January 31, 2017

On Tuesday, December 19, the Food and Drug Administration (FDA)  issued a final ruling banning the use of powdered surgeon's gloves, powdered patient examination gloves, and the use of powder to don gloves in a healthcare setting, including all animal care and use facilities.
 
Per the FDA's statement , the continued use of powdered gloves presents numerous health risks, including allergic reactions, severe airway inflammation, wound inflammation, and post-surgical scar tissue formation.
 
The ruling went into effect on Wednesday, January 18, and applies to gloves already in commercial distribution and those already sold to the end user, as well as any gloves that would be sold or distributed in the future.
 
In accordance with the FDA's ruling, and in order to ensure the health and safety of both our program personnel and all animals under our care, please discontinue the use of any powdered gloves in your animal facility immediately. Any remaining gloves that meet the criteria listed above should be destroyed.*
 
* Use of these gloves for any other purpose is considered off-label use by the FDA;
therefore, these gloves should not be re-purposed for any other application within our facilities.
 
Should you have any questions or concerns about this new ruling, please contact the Animal Care & Use Office at acuoffice@umich.edu or call (734) 763-8028.


Latest Animal Care & Use Program Activities:
IACUC Working to Standardize Semi-Annual Inspection Schedule


The Institutional Animal Care & Use Committee (IACUC) has begun working to standardize their semi-annual inspection schedule. In the past, the IACUC has conducted semi-annual inspections on a rolling basis, meaning that different buildings were inspected each month.  Moving forward, the IACUC will conduct semi-annual inspections only in the Spring and Fall (i.e., March and September).
 
In order to effectively transition all facilities requiring semi-annual inspections, the IACUC will be re-inspecting any facilities on the old schedule over the next two months. As a result, facilities that were inspected as recently as December or January may receive an additional inspection notice for March.

The IACUC must inspect any animal rooms, surgical suite support spaces, and areas where procedures are conducted on animals every six months to comply with federal regulations and guidelines.
 
We apologize for any inconvenience this transition may cause, and are confident that the new standardized schedule will help simplify these processes moving forward. 
Changes to the Disposal Process for Schedules I and II
Controlled Substances in Research


The U.S. Drug Enforcement Administration (DEA) has recently identified issues with documentation associated with the disposal procedures for Schedules I and II controlled substances used in research at U-M. In order to comply with federal regulations regarding disposal of these controlled substances through a reverse distributor, the U-M Office of Research (UMOR) is changing the process, effective immediately.

In summary, the DEA research registrant or their authorized personnel will be required to complete the Supplier section of the DEA Form 222 and to verify the accuracy of all other portions of the form at the time of pick-up.
The DEA registrant is ultimately responsible for proper completion of the DEA Form 222. 

Mandatory
In-Person Training on This New Process
Will Be Provided on the Following Dates:
Wednesday, February 1
2:00 PM - 2:30 PM
Room 6311, Med Sci I
Monday, February 6
10:00 AM - 10:30 AM
Room 1122, NCRC Building 520
Tuesday, February 7
2:30 PM - 3:00 PM
Seminar Rooms - ABC, BSRB
Every DEA registrant with Schedule I or II controlled substances listed
on their IACUC protocol(s),
or one of their authorized personnel,
is  required to attend one of the half-hour training sessions.

For more detailed information on the disposal changes, please visit the UMOR  Controlled Substances Disposal Procedure page.
 
If you have any questions or concerns, please email the UMOR Controlled Substances Monitoring Program at  cs-monitors@med.umich.edu or call (734) 764-2003.
DEA Announces Changes in Registration Renewal Notifications

 
Starting in January 2017, the DEA will no longer be mailing a second renewal notification letter to controlled substance registrants. Registrants will now receive the second renewal reminder at the email address on file with the DEA.

Important reminders about the DEA registration renewal policy:
  • If a registration is renewed on time prior to the expiration, the registrant may continue to use their already stored controlled substances until they receive the new registration in the mail.

  • If the registration is not renewed during the calendar month of expiration, then the researcher must apply for a new DEA registration.

  • State and federal law prohibit the acquisition, use, storage, and handling of controlled substances under an expired license and/or registration. Possession of a controlled substance without a valid state license and DEA registration could result in fines or criminal prosecution. 
Please read the full DEA announcement outlining these changes. DEA research registrants can contact cs-monitors@med.umich.edu to check on the expiration date of their registration.
Help Protect Sensitive Information with These Best Practices

 
As members of the Animal Care & Use Program, we understand the positive impact our work has on improving both human and animal health. However, in the course of our day-to-day activities involving laboratory animals, it can be easy to forget that this work is still a very complex and sensitive subject for many individuals. Follow these best practices and guidelines to help protect this type of sensitive information:
  1. Properly secure your electronic devices - A new revision to UMHS Policy 01-04-502 now requires that all devices used to store, transfer, or access sensitive information be encrypted. This includes University-owned devices as well as personal laptops and cell phones used to access sensitive information pertaining to University business. Please review the full announcement and take the necessary precautions to ensure that our data, devices, and network are safeguarded. When in doubt, encrypt!
     
  2. Be careful when printing sensitive information - Always keep in mind that groups opposing animal research are constantly looking to find critical information that they can use to advance their cause. Sensitive information that could be used to do harm could include a list of animal housing facilities, personal contact information for faculty/staff involved in animal research, and passcodes to locked housing areas. If this information must be printed, please take special care to ensure that it is only made available to other U-M employees with a specific business purpose for accessing, and that it is shredded once it is no longer needed.
     
  3. Be mindful of your surroundings - Whenever possible, please refrain from discussing sensitive information, such as specific animal procedures or animal housing details, in public places. Conversations such as these should generally be reserved for designated animal housing areas and facilities. Finally, if you ever suspect that someone has gained improper access to any area where animals are present, or to the offices of faculty/staff involved in animal research, contact U-M's Division of Public Safety & Security (DPSS) at (734) 763-1131. Remember, "If You See Something, Say Something."
The Animal Care & Use Program is committed to maintaining a safe and secure environment for both our staff and our animals, which starts with protecting sensitive information. When in doubt, consult with our program experts on any sensitive topics that may concern the use of animals in research, testing, and teaching. We can help with everything from simple media inquiries to possible threats to health and safety.

If you would like more information, or have any concerns, please contact the Animal Care & Use Office at acuoffice@umich.edu
Help Shape Upcoming Animal User Group Meetings


As part of ongoing efforts to keep our research community apprised of updates and changes within the Animal Care & Use Program, we invite you to connect with your ULAM Faculty Veterinarian at an upcoming Animal User Group Meeting.

Scheduled topics of discussion include human-derived substances, cage density and breeding, veterinary technicians 'primary interventions,' PPE posting for animal use areas, and a brief AAALAC update. If there are specific issues that you would like to see addressed during these meetings, please email us and let us know!

Meeting dates and locations will be announced soon; stay tuned for more details.
REAL Offers Strategies for Pair Housing Rabbits
to U-M, Worldwide Researchers


On Wednesday, December 7, members of the
Unit for Laboratory Animal Medicine and the Refinement and Enrichment Advancements Laboratory (REAL) partnered with the American Association for Laboratory Animal Science (AALAS) to present a webinar entitled " Strategies for Social Housing of Rabbits " to over 90 institutions worldwide, including locations in Canada, Australia, Switzerland, and Hong Kong.
 
Led by Associate Attending Veterinarian for Performance Standards and Enrichment, Jennifer Lofgren, DVM, MS, DACLAM, and Sarah Thurston, Laboratory Research Technician lead for the Clinical Laboratory and REAL , the webinar focused on the team's development of a unique process to pair house a colony of New Zealand White rabbits.

Specific topics addressed during the presentation included:
  • Identifying expected social behaviors during paired rabbit interactions
  • Identifying behaviors predictive of pair failure
  • Integrated methods of intervention, such as enrichment and targeted monitoring,
    to increase the probability of a successful pairing
  • Description of a pairing process for adult females
All U-M research personnel can now view the archived webinar FREE OF CHARGE.
Please note: you must provide your name and U-M email address to access the webinar through AALAS. Access is guaranteed through March 12, 2017.
 
Learn more about REAL, one of the nation's only refinement and enrichment laboratories, by visiting the REAL website .
Study Team Feedback Leads to Multiple Programmatic Improvements


Fillable Fields Now Available on Surgical Guideline Forms
After receiving several requests, the Rodent Surgery and Post-Operative Record (Notebook Size) and Rodent Surgery and Post-Operative Record (Cage Card Size) appendices to the Guidelines on the Performance of Surgery in Rodents now feature fillable PDF fields which can be typed into. The documents were updated to increase functionality and ease-of-use for research personnel.
 
Questions or concerns about any of these documents should be directed to ULAM Veterinary Staff at ulam-vets@umich.edu or (734) 936-1696. The ULAM Training Core is also available to provide training on the techniques associated with surgery in rodents at no additional charge.  If you are interested in scheduling a training session for your laboratory or staff, please contact ulam-trainingcore@umich.edu or call (734) 763-8039.
 
Simplified Animal Use Protocols in eRAM
As part of ongoing efforts to relieve administrative burden on study teams, the Animal Care & Use Office has been working with ULAM Faculty Veterinarians to improve animal use protocols in the eResearch Animal Management (eRAM) system. Recently, the team has:
  • Removed 36 questions
  • Re-worded and simplified 46 questions
  • Combined 3 existing questions
  • Moved 9 questions within the protocol to be more consistent
This is the first in a series of three phases aimed at making protocol submissions less dense and easier to complete. A full list of eRAM updates, including a link to the Protocol Updates page, can be reviewed via eRAM's Bi-Weekly Release Notes .
 
Questions or concerns about these updates should be directed to the Animal Care & Use Office at acuoffice@umich.edu or (734) 863-8028.
 
Tools Being Developed to Streamline Biohazard Use in Animal Care
In response to study team feedback about new U-M Guidance for Animals Administered Human-Derived Substances , the Animal Care & Use Program has begun developing resources to better inform the research community about the processes involved with using biohazards in animal research.
 
Once completed, these materials will offer step-by-step guidance, beginning with the experimental planning phase to a possible Institutional Biosafety Committee (IBC) application, on what is required for the protocol approval process.

Thank you to all who provided us this valuable feedback, we look forward to sharing these resources with you soon.
Bob Dysko to Step Down as U-M's Attending Veterinarian,
Director of ULAM


Effective June 30, 2017, Robert C. Dysko, DVM, DACLAM,
will step down from his role as the University of Michigan's Attending Veterinarian and Director of the
Unit for Laboratory Animal Medicine (ULAM) .
 
During his tenure, Dr. Dysko has implemented a wide variety of initiatives to strengthen U-M's Animal Care & Use Program. Under his leadership, the program has:
  • Launched the In-Vivo Animal Core and the Refinement and Enrichment Advancements Laboratory to better serve the needs of U-M researchers and the animals under their care
     
  • Refined animal surgery, housing, and enrichment procedures, which has led to substantial improvements to animal welfare
     
  • Grown ULAM into a team of 200+ that supports over 3,000 researchers on U-M's main campus, as well as U-M Dearborn and Flint
"Laboratory animals are central to the advancement of knowledge that has led to countless benefits to both human and animal health," said S. Jack Hu, vice president for research. "Bob Dysko has played a central role in establishing U-M as a leader in the proper care and use of animals in research."
 
Prior to being appointed as the University's Attending Veterinarian and Director of ULAM in 2012, Dr. Dysko served as a member of the ULAM faculty, where his research focused on evaluating the quality of drinking water provided to laboratory animals. After completing his residency at U-M in 1986, he briefly taught at Wake Forest University before returning to the U-M as a full-time faculty member in 1990. One of his primary roles was serving as ULAM's representative during a period of major growth for the University, which included construction of new state-of-the-art animal housing facilities at the Life Sciences Institute, the A. Alfred Taubman Biomedical Science Research Building, and the occupancy of the North Campus Research Complex.
 
In addition to his many contributions to the University of Michigan, Dr. Dysko has also served on the board of directors for three national veterinary organizations: the American College of Laboratory Animal Medicine (ACLAM), the American Association of Laboratory Animal Science (AALAS), and the Association of American Veterinary Medical Colleges (AAVMC).
 
"It is difficult to overstate the impact that Bob has had on laboratory animal medicine, both at U-M and on a national scale," noted Steven L. Kunkel, PhD, Senior Associate Dean for Research at the U-M Medical School. "With all that Bob has achieved in his 30 years of service to the University, perhaps his greatest legacy is his deep commitment to mentoring and supporting his colleagues and students in their pursuit of new ways to improve the science of laboratory animal medicine."
 
The University will conduct a national search for the institution's new Attending Veterinarian/Director of ULAM. Questions about the search should be directed to the Search Committee at AVSearchCommittee@umich.edu .
Important Deadlines and Reminders


Keeping track of deadlines can be challenging. That's why we've compiled a list of several important deadlines affecting the animal care and use community.
 
For your convenience, contact information and additional resources are also provided below.


In-Person Training: Changes to the Disposal Process
for Schedules I and II Controlled Substances in Research
2:00 PM - 2:30 PM | Room 6311, Med Sci I
Every DEA registrant with Schedule I or II controlled substances listed on their IACUC protocol(s), or one of their authorized personnel, is required to attend one of the half-hour training sessions.
 
Questions? Contact the UMOR Controlled Substances Monitoring Program at cs-monitors@med.umich.edu or (734) 764-2003.

In-Person Training: Changes to the Disposal Process
for Schedules I and II Controlled Substances in Research
10:00 AM - 10:30 AM | Room 1122, NCRC Building 520
Every DEA registrant with Schedule I or II controlled substances listed on their IACUC protocol(s), or one of their authorized personnel, is required to attend one of the half-hour training sessions.
 
Questions? Contact the UMOR Controlled Substances Monitoring Program at cs-monitors@med.umich.edu or (734) 764-2003.

In-Person Training: Changes to the Disposal Process
for Schedules I and II Controlled Substances in Research
2:30 PM - 3:00 PM | Seminar Rooms - ABC, BSRB
Every DEA registrant with Schedule I or II controlled substances listed on their IACUC protocol(s), or one of their authorized personnel, is required to attend one of the half-hour training sessions.
 
Q uestions? Contact the UMOR Controlled Substances Monitoring Program at  cs-monitors@med.umich.edu or (734) 764-2003.

ULAM-12200 Mouse Breeding:
Improving Breeding Efficiency Workshop

12:00 PM - 1:30 PM | Seminar Rooms - ABC, BSRB
Enroll today (have your uniqname and Level-2 password ready)

Questions should be directed to the ULAM Training Core
at ulam-trainingcore@umich.edu or (734) 763-8039.


ULAM-12200 Mouse Breeding:
Improving Breeding Efficiency Workshop
12:00 PM - 1:30 PM | 3rd Floor Library, Life Sciences Institute
Enroll today (have your uniqname and Level-2 password ready)

Questions should be directed to the ULAM Training Core
at ulam-trainingcore@umich.edu or (734) 763-8039.

ULAM-12200 Mouse Breeding:
Improving Breeding Efficiency Workshop
10:00 AM - 11:30 AM | 6th Floor Conf. Rm, Brehm Kellogg Eye Ctr.
Enroll today (have your uniqname and Level-2 password ready)

Questions should be directed to the ULAM Training Core
at ulam-trainingcore@umich.edu or (734) 763-8039.

Animal Research Spotlight

 
For more than a decade, Celina Kleer, M.D. , Harold A. Oberman Collegiate Professor of Pathology and director of the Breast Pathology Program at the U-M Cancer Center, has been studying how a poorly understood protein called CCN6 affects breast cancer.

To learn more about its role in breast cancer development, Kleer's lab designed a special mouse model that deleted CCN6 from the mammary gland in mice, which allowed the team to study effects specific to the loss of the protein. The results, recently published in Oncogene , have revealed a key genetic driver for a rare form of metaplastic breast cancer. Keep reading .
For more information about the Animal Care & Use Program  at the University of Michigan,  CLICK HERE .
Our mission in the Animal Care & Use Office is to support the Institutional Animal Care & Use Committee, fostering sustained excellence in animal care and use in scientific research and education, and promoting the philosophy that the highest animal welfare standards are necessary for impactful science.