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.
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...
In follow up to previous articles, we note that a consumer group last week released a report that alleged that caramel colored sodas (Coke,Diet-Coke, Pepsi and Diet Pepsi) contain levels of 4-methylimidazole (4-MEI) that reached a level of 7 in a million cancer risk. The Center for Science in the Public Interest, claims that the carcinogen forms when ammonia or ammonia and sulfites are used to manufacture the caramel coloring that gives those sodas brown colors. In conjunction with their report the group requested that the Food and Drug Administration revoke its authorization for caramel colorings that contain 4-MEI, and in the interim to change the name of the additive to ammonia-sulfite process caramel coloring or chemically modified caramel coloring for labeling purposes.
Although according to industry experts the amount of soda that would trigger these effects is excessive, Coca Cola and Pepsi recently announced that they were changing their formulas, because of California's Prop 65 law that would require labeling if, as alleged, these products exceed the 1 in 100,000 risk that triggers labeling requirements.
As we noted earlier a sixty day notice has already been served on certain grocers with respect to similar products. The sixty day notice is the first step in the Prop 65 private enforcement process.
Attorneys Lee N. Smith and Melissa A. Jones participated in the GMA 2012 Food Claims and Litigation Conference in Dana Point. Mr. Smith (his real name) spoke on the effect of the New Food Safety Modernization Act and its potential impact on litigation, and Ms. Jones (her real name) and Mr. Smith also presented an overview of Proposition 65 and recent developments with particular regard to food products.
How FSMA May effect Litigation
It was our premise that FSMA will affect litigation in two main areas. One related to the threshold standards under the statute, which have yet to be defined in detail by law or regulation and two, related to the potential increase in government actions under those standards and the commensurate increase in related plaintiff litigation.
The areas under FSMA that have similar thresholds are those that trigger recalls (Sec. 206) , reporting to the food registry (Sec. 211), deregistration (Sec 102), additional record review (Sec.101) and finally those that may trigger administrative detentions (Sec. 207). The first four sections are triggered by the reasonable probability standard, which is usually taken to be mean more than 50% or more probable than not; which is a low standard to trigger recalls or reporting. The other standard for detention is “A reason to believe” food is “adulterated or misbranded.” for administrative detentions." We believe that these standards will trigger litigation similar to the Del Monte Fresh litigation where industry challenged the FDA's lack of evidence available to require a detention and recall.
With respect to Prop 65 we discussed the Prop 65 listing process, and recent case law California Chamber of Commerce v. Schwarzenegger et al., 196 Cal. App 4th, 233 (2011) that supports listing that comes directly from listing made under the labor code.
We identified a recent preemption case that found that the regulation of poultry did not in fact pre-empt prop 65 (see Physicians Comm. for Responsible Med. v. McDonald’s Corp., 187 Cal. App. 4th 554 (2010) (federal Poultry Products Inspection Act did not preempt Prop 65 warnings) and discussed the naturally occurring defense under Prop 65 which is difficult and can costly to prove.
We also noted a recent sixty day notice for MEI; which was just listed last year. The chemical 4-MEI is a fermentation byproduct in certain food products including caramel coloring, soy sauce, Worcestershire sauce, wine and ammoniated molasses, as well as ammoniated livestock feed. The chemical is used in the manufacture of pharmaceuticals, photographic chemicals, dyes and pigments, cleaning and agricultural chemicals, and rubber. First Sixty Notice to grocers in Feb. 2012 as to carbonate soft drinks with caramel coloring.
We mentioned the recent listing of Sulphur Dioxide and the current dispute over safe levels. SO2 is a colorless, nonflammable gas with a pungent odor. As a component of ambient air pollution, SO2 is found in combination with sulfuric acid, sulfur trioxide, ozone, nitrogen dioxide, and particulates, and its presence in ambient air occurs primarily as a result of fossil fuel consumption at power generation and other industrial facilities
• Used in many food products as a preservative including on Cherries and Raisins.
• Should have been listed as an inhalant hazard only.
Please contact us if you have any questions.
United States House Representative, Frank Pallone, Jr. introduced H.R. 3984 on Wednesday that would set arsenic and lead limits in juice. The "Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012," otherwise known as the "APPLE Juice Act of 2012" is in direct response to Consumer Reports investigations. The investigative reports found levels of arsenic and lead exceeding federal drinking water standards in 10 percent of apple and grape juice samples tested in New Jersey, New York and Connecticut. The Act would require FDA to establish standards for the juices within two years.
For those of us in the California market, we can expect potential limits to be set, but how they match up to potential Proposition 65 warning levels and whether any preemption issues may be raised will remain to be seen.
The International Food Information Council’s expert panel, organized for the January 26, 2012 press webinar, found that acrylamide cannot be shown to pose any health risks. Acrylamide, which is also listed as a Prop 65 chemical was thought to be a carcinogen based on tests performed on rats at high doses. A study that included approximately 40 human epidemiological studies reviewed levels in food and none of which conclusively associated acrylamide with any increased heath risks.
Most notably, acrylamide is produced by browning or burning foods. It is also thought to be in coffee and many baked goods. Plant-based foods that are rich in carbohydrates may form acrylamide when baked, fried or roasted –French fries, potato chips, other fried and baked snack foods, coffee, roasted grain-based coffee substitutes, roasted asparagus, canned sweet potatoes and pumpkin, canned black olives, roasted nuts, prune juice, breakfast cereals, crackers, cookies, breads, and toast all may contain varying amounts of acrylamide. Foods that have been boiled or steamed do not contain acrylamide.
On December 8, 2011 I participated in a webinar organized by the Strafford Publication Group. In conjunction with Jonathan Cohen from the Gilbert firm and Joseph Bottiglieri with Bonner Kiernan Trebach & Crociata LLP, we presented Food Safety Claims: Products Liability Issues on the new requirements under the Food Safety Modernization Act.
Nicole Hancock of our Boise office and I will be presenting on Tuesday, January 10, 2012 a webinar on The FDA Food Safety Modernization Act – Part I on related topics including the relation of FSMA to feed and pet products. This webinar will be managed by the University of Idaho farm extension. David Atchison of the Leavitt Partners firm will also be presenting.
Amy Edwards and I will be speaking on January 16, 2012 at the Northwestern Food Processors Association Expo on protecting the attorney-client privilege and how that interaction relates to the new FSMA requirements.
Melissa Jones from our Sacramento office, and I will make a presentation on Proposition 65 and Food Safety litigation at the 2012 Food Claims & Litigation GMA Conference at Dana Point California in February 21-23, 2012.
FDA Creates The Food Safety Preventive Controls Alliance (FSPCA) To Develop Training Courses And Materials For Prevention Of Contamination
The U.S. Food and Drug Administration (FDA) in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) created the Food Safety Preventive Controls Alliance (FSPCA) to develop materials to will help the industry comply with the new preventive control rules.
The Alliance is composed of members from the FDA, loca and state food protection agencies, the food industry and academia.
Under the FSMA, facilities are required to develop food safety plans that evaluate food safety hazards and identify the preventive measures to guard against those hazards. Facilities must also monitor preventive measures and manufacturers must also develop a plan of action to correct any problems that are discovered.
The Alliance will develop training modules, to train the trainer, develop industry specific measures, assess the need for future research, and prioritize the need for specific controls.
The Department of Toxic Substances Control (DTSC) released new informal draft regulations whose stated purpose is: "to make safer consumer products ....widespread in California...[and].... provide more protection against toxic chemicals in products on store shelves, while creating market opportunities for industry."
The draft released on October 31, 2011, creates regulations identifying consumer products that contain toxic chemicals. The DTSC claims it will use a science-based process that requires the identification of toxic ingredients and the analysis of alternatives to that ingredient. Based on the results of the analysis, removal of the toxic ingredient and/or posting product information may take place.
The DTSC’s draft regulations encompassed the following:
1) The regulations establish a list of Chemicals of Concern (~3,000) based on the work already done by other authoritative organizations. The rules also allow DTSC to identify additional chemicals as Chemicals of Concern.
2) The regulations require DTSC to develop a list of “Priority Products” that contain Chemicals of Concern for which an alternative assessment must be conducted.
3) The regulations require responsible entities (manufacturers, importers, and retailers) to notify DTSC when their product is listed as a Priority Product. DTSC will post this information on its website. Manufacturers (or other responsible entities) for a product listed as a Priority Product must perform an alternatives assessment (AA) for the product and the Chemicals of Concern in the product to determine how to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the Chemical of Concern in the product.
4) The regulations require DTSC to identify and impose regulatory responses to effectively limit potential adverse public health and/or environmental impacts posed by the Priority Product/Chemical of Concern (if the manufacturer decides to retain the Priority Product), or the potential adverse impacts posed by the alternative chemical/product selected to replace the Priority Product.
A prior proposed set of regulations were introduced in 2010, but additional time was required to refine the concepts. The version released in October greatly shortens timeframes, immediately establishes a list of chemicals of concern, and is intended to stimulate a change in the way products are created by incorporating impacts to health and the environment into the design phase. The regulations will be discussed by DTSC’s Green Ribbon Science Panel on November 14-15 in Sacramento.