Topic 3

19. Aquaculture activities should be conducted in a manner that assures the health and welfare of farmed aquatic animals, by optimizing health through minimizing stress, reducing aquatic animal disease risks and maintaining a healthy culture environment at all phases of the production cycle. Guidelines and standards set by OIE should be the specific normative basis.

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.

24. Use of species in polyculture or integrated multitrophic aquaculture should be carefully considered in order to reduce potential disease transmission between cultured species.

25. Aquaculture animals should be kept under farming conditions suitable for the species concerned, in particular taking into account water temperature and quality.

34. Aquaculture facilities and operations should maintain good culture and hygienic conditions, including:

·   Good hygiene practices in the farm surroundings should be applied aiming at minimizing contamination of growing water, particularly from waste materials or faecal matter from animals or humans.

·   Good Aquaculture Practices should be applied during culture to ensure good hygienic culture conditions and safety and quality of aquaculture produce.

·   Farms should institute a pest control programme, so that rodents, birds and other wild and domesticated animals are controlled, especially around feed storage areas.

·   Farm grounds should be well maintained to reduce or eliminate food and feed safety hazards.

·   Appropriate techniques for harvesting, storing and transportation of aquaculture products should be applied to minimize contamination and physical damage.

The Commercial Aquaculture Health Program Standards (CAHPS) developed by the National Aquaculture Association in collaboration with the United States Department of Agriculture - Animal and Plant Health Inspection Service - Veterinary Services, provide a framework for the improvement and verification of the health of commercially farmed aquatic animals produced in the U.S. The CAHPS is authorized by the Animal Health Protection Act as a way to implement the National Aquatic Animal Health Plan: “The Secretary may enter into a cooperative agreement with an eligible entity to carry out a project under a national aquatic animal health plan … for … promoting species-specific best management practices” (USC 7-109-§ 8322). The CAHPS recognize that there are regional differences in aquatic animal pathogen prevalence. 

The five CAHPS principles consist of implementing: 

1. an Aquatic Animal Health Team

2. Risk Characterization and Management 

3. Surveillance

4. Investigation and Reporting

5. Response

For food fish/shellfish, the development of HACCP plans with comprehensive system verification (i.e., inspection) occurring on a yearly basis by "Independent Expert(s)", i.e., "Done by others than the team writing and implementing the (HACCP) plan" (FDA-HACCP 1997), ensures that a healthy culture environment is maintained at facilities. Animals cultured for biomedical and behavioral research are inspected by Institutional Animal Care and Use Committees (IACUC) semi-annually to ensure proper care and treatment of animals in all study areas and facilities of the research entity. 

The State of Florida requires aquaculture facilities holding a state Aquaculture Certificate of Registration be inspected twice per year to ensure compliance with state regulatory Best Management Practices. 

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

Goal 3. Uphold Animal Well-Being, Product Safety, and Nutritional Value

Objective 3.1: Develop strategies to protect the health and well-being of aquaculture species

Disease causes economic and ecological losses across the aquaculture sector. In addition to direct losses to production, disease can have broader indirect impacts on the surrounding ecosystem, public perception, demand for cultured products, and policy decisions. Accordingly, significant investments should be directed toward understanding priority disease issues and developing tools and capabilities to proactively address them. Wherever possible, prevention of disease through good farm management (i.e., maintaining good water quality, not overfeeding, not overstocking) and sound on-farm biosecurity programs and vaccination is preferred to treatment with pharmaceuticals. This also includes the need to integrate oceanographic and epidemiological models to help site and manage marine aquaculture. Disease prevention is also improved by national and regional biosecurity efforts, including inspection and approval protocols for aquaculture inputs such as feed, eggs and juveniles.

Where preventive measures have not been developed or are not adequate, safe and effective treatment options must be developed to avoid unnecessary losses and protect animal and plant welfare. Research is needed to characterize important and emerging disease issues, identify effective prevention measures, including vaccines, and develop safe and effective treatment options using approved drugs and biologics.

Domesticating aquaculture species for commercial production often requires treatments with specific drugs to better predict spawning times and enhance reproductive success or develop monosex or sterile populations. These treatments can reduce the impacts of sexual dimorphism, reduce risks associated with escapes, and protect investments in selected stocks. Anesthetics are also needed for tagging, weighing, and nonlethal sampling wild and domesticated stocks.

Key actions listed below will protect aquatic animal health and the agencies listed will support or conduct R&D activities or consult with science programs to identify research priorities and form science-based policy.

• Action 3.1.1 USDA (APHIS, ARS, NIFA), DOC NOAA (SG, NMFS), and DOI (USGS, USFWS) will support or conduct research and industry outreach to improve farm-level biosecurity and management practices including non-lethal pathogen testing to maintain adequate water quality, minimize animal stress, and prevent diseases.

• Action 3.1.2 DOI (USFWS), USDA (APHIS), and DOC NOAA (SG, NMFS) will conduct outreach to improve regional and national biosecurity procedures including transfers of juveniles and other aquaculture inputs and products.

• Action 3.1.3 HHS (FDA), USDA (APHIS, ARS, NIFA), DOI (FWS, USGS), and DOC NOAA (SG, NMFS) will collaborate to support or conduct research that identifies and characterizes key unmet needs or provides information on the safety and effectiveness for drugs and biologics across the aquaculture sector, including vaccine and disease treatments, anesthetics, marking agents, and tools to aid in spawning and gender control.

• Action 3.1.4 HHS (FDA), and DOC NOAA (NSIL) will validate new chemical detection methods for residues of approved and unapproved drugs to support regulatory compliance and surveillance activities.

• Action 3.1.5 HHS (FDA), USDA (APHIS), and DOI (USFWS) will develop standardized criteria to interpret laboratory tests intended to provide surveillance for monitoring antimicrobial resistance and to inform judicious use of antimicrobials.

• Action 3.1.6 HHS (FDA), DOI (USFWS) and DOC NOAA (NMFS) will investigate alternative approaches to the standard drug development process to increase availability of approved therapies for U.S. aquaculture.

• Action 3.1.7 USDA (APHIS, ARS), DOI (USGS) and DOC (NMFS) will conduct research to detect and characterize important and emerging aquatic diseases to support early detection (biosurveillance) and develop effective responses.

The Commercial Aquaculture Health Program Standards (CAHPS) provide a framework for the improvement and verification of the health of commercially farmed aquatic animals produced in the United States. Expanding the implementation of CAHPS could be considered for future action to maintain healthy culture environments throughout the production cycle.

§ 8322 National aquatic animal health plan

(a) In general
The Secretary of Agriculture may enter into a cooperative agreement with an eligible entity to carry out a project under a national aquatic animal health plan under the authority of the Secretary under section 10411 of the Animal Health Protection Act (7 U.S.C. 8310) for the purpose of detecting, controlling, or eradicating diseases of aquaculture species and promoting species-specific best management practices.

§ 42  Importation or shipment of injurious mammals, birds, fish (including mollusks and crustacea), amphibia, and reptiles; permits, specimens for museums; regulations

(a)(2) As used in this subsection, the term “wild” relates to any creatures that, whether or not raised in captivity, normally are found in a wild state; and the terms “wildlife” and “wildlife resources” include those resources that comprise wild mammals, wild birds, fish (including mollusks and crustacea), and all other classes of wild creatures whatsoever, and all types of aquatic and land vegetation upon which such wildlife resources are dependent.

(b) Whoever violates this section, or any regulation issued pursuant thereto, shall be fined under this title or imprisoned not more than six months, or both.

(c) The Secretary of the Interior within one hundred and eighty days of the enactment of the Lacey Act Amendments of 1981 shall prescribe such requirements and issue such permits as he may deem necessary for the transportation of wild animals and birds under humane and healthful conditions, and it shall be unlawful for any person, including any importer, knowingly to cause or permit any wild animal or bird to be transported to the United States, or any Territory or district thereof, under inhumane or unhealthful conditions or in violation of such requirements. In any criminal prosecution for violation of this subsection and in any administrative proceeding for the suspension of the issuance of further permits—

(1) the condition of any vessel or conveyance, or the enclosures in which wild animals or birds are confined therein, upon its arrival in the United States, or any Territory or district thereof, shall constitute relevant evidence in determining whether the provisions of this subsection have been violated; and

(2) the presence in such vessel or conveyance at such time of a substantial ratio of dead, crippled, diseased, or starving wild animals or birds shall be deemed prima facie evidence of the violation of the provisions of this subsection. 

§ 342  Adulterated food.
A food shall be deemed to be adulterated—

(a) Poisonous, insanitary, etc., ingredients

(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter;

§ 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.

Subchapter I Research and Related Programs

§ 1251 Congressional declaration of goals and policy

(a) Restoration and maintenance of chemical, physical and biological integrity of Nation’s waters; national goals for achievement of objective. The objective of this chapter is to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters. In order to achieve this objective it is hereby declared that, consistent with the provisions of this chapter—

(2) it is the national goal that wherever attainable, an interim goal of water quality which provides for the protection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water be achieved by July 1, 1983;

§ 289d Animals in Research

(b) Animal care committees; establishment; membership; functions

(1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this chapter (including the National Institutes of Health and the national research institutes) to assure compliance with the guidelines established under subsection (a).

(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is established, shall be composed of not fewer than three members, and shall include at least one individual who has no association with such entity and at least one doctor of veterinary medicine.

(3) Each animal care committee of a research entity shall—

(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semi-annually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment;

(B) keep appropriate records of reviews conducted under subparagraph (A); and

(C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a certification that the review has been conducted, and (ii) reports of any violations of guidelines established under subsection (a) or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations.
Reports filed under subparagraph (C) shall include any minority views filed by members of the committee.

Subchapter E Regulatory Requirements Under the Federal Meat Inspection Act and the Poultry Products Inspection Act : Part 417. Hazard Analysis And Critical Control Point (HACCP) Systems 

§ 417.2 Hazard Analysis and HACCP Plan.

(a) Hazard analysis.

(1) Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

(2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.

(3) Food safety hazards might be expected to arise from the following:

(i) Natural toxins;

(ii) Microbiological contamination;

(iii) Chemical contamination;

(iv) Pesticides;

(v) Drug residues;

(vi) Zoonotic diseases;

(vii) Decomposition;

(viii) Parasites;

(ix) Unapproved use of direct or indirect food or color additives; and

(x) Physical hazards.

(b) The HACCP plan.

(1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section…

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

(1) List the food safety hazards identified in accordance with paragraph (a) of this section, which must be controlled for each process.

(2) List the critical control points for each of the identified food safety hazards, including, as appropriate:

(i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and

(ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment;

(3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met;

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

(5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point;

§ 417.8 Agency verification. 

FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part and all other applicable regulations. Such verification may include:

(a) Reviewing the HACCP plan;

(b) Reviewing the CCP records;

(c) Reviewing and determining the adequacy of corrective actions taken when a deviation occurs;

(d) Reviewing the critical limits;

(e) Reviewing other records pertaining to the HACCP plan or system;

(f) Direct observation or measurement at a CCP;

(g) Sample collection and analysis to determine the product meets all safety standards; and

(h) On-site observations and record review.

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

§ 534.1 General.
Fish that are harvested for use as human food must have grown and lived under conditions that will not render the fish or their products unsound, unwholesome, unhealthful, or otherwise unfit for human food.

§ 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.

§ 534.4  Transportation to processing plant. 

A vehicle used to transport fish from a producer's premises to a processing establishment must be equipped with vats or other containers for holding the fish. The vats or other containers must be maintained in a sanitary condition. Sufficient water and sufficient oxygen must be provided to the vats that hold the fish to ensure that fish delivered to the processing establishment will not be adulterated. Any fish that are dead, dying, diseased, or contaminated with substances that may adulterate fish products are subject to condemnation at the official fish processing establishments.

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

(a) Hazard analysis.  Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that the processor can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.

(b) The HACCP plan.  Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, as described in paragraph (a) of this section...

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

(1) List the food safety hazards that are reasonably likely to occur, as identified in accordance with paragraph (a) of this section, and that thus must be controlled for each fish and fishery product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following: 

(i) Natural toxins; 

(ii) Microbiological contamination; 

(iii) Chemical contamination; 

(iv) Pesticides; 

(v) Drug residues; 

(vi) Decomposition in scombroid toxin-forming species or in any other species where a food safety hazard has been associated with decomposition; 

(vii) Parasites, where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so consumed; 

(viii) Unapproved use of direct or indirect food or color additives; and 

(ix) Physical hazards; 

(2) List the critical control points for each of the identified food safety hazards, including as appropriate: 

(i) Critical control points designed to control food safety hazards that could be introduced in the processing plant environment; and 

(ii) Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest; 

(3) List the critical limits that must be met at each of the critical control points; 

(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; 

(5) Include any corrective action plans that have been developed in accordance with § 123.7(b), to be followed in response to deviations from critical limits at critical control points;

(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. 

Chapter 3: Environment, Housing, and Management

The design of animal facilities combined with appropriate animal housing and management are essential contributors to animal well-being, the quality of animal research and production, teaching or testing programs involving animals, and the health and safety of personnel. An appropriate Program (see Chapter 2) provides environments, housing, and management that are well suited for the species or strains of animals maintained and takes into account their physical, physiologic, and behavioral needs, allowing them to grow, mature, and reproduce normally while providing for their health and well-being. Well-being is determined by considering physical, physiologic,

and behavioral indicators, which vary by species.

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.

ANIMAL PROCUREMENT AND TRANSPORTATION

Transportation of Animals

...Special considerations may be necessary for transporting animals during certain phases of their life or in certain conditions, such as pregnant, perinatal, and geriatric animals; animals with preexisting medical conditions (e.g., diabetes mellitus); ...

SEC. III Public Health Reasons and Explanations

Chapter X. General Requirements for Dealers

.01 General HACCP Requirements

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 ... 

FDA-HACCP. 1997. United States Food and Drug Administration website "HACCP Principles & Application Guidelines" Adopted August 14, 1997: Home » Food  » Guidance & Regulation (Food and Dietary Supplements) » Hazard Analysis Critical Control Point (HACCP) » HACCP Principles & Application Guidelines. https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines; Content current as of: 02/25/2022.

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/