Please Help, Young Children and other Sensitive People not considered in CPSC Risk Assessment
Final public meeting is Feb 1, Final CPSC vote on Risky new law is Feb 16
The US Consumer Products Safety Commission has completed its final Risk Assessment and draft of final law to protect mattresses from open flames. A public meeting is to be held February 1, and the final decision meeting will be held February 16. The law is expected to become effective July ’07. Meanwhile all mattresses sold in California, and 1/3 of all new mattresses sold nationwide, already contain toxic chemicals in anticipation of the new law.
The New CPSC Risk Assessment proves conclusively that:
1. Acutely toxic and cancer causing chemicals are used in most barriers to flame proof mattresses (See CPSC Table 1)
2. These chemicals leach and migrate to the surface of the mattress
3. These chemicals are absorbed by our bodies in significant and measurable amounts, every day for the rest of our lives.
4. CPSC calculations predict we will receive a daily dose of .8 mg of Antimony Trioxide, and .08 mg of Boric Acid. Even the CPSC admits there is uncertainty in the analysis. It is difficult to predict the future. Our real daily dose might be much higher.
The CPSC says all of this is safe for everyone, except children under age five who they assume will be protected by a plastic sheet over their mattresses. The Agency for Toxic Substances & Disease Registry (ATSDR), a division of the CDC, disagrees with the CPSC on the amounts of exposure the CPSC assumes is safe. Among other things they say there is no safe exposure level for Antimony Trioxide, and that Antimony Trioxide accumulates in our bodies. When pressed by TERA about the cancer risk from Antimony Trioxide the CPSC admits: “The cancer effects are cumulative. Every exposure contributes to the overall lifetime risk of developing cancer.”
The CPSC internal risk assessment was reviewed by an independent group called Toxicology Excellence for Risk Assessment (TERA, www.tera.org). This review found significant problems, errors, and omissions with the CPSC report. The CPSC excluded children under age five from the risk assessment. This group is the most vulnerable to poisoning and developmental effects. Numerous studies over the past 30 years have shown young children are particularly sensitive to even very low levels of toxic exposure, i.e. Lead. Antimony is also a heavy metal like Lead. The flame proofing law also applies to youth and crib mattresses. Buried deep in the CPSC document are the written comments from TERA and answers to these comments from the CPSC. Listed below are quotes from the comments and the CPSC answers: See the full text in Tab D, with TERA comments beginning on page 60, http://www.cpsc.gov/library/foia/foia06/brief/matttabd.pdf Quotes from CPSC documents are presented in the font Times Roman, our comments are in the Arial style font. Page number references are of the pdf page, not the original document page.
Comment 9. Mouthing area should be increased to include 50 cm2 of direct mouthing of sheets.
Answer. TERA suggested mouthing rate and area (1 hour daily, 50 cm2) originated with the National Academy of Sciences' (NAS) National Research Council (NRC) study of flameretardant chemicals (2000) for use in upholstered furniture. That estimate assumed exposures of a 1 -year old child to furniture designed for day-time use. However, CPSC staffs mattress exposure estimate requires consideration of furniture designed for night-time use when children are primarily asleep, and therefore interacting less vigorously with their environment. Additionally, CPSC staff has chosen to examine older children (5 year olds) because younger children's mattresses are more likely to be waterproofed due to their higher likelihood of bedwetting. This waterproofing, either with fluid-resistant ticking or mattress covers, is expected to reduce contact with FR chemicals, …”
Children under 5 were not considered in this risk assessment! The CPSC was directed by Congress to obtain the above referenced independent NAS study of the safety of 16 flame retardant chemicals. The NAS recommended against using 8 of the 16 chemicals due to toxic and cancer risks. The NAS also recommended against using Antimony Trioxide because of heart damage and cancer risks. Yet the CPSC now thinks Antimony in mattresses is safe. The NAS study cited research proving Antimony leeched from the vinyl in crib mattresses, and was found in large quantities in the livers of dissected dead human infants. The above assumption that a vinyl cover would protect us from chemical absorption might be wrong. It seems likely Antimony could leach through the vinyl.
It seems a wrong assumption that everyone would use a plastic sheet on mattresses of children under five, only twenty percent of these children have bed wetting problems. Additionally, there are other mattresses in the home children might sleep or suck on. Also the CPSC assumed exposure data from sucking of chemicals that had already leached to the surface of the mattress. We know young children have a strong instinct to suck, they suck on everything, at least in the case of water soluble boric acid it seems children could suck out large quantities of the chemical. Children also spend a fair amount of time in bed awake and may then suck on the mattress, they may suck while asleep, as well as awake time walking around the house where they might also suck on mattresses. We previously asked the CPSC to perform a proper child sucking test as our calculations show a boric acid mattress would clearly fail this test. This danger alone might stop this law. Instead the CPSC changes all the rules of the child sucking test and makes seemingly unreasonable assumptions to avoid this test. Why? Are they trying to avoid a negative result and reach a preexisting conclusion?
ADI discussed below is Acceptable Daily Intake
Comment 15. Please explain the statement (P. 33, in the context of the inhalation-specific AD1 and related risk) that the effects of antimony (trioxide) inhalation are "not cumulative," particularly in light of the long half-life described above. This appears to be a nonconservative assumption.
Answer. There was a misinterpretation of the text by the reviewers which was addressed in a telephone discussion with the reviewers. The inhalation effects of antimony are assessed by CPSC staff based on daily exposures. An inhalation average daily exposure (ADE) is calculated, and exposures are estimated to determine whether they would exceed the acceptable daily exposure. The cancer effects are cumulative. Every exposure contributes to the overall lifetime risk of developing cancer. (p. 64)
Finally some truth comes out. The entire draft law and risk assessment minimizes the cancer risk and calls it safe. The cancer effects are cumulative! Chronic exposure of 8 hours every day for the rest of our and our children’s lives greatly increases our risk of developing cancer!
Comment 14. Exposures from other sources (e.g., upholstered furniture) and their potential impact on risk should be mentioned.
Answer. CPSC staff estimates the potential risks resulting from the exposure from a specific consumer product. Aggregate exposures resulting from the use of other products that may contain the same FR chemical are not considered.
This is a very narrow view. Proper risk assessment requires considering all sources of exposure and our total toxic load. We have many Environmental doctors, M.D.’s, and a Medical School professor who oppose this law for this very reason. They are concerned our toxic load is already too high and that the addition of our absorbing more toxins through this new chronic exposure will put many people over the edge. On a daily basis these Doctors see the chronic pain, suffering, and slow death of these people poisoned by our modern environment.
Comment 12. Comments on specific chemical assessments
Comment 12a. Derivation of the AD1 for decabromodiphenyl oxide (DBDPO) should consider new studies.
(1 The acceptable daily intake (ADI) is the amount of a compound that one may be exposed to on a daily basis without posing a significant risk of health effects.)
Comment 12b. The possible carcinogenicity of DBDPO should be discussed.
Answer. CPSC staff previously determined that DBDPO is a possible carcinogen. …
Comment 12c. Chemical specific adjustment factors could be applied to the ADI derivation for boric acid.
Answer. In accordance with the CPSC's Chronic Hazard Guidelines, chemical specific adjustment factors (i.e., safety factors) are not applied. …
Comment 12d. An inhalation AD1 for boric acid should be calculated.
Answer. An inhalation AD1 for boric acid was not calculated by CPSC staff. ADIs are calculated when a given chemical is considered "toxic" due to its chronic effects and sufficient toxicity information is available. In accordance with the guidance provided in the CPSC's Chronic Hazard Guidelines on how to evaluate toxicity studies, the CPSC staff determined that there is not sufficient evidence of systemic toxicity in humans caused by chronic inhalation exposure. Thus, staff only developed an oral AD1 for which there was sufficient evidence of developmental toxicity due to oral exposure.
It is outrageous to say Boric Acid through inhalation is not toxic. It is a known respiratory irritant through many studies. Oral and Inhalation absorption are roughly equivalent. One human study showed inhalation of Boric Acid lowered sperm counts and reduced sexual activity in human males.
“Inhalation: Causes irritation to the mucous membranes of the respiratory tract. May be absorbed from the mucous membranes, and depending on the amount of exposure could result in the development of nausea, vomiting, diarrhea, drowsiness, rash, headache, fall in body temperature, low blood pressure, renal injury, cyanosis, coma, and death.
Ingestion: Symptoms parallel absorption via inhalation. Adult fatal dose reported at 5 to > 30 grams.
Chronic Exposure: Prolonged absorption causes weight loss, vomiting, diarrhea, skin rash, convulsions and anemia. Liver and particularly the kidneys may be susceptible. Studies of dogs and rats have shown that infertility and damage to testes can result from acute or chronic ingestion of boric acid. Evidence of toxic effects on the human reproductive system is inadequate.
Aggravation of Pre-existing Conditions: Persons with pre-existing skin disorders or eye problems, or impaired liver, kidney or respiratory function may be more susceptible to the effects of the substance.”
From the Boric Acid MSDS: http://www.jtbaker.com/msds/englishhtml/b3696.htm
Comment 12e. Slow clearance of antimony from the lung could be considered, but it is unlikely to have a major impact on systemic exposure.
Comment 12f. The derivation of the vinylidene chloride ADI should be reconsidered.
Answer. No adjustments to the vinylidene chloride ADI were made. …
Comment 12g. An inhalation AD1 for vinylidene chloride could be developed since the compound is volatile.
Answer. Inhalation exposure to vinylidene chloride is expected to be negligible and staff concludes that it would not be sufficient to result in an unreasonable risk of health effects.
Comment 3. The worst case scenarios should be included (95th percentile).
Comment 7. The total mass of airborne particles should be included in the risk assessment rather than the respirable fraction. In the absence of data, a 5- or 30- fold correction should be made.
Comment 8. The volume of air that will contain particles should be reduced.
Comment 10. The rationale for extrapolating the aging results to a 10 year mattress lifetime should be substantiated or presented as indeterminate aging.
Comment 17. The logic regarding the exposure to vinylidene chloride is not clear. While the volatility of the monomer would minimize the oral and dermal exposure, one might expect the volatility to increase the inhalation exposure to this chemical, particularly for a new mattress.
The CPSC pretty much ignores the comments of the reviewers and insists it is right. It also insists on using old and outdated information (FHSA 1992).
Comment 11. CPSC staff should consider harmonizing methods of calculating ADI's with other organizations.
Answer. CPSC staff is obligated to assess the potential hazards of chemicals using the
methodology outlined in the Federal Hazardous Substances Act (FHSA) and the supporting Chronic Hazard Guidelines (CPSC, 1992).
This is important because the Department of Health and Human Services, Agency for Toxic Substances & Disease Registry (ATSDR) http://www.atsdr.cdc.gov/ gives ADI numbers that are quite different than the CPSC assumptions. They say an acceptable exposure number for Antimony can not be calculated and more. Antimony is contained in their 2005 CERCLA Priority List of Hazardous Substances, “which are determined to pose the most significant potential threat to human health due to their known or suspected toxicity and potential for human exposure.” See more on this later in the Errors section of this document.
Staff recently became aware of the use of ammonium polyphosphate barriers in mattresses. Therefore, CPSC laboratory staff also measured the migration of ammonium polyphosphate from a commercially available twin mattress containing an ammonium polyphosphate barrier, as described above. Although a substantial amount of ammonium polyphosphate was released from the barrier, ammonium polyphosphate is not expected to result in any health effects in consumers because it is not considered "toxic" under the FSHA.
Again the CPSC appears to rely on 14 year old information of FSHA 1992. The EPA and others say Ammonium Polyphosphate is Toxic, yet they choose not to study it.
The CPSC really only examined three chemicals, Boric Acid, Antimony Trioxide, and DBDPO. There are many other chemicals mattress manufacturers might use to flame proof mattresses that were not considered for risk, i.e. the eight chemicals the NAS study recommended against.
A CPSC preferred flame proofing system is made from the reaction of formaldehyde and melamine. The original draft law called this system low risk. This system contains free formaldehyde, and more formaldehyde may be released over time, all things eventually break down. The CPSC made an attempt to measure melamine migrating from mattresses, but no attempt was made to measure how much formaldehyde is released and absorbed by our bodies. While melamine is relatively low toxicity, it is associated with the formation of stones in the urinary bladder. However, formaldehyde is a known sensitizer, acutely toxic, and known to cause cancer.
“As with any risk assessment, there are assumptions, limitations, and sources of uncertainty. These are discussed below.
Risk assessment is an iterative process. Data on carcinogenicity, developmental and reproductive toxicity, or neurotoxicity were not available for all chemicals. Furthermore, it should be noted that percutaneous [skin] absorption data were not available for antimony.” P 40
Assumptions are everything. If one or more assumptions are wrong, even if the math is correct, the results and conclusions are completely invalid.
Table 8, on page 27, shows the CPSC assumptions on the Percutaneous (skin) absorption rate. They chose a value of .002 for Antimony and .00009 for Boric Acid. This means that of the chemical that has migrated to the surface of the mattress, only 2/1,000 ths of the Antimony, or less than 1/10,000 of the Boric Acid is absorbed by our bodies. These are very tiny numbers. If the CPSC is trying to reach a preexisting conclusion of flame proof mattresses being safe, these tiny number assumptions would help them greatly.
We know from the quote above that the Antimony number is a guess, and we don’t know where the CPSC got the 1/10,000 number for Boric Acid absorption. But, science is clear that Boric Acid is readily absorbed through burned or damaged skin.
Below are quotes from the Department of Health and Human Services, Agency for Toxic Substances & Disease Registry (ATSDR) http://www.atsdr.cdc.gov/ Antimony is contained in their 2005 CERCLA Priority List of Hazardous Substances, “which are determined to pose the most significant potential threat to human health due to their known or suspected toxicity and potential for human exposure.”
“Death was observed in rabbits following a single [dermal] application of Antimony. p 22
Two out of four rabbits died after 6-8 topical applications of antimony trioxide paste. The antimony trioxide was combined with a mixture formulated to resemble acidic sweat.
Inhalation and oral MRLs [Minimal Risk Level, the equivalent of ADI]for antimony and compounds were not derived. Damage to the lungs and myocardium has been observed in several species of animals following acute, intermediate, and chronic inhalation exposure (Brieger et al. 1954; Bio/dynamics 1985, 1990; Gross et al. 1952; Groth et al. 1986; Watt 1983). These effects have also been observed in humans chronically exposed to airborne antimony (Brieger et al. 1954; Potkonjak and Pavlovich 1983). At the lowest exposure levels tested, the adversity of the effects was considered to be serious. Thus, the data were inadequate for the derivation of an acute-, intermediate-, and chronic-duration inhalation MKL values.
Developmental Effects. An increase in the number of spontaneous abortions was observed in women exposed to airborne antimony in the workplace.
Reproductive Effects. Human exposure to antimony dust in the workplace has resulted in disturbances in menstruation (Belyaeva 1967). In animals, the failure to conceive and metaplasia in the uterus have been observed following inhalation exposure to antimony trioxide (Belyaeva 1967)… These data suggest a potential for antimony to cause reproductive effects in humans.
2.7 POPULATIONS THAT ARE UNUSUALLY SUSCEPTIBLE
Individuals with existing chronic respiratory or cardiovascular disease or problems would probably be at special risk, since antimony probably exacerbates one or both types of health problems. Because antimony is excreted in the urine, individuals with kidney dysfunction may be unusually susceptible.
2. HEALTH EFFECTS
Adverse health effects in humans following antimony exposure appear to target on the respiratory and cardiovascular systems. Eye and skin irritation have also been noted.
Antimony may be found in the blood and urine several days after exposure.
Chronic-Duration Exposure and Cancer. There are several human and animal chronic inhalation studies that indicate the targets appear to be the respiratory tract, heart, eye, and skin (Brieger et al. 1954; Cooper et al 1968; Potkonjak and Pavlovich 1983). … A no-effect level (NOEL) for respiratory or cardiovascular effects following exposure to antimony was not identified in the available literature. The NOEL is an important level in evaluating the risk of exposure to antimony, and it can be used along with protective uncertainty factors to help determine the amount of antimony humans can be exposed to without experiencing health effects. … Chronic toxicity information is important because people living near hazardous waste sites might be exposed to antimony for many years.
Oral studies have shown that antimony tends to accumulate in the liver and gastrointestinal tract (Ainsworth 1988; Sunagawa 1981)”
Above quotes from: http://www.atsdr.cdc.gov/toxprofiles/tp23-c2.pdf
You can see from the above quotes there are no acceptable daily exposure levels for Antimony and that is quite toxic to humans, and it accumulates in our bodies over time, not to mention the cancer risk.
We see the following table in the CPSC report:
You can see above that CPSC calculations show we will get a daily dose of .8 mg of Antimony, and .08 mg of Boric Acid.
They Assume an ADI (Acceptable Daily Intake) of 2.3 mg/kg/d for Antimony and 0.1 for Boric Acid.
When you look at the web page from ATSDR http://www.atsdr.cdc.gov/mrls.html they show “ATSDR MINIMAL RISK LEVELS (MRLs) December 2005” that are considerably different than the CPSC assumptions. For Boron (Boric Acid) they show a minimal risk level of .01 mg/kg/d for intermediate exposure risk. They do not list a number for chronic exposure risk as would be the case in mattresses. Even so their number for acceptable exposure is 10 times less than the CPSC assumption.
The ATSDR does not show a minimal risk number for Antimony, because as they said in the other document on Antimony, one can not be calculated because human damage was seen at even the lowest exposures.
In CPSC assumptions for inhalation exposure they used a value of .5 per hour for average air change in a room. The NAS study used a value of .25 air changes per hour in their independent study. The CPSC repeatedly insists they use very conservative assumptions, but the facts seem to show otherwise.
Most of the CPSC tests and absorption calculations assume bed sheets are used, and this helps protect from exposure to toxic chemicals. We know of poor children who do not sleep on sheets. There are likely millions of poor children who do not sleep on sheets.
We have seen the CPSC choose not to include small children under age five in this risk analysis. They assume children under five will sleep on a vinyl or plastic cover over the mattress and under the sheets. They say the plastic sheet will protect small children from toxic chemical exposure. Therefore they don’t consider small children in their risk analysis. Antimony is proven to leach from vinyl in crib mattresses; it could also leach through vinyl. It seems ridiculous to assume everyone will use plastic sheets on their children’s mattresses. My five children never slept on plastic sheets. Other parents I have spoken with also say their children never slept on plastic sheets. Additionally, almost all mattress manufacturers will lie and say they don’t use toxic chemicals in their flame barriers. Consumers will never know their children’s mattresses contain toxic chemicals. Also they have not considered developing fetuses or other special populations. What else is missing or has wrong assumptions?
There entire risk assessment is only about 50 pages, where the NAS study of flame retardants was over 500 pages.
All of this points to the need for a least a thorough independent risk assessment from people who are not emotionally involved with this project. Surely it is worth a small delay and expense before we force our entire population to sleep in known toxic chemicals.
Even a good risk assessment is not perfect. It is an attempt guised as science to predict the future of the next 100 years or more.
CPSC Response to Public Comments
In the comments discussed below, numbers in parentheses refer to the list of individuals or groups that provided written comments (CPSC 2005). Names in parentheses refer to individuals who provided oral comments.
Numerous commenters stated that they were concerned about the possible toxicity of flame retardant (FR) chemicals in general (1 -8, 10-501,5 11,513,5 14,5 18,537-539, and 541). One of these (35) is a specialty mattress manufacturer who is also affiliated with the non-governmental organization People for Clean Beds. This organization and the manufacturer are opposed to the proposed flammability requirements for mattresses and have solicited comments to be sent directly to CPSC. Many of the commenters concerned about toxicity are directly associated with the organization and manufacturer (44-47, 5 1-53,57-64,68-76, 84, 85, and 493) and many more used identical or essentially similar language.
A number of commenters were specifically concerned about the toxicity of boric acid, which is used to treat cotton batting (3, 18, 19,2 1,24,28,35, 99, 123, 135, 163, 166, 168, 170, 172, 198,199,204,208,220,221,225,226,235,262,327,362,373,390,432,446, and 487). Some of these commenters also cited the use of boric acid as an insecticide as purported proof of its toxicity. As above, many of these comments are associated with one particular manufacturer and non-governmental organization.
This is an attempt to discredit the over 800 people who wrote in to oppose this law. There were about 540 votes against this law, and 20 for, during the public comment period. Since then we have received an additional 300 votes and comments against the law and forwarded them to the CPSC. None of these people are associated with www.PeopleForCleanBeds.org or Strobel Technologies www.Strobel.com , other than myself. There is no need to prove Boric Acid is acutely toxic. The opinions of the many people who oppose this law are their own.
Yes this is me. Mark Strobel, President and Owner of Strobel Technologies, and Director of People For Clean Beds.org. I am the one who has led the fight against this law. I am a specialty mattress manufacturer who has been in business for 32 years. I know a lot about my industry and became concerned when I learned how toxic the chemicals used to flame proof mattresses are. I also became concerned when I learned the big mattress companies went to the CPSC and asked for this law for their own financial benefit. I have spent my whole business life trying to develop the perfect bed and hold numerous US Patents. My crowning achievement has been the Patented Supple-Pedic mattress with its Patented “Lever Support System.” This mattress system balances pressures through lever action and gives Proven Best Back Support, 90% Less Tossing and Turning, and Clinically Proven Better Sleep. Many M.D.’s and Chiropractors have stated they think the Supple-Pedic is the best bed on the market. Supple-Pedic mattresses are seen regularly nationally on CBS’s “The Price is Right.” I think Supple-Pedic is the best bed in the world. I take pride in what I do in providing better health and comfort to my customers. Understandably, I became upset to learn the government was forcing me to include toxic chemicals in my mattresses. I spent a lot of time trying to find a chemical free and safe system to flame proof my beds – I still haven’t found one. The more I have researched the issue, the more alarmed I have become.
I did put up a website called www.PeopleForCleanBeds.org or the short version www.CleanBeds.org to tell the truth about the toxic chemicals used to flame proof mattresses under this law. It has been difficult to get the truth out about these chemicals because all the major manufacturers have been saying they don’t use chemicals to flameproof their beds. Finally, the newly released CPSC documents prove I am correct. All or almost all flame proof mattresses use known toxic and cancer causing chemicals. (See CPSC Table 1) And that these toxic chemicals leach and migrate to the surface of our mattresses, to be absorbed by our bodies. Major innerspring mattress manufacturers will now have a harder time double talking their way out of this one that they don’t use toxic chemicals in their mattresses. Perhaps there is a chance to stop this law.
We have gotten news for the issue on TV, newspapers, and even the Washington Post. The Washington Post article was reprinted by many newspapers across the country. http://www.peopleforcleanbeds.org/making-news.htm
Some commenters argued that the risk of dying in a fire is lower than the risk of adverse health effects from exposure to FR chemicals (3, 1 1, 14, 15,2 1,25, 32,34-37,39,42,49,50, 55, 57, 98, 142, 143, 147, 150, 151, 157, 173, 175, 179, 181, 185,218,221,222,231,238,241,302, 310, 311, 313,322,3215,343,347,424,456, and 478).
The CPSC staff disagrees with the claim of some commenters that the risk of dying in a fire is lower than the risk of adverse health effects from exposure to FR chemicals. Commenters did not provide supporting data to substantiate this claim. There are approximately 15,300 fires per year in the U.S. in which mattresses or bedding were the first item ignited, resulting in about 1,750 injuries and 350 deaths per year (
From CBS News: “Asbestos Deaths Soar Since '60s, (AP) Asbestos deaths in the United States have skyrocketed since the late 1960s and will probably keep on climbing through the next decade because of long-ago exposure to the material, once widely used for insulation and fireproofing, the government said Thursday.
The Centers for Disease Control and Prevention said 1,493 people died from asbestos in 2000, compared with 77 in 1968.
It can take up to 40 years between the time someone is exposed to the material and dies from it - asbestos deaths will probably increase through the next decade, said Michael Attfield, a CDC epidemiologist.”
Only a small number of people were exposed to asbestos, our entire population will sleep in toxic chemicals. If we find harm years later, it will be too late. Millions could die.
From the National Safety Council 'Odds of Dying' Table: “Accidental poisoning by and exposure to noxious substances, X40-X49:” 17,550 annual deaths (more than in car accidents)
Numerous commenters stated that they have multiple chemical sensitivity (MCS), allergies, or other health conditions that could be exacerbated by exposure to FR chemicals (2-4,6, 14, 16,19,21, 31,22,32, 35,42,43,46,48-51,57,65, 8397, 100, 104, 105, 107, 108, 115, 121, 123-125, 129, 131, 133, 135, 137, 138. 141, 147, 152, 153, 158, 160, 163, 167, 169, 176, 178, 180-184, 189, 190, 192, 194, 196, 198,200,204,205,209,210,214-216,219,221 -223,225-227, 229,233,234,237,240,245,248,249,251,254,257,258,261,264,267-269,280,281,286- 288,291,293,297,298,300, 307-310,312,313,315-318,321,325,332,334,336,339,341, 342, 345,348,353, 354,364, 367, 370,375,384,387,389,395,403,409,415,417,420,437, 439,442-444,454,459,461,470-472,474,479,480,482,484,486,488,491, and 538).
The CPSC staff concludes that there is no evidence to suggest that FR chemicals would contribute to the causation or exacerbation of allergies, asthma, or multiple chemical sensitivity (MCS).
The above is a lot of comments and votes against this law. Here is a quote from a leading doctor who disagrees with the CPSC.
Lawrence A. Plumlee, MD
Chemical Sensitivity Disorders Association
Dallas, TX 75220-3757
“The benefits do not outweigh the risks. I know many chemically sensitive people who do not tolerate treated mattresses. And how many are intolerant who don't know why they can't sleep or feel bad? This law is premature, and just a measure by mattress manufacturers to avoid liability for fires. Why not address this directly?”
One commenter reported her friend died from an asthma attack after inhaling Boric Acid as a carpet treatment: “My good friend acquired asthma after prolonged exposure to boric acid. (carpet treatment) Subsequently, she died from an asthma attack. This happened over a period of two years!!!”
Boric Acid is a known respiratory irritant. We have had reports from asthma sufferers who have difficulty breathing after sleeping on a boric acid mattress for several days, but report relief after changing mattresses.
Asthma affects an estimated 17 million people in the U.S. alone.
In industrialized countries, asthma is becoming more common and severe. Five thousand people die of it every year in the U.S. Currently, it is the sixth most common chronic condition in the nation.
Since the public comment period closed we have received numerous complaints that people can not tolerate their new mattress with flame retardants and find relief by going back to their old mattress. Several of these had mattresses which use Boric Acid cotton batting.
From the Boric Acid MSDS:
Causes irritation to the mucous membranes of the respiratory tract. May be absorbed from the mucous membranes, and depending on the amount of exposure could result in the development of nausea, vomiting, diarrhea, drowsiness, rash, headache, fall in body temperature, low blood pressure, renal injury, cyanosis, coma, and death.
Symptoms parallel absorption via inhalation. Adult fatal dose reported at 5 to > 30 grams. …
Aggravation of Pre-existing Conditions:
Persons with pre-existing skin disorders or eye problems, or impaired liver, kidney or respiratory function may be more susceptible to the effects of the substance.
The American Association of Poison Control Centers reports an average of 6,463 cases of Boric Acid Poisoning each year, with 200 cases from topical preparations alone.
Some comrnenters claimed that FR chemicals may cause sudden infant death syndrome (SIDS) (12,64, and 283).
The CPSC staff disagrees with the claim that antimony compounds or any other FR chemicals may cause sudden infant death syndrome.
The link was made by researchers Jenkins; Craig; Goessler; Irgolic, in their study, “Antimony leaching from cot [crib] mattresses and sudden infant death syndrome (SIDS),” but it is difficult to conclusively prove because we absorb Antimony from many other sources. They did prove Antimony leached from crib mattresses. High levels of Antimony were found in the livers of dissected dead human infants. Antimony is a very commonly used flame retardant used in many household products such as carpets. It is thus difficult to prove direct cause and effect. It took over 20 years and many studies to prove Asbestos is harmful.
http://www.peopleforcleanbeds.org/Antimony-SIDS.htm and http://www.ingentaconnect.com/content/arn/het/1998/00000017/00000003/0900525a
Some individuals commented that there is no guidance for manufacturers to consider toxicity and exposure when selecting FR chemicals (38 and 188).
As a mattress manufacturer we agree. The CPSC tells us every chemical we might choose is safe. All the barrier suppliers try to tell us they don’t use chemicals. Then all the mattress manufacturers tell consumers they use no chemicals in their barrier systems.
At least the CPSC knows which chemical are used as presented in the table below:
BARRIER SAMPLE ID AND FRC LOAD
Information on the various barrier samples along with the average chemical load found by LSC are contained in Table 1. The FRC percentages listed in Table 1 are the average from 5 replicates.
To help you read the table below:
H3BO3 is Boric Acid
SB2O3 is Antimony
PVDC is Dichloroethene (Vinylidene chloride)
DBDOP is Decabromodiphenyl Oxide, also called Deca which www.ewg.org is trying to get banned.
Melamine Resin contains Formaldehyde
Si is Silicon, which also has health risks: “Silicon may cause chronic respiratory effects. … Inhalation will cause irritation to the lungs and mucus membrane. Several epidemiological studies have reported statistically significant numbers of excess deaths or cases of immunologic disorders and autoimmune diseases in silica-exposed workers. These diseases and disorders include scleroderma, rheumatoid arthritis, systemic lupus erythematosus, and sarcoidosis. Recent epidemiological studies have reported statistically significant associations of occupational exposure to crystalline silica with renal diseases and subclinical renal changes. Crystalline silica may affect the immune system, leading to mycobacterial infections (tuberculous and nontuberculous) or fungal, especially in workers with silicosis Occupational exposure to breathable crystalline silica is associated with bronchitis, chronic obstructive pulmonary disease (COPD) and emphysema. … Lung cancer is associated with occupational exposures to crystalline silica
EPA Boric Acid Review, June 2004, Conclusions: “have identified the developing fetus and the testes as the two most sensitive targets of boron toxicity … high prenatal mortality, reduced fetal body weight and malformations and variations of the eyes, central nervous system, cardiovascular system, and axial skeleton … The testicular effects that have been reported include reduced organ weight and organ:body weight ratio, atrophy, … reduced fertility and sterility” http://www.epa.gov/iris/toxreviews/0410-tr.pdf
Antimony Oxide MSDS: “Potential Health Effects: ... May cause heart to beat irregularly or stop. … Chronic Exposure: Prolonged or repeated exposure may damage the liver and the heart muscle. Prolonged skin contact may cause irritation, dermatitis, itching, and pimple eruptions. There is an association between antimony trioxide production and an increased incidence of lung cancer.” http://www.jtbaker.com/msds/englishhtml/a7236.htm
FORMALDEHYDE MSDS: "POISON! DANGER! SUSPECT CANCER HAZARD. MAY CAUSE CANCER. Risk of cancer depends on level and duration of exposure. VAPOR HARMFUL. HARMFUL IF INHALED OR ABSORBED THROUGH SKIN. CAUSES IRRITATION TO SKIN, EYES AND RESPIRATORY TRACT. STRONG SENSITIZER. MAY BE FATAL OR CAUSE BLINDNESS IF SWALLOWED. CANNOT BE MADE NONPOISONOUS." http://www.jtbaker.com/msds/englishhtml/F5522.htm
Table 1 from Tab H, p 17
As you can see above 7 of the barriers contain Antimony and 5 contain Boric Acid. It is no wonder there are no labeling requirements for the FR chemicals used in mattresses. Which of the above systems would you choose to sleep in? We don’t think any of these systems are safe, they all have risks.
Cotton Batting barriers contain 10% poison, 7.5% Boric Acid plus 2.4% Antimony. Melamine Resin barriers contain Formaldehyde. Silicon and Formaldehyde were not studied.
We keep hearing about inherently flame resistant fibers from the CPSC and mattress manufacturers. These inherently flame resistant fibers have chemicals blended with the fiber as the fiber is made. The only true inherently flame resistant fiber is fiberglass, and even that is blended with chemicals to make a barrier as you can see in the table above.
We are glad to see the CPSC proved all the fire barriers contain toxic chemicals, maybe the truth can be told to the public.
Some commenters expressed concern about legal liabilities they felt that retailers and manufacturers could face due to the use of FR chemicals used in mattresses to meet the draft standard (88, 238,239, 328).
As discussed in the briefing package and memos, the staff believes that numerous FR materials are available that will enable mattresses to meet the draft standard without posing any appreciable risk of health effects to consumers.
This is the standard answer from the CPSC.
Some individuals commented that the "precautionary principle" should be applied to FR chemicals, that is, they should not be used until proven safe (7,26,44,47, and 5 1).
All of the statues that provide regulatory authority to the CPSC explicitly require risk-based decision making, thus precluding application of the "precautionary principle." P67
Hippocrates left us with
the admonition: "First do no harm.”
Below are quotes from some Doctors who oppose this law:
Dr. Mayer-Proschel, Ph.D.
Rochester, NY 14534
Dr. Mayer-Proschel is a professor and scientist at a major US Medical School, and has published 18 scientific studies in neurotoxicology.
“After doing my own literature research it is quite incredible that law makers are willing to risk the health of thousands of people. According to available scientific data it is NOT clear whether the levels of chemicals one is exposed to on a chronic basis by sleeping on treated mattresses is safe, especially for children and pregnant women. I have yet to find a single scientific study that supports the use of these chemical in mattresses and labels them as "safe". It is another example of an ignorance beyond reason and one begins to questions the true motivation of the individuals pushing for a national law to include these chemical in all mattresses. Maybe one should start to ask who would financially benefit from such a law to get the true motivation?
In light of the information available, I support your quest for caution and agree that the potential danger far outweighs the benefits of fire prevention
Thanks for fighting a "nonsense law" that seems dangerous and agenda driven.
Dr. Liberman, M.D., F.A.A.E.M., made the following statement:
“We live in a very technologically advanced world, which advocates the advantages of these technologies but rarely ever considers the disadvantages or potential harm. Everything in life must be considered on a cost/effectiveness ratio basis.
It seems ill advised to expose hundreds of millions of people to a potential health hazard in order to protect a very few. …. I am absolutely opposed to adding the proposed toxic chemicals to mattresses. I render my opinion based on my education, training and experience in the field of occupational and environmental medicine.”
Allan D. Lieberman, MD
Consultant in Occupational and Environmental Medicine”
See the comments of many more Medical Doctors, PhD’s, public, and retailer comments at: http://www.peopleforcleanbeds.org/retailer-comments.htm
The CPSC gave no recognition of the many doctors who oppose this law.
A new law already effective in California, and soon to be enacted nationwide by the Consumer Products Safety Commission (CPSC) requires mattresses to resist ignition from open flames, even though a 1973 federal law already requires all mattresses to resist ignition from burning cigarettes, and mattress fires have already declined by 68%. Since it requires toxic chemicals in the surface of all new mattresses to meet the new law, we think the risks of the new law outweigh the benefits.
The CPSC hopes to save up to 300 lives annually after ten or more years, after all existing mattresses are replaced. This seems overly optimistic and the real number saved can be calculated to only 21 using the CPSC's own data. With 300 million people in the United States unknowingly taking the risk of sleeping in toxic chemicals, they avoid the one in one million risk of dying in a mattress fire. Using the 21 saved number the risk is one in fourteen million. By comparison annual US deaths are 6,091 as a pedestrian, 16,337 as a car occupant, and 17,550 from accidental poisoning by and exposure to noxious substances. Even before the new law, your risk of dying from toxic chemicals, is greater than your risk of dying in a car accident. See Odds of Dying.
There is an entire specialty of real medicine that treats people poisoned by the toxic chemicals in our modern environment, real M.D.'s taught by top schools such as Harvard Medical School. These Doctors see first hand the pain, suffering, and death of these people. All of these Doctors oppose this law.
Every life is important and it is hard to argue with fire safety. However, if this law kills even one more than it saves, it is clearly wrong. It has the potential to kill millions of people. If only 15% of our mattresses prove toxic -- 45 Million people will die.
People are not averages. We know some people react and die from drugs that are safe for most people. My good friend is a Dentist and says many people have reactions to the whitening agent in whitening toothpaste, and that 1% of our population can not tolerate the material in dental fillings that the rest of us tolerate fine. 1% of our population is 3 Million people. The CPSC risk assessment did nothing to address the needs and risks of special populations as most risk assessments would. There are 10’s of millions of people with preexisting health conditions. The CPSC excludes the risks to children under age five, one of our most sensitive populations. As Dr. Rapp said,
“Until the powers that be can prove that what they propose for protecting mattresses against fire will not harm a pregnant woman, an unborn baby, an infant, a child, the elderly or a normal male or female they should UNQUESTIONABLY NOT EVEN CONSIDER PUTTING CHEMICALS INTO EVERY MATTRESS.”
Doris J. Rapp, MD, F.A.A.A., F.A.A.P. Is a board-certified environmental medical specialist and pediatric allergist. She was a clinical assistant professor of pediatrics at the State University of New York at Buffalo. Dr. Rapp is the founder of the Practical Allergy Foundation and is a past President of the American Academy of Environmental Medicine. She is also the author of several books.
The CPSC has now extracted and measured the toxic and cancer causing chemicals contained in most barriers to flame proof mattress. This proves all or almost all mattresses will contain known toxic chemicals to meet the new law. See CPSC Table 1 above.
CPSC tests have now proven that these toxic chemicals will migrate to surface of our mattresses and be absorbed by our bodies in significant and measurable amounts.
CPSC calculations predict we will be given a daily dose of .8 mg of Antimony Trioxide, and .08 mg of Boric Acid. These amounts are really just an educated guess and the real amounts might be much higher.
The Department of Health and Human Services, Agency for Toxic Substances & Disease Registry (ATSDR) http://www.atsdr.cdc.gov/ disagrees with the CPSC on the amounts of exposure the CPSC assumes is safe. Among other things they say there is no safe exposure level for Antimony Trioxide.
An independent toxicological organization (TERA) has reviewed the CPSC risk assessment and found significant problems, errors, and omissions with the CPSC risk assessment. Yet, the CPSC concludes this chemical exposure will be safe for everyone, except small children under age 5 who they assume will always be protected by a plastic sheet over these mattresses. There are no labeling requirements and consumers will never know their new mattress contains toxic and cancer causing chemicals.
Small children under age five and other sensitive populations are not considered in the CPSC risk assessment.
The CPSC omitted the fact that many of these toxic and cancer causing chemicals can accumulate in our bodies. The ATSDR says Antimony will accumulate in our bodies over time.
For the cancer risks of Antimony, when pressed by TERA the CPSC admitted that: “The cancer effects are cumulative. Every exposure contributes to the overall lifetime risk of developing cancer.” When again pressed by TERA “The possible carcinogenicity of DBDPO should be discussed.” The CPSC Answer: “CPSC staff previously determined that DBDPO is a possible carcinogen.
The CPSC studied only a limited number of the chemicals used to flame proof mattresses. Ammonium Polyphosphate was dismissed as being non toxic.
“Although a substantial amount of ammonium polyphosphate was released from the barrier, ammonium polyphosphate is not expected to result in any health effects in consumers because it is not considered "toxic" under the FSHA.” Other organizations say it is toxic. DBDPO, Deca, was dismissed as being safe even though some groups are trying to get this flame retardant banned. Silicon contained in some barriers was not studied even though it is known to be toxic. Formaldehyde is contained in melamine resin barriers, but was not studied. Formaldehyde is a known sensitizer, acutely toxic, and known to cause cancer..
Nothing in life touches us more than our mattresses. We have close chronic full body and breathing exposure 11 hours every day as children, and 8 hours every day as adults. Even test animals in chronic exposure studies usually get the weekends off to simulate workplace exposures. We can not imagine an exposure risk to known toxic and cancer causing chemicals that could be worse.
We are supposed to live in a free country and a democracy. There are statutes like the Freedom of Information Act to protect us from government abuse. In this case Americans will be lied to about the chemicals in their mattress and freedom of choice will be taken away from them. The CPSC has received over 800 votes and public comments against this law, and only about 20 votes and comments in favor of the law, the for votes were mostly from parties who will profit from the law. These votes are a 40 to 1 ratio against the new law, However the CPSC will likely vote to enact the law because they think they know better than we do of what is best for us. Some commenters have called this law “A human experiment without consent.”
If American consumers were told the truth about the toxic chemicals in mattresses, and that the chemicals will leach out and enter our bodies, most would choose not to take this risk. It would not matter that the CPSC predicts the poisons would not reach toxic levels, most people would choose to take the one in one million risk of dying in a mattress fire.
The CPSC has stated that if harm is ever found other agencies could ban that specific chemical. It would take years to prove cause and effect. With huge magnitude of our 300 million population, millions, tens of millions, or hundreds of millions of people could be harmed. It is too late to say you’re sorry if you kill many more than you save. It is better to follow the advice of Hippocrates: “First, do no harm!”
A note to CPSC Commissioners and Staff: I respect the work you do to protect the public. This is not personal attack on you, it is only that I have a different opinion on this issue of how to protect the greater number of people. It is easy to visualize 300 people and want to save them as quickly as possible. It is much harder to visualize the huge magnitude of 300 million people, our entire population. You are charged with protecting all of us, not just a few. You know this law puts our entire population at some level of risk. Please don’t take this casually and say it will probably be OK. In your documents you have called it low risk, moderate risk, not an appreciable risk, and a negligible risk. However you call small risk, it becomes a huge risk when applied to our entire population. Verbally you will likely acknowledge you are not perfect, that you have made mistakes in the past, and might make mistakes in the future. But do you take this to heart? We all tend to think our opinion is the correct one. If this law is enacted and you are later proven wrong, the human cost will be enormous!
The world is changing. We have made great strides in eliminating fire risks. The 1973 law on mattress cigarette ignition reduced bedroom fires by 68% and their related deaths by 50%. This law did not create any attendant risks. We are now approaching diminishing returns. It is emotionally difficult to abandon a project you have worked on for several years; you want to get the project over and done with. Your experience shows almost all your projects save lives. My experience in business shows most of my new ideas fail, and I have only occasional successes. This law with its risks has the potential to prove catastrophic. At the very least this issue needs a lot more independent study before enacting the law, but we hope you will abandon it and move on to other things. The risk outweighs the benefit!
The new risk in our modern world is our exposure to toxic substances. The National Safety Council says 17,550 people die each year from “Accidental poisoning by and exposure to noxious substances, this number now exceeds deaths in car accidents. Please work on this risk, not add to it.
Thank you for your time and consideration.
President, Strobel Technologies, www.Strobel.com
Director, People For Clean Beds, www.CleanBeds.org
Address: 3131 Industrial Parkway, Jeffersonville IN 47130
Master list of CPSC briefing packages: http://www.cpsc.gov/library/foia/foia06/brief/briefing.html
See the CPSC quotes in this document at: http://www.cpsc.gov/library/foia/foia06/brief/matttabd.pdf
See CPSC Table 1 showing the percentage of Known Toxic Chemicals contained in various mattress flame barrier systems at: Tab H, p 17 http://www.cpsc.gov/library/foia/foia06/brief/matttabh.pdf
Wednesday, Feb. 1, 2006
Room 420, Bethesda Towers
4330 East West Highway
Unfortunately I can’t be at the meeting as the date conflicts with our exhibiting at the Las Vegas Furniture Market, Jan 30 – Feb 3. This show has become the largest wholesale to dealers mattress show in the U.S.
Notice: The statements and questions contained in my writings are not intended to convey allegations regarding any particular company, person, or association. Readers should conduct their own investigation of a company or association or person to ascertain the particular policies, practices, and motivations of that entity. I have reported what I believe to be true and correct to the best of my knowledge and opinion at the time of its writing in a free speech effort to avert a public health disaster.