September 11, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update: FDA's Revision of Nutrition Labeling; NOSB Meeting; Notice of Intent to List Certain Pesticides Under Proposition 65; NYC to Require Salt Warnings on Menu Items; Export Certificate Fees Announced; EU Ban on Animal Clones

FDA’s Revision of the Nutrition Facts Label

In July 2015, JPA notified members that the Food and Drug Administration (FDA) had issued a supplemental notice of proposed rulemaking (80 FR 44303; July 27, 2015), here, requesting input on a limited number of topics as part of the Agency’s efforts to update the nutrition labeling regulations, including the Nutrition Facts Panel. As part of this effort, members were advised that the Agency had published two consumer studies (“Eye-Tracking Experimental Study on Consumer Responses to Modifications to the Nutrition Facts Label” and “Experimental Study of Proposed Changes to the Nutrition Facts Label Formats”) to assess consumers perception of the proposed changes to the Nutrition Facts label. Members were advised that the Agency had established September 25, 2015 as the deadline to comment on the consumer studies.

Yesterday, the FDA issued a proposed rule/notification in the Federal Register (80 FR 54446; September 10, 2015), available here, announcing that the Agency is extending the deadline to comment on the consumer studies to October 13, 2015, which is the same deadline to comment on the supplemental proposed rule.

The Agency also notes that when the supplemental proposed rule was issued in July 2015, two other consumers studies were added to the docket – one study pertained to the proposed declaration of added sugars on the Nutrition Facts Panel and the other study pertained to the proposed footnote statements. The consumer studies are available here (study on added sugars declaration) and here (study on the footnote statements). Comments on these studies can also be submitted to the FDA by the October 13 deadline.

The Federal Register notice also states that the Grocery Manufacturers Association (GMA) requested that the Agency publish the raw data underlying the four consumer studies noted above. The FDA has made the raw data files available. The data files are quite large and can be accessed by contacting me.

JPA's Nutritions Facts Task Force is in the process of drafting comments to the FDA regarding the supplemental proposed rule and the two consumer studies pertaining to the Nutrition Facts label format. Those draft comments will be shared with JPA members in the near future for review and comment.

USDA Announces Meeting of the National Organic Standards Board

The United States Department of Agriculture (USDA) recently published a Federal Register notice (80 FR 53759; September 8, 2015), available here, announcing the next meeting of the National Organic Standards Board (NOSB) will be held October 26-29, 2015 in Stowe, Vermont. The NOSB will also hold two webinars to receive public comments – one on October 13 and one on October 20. The meeting agenda can be accessed here. In part, the NOSB will consider substances on the National List of Allowed and Prohibited Substances (the National List) that will sunset (i.e., their use will expire) in 2017. The list of substances for review is included in the meeting agenda. The Organic Foods Production Act of 1990 (OFPA) requires that all substances on the National List be reviewed every five years by the NOSB. In the past, JPA has submitted comments to the NOSB regarding the sunset review of substances of interest to the juice industry.

A detailed communication highlighting those substances for review by the NOSB will be provided in the near future. The deadline to submit written comments to the NOSB is October 5, 2015.

Notice of Intent to List Certain Pesticides Under Proposition 65

The California Environmental Protection Agency's (EPA's) Office of Environmental Health Hazard Assessment (OEHHA) recently published a "Notice of Intent" to list tetrachlorvinphos, parathion, malathion and glyphosate under Proposition 65. The notice, available here, states these substances meet the requirements for listing as they are known to cause cancer.

OEHHA has not developed No Significant Risk Levels (NSRLs) or safe harbor levels for these substances. Exposure levels that are below the NSRL are exempt from the requirements of Proposition 65. If the Agency does not publish NSRLs for these pesticides, businesses that expose individuals to these pesticides would be required to provide a Proposition 65 warning, unless the firm can show that the exposure level will not pose a significant risk of cancer.

Of particular note, malathion and glyphosate may be used on agricultural crops including fruits. In part, the EPA established pesticide residue tolerances for malathion (40 Code of Federal Regulations Part 180.111) on an number of fruits including apple, orange, grape, nectarine, cherry and cranberry. In part, glyphosate (40 Code of Federal Regulations Part 180.364) tolerances have been established for citrus fruit, pome fruit and stone fruit. Product registrations for parathion in the U.S. have been cancelled, and there are no established tolerances for tetrachlorvinphos on produce.

The deadline to submit comments to OEHHA on the "Notice of Intent" is October 5, 2015.

New York City to Require Salt Warnings on Restaurant Menus

According to an article recently published by the Associated Press, available here, the New York City Board of Health voted unanimously to require chain restaurants to put salt-shaker emblems on menus to denote food items with more than the recommended daily limit of 2,300 milligrams of sodium (about one teaspoon). The article notes the requirement will become effective on December 1, 2015 for restaurant chains with at least 15 outlets nationwide. The American Heart Association and the Center for Science in the Public Interest are in favor of the measure while the Salt Institute and New York State Restaurant Association expressed concern regarding the new requirement.

FDA Announces Export Certificate Fees for Animal Food

Yesterday, the FDA issued a Federal Register notice (80 FR 54569; September 10, 2015), available here, announcing fees for animal food and feed ingredient export certificates. According to the notice, the FDA Food Safety Modernization Act (FSMA) authorizes the Agency to charge fees for export certification for animal food (as well as human food). The export certificates are issued for regulated products that are legally marketed in the U.S., as well as for these same types of products that are not legally marketed in the U.S. but are legally exported. The export certificate fees for animal food will be $175 for the first certificate, $155 for the first duplicate original and $70 for the each subsequent copy. The FDA’s press release is available here.

European Union Ban on Animal Clones

According to an article published in the September 9, 2015 edition of POLITICO Morning Agriculture, the European Parliament voted in favor of banning the cloning of animals for use in food. The article notes the “legislation extends a Commission proposal prohibiting the cloning of animals in select species as well as the marketing of products from cloned animals in the EU, broadening it all to farm animals, their offspring and their semen and embryos, as well as marketing and import of these.” The ban would be issued as a regulation, which has more force than a directive.

As always, please contact me with questions or comments.

Patricia Faison

(404) 252 - 3663

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