APHIS Announces Changes to Requirements for Research Facilities to Implement the 21st Century Cures Act

Nov 24, 2021

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a final rule amending the Animal Welfare Act (AWA) regulations to reduce duplicative requirements and the administrative burden for research facilities while continuing to ensure humane animal care. The changes apply to registered facilities that use animals to conduct research, teaching, testing and experimentation.

APHIS is taking this action in response to requirements under the 21^st Century Cures Act, which directs USDA to work with the Food and Drug Administration and the National Institutes of Health to complete a review of regulations and policies for the care and use of laboratory animals.

Specifically, the changes include:

Eliminating the administrative requirement to update the research facility registration every 3 years, as it is a duplicative requirement. Facilities are already required to notify APHIS of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility, within 10 days after making such change.
Clarifying the duration of registration and conditions for termination of registration. A research facility registration will no longer be valid or effective if a research facility voluntarily requests registration termination; fails to file an annual report of animal use to the appropriate Animal Care office for 2 consecutive years; goes out of business or ceases to function as a research facility, or changes its method of operation so that it no longer uses, handles, or transports animals, and does not plan to use, handle, or transport animals for a period of at least 2 consecutive years.
Eliminating the requirement for a research facility that has not used, handled, or transported animals for a period of at least 2 years to request being placed on an inactive status to reduce the administrative burden associated with submitting an annual report of animal use while inactive.
Replacing annual reviews of protocols already approved by the IACUC with a requirement to conduct a complete review of IACUC-approved protocols at 3-year intervals instead. This will result in a protocol remaining valid for 3 years after IACUC approval and requiring a new submission to the IACUC for review and approval at the end of the 3-year term. This harmonizes APHIS’ protocol with that of the National Institutes of Health into one timeline.
Eliminating the requirement for facility chief executive officer or institutional official signatures on the Annual Report to guard against identity theft through signatures, while maintaining the assurance requirements regarding the content of the Annual Report and practices at the research facility.

The final rule is effective on December 27, 2021 and may be viewed in today’s Federal Register.

Source : usda.gov

Video: Western Canadian Agriculture: Hard Times Made the World's Best Farmers

Western Canadian agriculture produced the most advanced farmers in the world not through abundance but through adversity. The crow rate fell. The wheat price went nowhere. The brown envelopes stopped.

When the subsidies disappeared, the bad farmers left and the good ones stayed. And the ones who stayed could not just grow wheat anymore. They started growing lentils and canola and peas and flax and faba beans. They built crop rotation. They got serious about agronomy because there was no government backstop. That process produced the Western Canadian agriculture Dennis Bulani describes in this clip: the most advanced, most educated farming culture in the world.

His contrast with Iowa corn and soybean farmers is sharp. At a DeKalb farmer meeting in Okoboji, Iowa, he asked what crop rotation they ran. Beans on corn stubble, corn on bean stubble. How do you fertilize? The co-op agronomist handles it. Have you considered other crops? No need. We make so much money on corn and soybeans. Western Canadian agriculture was never allowed that comfort. And now those Iowa farmers are watching soybean markets lock up with China and corn prices slide, and they do not have the agronomy knowledge or the research base to pivot. Western Canadian farmers adapted on a dime because they had done it before.

Dennis also makes the case that Western Canadian agriculture keeps adapting in real time. Low commodity prices over the past year have pushed growers to look seriously at precision spot-spray technology. He knows a neighbor who bought a sprayer with the seeing-eye system and sprayed only 80 out of 320 acres. As a chemical retailer Dennis acknowledges that will affect his sales. He supports it anyway, because if it advances Canadian agriculture and makes farmers money, that is a good outcome.

The lesson Dennis draws from the tale of two farms: continuous improvement is the only durable strategy. When canola was $22 a bushel some growers went to Arizona instead of the Crop Production Show. When the price came down those same growers came back to the research and the discipline. Products do not go on Rack Petroleum's shelves unless they pass a replicated trial first. That is what Western Canadian agriculture built through hard times: farmers who do the work whether the times demand it or not.

Dennis Bulani is CEO of Rack Petroleum and Ultimate Yield in Biggar, Saskatchewan. Dan Aberhart hosts GTF Productions, Western Canadian Agriculture's foremost live briefing platform and its foremost AI training platform for ag operators