Inotiv’s top priority has been and always will be practicing appropriate standards of animal welfare. We strive to maintain facilities that are compliant with applicable federal, state, and local laws and regulations and consistent with our core value to always do the right thing.
On June 3, 2024, we announced an agreement with the U.S. Department of Justice to resolve a previously announced investigation into the shuttered legacy Envigo canine breeding facility located in Cumberland, Virginia.
With the resolution of this matter, we are able to turn our full attention back to providing our customers with the tools and solutions they need to conduct critical drug discovery and development efforts that are essential to saving human lives.
We want to ensure that Inotiv’s valued customers, partners, employees, and all of our stakeholders have a comprehensive understanding of the facts of this matter and our longstanding and core commitment to the welfare of our animals.
Immediately after acquiring Envigo in November 2021, Inotiv invested approximately $3 million to improve the Cumberland facility and address staffing shortfalls. We believe we made considerable strides in improving conditions at the Cumberland facility, and we were committed to addressing the issues identified by the USDA as quickly as possible after the acquisition, but the government intervention led to the closure of the Cumberland facility, halting the progress we had made.
The Cumberland facility ceased commercial operations in September 2022.
Our Longstanding Commitment to the Welfare of Our Animals
We operate under strong governing principles and a universal code of conduct . We uphold our commitment to scientific integrity and our ethical responsibilities to our animals, employees, and customers.
We regularly review and evaluate our facilities to ensure compliance with the law and our own internal code of conduct, and that our operations reflect industry standards and best animal welfare practices.
Our operations are underpinned by a set of defined best-in-class animal welfare principles that actively foster a culture of care at all levels of the company across all operations.
Our Animal Welfare Principles
- There will be a sustained investment program and maintenance schedule to ensure animal facilities, plant and equipment meet national guidelines, codes of practice and operating criteria
- Each operating establishment will have policies, systems and procedures supporting local (national) legislative compliance and best animal welfare practices
- Each operating establishment will provide sufficient and adequately trained staff to ensure legislative compliance and maintenance of high animal welfare standards
- Each operating establishment will maintain an animal welfare and ethical review body (AWERB) or an institutional animal care and use committee (IACUC) where required
- AWERBs and IACUCs, where appropriate, will have responsibility for overseeing ethical review standards and processes, standards of animal care (including environmental and social enrichment) and the application of the 3R principles – reduction, refinement and replacement — to all study protocols. If an AWERB or IACUC does not exist that responsibility lies with local management
- Animal care and technical staff will hold the necessary qualifications appropriate to their positions and responsibilities
- All members of the animal care and technical staff will receive education and training commensurate with their positions and responsibilities
- All members of the scientific (animal studies) and animal care staff will be encouraged to undertake continuing professional development (CPD) in the field of laboratory animal science, with special reference to animal welfare and the 3R’s
- Members of the scientific and animal care staff will be encouraged and supported in the publication and presentation of material which will further the dissemination of information on animal welfare and the application of the 3R’s
1. What were the terms of the resolution?
Please find details of the resolution in our press release announcing the resolution, available here.
2. What processes have been put in place to ensure this doesn’t happen again and ensure proper animal welfare across all our facilities?
Across our entire business, we are committed to the welfare of the animals in our care and operate under strong governing principles and a universal code of conduct. We regularly review and evaluate our facilities in an effort to ensure that our operations and animal facilities meet applicable standards for quality, safety, and animal welfare.
Additionally, the USDA and independent auditing organizations such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) regularly inspect all of our facilities. We are committed to making every effort to comply with applicable federal, state, and local laws and regulations concerning animal welfare, and we seek to address areas of improvement identified by internal or outside assessments.
3. What standards do you follow to ensure adequate care and treatment for the animals in your care?
We adhere to the animal welfare standards required by the applicable federal, state, and local laws and regulations in the areas in which we operate. In addition, our breeding operations also voluntarily endeavor to follow the standards set out by the AAALAC Guide, and our compliance with those standards is regularly audited by AAALAC.
Our overall ethos and approach with respect to animal welfare are codified by internal policy. You can find our governing principles and code of conduct here.
4. What is the status of the Cumberland facility?
The Cumberland facility ceased commercial operations in September 2022 and is now closed.
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