Topic 1

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.

According to an FAO Fisheries Technical paper (Bondad-Reantaso et al. 2001), “stress” is “the sum of biological reactions to any adverse stimuli (physical, internal or external) that disturb the organism's optimum operating status.” Thus, by definition, it is a very broad term that encompasses many factors. Distress occurs when stress is severe, prolonged, or both (NRC 2008). 

From the United States Department of Agriculture Animal and Plant Health Inspection Service website “Animal Welfare Act” (USDA-AWA 2022):

The AWA (Animal Health Welfare Act), which became law in 1966, does not cover every type of animal used in every type of activity. The following animals are not covered: farm animals used for food or fiber (fur, hide, etc.); coldblooded species (amphibians and reptiles); horses not used for research purposes; fish; invertebrates (crustaceans, insects, etc.); or birds, rats of the genus Rattus, and mice of the genus Mus that are bred for use in research. Birds (other than those bred for research) are covered under the AWA but the regulatory standards have not yet been established.

However, federal agencies tend to apply the AWA as policy to fish and other vertebrates as well. For example, Institutional Animal Care and Use Committees (IACUC) are working groups appointed at research facilities as dictated by the AWA and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The Health Research Extension Act of 1985 (Public Law 99-158) “Animals in Research” (November 20, 1985) provides the statutory mandate for the Public Health Service Policy. The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training were released in 1985 by the Interagency Research Animal Committee and adopted by U.S. Government agencies that either develop requirements for or sponsor procedures involving the use of vertebrate animals. These Principles were incorporated into the Public Health Service Policy in 1986 (PHS 2015).

The Health Research Extension Act of 1985 applies to facilities that receive federal funding for research, while the Animal Welfare Act applies to all facilities, regardless of the source of funds. Typically, protection is only accorded to animals used in scientific procedures and does not apply to aquaculture or public aquaria, unless research is being carried out in those facilities (Browman et al. 2018).

U.S.C. Title 18 Crimes and Criminal Procedure describes requirements for transporting wild animals under The Lacey Act, and deems it “unlawful...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.” This is relevant to aquaculture facilities that may collect and transport broodstock from wild stocks. 

To summarize, in the United States, aquaculture facilities collecting and transporting broodstock from wild stocks must conform to Topic of Pertinence #1 (as per The Lacey Act), as do facilities receiving federal grant monies to conduct research (e.g., cooperative research with academia and/or government extension agencies; as per the Health Research Extension Act). In addition, food products are considered “adulterated” if the animal died by any other means other than intentional slaughter (as per the Food Safety Modernization Act).  At the federal level, clear directives or guidance to minimize stress do not appear for ornamental or baitfish production (unless under the auspices of the above regarding The Lacey Act and/or the Health Research Extension Act). 

Some states, such as Alabama, include guidance to minimize stress within the aquaculture best management practices resources distributed by their extension agencies.  From the Auburn University and USDA/Natural Resources Conservation Service Feed Management BMP No. 7 publication: “Deterioration of water quality in ponds stresses fish and causes them to eat less, grow slowly, and to be more susceptible to disease.” The suggested practice is to “Maintain adequate dissolved oxygen concentrations in ponds to prevent fish stress and enhance the capacity of the pond to assimilate metabolic wastes”. In addition, they add that “Poor environmental conditions such as low dissolved oxygen concentration and high ammonia concentration or high pH stress fish and depress their appetite as well as their ability to convert consumed food into growth” and recommend providing aeration since “Mechanical aeration prevents low dissolved oxygen concentrations and fish stress can be avoided” (AU 2002). 

As per the Best Aquaculture Practices Aquaculture Facility Certification Standards for Finfish and Crustacean Farms (BAP-FC 2017):

When farmed animals are exposed to continuing stress, their feed consumption and growth rates can decline. Stressed animals are also less resistant to diseases, and mortality usually increases. Animal suffering can be prevented and production efficiency enhanced by applying good husbandry techniques to avoid stressful culture conditions. 

Thus, producers logically aim to “minimize stress on farmed aquatic animals”. Unstressed fish remain healthier (i.e., less financial loss due to mortality) and product quality increases (e.g., stress-triggered biochemical release is minimized/eliminated during slaughter, increasing shelf life and decreasing off-flavors in the filets; Secci et al 2016). 

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.

From the Guide for the Care and Use of Laboratory Animals: Eighth Edition (2011):

Laboratory animal science is a rapidly evolving field and the Committee (for the Update of the Guide for the Care and Use of Laboratory Animals; Institute for Laboratory Animal Research; Division on Earth and Life Studies; National Research Council) identified a number of areas in which current available scientific information is insufficient; additional objective information and assessment are needed to provide a scientific basis for recommendations in future editions of the Guide. Although pursuing these concepts was beyond this Committee’s charge, the following two topics merit further study: (1) space and housing needs of laboratory species and (2) the need and best methods for providing enrichment, exercise, and human contact.

Novel slaughter techniques can reduce animal stress while enhancing seafood product quality. Ike Jime involves a series of controlled steps designed to mitigate the effects of biochemical reactions (e.g., lactic-acid production, muscle activity, respiration, body temperature), which spike during slaughter. When properly implemented, the procedure is touted to preserve natural flavor, texture, freshness, and to promote umami or savory taste.  The method requires rapidly severing the spinal cord to prevent further depletion of adenosine triphosphate. Similarly, the Conservation Fund’s Freshwater Institute implements stunning technology to strike the brainstem of salmon reared in its recirculating aquaculture systems during harvest, rendering the fish dead immediately. Unlike Ike Jime, this stunning method does not destroy the spinal cord. Both methods have been promoted as “humane” slaughter protocols (Dodd 2016).

§ 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

(a) Establishment of guidelines
The Secretary, acting through the Director of NIH (National Institutes of Health), shall establish guidelines for the following:

(1) The proper care of animals to be used in biomedical and behavioral research.

(2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall require—

(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and

(B) appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research.

Such guidelines shall not be construed to prescribe methods of research.

(3) The organization and operation of animal care committees in accordance with subsection (b).

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

(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.

(c) Assurances required in application or contract proposal; reasons for use of animals; notice and comment requirements for promulgation of regulations.
The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on November 20, 1985—

(1) assurances satisfactory to the Director of NIH that—

(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and

(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the applicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and

(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract.

Notwithstanding subsection (a)(2) of section 553 of title 5, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section.

(d) Failure to meet guidelines; suspension or revocation of grant or contract. If the Director of NIH determines that—

(1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agreement involving research on animals under this subchapter do not meet applicable guidelines established under subsection (a);

(2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable opportunity to take corrective action; and

(3) no action has been taken by the entity to correct such conditions;

the Director of NIH shall suspend or revoke such grant or contract under such conditions as the Director determines appropriate. 

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.

Part 10 General Provisions

Subpart A Introduction

§ 10.3 Other applicable laws. 

No statute or regulation of any State shall be construed to relieve a person from the restrictions, conditions, and requirements contained in this subchapter B. In addition, nothing in this subchapter B, nor any permit issued under this subchapter B, shall be construed to relieve a person from any other requirements imposed by a statute or regulation of any State or of the United States, including any applicable health, quarantine, agricultural, or customs laws or regulations, or other Service enforced statutes or regulations.

Preface

The purpose of the Guide for the Care and Use of Laboratory Animals (the Guide), as expressed in the charge to the Committee for the Update of the Guide, is to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. The Guide is also intended to assist investigators in fulfilling their obligation to plan and conduct animal experiments in accord with the highest scientific, humane, and ethical principles. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with both high-quality research and humane animal care and use. These recommendations should be used as a foundation for the development

of a comprehensive animal care and use program, recognizing that the concept and application of performance standards, in accordance with goals, outcomes, and considerations defined in the Guide, is essential to this process.

The Guide is an internationally accepted primary reference on animal care and use, and its use is required in the United States by the Public Health Service Policy.

Chapter 1: Key Concepts

APPLICABILITY AND GOALS

In the Guide, laboratory animals (also referred to as animals) are generally defined as any vertebrate animal (i.e., traditional laboratory animals, agricultural animals, wildlife, and aquatic species) produced for or use in research, testing, or teaching. Animal use is defined as the proper care, use, and humane treatment of laboratory animals produced for or used in research, testing, or teaching.

When appropriate, considerations or specific emphases for agricultural animals and nontraditional species are presented. The Guide does not address in detail agricultural animals used in production, agricultural research or teaching, wildlife and aquatic species studied in natural settings, or invertebrate animals

(e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations.

INTENDED AUDIENCES AND USES OF THE GUIDE

The Guide is intended for a wide and diverse audience, including

• the scientific community

• administrators

• IACUCs

• veterinarians

• educators and trainers

• producers of laboratory animals

• accreditation bodies

• regulators

• the public.

THE THREE RS

Refinement refers to modifications of husbandry or experimental procedures to enhance animal well-being and minimize or eliminate pain and distress. While institutions and investigators should take all reasonable measures to eliminate pain and distress through refinement, IACUCs should understand that with some types of studies there may be either unforeseen or intended experimental outcomes that produce pain. These outcomes may or may not be eliminated based on the goals of the study.

Reduction involves strategies for obtaining comparable levels of information from the use of fewer animals or for maximizing the information obtained from a given number of animals (without increasing pain or distress) so that in the long run fewer animals are needed to acquire the same scientific information...

Refinement and reduction goals should be balanced on a case-by-case basis. Principal investigators are strongly discouraged from advocating animal reuse as a reduction strategy, and reduction should not be a rationale for reusing an animal or animals that have already undergone experimental procedures especially if the well-being of the animals would be compromised. Studies that may result in severe or chronic pain or significant alterations in the animals’ ability to maintain normal physiology, or adequately respond to stressors, should include descriptions of appropriate humane endpoints or provide science-based justification for not using a particular, commonly accepted humane endpoint. Veterinary consultation must occur when pain or distress is beyond the level anticipated in the protocol description or when interventional control is not possible.

Chapter 2: Animal Care and Use Program

REGULATIONS, POLICIES, AND PRINCIPLES

The use of laboratory animals is governed by an interrelated, dynamic system of regulations, policies, guidelines, and procedures. The Guide takes into consideration regulatory requirements relevant to many US-based activities, including the Animal Welfare Regulations (9 CFR 1A; 42 USC § 289d) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals. The use of the Guide by non-US entities also presumes adherence to all regulations relevant to the humane care and use of laboratory animals applicable in those locations. The Guide also takes into account the U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and endorses the following principles:

• consideration of alternatives (in vitro systems, computer simulations, and/or mathematical models) to reduce or replace the use of animals

• design and performance of procedures on the basis of relevance to human or animal health, advancement of knowledge, or the good of society

• use of appropriate species, quality, and number of animals

• avoidance or minimization of discomfort, distress, and pain

• use of appropriate sedation, analgesia, and anesthesia

• establishment of humane endpoints

• provision of adequate veterinary care

• provision of appropriate animal transportation and husbandry directed and performed by qualified persons

• conduct of experimentation on living animals exclusively by and/or under the close supervision of qualified and experienced personnel

PROGRAM OVERSIGHT

The Role of the IACUC

Protocol Review

The animal use protocol is a detailed description of the proposed use of laboratory animals. The following topics should be considered in the preparation of the protocol by the researcher and its review by the IACUC: 

• rationale and purpose of the proposed use of animals

• a clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee

• availability or appropriateness of the use of less invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation (see Appendix A, Alternatives)

• justification of the species and number of animals proposed; whenever possible, the number of animals and experimental group sizes should be statistically justified (e.g., provision of a power analysis; see Appendix A, Experimental Design and Statistics)

• unnecessary duplication of experiments

• nonstandard housing and husbandry requirements

• impact of the proposed procedures on the animals’ well-being

• appropriate sedation, analgesia, and anesthesia (indices of pain or invasiveness might aid in the preparation and review of protocols; see Appendix A, Anesthesia, Pain, and Surgery)

• conduct of surgical procedures, including multiple operative procedures

• postprocedural care and observation (e.g., inclusion of post-treatment or postsurgical animal assessment forms)

• description and rationale for anticipated or selected endpoints

• criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated

• method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion

• adequacy of training and experience of personnel in the procedures used, and roles and responsibilities of the personnel involved

• use of hazardous materials and provision of a safe working environment.

Special Considerations for IACUC Review

Certain animal use protocols include procedures or approaches that require special consideration during the IACUC review process due to their potential for unrelieved pain or distress or other animal welfare concerns...

Experimental and Humane Endpoints The experimental endpoint of a study occurs when the scientific aims and objectives have been reached. The humane endpoint is the point at which pain or distress in an experimental animal is prevented, terminated, or relieved. The use of humane endpoints contributes to refinement by providing an alternative to experimental endpoints that result in unrelieved or severe animal pain and distress, including death...

Physical Restraint

Restraint devices should be suitable in size, design, and operation to minimize discomfort, pain, distress, and the potential for injury to the animal and the research staff...

Agricultural Animals The use of agricultural animals in research is subject to the same ethical considerations as for other animals in research... Regardless of the category of research, institutions are expected to provide oversight of all research animals and ensure that pain and distress are minimized.

Chapter 3: Environment, Housing, and Management

AQUATIC ANIMALS

Aquatic Management

Behavior and Social Management

... The use of appropriate nets by well-trained personnel can reduce skin damage and thus stress...

Chapter 4: Veterinary Care

PREVENTIVE MEDICINE

Quarantine and Stabilization

Regardless of whether the animals are quarantined, newly received animals should be given a period for physiologic, behavioral, and nutritional acclimation before their use (Obernier and Baldwin 2006).

Separation by Health Status and Species

Physical separation of animals by species is recommended to prevent interspecies disease transmission and to eliminate the potential for anxiety and physiologic and behavioral changes due to interspecies conflict (Arndt et al. 2010).

PAIN AND DISTRESS

An integral component of veterinary medical care is prevention or alleviation of pain associated with procedural and surgical protocols...

Pain is a stressor and, if not relieved, can lead to unacceptable levels of stress and distress in 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 VII. Wet Storage in Approved and Conditionally Approved Growing Areas

Careful consideration must be given to designing and operating onshore wet storage tanks to ensure that shellfish are not contaminated during holding or do not die from physiological stresses such as low dissolved oxygen and unsuitable temperatures or salinity. 

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 ... 

.08 Wet Storage in Artificial Bodies of Water.

Careful consideration must be given to designing and operating onshore wet storage tanks to assure that shellfish are not contaminated during holding or do not die from physiological stresses such as low dissolved oxygen and unsuitable temperatures or salinity.

Chapter XV. Depuration

Requirements for the Authority
Shellfish destined for depuration plants shall be protected as necessary during harvesting and transporting to prevent further contamination and undue physiological stress that could reduce the effectiveness of the depuration process.

IV. Implementation by Institutions

A. Animal Welfare Assurance

1. Institutional Program for Animal Care and Use

The Assurance shall fully describe the institution's program for the care and use of animals in PHS-conducted or supported activities. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing an institutional program for activities involving animals. The program description must include the following:

g. a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;

C. Review of PHS-Conducted or Supported Research Projects

1. In order to approve proposed research projects or proposed significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the research project conforms with the institution's Assurance and meets the following requirements:

a. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.

b. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator.

c. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional Official shall ensure that these principles are adhered to:

I. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 USC § 2131 et. seq.) and other applicable Federal laws, guidelines, and policies.

IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.

V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.

VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

Arndt, S. S., Lohavech, D, van’t Klooster, J., & F. Ohl. 2010. Co-species housing in mice and rats: Effects on physiological and behavioural stress responsivity. Horm Behav 57:342-351. https://doi.org/10.1016/j.yhbeh.2010.01.003

AU. 2002. Feed Management. BMP No. 7. Alabama Aquaculture Best Management Practice (BMP). Auburn University and USDA/Natural Resources Conservation Service. 04/02. 

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