Despite Changes, Prop 65 Proposed Revisions Unnecessary – CRN

A revised draft proposal to create a process to expand the list of nutrients that require a warning under California's Proposition 65 "contains significant ambiguities" and should be dismissed, says the Council for Responsible Nutrition.

The California Office of Environmental Health Hazard Assessment revised proposed draft regulations that would identify when vitamins and minerals necessary for good health reach harmful levels. The regulations also would create a protocol to add nutrients to the list of Prop 65 substances that require cancer and reproductive health warnings.

If adopted as drafted in the November revision, the proposed rule would apply to vitamin A retinol, the only beneficial nutrient currently listed in Prop 65. It also would apply to any nutrients added in the future, such as boron, certain boron compounds and manganese, which the agency says it may add.

In comments submitted Jan. 5, CRN argues "this project is not needed" and recommends OEHHA "discontinue the development of this new regulatory policy."

The proposed draft regulations are unnecessary because OEHHA added retinol in 1979 to the list of nutrients that require health warnings under Prop 65 without a regulatory protocol, John Hathcock, senior VP for scientific and international affairs at CRN, said in an interview.

He added the regulations are unnecessary also because in the current draft proposal, OEHHA does not acknowledge that it will ever need to determine whether additional chemicals or nutrients must be added to the list.

The American Herbal Products Association agrees that the draft proposed regulations are unnecessary.

If the agency adds boron and manganese to the Prop 65 list, it should list them the same way it lists vitamin A retinol - with an asterisk that indicates products need a warning only if they include more than 10,000 IU of the substance, said AHPA President Michael McGuffin.

The addition of retinol to the Prop 65 list without the regulation makes it clear the agency already knows how to qualify beneficial nutrients and that it does not need a regulation, McGuffin added.

However, McGuffin observed that OEHHA could be creating the regulation to safeguard against potential suits because it might not have the authority to qualify chemicals on the Prop 65 list.

If halting the rulemaking is not an option, CRN urges OEHHA to clarify how it will establish when a beneficial nutrient reaches dangerous levels that require a warning.

Both CRN and AHPA argued against using recommended dietary allowances and tolerable upper limits to determine safe nutrient levels in comments on the original draft proposal (¹ (Also see "Proposed Prop 65 Regulation Changes Based On Faulty Science, Groups Say" - Pink Sheet, 12 May, 2008.), p. 11).

After reviewing those comments, OEHHA significantly altered the proposed draft to establish a threshold for the warnings on a case-by-case basis for each nutrient - a change CRN says it endorses.

"A flat, arbitrary across-the-board level is neither workable nor useful" because "nutrients are vastly different in their metabolism and usage by the human body," according to CRN's latest comments, written by President and CEO Steven Mister and Hathcock.

"A flexible approach that accounts for nutrient differences ... has much more likelihood of addressing necessary and recommended levels of these beneficial nutrients," CRN says.

However, CRN says establishing the maximum daily exposure level of a nutrient from a food product on a case-by-case basis "is not sufficient to assure scientifically justified outcomes" because the draft does not include criteria to establish these values.

It recommends the agency exempt beneficial nutrients if the amount in a product has an RDA, an acceptable intake level or if the U.S. Food and Nutrition Board recognizes the nutritive effects in its Dietary Reference Intakes documents.

CRN says a nutrient amount also must not exceed the tolerable UL, the guidance level established by the U.K. Expert Committee on Vitamins and Minerals or the equivalent of the highest observed intake as defined by the World Health Organization.

CRN Urges Clarification On Plant Nutrients

CRN also recommends OEHHA clarify when a chemical is exempt because it qualifies as a "plant nutrient."

The revised draft proposal differentiates between plant nutrients, which plants need to grow, and beneficial nutrients, which humans need and directly consume.

Just as with beneficial nutrients, the proposed draft regulation says OEHHA will require a Prop 65 warning if the nutrient reaches a maximum daily exposure from a food measured in micrograms. Also as with beneficial nutrients, OEHHA does not say how it will determine this threshold.

CRN recommends OEHHA exempt nutrients as a "plant nutrient" under criteria recognized by plant nutrition experts if the amount of the residual substance in products also does not exceed tolerable UL or the levels set by the U.K. panel or WHO.

Exemption Too Narrow For Supplements

CRN also raises concerns that limiting the exemption to nutrients in products at "naturally occurring" concentrations would not protect dietary supplements.

The trade group argues the burden of proof for a supplement to meet the "naturally occurring" exemption "seems nearly impossible" because by definition supplements increase natural consumption of vitamins and minerals.

Under the current exemption, "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,'" CRN explains.

CRN also questions OEHHA's ability to determine when a nutrient concentration occurs naturally or what amount is necessary for healthy plant development under the proposed exemption.

OEHHA is accepting comments on the revised draft through Jan. 12.

- Elizabeth Crawford ([email protected])