USDA Readiness Review Colleen Bennett Oversight & Outreach Manager (Animal Research)

- USDA Inspection & enforcement process - OIG audit of APHIS - Identify potential areas of risk & how to reduce our chances of citations

USDA’s Animal Care (AC) unit Inspection & Enforcement Process All facilities conducting AWA-covered activities must be licensed or registered with APHIS and are subject to unannounced inspections by USDA Veterinary Medical Officers (VMO) If violations of the AWA standards are discovered during an inspection, AC issues a citation and requires the facility to correct the problem(s) with a given timeframe. Moderate repeat violations (eg incomplete records) may be settled with an official warning. More serious violations (eg animal deaths due to negligence & lack of veterinary care) are referred to the Investigative and Enforcement Services (IES) unit.

USDA’s Animal Care (AC) unit Inspection & Enforcement Process The IES will conduct a formal investigation, which includes gathering documentary evidence, interviewing witnesses and other actions. After the investigation is completed, IES national office staff review the evidence and determine, with the concurrence of the AC, whether to take enforcement action. IES can either issue an official warning or offer a settlement agreement, which includes a monetary penalty (up to $10K per violation). Cases that cannot be resolved may undergo a formal administrative hearing before USDA’s administrative law judges. Formal actions include license suspensions or loss and/or monetary penalties.

USDA Office of Inspector General APHIS Oversight of Research Facilities Report December 2014 Objectives To evaluate the adequacy of VMO’s and IACUC’s review of research facilities To determine the effectiveness of IES’ role in imposing enforcement actions To assess AC’s new mission critical information system for reliability and integrity To follow up on APHIS’ implementation of prior audit recommendations (2010)

USDA Office of Inspector General APHIS Oversight of Research Facilities Report December 2014 Findings AC inspected research facilities that stopped using regulated animals (~500 inspections at 107 research facilities). AC did not follow its own criteria in closing open investigations. There were inconsistencies in enforcement actions for similar violations. IES issued penalties that were on average 86% less than what they should have been. VMOs did not always review protocols and Annual Reports, as required. As a result, AC has reduce assurance that protocols are properly completed, approved and adhered to and that animals are always receiving basic humane care and treatment.

USDA Office of Inspector General APHIS Oversight of Research Facilities Report December 2014 Recommendations APHIS should revise its inspection criteria for active research facilities that have not used, handled or transported regulated animals. AC will document its rationale for closing any case that is not closed by IES. APHIS should formally document how it assesses penalties, including documentation of “good faith” assessments for penalty reduction. APHIS should provide training or guidance to research facilities on protocol review/approval, continuing review and annual reports.

USDA Office of Inspector General APHIS Oversight of Research Facilities Report December 2014 APHIS Response APHIS will develop and distribute guidance to research facilities on conducting protocol review/approval, on continuing reviews of their animal use activities and on accurate preparation of the Annual Report by 6/30/15. VMOs will document and maintain a record of protocols they reviewed and rationale for selecting them. They will follow the AC Inspection Guide in selecting and reviewing protocols and to review annual reports for accuracy. Can be FOIA-ed, although VMOs only have to document how many protocols were reviewed for each category.

From: Inspection Protocol Review Guidance Always review the following protocols: All protocols identified during inspection as a concern All Category E protocols All protocols with IACUC-approved exemptions/exceptions Protocols cited as noncompliant & not corrected during the last inspection

From: Inspection Protocol Review Guidance Additionally: Select one protocol for each regulated species Select one from each of the categories below, if applic. - Category D - Surgical procedures - Antibody Production - Toxicity Studies - Food/water restriction - Infectious disease studies - Neuromuscular blockers - Vaccine potency/efficacy studies - Teaching or trauma training protocols More protocols will be pulled for review.

From: Documenting Inspection Findings Problems Addressed by the Facility Before Inspection If you learn during the course of an inspection that the facility identified and corrected a problem in the past, a citation will not be written if all of the following are true: the licensee/registrant found and corrected the problem in a timely manner the licensee/registrant took steps to prevent the problem from recurring there is not an ongoing pattern of violations, and there were no serious animal welfare impacts associated with the current problem If the problem results in a citation, the report should include a correction date or indicate that the problem has been corrected.

From: Documenting Inspection Findings New NCIs Identified If a new NCI(s) is identified, cite it in the inspection report narrative. The citation should include the following four parts: 1. The section number and most specific subsection letter/number of each noncompliance 2. A clear, detailed description of the noncompliance including, when appropriate, the number of animals affected. 3. An explanation of why the item is a noncompliance and/or the impact it is having on the animals. 4. A correction deadline and a “general” description of what the licensee/registrant needs to do to correct the problem, and assure that it does not continue/recur. …A correction deadline should be appropriate to the severity of the NCI… Use “Direct” NCI designation, if appropriate. If a noncompliant item falls into more than one section or subsection, cite the noncompliance only in the most applicable section or subsection for each species affected.

“Direct” NCI A “Direct” noncompliance is a noncompliance that is currently adversely affecting the health and well-being of the animal, or has the high potential to adversely affect the health and well-being of the animal in the near or immediate future. A prior adverse incident discovered during the inspection that had serious animal welfare consequences is a Direct only if there are ongoing risks at the time of the inspection. Examples Facilities not maintained; animals escape (Section 3.1(a) Housing Facilities General) Death or severe injury to animal as a result of handling procedures; also behavioral stress due to handling non-compliances (Section Handling of Animals) Any untreated, prolapsed, open lesion/wound where the skin is pulled back to expose underlying tissue, muscle, bone (Section 2.40 AV and Adequate Vet Care)

Serious AEs are incidents that led to significant injury or illness, unrelieved pain or distress or death of a regulated animal. Inspection reports will reflect self-corrections made by a facility…to accurately portray the compliance status of the facility. A citation will be written if the incident resulted in Significant injury or illness Unrelieved pain or distress Or death as a result of a non- compliance with a regulation or standard.

Examples of Citations Issued

Harvard Medical School (Sept. 5, 2013) 9 citations from Feb 2011-July 2012 During a survival surgery, the anesthetist increased the dose of anesthesia for an NHP in response to monitoring parameters, but did not later adjust to a lower maintenance dose which caused acute renal failure. The NHP was euthanized. An NHP escaped from its enclosure when a research staff member was removing the animal for transport to another room for imaging. Patchy hair loss observed on 4 NHPs. The facility did not provide special attention to these animals. The facility failed to ensure that all employees were properly trained and qualified to perform their duties. Employee failed to observe that a watering device was not functioning. 2 NHPs became dehydrated. One had to be euthanized. An employee failed to provide a water bottle to a NHP, which became dehydrated and was subsequently euthanized. $24,036

Harvard Medical School 9 citations from Feb 2011-July 2012 $24,036 NHPs escaped from their enclosure when a food hopper was not secured properly. During a pre-MRI x-ray, a foreign object was found in an animal. A researcher, who was not a vet and was not listed on the protocol, removed the foreign object. A NHP sustained a fracture of the rear leg tibia and fibula when its leg was caught under a drop door as it closed during a routine enclosure change. The facility failed to protect a NHP from injury when the animal died with the chain from an EE toy wrapped around its neck. A NHP escaped from its enclosure and caused injury to another NHP. During an inspection, the VMO observed a NHP that had a metal object in its mouth. The object was determined to be a metal clip from an EE device fastener.

OFFICIAL WARNING

OFFICIAL WARNING

OFFICIAL WARNING

OFFICIAL WARNING

Fined $3,143