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Notice of Readoption of Emergency Action to Amend Section 25603.3 Title 27, California Code of Regulations - Warnings for Exposures to Bisphenol A from Canned and Bottled Foods and Beverages

How do I comment on this proposed emergency regulation?

If you wish to comment on proposed emergency regulations, you must submit the comment directly to OAL within five calendar days of when OAL posts the proposed emergency regulations on the OAL web site at http://www.oal.ca.gov/Emergency_Regulations_Under_Review.htm.

Submit comments to:

OAL Reference Attorney
by mail to 300 Capitol Mall, Suite 1250
Sacramento, California 95814

by fax to (916) 323-6826

or by e-mail to staff@oal.ca.gov.

Please also send a copy of your comments to OEHHA at:

P65Public.Comments@oehha.ca.gov or:

Monet Vela
Office of Environmental Health Hazard Assessment
Street Address:  1001 I Street, 23nd Floor
Sacramento, California  95814
Mailing Address:  P.O. Box 4010
Sacramento, California  95812-4010

Regulatory language - 25603.3. Warnings for Specific Consumer Products Exposure

  1. Introduction

The Office of Environmental Health Hazard Assessment (OEHHA) is the state entity responsible for the implementation of Proposition 65.[1]  OEHHA has the authority to adopt and amend regulations to implement and further the purposes of Proposition 65.  OEHHA maintains a list of chemicals known to cause reproductive toxicity or cancer.  Proposition 65 requires businesses to provide a warning when they knowingly and intentionally cause an exposure to a listed chemical, and prohibits the discharge of listed chemicals into sources of drinking water.

On May 11, 2015, bisphenol A (BPA) was added to the Proposition 65 list of chemicals known to cause reproductive toxicity based on the female reproductive toxicity endpoint.[2]  Female reproductive toxicity occurs when a chemical damages any aspect of the female reproductive system.  Effective May 11, 2016, warnings are required for exposures to BPA unless the person causing the exposure can show that an exposure 1,000 times the level in question has no observable effect.[3]  OEHHA has adopted an emergency regulation to allow temporary use of a standard point-of-sale warning message for BPA exposures from canned and bottled foods and beverages.[4] This emergency regulation is in effect for a limited time of 180 days.  OEHHA is proposing a readoption of this emergency regulation for 90 days after the initial 180-day period expires on October 18, 2016.

  1. BACKGROUND

Proposition 65 was a 1986 ballot initiative that passed with 63 percent of the popular vote.  In part, the statute says:

“No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving a clear and reasonable warning…”[5]

Proposition 65 is a right-to-know law based on the concept that members of the public have a right to know when they are being exposed to listed carcinogens or reproductive toxicants. A Proposition 65 warning is not a regulatory decision that a product is safe or unsafe.  Rather, the law is designed to help consumers decide whether to assume the risks of purchasing particular products that result in exposures to listed chemicals.  

BPA is commonly used in the linings of metal cans and lids of glass bottles containing food and beverages.  Some BPA can move from these liners and lids into the food or beverage, thereby resulting in an exposure to the consumer of the food or beverage. 

On April 1, 2016, OEHHA posted a Notice of Emergency Action proposing an amendment to 25603.3.[6] The amendment allows businesses to provide point-of-sale warnings for food and beverage cans and bottles that cause exposures to BPA.  This prevented the need for retailers to post a plethora of signs throughout retail stores that likely would have confused consumers. This emergency rulemaking became effective on April 18, 2016 and will expire on October 5, 2016.

  1. Readoption of emergency action is needed

The emergency regulation that became effective April 18, 2016 is intended to provide a reasonable transition period to help avoid consumer confusion and at the same time ensure that informative warnings are provided to consumers about significant exposures to BPA. Businesses throughout the state of California are using this temporary warning in the manner outlined in the regulation.  However, the emergency regulation can only remain in effect for 180 days and will expire on October 18, 2016 (Government Code section 11346.1(e)).  OEHHA initiated a regular rulemaking process on July 29, 2016 to adopt the regulation. The regular rulemaking will not be complete before the 180 days expire. If the emergency regulation is allowed to expire before the regular rulemaking process is completed, California businesses would lose this temporary warning process and would have to revert to providing a multitude of warnings in retail stores for canned foods and beverages that cause exposures to BPA.

IV. Finding of an Emergency

  1. Section 48 Statement

Title 1 of the California Code of Regulations, section 48 requires the following statement:

“Government Code section 11346.1 (a)(2) requires that, at least five working days prior to submission of the proposed emergency action to the Office of Administrative Law, the adopting agency provide a notice of proposed emergency action to every person who has filed a request for notice of regulatory action with the agency.After submission of the proposed emergency to the Office of Administrative Law, the Office of Administrative Law shall allow interested persons five calendar days to submit comments on the proposed emergency regulations as set forth in Government Code section 11349.6.”

  1. Incorporation by Reference

All documents in the emergency regulation file no. 2016-0408-02E filed with the Office of Administrative Law on April 8, 2016, are hereby incorporated by reference.

  1. Facts Constituting the Need for an Emergency Readoption

OEHHA has made substantial progress and proceeded with diligence toward adopting the provisions of the emergency regulation via the regular rulemaking process.  On July 19, 2016, OEHHA submitted the initial file for the regular rulemaking process to OAL.  The Notice of Proposed Rulemaking was published on the California Regulatory Notice Register on July 29. A public hearing on this proposed rulemaking was held on September 12, 2016, and public comments are due September 26, 2016.

This readoption is necessary because the emergency circumstances have not changed since the initial emergency adoption.  Further, businesses in California are relying on the emergency regulation to comply with the requirements of Proposition 65 when selling their products in cans or bottles that were manufactured before the listing of BPA became effective.  Once the regular rulemaking is complete, these businesses will continue to have the option to provide point-of-sale warnings until the regulation sunsets in December 2017.  When the regulation sunsets, OEHHA anticipates that product manufacturers will have either switched to non-BPA materials or will have made arrangements to provide product-specific warnings. While it is possible some point of display shelf warnings will still be needed, the volume of such signs should be significantly reduced, thus eliminating the need for a point-of-sale warning.

V. TECHNICAL, THEORETICAL, AND/OR EMPIRICAL STUDY, REPORTS, OR DOCUMENTS RELIED UPON

Citations to documents relied on for this proposal are provided in this document and the documents incorporated by reference herein.  No other technical, theoretical or empirical material was relied upon by OEHHA in proposing the readoption of this emergency regulation.

VI. AUTHORITY

Health and Safety Code section 25249.12(a)

VII. INFORMATIVE DIGEST

  1. Background (see Section II, above)
  2. Specific Benefits of the Proposed Regulations

This regulatory readoption is intended to further the purposes of Proposition 65 by extending a temporary emergency regulation that allows for the use of a consistent and informative point-of-sale warning for BPA exposures from canned and bottled foods and beverages.  (See Emergency Rulemaking file number 2016-0408-02E incorporated by reference.)

  1. No Inconsistency or Incompatibility with Existing Regulations

OEHHA has conducted an evaluation and has determined that this is the only regulation specifically addressing Proposition 65 warnings for exposures to BPA from canned and bottled foods.  Therefore, the proposed emergency readoption of this regulation is neither inconsistent nor incompatible with any other existing state regulations.  The proposed readoption of the emergency regulation does not change the existing mandatory requirements on businesses subject to Proposition 65, state or local agencies and does not address compliance with any other law or regulation.

  1. Local Mandate/Fiscal Impact

Because Proposition 65 by its terms[7] does not apply to local agencies or school districts, OEHHA has determined the proposed readoption of the emergency regulation would not impose a mandate on local agencies or school districts, nor does it require reimbursement by the State pursuant to Part 7 (commencing with section 17500) of Division 4 of the Government Code.  OEHHA has also determined that no nondiscretionary costs or savings to local agencies or school districts will result from the proposed readoption of the emergency regulation.  Also, the proposed readoption of the emergency regulation will not create any cost or saving to any state agency, and will not create any cost or savings in federal funding to the state.

  1. Costs of Savings to State Agencies

Because Proposition 65 by its terms[8] does not apply to any state agency and this proposed action is simply the extension of an emergency regulation that provides compliance assistance for businesses subject to the Act, OEHHA has initially determined that no significant savings or increased costs to any state agency will result from the readoption of the emergency regulation.

  1. Efforts to Avoid Unnecessary Duplication of Conflicts with Comparable Federal Regulations

Proposition 65 is a California law that has no federal counterpart.  OEHHA has determined that the readoption of the emergency regulation does not duplicate and will not conflict with federal regulations.

VII. FISCAL IMPACT

  1. Costs to Local Agency or School District

Because Proposition 65 by its terms[9] does not apply to local agencies or school districts, OEHHA has determined the proposed readoption of the emergency regulation would not impose a mandate on local agencies or school districts, nor does it require reimbursement by the State pursuant to Part 7 (commencing with section 17500) of Division 4 of the Government Code.  OEHHA has also determined that no nondiscretionary costs or savings to local agencies or school districts will result from the proposed readoption of the emergency regulation.  Also, the proposed readoption of the emergency regulation will not create any cost or saving to any state agency, and will not create any cost or savings in federal funding to the state.

  1. Cost of Savings to State Agencies

Because Proposition 65 by its terms[10] does not apply to any state agency and this regulation is simply provides compliance assistance for businesses subject to the Act , OEHHA has initially determined that no significant savings or increased costs to any state agency will result from the proposed readoption of the emergency regulation. 

Footnotes and References

[1] The Safe Drinking Water and Toxic Enforcement Act of 1986, codified at Health and Safety Code section 25249.5 et seq., commonly referred to as “Proposition 65”.

[3] Health and Safety Code, sections 25249.10(b), 25249.10(c)

[4] In a separate rulemaking process, OEHHA adopted a Maximum Allowable Dose Level (MADL) that established a level of dermal exposure to BPA from solid surfaces that does not require a warning. This regulation will become effective October 1, 2016. The MADL is unrelated to this rulemaking package because exposures from canned and bottled foods and beverages are not dermal exposures.

[5] Health and Safety Code, section 25249.6

[7] Health and Safety Code section 25249.11(b).

[8] Health and Safety Code section 25249.11(b).

[9] Health and Safety Code section 25249.11(b).

[10] Health and Safety Code section 25249.11(b).