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: The 15-Year Bet Behind Every New Variety!

Canada is trying to decide how much agricultural research capacity it can afford to lose. Brian Rossnagel believes the better question is whether the country can afford to rebuild it.

The longtime barley and oat breeder makes the case with a simple fact about his profession: the consequences of today’s decisions may not become visible for 10 or 15 years.

“Pick the right parents. That’s the biggest thing,” Rossnagel says. “If you pick the wrong parents, you’re not going to get anywhere—and you don’t know that until 10 years, 15 years later.”

That warning carries particular weight as Agriculture and Agri-Food Canada moves to reduce spending and streamline parts of its science operations. The department’s 2026–27 plan anticipates the loss of approximately 665 positions by 2028–29 and says some research will be reduced where capacity exists in academia or industry. AAFC says the changes will make its science operations more cost-effective over the long term.

For Canada’s seed industry, Rossnagel’s career illustrates what is at stake.

This fall, the retired University of Saskatchewan breeder will be inducted into the Canadian Agricultural Hall of Fame. During his 35-year career at the Crop Development Centre, he helped develop more than 100 barley and oat varieties, including CDC Austenson—one of Western Canada’s most widely grown feed barleys. His induction recognizes not only those varieties, but the collaboration and research system that made them possible.

Rossnagel is quick to emphasize that none of it was the work of one person.

“The first thing I thought about was all the other people who contributed to whatever success I and my program had over the years,” he says. “We know that it’s not an individual who does this. It’s a group—a team.”

That team extends well beyond the breeder whose name appears beside a variety. It includes technicians, pathologists, quality specialists, statisticians, regional testing sites, seed growers and industry partners. It also includes the breeders who came before and those who will carry the germplasm forward.

CDC Fraser barley, for example, moved through three breeding careers. Its parents came from Brian Harvey’s program. Rossnagel advanced the material after Harvey retired, and Aaron Beattie later guided it through registration and release.

That kind of handoff is normal in plant breeding. The person who makes the original cross may never see the resulting variety reach farmers.

It also explains why lost research capacity cannot simply be switched back on when budgets improve.

“If you shut it off, it’s very, very difficult—and particularly costly—to start it up again,” Rossnagel says. “If you have to start from scratch, it’s going to be at least 10 years before anybody notices whether you’re getting anything done or not.”

The concern is not simply how many experimental lines Canada can process. Modern equipment, statistical tools and genetic technologies allow today’s breeding programs to evaluate tens of thousands of lines—far more than Rossnagel could handle when he entered the field in the early 1970s.

But efficiency and automation do not generate every idea.

“If you pare back down, and instead of having six or seven individual scientists concentrating on wheat breeding, you go down and say three people could handle all this, well, that’s half the ideas gone,” he says. “Particularly if you happen to lose the three people who had the really neat and innovative ideas, boy, that’s a problem.”

It is a timely distinction for Canadian agriculture. Consolidating programs may preserve the volume of material moving through a system, at least initially. It may not preserve the diversity of thinking, regional knowledge or willingness to pursue unconventional crosses.

That regional knowledge matters because Canadian agriculture is not one uniform production environment. A variety suited to southern Alberta may face different disease, moisture and maturity pressures than one grown in Manitoba, Ontario or Atlantic Canada.

“Agriculture is applied biology,” Rossnagel says. “Biology, all around the Earth, moves from the poles to the equator. It does not move from Newfoundland to B.C. like politics do.”