Inspections and the Appeals Process

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

2. Animal CareDeputy 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 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 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 Care Resource Guide Policies Guidelines for regulation interpretation updated 3/2011

4. 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…. • 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. 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

9. Inspection of Research Facilities

10. Harmonization The USDA, FDA and NIH have a MOUto ensure consistency between agencies. AWA §2145: Consult and cooperate with other federal and state agencies

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

15. Facilities and Inspections NCI: Non compliant item Direct NCI: A violation that directly affects animal health & well-being Repeat NCI: A violation that was previously cited

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

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 USDADecision - No citation • No recent enforcement actions or similar incidents • Deemed an act of nature

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

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

25. 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