USDA Asks for Input on AWA Licensing Requirements

This morning the U.S. Department of Agriculture (USDA) published in the Federal Register an advanced notice of proposed rulemaking and request for public comments regarding procedures for applying for licenses and renewals at the department’s Animal and Plant Health Inspection Service (APHIS). The notice in the Federal Register states, “We are soliciting public comment on potential revisions to the licensing requirements under our Animal Welfare Act (AWA) regulations to promote compliance with the Act, reduce licensing fees, and strengthen existing safeguards that prevent any individual whose license has been suspended or revoked, or who has a history of noncompliance, from obtaining a license or working with regulated animals. We are soliciting public comment on these topics to help us consider ways to reduce regulatory burden and more efficiently ensure the sustained compliance of licensees with the Act.”

The notice outlines several changes regarding licensing requirements that are under consideration by the USDA, such as eliminating license application fees and annual license fees, requiring applicants to disclose animal cruelty violations, and specifying procedures so licensees have time to apply for licenses.

The USDA invites the public to provide data and information regarding potential economic effects, alternatives to reduce regulatory burden, and suggestions to ensure the compliance of licensees with the AWA.

Additionally, the USDA’s notice calls for comments on four questions, which are excerpted below in full:

  1. Should we propose to establish a firm expiration date for licenses (such as 3-5 years) and if so, what should that date be and why? Please provide supporting data.
  2. What fees would be reasonable to assess for licenses issued? Are the existing license fees (9 CFR 2.6) reasonable, or should they be adjusted to take additional factors into consideration, such as the type of animals used in regulated activities? Please provide data in support of any proposed adjustments to the license fees.
  3. In addition to the existing prohibitions on any person whose license has been suspended or revoked from buying, selling, transporting, exhibiting, or delivering for transportation animals during the period of suspension or revocation (9 CFR 2.10(c)), should such persons be prohibited from engaging in other activities involving animals regulated under the AWA, such as working for other AWA-regulated entities or using other individual names or business entities to apply for a license? Please suggest specific activities that should be covered and provide supporting data and information.
  4. Do you have any other specific concerns or recommendations for reducing regulatory burdens involving the licensing process or otherwise improving the licensing requirements under the AWA?

The announcement of this notice coincides with the 51st anniversary of the AWA. Public comments may be submitted online or in writing through October 23, 2017. Comments will be available for public viewing after submission. NABR plans to submit comments and we encourage your institution to do so as well.

USDA Calls for Public Comments on Regulatory Reform

The U.S. Department of Agriculture (USDA) published a notice in the Federal Register requesting comments from the public about the regulatory burden they have experienced and ideas for regulatory reform at the department. Specifically, USDA is looking for “public ideas on regulations, guidance documents, or any other policy documents that are in need of reform, for example ideas to modify, streamline, expand, or repeal those items.”

Public comments will be accepted in four batches over a one-year period; the deadline for the first batch is September 15. The second batch of comments is due on November 14. The third and fourth batches are due on February 12, 2018 and July 17, 2018, respectively. NABR is planning to submit comments during the November batch and we encourage your institution to submit comments as well.

The questions below have been excerpted in full from the USDA’s notice in the Federal Registrar:

  1. Are there any regulations that should be repealed, replaced, or modified?
  2. For each regulation identified in question number 1, please identify whether the regulation:
    1. Results in the elimination of jobs, or inhibits job creation;
    2. Is outdated, unnecessary, or ineffective;
    3. Imposes costs that exceed benefits;
    4. Creates a serious inconsistency or otherwise interferes with regulatory reform initiatives and policies;
    5. Is inconsistent with the requirements or regulations of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), which requires that agencies maximize the quality, objectivity, and integrity of the information (including statistical information) they disseminate; or
    6. Derives from or implements Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
  3. Are there any existing USDA requirements that duplicate or conflict with requirements of another Federal agency? Can the requirement be modified to eliminate the conflict?
  4. What are the estimated total compliance costs of the USDA regulations to which you or your organization must comply? This should include the costs of complying with information collections, recordkeeping, and other requirements subject to the Paperwork Reduction Act.

Comments may be submitted electronically, by mail, hand delivery, or courier. The USDA has requested that submitters please specify “Identifying Regulatory Reform Initiatives” in the comment for submission. To read the full notice in the Federal Register and to submit comments, please click here.

Paralyzed Veterans of America Explains the Importance of Dog Studies at the VA

Sherman Gillums Jr., Executive Director of the Paralyzed Veterans of America (PVA) published an op-ed in The Hill yesterday in strong opposition to legislation that would hinder medical advancements for disabled veterans. “For a veteran facing a lifetime of paralysis after suffering a spinal cord injury, hope is often the last thing to die. Yet, the recently introduced House bill, H.R. 3197, threatens to crush what little hope to which I, and the approximately 60,000 veterans living with spinal cord injury, cling. The act proposes to reduce investment in medical research, and the reason is as simple as it is controversial: animal research.”

Introduced in July by Rep. Dave Brat (R-VA), H.R.3197 would effectively eliminate important research with dogs at the U.S. Department of Veterans’ Affairs. An amendment to the homeland security minibus serving the same purpose was passed by the full House last month. This legislation has serious implications for veterans because research with dogs has led to life-saving and life-improving treatments for veterans suffering from spinal cord injuries, heart conditions, diabetes, respiratory illnesses, and other diseases experienced through military service.

“The VA has a responsibility to consistently find new and better ways of treat America’s heroes. Animal research helps the department do that. The program has helped save and improve countless lives, and it will continue to do so—unless ideology, and in some cases extremism on the issue of animal rights, succeed in forcing the public's attention away from VA waiting rooms, inpatient wards, and rehabilitation gyms across the country. This is where the price of wars across several eras can be seen almost daily, as well as where medicine and science find their ripest opportunities.”

For more information about the importance of dogs in research, please click here.

To read the letter, click here.

USDA FOIA Logs Posted

The U.S. Department of Agriculture (USDA) has published on its website a list of all Freedom of Information Act (FOIA) requests that were submitted to the department in 2017. NABR is analyzing the documents and will report any findings of interest to the biomedical research community.

FOIA was enacted in 1966 to promote transparency and ensure accountability of government officials and agencies. The law permits the public to request records owned by federal agencies, such as the U.S. Department of Agriculture, the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).

To review NABR’s analysis of FY 2016 FOIA requests from animal rights groups please click here (log-in required).

NABR President Rebuts PETA Letter to The Hill

As you’ll recall, last week shortly after National Institutes of Health (NIH) Director Dr. Francis Collins said in an interview that “Animals are still crucial to our understanding of how biology works,” People for the Ethical Treatment of Animals (PETA) fired back with a letter to The Hill calling for a systematic review of animal studies at the NIH. This letter, “A need to rethink spending on animal-based research at NIH,” is part of PETA’s call to defund the NIH because of its use of animal models in lifesaving and live-improving research.

Today, NABR’s President Matt Bailey penned a response letter to The Hill discussing not only the benefits of animal research in medical discovery from conditions like HIV/AIDS, malaria, cancer, and Alzheimer’s, but covering the immense economic impact of taxpayer funded studies. The United States’ investment in research, specifically with the NIH, supports 350,000 jobs and produced $60 billion in new economic activity in 2015.

Take a moment to read Bailey’s letter and share it with your friends, family, colleagues, and on social media and encourage others to do the same.

Spending Bills Approved and Advanced on Capitol Hill

Late last week the Senate Appropriations Committee approved a $20.5 billion agriculture spending bill. The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act will fund programs at the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) for FY2018. The bill includes a $4.8 billion increase to the amount proposed in President Donald Trump’s budget blueprint, but $7.9 billion less than the previous year’s funding level. Of interest to the animal research community is the allocation of $953.2 million for the USDA Animal and Plant Health Inspection Service (APHIS), the agency that regulates and inspects animal research laboratories. This is $143.2 million above Trump’s budget request for APHIS and $7 million above the funding level for FY2017. The bill was approved by the Senate Agriculture Appropriations Committee on Tuesday.

Also last week the House Appropriations Committee passed a $156 billion Labor-HHS-Education spending bill for FY 2018. The Labor, Health and Human Services, Education, and Related Agencies Bill contains $21.6 billion more than the amount proposed by Trump and $34.7 billion more than the funding level for FY2018. The spending bill contains $35.2 billion for the NIH ($8.6 billion increase to the Trump’s budget proposal and $1.1 billion increase to FY 2017 allocation) and was approved by the subcommittee on July 13. The bill contains language that directs the NIH to develop a plan to speed up the process of transferring retired research chimpanzees to retirement sanctuaries.

Please stay tuned for more important updates from NABR during the Appropriations process.

NABR Releases FY2016 FOIA Analysis – Government Costs Increase

NABR has prepared a review of federal Freedom of Information Act (FOIA) requests that were submitted by animal rights organizations in Fiscal Year 2016. FOIA was enacted in 1966 to promote transparency and ensure accountability of government officials and agencies. The law permits members of the public to submit requests for records in the possession of federal agencies, such as the U.S. Department of Agriculture, National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).

In FY 2016, both USDA’s Animal and Plant Health Inspection Service (APHIS) and the NIH received a significant number of requests from animal rights activists. As outlined in further detail in NABR’s FY2016 FOIA Analysis (log-in required), these agencies received 12% more requests from animal rights groups than the previous year, and the cost for the government to respond to the requests increased by 20%.

NABR believes animal rights activists will continue to submit broad requests for large amounts of data about research facilities in FY 2017 in part because of the USDA’s decision on February 3 to temporarily remove the Animal Care Inspection Service (ACIS) database. NABR will continue to monitor FOIA requests submitted to federal agencies and, when possible, alert members if they are named in the requests. Research facilities should carefully review all information submitted to federal agencies. To read the full FY2016 FOIA Analysis, please click here (log-in required).

House Appropriations Committee Marks-Up FY18 Agriculture Appropriations Bill

Last Wednesday the full House Appropriations Committee considered the Agriculture, Rural Development, Food & Drug Administration, and Related Agencies Appropriations Bill for FY18 to fund the U.S. Department of Agriculture (USDA) and Food & Drug Administration (FDA).

The Animal and Plant Health Inspection Service (APHIS) was appropriated $906 million, $96 million more than the President’s requested amount, but $40 million short of the FY17 funding level. The FDA will receive $2.8 billion, the same as in FY17. The bill also appropriates $60 million to the FDA as part of the 21st Century Cures initiative enacted last winter. Including revenue from user fees, total funding for the FDA is $5.2 billion, $490 million more than in FY17. The USDA will not resume funding the renewal of Class B licensed dealers in FY18. The report requires that most of a $400,000 increase be used to establish an Institutional Animal Care and Use Committee (IACUC) by the Agricultural Research Service (ARS). The committee also addressed the February 3 removal of data from the USDA’s Animal Care Inspection System database, noting in the report that the USDA “must utilize the resources provided in this bill to promptly finish reviewing the information on its website, restore all legally permissible records previously removed, and resume posting on the USDA website.”

To read the FY18 agriculture appropriations bill, click here. The committee’s report on the bill can be found here.

House Labor-H Subcommittee Passes FY18 NIH Appropriations Bill

On Thursday, July 13, the House Labor, Health and Human Services, Education, and Related Agencies Subcommittee of the House Appropriations Committee passed the FY18 National Institutes of Health (NIH) appropriations bill. It now heads to the full committee for consideration.

The bill provides $34.6754 billion in base funding for the NIH and includes the full $496 million designated for FY18 in the NIH Innovation Account established in the 21st Century Cures Act, for $35.1714 billion in total FY18 funding. This marks a $1.1 billion increase from last year; the final FY17 omnibus provided $33.732 billion in base funding and $34.084 billion including money appropriated for 21st Century Cures. The bill rejects the President’s proposal with regards to facilities and administration expenses. The bill also specifies that, “None of the funds made available by this Act may be used to conduct or support research using human fetal tissue if such tissue is obtained pursuant to an induced abortion.” Critical research endeavors were also provided increases:

• $1.8 billion, a $400 million increase, for Alzheimer’s disease research
• $336 million, a $76 million increase, for the Brain Research through Application of Innovative Neurotechnologies (BRAIN) initiative
• $400 million, a $80 million increase, for the All of Us research initiative (formerly called the Precision Medicine Initiative)
• $300 million for the Cancer Moonshot
• $10 million, an $8 million increase, for regenerative medicine research
• $12.6 million for the Gabriella Miller “Kids First” pediatric cancer research initiative.

Federal Bill Introduced to Prevent Veterans Administration from Using Dogs in Studies

Wednesday evening it was announced that Reps. Dave Brat (R-VA) and Dina Titus (D-NV) have introduced the Preventing Unkind and Painful Procedures and Experiments on Respected Species Act of 2017, or PUPPERS Act.

Likely the result of recent attention on experiments by the Veterans Administration (VA) highlighted by the White Coat Waste (WCW) Project, the bill is relatively straightforward. The PUPPERS Act states the Secretary shall not “purchase, breed, transport, house, feed, maintain, dispose of, or experiment on dogs as part of the conduct of any study that causes significant pain or distress” by the VA. “Pain or distress” is defined in the legislation as research classified in category D or E by the U.S. Department of Agriculture (USDA).

Aside from Brat and Titus, the bill is currently sponsored by Reps. Brian Mast (R-FL), Ted Lieu (D-CA), Dan Donovan (R-NY), and Brendan Boyle (D-PA). Click here to read more coverage in The Hill.

Page 2 of 812345...Last »