No Significant Risk Levels

BCCR. 1990. Barclays California Code of Regulations. Article 5.5. Primary Standards-Organic Chemicals Article 7. No Significant Risk Levels. Title 22. Register 90, No.26-31. San Francisco, California. 

The following statement(s) is (are) made in order to comply with the California Safe Drinking Water Act WARNING This product contains 1,2-Dichloroethane, a chemical known to the state of California to cause cancer. California No Significant Risk Level CAS 107-06-2 10 jLg/day NSRL... 

For a chemical that causes cancer, the no significant risk level is defined as the level of exposure that would result in not more than one excess case of cancer in 100000 individuals exposed to the chemical over a 70 year lifetime. In other words, a person exposed to the chemical at the no significant risk level for 70 years would not have more than a one in 100 000 chance of developing cancer as a result of that exposure. 

OEHHA (2008). Proposition 65 Safe Harbor Levels No significant risk levels for carcinogens and maximum allowable dose levels for chemicals causing reproductive toxicity. Office of Environmental Health Hazard Assessment, California Environmental Protection Agency, Oakland, CA. Accessed at http //www.oehha.ca.gOv/prop65/pdf/Feb2008StatusReport.pdf. 

Based on current analytical methodology, it is possible to identify literally hundreds of constituents in an essential oil and quantify the constituents to part per million levels. But is this necessary or desirable From a practical point of view, the level of analysis for constituents should be directly related to the level of exposure to the essential oil. The requirements to identify and quantify constituents for use of 2,000,000 kg of peppermint oil annually should be far greater than that for use of 2000 kg of coriander oil or 50 kg of myrrh oil annually. Also, there is a level at which exposure to each constituent is so low that there is no significant risk associated with intake of that substance. A conservative no-significant-risk-level of 1.5 pg/d (0.0015 mg/d or 0.000025 mg/kg/d) has been adopted by regulatory authorities as a level at which the human cancer risk is below one in one million (FDA, 2005). Therefore, if consumption of an essential oil results in an intake of a constituent that is <1.5 pg/d, there should be no requiranent to identify and quantify that constituent. 

Use of pre-existing standards and criteria to set mandatory levels of clean-up would preclude any site-by-site consideration of exposure and risk, and could result in huge clean-up costs where the risks were inconsequential. In addition, as a formal matter, the Federal water quality criteria for many substances have been left at zero pending full scientific and risk assessment, and use of these criteria would require a zero-release clean-up in a situation which imposed no significant risk in the first place (2). 

There are no significant risks associated with low cholesterol levels. 

The effect of intravenous iodinated contrast material administration to the neonatal thyroid levels in pregnant women were investigated in a retrospective study of 64 newborns. All 64 newborns, except for one premature and one septic patient were found to have normal thyroid hormone levels. Although the patient group was small, the study found that there was no significant risk of thyroid function abnormalities to the neonates after intravenous administration of contrast material to the mothers [5 ]. 

Vanillin has a low potential for acute and chronic toxicity, with a reported oral LD q in rats of 1580—3300 mg/kg. Dietary doses up to 20,000 ppm adrninistered to rats for two years resulted in no adverse toxicologic or carcinogenic effects. Vanillin is classified as a GRAS substance by EEMA. Consequently, at levels normally found in the human diet, vanillin would present no significant health or carcinogenic risk to humans. 

The significance of the exposure levels shown in the Levels of Significant Exposure (LSE) tables and figures may differ depending on the user s perspective. Public health officials and others concerned with appropriate actions to take at hazardous waste sites may want information on levels of exposure associated with more subtle effects in humans or animals (LOAELs) or exposure levels below which no adverse effects (NOAELs) have been observed. Estimates of levels posing minimal risk to humans (minimal risk levels or MRLs) may be of interest to health professionals and citizens alike. 

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