The Reporting of Adverse Events at Research Facilities on USDA Inspection Reports

 

USDA Animal Care enforces the Animal Welfare Act, which regulates the use of certain animals in certain activities – including using covered animals for medical research, testing and education. We inspect facilities that conduct these activities to ensure compliance with the Animal Welfare Act and its associated regulations.

 

Serious adverse events are incidents that led to significant injury or illness, unrelieved pain or distress, and/or death of a regulated animal. Inspection reports will reflect self-corrections made by a facility of a serious adverse event to accurately portray the compliance status of the facility.

 

Inspection procedures regarding self-corrected serious adverse events are currently outlined in the Animal Welfare Inspection Guide¹ and the 2012 stakeholder announcement². A citation will be written if the incident resulted in significant injury or illness, unrelieved pain or distress, and/or death of the animal as a result of a non-compliance with a regulation or standard. In accordance with the memorandum of understanding³ which permits information sharing between USDA/APHIS and the National Institutes of Health’s Office of Laboratory Animal Welfare (OLAW), an inspector may choose to indicate OLAW’s decision regarding the incident on the inspection report when there is documentation.

 

We will not cite a facility for an incident if it caused no serious adverse effects, had no history of repeat noncompliance, was corrected timely manner, or led to effective preventative measures. A citation will be issued if any one of these criteria is not met.

 

We will not revisit complaints from third parties involving previously reviewed non-compliances or events that are over three years old unless new information has been provided. OLAW agrees with this approach, which is in accordance with the memorandum of understanding which is designed to foster continual improvements in animal welfare, reduce duplicity in oversight, and lessen regulatory burden.

 

We have created a tech note on this topic and have posted it here on our website.

 

 

At USDA Animal Care, ensuring the welfare of the animals we regulate is at the heart of everything we do.

 

 

Cited references:

1. http://www.aphis.usda.gov/animal_welfare/downloads/Inspection%20Guide%20-%20November%202013.pdf

2. http://www.aphis.usda.gov/publications/animal_welfare/2012/inspection_incident_response_sa.pdf

3. http://grants.nih.gov/grants/olaw/references/finalmou.htm