Formaldehyde in Baby Shampoo: Cancer or Sensitivity Issue?

An article was recently published in Slate about Johnson & Johnson reformulating its baby shampoo to remove formaldehyde. The article discussed how some people’s somewhat misguided fears about a known carcinogen, formaldehyde, caused its removal from baby shampoo, when in reality if you are worried about carcinogenic exposure to formaldehyde, baby shampoo should be the least of your concern. As the article’s author, Tara Haelle, correctly points out, formaldehyde is a naturally occurring substance. It is produced in normal atmospheric reactions and when wood burns, both during natural forest fires and human caused fires. It is also produced during anthropogenic activity from numerous industrial processes and petroleum fueled combustion, i.e. cars, ships, airplanes (Salthammer et at. 2010).

I have a few issues with this article, however. First, it states “high enough doses of inhaled formaldehyde can cause cancer, leading OSHA and the EPA to set limits for safe exposures.” Second, it quotes two chemists who say in different ways that the toxicity of a chemical is related to its dose or the amount of exposure, and it essentially states that formaldehyde only causes cancer in high doses. Finally, it completely fails to mention another reason why formaldehyde may have been removed that has nothing to do with cancer.

The problem I have with the second point, is that formaldehyde is a carcinogen, and the toxicological theory with carcinogens, is that exposure to one molecule of a carcinogen can theoretically cause cancer, depending on the carcinogen’s mode of action. With non-carcinogens, it is appropriate and scientifically accurate to say that the dose makes the poison. There are substances that to be healthy you need in some dose, but exposure to too high of doses can lead to detrimental health effects, for example iron and a whole bunch of metals. There are others that you don’t need at all, but you can be exposed to a certain dosage with no ill effects. However, with carcinogens depending on the mode of action for the carcinogenicity, it is believed that there is no safe level of exposure. In theory, all it takes is one molecule to cause a cell to multiply out of control and cause cancer. This is where the carcinogenic mode of action is important. The carcinogenic mode of action refers to how a particular carcinogen actually causes cancer to be initiated. If, for example, a carcinogen’s mode of action is mutagenicity, like radiation, then exposure of any dose can potentially cause the effect that leads to cancer. Thus, there is considered to be absolutely no safe level of exposure to that carcinogen. Each additional exposure increases your risk of getting cancer. However, there are other carcinogenic modes of action, and carcinogens with certain other modes of action would be considered to have a exposure threshold below which no cancer would occur.

So what about formaldehyde? What is its mode of action for carcinogenicity? Is there a safe level of exposure below which there is no risk of cancer? In the US, that appears to be in debate. This brings me to my next point. It is misleading, and in my opinion just plain legally and scientifically incorrect, to state that OSHA and EPA set limits for safe levels of exposure. The EPA has calculated formaldehyde’s Inhalation Unit Risk (IUR) for cancer to be 1.3 x10-5 per µg/m3. “EPA estimates that, if an individual were to continuously breathe air containing formaldehyde at an average of 0.08 µg/m3 (8.0 x 10-5 mg/m3) over his or her entire lifetime, that person would theoretically have no more than a one-in-a-million increased chance of developing cancer as a direct result of breathing air containing this chemical.” The word “increased” is important. It means that it is already assumed that there will be a certain number of cancer cases, and this concentration would cause additional cases above background. Furthermore, EPA states that for calculation of cancer risk from formaldehyde exposure, a linear approach with a multistage procedure due to additional risk at higher concentrations should be used. A linear approach means that any exposure causes a cancer risk with each exposure increasing the risk, and the multistage procedure means that high concentration exposure causes risk to increase at a greater rate. A linear approach is the more conservative method with carcinogens and is normally used when there is not enough scientific evidence to devise a threshold or a different risk method. With that being said, EPA is currently reviewing its toxicity assessment for formaldehyde, and it is possible when that assessment if finalized, EPA will change it cancer risk approach. With respect to OSHA, they have set an permissible exposure limit (PEL) at 0.75 parts formaldehyde per million parts of air (ppm) as an 8-hour time weighted average. The reasoning behind this level is complex, but in part, they state “this PEL represents OSHA’s best judgment of the exposure limit, along with the ancillary provisions, necessary to eliminate a significant risk of harm to employees.” The phrase “significant risk” is in there because their calculations, like the EPA’s, involve uncertainty and probabilities. They are not stating that below the PEL there is no risk, it is just not as significant. Neither OSHA or EPA is stating that below some level of exposure, formaldehyde will not give you cancer. They are stating it unlikely or insignificant compared to a background cancer risk. Below the set levels, the risks are really low, but they still exist.

Back to the baby shampoo. I do, in fact, agree with the point of the article that formaldehyde in baby shampoo is not a concern for cancer. However, I would not state it will not cause cancer. I would state that possible formaldehyde exposure in baby shampoo is highly unlikely to cause cancer. An additional point, which is not in the article, is that formaldehyde is not readily absorbed through the skin, and the amount of volatilization of formaldehyde, which could then be inhaled, from baby shampoo is likely to negligible.

With all that being said, I don’t necessarily agree that removal of formaldehyde from baby shampoo is a case of chemophobia and an overblown reaction by a company. It is possible that Johnson & Johnson removed formaldehyde not because of cancer concerns but because formaldehyde is a known sensitizer and allergen. Many skin care products contain formaldehyde or formaldehyde-releasing preservatives, which include quaternium-15, diazolidinyl urea, DMDM hydantoin, imidazolidinyl urea, bronopol, and tris nitro. While only a small percentage of people have a sensitivity or allergy to formaldehyde, for those that do, it is safest to avoid any exposure. Whether or not baby shampoo containing formaldehyde could cause a person to actually develop a sensitivity or allergy is another subject.

I have no idea why Johnson & Johnson actually decided to remove formaldehyde from baby shampoo, other than that it was a business decision. However by removing formaldehyde, regardless of any cancer concerns, there is now a small but real percentage of potential consumers who can buy their baby shampoo without concern of skin reactions due to their formaldehyde sensitivity or allergy. Thus assuming there is another safer preservative that can be used in place of formaldehyde, its removal would seem, to me at least, to be a good business decision, as they have increased their customer base to people with certain skin sensitivity and allergies.

For My Safety

Like probably many health insurers, my health insurance company encourages me to use a mail order pharmacy for my maintenance drugs. As encouragement to use it, with the mail order pharmacy, I can order a 90 day supply, but only pay a co-pay for 60 days. Most of my maintenance drugs are actually generic, and I get generic drugs for free, so the only real advantage to me using the mail order pharmacy is laziness. I admit it is kind of nice just to log onto the website, hit refill, and have the drugs sent to me. At the beginning of the year, my insurance company switched to a different mail order pharmacy, so for most of my prescriptions, I have had to submit requests to my doctors for new prescriptions. Annoying, but no big deal, until I started getting them filled. I have rosacea, and I take one oral medication for it as well as using two face creams and one face wash, all prescriptions for it. I had my dermatologist call in a new prescription for the oral medication, and when it came from the mail order pharmacy, they only sent 34 pills with a note saying they had reduced the amount for my safety. The pill (Oracea) is designed and approved by the FDA as a maintenance drug for rosacea. It is supposed to be taken everyday. It is a low dose antibiotic taken for its anti-inflammatory properties. I don’t know of any way to get high off of it, not that I have tried. After a long conversation with the pharmacy trying to ascertain why they deemed this not safe enough to send me more than 34 pills, even though I have been taking this pill for well over a year, or for that matter why they sent me the strange amount of 34 pills, as opposed to 30, the pharmacy stated it was my insurer who decided this was not a maintenance drug. A call to my insurer resulted in me being told I would essentially need to petition them to recognize what the FDA calls a maintenance drug, as a maintenance drug. They also said I could go to my retail pharmacy and get the same deal they offer through the mail order pharmacy of a 90 day supply for the cost of 60. Why they offer this deal through the retail and thus what is the point of trying to get me to use the mail order pharmacy is not something I could understand, and if I continued to try to talk to them, I was going to need a drink. I gave up.

Now, however, my health insurer’s and the mail order pharmacy’s concern for my safety has gone to comical levels. As I said above, I also use a prescription face wash for my rosacea. It is a cleanser with sodium sulfacetamide and sulfur in it. It is an old formula and has been used by rosacea sufferers and people with other skin issues for decades. I have used it for at least two years, and I think it helps a bit. Because it is such an old formula, there are of course generics, to which my insurer automatically switches my prescription. I don’t care, and I get the face wash for free because it is generic. I had my dermatologist send in a new prescription to the mail order pharmacy, and it arrived today. Just in case you can’t guess, enclosed with the 12 oz bottle of face wash, was a note that reads as follows.

“Enclosed is a reduced quantity of your prescription drug. Your prescription drug coverage has quantity limits for certain drugs. This is a type of drug coverage review that limits how many doses you can receive. The goal is to make sure you get a safe amount of your drug.”

That’s right, they sent me a reduced quantity of my sulfur face wash for my safety. Thank goodness because otherwise I might wash my face too many times. It’s true. Washing your face with sulfur can get quite addictive. I love the smell of sulfur. (It actually does have a slight smell of sulfur but nothing repulsive.) I get in the shower and just keep washing my face knowing that the wash is free. Of course, it bears pointing out that they sent me a 12 oz bottle. The earliest I can refill it according to the label is in three weeks. This 12 oz bottle will probably last me three months or more. I don’t really count. I just reorder when I need it. I really don’t know what my pharmacy and insurer thinks I do with this stuff. Maybe they think I have a really dirty face. I have no idea. I can’t fantom how someone misuses sulfur face wash. I don’t think I want to know. Maybe they are afraid I am going to drink the stuff. All I know is that if my health insurer and mail order pharmacy think they have to protect me from too large an order of sulfur face wash then there probably is no hope for humanity. As an engineer, I have stated on many occasions, I have to design for the stupid. Not even I thought people were this stupid. I guess I overestimate people.

Biomarkers: What are they and why do we study them?

In my previous post, I stated that as part of the research of which I was involved, we took blood and urine samples from our subjects, i.e. the guys we were studying. These men are exposed to chemicals during the normal course of their workday. [I say men because the all the people in our study were men. We would have happily used women in our study, but the industry we were studying is dominated by male workers, and we did not find any females to participate or who even worked at that type of job.] While the men were exposed to numerous chemicals, we were interested in one specific chemical that is known to cause detrimental health effects. While the subject was working with this chemical, we had a personal air sampling device clipped to his clothing in the shoulder area. This gave us estimate of the amount of chemical that was in his breathing air space. It was important for us to measure the breathing air space to determine exposure because the worker was spraying this chemical, so the chemical concentration would not be uniform in the air around him. As an example, if you are standing in your house, you can presume the air around you is evenly mixed. However, if while standing there, you spray air freshener or something like that, then as you spray and right after you spray, there will be a very high concentration of the air freshener in front of the direction you sprayed it. There will be a lower, but still high concentration right behind the sprayer, presumably this would be where you are, as the spray mixes. The high concentration will quickly spread out, and the freshener will mix in the rest of the room. If the house’s ventilation system is operating at the time, the freshener will mix faster than if the ventilation is currently off. Thus, the air sample that was taken in the breathing air space gave us an estimate of what the worker would have breathed in had he not been wearing a respirator. All the workers wore respirators though. Some wore half-face filter type respirators (similar to what you buy at a hardware store), which generally reduce the chemical concentration in the air breathed in by a factor about ten or so, if they are worn properly. Some workers wore supplied-air respirators, like a firefighter only these were attached to a hose with an outside air supply. This type of respirators generally reduces the chemical concentration in air breathed in by a factor of 1000. Therefore, we got an estimate of what the worker was exposed to in the air but not of the amount that made it into the lungs.

After the subject worked with the chemical, we applied and quickly removed tape strips (medical tape) to his arms, wrists, hands, and neck to determine the amount of the chemical that made it onto his skin in those areas. The medical tape removed the very top layer of epidermis and any chemical that was in that layer. Basically it was like we applied and then removed a band-aid without the gauze section. Thus, the tape strip gave us an estimate of how much chemical made it on to his skin, but it couldn’t tell us how much of the chemical actually made it through the layers of the skin and into the blood stream. Previous research had indicated that it was possible for this chemical to be absorbed through the skin. Despite what some people might think, skin is not impervious to chemicals. If it was, the nicotine patch and the estrogen patch wouldn’t work.

To summarize, we could estimate what the worker was exposed to via inhalation and dermal exposure, but we didn’t know what he actually absorbed or what made it into his body. That is where biomarkers can be useful. Biomarkers are measurements of a chemical or some other tell-tale sign of exposure in some biological sample. They can be measured in the blood, urine, fecal matter, exhaled breath, and many other bodily fluids or materials. Some materials are used more frequently because they are a lot easier to get. It is much easier to get someone to agree to urinate in a cup then to let you do a spinal tap for spinal fluid. Which bodily material is used also depends on what the chemical of interest is. If you are looking for a volatile chemical, the exhaled breath might be used. To get the exhaled breath, the person simply exhales into a specially designed glass tube. Similarly, a suspected drunk driver who has just been pulled over by the police, may be asked to breath into a breathalyzer. The concentration of the alcohol, or chemical, in that air can then be measured. This is a biomarker. If the chemical or its metabolite is excreted quickly, then it would be more useful to study the urine than the blood because there would probably be higher concentrations in the urine than the blood. However, the concentration in the urine is generally more representative of short term exposure, while the blood is more representative of long-term exposure.

The metabolism of the chemical is very important because it indicates what chemical you are actually looking for in the body and also where to look for it. For example, when a person is exposed to lead, it does not change into another chemical because lead is an element. Thus, blood lead level is a biomarker used to indicate exposure to lead. A person’s intoxication level can be measured by exhaled breath as stated. A suspected intoxicated person can also have a blood sample withdrawn, and the amount of alcohol in the blood can be measured. It is called the blood alcohol content, and it a biomarker of alcohol exposure. The body metabolizes alcohol and uses it for fuel, so looking for it in the urine is not all that useful, or least not for the police. Alcohol in the urine is more indicative of consumption hours beforehand (i.e. it doesn’t tell the police how drunk the person is at that moment, crucial for legal reasons), and it is not completely accurate because the rate and amount that a person metabolizes alcohol differs from another person. Like alcohol, many other chemicals that people are exposed to, are metabolized or partially metabolized by the body. Unlike alcohol, if it is a chemical that the body does not need and can’t use for nutrition, then the body will generally try to get rid of it as quickly as possible, if it can. The chemical we were studying in our research was like this. The body has no use for it, so it is partially metabolized and excreted. Thus we looked for the metabolite, not the chemical itself, in the urine or blood. To what degree a chemical or metabolite can be found in the urine versus the blood versus some other bodily fluid or tissue depends on the physical and chemical properties of the chemical or its metabolite. The metabolism, storage, and excretion pathway in the body of different chemicals is the subject of fascinating research and possibly another blog post.

Empathy for Technophobes

I was in a discussion recently about bovine spongiform encephalopathy (BSE) otherwise known as mad cow disease. The important background of it and why I am mentioning it, is that dairy cows need protein supplements because of how much milk they produce. In North America, the protein supplements were mainly in the form of soy, but in the United Kingdom, the supplements came mainly from rendered animal parts. These animal parts included other cows. I can remember when BSE first became a huge news item, and the practice of feeding cattle rendered animal parts came to light, I was disgusted like I imagine many people were. Part of my disgust was my questioning why would you take a herbivore, and not only turn it into a carnivore, but also a cannibal? Leaving aside the point that BSE showed that this practice had serious risks, there is a more basic question I have to ask myself, which is protein is protein, so does it matter where it came from? In this case, of course, the answer is yes. On a molecular level, amino acids like lysine and tryptophan, are the same no matter where they come from. However, the proteins and other compounds in soy differ quite a bit from the proteins and other compounds in rendered animal parts. Also, in the case of BSE, it is the shape of the proteins in animal parts that was really important. Thus in this case, it really does matter where the protein is coming from.

The turning a cow into a cannibal is still a bit of a different issue. The idea in general just seems wrong and repulsive to me. It is not natural. I think that reaction I have is somewhat common, and it has implications for how people react to certain technology. Humans are naturally repulsed and scared of certain things, and this has for the most part served us well through history. Humans in general, are repulsed by human excrement. We all urinate and defecate, but once we do, we all want the urine and feces to go away, never to be seen again. This is not a bad reaction in that, feces can have multitudes of infectious agents in it, so having it go away is a good thing. I am speaking personally to a only certain extent though. I have worked in wastewater treatment design, I have sampled at a wastewater treatment plant, and I spent several years collecting and analyzing other people’s urine for my dissertation research. I am kind of fascinated by human excrement and the information it can provide about the health of an individual. That being said, I would never touch it with my bare hands.

Humans’ natural repulsion to their own excrement causes an interesting reaction to its treatment. In urban and suburban areas, wastewater is collected, treated, and then normally discharged to some body of water such as a river, lake, or the sea. What many people don’t seem to realize, is that if the wastewater is discharged to a river or lake, then there is a very good chance, it will flow some distance and then be collected and pumped to a water treatment plant where it will then be treated and become the water supply for some other municipality. Due to the scarcity of water in many areas, some municipalities are starting to take some of their wastewater effluent and reuse it for purposes where potable water (drinking water quality) is not needed, like watering golf courses. There are normally some differences in the treatment of water to be reused than water to be discharged, but not a great deal. Once water is discharged to a river or lake, the only real, further treatment that occurs to it is dilution. Depending on the water to which it is discharged, it can be diluted by a factor as low as three (and possibly lower in a drought) or as high as 1000. A certain amount of biodegradation and other treatment may occur after discharge, but sometimes the water source into which it is discharged, can be polluted in its own way. However, the wastewater once put into a water source, does not become magically clean. Also, the amount the wastewater is treated before being discharged is based on regulations and also money and design. Regulations require it to be cleaned to a certain level. The technology exists to clean wastewater enough to turn it back into drinking water. It is not that difficult. It just requires the plant to be designed to do that, and extra costs, both in capital costs and operating costs. Years ago, a colleague once told me of a wastewater treatment plant that was designed to do just that. The wastewater was cleaned enough to meet drinking water standards. It was designed for a municipality with constant water shortages and thus needed to recycle water. However, the municipality required the water to discharge into a lake before it was then used as drinking water. By requiring this, the water actually became dirtier and picked up contaminants while in this lake. The municipality required this purely for the ick factor. They did not think the public would drink water that came straight from a wastewater treatment plant. The municipality was worried people would have the reaction of being disgusted to drink treated wastewater. This is a somewhat normal and understandable reaction, but it is completely ignorant of the treatment process nonetheless. It should be noted that even highly educated people suffer from the ick factor. Mary Roach in her wonderful book “Packing for Mars” describe how astronauts are not completely enthusiastic about recycling urine to drink.

There is a good chance that even if you educate people about the treatment process, some people would still not be able to get over the ick factor. I, at least, can’t really blame them. It really is natural to be repulsed. I’ve seen discussions among scientists that I am afraid sometimes almost borders on contempt for the ignorance of people who are scared of certain technologies. If people were educated about certain technologies, many would accept the technologies, but many still wouldn’t. Genetically modified organisms (GMOs) are an example of this. I fully admit I have a problem with some GMOs but not all. I have a serious issue with plants that have been modified to produce Bt toxin, but my issue with this is not about the plants ability to produce the toxin, but the effect it might have on organic plants, which many times are treated with Bt toxin to kill insects. I like organic foods for a multitude of reasons that I won’t go into here, but I don’t think there has been enough research or even concern about how GM plants that produce Bt toxin might have on organic plants. I also have an issue with GM plants that have been modified to be resistant to herbicides, but again I don’t actually have an issue with the actual genetic modification. I have a problem with the fact that this allows greater use of herbicides, and the effect this can have on the ecosystem and also the effect this can have on the workers who work with the herbicide. Conversely, I don’t like certain GM animals such as GloFish, and I would put this into the category of just because we can do something, doesn’t mean we should. Perhaps it is ignorance and the ick factor. I’m not scared of them. I just think sometimes humans do things that perhaps we shouldn’t. Sometimes, it really isn’t nice to play with Mother Nature.

I have discussed my issues with GMOs to a certain extent with a person I know who works on GMOs. She is constantly fighting ignorance and fear about GM foods. We have discussed a little the issue of labeling GM foods. I support the labeling of GM foods, and she has stated it is not that simple. I don’t have all the facts, but I think part of this has to do as to where “traditional” plant hybridization and breeding end and where does genetic modification start. The problem is that when GM foods are not labeled, it gives people who don’t like GM foods more ammunition to fight GM foods because they can say the public is being lied to and information withheld. I have heard the argument that if foods that include GMOs are labeled as such, then people won’t buy them out of ignorance. I don’t think this is a valid argument. That is a consumer’s right. Some people who oppose GMOs when educated about what GMOs are and are not, will probably start to accept them, and other will never accept them. However people must be free to make their own choices even if out of ignorance and fear. [I am leaving aside the issue of ignorance and fear leading to people making decisions that not only affect themselves but others, which is a whole other issue.] Further, taking the attitude that people don’t need to know certain things because they wouldn’t understand, is arrogant, and educated people must stop themselves from becoming arrogant. Educated people need to fight harder to educate others.

Nuclear power is another example of technology of which many people are scared. A large problem with nuclear power of course, is that it is a relatively safe technology, but if something goes wrong, it can really go wrong. Nuclear accidents are thankfully relatively rare, but they have the potential to affect a huge number of people as seen with the Chernobyl and Fukushima disasters. Considering how long nuclear power has been around, I think it is unlikely that some people will ever accept nuclear power even if fully educated about it. Nuclear power may also be one of the technologies where people think we are doing something we should not be, as in it it not natural. I am not sure, but I also think nuclear power suffers from an engineering problem. From my limited knowledge of both Chernobyl and Fukushima, both had design flaws, in that possible, known “what ifs” were not properly addressed in the design and construction. I learned recently of new nuclear power designs that would not have the risks associated with current nuclear power plants, like meltdowns. I am very excited to see if these designs will discussed and used in the coming years, but I worry that bad memories of old technologies will prevent people from accepting these new technologies.

People have a very long memory when new technology goes wrong. Scientists and engineers are really good about learning from when things go wrong. However, if when things go wrong, people, the environment, property, or something else is harmed, then not only do scientists and engineers have to learn how to improve the technology, but we also have to regain people’s trust. That can be an even more difficult process. Some people fear technology that they don’t understand. Also, when the previous technology had problems, and people don’t understand what has changed between technologies, it is going to very difficult for them to accept the newer technology. Then again, some people fear technology that they do understand. Perhaps the fear is due to the ick factor or the your-playing-God factor. I am empathize with this fear. Education can help to alleviate fear but not always. Sometimes fearing, distrusting, or not accepting a technology is not just an education issue. Sometimes it is a deep-seated, human instinct. Perhaps this is both good and bad. I think those of us who work with and on technology would be best served to remember that.