USDA Inspections and the Appeal Process - CClarke

Report
Inspections and the Appeals Process
2014 IAA State College, PA
Dr. Carol Clarke
USDA, APHIS, Animal Care
Animal Care
Deputy Administrator – Dr. Chester Gipson
Headquarters
Riverdale, MD
Regional Offices
Raleigh, NC
Fort Collins, CO
Center for Animal Welfare
Kansas City, MO
Areas of Expertise
Breeders/Dealers
Transporters
Exhibitors
Research Facilities
Emergency Management
Bio-physiology
Elephants
Non-Human Primates
Big Cats/Marine Mammals
Dog/Cat Kennels
Total: ~224 employees
Animal Welfare Act
Public Law 89-544,
US Code 7 § 2131-2159,
A statute enacted by
Congress in 1966.
This law governs the
care & use of animals in
research for both gov’t
& non-gov’t facilities
Animal Welfare
Regulations
Code of Federal Regulations
9 CFR Chapter 1Subchapter A.
Every regulation listed in the
CFR must have an enabling
statute (in this case the AWA).
The purpose of the
regulations is to describe in
greater detail how an agency
should interpret the law.
Animal Care Resource Guide Policies
Guidelines for regulation interpretation updated 3/2011
The Inspectors
• Qualified veterinarians who are graduates of
accredited veterinary schools
• Receive comprehensive training in the
regulatory requirements through the Center
for Animal Welfare.
• Perform duties using the Inspection Guide as
a tool
Inspectors are allowed access
§2.38 (b): Access of records & property
• During business hours APHIS official allowed to:
–
–
–
–
Enter the business,
Examine required records and make copies,
Inspect where deemed necessary,
Document findings of noncompliance (pictures, other
means)
FYI: Citations can occur when….
• Records not available for inspection
– Person with keys or access not available
Correction: always have a person with access
• Required documentation not maintained
Correction: check via semiannual inspection
Risk Based Inspection System
• RIBIS is an Animal Care internal system
which determines how often an inspector
visits a facility
• This system is proprietary hence not for
public access
Annual Inspections
• Cannot substitute the USDA Annual
inspection with one from another agency.
– Annual visit mandated under AWA § 2146a
– A change is an act of Congress
Inspection of Research Facilities
Agency/
Organization
Frequency
of visitation
Announced
Regulatory Focus
Authority
USDAAPHIS
Annual
Inspections
Or as often
as needed
No
Animal
Minimize
Welfare
pain/distress
Act:
P.L. 89-544
§ 2146a
NIH-OLAW
Site visits
are Ad hoc
or for cause
Yes
Health
Research
Extension
Act
P.L. 99-158
§ 495
FDA
Inspections
every 2-3yrs
Depending
on # of GLP
studies
No
Food,
Compliance
Drug, &
with GLP
Cosmetics mandates
Act
P.L. 75-717
AAALAC
Site visits
are every
3yrs
Yes
None
PHS policy &
ILAR Guide
8th ed
Program
accreditation
Harmonization
The USDA, FDA and NIH have a
MOU to ensure consistency between
agencies.
AWA §2145: Consult and cooperate with
other federal and state agencies
The Animal Welfare Inspection Guide
• Designed to facilitate the decision-making
process of the inspector
– Not designed to replace professional judgment
• It is a tool to provide consistency & improve the
quality of inspections
– It is not a regulation or a policy
• Available to public due to USDA commitment to
transparency
Animal Care Information System
• ‘ACIS’ was developed in 2011
• Provides public access to inspection and
annual reports
• A revised ACIS is expected at end of 2014
Facilities and Inspections
FY 2010
FY 2011
FY 2012
FY2013
# of RFs
1111
1097
1112
1124
# of Inspections
1725
1616
1528
1493
# of Direct NCIs
22
26
36
27
# of Repeat NCIs
93
65
91
68
1172
(68%)
1086
(70%)
1109
(73%)
1156
(77%)
No NCIs
NCI:
Non compliant item
Direct NCI: A violation that directly affects animal health & well-being
Repeat NCI: A violation that was previously cited
Self –Reporting Required
• Change of operations:
– 9 CFR Ch.1 Subpart C AWR §2.30 (c) (1)
• Protocol suspension:
– 9 CFR Ch.1 AWR §2.31 (d)(7)
• Uncorrected deficiencies from semi-annual inspection
– 7 USC Ch. 54 AWA § 2143(b)(4)(C)
• The Annual Report
– 9 CFR Ch.1 Subpart C AWR §2.36 (b)
FYI: Self-Reporting
Not Required
Unapproved activities discovered during PAM
• May require an Amendment
• May be a precursor to IACUC suspension
Unexpected animal deaths
• Study related (unanticipated adverse event)
Incidents
• Over heating deaths
• Going through cage wash
FYI: Self-Reporting
PROS
A sign of good faith
 AWA § 2149(b)
The proper persons are
informed before
problem is discovered
by the VMO or public
CONS
FOIA requests
– IACUC minutes
Self-Correction
No Citation: The IACUC found the problem in a
timely manner, took timely and appropriate
corrective action, no ongoing pattern of
violations, and there were no serious animal
welfare impacts associated with the current
problem
Citation: The problem was not discovered
and/or corrected in a timely manner, and/or
there is a regular pattern of ongoing AWA
violations, and/or there were serious animal
welfare impacts
“They all look like
this after surgery.”
“They all look like
this after surgery
with post-operative
analgesia.”
Citations
• The incident that adversely affected
animal health and well-being which was
self -corrected will not be designated as a
direct NCI
• Inspection report may include the self correction at the discretion of the inspector
HVAC Failure with Deaths
IACUC investigation:
– System was properly serviced and included
appropriate back-ups, fail safes, and alarms
– Determined failure to be an act of nature
Facility self reported to USDA
USDA Decision - No citation
No recent enforcement actions or similar
incidents
Deemed an act of nature
Revised: Appeal Process
Old System
• 1st Appeal: Submitted in
writing & reviewed by the
Inspector’s supervisor(30d)
• 2nd Appeal: Submitted in
writing & reviewed by the
RD (30d)
New System
• Discuss with Inspector
during visit or exit briefing
• If unresolved, written
appeal submitted to the
Regional office within 21d
of report.
• No appeal accepted after
• Further: RD confers with
Deputy Administrator (30d)
21d
New Appeal Process
Team consists of:
• The Regional Director,
• Asst. Regional Director of the other region,
• Subject Matter Expert
All decisions final
Animal Care is Available for Guidance
Your VMO or Regional Office is available to listen!
Get updates through our stakeholder registry
https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new

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