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.
Recently I drafted an article on California's Proposition 65, which was published on FoodProcessing.com on April 9, 2012. More information about the article, with a link to the article on Proposition 65 can be found here: www.stoel.com/showarticle.aspx
Yesteday, Governor Brown appointed George Alexeeff as the Director of the Office of Environmental Health Hazard Assessment (OEHHA) at the California EPA. Alexeeff has been the deputy director of OEHHA since 1998 and has worked at the department since 1988. He has a doctorate in pharmacology and toxicology from U.C. Davis.
Among other duties, OEHHA is responsible for maintaining the State's list of chemicals known to cause cancer or reproductive toxicity for purposes of Proposition 65. OEHHA also develops "safe harbor" numbers for some of the chemicals on the list (there are approximately 300 chemicals out of the 800+ Proposition 65 chemicals that have safe harbor numbers).
As of March 16, 2012 Methanol was added to the Prop 65 list as a reproductive hazard. According to OEHHA ,Methanol occurs naturally in fruits and vegetables. Methanol is also formed when fruits and vegetables are physically prepared for consumption by slicing, chopping, pureeing and juicing. The production of free methanol in all these instances is the result of reactions in pectin, a principal component of plant cell walls and the middle lamella between them. Pectin is heteropolysaccharide contained in the primary cell walls of terrestrial plants. It is produced commercially as a white to light brown powder, mainly extracted from citrus fruits, and is used in food as a gelling agent particularly in jams and jellies. It is also used in fillings, medicines, sweets, as a stabilizer in fruit juices and milk drinks, and as a source of dietary fiber. Pectin will break down to methanol when the plant cell walls and middle lamellae are disrupted, as can happen through physical processes of food preparation. Methanol is also produced when pectin is digested after eating fruits and vegetables, but OEHHA does not believe that the pectin that is activated by chopping and slicing will increase over the amount that is produced during digestion.
In addition to the notice that methanol is now on the Prop 65 list, OEHHA released the Interpretive Guideline No 2012-01 that indicates that methanol resulting from Pectin in Fruits and Vegetables is considered to be Naturally Occurring under section 25501 of Prop 65 and thus not required to comply with the Prop 65 warning requirements. The interpretation leaves the door open as to whether pectin that is added to products is subject to Prop 65. The text of the exemption which excludes levels of these chemicals that occur naturally in food without addition by human activity, may be a hard standard to meet.
OEHHA has also proposed regulatory levels for the consumption of methanol both by ingestion and inhalation. The numbers although they appear to be high on their face, Maximum Allowable Dose Levels for methanol of 47,000 micrograms per day for inhalation and 23,000 micrograms per day for ingestion are not. Based on the numbers derived from the pectin interpretation, fresh orange juice may have methanol concentrations as high as 80 ppm. At that concentration the Prop 65 MADL level is arguably reached with just ten ounces of juice.
Comments may still be transmitted to OEHHA on these proposed MADLs until April 30, 2012.
Effective March 1, 2012, the FDA implemented an Interim Final Rule on the “Establishment, Maintenance, and Availability of Records” under the Food Safety Modernization Act, “FSMA”.
The FSMA statute among other new provisions, expanded the FDA’s authority to access and demand records from relating to the specific suspect article of food records, to include those relating to any other article of food that the FDA “reasonably believes is likely to be affected in a similar manner.” Although they are already in effect, the comment period for these rules is May 23, 2012. . These rules were not subject to the normal public review procedure because the FDA found that it was contrary to the public interest to delay them as the FSMA statute called for that access from its inception. The FDA has always indicated that” reasonable belief” determinations are made on a case by case basis because such decisions are fact-specific.
The expanded rule continues to reflect the requirement that records “must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee only designated by the Secretary of Health and Human services who presents appropriate credentials and a written notice.”Continue Reading...