California’s Proposition 65, technically called the “Safe Drinking Water and Toxic Enforcement Act of 1986” (but commonly referred to as “Prop 65”), has affected consumer products since soon after it became law. The electronics industry has felt its wrath since at least 2000 when numerous manufacturers were successfully sued for not providing required warnings on lead in power cords and other cables.
In 2016, the California Office of Environmental Health Hazard Assessment (OEHHA, pronounced as three distinct syllables, “ō-ē-hŏ”) passed an amendment that required the “Clear and Reasonable Warnings” defined in Article 6 to include chemical names, along with other changes.
Until then, few manufacturers other than the major consumer electronics brands really seemed to pay any attention to it. For some reason, this change resulted in significantly improved awareness, if not better understanding, of Prop 65.
What Prop 65 Requires
If a product can expose a consumer or occupational user to any of the over 900 substances on the Proposition 65 list of chemicals “known to cause cancer, birth defects or other reproductive harm,” those individuals must be warned prior to any exposure occurring.
The manufacturer is in the best position to make this determination and may have to either label the product (or its “immediate packaging”) or else provide this information downstream so that distributors and retailers can provide the warning.
Since electronics manufacturers and their supply chains are populated with electronic and mechanical engineers (as well as some physicists, materials scientists, and an occasional chemist), “exposure” is not a concept they may understand without education or in-house toxicology expertise. We understand chemical substance concentration – partly because of RoHS, to be sure – somewhat better because it is parametric and, with proper definition, objective.
However, “exposure” as related to a product sold by an electronics manufacturer is different. Specifically, Prop 65 defines it as follows:
“Consumer product exposure” means an exposure that results from a person's acquisition, purchase, storage, consumption, or any reasonably foreseeable use of a consumer product, including consumption of food.
This can be quite subjective. How a manufacturer defines “reasonably foreseeable use” for their product can vary dramatically based on how they sell it, who they sell it to and how the product is intended to be used.
Exposure to a chemical substance from an article is generally assumed – incorrectly – to be zero. But toxicologists can demonstrate readily that we are always exposed to chemical substances by handling certain articles, being near them or simply inhaling near them.
And exposure limits in micrograms per day – beyond which level a label is required – are defined for some of the substances on the Prop 65 list:
- No Significant Risk Level (NSRL) for cancer-causing chemicals
- Maximum Allowable Dose Level (MADL) for chemicals that cause reproductive and/or developmental harm
For instance, lead (Pb) is both a carcinogen and a reprotoxin; OEHHA has defined the “safe harbor” limits for lead at an NSRL of 15 micrograms/day and MADL of 0.5 microgram per day.
The amount a user is exposed to is most often related the concentration of the substances at the surface of a product that may be accessible to a user; how, and how long or often, the user is exposed to that surface in the course of a day; and how readily the substance is released from that surface. Assessing these details usually requires product testing defined by and run under the supervision of a knowledgeable toxicologist.
If the level is exceeded, a warning is required. Many chemicals have no levels defined; any exposure at all to those requires a warning (unless the manufacturer develops a study that demonstrates a lack of harm).
What Manufacturers Must Know
Initially, manufacturers must know which Prop 65 chemical substances are being made available to users of their products, whether those users are occupational users (e.g., assemblers) or consumers, or both. Knowing the concentration is interesting, but not necessarily material to making a decision to label.
The next step is to decide whether to engage a toxicologist to determine whether labeling is required or not. That is beyond the scope of this short column. Let’s focus on the conversation between the manufacturer and the supplier. I constantly see issues in this discussion.
What Manufacturers Must Ask For
Asking suppliers for full material disclosure (FMD) and whether their products comply with RoHS and REACH substance limits (and whether any exemptions are used for RoHS) is a good baseline for manufacturers who do not have their own Restricted and Declarable Substance List (otherwise ask for whether the product the supplier is providing complies with that…and FMD). On the other hand, I often see manufacturers ask the wrong question – “does your product comply with RoHS and REACH and Prop 65?” – or a supplier knee-jerk response answers the wrong question.
Focusing on Prop 65 (I addressed other regulations in a separate four-part series), customers of parts, materials, and mixtures (such as plastic resins, solders, adhesives, paints, and lubricants) must not ask suppliers if their product complies with Prop 65; they should ask only whether the product contains Prop 65 substances and, if so, which ones and how much.
While suppliers should be able to provide that information, as noted above, determining compliance is the responsibility of the manufacturer of the finished good. Only they have the understanding of their business and their market that is required to determine whether there may be exposure that requires a warning.
Manufacturers furthermore should only bother asking this of suppliers of parts and materials that their customers can come into contact with under “reasonably foreseeable circumstances.” Do not ask every semiconductor, connector, resistor, and capacitor manufacturer about Prop 65 unless your customer can touch, inhale or swallow them…under “reasonably foreseeable circumstances.”
What Suppliers Should Do – and Avoid Doing
Suppliers often provide Prop 65 statements for their products. This is not a good idea, unless the supplier has a solid understanding of how their customers are incorporating the product into their products and how the customer’s occupational or end-user customer is using and handling it in finished goods. That’s rarely the case.
Supplier Don’ts:
- Don’t be coy. I have seen declarations that say a product contains a chemical that is “at or below” Prop 65’s safe harbor levels. Suppliers cannot be sure how their product is used and under what conditions.
- Don’t say, “We don’t care because we manufacture it outside California.” If it can be sold into or used in California (where we can sell and use just about anything anyone can produce) the customer (who is asking for the information) needs it.
- Don’t disclose the presence of Prop 65 substances in a product without stating where those substances are on it. This is about exposure: unless a user of the product can be exposed to it under “reasonably foreseeable circumstances,” do not bother disclosing internal substances for the purpose of meeting a Prop 65 disclosure request.
- Don’t make assumptions about your customers’ use cases.
- The Prop 65 chemical list contains over 900 substances. Don’t make a statement about BPA and phthalates not being used on external surfaces without also addressing all the others. While a high percentage of the 900-plus Prop 65 substances are not even remotely likely to be present, a good number of substances that the electronics industry needs to be concerned about – and has been subjected to lawsuits about – very well could be.
Supplier Do’s:
- Provide detailed full material disclosures. This helps customers better than anything else, especially if they ask for it.
- Provide a Prop 65 “Certificates of Compliance,” if desired; this should only state one of two things:
- The product contains no Prop 65 substances on accessible surfaces; or
- The product contains specific Prop 65 substances on accessible surfaces: identify the substances, the specific accessible surfaces (if applicable – mixtures/chemical substances do not have “accessible surfaces”) and the concentration or concentration range. An SDS is adequate to provide this information for mixtures/chemical substances.
- If a customer asks if the product complies with Prop 65, tell them that’s probably their determination to make. However, suppliers may be asked for additional information in the course of that assessment.
The obligation to understand and ensure their products comply with Prop 65 requirements lies with the product manufacturer and their downstream supply chain, through distributors and retailers. The upstream supplier’s obligation is to provide information about the presence of chemical substances on the surface of their products to their customers.
Another U.S. State: Safer Products for Washington
Real quick, check out the draft report on priority consumer products that the Washington State Department of Ecology published recently. There’s a section on priority products and priority chemicals in electrical and electronic equipment that may be applicable.
If your product uses a flame-retardant plastic enclosure, this could be important. A public comment period is open through March 2. In addition, here’s the link to the department’s email list to keep updated on developments.
Visit DCA at www.DesignChainAssociates.com or email the author with any questions or comments on this post.
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