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, 2006
(Law Passed)
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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).
P 62
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.
Omissions
Ammonium Polyphosphate
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.
Formaldehyde
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.
Errors
“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:
P 45
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.
Comment
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.
Comment
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.
P 68
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
Comment
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).
Response
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.”
http://www.cbsnews.com/stories/2004/07/22/health/main631345.shtml
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)
http://www.nsc.org/lrs/statinfo/odds.htm
Comment
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).
Response
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.
“Dr
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.
http://my.webmd.com/medical_information/condition_centers/asthma/default.htm
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.
http://www.library.ca.gov/SITN/2003/0337.htm
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:
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. …
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.
http://www.peopleforcleanbeds.org/sucking_test.htm and
http://www.aapcc.org/Annual%20Reports/03report/Annual%20Report%202003.pdf
Comment
Some comrnenters claimed that FR chemicals may
cause sudden infant death syndrome (SIDS) (12,64, and 283).
Response
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
Comment
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
http://www.lenntech.com/Periodic-chart-elements/Si-en.htm#Health%20effects%20of%20silicon
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
http://www.cpsc.gov/library/foia/foia06/brief/matttabh.pdf
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.
Comment
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).
Response
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.
Comment
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).
Response
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.
Sincerely
M. Mayer-Proschel
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.”
Sincerely,
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.
Overview:
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.
-
The chemicals used to flameproof mattresses have
never been studied for human exposure risk in this application.
Except now the CPSC
has released an internal risk assessment that gives more questions than
answers. Children under age five are excluded from this risk assessment.
This is not sufficient basis to pass this law.
-
We know almost all the chemicals to flameproof mattresses are
acutely toxic and many also cause cancer.
-
The science of Toxicology uses high-dose short-term exposure on various
animals to predict the effect of low-dose long-term exposure on humans. This
is exactly the risk in mattresses, close chronic
exposure eight hour per day for the rest of our and our children's
lives.
-
The developing fetus and young child is particularly vulnerable to certain
environmental toxins. Over the past three decades, researchers have found
that remarkably
low-level exposures to these toxins are linked with less overt symptoms
of toxicity—intellectual impairments, behavioral problems, spontaneous
abortions, or preterm births.
-
Antimony Trioxide is the most commonly used flame retardant in mattresses to
meet the new law. Antimony is a heavy metal like Lead with similar toxic
effects. Antimony is proven to leach from mattresses and linked to heart
damage, cancer, and
SIDS.
-
Boric Acid, also a roach killer, is commonly used as a flame retardant in
mattresses to meet the new law. It is known to attack the developing fetus
and testicles as it primary targets. In addition to death, birth defects,
infertility, and sterility, studies show overexposure
reduces sexual activity in humans.
-
Children could be poisoned from
sucking on a Boric Acid mattress. There are 6,463 cases of Boric Acid
Poisoning in the US each year.
-
Formaldehyde, Bromine, and other dangerous chemicals are also used in many
systems. It is difficult if not impossible to find the truth. Even mattress
manufacturers usually don't know which chemicals are present in their flame
barrier systems. We can't find any, but even if safe systems exist, all
mattresses must be safe or we will eventually harm or kill a percentage
of our people. If 33% prove toxic, 100 Million people are harmed. If only 1%
prove toxic, it is still 3 Million people harmed or killed.
-
We should learn from our toxic legacies of the past. We have made previous
mistakes with flame retardants such as PCB's banned in the 70's, Tris,
Asbestos, and now PBDE's are being found in peoples bodies and women's
breast milk in alarming and growing amounts.
-
The chemical industry estimates we save up to 960 people per year with the
1.2 Billion pounds of flame retardants the US uses annually. Now we will be
required to sleep in them too. We have already
killed 300,000 people, and continue to kill 10,000 annually, with
Asbestos alone.
-
Consumers will be forced to pay an average of $100 more for every new
mattress purchased to meet this law.
-
The innerspring mattress industry through their trade association ISPA went
to the CPSC and
asked for this law. It seems clear it benefits the large companies by
restraining competition, forcing the smaller companies out of business, and
raising prices, revenue, and profits.
-
Even the man who started and wrote this law in California,
Whitney Davis, is now having second thoughts: "The Problem: the only
chemicals they can use to achieve compliance are listed as toxic to humans
by the EPA.” and "You don't know until 10 years down the road and there's
a problem," he said. "We feel responsible."
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.
Conclusions
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.
Sincerely,
Mark Strobel
President, Strobel Technologies,
www.Strobel.com
Director, People For Clean Beds,
www.CleanBeds.org
Phone: 812-282-4388
Fax: 812-282-6528
Email:
Mark@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
Public Meeting:
Commission Meeting
Wednesday, Feb. 1, 2006
10:00 a.m.
Room 420, Bethesda Towers
4330 East West Highway
Bethesda, Maryland
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.
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