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Background: Frequencies of sensitization to formaldehyde among US patients patch tested for suspected contact dermatitis are higher than in Europe. Cosmetics are an important source of contact with formaldehyde., Objectives: To acquire data on the frequency of use of formaldehyde-releasers in cosmetics sold in the USA and Europe and their use concentrations. To assess whether any observed differences may contribute to the discrepancies in sensitization rates., Methods: Enquiries with Food and Drug Administration (FDA), the European Cosmetics Association, and the Dutch Cosmetics Association. Reading the labels of skin care cosmetics in a local drugstore., Results: The FDA provided data on the presence of formaldehyde and releasers. Nearly one fifth of all cosmetics contain a releaser. In 25% of 496 examined skin care products, releasers were present. In comparable FDA data categories, the percentage was 24. No data were found on use concentrations of the releasers in cosmetics in either the USA or Europe., Conclusions: The percentages of stay-on skin care products containing a formaldehyde-releaser are virtually identical in the USA (FDA data) and our local drugstore sample. However, this does not necessarily imply that cosmetics play no part in the differences in formaldehyde sensitization rates.

This is the second part of an article on formaldehyde-releasers in cosmetics. The patch test relationship between the releasers in cosmetics to formaldehyde contact allergy is reviewed and it is assessed whether products preserved with formaldehyde-releasers may contain enough free formaldehyde to pose a threat to individuals with contact allergy to formaldehyde. There is a clear relationship between positive patch test reactions to formaldehyde-releasers and formaldehyde contact allergy: 15% of all reactions to 2-bromo-2-nitropropane-1,3-diol and 40-60% of the reactions to the other releasers are caused by a reaction to the formaldehyde in the test material. There is only fragmented data on the amount of free formaldehyde in cosmetics preserved with formaldehyde donors. However, all releasers (with the exception of 2-bromo-2-nitropropane-1,3-diol, for which adequate data are lacking) can, in the right circumstances of concentration and product composition, release >200 p.p.m. formaldehyde, which may result in allergic contact dermatitis. Whether this is actually the case in any particular product cannot be determined from the ingredient labelling. Therefore, we recommend advising patients allergic to formaldehyde to avoid leave-on cosmetics preserved with quaternium-15, diazolidinyl urea, DMDM hydantoin, or imidazolidinyl urea, acknowledging that many would tolerate some products.

In this part of a series of review articles on formaldehyde-releasers and their relationship to formaldehyde contact allergy, formaldehyde-releasers in cosmetics are discussed. In this first part of the article, key data are presented including frequency of sensitization and of their use in cosmetics. In Europe, low frequencies of sensitization have been observed to all releasers: 2-bromo-2-nitropropane-1,3-diol 0.4-1.2%, diazolidinyl urea 0.5-1.4%, imidazolidinyl urea 0.3-1.4%, quaternium-15 0.6-1.9% (for DMDM hydantoin no recent data are available). All releasers score (far) higher prevalences in the USA; the possible explanations for this are discussed. The relevance of positive patch test reactions has been insufficiently investigated. In the USA, approximately 20% of cosmetics and personal care products (stay-on products: 17%, rinse-off products 27%) contain a formaldehyde-releaser. The use of quaternium-15 is decreasing. For Europe, there are no comparable recent data available. In the second part of the article, the patch test relationship of the releasers in cosmetics to formaldehyde contact allergy will be reviewed and it will be assessed whether products preserved with formaldehyde-releasers may contain enough free formaldehyde to pose a threat to individuals who have contact allergy to formaldehyde.

The precautionary principle asserts that the burden of proof for potentially harmful actions by industry or government rests on the assurance of safety and that when there are threats of serious damage, scientific uncertainty must be resolved in favor of prevention. Yet we in public health are sometimes guilty of not adhering to this principle. Examples of actions with unintended negative consequences include the addition of methyl tert-butyl ether to gasoline in the United States to decrease air pollution, the drilling of tube wells in Bangladesh to avoid surface water microbial contamination, and villagewide parenteral antischistosomiasis therapy in Egypt. Each of these actions had unintended negative consequences. Lessons include the importance of multidisciplinary approaches to public health and the value of risk-benefit analysis, of public health surveillance, and of a functioning tort system-all of which contribute to effective precautionary approaches.

A widely used gasoline additive, methyl tertiary butyl ether (MTBE), has been controversial, in part because of concerns about potential inhalation health effects and more recently because of added concerns about water contamination. Although many of the issues related to MTBE have not been fully resolved, several apparent paradoxes can be discerned, including the fact that something intended to improve air quality is now seen as a threat to water quality. Among the lessons that can be derived from the MTBE experience is the value of a comprehensive understanding of the potential risk-benefit tradeoffs of different fuels and fuel additives.

A field study was conducted June through August 1996 in an attempt to quantify short-term exposure levels to Coast Guard personnel performing routine inspection activities aboard commercial tank barges carrying gasoline. Transfer and fleeting operations were monitored in the ports of Pittsburgh, Pa., Huntington, W.Va., Baton Rouge, La., and Galveston, Tex. A total of 43 personal and 68 area samples were analyzed for benzene and total hydrocarbons as gasoline ("gasoline"). Results can be summarized as follows: Personal exposure to benzene gave 15-min time-weighted-average (TWA) results ranging from <0.10 to 0.50 ppm. Area benzene levels ranged from <0.04 to 170 ppm. Personal monitoring for gasoline revealed a range of <2.0 to 590 mg/m3 with a GM of 23 mg/m3. Area sample results for gasoline ranged from 1.7 to 90,000 mg/m3. Twelve personal samples were collected for methyl-tert butyl ether (MTBE). Only two of these were above the limit of detection and had 15-min time-weighted averages of 22 ppm and 1.3 ppm. Eighteen MTBE area samples ranged in value from <3.0 to 38 ppm. Although none of the personal samples met or exceeded proposed or established short-term exposure standards, many of the area sampling results indicated that a significant risk of acute exposure exists in the vicinity of valves, pressure lines, and connections. This includes anticipated sources such as pressure vent valves as well as unexpected sources resulting from structural deficiencies onboard the vessels. These results further emphasize the value of safe work practices and proper vessel maintenance in controlling exposure to harmful chemicals.

Methyl tertiary butyl ether has caused the following cancers in rats and mice: kidney, testicular, liver, lymphomas, and leukemias. Thus, in the absence of adequate data on humans, it is biologically plausible and prudent to regard methyl tertiary butyl ether-for which there is sufficient evidence of carcinogenicity in experimental animals-as a probable human carcinogen. This means that some humans are at extreme risk of contracting cancers resulting from their exposure to oxygenated gasoline containing methyl tertiary butyl ether. Immediately after the introduction of methyl tertiary butyl ether into gasoline, many consumers of this product in New Jersey, New York, Alaska, Maine, Pennsylvania, Colorado, Arizona, Montana, Massachusetts, California, and other areas, experienced a variety of neurotoxic, allergic, and respiratory illnesses. These illnesses were similar to those suffered by refinery workers from the Oil, Chemical, and Atomic Workers Union who mixed methyl tertiary butyl ether with gasoline. Additionally, these illnesses occurred following exposure to extremely low levels of methyl tertiary butyl ether in gasoline, particularly when compared to the adverse health effects that occurred only after exposure to very high levels of conventional gasoline. Thus, gasoline containing methyl tertiary butyl ether exhibited substantially more toxicity in humans than gasoline without this additive. A number of oil industry-sponsored or influenced reports alleged that these illnesses were either unrelated to exposure to reformulated gasoline or were characteristic of some yet-to-be-identified communicable disease. These studies further alleged that the widespread concern was not about illness, but was merely a reaction to the odor and the five cent increase in the price of gasoline. To clarify the significance of this issue, it is important to note that consumers have been using gasoline for many decades, with complaints only occurring following exposure to high levels at 100s ppm or higher. After the introduction of methyl tertiary butyl ether gasoline there were thousands of human health complaints. The sudden increase in widespread illnesses from which many thousands of individuals throughout the United States began to suffer immediately following the introduction of methyl tertiary butyl ether into gasoline provides strong and unquestionable evidence that gasoline containing methyl tertiary butyl ether is associated with human illnesses. When considering the severity of the illnesses in humans, it is prudent that this highly dangerous chemical be promptly removed from gasoline and comprehensive studies be conducted to assess the long-term effects that human may experience in the future from past and current exposure.