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September 2008

CLEAN AGE Summary


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No. 28 (September 2008)

Inside of this issue
1.Clean Seminar: How is Safety Reassured?
Lectured by Hiroaki Aoyama

2.What is the Point in Considering about Sense of Security in Consumer Life?
Interviewed Itaru Yasui

3.Background and Meaning of JSDA's Public Announcement on "Human and Environmental Safety Risk Assessment of Fluorescent Agent"
4.The 6th ASDAC in Taiwan


1. Clean Seminar: How is Safety Reassured?

Lectured by Hiroaki Aoyama, Ph.D; Associate Director / Chief, Laboratory of Reproductive Toxicology, The Institute of Environmental Toxicology
asdac

JSDA conducted a lecture entitled "How is safety reassured?" which content included the toxicity evaluation and the risk management. Dr. Aoyama provided the following comment as his opinion about current science.
"The safety risk of various poisonous substances contained in food or in the environment is presumed by the multiplication of harmfulness of the material (hazard or toxicity) and the level of exposure (intake). In this risk assessment process, it is crucial to use scientifically correct hazard and exposure data and to develop reasonable risk management procedure based on the result of the risk assessment. However, looking at the reality in Japan, regrettably there are many misunderstandings, failures or correspondences, which are believed scientifically correct but are actually incorrect."
In the lecture, he expressed that a road for wise consumers lies between academic science and regulatory science. In this edition, weユd like to introduce the summary in this particular area. (The JSDA Editorial Department takes responsibility for the content of this summary.)

Misunderstanding about the term of "chemical substance"
Thinking thoughtfully, "chemical substance" is a strange term. Everything existing on the earth like an apple and a computer is a material, and they are all chemical compounds. It seems that a word of "chemical" is applied to certain materials in order to develop an impression of harmful material that a man made by force. As a result, general recognition of "chemical substance = artificial product = harmful material" has somehow penetrated into consumers. Hundreds of 1000 materials exist on the earth, and we live relying on them. It is practically impossible to assess the safety risk for all of them. Current practice is to set priorities based on experience, and take an action from the one with, for instance, high production volume, while responding immediately if an unexpected adverse event unfortunately takes place or a trouble is developed.

How to interpret words of specialists
Although people think that they understood what a specialist talked during the lecture, they are difficult to recall what was taught when coming back to the house. Regarding safety of a material, for instance, consumers do not understand what is safety and to what extent the material is safe. Even in the homepage of the government or the local governments, it is usually written at the end that it is important to think carefully on own responsibility. So, consumers are at a loss after all. Also, in the field of toxicology there are a lot of researchers who express their interest in safety from the academic point of view, but in reality they do not even understand the approach of risk assessment. Some researchers might have thought that it is better to say for the time-being that this is a problem and it is necessary to research, in order to acquire the research budget. Actually, this happened at the time when the environmental hormone issue took place and a large sum of budget to the research was provided. As a result, the safety for consumers and the risk assessment had been left somewhere, while a lot of physiology revitalization data (as opposed to "toxicity data") of various materials were developed. After all, consumers' concern about the safety has never been answered.

Academic science and regulatory science
First of all, it is necessary to understand that there are two kinds of science, i.e. academic science and regulatory science, in order to correctly understand the safety issue and its assessment. The test method to examine the toxicity necessary for the risk assessment is typical regulatory science. The purpose is to guarantee the safety for consumers. Here, the efforts are concentrated on development of counter measures by examining all the scientific facts available within a definite period of time. However, there are always uncertain areas, where supplemental data need to be developed, because everything is never perfectly clear from the science point of view. On the other hand, a research in academia such as studies in universities is academic science, and its purpose is to study the issue thoroughly to the very last possible moment. If there is something unproven, it will be the next theme of the research. Therefore, there always remain unsolved issues and the research continues almost endless.

Problems of administrative agencies and media
We often observe cases that administrative agencies or media mislead consumers with academic science. Today, it is a normal practice by administrative agencies to form a study committee gathering specialists when a problem occurs. However, there are no strategic considerations on how to choose the committee members. In many cases, the discussion always goes parallel with a conclusion that further research is necessary, because the committee members are evenly chosen among disputants who have conflicting opinions. It is preferable to first evaluate the general situation of the problem, and then to choose the committee members by proportional representation method. In terms of media, they tend to request an opinion from the same researcher no matter what is the problem. However, even a researcher who has distinguished achievements in a certain field is an amateur in the unprofessional field. In such a field, he could make a mistake and provide unprepared comment, which is not necessarily correct in a scientific manner and might mislead consumers.

Domain of science and area of psychology
In risk assessment, acceptable maximum dose is provided as a standard. The amount is 1/100 of the maximum dose of which toxicity is not observed in the animal experiment (maximum no effect dose). To this extent, it is an area of science. If a logic that it should be absolutely safe or the risk assessment is not trustworthy is brought in here, it is no longer a science but an issue of psychology.


2. What is the Point in Considering about Sense of Security in Consumer Life?

Interviewed Itaru Yasui, Ph.D; Principal Fellow, Center of Research and Development Strategy, Japan Science and Technology Agency; Vice Rector Emeritus, United Nations University
photo Dr. YasuiConsumers in Japan have been paying more and more attention on safety and sense of security due to the frequent news of safety-related incidents and accidents in recent years. Safety and sense of security are different, but consumers seem to escalate their desire to the point that they cannot be relieved unless it is 100% safe. Provided this as background, we asked Dr. Yasui how we should think about the safety of chemicals that inseparably bond to the consumer life.

[Interviewer] Synthetic detergent remains in a position of villain in the chemical industry in Japan together with food additives and pesticides, despite of the continuous efforts of the industry association to have consumers understand correctly.

[Dr. Yasui] An essential part of today's science is that we cannot discuss anything without a concept of trade-off of the risk. In other words, if we choose one, we have to give up another. For instance, the safety risk of food is infectious disease caused by bacillus in many cases, and the risk level has significantly declined on the whole thanks to food additives. This is why food with no additives can exist. Various consequences would happen, if the use of food additives is stopped, and, I think, business of food with no additives cannot hold on their current position. I wish if we could prove that the existence of food additives has lowered the risk; however, there is no way to prove it, unfortunately.
While it was probably good to remove ABS, which was originally contained in synthetic detergent, it is not scientifically true that soap is better than synthetic detergent. What is good for the environment is, I would say, not to use any of them. This is also a trade-off. Using none of them is not acceptable either, since a majority of consumers hope to live in the hygienically clean and civilized life.
In my opinion, it requires approximately 35 years reaching the point that the consumers finally recognize that the risk has reduced and the issue has become no longer a problem.
For instance, let's assume that an activist against synthetic detergent is about 35 years old. Generally, such person never hears others' opinion no matter how it is stressed that the human safety is scientifically confirmed and there are no issues on the load to the environment. The problem will be never solved until the person becomes 70 years old, i.e. 5 years after his retirement. An idea accepted once is never changed as a nature of human-being. Especially, for those who have engaged in such movements, they are difficult to accept different opinion. They would feel that their whole life is denied, if they were said that what they have done was wrong.

[Interviewer] There are some people, who have long stuck to the idea and never change their opinion that synthetic detergent is unsafe.

[Dr. Yasui] Though the conversion from ABS to LAS completed about 30 years ago, the safety assessment methodology of detergent was established in Japan in 1983 and thus it will take another ten years to diminish the fuss, taking my personal opinion into consideration.
Some people who deeply engaged in the soap campaign might have the pure belief that they are doing something really good for consumers, but some make synthetic detergent a bad guy and avail the opportunity to do their business. This obviously supplies energy to the campaign. There are many cases in the world that the existence of something harmful turns into a business chance. Examples include; a business to sell vegetables without pesticides or organic vegetables because consumers dislike agricultural chemicals, a business to sell mineral water or water purifiers claiming that tap water is dangerous, etc. It is normally easier to make business by having someone to be denounced, and this is one of the structures of the world. Recently, the safety of food is especially amplified, and this leads to greater consumer awareness in various ways. As a result, disposal of food with expired "good taste period" has increased on the site of sales. Such a flow would never change, unless a food crisis takes place.

[Interviewer] In general, consumers in Japan believe information such as good-taste-period without any doubt and do not judge by themselves. They do not even smell to confirm the freshness. Actually, there is an opinion that such situation is rather dangerous. It seems that today's consumers in Japan cannot judge safety and security, and leave the judgment on others.

[Dr. Yasui] Risk management is not unfortunately made at an individual level. The safer the world becomes, the more consumers rely on others to assure safety. I personally think that the good-taste-period is unnecessary, while consumption-limit may be necessary. Recently, consumers have greatly influenced by such a flow, reaching to the level of conviction that food with shorter good-taste-period is even better.
Safety risk has reduced in various respects compared with the time when the risk factor was high. In consideration of the safety risk, there is an idea of safety range and every product currently in the market is already in the range. Consumers, however, cannot understand the concept of the safety range. The reason why they do not understand is that no one teaches it. I think this is because teaching it has no commercial value.
Regarding a way to understand the safety range in the risk assessment, active oxygen, for instance, plays a vicious role in the mechanism to develop cancer in the human body. The risk of the active oxygen intake is related with the risk of breathing. However, the risk of not breathing is higher than the risk of breathing. Once everyone understands this logic, it should be also understood that the risk level of carcinogen contained in food is acceptable, unless the concentration exceeds over a certain level.
However, determining the acceptable level correctly is also difficult. Because the acceptable level of harmful substances has lowered, it is difficult to determine the risk scientifically and quantitatively. No one can prove it acceptable or unacceptable at the level provided, even if it is considered safe.
Everyone is living now under such an extremely luxurious condition. Therefore, my conclusion is that it is not necessary to worry any more, if I say a little violently. I think we should worry about only three major issues today, i.e. energy, resource and garbage, rather than continuously debating "that is dangerous" or "this is not dangerous".
I think, however, way of thinking about the risk may be moving toward good direction recently, as evidenced by the fact that major attention is being paid recently to the risk at the global level including the global warming issue.

[Interviewer] Safety and sense of security are mixed up, and this makes discussion difficult. There is no end in discussion to what extent we need to assure the sense of security, though there is a way to manage the safety. Consumers tend not to be relieved unless it is 100% safe.

[Dr. Yasui] Increased sensitivity to allergy might be one of the reasons of distrust in chemicals. However, infant mortality rate of Japan, which was roughly 200/1000 about 100 years ago, has fallen down to 3/1000 thanks to chemicals.
You may understand how consumers raise problems which are not important and worry about them, if you at least understand and share overall picture based on historical trends in the change of living environment on mortality rate, causes of death and as such. Consumers, however, do not think this way to our regret.
There are two fundamentals to consider about safety at the popular level. One is that things completely safe cannot exist on the earth, and the other is that a human life is limited. So far, my opinion is that we must keep communicating this repeatedly.


3. Background and Meaning of JSDA's Public Announcement on "Human and Environmental Safety Risk Assessment of Fluorescent Agent"

Yutaka Takagi D.V.M; Environment and Safety Special Committee, Japan Soap & Detergent Association
photo● Why did JSDA conduct the risk assessment?
The reason why JSDA conducted the risk assessment of fluorescent agent is that the data necessary for the risk assessment can be only obtained by the manufacturer that makes the end-product; i.e. detergent.
The amount of fluorescent agent contained in detergent and how much the product is used in daily washing are important information on the risk assessment. Thus, we think only we, who are making the product and have the actual usage data, can conduct the risk assessment correctly based on this proprietary information.

● Why is it on this timing?
It is a current global trend to reconfirm the safety of chemicals. As for the point why it is now, it relates to the fact that the result of the risk assessment conducted by HERA (Human and Environmental Risk Assessment) was published in Europe. HERA is an independent organization in Europe, where the industry of soap and detergent manufacturers and the industry of chemical manufacturers collaborate and voluntarily conduct the risk assessment of various chemicals used in detergent. Its activity began in 1999. However, the assessment was made based on the usage condition of detergent in Europe and analysis of river water there.
What we examined was the safety risk of fluorescent agent, using the exposure data to the human and the amount existing in the environment in Japan, while applying the hazard data used in HERA's risk assessment. In general, two kinds of fluorescent agent are used in detergent both in Japan and Europe; FWA-1 and FWA-5. About 14,000 tons of fluorescent agent is used in a year in Japan, and 300 tons is estimated in laundry detergent. We voluntarily conducted the risk assessment as a responsibility of the manufacturer and the industry.

● Human and environmental safety of fluorescent agent
First, it is necessary to determine hazard level of the material correctly in order to assess the safety. Then, we compare how much the material taken into the body with the maximum amount that the negative safety effect is not shown. The negative effect doesn't appear to the human, if the amount taken into the body is extremely small. To examine this is the risk assessment on human safety.
In terms of the environmental safety, we know that fluorescent agent exists in the river in Japan at extremely low level from the analysis of the river water, where sampling was conducted. However, the risk assessment requires the data not only at the point we conducted the sampling but also the amount existing in the environment across the country. JSDA has conducted monitoring of the surfactant in the river over many years, and can estimate the concentration of fluorescent agent in the river across Japan based on the point analysis data.
This is how the human and environmental safety risk assessment of fluorescent agent was made.

● How about the result of the risk assessment?
As a result, we reached a conclusion that the human and environmental safety risk of fluorescent agent is low. Since the human safety risk is low, no major negative effect to the human body is anticipated, even if detergent with fluorescent agent is used. Also, it can be said that there is no major negative impact on living creatures in the environment.
However, an expression that the risk is low is sometimes taken as "after all, there is a risk". This is not correct at all. "The risk is low" means that there is no major negative impact on human and environmental safety, as long as the product is normally used.
To assess safety, the worst case scenario is applied. For instance, we assume that all the material available is taken into the body 100%, whereas the actual amount taken into the body through the skin is extremely low with about 0.1%. We concluded that it is safe even under such an extreme condition.

● Safety rate
In the human safety risk assessment, there is an idea of safety rate. Because fluorescent agent is used in washing every day, it is necessary to assess a long-term effect to the human. In risk assessment, we compare the maximum amount that negative effect is not shown in the animal chronic toxicity test (maximum no effect dose) with the amount of fluorescent agent that is actually taken into the human body. The safety rate is applied in this process. The rate consists of two factors. One is the differentiae between animal and human, which is ten times. And, the other is an individual variation due to various differences of receptivity, which is also ten times. In net, a total of 100 times is the basic idea of the human safety rate. In other words, no negative effect is presumed to the human, if the exposure level is less than 1/100 of the amount, of which any negative effect is not shown in the animal testing.
The environmental impact was determined in comparison between the concentration in the domestic river and the toxicity examination result of the aquatic life. Based on this assessment, we concluded that there is no negative impact on the environment at the level currently existing in the environment in Japan.

● Misunderstanding to fluorescent agent
Wrong information that fluorescent agent is or may be a carcinogen is still around. This was originated by the experiment conducted in Germany about 40 years ago. However, this was actually denied through various follow-up experiments and even by re-experiment of the proponent.
Additionally, this misperception was amplified by such facts as the structure looks like a known carcinogen, the material is not approved as a food additive, the material is not allowed to be used in medical devices like bandage and gauze, etc.
Because a food additive is the material intending to process or preserve food while fluorescent agent is not intended for such usage, it was never requested to obtain approval as a food additive. The reason why fluorescent agent should not be detected in medical devices such as bandage or gauze is to prohibit using recycled clothes in these medical devices. Because white clothes normally contain fluorescent agent, the standard was developed to confirm that recycled clothes are not mixed.

● Why is fluorescent agent used in detergent?
White clothes are originally treated by fluorescent agent, when manufactured. However, it falls off at the time of each washing, and in order to supplement it fluorescent agent is added in detergent. Fluorescent agent in detergent plays an important role, since it can extend the longevity of clothes so that the same clothes can be used more times. This is important from the view point of conservation of energy and saving resource.


4. The 6th ASDAC in Taiwan

asdacThe 6th ASDAC, sponsored by Taiwan Soap & Detergent Association, was held at Nice Prince Hotel in Taiwan on September 18, 2007. About 180 people were present from Australia, China, India, Japan, Malaysia, Taiwan, the United States and Europe, and 13 speeches were given with 18 technical booth exhibitions.
photo16 people including Mr. Nakajima (Chairman, JSDA) and Ms. Tsujimoto (Chairman, International Affairs Committee) participated from JSDA. Ms. Akiko Yamamoto gave a speech entitled "GHS Implementation for Consumer Product in Japan", which content included the GHS progress in Japan and other countries and the GHS execution guideline that JSDA voluntarily developed.
In addition, the ASDAC Steering Team Meeting was conducted on September 17, 2007, the day before the conference. The agenda included confirmation of the latest situation of GHS development and the activity of ASDAC in the future. In the meeting, it was agreed and reported in the conference that the name of ASDAC is changed to "AOSDAC" (Asia Oceania Soap and Detergent Association Conference) along with the agreement to have ACCORD of Australia as a new member.
AOSDAC is expected to become a broader soap and detergent conference than before, expanding the activity into a wide area including northeast Asia, Southeast Asia, South Asia and Oceania in the future.


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