Information Collection Request:

Concentrated Aquatic Animal Production Effluent Guidelines (Renewal)

ICR No. 2087.03, OMB No. 2040-0258

September 2007

Prepared for

U.S. Environmental Protection Agency

Office of Wastewater Management

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

EPA Contract Number EP-C-05-046

EPA Work Assignment Number 1-24

Content

  TOC \o "2-3" \h \z \t "Heading 1,1"    HYPERLINK \l "_Toc178394578" 
1.  Identification of the Information Collection	  PAGEREF _Toc178394578
\h  1  

  HYPERLINK \l "_Toc178394579"  1.a.  Title of the Information
Collection	  PAGEREF _Toc178394579 \h  1  

  HYPERLINK \l "_Toc178394580"  1.b.  Short Characterization/Abstract	 
PAGEREF _Toc178394580 \h  1  

  HYPERLINK \l "_Toc178394581"  2.  Need for and Use of the Collection	 
PAGEREF _Toc178394581 \h  2  

  HYPERLINK \l "_Toc178394582"  2.a.  Need and Authority for the
Collection	  PAGEREF _Toc178394582 \h  2  

  HYPERLINK \l "_Toc178394583"  2.b.  Practical Utility and Users of the
Information	  PAGEREF _Toc178394583 \h  3  

  HYPERLINK \l "_Toc178394584"  3.  Nonduplication, Consultations, and
Other Collection Criteria	  PAGEREF _Toc178394584 \h  3  

  HYPERLINK \l "_Toc178394585"  3.a.  Nonduplication	  PAGEREF
_Toc178394585 \h  3  

  HYPERLINK \l "_Toc178394586"  3.b.  Public Notice Required Prior to
ICR Submission to OMB	  PAGEREF _Toc178394586 \h  4  

  HYPERLINK \l "_Toc178394587"  3.c.  Consultations	  PAGEREF
_Toc178394587 \h  4  

  HYPERLINK \l "_Toc178394588"  3.d.  Effects of Less Frequent
Collection	  PAGEREF _Toc178394588 \h  5  

  HYPERLINK \l "_Toc178394589"  3.e.  General Guidelines	  PAGEREF
_Toc178394589 \h  5  

  HYPERLINK \l "_Toc178394590"  3.f.  Confidentiality	  PAGEREF
_Toc178394590 \h  5  

  HYPERLINK \l "_Toc178394591"  3.g.  Sensitive Questions	  PAGEREF
_Toc178394591 \h  5  

  HYPERLINK \l "_Toc178394592"  4.  Respondents and Information
Requested	  PAGEREF _Toc178394592 \h  5  

  HYPERLINK \l "_Toc178394593"  4.a.  Respondents/NAICS Codes	  PAGEREF
_Toc178394593 \h  5  

  HYPERLINK \l "_Toc178394594"  4.b.  Information Requested	  PAGEREF
_Toc178394594 \h  6  

  HYPERLINK \l "_Toc178394595"  4.b.i. Data Items, Including Reporting
and Recordkeeping Requirements	  PAGEREF _Toc178394595 \h  6  

  HYPERLINK \l "_Toc178394596"  4.b.ii. Respondent Activities	  PAGEREF
_Toc178394596 \h  9  

  HYPERLINK \l "_Toc178394597"  5.  Information Collected: Agency
Activities, Collection Methodology, and Information Management	  PAGEREF
_Toc178394597 \h  11  

  HYPERLINK \l "_Toc178394598"  5.a.  Agency Activities	  PAGEREF
_Toc178394598 \h  11  

  HYPERLINK \l "_Toc178394599"  5.b.  Collection Methodology and
Management	  PAGEREF _Toc178394599 \h  11  

  HYPERLINK \l "_Toc178394600"  5.c.  Small Entity Flexibility	  PAGEREF
_Toc178394600 \h  11  

  HYPERLINK \l "_Toc178394601"  5.d.  Collection Schedule	  PAGEREF
_Toc178394601 \h  11  

  HYPERLINK \l "_Toc178394602"  5.e.  Information Management	  PAGEREF
_Toc178394602 \h  12  

  HYPERLINK \l "_Toc178394603"  6.  Estimating the Burden and Cost of
the Collection	  PAGEREF _Toc178394603 \h  13  

  HYPERLINK \l "_Toc178394604"  6.a.  Estimating Respondent Burden	 
PAGEREF _Toc178394604 \h  13  

  HYPERLINK \l "_Toc178394605"  6.b.  Estimating Respondent Costs	 
PAGEREF _Toc178394605 \h  14  

  HYPERLINK \l "_Toc178394606"  6.c.  Estimating Agency Burden and Cost	
 PAGEREF _Toc178394606 \h  15  

  HYPERLINK \l "_Toc178394607"  6.c.i. Burden on NPDES Authorized States
  PAGEREF _Toc178394607 \h  15  

  HYPERLINK \l "_Toc178394608"  6.c.ii. Costs to NPDES Authorized States
  PAGEREF _Toc178394608 \h  16  

  HYPERLINK \l "_Toc178394609"  6.d.  Estimating the Respondent Universe
and Total Burden and Costs	  PAGEREF _Toc178394609 \h  16  

  HYPERLINK \l "_Toc178394610"  6.e.  Bottom Line Burden Hours and Cost
Tables	  PAGEREF _Toc178394610 \h  21  

  HYPERLINK \l "_Toc178394611"  6.f.  Reasons for Change in Burden	 
PAGEREF _Toc178394611 \h  22  

  HYPERLINK \l "_Toc178394612"  6.g.  Burden Statement	  PAGEREF
_Toc178394612 \h  22  

 

Tables

  TOC \h \z \t "TC,1"    HYPERLINK \l "_Toc178394344"  Table 4-1	NAICS
Codes	  PAGEREF _Toc178394344 \h  6  

  HYPERLINK \l "_Toc178394345"  Table 6-1	Hourly rates used in this ICR	
 PAGEREF _Toc178394345 \h  15  

  HYPERLINK \l "_Toc178394346"  Table 6-2	Annual Burden for Flow Through
and Recirculating Commercial Facilities	  PAGEREF _Toc178394346 \h  18  

  HYPERLINK \l "_Toc178394347"  Table 6-3	Annual Burden for Flow Through
and Recirculating Non-Commercial Facilities	  PAGEREF _Toc178394347 \h 
18  

  HYPERLINK \l "_Toc178394348"  Table 6-4	Annual Burden for Net Pen
Facilities	  PAGEREF _Toc178394348 \h  19  

  HYPERLINK \l "_Toc178394349"  Table 6-5	Annual Burden Estimate for
State Permitting Authorities	  PAGEREF _Toc178394349 \h  19  

  HYPERLINK \l "_Toc178394350"  Table 6-6	Annual Burden Estimate for
Federal Permitting Authorities	  PAGEREF _Toc178394350 \h  20  

  HYPERLINK \l "_Toc178394351"  Table 6-7	Total Estimated Burden for
Facilities for the CAAP Effluent Guidelines Regulation	  PAGEREF
_Toc178394351 \h  21  

  HYPERLINK \l "_Toc178394352"  Table 6-8	Total Estimated Burden for
Permitting Authorities	  PAGEREF _Toc178394352 \h  21  

  HYPERLINK \l "_Toc178394353"  Table 6-9	Annual Facilities and States
Respondents Tally	  PAGEREF _Toc178394353 \h  21  

 

1.  Identification of the Information Collection

1.a.  Title of the Information Collection 

Title: Concentrated Aquatic Animal Production Effluent Guidelines
(Renewal)

EPA ICR Number 2087.03

OMB Control Number 2040-0258

1.b.  Short Characterization/Abstract 

This Information Collection Request (ICR) requests OMB renewal of the
approval for the Concentrated Aquatic Animal Production (CAAP) Effluent
Guidelines.  The rule establishes specific reporting requirements for a
segment of CAAP facilities through NPDES permits.  The rule covers
facilities which are defined as CAAP facilities (see 40 CFR 122.24 and
40 CFR Part 122 Appendix C) and produce at least 100,000 pounds per year
in flow through, recirculating and net pen systems.

The rule includes special reporting and recordkeeping requirements which
are the subject of this ICR.  CAAP facility owners or operators are also
required to file reports with the permitting authority when drugs with
special approvals are applied to the production units or a failure in
the structural integrity occurs in the aquatic animal containment
system.  

When CAAP facilities apply either an Investigational New Animal Drug
(INAD) or a drug that has been prescribed extra-label by a veterinarian
to treat the aquatic animals at their facility, the owner or operator
must report this use to the permitting authority.  In addition, the
owner or operator of a CAAP facility must notify the permitting
authority upon agreeing to participate in an INAD study.

Whenever a structural failure occurs in the aquatic animal containment
system, the owner or operator must report this to the permitting
authority.  For the purposes of this requirement, the aquatic animal
containment system is defined as the unit(s) that contain(s) the aquatic
animals and in which their culture takes place, as well as the
wastewater handling and treatment units associated with aquatic animal
production.

CAAP facilities subject to this regulation are also required to develop
and implement a Best Management Practices (BMP) plan that ensures that
the regulatory requirements will be met.  Upon completion of this BMP
plan the owner or operator must certify to the permitting authority that
the plan has been developed.

CAAP facilities are also expected to keep records on the feed inputs
along with an estimate of the number and weight of the animals being
raised.  These records are to be used to calculate the feed conversion
ratios for the facility.  Records must also be kept documenting the
frequency of facility inspections, maintenance and repairs, along with
the cleaning of the rearing units at flow through and recirculating
facilities or changing the nets at net pen facilities.

2.  Need for and Use of the Collection  

2.a.  Need and Authority for the Collection 

The purpose of the Clean Water Act (CWA) is to restore and maintain the
chemical, physical, and biological integrity of the Nation’s waters. 
To meet that end, the CWA establishes the NPDES program to regulate the
discharge of any pollutant or combination of pollutants from point
sources into waters of the United States.

EPA promulgated technology-based effluent limitation guidelines and
standards (ELGs) for a subset of CAAP facilities required to obtain
NPDES permits.  The requirements in the ELGs are incorporated into the
NPDES permits issued by EPA and states.  

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.  The Concentrated Aquatic Animal
Production ELG requires reporting in the event that drugs are used which
are either under a conditional approval as 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 extra-label use.  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 impact as approved drugs.  Reporting is also required when
the facility has a failure in the structural integrity of the aquatic
animal containment systems. This reporting is necessary to alert the
permitting authority to the release of large quantities of material from
these facilities. 

Any CAAP facility that agrees to participate in an INAD program is
required to notify the permitting authority within 7 days of its
agreement.  Facilities are to report the identity of the INAD, the
method of application, the dosage and the disease or condition it is
intended to treat.  This reporting provides the permitting authority
with the opportunity to require some monitoring or even controls on the
discharge of the wastewater containing these drugs if they believe there
is any reason for concern.  It can also serve to identify multiple
applications of a specific extra-label drug or INAD in the same
watershed which could contribute to an unacceptable loading to that
watershed.  This has been raised as a concern where there are several
CAAP facilities located in the same watershed. 

Facilities are required to file two reports to the permitting authority
whenever an INAD or extra-label drug is used at their facility.  The
first report must be made orally within 7 days of initiating the use of
an INAD or extra-label drug.  The owner or operator shall notify the
permitting authority of the drug active ingredient being applied and the
reason for using it.  The second is a written report which must be filed
within 30 days of the conclusion of application of the drug.  This
report must identify the drug added, the reason for treatment, the
date(s), time(s) and duration of addition, the total amount of active
ingredient added, the total amount of medicated feed added (if that is
the application method) and the estimated number of aquatic animals
treated with the additions.

Reporting a failure in the structural integrity of the aquatic animal
containment system also involves making two reports to the permitting
authority.  The first report is to be made orally within 24 hours of
discovery of the system failure, and must provide the likely cause of
the failure and an estimate of the material released.  Seven days
following the discovery of the failure, the facility owner or operator
must file a written report which includes all the same information that
was included in the initial report as well an estimate of the time
elapsed until the failure was repaired and steps being taken to prevent
a reoccurrence.

Failures tend to be rare, especially at flow through and recirculating
facilities.  However, when they do occur, they can have significant
environmental impacts including the discharge of large quantities of
solids, fish carcasses and live fish.  

2.b.  Practical Utility and Users of the Information 

The information on the use of INAD and extra-label drugs may lead to
permit requirements to prevent or minimize further discharges of the
drug.  Advance notice of a CAAP facility’s participation in an INAD
program can provide the permitting authority an opportunity to obtain
information concerning the effects of the drug and determine if any
controls on the discharge of the INAD is warranted.  If a determination
is made to limit the discharge when the INAD is being used in accordance
with 40 CFR §125.3, and 122.44, the facility can subsequently determine
how the limits can be achieved.  Furthermore, in the event that adverse
environmental impacts are noted from the use of an investigational drug,
the permitting authority could share the information with the Food and
Drug Administration (FDA).  Based on this information, FDA could
determine whether to withdraw the investigational approval. 

The information on the failure of structural integrity can provide the
permitting authority with some indication of pollutant slugs discharged
to the receiving streams.  These slugs may include solids, carcasses,
and fish.  The impact on the receiving water can be severe although in
most cases brief.  In addition to the solids loading, the release of
fish from the CAAP facility may pose concerns if the fish being produced
are non-native. The permitting authority may need to alert state fish
and game authorities when non-native species have been released.  Early
intervention can minimize the establishment of a species and thus avoid
the negative economic and environmental impacts associated with
establishment of a non-native species.

3.  Nonduplication, Consultations, and Other Collection Criteria

3.a.  Nonduplication 

During the rulemaking process prior to 2004, EPA examined all other
reporting requirements contained in the CWA and 40 CFR Parts 122, 123,
124, 125, 501, and 503.  The Agency also met with other Federal Agencies
including the Food and Drug Administration (FDA), National Marine
Fisheries Service (NMFA) of the Department of Commerce, the National
Invasive Species Council, and the Animal and Plant Health Inspection
Service (APHIS) of the Department of
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	the EPA Information Systems Inventory

	the EPA Inventory of Information Collection Requests, and

	the Federal Information Locator System.

Examination of these databases and discussions with other Federal
Agencies did not identify any reporting requirements that were
duplicative with existing requirements.  

3.b.  Public Notice Required Prior to ICR Submission to OMB 

In compliance with the 1995 Paperwork Reduction Act (PRA), any agency
developing a non-rule-related ICR must solicit public comments before
submitting the ICR to OMB.  These comments, which are used partly to
determine realistic burden estimates for respondents, must be considered
when completing the Supporting Statement that is submitted to OMB.

This ICR was published in the Federal Register on June 27, 2007 (72 FR
35227-35230).  The notice included a request for comments on the content
and impact of these information collection requirements on the regulated
community.  EPA received no comments on this ICR.

3.c.  Consultations 

During the rule development process, EPA met with several other Federal
Agencies to better understand their programs and how they relate to
EPA’s development and implementation of this ELG.  EPA met with
representatives of FDA, the APHIS in USDA, U.S. Fish and Wildlife
Service (USFWS) in the Department of Interior, and the National Marine
Fisheries Service of the National Oceanic & Atmospheric Administration
(NOAA) in the Department of Commerce.  Each of these Agencies has some
authority over issues related to aquatic animal production and has some
ability to address environmental concerns related to this sector.  

FDA indicated that they do not have authority to control the drug
residues present in the wastewater discharges from CAAP facilities that
have used a drug.  The FDA does conduct an environmental assessment to
evaluate the potential environmental impacts that could be associated
with the use and release of the drug into the environment, but they
don’t necessarily have the authority to withhold a drug’s approval
solely on the basis of potential environmental impacts.  Further, the
environmental assessment does not account for all the various
site-specific conditions or the possible cumulative effects when several
facilities use the same drug and discharge wastewater into the same
watershed.  FDA did not have any objections to EPA including the
reporting requirements for INADs and extra-label drugs in the
regulation.

APHIS is responsible for tracking, reporting and taking action when
there are disease outbreaks at aquatic animal production facilities. 
Diseases that require action by APHIS include those identified by the
World Organization for Animal Health (formerly known as Office
International des Epizooties).  APHIS works with State Departments of
Agriculture which typically have the responsibility to take action when
a reportable disease is identified at a facility.  Action can include
confiscating and destroying the animals and shutting the facility down
for a period of time or until the facility can demonstrate that they are
disease free.  APHIS also has responsibility for preventing the entry of
invasive species and controlling the spread of established populations
of invasive species.  APHIS is responsible for implementing several Acts
related to the control of invasive species including disease.  Since
APHIS in conjunction with State Departments of Agriculture have
considerable authority to take action to prevent the spread of diseases
from aquaculture facilities, EPA is not establishing any additional
requirements specific to this concern. 

EPA also had discussions with NOAA’s National Marine Fisheries Service
to discuss their program to develop off-shore aquaculture.  Some of the
concerns related to this topic include the control of pollutants at open
water systems and the potential for system failure.  NOAA believes that
many concerns related to the development of aquaculture off-shore will
be dealt with when suitable sites are identified and indicated that new
off-shore sites would be subject to an Environment Impact Statement
under NEPA.

3.d.  Effects of Less Frequent Collection 

EPA requires minimal reporting in this regulation.  Facilities are
expected to certify to the permitting authority that they have developed
a BMP plan only once over the course of the permit cycle (usually 5
years).  The certification itself is expected to consist of a letter
that states that the BMP plan has been developed in accordance with the
requirements of the regulation.  

The other reporting associated with the use of drugs or failure in the
structural integrity are only required in the event one of these
activities occurs.  The reporting itself for either of these situations
is minimal.  EPA requires an oral report to be made initially, followed
by a more detailed written report.  EPA has determined less frequent
reporting would impede the ability of the permitting authority to take
action to minimize harm to the environment when warranted.

3.e.  General Guidelines 

This information collection complies with Paperwork Reduction Act
guidelines at 5 CFR 1320.5(d)(2).  Requests for supplemental information
for the purposes of emergency response of enforcement activities are
exempt from Paperwork Reduction Act requirements.

3.f.  Confidentiality 

This information collection may contain Confidential Business
Information (CBI), especially the reporting requirements associated with
investigational drug use.  If this is the case, the respondent may
request that such information be treated as confidential.  All
confidential data will be handled in accordance with 40 CFR 122.7, 40
CFR part 2.  However, CWA sec. 308(b) specifically states that effluent
data may not be treated as confidential.

3.g.  Sensitive Questions 

This information collection does not include sensitive questions.

4.  Respondents and Information Requested

4.a.  Respondents/NAICS Codes 

The NAICS codes that apply to the CAAP facilities included in EPA’s
regulation are listed on Table 4.1.

Table 4-1	NAICS Codes

Examples of regulated entities include facilities engaged in aquatic
animal production  	Primary NAICS codes

Finfish Farming and Fish Hatcheries	112511

Other Animal Aquaculture	112519



Not all facilities classified in these two NAICS codes will be subject
to the reporting requirements included in this request.  Other rules
established a subset of facilities engaged in aquatic animal production
as concentrated aquatic animal production facilities and by definition
these facilities must obtain an NPDES permit.  The definition of CAAP
can be found at 40 CFR 122.24 and Appendix C of 40 CFR Part 122.  The
regulations covered by this ICR in turn only apply to a subset of CAAP
facilities.  These facilities are defined in the applicability of the
final rule at 40 CFR 451.  EPA estimates that 242 facilities will be
subject to these requirements.  

Not all of the 242 regulated facilities will be subject to all of the
reporting requirements included in the final rule.  Many of the
reporting requirements apply only when certain events or conditions
exist at the facility.  EPA does not expect all facilities will
experience these conditions or events annually and thus will not incur
the burden or cost associated with the reporting requirements.

4.b.  Information Requested 

This section presents the data items, including recordkeeping
requirements and required respondent activities in preparing and
submitting those data items.

4.b.i. Data Items, Including Reporting and Recordkeeping Requirements

EPA established reporting and recordkeeping requirements to ensure that
the facilities are implementing BMPs and reporting on the use of certain
classes of drugs and any failures to the structural integrity of the
rearing units, net pens or wastewater treatment structures.  EPA also
established requirements for facilities to perform feed monitoring at
net pen facilities which can include the use of real-time monitoring
systems such as video monitoring, the use of sediment sampling, benthic
monitoring or devices designed to capture solids that have fallen
beneath the nets.  Finally, EPA required facilities to maintain records
on the feed added, the number and weight of the animals being raised as
well as records on the frequency of inspections, maintenance and repairs
to the facility aquatic animal containment system.  Also the regulation
required facilities to keep records on the frequency that the rearing
units at flow through and recirculating facilities are cleaned or nets
are changed at net pen facilities.

EPA established reporting requirements associated with the application
of INAD and extra-label drugs.  When a CAAP facility agrees to
participate in an INAD program EPA requires the owner or operator to
notify the permitting authority in writing within 7 days of the date
that the facility signed up to participate in this program.  The report
would include the name of the INAD, the method of application, the
dosage and the disease or condition it is intended to treat.  Reporting
is not required if the INAD or extra label drug use does not exceed the
approved dosage for the same drug in use under similar conditions.  When
an INAD or extra-label drug that does not meet the exception is used at
a CAAP facility, the owner or operator must file two reports with the
permitting authority concerning this use.  The first report is made
orally and must be made no later than 7 days after initiating treatment.
 The facility owner or operator must notify the permitting authority
that either an INAD or extra-label drug application is occurring at the
facility.  The report must identify the drug and the reason for its
addition.

The second report is a written report which must be provided to the
permitting authority within 30 days of concluding treatment.  The
written report must include the identity of the drug, the reason for
treatment, the date(s), time(s) and duration of the treatment, the total
amount of active ingredient added, or the total amount of medicated feed
added when this is the method of application and the estimated number of
animals treated. 

FDA’s Center for Veterinary Medicine (CVM) under the authority of the
Federal Food, Drug and Cosmetic Act (FFDCA) approves drugs to treat
specific diseases in specific species of aquatic animals.  FDA also
issues exemptions of approval for Investigative New Animal Drugs that
can be used to treat specific diseases in specific species.  As part of
the evaluation of a drug for its approval, FDA is required to conduct an
environmental assessment.  Thus, approved drugs have been studied for
the potential effect their use would have on the environment.  Although
FFDCA does not provide FDA the authority to disapprove a drug solely on
the basis of environmental concerns, the environmental assessment
information is publicly available. This information can be accessed by
permit writers or producers so they can take action on a case-by-case
basis to protect the environment should residual drug active ingredients
be discharged from the facility in levels which pose environmental
concern.  

The FFDCA authorizes veterinarians to prescribe drugs which have been
approved for treating humans or animals of a different species or to
treat a different condition.  Veterinarians prescribe extra-label drugs
when the animals’ health is suffering or threatened; however, the
treatment may not result in a violative food residue.

INADs and extra-label drugs used at dosages which exceed approved dosage
and under different conditions have not undergone the same degree of
scrutiny for their environmental effects.  Therefore, EPA believed it
was appropriate to establish requirements for CAAP facility owners or
operators to report to the permitting authority when these classes of
drugs are being used at their facilities.

EPA required facilities to report to the permitting authority any time
the facility experiences a failure or damage to the aquatic animal
containment system resulting in a material discharge to waters of the
United States.  The aquatic animal containment system is defined as the
culture or rearing unit including raceways, ponds, tanks or nets used to
contain, hold or produce aquatic animals.  The containment system also
includes structures designed to hold sediments and other materials as
part of the wastewater treatment system.  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.  Physical 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.  Because the determination of what constitutes damage
resulting in a “material” discharge varies from one facility to the
next, permitting authorities are encouraged 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.  A failure of the
containment system that results in a material discharge must be reported
within 24 hours of discovery of the failure.  This report would be made
orally to the permitting authority and would describe the cause of the
failure in the containment system and identify materials that may have
likely been released to the environment as a result of this failure. 
The facility would also be required to 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.  

EPA required reporting of failures and damage that lead to a material
discharge to ensure that permitting authorities are alerted to the
release of significant pollutant loads over a relatively short time
frame.  EPA did not expect this type of failure to occur very frequently
at flow through and recirculating facilities.  EPA anticipated that
there will be a greater number of these events occurring at net pen
facilities.  The location of these facilities in open water makes them
vulnerable to damage from predators and accidents.  Failures at net pen
facilities have the potential to release the contents of the nets
including fish and fish carcasses.

EPA included requirements that address the structural maintenance of the
aquatic animal containment system and a requirement that facilities keep
records on the frequency of inspections, maintenance and repairs to the
facility to avoid structural failures.  The type of records this
requirement might include would be a log of dates when inspections occur
and brief notations when something is found.  Also records would be kept
on maintenance and repair activities, including the date and the actions
taken.  

EPA required reporting of any spills of drugs, pesticides or feed that
result in a discharge to waters of the United States.  The regulation
requires CAAP facilities to ensure proper storage of these materials and
to implement procedures for properly containing, cleaning and disposing
of any spilled material.  Therefore, the occurrence of spills should be
minimal.  Since the facility is operating in an aquatic environment, it
would not be difficult for any spill to result in a pollutant discharge.
 Therefore, EPA believed this reporting requirement was important to
notify permit writers of the potential for environmental effects in the
receiving stream.

The ELG for the CAAP category is based on requirements to reduce the
discharge of solids, avoid spills of materials, and ensure the facility
is being properly operated and maintained through implementing BMPs. 
Each of these requirements is based on the presumption that the CAAP
facilities will achieve compliance by implementing BMPs.  EPA required
CAAP facilities to develop a BMP plan which identifies the BMPs and
documents any associated activities such as recordkeeping, and training
associated with the BMPs.  The Plan will be maintained at the CAAP
facility, but must be made available to the permitting authority upon
request.  EPA also required that CAAP facilities certify in writing to
the permitting authority once upon issuance of a permit that the BMP
plan has been developed.  

In addition to the recordkeeping described above related to the
inspections, maintenance and repair of the facility, EPA also required
CAAP facilities to keep records on the amount of feed added to each
rearing unit along with an estimate of the number of animals contained
in the unit and the weight of the animals.  From these records the
facility should calculate a representative feed conversion ratio for the
animals produced at the facility.  EPA also required CAAP facilities to
keep records on the frequency of cleaning the rearing units and changing
the nets at net pen facilities.

4.b.ii. Respondent Activities

All facilities subject to this regulation will be required to develop,
and implement BMPs which address a variety of aspects of their facility.
 These BMPs must also be documented in a BMP plan, and a letter
certifying that the Plan has been developed must be sent to the
permitting authority.  EPA estimates that these activities will require
40 hours to accomplish.  This activity is expected to be done once over
the term of the permit which is typically five years.  Thus the annual
estimated burden pro-rated across the five year permit term is 8 hours
per year.  

The number of facilities that reported participating in INAD programs in
response to EPA’s detailed survey indicates that there would likely be
less than 20 facilities annually affected by EPA’s INAD or extra-label
reporting requirement.  The rule specifies that facilities report when
an INAD and extralabel drug is used and they would file less than 40
reports on the use of an INAD or extra-label drug in any given year. 
All of the facilities that reported participation in an INAD study were
non-commercial facilities that were either State or Federal hatcheries. 
EPA’s data do not provide the details on the use of extra-label drugs
at CAAP facilities.  Thus, EPA is making an assumption that facilities
will use either extra-label or INAD drugs in any given year, and the
number of applications requiring reporting will be less than 40.  EPA is
assuming that the facilities that will apply extra-label drugs will not
be just non-commercial facilities.  The number of commercial facilities
is likely to be substantially smaller than non-commercial facilities in
part due to withdrawal concerns.

The burden associated with reporting for INADs and extra-label drugs
will include an hour of a manager’s time to prepare and mail a letter
notifying the permitting authority that the facility is participating in
an INAD study.  EPA estimates that a manager will spend half an hour
filing the oral report on either INAD or extra-label drug use and
subsequently an additional hour writing the letter that notifies the
permitting authority when the treatment is concluded.  EPA also
anticipates that unskilled labor will spend some time keeping records
throughout the application of the drug.  This data will be used by the
manager in the written report.  However, EPA expects that this staff
will also be doing these activities to respond to requirements of the
INAD agreement or simply for the purposes of good husbandry in the case
of extra-label drug applications.

EPA assumes that few flow through and recirculating facilities will
experience structural failures in their aquatic animal containment
systems.  This is in part based on the very small number of facilities
that EPA is aware of that have experienced such failures in the past. 
EPA is estimating that 22 facilities will experience a reportable
failure each year.  Failures are unlikely to affect only non-commercial
or commercial facilities; thus, EPA is assuming that the failures will
be distributed between non-commercial and commercial facilities.  Net
pen facilities are expected to experience reportable failures at a much
higher rate due to the inherent vulnerabilities of the system.  EPA is
assuming that each net pen facility will have one reportable failure
each year. 

Failures can be minimized through frequent inspection of the rearing
units and wastewater treatment system and prompt repair of any damage
identified.  EPA is requiring that facilities keep records on the
frequency of the inspections and any repairs and maintenance activities
performed.  EPA assumes the inspections will be performed by each
facility once per week while production is occurring.  For the flow
through and recirculating facilities, EPA believes that inspections
would occur on each rearing unit and wastewater treatment structure
taking approximately 5 minutes per unit.  Net pen inspections require
divers to inspect the facility underwater.  Based on available
information, all net pen facilities are believed to be currently
conducting these inspections on a regular basis, and these inspections
are assumed to continue at the same frequency.

Reporting of spilled drugs, pesticides or feed that result in a
discharge to waters of the United States, must be reported orally to the
permitting authority within 24 hours of occurrence, followed by a
written report within 7 days.  The report must identify the material
spilled and an estimated amount.  EPA does not expect spills will occur
very often, since facilities are required to implement proper storage
and implement procedures for proper cleaning, containing and disposing
of the spilled material.  Again for the purpose of estimating the
burden, EPA is assuming that more net pen facilities will experience a
spill in any given year, and noncommercial flow through and
recirculating facilities may experience a slightly higher rate of
spills, since they tend to report a higher rate of drug and pesticide
use.  

Other recordkeeping required by the CAAP regulation involves recording
the amount of feed added to each rearing unit and tracking the number of
animals and the weight of the animals contained in the rearing unit. 
The feed inputs are assumed to be tracked on a weekly basis during
periods when feeding occurs.  The number of animals and weight of the
animals will be tracked less frequently.  Animal numbers can be
estimated using the approximate number added to the unit when stocking
occurred less the mortalities removed from the unit over time.  The
weight can be measured at the time of harvest.  These values in
aggregate by facility or by species shall be used to calculate a
representative feed conversion ratio.  The feed conversion ratio
represents the proportion of feed provided in relation to the amount of
weight gained.  These records shall be maintained at the facility and
provided to the permitting authority when requested or made available to
inspectors.  The facility owner or operator should also use this data to
evaluate whether the feeding regime is achieving the intended results.

EPA also included a requirement that all net pen facilities conduct some
form of feed monitoring.  This monitoring can be in the form of
real-time monitoring such as video monitoring to observe feed passing
beneath the net, sediment or benthic sampling, and physical devices
designed to capture uneaten feed that passes below the net or other good
husbandry practice that is approved by the permit authority.  The
objective of this requirement is to minimize the discharge of uneaten
feed from the net pen system.  Based on available information and
existing permits, all existing net pen facilities are currently using
one of these techniques to minimize the discharge of uneaten feed.

5.  Information Collected: Agency Activities, Collection Methodology,
and Information Management

5.a.  Agency Activities 

The Agency’s activities as the NPDES permitting authority for five
States and all U.S. territories except the Virgin Islands are exactly
the same for the 45 NPDES authorized States and the Virgin Islands and
consist of processing and reviewing permit applications and Notices of
Intent (NOIs).  Permit authorities will also process certifications that
BMP plans have been developed and document receipt of oral and written
reports filed by the permittees concerning INAD and extra-label drugs,
and the failure of aquatic animal containment structures.

5.b.  Collection Methodology and Management 

Each of the NPDES permitting authorities will have the ability to access
the information kept by the owners or operators at the CAAP facilities. 
In addition, the permitting authorities will maintain records of reports
made under the Special Reporting Requirements described above.  This
data may be made available to the public consistent with EPA’s
regulations concerning the protection of Confidential Business
Information (CBI), (40 CFR part 2).

INADs can be considered CBI during the investigative studies.  Reports
required to be filed with the permitting authority under this regulation
that contain CBI should be clearly marked and should be handled by the
permitting authority in accordance with 40 CFR 122.7, 40 CFR part 2 and
EPA’s Security Manual, Part III, chapter 9.

5.c.  Small Entity Flexibility 

For the CAAP ELG rule, EPA conducted analyses required by the Regulatory
Flexibility Act of 1980 (RFA) as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA).  See section
XIII.B of the preamble in the proposed rule for a summary of these
analyses.

EPA believes the burden on small facilities is minimal since reporting
is only linked with specific conditions or occurrences at the facility. 


5.d.  Collection Schedule 

The regulation requires the development of a BMP plan to assist in
compliance with the requirements along with a certification that a BMP
plan has been developed.  These activities will occur upon coverage
under an NPDES permit that incorporates the ELG requirements.  This BMP
plan must be completed and certification filed once during the term of
the NPDES permit.  Reporting requirements associated with INAD and
extra-label drugs are related to specific events.  Likewise the
reporting associated with an aquatic animal containment system failure
is linked to a specific event.  The reporting requirements do have a
related time frame on which the report must be filed.  INAD study
participation must be reported within 7 days after agreeing to
participate in an INAD study or initiating the use of an INAD or
extra-label drug chemical.  In conjunction with the use of the INAD or
extra-label drug, a written report must follow the initial oral report
within 30 days of initiation the use.  Likewise reporting associated
with a failure damage resulting in a material discharge must be made
orally within 24 hours of discovery followed by a written report within
7 days of the event.  EPA considers this collection schedule to be
reasonable.  The certification of the BMP plan should be a
straightforward document, most likely taking the form of a letter from
the owner or operator at the CAAP facility addressed to the permitting
authority.  This letter need only be submitted once for each permit
cycle which is typically 5 years.  Likewise the effort associated with
developing the BMP plan is expected to be expended once during the
permit cycle.

The reporting of participation in an INAD program is required to occur
within 7 days of agreeing to participate in the program.  This time
lapse provides the CAAP owner or operator ample time to assemble the
required information and prepare a letter that will serve to notify the
permitting authority.  Facilities are generally not expected to require
the application of the INAD immediately, however, if agreeing to
participate in the INAD program coincides with use of the INAD, the
facility would report consistent with the use reporting requirements. 
INAD and extra-label drug use reporting requires that an oral report be
filed as soon as possible, but no later than 7 days after beginning
treatment.  EPA recognizes that facility owners and operators will be
focusing on the health and welfare of the aquatic animals being treated
and thus may not be able to file a report immediately, however, within
the first 7 days of treatment, the owner or operator can provide an oral
report.

The written report related to the use of INAD or extra-label drugs must
be filed within 30 days following completion of the treatment.  EPA does
not expect this time period will impose any hardship on facilities to
compile the required information into a letter that can be sent to the
permitting authority.

The occurrence of a failure in the aquatic animal containment system
must be reported orally through a phone call to the permitting authority
within 24 hours of discovery.  The urgency associated with this
reporting is to allow the permitting authority to take rapid action to
mitigate any harmful effects that could occur as a result of the
failure’s releasing pollutant slugs into the receiving stream.  The
subsequent written report describing the failure and steps taken to
prevent its reoccurrence among other things, is due within 7 days of
discovering the failure.  EPA expects that operators will be busy taking
steps to address the failure, but also believes filing a prompt report
will ensure that the facility is actively addressing the causes and
looking for ways to prevent reoccurrences to the extent possible.

Spills of drugs, pesticides and feed that result in a discharge to
waters of the United States, must be reported orally to the permitting
authority within 24 hours of occurrence.  A written report must be
submitted within 7 days.  The report must identify the material that
spilled and an estimated amount.

5.e.  Information Management 

Permitting Authorities will keep the written reports received through
this regulation in the permit file.  The information may be made
available to the public unless it is subject to a claim of CBI.  EPA
anticipates that there may be such claims attached to reports related to
the participation or use of INADs.

The permitting authority may refer to these reports in the event that
subsequent reports are filed.  For example, previous reports of failures
may be reviewed upon oral notification of a failure.  If the permitting
authority determines that sufficient steps may not have been taken to
avoid further failures from occurring, the authority may require the
facility to take specific actions.  

Upon receipt of a notification report of participation in an INAD
program, the permitting authority may choose to gather information on
the potential environmental effects of the INAD.  EPA anticipates that
this could involve some combination of web searching, contacts with the
FDA and academics and contacts with the EPA regional office or
Headquarters.  Based on findings from this research, the permitting
authority may choose to establish site-specific controls for the
discharge when the INAD is being used.

Upon receipt of the oral notification of the use of an INAD or
extra-label drug, the permitting authority may gather the same type of
information described above from the same sources.  It is unlikely that
this information would be used to control the occurrence of the drug’s
use, but it could lead to discharge requirements for any following use
of that drug.

6.  Estimating the Burden and Cost of the Collection

In this section EPA presents estimated burden on the CAAP facilities and
NPDES Authorized States based on the requirements included in the final
regulation.  In most cases the total burden per activity is estimated on
an annual basis and then multiplied by three to derive the total burden
associated with this ICR.  There are some requirements in the effluent
guidelines regulation that are expected to occur only once during the
permit cycle which is typically five years long.  The burden estimate
for these requirements is estimated based on the time required to
accomplish the activity divided by five to provide an annual estimated
burden.

6.a.  Estimating Respondent Burden 

There are requirements which will affect all 242 CAAP facilities
estimated to be subject to this effluent guidelines regulation.  The
requirements include the identification of best management practices,
their incorporation into BMP plans and certifications to the permitting
authority that the plans have been developed and are being implemented.

Other requirements will affect CAAP facilities dependent on
circumstances or the conditions at the facility.  CAAP facilities are
required to report a failure or damage to the aquatic animal containment
system which result in a material discharge of pollutants to waters of
the U.S.  Permit authorities should specify what constitutes damage
resulting in a material discharge to waters of the United States when
they issue the permits.  These determinations should take into
consideration factors such as the production system type, sensitivity of
the receiving waters and other relevant factors.  For example, the
requirement to report a failure or damage in the containment system is
more likely to affect facilities which are located in open water such as
net pens systems.  These facilities are more vulnerable to containment
system failure due to weather related events, man-made accidents, or
predator activity.  Therefore, EPA has distinguished the burden imposed
on this category of facilities separately from land-based facilities. 

The tables presented below under section 6.d provide the burden and cost
associated with the regulation.  The tables present the information over
three tables, Tables 6-2 through 6-4.  EPA has estimated a separate
burden and cost associated with the two subcategories, the flow through
and recirculating subcategory and the net pen subcategory.  Although
both subcategories have essentially the same requirements under the
rule, the frequency of reporting for some of the requirements is likely
to be different.  EPA is also subdividing the estimated burden for the
flow through and recirculating facilities into two tables. One table
(Table 6-2) presents the burden and costs for commercial flow through
and recirculating facilities. The second (Table 6-3) presents the burden
and costs for non-commercial facilities.  Commercial facilities are
those which raise aquatic animals for sale; the non-commercial
facilities are mostly state or federal facilities and are raising the
animals for the purpose of stocking and enhancement of wild populations.
 The two types of facilities are presented separately because the
frequency of reporting is likely to be different for some of the
reporting and because the labor rates of the two types of facilities is
very different.  Non-commercial facilities are actively engaged in the
INAD programs through the USFWS which is has been a sponsor of INAD drug
products.  Other non-commercial facilities are invited to participate in
these INAD programs, and several facilities reported to EPA in the
detailed surveys that they have used INADs at their facilities.  This
appears to be much less prevalent at commercial facilities although
there have been INAD programs that have been focused on commercial
producers.

6.b.  Estimating Respondent Costs 

EPA has estimated costs associated with the time required to comply with
this regulation.  Since the regulation is based on the compliance with
narrative effluent standards which are based on the implementation of
BMPs rather than wastewater treatment technologies, there are no capital
and operation and maintenance costs associated with this rulemaking. 
EPA used the annual estimated hours required to respond to the various
requirements and multiplied these costs by a national average labor rate
according to labor classification, management or unskilled labor.  EPA
also distinguishes between commercial facilities and public facilities
in the estimation of the costs associated with the information
collection.  Public facilities are subject to public sector wage
schedules; the costs to private, commercial facilities were estimated
based on the information reported by respondents to the detailed surveys
and data included in the comments on the proposed regulation.  The costs
presented in this document are calculated using national average hourly
rates; however, the costs estimated for the purpose of assessing
economic impact were based on more regionally appropriate wages when
available.  EPA received wage information from CAAP facilities in the
detailed surveys and updated them to December 2006 dollars. Table 6.1
presents the labor rates used in this ICR.

In two instances EPA has estimated the costs associated with the
requirements based on a more regionally specific labor rate.  As
described above, net pen facilities are more vulnerable to system
failures resulting in the release of large numbers of fish which are
potentially non-native species.  Thus for net pen facilities a different
reporting frequency is assumed for the reporting of the failure of the
aquatic animal containment system.  Net pen facilities are presently
located in the Northeast and Northwest coastal waters.  Thus an average
labor rates reported in survey responses for these two regions were used
to estimate the costs associated with this requirement.  The same
average labor rate used to calculate costs for reporting non-native
releases was also used to estimate the costs for the burden associated
with active feed monitoring.

Table 6-1	Hourly rates used in this ICR

Labor category	$/hr

Flow-through and Recirculating (Commercial)

	Facility Management	$24.13

	Facility Unskilled Labor	$13.94

Flow-through and Recirculating (Non-commercial)

	Facility Management	$32.48

	Facility Unskilled Labor	$23.08

Net Pens

	Facility Management	$31.62

	Facility Unskilled Labor	$15.10

Source: 2004 ICR (EPA ICR No. 2087.02) updated to December 2006 dollars
using the BLS Employer Costs for Employee Compensation Index.



The costs associated with the structural failure reporting at flow
through and recirculating CAAP facilities are derived using a national
average hourly rate which excludes the rate associated with net pen
facilities.

6.c.  Estimating Agency Burden and Cost 

6.c.i. Burden on NPDES Authorized States

EPA estimated the burden for State permit writers for the specific
actions related to the Alternate Compliance Provision provided in the
final regulation.  

All CAAP facilities subject to the Effluent Guidelines Regulations are
required to develop and implement a BMP plan that addresses specific
aspects of the facility.  Facility owners or operators are required to
certify to the permitting authority that the BMP plan has been developed
and is being implemented.  As described elsewhere in this document, EPA
assumes this certification will take the form of a letter addressed to
the permitting authority.  EPA estimates that the permitting authorities
will spend approximately 15 minutes per certification, reading over the
letter and filing it with the facility’s permit file.  This
certification will be filed once in the permit term of five years.  Thus
the annual burden on the permitting authority per permitted facility is
less than one tenth of an hour. 

CAAP facilities are required to file reports in conjunction with
specific events at their facilities.  When animals are treated with a
drug or chemical either under an investigative approval from FDA
(Investigative New Animal Drug) or at the direction of a licensed
veterinarian, the facility owner or operator is required to report it to
the permitting authority.  Related to the use of an INAD or extra-label
drug, the owner or operator must provide an oral report and a written
report.  The intended purpose of these reports is to provide the
permitting authority with the necessary information to make decisions on
the potential impact these drugs and chemicals may have on the receiving
stream and to determine the need for effluent monitoring or controls
associated with the use of these drugs or chemicals.  Based on the
reports of INAD or extra-label drug use reported in the responses to the
detailed survey of CAAP facilities, EPA assumes that most of the INAD
applications will be of the same drug for repeated treatments or will be
extra-label treatments with drugs which are already widely used for
other applications.  EPA anticipates that permitting authorities will
spend a minimum of two hours researching the potential environmental
effects of the drugs being reported.  If there is some concern that
warrants further research and the establishment of some effluent
controls, the permitting authority may spend as much as an additional 8
hours.  For the purpose of this ICR, EPA is assuming an average of 3
hours to conduct research and an additional 3 hours to determine limits
or restrictions on the discharge of the drug.  This is considered a
reasonable estimate, since not all reports will require this much effort
while others will require more.

Reporting requirements associated with a failure in the aquatic animal
containment system will provide the permitting authority with
information concerning the release of large quantities of pollutants
over a short span of time.  It can provide the permitting authority with
the ability to anticipate possible stream impacts that could result from
this release and if possible take steps to mitigate them.  A release of
live fish that are not native to the region may pose a threat to native
species.  EPA anticipates that the permitting authority will notify the
State Department of Fish and Wildlife so that appropriate action may be
taken to mitigate this release in a timely manner.  Any subsequent
failures at the same facilities should also be reviewed in light of the
previous reports to determine whether the facility’s BMP plan may need
to be updated.

6.c.ii. Costs to NPDES Authorized States

The cost to NPDES authorized States is calculated by multiplying the
estimated total burden for each respondent by the labor rate of $ $38.28
(December 2006 dollars).  This labor rate was based on the average
hourly rate for state and municipal employees as determined by the U.S.
Department of Labor, Bureau of Labor Statistics (BLS), updated to
December 2006 dollars using the BLS Employer Costs for Employee
Compensation Index.  EPA estimates that there are 204 CAAP facilities in
NPDES authorized States.  Of these 204 CAAP facilities, an estimated 176
facilities use flow-through system, 9 facilities use recirculating
systems and 19 facilities use net pens to produce aquatic animals.  The
cost for authorized states is presented in Table 6-5.

The estimated burden to EPA per permit is estimated to be the same as
the burden associated with state permitting authorities.  EPA is the
permitting authority in five states.  There are an estimated 39
regulated CAAP facilities in these 5 states.  The estimated burden
associated with the proposed BMP and reporting requirements that would
be included in the permits issued to the 39 facilities in these 5 states
is shown below in Table 6-6.  The State of Idaho has the largest
population of CAAP facilities.  CAAP facilities in Idaho are already
subject to permits that require them to establish a BMP plan and keep
records on feed; thus, this ICR does not account for that burden.

6.d.  Estimating the Respondent Universe and Total Burden and Costs 

The following tables present the estimated annual burden and cost for
regulated facilities aggregated by subcategory (e.g., net pen
subcategory and the flow through and recirculating subcategory).  EPA
has not estimated any capital start-up or operational costs.  The
regulation does not require any specific wastewater treatment be
installed and focuses on implementation of practices rather than
operation of technologies as the means to ensure compliance with these
requirements.  EPA’s estimated costs are based on the burden and
associated labor rates.  The labor rates shown on the following tables
are averages of the labor rates reported in EPA’s detailed survey. 
These are loaded labor rates as reported by respondents to the detailed
survey and updated to December 2006 dollars.

Facilities in the flow through and recirculating subcategory are
subdivided by commercial facilities and noncommercial facilities.  The
majority of noncommercial facilities are publicly owned State or Federal
hatcheries that are producing fish for stocking or restoration purposes.
 The burden and costs estimates for these two types of facilities are
presented separately because of the different wages paid to employees of
these two types of facilities which has a significant effect on the
overall estimated costs of the reporting requirements.  

As discussed above in Section 4.b., there are some different assumptions
made in the frequency of reporting at noncommercial flow through and
recirculating facilities as well.  Based on data provided by CAAP
facilities in response to EPA’s detailed survey, noncommercial
facilities have a higher use of INAD drugs.  Survey responses from
commercial facilities give no indication that INAD or extra-label drugs
are used at these facilities; however, EPA is assuming that one facility
each year will use an INAD and will incur the burden of reporting for
that drug.  

EPA’s final CAAP regulation requires all facilities to develop a BMP
plan and to certify to the permitting authority that this plan has been
developed.  EPA is including the burden for the plan development for all
CAAP facilities subject to this regulation except for flow through and
recirculating facilities located in the States of Washington and Idaho. 
Facilities in these two States are already required to develop BMP plans
under existing NPDES permits.  Likewise facilities in these two States
are already required to perform the feed management practices and
associated recordkeeping.  

All of the existing net pen facilities indicated that they currently
keep records on the feed inputs and inspections, net changes and
maintenance and repairs.

Table 6-2	Annual Burden for Flow Through and Recirculating Commercial
Facilities

Activity	Management hours (hrs/facility/yr)	Unskilled labor hours
(hrs/facility/yr)	Management cost	Unskilled labor cost	No. of facilities
Total hours 	Total dollars

BMP Plan Development	8	0	$193.04	$-	59	472	$11,389

BMP Plan Certification	0.25	0	$6.03	$-	59	15	$356

Training for BMPs	2	4	$48.26	$55.76	59	354	$6,137

INAD Program Sign-up Report	1	0	$24.13	$-	1	1	$24

INAD or Extra-Label Use Report	1.5	0	$36.20	$-	1	2	$36

Spill Report	2	0	$48.26	$-	2	4	$97

Structural Failure Report	5	0	$120.65	$-	8	40	$965

Feed Management Records	13	90	$313.69	$1,254.60	59	6,077	$92,529

Inspection, Cleaning, Maintenance & Repair Records	13	90	$313.69
$1,254.60	59	6,077	$92,529



Table 6-3	Annual Burden for Flow Through and Recirculating
Non-Commercial Facilities

Activity	Management hours (hrs/facility/yr)	Unskilled labor hours
(hrs/facility/yr)	Management cost	Unskilled labor cost	No. of facilities
Total hours 	Total dollars

BMP Plan Development	8	0	$259.84	$-	122	976	$31,700

BMP Plan Certification	0.25	0	$8.12	$-	122	31	$991

Training for BMPs	2	4	$64.96	$92.32	122	732	$19,188

INAD Program Sign-up Report	1	0	$32.48	$-	15	15	$487

INAD or Extra-Label Use Report	1.5	0	$48.72	$-	15	23	$731

Spill Report	2	0	$64.96	$-	3	6	$195

Structural Failure Report	5	0	$162.40	$-	14	70	$2,274

Feed Management Records	13	105	$422.24	$2,423.40	122	14,396	$347,168

Inspection, Cleaning, Maintenance & Repair Records	13	105	$422.24
$2,423.40	122	14,396	$347,168



Table 6-4	Annual Burden for Net Pen Facilities

Activity	Management hours (hrs/facility/yr)	Unskilled labor hours
(hrs/facility/yr)	Management cost	Unskilled labor cost	No. of facilities
Total hours 	Total dollars

BMP Plan Development	8	0	$252.96	$-	19	152	$4,806

BMP Plan Certification	0.25	0	$7.91	$-	19	5	$150

BMP Training	2	4	$63.24	$153.11	19	114	$4,111

INAD Program Sign-up Report	1	0	$31.62	$-	1	1	$32

INAD or Extra-Label Use Report	1.5	0	$47.43	$-	1	2	$47

Spill Report	2	0	$63.24	$-	4	8	$253

Structural Failure Report	5	0	$158.10	$-	19	95	$3,004

Feed Management Records	0	0	$-	$-	0	-	$-

Inspection, Net Replacement, Maintenance & Repair Records	0	0	$-	$-	0	-
$-



Table 6-5	Annual Burden Estimate for State Permitting Authorities

Activity	Hours (hrs/permit/yr)	$/permit	No. of permits	Total hours 
Total dollars

BMP Plan Certification Receipt	0.05	$1.91	202	10.1	$386

INAD Program Sign-up Report Receipt	0.5	$19.14	13	6.5	$249

Research on Environmental Affects of INAD 	3	$114.84	13	39	$1,493

Determination of Site Specific Limits for INAD	3	$114.84	7	21	$804

INAD or Extra-Label Drug Report Receipt	0.5	$19.14	13	6.5	$249

Spill Report Receipt	0.5	$19.14	7	3.5	$134

Structural Failure Report Receipt	0.5	$19.14	31	15.5	$593

Notify State Fish & Wildlife Department	0.5	$19.14	24	12	$459

Review cause of failure and past reports to evaluate effectiveness of
practices	1	$38.28	20	20	$766



Table 6-6	Annual Burden Estimate for Federal Permitting Authorities

Activity	Hours (hrs/permit/yr)	$/permit	No. of permits	Total hours 
Total dollars

BMP Plan Certification Receipt	0.05	$1.91	8	0.4	$15

INAD Program Sign-up Report Receipt	0.5	$19.14	4	2	$77

Research on Environmental Affects of INAD 	3	$114.84	4	12	$459

Determination of Site Specific Limits for INAD	3	$114.84	1	3	$115

INAD or Extra-Label Drug Report Receipt	0.5	$19.14	4	2	$77

Spill Report Receipt	0.5	$19.14	2	1	$38

Structural Failure Report Receipt	0.5	$19.14	10	5	$191

Notify State Fish & Wildlife Department	0.5	$19.14	5	2.5	$96

Review cause of failure and past reports to evaluate effectiveness of
practices	1	$38.28	3	3	$115



6.e.  Bottom Line Burden Hours and Cost Tables 

The following table presents the total estimated burden and cost for the
three year term of this ICR.

Table 6-7	Total Estimated Burden for Facilities for the CAAP Effluent
Guidelines Regulation

Activity	Flow through & Recirculating	Net pen

	Total hours	Total cost	Total hours	Total cost

BMP Plan Development	4,344	$129,270	456	$14,419

BMP Plan Certification	136	$4,039	14	$451

Training for BMPs	3,258	$75,976	342	$12,333

INAD Program Sign-up Report	48	$1,534	3	$95

INAD or Extra-Label Use Report	72	$2,301	5	$142

Spill Report	30	$874	24	$759

Structural Failure Report	330	$9,716	285	$9,012

Feed Management Records	61,419	$1,319,092	0	$-

Inspection, Cleaning, Maintenance & Repair Records	61,419	$1,319,092	0
$-

Subtotal by Subcategory	131,056	$2,861,894	1,129	$37,210







TOTAL RESPONDENT BURDEN & COST	132,185 hours	$2,899,103

Annual Respondent Burden & Cost	44,062 hours/year	$966,368/year



Table 6-8	Total Estimated Burden for Permitting Authorities

Activity	State permitting authorities	Federal permitting authorities

	Total hours	Total cost	Total hours	Total cost

BMP Plan Certification Receipt	30.3	$1,157	1.2	$46

INAD Program Sign-up Report Receipt	19.5	$746	6	$230

Research on Environmental Affects of INAD 	117	$4,479	36	$1,378

Determination of Site Specific Limits for INAD	63	$2,412	9	$345

INAD or Extra-Label Drug Report Receipt	19.5	$746	6	$230

Spill Report Receipt	10.5	$402	3	$115

Structural Failure Report Receipt	46.5	$1,780	15	$574

Notify State Fish & Wildlife Department	36	$1,378	7.5	$287

Review cause of failure and past reports to evaluate effectiveness of
practices	60	$2,297	9	$345

Subtotal by Subcategory	402.3	$15,398	92.7	$3,548







Annual Burden & Cost	134	$5,133	31	$1,183



Table 6-9	Annual Facilities and States Respondents Tally

Respondent	Respondents	Responses	Burden	Cost

Facilities	200	566	44,062	$966,368

States	45	168	134	$5,133

Total	245	734	44,196	$971,500



The total estimated annual burden for the CAAP Effluent Guidelines
Regulation is 44,196 hours and the estimated cost is $971,500.  The
total burden over the three year ICR approval would be 132,587 hours and
$2,914,501.

6.f.  Reasons for Change in Burden

There is a decrease of 804 hours (1.8%) in the total estimated burden
currently identified in the OMB Inventory of Approved ICR Burdens.  This
decrease reflects EPA’s corrections to the 2004 ICR and is not the
result of changes to the requirements covered by this ICR. These
corrections were made for three types of errors detected:

Precision errors when approximations were incorrectly done (e.g., 52
hours approximated to 50 hours)

Assumption error: when assumptions were incorrectly used in the
calculations (e.g., 30 minutes entered as 0.3 hours as opposed to 0.5
hours)

Mathematical errors: clear arithmetic problems (e.g., 8x122=1,720)

6.g.  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 180 hours per respondent per
year.  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; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; and
transmit or otherwise disclose the information.  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 are
listed in 40 CFR Part 9 and 48 CFR Chapter 15.

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摧椔=᠀s, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA.  Please include
the EPA Docket ID No. EPA-HQ-OW-2007-0142 and OMB control number
2040-0258 in any correspondence.

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