Evolving to a Macro-Environmentally Friendly, Bucketless Cleaning System
Developing Quality Workforce Training: Breaking with Traditional Scoring
Resolving Confusion Regarding the Alternate IACUC Member
Mid-South Branch and Three Rivers Branch Hold Meetings
By Jeffrey Frankel, VMD and Imani Nicolis, DVM
Evolving to a MacroEnvironmentally Friendly, Bucketless
By Arrow Megginson, BS, RLATG
Reducing Hay Waste from New Zealand White Rabbits (Oryctolagus cuniculus) by Switching to Hanging Wire Feeders from Conventional Food Bowls
Volunteering Highlights and Reminders! Ad List The Evolution of Podcasts in Laboratory Animal Science By Jennifer C. Smith, DVM, DACLAM LASPro General Interest: Medication Storage, Expiration, Beyond-Use, and In-Use Dating
By Jonathan Decker, BS, LATG and Patrick Lester, DVM, MS, BCPS, DACLAM
By Ron A. Hayes, Carol L. Baker, DVM, PhD, and Leslie L. Birke, DVM, MPH, DACLAM
AALAS Connections
2024 Branch Meetings, GLAS Updates, and the OLC Meeting
AALAS Foundations
By Fernando De La Garza ALAT, Dr. Charles Tyler Long DVM,
DABT, and Dr. Coralie Zegre Cannon DVM, DACLAM
On the cover; “Chiquita” painting a Piggy Picasso. In 2023, one of her paintings was donated to the AALAS Foundation auction at the National Meeting in Salt Lake City.
EXECUTIVE COMMITTEE
PRESIDENT
Robert H. Quinn
VICE PRESIDENT
James D. Macy
VICE PRESIDENT-ELECT
Jori K. Leszczynski
PAST PRESIDENT
Pamela A. Straeter
SECRETARY/TREASURER
Timothy D. Mandrell
EXECUTIVE DIRECTOR
Thomas L. Joseph
TRUSTEES
District One
Jennifer L. Asher
District Two
Erin E. Vogelsong
District Three
Donna D. Tignor
District Four
Janet Lynn Steele
District Five
Stacy R. Cantrell
District Six
Stephen I. Levin
District Seven
Adrienne Ferguson
District Eight
Katherine M. Marshall
AT-LARGE TRUSTEE
Debra L. Hickman
Kenneth B. Shapiro
Gordon Yee
Jason S. Villano
Thomas L. Joseph Publisher
Ashlee Vaughn Associate Editor
STAFF
Chris Lyons Associate Publisher
Degan Mesler Production Zara Garza Design
Jennifer C. Smith Editor
Heather Lampi Ad Sales
EDITORIAL ADVISORY BOARD
Leslie Birke Louisiana State Univ
Andrew Burich Benaroya Research Institute
Bob Dauchy Tulane Univ School of Medicine
David DeOrnellis Champions Oncology
Penny Devlin Pennsylvania State Univ College of Medicine
Sonia Doss Duke Univ Medical Center
Kelly Ethun Emory University
Glenn Jackson Cornell University
Richard Marble Alpha Genesis Inc.
Elizabeth Nunamaker Charles River Laboratories
MISSION STATEMENT
Sara Oglesby Abbvie
Jane Olin Edwards Life Sciences
Karuna Patil Seattle Children's Research Institute
Amy Pierce Tulane Univ School of Medicine
Stacy Pritt The Texas A&M University System
Laboratory Animal Science Professional (LAS Pro) is the official magazine for American Association for Laboratory Animal Science members. LAS Pro provides a wide range of useful resources and knowledge to the association’s 15,000 laboratory animal science professionals who are involved in advancing responsible laboratory animal care and use to benefit people and animals. All signed articles, including, committee reports, news, and commentary, reflect the individual views of the authors and are not official views of AALAS.
Authorization to photocopy portions for personal or internal use is granted by the American Association for Laboratory Animal Science. Photocopying for purposes of resale or outside distribution is prohibited unless written approval is obtained from the AALAS Director of Communications.
Copyright 2024 by the American Association for Laboratory Animal Science.
Laboratory Animal Science Professional (USPS 010-730) is published bimonthly by the American Association for Laboratory Animal Science, 9190 Crestwyn Hills Drive, Memphis, TN 38125. Periodicals Postage paid at Memphis, TN 38101 and additional mailing offices. POSTMASTER: Send address changes to AALAS, 9190 Crestwyn Hills Drive, Memphis, TN 38125-8538.
As I write this, I am halfway through my year as your President. How can that be? Seems like just yesterday we were in Salt Lake City enjoying all that the National Meeting has to offer. So much has happened in these 6 months that I would like to share with you.
I was fortunate to be able to jump right into things in November attending the FESAHANCCCAL meeting in Panama City, Panama. It was really wonderful to meet all the truly dedicated technicians and scientists working so hard to improve the conditions for the animals as well as the quality of research. It is a beautiful country filled with very warm and welcoming people. Although I do not speak Spanish, everyone was very patient and worked very hard to try to help me understand as much as possible. I highly recommend visiting if you ever get the chance.
The rest of the time I have been hopping around our own country meeting many of you for the first time. I attended the Texas Branch annual meeting in San Marcos, TX in early February and virtually attended the Northern Mountain Branch meeting in early March. After that I was able to come back to my old stomping grounds and attend QUAD (District 1) in early April. All these trips and interactions have just cemented an idea that I already knew; laboratory animal science hands-down has some of the brightest, friendliest, and most dedicated professionals of any field out there. You should all be incredibly proud of what you do for animals and for people every day!
The last thing I will mention is that I just returned from the National Meeting Program Committee meeting in Nashville. We had the opportunity to see the convention center and layout of the hotels and surrounding amenities. I was enthusiastic about the meeting being in Nashville before, but now I’m really excited. The convention center is beautiful, but more importantly, it will be easy to get to and from every hotel and the layout within the convention center will make moving between sessions very simple. Whether you’re a seasoned national meeting pro or have just always wanted to go, this is the one to attend. I hope to see every one of you there for what will be a wonderful meeting.
Robert H. Quinn, DVM, DACLAM President American Association for Laboratory Animal Science
Helpful Outreach Resources
By: Jessica Hunt, MPA, BS, BA, RLATG, ILAM
Ihave been participating in Take Your Child to Work Day events for several years; my eldest child was in elementary school when I first began to participate, and she is now 29. I have always used the free materials made available by the AALAS Foundation. My personal favorite is the poster outlining animal roles in medical discoveries since 1901. I also love to share the “Careers in Biomedical Research” brochure.
I like to get the students to start thinking about opportunities in our field as soon as elementary school. Representation matters, and I often say if I had met a minority veterinarian while in grade school, I may have chosen that as a career. I did not meet a minority veterinarian until I joined Research Triangle Branch (RTB) AALAS in 2002.
The Kids 4 Research mouse and frog cut-outs seem to be popular amongst children of various ages. The cut outs are also great for adults and are a great way to take a break and engage in some self-care. My staff has put some together, and they are hanging on the board in our break room.
I used the Animal Flash Facts game for the first time this year. While this resource is not free, at $15 it was worth every penny! The students at this year’s Bring Your Child to Work Day event were so engaged as they tried to guess and correctly identify the animal model which helped scientists achieve each medical discovery described. The cards contained helpful hints to use if a student was struggling to answer. As a prize, they were given a trading card to keep or trade with other students. The trading cards contain “fun facts” about twenty-nine animal models that have helped scientists in their quest for medical discoveries. The game and cards are even great to have in your home gaming library to be used at your family game nights!
I am so proud of the AALAS Foundation and all the helpful resources they provide. Be sure to check out what they offer at www. aalasfoundation.org
Figure 2: Table set-up for Bring Your Child to Work Day.
Figure 1: Jessica Hunt with the Animal Flash Facts Game.
Certification AWARDEES
AALAS recognizes the achievements of the following members who have successfully completed their certification during March-April, 2024
CMAR Certification Recipients
March 2024
Jessica Keding-Casey
Heidi L Abbott-Andersen
Veronica C Bullock
Kristin L Fox
Amber M Lopez
Holly McAleese
Carrie J Montesari
Nathan Ramseyer
Christopher A Wold
Darrin Chester
Jennifer Houle
Sandra-Kelly S Atkinson
Muhammad Kamal Bin Solehan
Gregory J Davis
Ariana P Dina
Alexandra C Epstein
Alexa M Gil
Javier Kaien Loo
Travana Matthews
Yahaira Soto
Norhashimah Binte Sulaiman
Emily Deiss
Paige Gabitzer
Miranda G Magnan
Nurys A Mateo
Stephanie M Mautner
Tayna Victoria Moreira Silva
Cassidy K Mucherino
Jennifer L Walker
Millie Zheng
Benjamin S Macklin
Gregorio A Alvarado
Daijia L Atkinson
Tiffany Brown-Mangum
Kayla Castleberry
Alyse M Crownover
Claudia Fang
April 2024 Amaurys Mendez
LATG Certification Recipients
Vincent Shaw
James P Jasiek
Priscilla Nimako
Antonio Reyes
Sonia T Thomas
Tiara D Kimbrough
Crystal M West
Henry A Isadiah
Jonnel C Paloma
Prosper A Tah
Stephen A Carroll
Kelly M Charpentier
Kyla R Emerson
Daveenah Guise
Kayla A Hopper
Jocelyn V Munguia
Bridget A Skinski
Daniel C McMaster
John P McNamara
Alexia H Shivers
LAT Certification Recipients
Leah Nielsen
Ariana A Przybylowski
Ryan Raber
Gilbert Alvarez
Christopher T Cordova
Virginia E Duncan
Megan Jingwi
Emily A Lafferty
William A Lamoureaux
Jared R Mooney
Jeanne M Quillen
Dayna Rutherford
Rebecca D Taylor-Emigh
Melissa Babbitt
Jessica M Lopez Cano
Trinity M Mersmann
Devanshi Ragha
Andrea M Sandoval
Danielle Sang
Jonathon R Cantu
Robert J Davies
Genitta George
Maria Platero
Nicole Rose Ravetti
Lora E Roberts
Laryssa M Rodriguez
Marcy Seale
Karissa Sharp
Erika L Stamp
Jaquan K Williams
Felipe Sotelo
Natalie J Blanton
Alex Carreon
Casey R Clavecilla
Savannah Linwood
Marguerite Lubarski
Kaitlin Shrum-Hammer
Lauren M Souza
Olivia M Tuminelli
Sofia C Viebranz
ALAT Certification Recipients
Jacob Fisher
Cheyenne Hamilton
Kathryn Y King
Stefanie Kremer
Kevin Luke
Megan Mackay
Abigail M Snow
Lisa Wallace
Xifeng Wang
Xuehai Zhu
Morgan E Campbell
Noelle Clough
Kimberleigh Martinson
Ashley Marie Nino
Victoria L Shoemaker
Judah D Thornton
Jiayi Xu
Conor H Zawilinski
Brenda Ball
Mirelle Baptista
Aldy A Bello
Sarah E Brewster
Matthew R Demeule
Steve Downes
Madison P Eaton
Rebecca M Elissa
Jennifer Knowlton
Kaitlyn M Mayberry
Serena D McElroy
Katelynne N Nelson
Kaileen M Nicholls
Lauren G Rose
Danqi Shen
Brianna J Stuckey
Amanda B Tresler
Kelsey Visser
Angelica Zapata
Leslie W Gazzola
Lindsay Glasovatz
Nick Ho Choon Teck
Terry Irham
Jessica Johns
Taylor O Jones
Eric Koeninger
Ariel Miller
Krista F Nayadley
Chantal Nolli
Laura Nicole Paettie
Matthew RC Santos
Megan Sousa
Damaris Tellez Villa
Karen Thurman
Nathan Vandecar
Joshua Whitt
Katie A Brown
Erica J Daum
Collin J Dupuy
Evan McGregor
Nicole L McInnis
Joseph E McKinney
Lauryn Novak
Antonio Ringgold
Alissia Snyder
Jennifer L Cartwright
Kati O Anonen
Jill M Argall
Sydney Barnett
Shemari Caesar
Emma Clayton
Jocelyn Diggs
Mackenzie L Garnett
Benjamin C Hail
Morgan K Haney
Megan Hill
Samuel J Horvath
Christopher Lopez
Ashley Markewinski
Thu Nguyen
Rosalie Ngameni Epse
Nitcheu
Rachel E Patterson
Bryson K Satterwhite
Thomas J St Pere
Roberto D Vaquiz
Chiara M Vazquez
Miya C Wai
Justin Bagby
Danielle Barron
Kelly Brinkmoeller
Sierra L Bullock
David J Fullmer
Christine Geiger
An Le
Tiffany C Rodriguez
Stacey Suharja
Jade N Swanson
Victoria G Tollett Howle
Hope Babcock
Rachel M Brokish
Lanika N Brown
Charity J Calhoun
Crystal Carpenter
Gabriel A Dominguez
Nyesha N Dunn
Jose L Escamilla
Sarah A Fedder
Ciana Ferl
Matthew Freedman
Sequoia Globke
Caitlin A Greene
Molly K Halverson
Brooke C Lamontagne
Linsey M Lee
Emily A Moller
Lukcas Nightingale
Angela Peter Molly Petit
Dilly Placeres
Kenia Robles
Ayla Ryan
Colin J Schultz
Sierra S Sutton
Alyssa L Trembly
Aryanna Welch
Quirt R Wilson
Krysta Zmich
Tyler M Annarino
Michael Bittner
Benjamin Carter
Regan French
Richard M Griffiths IV
Zixuan Hao
Corrina A Jeffers
Makhai X Kindle
Jasabel Martinez
Gerald McNeil
Jessie Nalepa
Amanda Neal
Gabriel P Smith
Hanna C Smith
Jarin T Snyder
Arturo Rodriguez Patino
Julian E Aguilera
Chandler Aucoin
Sarah Barron
Hector Cuellar
Dasia Edwards
Kaitlyn R Haggerty
IN MEMORIAM
Noel D.M. Lehner, DVM, MS, DACLAM
Christopher Martin
Natasha R McDaniel
Connor G McLeod
Alexandria R Meier
Adam Potter
Nesmarie Rivera Colon
Angela C Rodriguez
Justina E Theado
Jeremy Torres
Layla Alshameh
Rene A Arboleda
Audrey N Birrueta
Julia R Brown
Emily M Carr
Valerie B Conover
Lames M Elgammal
Yael T Goldstein
Valery Gutierrez Guzman
Rachel C Hennis
Alexandra N Hernandez
Claudia Ee Lin Ho
Luis Jimenez
Jingxian Li
Xuchen Liu
Lionelle Ponde
Victoria Reynolds
Sydney G Salgado
Andres Schreiner Thennet
Charisse Ursin
Taylor N Ward
Maelyn R Wolber
Katelyn Zicker
Dr. Lehner (Salem, South Carolina), 86, died November 19, 2023. Following veterinary school graduation (Illinois, ’61), he served in the Army Veterinary Corps, attaining the rank of captain. Dr. Lehner subsequently earned his master’s in laboratory animal medicine at Wake Forest University, where he became a member of the faculty and headed the animal resources program. He later served as director of the Division of Laboratory Animal Resources at Emory University. During his career, Dr. Lehner also served as overseeing veterinarian for Morehouse College School of Medicine.
Known for his expertise in primate medicine, he initiated the use of humane facilities and protocols for nonhuman primates and co-edited the book “Planning and Designing Research Animal Facilities.” Dr. Lehner was a diplomate of the American College of Laboratory Animal Medicine and served on the AALAS board of trustees, AAALAC Council on Accreditation, and the Georgia Technical Institute IACUC.
In 2002, AALAS honored him with the Joseph J. Garvey Award for accomplishments in administration, education, or support programs related to the care, quality, or humane treatment of laboratory animals. Dr. Lehner’s wife, Betty, and a son and a daughter survive him.
Credit: AVMA
Getting Personal
What companion animals do you have? If you have none, then what kind of pet would you like to have?
I have 4 chickens (all named chicken), 3 retired research beagles (Smokey, Cub, and Griz), and 1 cat named Blue.
Best binge-watching TV series?
I am a sucker for Grey’s Anatomy and Private Practice.
What are your favorite hobbies?
I just got into gardening, but I love fishing, kayaking, and archery.
Where is your dream vacation spot?
Fiji, but any tropical beach will do!
What is your favorite dessert?
Huckleberry Cheesecake for sure!
5
LAS PRO-files minutes with... Brianna Wrightson, BS, RLAT
Facility/Employer: Fred Hutchinson Cancer Center
Job Title: Preclinical Imaging Specialist
How did you get in this field?
After graduating from the University of Washington with a BS in Biology, I went looking for a job relating to animal science. I started out as a husbandry tech at Fred Hutch and out of curiosity applied for the animal imaging position. For the past 4 years I have enjoyed learning and growing into a specialist position.
Who were your mentors?
My predecessor, Teri Blevins, helped prepare me for their departure by providing support and trust and the opportunity to grow professionally in my position. Her positive friendly personality helped give me the confidence to succeed and pursue my curiosity.
What are your current interests in animal science?
I am enjoying optimizing imaging procedures for each modality to provide better data as well as instructing researchers how to utilize their data accurately. My passion is to continue to learn more about the technology and be able to help others in the process.
Where do you see yourself in 5 years?
I love my job and the organization I work for, so still at the Hutch!
What is your favorite part of your job?
I relish the opportunity to learn about several research areas including understanding how to support each study with an imaging modality. Being able to assist scientists with their research that will potentially help many people who may be suffering is the goal.
What advice do you have for others just beginning their animal science career?
I recommend taking advantage to learn and understand the variety of positions related to animal science. Ask questions and participate in as many opportunities to gain knowledge and experience.
What is the most rewarding aspect of your career? Providing usable data for researchers and investigators that support their study goals is very rewarding. I appreciate having the ability to network with like-minded folks and collaborate on how to improve on ways that are beneficial for both research and the animals involved.
What is something unexpectedly interesting about your career?
Coming to the realization I enjoy teaching and training folks about in vivo imaging systems. The care and patience it takes to also provide exceptional service for scientists while being humane and objective.
The Evolution of Podcasts in Laboratory Animal Science
Jennifer C. Smith, DVM, DACLAM
Introduction
The word of the year in 2005, as determined by the New Oxford Dictionary, was ‘podcast.’ This marked the beginning of a significant entertainment and education innovation.8 The word itself has a fascinating history—its origin is credited to a clever journalist who combined the words ‘iPod’ and ‘broadcast’ to describe this new phenomenon in the early 2000s.3 Since then, podcasts have evolved from humble audio files distributed by RSS feeds for downloading to sophisticated audio-engineered hosted episodes. This evolution, particularly in the laboratory animal science community, is a testament to this medium’s continuous development and potential. Consequently, it’s hard to find an industry today that doesn’t have podcast representation, and it’s estimated that over 80 million people listen to podcasts weekly in the U.S. alone.5 As the podcast industry continues to grow, this article provides insight into the evolution of podcasts in the laboratory animal science community and highlights some current podcasts, inviting you to explore the potential of this medium. The numerous benefits of podcasts include their ability to provide timely and flexible learning, enhance accessibility to expert knowledge, and facilitate engagement with the scientific community.
Origins and Early Adoption
In laboratory animal science, forward-thinking professionals have often recognized the potential for innovative educational technology to enhance training and meet regulatory requirements.4 These early adopters, with their vision and courage, paved the way for introducing other methodologies into our niche field, including podcasts. Early laboratory animal science podcasts tackled complex topics such as the ethical implications of animal research, strategies for improving animal welfare, and innovations in the 3Rs. These discussions provided a platform for in-depth exploration of issues that are often challenging to address in traditional publications. The journey of podcasts from popular science to scholarly communication is part of a broader trend toward multimedia content in academia, where conventional methods such as journals, conferences, and seminars are being supplemented by more dynamic and accessible forms of information dissemination.9 Recognizing the educational potential of podcasts, many academic institutions have integrated them into their curricula and require podcast listening as part of coursework. This integration was
particularly beneficial for remote learning scenarios, allowing students to access expert knowledge regardless of location. Moreover, professional certification bodies have begun acknowledging podcasts as valid continuing education units (CEUs). This recognition further cemented podcasts’ role as a legitimate and valuable educational tool within the industry.
The LASt Word, an AALAS Podcast
The adoption of podcasts within the laboratory animal science community offered a new avenue for timely and flexible learning, allowing professionals to stay informed while multitasking, such as during commutes or routine animal care. Scientific journals have long been the cornerstone of scholarly communication, relying on print or digital text to disseminate critical research findings. Today, scientific journals are increasingly adopting multimedia formats to engage a broader audience, enhancing the accessibility and impact of scientific content.9 Notable journals like Nature and Science were among the first to launch podcast series featuring interviews with researchers, summaries of recent publications, and discussions on current trends in science. These podcasts provided a new avenue for scientists to share their work and engage with the scientific community and the public.6 This initiative aimed to provide listeners with an overview of the latest scientific advancements, making complex research more accessible through engaging narratives and expert commentary. The benefits of podcasts relating specifically to scientific journals include enhanced accessibility and education and a platform for researchers from different backgrounds and disciplines to share their perspectives and experiences.6
Following these trends, AALAS introduced a scientific-based podcast titled The LASt Word, which debuted in November 2023.10 A member of the Editorial Team hosts this unique podcast, which highlights the research in articles recently published in AALAS scientific journals, JAALAS and Comparative Medicine. By interviewing journal authors, this podcast allows for quick dissemination of information on the latest research in the laboratory animal science industry. Using the podcast format, The LASt Word reaches non-specialists, policymakers, and educators, extending the diversity and impact of scientific findings and humane animal care on research. By embracing innovations and addressing challenges, The LASt Word aims to harness the full potential of podcasts to advance science communication and education, ultimately contributing to research progress.
Laboratory Animal Science Podcasts
Several other podcasts related explicitly to the laboratory animal science community are currently available, and we encourage you to subscribe and listen. Below, we highlight a few examples:
GetReal! With Dr. Cindy Buckmaster
A podcast hosted by Dr. Cindy Buckmaster and the National Animal Interest Alliance (NAIA) dedicated to open discussion about animal research: the good, the bad, and the ugly.1 Cindy explores the deep truths, so we can make compassionate choices for people and animals to shape our medical future… together. Dr. Buckmaster holds a PhD in Neurobiology and Behavior and has worked in research and laboratory animal science for nearly 30 years. Cindy’s involvement in the lab animal community spans various educational, advocacy, and public outreach organizations.
Gettin’ Fishy With It Podcast
A podcast created by three friends who met while working with zebrafish in biomedical research and became involved with the Zebrafish Husbandry Association.2 They are passionate about research and elevating the zebrafish as a model organism.
Amber Park Chiodini, an IACUC Analyst at Northwestern University, produced and hosted this podcast. Josh Barber, Senior Manager of Aquatic and Reptilian Life at Columbia University, and Christine Archer, Zebrafish Facility Coordinator at the University of Colorado Anshutz Medical Campus, also serve as hosts.
Lab Rat Chat
A podcast dedicated to providing an accurate and alternate narrative to the public regarding the necessity of humane and ethical animal research.7 Lab Rat Chat has been made possible through the Michael D. Hayre Fellowship in Public Outreach, sponsored by the biomedical research advocacy group Americans for Medical
From left to right: Christine Archer, Amber Park Chiodini, and Josh Barber
Progress. Previous AMP Hayre Fellow Dr. Jeff Marshall, a small animal veterinarian and practice owner, created Lab Rat Chat. In each episode of the podcast, Jeff and his cohost, Danielle Dady, Senior Research Compliance Coordinator at Old Dominion University, examine the importance and applicability of animal research to both veterinary and human medicine. The podcast features easy-to-understand, engaging conversations with various guests, including veterinarians, animal care and welfare specialists, and researchers.
The Future of Podcasts in Laboratory Animal Science
Looking ahead, the role of podcasts within our industry will likely continue growing. Advances in technology and increasing acceptance of digital media will further integrate podcasts into the fabric of professional development and education. Specifically, the rise of video and interactive podcast formats promises to make these resources more engaging and informative. These technologies can provide a new dimension of understanding that goes beyond traditional audio content.9
Emerging topics such as the integration of artificial intelligence in laboratory settings, advances in non-invasive research techniques, and the ongoing evolution of ethical standards in animal research will provide rich material for future podcast episodes. As the field of laboratory animal science continues to evolve, podcasts will remain a vital medium for sharing knowledge, fostering community, and driving progress.
Conclusion
Podcasts have securely found their place in laboratory animal science. These audio programs have made staying updated with the latest research, discussing ethical considerations, and receiving professional education and training more accessible than ever. Podcasts have also been crucial in building and strengthening the laboratory animal science community. Podcasts foster a sense of connection and shared purpose among listeners by featuring voices from various sectors of the field. They offer a platform for professionals to share their experiences, challenges, and successes, creating a more diverse, collaborative, and supportive environment.
This article highlighted the history and impact of podcasts in laboratory animal science, shedding light on critical developments and contributions to the community. If you haven’t done so already, we encourage you to listen to one of these podcasts to stay informed, connected, and inspired.
REFERENCES:
1. Get Real Podcast. [Internet]. [Cited 28 May 2024]. Available at: https://www.getreal.naiaonline.org/
2. Getting’ Fishy With It Podcast. [Internet]. [Cited 28 May 2024]. Available at: https://gettingfishypod.substack.com/
3. Hammersley B. [Internet]. 2004. Audible Revolution. The Guardian. [Cited 28 May 2024]. Available at: https://www. theguardian.com/media/2004/feb/12/broadcasting.digitalmedia
4. Ketelhut DJ, Niemi SM. 2007. Emerging technologies in education and training: applications for the laboratory animal science community. ILAR J. 48(2):163-9.
5. Kiernan MA, Mitchell BG, Russo PL. 2023. [Internet]. The power of podcasts: Exploring the endless possibilities of audio education and information in medicine, healthcare epidemiology, and antimicrobial stewardship. Antimicrob Steward Health Epidemiol. [Cited 28 May 2024]. Available at: https://www. ncbi.nlm.nih.gov/pmc/articles/PMC10265733/
6. MacKenzie LE. 2019. Science podcasts: analysis of global production and output from 2004 to 2018. R Soc Open Sci. Jan 9;6(1):180932.
7. Lab Rat Chat Podcast. [Internet]. [Cited 28 May 2024]. Available at: https://www.amprogress.org/raising-voices/lab-ratchat/
8. Picardi I, Regina S. (2008). [Internet]. Science via podcast JCOM 7(02). [Cited 28 May 2024]. Available at: https:// doi.org/10.22323/2.07020305
9. Quintana D, James S, Heathers AJ. 2021. How Podcasts Can Benefit Scientific Communities. Trends in Cognitive Sciences. 25(1): 3-5.
10. The LASt Word Podcast. [Internet]. [Cited 28 May 2024]. Available at: https://www.aalas.org/education/educational-resources/the-last-word-an-aalas-podcast
From left to right: Dr. Jeff Marshall and Danielle Dady.
Small Animal Research Solutions for:
Low-Flow Anesthesia
Physiological Monitoring
Noninvasive Blood Pressure
Ventilators
Animal Warming
Surgical Platforms
INSIDE the IACUC
One of my favorite things about serving as a Co-Editor of this column on regulatory-related subjects is having the freedom to select topics that are timely and relevant to my own circumstances. Recently, the topic of alternate members appointed to the IACUC was raised within our veterinary team; while there was universal support for the process, there was no consensus or full comprehension about how best to use alternates on the committee and when alternates are not allowed.
Membership on the IACUC, in fulfilling specific roles (e.g., non-scientist, scientist, non-affiliated roles) and with the inclusion of subject matter experts, is critically important to adhere to federal regulations. Also, a quorum of committee members is essential to conduct voting and business practices for animal care programs. Research programs rely upon the IACUC and administrative team to facilitate review and approvals, provide compliance education and support, and systematically apply the 3Rs approach to support animal welfare.
Alternate members to the IACUC are supported both by OLAW and USDA/ APHIS, and we appreciate efforts from colleagues in both areas for their review and aid with this column. We hope that the following information will provide the most current and clear direction on the use of this resource to the benefit of IACUCs across the country.
Corresponding contact: fclaire@upenn.edu
Stacy Pritt, DVM, MS, MBA, CPIA, CHRC, DACAW is the Associate Vice President of Research Support and Regulatory Management and Assistant Professor in Psychiatry at the University of Texas Southwestern Medical Center in Dallas, TX.
F. Claire Hankenson, DVM, MS, DACLAM, is the Associate Vice Provost for Research and Attending Veterinarian and Executive Director, University Laboratory Animal Resources, at the University of Pennsylvania in Philadelphia, PA.
No Need to Puzzle: Resolving Confusion Regarding the Alternate IACUC Member
By Jeffrey Frankel, VMD and Imani Nicolis, DVM
Introduction
Alternate members of the Institutional Animal Care and Use Committee (IACUC), commonly referred to as ‘alternates,’ serve as an important resource to ensure the fulfillment of committee responsibilities. However, utilizing this resource requires a careful review of the regulations to ensure alternate members are aware of their responsibilities and the expectations of their roles. In 2001, the NIH Office of Extramural Research released “Guidance Regarding Administrative IACUC Issues and Efforts to Reduce Regulatory Burden”, which served as the original guidance on the use of alternates.2 An updated version of this document was most recently published in 2011.3 Despite federal guidance, approaches to committee involvement of alternate members still serves as a cause of confusion at times. In this primer on the topic, questions like: “How should alternates be appointed?”, “Who can be appointed as an alternate for whom?”, “How can alternates be involved in official IACUC business?” and related items will be addressed.
How should alternates be appointed?
Neither the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals nor the United States Department of Agriculture (USDA) Animal Welfare Act and Regulations (AWAR) contain explicit language regarding alternate IACUC members; however, both OLAW and USDA permit their appointment and use under specific circumstances.1,3,6 All IACUC members including alternates must be appointed by the CEO, who may also serve as the Institutional Of-
ficial (IO), or their designee.6 Although the PHS Policy and USDA AWAR do not include language on how IACUC member appointments must be made, as of April 2024, institutions are guided to appoint IACUC members and alternate members in writing based on discussion with OLAW.3 Alternates must meet the specific membership requirements for which they are qualified, and they must fulfill all membership requirements held by the regular member for whom they are alternating.3 It is acceptable for an individual to be appointed as an alternate for more than one regular member, but an alternate may not represent more than one IACUC member at any one time.3 Given these parameters, an individual may be appointed as an alternate IACUC member by membership role (e.g., scientist, veterinarian, non-scientist, non-affiliated) and serve in place of any appointed regular member with that role when the regular member is unavailable, and it is also acceptable for an individual to be appointed as the alternate IACUC member for one or more regular IACUC member(s).3 One membership role or one regular member may have multiple appointed alternates.3 For example, regular members Adams, Brown, and Campbell all serve in non-scientist roles. Alternate appointees Murphy and Newman meet the appropriate qualifications and may be appointed as alternate non-scientist IACUC members and serve as alternates for any of the three non-scientist members. Their institution might also appoint Murphy and Newman as specific alternates for Adams and Brown, respectively, as non-scientist members. Further, if Murphy or Newman are also non-affiliated with the institution, they
may be appointed as alternate non-affiliated IACUC members and serve as alternates for any regular members filling that role as well.
As with the appointment of any regular IACUC member, alternates must be provided with appropriate training about committee responsibilities and the governance of animal research to best fulfill their IACUC responsibilities, which may include at minimum: the ability to vote at convened meetings of the committee, review of proposed IACUC activities, and participation in semi-annual facility inspections.3
When may alternates vote at a convened meeting of the IACUC?
Alternate members are permitted and encouraged to attend IACUC meetings and other relevant committee activities even when the regular member is present. However, the regular member and their appointed alternate are not permitted to simultaneously contribute to the meeting’s quorum nor both act in an official manner at a convened meeting.3 To be clear, an appointed alternate can only vote when the regular member is not in attendance or if the regular member has recused themself due to a perceived conflict of interest.3
If a regular member is unavailable and the alternate steps in during a convened meeting, it is a helpful practice for the IACUC Chair or IACUC administrator to announce this change. The alternate member should vote their conscience and not attempt to represent the position of the regular mem-
ber for whom they serve. Further, even though one alternate may be appointed to serve for multiple regular members, a single alternate cannot represent more than one member at any one time.2 Therefore, Murphy may not represent and vote in place of both Adams and Brown in the same meeting.
When may an alternate request FCR? When
may an alternate perform DMR?
Before review, each IACUC member must be provided a list and description of activities to be reviewed.1,6 Any member may request a full-committee review (FCR) during a timeframe specified by the IACUC, after which the Chair will assign at least one member, qualified to conduct the review, to perform a designated member review (DMR) if FCR is not requested.1,6 Should an alternate request FCR or perform DMR while the regular member is available, this would be inconsistent with OLAW guidance and would represent a reportable noncompliance event per OLAW.3 The IACUC may also choose to utilize a “silent assent” methodology, where the lack of response to communication regarding activities to be reviewed indicates agreement with the decision to proceed with DMR. This method requires clear communication between IACUC members to ensure all have the opportunity to call for FCR in the specified timeframe.6
Due to the necessity of communication among IACUC members, many institutions rely on electronic methods to provide the list of proposed activities to members. However, if
a regular member does not read and respond to an email, this does not constitute true unavailability; therefore, it is difficult to ascertain when would be appropriate for an alternate to review such proposals and potentially call for FCR. Institutions can navigate this ambiguity by requesting regular members provide IACUC administrative staff advanced notice of when they will be unavailable so that alternates can be notified explicitly that they are being asked to step in. This mitigates the risk of alternates calling for FCR or being assigned to DMR at the same time their regular member could have done so. Of importance, allowing a regular member to request an alternate to review protocols in their place due to heavy workload rather than true unavailability does not meet the intent of OLAW’s guidance on the role of an alternate
May alternates participate in semi-annual facility inspections (SAFIs) and semi-annual program review?
Both the PHS Policy and AWAR require all animal areas to be inspected at least once every six months.1,6 For areas involving work with AWA-regulated species, at least two committee members are required to perform the facility inspections and the program review.1,6 For programs that do not involve AWA-regulated species, these duties may involve as few as one trained and qualified individual—who may or may not be an appointed IACUC member.4,5
In either scenario, supplementary ad hoc individuals and consultants are often encouraged to participate; therefore, alternate members may take part in this ad hoc capacity, even if they are not filling in for a regular member. Similar to a convened meeting, alternates may only perform official IACUC duties (e.g. semiannual inspection, contribution to quorum) if the regular member is unavailable 6 If the regular member indicates that they are unavailable for a certain day or time, the IACUC administrator can call on the appointed alternate. If the regular member marks that they can participate and are available, even if both regular and alternate members are not performing an inspection at the same time, the alternate may not be utilized. For example, in preparation for an upcoming SAFI, if regular member Adams is available to participate on Monday at 9:00 am, their alternate Murphy may not be called upon to conduct an inspection at that time, even if both Adams and Murphy are not performing the inspection simultaneously. The alternate’s role during SAFIs is not to decrease regulatory burden on the regular member, but instead to serve if the regular member is truly unavailable or has a conflict of interest.
Determining availability can be complicated at large institutions with an abundance of activities and animal areas that require inspection. Federal regulations do not provide explicit guidance regarding the definition of unavailability in the context of these official IACUC duties. At our current institution, with a SAFI spanning six weeks with one-to-three inspections held per day, each inspection session is treated as an individual event. Therefore, if a regular member indicates that they are unavailable for a particular scheduled time, the alternate may be appointed in their place, while a regular
member would still be able to complete inspections on other days. Other institutions may conservatively define the entire SAFI schedule as a single event, regardless of whether several visits are scheduled to complete the review; in this case, the regular member must be unavailable for all inspections in order for the alternate to perform duties. These are key nuances that will require clarification at the individual institutional level. Similar to scheduling a SAFI, to conduct a semi-annual program review, the regular member needs to indicate clear unavailability for the alternate to step in. Regardless of how an institution conducts these two important tasks, it is required by the PHS Policy and USDA AWAR that no IACUC member be involuntarily excluded from the semiannual inspections or program review and that the IACUC remains responsible for the evaluation and report to the IO.1,6
Conclusion
The role of alternates in the animal care program can be incredibly beneficial to the conduct of official IACUC business. Their involvement is primarily to replace an unavailable regular committee member. In some settings, alternates may not be considered to share in the administrative burden of IACUC efforts; however, this does not meet with the spirit of the regulations. If increasing workload, missed deadlines, and member unavailability are recurrent issues among the institution’s IACUC membership, the recommendation would be for more regular members to be appointed rather than over reliance on alternates to meet the demands of the committee. Consideration of appointing alternate IACUC members especially for membership roles that are traditionally challenging to fill, such as non-affiliated and nonscientist categories, can further serve to ensure a duly-constituted IACUC is in place should a primary member become unavailable to fulfill their role. We hope that summarizing these expectations surrounding IACUC alternate members will aid institutions in compliance with the regulations and provide effective and efficient oversight of their programs.
Jeffrey Frankel, VMD and Imani Nicolis, DVM are resident veterinarians in the University Laboratory Animal Resources at the University of Pennsylvania in Philadelphia, PA.
Acknowledgments:
The authors wish to thank the helpful input and consultation with the following subject matter experts:
Jennifer Davis, DVM, DACLAM, CPIA, Director of the Office of Animal Welfare at the University of Pennsylvania; Louis DiVincenti, DVM, MS, DACLAM, DACAW, Senior Veterinary Medical Officer, USDA-APHIS;
Neera Gopee, DVM, PhD, DACLAM, DABT, Associate Director for Animal Welfare Policy, OLAW;
2. NIH Office of Laboratory Animal Welfare. 2001. NOTOD-01-017 “Guidance Regarding Administrative IACUC Issues and Efforts to Reduce Regulatory Burden”. [Internet.] Available at: https://grants.nih.gov/grants/guide/notice-files/NOTOD-01-017.html
3. NIH Office of Laboratory Animal Welfare. 2011. NOTOD-11-053 “Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates”. [Internet.] Available at: https://grants.nih.gov/grants/ guide/notice-files/NOT-OD-11-053.html
4. NIH Office of Laboratory Animal Welfare. 2024. NOTOD-24-075 “Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities”. [Internet.] Available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-075. html
5. NIH Office of Laboratory Animal Welfare. 2024. NOTOD-24-076 “Guidance on Flexibilities for Conducting Semiannual Program Review”. [Internet.] Available at: https://grants. nih.gov/grants/guide/notice-files/NOT-OD-24-076.html
6. Public Health Service Policy on Humane Care and Use of Laboratory Animals. 2015. [Internet.] Available at: https:// grants.nih.gov/grants/olaw/references/phspolicylabanimals.pdf
Medication Storage, Expiration, Beyond-Use, and In-Use Dating
By Jonathan Decker, BS, LATG and Patrick Lester, DVM, MS, BCPS, DACLAM
Principal Investigators, research personnel, veterinarians, and Institutional Animal Care and Use Committee (IACUC) members must navigate and follow guidelines, laws, regulations, and best practices regarding proper use and storage periods for pharmaceutical products used in laboratory research. The goal of this article is to review various laws, regulations and guidance documents that are currently available and used in human and veterinary healthcare settings. Depending upon scope, this may apply or could be used for additional guidance in a laboratory research setting.
The Animal Use and Drug Act of 1994 (AMDUCA) granted veterinarians the ability to utilize medications in an extra-label fashion or in a manner that deviates from the approved labeling.2
This is exceedingly important, as there are few Food and Drug Administration (FDA) approved medications specifically labeled or manufactured at concentrations to facilitate their use in common laboratory animal species. Although medications can be used in an extra-label fashion, adherence to manufacturer in-use and expiration dates must be followed to maintain regulatory compliance with federal and state guidelines.
The Minor Use Act of 2004, created additional pathways to market FDA approved medications for minor species such as ornamental fish, sheep, rodents, zoo animals, or animals other than humans that are not considered a major species (e.g., dogs, cats, horses, cattle, pigs, turkeys, and chickens). The category of indexed drugs was included within the act to allow for development of drugs for minor species such as laboratory rodents. The indexed pathway requires an expert panel to review available safety and efficacy data as part of the application to the FDA, which also approves product labeling and manufacturer criteria that must adhere to current good manufacturing practices (cGMP). Current indexed medications for laboratory animal species include Ethiqa XR® (rodents, ferrets and non-human primates) and Alfaxalone® (ferrets).
Pharmaceutical compounding may be performed by a practitioner or pharmacist at a state-licensed pharmacy or outsourcing facility. Such practices or facilities are generally regulated by their state board of pharmacy, state board of medicine, and/or FDA depending upon scope of practice or if manufacturing under current good manufacturing practice (cGMP) regulations. Under section 503a of the Food Drug and Cosmetic Act, state-licensed pharmacies are exempt from cGMP requirements and are regulated by each individual state. State pharmacy boards and accreditation groups such as the Pharmacy Compounding Accreditation Board (PCAB) rely on United States Pharmacopeia (USP) chapters for guidance or accreditation standards. USP chapters less than 1000 such
as USP <797> Pharmaceutical Compounding-Sterile Preparations9, USP <795> Pharmaceutical Compounding – Nonsterile Preparations8, and USP <800> Hazardous Drugs – Handling in Healthcare Settings7 are enforceable, yet chapters greater than 1000 are utilized for pharmaceutical informational purposes. To maximize probability of sterility and stability, USP chapter <797> utilizes the concept of beyond use dating to describe optimal storage durations and administration times at various temperatures when prepared under a variety of aseptic conditions (e.g., clean surface, segregated compounding room, or aseptic facility with particle monitoring). USP <795> also uses beyond-use dating to ensure stability especially for oral products containing water. The Drug Quality and Security Act (DQSA) of 2013 created the option for pharmacies to register as outsourcing facilities with the FDA as a manufacturer if specific criteria are met such as FDA inspections, product labeling requirements, and reporting of adverse events. The DQSA applies to manufacturing of human pharmaceuticals to address drug shortages, yet several outsourcing facilities are now providing veterinary drug options. The benefit of outsourcing facilities is their strict adherence to cGMP regulations and FDA oversight, which requires strict testing and validation to determine product storage expiration dates similar to FDA approved medications. An in-depth review of pharmaceutical compounding is beyond the scope of this article; the FDA and American Veterinary Medical Association offer detailed information.1,3,4
USP is an independent organization that sets professional standards for pharmaceutical compounding and monographs indicating quality expectations for pharmaceutical products. USP chapters regarding pharmaceutical compounding are generally enforced by state and federal agencies or as a requirement for healthcare accreditation. USP chapters such as <797> and <795> describe detailed guidelines and standards
for training, preparing, facility design, and environmental monitoring. These chapters describe the concept of beyond-use dating which is defined as the time and date that a compounded preparation must not be used, stored, or transported. Beyond-use dating differs from a manufacturer expiration date as expiration dates are assigned by the manufacturer based upon results from strict analytical testing for chemical and physical stability via stability-indicating methodology, sterility, and package integrity specific to the container and stated exposure conditions for light and temperature. A stability-indicating method indicates that analytical methods were utilized to ensure separation of degradation products from the active pharmaceutical ingredients to minimize interference. This usually requires the testing formulation to be subjected to force degradation via acid or base hydrolysis, oxidation, humidity, UV exposure, or heat as outlined in USP <1225> Validation of Compendial Methods.
USP describes sterile compounding as “combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.” Such actions do not include mixing or reconstituting as described in a manufactured product’s approved labeling or supplemental material and when used for a single patient or herd. Compounding differs from manufacturing in that it is patient or “herd” specific and specific to a practitioner’s instruction or order. As a result, the rigorous chemical and physical stability, sterility, and vial integrity studies performed to best determine an accurate expiration date is generally not available or comparable to FDA approved medications manufactured under cGMP regulations. Compounded preparations must state a conservative beyond-use date based upon the risk of compromised sterility and chemi-
pounded sterile preparations made in an aseptic clean room facility with strict microbiological monitoring using FDA approved sterile products and followed by post-batch sterility testing will have a longer beyond-use date (e.g., 30 days room temperature) compared to a compounded preparation that is prepared on a benchtop for immediate use (e.g., < 4 hours). Standard beyond-use dates per environmental control category are stated within USP chapters <795> and <797> and generally can only be extended under specific conditions pending results from strict sterility, stability-indicating analytical methods, and particle matter assessment when applicable. USP chapters were designed to apply to everyone who prepares and all places including human and veterinary practice sites where compounded preparations may be prepared. Beyond-use dating based on USP chapters may have limited applicability in most laboratory research facilities unless such institutions have the infrastructure to support such activities as outlined in the corresponding USP chapters. In addition, enforcement of such guidelines including beyond-use dating is dependent upon institutional, state, and/or federal regulations and thus may vary by location or institutional focus. However, research institutions may utilize USP compounding chapters as guidance for determination of institution specific and/or IACUC approved beyond-use dating to best assist researchers utilizing test articles or diluted medications per IACUC approved protocols. Alternatively, compounded medications may be acquired from a compounding pharmacy or an outsourcing facility and generally will have longer beyond-use dating periods due to strict compliance with USP chapters or cGMP. Compounded controlled substances may be restricted in states that prohibit the acquisition of controlled substances via prescription for
office use to be used in multiple patients. In this instance, controlled substance formulations may be acquired from an outsourcing facility (503b) that may also be registered with the Drug Enforcement Administration (DEA) as a manufacturer to facilitate transfer to a DEA registered researcher, practitioner, or pharmacy.
Multi-dose products or veterinary FDA approved pharmaceuticals labeled for use in multiple animals are also subject to in-use dating in addition to the manufacturer’s expiration date. Multi-dose pharmaceuticals labeled for human use have a maximum in-use date of 28 days once the vial is first punctured per USP <51> Antimicrobial Effectiveness Testing6 guidelines and a volume limit of 30 mL. Contrary to human multi-dose container volume limitations, there is no volume limit for multi-dose veterinary drug products. As large volume multi-dose products are labeled for use in multiple animals, such products are subject to in-use dating and maximum number of puncture guidelines as determined by the appropriate FDA Center for Veterinary Medicine Target Animal Division and subsequent stability-indicating and sterility assay results. For additional information, readers are encouraged to review the FDA Guidance for Industry #242, In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.5 In-use dating refers to the length of time a product may be utilized once the vial or container is punctured and stored at manufacturer recommended storage conditions. In-use dating may also be dependent on maximum number of punctures necessitating disposal of a product even if within the recommended in-use storage date. Maximum number of container punctures is determined by
evaluating the range of needle size and drug volumes that will be used when removing or administering a drug product for the various species for which the product is labeled. For example, an antibiotic for use in cattle and swine may use different volumes to acquire the recommended mg/kg dose and different needle sizes if used for intramuscular administration. The difference in needle gauges used between species of different size may have variances in multidose vial elastomeric stopper integrity and variances in volume may determine maximum number of doses that can be removed over time. As a result, both needle gauge and dosing volume are used to make in-use recommendations in addition to stability-indicating assays, sterility, enclosure integrity, or other testing as required for manufacturing and FDA compliance. In-use dates and maximum number of puncture information may be included on the vial label, container package, or listed in the package insert. It is advised to thoroughly review all package labeling to ensure if an in-use date or maximum number of punctures is indicated. Multi-dose vials or containers can be labeled to indicate in-use dating or maximum number of punctures. We have developed a list for in-use dating and maximum number of punctures for FDA approved and indexed products that can be found at https://animalcare.umich.edu/in-use-date-chart . Single dose vials or products without in-use dating should be used for a single use, single patient, or batched to be used on multiple animals at same time when possible. Alternatively, single dose medications could be repackaged with beyond use dating per USP chapters when applicable or via institutional specific storage and use guidelines with veterinary and IACUC oversight.
In summary, pharmaceutical products, compounded medications, and multi-dose vials are subject to multiple laws, regulations, and best practices regarding their beyond-use, in-use, and expiration periods which need to be monitored or have policies and procedures in place for optimal compliance. Utilizing products that exceed their beyond-use, in-use, or manufacture expiration date may lead to impacts on research data or animal welfare due to risk of contamination or sub-optimal pharmacotherapy.
Jonathan Decker is a Veterinary Student at The Ohio State University in Columbus, OH.
Patrick Lester, DVM, MS, BCPS, DACLAM is a Clinical Professor in the Unit for Laboratory Animal Medicine at University of Michigan in Ann Arbor, MI.
REFERENCES:
1. American Veterinary Medical Association. [Internet]. 2024. Compounding. [Cited 16 February 2024]. Available at: https:// www.avma.org/resources-tools/animal-health-and-welfare/animal-health/compounding
2. United States Code of Federal Regulations. 2024. 21 CFR § 530.3.
3. United States Food & Drug Administration. [Internet]. 2024. Compounding and the FDA: Questions and Answers. [Cited 16 February 2024]. Available at: https://www.fda.gov/ drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
4. United States Food & Drug Administration, Center for Veterinary Medicine. [Internet]. 2024. Animal Drug Compounding. [Cited 16 February 2024]. Available at: https://www.fda.gov/ animal-veterinary/unapproved-animal-drugs/animal-drug-compounding
5. United States Food & Drug Administration, Center for Veterinary Medicine. [Internet]. 2024. Guidance for Industry: In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products. [Cited 16 February 2024]. Available at: https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/cvm-gfi-242-use-stability-studies-and-associated-labeling-statements-multiple-dose-injectable-animal
6. United States Pharmacopeia National Formulary (USP-NF). [Internet]. 2024. Antimicrobial Effectiveness Testing, <51>. [Cited 9 January 2024]. Available at: https://www.uspnf.com
7. United States Pharmacopeia National Formulary (USP-NF). [Internet]. 2024. United States Pharmacopeia General Chapter: USP. Hazardous Drugs – Handling in Healthcare Settings, <800>. [Cited 9 January 2024]. Available at: https://www. uspnf.com
8. United States Pharmacopeia National Formulary (USP-NF). [Internet]. 2024. Pharmaceutical Compounding-Nonsterile Preparations, <795>. [Cited 9 January 2024]. Available at: https://www.uspnf.com
9. United States Pharmacopeia National Formulary (USP-NF). [Internet]. 2024. General Chapter: Pharmaceutical Compounding-Sterile Preparations, <797>. [Cited 9 January 2024]. Available at: https://www.uspnf.com
Having served the research community for more than 50 years, we are well known for creating products that meet the unique needs of research animals.
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Developing Quality Workforce Training: Breaking with Traditional Scoring
By Kelly LaRue Brackett, PhD
When thinking about grades, most of us naturally think of the numerical scoring system: a scale of 0-100% correct. While two trainees could have equivalent numerical scores, it is unlikely that they got the same questions correct (Figure 1A). Identifying which types of questions they got correct could be more informative and demonstrate each trainee’s unique strengths and weaknesses.
Developing Standards
An alternative to the numerical system is standards-based grading (SBG). Put simply, a standard is an expectation for learning. You can use your course learning goals, broad statements that outline your expectations for different content elements or skills, as a framework for creating standards.2 A standard is scored on a 1-4 scale. 1 indicates Beginning: does not retain knowledge or skill and needs substantial support. 2 is Developing: retains some knowledge or skill but needs additional support. 3 is Proficient: retains sufficient knowledge or skill and does not need additional support. 4 is Mastery: demonstrates advanced knowledge or skills.
Each level of a standard represents increasing cognitive abilities on that topic. An easy tool called Blooms Taxonomy can assist you in setting cognitive levels.3
Table 1 uses the Sanitation, Disease Prevention and Control topic from the ALAT Certification Exam as an example of a standard. For Animal Care Technicians, I typically set the ability to apply concepts to their work as the Level 3 proficiency expectation. The statement can then be diminished to demonstrate Level 2 and 1 and enhanced to demonstrate Level 4. Once you have memorized terminology and their definitions (Level 2), then you can apply that terminology to a process (Level 3). Once you have knowledge of multiple processes, then you can analyze purpose, context, and relationships between multiple concepts (Level 4). It is highly unlikely that a student who is answering Level 4 questions correctly is getting Level 2 questions wrong.
Additionally, not all standards are made equal. Outlining your learning expectations for a course may reveal
Figure 1. Standards-Based Grading (SBG) provides more information on trainee performance. Example of trainee multiple choice exams scored using A) numerical grading versus the same exams scored using B) SBG. Alignment of exam questions to standards are color coded. Incorrect answers are marked with a red X.
Standard Level
1 - Beginning I do not understand sanitation, disease prevention and control
2 - Developing I can define features of sanitation, disease prevention and control.
Example Questions
Questions should be written for Level 2 and above.
Which of the following is a disinfectant?
Bleach
Soap
Hot water
Ethylene Oxide
3 - Proficient I can explain processes used in sanitation, disease prevention and control.
4 - Mastery I can connect concepts and context in the need for sanitation, disease prevention and control.
What processes does “direct sentinel testing” involve?
Putting soiled bedding from colony animals into the sentinel cages
Removing colony animals for testing
Placing sentinel animals into cages with colony animals
None of the above
Why should quarantine rooms be under negative pressure?
To prevent microorganisms from entering the room and infecting new animals
To prevent microorganisms from getting out of the room and infecting colony animals
To provide a quiet space for acclimation
New animals have unknown health status
skills or knowledge that are of the utmost importance. The topics of Sanitation, Disease Prevention and Control (Figure 1B, Standard 1) and Husbandry Practices (Figure 1B, Standard 2) occupy as much as 36% of the exam.1 All other 14 topics, including Formulas and Calculations (Figure 1B, Standard 3) carry minor weight. In my courses, non-critical standards can vary in their SBG scores (as long as the average is 3.0), whereas achieving a 3.0 or above in all critical standards are required to pass the course. This practice is what really sets SBG apart from numerical scoring, which inherently assumes that all topics and questions are of equivalent importance.
Design, Alignment, and Scoring
When designing your exam, make sure there are multiple questions that apply to each standard being tested to give trainees ample opportunity to demonstrate their knowledge. It is also advisable to have several questions that apply to each level of your standard. Without a handful of Level 4 questions, you cannot be confident that the trainee displays advanced thinking.
SBG can be done with any type of exam, from multiple choice to open ended questions and it does not require that questions of the same topic be lumped together or that levels progress in order. You will simply need to align each question in your assessment to the appropriate standard. It is also possible for a question to address multiple standards at once (this is the ultimate type of Level 4 question). To do this, evaluate each ques-
tion for what knowledge or skills your learners should use to arrive at the answer. In the example provided in Figure 1B, the test standards and their aligned questions are color coded. This process of alignment will also help you to identify and eliminate any extraneous questions that do not apply to an established standard. By taking the time to align each question, you will develop a map for your grading process.
SBG requires a slightly more complex scoring method than numerical grading. First, grade the entire exam for correctness. Then, develop a score for each standard by evaluating all the questions that apply to that standard collectively. For example, in Figure 1B questions 11, 14, 16, 18, and 19 apply to Standard 2. Are all questions that apply to the standard correct, including the Level 4 questions? Score a 4 (achieved by Trainee 1 in Figure 1B). Are just the Level 4 challenging questions incorrect? Score a 3 (achieved by Trainee 2 in Figure 1B). Are there several incorrect Level 3 questions or gaps in their knowledge? Score a 2. Are questions blank or is almost everything wrong? Score a 1. Note that scoring 1s may indicate that a trainee needs additional assistance. It is always worth a conversation to explore and encourage them to pursue learning accommodations.2
Additionally, answers within questions can represent different Levels of ability. In Table 1, the Level 4 example question, “Why should quarantine rooms be under negative pressure?”, requires knowledge of what kinds of animals are in a quarantine room, what negative pressure
Table 1. Example of leveling a standard within a rubric.
means, and the connection between the two. Out of the four options, it has a best answer, b. To prevent microorganisms from getting out of the room and infecting colony animals (Level 4). It also has a similar distractor that will attract those who forget which direction the air flows in a negative pressure environment, a. To prevent microorganisms from entering the room and infecting new animals (Level 3). It has another option that reflects understanding of the purpose of quarantine but the inability to connect the concept of air pressure, d. New animals have unknown health status (Level 3). Then finally, it has a possible answer that demonstrates knowledge of the definition of a quarantine room, but lack of knowledge of the factor of animal health, c. To provide a quiet space for acclimation (Level 2).
Transparency
A rubric describes the expectations for each standard and its levels (Table 1). By providing a rubric to trainees, it allows them the opportunity to self-evaluate during their own studying or when exams are returned. By having a clear description of your expectations, they can know why they received a particular score, take responsibility for correcting their errors, and have a goalpost for leveling-up.4 One drawback of SBG is that it is somewhat subjective. However, defining the levels in a rubric can provide guidance in your scoring practices and help you be more objective. The rubric should be revised as you develop the boundaries of each standard and level over time.
A trainee’s pattern of correct and incorrect questions will bring to light which standard(s) the trainee is excelling in and struggling with, respectively. In the example provided in Figure 1B, Trainee 1 scored lowest in Standard 3 and highest in Standard 2. While Trainee 1’s numerical score is barely passing, SBG reveals that they can be confident in their knowledge when it comes to husbandry. Immediately upon distribution of test scores, the trainee has received personalized and informative feedback on their performance. They can then concentrate their efforts for improvement on the topics they struggle with and not waste time on the things that they already do well. It also guides instructors on where to focus their efforts and conversations with individual students. Personalization is one of the foundations of Adult Learning.2
This method of grading also provides transparency to management. Knowing the details of an individual’s performance can assist in promotion, hiring, and future training decisions. If an animal room supervisor is de-
ciding which trainee to involve a data collection project (all other factors being equal), the better choice is likely Trainee 2 who displays ability in numeracy and conversion (Figure 1B, Trainee 2, Standard 3).
Opportunity for Improvement
Another important characteristic of SBG is allowing trainees the opportunity to demonstrate improvement. Testing should not be the end game, but instead, viewed as instructional tool for learning and information retention5. Often my trainees come to me around the time of exams and explain the details of their lives that prevented them from studying. This doesn’t excuse them from taking the test, but as workforce instructors we should keep in mind that our trainees are adults with complex lives and responsibilities. Within my courses, all trainees are tested on each standard during two distinct exams. Only their best score is kept for each standard. Thus, trainees feel less pressure to perform by knowing they will have another chance for improvement. One important note is that my trainees will never see the same test question twice, which from my perspective is a truer assessment of learning than repeating the exact same test.
Additionally, because we are in a workforce setting, we are not beholden to semester-based schedules. Thus, anyone who doesn’t pass at the end of the course gets the opportunity to test one additional time on standards scored below proficiency. During this additional 6-month window, they can study at their own pace and meet with instructors one-on-one to prepare for their retest. This retesting exercise allows them the opportunity to improve on specific standards without having to repeat the entire class.
At The Jackson Laboratory, our internal Genetics course is a requirement for promotion. In the four years prior to SBG implementation, pass rates were 59%. During the four years of SBG practices, pass rates have improved to 83%. One of the major contributors is a steep decline in withdraw rates (27% to 6%). Failure is never inevitable; trainees can improve standards scores throughout the course and up until the last exam. Another reason is 86% of trainees that qualified for a post-course retest passed that exam, demonstrating that a vast majority of them are able learn from their mistakes with additional time and practice. By not outright failing trainees and forcing them to repeat the course, this has saved the organization nearly 650 hours of paid instructional time. It has facilitated a culture of learning and continuous improvement by mitigating the fear and risk of failure. Calculating out these two byproducts of SBG
implementation, pass rates would still be the same (54%). There are many different approaches and nuances to SBG, and how the concept is implemented matters. SBG has been slowly making its way into primary and secondary schools but has been met with backlash. There are complications with college admissions requirements, teacher bandwidth, subjectivity, and perspectives of achievement. In this article, I have highlighted several details of how I have chosen to carry out SBG in my organization. While I wish to provide you with practical examples of concept implementation, know that the decisions that I have made for my team and courses may not be appropriate for yours. I am simply encouraging a new perspective on grading and course performance that can be more informative to management, instructors, and trainees.
Thank you to Zoe Hsi, DVM, DACLAM, Clinical Veterinarian at The Jackson Laboratory, who offered quiz questions from her ALAT preparation course as examples (Table 1).
Kelly LaRue Brackett, Ph.D. is a Senior Manager of Curriculum and Learning Implementation at The Jackson Laboratory in Bar Harbor, ME. Kelly can be reached at kelly. brackett@jax.org.
REFERENCES
1. AALAS. [Internet]. 2020. Test Specification – ALAT. Available at: https://www.aalas.org/media/b7d23eca-e495-4698-b5c0-1f1b1da2efec/2xrRJw/CRT/Technician%20Certification/2020%20ALAT%20Content%20Outline-%20Website.pdf
2. Brackett KL. 2021. Developing Quality Workforce Training: Considerations for the Adult Learner. Laboratory Animal Science Professional Nov: 40–41.
4. Buckmiller T, Peters R, Kruse J. 2017. Questioning Points and Percentages: Standards-Based Grading (SBG) in Higher Education. College Teaching 65(4):151–157.
5. Roediger HL III, Bulter AC. (2011) The critical role of retrieval practice in long-term retention. Trends in Cognitive Science 15(1): 20–27.
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THE VRL ADVANTAGE
Getting to the Root of The Problem…How to Maximize Swine Environmental Enrichment Opportunities in the Laboratory Animal Setting
By Fernando De La Garza ALAT, Dr. Charles Tyler Long DVM, DACLAM, DABT, and Dr. Coralie Zegre Cannon DVM, DACLAM
Introduction
Swine rooting refers to the natural behavior of pigs to root or dig in soil with their snouts in search of food, roots, insects, and other edible items. This behavior is deeply ingrained in the natural instincts of swine and is an important part of their foraging and feeding activities. Given the significance of rooting, providing opportunities for swine to engage in this behavior is an important husbandry consideration. Whether through access to exercise hallways, toys, or other enrichment opportunities, allowing swine to root is an important aspect of promoting their overall welfare. These activities also decrease stress and lead to better research outcomes. It supports compliance with the USDA Animal Welfare Act1 and The Guide for the Care and Use of Laboratory Animals2 regulations and guidelines.
The Becton Dickinson (BD) Laboratory Animal Research Center of Excellence is committed to providing proactive and novel environmental enrichment and behavioral management opportunities to support animal welfare. All work described in the article has been approved by the BD IACUC. We work extensively with Yorkshire swine due to the research model requirements in approved IACUC protocols. The Yorkshire swine body weight range is between 30-100 kg, which helps to support human translation of medical device research and development. Our program also works with miniature swine when applicable. This publication will describe the environmental enrichment methodologies developed in our program to promote natural swine behaviors including rooting.
Materials and Methods
Rooting/Foraging Tubs (Tactile, Scent)
The program has focused on utilizing materials that are readily available. Rubbermaid® 50-gallon stock tanks are a versatile and practical way to provide environmental enrichment stimulation for all large animal models including swine and sheep. There are multiple applications to using stock tanks that will promote enrichment and behavior management in large animals, especially swine (Figures 1, 2, and 3). Rooting/Foraging tubs are one of the most preferred applications for swine to perform naturalistic instinctive behaviors.
Figure 2. Swine being raked to mimic scratching and to establish human-animal bonding.
1. Place rubber mat in the bottom of the stock tank to minimize slipping.
2. Pile rocks inside the stock tank to create the foraging area.
3. Spread hay or shavings to fill the tub.
4. Scatter scented treats or daily feed over the rocks/hay to encourage the pigs to explore, forage, and root.
5. Observe the swine as they interact with the rocks/hay, ensuring that they are doing so safely and without signs of stress. This allows veterinarians and technicians to conduct physical exams and perform behavioral assessments while the pigs play.
Puzzle Feeders
Swine puzzle feeders are designed to provide mental stimulation and enrichment for pigs by making them work for their food/treats, which will reduce boredom and encourage natural foraging behaviors. Here are a couple of ideas for DIY swine puzzle feeders that you can create for your pigs.
Materials Needed
• 2.5-gal Pan Feeder bowl (Tuff Stuff Products)
• Stainless steel chain (long enough to reach across the feed bowl)
• 2-3 Bio-Serv Jingle Balls™ (or any kind of ball with holes in it)
• Stainless steel carabiner clip
1. Drill 1 hole on each side of the plastic feed bowl. The holes should be large enough for the chain to slide through each.
2. String the chain through 3 Jingle Balls and out of each hole, securing with clips (Figure 4).
3. Ensure that the size of the enrichment device is appropriate for the size of pig using it, to prevent them from getting stuck or injured while utilizing it.
4. Fill bowl with daily ration or scented treats to prolong eating and prevent ingurgitation.
Figure 3. Rock rooting tub.
Figure 4. Large animal puzzle feeders.
Prang® Ice blocks (Taste, Scent)
Creating ice blocks for pig enrichment is a great way to provide entertainment and mental stimulation for pigs (Figure 5). Prang® (bio-serv) and Gatorade® ice blocks are an essential part of our enrichment program. Frozen blocks may be provided to animals during pre-anesthetic fasting periods to provide activity and distraction. It also ensures the swine are well hydrated and receiving electrolyte supplementation. Swine also receive Prang® popsicles immediately after arrival into the vivarium to connect a positive reward with their new environment. Here is a simple guide on how we create our ice blocks.
Materials needed:
• Silicone Molds for specific cube size, or ice cube trays
• 1 gallon pitcher
• Powdered Gatorade® or Prang®
• Certified Prang® for Good Laboratory Practices (GLP) studies
• Freezer Space
1. Choose appropriately sized ice tray or silicone mold that fits your needs and that can store in your freezer space.
2. Fill your pitcher with 1 gallon of water and 4 scoops of Gatorade® (280 g) or Prang® (120 g).
3. Pour liquid into mold (you can also drop in some pig-friendly fruits and vegetables in the ice block molds).
4. For added enrichment you can freeze chains or other small toys (KONGs®) in the ice blocks, ensuring the items are pig safe.
5. Place the molds in the freezer and let it freeze completely. This may take several hours or overnight depending on the size of mold.
6. Once the blocks are frozen solid, remove the container from the freezer. You can run warm water on the outside of the container to help release the ice blocks.
7. Place ice block in animal enclosure and monitor the pigs while they interact with it. Ensure they are safe and enjoying the enrichment.
Piggy Picasso (Taste, Scent)
Creating a Piggy Picasso can be a fun and rewarding activity and allows team members to bond with their animal heroes while also expressing their creativity (Figure 6). Here are some steps to guide you through the process.
Materials Needed:
• Canvas sheets
• Non-Toxic pet-safe paint (Shuttle Art Acrylic Paint)
1. Choose a canvas sheet of your choice, ensuring the canvas will fit into the resealable bag.
2. Select the colors of paint that you would like and pour them over the entire canvas.
3. Place a sheet of wax paper over the paint covering the entire canvas.
4. Insert the covered canvas into a plastic resealable bag.
5. Smear peanut butter over the entire bag, you can also crush up scented treats and sprinkle them onto the peanut butter for an added treat.
6. Place the bagged canvas in the pig enclosure or play area.
7. Feel free to sit with the animal and encourage the pig to interact with the painting.
8. Sprinkle additional treats to guide their movements and keep them engaged and inspired!
9. Once the pig has eaten all the peanut butter, remove the canvas from the bag.
10. Peel off the wax paper sheet from the canvas and reveal your masterpiece!
11. Let the paint dry completely before displaying or framing the artwork.
This activity is about having fun and creating a special memory and gratitude for your laboratory animal hero.
Figure 5. Frozen Prang® or Gatorade® blocks.
Raking (Tactile)
Pigs have natural behaviors related to scratching and grooming that are essential for their well-being and comfort. Scratching pigs with rakes can be a way to provide them with physical stimulation and relief from itching or discomfort (Figure 7).
Materials Needed:
• Handheld plastic or stainless-steel rake, able to sanitize. (Amazon: Garden Guru Stainless Steel Hand Rake Soil Tiller)
• Choose a rake with blunt or rounded tips rather than sharp or pointed tips to prevent injury to the pig skin.
1. Approach the pig calmly: pigs can be sensitive animals, so approach them calmly and gently when using the rake to scratch them. Let the pig sniff and investigate the rake before attempting to scratch them.
2. Start with light scratching: begin by gently scratching the pig’s back or sides with the rake to see how they respond. Pay attention to their body language to ensure they are comfortable and enjoying the scratching.
3. Avoid sensitive areas: be cautious around the pig’s head, ears, belly, and other sensitive areas.
4. Feeding, foraging, or rooting exercises are also great times to perform raking. Animal holding rooms may have Nepco Pine Shavings to further promote rooting opportunities.
Figure 6. One of our animal heroes making a unique Piggy Picasso!
Figure 7. Raking provides animal care staff time to bond with the patients.
Exercise Hallway
Our exercise hallway is designed to encourage our pigs to move around, explore and engage in natural behaviors like rooting and running. Such space may include obstacles, rooting/foraging opportunities, social enrichment, and wallowing in water, that help stimulate the pigs to exercise natural instinctive behaviors (Figure 8).
• Measures: 70’ x 6’ (450 sq ft).
• Swine have access to the exercise hallway twice a day during cage cleaning.
• Hallway is washed down daily after use and is sanitized every 14 days or as needed to ensure biosecurity and to decrease stress.
• Enrichment activities and post anesthetic recoveries may be performed in the hallway.
• Helps BD share the Laboratory Animal Research program with visitors to “Tell Our Story First” and build awareness.
Environmental Enrichment Kitchen and Enrichment Freezer
Our environmental enrichment kitchen is the designated area where enrichment items and activities are prepared, stored, and managed for our animal care program (Figures 9 and 10). The kitchen may also serve as a central location for planning, evaluating enrichment toys, and ensuring appropriate and engaging enrichment opportunities. Enrichment treats are often used to stimulate animals mentally and physically, providing them with opportunities for play and engagement. All our enrichment treats are labeled with a received date and expiration date (14 days after receive date).
Figure 8. Enrichment hallway.
Figure 9. Dedicated enrichment kitchen.
Figure 10. Enrichment freezer.
Discussion
The behavior management refinements have helped to develop a culture of care and welfare at BD. The swine patient models directly benefit from the dedicated program of animal welfare. Consistent communication of benefits are delivered to management to help grow awareness and support. Key benefits observed are enhanced animal care team health and satisfaction, decreased time associated with daily cleaning and patient preparation, positive perception by the institution regarding use of animals in biomedical research and strong engagement by the team dedicated to continuous improvement. Frequent updates to the IACUC have also helped to establish the program support and institutional engagement.
The environmental enrichment program directly enhances sensory stimulation for the swine patient models. The olfactory sensory system is stimulated using cinnamon and other treats in multiple rooting opportunities. The use of frozen Prang® and Gatorade® has helped to stimulate taste while ensuring patients are well hydrated and active while waiting for approved anesthetic events. The tactile sensation of rooting is also supported by a variety of these processes. The use of wood shavings in the animal's home cage supports rooting by hiding desirable food treats within bedding and also keeps the animals clean. In addition, the raking directly replicates the swine’s tactile need to scratch and desire to rub against items. Animal care staff can sign up for dedicated ‘raking time’ which serves a two-fold purpose--time for human enrichment and observation of animals in their home environment.
Vivarium space also provides the opportunity to use these approaches across singly housed and socially housed animals. Animal housing space can be manipulated to support the rooting tubs or Prang® popsicles. Animals on IACUC-approved protocols can still receive dedicated enrichment across cohorts within their home environment.
The dedicated program helps patients to quickly build caretaker trust which leads to better animal care oversight. During each allotted play session caretakers continuously monitor the swine to determine if they are engaged in the activity or if they prefer not to participate. If they show lack of interest in one activity, the caretakers engage them in another type of enrichment session and/or allow swine to opt out and return to their home cage environment. Activities and treats are rotated daily to provide variety and determine patient preferences. Eyes on the animals during raking or rooting observations leads to effective animal wellbeing assessments and veterinary care. It also enables the patient models to acclimate to their handlers more quickly, resulting in reduced stress because routines are
more predictable, and interactions are designed to be positive experiences. This allows the animals a sense of control over their home environment.
The Piggy Picasso projects have also helped BD build a program of openness, transparency, and mutual respect for laboratory animal research and our animal heroes the patient models. It helps build a sense of appreciation and value for research teams to have creative paintings to honor their laboratory animal heroes’ contributions. BD leadership has paintings displayed in their offices and in conference rooms which tells “Our Story First”. They also have been donated to the National American Association of Laboratory Animal Science (AALAS) meeting and auction!
In conclusion, providing swine patient models opportunities to display natural behaviors such as rooting and foraging behaviors directly contributes to their overall well-being and mental stimulation. In addition, providing enrichment drives creativity, which allows for low cost positive benefits for animals. As noted, these items are all readily available and can easily be used with single housed or socially housed research animals.
Fernando De La Garza ALAT is a Behavior Management/In Vivo Project Specialist, Veterinary Medical Services at Becton, Dickinson and Company (BD) in Research Triangle Park, NC.
Charles Tyler Long DVM, DACLAM, DABT is a Senior Staff Clinical Veterinarian at Becton, Dickinson and Company (BD) in Research Triangle Park, NC.
Coralie Zegre Cannon DVM, DACLAM is the Corporate Director, Veterinary Medicine and Attending Veterinarian at Becton, Dickinson and Company (BD) in Research Triangle Park, NC.
REFERENCES
1. Animal Welfare Act as Amended. 2008. 7 USC §2131–2156
2. Institute for Laboratory Animal Research. 2011. Guide for the care and use of laboratory animals, 8th ed. Washington (DC): National Academies Press.
ADDITIONAL REFERENCES
• De La Garza F, Cannon C. 2020. Piggy See Piggy Do: A Swine Training Program Enhances Animal Welfare and Research Efficiency. Laboratory Animal Science Professional March 2020:54-57.
• Wilkinson L, O’Malley C, Moreau E, Bryant T, Hutchinson B, Turner P. 2023. Using Stakeholder Focus Groups to Refine the Care of Pigs Used in Research. J Am Assoc Lab Anim Sci 62:123-130.
Evolving to a Macro-Environmentally Friendly, Bucketless Cleaning System
By Arrow Megginson, BS, RLATG
Introduction
While vivarium mopping tools have been stuck in the Stone Age, is it time for an evolution revolution in cleaning technology? Per “The Guide for the Care and Use of Laboratory Animals,” all areas of the laboratory animal facility should be regularly cleaned and disinfected. The cleaning and disinfection components used in laboratory animal research facilities should be made of durable materials that resist corrosion, withstand regular sanitation, and are assessed and replaced regularly. Effective monitoring of sanitation practices may include visual inspection and microbiologic monitoring.3
At the Midwestern University, (Glendale, Arizona) Animal Resources facility, the expensive and rapidly deteriorating conventional mop and bucket system was failing by nearly every metric per “The Guide” recommendations.3 After struggling to keep the equipment functioning without frequent costly replacements, we began to search for alternatives. In sourcing a possible replacement, we were not able to purchase all the available alternatives to the bucket mop system to perform a comprehensive comparison study due to budgetary constraints. Consequently, we performed a preliminary analysis of the available options and pre-selected the most likely successful alternative, which is the subject of this comparative study. We conceived a side-by-side evaluation study to compare the two systems over 12 weeks of normal vivarium use, to ensure that the alternative would yield similar if not superior results.
The Heavy Duty Microfiber Spray Mop System from Uline1 (spray mop1) features a fully integrated package (Figure 3); including a head with Velcro® for attaching a flat microfiber pad, a sprayer handle, and an 18-ounce reservoir bottle that dispenses the solution of your choice.1 Although a microfiber mop-head was included, alternative LavexTM 18” Hook & Loop Scrubbing Wet Mop Pads2 (mop-pad2) were purchased (Figure 4) which were advertised as ideal for heavy-duty
Figure 1. The conventional mopping system storage area.
Figure 2. Fiberglass mop handle and side gate with a string-style washable cotton/synthetic mop-head.
scrubbing, creating a net to trap and hold dirt particles.2 These also fit our existing broom and mop-head color-coding chart.
Tryptic Soy Agar Contact RODAC® Plates were used to take dirty samples before mopping as well as clean samples after mopping, the following morning in similar locations of each room.
For the study, a representative sample of four mouse (Mus musculus) rooms were selected. Two rooms continued using the conventional legacy mopping system, while the other two used the new spray mop.1 All four rooms were of the same size (140ft2), layout, caging type, and traffic flow, and were mopped twice weekly by the Animal Resource’s Technicians. The mopping pattern for the legacy mop system was a side-to-side motion across the room. The spray mop1 used a push-pull motion as the sprayer handle was pressed with every push motion, as well as the pad was presoaked by spraying a small puddle from a few sprays before mopping. Mopping started at the clean door and the technician worked backward to the dirty hallway door. RODAC® plates were collected after mopping to verify the sanitation effectiveness. At the beginning and end of the study on Tuesday morning before mopping, a plate from each room was taken from the middle of the room to verify
dirtiness. Clean samples were collected from just underneath the corner of the biosafety hood, closest to the clean side door, to be sure that foot traffic didn’t contaminate clean samples, as they were taken Wednesday mornings after mopping. Moppads2 were washed by machine after each use with Seventh Generation® Free and Clear Laundry Soap. This was an acceptable practice according to the manufacturer.2 Conventional mops continued to be sent through the rack washer per our standard practice with Alka-Det® HW. Both used their respective non-steam-generated hottest water settings that do not guarantee sanitization.
Results
Visible Cleanliness
Soon after beginning the project, it became clear that the rooms using the spray mop1/mop-pad2 were visibly cleaner. To confirm, before and after photos of the mop-heads were taken upon introducing the new mop system to a new room. The photos illustrate that mop-pads2 are empirically more effective at removing dirt from the textured epoxy floor.
Mop-pad2: New (Figure 4). After the first mopping (Figure 5). Mop-pad2 after 12 weeks of use (Figure 6).
RODAC® Samples
Colony counts from floors mopped with the spray mop1/moppads2 were in every sampling =/<38 CFU (Figure 7). (*except for 3 that tested with anomalous higher levels towards the end
Figure 3. The heavy duty microfiber spray mop system.
Figure 4. New mop pad.
Figure 5. Mop pad after first mopping.
Figure 6. Mop pad after 12 weeks of use.
(89.973)
Range 15.000250.000 2.000 - 55.000 2.000250.000
Table 1. Statistical test comparing means between mop heads.
of the study due to residual mop-pad2 staining and contamination). Colony counts for the conventional mops routinely exceeded 38 CFU and the majority were Too Numerous To Count (TNTC). Note: After 12 weeks of use the mop-pads2 became permanently stained with residual dirt particles due to how ineffective the conventional string mop-heads were at lifting dirt. This caused a spike in CFUs. Once they were replaced, CFUs came back down. After all rooms were swapped to the spray mop1/mop-pad2 all CFUs came down to =/<38 CFU, proving that the mop-pads2 were much more effective at picking up the dirt particles.
Statistical Analysis
There is a statistically significant difference (p-value < 0.001 from two-sample t-test) in mean RODAC® plating collection between conventional (mean = 121.188 SD = 104.964) compared to microfiber (mean = 19.938 SD = 15.657). There was a significant reduction with the microfiber mop-head (Table 1).
Quatricide® & Water Usage
The spray mop1 yielded an astounding savings of over 98% on Quatricide®4 and water usage, accounting only for disinfectant use in buckets versus bottles. This was a fantastic result but not unexpected, as the new mop required only 18 ounces1 instead of 35 quarts to operate.5 To put this into perspective, it takes 62.2 of the 18 ounce bottles to fill the conventional mop bucket. Quatricide®4 dispensing was reduced from 4.38 ounces
to 0.07 ounces for every use.4 This made quite an impact on the amount of wastewater that would otherwise be sent into the sewer system.
Ergonomics
The differences in overuse injuries with the two mops would likely be greater with the conventional bucket-style mop. Because the spray mop1 is smaller and lighter (the wringer-style mops can get very heavy). The only concern would be the smaller muscles necessary for the trigger-style spray mop.1 However, this will likely be a non-issue as the person will not hold the sprayer for the full mopping. Overuse risk is also less likely during the actual mopping using a spray mop1 because it is lighter, with no pushing/pulling a bucket full of water. There is also less bending and usually less drag on a spray mop (Figure 8).1
Storage & Environment
Though the exact amount of water savings was unquantifiable, it can be reasonably concluded that the reduction in water use/waste is significant since mops are no longer processed through the cage wash, which dumps approximately 60 gallons of water or more per load.
The conventional mopping system storage area was measured and took up 140ft2 of space in the cage wash area (Figure 1). All that space was reclaimed after transitioning to the spray
Figure 8. The mop system being used in a facility.
Figure 7. RODAC collection by mod head type.
mop1 as the new system hangs on the wall in the designated room (Figure 3) occupying zero floor space. This space savings now allows for safer and more efficient maneuvering of the large racks in the cage wash area.
Cost Savings Analysis
The average cost per unit of the conventional mop came out to $187.81, while the new spray mop1 was significantly less at $37.66 per unit. The total savings represented on the cost of spray mop1 over conventional mops was 80% of the total investment required. An additional savings is represented in the semi-annual replacement cost of the mop-heads, which netted a 35% savings on mop-pads2 over conventional.
Conclusion
The study demonstrated that the spray mop1/mop-pad2 outperformed the legacy-type conventional mop and bucket system by a wide margin, yielding both superior cleaning effectiveness as well as substantial cost savings. Additionally, the use of the spray mop1 saw a drastic reduction in Quatricide®2 and water use/waste, required storage area, and an unquantifiable but probable ergonomic benefit to those tasked with cleaning duties.
After more than a year of regular practical use, there has yet to be any need for repairs or replacements. As a result, we are happier with the new system, with it not falling apart in associated tasks and decreasing the amount of required physical labor pulling and pushing. The affordable spray mop1/moppad2 provides a hygienic floor, all while being ergonomically superior, more environmentally friendly, and all-around easier to use and care for.
Mr. Arrow Megginson, BS, RLATG is the Supervisor of Animal Resources at Midwestern University in Glendale, AZ.
Acknowledgments
Kylie Scott, PJ, DPJ, CMPJ from the Physical Therapy Program for expertise in ergonomics comparison.
Charlotte Bloch, Ph.D., M.S. the Associate Director of Research and Sponsored Programs, for assistance calculating the Analysis Results.
Dr. Scott Nichols, D.V.M. the Attending Veterinarian (Consulting)
Joanna Kammholz, B.S., RLATG the Associate Director of Research Operations
Catherine Cruz, B.S. the Microbiology Technician
The Midwestern University Animal Resources Technicians
REFERENCES
1. Heavy Duty Microfiber Spray Mop System – 18”. Uline. (n.d.). https://www.uline.com/Product/Detail/H-6496/Mops-andSqueegees/Heavy-Duty-Microfiber-Spray-Mop-System-18
5. TOUGH GUY Mop Bucket and Wringer: Down Press, 8 3/4 gal Capacity, Plastic, Orange, Down Press. 2024. Grainger. https://www.grainger.com/product/TOUGH-GUY-Mop-Bucketand-Wringer-Down-5CJK5.
Reducing Hay Waste from New Zealand White Rabbits (Oryctolagus cuniculus) by Switching to Hanging Wire Feeders from Conventional Food Bowls
By Ron A. Hayes, Carol L. Baker, DVM, PhD, and Leslie L. Birke, DVM, MPH, DACLAM
Introduction
Rabbits require daily dietary fiber (hay) to help maintain a healthy digestive tract. As per our standard operating procedure (SOP), we give the rabbits hay and other daily food enrichment in a bowl. Rabbits are intelligent, playful, and curious animals and will find a way to tip the bowl over, spilling out the contents. This spilled hay falls into the waste catch pan or becomes soiled by rabbit urine and/or fur. Furthermore, the Animal Welfare Act and The Guide for the Care and Use of Laboratory Animals states that floor space taken up by food bowls, water containers, litter boxes, and enrichment devices should not be considered part of the floor space.1,2 We suspected that this was a hidden cost that was not benefiting the animals and was contributing to environmental waste. We saw this as an opportunity to improve our SOP and decided to replace the bowls with a hanging wire feeder. We theorized that the hanging feeders would keep the hay off the floor thus minimizing waste and soilage. In this study, we measured how much hay was wasted using our typical SOP compared to the new wire hanging feeders. We hypothesized that switching to the wire hanging feeders would result in less hay waste than the bowls while maintaining rabbit health. Overall, we found that the rabbits transitioned to the feeders without any issues and that the new feeders drastically reduced the amount of hay wasted per day for each rabbit.
Materials and Methods
Eight (4 males and 4 females) healthy adult conventionally housed New Zealand White rabbits (Oryctolagus cuniculus) that were not on any concurrent study and housed in non-ventilated Allentown suspended cages were used in this study. Rabbits had access to measured pellet diet (LabDiet 5321) and had access to reverse osmosis autowater. The wild type rabbits were originally procured from the facilities in house breeding colony and are between 1-4 years old. All rabbits started with a body condition score of 2.5/5 with weights between 4.3-5 kg. The rabbit room is kept at 68 °F with humidity between 30%-70% with a 12-hour light cycle. The rabbits’ cages are changed once a month and spot cleaned daily which
BAFigure 1. A) A representative image of a rabbit that has knocked its enrichment bowl over. Some hay has already fallen to the newly placed pan liner. The bowl is designed to friction fit into the enclosure floor holes, but rabbits easily can knock it over. B) A representative image of a rabbit eating hay from the hanging feeders.
did not interfere with this study. Each rabbit is given a chew toy and fresh vegetables daily for enrichment. This study was added to an existing protocol via amendment and approved by our facility’s IACUC. The rabbits were fed Timothy hay (Standlee Premium Western Forage) throughout the 3-week study. Rabbits in the study were previously assigned single housing due to compatibility issues. Week 1, we gathered baseline measurements for each rabbit using our standard hay bowl (Figure 1A). Week 2, rabbits were gradually transitioned to the hanging feeders (Bio-Serv small Stainless Steel Wire Feeders) before taking measurements. This was done by giving them hay in both the hanging feeders and in the bowls for 3 days, then removing the bowls and monitoring the
Average Hay Waste Comparison
Arabbits for the next 4 days. Week 3 gathered the same measurements as week 1 with just the hanging feeders (2x feeders per cage) (Figure 1B). We measured waste by weighing the amount (grams) of hay placed into the cage and the amount (grams) of hay that fell into the catch pan after 24 hours. Each rabbit’s health was monitored by measuring the amount (grams) of urine/feces each rabbit produced by weighing the pan liner and changing it with a fresh one daily, evaluating the quality of rabbit feces (shape, consistency, and amount), measuring the daily intake of pellet food and water, assessing each rabbit’s mentation daily, and measuring rabbits’ weight once per week throughout the study.
Results and Conclusions
On average the rabbits would waste about 31% of the total hay given in a bowl each day (range of 22%-38%) (Figure 2A). This was a stark difference to what was seen with the hanging feeders where the average hay wasted was 6% (range of 0%-13%) (Figure 2B). This translates as a 25% drop in waste between hanging feeders and the bowl (Figure 3). The hanging feeders could not hold as much hay as a bowl, but we found that the rabbits either ate or had access to roughly the same amount of hay that was given in the bowl. We suspect that there was more wasted hay using the bowl method that was not calculated as it was in the enclosure itself (instead of falling to
Figure 2. A) A representative image of what the waste pan would look like after 24 hours using a bowl. B) A representative image of what the waste pan would look like after 24 hours using the hanging feeders. (A/B
from the same rabbit)
Figure 3. The bowl data is represented in blue, and the hanging feeder data is represented in orange. This figure represents the average daily waste of hay for each rabbit after 1 week. The average percentage of hay wasted when using the bowl method by all rabbits was 31% while the average for the hanging feeder was 6%.
the waste pan) due to it being spoiled by fur and urine (Figure 4). This hay was not measured as urine-soaked hay would weigh more than what was initially given to the rabbits. Throughout the 3-week study, rabbits maintained a healthy starting weight, had normal feces, produced similar amount of feces/urine, and had normal mentation.
The rabbits were able to eat approximately the same amount of hay each day regardless of hay container. The hay remained free from spoilage when in the hanging feeder and rabbits adapted well to the change. Something we did not consider in the beginning was that the hanging feeders gave us an additional health parameter that we could observe daily as the feeders are clearly visible on the cage door and care staff could easily see if a rabbit stopped eating the hay. A downside of the hanging feeders is that it takes about twice as long to
refill than a bowl and was slightly messier. We found on average that 10 g of hay fell to the floor after refilling the rabbits’ hanging feeders (16 feeders in total). This equates to an estimated 4% increase in wasted hay per rabbit, which would increase the feeder’s average hay waste percentage to about 10%, which is still far less than the 31% wasted by the bowl. Our technicians noted that adding a compressed hay cube at the bottom of the hanging feeder helped prevent additional waste from falling out the bottom (seen in Figure 1B) and having a bowl under the hanging feeder while refilling it helped prevent the mess and floor hay waste. An estimated 1 bag of hay per week is saved by switching to the feeders for the 8 rabbits in the study. With this hay bag retailing around $16 a bag, that is an estimated savings of $768 per year. The added time that it takes would vary on the hour rate of the employee taking care of the rabbits but for our institute with a smaller rabbit colony the savings in hay outweighs the technician’s time.
At the conclusion of this study, we have switched to hanging feeders for rabbit hay as it reduced waste and added a rabbit health marker. This study was not sponsored or endorsed by any compa ny and the authors have no conflict of interests.
Ron A. Hayes is a large animal care technician at the Louisiana State University Health Science Center in New Orleans, LA
Carol L. Baker, DVM, PhD is a Laboratory Animal Veterinary Resident at the Louisiana State University Health Science Center in New Orleans, LA
Leslie L. Birke, DVM, MPH, DACLAM is the Director of the Division of Animal Care at the Louisiana State University Health Science Center in New Orleans, LA
REFERENCES
1. Animal Welfare Act as Amended. 2020. 7 USC §2131–2156.
2. Institute for Laboratory Animal Research. 2011. Guide for the care and use of laboratory animals, 8th ed. Washington (DC): National Academies Press.
Figure 4. A representative image of how hay can become embedded in rabbit fur in less than 24 hours.
Controlled Warming with Thermacage
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Maxi Thermacage
Type 4 cage base, floor area and height make Maxi Thermacage suitable for larger animals such as rats and guinea pigs.
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Opioid Analgesic For subcutaneous use only in mice, rats, and ferrets, and non-human primates.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF 900-014. Extra-label use is prohibited. This product is not to be used in animals intended for use as food for humans or food-producing animals.
HUMAN SAFETY WARNING
Abuse Potential
ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ETHIQA XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g., depression).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.
Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.
Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants
Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
See HUMAN SAFETY WARNINGS for detailed information.
DESCRIPTION
Ethiqa XR is an injectable suspension of extended-release buprenorphine. Buprenorphine hydrochloride, an opioid analgesic, is the active ingredient in Ethiqa XR. Lipid-bound buprenorphine hydrochloride is suspended in medium chain fatty acid triglyceride (MCT) oil. Lipids encapsulate the buprenorphine limiting diffusion which provides for larger doses and prolonged action.1,2 Ethiqa XR has a slightly yellow to white opaque appearance. Each mL contains approximately 1.3 mg buprenorphine hydrochloride. The sterile product contains cholesterol, benzyl alcohol, glyceryl tristearate, and buprenorphine hydrochloride suspended in MCT oil. Buprenorphine belongs to the opioid class of drugs and is a narcotic under the Controlled Substances Act due to its chemical derivation from thebaine.
Buprenorphine Formula C29H41NO4
INDICATIONS
Ethiqa XR is indicated for the control of post-procedural pain in mice, rats, ferrets, and non-human primates.
DOSAGE AND ADMINISTRATION
Wear protective clothing when administering Ethiqa XR.
Do not dispense Ethiqa XR for administration at home by the pet owner (see HUMAN SAFETY WARNINGS).
Dosing
At the doses stated in the table below, therapeutic blood levels are maintained for 72 hours after the initial dose. If needed, a single repeat dose may be administered 72 hours after the initial dose.
Administer Ethiqa XR subcutaneously according to the dosage for the appropriate species listed in the Dosing Chart below.
DOSING TABLE FOR SUBCUTANEOUS INJECTION OF ETHIQA XR
Species Mice
Rats Ferrets Non-human primates
Administration
Animals may exhibit an obtunded response to stimuli up to 4 hours after receiving Ethiqa XR.
When using Ethiqa XR, an opiate antagonist such as naloxone, should be available in case reversal is required.
Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal mobility, and respiratory depression. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression.
Animals should be monitored for signs of decreased cardiovascular and respiratory function when receiving Ethiqa XR.
The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised animals.
ADVERSE REACTIONS
Two Laboratory Studies in Mice
No adverse reactions were observed in sixteen of 20-to-25-gram young adult mice (8 males, 8 females) after a single subcutaneous injection of 16.25 mg/kg Ethiqa XR (5X). Laboratory parameters evaluated in the study included hematology and clinical chemistry; histopathology was also performed.11 In a second study, 16 adult mice (8 males, 8 females) received 16.25 mg/Kg (5X) Ethiqa XR subcutaneous for three doses at four-day intervals. A surgical procedure was performed on the mice prior to receiving each of the three doses of Ethiqa XR. Mortality was seen in two male mice after the third surgical procedure and third dose of Ethiqa XR (total dose of 49 mg buprenorphine/Kg body weight in 8 days). Weight loss was observed postprocedurally in mice administered Ethiqa XR.11
Two Laboratory Studies in Rats
Adverse reactions were evaluated in twenty-four 180-to-200-gram young adult rats (12 male, 12 female) after a single subcutaneous injection of Ethiqa XR. A surgical procedure was performed on the rats prior to receiving a single dose of Ethiqa XR of 0.65 (1X), 1.3 (2X), 3.9 (6X), or 6.5 mg/ Kg (10X); Six in each group (3 male and 3 females).12
Adverse reactions also were evaluated in 24 young adult rats (8-weeks at start). There were 12 male and 12 females. The female rats weighed between 128-164 grams and males weighed between 169-219 grams. Each rat received a subcutaneous injection of 1.3 (2X), 3.9 (6X), or 6.5 mg/Kg (10X) Ethiqa XR for three doses at four-day intervals (8 rats per group; 4 males, 4 females). A surgical procedure was performed on the rats prior to receiving each of the three doses of Ethiqa XR. Laboratory parameters evaluated in the study included hematology, clinical chemistry, urinalysis, histopathology, and bodyweight.3,12 Signs of nausea were observed at all dose levels (1 rat at 1.3 mg/Kg, 3 rats at 3.9 mg/Kg, 2 rats at 6.5 mg/Kg) within 24 hours of the dose. Signs included self-licking, self-gnawing and efforts to eat wood-chip bedding. Mortality was seen in 1 of 36 rats exposed to wood chip bedding. Necropsy revealed the stomach and esophagus were compacted with bedding, the bladder was abnormally distended, and the urine contained blood.3,12 3 out of 222 rats (the 222 rats are from five (5) pharmacokinetic and safety studies) were observed to bleed profusely from the jugular vein, which was used for obtaining blood samples, and subsequently died.
Two Laboratory Studies in Ferrets
No studies have been published administering Ethiqa XR to ferrets. One unpublished study reports that no adverse reactions were observed after 4 adult female ferrets received a single subcutaneous injection of 0.6 mg/Kg of Ethiqa XR.13
In a pharmacokinetic single-dose study, no adverse reactions were observed in 6 male, approximately 1-year old, ferrets after receiving 0.04 mg/Kg buprenorphine immediate-release.9
Two Laboratory Studies in Non-Human Primates
In a pharmacokinetic study, 25 adult common marmosets received a single SQ dose of Buprenorphine SR (0.15 mg/Kg, N=8) or Ethiqa XR (0.1 mg/kg, N=6, 0.15 mg/Kg, N=3, and 0.2 mg/kg, N=8). Injection site reactions were scored based on gross examination of erythema and swelling. Mild sedation was noted at 8- and 24-hours post-dose in all groups. Body weights decreased relative to baseline in all groups except Ethiqa XR 0.15 mg/Kg; however, these decreases were not clinically significant (<10% of body weight). Buprenorphine injections of either formulation resulted in increased cage movement that was dose dependent. Both Buprenorphine SR and Ethiqa XR acute injection sites exhibited acute necrosis and inflammation. The degree of inflammation was overall similar for chronic both drugs; however, qualitatively different. The Burprenorphine SR injection sites were associated with mainly macrophages and neutophils, while the Ethiqa XR sites were associated with macrophages and multinucleated giant cells and cholesterol clefts in response to the vehicular medium.6 In a pharmacokinetic study, four adult male cynomolgus monkeys were administered a single dose of Ethiqa XR (0.2 mg/Kg) SQ. No abnormal behaviors or clinical signs were observed up to 120-hours post injection.7
CONTACT INFORMATION
Contact Fidelis Animal Health at 1-833-384-4729 or www.ethiqaxr.com. To report suspected adverse drug experiences, contact Fidelis Animal Health at 1-833-384-4729.
For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
CLINICAL PHARMACOLOGY3
Mechanism of Action: Buprenorphine exerts its analgesic effect via high affinity binding to various subclasses of opiate receptors particularly mu, in the central nervous system. Buprenorphine analgesic and adverse reactions are mediated by mu opioid receptor agonism. Due to its partial agonist activity, buprenorphine exhibits a ceiling affect to its actions and thus has a greater therapeutic index compared to full mu opioid receptor agonists such as morphine. Buprenorphine binds tightly to and dissociates slowly from the opioid receptor. Therefore, the pharmacological effects of buprenorphine are not directly related to plasma concentrations.
3.25 mg/Kg
0.65 mg/Kg
Dose mg/Kg Body Weight Time to Reach Therapeutic Blood Levels after Administration Comments 30 minutes10 6 hours4 30 minutes13 15 minutes6
Ethiqa XR can be administered 30 minutes prior to painful stimulus10
0.6 mg/Kg 0.2 mg/Kg
Ethiqa XR can be administered 15 minutes prior to painful stimulus6
Shake the vial well before each use to ensure uniform suspension. If stored refrigerated, bring to room temperature before use.
Use aseptic technique to subcutaneously administer Ethiqa XR by utilizing minimally stressful restraint techniques or sedation.
An oily sheen may be observed in the fur after injection due to leakage of Ethiqa XR, which is an oil-based drug suspension, from the injection site. The oily sheen may last for 4 to 5 days post-injection. Leakage from the injection site can be minimized by slowly injecting Ethiqa XR into the subcutaneous space.
Do not return any unused drug suspension from the syringe back into the vial. The animal can be returned to its cage immediately after receiving Ethiqa XR. (See CONTRAINDICATIONS PRECAUTIONS, and ADVERSE
REACTIONS for additional information on bedding.)
CONTRAINDICATIONS
Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intraperitoneal injection.
Do not use in animals with pre-existing respiratory compromise.
Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Signs of nausea, including pica, have been observed in rats for up to 3 days post-treatment with Ethiqa XR. Pica involving wood chip type bedding can be lethal (see ADVERSE REACTIONS).
HUMAN SAFETY WARNINGS
Not for use in humans. Keep this and all medications out of reach of children and pets.
Human User Safety While Handling Ethiqa XR in the Hospital: Ethiqa XR should only be handled and administered by a veterinarian, veterinary technician, or laboratory staff trained in the handling of potent opioids.
To prevent human adverse reactions or abuse, at least 2 trained administrators should be present during injection of Ethiqa XR.
Wear protective clothing when administering Ethiqa XR.
Mucous Membrane or Eye Contact During Application:
Direct contact of Ethiqa XR with the eyes, oral, or other mucous membranes could result in absorption of buprenorphine and the potential for adverse reactions. If accidental eye, oral, or other mucous membrane contact is made during application, flush the area with water and contact a physician immediately. If wearing contact lenses, flush the eye first and then remove the contact lens.
Skin Contact During Application:
If human skin is accidentally exposed to ETHIQA XR, wash the exposed area immediately with soap and water and contact a physician. Accidental exposure could result in absorption of buprenorphine and the potential for adverse reactions.
Drug Abuse, Addiction, and Diversion of Opioids:
Controlled Substance:
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids.
Abuse: Ethiqa XR contains buprenorphine, an opioid substance, that can be abused and is subject to misuse, abuse, and addiction, which may lead to overdose and death. This risk is increased with concurrent use of alcohol and other central nervous system depressants, including other opioids and benzodiazepines.
Ethiqa XR should be handled appropriately to minimize the risk of diversion, including restriction of access, the use of accounting procedures, and proper disposal methods, as appropriate to the clinical setting and as required by law.
Prescription drug abuse is the intentional, non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Buprenorphine has been diverted for non-medical use into illicit channels of distribution. All people handling opioids require careful monitoring for signs of abuse.
Storage and Disposal:
Ethiqa XR is a Schedule III opioid. Store in a locked cabinet according to federal and state controlled substance requirements/guidelines. Discard any broached vials after 90 days. Any unused or expired vials must be destroyed by a reverse distributor; for further information, contact your local DEA field office or call Fidelis Animal Health at 1-833-384-4729.
Information for Physician:
Ethiqa XR contains a mu opioid partial agonist (1.3 mg buprenorphine/mL). In the case of an emergency, provide the physician with this package insert. Naloxone may not be effective in reversing respiratory depression produced by buprenorphine. The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride has also been used as a respiratory stimulant.
PRECAUTIONS
Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly in mice.5
The use of paper or soft bedding for up to 3 days following administration of Ethiqa XR should be considered (see CONTRAINDICATIONS and ADVERSE REACTIONS).
Buprenorphine is excreted in the feces (see CLINICAL PHARMACOLOGY). Coprophagy may lead to ingestion of buprenorphine or its metabolites by animals treated with Ethiqa XR and untreated cage mates. Ethiqa XR forms a depot near the injection site. Granulomatous inflammatory nodules have been observed in naked-skinned mice and rats administered Ethiqa XR.4,5 Injection site reactions including inflammation and necrosis have been observed in common marmosets.6
Buprenorphine can act as an agonist and antagonist at different classes of opioid receptors. Agonism at the mu opioid receptor and, in some cases, antagonism at the kappa or delta opioid receptors are possible underlying mechanisms for the ceiling effect and bell-shaped dose-response curve of buprenorphine. Studies with knockout mice have shown that the antinociceptive effect of buprenorphine, which is mediated primarily by the mu opioid receptor, is attenuated by the ability of the drug to activate the opioid receptor like (ORL-1) receptor. The drug can be described as a ‘full’ and a ‘partial’ agonist at the same receptor depending on the specific assay. There appears to be no ceiling effect for analgesia, but there is a ceiling effect for respiratory depression. Pharmacokinetic studies with bolus injections of buprenorphine in mice and rats provide similar models. After bolus intravenous administration, plasma levels decline tri-exponentially. The drug is n-dealkylated in the liver to norbuprenorphine (NBN), an active metabolite. Studies have shown that glucuronide metabolites of buprenorphine and NBN are also metabolically active, and can approximate or exceed the concentration of the parent drug. Un-metabolized drug excreted in the urine and feces one week after injection was 1.9 and 22.4% of the dose, respectively, and 92% of the dose was accounted for in one week.3
Mice
Pharmacokinetic parameters of Ethiqa XR were studied in 6-8 week old male and female Balb/c mice following a single subcutaneous injection of 3.25 mg/kg bodyweight. Therapeutic blood levels were observed up to 72 hours after subcutaneous injection.
Rats
Pharmacokinetic parameters of Ethiqa XR were studied in 8 week old male and female Fischer rats following a single subcutaneous injection of 0.65 mg/kg bodyweight. Therapeutic blood levels were observed up to 72 hours after subcutaneous injection.
Ferrets
Pharmacokinetic parameters of Ethiqa XR were studied in 4 adult female ferrets following a single subcutaneous injection of 0.6 mg/Kg body weight. Therapeutic significant blood levels were observed within 30 minutes up to 72 hours after administration.13
Non-Human Primates
In a pharmacokinetic study, 25 adult common marmosets were evaluated after receiving a single SQ dose of Buprenorphine SR (0.15 mg/Kg, N=8) or Ethiqa XR (0.1 mg/kg, N=6, 0.15 mg/Kg, N=3, and 0.2 mg/kg, N=8). Therapeutic blood levels were observed within 30 minutes to 72 hours after subcutaneous injection.6
In a pharmacokinetic study, four adult male cynomolgus monkeys (6.41-9.58 Kg) were administered a single dose of Ethiqa XR (0.2 mg/Kg) SQ. Therapeutic blood levels peaked above 0.5 ng/mL for at least 96-hours and remained in the significant range.7
In adult baboons (5 male and 5 females), onset of concentrations of buprenorphine hypothesized to produce analgesia (0.1 ng/mL) occurred within 30 minutes of SQ administration of Buprenorphine SR (0.2 mg/Kg) and remained there for at least 120-hours.8
HOW SUPPLIED
Ethiqa XR is supplied in a 5 mL glass vial containing 3 mL of injectable drug suspension.
STORAGE INFORMATION
Store between 15° and 25°C +/- 2°C (59° and 77°F) or refrigerated. DO NOT FREEZE. If stored refrigerated, bring to room temperature before use. Once broached, the multi-dose vial should be discarded after 90 days.
Product could change its physical properties if not stored within the specified storage conditions and original vial container.
REFERENCES
1. Mishra et al. Engineering solid lipid nanaparticles for improved drug delivery: promises and challenges of translational research. Drug Deliv. and Transl. Res, 2: 238-253; 2012.
2. Bethune et al., The role of drug-lipid interactions on the disposition of liposome-formulated opioid analgesics in vitro and in vivo. Anesth Analg. 93(4):928-33; 2001.
3. Guarnieri et al.,Safety and efficacy of buprenorphine for analgesia in laboratory mice and rats. Lab Animal, 41(11): 337-343; 2012.
4. Levinson BL, Leary SL, Bassett BJ, Cook CJ, GormanGS, Coward LU. Pharmacokinetic and Histopathologic Study of an Extended-Release, Injectable formulation of Buprenorphine in Sprague-Dawley Rats. J AM Assoc Lab Anim Sci. Jan 1, 61(1): 81-8; 2022.
5. Fidelis’ postmarketing surveillance database.
6. Fabian NJ et al. Evaluation and comparison of pharmacokinetic profiles and safety of two extended-release buprenorphine formulations in common marmosets (Callithrix jacchus). Scientific Reports, 13, 11864; 2023.
7. Klein H. et al. A pharmacokinetic study of extended-release buprenorphine in Cynomolgus monkeys (M. fasicularis). Journal of Medical Primatology. 52(6):369-373; 2023.
8. Williams W et al. Pharmacokinetics of sustained-release buprenorphine in adult baboons (Papio Anubis). 2021 National Meeting of the Am Assoc for Lab Anim Sci (virtual).
9. Katzenbach JE, Wittenburg LA, Allweiler SI, Gustafson DL, Johnson MS. Pharmacokinetics of single-dose buprenorphine, butorphanol, and hyromorphone in the domestic ferret (Mustela putorius furo). J Exotic Pet Med 27:95-102; 2018.
10. Chan G et al. Assessment of the Safety and Efficacy of Pre-emptive Use of Extended-release Buprenorphine for Mouse Laparotomy. J Am Assoc Lab Anim Sci 99(99): 1-7;2022.
11. Traul KA et al. Safety studies of post-surgical buprenorphine therapy for mice. Lab Anim. 49(2):100-110;2015.
12. Cowan A et al. Lack of adverse effects during a target animal safety trial of extended-release buprenorphine in Fisher 344 rats. Nature America, Inc. Jan Vol 45(1):28-34; 2016.
13. Plunkard J, Jimenez I, Craney M, Villano J. Pharmacokinetics and efficacy of extended-release buprenorphine for post-operative pain management in the domestic ferret (Mustela putorius furo). Submitted for publication; 2024.
MANUFACTURED FOR Fidelis Animal Health™ 685 US Highway One, Suite 265 North Brunswick, NJ 08902 833-384-4729 www.EthiqaXR.com Fidelis, Fidelis Animal Health, and Ethiqa XR are trademarks of Fidelis Animal Health, Inc., a Delaware Corporation. NDC 86084-100-30. U.S. Patent Nos. 10,555,899; 11,058,629 FID-ETH-PIMA016 April 2024
Never compromise
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Unlike compounded forms of buprenorphine, only Ethiqa XR meets the highest FDA standards for quality in efficacy, safety, purity, and manufacturing.
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Ethiqa XR is a subcutaneously-administered opioid analgesic indicated for the control of post-procedural pain in mice, rats, ferrets, and non-human primates.
HUMAN SAFETY WARNING
Abuse Potential
ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ETHIQA XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g., depression).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.
Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.
Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants
Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
See HUMAN SAFETY WARNINGS for detailed information.
Important Safety Information For Rats, Mice, Ferrets, and Nonhuman Primates:
Only administer Ethiqa XR® by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use in animals with pre-existing respiratory compromise. Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly in mice.
Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip type bedding can be lethal.
Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal mobility, and respiratory depression. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. Animals should be monitored for signs of decreased cardiovascular and respiratory function when receiving Ethiqa XR. The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised animals.
For Humans:
Not for use in humans. Keep out of reach of children and pets.
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids, which may lead to overdose and death.
Ethiqa XR should be handled appropriately to minimize the risk of misuse, abuse, addiction, and criminal diversion, including restriction of access, the use of accounting procedures, and proper disposal methods as appropriate to the laboratory setting and as required by law.
Ethiqa XR should only be handled and administered by a veterinarian, veterinarian technician, or laboratory staff trained in the handling of potent opioids. Wear protective clothing when administering Ethiqa XR to avoid direct contact with human skin, eyes, oral, or other mucus membranes which could result in absorption of buprenorphine and adverse reactions. For more information, consult the Prescribing Information including the Boxed Warning.
Mid-South Branch Holds Spring 2024 Meeting in Birmingham, AL
By Janet Steele, BS, RLATG, CMAR
The Spring 2024 Mid-South Branch Conference and Meeting occurred on April 24, 2024 at the Hilton Birmingham at the University of Alabama at Birmingham. The conference and meeting they organized was a great success, exceeding their mission. The Mid-South Board worked hard to ensure the event’s success. The venue was spacious and accommodating, and the program had interactive activities for technicians. Attendees also had the opportunity to visit the full-table exhibition displays of more than 20 vendors.
I had a wonderful time at the Mid-South AALAS Spring Meeting in Birmingham, Alabama. Though my trip was short, I established great connections and engaged in meaningful conversations. It was an honor to represent National AALAS as the District 4 Trustee. I am looking forward to attending more events hosted by the Mid-South Branch.
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“The mission of the Mid-South Branch AALAS is to sponsor and promote educational and training programs for its members and others who are professionally engaged in the care and handling of laboratory animals.”
Three Rivers Branch AALAS Holds Special Meeting April 2024
By Amy S Ingraham, BA, RLATG
The Three Rivers Branch of AALAS (TRB AALAS), serving western Pennsylvania and West Virginia laboratory animal professionals, held its Spring branch meeting on April 11, 2024, in the Starzl lecture hall at the University of Pittsburgh.
TRB AALAS Program Chair Frank Ali, RLATg, was pleased to introduce Cindy Buckmaster, PhD, to the largest attended branch meeting since pre-COVID days. Dr. Buckmaster lectured on topics from her “Get Real!” podcast to the full house. Despite inclement weather and flooding outside, attendees hung on every word and concluded the meeting by talking to each other and sharing with Dr. Buckmaster about personal experiences. A special topic that Dr. Buckmaster discussed was the research community’s response to the early days of COVID.
Branch President Paula Chalmers, RLATg, thanked Dr. Buckmaster and encouraged the attendees to enjoy the light reception the branch provided.
There were several impromptu open-ended discussions following the presentation. Dr. Buckmaster was, as always, amazing, thought-provoking, and encouraged all who attended to consider their own “Get Real” moment.
Photographs provided by Ms. Christina Curci.
TRB AALAS Air Guitar Band performance
TRB AALAS Board 2024
GLAS Updates!
GLAS Research Advancing Animal Health and Welfare
The mission of the AALAS Grants for Laboratory Animal Science (GLAS) program is to enhance scientific knowledge in laboratory animal health and welfare through research and to promote collaborative efforts by the AALAS membership within the broader scientific community. In 2024, GLAS program funding rate was 26% and 6 GLAS grants were awarded.
The Scientific Advisory Committee is proud to announce the 2024 GLAS awardees. Congratulations to the new recipients!
2024 GLAS Grant Awards and Recipients†
Pharmacokinetics and Efficacy of Long-Acting Transdermal Formulation of Buprenorphine (Zorbium) in NOD-SCID-Gamma and C57Bl/6 Mice
PI: Alicia Braxton, DVM, DACLAM, PhD; Medical University of South Carolina
Pharmacokinetics and Safety of Pharmaceutical-Grade, Extended-Release Meloxicam in Zebra Finches (Taeniopygia guttata) and Interspecies Comparison of Drug Metabolism
PI: Niora Fabian, MS, DVM, DACLAM; Massachusetts Institute of Technology
Co-I: Kelly A. Metcalf Pate; DVM, PhD, DACLAM; Sarah Gurnon, DVM; Anthony Mannion, PhD
Dose-dependent Effects of Buprenorphine on Immune Modulation in Nonhuman Primates
PI: Melanie Graham, MPH, PhD; Scott Hunter Oppler, PhD; University of Minnesota
Evaluating the Impact of Experience Level on Clinical and Histologic Outcomes Following Retro-Orbital Injection in Mice.
PI: Karuna Patil, VMD, MS, DACLAM, MBA; Seattle Children’s Research Institute
The Effects of Transport Stress on Behavioral and Physiological Indicators of Welfare in Mice
PI: Anna Ratuski, BSc, PhD; Board of Trustees of the Leland Stanford Junior University
Co-I: Joseph Garner, BA, PhD; Flavio H Alonso, DVM, PhD; David Bentzel, BS, VMD, MPH, MS
Impact of Maropitant Citrate on Acute Radiation Sickness in NSG Mice Undergoing Total Body Irradiation
PI: Tim Ryan, DVM; McMaster University
Co-I: Mick Bhatia, PhD
†PI is Principal Investigator; Co-I is Co-Investigator.
On April 24-25, the Online Learning Committee (OLC) met in Memphis. The OLC is charged with reviewing, assessing, and updating existing courses in the AALAS Learning Library (ALL) to ensure that they are useful, current, and relevant for learners.
The committee focuses on meeting the training needs of the laboratory animal science community with courses on topics that range from individual species to biosafety to compliance and regulations. Committee members may write a course, contribute subject matter expertise, or find other subject matter experts to help with particular courses.
In 2003, the ALL platform launched with 63 courses and has grown to over 250 courses today. Each course undergoes review every 3 years – which keeps the OLC busy!
AALAS Foundation Updates!
AALAS Foundation Seeks Super Stars for Video Campaign!
We need YOUR SUPER STAR appearance in an upcoming social media video campaign that will be used to spread awareness about the amazing career opportunities in the field of laboratory animal science. Simply send us a short video sharing what you love most about your work in laboratory animal science and why you're passionate about it! Plus, everyone who submits a video will be entered into a drawing for a chance to win a special 25th anniversary commemorative prize! For more details, email us at foundation@aalas.org
POE AWARD – New Individual Category!
The AALAS Foundation has added an individual category to its Public Outreach & Education (POE) Award!
Beginning this year, we're not only recognizing outstanding Branches for their public outreach efforts but also highlighting an individual AALAS member who has made significant contributions to public outreach.
The selection process will be based on submissions received from both AALAS members and Branches – highlighting their and their members’ outreach activities conducted from September 1st, 2023 through August 31, 2024. The POE Award recipients will be recognized at the Appreciation Reception at the National Meeting in Nashville, Tennessee. Each POE award recipient will be presented with a $100 gift card as a token of appreciation.
Don’t miss out on this opportunity to showcase your and your Branch’s dedication to public outreach. Submit your POE Award form at https://tinyurl.com/POE-AWARD
AALAS Foundation Staff & Volunteers Reach Out to Science Teachers
Our AALAS Foundation staff and volunteers have been hard at work reaching out to science teachers! AALAS Foundation staff members Amanda Pinto and Vicki Campbell exhibited at the 2024 National Science Teachers Association conference held March 20 -23, 2024, in Denver, Colorado.
Thousands of science teachers from across the USA attended this annual conference and the AALAS Foundation was delighted to distribute its free educational materials to the educators who stopped by their booth over the three day period.
We were excited that one of our former “Celebrate the Mouse” video essay contest student winners stopped by our booth to say “hello” and thanked us again for the opportunity of learning more about animals in biomedical research and career opportunities in laboratory animal science.
Thanks to local Denver area AALAS members, Jen Philipson, Kyrsten Holle, Derek Fong, Melissa Card, Toni Mufford, Nikki Tsuji, and Leanna Chaffee for volunteering to help us out at the booth.
2024 Silent & Live Auction
The AALAS Foundation is excited to offer a hybrid Silent Auction once again this year. All auction donation items will be on display at the National Meeting in Nashville, Tennessee; however, all bidding on the items will be conducted online! This means that even if you’re not able to attend the 2024 National Meeting, you will still have an opportunity to bid on any of the items in the Silent Auction! We are currently seeking auction item donations to support this year’s auction.
Please consider donating an auction item. Auction item donors making pledges of auction donations by August 31, 2024, will be recognized in the 2024 National Meeting Final Program. The deadline to pledge an auction item for this year’s Silent & Live Auction is October 18th, 2024.
Visit https://tinyurl.com/2024-AF-Auction for more information and to pledge an auction item donation.
Reminders!
Support the $25 on the 25th Anniversary Campaign!
“Tune Up for Research” Contest – Sponsored by Charles River Laboratories
Deadline to enter is September 3, 2024! Scan the QR code below to register or go online at https://tinyurl.com/in-tuneResearch
It’s not too late to help celebrate the AALAS Foundation’s 25th Anniversary by participating in the $25 on the 25th campaign! Simply scan the QR code below to make your monthly donation and/or make a “catch up” donation ($25 for each month) and continue making your $25 donation each month for the remainder of the year. Everyone fully participating in the campaign will receive a commemorative 25th anniversary gift!
Participating in this campaign will not only show your support of the AALAS Foundation and its 25 years of providing free public outreach programs and materials, it will also serve to support the AALAS Foundation’s “Speak Up & Reach Out” initiative which includes producing video tutorials that will inspire and help laboratory animal science professionals Speak Up & Reach Out to the public like a super star!
Automation
■ Tailored solutions for your specifi c facility and research requirements
■ Enhanced cage wash throughput capabilities and maximized effi ciency
■ Prioritized personnel safety and wellness
■ Optimized expenses and environmental impacts
Note: System requires a tunnel washer, not shown above.
