage. The permittee must:
    (1) Ensure proper storage of drugs, pesticides, and feed in a 
manner designed to prevent spills that may result in the discharge of 
drugs, pesticides or feed to waters of the U.S.
    (2) Implement procedures for properly containing, cleaning, and 
disposing of any spilled material.
    (c) Structural maintenance. The permittee must:
    (1) Inspect the production system and the wastewater treatment 
system on a routine basis in order to identify and promptly repair any 
damage.
    (2) Conduct regular maintenance of the production system and the 
wastewater treatment system in order to ensure that they are properly 
functioning.
    (d) Recordkeeping. The permittee must:
    (1) In order to calculate representative feed conversion ratios, 
maintain records for aquatic animal rearing units documenting the feed 
amounts and estimates of the numbers and weight of aquatic animals.
    (2) Keep records documenting the frequency of cleaning, 
inspections, maintenance and repairs.
    (e) Training. The permittee must:
    (1) In order to ensure the proper clean-up and disposal of spilled 
material adequately train all relevant facility personnel in spill 
prevention and how to respond in the event of a spill.
    (2) Train staff on the proper operation and cleaning of production 
and wastewater treatment systems including training in feeding 
procedures and proper use of equipment.


Sec.  451.12  Effluent limitations attainable by the application of the 
best available technology economically achievable (BAT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must meet the following 
requirements representing the application of BAT: The limitations are 
the same as the corresponding limitations specified in Sec.  451.11.


Sec.  451.13  Effluent limitations attainable by the application of the 
best conventional technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must meet the following 
requirements representing the application of BCT: The limitations are 
the same as the corresponding limitations specified in Sec.  451.11.


Sec.  451.14  New source performance standards (NSPS).

    Any point source subject to this subpart that is a new source must 
meet the following requirements: The standards are the same as the 
corresponding limitations specified in Sec.  451.11.

Subpart B--Net Pen Subcategory


Sec.  451.20  Applicability.

    This subpart applies to the discharge of pollutants from a 
concentrated aquatic animal production facility that produces 100,000 
pounds or more per year of aquatic animals in net pen or submerged cage 
systems, except for net pen facilities rearing native species released 
after a growing period of no longer than 4 months to supplement 
commercial and sport fisheries.


Sec.  451.21  Effluent limitations attainable by the application of the 
best practicable control technology currently available (BPT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must meet the following 
requirements, expressed as practices (or any modification to these 
requirements as determined by the permitting authority based on its 
exercise of its best professional judgment) representing the 
application of BPT:
    (a) Feed management. Employ efficient feed management and feeding 
strategies that limit feed input to the minimum amount reasonably 
necessary to achieve production goals and sustain targeted rates of 
aquatic animal growth. These strategies must minimize the accumulation 
of uneaten food beneath the pens through the use of active feed 
monitoring and management practices. These practices may include one or 
more of the following: Use of real-time feed monitoring, including 
devices such as video cameras, digital scanning sonar, and upweller 
systems; monitoring of sediment quality beneath the pens; monitoring of 
benthic community quality beneath the pens; capture of waste feed and 
feces; or other good husbandry practices approved by the permitting 
authority.
    (b) Waste collection and disposal. Collect, return to shore, and 
properly dispose of all feed bags, packaging materials, waste rope and 
netting.
    (c) Transport or harvest discharge. Minimize any discharge 
associated with the transport or harvesting of aquatic animals 
including blood, viscera, aquatic animal carcasses, or transport water 
containing blood.
    (d) Carcass removal. Remove and dispose of aquatic animal 
mortalities properly on a regular basis to prevent discharge to waters 
of the U.S.
    (e) Materials storage.
    (1) Ensure proper storage of drugs, pesticides and feed in a manner 
designed to prevent spills that may result in the discharge of drugs, 
pesticides or feed to waters of the U.S.
    (2) Implement procedures for properly containing, cleaning, and 
disposing of any spilled material.
    (f) Maintenance.
    (1) Inspect the production system on a routine basis in order to 
identify and promptly repair any damage.
    (2) Conduct regular maintenance of the production system in order 
to ensure that it is properly functioning.
    (g) Recordkeeping.
    (1) In order to calculate representative feed conversion ratios, 
maintain records for aquatic animal net pens documenting the feed 
amounts and estimates of the numbers and weight of aquatic animals.
    (2) Keep records of the net changes, inspections and repairs.
    (h) Training. The permittee must:
    (1) In order to ensure the proper clean-up and disposal of spilled 
material adequately train all relevant facility personnel in spill 
prevention and how to respond in the event of a spill.
    (2) Train staff on the proper operation and cleaning of production 
systems including training in feeding procedures and proper use of 
equipment.


Sec.  451.22  Effluent limitations attainable by the application of the 
best available technology economically achievable (BAT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the application of BAT: The 
limitations are the same as the limitations specified in Sec.  451.21.


Sec.  451.23  Effluent limitations attainable by the application of the 
best conventional technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent

[[Page 51930]]

limitations representing the application of BCT: The limitations are 
the same as the limitations specified in Sec.  451.21.


Sec.  451.24  New source performance standards (NSPS).

    Any point source subject to this subpart that is a new source must 
meet the following requirements: The standard is the same as the 
limitations specified in Sec.  451.21.

[FR Doc. 04-15530 Filed 8-20-04; 8:45 am]
BILLING CODE 6560-50-U