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Establishing Legal Restrictions and

the Need for Acquiring Actual Situations

in Japan

6th World Congress on Alternatives & Animal Use in the Life Sciences
Special Symposium - Dialogue with Citizens - 25 Aug. 2007
Asako Araki

1. For the Advancement of Alternatives to Animal Experiments

2. Alternatives : Researchers and Citizens

We are not scientists or experts on science. We are just ordinary citizens whose wish is to end the suffering of animals.

We see two standpoints when we say “alternatives to animal experiments”.

One is from the scientific research point of view. In scientific research animals are merely subject of research, a “thing”, where a part of it is taken out and data is gathered, analyzed, put into statistics, have some kind of conclusion drawn, written in a paper and published. In this process, researchers can try to reduce the number of animals used in their experiments. Or they can try to reduce the stress, pain, and suffering of the animals. They may also think of replacing vertebrates with other subjects. This is the idea of alternatives, or 3R, from the scientific research point of view.

On the other hand, the alternatives that we citizens can practice differ from those of the researchers. For example, when we hear that animals are being poisoned to check the toxicity of a certain chemical substance, we try to choose products that don’t require these tests. This means using natural products whose safety have been proven by years of long use. When we find out that a tremendous number of animals are experimented on pharmaceuticals, we change our views on health and sickness. We try to get treatment in alternative medicine, that is, medicine not dependent on animal experiments. Furthermore, we look for ways to stay healthy and fit, focusing on preventive medicine. These changes in our lifestyle are all alternatives that we citizens can choose and practice.

Today the theme of this symposium is for us citizens to ask researchers and scientists for further advancement in the use of alternatives. We therefore would like to make a few suggestions on how this could be done.

3. 3R and Social Consensus

People conducting animal experiments insist that animal experiments are necessary in medical and scientific research, while citizens feel sorry for the animals and ask for dignified respect for life. These two standpoints often come into conflict with each other, sometimes leading to serious arguments. We can say that the 3R in animal experiments are a result of both parties trying to settle the matter.

4. 3R in Animal Welfare Law

The Japanese had been using traditional medicine before modern western medicine took over 100 years ago. Along with modern medicine, the method of animal experimenting was also introduced. Since then, without any grasp of the actual situation or legal restrictions, and without ever being debated whether or not the method was right or wrong, animal experimenting has been conducted to date.

In present Japan there is no knowing who is conducting what kind of animal experiment using how many and what kind of animals and where it is being conducted. There is no system to grasp the actual situation.
For years, we have been taking action towards the Japanese government for legal restrictions on animal experiments and finally, Animal Welfare Law was revised in 2005, incorporating the principles of the 3R.
Although it states in the law that it is obligatory for those performing animal experiments the refinement, or reduction of pain and distress, unfortunately, there is no system to supervise this. As for the reduction of animals and replacement to other non-animal methods, they are merely stated as an “effort”.

Ministry of the Environment has set standards for animals used in experiments in Standards Relating to the Care and Management of Laboratory Animals and Relief of Pain, but with no tools enforce them. Ministry Of Education, Culture, Sports, Science and Technology and Ministry of Health, Labor and Welfare both have set relevant guidelines, but with no practical effect.

ALIVE is in the process of making disclosure claims to state run research institutions conducting animal experiments. Surprisingly, many of the institutions were not even aware of the guidelines.

5. Articles Necessary in the Revision of the Current Standards

Although there are standards and guidelines for animal experiments, there are no ways or systems to see that they are being followed. This is the current situation in Japan.

That is why we are asking for a registration system of all institutions conducting animal experiments. Furthermore, we think that it is necessary for on-the-spot inspection by the authorities to check that the law and standards are being followed.

And then there is the problem of pet shops and animal breeders selling the animals on the “black market” for use in animal experiments.

There is also the fear of wild monkeys being illegally used in animal experiments. In order to assure worried citizens that these acts will not be the case, we believe that breeders of laboratory animals should be registered as well.

In Animal Welfare Law, it is stated that it is the obligation of those performing animal experiments to reduce pain and distress of the animals, but there are no ways in which to check that this is being followed and we think that this is a big problem. It should be at least documented and submitted for review.

6. What 3R Can Achieve

The 3R cannot do away with all animal experiments in the present situation, but there are places where it can make a difference.

First of all, in the field of education. Animals should not be hurt or killed in order to convey facts already known. This goes for learning techniques in medicine as well. Animal experiments for the sole purpose of writing graduation thesis should also not be performed.

Avoiding redundancies in experiments is another. Regardless of the outcome, all experiments should be made public and accumulated onto a data base. By doing this, unnecessary experiments can be avoided.
At this World Congress various active measures are being taken in the field of toxicology. This is not just animal friendly but has proven to be extremely efficient.

7. Advancement of 3R

To actually further advance the 3R there is a need for a new system. But researchers and scientists and those others conducting animal experiments claim that instead of a new system, the traditional “voluntary effort” is enough. “Voluntary effort” here, meaning self-inspection and self-review. But we all know that buildup and fanfare do not move forward a plan. There needs to be some kind of external pressure to guarantee real results.

Setting numerical targets can be an incentive in getting results.

We can say, ”Compared to he traditional method of experimenting where * number of animals have been used, the method employing alternatives enables a reduction of *% in the number of animals being used.” In other words, setting a realistic goal and carrying it out.

And it is also necessary to review whether or not the target has been reached, and how effective the alternatives had been.

In order to materialize this plan there is a need for an alternative validation system. There will be a strong public support for a system of this kind. Public support means a “yes” for using the taxpayers’ money. A highly supported project will receive larger financial aid from the government.

And of course, giving legal base for this system is more than desirable.

8. Reviewing Animal Welfare

In the Animal Welfare Law it states that all animals bred, pets and laboratory animals and farm factory animals included, should be handled appropriately. To ensure conditions are in accordance with this law and for the advancement of the welfare of animals, there needs to be in place a reviewing system by a third party. The following items should be included in the Animal Experiment Protocol.

  • Selection of laboratory animals – Why a certain breed of animal was selected and why a certain number of animals are used should be closely examined by a reviewing committee including a well-informed outsider.
  • Acquirement of the laboratory animals and maintenance condition – Confirmation of legal acquirement of the animals, not by an illegal breeder, and confirmation that the animals’ living conditions are in accordance with the welfare of the animals should be verified by a third party committee.
  • A close examination on how pain and distress of the laboratory animals can be reduced or avoided.
  • The disposal method of the dead animals should be documented from the environmental pollution point of view, not to mention euthanasia.

Most importantly, the Animal Experiment Protocol should be reviewed not only by insiders and not just as a formality, but by a third party and by the public. Finally, the Animal Experiment Protocol should be disclosed to the public.

9. Setting Numerical Target

Setting a numerical target is undoubtedly one certain way of advancing the 3R. We are asking for concrete results, not just words.

As for “Reduction of Pain and Distress” there are currently 4 levels of evaluating the animals’ pain and distress, but there should be a more detailed evaluation specifying the pain and distress a certain action towards the animal would cause.

Maintenance of the animals, or living conditions, should also be a subject to evaluation on the basis of the five principles of animal welfare(five freedoms), that is, sufficient supply of food and water, comfortable and sanitary living space, treatment for diseases and injuries, no infliction of unnecessary fear, agony or anguish, and adequate space in consideration of the animals’ natural behavior.

In regard to “Reduction of Number of Animals” a concrete number of the actual reduction in the number of animals used should be shown, as in the case of LD50 tests where we saw a great decrease in the number of animals used by employing alternative methods.

Concerning “Replacement of Animal Experiments”, unmistakably the core for alternatives, there is much room for research and development. The potentials of alternatives in the different areas and potential alternatives should be explored. Active funding for the research is crucial on the side of the policy-makers.

10. 3R Assessment Committee

In the current research system once an experiment is performed, it is difficult to trace which experiment was presented with what specific results, let alone in what form the experiment was returned to society.
We therefore propose for the advancement of the 3R the setting of numerical target and forming a third party organization to assess the achievement of the target. The organization should be composed of members with knowledgeable people from a wide variety of fields, including members representing the citizens.

This assessment committee should not only disclose results of the assessment but also contribute opinions to scientific journals and have the authority to comment on funding applications. The committee shall play an important role in the advancement of the 3R.

11. Funding System for Alternatives

One reason for the slow progress in alternatives research in Japan is that alternatives are not acknowledged and the importance not sufficiently understood by the people. We must explain to the public in clear form that the use of alternatives can reduce the animals’ suffering and at the same time, cut costs.

It is difficult to imagine anyone disagreeing to this.

With the public assent we can expect more funding from the government for alternatives research, and contribution from private institutions and individuals.

12. 3R Advancement Plan

In order for the 3R to be put into practice without fail, we must establish a concrete action plan. EU’s restrictions on chemical substance, or REACH, which came into effect this June are a set of regulations concerning registration, evaluation, licensing, and restriction of chemical substances. It is said that it was originally drafted to reduce the use of animals in experiments by actively employing alternative methods. It is predicted that for the first eleven years after REACH takes into effect, we will see an estimated 3% increase in animal experimentation in the EU, but after that period, having sufficiently covered all problems concerning the 30,000 chemical substances used today, the number of experiments conducted will decrease dramatically, with only a few new substances to be tested yearly.

Ministry of the Environment information on REACH

In order to make a valid prediction as mentioned above, there needs to be a clear understanding of the present level.

But unfortunately in Japan, there is no knowing at which institution, what kind of animal experiments are being conducted using what kind of animals, and how many. We do not have a clue to even the most basic facts about these experiments. In this current situation, even if the 3R were to be advanced, there are no ways to compare or evaluate their effectiveness.

If animal experiments must be conducted, and if the lives of these animals are precious and noble as scientists and researchers claim them to be, then they should be treated accordingly, by taking accurate record of the animal experiments performed and having them assessed by a third party. Not a single life should be wasted. An animal experiment not returned to the people in any form should immediately be put a stop to.

In Japan now, a new system of evaluating achievements are being introduced to administrative agencies, research institutions, and private corporations. Animal experimentation shouldn’t be an exception. We must not let insiders continue to evaluate each other out of formality. As with the rest of the society, the traditional system should be changed to a system where citizens and residents can participate.

13. Legal Restrictions and Promotion of Public Interest

In Japan we do not have any laws or regulations to restrict animal experiments and now is the time for one.
We must first grasp the actual situation by registering those conducting animal experiments and facilities and institutions where they are being performed.

We have many large-scale earthquakes every year here in Japan. There is always the possibility of an animal experiment facility being damaged or destroyed. From the crisis management point of view, a better understanding of the current situation is crucial. Without this information speedy measures cannot be taken
Having legal restrictions can also ensure procedural efficiency and transparency of the whole process. The effectiveness to research cost would become visible and assessable. Having a legal basis for saving animal lives and cutting cost will be the driving force for the advancement of the 3R.

Furthermore, a larger social recognition towards animal sacrifice will lead to enrichment in financial aid and support in manpower for alternative research.

14. Many people are saddened by animal experiments.

We believe that a social consciousness towards animal experiments will lead to a better understanding of and support for alternatives.

We hope for researchers and scientists and citizens to all get together and have a thorough discussion on what we can and should do.