Inspections and the Appeals Process

Dr. Carol ClarkeUSDA, APHIS, Animal Care

2014 IAA State College, PA

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 ExpertiseBreeders/DealersTransportersExhibitorsResearch FacilitiesEmergency Management Bio-physiologyElephantsNon-Human PrimatesBig Cats/Marine MammalsDog/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 availableCorrection: always have a person with access

• Required documentation not maintainedCorrection: 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

• 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

Agency/ Organization

Frequency of visitation

Announced Regulatory Authority

Focus

USDA-APHIS

Annual Inspections Or as often as needed

No Animal Welfare Act:P.L. 89-544 § 2146a

Minimize pain/distress

NIH-OLAW Site visits are Ad hoc or for cause

Yes Health Research Extension Act P.L. 99-158 § 495

PHS policy & ILAR Guide 8th ed

FDA Inspections every 2-3yrsDepending on # of GLP studies

No Food, Drug, & Cosmetics ActP.L. 75-717

Compliance with GLP mandates

AAALAC Site visits are every 3yrs

Yes None Program accreditation

Inspection of Research Facilities

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

No NCIs 1172 (68%)

1086 (70%)

1109 (73%)

1156(77%)

NCI: Non compliant itemDirect NCI: A violation that directly affects animal health & well-beingRepeat 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

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

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

incidentsDeemed 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)

• 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

New Appeal Process

Team consists of: • The Regional Director,• Asst. Regional Director of the other region, • Subject Matter Expert

All decisions final

Your VMO or Regional Office is available to listen!

Get updates through our stakeholder registry

https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new

Animal Care is Available for Guidance