September 7, 2023
None
Office of The Director, National Institutes of Health (OD)
Through this Request for Information (RFI), the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) is seeking input on proposed guidance for use of cephalopods in research, research training, experimentation, or biological testing, or for related purposes. The proposed guidance describes practice standards for institutions with an approved Animal Welfare Assurance (Assurance), Institutional Animal Care and Use Committees (IACUCs), and other oversight bodies on avoiding or minimizing discomfort, distress, and pain to cephalopods used for these purposes.
Background
Cephalopods are a class of aquatic invertebrate animals that includes over 800 living species. This group of mollusks includes octopuses, squid, cuttlefish, and nautiluses. A growing body of evidence demonstrates that cephalopods possess many of the requisite biological mechanisms for the perception of pain, such as nociceptors and a centralized nervous system. In addition, it has been shown that cephalopods exhibit adaptive learning, alter their behavior in response to noxious stimuli, and exhibit mammalian-like responses to anesthetics. However, the structural and functional organization of the cephalopod nervous system is very different from mammals, and additional research is necessary to fully understand cephalopod perception. Please see the OLAW Cephalopods in Research webpage for selected resources.
In recognition of this emerging data, the 2015 Guidelines for the Care and Welfare of Cephalopods in Research A consensus based on an initiative by CephRes, FELASA and the Boyd Group, were authored by a diverse group of cephalopod experts from around the world. More recently, AAALAC International, a voluntary accreditation organization for laboratory animal care and use programs, has included cephalopod welfare in its accreditation requirements and is using this consensus document, with some clarifications and exceptions, as their standard. Many nations have also adopted regulatory requirements for cephalopod welfare in research, including the members of the European Union, the United Kingdom, Switzerland, Norway, Canada, Australia, and New Zealand.
Currently, in the United States, cephalopods are not regulated under the Animal Welfare Act and Animal Welfare Regulations and are not included in the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Policy). Further, other than in the AVMA Guidelines for the Euthanasia of Animals, cephalopods are not included in any of the documents that the PHS Policy incorporates by reference. Because species-specific standards for husbandry and housing, and professional standards for veterinary care are still being developed by the veterinary and research communities and require additional scientific study and validation, the application of and compliance with the PHS Policy is problematic. However, the U.S. Government Principles II, III, IV, and IX outline practices that can be applied to this class of animals despite the current gaps in knowledge. The other Government Principles can be applied to the extent possible based on applicability and current knowledge. The following guidance seeks to clarify the application of the U.S. Government Principles to cephalopods.
Information Requested
The NIH is seeking input on the following proposed guidance for institutions with approved Animal Welfare Assurances:
Assured Institutions are expected to ensure that cephalopod activities are subject to review and approval by IACUCs or other oversight bodies, and subsequent post-approval oversight, in accordance with U.S. Government Principles. This would involve including cephalopod programs and facilities in semiannual evaluations. Institutions may also choose to include cephalopod programs in other methods of post-approval monitoring used by the institution and may choose to voluntarily self-report any deficiencies to OLAW. Ad hoc consultants may be invited to assist with oversight activities. Institutions using cephalopods are expected to provide appropriate husbandry and veterinary care by employing research, husbandry, veterinary care, and physical plant staff with qualifications and training relevant to the species being used, as determined by the IACUC or other oversight body.
IACUCs and oversight bodies are encouraged to develop institutional policies and Standard Operating Procedures (SOPs) that summarize expectations and promote consistency and quality of cephalopod care and use. OLAW recognizes that there is tremendous variation in the life history, reproductive strategies, development, and captive breeding challenges among the several hundred known cephalopod species. Care requirements will necessarily differ based on these biological and environmental factors. In addition, cephalopod use varies with research aims (please see the OLAW Cephalopods in Research webpage for selected resources on these topics). Institutions have the discretion to develop institutional guidance that works best for their needs but should base their requirements on the U.S. Government Principles, as well as the most current data and professionally accepted standards. The Guide for the Care and Use of Laboratory Animals, 8th edition includes a section on aquatic animals with information on water quality and life support systems that can assist with some aspects of cephalopod care. In addition, information on current practice standards may be found on the AAALAC Resources page. The AVMA Guidelines for the Euthanasia of Animals provide guidance on the humane euthanasia of invertebrates, and institutions are expected to follow the most current version of these guidelines for the euthanasia of cephalopods. Practice standards will evolve based on new information in this expanding area of interest, and institutions are expected to keep apprised of the most updated information. Institutions are also encouraged to share their knowledge on the welfare of these research animals in conferences and publications.
How to Submit a Response
All responses to this RFI must be submitted electronically on the RFI webpage by December 22, 2023, at 11:59 ET. The comments may be made available on the OLAW website.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
Office of Laboratory Animal Welfare
Telephone: 301-496-7163
Email: [email protected]
and Human Services (HHS)
