June 7, 2018

GAO Releases Report on Federal Animal Research

You may recall that in February of 2017 sixteen Members of Congress requested that the Government Accountability Office (GAO) review transparency surrounding government-conducted studies involving animal models. The White Coat Waste Project (WCWP) touted it as the “first-ever audit of billions in spending on and transparency about federal experiments on dogs and millions of other animals.” On Thursday of last week, the GAO released its report entitled, “Animal Use in Federal Research: Agencies Share Information, but Reporting and Data Quality Could Be Strengthened.”

The 55-page report examined the reporting of animal use data in government studies and the transparency of these figures. The GAO found that the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) and the National Institutes of Health (NIH), “publicly report some data on animal use but do not report other data unless asked.” Additionally, GAO writes that APHIS does not provide adequate instructions to facilities it oversees when it comes to compliance with the Animal Welfare Act (AWA).

The report cites that APHIS’s instructions to research facilities are unclear regarding reporting research with birds, activities outside the United States, and field studies. The GAO reports that APHIS’s lack of voluntary sharing of data online for some studies using birds or field studies not covered by AWA provide “the public” with an incomplete picture of animal research. The GAO report recommends, among other things, that “APHIS clarify its reporting instructions and fully describe the potential limitations of the animal use data it makes available to the public.” You can find the four recommendations from GAO here: https://www.gao.gov/products/GAO-18-459.

Another interesting excerpt from the report is the list of organizations participating in GAO’s survey. WCWP, which has attempted to bill themselves as a taxpayer watchdog group on Capitol Hill and the media, finds itself listed on page 36 under “animal advocacy organizations” alongside the American Anti-Vivisection Society (AAVS), Animal Legal Defense Fund (ALDF), Humane Society of the United States (HSUS), People for the Ethical Treatment of Animals (PETA), and the Physicians Committee for Responsible Medicine (PCRM), all well-known opponents to ethical and humane animal research.

It is not yet known whether any legislative or regulatory action will come from last week’s report, but NABR staff plan to keep a close eye on the terrain ahead. NABR anticipates that the report will likely be used to promote the FACT Act (H.R. 816), federal legislation that seeks to require a full census of all animals in toxicological testing that is conducted, supported, required by, or submitted to the federal government. No action has been taken on FACT Act since its introduction last year. It is important to note that none of the animal rights groups listed in the GAO’s report, WCWP included, have pushed out any communications to the public about its findings.

NABR Submits Comments for NIH RFI on Regulatory Burden

The NIH released NOT-OD-18-152 on March 14, a Request for Information (RFI): Animal Care and Use in Research. The RFI’s stated objective is to assist the Office of Laboratory Animal Welfare (OLAW) with obtaining “information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d).” The background information of the notice states that “the NIH in collaboration with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) [will] complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions to reduce administrative burden on investigators. In carrying out this effort, the law requests NIH seek input to identify ways to ensure regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative.”

NABR has submitted comments to the RFI, which can be viewed here. Members are encouraged to read NABR’s comments and use the language for their own submittals. Responses must be submitted electronically at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=71 by June 12, 2018.

In the April 5th issue of the NABR Update we provided our perspective of the RFI. The RFI indicates that in carrying out the review mandated in the language of the 21st Century Cures Act, the NIH, USDA, and FDA will be reviewing several reports and surveys. However, there is no indication they will actually be conducting a review of applicable regulations and policies, nor seeking the input of experts where appropriate in this process, as required by the Act. The RFI’s stated goal is to seek input on only the three process-related duties of the Director of the NIH, rather than the primary mandate. The primary mandate in the 21st Century Cures Act, Section 2034(d) is the review and revision of applicable regulations and policies in order to provide regulatory relief to investigators. Moreover, the Act does not require the NIH Director to seek the input of experts on the three processes as presented. The fact the RFI is seeking input on “proposed actions that the agencies have identified to improve coordination and harmonization of regulations and policies” does not appear to be consistent with the mandate in the Act. Additionally, the word count restriction for submissions prevents the research community from fully providing its desired comments regarding the USDA’s current RFI, Identifying Regulatory Reform Initiatives.

Your Help Needed to Support Regulatory Relief

NABR still needs you and your institution to help push for a reform that will provide regulatory relief to the animal research community. NABR is working with offices in the U.S. Senate to introduce an amendment to their version of the Farm Bill which would strike the mandated annual USDA inspections while maintaining the Secretary’s authority to conduct “at-will” inspections. This would change would facilitate full use of the USDA’s Risk Based Inspections System, which is currently employed for all other regulated entities under the Animal Welfare Act (AWA), thus harmonizing the act. To be clear, this modification makes NO CHANGE to the Agriculture Secretary’s ability to conduct inspections as frequently as he deems necessary.

NABR strongly supports this move toward regulatory relief for the biomedical research community and improved flexibility for the USDA to focus efforts on problematic facilities.

• The National Science Board (NSB) has reported that researchers spend as much as 42% of their time responding to regulatory and administrative burdens.
• Numerous reports, including the October 2010 report by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the National Association for Biomedical Research (NABR) have made recommendations for reducing regulatory burdens in biomedical research.
• The 21st Century Cures Act, enacted last year, mandates that federal agencies overseeing animal research work to find ways to reduce regulatory burden.
• There are roughly 1,000 USDA registered research facilities, and currently, research is the only regulated sector required by the AWA to be inspected annually, in contrast with all other regulated animal entities under the Act.
• Year-to-date approximately 481 research facilities have been inspected, out of which only 2 were found to have any non-compliance directly related to animal welfare.
• In FY 2017, 82% of all research facility inspections resulted in NOcitations.
• Between FY 2006 and FY 2016, the number of citations directly attributable to research facilities dropped 87%.
• If this reform was realized, USDA would conservatively save $13,630,000 over ten years. The savings to the research community would be even greater. A single inspection, depending on the size of the research facility and duration of the inspection, can cost $1,321-$20,000. In a survey of 17 top research facilities, the average inspection cost was $5,780. This would average out to a savings of $57,800,000 over ten years.
• Taxpayer savings and regulatory relief would be realized if the annual inspection requirement were amended out of the AWA. This action would prevent needless routine inspections of consistently compliant facilities, and would encourage the use of USDA’s Risk-Based Inspection System in order to more efficiently focus efforts on problematic facilities. This action would also bring research into line with how USDA APHIS handles inspections for dealers, exhibitors, intermediate handlers, carriers, or operators of an auction sales.

How can you help? If your institution would like to send an individual letter of support or be added to the coalition letter, please contact Mike Dingell, NABR’s Vice President for Government Affairs, at mdingell@nabr.org. So far 44 organizations have joined the sign-on letter and 27 universities, associations, and societies have sent Congress their own letters.

Have You Registered for ’Q&A with the USDA’?

If you haven’t yet reserved your spot for NABR’s next webinar on Tuesday, July 24, please do so ASAP. NABR once again welcomes Drs. Elizabeth Meek and Bill Stokes, the Eastern and Western Region Assistant Directors for Animal Welfare Operations, to its headquarters for the Sixth Edition of "Q&A with the USDA." Drs. Meek and Stokes are directly responsible for the oversight of the inspection and reporting process. NABR members will have a unique opportunity like none other, to ask questions directly to the leadership of the USDA Animal Care’s Animal Welfare Operations. Rarely do organizations get this kind of direct access so be sure to mark your calendars.

All questions must be submitted in advance to info@nabr.org. They will be reviewed and formatted to prevent duplication and will be answered in the order they are received, so please submit them as soon as possible. We will schedule the session for an hour (12:30 p.m. – 1:30 p.m. Eastern), but will continue the webinar until all questions have been answered.

First Ever Celebrate Life Science Fair on Capitol Hill

The Federation of American Societies of Experimental Biology (FASEB) and the Coalition for Life Sciences (CLS) are hosting the inaugural Celebrate Life Science Fair on Capitol Hill on Wednesday, July 18 from 5:00 p.m. -7:00 p.m. in the Rayburn House Office Building, Room 2043 and 2044. This is a wonderful opportunity for the biomedical research community to engage Members of Congress and their staff about the advancements in public health because of scientific progress. Various sponsorship opportunities are available and booth space is limited because of space. Interested in learning more? Please click here.

FBR President Pens Thought-Provoking Piece in The Washington Times

The Washington Times ran an opinion piece by Foundation for Biomedical Research (FBR) President Matthew Bailey yesterday detailing the discoveries that animal research delivers to both humans and their beloved pets. The piece starts with the story of Dover, a 7-year-old bull mastiff suffering from lymphoma which caused him to go blind. Dover was enrolled in a clinical trial at Tufts University and the results were fantastic. The treatment restored the dog’s sight overnight and currently his cancer is in remission.

Take another example from the University of Pennsylvania, where researchers are working to save dogs with osteosarcoma, a type of bone cancer. Researchers there have developed genetically-modified bacteria that, once injected, enables the dog’s own immune system to attack the tumors. At University of California, Davis they have tested a treatment for heart disease which affects 1 out of 7 cats. UC Davis and Kansas State University have also teamed up to develop an antiviral drug to combat feline infectious peritonitis.

It is important for the research community to showcase stories like these because they illustrate the focus of FBR’s latest campaign, “Love Animals? Support Animal Research”  because animal lovers should be the most ardent supporters of animal research. Animal research not only saves human lives, but also many pets, as well. Forty-three million U.S. households have a dog, thirty-one million have a cat, and ninety percent of those Americans consider their pets part of their family. Unfortunately, our beloved pets suffer from cancer, diabetes, kidney and heart disease, and other ailments, just like their human counterparts. But animal research can provide hope for our furry family members while providing a foundation of scientific data and understanding to treat humans. To read Bailey’s piece click here and be sure to visit www.FBResearch.org to learn more about FBR’s “Love Animals? Support Animal Research” campaign.

Support the National Primate Research Centers, Visit their New Website Today!

The seven National Primate Research Centers have created a website and Twitter account to boost awareness of the importance of their work with animals to improve human and animal health and highlight their breakthrough research. NABR applauds the NPRCs for creating this visually stimulating and easy-to-understand website, and encourages readers to visit their site and Twitter feedtoday!