New Federal Legislation Would Require Broad Reporting of Animal Use Data

Representative Ken Calvert (R-CA) has introduced H.R. 816, the Federal Accountability in Chemical Testing (FACT) Act. The bill would amend the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 and would add a requirement that federal agencies must “include a description of the progress on the development, validation, acceptance, and utilization of alternative test methods (including animal use data by species, number, and test type) for toxicological testing conducted, supported, or required.” In short, Calvert’s bill would require the addition of animal census information for all research species (including rodents) to be included in the biannual ICCVAM report. The legislation would appear to represent an additional reporting requirement for federal agencies. Agencies affected include: USDA, DOD, DOE, Department of Interior, DOT, EPA, FDA, NIH, OSHA and the Agency for Toxic Substances and Disease Registry. The impact of this legislation likely extends beyond federal agencies, as a number of them require animal testing to be conducted outside the agency.

The introduction of the bill was stirred by the White Coat Waste Project (WCW), an animal activist organization that aims to end the use of animals in federally funded research. WCW is engaging with Republican members of Congress by claiming taxpayers could save money by eliminating animal research at the federal level. According to WCW’s website, its approach is to “drain the swamp: cut government spending that hurts animals and taxpayers.”

At the time of this writing, the bill has acquired 13 cosponsors: Representatives Ed Royce (R-CA), Vern Buchanan (R-FL), Mike Bishop (R-MI), Dina Titus (D-NV), Betty McCollum (D-MN), Tom Marino (R-PA), Lucille Roybal-Allard (D-CA), Raul Grijalva (D-AZ), Earl Blumenauer (D-OR), Peter DeFazio (D-OR), Mike Quigley (D-IL), Eliot Engel (D-NY) and Julia Brownley (D-CA). The bill has been referred to the House Energy and Commerce Committee and will remain alive until the end of the legislative session in December of 2018. For the full bill text, click here.

USDA’s APHIS Removes Enforcement Action Database; Information Still Available Through FOIA

UPDATED - February 9, 2017

On Friday, February 3, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) notified stakeholders that during the last year it had “conducted a comprehensive review of the information it posts on its website” and “will remove from its website inspection reports, regulatory correspondence, research facility annual reports, and enforcement records that have not received final adjudication.”  The move impacts information related to research facilities subject to the Animal Welfare Act and entities subject to the Horse Protection Act.

APHIS indicated that such records can be requested under the Freedom of Information Act (FOIA) and will be released when authorized and in a manner consistent with the FOIA and Privacy Act.  NABR members attempting to access information on the APHIS website will notice changes including deactivation of the Animal Care Search Tool known as ACIS. The only information currently available on the website is a list by name and state of licensed and registered facilities.

The APHIS website changes have been widely reported by news media as an “abrupt removal” of information and animal rights groups have speculated that the changes may be driven by the new administration.

However, it is more likely the changes are related to a federal lawsuit filed by individuals and organizations involved with the horse industry in a February 2016 filing against USDA in the U.S. District Court for the Northern District of Texas (Contender Farms vs. USDA). The lawsuit alleges that APHIS’ publication of enforcement actions is unlawful, misleading and falsely identifies thousands of people who never received notice of an alleged violation, never had a USDA complaint filed against them and were never afforded the opportunity for a formal hearing as “violators.”

In reviewing the information currently available to NABR, the net result of this action appears to be that all of the information available on the USDA website related to inspection and annual reports will still be available to anyone who files a FOIA request with the personally identifying information redacted. FOIA requests can be filed here:

UPDATE - February 9, 2017

NABR supports transparency for information that serves the public good. Historically we have found USDA enforcement data extremely valuable in tracking and analyzing animal use trends in research. We hope the USDA can strike the proper balance between protecting personal privacy and informing the public as expeditiously as possible.

NABR will continue to report as new information becomes available. Please continue to check your email, visit or follow us on Twitter.

Mice Playing Important Role in Promising New Tuberculosis Vaccine Trial

A new tuberculosis (TB) vaccine is showing promise in mice trials and if successful could be the first new TB vaccine since 1921, reports Science Daily. “Biobeads,” natural polyesters that non-TB bacteria assemble into small spheres, are used by the vaccine as a vehicle to deliver antigens from the TB bacterium into the immune system. In earlier studies, these E. coli biobeads provoked immune responses in mice that could potentially protect against TB. 

According to principal investigator Axel Heiser, PhD, “We saw evidence of cell-mediated immunity with the potential to be protective against TB. Future studies will include a vaccination followed by challenge with TB to show protection, and also the development of more efficient production and purification methods for the vaccine.” Using these mycobacterial biobeads could provide a new, cost-efficient alternative to live vaccines by creating a platform for combining large antigenic capabilities without the use of infectious material.   
The news of a potentially new TB vaccine for global public health is very noteworthy, especially for low and middle-income countries. According to the Centers for Disease Control (CDC), 10.4 million people contracted TB in 2015, resulting in 1.8 million deaths worldwide. The World Health Organization says that nearly half a million of the new cases were multidrug-resistant, with 95% of the deaths occurring in low and middle-income countries. 
The availability and effectiveness of a new TB vaccine would be a tremendous advancement for public health worldwide. The nearly century-old vaccine has numerous shortcomings, one of which is possibly creating the infection in immunocompromised patients.  
To read news coverage on this exciting discovery, please click here.

BBC Reports New Study with Mice Could Be Breakthrough in Hearing Loss

According to a news report by the BBC, a study recently published in Nature Biotechnology has shown great advances in the treatment of hearing loss. Researchers at Boston Children’s Hospital and Harvard University have found that a synthetic virus based on an adeno-associated virus already used in gene therapies can remedy Usher syndrome in mice.

Usher syndrome is a disorder which causes the sound-sensing hairs in the ear to grow incorrectly, leading to substantial hearing loss. However, after being given a dose of the virus, which contained the correct genetic material for the sound-sensing hairs, previously deaf mice were able to hear sounds as quiet as a whisper, or 25 decibels, for at least six months.

At this stage researchers are unsure if this treatment will be able to correct Usher syndrome in newborn babies, given that babies’ ears are much more developed than those of newborn mice but this study is an important step forward in the quest to correct hearing loss in both animals and people.

To read more about Usher syndrome and these exciting results, please click here.

NABR Provides Members with Tracking Sheet for Mandatory Lab Animal Adoption Bills

In order to keep NABR members informed and up-to-date on legislative matters affecting animal research, NABR has created a document tracking the mandatory research dog adoption bills that have been introduced in state legislatures thus far in 2017. The document provides detail for each proposed adoption bill, including the sponsor and a summary of the impact of each bill. In addition, it provides a timeline tracking the status of the bills as they progress through each state legislature, noting key information and highlighting important future dates.

NABR recognizes the importance of keeping a finger on the pulse when it comes to important legislation that will directly affect the work of its member organizations and biomedical research. We anticipate this document will become a key tool for researching and assessing state legislative developments that directly impact biomedical research efforts. Click here to find the full tracking chart in the Legislative portion of NABR’s Members Only section (log-in required). It will be updated as bills progress, so make sure to check often to stay up to date on the status of these bills.

Live Vaccines Could Mean Fewer Veterinary Visits

Did you know that our pets can contract the influenza virus?  We may someday be able to thank biomedical research for helping us avoid another trip to the veterinary office. A team of researchers at the University of Rochester School of Medicine and Dentistry has developed two live vaccines that may help prevent the highly contagious canine influenza, as well as improve human health.

Led by Luis Martinez-Sobrido, Ph.D., associate professor in the Department of Microbiology and Immunology, the team developed a live vaccine that replicates in the main point of entry for the virus—a dog’s nose—which could prevent the virus from spreading to the rest of the body. The results of the study showed that the vaccine is not only safe, but also more effective in protecting dogs against the H3N8 canine influenza virus than currently available inactivated vaccines.

Martinez-Sobrido’s team also used a new technique to remove the NS1 protein from the H3N8 canine influenza virus, successfully weakening the flu virus so an immune response is created without the unpleasant accompanying illness. This approach has been shown to potentially be more safe and effective than the traditional inactivated H3N8 vaccine.

Next, the team will test the two live vaccine approaches in clinical trials with dogs. They ultimately hope to address the spread of influenza in shelters and kennels, as well as from dogs to humans. This research is further being used to address other dog flu viruses, including the H3N2 canine influenza. Early studies indicate that the H3N2 live-attenuated vaccine outperforms the only currently available inactivated vaccine in protecting against the H3N2 virus.

To stay up to date on new studies in the animal research community, make sure to follow NABR on Twitter.

Veterinary Medicine Day Declared in Georgia!

The Georgia State Senate has passed SR79, legislation marking February 8, 2017 as Veterinary Medicine Day at the state capitol.

The resolution, passed last Thursday, January 26, recognizes all veterinarians for the scientific knowledge and skills that they contribute towards the protection of animal health and welfare and for their commitment to the betterment of the animal world.

SR79 acknowledges the importance of veterinary medicine by proclaiming, “veterinarians use their scientific knowledge and skills for the benefit of society through the protection of animal health, the relief of animal suffering, the conservation of livestock resources, the promotion of public health, and the advancement of medical knowledge,” adding that they, “protect, promote, and preserve the public health, safety, and welfare of the citizens of Georgia.”

New NABR President Emphasizes that Animal Research Also Saves Animals

Matthew R. Bailey has been named President of the Foundation for Biomedical Research (FBR) and the National Association for Biomedical Research (NABR). He was previously the Executive Vice President for both organizations. “The ultimate goal of FBR and NABR is to educate the public and policy makers about the irreplaceable role of animal research,” Bailey said, “and we will do that by demonstrating how animal research improves the lives of both humans and companion animals.”

“The public often gets caught up in the myth that animal testing and research doesn’t translate to humans,” said Mr. Bailey. “We forget that animal testing and research actually helps animals’ lives, too.”

“Last year, Americans spent $60B on their pets, much of it on pet healthcare. It is imperative every pet owner understands that without animal research their pets wouldn’t benefit from new veterinary treatments for cancer, new vaccines for emerging diseases, and the best possible nutrition available. Thanks to animal research our pets live longer and healthier lives than ever before.”

Bailey joined NABR in 2005, was appointed Vice President in 2008, and was appointed Executive Vice President in 2014. In early 2016, he was tapped to serve as Executive Vice President for NABR’s sister organization, the Foundation for Biomedical Research.

Frankie Trull, founder and former president of FBR and NABR, said of her successor, “I’ve had the opportunity to work with Matt and watch him grow as a leader for eleven years and I could not have left both organizations in better hands. He has demonstrated the energy and passion that has made FBR and NABR the premier advocates for the biomedical research community. I am confident that Matt will lead both organizations successfully into the next chapter.”

A deep dedication to supporting the search for cures and treatments for diseases is an undeniable requirement for such a role. And many who have worked with Matt agree that he is the right person for the job.

“Matt is an outstanding leader who brings great commitment to his work as a dedicated advocate for biomedical research,” said Claire Pomeroy, MD, MBA, President of the Albert and Mary Lasker Foundation and FBR Board Chair. “He passionately articulates the FBR message that ‘animal research saves lives’ and effectively brings together stakeholders ensuring that scientists are able to continue their research to improve both animal and human health. As we battle new diseases such as Zika, as well as long-standing illnesses including cancer and heart disease, his voice will help safeguard the efforts to create a healthier world through scientific inquiry.”

“The NABR Board is thrilled that Matt has chosen to assume this important responsibility. We are grateful for his leadership, and look forward to working with him as we advance the biomedical research mission,” said Mark Hamrick, PhD, NABR Board Chair and Regent's Professor, Medical College of Georgia.

As a government relations and communications professional with extensive experience in science and technology issues, Mr. Bailey’s Washington career has spanned more than 20 years. His expertise was instrumental in the bi-partisan passage of the Animal Enterprise Terrorism Act (AETA) into law which provides greater protection for the biomedical research community and their families against intimidation, threats, and harassment.

A graduate of the University of Arkansas at Little Rock, Mr. Bailey was appointed to serve as a Congressional Liaison for the United States Secretary of Commerce in 1996, and later went on to handle Congressional Affairs for the National Institute for Standards and Technology (NIST). His bi-partisan Capitol Hill experience includes time as both a legislative aide for Senator Dale Bumpers (D) of Arkansas and Representative Connie Morella (R) of Maryland.

As always, for the latest in news impacting the biomedical research community, please visit or follow us on Twitter.

BREAKING NEWS: Dr. Francis Collins to Continue as NIH Director for Now

According to the Washington Post, the National Institutes of Health (NIH) announced late yesterday that Dr. Francis Collins, the current director of the NIH, will remain on the job at least temporarily.

An NIH spokesperson said that Dr. Collins has been “held over by the Trump administration,” however it is unclear whether President Donald Trump (R) will formally reappoint him or if he will serve until a possible permanent director is selected. President Trump has asked some 50 senior members of the Obama Administration to stay on to assist in the transition.

Others rumored to be possible candidates for the top post at NIH have been physician and U.S. Representative Andy Harris (R-MD), biotech billionaire Patrick Soon-Shiong and Geoffrey Ling, former biotech director of the Defense Advanced Research Projects Agency (DARPA).

Dr. Collins, a geneticist, became director of the NIH in August of 2009. Because he was confirmed by the Senate during the Obama Administration he would not need to be reconfirmed if brought onboard by President Trump.

For more information on this breaking news, please see the coverage by the Washington Post, Science, and Nature.

As always, for the latest in news impacting the biomedical research community, please visit or follow us on Twitter.

NABR Submits Comments to FDA on GLP Proposed Rule

Last August, the Food and Drug Administration (FDA) published a proposed rule the in the Federal Register (Vol. 81, No. 164) titled, “Good Laboratory Practice for Nonclinical Laboratory Studies” [Docket No. FDA–2010–N–0548]. FDA has proposed amending the current regulations to require a complete quality system approach which they refer to as a GLP Quality System.

The proposed system would be required for safety and toxicity studies to support applications or submissions to the FDA. Proposed changes that would impact animal research facilities include additional management responsibilities, changes to SOP procedures and changes to address the management of multisite nonclinical laboratory studies.

NABR submitted comments to the FDA this afternoon, expressing concern that creating additional rules would be redundant with existing regulations and confusing for researchers, as research facilities are already governed by numerous other animal welfare requirements. A copy of our comments can be found here and NABR members are encouraged to use them as a basis for filing their own at Comments must be submitted by January 21, 2017.