January 7, 2016

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update: USDA Final Rule – Expansion of the Organic Assessment Exemption; Food Additive Petition to Ban Certain Synthetic Flavorings; USDA Monitoring Sodium in Foods - Tomato Juice and Carrot Juice Mentioned; FDA Bans Three Substances in Food Packaging; Genetically Modified Papaya Developed by Researchers in Florida

USDA Final Rule – Expansion of the Organic Assessment Exemption

The USDA’s Agricultural Marketing Service (AMS) published a final rule in the Federal Register (80 FR 82006; December 31, 2015), available here, to amend the organic assessment regulations to allow entities that produce, handle, market, process, manufacture, feed, or import, “organic” and “100 percent organic” products to be exempt from paying assessments associated with commodity promotion activity regardless of whether the entity requesting the exemption also produces nonorganic or conventional products. According to the USDA, the current exemption applied only to entities that solely produced, handled, marketed, processed, manufactured, or imported products that were certified “100 percent organic.” In addition, the current regulation stipulates that entities that handle or market any quantity of nonorganic or conventional products in addition to their organic products are not eligible to claim an assessment exemption on any of the products they handle. In part, the 2014 Farm Bill extended the exemption to include firms that grow, ship or handle nonorganic products.

There are 22 national research and promotion programs and 23 marketing order programs. For the research and promotion programs, eligible producers, handlers, marketers, processors, manufacturers, feeders, and importers can apply for an exemption from assessments on products certified as “organic” or “100 percent organic.” Research and promotion programs have been established for beef, blueberries, dairy, eggs, fluid milk, Hass avocados, honey, lamb, mangos, mushrooms, peanuts, popcorn, pork, potatoes, raspberries, sorghum, soybeans, watermelons, softwood lumber, paper and paper-based packaging, cotton and Christmas trees.

Under the federal marketing order programs, eligible handlers can apply for exemption from the portion of the total assessment that is designated for market promotion activities. According to the USDA, the marketing orders that will provide exemptions are for Florida citrus, Texas citrus, Florida avocados, Washington apricots, Washington sweet cherries, Southeastern California grapes, Oregon/ Washington pears, cranberries, tart cherries, California olives, Colorado potatoes, Georgia Vidalia onions, Washington/Oregon Walla Walla onions, Idaho/Eastern Oregon onions, Texas onions, Florida tomatoes, California almonds, Oregon/Washington hazelnuts, California walnuts, Far West spearmint oil, California dates, California raisins, and California dried prunes.

The final rule becomes effective on February 29, 2016.

Food Additive Petition to Ban Certain Synthetic Flavorings

The Food and Drug Administration (FDA) recently issued a Federal Register notice (81 FR 42; January 4, 2016), available here, announcing receipt of a petition requesting that the Agency amend the food additive regulations (21 Code of Federal Regulations Part 172.515, “Synthetic flavoring substances and adjuvants”) to no longer permit the use of the following seven synthetic flavorings: Benzophenone (also known as diphenylketone), Ethyl acrylate, Eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol), Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene), Pulegone (also known as p-menth-4(8)-en-3-one), Pyridine and Styrene. The petitioners (Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids’ Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff) assert that new data is available, which shows these food additives are carcinogenic and not safe for use in food pursuant to the Delaney Clause. The Delaney Clause prohibits the use of a substance as a food additive that has been found to cause cancer in man or animal. The petitioners also request that the FDA amend §172.515 to establish a zero tolerance for these flavorings.

A copy of the petition can be accessed here. Trans,trans-2,4-hexadienal, a flavoring mentioned in the petition, is not addressed in the Federal Register notice.

The deadline to submit comments to the FDA is March 4, 2016.

USDA Monitoring Sodium in Foods - Tomato Juice and Carrot Juice Mentioned

The United States Department of Agriculture (USDA) recently announced the Agency, in collaboration with the Centers for Disease Control and Prevention (CDC) and FDA, launched an online dataset of foods containing sodium. The Agency sampled and analyzed a variety of foods between 2010 and 2013 to establish a baseline. According to the USDA, “The foods being monitored serve as indicators for assessing change over time in the sodium content of common sodium-contributing commercial foods.” In addition, these foods are reported as commonly consumed by respondents of “What We Eat in America,” a national food-intake survey. In addition to sodium, data for total sugar, saturated fat, total fat, potassium and total dietary fiber are included in the dataset, which can be accessed here.

The dataset consists two main categories, “Sentinel Foods” and “Priority-2 Foods.” The USDA notes Sentinel Foods consist of approximately 125 popular foods that are sampled periodically at stores and restaurants around the country and then analyzed. Of particular note, tomato juice is included among the Sentinel Foods (baseline). Priority-2 Foods consist of approximately 1,100 foods, which are evaluated every two years using information from manufacturers and restaurants. Carrot juice is included among the Priority 2-Foods (baseline).

According to the USDA, the data can be used by public health officials to track sodium reduction efforts and consumers and health professionals can use the data to make educated food choices. Review the dataset for complete details regarding sodium and other nutrient levels in vegetable juices.

FDA Bans Three Substances in Food Packaging

The FDA recently published a final rule in the Federal Register (81 FR 5; January 4, 2016), available here, announcing the food additive regulations (21 Code of Federal Regulations 176.170) will be amended to no longer permit the use of three perfluoroalkyl ethyl containing food-contact substances(FCSs) – diethanolamine salts of mono- and bis phosphates, pentanoic acid, and perfluoroalkyl. According to the Agency, these substances were used as oil and water repellants for paper and paperboard used to package aqueous and fatty foods. The FDA concluded “there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs” based on new data.

The final rule is in response to a petition filed by the Breast Cancer Fund, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Children’s Environmental Health Network, Clean Water Action, Environmental Working Group, Improving Kids’ Environment, and the Natural Resources Defense Council.

The final rule became effective on January 4, 2016. Objections and requests for a hearing must be submitted by February 3, 2016.

Genetically Modified Papaya Developed by Researchers in Florida

According to an article recently published by The Packer, available here, the University of Florida Institute of Food and Agricultural Sciences has developed a papaya that has been genetically modified (GM) to include a papaya ringspot virus coat gene. The Environmental Protection Agency (EPA) accepted comments on the Agency's preliminary decision to approve the GM papaya. The researchers said they have demonstrated the ringspot virus resistant papayas do not pose a risk to health and contain the same nutrient content as conventional papaya.

The article notes GM papayas have been grown in Hawaii since 1998 and no adverse human or environmental effects have been documented from consuming the papayas.

Additional details regarding the new GM papaya are available here.

As always, please contact me with questions or comments.

Patricia Faison

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