OEHHA Issues Final Regulations Related To Its Prop 65 Website
On January 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) announced the adoption of final regulations (Regulations) related to the development and maintenance of a website to “provide information to the public regarding exposures to listed chemicals for which warnings are being provided” under Proposition 65 (Prop 65). Final Statement of Reasons (FSOR) at 11. OEHHA states that its intent with these Regulations is to “increase the availability of consistent, understandable information to the public regarding warnings provided for potential exposures to listed chemicals” by establishing a “one-stop shop for supplemental information concerning the warnings Californians see on products and at locations throughout the state.” Initial Statement of Reasons (ISOR) at 2. More information about the Regulations is available on our website.
The Regulations, which become effective on April 1, 2016, will establish a new Prop 65 website including information compiled and reviewed by OEHHA scientific and legal staff, with the option for OEHHA to require information from companies subject to Prop 65 warning requirements. If OEHHA’s November 27, 2015, proposed regulations revising its existing warning regulations are issued in final as is, they would require companies to include the uniform resource locator (URL) of OEHHA’s website on Prop 65 warnings which will create much more traffic to this Prop 65 website. Anyone doing business in California and impacted by Prop 65 should be familiar with these final Regulations, as companies may be required to submit information or, at a minimum, review information posted by OEHHA for accuracy.
OEHHA released on March 7, 2014, a pre-regulatory proposal that included proposed provisions regarding its website and provisions revising existing warning regulations. OEHHA separated the regulation regarding the website from the other elements of the proposal in response to comments and concerns that combining the proposals could imply that the website regulations were enforceable by private plaintiffs. In fact, in addition to separating the website regulations from the other proposed Prop 65 regulations, OEHHA added a provision (what is now Section 25205(g)) to reinforce the point that failure to comply with the requirements of these Regulations is not a violation of the “clear and reasonable” warning requirements under Prop 65.
OEHHA sought comments on its proposed Prop 65 website regulations on January 16, 2015. After receiving comments, on May 22, 2015, OEHHA released for comment modified regulations on September 4, 2015. OEHHA states that it did not modify the regulatory text further in response to the last round of comments received and has included its response to those comments in its FSOR.
The crux of the Regulations, as stated above, is the development of a website to “provide information to the public regarding exposures to listed chemicals for which warnings are being provided” under Prop 65. Section 25205(a) sets forth the following components of the website:
- Information concerning exposures to listed chemicals, including common routes or pathways of exposure such as:
- Ingesting foods;
- Contact with or use of products or services;
- Common environmental scenarios; and
- Occupational activities;
- Ingesting foods;
- Strategies for reducing or avoiding exposure to those chemicals;
- Links, as appropriate, to information compiled by other authoritative entities; and
- “Reasonably available” information concerning human exposure to listed chemicals.
Regarding the information to be included in the website, OEHHA states that it “plans to provide the information in a way that does not generally focus on particular brands or products,” and the website will “primarily focus on categories of products and types of locations where exposures to listed chemicals can occur.” FSOR at 10.
Section 25205(a)(5) states that OEHHA will provide a process for stakeholders to request corrections to information provided on the website. Under this process, the “person making such a request shall provide information showing that such material is inaccurate.” Other than this, the Regulations provide no additional details regarding this process.
Section 25205(a)(6) states that OEHHA will provide a disclaimer on the website “indicating that OEHHA cannot assure the accuracy of information it has received from third parties.” OEHHA also states that the “website will clearly reflect that it is owned and managed by OEHHA and will contain information compiled by OEHHA technical staff in much the same way as OEHHA’s existing website.” FSOR at 7.
OEHHA states that it anticipates that most information provided on the website will be obtained from authoritative agencies, and will be compiled and reviewed by OEHHA scientific and legal staff. FSOR at 13-14. OEHHA notes, however, that “in some situations it may not be possible for OEHHA to locate information about a particular exposure from public sources.” FSOR at 14. The Regulations thus provide a procedure under which it can obtain information it needs from third parties.
Specifically, under Section 25205(b), a manufacturer, producer, distributor, or importer of a product, including food, or a particular business that is providing a Prop 65 warning must provide the following information within 90 days of OEHHA’s request:
- The name and contact information for the person providing the information.
- The name and contact information for the manufacturer of the product.
- The name of the listed chemical or chemicals for which a warning is being provided.
- For environmental warnings, the source of the chemical or chemicals and the area for which the warning is being provided. Regarding the “source” of the chemical, OEHHA states: “when considering a warning that is being provided at a particular location (such as an industrial facility or site), OEHHA could request information about the ‘source’ of the exposure for which the warning is being given if it is not clear.” FSOR at 56.
- For product warnings, the location of the chemical or chemicals in the product. An example provided by OEHHA for when this information may be required is “if a warning for lead is being provided on a garden hose, a consumer may want to know whether the listed chemical is in the brass fitting or in the plastic hose.” FSOR at 18.
- For product warnings, the concentration (mean, minimum, maximum) of the chemical or chemicals in the final product. If the product contains multiple component parts, the business must provide the concentrations (mean, minimum, maximum) of the chemical or chemicals in each of the component parts. As an example, OEHHA states it may seek information regarding the individual components rather than the total final product. Specifically, OEHHA states: “For example, if there is lead in the hose, OEHHA may inquire as to the concentration of lead in the hose itself as compared to the nozzle.” FSOR at 18.
- For product warnings, the matrix, as defined in subsection 25900(g) of this chapter, in which the listed chemical or chemicals is found in the product and the concentration of the listed chemical(s) in the product matrix, if known. An example provided by OEHHA is “carpet tile with listed chemicals only in the secondary backing layer,” in which case OEHHA may request information regarding the concentration in the matrix or in the secondary backing layer. FSOR at 18.
- The anticipated routes and pathways of exposure to the listed chemical(s) for which the warning is being provided. Regarding this information, OEHHA states: “The entity receiving a request to provide information is providing a warning under [Prop 65] because they expect or predict an exposure to a listed chemical. The term ‘anticipated’ thus refers to that of the party providing requested information under subsection (b), i.e., the manufacturer, producer, distributor, importer, or particular business.” FSOR at 23.
- The estimated level of exposure to the chemical or chemicals. Regarding this element, OEHHA states that it “disagrees with the characterization of the phrase ‘estimated level of exposure’ as ambiguous since it is a necessary part of the determination of whether a warning is required at all.” FSOR at 49.
- Any other related information concerning exposures to listed chemicals for which warnings are being provided pursuant to Section 25249.6 of [Prop 65].
Even though the Regulations specify a timeframe of 90 days, they also state that the information must be provided “when reasonably available.” Although this term is not defined in the Regulations, its scope is clarified in Section 25205(c) by stating that a business is not required to perform any new or additional testing or analysis for the purpose of responding to a request from the lead agency. Further, the amended text expressly provides that if the requested information is not in the possession or control of a business, the business is not required to procure it for the purpose of providing the information to the lead agency. These important provisions provide much needed guidance to define the scope of information that businesses must provide. OEHHA notes that since “information that is not in the possession or control of the business is not required to be procured for the purpose of providing it to OEHHA,” then “there is no need to specifically identify downstream formulators and upstream suppliers in the proposed regulatory language.” FSOR at 55.
Section 25205(d) clarifies that if OEHHA requests information from two or more businesses regarding the same product or exposure, those businesses may respond to the request through their trade organization. This provision was added in response to comments seeking clarification that trade associations are among the list of entities able to submit data and information requested by OEHHA. FSOR at 35, 48.
Section 25205(e) sets forth the process under which companies can identify information required to be submitted under Section 25205(b) as trade secret. Under this process, all information submitted to OEHHA shall be open for public inspection, except for such material clearly identified as trade secret. If a business believes that certain information required to be submitted should not be available for public inspection because it is trade secret as defined in Civil Code Section 3426.1, and that is exempt from disclosure under the Public Records Act (Government Code Section 6250, et seq.), Evidence Code Section 1040, or Evidence Code Section 1060, “the response shall specifically identify the information and the basis for the claim that the information should be designated a trade secret.”
If OEHHA believes that any information identified as trade secret is not entitled to such protection, it must notify the business that claimed trade secret status in writing at least thirty (30) days prior to releasing such information. Section 25205(e) states: “During this 30-day period the business will have an opportunity to submit additional justification for the claim or contest the determination in an appropriate legal proceeding.” There is no guidance as to what an “appropriate legal proceeding” will entail, however.
In addition, Section 25205(f) provides that information is not required to be submitted if it is exempt from disclosure under the legal privileges described in Evidence Code Section 954 or California Code of Civil Procedure Section 2018.030 (e.g., attorney-client or attorney work product).
The Regulations have been through several iterations, and OEHHA has improved the content since its first proposal, including but not limited to eliminating the requirement that certain information be provided under Section 25205(b) (e.g., information concerning the “anticipated level of” human exposure, and other related information that OEHHA “deems necessary”). This provides a process for a person to request a correction of potentially inaccurate information, clarifying that information should be provided only when “reasonably available,” allowing stakeholders to request that information submitted to OEHHA be treated as trade secret. It also extends the time when OEHHA must notify businesses if it intends to disclose information identified as trade secret, allowing such businesses to submit additional justifications for their claims, from 15 to 30 days.
There nevertheless remain concerns with these Regulations.
While OEHHA now provides an opportunity under Section 25205(a)(5) for persons to request corrections to materials posted on the website, OEHHA rejected requests that it offer the opportunity to review information and request corrections before the information is posted. OEHHA states that “the routine submittal of information to stakeholders for review prior to posting will discourage public acceptance of the website as a credible, unbiased source of information.” FSOR at 6. OEHHA provides no explanation regarding how promptly corrections (or any updates) will be made, instead noting that “[f]requency of updating and timeframes for adding information are aspects of internal management, based on the availability of resources and are therefore not addressed in this rulemaking.” FSOR at 41. The result could be that materially inaccurate information on a substance remains on OEHHA’s website for an inappropriate length of time, which would not be “consistent with [OEHHA’s] mission to protect public health and the environment.” FSOR at 6, 33.
The requirement to provide information under Section 25205(b) with the need to protect trade secret information also raises issues. OEHHA notes, for example, that it may request information from businesses if it not “clear from a Proposition 65 warning where a listed chemical is located in a product with multiple components, and how individuals could be exposed to the chemical.” FSOR at 14. Information regarding a product’s composition may be exactly the type of information businesses believe to be trade secret, however. OEHHA also provides little guidance for how companies can object to an OEHHA decision to disclose information claimed as CBI other than stating companies should submit “additional justification” or seek judicial review.
In Section 25205(g), OEHHA clarifies that providing the information requested under Section 25205(b) “shall not be deemed to constitute compliance with the requirement to provide a ‘clear and reasonable’ warning pursuant to Section 25249.6 of [Prop 65], nor shall failure to comply with this section constitute a violation of Section 25249.6 of [Prop 65].” While this provision was intended to allay concerns about increased lawsuits alleging failures to warn, only time will tell whether the website will be used to compare information and target products in new litigation.
Once the Regulations are effective and the website is active, companies are encouraged to monitor information provided and request corrections to the extent information is believed to be inaccurate. OEHHA plans to create a “listserv” where companies can add their names to be notified by OEHHA when changes are made to its website.