Food and Nutrition Labeling Regulatory Trends. at the 84 Annual NIOP Convention Indian Wells, CA
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1 Food and Nutrition Labeling Regulatory Trends at the 84 Annual NIOP Convention Indian Wells, CA ROBERT COLLETTE, INSTITUTE FOR SHORTENING & EDIBLE OILS
2 J. G. Boswell Company
3 Outline of Labeling Topics Bioengineered Food Labeling Nutrition Labeling Health Claims
4 GMO Ballot Initiatives Fail ( ) - Food and Agriculture Industry campaigns succeeded in defeating multiple ballot initiatives but this came at a high cost - Convinced voters product was safe and labeling would increase food prices - Victory margin only 1-2%.
5 State-Level GMO Legislation More Successful ( ) By 2016 at least 30 states had introduced some type of GMO labeling legislation and 3 states Connecticut, Maine and Vermont had passed GMO labeling mandates.
6 Bioengineered Food Labeling State by state GMO labeling untenable so On July 14, 2016, the House of Representatives passed S. 764, An act to reauthorize and amend the National Sea Grant College Program Act, and for other purposes. Among other actions, S. 764 mandates that the U.S. Department of Agriculture to promulgate regulations establishing a mandatory disclosure regime for bioengineered foods.
7 Key Provisions S. 764 requires mandatory disclosure of bioengineered foods and: defines bioengineering, with respect to a food, as a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. authorizes USDA to establish a mandatory bioengineered food disclosure standard, including the requirements and procedures needed to implement the standard within 2 years (July 2018) allows disclosures to be in the form of text, a symbol, or an electronic or digital link, at the discretion of the food manufacturer. prohibits state/local governments from establishing or continuing any requirement relating to whether a food or seed is genetically engineered or was developed or produced using genetic engineering.
8 USDA AMS Sought Comments to 30 questions On June 27, 2017, USDA AMS posted 30 questions related to the establishment of a mandatory bioengineered food labeling standard for consideration by interested stakeholders. The deadline for input was August 25, 2017 Proposed Rule March 2018??? Final Rule July 2018? AMS received over 112,000 public comments that it will use in drafting a proposed rule. June-Aug questions issued for comment
9 Coalition for Safe Affordable Food (CFSAF) Broad coalition of agriculture and food industry associations including ISEO Representing seed producers, growers, processors and food manufacturers and food retail companies Seeking consensus across the food chain on comments Set up working groups to address 30 questions from USDA AMS and reached agreement on the vast majority of responses
10 Full Agreement on 26 out 30 Questions Full agreement reached on 26 of the responses (i.e. all but questions 1, 4, 8 and 12) and reached partial agreement on 3 of those 4 questions And, importantly the Coalition strongly agreed that: USDA-AMS should reinforce the fact that the bioengineered food disclosure standard is a marketing standard, and not a health, safety, or nutrition standard,
11 Consumer Recognition that the BE Labeling Standard Should Emphasize the Safety of Bioengineered Food The Center for Science in the Public Interest (CSPI) argued that any information provided to consumers should not suggest, directly or indirectly, that a food or an ingredient from a GE crop is in any way less safe or less nutritious than the same food or ingredient from a non-ge crop. There is an international scientific consensus that ingredients from existing GE crops are safe to eat and nutritionally identical to their non-ge counterparts. That consensus was recently affirmed in a thorough study conducted by the National Academy of Sciences.
12 Examples of differing views on USDA AMS questions 1, 4, 8, and 12
13 Question 1. What terms should AMS consider interchangeable with bioengineering? (Sec. 291(1)) Coalition Response Because the Coalition represents all segments of the U.S. food value chain with a broad range of interests and perspectives, individual Coalition members will offer USDA-AMS recommendations on how to address Question 1.
14 Question 1. What terms should AMS consider interchangeable with bioengineering? (Sec. 291(1)) Food and Ag Example 1 food manufacturers should be given flexibility to use other terms such as genetically engineered when disclosing under the Standard. However, AMS should also clarify that the term genetically engineering as used in the pre-emption section is broader than the term bioengineering. Food and Ag Example 2-- No terms other than bioengineering should be considered interchangeable with bioengineering for the purposes of mandatory disclosure and use of a single term would be simplest for consumers.
15 Question 1. What terms should AMS consider interchangeable with bioengineering? (Sec. 291(1)) Example of NGO Response-- AMS should consider the terms genetic engineering, genetic modification, and biotechnology as interchangeable with bioengineering because of their contemporaneous use in state and federal policy, as well as in international standards and guidelines developed by Codex Alimentarius. *States and the International Codex Alimentarius definitions could be viewed as a means of broadening the scope of labeled products
16 Question 4. Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops? Final CFSAF Comment-- Urged USDA-AMS to abandon the term highly refined and instead use the more accurate term "refined ingredients" when referring to single food components, such as sugar and oils.
17 Question 4. Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops? Several food trade associations supported the inclusion of highly refined ingredients (HRI) and foods, such as oils and sugars derived from bioengineered crops within the mandatory disclosure standard whether or not rdna material was present The rational for their support of mandatory disclosure is tied to their belief in transparency to build consumer trust in the use of bioengineered ingredients and foods.
18 Question 4. Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops? Several other trade associations did not support the inclusion of highly refined ingredients (HRI) and foods, such as oils and sugars from bioengineered crops, in the mandatory disclosure standard, when the rdna material is absent. Rational: the Act clearly defines food from bioengineering as food that contains recombinant DNA material which are absent in most HRIs
19 Question 4. Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops? An NGO Coalition told AMS it should require disclosure even for highly refined sugars and oils and processed corn and soy ingredients, whether the presence of GE ingredients is undetectable or not: They are still GE foods. And, urged AMS to broaden the standard further to roll in other technological advancements such as gene editing (e.g. CRISPR-Cas9) and gene silencing (e.g. RNA interference or RNAi)
20 Question 8. What is the amount of a bioengineered substance present in a food that should make it be considered bioengineered? CFSAF Final Response Whatever the selected threshold or amount of a bioengineered substance present in food that triggers mandatory disclosure, USDA-AMS should reinforce that the disclosure standard is a marketing standard, and not a health, safety, or nutrition standard.
21 Question 8. What is the amount of a bioengineered substance present in a food that should make it be considered bioengineered? Food and Ag Example 1-- Refined ingredients derived either from bioengineered crops should be disclosed only when the de minimis threshold for disclosure is met. Food and Ag Example 2 when ingredients are derived from a non bioengineered source OR one that is identity preserved they should not be subject to the disclosure even if there may be low level presence of bioengineered material. But, ingredients that can be sourced from bioengineered crops should be included Food and Ag Example 3-- AMS should set a 5% threshold because it supports biotechnology, appropriately balances disclosure, market dynamics, and international trade, and is consistent with other U.S. regulatory programs, including the USDA Organic Program that allows up to 5% of non-organically produced agricultural ingredients.
22 Question 12: If a manufacturer chooses to use text to disclose a bioengineered food, what text should AMS require for a text disclosure? Coalition Response The term may should be permitted given that food manufacturers may intermittently alternate between using both bioengineered and non-bioengineered ingredients in the same product throughout the year. In addition, may might be appropriate if food manufacturers are unsure of the source of an ingredient that can be either bioengineered or nonbioengineered. The agency should establish a compliance date that provides sufficient time for companies to revise their labels and should also consider harmonizing the compliance date with other relevant labeling changes required by new Federal regulations.
23 Question 12: If a manufacturer chooses to use text to disclose a bioengineered food, what text should AMS require for a text disclosure? Food and Ag example 1-- AMS should not allow manufacturers to continue using the disclosures established under the Vermont law because Congress expressly rejected Vermont s approach and instead defined bioengineering with respect to a food as one that contains genetic material. AMS should adopt one standard text disclosure, namely contains bioengineered ingredients or May contain bioengineered ingredients.
24 Question 12: If a manufacturer chooses to use text to disclose a bioengineered food, what text should AMS require for a text disclosure? Food and Ag example 2--AMS should establish a grandfathering provision that for disclosure language that complies with the Vermont labeling rule (i.e., [Partially] [May Be] Produced with Genetic Engineering AND, The term bioengineered in the disclosure text is also supported and AMS should consider the following two options for the mandatory disclosure: Ingredients sourced from bioengineered crop(s) (or animal as appropriate) Ingredients may be sourced from bioengineered crop(s) (or animal as appropriate)
25 What is Next for the Bioengineered Food Labeling Rule? Late March or early April Publication of a Proposed Rule 30 or 60 day Public Comment Period Thousands more comments will be submitted to USDA/AMS Will USDA meet the statutory deadline of July 14, 2018??? If not, it could face NGO lawsuits. Will highly refined ingredients be subject to disclosure when no rdna material is present???
26 Media Coverage Expected to Spike During Comment Period
27 Does It Matter Michigan State University Survey Question: GMOs have genes and non GMOs do not, true or false? True 37% False 63% Another survey asked consumers if GMO ingredients should be labeled, 73% said Yes. But when asked the open-ended question, What information would you like to see on food labels that is not already on there? only 7% called for GMO labels unprompted Seemingly this puts 66% of consumers in the Sure, why not camp.
28 Which One Is Bioengineered?
29 Nutrition and Menu Labeling
30 New Nutrition Facts Panel FDA released the final rule for the new Nutrition Facts Panel (NFP) on May 27, FDA proclaimed that the new NFP would reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease and would make it easier for consumers to make better informed food choices.
31 Changes to NFP Serving size declaration in larger bolder type Serving sizes updated Updated daily values New added sugars Vitamins & minerals change and amounts are declared New footnote language Fats Calories from Fat is no longer permitted. Trans fat remains on the label
32 Changes to NFP Serving size declaration in larger bolder type Serving sizes updated Updated daily values New added sugars Vitamins & minerals change and amounts are declared New footnote language Fats Calories from Fat is no longer permitted. Trans fat remains on the label
33 Implementation of the New NFP Delayed FDA has proposed to delay the compliance date of the NFP regulations and, until that decision is finalized, will exercise enforcement discretion and extend the enforcement dates to January. 1, 2020, for manufacturers with $10 million or more in annual food sales, and to January 1, 2021 for manufacturers with less than $10 million in annual food sales. Industry goal is to have USDA and FDA align enforcement of bioengineered food labeling with the new NFP
34 Menu Labeling-- arriving soon at restaurant near you April 2011, FDA proposes menu labeling rule Dec. 2014, FDA issues final menu rule Dec.2015, Consolidated Appropriations Act, Section 747 forces delay May 2016, FDA issues final guidance May 2017 enforcement deadline extended to May 5, 2018
35 Scope: Who is Covered and for Which Foods? A covered establishment is a restaurant : with 20 or more locations, doing business under the same name, offering for sale substantially the same menu items, and selling restaurant-type foods*. *The key attribute of restaurant-type foods is that they are usually eaten on the premises, while walking away, or soon after arriving at another location.
36 Minimum Mandatory Requirements Three basic requirements: Disclose calories or cal for standard menu items on a menu, menu-board, or signs adjacent to foods on display and self-serve foods that are standard menu items. Post a statement concerning suggested daily caloric intake ( 2000 calories a day is used for general nutrition advice, but calorie needs vary ) Post a statement advising that written nutrition information for standard menu items is available upon request (including calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, and protein). - provided on a counter card, sign, poster, handout, booklet, looseleaf binder, electronic device, or in a menu.
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39 Multiple Self-Serve Items
40 Multiple Food Combinations
41 Much Gnashing of Teeth Over Pizza
42 Will it Matter? MAYBE NOT RESEARCH ARTICLE Five Years Later: Awareness Of New York City s Calorie Labels Declined, With No Changes In Calories Purchased MAYBE YES UK Study says Putting calories on restaurant and cafe menus cuts intake by around 12 per cent, research suggests.
43 Health Claim for Soybean Oil
44 Qualified Health Claim for Soybean Oil In July 2017, FDA authorized following claim language for soybean oil: Supportive but not conclusive scientific evidence suggests that eating about 1½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil.
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