THE MOST POORLY TESTED CHEMICALS IN THE WORLD
FACTS AND FIGURES
* More than 7 million recognized chemicals are in existence, and
approximately 80,000 of them are in common use worldwide (GAO
* A 1979 inventory of chemicals mandated by the Toxic Substances
Control Act (TSCA) contained 62,000 chemicals that were reported by
manufacturers as being in commercial use at that time. The
inventory is up to 73,757 chemicals as of February 2001.
* EPA and the FDA have no idea exactly how many chemicals are used in
consumer products, nor what products they are used in.
* An unknown number of new chemicals are not among this total. Only
new organic chemicals - chemicals that contain carbon - are added
to the list. New chemicals that are exempt from the official
listing process include inorganics, pesticides, food additives,
some large polymer molecules, and any chemical produced in low
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REGULATIONS AND TESTING REQUIREMENTS: NEW VS. OLD CHEMICALS
. . .
New chemicals are defined here as chemicals that have yet to enter or
are still within the Premanufacture Notification (PMN) process. During
the 90 day PMN process EPA staff can ask for some limited data on the
toxicity and physical characteristics of a chemical, although they
rarely do. EPA reviews between 2000 and 2500 applications through the
PMN program each year, or between 40 and 50 new chemical applications
each week. (EPA 1997, pg. 6 and 44).
* More than half of all PMNs come in the door with no toxicity or
environmental fate data. Data on physical and chemical properties
like melting point and boiling point may have been submitted for a
small percentage of these chemicals (DiCarlo et al 1986, referenced
in EPA 1997).
* 8 out of every 10 PMN applications are approved within three weeks,
with or without test data (EPA 1997, pg 36).
* 90% of 23,971 PMN chemicals approved by EPA between 1976 and 1994
were approved with no restrictions on their proposed use and
production and with no requests for additional test data,
regardless of the amount of data submitted.
It is not just health data that is lacking in the PMN process. There
is precious little data of any kind submitted with PMNs, chiefly
because none is required. As 3M puts it on their PMN forms posted on
EPA's web site, "You are not required to submit the listed test data
if you do not have it." And chemical manufacturers almost never have
* Fewer than 5 of every 100 PMN submissions have any data pertaining
to how toxic the chemical might be to wildlife (ecotoxicity data)
(Zeeman et al. 1993, referenced in EPA 1997, pg 11).
* Fewer than 4 of every 100 PMN submissions contain any measured
values for physical and chemical properties of the chemical (Lynch
et al 1991, referenced in EPA 1997, pg 11). This is an
extraordinarily significant omission, because EPA routinely uses
parameters like a chemical's boiling point and melting point to
estimate risks to human health.
* Fewer than 1 of every 100 PMN submissions contain any
biodegradation data - an indicator of how persistent the chemical
will be in the environment (Boethling and Sabljic 1989, referenced
in EPA 1997).
Because it receives virtually no data from industry, EPA relies on
estimates of key parameters to judge if the chemical might be toxic to
humans, for the vast majority of new chemicals. EPA's standard
approach includes a concept called the structure-activity relationship
(SAR), which is a comparison of the chemical with other chemicals that
are structurally similar for which toxicity data are available. In
essence, EPA uses test results for chemical cousins to estimate how
toxic a new chemical might be. This is a risky way to do business. The
General Accounting Office points to a case where EPA underestimated
the risk of a chemical (dialkyldialkoxysilane) by a factor of 100
because they were forced to rely on SARs in their original risk
assessment (GAO 1994b).
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Old chemicals are defined here as all chemicals that were on the
market when TSCA passed in 1976, plus any chemical that has made it to
market through the PMN process. EPA has even less authority to require
tests for old chemicals than for new ones. For old chemicals EPA must
go through a rulemaking to request a single test on a single chemical.
As of 1998, EPA had requested tests for only 263 chemicals, or only
about 0.4 percent of the (approximately) 70,000 "old" chemicals in
commercial use in the United States (ED 1998). These are only single
tests for one effect, such as cancer, or perhaps just an acute
toxicity test. This does not mean that EPA has requested comprehensive
testing for 263 chemicals.
What about high production volume chemicals? Isn't industry
participating in a wildly successful voluntary test program?
In 1998, EPA reported that the most heavily used chemicals in
commerce are largely untested:
* 43% of 2,800 chemicals produced in volumes of 1,000,000 per year o rmore, have no basic toxicity data, or screening level data, at all.
* 50% have incomplete screening data.
* Only 7% of these so-called high production volume (HPV) chemicals
have a complete set of screening level toxicity data.
Screening level data, even if they indicate a problem, are not
sufficient to restrict the use of a compound.
On October 9, 1998 EPA's administrator Carol Browner sent letters to
the CEO's of more than 900 chemical companies that manufacture HPV
chemicals, inviting them to participate in EPA's voluntary testing
initiative, the "HPV Challenge Program." As of February 2001, 28
months after these invitations were mailed, industry had submitted
only 17 testing work plans to EPA - and EPA has not received the
results of any new tests.
About half of the companies have not responded, and presumably will
not respond to the invitation, while 469 companies have indicated some
level of commitment. Of the 2,863 chemicals initially identified, 25%
(708 chemicals) remain entirely without a commitment for testing from
The program deadline for all tests to be completed recently slid
several years - EPA is now asking for all new test results to be
submitted by 2005, but if past is prologue this deadline is not likely
to be met.
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CURRENT STATUS OF HPV TESTING
The EPA website on the HPV challenge program now refers people to an
industry-sponsored site (http://www.hpvchallenge.com) for updates on
industry commitments under the program. Industry data on this site
* 34 tests were completed in 1999 (5 physical property tests, 14
environmental fate tests, 6 ecotoxicity tests, and 9 toxicity
* 29 tests were completed in 2000 (5 physical property tests, 5
environmental fate tests, 7 ecotoxicity tests, and 12 toxicity
Only 21 of these 63 tests are directly relevant to human health.
As of February, 2001, none of these test results had been submitted
to EPA under the HPV program.
Companies that fail to participate in the voluntary initiative may be
subjected to formal testing requirements under legally binding test
rules. In December 2000 EPA issued the first of these test rules,
covering 37 of the 708 chemicals for which there is no voluntary
testing commitment. If EPA continues this rulemaking pace each year,
test rules for all 708 chemicals will be in place in the year 2022.
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Environmental Protection Agency (EPA). 1997. Chemistry Assistance
Manual for Premanufacture Notification Submitters. Office of Pollution
Prevention and Toxics. EPA 744-R-97-003. March 1997.
General Accounting Office (GAO). 1994b. Toxic Substances Control Act:
Preliminary Observations on Legislative Changes to Make TSCA More
Effective (Testimony, 07/13/94, GAO/T-RCED-94-263).
Environmental Defense Fund (ED). 1998. Toxic Ignorance. Washington,
Environmental Protection Agency (EPA). 1998. Chemical Hazard Data
Availability Study. What do we really know about the safety of high
production volume chemicals? EPA's 1998 baseline of hazard information
that is readily available to the public. Office of Pollution
Prevention and Toxics. April 1998.
General Accounting Office (GAO). 1994a. Toxic Substances Control Act:
Preliminary Observations on Legislative Changes to Make TSCA More
Effective (Testimony, 07/13/94, GAO/T-RCED-94-263). Summary available
Updated: Wed, Mar 21 09:51 PM EST
By ERIN McCLAM, Associated Press Writer
ATLANTA (AP) - Americans' bodies harbor surprisingly high
amounts of mercury and a questionable chemical used in soap and
cosmetics, federal health officials reported Wednesday in a
landmark study on environmental toxins in the body.
The study is the first nationwide to measure levels of 24
environmental toxins in people's blood and urine, providing
crucial information that could be used to pinpoint pollutants
that cause disease.
Animal studies have suggested that large amounts of the
chemical, diethyl phthalate, may disrupt normal hormone function
and cause birth defects. Its effect on humans hasn't been
The report found that phthalates - additives found in products
from perfume to nail polish - appeared in humans at levels
"considerably higher than one would have predicted," said Dr.
Richard Jackson, director of the National Center for
Previous studies of environmental toxins had only tested air,
soil and water.
"Seeing chemicals in people's bodies elevates their importance,"
said Lynn Goldman, a former Environmental Protection Agency
The cosmetics industry contends phthalates are perfectly safe.
"We haven't seen any documented health effects in humans from
this," said Marian Stanley, manager of the American Chemistry
Council's phthalate panel.
The study also found higher than expected levels of mercury,
which is believed to cause fetal brain damage.
While the study found low levels of mercury in children 1 to 5
years old, women of childbearing age reflected higher levels
than previously estimated by the EPA, Goldman said.
"That would mean we haven't been taking the problem seriously
enough," she said.
The numbers, based on a 1999 study of 3,800 people across the
country, may affect government regulation of toxins such as
lead, mercury and pesticides. In many cases, there are no
previous numbers available for comparison.
The government plans to conduct the study annually, expanding it
to more than 100 chemicals. The reports will be broken down by
demographic categories such as race, age, education and
"It could be revolutionary in terms of environmental health in
the United States," Jackson said.