Request for Public Participation, Notice of Public Workshop - Proposition 65 Regulatory Update Project, Beneficial Nutrients Regulatory Concept

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The Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for implementation of Proposition 65 (The Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code section 25249.5, et. seq., hereafter referred to as Proposition 65 or the Act).  As part of its responsibilities related to Proposition 65, OEHHA maintains the regulations implementing the Act.  These regulations can be found in Title 22 of the California Code of Regulations, sections 12000-14000 inclusive.

Certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or to ensure the healthy growth of food crops.  Excessive exposures to these same chemicals or compounds can cause cancer or adverse reproductive effects.  OEHHA is seeking a way to balance the need for these nutrients with the necessity for providing Proposition 65 warnings for exposures to listed chemicals in foods.  OEHHA has developed draft regulatory language that addresses this issue, which can be found below.

OEHHA is requesting input from stakeholders in the enforcement and business communities, as well as other members of the public, concerning issues that may arise if OEHHA proceeds with such a regulatory proposal.  In addition, OEHHA is requesting input on the possibility of adopting specific provisions into the existing “safe harbor” warning regulations (Title 22, Cal. Code of Regs., section 12601), that would address the content of warnings for those exposures to listed chemicals that are beneficial nutrients that may require a warning.

On Friday, April 18, 2008 from 10:00 a.m. to Noon in the Sierra Hearing Room at the California Environmental Protection Agency Headquarters Building located at 1001 I Street, Sacramento, California, OEHHA will hold a public workshop for the purpose of gathering input from interested parties concerning the issues raised by these regulatory concepts.  Stakeholders are encouraged to provide input concerning these concepts including alternative regulatory language or other approaches that would address these issues. 

Interested parties may also submit their ideas in writing.

In order for the comment to be considered at this point in the process it must be received by 5:00 p.m. on Friday, May 2, 2008.  Should OEHHA proceed to propose regulations on this issue, additional opportunities for public comment will be provided.  All submissions should be directed to:

Fran Kammerer
Staff Counsel
Office of Environmental Health Hazard Assessment
1001 I Street
Sacramento, CA 95812
Or via e-mail to fkammerer@oehha.ca.gov

If you have special accommodations or language needs, please contact Monet Vela at (916) 323-2517 or mvela@oehha.ca.gov by April 11, 2008.

Possible Regulatory Language (Concept only, this is not a formal regulatory proposal):

Section 1250X.  Exposure to Beneficial Nutrients in a Food

(a) Human consumption of a food shall not constitute an “exposure” for purposes of Section 25249.6 of the Act to a listed chemical in a food if the person causing the exposure to the chemical can show that the chemical is a nutrient that is beneficial to human health and that the total amount of the chemical consumed in a food, whether naturally occurring, intentionally added to the food, or otherwise present, does not exceed the level established in subsection (c).
(b)  For purposes of this section, a chemical is beneficial to human health if a daily value or allowance has been established for the chemical or compound by the Food and Nutrition Board of the Institute of Medicine, National Academies.
(c)  This section applies only to exposures that do not exceed the Recommended Daily Allowance (RDA) established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine, National Academies, current edition, if one is established.  If no RDA is established, this section applies only to exposures that do not exceed 20 percent (20%) of the Tolerable Upper Intake Level established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine, National Academies, current edition.

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