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#603 - Experimenting On Children, 17-Jun-1998

Health authorities in several European countries, including Austria,
Belgium, Denmark, Germany, and the Netherlands have recommended a ban
on soft PVC toys, such as teething rings and bath toys. The Spanish
government requested action by the European Union (EU) in March, 1998.
PVC, or polyvinyl chloride (also known as vinyl), is a common plastic
that frequently contains toxic additives. Despite its well-publicized
goal to "protect children's health," the Clinton administration is
lobbying aggressively to avert a European ban on PVC toys.[1]

At issue are a family of chemicals called phthalates (pronounced
"thalates"). Phthalates (phthalic esters or benzenedicarboxylic acid
esters) are used primarily as plasticizers added to PVC to make it soft
and elastic. Plasticizers account for more than half the weight of some
flexible PVC products. About 95% of phthalates are used in PVC.[2]

Since they are not chemically bound to the PVC polymer itself,
phthalates readily leach out of PVC products. Up to 1% of the phthalate
content of PVC products is released each year.[3] As a result of their
continuous release during the production, use and disposal of PVC
products, phthalates are often described as the "most abundant man-made
environmental pollutants." (See REHW #438).

Although phthalates vary in toxicity, the most widely-used phthalates
such as DEHP [di(2-ethylhexyl)phthalate] have been linked in animal
studies to a variety of illnesses, including reproductive damage and
damage to the kidneys and liver.[4] Several agencies, including U.S.
EPA [Environmental Protection Agency], have labeled DEHP a probable
human carcinogen.[4] One recent study found a strong correlation
between testicular cancer and exposure to PVC in workers who make PVC
products. The authors of the study suspect that phthalates may play a
role in their findings.[5]

Other studies suggest that phthalates or their metabolites can interact
synergistically with other common chemical contaminants,[6] may be
slightly estrogenic[7] (which means they may play a role as endocrine
disrupters), can affect blood pressure and heart rate,[8] and may cause
asthma when absorbed on airborne particles.[9]

The simple truth about phthalate toxicity is revealed by the warning
label on a bottle of DINP, the phthalate most commonly found in toys.
The label on a bottle of DINP sold to an experimental laboratory says,
"May cause cancer; harmful by inhalation, in contact with skin, and if
swallowed; possible risk of irreversible effects; avoid exposure; and
wear suitable protective clothing, gloves, and eye/face
protection."[10] On the other hand, a typical PVC teething ring or bath
duck containing about 40% by weight of DINP either has no label or
carries a label that reads "Non-Toxic."

Although no standard method exists for the investigation of release of
phthalates from toys, a group of Danish scientists found significant
migration of phthalates used in toys.[11] Soon after, some of Denmark's
biggest retailers took precautionary action by pulling a number of
chewable PVC toys off theit shelves. Since then, a number of retailers
in Spain, Sweden Italy, Germany, the Netherlands and Belgium have
stopped selling PVC teething toys.

No major U.S. retailers have taken similar precautionary action,
chiefly because the U.S. Consumer Product Safety Commission (CPSC),
which is responsible for toy safety regulations, has yet to take a
position. In the mid-'80s, after the CPSC looked into the leaching of
DEHP from teethers, the toy and chemical corporations deflected
restrictions on the use of PVC by voluntarily substituting another
phthalate for DEHP.

When the EU was asked to restrict PVC toys, it called upon its own
Scientific Committee, which investigated and then issued a report in
April 1998. The report acknowledged that the EU's assessment "did not
take into account that more than one phthalate may occur in children's
toys or that there may be additional exposures through food, air and by
dermal contact to these phthalates."[12] Nevertheless, the EU's
Scientific Committee found that two common phthalate plasticizers used
to make flexible toys (DINP and DEHP) leached from PVC toys at levels
of concern.

Phthalates migrate into food from plastic food wraps. A recent survey
of U.S. cheeses by CONSUMER REPORTS magazine found that phthalates and
adipates (another PVC plasticizer) directly migrate from commercial PVC
and PVDC plastic wrapping into cheeses.[13] "In the cheeses [Consumer
Reports] found:

"...very heavy migration (50 to 160 parts per million) of the adipate
plasticizer DEHA into cheeses in deli cling wrap. People who ate
several ounces of this cheese every day could get doses nearly as high
as those linked to a host of health problems in lab animals.

"...moderate migration (1 to 4 parts per million) of the most common
phthalate, DEHP, into some of the shrink-wrapped cheeses and into two
waxed cheeses with clear plastic overwrap."

The June CONSUMER REPORTS says, "It's impossible to say whether a tiny
serving of plasticizers is risky. If you want to play it safe, buy one
of the wraps we found to be free of suspect plasticizers, or buy any
polyethylene wrap." A sensible recommendation that would help reduce

The toy and PVC industries point to the use of PVC in medical devices
to suggest that its use in toys and food wraps is safe. Yet phthalates
DO leach from medical products, often resulting in high exposures to
particularly vulnerable individuals, including people with suppressed
immune systems, pregnant women, and children. Estimates of exposure
levels indicate that hemophiliacs may be exposed to 1 to 2 milligrams
per day (mg/day) and dialysis patients may receive doses as high as 40
mg/day. In one study, seven out of twelve samples of lung tissue, taken
at autopsy from patients who had received transfusions of stored blood,
contained DEHP at concentrations of 13.4 to 91.5 milligrams per
kilogram (mg/kg) (dry weight).[14]

Preliminary evidence has linked illnesses to high levels of exposure to
phthalates from medical devices. For instance, unusual lung disorders
were observed in pre-term infants artificially ventilated with PVC
respiratory tubes.[15] Infants in neonatal intensive care units are
regularly exposed to DEHP following blood transfusions or respiratory
oxygenation. As the authors of one study put it, "whether such exposure
leads to increased morbidity is not known, although elevated levels of
DEHP have been associated with necrotizing enterocolitis and
cholestasis. There is no appropriate risk assessment for neonatal
infants who are exposed to this compound."[16]

While high levels of phthalates appear to be leaching from products
such as medical devices, toys and packaging (products coming directly
in contact with humans or food), these are just a small part of the
widespread dispersion of phthalates into the environment. The Swedish
EPA estimates that "the greatest spread of phthalates should occur from
the outside use of coated fabric and coated plating, and from
(automobile) underseal compound. As an estimate, these products are
responsible for 90% of phthalate emissions..."[17] Other studies have
shown that plasticizers are extracted from PVC flooring when it is
washed and from textiles imprinted with PVC.[18] Phthalates are also
found in leachate from landfills (released from buried PVC).[19]

Only a total phase-out of flexible PVC products can address the global
spread of phthalates. Such a large-scale phase-out is feasible because
alternatives exist for nearly every use of PVC.[20] In most cases, the
alternatives are cost-effective. For instance, PVC-free intravenous
solution bags are cheaper than PVC bags.[21] The plastics industry is
also developing a new generation of high-performance polyolefins
(chlorine-free plastics such as polypropylene and polyethylene) which
industry analysts contend will soon be cost competitive with PVC in
applications "where the plasticizer cost has a significant impact on
total end use cost" (for example, flexible PVC with phthalate
additives).[22] None of these other plastics requires PVC's extensive
use of toxic additives.

Since PVC products are common, the immediate goal should be to change
the composition of products that people (especially children) contact
directly. Thus, banning PVC teething rings would set an important
precautionary precedent. In May the government of Sweden proposed a ban
on the use of phthalates in all toys for children under age 3.

As cable traffic between the Department of Commerce and the U.S. EU
delegation reveals, the U.S. has pressured the EU to not take any
action until studies by the Consumer Product Safety Commission are
completed. A draft of the CPSC's report (which relies almost
exclusively on data provided by phthalate manufacturers) concludes that
DINP can be regarded as toxic under the Federal Hazardous Substances
Act but additional information is needed on the release of DINP from
children's products before the CPSC could recommend action.[23]

Thus, although there is no standard testing procedure to measure
phthalates released when children suck or chew on PVC toys, and though
countries such as Denmark, and the EU's Scientific Committee, have
concluded that phthalates leach from toys at levels of concern, more
data are needed before the CPSC will make up its mind.

Meanwhile, the nation's children are being used as guinea pigs.

--by Charlie Cray


[1] James Gerstenzang, "U.S. Urges European Union to Avert Toy
Restrictions," LOS ANGELES TIMES, May 28, 1998, p. A1.

[2] T.J. Wams, "Diethylhexylphthalate as an Environmental Contaminant--
A Review," SCIENCE OF THE TOTAL ENVIRONMENT Vol. 66 (October 1987),
pgs. 1-16.

Belgium: European Council for Plasticisers and Intermediates, 1993).

[4] Agency for Toxic Substances and Disease Registry, TOXICOLOGICAL
Agency for Toxic Substances and Disease Registry, April, 1993).

[5] Lennart Hardell and others, "Occupational exposure to polyvinyl
chloride as a risk factor for testicular cancer evaluated in a case-
control study," INTERNATIONAL JOURNAL OF CANCER Vol. 73 (1997), pgs.

[6] M.G. Narotsky and others, "Nonadditive Developmental Toxicity in
Mixtures of Trichloroethylene, Di(2-ethylhexyl) Phthalate [sic], and
Vol. 27 (1995), pgs. 203-216.

[7] Catherine A. Harris and others, "The Estrogenic Activity of
No. 8 (August 1997), pgs. 802-811. And see Susan Jobling and others, "A
Variety of Environmentally Persistent Chemicals, Including Some
Phthalate Plasticizers, Are weakly Estrogenic," ENVIRONMENTAL HEALTH
PERSPECTIVES Vol. 103, No. 6 (June 1995), pgs. 582-587.

[8] Gail Rock and others, "Hypotension and cardiac arrest in rats after
infusion of mono(2-ethylhexyl)phthalate (MEHP), a contaminant of stored
blood," NEW ENGLAND JOURNAL OF MEDICINE Vol. 316 (May 7, 1987), pgs.

[9] Leif Oie and others, "Residential Exposure to Plasticizers and Its
Possible Role in the Pathogenesis of Asthma," ENVIRONMENTAL HEALTH
PERSPECTIVES Vol. 105, No. 9 (September 1997), pgs. 972-978.

[10] Matthew Wald, "Lead Content is Found High in Plastic Items," NEW
YORK TIMES, October 10, 1997, pg. unknown. And see Joe Di Gangi, LEAD
1997). Available at <http://www.greenpeaceusa.org>.

[11] K. Vinkelsoe and others, "Migration of Phthalates from Teethering
[sic] Rings," Department for Environmental Chemistry, Danmarks
Miljoundersogelser, Frederiksborgvej 399, 4000 Roskilde, Denmark.
Telephone +45 4630 1200; fax: +45 4630 1114. April 15, 1997.

Union, April 24, 1998).

[13] "Hormone Mimics: They're in our food; should we worry?" CONSUMER
REPORTS, June, 1998, pg. 52-55. See also, J.H. Petersen and others,
"PVC cling film in contact with cheese: health aspects related to
global migration and specific migration of DEHA," FOOD ADDITIVES AND
CONTAMINANTS Vol. 12, No. 2 (March 1995), pgs. 245-253.

[14] Charlotte Nilsson, editor, PHTHALIC ACID ESTERS USED AS PLASTIC
(Solna, Sweden: Swedish National Chemicals Inspectorate, 1995[?]). See

[15] B. Roth and others, "Di-(2-ethylhexyl)-pththalate as plasticizer
in PVC respiratory tubing systems: indications of hazardous effects on
pulmonary function in mechanically ventilated, preterm infants,"
EUROPEAN JOURNAL OF PEDIATRICS Vol. 147 (1988), pgs. 41-46.

[16] S.L. Plonait and others, "Exposure of newborn infants to di-(2-
ethylhexyl)-phthalate and 2-ethylhexanoic acid following exchange
transfusion with polyvinylchloride catheters," TRANSFUSION Vol. 33, No.
7 (1993), pgs. 598-605.

[17] Swedish National Chemicals Inspectorate, ADDITIVES IN PVC; MARKING
Swedish National Chemicals Inspectorate, June 28, 1996

[18] J. Vikelsoe and E. Johansen, "Phthalates emitted when washing
floors and textiles containing PVC." Place of publication and publisher
unknown. Cited in Swedish National Chemicals Inspectorate, ADDITIVES IN
Sweden: Swedish National Chemicals Inspectorate, June 28, 1996.

[19] Danish Technological Institut [sic], ENVIRONMENTAL ASPECTS OF PVC
(Copenhagen, Denmark: Danish Technological Institut, November 1995),
pg. 91.

[20] See, for example, Danish Technical Institute, PVC AND ALTERNATIVE
MATERIALS [Ministry of the Environment Report 18/1993] (Copenhagen:
Ministry of the Environment, Danish Environmental Protection Agency
[Strandgade 29, DK-1401 Copenhagen, Denmark], 1993.

[21] Conversation with Dan Rice, Midwest Sales Representative, McGaw,
Inc., April 1997. Telephone: (800) 345-7744 ext. 4230 or 773-693-2170.

[22] Robert B. Wilson, SRI International, "The Impact of Metallocenes
on PVC," unpublished paper presented at the World Vinyl Forum,
September 1997. SRI International, 333 Ravenswood Avenue, Menlo Park,
CA 94025. Telephone (650) 326-6200.

[23] Memorandum from Michael A. Babich, Ph.D., Chemist, Division of
Health Sciences, U.S. Consumer Product Safety Commission, to Ronald L.
Medford, Assistant Executive Director for Hazard Identification and
Reduction, March 10 1998.

Descriptor terms: pvc; polyvinyl chloride; vinyl; plastics;
carcinogens; di(2-ethylhexyl)phthalate; dehp; adipate; plasticizers;
deha; food safety; consumer product safety commission; cpsc; toys;
children; blood; phthalates; european union; eu; hazardous substances
act; testicular cancer;