Proposition 65 and the “Naturally Occurring” Exemption
Proposition 65 warnings must be "clear and reasonable" and likely to be seen by a consumer, under the Attorney General's regulations. In recent years, reports against cosmetic products on exceeding amounts of toxins has been heard more often. An update to this exemption is sorely needed. Proposition 65 requires the state of California to publish and maintain a list of chemicals knows to the state of California to cause cancer, birth defects, or other reproductive harm. People ex. Your email address will not be published. In this guide, we list some products covered by CA Prop 65, including clothing textiles, accessories, watches and more. 171 Cal. Sources of acrylamide in the diet include French fries, potato chips, other fried and baked snack foods, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, roasted grain-based coffee substitutes, prune juice, breakfast cereals, crackers, some cookies, bread crusts… That trial involved lead in fruit products.5 In this case, although there were multiple defendants claiming that neither they nor their growers added lead to the food products or ingredients, the court ruled that the defendants’ evidence was insufficient and that they “failed to adduce evidence showing the proportion of lead in their products which is naturally occurring (distinguishing and then proving man-made versus pre-existing levels of lead)” and that they “could have done more (through manufacturing processes) to reduce the lead in their products to the lowest level currently feasible.”
List of chemicals: Proposition 65 requires the Governor to publish a list of chemicals that are known to the state of California to cause cancer or reproductive toxicity, and to update this list at least once a year. For example, one of the most commonly detected categories of toxic chemical substances is plasticizers, which are often used in erasers. But these Prop 65 labels can make even … Save my name, email, and website in this browser for the next time I comment. After all, most companies in this industry simply obtain the product from a supplier and sell it—they do not add chemicals to it in their manufacturing process. Yes, good question. List of California Proposition 65 Product Testing Companies Disclaimer: The content on this website is provided for general information only. Third, it is difficult for food & beverage companies to comply with the warning requirement of Prop 65 because consumers are likely to be alarmed if they see such a warning. Proposition 65 (Prop 65) is a California law proposed initially as the Safe Water and Toxic Enforcement Act and approved by voters in 1986. Newly-purchased furniture generally gives out odors that contain harmful chemical substances such as formaldehyde, ammonia, benzene, TVOC, and other volatile organic gas. If a manufacturer can establish it has been certified as 100 percent organic under existing regulations, should it get some credit or exemption from Proposition 65? The current Proposition 65 list is available on-line below, as a pdf or Excel download or through WestLaw.The Excel document also includes the listing mechanism for each chemical listing and the safe harbor level, if one has been adopted. What this means in practice is that to show a chemical is naturally occurring requires the company to prove the chemical is not added as a result of any human activity and that Good Manufacturing Practices could not prevent the chemical from being part of the product. Create an automatically generated PDF report covering product safety requirements, labeling, certification, and lab testing rules for a wide range of products in the EU and the United States. She currently works as a content editor for Compliancegate.com, JUST ORDERED BEDSPREAD WITH PROP 65 HOW SERIOUS IS THIS AND WHY THE HELL DO THEY USE SOMETHING THAT CAN CAUSE CANCER I LIVE IN ARIZONA NEVER KNEW ABOUT THIS LAW. Toxic chemicals such as flame retardant chemical, phthalate, PVC, hydrogen cyanide could sometimes be found in the coatings of plastic toys. The lawsuit seeks to enjoin the Attorney General and private bounty hunter plaintiffs from enforcing Proposition 65 regulations relating to acrylamide in food. 4. The proposition protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to • Is the safe harbor amount good science? Food and supplement manufacturers and retailers selling products in California are frequent targets of Proposition 65 actions. A Prop 65 warning on your food or supplement label doesn't necessarily mean the product is unsafe, or that you shouldn't take it. Food is essential to life and good health. As a practical matter, Prop 65 warnings are required for any product (food or non-food) that exposes an individual in California to virtually any detectable amount of a listed chemical. The defendants were able to provide extensive peer-reviewed studies focusing on historic levels of methylmercury in the ocean environment to the trial court’s satisfaction. 2. Most major testing companies, such as Intertek and QIMA offers CA Prop 65 testing. This law became commonly known as Prop 65. Prop 65 requires California to once a year publish a list of chemicals known to the state of California to cause cancer or birth defects or other reproductive harm. The Prop 65 exposure standards are strict that whole foods such as carrots, apples, tomatoes, green beans, lettuce, potatoes, and corn contain exposures in excess of Prop 65 limits. All Proposition 65 notices. The California Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program and publishes the listed chemicals, which includes more than 850 chemicals. This places the burden on the company and not a plaintiff bringing the suit, and it means proving two difficult negatives. If the company and its vendors can establish that they each added no Proposition 65 chemicals in their respective manufacturing processes to the product, should that be a factor in determining whether there is a violation, regardless of the many years of prior human activity? Law and Regulations. What types of chemicals are on the Proposition 65 list? The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer, birth defects or other forms of reproductive harm. These toxins can cause harm to the skin, brain and nervous system and even cancer and, as such, they are under the purview of California Proposition 65. Meetings, Hearings and Workshops. We will continue to monitor and report on these very important and potentially far-reaching developments. Chemicals | August/September 2015 Proposition 65’s “Naturally Occurring” Exemption.
Some restricted chemical substances and heavy metals by California Proposition 65 could be found in apparel and textile products, such as phthalates, lead, and cadmium. The regulation lays out a stringent three-part requirement a defendant must meet to be able to invoke the defense: (1) prove the “natural background” of the chemical in the area where the food is grown or raised; (2) prove that the chemical did not result “from any known human activity;” and (3) prove that by Good Manufacturing Practices, the chemical exists in its lowest feasible level. Reform of the naturally occurring exemption should be explored by OEHHA to make it effective and winnable for more than a select few. CA Prop 65 restricts more than 800 chemicals and heavy metals in consumer products. Foods; California’s Prop 65 compared to National Standards. Current Proposition 65 List. Upcoming and past meetings, hearings and workshops. This level is considered a “safe harbor.” Any level over that requires a warning or an exemption, allowing the defendant to avoid a warning. Some foods contain chemicals on the Proposition 65 list. RG11597384 (2013). The agency previously circulated draft regulations that, if enacted, would dramatically change Proposition 65’s warning requirements, and these are likely to be adopted later this year as part of an ongoing comprehensive revision to the law begun in 2013. Got it! General election, November 4, 1986, argument in favor of Proposition 65, p. 54. In addition to counseling and representing clients in Proposition 65 matters, he represents medical device and pharmaceutical clients in product liability matters in both state and federal courts. Ct. Alameda County, No. Lead is listed as a “reproductive toxicant,” and Proposition 65 imposes a stringent (and some would argue a scientifically dubious) maximum level of 0.5 micrograms of lead per day as safe. About California Proposition 65 – Amazon Guidelines, 3. A majority of California voters in 1986 approved a ballot initiative known as Proposition 65, officially titled California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). Proposition 65, known as the “Safe Drinking Water and Toxic Enforcement Act,” was passed by California voters as a ballot initiative in 1986. Underscoring the difficulty of proving the naturally occurring exemption is the fact that there is just one case where a court has found this defense was proven. That said, there are some exemptions for small companies, and if the products carry a warning label. A long list of toxic chemicals is restricted by California Proposition 65 to be used in the making of watches and its components such as the strap, case, and others, such as lead, nickel, PVC, antimony, arsenic, chromium, mercury, barium, cadmium, or selenium. The Proposition 65 list contains many different chemicals, including dyes, solvents, pesticides, drugs, and food additives. Such substances are banned or restricted by California Proposition 65 in the use of consumer products, including toys.  In this case, plaintiffs targeted tuna fish manufacturers, alleging Proposition 65 violations over methylmercury in their tuna products. She has also worked as a merchandiser in the garment industry, where she gained expertise in material sourcing and production management. CA Prop 65 compliance can only be verified through third-party lab testing. • Food and supplements are unique. Apr 28, 2011; Request to the Proposition 65 Food Warning Workgroup - Your Feedback is Requested It is a toxics right-to-know law requiring warnings on products sold in California if they contain certain chemicals that are on a state list of “known” carcinogens or reproductive toxicants.  When Proposition 65 chemicals are found in food, but are proven to be “naturally occurring,” they provide an exemption to the requirement to warn. Other than toys that are made of plastic, toys that contain or made of materials such as plush, fabric, wood, ceramic, rubber or other materials, could contain restricted toxic substances under the regulation of California Proposition 65. Labor Code: Proposition 65 requires the listing of substances identified by IARC as causing cancer in humans or laboratory animals. Proposition 65’s Regulations Make Proving the Defense Difficult
The current Proposition 65 list is dated December 18, 2020. To be certified as an organic grower, one must comply with various specific and detailed federal and state regulations regarding pesticides and growing practices, among other things. such as Intertek and QIMA offers CA Prop 65 testing, heavy metals and other substances contained in jewelry, About California Proposition 65 – Amazon Guidelines, List of California Proposition 65 Product Testing Companies. Today, the list contains approximately 800 chemicals which are found in food, household products, household appliances, dinnerware, drinkware, and utensils, among other things. Learn more. The law was intended to address public concerns in the 1980s when residents started learning more about chemicals and compounds in the environment. However, many foods contain substances, such as saturated … What’s Next? Feel free to reach out if you have questions. However, California Proposition 65 only regulates the concentration and usage of toxins, chemical substances, and heavy metals and other pollutants in electronic products. Pollution, or runoff that causes chemicals to leach into the groundwater from miles away, or that falls as rain, can be considered the result of “human activity” dating far back in time. Though a good result, this case took a multimillion-dollar coordinated endeavor by the massive, worldwide tuna industry. References
Prop 65 compliance in the food industry has not received a great amount of attention and the amount of information available to public is limited. Pleasantly surprising for many in the nutritional supplement industry that are increasingly mired in expensive and often frivolous, alleged violations, the state agency overseeing Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA), proposed in late 2014 to take a fresh look at reforming the defense. Smithfield Foods Sued for False Food Safety Claims, 10 Reasons Why You Should Be Using Chlorine Dioxide, Undeclared Allergens and Automation: The Crossroad of Food Safety and the Reduction of Recalls, Sanitizers and Disinfectants: The Chemicals of Prevention, FDA Temporarily Eases Food Labeling Requirements During Pandemic, Johnson Sea Products Issues Allergy Alert on Undeclared Wheat & Soy in “Home Style Crab Cakes”, New Hoque and Sons, Inc. Prop 65’s warning standards are uniquely low and not safety-based. How to Reform the Naturally Occurring Defense
rel. Proposition 65 Regulatory Update Project, 2011-2012 Project List. Dennis E. Raglin, Esq., is a partner in the San Francisco, CA, office of Sedgwick LLP. There was also a wealth of existing scientific data on relevant ocean life already in the public domain that the defense was able to utilize with the analysis of expert witnesses. This allowable lead level is particularly burdensome to manufacturers and distributors of food-based products and nutritional supplements because both the natural environment (soil and water) and some common dietary elements (such as calcium) already contain lead naturally, meaning that often a product can exceed the safe harbor lead level allowed in Proposition 65 based on average daily dosing. Other than cadmium, the following toxic heavy metal substances are often found for the making of the jewelry, which is banned or restricted by California Prop 65: Below you find some examples of products that might contain the above-mentioned restricted substances. 3. Brown v. Tri-Union Seafoods, LLC. Thus far, there is no timeline on when OEHHA might propose revised regulations. • Organics. Plaintiffs argued that tuna fish cans should carry Proposition 65 warnings because methylmercury is a reproductive toxicant on the Proposition 65 list. They include additives or ingredients in pesticides, common household products, food… Try our Product Compliance Software Tool Here. Awareness raised by Prop 65 led Coke to change its use of 4-MEI, a potential carcinogen found in some caramel coloring. The end result is that the company making the product is likely responsible for chemicals found in the constituent crops caused by some form of human activity, regardless of whether these chemicals are recently deposited or the result of deposits in the soil over many years, perhaps tens, hundreds or even thousands. Environmental Law Foundation v. Beech-Nut Corporation. If you continue to use this site we will assume that you are happy with it. App. The rise of the organic food and supplement industry continues to drive change in the market. 
These chemical substances are used during the manufacturing processes of textiles and their accessories. By Dennis E. Raglin, Esq. ; … Recalls Radhuni Curry Powder Because of Possible Health Risk, Ramar Foods Recalls Mint Chocolate Chip With Hidden Spinach Ice Cream Because of Possible Health Risk, Mellace Family Brands California Inc. (Johnvince Foods) Recalls Wegmans Semi-Sweet Chocolate nonpareils, 18.5oz (1lb 2.5oz) 524g Due to Undeclared Milk Allergen, UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Health Risk, Nestle Prepared Foods Company Recalls Lean Cuisine Fettuccini Alfredo Products Due to Misbranding and Undeclared Allergens, Conagra Brands, Inc. In fact, the voter pamphlet for Proposition 65 suggested that the intent of the proposition’s drafters was to require warnings where toxicants were intentionally added. All the above-mentioned chemical substances are restricted or banned to be used by California Proposition 65. These large defendants undertook an extensive—and expensive—defense, relying on detailed testimony and historic evidence with scientific expert opinion. The list is updated periodically and currently contains over 800 substances. California Proposition 65 regulates the amount of heavy metals and other substances contained in jewelry. Here are a few points that should serve to drive discussion:
2. 1. What is the Prop 65 List? Some of our products contain naturally occurring elements that are included on the Prop 65 list of substances that require a warning. But one size does not fit all when it involves food and supplement manufacturers, because while a table lamp maker can source a vendor who uses no lead in lamps, most nutritional supplement makers can reduce lead but cannot go “lead-free” given the natural occurrence of the chemical, and defendants cannot correct thousands of years of chemicals added to the ecosystem.