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Fact #1: No health tests are required by law to put a chemical on the market


As amazing as it may seem, there are no mandatory pre-market health testing or approval requirements under any federal law for chemicals in cosmetics, toys, clothing, carpets, or construction materials, to name just a few obvious sources of chemical exposure in everyday life.

The EPA does require some tests for a handful of new compounds (as opposed to heavily used older compounds) via the pre-manufacture notice (PMN) program. These tests provide little protection for the public, however, because they apply only to chemicals that are new and little used, and because studies for critical human health effects like cancer, birth defects, and nervous system toxicity are rarely if ever required.

This explains in large part why products like hair spray, hair dye, pacifiers, stain repellants, glues, construction materials, and plastic wraps, just to name a few, are put into commerce for decades before their dangers are discovered and the products are removed or reformulated.

Here is how the FDA describes testing requirements for chemicals in cosmetics:

FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by FDA before they are sold to the public. (FDA 1995)

Here is how EPA describes its authority to require health testing under the Toxic Substances Control Act. In general, EPA can require safety testing of chemicals only if the Agency can prove that the chemical potentially poses a risk, which it can almost never do because the law essentially prohibits the agency from mandating health studies by chemical manufacturers for every individual test it seeks:

EPA must make the following statutory "findings" in order to require the chemical industry to test chemicals they manufacture, import and/or process:

* Hazard or "A" Finding - EPA must determine that existing data show that the subject chemical "may present an unreasonable risk of injury to health or the environment" and that the probability of exposure to the subject chemical substance is more than just theoretical; and/or

* Exposure or "B" Finding - EPA must show that the chemical is produced or imported in substantial quantities, and either enters the environment in substantial quantities or there is substantial or significant human exposure; and

- EPA must show that existing data are inadequate for risk assessment; and

- EPA must show that testing is needed to develop the data necessary to conduct the needed risk assessment. (EPA 2001)

How did this happen?

The chemical industry wanted it this way.

Since the 1950's the chemical industry has effectively blocked efforts to require health studies for the compounds it produces. Comprehensive testing for the health effects of chemicals is not required under the Occupational Safety and Health Act, the Toxic Substances Control Act, nor the cosmetics provisions of the Food Drug and Cosmetics Act. (Testing is required for chemicals directly added to food).

But what about industry's voluntary testing program?

It's a total bust.

In 1998, the EPA and the chemical industry launched their much-ballyhooed voluntary testing program for high production volume chemicals. To date, the program has been little more than a PR exercise. As of February 2001, the EPA has received no new tests - zero - as a result of the HPV program. Indeed, only 17 plans for tests have been submitted so far, which cover about 10% of the chemicals that need to be tested. And the tests themselves are only screening tests, preliminary indicators of a toxic effect that will not support a regulatory action to restrict the use of a chemical.

The HPV voluntary testing program is not a victory for the public or a concession by industry. It is the end result of a decades-long coordinated strategy to avoid comprehensive testing requirements that would surely lead to restrictions on major products.

Voluntary testing means no testing

In 1998, EPA reported that 43% of 2,800 chemicals produced in volumes of 1,000,000 pounds per year or more, have no basic toxicity data, or screening level data, at all. Fifty percent have incomplete screening data, and 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, not a single test has been submitted and just 17 testing work plans have been submitted to EPA. 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.

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.

References

U.S. Food and Drug Administration (FDA). 1995. FDA authority over cosmetics. Center for Food Safety and Applied Nutrition, Office of Cosmetics Fact Sheet, February 3, 1995. http://vm.cfsan.fda.gov/~dms/cos-206.html.

U.S. Environmental Protection Agency (EPA). 2001. TSCA Chemical Testing Policy. Office of Pollution Prevention and Toxics. http://www.epa.gov/opptintr/chemtest/sct4main.htm

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last updated: march.27.2009

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