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NABR Update June 20, 2019

 

June 20, 2019


House Appropriations Language Would Cut Off VA Canine Research: Sign on to Letter by Mon, June 24

The House Appropriations Committee has approved an FY2020 VA funding billthat would eliminate funding for all Category D and E canine research at the U.S. Department of Veterans Affairs (VA). The language reads as follows:

Sec. 247. (a) Except as provided by subsection (b), none of the funds made available by this Act may be used by the Secretary of Veterans Affairs to purchase, breed, transport, house, feed, maintain, dispose of, or experiment on, dogs as part of the conduct of any study including an assignment of pain category D or E, as defined by the Pain and Distress Categories of the Department of Agriculture (or such successor categories developed pursuant to section 13 of the Animal Welfare Act (7 U.S.C. 2143).

AAMC and NABR have organized a community institutional sign-on letter to urge the leaders at the Senate Appropriations Committee not to include this language in the Senate version of the bill.

The deadline to sign on is Mon, June 24. If your institution would like to sign onto this letter and join the 42 institutions that have already signed, please email NABR’s Government Affairs Director, Rocco Praglowski at rpraglowski@nabr.org. The American Physiological Association, the American Psychological Association, and FASEB have submitted similar letters to Congress.

The Institute for Laboratory Animal Research (ILAR) Committee “Assessmentof the Care and Use of Dogs in Biomedical Research Funded by or Conducted at the U.S. Departments of Veterans Affairs” is ongoing. All materials submitted to the Committee by the VA can be found here. More information on the VA canine research program can be found here.

House Appropriations Report Language Targets NIH & FDA Primate Research

The House Appropriations Committee Labor-HHS funding bill for FY 2020 was approved by the full Committee. Included in the bill is a $2 billion increase for the National Institutes of Health (NIH). However, there is troubling report language pushed by the White Coat Waste Project (WCWP) and Rep. Lucille Roybal-Allard (D-CA).

The report language reads as follows:

“Intramural Non-Human Primate Research.—The Committee has expressed concern since 2015 about the NIH’s intramural use of nonhuman primates in biomedical research. The Committee is especially concerned by a nearly 50 percent increase in NIH’s use of nonhuman primates in research involving pain and distress since fiscal year 2014. The Committee is encouraged, however, by the NIH’s January 2019 to Congress expressing support for the retirement of primates no longer needed for research. The Committee urges the NIH to accelerate efforts to reduce and replace the use of nonhuman primates with alternative research models and directs the NIH to provide a report to the Committee no later than 180 days after enactment that includes: (1) an overview of current NIH nonhuman primate use, including a table with summaries of all active projects, USDA pain categories, and their cost; (2) a detailed explanation of current NIH efforts to reduce and replace the use of primates in research with alternative methods; (3) an assessment of existing research technology not already in use by NIH to reduce and replace primate research and the feasibility of employing it to meet current and future research needs; (4) an assessment of areas where alternatives to primate research may not yet be available; (5) a detailed strategy and timeline for the reduction and replacement of NIH primate research with alternative research methods; and (6) standard operating procedures for the retirement of nonhuman primates no longer needed in research to suitable sanctuaries.”

FASEB has sent a letter to Senate L-HHS leadership emphasizing the importance of non-human primates (NHP) in research. The letter can be found here. The letter urges appropriations leadership to keep such language out of the Senate’s appropriations bill.

This report language is not the only report language that targets federal use NHPs. Rep. Roybal-Allard has also included report language in the Agriculture Appropriations bill that reads as follows:

“Non-Human Primates.—The Committee commends the FDA for its work to reduce research on non-human primates and relocate non-human primates no longer needed in research to sanctuary. The Committee directs the FDA to deliver a report within 12 months of enactment of this Act that outlines a strategy, including a detailed timeline, for the reduction and replacement of non- human primates in FDA intramural testing and research with suitable alternative models. The report should also detail plans for the relocation of non-human primates no longer needed in FDA research to appropriate sanctuaries.”

An article published in Stat Magazine on the report language quoted NABR President, Matthew Bailey: “Science, not politicians catering to special interest groups, should determine the most appropriate models for their work. The language is part of a much broader effort to reduce or end federal and federally-funded biomedical research by animal rights activist groups, and it represents a very concerning slippery slope.”

You can contact Congress here: 
https://www.votervoice.net/NABR/campaigns/66122/respond
.

House Agriculture Appropriations and Report Language Targets APHIS

Language in the FY 2020 Agriculture House Appropriations Bill seeks to restore the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection (APHIS) searchable database.

The language reads as follows:

SEC. 760. The Animal and Plant Health Inspection — Service shall, notwithstanding any other provision of law: (a) within 60 calendar days, restore on its website the searchable database and its contents that were available on January 30, 2017, and all content generated since that date; and (b) hereafter, make publicly available via searchable database, in their entirety without redactions except signatures, the following: (1) all Animal Welfare Act inspection reports, including all reports documenting all AWA non-compliances observed by USDA officials and all animal inventories; (2) all Animal Welfare Act and Horse Protection Act enforcement records; (3) all reports or other materials documenting any non-compliances observed by USDA officials; and (4) all Animal Welfare Act research facility annual reports, including their attachments.

Similar language appears in the report:

Animal Research.— The Committee continues to monitor closely the compliance by ARS animal research facilities with the requirements of the Animal Welfare Act. The Committee notes that ARS has not yet submitted the single report discussing all the violations found by APHIS to date that was mandated in the 2019 Act and that the first quarterly report since the 2019 Act was enacted failed to include any discussion of violations found by APHIS and specific actions taken. Thus, the Committee directs ARS to revise the mandated report accordingly.

Additional report language calls for the USDA Animal Care Program to no longer use their “teachable moment” mechanism.

That language reads as follows:

Animal Care Program.—The Committee is deeply concerned by how the Animal Care program is being managed. In particular, it has employed mechanisms such as ‘‘teachable moments’’ to avoid documenting violations of the laws it enforces. To address these concerns, the Committee directs Animal Care to immediately require all its inspectors to cite every observed violation at any visit to a regulated entity.

Amendment to National Defense Authorization Act (NDAA) Targets Animals in Medical Training

NABR Update readers may remember the BEST Act, S. 498, introduced in the 115th Congress. The “Battlefield Excellence through Superior Training Practices Act” sought to eliminate the use of live animals in Department of Defense trauma training. The bill was pushed by the Physician’s Committee for Responsible Medicine. Though the bill did not move in the 115th Congress, it has now resurfaced as an amendment, submitted by Sen. Ron Wyden (D-OR), S. Amdt. 308, to S. 1790, the National Defense Authorization Act (NDAA) for Fiscal Year 2020. The text of the amendment is identical to the language of the previously introduced BEST Act.

The amendment reads:

“Not later than October 1, 2022, the Secretary of Defense shall only use human-based training methods for the purpose of training members of the armed forces in treatment of combat trauma injuries; and may not use animals for such purpose.”

As of yesterday, the Senate adopted 88-11 the motion to invoke cloture on the motion to proceed to the FY 2020 NDAA. There have been 532 amendments submitted to this year’s NDAA.

House Minibus Includes FY 2020 Labor-H Appropriations

Last week, the House began consideration of H.R. 2740, a combined ‘minibus’ bill which includes the House Appropriations Committee FY 2020 Labor-HHS-Education (Labor-H) Appropriations bill and the Defense, Energy and Water Development, and State-Foreign Operations bills. This minibus contains $982.8 billion in spending.

The House Rules Committee met June 10-11 to approve 221 amendments for floor debate, including nearly 100 amendments to the Labor-HHS spending bill. No amendments were included that directly target federal or federally-funded research. However, report language targeting National Institutes of Health (NIH) intramural non-human primate (NHP) research is still included.

Consideration of the entire four-bill minibus is expected to continue into the week this week before the House votes on final passage.

NABR’s Review of Revisions to the USDA’s Animal Welfare Inspection Guide:

Chapter 7 of the Research Facility Inspection of the Animal Welfare Inspection Guide has been revised and is available at https://www.aphis.usda.gov/animal_welfare/downloads/Animal-Care-Inspection-Guide.pdf. The revised version is 22 pages shorter than the previous version. NABR’s full review can be found here.

Oregon Mandatory Adoption Bill Signed into Law

Oregon has become the most recent of 11 states to pass mandatory adoption legislation. Similar legislation has been introduced in 10 other states. There are currently two federal mandatory adoption bills in the House of Representatives.

The Oregon bill, SB 638, requires the adoption of certain cats and dogs used in biomedical research. This is the first mandatory adoption bill that has passed with reporting requirements. Bill text reads as follows:

Not later than December 31 of each year, all research facilities described in subsection (1) of this section that are not public bodies as defined in ORS 192.311 shall submit to the Secretary of State an annual report that includes the following information for the preceding year

While there are mild confidentiality protections, “the Secretary of State shall make the aggregate data available to the public upon request.” It is anticipated that animal rights groups will use this data to engage in press targeting of Oregon institutions involved in research with canines and felines.

The Beagle Freedom Project is celebrating the passing of what they call the “Beagle Freedom Bill”.

NABR Appeals to Trump Administration on Chinese NHP Tariffs

As previously reported, the Trump administration has been laying the foundation for a sweeping series of tariffs with China over a number of trade disputes. Included in the administration’s tariff proposal is non-human primates (NHPs). In response, on July 17, NABR filed detailed comments with U.S. Trade Representative Robert E. Lighthizer. NABR’s comments can be viewed here: https://www.nabr.org/wp-content/uploads/2019/06/2019.06.17.National-Association-for-Biomedical-Research.USTR-2019-0004-WrittenComments.pdf.

Institutions that depend on NHPs from China for their research are encouraged to comment on the Regulations.gov docket USTR-2019-0004 before the comment period closes on July 2. The docket can be found here: https://www.regulations.gov/docket?D=USTR-2019-0004 and you can comment directly here: https://www.regulations.gov/comment?D=USTR-2019-0004-0001.

Upcoming NIH ACD Working Group on Rigor and Reproducibility for Animal Studies

NABR has recently learned of an upcoming National Institutes of Health (NIH) Advisory Council to the Director (ACD) working group that will focus on Rigor and Reproducibility for Animal Studies. The group will be co-chaired by Lawrence Tabak, NIH Deputy Director, and Barbara Wold. Barbara Wold is a professor of molecular biology and primary investigator (Wold Lab, bioinformatics) at the California Institute of Technology.

The proposed charge of the ACD WG is as follows:

  • Identify gaps and opportunities to improve the rigor, reproducibility, translational validity, and transparency of studies involving animal models
  • Evaluate how animal models of human disease are currently developed, validated, and accepted into routine use, and how this process could be improved
  • Assess the current state of science for validating alternative models to animal research
  • Consider the benefits and burdens of registering animal studies that aim to lead to first in human trials (e.g., preregistration of the experimental plan)
  • Model the financial implications of potential changes in the average costs of grants using animal models, the number of studies funded, or the need to develop multi-lab consortia to achieve appropriate statistical power
  • Consider how rigor in animal research is incorporated into training (e.g., statistical training; experimental design)

The NIH has yet to publicly post any information regarding the working group or its objectives. This is NABR’s current and best understanding of this working group. As we receive further information and clarification, we will be sure to inform the research community as this develops.

NABR Webinar: Q&A with the USDA – The Seventh Edition

NABR is pleased to announce the return of one of its most requested webinars, the Seventh Edition of “Q&A with the USDA.” In addition, due to an unexpected conflict in scheduling for Deputy Administrator Bernadette Juarez, we are pleased to welcome back Dr. Betty Goldentyer, a veteran of our Q & A webinars. This much-requested webinar will take place on Wednesday, Jul 10, 2019, at 12:30 PM EDT.

Join USDA-APHIS’ Associate Deputy Administrator for Animal Care Dr. Betty Goldentyer and Dr. Cody Yager, Supervisory Animal Care Specialist, for “Q&A with the USDA: The Seventh Edition” on Wednesday, July 10th. This webinar provides NABR members with a unique opportunity to ask questions directly to the leadership of Animal Care’s Animal Welfare Operations who are responsible for the oversight of the inspection and reporting process and should not be missed.

Since the last Q&A webinar, a lot has happened including the release of the Draft Report on Reducing the Administrative Burden for Researchers: Animal Care and Use in Research, revisions to the Animal Care Policy Manual and Animal Welfare Inspection Guide and a Proposed Rule to Amend the Requirements for Licensing and the Care of Dogs. To better understand what impact these and other ongoing changes may have on your institution, you should take advantage of this unique opportunity provided to NABR members to get your questions concerning compliance with the Animal Welfare Regulations answered.
Questions should 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. As in the past, we will schedule the session for an hour but will continue the webinar until all questions have been addressed.

After registering, you will receive a confirmation email containing information about joining the webinar.

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