Agencies Seek Ideas for Reducing Administrative Burden

Three federal agencies are conducting a review of animal welfare oversight regulations in response to a Congressional mandate to “reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.” As part of this effort, representatives of NIH, USDA, and FDA held a listening session on January 9, 2018. The mandate stems from a bill known as the 21st Century Cures Act that won overwhelming bipartisan support in both the House and Senate and was signed into law in December, 2016. It authorized new research directions at the NIH and called for improvements in drug approval processes at the FDA. It also included a provision instructing NIH, USDA, and FDA to “take steps to eliminate or reduce identified inconsistencies, overlap, or duplication” of animal welfare oversight regulations and policies.

At the January 9 meeting, Patricia Brown, head of NIH’s Office of Laboratory Animal Welfare, (OLAW) explained that an inter-agency working group has been meeting quarterly since February, 2017 and is now seeking input from stakeholders. A request for public comments will be issued soon in the Federal Register, and additional agency listening sessions will be held throughout 2018. The discussion topic on January 9 was, “What could OLAW, USDA, & FDA change to reduce burden on researchers?” In addition to Brown, the other officials present were Betty Goldentyer of USDA’s Animal and Plant Health Inspection Service and Estella Jones of the Food and Drug Administration. Some 50 people attended the session, and others participated via conference call. Participants included representatives of research institutions, professional associations, and animal rights groups.

One recurrent topic of discussion was the report Reforming Animal Research Regulations published in October, 2017. This report was based upon a workshop convened several months earlier by FASEB, the Association of American Medical Colleges, Council on Government Relations, and National Association for Biomedical Research. Workshop participants sought to identify ways to improve the efficiency of animal research oversight in light of the 21st Century Cures mandate. (For more information about this report, see “Groups Urge Streamlining Animal Research Oversight.”)

J.R. Haywood, an APS member who is also a Past President of FASEB and one of the workshop organizers, submitted Reforming Animal Research Regulations for the record and explained its genesis. He noted that the current oversight system has been in place for 30 years and has been expanded, but not reviewed critically. Workshop participants were therefore asked to suggest changes that could make the system more effective in both protecting animals and advancing research. He underscored that addressing both of these considerations was the guiding principle for the workshop.

American College of Laboratory Animal Medicine President Stuart Leland recommended that the agencies apply a risk-based approach to animal research review requirements, similar to the approach used for human subjects’ research under the Common Rule. By using a tiered system according to the nature of the activity, agencies and institutions could calibrate the review process according to what is needed to ensure the animals’ welfare.

Norman Peterson of MedImmune urged the agencies to engage pharmaceutical companies, pointing out that they are also stakeholders in the regulatory process and have important expertise to share.

Ellen Paul spoke on behalf of the Ornithological Council, a coalition of 11 scientific societies whose members study more than 10,000 different species of birds. She noted that divergent requirements from different agencies can make it difficult for ornithologists to know which rules apply to their work. She also urged the agencies to seek input from researchers earlier in the regulatory process and to avoid issuing internal guidance documents that skirt the formal rulemaking process.

Representatives of several animal rights groups objected to the premise of the meeting. They urged the agencies to expand upon existing regulations rather than seeking to reduce them. Many also offered suggestions that would require changes to current laws, which may be beyond the scope of the current inter-agency review. Several also criticized recommendations of the Reforming Animal Research Regulations report.

Cathy Liss of Animal Welfare Institute (AWI) questioned whether there were any data showing that animal research regulations are burdensome to scientists. She called it “appalling” that agencies would consider reducing regulations and said her organization would “vehemently oppose” any reduction in protection to animals.

Alka Chandna of People for the Ethical Treatment of Animals (PETA) said that her organization believes that the recommendations of Reforming Animal Research Regulations would “gut the current, minimal protections” provided to research animals.

Ryan Merkley of Physicians for Responsible Medicine (PCRM) said that to reduce regulatory burden, agencies should reduce the use of animals. He suggested that this might be done by requiring researchers to use alternative methods when available and by removing the FDA’s requirement for animal safety and efficacy data to be submitted for new drugs.

Jennifer Ball of Humane Society of the U.S. (HSUS) called upon the agencies to “streamline” regulations by requiring the “highest level of care for the most animals.”

Sue Leary of Alternatives Research and Development Foundation (ARDF) urged the agencies to apply the Guide for the Care and Use of Laboratory Animals more broadly and to harmonize U.S. regulatory requirements with those of other countries.