Fact and Fiction
The Most Poorly Tested Chemicals in the World
Facts and Figures
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).
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 it.
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).
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:
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 manufacturers.
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.
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 show that:
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.
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, D.C.
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 on http://www.gao.gov.
last updated: march.27.2009