Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals.  Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not considered in human clinical trials, where the individual involved in such trials is able to provide consent for inclusion in the trial.  Clearly, the animals that may be subject to such studies, cannot provide specific consent—their owner would have to do so on their behalf.  Those advocating for a change in status of animals as “property” to “persons” would be expected to object to such clinical trials, even if they benefit animals and people and help save their lives.

This issue was critically analyzed by veterinarians analyzing whether clinical veterinary studies must be reviewed by institutional animal care and use committees pursuant the Animal Welfare Act; the Office of Laboratory Animal Welfare for those studies funded by NIH; and/or reviewed and approved by a Veterinary Clinical Studies Committee established by a research entity, in a JAVMA published study, “Institutional animal care and use committee review of clinical studies.”

The study found

Determining whether activities conducted under the auspices of a clinical study are regulated by the USDA or OLAW, and thus require IACUC oversight, is not always a clear and simple issue. Institutions should develop their own guidance on how the IACUC oversees-or does not oversee-clinical trials.

Whether and to the extent certain clinical trials required review and approval by the IACUC pursuant to the Animal Welfare Act and/or OLAW requirements was dependent on whether the studying entities purchased the animals involved in the clinical trial and whether the proposed procedures would be required for the animal’s care, or were additional procedures only required for the purposes of the clinical trial.

The article presents 6 examples to help determine when USDA or OLAW oversight would be required.

Clearly, clinical trials, as utilized in human medicine, provide critical data related to the final approval of drugs and medical devices that will help prevent, diagnose and/or treat animals affected with life-altering diseases and conditions.

In a bulletin published on September 25, 2018, USDA announced “four overarching goals for advancing animal disease traceability to protect the long-term health, marketability and economic viability of the U.S. livestock industry.”

Advance the electronic sharing of data among federal and state animal health officials, veterinarians and industry; including sharing basic animal disease traceability data with the federal animal health events repository (AHER).

Use electronic ID tags for animals requiring individual identification in order to make the transmission of data more efficient;

Enhance the ability to track animals from birth to slaughter through a system that allows tracking data points to be connected; and

Elevate the discussion with States and industry to work toward a system where animal health certificates are electronically transmitted from private veterinarians to state animal health officials.

Animal disease traceability has been a long-term goal of state and federal officials, as well as farmers and ranchers interested in protecting their livestock from the spread of contagious, infectious diseases.

A State-Federal Working Group reviewed the existing program and potential future goals, the results of which are published in a Summary of Program Reviews and Proposed Directions, dated April 2018.

The working group expressed general concerns about, in part: (1) confidentiality and security of information systems; (2) producer liability based on disease transmission, and animal and human injury resulting from applying and reading identification tags; (3) cost; (4) lack of proportionality of scale for small compared to large producers; and (5) beef feeder cattle under versus over the age of 18 months; practicality of identifying livestock at birth premises; flexibility, among other issues.

There was particular concern over electronic ID (EID), related technology and costs:

  • “If radio frequency ID (RFID) is to be utilized, the establishment of standards, including one technology (low-frequency (LF) vs ultra-high frequency (UHF)) is critical. Most stakeholders supported a dual technology tag as an interim measure.
  • The infrastructure must be in place to support the transition to EID.
  • Cost remains the primary concern of producers and representatives from other sectors of the industry for both the reader infrastructure and tags; however, the use of EID would provide substantial savings due to the increased efficiency associated with the technology.
  • Availability and use of electronic forms, in particular, electronic ICVIs. Obtaining records electronically would decrease cost and improve the completeness and accuracy of the data. Additionally, retiring animal numbers at slaughter would be feasible, where it has been cost-prohibitive with visual-only tags.
  • A cost analysis on metal NUES tags to show the full cost of tags when working cattle to manually record ID numbers (labor, stress and shrink, injury, etc.), as well as their limitations relative to traceability, e.g., tag retirement, to more accurately illustrate the 14 costs of both visual-only and EID tags.
  • Proportionally higher implementation costs for smaller producers, who sell direct to consumers and believe their livestock are already highly traceable.”

USDA’s current goals build on its final rule adopted on January 9, 2013, “Traceability for Livestock Moving Interstate,” which requires cattle, bison, horses and other equine species, poultry, sheep and goats, swine, and captive cervids moving interstate to be officially identified and accompanied by an interstate certificate of veterinary inspection (ICVI) or other documentation, with limited exemptions.

The proposals from the Working, as published in the report, include:

  1. Maintain the policy that traceability regulations do not apply to interstate movements to a custom slaughter facility in accordance with Federal and State regulations for preparation of meat.
  2. Maintain the current population of livestock covered by the official ID requirements. The ADT rule will continue to include:
  • All dairy
  • Beef cattle > 18 months of age
  • All rodeo and exhibition cattle.
  1. Cattle should be identified to their birth premises , thus the official ID records must provide birth premises information for the animal. APHIS should revise Federal regulations to include interstate commerce and the appropriate authority – either USDA or State officials – should establish regulations that trigger official ID requirements at:
  • Change of ownership
  • First point of commingling
  • Interstate movement (may reflect no sale and no commingling).
  1. The United States must move toward an EID system for cattle with a target implementation date of January 1, 2023. A comprehensive plan is necessary to address the multitude of very complex issues related to the implementation of a fully integrated electronic system. A specialized industry-lead task force with government participation should develop the plan, with a focus on several key objectives (see report for specifics).
  2. APHIS and States must make the advancement of electronic records an immediate high priority. The enhancements recommended below would increase the ease of collecting data in a standardized format and subsequently provide access to accurate data in near real-time, greatly enhancing the effectiveness of U.S. traceability and disease control programs. (See report for specifics).
  3. Enhanced enforcement of existing regulations.
  4. APHIS should continue the efforts of the State/Federal Slaughter Plant Working Group to improve the rates of ID collection and correlation at slaughter.
  5. APHIS and States need to establish a partnership with industry that would enable utilization of private information systems for disease surveillance and response events. Ideally, establish a communication protocol between the private systems and an animal disease traceability portal that would allow producer data to be maintained in the private systems and made available to animal health officials only when needed for animal disease control and response. Producers would have the choice to maintain their data in a private or public system. APHIS and the States would continue to protect producer data held in their systems and use it only for disease response. (See report for additional details).
  6. Review and update existing exemptions for official identification requirements.
  7. Concerns about electronic ICVIs and other electronic movement records are a high priority . . . Stakeholders support consistent requirements; however, the State of destination should be responsible for determining the documents appropriate for collection and compliance of key traceability components for livestock arriving to that State.
  8. Address lack of uniformity of state importation regulations. 9 CFR Part 86 should provide the national standards for official ID and movement documentation. APHIS should continue revision of the regulations to increase standardization considering that eliminating various exemptions will lessen confusion and State differences.
  9. The working group feels there is value in considering a standard, or uniform, official eartag to increase awareness and understanding that it is unlawful to remove the tag. APHIS should conduct a study to determine the potential advantages and disadvantages of having one national ID eartag for cattle. The study should examine the merit a standardized tag might bring to ease of recognizing official tags and its effect on compliance. The study should also include cost comparisons of the use of numerous tag styles, sizes, etc. versus one standard, uniform tag. APHIS should review this information and, if having one uniform tag has significant advantages, publish the one tag concept for public comment through the Federal Register. The actual change, if pursued, would require rulemaking.
  10. The ability to maintain the identity of imported cattle is essential. As such, the working group recommends that APHIS allow the retagging of such animals with an official EID tag by revising the traceability regulation to define an “Import Tag” (with a specific range of AINs and tag color). For example, APHIS could reserve a range of 840 numbers starting with “8409” for use on these tags. To help distinguish “Import Tags” that have a panel component, the panel piece of the tag should include the text “Import”. This ID option would clearly identify animals tagged with an 840 Import Tag after importation to the United States; provide producers the option to use compatible EID technologies as preferred; and allows for re-tagging visual only tagged imported cattle with an 840 EID Import Tag (even if the visual only official tag of the exporting country is in the ear). Producers using UHF technology could use USDA approved UHF 840 tags or the USDA approved UHF NUES tags when the State Animal Health Official authorizes this option. The recordkeeping requirements for tagging imported animals would remain the same as currently written in 9 CFR Part 86 for retagging and adding a second official tag. The working group recommends that APHIS prohibit the use of visual only 840 tags in imported animals.
  11. Considerations related to official identification of beef feeders to include beef cattle under 18 18 month of age after additional analysis.

“Moving forward, USDA wants to continue to build on the current momentum around animal disease traceability, and will begin implementing these ADT goals starting in fiscal year 2019.”