- USDA Inspection & enforcement process - OIG audit of
APHIS - Identify potential areas of risk & how to reduce our
chances of citations
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USDAs 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.
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USDAs 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 USDAs
administrative law judges. Formal actions include license
suspensions or loss and/or monetary penalties.
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USDA Office of Inspector General APHIS Oversight of Research
Facilities Report December 2014 Objectives To evaluate the adequacy
of VMOs and IACUCs review of research facilities To determine the
effectiveness of IES role in imposing enforcement actions To assess
ACs new mission critical information system for reliability and
integrity To follow up on APHIS implementation of prior audit
recommendations (2010)
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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 2.131 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)
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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
facilityto 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.
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Examples of Citations Issued
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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
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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.
