Tuesday, July 9, 2013

Time: 12:30 PM – 1:30 PM EDT

Join NABR and Drs. Betty Goldentyer and Robert Gibbens, the Eastern and Western Regional Directors, USDA/APHIS/Animal Care, for this exclusive webinar to answer YOUR questions!

If you currently use USDA regulated species in research or want to know more, this opportunity to ask hear directly from the USDA is not to be missed!

Q & A With The USDA: Follow Up Questions

Following the webinar the USDA representatives received comments related to the questions on the issues of review of SOPs, Annual Reviews and Training of Veterinary Students and they addressed these comments directly to the individual that contacted them. We have elected to include those (as received by the USDA) along with questions that NABR received following the webinar and the requests for clarifications that the USDA received. The responses/answers will appear in italics.


1. USDA has very much changed their position on SOP review from just IACUC 301 on June 6 and the lab animal “Word from USDA and OLAW” when we were told every 6 months or every year depending on the nature of the SOP.

This issue has been a difficult one to address because SOPs are not specifically mentioned in the regulations. The answer given on the webinar is USDA’s current position.

2. The timing on continuing review also flies in face of what USDA has stated at every 101 (it is one of our standing scenarios and has been for years). The response has always been 365 days or less, no ands, ifs or buts. Now it’s annually with 30 day leeway.

Hopefully the webinar has answered any questions surrounding this issue. The VMOs will receive the same Q & A from the webinar, so there should not be any doubt about what may be cited during an inspection.

3. Also, vet students being trained in ag animal procedures has always been stated as “regulated” at 101 while an ag student would NOT be similarly regulated. Now, USDA is saying vet students being trained in ag animal procedures is not regulated activity. This is a big change as well.

The question focused on whether a training activity for veterinary students utilizing agricultural animals is a covered activity. If the veterinary school owns the animal(s) and uses it for training, the activity is covered. If the veterinary school is providing clinical services to a farm (this farm could be a different department within the university) then the (even though the veterinary students are involved and therefore are being “trained”), the activity is not covered because the primary activity is providing requested/needed clinical services, and the training occurs in the natural course of providing those services.

Additional Questions

1. How does the USDA look at positive reinforcement devices with respect to restraint devices?

When and if to use positive reinforcement in lieu of restraint is a decision that the facility must make. In general, the USDA encourages and supports this option when safe and appropriate.

2. What can research veterinarians do to more actively contribute to the education of VMOs?

Our VMOs receive training on an ongoing basis, much of which is focused on how to apply the regulations to a wide variety of situations and activities. It is helpful to us when the industry lets us know specific areas for which you believe our VMOs could use additional training. You can provide that information to your Regional Office, or to AC Headquarters.

3. Does APHIS have personnel practices which provide opportunities for the VMOs to attend some professional meetings such as PRIM&R, AALAS and AAZV?

Yes, and although we try whenever possible to get our VMOs to local, regional, and/or national meetings, those opportunities have been reduced by budgetary realities and travel restrictions which impact all Federal agencies.

4. Can VMOs have a cup of coffee with the Attending Veterinarians in order to create more collegial visits? The typical visit too often takes on the aura of a visit from the Grim Reaper.

The short answer is yes, but this is an interesting question, and can be a conundrum for our VMOs. We hear concerns about the length of our inspections and the inconveniences they cause for the facility being inspected. So while we encourage informal visits such as the type you describe, at the same time we ask our VMOs to try to minimize inconveniences for the facility. If you make it clear to your VMO that you would like to have an informal discussion and share a cup of coffee, most will respond positively unless they have competing priorities at the time.

NABR Comments – In previous webinars on managing the inspection process NABR has emphasized the need to have a good relationship with the VMO. It is important to remember that the goal of the facility and the VMO are the same and that is to assure the welfare of the animals that are being housed and used in the facility.

5. If during the course of an inspection an institution provides the VMO inaccurate information that leads to a citation, is there a mechanism for correcting that report besides a formal appeal?

The best time to do this is at the exit interview, as the inspection report is still able to be modified by the VMO at that time. If it is not discovered until after the exit interview, the appeal process is the best method for correcting the situation.

Requests for Clarification

1. A clarification was requested regarding the due date of the Annual Report – Is the report due within 30 days after the original IACUC approval date, or within the month it was due?

The annual review should be completed within the month that it was previously approved by the IACUC. This gives some flexibility but still keeps it simple for the IACUC and the VMO to assure compliance.

What about months that are 28 and 31 days?

As stated above, keep it in the same month.

Can a report be submitted up to 30 days prior to the IACUC approval date?

Annual review can always be done early – the next year starts at the renewal date.

2. A requirement for medical records was mentioned. The AWAR do not specifically mention ‘medical records’ under AWAR 2.31 d 1 x, 2.35, or 2.33, however Policy 3 states: “Appropriate post-operative records should be maintained in accordance with professionally accepted veterinary procedures regardless of the location of the animal.”

What would the citation be if the VMO found no post-op records but the animals were receiving good care?

Appropriate medical records are part of adequate veterinary and post-operative care. In general, lack of records will not be cited unless there are impacts to the health and well-being of the animal.

3. Why must there be a justification to use a supersaturated NPG KCL solution to euthanize a large animal (AVMA requirements) when the animal is being killed anyway and no pharmaceutical grade supersaturated solution is available?

That fact that no pharmaceutical grade solution is available is the justification.