FINAL_EMA_Animal_Care_and_Use_Policy_Version_1_0_0001.pdf

United States Department of the Interior

U.S. GEOLOGICAL SURVEY

Reston, Virginia 20192

ECOSYSTEMS MISSION AREA

TECHNICAL MEMORANDUM 1.0

Subject: Ecosystems Mission Area Animal Care and Use Policy

Effective: January 12, 2022

Authors: Cindy Kolar Tam, Biological Threats & Invasive Species Research Program Coordinator, ctam@usgs.gov, 703-648-4023 Guelaguetza Vazquez-Meves, Biosecurity Specialist, gvazquez-meves@usgs.gov, 703-

648-4064

Revision: NA

I. Purpose and scope

A. This technical memorandum describes the definitions, responsibilities, authorities, and principal components of the U.S. Geological Survey (USGS) Ecosystems Mission Area (EMA) Animal Care and Use Policy (hereafter referred to as Policy).

B. This Policy has these main purposes:

1. To convey that the EMA in its entirety is registered with the U.S. Department of Agriculture

Animal Plant Health Inspection Service (USDA APHIS) Animal Care unit as a single research institution. Thus, it follows that: a) the jurisdictional extent of the EMA Chief Executive Officer (CEO), being the sole CEO recognized by the USDA APHIS Animal Care unit, encompasses all USGS Regions and Centers of the EMA; and b) that every EMA Center that handles animals (as defined in Section IV, S) or conducts research, teaching, testing, experimentation, or exhibition involving animals must appoint an Institutional Animal Care and Use Committee (IACUC).

2. To assure that EMA animal research is compliant with pertinent statues and regulations. By executing the Animal Welfare Act Regulations (AWAR)-mandated IACUC functions (described herein), the IACUCs will ensure that activities involving the use of vertebrate animals comply with the Animal Welfare Act (AWA), AWAR, and recommendations of the Interagency Research Animal Committee (IRAC).

3. To provide a common understanding of the requirements for upholding humane standards while standardizing the care and humane treatment of animals used in research across EMA Centers, in part by using shared terminology (Section IV).

mailto:ctam@usgs.gov mailto:gvazquez-meves@usgs.gov

4. To facilitate – through the promotion of animal care and use protocols – the highest possible standards of science and natural resource stewardship in the EMA.

C. This Policy applies to EMA personnel that handles animals or performs animal research (as defined in Section IV, C) and describes the minimum core principles that serve as a foundation for EMA animal care and use to ensure compliance with AWA, AWAR, and IRAC. EMA Centers receiving funds for animal research from the Public Health Service or the National Science Foundation must also comply with the Public Health Service Policy on Humane Care and Use of laboratory Animals (https://olaw.nih.gov/policies-laws/phs-policy.htm), which is beyond the scope of this Policy. USGS Centers from other Mission Areas may adopt the requirements and procedures in this Policy as they deem appropriate for their animal care and use activities.

II. Regulatory authorities governing animal use This Policy derives its mandate and purpose from the AWA and its regulations (AWAR; § 2.31 (a)):

“The CEO of the research facility shall appoint an IACUC, qualified through the experience and expertise of its members to assess the research facility’s animal program, facilities, and procedures”.

USDA APHIS Animal Care is the administrative unit charged with enforcing the AWA (https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare), and its amendments, codified at 7 USC 2131 et. seq. and Code of Federal Regulations (CFR) Title 9 (AWAR) (https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_FINAL_2017_508co mp.pdf). Federal institutions are responsible for complying with all USDA standards of animal care that pertains to animal research. EMA Centers performing animal research must comply with these requirements. In addition to ensuring compliance with the AWA and AWAR, IACUCs ensure that the EMA upholds the “Government Principles for the Utilization and Care of Vertebrate Animals Used in Teaching, Research, and Training”, developed by the IRAC (provided in Appendix A) and adopted by the Office of Science and Technology in 1985.

By executing these Policy-mandated IACUC functions (described herein), the IACUCs will ensure that activities involving the use of vertebrate animals in EMA Centers comply with the AWA, the AWAR, the IRAC, and pertinent state regulations. The EMA endorses the animal care principles articulated in guidelines published by relevant professional societies (see Section VIII for partial listing of professional guidelines). In keeping with these standards, the EMA recognizes that a robust oversight system is integral to success and has mandated that a qualified IACUC must be established at each EMA Center to guide these efforts.

III. Benefits

A. Culture and credibility. The EMA is committed to promoting and providing a culture of exemplary and responsible animal research by continuously striving to improve quality of research, animal care and use. Efforts to maintain credibility include IACUC approval documentation, which is essential for publishing in scientific journals, obtaining federal and state agency wildlife permits, and balancing the use of animals in research with societal and ethical concerns.

B. Improvements and efficiencies. Regular oversight of research involving animals and monitoring and documentation of all active protocols and holding areas allows EMA Centers to identify problems at early stages allowing quick corrective actions, avoiding repeating mistakes, and improving animal well-being. Reviewing protocols and monitoring protocol activities allows IACUCs to ensure that the animal welfare measures and uses are adequate and appropriate through time.

C. Documentation: This Policy describes how animal care and use records should be maintained in order to achieve compliance with applicable regulations (See Appendix B, VII).

https://olaw.nih.gov/policies-laws/phs-policy.htm https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_FINAL_2017_508comp.pdf https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_FINAL_2017_508comp.pdf

D. Competency: Implementing this Policy ensures competency of research support staff and operational support staff through training, testing, and required compliance with the AWAR.

IV. Definitions A. Animal: For the purposes of this Policy, ‘animal’ is defined as organisms in the subphylum

Vertebrata of the phylum Chordata (chordates) as classified in the Integrated Taxonomic Information System (https://www.itis.gov/) used or intended for use in research, teaching, testing, experimentation, or exhibition, and those that are maintained to protect or assist in the management of other animals (e.g., dogs used to detect invasive species). Excluded from this definition are all invertebrates, all Chordates not in Subphylum Vertebrata (i.e., subphyla Urochordata and Cephalochordata), and all eggs, embryos, or larvae of vertebrates that have not developed beyond exclusive reliance on their own yolk nutrients.

B. Animal Care and Use Program (ACUP): The program developed by the IACUC at the EMA Center that encompasses all activities conducted by that Center that have a direct impact on the well-being of animals, including, but not restricted to, animals that are held for more than 12 hours. An ACUP includes animal and veterinary care, institutional policies and procedures, EMA personnel and program management and oversight, IACUC functions, and animal facility design and management. The program should be reviewed semi-annually.

C. Animal research: Scientific investigations or activities that depend on the use of animals, as defined herein, for the direct or indirect generation of data. These studies involve the handling of animals, animals that are held (in a cage or otherwise restrained) for 12 hours or longer, and collection of samples from live animals or from animals that have been euthanized by EMA personnel specifically for the purpose of tissue harvest. The IACUC determines if the animal research meets the definition of field study or if it meets the exemption. See definition of Field Study (this section, M).

D. Animal Welfare Act (AWA): The Public Law that, in part, ensures animals used in EMA Centers and/or by EMA personnel (as defined therein) are provided humane care and treatment (the complete, amended Act can be found in Title 7 of the U.S. Code, Sections 2131-2156).

E. Animal Welfare Act Regulations (AWAR): Detailed regulations and standards for implementing the AWA (found in Title 9 of the Code of Federal Regulations, Chapter 1, Subchapter A, Parts 1, 2, and 3.9).

F. Attending Veterinarian (AV): The veterinarian with direct or delegated authority for the ACUP at an EMA Center that is appropriately trained, experienced, and credentialed to assume these duties (outlined in Appendix C, I). If less than full time, the AV can delegate responsibility for activities involving animals to appropriately experienced and trained EMA personnel, as long as a mechanism of direct and frequent communication between the AV and EMA personnel is established. A document indicating this delegation and outlining the specific responsibilities covered should be generated and reviewed during the semi-annual program review.

G. AWA USDA Annual Report: As a USDA-registered research facility, the CEO is required to submit an annual report (APHIS Form 7023). This report documents EMA use of animals as defined by the AWA (i.e., warm-blooded animals) for research, testing, teaching, experimentation, exhibition, and surgery. The EMA annually compiles EMA annual compliance reports into a unified EMA AWA USDA Annual Report and sends it to USDA-APHIS on or before December 1.

H. Chief Executive Officer (CEO): The Health Research Extension Act of 1985 defines the CEO as the highest operating official of the organization for which the committees are established. EMA in its entirety is registered with the USDA APHIS Animal Care unit as a single research institution with a single CEO (the Associate Director of Ecosystems). Duties relevant to this policy are provided in Appendix D, II.

https://www.itis.gov/ https://www.aphis.usda.gov/library/forms/pdf/APHIS_7023.pdf

I. Concept of alternatives: Any system or method that covers one or more of the following: 1) replacing the use of research animals altogether; 2) reducing the number of animals required; or

3) refining an existing procedure or technique to minimize the level of pain/distress perceived by the animal (also known as “the 3 Rs” for replacement, reduction, and refinement; Russell and Burch 1959).

J. Continuing protocol review: Review of protocols by the IACUC is required prior to beginning research and again 3 years after the initial approval if the protocol will continue.

K. Designated Member Review: One of two valid methods of IACUC review and approval that involves one or two voting members conducting a review on the full committee’s behalf, after all voting members have been provided with an opportunity to request that these actions be performed at a convened meeting and unanimously agree to the use of Designated Member Review instead.

L. EMA annual compliance form: Each EMA Center is required to provide an annual pledge of their compliance with AWAR and this Policy (template provided in Appendix E), with concurrence provided by the Regional Point of Contact, by November 30th.

M. EMA Center: For the purposes of this policy, an EMA Center includes all traditional EMA Science Centers, Cooperative Research Units, Climate Adaptation Science Centers, and their associated field stations, facilities, holding areas and vivaria (see Appendix F for EMA Centers).

N. EMA personnel: Principal investigators, research support staff, and operational support staff involved in animal research, as defined herein.

O. Euthanasia: The use of humane techniques to end the life of an animal in a way that minimizes or eliminates pain and distress to the greatest extent possible; acceptable methods and conditions for their use are described in the most recent version of the American Veterinary Medical Association Guidelines for the Euthanasia of Animals (currently the 2020 Edition).

P. Externally administered IACUC: An IACUC that is administered by an entity other than the EMA Center performing the animal research (i.e., university or non-EMA research entity such as another Agency) and serves as the IACUC of record for that protocol (see Appendix B, VIII for Externally administered IACUCs). Externally administered IACUCs cannot be used when the animals are held (in a cage or otherwise restrained) for 12 hours or longer in an EMA Center.

Q. Field study: Any study conducted on free-living wild animals in their natural habitat that does not involve animal manipulation and does not harm or materially alter the behavior of the animals under study [as defined in the AWA, 9 CFR §2.31 (c)(2) and (d)(1)] are exempted from the AWA and IACUC oversight. However, those field studies that do not meet that exemption are subject to IACUC review (e.g., requires inspection of holding areas and Post Approval Monitoring by the IACUC if wild animals were held in captivity for 12 hours or longer). The IACUC determines if field studies meet or not this exemption.

R. Full Committee Review. One of the two valid methods of IACUC review and approval that involves a quorum of voting members performing the review during the convene meeting.

S. Handling animals: Petting, feeding, watering, manual cleaning of cages/enclosures, manipulating, loading, crating, shifting, transferring, immobilizing, restraining, treating, training, working, and moving, or any similar activity with respect to any animal.

T. Holding area: Any land, premises, shed, barn, building, trailer, enclosure, cage, tank, or other structure or area housing or intended to hold animals for 12 hours or longer.

U. Inspection of vivaria and holding facilities for animal care and use: The IACUC must inspect animal care and use facilities, including holding areas and transient holding areas, vivaria, and sites used for animal surgeries, every 6 months.

V. Institutional Animal Care and Use Committee (IACUC): The committee established at each EMA Center (EMA Center committee), qualified through the experience and expertise of its members, to oversee its ACUP, facilities, and animal procedures. The IACUC is charged with ensuring compliance with professional guidelines, and AWAR (specific duties and membership requirements provided in Appendix B) for all USGS operations at or through that EMA Center.

W. Institutional Animal Care and Use Committee (IACUC) Chair: The individual appointed by the Institutional Official to Chair the IACUC. See Appendix C, II for a summary of duties.

X. Institutional Official (IO): The individual at each EMA Center delegated responsibility for local research activities involving animals, and who has the legal authority to commit EMA personnel, resources, and institutional priorities to ensure the program adheres to relevant EMA policies and standards concerning the care and use of animals; the IO is typically the Director of an EMA Center. The IOs for the Cooperative Research Units and Climate Adaptation Science Centers are appointed by the Chiefs/Leads of those national programs and serve jointly as the equivalent to the Regional Point of Contact. See Appendix D, II for specific duties and responsibilities.

Y. Non-compliance: Conducting animal research in a manner that disregards or violates the AWA (includes conducting animal activities not approved by the IACUC), AWAR, IRAC, pertinent state regulations, this Policy, or EMA Center-level policies and procedures.

Z. Operational support staff: Individuals responsible for routine animal care and/or facilities maintenance and repairs (e.g., support staff, animal caretakers, facility maintenance); these individuals provide basic husbandry services and maintain a healthy living environment for the animals at an EMA Center and holding areas and may be employed by the EMA, or be a collaborator, contractor, student, intern, emeritus staff, or volunteer. Routine animal care includes but is not limited to functions such as daily observations, facility and equipment sanitation, provision of food and water, animal transportation, weighing animals, and egg collection. Environmental maintenance and repairs include facility and fence construction or repairs, maintenance, and repair of facility infrastructure (e.g., heating, ventilation, and air conditioning systems, plumbing, and electrical systems), and pest management services.

AA. Post Approval Monitoring: In the broadest sense, consists of all types of protocol monitoring after the IACUC’s initial protocol approval and until the protocol is completed such as: continuing protocol review, veterinary or IACUC observation of selected procedures;

observation of animals by IACUC members, AV or delegated person, and other animal care staff and inspection of animal care and use vivaria and holding facilities (conducted either during regular facilities inspections or separately). The level of formality and intensity of Post Approval Monitoring must be tailored according to the applications and needs for each individual Center, and in all cases must support a culture of care focusing on the animals’ well-being.

BB. Principal investigator (PI): A scientist acting as the research lead for a specific protocol that can be from the EMA or from an external organization that performs animal research in an EMA Center, and who helps to plan and oversee various research initiatives undertaken by that group;

the PI is also an active researcher. See Appendix D, III for specific duties.

CC. Protocol: A written document or completed form that provides a detailed description of how animals will be used to achieve specific objectives and that is submitted to the IACUC to consider approval for these activities. Protocols are needed for all these activities: animal research, teaching, testing, experimentation, and exhibition.

DD. Protocol review: The process of reviewing and rendering a decision on approval or non-approval of an IACUC review for studies involving animals except where exempt due to qualification as “field study”. IACUC protocol review ensures that activities involving the use of vertebrate animal comply with this Policy.

EE. Quorum: The minimum number of members that must be present at an IACUC meeting to conduct official business and validate the proceedings (usually a majority, i.e., >50% of the membership).

FF. Regional Point of Contact: The regional staff member, appointed by the Regional Director, that engages with regional IACUCs, is the point of contact for animal welfare issues, and executes duties specified in Appendix D, IV. The equivalent of the Regional Point of Contact for the Cooperative Research Units and the Climate Adaptation Science Centers are appointed by the Chiefs of these national programs and the individual serves jointly as the IO.

GG. Research support staff: Individuals who assist scientists in the performance of skilled research activities (e.g., research staff, support scientists, and technicians), including experimental procedures, special observations, collection of data, and other specialized animal care that may be required while an experiment is in progress; research staff may be employed by the EMA, a collaborator, contractor, student, intern, emeritus staff, or a volunteer.

HH. Standard operating procedure (SOP): A set of step-by-step written instructions to help EMA personnel carry out routine procedures.

II. Surgical procedure: The EMA uses the definition for surgical procedure provided in The Guide for the Care and Use of Animals; generally a procedure where instruments are used to incise tissue and penetrate a body cavity or subcutaneous fascia; it can be classified as either survival or non-survival.

JJ. Training: The action of teaching a person particular skills or types of behaviors to enable them to do particular jobs efficiently. All EMA personnel participating in the care and use of animals under an IACUC-approved protocol must receive appropriate training in humane methods of animal maintenance and experimentation (see Appendix B, I); methods to limit the level of pain or distress experienced by animals used in research activities; proper use of anesthetics, analgesics, and tranquilizers; reporting of animal care concerns and program deficiencies; and accessing databases and online services that prevent unnecessary duplication of research and/or provide information on alternatives to the use of live animals in research.

KK. Unaffiliated At-Large-Member: An IACUC member that represents the general community interest in the proper care and use of animals. This member must not be a laboratory animal user or former user, must not be affiliated with the institution other than as member of the IACUC, and must not be a member of the immediate family of a person who is affiliated with the institution (specific duties are described in Appendix C, III).

LL. USDA APHIS Animal Care unit: The administrative unit in USDA APHIS that is charged with enforcing the AWAR and standards.

MM. Vivarium: An enclosed area for keeping and raising animals under seminatural conditions for observation and research.

NN. Whistleblower Policy: An organizational policy that outlines procedures for reporting concerns related to animal care and use and includes provisions to protect individuals who raise these concerns from discrimination and/or reprisal.

V. Policy A. Each EMA Center that conducts animal research must establish a qualified IACUC and develop an ACUP. The IACUC can be administered by EMA personnel (whether for an individual EMA Center or one IACUC to be administered jointly with other EMA Center(s)) or by an external research partner. If the IACUC is to be administered by an external research partner or is administered jointly among EMA Centers, the IO is encouraged to describe the arrangement in an agreement (e.g., by Memorandum of Understanding, Memorandum of Agreement, or letter; see Appendix G for an example letter) to document clear oversight of animal welfare. The IACUC representing each EMA Center must be granted authority to ensure all animals are treated humanely and receive care that is consistent with prevailing standards for the species and the type of research that is conducted (see Appendix B, VIII for Externally administered IACUCs).

B. Each EMA Center conducting animal research will provide annual assurance of their compliance with this Policy by submitting the EMA annual compliance form (Appendix E), with concurrence of the Regional Point of Contact, to the CEO.

https://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-laboratory-animals.pdf

C. Each EMA Center that uses animals for research, teaching, or exhibition will implement the policy elements provided in Section VI of this Policy to ensure the ethical use of animals.

D. Each EMA Center that uses animals for research, teaching, or exhibition will ensure documentation of animal care and use that is developed, reviewed, approved, and filed by the IACUC and retained for 3 years. Animal care and use data and supporting documentation will be created, filed, stored, and migrated to new formats to ensure preservation that maintains integrity, control, retrievability, eligibility, traceability, and preservation in accordance with USGS records management requirements (see Survey Manual Chapters 431-433 and Appendix B, Section F, VII).

E. Each EMA Center that handles or uses animals will implement, and make known to personnel, a system to report concerns regarding Animal Care and Use (e.g., by phone, in writing, or in person

– in accordance with the IACUC). Under no circumstances will reporting such incidents be detrimental to an individual within the institution; individuals shall be protected from retaliation as described by the No FEAR ACT (Public Law 107-174). The IACUC must investigate all reports of suspected animal abuse or mistreatment. All information obtained from individual reporting, as well as information obtained during an investigation, will remain confidential (5 USC Section 552 (b) (7) (C) DOJ FOIA Guide Exemption 7(C)).

VI. EMA Animal Care and Use Policy elements Each EMA Center that conducts animal research will implement the following elements to ensure compliance with animal care and use legal and regulatory requirements.

1. Animal Care and Use Practices. Ethical, practical, and care standards for animal care and use that meet requirements of the AWA, AWAR, and IRAC by providing a system of self-regulation and regulatory oversight where animal users and the institution have assigned duties.

2. Animal Care and Use Training. All EMA personnel involved in animal research need to be appropriately trained. See Definitions Section (IV, HH) for the definition of training and Appendices B, C, and D for responsibilities of providing, developing, and receiving training.

3. Documentation and Forms. Animal care and use activities will be recorded for verifying purposes. SOPs and methods developed by the IACUC and may be unique to the EMA Center or may be developed across centers, at the discretion of the IACUC. Document SOPs and methods following USGS Quality Management Systems directions found in IM OSQI 2018-01, Quality Management System for USGS Laboratories. Each IACUC must develop and provide a set of forms (e.g., ACUP Checklist review, Checklist for inspections) to guide protocol submitters through that IACUC’s process.

4. Holding Area Inspections and Program Reviews. Each IACUC is required to review the ACUP and to inspect holding areas, vivaria, and sites used for animal surgeries biannually, or more if needed either in response to a specific request or resulting from a concern, courtesy inspection, complaint, or similar “whistleblower” action, as outlined in Appendix B.

5. Protocol Review. Any activity involving the use of vertebrate animals, as defined herein, requires submission, review, and approval by a quorum of voting members of the IACUC. Studies determined to be field studies as defined in Section IV, P, are exempted from AWA and IACUC oversight. Studies found to not be exempt are subject to IACUC review (e.g., requires Post Approval Monitoring including inspection of holding areas by the IACUC if wild animals would be held for 12 hours or longer). See Appendix B, Section III, B, for more information.

6. Records. Data regarding animals will be recorded such that they can be traced back through the IACUC process. All Animal Care and Use related records will be preserved for 3 years after the end of the study following (see Appendix B, Section VII).

7. Reports. The IO will develop and submit the EMA annual compliance form (template provided in Appendix E), while the IACUCs are primarily responsible for the development, maintenance, https://www.opm.gov/information-management/no-fear-act/ https://www.justice.gov/oip/freedom-information-act-5-usc-552 https://www.justice.gov/oip/freedom-information-act-5-usc-552 https://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/exemption7c.pdf https://www.usgs.gov/about/organization/science-support/survey-manual/im-osqi-2018-01-quality-management-system-usgs https://www.usgs.gov/about/organization/science-support/survey-manual/im-osqi-2018-01-quality-management-system-usgs submission, and documentation of three main reports: the AWA USDA Annual Report (if required, i.e., conduct animal research using warm-blooded animals); the IACUC Semi-annual Report; and any General Report(s) of Non-Compliance (as outlined on Appendix B, VI).

8. Statement for publication. USGS authored manuscripts that result from animal research must include an animal care and use statement. The statement should identify the institution associated with the overseeing IACUC. Statement suggested by USGS Bureau of Approving Officials: All animal procedures were reviewed and approved by the (U.S. Geological Survey’s [add name of EMA Center here] or [associated University or other institution, when applicable]) Institutional Animal Care and Use Committee. Journals or other publishers may require further information such as IACUC protocol number.

VII. Key EMA Personnel in Implementing this Policy A. USGS Director: Has final authority and responsibility for USGS Animal Care and Use.

B. Associate Director, Ecosystems: The CEO of EMA.

C. Regional Director: Appoints the Regional Point of Contact.

D. Regional Point of Contact: The regional staff member that engages with regional IACUCs and is the point of contact for animal welfare issues, and execute duties specified in Appendix D, IV.

E. EMA Center Director: The Center Director is typically the IO. Duties and responsibilities are outlined on Appendix D, II.

F. Animal Care and Use Administrator: EMA employee that assists the CEO and facilitates communication among the IACUCs, the USDA APHIS Animal Care unit, and third parties, with the authority to receive, handle, provide comment on, and present both official and unofficial documents from the IACUC Chairs, the USDA APHIS Animal Care unit, and third parties;

consult with these groups; and serve as deemed necessary by the CEO. The Animal Care and Use Administrator does not have the authority of signature, approval, or rejection of any documents or policies reserved for the CEO.

G. IACUC members: The specific responsibilities for implementing, administering, and applying this Policy by the IACUC and its component members are found in Appendix B and C.

H. USGS Records Officer: Responsible for creating and revising records schedules and bureau-wide filing codes for application to USGS records and enabling consistent filing and legal disposition of Federal records.

VIII. References U.S. Government Principles, Regulations and Guidelines

1. American Veterinary Medical Association Guidelines for the Euthanasia of Animals: 2020

Edition. Found at: https://www.avma.org/sites/default/files/2020-01/2020-Euthanasia-Final-1-17- 20.pdf.

2. The Animal Welfare Act (AWA), 18th edition. United States Code: Title 7 – Agriculture; Chapter 54 – Transportation, Sale, and Handling of Certain Animals. §2131 through 2159. Found at:

https://www.aphis.usds.gov/animal_welfare/downloads/bluebook-ac-awa.pdf.

3. The Animal Welfare Act Regulations (AWAR) Revised as of January 1, 2018. United States Code of Federal Regulations: Title 9 – Animals and Animal Products; Chapter 1 – Animal Plant Health Inspection Service, Department of Agriculture; Subchapter A – Animal Welfare. Found at:

https://www.aphis.usds.gov/animal_welfare/downloads/bluebook-ac-awa.pdf.

4. Laboratory Animal Welfare: U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training, 50 Fed Reg. 20,864 (May 20, 1985)

5. The Guide for the Care and Use of Laboratory Animals, 8th edition. The Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council. National Academy https://www.avma.org/sites/default/files/2020-01/2020-Euthanasia-Final-1-17-20.pdf https://www.avma.org/sites/default/files/2020-01/2020-Euthanasia-Final-1-17-20.pdf https://www.aphis.usds.gov/animal_welfare/downloads/bluebook-ac-awa.pdf https://www.aphis.usda.gov/animal_welfare/downloads/bluebook-ac-awa.pdf https://www.aphis.usds.gov/animal_welfare/downloads/bluebook-ac-awa.pdf

Press, Washington D.C. 2011. Found at: https://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-laboratory-animals.pdf.

6. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Office of Laboratory Animal Welfare (OLAW). Found at https://olaw.nih.gov/policies-laws-phys-policy.htm).

7. Russell W.M.S, and R.L. Burch. 1959. (as reprinted 1992). The principles of humane experimental technique. Wheathampstead (UK): Universities Federation for Animal Welfare.

Found at: https://caat.jhsph.edu/principles/the-principles-of-humane-experimental-technique.

Professional Guidelines

1. Guide for the Care and Use of Agricultural Animals in Research and Training. Federation of

Animal Science Societies. Found at:

https://poultryscience.org/files/galleries/AG_Guide_4th_Ed_2020.pdf.

2. SOT Guidelines principles in the Use of Animals in Toxicology. Society of Toxicology. Found at:

https://www.toxicology.org/pubs/statements/air.asp.

3. Guidelines for the Treatment of Animals in Behavioral Research and Teaching. Animal Behavior Society. Found at: http://cdn.elsevier.com/promis_misc/ASAB2006.pdf.

4. Ethical Treatment of Animals in Applied Animal Behavior Research. International Society for Applied Ethology. Found at: https://www.applied-ethology.org/Ethical_Guidelines.html.

5. Guidelines to the Use of Wild birds in research. The Ornithological Council. Found at:

https://birdnet.org/info-for-ornithologists/guidelines-to-the-use-of-wild-birds-in-research__trashed/guidelines-english-3rd-edition-2010/.

6. Guidelines of the American Society of Mammologists for the Use of Wild Mammals in Research.

American Society of Mammologists. Found at:

http://www.mammalogy.org/uploads/Sikes%20et%20al%202011.pdf.

7. Guidelines for the Use of Fishes in Research. American Fisheries Society. Found at:

https://fisheries.org/docs/policy_useoffishes.pdf.

8. Guidelines for Use of Live Amphibians and Reptiles in Field Research. American Society of Ichthyologists and Herpetologists. Found at: https://www.aaalac.org/pub/?id=E90180D2-EE29-

8F8B-A493-AC0C8F911AAC.

9. Guidelines for animal surgery in research and teaching. AVMA Panel on Animal Surgery in Research and Teaching, and the ASLAP (American Society of Laboratory Animal Practitioners).

Found at: https://pubmed.ncbi.nlm.nih.gov/8239147/.

10. Guidelines on the Care and Use of Fish in Research, Teaching and Testing. Canadian Council on Animal Care Guidelines. Found at: https://www.aaalac.org/pub/?id=E9011FA1-B60F-120C-

7326-0EEE9DB613AF.

11. AVMA Guidelines for the Euthanasia of animals: 2020 Edition. American Veterinary Medical Association. Found at: https://www.aaalac.org/pub/?id=E9016A60-0A9E-F3DA-E406-

237BA19E8A1A.

12. Guidelines for the Care and Welfare of Cephalopods in research -A consensus based on an initiative by CephRes, FELASA and the Boyd Group. CephRes, FELASA and the Boyd Group.

Found at: https://www.aaalac.org/pub/?id=E9012458-E8F7-1CB9-E298-B0A29C3193A5.

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Appendix A. The Interagency Research Animal Committee (IRAC) Principles for the Care and Use of Animals Used in Testing, Research, and Training

The Principles below were prepared by the Interagency Research Animal Committee (IRAC). This committee, established in 1983, served as a focal point for federal agencies' discussions of issues involving all animal species needed for biomedical research and testing. The committee's principal concerns were the conservation, use, care, and welfare of research animals. Its responsibilities include information exchange, program coordination, and contributions to policy development.

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

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

U.S.C. 2131 et seq.) and other applicable Federal laws, guidelines, and policies.

II. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.

III. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.

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.

VII. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.

VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of research [laboratory] animals.

IX. Where exceptions are required in relation to the provisions of these Principles, the decision should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an Institutional Animal Research Committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

The IRAC body was composed of representatives from the following federal agencies: the U.S.

Department of Agriculture, U.S. Department of Defense, U.S. Department of Energy, U.S. Department of the Interior, U.S. Department of Health and Human Services, U.S. Department of State, U.S.

Department of Transportation, U.S. Department of Veterans Affairs, The Consumer Products Safety Commission, the Environmental Protection Agency, the National Aeronautics and Space Administration, the Smithsonian Institution, the U.S. Agency for International Development, the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Office of International and Refugee Health.

Appendix B. Duties and membership of the Institutional Animal Care and Use Committee

(IACUC)

IACUCs must have at least three members including an attending veterinarian, an unaffiliated at-large-member, and a Chair. The IACUC could also have scientist(s) trained and experienced in the husbandry, management, and handling of animal species and animal research activities relevant to the EMA Center.

One individual may be qualified to fulfill more than one of the required roles concurrently, however, such conditions should be temporary. A minimum of three voting members is required. The following summarizes duties of the CEO for Animal Care and Use Committee that apply to the EMA1:

I. Training: The AWAR requires that EMA personnel are trained in aspects of animal care and use, depending upon their role, and that documentation of training plans and records is maintained:

A. IACUC members must be properly trained in their roles and responsibilities to fulfill their committee responsibilities.

IACUCs under the direction of the IO and the IACUC Chair must ensure that each member of the IACUC has received training in their roles, responsibilities, and expectations to fulfill their responsibilities as part of the IACUC. One resource to meet this training requirement are free webinars provided by the American Association for Laboratory Science available at https://www.aaalas.org/iacuc/training-resources.

B. EMA personnel must be properly trained in their roles and responsibilities to provide for animal care and use.

IACUCs must ensure that all EMA personnel are sufficiently trained, as appropriate base on their role, to ensure animal welfare in carrying out their job duties. Training for EMA personnel must include humane methods of animal maintenance and experimentation; methods to limit the level of pain or distress experienced by animals used in research activities; proper use of anesthetics, analgesics, and tranquilizers; and reporting of animal care concerns and program deficiencies.

Required training to meet this need is protocol and species-specific and therefore will be unique for each EMA Center. Designing a training program to meet this need is at the discretion of each IACUC. Training methods might include online courses, ad hoc presentations developed by the IACUC, review of IACUC selected-continuing education articles, attending Animal Welfare conferences, individual training provided by local subject matter experts in animal care and use, or other methods the IACUC decides to approve. Helpful resources can be found at https://www.aaalas.org/iacuc/training-resources and https://ccac.ca/en/training/modules/core-stream.

C. PIs must be trained in the Concept of Alternatives (see Section IV, I, for definition).

IACUCs must ensure that PIs have been trained to 1) replace the use of research animals altogether; 2) reduce the number of animals required; or 3) refine an existing procedure or technique to minimize the level of pain/distress perceived by the animal. This training need can be met by training on accessing databases and online services that prevent unnecessary duplication of research and/or provide information on alternatives to the use of live animals in research activities (training provided by the Animal Welfare Information Center (AWIC) National Agricultural Library (NAL)/USDA).

II. Convening meetings

1 This list is summarized from the following sections of the AWAR: [AWAR §2.31: (a); (b); (c); (d); §2.32:

(a) (b) (c); §2.33: (a) (b) (c) (f); §2.35: (a) (b); §2.36: (a) (b); §2.37: (a) (b)] https://www.aaalas.org/iacuc/training-resources https://www.aaalas.org/iacuc/training-resources https://ccac.ca/en/training/modules/core-stream https://ccac.ca/en/training/modules/core-stream

A. A quorum must be present for official business to be conducted. Members may participate by attending the meeting in person, by telephone, through videoconference, or other web-based methods. Any method used must facilitate real-time discussion among all members in attendance.

B. The IACUC must meet at regular intervals, and at a frequency that conforms to the research program’s needs, but no less than twice each year (i.e., approximately every 6 months).

C. The Chair has the option to convene an emergency meeting when urgent issues arise.

D. Alternate members of the IACUC are selected, nominated, and invited to serve in the same fashion as those chosen for full-time membership. Individuals nominated for alternate status are identified as such on their individual nomination submissions to the IO. Alternate IACUC members assume active, full-time membership duties at the discretion of a request from the IO, or as circumstances dictate, e.g., in surrogate by request of the IACUC Chair to achieve a quorum or conduct an inspection. Alternates may serve on active, full-time status as long as they are needed to do so, or as long as practicality demands. Alternates may be promoted to full-time status with approval of the IO.

III. Reviewing and approving research activities that involve animals A. The IACUC must review and approve all protocols involving live animals before initiation, including field studies. If the IACUC determines the protocol is a field study, it is thus exempted from further consideration by the IACUC. If Committee members decide that a given exempted protocol contains significant animal welfare concerns, however, they can decide to treat the protocol as if though it was not exempted. No IACUC member can review their own proposal.

B. The Committee has the option to conduct reviews during a convened meeting of a quorum of members (i.e., Full Committee Review) or to delegate review and approval authority to one or more designated members acting on the Committee’s behalf (Designated Member Review). For a Designated Member Review, all IACUC members must have the opportunity to call for Full Committee Review prior to approval of a submitted protocol (usually for a minimum amount of time prior to the protocol being assigned to designated member review). A Designated Member Review cannot withhold approval but must refer the protocol to full committee review if there are concerns that approval cannot be granted. At minimum, the review process must include:

1. An assurance that the research does not unnecessarily duplicate previous research.

2. Criteria for species selection and specifically why lower-order vertebrates or non-animal models cannot be used.

3. Justification for the number of animals requested.

4. Rationale for the use of live animals in lieu of available in vitro or other non-animal alternatives.

5. Strategies to minimize pain and distress.

6. Establishment of humane endpoints.

7. An animal disposition or euthanasia plan.

C. Departures from standards articulated by the AWAR or industry standards (e.g., professional guidelines listed in Section VII of this Policy) must be scientifically justified in the protocol and approved by the IACUC.

E. The review process results in the protocol being approved as submitted, the protocol requiring modifications to secure approval, or approval of the protocol is withheld.

F. Significant modifications to an approved protocol must also be reviewed and approved by the IACUC before implementation.

F. Full IACUC approved ongoing protocols must be reviewed every three years. This results in a protocol remaining valid for 3 years after IACUC approval and requiring a new submission to the IACUC for review and approval at the end of the 3-year term.

G. The IACUC must ensure the principles of reduction, refinement, and/or replacement (the 3 R’s) are incorporated into all phases of research planning and conduct.

H. The IACUC must support, participate in, or coordinate the development and review of EMA Center level SOPs for the care and use of animals, and ensure staff working with animals adhere to these established SOPs.

IV. Post Approval Monitoring, conducting semiannual program reviews and facility inspections using “The Guide for the Care and Use of Laboratory Animals” and Title 9: Code of Federal Regulations, Chapter 1, subchapter A-Animal Welfare, respectively, as standards for evaluation.

Minimum once every 6 months the IACUC must:

A. Evaluate the EMA Center’s ACUP.

B. Inspect areas where animals are held, transported, housed, or maintained, and/or other space that is directly used in routine animal care or research activities (e.g., feed and bedding storage, surgical suites, restraint systems, scales, procedure areas, carcass storage, etc.)

C. A checklist, developed by the IACUC, will be used to guide IACUC members during program reviews and will be reevaluated semiannually by the IACUC Chair to ensure compliance with all Federal, State, and EMA policies. (An example of a “Semiannual Program Review and Facility Inspection Checklist” including terrestrial and aquatic holding areas, can be found at:

https://olaw.nih.gov/resources/documents/checklist.htm).

D. A minimum of two members must actively participate in the inspection process, although all members are encouraged to contribute and be involved to the greatest extent possible. The IACUC has the option to consult with external subject matter experts during its evaluation of unusual species and/or alternate environments required for certain studies.

E. The results of this assessment are compiled into a final report that identifies the ACUP’s departures from regulations or recognized performance standards, with an explanation or reason for each departure.

F. The report must also incorporate the IACUC’s recommendations to the IO relative to the ACUP, facilities, and personnel training.

G. The final report must be reviewed and approved by the IACUC, and then signed by a…