USDA-APHIS Will Not Recognize Third-Party Inspections and Certifications

On May 25, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) released a statement which reads, “it will not establish new criteria for recognizing third-party inspection and certification programs when determining the Agency’s own inspection frequency under the Animal Welfare Act (AWA).”

APHIS had announced a series of public listening sessions starting in December of 2017 to hear feedback from the regulated community and others. APHIS also posted a Federal Register notice in January 2018 asking for written comments through March 21. In the end, APHIS received over 35,000 written comments, many of which were submitted by animal rights groups. APHIS asserts the vast majority of comments they received expressed concern with AWA compliance being in jeopardy if third-party inspections were utilized.

APHIS continues to support its risk-based inspection system when determining the frequency of their AWA inspections. You can view the listening session comments here and the Federal Register comments here.

Farm Bill Amendment for Regulatory Relief Filed in U.S. House

Rep. David Rouzer (R-NC) has filed an amendment to H.R. 2, the 2018 Farm Bill, to address the need to provide regulatory relief for the nation’s animal researchers. The proposed change, as drafted by Rep. Rouzer, replaces the yearly mandate for U.S. Department of Agriculture (USDA) inspections at animal research facilities with “every three years.” As a draft amendment, it must clear the House Rules Committee. The Senate, which has yet to hammer out their own version of the Farm Bill, has not indicated whether a similar provision will be included. It is important to clarify that this amendment in no way ends USDA's inspections.

NABR strongly supports this move towards regulatory relief for the biomedical research community and improved flexibility for the USDA to focus efforts on bad actors. 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. Additionally, the 21st Century Cures Act signed into law, signed into law on December 13, 2016, mandates that federal agencies work to reduce regulatory burden on the animal research community.

 

House Agriculture Committee Releases 2018 Farm Bill

Yesterday the House Agriculture Committee released their text of the 2018 Farm Bill. Why is this important to the research community? The Farm Bill effects virtually all actions taken by the U.S. Department of Agriculture (USDA), including the agency’s oversight of the Animal Welfare Act (AWA). This bill is a perennial target for use as a vehicle to enact further restrictions on animal research.

The Senate has yet to release its version of the bill. The question of whether a House version would be introduced was in doubt due to controversy over nutrition and food stamps issues.

Please visit the House Agriculture Committee’s web page on the Farm Bill to read the bill, fact sheets, and other resources.

NIH Director Testifies at FY19 Budget Hearing

Dr. Francis Collins, Director of the National Institutes of Health (NIH), appeared before the House Appropriations Subcommittee on Labor, Health and Human Services, and Education on Wednesday to discuss the FY 2019 budget.

Dr. Collins received nearly universal, bipartisan support for the work that NIH has done over the years. Many of the questions predominating the hearing revolved around the current opioid crisis and what work was being done to treat and prevent addiction. During one exchange with Rep. Mark Pocan (D-WI), Dr. Collins discussed how technology is rapidly changing the research arena, using a “kidney on a chip” as an example.

The consensus of the hearing was that, in strained financial times, the money spent on NIH was a worthwhile investment given the current opioid crisis and continued need for biomedical research. Dr. Collins noted that nearly 100% of the drugs approved by the Food and Drug Administration (FDA) between 2010 and 2016 benefited in some way by NIH’s involvement.

Please click here if you’d like the view the hearing.

Trump Picks HIV/AIDS Researcher as New CDC Director

President Donald Trump has named Robert Redfield as the new director of the Centers for Disease Control and Prevention (CDC). His appointment comes after former Director Brenda Fitzgerald resigned following a POLITICO investigation revealing she had traded tobacco, food, and drug stocks while leading the agency.

Redfield, a clinical scientist and former Army doctor, co-founded the Institute of Human Virology at the University of Maryland School of Medicine. He also previously served on President George W. Bush’s HIV/AIDS advisory panel and in various advisory roles at the National Institutes of Health (NIH).

The decision has been criticized because of Redfield’s earlier research and views, controversies that POLITICO highlights in coverage of his appointment. He has, however, received the support of Rep. Elijah Cummings (D-MD) who said in a statement, “Although I seldom agree with the Trump administration, I am in complete agreement that Dr. Bob Redfield is the best choice to lead the CDC."

President Signs Omnibus Bill

Earlier today, President Donald Trump signed the FY18 omnibus bill to keep the federal government open until September 30. President Trump had previously announced via Twitter earlier in the morning that he was considering vetoing the bill because of the border wall and Deferred Action for Childhood Arrivals (DACA) issues.

There were several animal provisions in the bill. The omnibus will include $30,810,000 (a $2 million increase from FY17) for enforcement of the Animal Welfare Act (AWA), including continuing inspections of U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) locations conducting research with farm animals.

The omnibus also addresses the USDA database issue by noting, “On February 3, 2017, USDA restricted the public's access to the search tool for the Animal Care Inspection System, saying it needed to conduct a comprehensive review of the information on its website. USDA is now posting heavily redacted inspection reports that make it difficult in certain cases for the public to understand the subject of the inspection, assess USDA's subsequent actions, and to evaluate the effectiveness of its enforcement. USDA's actions to date do not meet the requirements in H. Rpt. 115-232 that the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws. USDA is directed to comply with these requirements and is reminded that as part of its oversight responsibilities, Congress has the right to make any inquiry it wishes into litigation in which USDA is involved. USDA is directed to respond to any such inquiries fully.”

Level funding of almost $21.5 million for the Environmental Protection Agency’s (EPA) Computational Toxicology program was also included in the bill to develop effective alternatives, as required by the 2016 reauthorization of TSCA, the Toxic Substances Control Act. Rejecting a $212 million cut proposed by the President, the bill also increases funding of the National Institute (NIH) National Center for the Advancement of Translational Sciences (NCATS) by over $36 million.

The omnibus didn’t stop there. Aside from encouraging the expedited transfer of NIH’s retired chimpanzees and expansion of the federal sanctuary system, it also contained a prohibition on funding for Class B licenses by the USDA, which has been included several times before. It also prohibits the Department of Veterans Affairs (VA) from using funding for “research using canines unless: the scientific objectives of the study can only be met by research with canines; the study has been directly approved by the Secretary; and the study is consistent with the revised Department of Veterans Affairs canine research policy document released on December 18, 2017.” Also, it requires the VA Secretary to submit to both the House and Senate Appropriations Committees a “detailed report outlining under what circumstances canine research may be needed if there are no other alternatives, how often it was used during that time period, and what protocols are in place to determine both the safety and efficacy of the research.”

To read the full 2,232 page FY18 omnibus, please click here.

Chairman of Senate Committee on Appropriations Announces Retirement

Senator Thad Cochran (R-MS) announced last week that he will retire from the U.S. Senate on April 1 for health reasons.

Elected in 1978, Cochran is chairman of the powerful Senate Committee on Appropriations. His retirement will lead to two Senate races in Mississippi this fall, as his colleague Sen. Roger Wicker (R-MS) is also up for reelection. Republican Gov. Phil Bryant will appoint a temporary replacement for Cochran until a special election in Nov.

As for his Chairmanship, the position will be filled by Senator Richard Shelby (R-AL) who told The New York Times “It would be a great honor, but I’m not there yet,”  adding, “I would be interested at the proper time.”

New NIH Working Group to Develop Guidelines for Chimpanzee Retirement

What to do with nearly 300 retired research chimpanzees has remained a question for quite some time. Currently in three medical research centers, the animals have been awaiting transfer to the only federal retirement sanctuary: Chimp Haven.

The National Institutes of Health (NIH) plans to organize a working group for developing recommendations for veterinarians to consider when or if to transfer chimpanzees. This comes after a number of deaths of former research chimps shortly after arriving at the sanctuary. The unavoidable stress of moving the animals, many of which are elderly and sick, has raised concerns leading many to question whether moving the animals at all is a wise endeavor.

“Retirement in place” at the medical research centers, in the animals’ existing social groupings, has been suggested as a preferable alternative. The NIH’s formation of a working group could signal a reevaluation of the subject of research chimpanzee retirement.

Nature covered this story early in the week, which can be read in its entirely here.

Alex Azar, Nominee for Secretary of HHS, Confirmed by Senate

Alex Azar, President Donald Trump’s nominee for secretary of Human and Health Services (HHS), was confirmed yesterday by the Senate.

As former president of the U.S. arm of Eli Lilly & Co., Azar’s nomination has been generally well-received by lawmakers, and his confirmation comes as no surprise. Having also served HHS as general counsel under the George W. Bush administration, he brings both executive branch experience and pharmaceutical company experience to the table. Azar is expected to tackle increasing drug prices.

Sen. Orrin Hatch (R-Utah) has expressed full confidence in Azar, stating, “Clearly, Mr. Azar has seen both the good and bad at HHS and knows how to manage them. I don’t think there is anyone here, even on the other side of the aisle, who would contest that.”

HHS Nominee Advanced by the Senate Finance Committee

Alex Azar, President Trump’s nominee for secretary of Human and Health Services (HHS), has been advanced by the Senate Finance Committee.

With a 15-12 vote, decided primarily by party affiliation, Azar was approved by the Committee last Wednesday afternoon. As former president of the U.S. arm of Eli Lilly & Co., Azar’s nomination has generally been well-received by lawmakers, and he is expected to be confirmed by the full Senate. Finance Chairman Orrin Hatch (R-Utah) said, “By any objective account, Mr. Azar is very well qualified for his important position.” If confirmed for the position, Azar has promised to tackle increasing drug prices, citing his ten years with Eli Lilly & Co. as evidence for his leadership on this front.

Though a final vote for the full Senate has not yet been scheduled, his confirmation is expected by the end of the month.

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