Deadline to submit comments has passed.
At the direction of Congress, last year, the National Institutes of Health (NIH) announced it was seeking public comments on ways to reduce the so-called “regulatory administrative burden” for researchers using animals in experiments. Powerful animal research lobbyists tried to capitalize on this as an opportunity to push their agenda, which could have drastically compromised the welfare of hundreds of thousands of animals in labs. However, a recent NIH report summarizing public comments on this issue, and that provides analysis and proposed actions by a special Working Group representing NIH, Food and Drug Administration, and U.S. Department of Agriculture, indicates that animal research proponents’ hope of reducing regulatory oversight and transparency, may be dimmed. However, this process is not over, and NIH is now seeking comments on the Working Group’s proposed actions.
Last year we asked AAVS supporters to contact NIH on this issue and demand that that the agency not put animal lives at risk by loosening regulatory requirements meant to protect animal welfare. Based on the Working Group’s proposed actions, they heard you! Now, we must keep this momentum moving forward.
Many of the Working Group’s proposed actions involve the work of Institutional Animal Care and Use Committees (IACUCs), which essentially provide self-policing, internal oversight of animal research at their facilities. Although far from ideal, IACUCs are meant to keep researchers accountable, particularly as it pertains to the care and treatment of the animals used in experiments. IACUCs conduct protocol reviews to help ensure that animal welfare laws and regulations are followed and they sometimes rely on USDA policies that provide additional instructions to guide compliance.
However, in July 2018, USDA removed its Animal Care policy manual from its website, stating that it’s “inoperative” while it reviews agency policies to ensure conformity with the AWA and its regulations. This leaves a gap where researchers can interpret regulations to suit themselves.
For example, Policy #12 requires researchers to conduct a search for alternatives and “recommend[s] a database search as the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures.” But some animal research proponents claim that Policy #12 is problematic because “keyword/literature searches are not required” in the Animal Welfare Act (AWA) and they consider them to be “ineffective.” While AWA regulations do not specifically mention database searches, they do require researchers to provide their IACUC with a “written narrative description of the methods and sources…used to determine that alternatives were not available.” Including the use of alternatives in the law and regulations is an important way to help protect animals from suffering in labs, and at a time when new alternative methods are being developed at a rapid pace, researchers may miss opportunities to incorporate non-animal methods and implement the 3Rs—to replace, reduce, or refine their experiments to minimize animal pain and distress.
Another example is Policy #14, which provides guidance for researchers to prevent them from conducting more than one invasive surgical procedure on an individual animal, preventing one of the most egregious situations in which severe animal suffering can occur. The USDA is neglecting its duties when it removes instructions that prevent this.
In addition, it is very concerning that the USDA appears to be aiding researchers and institutions in hiding their violations of laws, including those that can have a direct effect on animal welfare. There should be no exceptions in reporting violations of basic laws protecting animals and having that information be publicly available.
WHAT YOU CAN DO
Tell NIH that animal welfare should never be compromised nor be considered a “burden.” Ask that any policy or regulatory changes always default to the highest standard of care and treatment for animals.
NIH is only accepting comments on this issue that are submitted through its website. Please follow the directions below and feel free to copy and paste the sample comments.
Deadline to submit comments has passed.
- Go to the NIH website.
- Write your comments (or copy and paste from the sample letter) in the box.
- Scroll down and provide your name, e-mail, city, and state.
- In the gray box, below where it says “Enter any input you may have on the draft report,” enter your comments.
- When finished, scroll down to where it says “Notes.” Below this section, there is a reCAPTCHA box. Click box where it says “I am not a robot.”
- Then click “Submit,” and you’re done.
Thanks for taking action!
I have concerns about the stated intentions of the agencies to reduce “regulatory burden” on researchers who use animals in harmful experiments.
In particular, USDA’s cancellation of policy guidance, subject to a lengthy process of review and comment, leaves a gap in which researchers can interpret regulations to suit themselves. For example, Policy #12 requires researchers to conduct a search for alternatives. At a time when new alternative methods are being developed at a rapid pace, they may miss opportunities to implement the 3Rs, to replace, reduce or refine their experiments. Policy #14 guides against multiple survival surgeries on animals in experiments, preventing one of the most egregious situations in which severe animal suffering can occur. The USDA is neglecting its duty to protect vulnerable animals by removing instructions that prevent this.
In addition, I am concerned that the agencies appear to be aiding researchers and institutions in hiding their violations of the laws. There should be no exceptions in reporting violations of basic laws protecting animals and having that information be publicly available.
Overall, I oppose any weakening of existing regulations or policies that protect animals, and encourage the agencies to use this opportunity to strengthen them instead.