Proposition 65: OEHHA Proposes Revisions to Proposition 65 Warning Regulations
On The month of january 12, 2015, work of Ecological Health Risk Assessment (OEHHA) suggested important new rules that will repeal and switch the existing Article 6 rules concerning the all-important “obvious and reasonable warnings” needs under Proposition 65 (Suggested Rule). OEHHA formerly launched a Pre-Regulating Proposal for any potential draft regulation amending Proposition 65 (Prop 65) rules with a few sweeping and questionable suggested changes, including, for instance, more in depth needs for that content of needed warnings. OEHHA concurrently suggested a guide to determine the framework for any website run by OEHHA that will provide supplemental information towards the public about potential exposures to Prop 65 listed chemicals (Website Suggested Rule).
A memorandum discussing OEHHA’s March 7, 2014, Pre-Regulatory Proposal is available online. The text of the Proposed Rule and the Initial Statement of Reasons regarding Prop 65 warnings are available on OEHHA’s website. The text of the Website Proposed Rule and the Initial Statement of Reasons for the Prop 65 website (Website Initial Statement of Reasons) are available on OEHHA’s website. Public hearings on both Proposed Rules will be held in Sacramento, California, on March 25, 2015. Comments on both Proposed Rules are due by April 8, 2015.
Below we discuss OEHHA’s Proposed Rule and the proposed changes to the warnings, including the ways in which the Proposed Rule differs from existing regulations and the Pre-Regulatory Proposal.
Importantly, OEHHA proposes a 2-year postponed effective date to permit companies time for you to adhere to new needs. OEHHA notes it desires to provide companies having a transition period to “sell through” items using the old warning language in addition to provide the required time for businesses to find out compliance using the new rules.
OEHHA is also suggesting to permit an “interested party” to request OEHHA to consider additional rules that address exposures to listed chemicals in items or even the atmosphere towards the extent they aren’t already sufficiently taught in rules. Section 25600(c). OEHHA states this provision is supposed to “encourage companies to carry on to utilize OEHHA to build up a tailored warning method or message in which the existing regulating provisions aren’t sufficient to deal with a specific exposure scenario.” Initial Statement of Reasons at 5. This request perhaps also enables any entity to critique the sufficiency associated with a warning requirement, a troubling possibility thinking about the extra needs and particulars already being suggested as talked about below.
The Proposed Rule will re-adopt many of the definitions currently in the regulations, with the following exceptions:
- New Definitions for “Food,” “Knowingly,” and “Retailer.” OEHHA is proposing new definitions for “Food,” “Knowingly,” and “Retailer,” which it states is for the purpose of clarity and consistency with other provisions of the law. “Food,” for example, references existing statutory definitions for “food” and “dietary supplements.”
- Modified Definitions for “Consumer Product Exposure,” “Environmental Exposure,” “Label,” “Labeling,” and “Sign.” OEHHA is proposing to change “Consumer Product Exposure” to “Product Exposures” “to clarify that a warning for an exposure to a listed chemical from any product, or component of a product, whether it is sold directly to a consumer or not, may be provided using the methods and content described in the regulation.” Initial Statement of Reasons at 8. The definitions for “Label” and “Labeling” are updated to reference electronic use technology as a means to communicate required warnings.
Proposed Rule Section 25600.1.
Responsibility to Provide Product Warnings
The Suggested Rule’s Section 25600.2 is totally new (i.e., away from the existing rules) and sets forth the conditions to which the maker, producer, packager, importer, or distributor has primary responsibility for supplying the warning, and also the more limited conditions once the store accounts for supplying the warning. OEHHA states it’s suggesting this as a result of demands for additional clearness concerning the relative duties between producers and retailers to supply warnings.
- Proposed Section 25600.2 is intended to clarify that the primary responsibility for providing warnings for consumer products, including foods, is with the manufacturer, importer, distributor, producer, or packager of those products. In these cases, the retailer is responsible for placing and maintaining any warning materials it receives from the manufacturer, importer, distributor, producer, or packager.
- The retailer has responsibility to provide warnings only where the retail seller itself is responsible for introducing a listed chemical into the product, for example, when the retailer is selling the product under its own brand name, or when it has “actual knowledge” of the potential product exposure requiring the warning, and there is no product manufacturer, producer, packager, importer, or distributor of the product that is subject to Prop 65 warning requirements. For example, when a retailer would be responsible is when a product requiring a warning is produced and packaged by a foreign company with no agent for service of process in the United States, and it is distributed by an importer with fewer than ten employees. Initial Statement of Reasons at 11-12. “Actual knowledge” is defined as “specific knowledge of the product exposure that the retailer receives from any reliable source.” Section 25600.2(d)(5)(C).
Warnings Covered by Existing Court-Approved Settlements
In the Pre-Regulating Proposal, OEHHA suggested a piece that will recognize warnings included in existing court-approved pay outs. Particularly, OEHHA considered supplying that any new needs wouldn’t affect parties to pay outs which have been approved with a court just before The month of january 1, 2015. This provision isn’t incorporated within the existing rules or even the Suggested Rule. OEHHA’s reason behind getting rid of it’s the following:
The pre-regulatory draft of these regulations released by OEHHA for comment in April 2014 contained a provision stating that the new requirements in the regulations would not apply to the parties to settlements that have been approved by a court prior to January 1, 2015. This “grandfathering” provision is not, however, incorporated in this formal regulatory proposal.
The Agency agreed with comments from stakeholders questioning the need for a grandfathering provision in light of the non-mandatory, safe harbor approach in the proposed regulation and the fact that businesses who are parties to a settlement or judgment must comply with the provisions of the court’s order, regardless of whether this regulation states that fact. Further, under proposed Section 25600(c), a non-party has the option of petitioning the Agency to adopt warning content or methods specific to a product, chemical or type of exposure pursuant to Government Code Section 11340.6 et seq., including warning methods or content contained in a court settlement.
Initial Statement of Reasons at 13.
Safe Harbor Warnings — Methods and Content
Suggested Section 25601 claims that an alert is recognized as “obvious and reasonable” if this matches all relevant needs want to know ,. This is comparable to the present rules and also the Pre-Regulating Proposal, even though the current rules condition further that the obvious and reasonable warning be “reasonably calculated” to help make the warning available and “clearly communicate” the warning.
Chemical Name Disclosures in Warnings
The present Prop 65 rules don’t contain any provisions concerning the specific disclosure of chemical compounds within the text from the warning. OEHHA’s Pre-Regulating Proposal talked about the disclosure of 12 chemicals within the warning, and also the Suggested Rule also proposes 12 chemicals to become named particularly in warnings to create such warnings “more informative and significant towards the public,” even though the substances won’t be the same because the 12 initially suggested. Initial Statement of Reasons at 15. The Suggested Rule adds three substances — deadly carbon monoxide, hexavalent chromium, and methylene chloride — while shedding 1,4-dioxane, cigarettes, and toluene. The entire listing of the substances within the Suggested Rule is really as follows:
- Carbon Monoxide;
- Chlorinated Tris;
- Hexavalent Chromium;
- Methylene Chloride; and
As a result of comments questioning OEHHA’s listing of substances, OEHHA provides the next criteria that previously select chemicals:
- Widespread prevalence of the listed chemical in products and/or locations beyond those that are covered by specific warning language in Section 25608;
- Potential for significant exposure to the listed chemical through human interactions with products, including food, or at locations frequented by the public;
- Recent Prop 65 enforcement activity;
- Recognizability of the chemical name among the general public; and
- The general availability of additional authoritative information and resources for the public on the toxicity and exposure to the chemical, doses of concern, and ways to prevent or reduce exposure.
Initial Statement of Reasons at 14. In the Initial Statement of Reasons, OEHHA also sets forth, for every listed chemical, more specific specifics of how these chemicals met the factors for inclusion within this Section. As with the Pre-Regulating Proposal, OEHHA claims that the “chemical names needed to become incorporated inside a warning under this isn’t intended as thorough and could be altered with time because the public gets to be more acquainted with the enhanced warning format.” Initial Statement of Reasons at 22. OEHHA notes the very first time that it’ll not, however, add or remove a compound out of this list without dealing with a proper regulating process (together with a public notice, hearing, and chance for comment). Id.
Product Exposure Warnings — Methods of Transmission
Prop 65 rules presently provide several techniques of transmission for warning messages, including signs, notices, stickers, or labels. The Pre-Regulating Proposal and Suggested Rule expand their email list of acceptable techniques for supplying an alert to have an contact with a listed chemical from the product to include warnings via electronic means. The particular listed techniques of transmission are:
- A product-specific warning provided on a shelf tag or on a shelf sign for the product at each point of display of the product. The entire warning message must be in a font no smaller than the largest type size used for other information on the shelf tag or shelf signs for the same or similar products.
- A product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the product, without requiring the purchaser to seek out the warning.
- A label on the product that includes all the elements specified in Section 25604.
Section 25603(a). For Internet purchases, OEHHA specifies that “the warning message should be supplied by a clearly marked hyperlink around the product display page, or else conspicuously displayed towards the customer prior to the customer completes their acquisition of the merchandise.Inch Section 25603(b). This really is more specific compared to Pre-Regulating Proposal, which claims that Internet purchases need “warnings provided on the web before the time the customer completes its acquisition of the merchandise.Inch For catalog purchases, OEHHA claims that “the warning message should be provided within the catalog in a fashion that clearly associates it using the item being bought.” Section 25603(c). This is actually the same language which was suggested within the Pre-Regulating Proposal.
Product Exposure Warnings — Content
Probably the most significant suggested revisions within the Suggested Rule address the required elements needed for any warning that need considering “obvious and reasonable.” Listed here are the minimum needed core elements for warnings this proposal would establish:
- Warning Symbol: Proposed Rule Section 25604(a)(1) requires the inclusion of a warning symbol, consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline:
OEHHA had previously proposed to use a Globally Harmonized System (GHS) pictogram, but changed the symbol in response to comments that the GHS pictogram would not be recognized and could result in confusion and unnecessary alarm.
OEHHA clarifies in Section 25604(a)(1) that when “other signage or labeling for the product is not provided in color, the symbol may be printed in black and white.” Further, the symbol must be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING.” OEHHA states that using a “graphic symbol that is familiar to consumers on both a domestic and international level is likely to enhance the effectiveness of the warnings, particularly for non-English speaking or low literacy populations.” Initial Statement of Reasons at 26.
- “WARNING” Signal Word: As in the Pre-Regulatory Proposal, the Proposed Rule would require that the signal word “WARNING” appear in all capital letters and bold print. Section 25604(a)(2). While “warning” is already required in the current Prop 65 regulations, OEHHA states the capital letters and bold print requirements “ensures that consumers will immediately know the information being provided is important and not just informational in nature.” Initial Statement of Reasons at 26.
- “Expose”: One of the most noteworthy changes in the warning requirements is the change of text from “This product contains a chemical known to the State of California to cause [cancer or birth defects or other reproductive harm]” to “This product can expose you to a chemical known to the State of California to cause [cancer or birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov/product.” Sections 25604(a)(2)(A)-(B) (emphasis added). OEHHA’s reasoning for this proposal is the same as it was in its Pre-Regulatory Proposal: “Since the existing regulations were adopted over 25 years ago, it has become clear that using the word ‘contains’ does not communicate the fact that individuals will actually be exposed to a chemical if they use a given consumer product.” Initial Statement of Reasons at 26. OEHHA was not persuaded by comments that the word “expose” could cause unnecessary alarm or allege an exposure that may not actually occur. Instead, OEHHA stated: “Requiring that the warnings include more specific, relevant information will further the right-to-know purposes of the law and reduce the likelihood that businesses will provide unnecessary warnings for non-existent or insignificant exposures.” Initial Statement of Reasons at 27. One improvement OEHHA made in response to comments is to modify the proposed language from “will expose” to “can expose” in recognition of concerns raised in comments that any individual sample may or may not actually expose a consumer. OEHHA also is now including a reference to its new website to assist consumers in more easily accessing the website.
- On-Product Labels: Businesses may use a more truncated warning on product labels, using the same symbol, “WARNING,” and website reference noted above, but with only the words “Cancer,” “Reproductive Harm,” or “Cancer and Reproductive Harm,” depending on the reason the chemical(s) requires a warning. Such truncated warnings, which need not identify any specific chemicals, would be subject to specific font size requirements (i.e., no smaller than 8-point type). OEHHA states it is proposing this option “to accommodate some product manufacturers’ stated concern that a longer warning message will simply not fit on the labeling or packaging of some small products.” Initial Statement of Reasons at 27.
Environmental Exposure Warnings — Methods of Transmission and Content
Within the Suggested Rule, OEHHA generally maintains exactly the same needs for that techniques of transmission for ecological exposure warnings, even though it updates individuals needs to “remove obsolete citations and also to reflect alterations in communication technology which have happened because the original regulation was utilized, while realizing that some people may not need current technology.” Initial Statement of Reasons at 28. For instance, rather than the present approach to warning inside a “notice mailed or else shipped to every occupant within the affected regionInch at least one time in almost any three-month period, the Suggested Rule now claims that a suitable technique is an alert provided inside a “notice mailed, or sent digitally or else shipped to every occupant within the affected region . . . a minimum of every three several weeks, in British as well as in every other language ordinarily utilized by the company to talk with the general public.Inch Section 25605(a)(2).
OEHHA is suggesting exactly the same changes towards the content of ecological exposure warnings to individuals suggested for product exposure warnings (e.g., symbol, “WARNING,” “can expose,” OEHHA website reference).
Occupational Exposure Warnings
Current Prop 65 rules established the techniques of transmission and content for work-related warnings. The Pre-Regulating Proposal and Suggested Rule don’t established any particular needs regarding techniques of transmission or content. Rather, the Suggested Rule states:
A warning to an exposed employee about the chemical in question which fully complies with all information, training and labeling requirements of the federal Hazard Communication Standard (29 Code of Federal Regulations, section 1910.1200), the California Hazard Communication Standard (Title 8, California Code of Regulations section 5194), or, for pesticides, the Pesticides and Worker Safety requirements (Title 3, California Code of Regulations section 6700 et seq.) meets the requirements of this Article.
Section 25607. OEHHA describes that it is proposal reacts to concerns elevated by stakeholders over the potential of federal preemption of Prop 65 warning needs for work-related exposures, which by integrating by reference existing federal and condition law and regulating needs associated with work-related exposure warnings, OEHHA expects to harmonize the Suggested Rule with existing laws and regulations and rules and “pose no preemption concern.” Initial Statement of Reasons at 28-29.
Specific Product, Chemical, and Area Exposure Warnings
Suggested Sections 25608 through 25608.27 provide tailored techniques for transmission of warnings and warning language for several situations that “would take advantage of exposure-specific techniques of transmission and content to be able to provide certainty to companies susceptible to the warning needs from the Act, while making certain the public is correctly cautioned concerning the exposures that may occur with these items of facilities.” Initial Statement of Reasons at 29. Additional specific warning needs are supplied for an additional items, chemicals, and area exposures:
- Food (including dietary supplements);
- Alcoholic beverages;
- Prescription drugs;
- Dental care;
- Raw wood;
- Diesel engines;
- Passenger vehicles;
- Parking garages;
- Amusement parks;
- Petroleum products;
- Service stations; and
- Designated smoking areas.
New OEHHA Website
Initially a part of OEHHA’s Pre-Regulating Proposal regarding revisions towards the warning rules, OEHHA suggested its rule associated with a suggested Prop 65 website like a separate but concurrent rulemaking (Website Suggested Rule). Underneath the proposal, OEHHA expects to “boost the accessibility to consistent, understandable information towards the public regarding warnings deliver to potential exposures to listed chemicals” by creating a “one-stop look for supplemental information in regards to the warnings Californians see on items and also at locations through the condition.” Website Initial Statement of Reasons at 2.
OEHHA’s decision to split up the warning and website rulemakings was as a result of comments and concerns that mixing the plans could imply the web site rules were enforceable by private plaintiffs. OEHHA also offers clarified that it is website is supposed to provide information towards the public that supplements the warning needs and isn’t an alternative to a obvious and reasonable warning for any given exposure. Section 25205(d).
The data for that website is going to be “acquired mainly from public sources or perhaps be produced by OEHHA, and from time to time from industry industries or companies supplying warnings.” Website Initial Statement of Reasons at 4. If asked for, the data to become presented to OEHHA is:
- 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 location of the chemical or chemicals in the area.
- For product warnings, the location of the chemical or chemicals in the product.
- 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.
- For product warnings, the matrix, as defined in subsection 25900(g), 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.
- The anticipated routes and pathways of exposure to the listed chemical(s) for which the warning is being provided.
- The estimated level of exposure to the chemical or chemicals.
- Any other related information that the lead agency deems necessary.
Section 25205(b). These details to become provided doesn’t start adding some information asked for within the Pre-Regulating Proposal which was potentially problematic, including although not restricted to the kind of work-related contact with a listed chemical the warning is supposed to cover, or no, and knowledge concerning actions an individual can decide to try minimize or eliminate contact with the listed chemical, or no. Other changes towards the Website Suggested Rule that OEHHA has incorporated as a result of comments received include supplying a procedure for an individual to request a correction of potentially any mistakes, clarifying that information ought to be provided only if “reasonably available,” and permitting stakeholders to ask that information posted to OEHHA be treated as Private Business Information (CBI) and for that reason ‘t be readily available for public inspection under provisions from the Public Record Information Act and Evidence Code.
The Suggested Rule includes changes as a result of comments around the Pre-Regulating Proposal that enhance the suggested rules, such as the alternation in warning language from “will expose” to “can expose,” separating the OEHHA website proposal in the warning needs to ensure that companies supplying information for that website aren’t susceptible to Prop 65 fugitive hunter lawsuits, and clarifying the work-related exposure warning needs to assist ensure there aren’t any preemption concerns.
The proposal still includes game-altering additional warning needs that still inspire debate for businesses which manufactures, distribute, or sell consumer items with Prop 65 warnings, specially the complexity from the different warning needs, ale plaintiffs to petition OEHHA to demand additional warnings for substances in items or even the atmosphere, and also the needs to supply information for OEHHA’s website. These suggested rules address only warning needs and don’t address lawsuit reform issues for example “possibilities for stopping.Inch Efforts to limit private enforcement and prevent frivolous and shakedown lawsuits must be went after beyond individuals already passed with AB 227.
Companies should review carefully the proposal and how the significant changes to the warning requirements will affect its cost and compliance capabilities. Comments should be submitted by April 8, 2015.