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Jennifer Grebow is editor-in-chief of Nutritional Outlook.
“It does not in any manner look to me like consumers will be better informed or that lawsuits will reduce."
Recently proposed changes to California’s Proposition 65 regulations met heavy criticism at an April meeting held by California’s Office of Environmental Health Hazard Assessment (OEHHA), which oversees Prop 65. At the “pre-regulatory workshop,” held April 14 in Sacramento to answer public questions, critics argued that the newly suggested mandates would hurt businesses and fail to help the consumer.
Prop 65 requires that companies must warn consumers if a product sold in California may contain any of the more than 850 Prop 65–listed chemicals “known to cause cancer, birth defects, or reproductive harm.” Current regulations call for a general, “safe harbor” warning: “This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.” However, under some of OEHHA’s newly proposed changes, companies would now need to, 1) list specific hazardous chemicals on warning labels, and 2) submit more specific information to OHHEA through a publicly viewable website, such as information on “the anticipated route, routes, and pathways of exposure to the listed chemical” and “reasonably available information concerning the anticipated level of human exposure to the listed chemical(s), if known.” Read more on the specifics.
The changes stem from California Governor Jerry Brown’s stated goal to make Prop 65 warnings more meaningful for the consumer. OEHHA suggests that the changes will help the consumer in several ways: 1) by providing more information about the potential harm a product may pose, both in warning statements and on the website, and 2) By cutting down on the amount of “over-warning” currently occurring. Many companies today adopt Prop 65 warnings as safeguards against the flood of Prop 65 bounty hunter lawsuits that exist today, even if their products may not contain the prohibited chemicals or at levels that would subject them to the law.
Nutritional Outlook spoke to several industry experts who argue just the opposite-that Prop 65 will help neither businesses nor consumers. Below is our Q&A with Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD); Justin Prochnow, attorney and shareholder for law firm Greenberg Traurig LLP (Denver, CO); and Anthony Cortez, an associate in Greenberg Traurig’s Sacramento office.
Would the proposed changes make Prop 65 warnings more meaningful and benefit the consumer?
McGuffin: The idea that consumers are today already inundated with these warnings that have come to mean nothing, and tomorrow there’s going to be some more words on the warning and all of a sudden they’re going to mean something-I think [OEHHA] skipped the focus group. What makes them think that people in the state of California are going to react more [to a Prop 65 warning] just because, instead of the product saying, ‘Warning! This product contains a chemical known to the state of California to cause birth defects…,’ it’s now going to say, ‘Warning! This product contains acrylamide, known to the state of California to cause birth defects’? So, everyone’s going to go, ‘Oh, yeah! I knew that about acrylamide. Gosh!’? No, they’re not. It’s not going to mean anything to consumers. It will mean something to chemists and scientists, but, again, I just think it’s regulation for the sake of regulation. It does not in any manner look to me like consumers will be better informed or that [number of] lawsuits will reduce.
Cortez: It’s important to understand where this is all coming from. Last year, Governor Brown issued his proclamation of Prop 65 reform, and it was based on two fundamental goals: first, to shake down the bounty hunter lawsuits, and secondly, to make the warning program more useful, functionality-wise. [N]obody pays attention to these [Prop 65] warnings. As a matter of fact, they’ve become sort of a national laughingstock. The Wall Street Journal recently published an article about how meaningless these warnings are because they don’t really tell you anything useful and because they’re everywhere and everyone just puts them up to avoid lawsuits, whether or not there’s even a chemical present.
On the issue [of whether warnings will become more meaningful], I could play devil’s advocate and say that, yes, I suppose if these regulations are put in place and the warnings are going to be more meaningful, maybe. And in some cases, I think that’s probably true. But I think it would be moreso the case if the warnings were more selective, if [OEHHA] heightened the requirements for when such a warning should be used. In other words, if you have a hundred products on the shelf and only one of them has a warning, that would provide a more useful warning because [the warning] would stick out and people would say, ‘This one has a warning. Why?’ I think there’s still some work to do in terms of making these warnings more meaningful.
McGuffin: [Perhaps] we come up with some kind of more acceptable warning that informs consumers that they shouldn’t use this product if they meet certain criteria. For example, what if a product that contains a low amount of lead-because lead is the main issue here with Prop 65-but still above the 0.5 microgram/day [Prop 65 threshold for lead]. [What if a warning label] said, ‘Not for use by pregnant or nursing woman’? That might be more effective.
How likely are consumers to regard a product more negatively if a warning label lists specific hazardous chemicals as oppose to the current safe harbor warning?
Cortez:It’s difficult to tell because Californians have been immune to these Prop 65 warnings signs for so long, largely because they’re so generic and so ubiquitous. I think once we start to get chemical-specific warnings and warnings that look dramatically different than ones we’ve seen in the past, there is going to be a heightened sense of concern [among] consumers because instead of [warnings] saying, ‘This product may or does contain [some chemical that nobody can even pronounce],’ you’re going to see a product that says, ‘This product has lead in it.’ And it’s going to be an affirmative statement, [saying that a product] actually does have lead in it, or arsenic, or some of these other chemicals that I think people are quite familiar with don’t have to be a scientist to know that they’re dangerous.
But what’s not going to be on the warning [are any statements clarifying] that this [product] has lead in it-but so does virtually every other product of its kind and that the lead [is present] in a very, very low amount. Those sorts of qualifying pieces of information are going to be absent. So I think that the necessary result of that is going to be heightened consumer awareness.
Additionally, while the proposed regulations exclude this requirement for food products, including dietary supplements, other products would be required to include the International Health Hazard Symbol, a rather scary-looking symbol of a man whose chest looks like it’s about to explode. If every other product will have to have that symbol, I think that even though foods and dietary supplements won’t have that symbol, once people start to see that symbol they may start to pay more attention to the warning signs generally. What may have escaped their notice previously is certainly going to capture it now, whether or not the symbol is on [a package]. I think it’s going to create a sort of frenzy, at least at the beginning, because it’s tantamount to putting a skull-and-crossbones on thousands of products that are being sold in California.
Prochnow: [These warnings] probably give consumers a more dire view of the products than what they actually are…even though there is almost no potential of there being any safety issues.
Cortez: The warning requirement is extraordinarily stringent-1/1000th of what would normally be dangerous. Products that have warnings on them may pose no threat whatsoever. As I said earlier, if warnings were only required on truly dangerous products-that is, not just a product that contains chemicals that are found everywhere, but truly dangerous-then I think that would be very, very useful to consumers. But when you have the threshold so low on what requires a warning, and everything basically requires a warning here, then I think regardless of where you stand, I don’t see how that warning is going to provide value to anybody.
How do the proposed changes stand to hurt businesses?
Cortez: It’s really going to be a procedural nightmare. While food and dietary supplement marketers probably only have to worry about the presence of one or two of the chemicals, if you were a manufacturer that has a number of different chemicals that might appear in various products, you would have to have an entire set of warnings-multiple warnings for different products, at different levels, at different times.
Even in the supplements industry, whereas before you could just use a fallback safe harbor warning even if you weren’t sure your product was above the safe harbor level, now you’re going to have to do some real investigation and really figure out whether you can put the warning on your package. You can’t just do it prophylactically [because the proposed regulations state that] the only way you can put the warning on is if you truly do have a chemical that causes an exposure above the safe harbor.
Under current Prop 65 rules, companies are not required to disclose the names of the exact chemicals present in a product, nor do they have to disclose any other information to OEHHA. Under the proposed changes, OEHHA would require companies to make public, via the website, a lot more information as part of the “clear and reasonable warning” Prop 65 requirement. Does this additional information in the public sphere-both on the website and lists of specific chemicals on product labels-create a greater number of “compliance pitfalls” that make a company more vulnerable to litigation? For instance, I can foresee numerous lawsuits regarding the proposal’s vague wording that companies must submit “reasonably available information” on the website. What is considered “reasonably available?” Also, OEHHA has stated that it believes that allowing companies to provide more information online may help, in essence, clear up any gray area regarding whether a company needs a warning and, in this way, help shrink the tide of bounty hunter lawsuits. What do you say to this?
Cortez: I don’t think that this is going to stem the flow of lawsuits at all. If it were going to stem the flow of lawsuits, then all of the plaintiffs’ bar would be screaming and kicking and yelling and fighting [the proposed changes], but they’re not. They’re supporting it. And there’s a reason they’re supporting it, because whereas before plaintiffs or defendants or industry could just put a warning on [a product] and not have to say what [the chemical is], now it’s actionable. Before, a generic warning would cover you for all chemicals, but now, not only do you have to have a warning, but you have to have a warning that’s exactly right. I can think of hundreds of different ways that could become a problem that would lead to more lawsuits. So I don’t buy that one bit.
McGuffin: I think exactly the opposite [of what OEHHA is saying] is likely. I mean, that might be their intention [to reduce the number of lawsuits], but I don’t see how placing greater burdens on the regulated trade is going to do anything other than create one more pond for aggressive private plaintiffs to fish in.
Cortez: The only thing that’s going to stem the tide of lawsuits is a ‘cure period,’ a really meaningful cure period. If a company said [to a plaintiff], ‘Okay, you’re right. We’ve researched your claims. We do have lead in our protein bars and we should put a warning on it,” but they had [a reasonable amount of time] to put on a warning label or amend their information, I think that would absolutely stop the bounty hunters in a significant way.
Editor’s note: OEHHA’s proposal would institute a cure period for “minor” violations, but only for small companies with 25 or fewer employees.
McGuffin: It’s frustrating because there are an awful lot of companies who are working very hard to [ensure their products do not contain hazardous chemicals]. Nobody’s adding lead as an ingredient. Nobody’s going in at night and saying, ‘Hey, bring the lead in, buddy!’ That’s not what’s happening.
Is the information companies provide on the website actionable in terms of litigation?
Cortez: That’s a good question….In other words, is the information provided on the website sort of a natural extension of the warning requirement? What if [the company makes] a mistake [when it submits its information online], or what if there’s an error [in the information]? Does that mean that it’s a legally insufficient warning and subject to penalties?
Editor’s note: Numerous attendees asked this question at the OEHHA meeting in April. The answer is somewhat unclear. Carol J. Monahan Cummings, OEHHA’s chief counsel, seemed to make some conflicting statements. She said, “Our intent is also that the information given on the website would not create a new cause of action under Prop 65.” However, when questioned on whether the website information would be considered part of the “clear and reasonable warning” requirements, she said, “You have to provide a clear and reasonable warning as required by the statute, and we’re giving you specific information that needs to be provided in order to comply with that law. So, the cause of action, if there is one, would be that you’re not providing a clear and reasonable warning under the statute. So, again, we’re trying to give some certainty to businesses so they know if they provide the warning information we request, then they have provided a compliant warning.”
A Better Solution: Raising the Threshold
Raising the threshold on chemical limits might be a better way to make Prop 65 warnings more meaningful by highlighting products that truly do contain these chemicals in hazardous amounts. But raising the threshold is not likely to happen, experts say. Why? Because of the way Prop 65 was written.
Prop 65 contains a clause stating that any amendments made must be “in furtherance of the voters' public health intentions in support of Proposition 65.” If raising thresholds would mean that fewer companies would need to employ warnings, that’s not likely to be viewed as being in “furtherance” of what Prop 65’s supporters intended.
Cortez comments on this.“One of the [reasons] why reform is so difficult and why everybody talks about it all the time and nothing ever gets done is this: Prop 65 was a ballot initiative, and it was voted in by the people of the state of California. It was not put in place by a legislature or a governor and therefore the legislature and the governor are limited in large respect by how they can amend Prop 65. Within the ballot initiative, it said that no amendment or statute can be implemented to amend Prop 65 unless it’s in furtherance of the goals of Prop 65. And so, any threat to institute significant reform, such as a cure period, has been threatened with years and years of litigation, because the plaintiffs’ bar always counters, ‘Is that truly in furtherance of Prop 65?’ So I think it’s important for your readers to understand: it’s not that there’s not a will on the legislature or a will on the [part of the] governor’s office [to enact change]; it’s just that our hands are tied.”
“Short of another ballot initiative that unties our hands, we’re really living with Prop 65 for a long, long time,” he concludes.
OEHHA has extended the comment period for its proposed changes to June 13, 2014. It plans to start the formal regulatory process this summer and aims to complete the final regulation by summer 2015.
"The takeaway from the workshop was that OEHHA is determined to implement the new regs by the end of summer, and they are confident they will become law," says Cortez. "The proposed regs may be amended slightly, but they are close to final."
Also, he adds, "apparently more clarification on the website is forthcoming."
“I would encourage your readers not to sit by the wayside,” he adds. “There needs to be some serious response here. The door is not closed to get this shelved. So, I’d encourage your readers to take action.”
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