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.

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.

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.

Time is Running Out to Register for NABR’s Next Webinar!

Time is running out to sign up for NABR's next webinar! If you would like to attend and have not yet reserved your spot for “The 2017 USDA Inspection Data: Celebrating a New Milestone in Compliance?”, scheduled for next Tuesday Feb. 6 at 12:30 p.m. (EST), please do so immediately.

NABR collects information from the USDA’s Animal Care Inspection System database each year to review the inspection results for the previous fiscal year. Our efforts this year were complicated by a lack of access to the searchable database which could be used to download data into spreadsheets for what would have been a relatively straightforward analysis of the actual inspection data. The new Public Search Tool provides data efficiently, but the data is difficult to analyze. Fortunately, with our analysis, we will provide you with valuable insight into the inspection process.

Join NABR next week on Tuesday, Feb. 6 as we look at FY2017 data and compare it to analyses from previous years. Our findings will demonstrate how the research community continues to improve compliance with the letter and spirit of the regulations. This information will help you manage your own animal care and use program in the coming fiscal year. As always, registration is complimentary for dues-paying NABR members and subscribers. Nonmembers are welcome to attend, but a fee will be applied

 

USDA-ACIS Database Lawsuit Dismissed

Last year, on February 3, 2017, in response to a privacy lawsuit about the Horse Protection Act (HPA), the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) removed from its website the Animal Care Information System (ACIS) database. The ACIS database consisted of documents concerning inspection and licensing of animal research facilities.

A coalition of animal rights groups and activists, including People for the Ethical Treatment of Animals (PETA), Delcianna Winders, Physicians Committee for Responsible Medicine (PCRM), Born Free USA, Massachusetts Society for the Prevention of Cruelty to Animals, and Beagle Freedom Project (BFP) filed a lawsuit alleging the removal of ACIS information violated the Freedom of Information Act (FOIA). As the lawsuit progressed, APHIS continued to review, update, and repost the documents, completing an official review and republishing many of the documents on its website in September 2017. APHIS then filed a motion to dismiss PETA’s lawsuit on various grounds.

On January 18, 2018, U.S. District Judge Christopher Cooper dismissed the case, finding PETA’s claims were moot, considering most of the documents had by this time been reposted by APHIS. Regarding the documents that were not reposted, the judge dismissed without prejudice PETA’s complaint, finding those documents could be obtained with a normal FOIA request by PETA, which would allow APHIS to decide whether the documents should be redacted or withheld.

Matthew R. Bailey, FBR President, said exactly that when he spoke to the media last year: “I would certainly agree that protection of personal information is of utmost importance, given the rich history of targeting individuals involved in animal research.” Read the 12-page opinion dismissal here.

Sign-Up Today for NABR’s First Webinar of 2018!

Please mark your calendar and join us on Tuesday, February 6 for NABR's first webinar of 2018, “The 2017 USDA Inspection Data: Celebrating a New Milestone in Compliance?”

Each year, NABR obtains information from the USDA’s Animal Care Inspection System database to review the inspection results for the previous fiscal year. This year, that effort was complicated by lack of access to the searchable database which could be used to download data into spreadsheets for what would have been a relatively straightforward analysis of the actual inspection data. The new Public Search Tool provides data efficiently, but the data is difficult to analyze. Fortunately, with our analysis, we will provide you with valuable insight into the inspection process.

We invite you to join NABR on Tuesday, February 6 when we look at the data from FY 2017 as we compare it to analyses from previous years. Our findings will demonstrate how the research community continues to improve its compliance with the letter and spirit of the regulations. This information will help you manage your own animal care and use program in the coming fiscal year. As always, registration is complimentary for dues-paying NABR members and subscribers. Nonmembers are welcome to attend.

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.

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).

Recording of “Q&A with the USDA: The Fifth Edition” Now Available for Online Viewing

If you were unable to attend NABR’s exclusive July 18 webinar or just want to see it again, the recording is now available online for on-demand viewing.

Please click here to view “Q&A with the USDA: The Fifth Edition.” You will need your NABR Members Only log-in credentials to watch the presentation.

You can find all of NABR’s past webinars, including this one, in an online library in the Members Only section of our website.

If you have problems logging in or have any questions about the webinar, please contact us at info@nabr.org.

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