Michelle Wright Consulting, LLC Regulatory & Labeling Consulting for the Food Industry. GMO Labeling PAST, PRESENT AND FUTURE

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1 GMO Labeling PAST, PRESENT AND FUTURE

2 Definition DNA changes naturally over time in all organism Referred to as an event GMO Organisms where DNA has been modified in a lab Organisms Plants Animals Microorganisms Terms Genetically Modified Organisms GMO Genetically Engineered GE Ingredients

3 DNA

4 History Monsanto did much of the work in the US 1980 First Patent was issued on GMO 1984 FDA approves first GMO E. coli Big question on FDA approval process 1994 GMO tomato is sold 1999 GMO crops dominate the market 2000 s Labeling and consumer questions persist

5 Approved GMO Crops Corn Soybeans Cotton Wheat Canola Squash Papaya Tomatoes Rice Flax Potatoes Coffee Beans Sugar Beets Bananas Lettuce Apples

6 Animal Testing and experimentation in many animals Salmon FDA Approved in 2015 Banned from sale until labeling is resolved Sold in Canada

7 US Approval EPA Regulates pesticides Many GMO change which changes pesticide resistance Must provide safe for environment Ensure proteins are not allergenic FDA Food safety GRAS Substantial equivalent Toxicology data

8 International Regulations Every country has own regulations Many countries require prior approval Growing vs Importing Labeling requirements Regulations continue to change

9 Countries Canada No labeling requirements EU 0.9% limit Must trace back to source Japan Required on certain foods and ingredients 5% threshold Korea Corn, cotton, canola, sugar beets 3% threshold

10 Testing Event specific Done using ELIZA method Different test for each type of GMO Have combined some tests Protein must be present to test

11 Traceability From farm to table

12 Certificates Not issued by government Several options 3 rd party certifications Non GMO project Lab for analysis Company certificate Rarely needed Some require traceability

13 State Labeling Proposals bills in 25 states

14 Vermont GMO Labeling Required GMO ingredients to be labeled Requires a statement if any ingredients are GMO Starting June 30, 2016 Product produced before allowed until Jan 1, 2017 Exemptions include: USDA products (including milk) Products grown without GMO Processing aids Less than 0.9% GMO Alcoholic beverages Products not for retail sale Medical foods

15 G.M.O. Labeling Bill Clears First Hurdle in Senate The Senate cleared a procedural hurdle with a vote on legislation that would block state-mandated biotech food labeling laws and permit food producers to use QR codes on products containing biotech ingredients instead of stating on labels that the products are biotech. Final Senate approval could occur as early as today. passes-first-hurdle-in-senate.html?wt.mc_id=smartbriefs- Newsletter&WT.mc_ev=click&ad-keywords=smartbriefsnl

16 AMS Proposed Rule AMS task with creating legislation July 2017 Ask for comments outside of Federal Register May 24, 2018 Published proposed rule July 3, 2018 Comments due Waiting for final rule Rumored Dec 2018

17 Proposed Rule Bioengineered food or bioengineered ingredient Not allowed GMO Genetically modified Genetically engineered Any others Does not imply food is more or less safe

18 Options Position 1 Label is not required if no DNA is present Position 2 Labeling is required for all foods Traceability to the source

19 Bioengineered Food List HIGHLY ADOPTED Canola Field Corn Cotton Soybean Sugar Beet NOT HIGHLY ADOPTED Apple Sweet Corn Papaya Potato Summer Squash

20 Incidental Additives Ingredients that Are removed during processing Are commonly found in food Have no technical or functional effed Do not appear on label Not specifically addressed in proposed rule May fall under thresholds

21 Thresholds 0.9% Aligns with EU regulations Reduced cost to implementation since already used by some companies 5% Ingredients Ingredient specific Grain cross contamination 5% Total Weight of Product

22 Exempt Foods Restaurant foods Based on ingredient statement Milk Meat Poultry 1 st word Or 1 st word after water, broth, stock or like ingredient

23 Required Labeling Bioengineered Foods Used on commodities Contains a bioengineered ingredient Used on processed foods May contain Allowed on not highly adopted BE foods in US Locations Next to address line on back panel On PDP

24 Symbols Option 1 Option 2 Option 3

25 Electronic Information Scan here for more information Scan icon for more information Quick Response Code (QR) or water mark Call for more information Text message Text [number] for more food information

26 Small Manufacturers Phone number Text message Between $2.5 and 100 million in sales annually Less than $2.5 million exempt

27 Small Packages Scan for info Text for info Call for info

28 Foods Sold in Bulk Signs required Text Symbol Electronic or digital Text

29 Recordkeeping Required when highly adopted foods are not labeled Include Sales confirmation Bill of Lading Supplier attestations Purchase receipt Written records Contracts Brokers statement Analytical tests Process Verification 2 year record retention after shelf life of product

30 Proposed Compliance Date January 1, 2020 Small entities January 1, 2021 Use of inventories until January 2, 2022

31 USDA Labeling Not required on products where Meat or poultry 1 st ingredient Meat or poultry 2 nd ingredient behind water, stock or broth

32 Animal Food Non organic animals are fed GMO food Examples Milk Meat Poultry Corn and soybeans most common No ruling from AMS on if this is GMO Non GMO project does not allow Some companies have policies Be careful with labeling

33 Proposed Rule Comments Food 0.9% Incidental Additives Traceback to source Ag Lobby As little labeling as possible Only where DNA is present Consumers Label everything 0%

34 Label Claims

35 Organic USDA Agricultural Marketing Service Covers more than foods Must be approved by a certified organization Specific ingredients and production requirements Labeling Organic - >95% Made with Organic 70 95% List organic ingredients - <70%

36 Non-GMO FDA has no definition Guidance advises not to use GMO free Non-GMO Project Private organization with GMO definition AMS GMO certification

37 GMO Petition October 2018 Request to FDA Would not allow Non GMO Project labeling Currently open for comments

38 Natural FDA ANPR on natural Comments due May 2016 Unclear what FDA will decide Industry does not have consistent views Could be years before final rule

39 Natural Lawsuits Class action lawsuits on rise About 170 in 2017 Included natural Ingredients and GMO Recommend not use natural on label ever

40 Natural Lawsuits Kellogg s Kashi GMO Settled $5 million Stevia in the Raw Maltodextrin and dextrose from GMO Carriers for the product Settled for $1.5 million B&G Foods Bagels chips GMO Highly processed In process

41 Natural Lawsuits cont General Mills Nature Valley High fructose corn syrup, maltodextrin Sued by CSPI CSPI is not typically after money Removed claim Kraft Cheese Citric acid and natural flavors Still in process Capri Sun GMO Still in process ConAgra Wesson Oil GMO Still in process

42 Natural Lawsuits cont PopChips GMO and highly processed Settled for $2.4 million Trader Joe s Ascorbic acid, cocoa processed with alkali, xanthan gum, mono- and diglycerides, SAPP Settled Pepsico Naked Juice with GMO Settled for $9 million

43 Animal Feed Lawsuit Filed in October 2018 Natural Claim Animal products fed GMO feed California and Maryland Chipotle Restaurants Very new No ruling

44 Company Policies Some companies choose not to sell GMO Chipotle Whole Foods Panera Campbell s states it will label

45 Whole Foods GMO 2013 announce all foods sold in stores would be GMO free by Sept 2018 Never had a good definition of GMO free EU Animal food Protein present Remove from private label first Branded foods second Have delayed this policy Believe waiting for AMS final rule

46 Panera Bread Ingredient Policy Established a list of ingredients that are allowed in products they serve Refer to as clean ingredients Prohibited Artificial flavors MSG Artificial trans fat Artificial colors Artificial sweeteners Preservatives

47 Smart Label GMA program Provide product information Uses QR code Allowed in federal regulations

48 Sample Labels