August, 2015

    September 2, 2015


    FDA to Hold Public Meeting on Antibiotic Use Data Collection

    The Food and Drug Administration (FDA) has recently announced its plan to hold a jointly sponsored public meeting to obtain public input on possible approaches for collecting additional on-farm antimicrobial drug use and resistance data. The meeting will be held in collaboration with the U.S. Department of Agriculture (USDA) and the Centers for Disease Control and Prevention (CDC). As a part of the government's response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, the agencies are working to improve the collection of antibiotic use data to better assess the impact of measures being implemented to foster the judicious use of medically important antimicrobial drugs in food-producing animals.

    The public meeting will be held on September 30, 2015 from 8:00am to 4:30pm, at the USDA's Jefferson Auditorium, located at 14th and Independence Avenue SW, Washington, DC 20201. Registration is required to participate in the public meeting. Registration information (including name, title, organization, address, telephone and fax numbers) should be sent by email to by September 18, 2015. Those interested in making an oral presentation during the public comment period must notify FDA by September 16, 2015, and submit a brief statement of the general nature of information they wish to present. A copy of the Federal Register notice with additional details about the meeting can be found here.

    Animal Welfare Policy Remains Hot Topic in Washington

    The issue of animal welfare has remained a hot topic during the summer of 2015. On July 23rd, the Animal Handling and Welfare Review Panel established by the U.S. Department of Agriculture (USDA) released its findings from the Phase II review entitled: "Final Report of the Findings and Recommendations on the Phase II Review of the Animal Care and Well-Being at the Agricultural Research Service to the REE Under Secretary." The review examined the agency-wide animal care and well-being policies, procedures, and standards for agricultural livestock in research at the Agricultural Research Services (ARS). Phase II of the review consisted of site visits to five additional ARS research locations conducting research on farm animals. While the report identifies areas where ARS processes can be improved, it was the “strong opinion of the panel that there was no evidence for misuse or abuse of animals at the ARS sites visited.”

    The Panel transmitted the final report to the National Agricultural Research, Extension, Education, and Economics (NAREEE) Advisory Board for additional discussion and public comment. On August 11th, the National Agricultural Research, Extension, Education and Economics Advisory Board (NAREEE Board) met via teleconference to discuss the Phase II final report. The NAREEE Board heard a summary of the report from the Aaron Olson, Chair of the Task Force. Dr. Olson reiterated that the Task Force found no evidence of animal mistreatment or improper handling during their review. He also stated that each of the sites visited during the review had a properly functioning Institutional Animal Care and Use Committee (IACUC). He then highlighted the major findings and recommendations of the report, which focus on refining the Agricultural Research Service's IACUC policies and procedures. A copy of the final report can be found here.

    Concurrent to activities undertaken by USDA and the review panel, Congress has also remained active on the issue of animal welfare. Both the House and Senate versions of the FY 2017 Agriculture Appropriations bill include language related to animal welfare at ARS. The House bill includes language that withholds $56 million from ARS until the Secretary certifies that ARS has taken steps to ensure proper animal care in its facilities. The Senate bill expresses directs ARS to ensure all of its facilities conducting agricultural research comply with standards that are equivalent to the Animal Welfare Act. The language also directs ARS to enter into an agreement with the Animal and Plant Health Inspection Service (APHIS) to have APHIS Animal Care conduct routine inspections of ARS facilities to ensure humane treatment of animals.

    In addition to appropriations activities, Congress is considering other legislation regarding animal welfare issues. For example, on July 21st, Rep. Blum of Iowa introduced H.R. 3136, the Enforcement Transparency Act of 2015. The legislation would require the Secretary of Agriculture to issue guidelines relating to civil fines imposed for violations of the Animal Welfare Act. The bill directs USDA to publish the guidelines to the public internet and update them on a quarterly basis.

    Given the actions on appropriations, the introduction of stand-alone legislation, and the recent release of final report of the USDA Task Force, expect animal welfare to remain a hot topic in the months to come.

    Congress Returns to Full Agenda in September

    As Members of Congress return to Washington after the August recess, they will find themselves with a very full agenda. Fiscal year 2016 appropriations, for agriculture and all of the other spending bills, will need to be addressed before October 1st, the beginning of the next fiscal year. Both the House and Senate committees have completed their work, but very few bills, have made it to the chamber floor for consideration, and none have passed both chambers and been presented to the President for signature. As a result, it is likely that Congress will develop a continuing resolution to keep the government running after September 30th. This will give the House and Senate additional time to develop an omnibus funding package for the remainder of FY 2016. At the same time, Congress will be debating issues such as the Iran nuclear agreement, surface transportation authorization and tax extenders. Add in the Jewish holidays and a joint meeting with the Pope, and the month of September will be extremely busy.