Topic 7

22. A culture environment should be maintained at all phases of the production cycle adapted to the species raised, to benefit aquatic animal health and welfare, and reduce the risks of introduction and spread of aquatic animal diseases. In particular, by

·   allowing for quarantining of stock where appropriate;

·   routine monitoring of stock and environmental conditions for early detection of aquatic animal health problems; and

·   implementation of management practices that reduce the likelihood of disease transmission within and between aquaculture facilities and natural aquatic fauna, and reduce stress on animals for the purpose of optimizing health.

35. Identification, classification, integrated management and monitoring programmes should be implemented in bivalve molluscs growing areas to prevent microbiological, chemical and reduce biotoxin contamination. Relaying and depuration of bivalve molluscs to remove microbial contamination should be carried in accordance with the requirements of the Codex.

45. Regular monitoring of on-farm and off-farm environmental quality should be carried out, combined with good record-keeping and use of appropriate methodologies.

The Interstate Shellfish Sanitation Conference (ISSC) requires States to monitor water quality three to five times per year for pollutants, with a shoreline survey for potential point sources conducted every three years and weekly monitoring for harmful algal blooms (pers. comm. R. Rheault, Executive Director, East Coast Shellfish Growers). 

The online Coastal Aquaculture Planning Portal (CAPP), which is a product of the NOAA National Ocean Service Office for Coastal Management, is a toolbox of coastal planning and siting tools designed to assist managers and industry with sustainable aquaculture development. The array of portals linked together through CAPP includes programs that monitor state shellfish advisories and closures.  Routine monitoring is conducted at the state and farm level.  

From "A National Strategic Plan for Aquaculture Research" prepared by the National Science and Technology Council Subcommittee on Aquaculture (NSTC  2022):

Goal 2. Improve Aquaculture Production Technologies and Inform Decision-making

Objective 2.2: Develop and refine production technologies to increase environmentally responsible food production and contribute ecosystem services

The need for practices to increase food production in a way that avoids or minimizes harm to the environment resonates globally in all agricultural production sectors, including aquaculture. Successful aquaculture depends on healthy ecosystems that provide clean water and nutrient cycling that processes or reuses wastes and co-products. In the United States, aquaculture’s environmental performance has improved dramatically during the past 20 years, driven by the need for more efficient use of resources and inputs due to rising costs of fuel and feed, increased awareness of environmental issues associated with aquaculture, application of science-based best management practices, technological innovation, knowledge about proper siting of facilities, and evolving aquaculture-specific environmental regulations at the State and Federal levels. Commercial aquaculture production in the United States operates under some of the most stringent environmental requirements in the world. Similarly, Federal agencies adhere to sound science and best management practices when employing aquaculture to fulfill their recovery and restoration missions.

Efficient and effective aquaculture production systems reduce inputs, operating costs, and wastes and create optimal conditions for growth, adaptability, and reproduction. Production efficiency and animal or plant well-being start with properly matching species to appropriate production environments and market demands. Defining optimal conditions requires a comprehensive understanding of the physiology of early development, growth, nutrition, stress response, and reproduction.

Aquaculture must not only have minimal impacts on host environments, but wherever possible it must contribute services that regenerate ecosystems, contribute to climate change adaptation and mitigation.

The following actions will improve production efficiency and develop new aquaculture production strategies that minimize environmental impacts. The agencies listed below will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• Action 2.2.1 DOC NOAA (NMFS, NOS, SG), USDA (ARS, NIFA), DOI (USGS), and DOE (ARPA-E, BETO) will support or conduct research to document the ecosystem services provided by aquaculture and identify new opportunities to utilize them, including increasing the effectiveness of monitoring environmental conditions in remote offshore environments.

• Action 2.2.2 DOC NOAA (SG), USDA (NIFA), and HHS (FDA) will conduct or support research to support innovation in aquaculture, traceability, and identification.

• Action 2.2.3 DOC NOAA (NMFS, SG) and DOI (USFWS) in association with State agencies and others will develop aquaculture methods that cost-effectively enhance, preserve, and rebuild wild stocks and their ecosystems.

Objective 2.4: Improve engineering systems for aquaculture 

Production systems for aquaculture in the United States include pond-based systems (e.g., catfish and crawfish production); raceway systems (e.g., rainbow trout and microalgae); near-shore and offshore net-pens and cages (e.g., Atlantic salmon and marine fish); hatcheries (e.g., Pacific salmon and marine fish); intertidal, off-bottom, and long-line coastal shellfish production; freshwater and marine algae (including seaweed) production systems; and recirculation systems (e.g., aquaponics, salmon, yellow perch, tilapia, ornamental species, and oyster spat). The hatcheries and nurseries for all these types of aquaculture represent unique engineering challenges, but all production systems would benefit from advanced monitoring and control systems, labor-saving process engineering, and other specialized devices. For example, renewable energy for the operation of offshore systems could be supplied by integrated marine wind and water power technologies. 

Aquaponics, the cultivation of plants in water downstream of aquatic animal production, demonstrates the potential of integrating hydroponics with modern aquaculture systems. Further R&D in combining complementary systems may enable large-scale production of both fish and vegetables in one system. This has the potential to help revitalize rural economies and provide for local production in food deserts where access to affordable, healthy food options is limited.

Significant opportunities exist to improve the performance and productivity of aquaculture production systems through innovative engineering and new devices and technologies. There is significant potential to adapt current commercial technologies and engineering solutions from other sectors, such as municipal wastewater treatment, manufacturing, medicine, information technology, artificial intelligence, sensors, and energy, that can be integrated into aquaculture systems to improve productivity and efficiency.

The following actions will improve the efficiency and sustainability of aquaculture production systems. The agencies listed below will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• Action 2.4.1 USDA (ARS, NIFA), DOC NOAA (SG, NMFS), and DOI (USFWS) will support research that ensures robust aquaculture system performance at reasonable costs that maximize production potential, safety, and economic performance and reduce risk to native populations (including endangered and threatened species), while minimizing labor needs and impacts on wild organisms.

• Action 2.4.2 USDA (ARS), DOE (BETO), and DOC NOAA (NMFS, SG) will support or conduct research that develops highly effective hatcheries and harvest and processing equipment.

• Action 2.4.3 USDA (NIFA), DOI (USGS), and DOC NOAA (SG) will support or conduct research to develop or improve various types of specialized aquaculture systems that may be appropriate for U.S. aquaculture.

• Action 2.4.4 DOC NOAA (SG, NMFS) and USDA (NIFA) will provide Extension Service support, test beds, and demonstration and production assistance through public-private partnerships to increase the rate of knowledge transfer from research to implementation and provide effective communication to researchers on behalf of farmers.

Subchapter I Generally

§ 1362 Definitions
For the purposes of this chapter-

(2) The terms "conservation" and "management" mean the collection and application of biological information for the purposes of increasing and maintaining the number of animals within species and populations of marine mammals at their optimum sustainable population. Such terms include the entire scope of activities that constitute a modern scientific resource program, including, but not limited to, research, census, law enforcement, and habitat acquisition and improvement. Also included within these terms, when and where appropriate, is the periodic or total protection of species or populations as well as regulated taking.

Subchapter II Conservation and Protection of Marine Mammals

§1371 Moratorium on taking and importing marine mammals and marine mammal products

(a) Imposition; exceptions

There shall be a moratorium on the taking and importation of marine mammals and marine mammal products, commencing on the effective date of this chapter, during which time no permit may be issued for the taking of any marine mammal and no marine mammal or marine mammal product may be imported into the United States except in the following cases:

(5)(A)(i) Except as provided by clause (ii), upon request therefor by citizens of the United States who engage in a specified activity (other than commercial fishing) within a specified geographical region, the Secretary shall allow, during periods of not more than five consecutive years each, the incidental, but not intentional, taking by citizens while engaging in that activity within that region of small numbers of marine mammals of a species or population stock if the Secretary, after notice (in the Federal Register and in newspapers of general circulation, and through appropriate electronic media, in the coastal areas that may be affected by such activity) and opportunity for public comment—

(I) finds that the total of such taking during each five-year (or less) period concerned will have a negligible impact on such species or stock and will not have an unmitigable adverse impact on the availability of such species or stock for taking for subsistence uses pursuant to subsection (b) or section 1379(f) of this title or, in the case of a cooperative agreement under both this chapter and the Whaling Convention Act of 1949 (16 U.S.C. 916 et seq.), pursuant to section 1382(c) of this title; and

(II) prescribes regulations setting forth—

(aa) permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for subsistence uses; and

(bb) requirements pertaining to the monitoring and reporting of such taking.

(D)(i) Upon request therefor by citizens of the United States who engage in a specified activity (other than commercial fishing) within a specific geographic region, the Secretary shall authorize, for periods of not more than 1 year, subject to such conditions as the Secretary may specify, the incidental, but not intentional, taking by harassment of small numbers of marine mammals of a species or population stock by such citizens while engaging in that activity within that region if the Secretary finds that such harassment during each period concerned—

(I) will have a negligible impact on such species or stock, and

(II) will not have an unmitigable adverse impact on the availability of such species or stock for taking for subsistence uses pursuant to subsection (b), or section 1379(f) of this title or pursuant to a cooperative agreement under section 1388 of this title.

(ii) The authorization for such activity shall prescribe, where applicable—

(III) requirements pertaining to the monitoring and reporting of such taking by harassment, including requirements for the independent peer review of proposed monitoring plans or other research proposals where the proposed activity may affect the availability of a species or stock for taking for subsistence uses pursuant to subsection (b) or section 1379(f) of this title or pursuant to a cooperative agreement under section 1388 of this title.

Subchapter I Generally

§ 1801 Findings, purposes and policy

(b) Purposes. It is therefore declared to be the purposes of the Congress in this chapter—

(1) to take immediate action to conserve and manage the fishery resources found off the coasts of the United States, and the anadromous species and Continental Shelf fishery resources of the United States, by exercising (A) sovereign rights for the purposes of exploring, exploiting, conserving, and managing all fish, within the exclusive economic zone established by Presidential Proclamation 5030, dated March 10, 1983, and (B) exclusive fishery management authority beyond the exclusive economic zone over such anadromous species and Continental Shelf fishery resources;

Subchapter I General Provisions

§ 4701  Findings and purposes

(b) Purposes

The purposes of this chapter are-

(3) to develop and carry out environmentally sound control methods to prevent, monitor and control unintentional introductions of nonindigenous species from pathways other than ballast water exchange;

Subchapter III Prevention and control of aquatic nuisance species dispersal

§ 4722  Aquatic nuisance species program

(a) In general

The Task Force shall develop and implement a program for waters of the United States to prevent introduction and dispersal of aquatic nuisance species; to monitor, control and study such species; and to disseminate related information.
(d) Monitoring

The Task Force shall establish and implement monitoring measures, within the program developed under subsection (a), to-

(1) detect unintentional introductions of aquatic nuisance species;

(2) determine the dispersal of aquatic nuisance species after introduction; and

(3) provide for the early detection and prevention of infestations of aquatic nuisance species in unaffected drainage basins.

§ 350g Hazard analysis and risk-based preventive controls

(a) In general

The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 342 of this title or misbranded under section 343(w) of this title, monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

§ 601  Definitions. As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below:

(w) The term “amenable species” means—

(1) those species subject to the provisions of this chapter on the day before November 10, 2005;

(2) all fish of the order Siluriformes; and

(3) any additional species of livestock that the Secretary considers appropriate.

§ 606  Inspection and labeling of meat food products

(a) In general. For the purposes hereinbefore set forth the Secretary shall cause to be made, by inspectors appointed for that purpose, an examination and inspection of all meat food products prepared for commerce in any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and for the purposes of any examination and inspection and inspectors shall have access at all times, by day or night, whether the establishment be operated or not, to every part of said establishment; and said inspectors shall mark, stamp, tag, or label as “Inspected and passed” all such products found to be not adulterated; and said inspectors shall label, mark, stamp, or tag as “Inspected and condemned” all such products found adulterated, and all such condemned meat food products shall be destroyed for food purposes, as hereinbefore provided, and the Secretary may remove inspectors from any establishment which fails to so destroy such condemned meat food products: Provided, That subject to the rules and regulations of the Secretary the provisions of this section in regard to preservatives shall not apply to meat food products for export to any foreign country and which are prepared or packed according to the specifications or directions of the foreign purchaser, when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is to be exported; but if said article shall be in fact sold or offered for sale for domestic use or consumption then this proviso shall not exempt said article from the operation of all the other provisions of this chapter.

(b) Certain fish. In the case of an examination and inspection under subsection (a) of a meat food product derived from any fish described in section 601(w)(2) of this title, the Secretary shall take into account the conditions under which the fish is raised and transported to a processing establishment.

§ 608  Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products

The Secretary shall cause to be made, by experts in sanitation or by other competent inspectors, such inspection of all slaughtering, meat canning, salting, packing, rendering, or similar establishments in which amenable species are slaughtered and the meat and meat food products thereof are prepared for commerce as may be necessary to inform himself concerning the sanitary conditions of the same, and to prescribe the rules and regulations of sanitation under which such establishments shall be maintained; and where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, he shall refuse to allow said meat or meat food products to be labeled, marked, stamped or tagged as "inspected and passed."

Subchapter III Standards and enforcement

§ 1311 Effluent limitations

(h) Modification of secondary treatment requirements

The Administrator, with the concurrence of the State, may issue a permit under section 1342 of this title which modifies the requirements of subsection (b)(1)(B) of this section with respect to the discharge of any pollutant from a publicly owned treatment works into marine waters, if the applicant demonstrates to the satisfaction of the Administrator that-

(3) the applicant has established a system for monitoring the impact of such discharge on a representative sample of aquatic biota, to the extent practicable, and the scope of such monitoring is limited to include only those scientific investigations which are necessary to study the effects of the proposed discharge;

(m) Modification of effluent limitation requirements for point sources

(1) The Administrator, with the concurrence of the State, may issue a permit under section 1342 of this title which modifies the requirements of subsections (b)(1)(A) and (b)(2)(E) of this section, and of section 1343 of this title, with respect to effluent limitations to the extent such limitations relate to biochemical oxygen demand and pH from discharges by an industrial discharger in such State into deep waters of the territorial seas, if the applicant demonstrates and the Administrator finds that-

(A) the facility for which modification is sought is covered at the time of the enactment of this subsection by National Pollutant Discharge Elimination System permit number CA0005894 or CA0005282;

(B) the energy and environmental costs of meeting such requirements of subsections (b)(1)(A) and (b)(2)(E) and section 1343 of this title exceed by an unreasonable amount the benefits to be obtained, including the objectives of this chapter;

(C) the applicant has established a system for monitoring the impact of such discharges on a representative sample of aquatic biota;

§ 1314 Information and guidelines

(i) Guidelines for monitoring, reporting, enforcement, funding, personnel, and manpower

The Administrator shall

 (1) within sixty days after October 18, 1972, promulgate guidelines for the purpose of establishing uniform application forms and other minimum requirements for the acquisition of information from owners and operators of point-sources of discharge subject to any State program under section 1342 of this title, and
(2) within sixty days from October 18, 1972, promulgate guidelines establishing the minimum procedural and other elements of any State program under section 1342 of this title, which shall include:

(A) monitoring requirements;

§ 1318 Records and reports; inspections

(a) Maintenance; monitoring equipment; entry; access to information

Whenever required to carry out the objective of this chapter, including but not limited to (1) developing or assisting in the development of any effluent limitation, or other limitation, prohibition, or effluent standard, pretreatment standard, or standard of performance under this chapter; (2) determining whether any person is in violation of any such effluent limitation, or other limitation, prohibition or effluent standard, pretreatment standard, or standard of performance; (3) any requirement established under this section; or (4) carrying out sections 1315, 1321, 1342, 1344 (relating to State permit programs), 1345, and 1364 of this title-

(A) the Administrator shall require the owner or operator of any point source to (i) establish and maintain such records, (ii) make such reports, (iii) install, use, and maintain such monitoring equipment or methods (including where appropriate, biological monitoring methods), (iv) sample such effluents (in accordance with such methods, at such locations, at such intervals, and in such manner as the Administrator shall prescribe), and (v) provide such other information as he may reasonably require;

(c) Application of State law

Each State may develop and submit to the Administrator procedures under State law for inspection, monitoring, and entry with respect to point sources located in such State. If the Administrator finds that the procedures and the law of any State relating to inspection, monitoring, and entry are applicable to at least the same extent as those required by this section, such State is authorized to apply and enforce its procedures for inspection, monitoring, and entry with respect to point sources located in such State (except with respect to point sources owned or operated by the United States).

§ 1321 Oil and hazardous substance liability

(m) Administrative provisions

(2) For facilities

(A) Recordkeeping

Whenever required to carry out the purposes of this section, the Administrator, the Secretary of Transportation, or the Secretary of the Department in which the Coast Guard is operating shall require the owner or operator of a facility to which this section applies to establish and maintain such records, make such reports, install, use, and maintain such monitoring equipment and methods, and provide such other information as the Administrator or Secretary, as the case may be, may require to carry out the objectives of this section.

(D) Public access

Any records, reports, or information obtained under this paragraph shall be subject to the same public access and disclosure requirements which are applicable to records, reports, and information obtained pursuant to section 1318 of this title.

Subchapter IV Permits and licenses

§ 1342 National pollutant discharge elimination system

(a) Permits for discharge of pollutants

(1) Except as provided in sections 1328 and 1344 of this title, the Administrator may, after opportunity for public hearing issue a permit for the discharge of any pollutant, or combination of pollutants, notwithstanding section 1311(a) of this title, upon condition that such discharge will meet either (A) all applicable requirements under sections 1311, 1312, 1316, 1317, 1318, and 1343 of this title, or (B) prior to the taking of necessary implementing actions relating to all such requirements, such conditions as the Administrator determines are necessary to carry out the provisions of this chapter.

(2) The Administrator shall prescribe conditions for such permits to assure compliance with the requirements of paragraph (1) of this subsection, including conditions on data and information collection, reporting, and such other requirements as he deems appropriate.

(3) The permit program of the Administrator under paragraph (1) of this subsection, and permits issued thereunder, shall be subject to the same terms, conditions, and requirements as apply to a State permit program and permits issued thereunder under subsection (b) of this section.

(b) State permit programs

At any time after the promulgation of the guidelines required by subsection (i)(2) of section 1314 of this title, the Governor of each State desiring to administer its own permit program for discharges into navigable waters within its jurisdiction may submit to the Administrator a full and complete description of the program it proposes to establish and administer under State law or under an interstate compact. In addition, such State shall submit a statement from the attorney general (or the attorney for those State water pollution control agencies which have independent legal counsel), or from the chief legal officer in the case of an interstate agency, that the laws of such State, or the interstate compact, as the case may be, provide adequate authority to carry out the described program. The Administrator shall approve each submitted program unless he determines that adequate authority does not exist:

(2)(A) To issue permits which apply, and insure compliance with, all applicable requirements of section 1318 of this title; or

(B) To inspect, monitor, enter, and require reports to at least the same extent as required in section 1318 of this title;

 § 243 General grant of authority for cooperation

(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees

The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence.

Subchapter F Mandatory Inspection of Fish of the Order Siluriformes and Products of Such Fish: Part 534 Pre-Harvest Standards and Transportation to Processing Establishment

§ 534.2  Water Quality For Food Fish

Farmers of fish should monitor the water in which the fish are raised for the presence of suspended solids, organic matter, nutrients, heavy metals, pesticides, fertilizers, and industrial chemicals that may contaminate fish. FSIS will collect samples of feed, fish, and water from producers, at intervals to be determined by the Administrator, for the purpose of verifying that fish are being raised under conditions that will yield safe, wholesome products.

Subpart A General Provisions

§ 123.6  Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) Plan.

(c) The contents of the HACCP plan.  The HACCP plan shall, at a minimum:

(4) List the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(g) Legal basis.  Failure of a processor to have and implement a HACCP plan that complies with this section whenever a HACCP plan is necessary, otherwise operate in accordance with the requirements of this part, shall render the fish or fishery products of that processor adulterated under section 402(a)(4) of the act. Whether a processor's actions are consistent with ensuring the safety of food will be determined through an evaluation of the processors overall implementation of its HACCP plan, if one is required.

§ 123.11  Sanitation control procedures.

(b) Sanitation monitoring.  Each processor shall monitor the conditions and practices during processing with sufficient frequency to ensure, at a minimum, conformance with those conditions and practices specified in part 110 of this chapter and in subpart B of part 117 of this chapter that are both appropriate to the plant and the food being processed and relate to the following: ...

(c) Sanitation control records.  Each processor shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by paragraph (b) of this section. These records are subject to the requirements of § 123.9.

Part 16 Injurious Wildlife

Subpart B - Importation or Shipment of Injurious Wildlife

§ 16.13 Importation of live or dead fish, mollusks, and crustaceans, or their eggs.

(e) Fish sampling requirements, sample processing, and methods for virus assays -

(1) Fish sampling requirements.

(i) Sampling for virus assays required by this section must be conducted within the six (6) months prior to the date of shipment of dead uneviscerated salmonid fish, live salmonid fish, live salmonid eggs, or salmonid gametes to the United States. Sampling shall be on a lot-by-lot basis with the samples from each lot distinctively marked, maintained, and processed for virus assay separately. A fish lot is defined as a group of fish of the same species and age that originated from the same discrete spawning population and that always have shared a common water supply. In the case of adult broodstock, various age groups of the same fish species may be sampled as a single lot, provided they meet the other conditions previously stated and have shared the same container(s) for at least 1 year prior to the sampling date.

Part 216 Regulations governing the taking and importing of marine mammals

Subpart I - General Regulations Governing Small Takes of Marine Mammals Incidental to Specified Activities

§ 216.102 Scope.

The taking of small numbers of marine mammals under section 101(a)(5) (A) through (D) of the Marine Mammal Protection Act may be allowed only if the National Marine Fisheries Service: 

(c) Prescribes either regulations or requirements and conditions contained within an incidental harassment authorization, as appropriate, pertaining to the monitoring and reporting of such taking. The specific regulations governing certain specified activities are contained in subsequent subparts of this part.

§ 216.105 Specific regulations.

(b) For allowed activities that may result in incidental takings of small numbers of marine mammals by harassment, serious injury, death or a combination thereof, specific regulations shall be established for each allowed activity that set forth:

(3) Requirements for monitoring and reporting, including requirements for the independent peer-review of proposed monitoring plans where the proposed activity may affect the availability of a species or stock for taking for subsistence uses.

Part 622 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic

Subpart F Offshore Marine Aquaculture in the Gulf of Mexico

§ 622.102 Recordkeeping and reporting. 

(a) Participants in Gulf aquaculture activities addressed in this subpart must keep records and report as specified in this section. Unless otherwise specified, required reporting must be accomplished electronically via the Web site. See § 622.100(a)(3) regarding provisions for paper-based reporting in lieu of electronic reporting during catastrophic conditions as determined by the RA. Recordkeeping (i.e., maintaining records versus submitting reports) may, to the extent feasible, be maintained electronically; however, paper-based recordkeeping also is acceptable. 

(1) Aquaculture facility owners or operators.  An aquaculture facility owner or operator must comply with the following requirements:

(iii) Recordkeeping requirements.  An aquaculture facility owner or operator must comply with the following recordkeeping requirements: 

(A) Maintain for the most recent 3 years and make available to NMFS or an authorized officer, upon request, monitoring reports related to aquaculture activities required by all other state and Federal permits (e.g., EPA NPDES permit) required for conducting offshore aquaculture.

§ 622.106 Aquaculture operations. 

(a) Operational requirements and restrictions.  An owner or operator of an aquaculture facility for which a Gulf aquaculture permit has been issued must comply with the following operational requirements and restrictions.

(7) Feed practices and monitoring.  The permittee must conduct feed monitoring and management practices in compliance with EPA regulations at 40 CFR 451.21, if applicable to the facility. 

(8) Monitoring and reporting compliance.  The permittee must monitor and report the environmental survey parameters at the aquaculture facility consistent with NMFS' guidelines that will be available on the Web site and from the RA upon request. The permittee also must comply with all applicable monitoring and reporting requirements specified in their valid ACOE Section 10 permit and valid EPA NPDES permit. 

(9) Inspection for protected species.  The permittee must regularly inspect approved aquaculture systems, including mooring and anchor lines, for entanglements or interactions with marine mammals, protected species, and migratory birds. The frequency of inspections will be specified by NMFS as a condition of the permit. If entanglements or interactions are observed, they must be reported as specified in § 622.102(a)(1)(i)(G).

Chapter 1: Key Concepts

KEY TERMS USED IN THE GUIDE

Engineering, Performance, and Practice Standards

Performance standard means a standard or guideline that, while describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those responsible for managing the animal care and use program, the researcher, and the IACUC. The performance approach requires professional input, sound judgment, and a team approach to achieve specific goals. It is essential that the desired outcomes and/or goals be clearly defined and appropriate performance measures regularly monitored in order to verify the success of the process.

Chapter 2: Animal Care and Use Program

PROGRAM OVERSIGHT

Postapproval Monitoring

Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. A variety of mechanisms can be used to facilitate ongoing protocol assessment and regulatory compliance. Postapproval monitoring (PAM) is considered here in the broadest sense, consisting of all types of protocol monitoring after the IACUC’s initial protocol approval...

Both the Health Research Extension Act and the AWA require the IACUC to inspect animal care and use facilities, including sites used for animal surgeries, every 6 months. As part of a formal PAM program some institutions combine inspection of animal study sites with concurrent review of animal protocols. Based on risks to animals and their handlers, other study areas may require more or less frequent inspections...

Chapter 3: Environment, Housing, and Management

AQUATIC ANIMALS

Aquatic Environment

Water Quality

Routine measurement of various water characteristics (water quality testing) is essential for stable husbandry. Standards for acceptable water quality, appropriate parameters to test, and testing frequency should be identified at the institutional level and/or in individual animal use protocols depending on the size of the aquatic program...

The specific parameters and frequency of testing vary widely (depending on the species, life stage, system, and other factors), from continuous monitoring to infrequent spot checks...

Life Support System

....Changes in water quality parameters (e.g., pH, ammonia, and nitrite) may negatively affect animal health and the efficiency of the biofilter, so species sensitive to change in water quality outside of a narrow range require more frequent monitoring.

Chapter 4: Veterinary Care

Veterinary care is an essential part of an animal care and use Program. The primary focus of the veterinarian is to oversee the well-being and clinical care of animals used in research, testing, teaching, and production. This responsibility extends to monitoring and promoting animal well-being at all times during animal use and during all phases of the animal’s life.

PREVENTIVE MEDICINE

Surveillance, Diagnosis, Treatment, and Control of Disease

All animals should be observed for signs of illness, injury, or abnormal behavior by a person trained to recognize such signs. As a rule, such observation should occur at least daily, but more frequent observations may be required, such as during postoperative recovery, when animals are ill or have a physical deficit, or when animals are approaching a study endpoint. Professional judgment should be used to ensure that the frequency and character of observations minimize risks to individual animals and do not compromise the research for which the animals are used.

Appropriate procedures should be in place for disease surveillance and diagnosis...

Procedures for disease prevention, diagnosis, and therapy should be those currently accepted in veterinary and laboratory animal practice. Health monitoring programs also include veterinary herd/flock health programs for livestock and colony health monitoring programs for aquatic and rodent species. 

Chapter 5: Physical Plant

GENERAL CONSIDERATIONS

Centralization Versus Decentralization

In a physically centralized animal facility, support, care, and use areas are adjacent to the animal housing space. Decentralized animal housing and use occur in space that is not solely dedicated to animal care or support or is physically separated from the support areas and animal care personnel. Centralization often reduces operating costs, providing a more efficient flow of animal care supplies, equipment, and personnel; more efficient use of environmental controls; and less duplication of support services. Centralization reduces the needs for transporting animals between housing and study sites, thereby minimizing the risks of transport stress and exposure to disease agents; affords greater security by providing the opportunity to control facility access; and increases the ease of monitoring staff and animals.

CONSTRUCTION GUIDELINES

Environmental Monitoring

Monitoring of environmental conditions in animal holding spaces and other environmentally sensitive areas in the facility should be considered. Automated monitoring systems, which notify personnel of excursions in environmental conditions, including temperature and photoperiod, are advisable to prevent animal loss or physiologic changes as a result of system malfunction. The function and accuracy of such systems should be regularly verified.

Goal 5. Industry Accountability – To secure long-term access to operate aquaculture facilities in federal waters, operators are held accountable for protecting the environment, wild species, and human safety and for conducting and reporting ongoing monitoring.

NOAA will achieve this goal by working with federal agencies and other partners to develop an appropriate framework through which operators of aquaculture facilities will:

- prepare, obtain federal approval for, and comply with a monitoring plan to meet all monitoring and reporting requirements, including reports of escapes, disease outbreaks, drug or chemical applications, nutrient discharges, and other environmental monitoring as required by NOAA or other federal agencies

SEC. III Public Health Reasons and Explanations

Chapter X. General Requirements for Dealers

.01 General HACCP Requirements

Hazard Analysis Critical Control Point (HACCP) is a preventive system of hazard control. It consists first of an identification of the likely hazards that could be presented by a specific product, followed by the identification of the critical control points in a specific production process where a failure to control would likely result in a hazard being created or allowed to persist. These critical control points (CCP) are then systematically monitored, and records are kept of that monitoring. Corrective actions are also documented when problems occur.

All dealers must conduct a hazard analysis or have one conducted on their behalf...

The hazard analysis must identify the hazard of pathogen contamination at the receiving CCP as a significant hazard for all raw, molluscan shellfish products. For this reason, all dealers must have and implement a written HACCP Plan ... 

NSTC.  2022. A National Strategic Plan for Aquaculture Research. Prepared by the National Science and Technology Council Subcommittee on Aquaculture. February 2022. Available at: https://www.ars.usda.gov/animal-production-and-protection/aquaculture/docs/national-strategic-plan-federal-aquaculture-research/