Proposition 65 Exposure/Averaging Changes – Update

Further to our previous blog that discussed OEHHA’s proposed changes to how concentration levels are to be calculated between lots of products from different manufacturing sites and averaging calculations for reproductive toxins, OEHHA has published an update that it will not be proceeding with the proposed changes.

 

This will be a welcomed decision by companies, as the proposed changes would have created a number of increased and excessive regulatory burdens without improving the safety of their products.

 

It appears that OEHHA took note of the many comments it received on the topic from a wide range of stakeholders. A sense of reason has prevailed (at least in this case).

Proposition 65 Exposure Evaluations and Averaging

The method for calculating consumer exposure to Proposition 65-listed chemicals that are reproductive toxins is undergoing a proposed change in response to a landmark 2015 court case (Environmental Law Foundation [ELF] vs. Beech-Nut Nutrition Corp). 

In this case the State of California affirmed a  lower court’s ruling that food companies may average exposures over time to determine if levels of reproductive toxicants in their products  are below Safe Harbor Levels, exempting them from the need to provide a Proposition 65 warning.

ELF (the plaintiff) argued that a single exposure to lead above  the 0.5 ug/day would cause a product to violate Proposition 65. The trial court disagreed. A question on appeal  was whether the Proposition 65 regulations administered by OEHHA prohibit the  averaging of exposures. The appeals court agreed with the defendants and  affirmed the trial court’s conclusions with respect to averaging. Overall, this means that  under certain circumstances it is appropriate to average exposures to reproductive toxicants for purposes of determining whether a warning is  required.

Now, OEHHA proposes:

a) that the reasonably anticipated rate of intake or exposure to a  reproductive toxin from a consumer product be calculated using the arithmetic mean only (instead of any appropriate method, such as  geometric mean, the median level, some other percentile, or the arithmetic mean). Essentially, using the arithmetic mean would include all data and gives all data points equal weight (even for rare instances of very high intake values). Using the geometric mean, as was used successfully in the Beechnut case, minimizes the effect of the outlier data so that the data is not skewed by data points that are not representative of the reasonable average intake of consumers. There are more details explanations in OEHHA’s statement of reason. Overall, it is concerning that calculating exposures would be dictated, instead of using sound statistical principles.

b) when determining the “level in question” of a listed chemical (reproductive toxin) in a food product, averaging of samples cannot be done with samples made at a different manufacturing facility, location, or producer. The reasoning is that if there are issues with the processing at one location, the average concentration may be artificially diluted and warnings would not be provided where they are needed. There are some indicating that averaging between lots is not permitted (at the same location); however, reading the proposed amendment does not seem to indicate such a prohibition.


There were many comments received regarding this proposal and industry anxiously awaits the final regulatory text and whether OEHHA adjusted its stance on any of the regulatory language.

RegTox will continue to monitor this situation and will post an update as soon as it is published by OEHHA. In the meantime, if you have questions about this or any aspect of Prop 65 compliance, reach out to one of our experts here.

Acrylamide, Coffee, and Prop 65

Naturally produced in various foods, California Proposition 65 has made acrylamide a costly thorn in the side of the food industry for over a decade – but that could change.

Acrylamide was initially added to the Prop 65 list in 1990 as a carcinogen based the “authoritative bodies” mechanism following the US EPA’s conclusion that  acrylamide was carcinogenic (“likely carcinogenic to humans”). OEHHA set an NSRL for acrylamide of 0.2 ug/day, which is an extremely low threshold. In 2011, acrylamide was also listed by OEHHA as a developmental, as well as a male reproductive toxin, with an MADL of 140 ug/day.

Although  acrylamide has been used for industrial applications since the 50’s in  the production of polymers and other chemicals, the real issues with acrylamide and Prop 65  centered around the fact that acrylamide is naturally formed in various  foods that are roasted or contain carbohydrates that are fried/baked at  high temperatures, called the Maillard reaction. This reaction occurs in many foods, such as breads, potato chips, crackers, coffee,  pastries, fries, cereals, and oatmeal. The presence of acrylamide in foods was only discovered in the early  2000’s but created a big problem for food companies. In the early days  of this discovery, numerous multinational fast-food companies were  targeted under Prop 65, who paid out millions in settlements.  To date, approximately 393 NOVs have been sent out in relation to  acrylamide.

However, as summarized by the National Cancer Institute (NCI), the American Cancer Institute (ACI), and recent reviews, there is no consistent evidence to suggest that the presence  of acrylamide in foods constitutes a cancer risk in humans. The  available evidence for carcinogenicity comes from animal studies, in which animals consumed very high doses of acrylamide in drinking water (1,000 to 10,000 higher levels than what might be consumed in foods). There are concerns that acrylamide may be metabolized to  glycidamide, a DNA-damaging metabolite; however, it appears that humans absorb and metabolize acrylamide far less than rodents do so the cancer risks may be even lower than anticipated.

Given  the state of the science, OEHHA has now proposed a regulation to exempt the need  to put warnings on coffee related to the presence of acrylamide. The US  FDA recently issued its own statement in strong support of the  exemption, as it considered that cancer warnings on coffee would be  misleading to the public. The US FDA has been working with industry to reduce levels of acrylamide in foods where technically feasible (fries and potato chips are generally the highest single food sources), but reiterates that a balanced diet high in fruit and vegetables is the best course of action and not to fear foods that have healthful properties. In fact, coffee consumption has been associated with the reduction of numerous cancers.

This would be  a very welcome turn of events for the coffee industry; however, it still faces numerous challenges: 1) the judge that originally ruled that coffee did require cancer warnings has refused to stay the coffee-acrylamide case based on a regulation that is not yet enacted and is therefore proceeding to the penalties phase of the trial; and 2) CERT (the plaintiff that brought forth the case) has countered OEHHA that the exemption regulation is unlawful. There is a more detailed legal summary of the situation here.

It  would seem inevitable that OEHHA will need to backtrack on warning requirements for other foods that contain acrylamide and are part of a  healthy diet (i.e., breads, cereals). Indeed,  a California appellate court sided with breakfast cereal manufacturers in stating that federal law pre-empts California state law and these companies were not required to put Prop 65 warnings on breakfast cereals due to the presence of acrylamide. So what about other foods containing acrylamide or other listed chemicals that naturally produced in cooking processes, such as furfuryl alcohol?

We will continue to monitor this situation and provide updates. If you have any questions about Proposition 65 compliance, please contact our experts.

 

  • Update (regulatory change of June 1, 2019 -> effective October 1, 2019):

OHHEA has ruled that acrylamide in coffee does not pose a significant cancer risk and therefore coffee and coffee products do not require cancer warnings! This is great news but raises questions about acrylamide in other foods. It’s at least a start.

Glyphosate, Proposition 65, and Your Breakfast Cereal

The internet has been awash in news related to glyphosate over the last few months. What is it all about? Well, that’s a bit of long story but I’ll provide an overview below. 

Glyphosate is a broad-spectrum herbicide that was originally patented almost 50 years ago by Monsanto and marketed in their “Roundup” herbicide products. It became extremely popular for a range of agricultural uses, especially in conjunction with Monsanto’s “Roundup Ready” engineered crops that were resistant to the effects of the herbicide (i.e., Roundup could be sprayed on crops and only the weeds would be killed off). This ingredient came off patent in 2000, and since then many companies have been selling glyphosate-containing products in over 130 countries, becoming the most widely used herbicide globally.

As with any pesticide product, glyphosate (the active ingredient and formulated/finished products) was comprehensively reviewed for safety by government agencies prior to being permitted for use in North America, EU, etc. These were then re-evaluated in the last few years to ensure any new relevant safety data was captured. Agencies like the Canadian Pest Management Regulatory Agency (PMRA), U.S. Environmental Protection Agency (US EPA), the European Food Safety Authority (EFSA)/European Chemicals Agency (ECHA), and the Australian Pesticides and Veterinary Medicines Authority (APVMA) have recently concluded that when used according to label instructions, glyphosate, and products that contain glyphosate, present a low toxicity hazard to humans and the environment. All of these agencies considered the potential for glyphosate to cause cancer in humans to be minimal, as robust evidence was lacking.

During this time, the International Agency on Cancer Research (IARC), a non-governmental agency within the World Health Organization (WHO), reviewed the potential for glyphosate to cause cancer in 2015 and concluded that there was sufficient evidence to categorize it as a Group 2A carcinogen (“probably    carcinogenic to humans). This was based on “sufficient” evidence in animals and  “limited” evidence for cancer in humans (note: IARC reported there was a positive association for non-Hodgkin’s lymphoma or NHL).

Interestingly, another group within the WHO, the Food and Agriculture Organization (FAO), concluded that glyphosate was unlikely to be carcinogenic to humans from dietary exposures.

Given the IARC classification, OEHHA was, by law*, required to list glyphosate on the Prop 65 list, which occurred on July 7th, 2017 with an NSRL of 1,100 ug/day derived based on a dietary cancer study in mice.  

This caused a great deal of controversy regarding the differing conclusions, especially as claims surfaced that: 

– key scientific data that supported a lack of carcinogenicity was omitted in the review by IARC;

– the use of published vs. unpublished data in different reviews;

– whether the evaluation focused on glyphosate alone or on the final mixed product (which contains various surfactants that may impact safety);

– the transparency of the processes; and 

– the potential for undo influence of industry in relation certain publications. 

Although there have been many rebuttals on both sides addressing these concerns, the truth on these claims appears to remain….. somewhat muddled. To delve into those details, would require a whole separate post. Overall, it appears that some of the issues relate to differing cancer classification criteria by different agencies and interpretations of the robustness of the studies when looked at from a weight-of-evidence approach. Generally, the overall evidence does NOT seem to support that there is actually a direct link between glyphosate exposure and NHL (for a great summary of the data, please see the post by Andrew Kniss here).

Regardless, after decades of use without major safety issues, one of Monsanto’s marquee products was being classified as a carcinogen, which raised additional concerns regarding Prop 65 labeling requirements in California. As such, Monsanto tried to petition OEHHA to reconsider the listing via the Labor Code mechanism (which failed), as well as take OEHHA to court on the grounds of free speech violations (i.e., forcing companies to put language on product labels that was not “uncontroversially” true). Clearly there appeared to be controversy surrounding whether glyphosate actually causes cancer in humans. Earlier this spring, a U.S. federal judge ruled in favor of Monsanto and temporarily blocked the need for labels in California to provide Prop 65 warnings for glyphosate. We will see if this remains the case; however, the NSRL provides an exposure threshold below which warnings are not required anyway.

The next flurry of headlines came mid-August after the conclusion of a landmark case in which a groundskeeper claimed that the use of Monsanto’s Roundup product for several years resulted in him getting non-Hodgkin’s lymphoma. He won and the jury awarded him a whopping $289-million in damages (which will be appealed).  Thousands of other plaintiffs are filing similar cases against Monsanto.

Finally, another flurry of headlines surfaced when the consumer-advocacy group, the Environmental Working Group (EWG) published a report in which it found that numerous breakfast cereals, contained detectable levels of glyphosate, some of which exceeded a safety threshold that was derived by EWG. It should be noted that government agencies set thresholds for residual pesticide levels in foods that take into account the intake of all foods that might contain a residue and are legally binding (these were not exceeded). EWG’s limit (not binding) seems to illustrate that they were looking to ensure they had headline-grabbing results (mission accomplished!). 

Determining causal links between exposure to a substance and cancer is an extremely complex and difficult problem.  Cancers take many years to form and trying to either look backwards to possible causes or to track all possible risk factors is rife with confounding issues and potential for biases. All eyes will remain on glyphosate in the news as further trials proceed and potentially more research is conducted to further investigate the safety of glyphosate, especially the alleged link to cancer. This a fascinating topic and we’ll provide updates as new data or information are published. 

 


*OEHHA is required to list any carcinogens that are classified by IARC as Group 1 or 2A carcinogens (per the “Labor Code Mechanism).

Prop 65: What is Changing After the August 30th 2018 Deadline?

Much has been written about the upcoming changes to the California Proposition 65 warning regulations but there still appears to be some confusion. The key changes relate to the requirements of the warnings themselves and the language used.

To more clearly outline the differences, see the examples below.

Thus, the new warnings will require: 1) an exclamation point within a yellow triangle, 2) disclosure of at least 1 (or more) chemicals that are triggering the warning, and 3) inclusion of web link to OEHHA’s Prop 65 lead agency website. 

Products manufactured prior to August 30th can still use the old warning language; however, businesses should be changing over as soon as possible to avoid the potential for perceived compliance issues. 

Specific language has also been updated or developed for specific industries, products, and chemicals. To learn more, check out the Agency’s website. 

Additional changes include a clearer delineation of the responsibilities of different parties in the supply chain regarding warning disclosure and their requirements. 

With regards to the approach and requirements for determining the compliance of your products, these still remain the same.

Ultimately, the change-over to the new warning language might create increased compliance scrutiny but due diligence will always be your company’s best defense against being targeted under Prop 65.

Whether, you need assistance with your Prop 65 warnings or compliance in general – RegTox provides comprehensive and affordable solutions!