Topic 2

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.

21. Movement of aquatic animals, animal genetic material and animal products should take place in accordance with the relevant provisions in the OIE Aquatic Animal Health Code to prevent introduction or transfer of diseases and infectious agents pathogenic to aquatic animals while avoiding unwarranted sanitary measures.

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.

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Veterinary Services (VS) Aquatic Animal Health Program upholds the mission “(t)o protect and improve the health of U.S. farm raised aquatic animals in order to produce safe wholesome seafood, healthy recreational and display/ornamental animals, as well as protect the nation’s aquatic animal natural resources” (Hartman 2018). The program incentivizes and implements voluntary Commercial Aquaculture Health Program Standards (CAHPS) to reduce disease risks of commercially farmed aquatic animals produced in the U.S.

From the United States Department of Agriculture Animal and Plant Health Inspection Service website "Aquaculture Information": CAHPS Concept Paper (USDA-APHIS-VS 2017):

The voluntary Commercial Aquaculture Health Program Standards (CAHPS) establish a framework for the improvement and verification of the health of commercially farmed aquatic animals produced in the U.S. Principles outlined in the CAHPS provide for early disease detection, surveillance, reporting, and response for the control of aquatic animal pathogens--especially those reportable to the World Organization for Animal Health (OIE)--and to prevent their dissemination via aquatic animal movement and/or trade.

The CAHPS are needed because of increasing demand from international markets and trading partners for improvements in aquatic animal health disease detection, reporting, control infrastructure, and health verification in the U.S. In conjunction with existing Federal and State authorities and efforts, this framework provides a model upon which commodity or pathogen-specific standards may be developed. Voluntary adoption of CAHPS will support various business objectives including actions to protect commercial aquatic animal livestock from disease, expand aquaculture business opportunities, and improve resource protection and environmental sustainability.

The principles of CAHPS … were developed through the ongoing collaborative effort of the National Aquaculture Association (NAA), representing domestic commercial aquaculture industry, and the United States Department of Agriculture, Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS). The CAHPS program recognize VS as the lead Federal agency responsible for the protection and promotion of the health of animals in commercial aquaculture and acknowledges that a number of other State and Federal agencies have similar responsibilities for aquatic resources. Moreover, it recognizes that at times, these interests may overlap between agency authorities. VS’ role is central to domestic and international farmed aquatic animal health discussions and negotiations, respectively, and for certifying the health of commercial aquaculture animals and products under the authority afforded them in the U.S. Animal Health Protection Act. VS is recognized by the OIE as the Competent Authority for animal health in the U.S. VS will formally recognize satisfactory participation in this voluntary program; and will provide oversight in its management.

The CAHPS recognize that there are regional differences in aquatic animal pathogen prevalence and encourage scientifically valid risk analysis when setting any aquatic animal pathogen control standards and regulations. For maximum national benefit from the CAHPS, industry, VS, other Federal agencies, and States must work together. CAHPS may be used to provide a consistent approach to harmonize health regulations for aquatic animal movement. A singular approach to verifying health unifies aquatic animal health protection both for commercial industry and natural resources.

While CAHPS was developed to implement the National Aquatic Animal Health Plan (NAAHP) for commercial aquaculture, these program standards may be utilized

as a tool or template to aid other Federal and State authorities when considering public resource protection, management and interstate movement of wild aquatic animals and/or their products. CAHPS encourage the sound aquatic animal health management of natural aquatic animal resources to help further protect the domestic commercial aquaculture industry.

From the Seafood HACCP Online Training Course - Module 3: Seafood Safety Hazards (AFDO-SHA-SG 2020):

To minimize the risk of illness from the consumption of molluscan shellfish, the National Shellfish Sanitation Program (NSSP) has developed an extensive system of controls. The NSSP is a joint program implemented by the FDA and state shellfish control authorities. The controls in the NSSP include criteria for monitoring harvest waters and closing waters that do not meet acceptable standards for shellfish harvesting. Additional controls require that shellfish harvesters and processors (including shippers, reshippers, shuckers, or repackers) be licensed, and that all containers of shellstock or shucked product be properly tagged or labeled so that they can be traced back to the original point of harvest.   

The United States Animal Health Association is a science-based, non-profit, voluntary organization made up of state and federal animal health officials, national allied organizations, regional representatives, and individual members that works with state and federal governments, universities, veterinarians, livestock producers, national livestock and poultry organizations, research scientists, the extension service and several foreign countries to protect animal and public health by serving as a national forum for communication and coordination on disease eradication, animal health, food safety, animal welfare and international trade. Together with the American Association of Veterinary Laboratory Diagnosticians, the two groups comprise a Joint Committee on Aquaculture, which provides a forum for discussion and cooperation between members of the diverse aquaculture industries, regulatory and tribal agencies, and diagnostic laboratories and research community, as they address problems and opportunities related to aquatic animal health and well-being, seafood safety, and public health. The Committee develops and recommends policies and actions that facilitate harmonization of aquatic animal health diagnostics, regulations and the activities of stakeholder federal, state, tribal, and local agencies, and in so doing, ensure the economic stability of the aquaculture industries. 

The American Fisheries Society - Fish Health Section publishes a manual referred to as the “Blue Book,” which provides suggested procedures for the detection and identification of certain finfish and shellfish pathogens (AFS-FHS 2016). The manual describes diagnostic procedures for finfish and shellfish pathogens, standard procedures for aquatic animal health inspections, and a quality assurance/quality control model for fish health laboratories. Thirty-three states cite the “Blue Book” as regulation (P. Zajicek, Executive Director of the National Aquaculture Association, personal communication, August 13, 2019).

For research animals, IACUC Committees must include at least one veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution (NIH-OLAW 2021). The IACUC Guidebook suggests implementing preventive medicine programs (e.g., immunization, monitoring, prophylaxis, quarantine) conducted under the guidance of the veterinarian to reduce the incidence of disease and maintain healthy animals (ARENA-OLAW 2002).

The Animal Health Protection Act authorizes U.S. cooperation with states and foreign governments, and as such the United States is a member of the Office International des Epizooties (OIE), an intergovernmental organization responsible for improving animal health worldwide.

From the United States Department of Agriculture Animal and Plant Health Inspection Service website "OIE and International Standards” (USDA-OIE 2020):

One of OIE’s important missions is to improve knowledge, as well as the transparency, of the world animal health situation. Members are obligated to report disease events of animal health significance. To achieve this, the OIE developed and manages a web-based reporting system called the World Animal Health Information System (WAHIS). Through the WAHIS Members must report to the OIE all notifiable terrestrial and aquatic animal diseases detected within their respective territories. This information then becomes immediately available to the world so that countries can take any necessary preventive action. As an OIE Member the United States takes its commitment to disease reporting seriously and responsibly. OIE maintains a list of notifiable diseases that is updated annually.

To summarize, under the auspices of the Animal Health Protection Act, the Federal Food Drug and Cosmetic Act (specifically the portion referred to as the Food Safety Modernization Act), and the Federal Meat Inspection Act, the U.S. management system implements measures to reduce the risk of introduction and spread of aquatic animal disease in U.S. aquaculture facilities. Food products are considered “adulterated” if the animal died by any other means other than intentional slaughter (as per the Food Safety Modernization Act), and Hazard Analysis and Critical Control Point (HACCP) inspections are required via the U.S. Department of Agriculture Food Safety and Inspection Service (for catfish), the Department of Health and Human Services Food and Drug Administration (for non-catfish seafood products), and the Interstate Shellfish Sanitation Conference (for molluscan shellfish). For finfish or shellfish transport across state lines, mandatory inspection by a veterinarian accredited by APHIS and licensed by the state is required. Semi-annual IACUC inspections ensure that research facilities receiving federal funds are following plans set out by the IACUC, which includes a veterinarian.

The Arkansas Safe Bait program provides a model for preventing the transfer of dangerous diseases, undesirable fish species, invasive plants, and exotic animals with baitfish.  The program promotes smart fish culture practices based on key principles (isolation, biosecurity and clean water) that apply to the farmer, the farm, and the fish.

From Safebait from the Natural State, Arkansas Agriculture Department's certified baitfish program website “Farms, Farmers, & Fish” (SB 2022): 

The FARMER -- The Arkansas Certification Program begins with a commitment from the farmer. A commitment to farm operations dictated by sound scientific principles established to prevent the contamination and spread of diseases and aquatic nuisance species. 

The FARM -- Each farm is inspected by a specially trained Arkansas Agriculture Department inspector to insure that farms use only well water for all ponds, tanks, and shipping containers. Inspectors conduct a visual inspection of the farm for aquatic nuisance species during appropriate times of year and observe farm operations to verify strict adherence to farm biosecurity standards.

The FISH -- Only fish spawned, hatched, and reared on a fish farm in Arkansas can be certified. Twice per year, fish from all areas of the farm are sampled by an APHIS-accredited veterinarian and transported to an approved laboratory for disease testing. To achieve and maintain certification, a farm must demonstrate two consecutive years of disease free status.

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.

Objective 3.2: Promote the safety and nutritional value of U.S. aquaculture products

Domestic seafood produced in aquaculture systems is safe and nutritious. The consumption of seafood has been associated with a lower risk of heart disease-related death and, part of a healthy eating pattern, with a lower risk of obesity.32 Seafood has also been associated with better health outcomes for children when mothers consume seafood while pregnant or breastfeeding. For these reasons, the 2020-2025 Dietary Guidelines for Americans recommends that the general population should eat at least 8 ounces of seafood per week; the average American consumes less than half that amount. Research that further documents the safety and benefits of seafood consumption will help inform the public and support increased consumption.

The following actions will inform consumers that seafood is safe and demonstrate the health benefits of domestic farm-raised seafood products. 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 3.2.1 HHS and USDA (ARS) will determine the overall seafood consumption benefits and risks and communicate dietary recommendations at various life stages to the public.

• Action 3.2.2 USDA (ARS) and DOI (USGS) will determine the nutritional profile of aquaculture and wild-caught products

• Action 3.2.3 HHS (FDA) and USDA (APHIS) will develop an integrated food safety and disease prevention program for use by domestic aquaculture farms.

From the American Fisheries Society Fact Sheet "Mythbusting Marine Aquaculture" (AFS 2019):

The Food, Drug and Cosmetic Act governs the availability and use of aquatic animal medicines. There are currently no antibiotics approved for use on cultured marine fish. The absence of an FDA-approved therapeutic drug is a major challenge for the marine aquaculture industry for disease management. Access to a legal treatment option would allow culturists to treat infected fish and control losses. 

Successful completion of the technical requirements for drug approval is time-consuming and expensive, with new drug approvals for fish being even more difficult to obtain than new drug approvals for virtually any terrestrial animal. In the 1990s, new aquaculture drug approvals required a minimum in-vestment of $3.5 million over the course of a decade. More recently, a new drug approval can cost in excess of $40 million and expanding the indications for a drug for other uses can cost as much as $8 million.

§ 8301  Findings. Congress finds that —

(1)  the  prevention,  detection,  control,  and  eradication  of diseases and pests of animals are essential to protect—

(A) animal health;

§ 8303  Restriction on importation or entry

(a) In general
With notice to the Secretary of the Treasury and public notice as soon as practicable, the Secretary may prohibit or restrict—

(1) the importation or entry of any animal, article, or means of conveyance, or use of any means of conveyance or facility, if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock;

(2) the further movement of any animal that has strayed into the United States if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of any pest or disease of livestock; and

(3) the use of any means of conveyance in connection with the importation or entry of livestock if the Secretary determines that the prohibition or restriction is necessary because the means of conveyance has not been maintained in a clean and sanitary condition or does not have accommodations for the safe and proper movement of livestock.

(b) Regulations

(1) Restrictions on import and entry
The Secretary may issue such orders and promulgate such regulations as are necessary to carry out subsection (a).

(2) Post importation quarantine
The Secretary may promulgate regulations requiring that  any animal imported or entered be raised or handled under post-importation quarantine conditions by or under the supervision of the Secretary for the purpose of determining whether the animal is or may be affected by any pest or disease of livestock.

§ 8305 Interstate movement. The Secretary may prohibit or restrict—

(1) the movement in interstate commerce of any animal, article, or means of conveyance if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock; and

(2) the use of any means of conveyance or facility in connection with the movement in interstate commerce of any animal or article if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction or dissemination of any pest or disease of livestock.

§ 8308 Detection, control, and eradication of diseases and pests

(a) In general
The Secretary may carry out operations and measures to detect, control, or eradicate any pest or disease of livestock (including the drawing of blood and diagnostic testing of animals), including animals at a slaughterhouse, stockyard, or other point of concentration.

§ 8308a  Animal disease prevention and management

(b) National Animal Disease Preparedness and Response Program

(1) Program required
The Secretary shall establish a program, to be known as the National Animal Disease Preparedness and Response Program (referred to in this section as “the Program”), to address the increasing risk of the introduction and spread within the United States of animal pests and diseases affecting the economic interests of the livestock and related industries of the United States, including the maintenance and expansion of export markets.

§ 8310 Cooperation

(a) In general
To carry out this chapter, the Secretary may cooperate with other Federal agencies, States or political subdivisions of States, national governments of foreign countries, local governments of foreign countries, domestic or international organizations, domestic or international associations, Indian tribes, and other persons.

§ 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.

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;

§ 1802 Definitions. As used in this chapter, unless the context otherwise requires—

(16) The term “fishing” means—

(A) the catching, taking, or harvesting of fish;

(B) the attempted catching, taking, or harvesting of fish;

(C) any other activity which can reasonably be expected to result in the catching, taking, or harvesting of fish; or

(D) any operations at sea in support of, or in preparation for, any activity described in subparagraphs (A) through (C).

Such term does not include any scientific research activity which is conducted by a scientific research vessel.

§ 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.

§ 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

§ 534.4  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. 

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.

(a) Upon an exporter filing a written declaration with the District Director of Customs at the port of entry as required under § 14.61 of this chapter, live or dead fish, mollusks, and crustaceans, or parts thereof, or their gametes or fertilized eggs, may be imported, transported, and possessed in captivity without a permit except as follows:

(3) Notwithstanding § 16.32, all Federal agencies shall be subject to the requirements stated within this section. Live or dead uneviscerated salmonid fish (family Salmonidae), live fertilized eggs, or gametes of salmonid fish are prohibited entry into the United States for any purpose except by direct shipment accompanied by a certification that: as defined in paragraph (e)(1) of this section, the fish lots, from which the shipments originated, have been sampled; virus assays have been conducted on the samples according to methods described in paragraphs (e)(2) through (4); of this section; and Oncorhynchus masou virus and the viruses causing viral hemorrhagic septicemia, infectious hematopoietic necrosis, and infectious pancreatic necrosis have not been detected in the fish stocks from which the samples were taken. In addition, live salmonid fish can be imported into the United States only upon written approval from the Director of the U.S. Fish and Wildlife Service.

(4) All live fish eggs of salmonid fish must be disinfected within 24 hours prior to shipment to the United States. Disinfection shall be accomplished by immersion for 15 minutes in a 75 part per million (titratable active iodine) non-detergent solution of polyvinylpyrrolidone iodine (iodophor) buffered to a pH of 6.0 to 7.0. Following disinfection, the eggs shall be rinsed and maintained in water free of fish pathogens until packed and shipped. Any ice or water used for shipping shall be from pathogen-free water.

(b)(1) The certification to accompany importations as required by this section shall consist of a statement in the English language, printed or typewritten, stating that this shipment of dead uneviscerated salmonid fish, live salmonid fish, or live, disinfected fertilized eggs or gametes of salmonid fish has been tested, by the methods outlined in this section, and none of the listed viruses were detected. The certification shall be signed in the country of origin by a qualified fish pathologist designated as a certifying official by the Director.

(d) Any fish caught in the wild in North America under a valid sport or commercial fishing license shall be exempt from sampling and certification requirements and from filing the Declaration for Importation of Wildlife. The Director may enter into formal agreements allowing the importation of gametes, fertilized eggs, live fish, or dead, uneviscerated fish without inspection and certification of pathogen status, if the exporting Nation has an acceptable program of inspection and pathogen control in operation, can document the occurrence and distribution of fish pathogens within its boundaries, and can demonstrate that importation of salmonid fishes into the United States from that National will not pose a substantial risk to the public and private fish stocks of the United States.

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

Subpart F Offshore Marine Aquaculture in the Gulf of Mexico

§ 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.

(5) Health certification.  Prior to stocking fish in an approved aquaculture system at an aquaculture facility in the Gulf EEZ, the permittee must provide NMFS a copy of a health certificate (suggested form is USDA/Animal and Plant Health Inspection Service (APHIS) VS 17-141, OMB 0579-0278) signed by an aquatic animal health expert, as defined in § 622.101(a)(2)(xv), certifying that the fish have been inspected and are visibly healthy and the source population is test negative for OIE pathogens specific to the cultured species and pathogens identified as reportable pathogens in the NAAHP as implemented by the USDA and U.S. Departments of Commerce and Interior.

Chapter 4: Veterinary Care

An adequate veterinary care program consists of assessment of animal well-being and effective management of

• animal procurement and transportation

• preventive medicine (including quarantine, animal biosecurity, and surveillance)

• clinical disease, disability, or related health issues

• protocol-associated disease, disability, and other sequelae

• surgery and perioperative care

• pain and distress

• anesthesia and analgesia

• euthanasia.

PREVENTIVE MEDICINE

Disease prevention is an essential component of comprehensive veterinary medical care and biosecurity programs. Effective preventive medicine enhances the research value of animals by maintaining healthy animals and minimizing nonprotocol sources of variation associated with disease and inapparent infection, thus minimizing animal waste and potential effects on well-being. Preventive medicine programs consist of various combinations of policies, procedures, and equipment related to quarantine and stabilization and the separation of animals by species, source, and health status.

Animal Biosecurity

Animal biosecurity refers to all measures taken to identify, contain, prevent, and eradicate known or unknown infections that may cause clinical disease or alter physiologic and behavioral responses or otherwise make the animals unsuitable for research. Animal biosecurity practices should be applied to all species, but they are most important when housing large numbers of animals in intensive housing conditions (e.g., laboratory rodents). Limiting exposure of animals to infectious disease agents requires consideration of physical plant layout and operational practices. Separation of clean and soiled caging and equipment, and sometimes the associated staff, is often fundamental to success.

A successful animal biosecurity program incorporates a number of elements: procedures that ensure that only animals of a desired defined health status enter the facility; personnel and materials, especially consumables, that do not serve as fomites; practices that reduce the likelihood of cross contamination if an infectious agent is inadvertently introduced; a comprehensive ongoing system for evaluating animals’ health status, including access to all animals; and containment and eradication, if desired, of introduced infectious agents. Related components include procedures for evaluating and selecting appropriate animal suppliers (these may include quarantine and determination of animal health status if unknown); treatment of animals or their products at entry to minimize disease risks (e.g., surface disinfection of fish eggs); a comprehensive pest control program that may include evaluation of the health status of feral animals; procedures to ensure that all biologics administered to animals are free of contamination; and procedures for intra- and interfacility animal transport (e.g., transport of animals to laboratory and other facilities outside the animal facility can present challenges to animal biosecurity) (Balaban and Hampshire 2001). Additional details pertaining to these topics are available in the sections of Chapter 2 that deal with occupational health and safety.

Quarantine and Stabilization

An effective quarantine program minimizes the risk of introduction of pathogens into an established colony...

Surveillance, Diagnosis, Treatment, and Control of Disease

Procedures for disease prevention, diagnosis, and therapy should be those currently accepted in veterinary and laboratory animal practice.

Separation by Health Status and Species

Physical separation of animals by species is recommended to prevent interspecies disease transmission. The veterinary medical staff should implement procedures for evaluating the health and, if appropriate, the pathogen status of newly received animals ...

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.

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 ... 

AFDO-SHA-SG. 2020.  Module 3: Seafood Safety Hazards: 3.11 3.11 Harvest Pathogens. Seafood HACCP Online Training Course. New York Sea Grant, Seafood HACCP Alliance, Association of Food and Drug Officials. https://seafoodhaccp.cornell.edu/ 

AFS. 2019. "Factsheet: Mythbusting Marine Aquaculture". American Fisheries Society, Bethesda, Maryland. Aquaculture. June 6, 2019. https://fisheries.org/2019/06/fact-sheet-mythbusting-marine-aquaculture/ 

AFS-FHS. 2020. Fish Health Section Blue Book. 2020 Edition. Suggested Procedures for the Detection and Identification of Certain Finfish and Shellfish Pathogens. American Fisheries Society, Bethesda, Maryland. 

ARENA-OLAW. 2002. Institutional Animal Care and Use Committee Guidebook, 2nd ed. 2002. Applied Research Ethics National Association (ARENA), Office of Laboratory Animal Welfare (OLAW), National Institutes of Health. 

Balaban, R.S. &  Hampshire, V.A. 2001. Challenges in small animal noninvasive imaging. ILAR Journal, 42(3): 248–262. https://doi.org/10.1093/ilar.42.3.248 

Hartman, K. H. 2018. “VS Aquatic Animal Health Program Update & CAHPS”. USAHA 2018.  Powerpoint Presentation. Veterinary Services. Animal and Plant Health Inspection Service. United States Department of Agriculture. Oct 21, 2018. 

NIH-OLAW. 2021. National Institutes of Health Office of Laboratory Animal Welfare website "The IACUC": Home » Resources » Tutorial: PHS Policy on Humane Care and Use of Laboratory Animals / The IACUC. https://olaw.nih.gov/resources/tutorial/iacuc.htm; Last Modified: Oct 22, 2021.

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/ 

SB. 2022. Safebait from the Natural State. Arkansas Agriculture Department's certified baitfish program website “Farms, Farmers, & Fish”: http://safebaitfish.org/about2.html; Accessed: Nov 21, 2022.

USDA-APHIS-VS. 2017. United States Commercial Aquaculture Health Program Standards (CAHPS) Concept Paper. Animal and Plant Health Inspection Service. United States Department of Agriculture. Riverdale, Maryland, USA. 

USDA-OIE. 2020. United States Department of Agriculture Animal and Plant Health Inspection Service website “OIE and International Standards”: Animal Health » Veterinary Accreditation » NVAP Reference Guide » Animal Health Emergency Management. https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-Reference-Guide/Animal-Health-Emergency-Management/OIE-and-International-Standards; Last Modified: Jun 2, 2020.