Proposition 65 Regulatory Update Project Regulatory Concepts for Exposures to Human and Plant Nutrients in Human Food - Opportunity for Public Participation, Notice of Second Public Workshop
The Office of Environmental Health Hazard Assessment 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 27 of the California Code of Regulations, sections 25000-27001 inclusive.
Certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or the healthy growth of plants. Excessive exposures to some of these same chemicals or compounds may have the potential to cause cancer or adverse reproductive effects and can result in the listing of these chemicals under Proposition 65. Vitamin A has been listed under Proposition 65 since 1989. OEHHA is aware of additional chemicals1 that may be considered for listing under Proposition 65 that can be considered human or plant nutrients.
While some nutrients are naturally occurring in a food (including dietary supplements) or food crops2, they are sometimes intentionally added to a food or to the soil or other growing medium to help supplement human or plant health. While it is important to support the adequate intake of these nutrients, it is also important for the public to receive a warning for excessive exposures that may cause adverse health effects. OEHHA is seeking a way to balance these competing interests through the adoption of a narrowly-tailored set of regulations that will identify certain levels of exposures to listed chemicals that are nutrients that will not require a warning.
It should be noted that this set of regulations, if adopted, will only apply to chemicals that are already on the Proposition 65 list, or that are added to the list in the future. The exposure level established in these potential regulations for a listed chemical would not limit the amount of the chemical that can be added to any particular product and would not restrict the sale or availability of any food product or supplement. Instead, these levels could be used by businesses subject to the Act to determine when a warning is required for an exposure to the listed chemicals in question in a food product.
In April 2008, OEHHA held a pre-regulatory workshop to discuss a possible regulation that would provide an exemption from the warning requirements of the Act for certain exposures to listed chemicals that are human or plant nutrients. Following review of the comments received at that workshop and in writing following the workshop, OEHHA has re-drafted the possible regulatory language. One significant change to the regulatory concept is that the levels established in the regulations for individual chemicals will be based on a chemical-by-chemical evaluation, rather than by relying on a Recommended Dietary Allowance (RDA) or a percentage of the Tolerable Upper Intake Level for a given chemical. Another change is that rather than proposing one regulatory concept that would cover both human and plant nutrients, OEHHA is proposing separate concepts for exposures to human nutrients in food and for exposures to plant nutrients in food. The latter concept addresses the situation where a listed chemical is used intentionally during food crop cultivation to support plant growth. The new regulatory concepts are provided below.
OEHHA is offering the public an opportunity to comment on the re-drafted concepts at a workshop and in writing.
The workshop will be held Friday, December 12, 2008 from 10 a.m. to Noon in the Sierra Hearing Room at the Cal/EPA Headquarters Building located at 1001 I Street, Sacramento, California. Interested parties are encouraged to provide input concerning the redrafted concepts including offering 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 January 5, 2009 January 12, 2009. 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.
Possible Regulatory Language (Concept only, this is not a formal regulatory proposal and is subject to change):
§ 25506. Exposure to a Human Nutrient in a Food
- Human exposure to a nutrient listed in subsection (b) in a food shall not constitute an exposure for the purpose of Section 25249.6 of the Act, to the extent that the person responsible for the exposure can show that the nutrient is naturally occurring in the food pursuant to Section 25501 of these regulations, or that the reasonably anticipated level of exposure to the nutrient from consumption of a food does not exceed the level set forth below.
- Nutrient Maximum Daily Exposure from a Food (micrograms per day)
Chemical A x
§ 25507. Exposure to a Plant Nutrient in a Food
- Human exposure to a plant nutrient listed in subsection (b) in a food shall not constitute an exposure for purposes of Section 25249.6 of the Act, to the extent that the person causing the exposure can show that the chemical is naturally occurring in the food pursuant to Section 25501 of these regulations, or was added to the soil or other growing media in an amount necessary for healthy plant development; and that the reasonably anticipated level of exposure to the chemical from consumption of a food does not exceed the level set forth below.
- Nutrient Maximum Daily Exposure from a Food (micrograms per day)
Link to Public Comments
Related Notices
Footnotes and References
1Boron, certain boron compounds and manganese
2Naturally-occurring levels of listed chemicals are not considered “exposures” for purposes of the Act., See Title 27, Cal. Code of Regs., section 25501 (Formerly Title 22, Cal Code of Regs., section 12501)
The comment period closed on January 12, 2009