Proposition 65 has been a law in California since 1986. Its purpose is to promote clean drinking water and to remove toxic materials or substances which can cause birth defects and cancer out of consumer products. Proposition 65 requires the Governor of California to publish a list of those chemicals known to the state, to cause cancer or reproductive toxicity, at least once per year.
In October of 2008, to the Office of Environmental Health Hazard Assessment (OEHHA) requested public inputs on a draft of proposed amendments that would provide an exemption from parts of the Act for certain exposures to listed chemicals that are nutrients.
The Council for Responsible Nutrition (CRN) has filed comments in response to this request: Proposition 65, Regulatory Update Project – Regulatory Concepts for Exposure to Human and Plant Nutrients in a Human Food, to the Office of Environmental Health Hazard Assessment. These comments were submitted January 5, 2009.
The comments reiterate CRN’s belief that the project is not needed, based on the position the OEHHA took previously with regards to retinol, which was dealt with on a case-by-case approach. Retinol, as it turns out, is currently the only chemical listed as a developmental and reproductive toxicant (DART) or carcinogen, that is also known to be a beneficial nutrient. According to CRN, “No other rules applied after retinol was identified as a DART when levels were sufficiently excessive.” The Food and Nutrition Board (FNB) later established a Tolerable Upper Intake Level (UL) based on this case-by-case approach.
CRN went on to further explain, “If OEHHA currently considers other beneficial nutrients to warrant possible listing as a DART or carcinogen, it should give public notice about which those are, so that stakeholders can prepare substantive comments with full information about the chemicals under consideration rather than dealing in hypotheticals.”
CRN, in its response, also addressed concerns about draft sections 25506 and 25507 dealing with exposures to human nutrients and human exposures to plant nutrients, while admitting that the case-by-case consideration did represent improvement over previous thinking and umbrella policy-making. They association contended that the sections contain “abiguities, misquotes, and misunderstandings…..”and “are incomplete in a manner that prevents any firm conclusion about whether the changes to a case-by-case approach…represents a step in the right direction.
The “naturally occurring” exemption deals with those that are shown to not be added. CRN questions how one proves that any specific level did not result in some way, fromhuman activity. Concern is focused on how “it appears that any chemical (including beneficial nutrients) known to be added to a product, or even to one’s daily regimen, in order to supplement the diet, such as in fortified foods and dietary supplements, may not qualify for ‘naturally occurring.’”
Other concerns include the sections “Lack of methods and standards for identification of quantitative ‘Maximum DailyExposure from a Food (micrograms per day)’,” “Confusion of ‘no observable effect level’ and Tolerable Upper Intake Level (UL)” and “Extrapolation from health effects not covered by Proposition 65 to DART or carcinogenic effects.”
CRN follows these concerns with recommendations to amend the policy, if their main recommendation of discontinuing the new regulatory policy is not followed. These secondary recommendations include exemptions for nutrients that fit criteria as “Beneficial Nutrients” or “Plant Nutrients.”
To see the submitted comments in full on CRN’s website, click on this link.
For more information from the OEHHA on proposition 65 and the list of chemicals known to the state to cause cancer or reproductive toxicity, click here.To view the FAQ page regarding Prop 65, click here.