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Inspections and the Appeals Process Inspections and the Appeals Process Dr. Carol Clarke USDA, APHIS, Animal Care 2014 IAA State College, PA.

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Presentation on theme: "Inspections and the Appeals Process Inspections and the Appeals Process Dr. Carol Clarke USDA, APHIS, Animal Care 2014 IAA State College, PA."— Presentation transcript:

1 Inspections and the Appeals Process Inspections and the Appeals Process Dr. Carol Clarke USDA, APHIS, Animal Care 2014 IAA State College, PA

2 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

3 Animal Welfare Act Public Law , US Code 7 § , A statute enacted by Congress in 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

4 The Inspectors 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

5 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)

6 FYI: Citations can occur when…. 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

7 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

8 Cannot substitute the USDA Annual inspection with one from another agency. –Annual visit mandated under AWA § 2146a –A change is an act of Congress Annual Inspections

9 Agency/ Organization Frequency of visitation AnnouncedRegulatory Authority Focus USDA- APHIS Annual Inspections Or as often as needed No Animal Welfare Act: P.L § 2146a Minimize pain/distress NIH-OLAWSite visits are Ad hoc or for cause Yes Health Research Extension Act P.L § 495 PHS policy & ILAR Guide 8 th ed FDAInspections every 2-3yrs Depending on # of GLP studies No Food, Drug, & Cosmetics Act P.L Compliance with GLP mandates AAALACSite visits are every 3yrs YesNone Program accreditation Inspection of Research Facilities Inspection of Research Facilities

10 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

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12 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

13 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

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15 Facilities and Inspections FY 2010FY 2011FY 2012FY2013 # of RFs # of Inspections # of Direct NCIs # of Repeat NCIs No NCIs1172 (68%) 1086 (70%) 1109 (73%) 1156 (77%) Non compliant item NCI: Non compliant item A violation that directly affects animal health & well-being Direct NCI: A violation that directly affects animal health & well-being A violation that was previously cited Repeat NCI: A violation that was previously cited

16 Self –Reporting Required 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)

17 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

18 PROS A sign of good faith AWA § 2149(b) The proper persons are informed before problem is discovered by the VMO or public CONS FYI: Self-Reporting FYI: Self-Reporting FOIA requests –IACUC minutes

19 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

20 “They all look like this after surgery.” “They all look like this after surgery with post-operative analgesia.”

21 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

22 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

23 Revised: Appeal Process Old System 1 st Appeal: Submitted in writing & reviewed by the Inspector’s supervisor( 30d) 2 nd Appeal: Submitted in writing & reviewed by the RD (30d) Further: RD confers with Deputy Administrator (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 21d

24 New Appeal Process Team consists of: The Regional Director, Asst. Regional Director of the other region, Subject Matter Expert All decisions final

25 Your VMO or Regional Office is available to listen! Get updates through our stakeholder registryhttps://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new Animal Care is Available for Guidance


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