We recently posted a blog concerning food products and Proposition 65. There have been several chemicals in the news lately that may concern food processors, including methanol, pulegone, beta-myrcene, and PCBs.
Methanol, also known as wood alcohol, can be produced by natural fermentation of fruits and vegetables, and additionally when fruit cell membranes are broken during processing. When the legal levels were proposed, the California Office of Environmental Health Hazard Assessment (“OEHHA”) also issued an Interpretive Guideline, indicating that naturally occurring methanol resulting from pectin was excluded. Although the proposed Maximum Allowable Dose Levels (“MADLs”) would exempt naturally occurring pectin, they might not apply to pectin made as a result of human activity or pectin used as an additive. Pectins are used as gelling agents, colloids, and stabilizers in various food and beverage products. One manufacturer of pectin requested a public meeting concerning the methanol MADLs. That meeting was scheduled for May 7, 2012, and the public comment period was extended to May 21.
In addition several food additives have been proposed for listing: Pulegone is a mint flavoring used in drinks, peppermint, dental products, and herbal medicines, and as a fragrance. Beta-myrcene is a component of essential oils such as hop, bay verbena, and lemongrass. It is also used for adding aroma to products and to flavor chemicals, concentrates, soaps, and detergents.
Several trade organizations have submitted comments that argue that the listings of these chemicals are based on faulty science and are premature. These chemicals are being listed under the Labor Code Mechanism, which was unsuccessfully challenged by producers last year. The trade organizations also indicated that the listing was premature because the actual monograph has not yet been issued. Industry commentators believe that the monograph will address the faulty data, and that the determination of listing should pass to the Carcinogen Identification Committee (“CIC”). The CIC requires more intense scrutiny than is required under the Labor Code Mechanism.
PCB NSRLs Reset
OEHHA recently proposed updated exposure limits for PCBs (polychlorinated biphenyls) in food; a No Significant Risk Level (“NSRL”) based on an EPA risk study. The agency proposed a NSRL of .35 micrograms per day for exposure as oppossed to the current level of .09 micrograms. OEHHA also proposed a MADL for PCBs of 2.3 micrograms for exposures causing reproduction toxicity that was based on a 1995 study. The proposed NSRL applies only to environmental mixtures of PCBs that are in food products, such as those found in certain meats, fish, shellfish, eggs, and dairy products. They do not apply to mixtures of water-soluble PCBs in aqueous solutions.
A recent settlement agreement should be of interest to other producers.
Muscle Milk Pays 2.6 Million
Muscle Milk brand products (Cytosport) is in the process of settling a class action lawsuit that alleged that its products contained elevated levels of arsenic, cadmium, and lead, which posed a health threat. The settlement, initially $2.6 million, contains a mechanism for Cytosport to identify naturally occurring levels of these chemicals on which to base a safe dosage level that also takes into account the naturally occurring levels. These levels relate to the Proposition 65 exemption for chemicals that contain naturally occurring levels, which may in some instances be subtracted from the total concentration before comparing them to the thresholds. Manufacturers must also show that they attempted to lower the levels and that no additional measures are feasible.