2010 NAFFS Yearbook

Legal/Regulatory Update
Patrick J. McNamara, Esq.
Scarinci & Hollenbeck

In June the USDA announced the United States and Canada had reached an equivalency agreement, which took effect June 30, that, if functions as designed, will create expanded market opportunities for organic producers in both nations. The agreement provides producers and processors certified to the National Organic Program Standards by USDA-accredited certifying agents do not have to become certified to the Canada Organic Product Regulation standards in order for their products to be represented as organic in Canada, and vice versa. The agreement also provides that both the Canada Organic Biologique label and the USDA Organic seal may be used on certified products from both countries. According to the Foreign Agricultural Service of the USDA, approximately 80 percent of Canada’s organic consumption comes from imports, with about 75 percent of that total originating from the United States.

On August 26 FDA published in the Federal Register a notice requesting comments, scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels.
According to FDA these foods contribute the most acrylamide to the U.S. diet: French fries (restaurant prepared), French fries (oven baked), potato chips, breakfast cereals, cookies, brewed coffee, toast, pies and cakes, crackers, soft (non-toasted) bread. There is also information that has been posted on the FDA website for consumers who are looking for ways to reduce acrylamide exposure from food.
At the end of the notice in the Federal Register is a detailed appendix citing some 65 different references, many of which are devoted to scientific papers, regarding the issue of acrylamide levels in food.

Health Canada placed acrylamide onto Schedule 1 of the Canadian Environmental Protection Act of 1999 in order to minimize the public’s exposure to the chemical. Health Canada announced that it was implementing a three-pronged risk management approach to cut the exposure of Canadians to the substance. The approach includes working with the food industry to develop and implement acrylamide reduction strategies for use by food processors in the foodservice industry; to regularly update consumption advise for consumers; and coordinating risk management efforts for acrylamide in food with key international food regulatory partners.

In beginning the first phase of its monitoring program, Health Canada announced the program will focus on establishing which foods present the greatest danger of acrylamide exposure. As such, it intends to examine food production practices involving bread; pizza; breaded chicken nuggets; coffee; French fries; breakfast cereals; potato chips; cookies; baby food; snack foods; baking chocolate and cakes; peanut butter; and other related foods.

An industry group called the Non-GMO Project began a campaign to test products and label those that are largely free of biotech ingredients. Companies involved in organic and natural foods believe their credibility in the marketplace requires them to now demonstrate to their potential consumers that their products do not come from genetically engineered plants. Participants in the Non-GMO Project include companies such as Whole Foods Market. Whole Foods announced its plan to place the project’s seal on hundreds of the products it markets under its store brand known as “365”. Nature’s Path, a leading manufacturing of organic packaged foods like cereals, frozen waffles and granola bars, has also embraced this initiative. A spokesman from Nature’s Path has said that testing and labeling are needed to protect the industry from the spread of biotech ingredients, noting that their company has already been performing such testing for a number of years and is improving the technology used to conduct those tests. Planting some crops with genetic modifications has risen significantly over the last decade. Approximately 85 percent of corn and canola and 91 percent of soybean acreage in 2009 was sown with biotech seed. FDA has said it does not have the authority to approve labels before they appear in the marketplace. However, once the label does go into use, the agency does have the authority to initiate a review if it receives consumer complaints or has concerns the label is misleading.

Other industry groups are also starting a separate labeling program under what is called “Smart Choices”, which is backed by most of the nation’s largest food manufacturers. It is a green and white label with a large green checkmark with the words about “Smart Choices Program Guiding Food Choices”. However, several organizations critical of the food manufacturing industry have attacked this process and labeling, noting that the labeling has shown up on cereals like Cocoa Krispies and Fruit Loops. Both FDA and USDA have placed the program’s managers on notice in a letter dated August 19, stating that both agencies intend to monitor the effect this program could have on the food choices of consumers. The letter said the agencies would be concerned if this label “had the effect of encouraging consumers to choose highly processed foods and refined grains instead of fruits, vegetables and whole grains. The companies participating in the Smart Choices program so far include Kellogg’s, Kraft Foods, ConAgra, Unilever, General Mills, Pepsico and Tyson Foods. Companies that participate pay up to $100,000 a year to be part of the program, with the fee based on the total sales of its products that bear the seal. In joining the Smart Choices Program, the companies agree to discontinue their own labeling systems, such as Pepsi having its “Smart Choices Made Easy” program and the “Sensible Solution” from Kraft.

On Sept. 9, USDA and the Department of Health and Human Services unveiled a website at www.foodsafety.gov. The site is intended to provide consumers with the latest information on food safety and food recalls on one single, convenient website. The site includes information from various agencies across the spectrum of the federal government that address food and food safety information. You can go to the website and sign up to receive various alerts on recalled or potentially unsafe food. You can also access information from various scientific experts on food safety. The website will also serve as a clearing house for information on the latest rules and guidance from the FDA and will also have information available from the Centers for Disease Control regarding tracking food borne illnesses.

Food facilities required to register with FDA under existing bioterrorism laws now have to submit a report electronically to the FDA within 24 hours if they find a reasonable probability an article of food may cause a severe health problem. There will be a direct link provided through the FDA website. The following information has to be submitted in any initial report to this electronic registry. It includes the following items:
1. The facility registration number of the responsible party.
2. The date on which the article of food was determined to be reportable.
3. A description of the article of food, including quantity or amount.
4. The extent and nature of adulteration.
5. The results of any investigation of the cause of the adulteration, if it may have originated with the responsible party, when known.
6. The disposition of the article of food, when known.
7. Product information typically found on packaging, including product codes, use-by dates and the names of manufacturers, packers or distributors in order to identify the article of food.
A copy of this guidance is included in the appendix to your materials.

Health and Human Services Secretary Kathleen Cebelius recently announced Dr.
John Howard would be returning as the director for NIOSH and coordinator for the Wall Trade
Center Health Programs under the Department of Health and Human Services. Dr. Howard previously served as NIOSH Director from 2002 to 2008.

On July 28, President Obama nominated David Michaels to serve as the assistant secretary for OSHA. Dr. Michael is affiliated with the George Washington University School of Public Health and Human Services as a research professor at its Department of Environmental and Occupational Health. Dr. Michaels has conducted numerous studies on the health effects of occupational exposure to toxic chemicals, including asbestos, metals and solvents. His nomination is currently pending in the U.S. Senate.

Last April OSHA convened a Small Business Regulatory Advocacy Review panel to review issues associated with OSHA’s intent to proceed with rulemaking regarding occupational exposure to diacetyl in food flavors containing diacetyl. The panel conducted meetings and gathered information throughout the spring of 2009 and has since issued a report, a copy of which is on the CD. The entire report with the numerous appendices runs nearly 260 pages. The report notes that in its current form, OSHA’s draft proposed regulation would apply only to employers who manufacture food products for flavorings using diacetyl and not to the end users of such products. The report also states the draft proposed rule does not cover naturally occurring diacetyl in fragrances or other non-flavoring uses of diacetyl. The report proceeds to provide some background regarding the various “popcorn lung cases” at various manufacturing facilities and other plants where numerous employees were diagnosed with bronchiolitis obliterans, which were alleged to have been triggered by exposure to diacetyl. While the report notes many of the compounds involved have not been carefully studied, diacetyl is the flavoring component that has received the most attention as an independent etiological agent in the development of this respiratory disease. The report states it is premature to regard diacetyl as the sole agent responsible for flavoring-related lung disease. The report also notes some butter flavorings used in microwave popcorn are undergoing significant reformulation away from diacetyl. In discussing the steps taken by some companies referred to as “small entity representatives” (“SER’s”) by OSHA, those that were involved in the manufacturing of microwave or ready to serve popcorn were already moving away from the use of diacetyl. They had implemented various manufacturing procedures, including personal protective equipment for employees, sealed heads on the kettles and ventilated under negative pressure their manufacturing rooms. Other companies said they were using a substitute for diacetyl since insurance carriers were requiring the company to use substitutes due to the potential for litigation. Of the three SER’s manufacturing flavorings for the food industry, all described various safety measures being taken to protect employees. One company eliminated the use of diacetyl, while the other two were continuing to use it but at a much reduced level given the demand from customers to reduce or eliminate its use. Other companies in the baking restaurant and scented candle industries also described their efforts to reduce or minimize the use of diacetyl. A number of the companies were concerned their industries were included in the draft proposed rule and that exemptions should be created for them in any formal rulemaking.

At the end of the report there were a series of panel findings and recognitions. The panel recommended:
1. OSHA carefully consider the cost benefits and possibility of risk associated with various regulatory approaches and ensure any rule is tailored to generate the least cost to employers consistent with OSHA’s requirement to protect worker safety. The panel recommended OSHA continue to gather exposure data on diacetyl and consider exclusion or limited requirements for employers with minimal exposures.
2. Iif the beer and wine industries are included in the proposed rule, OSHA should look more closely at whether they should be included to ensure an accurate count of potentially affected establishments and examine whether there is undercounting in terms of the number of facilities that would be included.
3. OSHA consider how to produce a preliminary economic analysis that best recognizes the values of timeliness and reflection of long-term business conditions. The panel also recommends OSHA remain up to date on special conditions affecting particular industries.
4. OSHA evaluate suggestions from the Grocery Manufacturers Association and a report from the Toxicology Excellence for Risk Assessment regarding the establishment of a personal exposure limit (“PEL”). The report noted OSHA was considering four different PELs. Questions were also raised as to the accuracy of measuring for PELs and its accuracy in the field.
5. OSHA ensure the language used in the proposed rule is clear and easy to understand, recognizing many of the potentially affected small businesses may have limited experience with OSHA health standards. It also stated OSHA has to consider how to deal with situations where employers may have both naturally occurring and added diacetyl present in the manufacturing process.
6. OSHA continue to monitor the use of replacement substances for diacetyl in food flavorings and to evaluate potential health effects associated with exposure to these compounds.
7. OSHA evaluate what is adequate respiratory protection, the need for protective clothing, how such clothing and equipment should be stored and training for employers to give to their employees.
8. OSHA reconsider whether it is necessary to have employees receive physical exams every six months or whether less-frequent intervals would be adequate. The panel also recommended OSHA consider providing additional guidance about what spirometry results may trigger further medical evaluation.

The report noted some companies favored a non-PEL approach, while others were concerned such an approach would lack flexibility or require significant expense for employers with relatively little employee exposure or risk. Some companies suggested OSHA allow individual employers to choose which approach worked best for them.

The panel recommended OSHA delineate the advantages and disadvantages of each alternative and to seek ways to make the non-PEL alternative as cost effective as possible. The panel noted determining the approach with the least burden on small business may involve gathering more information about the current levels of diacetyl exposure in the workplace and could vary by industry and situation.

USDA has ordered an independent audit of the National Organic Program, which is designed to increase transparency and to bring it in line with international standards. The audit will assess the NOP’s more-than 100 private certifiers to ensure USDA is adhering to international standards for accrediting them and overseeing their work.

In an interview earlier this month President Obama said he is willing to consider imposing a tax on soda and other sugary drinks as part of the debate in Congress concerning overhauling the health care system. Lawmakers have considered new taxes on sugar and sweetened soda to help pay the cost for this legislation, which is estimated to cost as much as $1 trillion over the coming decade. The president said while the proposal does face opposition from various lawmakers, higher taxes that wind up reducing soda consumption would be helpful in holding down health care costs. The president said in an interview in Men’s Health Magazine that “every study that has been done about obesity shows that there is a high correlation between soda consumption and obesity. Obviously it is not the only factor, but it is a major factor”. Various trade associations are working to oppose such a provision in any legislation. The Congressional Budget Office has estimated a $.03 tax on a typical 12-ounce can of soda would raise $50 billion dollars over a 10-year period.

Patrick J. McNamara, Esq. has served since 1994 as general counsel to NAFFS. Copies of the various reports and documents referenced in his speech can be obtained from NAFFS or directly from him. Please contact him at pmcnamara@scarincihollenbeck.com or call his office at 201-896-4100. The complete version of Mr. McNamara’s presentation is available at www.naffs.org.
National Association of Flavors & Food-Ingredient Systems
3301 Route 66, Suite 205, Bldg. C • Neptune, New Jersey 07753
(732) 922-3218 • Fax: (732) 922-3590 • info@naffs.org
Privacy Policy  |  Refund Policy
Powered by Wild Apricot Membership Software