Notice of Proposed Rulemaking, Amendments to Article 5, New Section 25501.1, Naturally Occurring Concentrations of Listed Chemicals in Unprocessed Foods

NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to adopt a new Section 25501.1 in Article 5 in Title 27 of the California Code of Regulations.  The new section would provide guidance for businesses and the public by establishing default natural background levels for arsenic in rice.  The default background levels would in turn assist businesses in determining the applicability of the requirements of Proposition 65.^[1]  The concentration levels derived in Section 25501.1 take into account the possible contribution of anthropogenic sources in deriving the naturally occurring safe harbor values for the section.  The proposed naturally occurring concentrations for of inorganic arsenic in rice are 80 parts per billion (ppb) for white rice and 170 ppb for brown rice.  Additional levels for other listed chemicals or types of foods may be adopted over time. 

PUBLIC PROCEEDINGS

Public Hearing

A public hearing on these proposed regulatory amendments will be scheduled on request.  To request a hearing, send an e-mail to Monet Vela at monet.vela@oehha.ca.gov or to the address listed above by no later than August 23, 2017, which is 15 days before the close of the comment period.  OEHHA will mail a notice of the hearing to the requester and interested parties on the Proposition 65 mailing list for regulatory public hearings.  The notice will also be posted on the OEHHA web site at least ten days before the public hearing date.  The notice will provide the date, time, and location of the hearing.

If a hearing is scheduled and you have special accommodation or language needs, please contact Monet Vela at (916) 323-2517 or monet.vela@oehha.ca.gov at least one week in advance of the hearing.  TTY/TDD/Speech-to-Speech users may dial the California Relay Service: 1-800-735-2929 (TTY), 1-800-735-2922 (Voice) TTY which is a Telecommunications Device for the Deaf, and is reachable only from phones equipped with a TTY Device.

Written Comment Period

Any written comments concerning this proposed regulatory action, regardless of the form or method of transmission, must be received by OEHHA by 5:00 p.m. on September 7, 2017, the designated close of the written comment period.  All comments will be posted on the OEHHA website at the close of the public comment period.

The public is encouraged to submit written information via e-mail, rather than in paper form.  Send e-mail comments to P65Public.Comments@oehha.ca.gov.  Please include “Naturally Occurring – Arsenic in Rice” in the subject line.  Hard-copy comments may be mailed, faxed, or delivered in person to the appropriate address below.

Please be aware that OEHHA is subject to the California Public Records Act and other laws that require the release of certain information upon request.  If you provide comments, please be aware that your name, address and e-mail may be available to third parties.

Inquiries concerning the proposed Proposition 65 regulation described in this notice may be directed to Monet Vela at (916) 323-2517, or by e-mail to monet.vela@oehha.ca.gov.  Mario Fernandez is a back-up contact person for inquiries concerning processing of this action and is available at (916) 323-2635 or mario.fernandez@oehha.ca.gov.

AUTHORITY

Health and Safety Code section 25249.12.

REFERENCE

  Health and Safety Code sections 25249.6 and 25249.10.

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW BACKGROUND

OEHHA is the state entity responsible for the implementation of Proposition 65.  OEHHA has the authority to adopt and amend regulations to make specific and further the purposes of Proposition 65.  Proposition 65 requires businesses to provide a warning when they knowingly and intentionally cause an exposure to a listed chemical^[2], and prohibits the discharge of listed chemicals into sources of drinking water^[3].  Warnings are not required and the discharge prohibition is not in force when exposures are sufficiently low, as specified in the Act.^[4]

Existing regulations provide that naturally occurring background levels of listed chemicals in food are not considered an exposure for purposes of Proposition 65.  The regulations state that the naturally occurring level of a chemical may be established by determining the concentration of the chemical that would be considered as background in the area where the food is grown, raised or obtained, using reliable regional and local data.^[5]  However, the existing regulations lack the specificity necessary for businesses to determine the natural background level.

In proposing this regulatory action, OEHHA intends to clarify the means by which natural background levels were derived for arsenic in rice and safe harbor naturally occurring concentration levels were established.  The proposed regulation provides compliance assistance for affected businesses and provides more useful information to Californians about their exposures to listed chemicals including those that occur naturally in certain foods.

SPECIFIC BENEFITS OF THE PROPOSED REGULATIONS

The proposed regulation will benefit the health and welfare of California residents by providing more information to the public and facilitating businesses’ compliance with the Act.  Businesses will be able to rely on the adopted safe harbor natural background levels to help them determine compliance with the requirements of Proposition 65 and the public will be able to make more informed decisions concerning the food products they purchase.

NO INCONSISTENCY OR INCOMPATIBILITY WITH EXISTING REGULATIONS

OEHHA has conducted an evaluation and has determined that this is the only regulation concerning Proposition 65 naturally occurring chemicals in food.  Therefore, the proposed regulation is neither inconsistent nor incompatible with any other existing state regulations. The 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.

LOCAL MANDATE/FISCAL IMPACT

Because Proposition 65 by its terms^[6] does not apply to local agencies or school districts, OEHHA has determined the proposed regulatory action 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 regulatory action.  Also, the proposed action will not create any cost or savings to any state agency, and will not create any cost or savings in federal funding to the state.

COSTS OR SAVINGS TO STATE AGENCIES

Because Proposition 65 by its terms^[7] does not apply to any state agency and this regulation is simply a clarification of existing procedures, OEHHA has initially determined that no significant savings or increased costs to any state agency will result from the proposed regulatory action.

EFFECT ON HOUSING COSTS

OEHHA has initially determined that the proposed regulatory action will have no effect on housing costs because it does not impose any new mandatory requirements on any business.

SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE

OEHHA has made an initial determination that the adoption of the proposed regulation will not have a significant, statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states.  The proposed regulation establishes safe harbor natural background concentrations to which businesses are not required to comply with but may do so voluntarily.

RESULTS OF ECONOMIC IMPACT ANALYSIS (Gov. Code section 11346.3(b))

Creation or Elimination of Jobs within the State of California

This regulatory action will not likely have a major impact on the creation or elimination of jobs within the State of California.

Creation of New Businesses or Elimination of Existing Businesses within the State of California

This regulatory action will not likely have a major impact on the creation of new businesses or the elimination of existing businesses within the State of California.

The Expansion of Businesses Currently Doing Business within the State

OEHHA does not anticipate any major impact on the expansion of businesses currently doing business within the state because the proposed regulation will not change the requirements under the Act.  

Benefits of the Proposed Regulation

The health and welfare of California residents will likely benefit from the increased information regarding exposures to listed chemicals and the clarity provided to businesses complying with the naturally occurring chemicals in food exposure exemption of the Act. More reliable warnings will further the purposes of Proposition 65 by increasing the public’s ability to make informed decisions regarding the food products they choose to purchase and their exposures to chemicals that cause cancer or reproductive effects.  Because businesses are given the option to use the safe harbor natural background concentration levels adopted by the lead agency, a business will have more certainty and confidence that it is in compliance with the naturally occurring chemicals in food exposure exemption while retaining the right to use other evidence, assumptions, principles or procedures consistent with Section 25501 to establish that a chemical in a food is naturally occurring. 

CONSIDERATION OF ALTERNATIVES

Pursuant to Government Code section 11346.5(a)(13), OEHHA must determine that no reasonable alternative considered by OEHHA, or that has otherwise been identified and brought to the attention of OEHHA, would be more effective in carrying out the purpose for which Proposition 65 is proposed, or would be as effective and less burdensome to affected private persons than the proposed action, or would be more cost-effective to affected private persons and equally effective in implementing the statutory policy or other provision of law.

EFFECT ON SMALL BUSINESSES

OEHHA has determined that the proposed regulatory action will not affect small business as it does not impose any mandatory requirements on small businesses. Proposition 65 expressly exempts businesses with less than 10 employees^[8] from the law.

KNOWN COST IMPACTS

OEHHA has determined that there are no known cost impacts that a representative private person or business would necessarily incur in the voluntary compliance with the proposed action.

BUSINESS REPORTING REQUIREMENT

OEHHA finds that that the proposed regulation does not require any reporting requirement from businesses.

AVAILABILITY OF STATEMENT OF REASONS AND TEXT OF PROPOSED REGULATIONS

OEHHA has prepared and has available for public review an Initial Statement of Reasons for the proposed regulation, all the information upon which the regulation is based, and the text of the proposed regulation.  These documents are available on OEHHA’s web site at www.oehha.ca.gov.

AVAILABILITY OF CHANGED OR MODIFIED TEXT

The full text of any proposed regulation that is changed or modified from the express terms of this proposed action will be made available at least 15 days prior to the date on which OEHHA adopts the resulting regulation.  Notice of the comment period on the revised proposed regulation and the full text will be mailed to individuals who testified or submitted oral or written comments at the public hearing, whose comments were received by OEHHA during the public comment period and anyone who requests notification from OEHHA of the availability of such change.  Copies of the notice and the changed regulation will also be available on the OEHHA Web site at www.oehha.ca.gov.

AVAILABILITY OF THE FINAL STATEMENT OF REASONS

A copy of the Final Statement of Reasons may be obtained, when it becomes available, from Monet Vela at the e-mail or telephone number indicated above.  The Final Statement of Reasons will also be available on OEHHA’s web site at www.oehha.ca.gov.

Dated: July 21, 2017