August 3, 2018
Congress Questions NIH Director on Regulatory Burden on Animal Research
On July 25, the Health subcommittee of the House Energy & Commerce (E&C) committee held a hearing titled “21st Century Cures Implementation: Updates from FDA and NIH.” A recording of the hearing can be viewed on the House E&C YouTube site. The intent of this hearing was to get an update from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) on their implementation of the 21st Century Cures Act.
Of interest to the animal research community is Section 2034(d) of the 21st Century Cures Act, enacted on December 13, 2016, which reads, “Not later than 2 years after the date of enactment of this Act, the Director of National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input of experts, as appropriate.”
On March 14 the NIH put out a Request for Information (RFI) regarding animal care and use in research in an effort to comply with Section 2034(d) of the 21stCentury Cures Act. However, in his written testimony submitted prior to the hearing, NIH Director Francis Collins included a section on reducing administrative burden and increasing efficiency, but did not mention animal research.
Two members of Congress on the Health subcommittee asked pointed questions of the Director on this issue. The first question came just after the 40:00 mark from Chairman Michael Burgess (R-TX), who asked, “We tried to identify ways to get regulations and policies that were inconsistent, and to give you some flexibility to move past some of these that are over-lapping and unnecessarily duplicative to relieve some of the administrative burden. I think the Act asked you to review that, so can you perhaps share with us where you are in the review and how NIH has identified some opportunities to relieve the burden on investigators?”
While Dr. Collins’ answer initially focused on how the NIH deals with grants, near the end of his answer he mentioned animal care and use by stating, “We’re looking right now at animal care and use and the oversight that is necessary, of course, to be sure that we’re dealing with animals in an ethical way. Some of those of those particular oversight mechanisms are now being reviewed. We put out an RFI and got 19,000 comments back from people who have opinions about how we might streamline these processes. Those are a few examples.”
Later, just after the 2:21:00 mark, Rep. “Buddy” Carter (R-GA) pushed Dr. Collins for a more direct answer by asking, “I wanted to ask about one of the initiatives of 21st Century cures, and that was to really review the regulations and policies with respect to research with laboratory animals. As I understand it you are working with USDA now and the FDA to try to complete a review of that. I wanted to ask you if you could tell us the current status of that review and when do you anticipate the completion of that review?”
Dr. Collins replied, “We did put out an RFI back in March to ask for comments in this area in terms of whether the oversight that we currently apply to animal experimentation is sufficient or whether it has areas that are overly bureaucratic, which has been a concern. Obviously, we are deeply concerned about maintaining our ethical responsibilities in terms of how we take care of animals that are subjected to various experimental approaches, from which we learn a great deal that has led to many medical advances. We got 19,000 responses to that request and they are currently being sorted at the moment. We would expect to have, based upon those, a draft set of recommendations about animal care and use sometime probably in September. We will then need to have responses to that. So, we would hope to have a final version of this by December, or early in 2019.”
Rep. Carter pressed further asking, “Any opportunities that you’ve identified thus far that may help you?”
Again, Dr. Collins highlighted grant issues by stating, “…I think there are concerns that some of the requirements that we put on grant applicants, in terms of animal care and use, could be delayed until the award is actually made as opposed to asking them to have all those things in place when they submit an application. That can add a lot of time and effort, and obviously our concern is that if we’re actually going to make the award we want to be sure that the animal care is being done in the best possible way. That is one area. Obviously, there are differences of opinion here and we’re seeing those in 19,000 responses and at some point, we have to try to come down on what we think is a fair and balanced approach.”
Research Animal Adoption Letter from 27 Members of Congress to Federal Agencies
Coming on the heels of a May 31 Government Accountability Office (GAO) report on animal use in federal research, a group of 27 lawmakers (18 Democrats and 9 Republicans) has written a letter urging federal agencies and research labs to release information on what happens to research cats, dogs, and NHPs after research is completed. The letter in question was reported by Roll Call and sent to the Department of Interior, the NIH, the VA, USDA, FDA, the Smithsonian Institution, the Centers for Disease Control and Prevention (CDC) and the Department of Defense.
The letter, which was obtained by NABR, states the NIH’s Office of Laboratory Animal Welfare as well as the American College of Laboratory Animal Medicine (ACLAM) supports the concept of animal adoption, yet “despite this guidance from NIH and independent experts, we were concerned to discover through our offices’ research a lack of formalized policies and procedures addressing this subject across federal agencies.”
As expected, the WCWP is the driving force behind this letter. Their motivations are made clear by the letter’s request for fiscal year 2016 and 2017 data on the number of cats, dogs, and NHPs used by the agencies in question and data on how many were adopted or retired in another manner. NABR anticipates this information will likely be used to attack federal agency animal research and possibly to push additional anti-research legislation at the federal level. A full list of the legislators who signed this letter can be viewed here: https://www.rollcall.com/news/politics/bipartisan-group-wants-labs-disclose-research-animals-end.
MA Legislature Advances Mandatory Adoption Bill, Time Runs Out on Formal Session
At the eleventh hour, just days before the end of the formal legislative session in Massachusetts, the State Senate passed S. 2624, An Act Protecting Research Animals, also known as the “Beagle Bill.” These mandatory research animal adoption bills are being pushed in multiple states by the Rescue + Freedom Project (R+FP), formerly known as the Beagle Freedom Project.
The State Senate passed S. 2624 on July 26 by a 38-0 vote whereupon it was sent to the House Ways and Means Committee. The clock ran out on this bill as the formal Massachusetts legislative session ended at midnight on July 31. However, NABR will continue to monitor this bill during the informal session. It is important, especially considering the unanimous vote in the Senate, for animal research institutions in the state of Massachusetts to double-down on their efforts to educate their legislators on the life-saving benefits of their work. NABR strongly encourages working closely with the Massachusetts Society for Medial Research on these efforts.
Wisconsin Town Facing Research Animal Ban
The Village of Mt. Horeb, WI will be allowing residents to vote on a referendumwhich gives input on an ordinance that would, “prohibit people from having animals in the village for the purpose of sending them for testing.”
Local citizens have collected over 650 signatures which they presented to the Village Board on August 1. The board considered either adopting the ordinance immediately or approving a resolution to put the ordinance on November’s ballot. The board chose the latter resolution, so this ordinance is set to be a referendum item on the November ballot in Mt. Horeb. This referendum demonstrates that the animal rights movement is continuing to push their agenda at the state and local level, as their federal initiatives largely flounder in Congress.
New VA Secretary Confirmed
On July 23, Acting Secretary Robert Wilkie was confirmed as the next Secretary for the Department of Veterans Affairs (VA) by a 86-9 vote in the Senate. VA secretaries typically have been confirmed by unanimous vote. The nine lawmakers who voted against Wilkie’s nomination were: Sens. Bernie Sanders (I-VT), Kirsten Gillibrand (D-NY), Kamala Harris (D-CA), Dianne Feinstein (D-CA), Ron Wyden (D-OR), Jeff Merkley (D-OR), Jeff Merkley (D-OR), Cory Booker (D-NJ), Elizabeth Warren (D-MA), and Ed Markey (D-MA).
The VA, over the last year, has been a target of animal rights activists from the White Coat Waste Project (WCWP). This organization pushed the introduction of H.R. 3197, also known as the “PUPPERS” Act, legislation which would prohibit the use of research with canines at the VA. NABR strongly opposes this legislation and will continue to our work to inform the Secretary as well as Members of Congress about the benefits of biomedical research for the veteran community. You can read Secretary Wilkie’s biographical information here: https://www.defense.gov/About/Biographies/Biography-View/Article/1394799/robert-wilkie/.
WCWP Takes (Another) Victory Lap Over EPA Probe
White Coat Waste Project (WCWP) President Anthony Bellotti posted a blog post on the WCWP website on July 19 claiming victory over the Environmental Protection Agency (EPA) in their ongoing campaign against animal research. This post, or more precisely this re-post of old news, claims their very public anti-EPA campaign coincides with the House of Representatives “voting to urge the EPA to reduce in-house animal tests.” They previously claimed language passed in a fiscal year 2019 EPA funding bill in the House of Representatives was a result of their efforts alongside the New England Anti-Vivisection Society (NEAVS).
The report language they cite simply reads, “The Committee commends EPA for recent progress towards reducing unnecessary animal testing by promoting the adoption of cutting-edge methodologies that allow chemical screening more efficiently and cost-effectively. The Committee encourages EPA to ensure that the Agency’s own research is also the subject of Agency efforts to reduce and replace animal tests.”
The biomedical research community currently engages in the adoption of three R’s; reducing, refining, and replacing animal models wherever possible. Despite this, WCWP is using the Committee report language to attack life-saving methodologies as, in the words of Rep. Matt Gaetz (R-FL), “horrific and inhumane.”
Animal Activist Previously Sentenced Under AETA Released from Prison
Nicole Kissane, an animal rights extremist, was released from prison on July 20. The release was profiled via a support web page and Facebook page. Kissane pled guilty to conspiracy to violate the Animal Enterprise Terrorism Act (AETA). Kassane admitted to illegally releasing minks from farms across the country and vandalizing the Furs by Graf store in San Diego. Further, she pled guilty to vandalizing La Mesa and Spring Valley homes of the Furs by Graf owner and the owner’s parents in 2013. Kissane was sentenced to 21 months in January 2017 while her co-defendant, Joseph Buddenberg, was sentenced to two years in prison in May 2016.
ICYMI: Last Week’s Members-Only Webinar Now Available Online
Last week’s NABR webinar, “Q&A with the USDA: The Sixth Edition” is now available online for on-demand viewing. If you missed the webinar or would like to watch it again, it has been posted in the Members Only section of our website.
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USDA Introduces New Animal Care Aids
The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has released new informational guides for individuals who own or care for animals. These short animal care aids are intended to cover many species and topics. The initial set of new documents focus solely on canines and can be found here: https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/caw/at_caw_animal_care_aids.