Edible Fats and Oils Regulatory Update. National Institute of Oilseed Products March 16-18, 2014 San Antonio, TX

Transcription

1 Edible Fats and Oils Regulatory Update National Institute of Oilseed Products March 16-18, 2014 San Antonio, TX

2 The Institute of Shortening and Edible Oils (ISEO) is a trade association representing the refiners of edible fats and oils in the United States. Our eighteen members manufacture the vast majority of the edible fats and oils produced domestically that are used in baking and frying fats (shortening), cooking and salad oils, margarines, spreads, confections and toppings, and ingredients in a wide variety of foods. 2

3 Regulatory Update Where do I begin???

4 E Edible Fats and Oils Regulatory Update Focus on Food Regulations and Initiatives GMO Labeling Partially Hydrogenated Oils Food Safety Modernization Act Nutrition Labeling

5 Mandatory GMO Labeling State or Federal Right to Know or Right to Scare??? OR

6 State GMO Labeling efforts continue in 2014 So far this year, 67 GMO labeling bills introduced in 25 states according to National Council of State Legislators In 12 states, at least one legislative committee has approved a GMO bill. They include Colorado, Illinois, New York, Utah and Vermont

7 Maine Governor LePage Signs GMO Label Law Requirements: Label: Retail food that is genetically engineered must bear a conspicuous statement "Produced with Genetic Engineering." Location: on the package or, for unpackaged food on a card or label at point of purchase Natural, Cannot be labeled Natural Enforcement Date Trigger: When substantially similar legislation passes in at least 5 states or in one or more states with a population or combined population of at least 20,000,000.

8 New Hampshire House kills GMO labeling bill New Hampshire, House of Representatives voted down its version of the GMO bill by

9 Debating GMO Bills Now in N.E Massachusetts must move bill out of Committee by March 19th & Others, including California, Maryland, Missouri, Minnesota and Rhode Island.

10 Washington State Votes Down I 522 Mandatory GMO Labeling Measure In November 2013, Washington state voters narrowly rejected mandatory GMO labeling law by vote count of 51% to 49%

11 Colorado, Next Ballot Initiative? Right to Know Colorado GMO launched a grassroots campaign to achieve mandatory labeling of GMOs statewide via November 2014 Ballot Initiative

12 Federal Legislative Efforts Sen. Barbara Boxer (D-CA) Congressman Pete Defazio (D-OR) Genetically Engineered Food Right-to-Know Act introduced 2013 No activity in House or Senate

13 National Level Initiative Campaign begun in 2011 continues to urge FDA to require GMO labeling of food Website claims 1.3 million consumers have signed its petition Supports State level GMO lobbying

14 Industry Activities at Federal Level Grocery Manufacturers Association activity 1. Campaigns helped defeat ballot initiatives in CA and WA 2. Launched consumer facing website Facts about GMOs 3.Organized Coalition for Safe Affordable Food Thirty two food and agriculture organizations supporting

15 Industry Activities at Federal Level Coalition for Safe Affordable Food Objectives 1.Provide policy makers, media and consumers factual information on GM technology; and 2. Advocate policy solutions at the federal level

16 Industry Activities at Federal Level Coalition for Safe Affordable Food supports federal legislation that would: Advance Food Safety: Require mandatory FDA safety reviews of all new GMO traits before commercialization. Authorize FDA to mandate the labeling of GMO food ingredients if there is a health, safety or nutrition issue with GMO technology. Inform Consumers: Establish federal standards to allow companies to voluntarily label their product for the absence-of or presence-of GMO food ingredients. Provide Consistency: Require FDA to define the term natural to provide a consistent legal framework that will guide food labels and inform consumer choice

17 17 PHOs and the Cayman Islands

18 FDA Notice of Nov. 7, 2013 (Fed. Reg.) FDA tentatively determined PHOs not generally recognized as safe (GRAS) for any use Basis = no consensus among qualified experts that PHOs, are safe for use in food. Targets PHOs only not other trans fatty acid (TFA) sources If finalized: PHOs will be non approved food additives not allowed in food or food ingredients without prior approval 18

19 Estimated Impacts of FDA Proposal FDA estimates (20-year net) costs to industry at $12 to $14 billion, FDA estimate benefits between $117 and $242 billion Based on CDC estimates reductions of: 10,000-20,000 coronary events 3,000-7,000 deaths annually 19

20 Trans Fat Intake Reductions US mean adult intake of TFA in 2003 = 4.6 g/day US mean for population over 2 years age in 2010 = 1.3 g/day 2012 update estimated the mean for this population = 1.0 g/day >75% reduction in TFA over past decade FDA claims certain individuals may continue to consume high levels of TFA from certain foods Trans Fat Intake 2003 vs vs Refrigerated biscuits 5 Frostings Frozen pizza Microwave popcorn Grams 20

21 FDA Notice Poses Questions FDA Poses 7 questions: 1. Should FDA finalize its tentative determination? 2. Are there data to support other possible approaches to addressing the use of PHOs in food, such as by setting a specification for trans fat levels in food? 3. How long would it take producers to reformulate food products to eliminate PHOs from the food supply? Are there likely to be differences in reformulation time for certain foods or for certain types of businesses? 4. If FDA makes a final determination that PHOs are not GRAS We welcome comments on what would be an adequate time period for compliance. 21

22 FDA Notice Poses Questions FDA Poses 7 questions (continued): 5. Are there any special considerations that could be made to reduce the burden on small businesses that would result from removal of PHOs from foods, such as additional time for reformulation? 6. Are there other challenges regarding the removal of PHOs from foods? Are there products that may not be able to be reformulated? If so, what sorts of products and what challenges are faced? 7. Is there any knowledge of an applicable prior sanction for the use of PHOs in food? 22

23 FDA Tentative Determination Raises Questions FDA Tentative Determination Raises Concerns Regarding: The scientific data at current TFA intake levels (i.e. was it adequately evaluated?) Procedural concerns (i.e. informal process vs. rulemaking and no apparent consideration of alternative actions) Suggests FDA expanding food safety to include unhealthy dietary components (i.e. does unhealthy ingredient now = unsafe ingredient???) The absence of a definition for PHOs vs. fully hydrogenated oils (FHOs) 23

24 FDA Resolve We Moved Forward on Many Fronts This Year this past year s accomplishments on behalf of public health have been as substantial as any in FDA s recent history. We also took important steps towards reducing artery-clogging trans fat in processed foods, and. Posted December 23, 2013 by FDA Voice: Comments from senior level FDA officials suggest: Confident with their authority, Duty to address the issue 24

25 Comment Deadline March 8, What is Next? FDA will review comments determine whether to finalize the determination or take another action If FDA elects to finalize GRAS determination for PHO it could simply issue another Federal Register Notice Timing of Notice (3-6 months???) Notice would likely set future enforcement date (> year???) OR FDA could pursue an alternative action (e.g. set a limit for TFA in food or fat ingredients or address TFA through nutrition labeling) 25

26 Food Safety Modernization Act

27 Food Safety Modernization Act Reg Section Comment Published Fed Reg Preventative Controls for Human Foods Publish Jan 2013 August 30, 2015 Produce Safety Publish Jan 2013 October 31, 2015 Foreign Supplier Verification July 2013 October 31, 2015 Preventive Controls for Animal Food Ext request June 30, 2014 August 30, 2015 Accredited Third Party Certification November 15, 2013 October 31, 2015 Intentional Adulteration Ext request June 30, 2014 May 31, 2016 Sanitary Transport May 31, 2014 March 31, 2016

28 FSMA Update Intentional Adulteration Intentional adulteration of the food supply with intent to cause public health harm is unlikely to occur but could have catastrophic impacts Illnesses/Injuries/Deaths INTENTIONAL ADULTERATION Unlikely to occur but Public Fear/Lost Confidence Economic Loss

29 FSMA Update Intentional Adulteration Food Defense Preventing Adulteration, Who is Covered? Applies to both domestic and foreign facilities that are required to register as a food facility under section 415 of the FD&C Act. Human Food, Yes Animal Food, No

30 FSMA Update Intentional Adulteration Yes Food Defense Preventing Adulteration, What is Covered? No

31 FSMA Update Intentional Adulteration Food Defense Plan: 1. Are there Actionable Steps? If yes, triggers 2. Focused Mitigation Strategies 3. Monitoring 4. Corrective Actions 5. Verification 6. Training 7. Recordkeeping Written Food Defense Plan How do you Control Access?

32 FSMA Update Intentional Adulteration Four Key Activities are Determinative: Bulk liquid receiving and loading Liquid storage and handling Secondary ingredient handling Mixing and similar activities

33 ISEO Technical Update Reg Section Comment Published Fed Reg Preventative Controls for Human Foods Publish Jan 2013 August 30, 2015 Produce Safety Publish Jan 2013 October 31, 2015 Foreign Supplier Verification July 2013 October 31, 2015 Preventive Controls for Animal Food Ext request June 30, 2014 August 30, 2015 Accredited Third Party Certification November 15, 2013 October 31, 2015 Intentional Adulteration Ext request June 30, 2014 May 31, 2016 Sanitary Transport May 31, 2014 March 31, 2016

34 FSMA Update Sanitary Transport of Food Bulk Liquid Trailers Dry Vans & Reefers Proposed February 5, 2014 Comment Deadline May 31, 2014 Railcars

35 FSMA Update Sanitary Transport of Food Cargo Aircraft X Tank Ships

36 FSMA Update Sanitary Transport of Food Food Food Food

37 FSMA Update Sanitary Transport of Food Shipper Carrier Receiver

38 FSMA Update Sanitary Transport of Food Sanitary Transport Human & Animal Food: I. Vehicles and transportation equipment: I. Ensure design (cleanabilty) & sanitary maintenance of vehicles & transportation equipment keep food from becoming contaminated II. Transportation operations Requires competent supervisor to assure measures taken during transportation prevent contamination, e.g. : separating food from non-food items in the same load Preventing contamination of food from prior cargo during bulk transport

39 FSMA Update Sanitary Transport of Food Sanitary Transport Human & Animal Food: III. Information exchange: Require procedures for exchange of information about prior cargos, and temperature control between the shipper, carrier, and receiver. E.g. a carrier transporting bulk vegetable oil would ensure that a vehicle that had previously hauled milk will not introduce milk allergens.

40 FSMA Update Sanitary Transport of Food Sanitary Transport Human & Animal Food: IV. Training: Training of carrier personnel in sanitary transportation practices and documentation of the training. V. Records: Maintenance of written procedures and records by carriers and shippers related to transportation equipment cleaning, & prior cargos.

41 FSMA Update Sanitary Transport of Food ISEO Bulk Transport Guidance

42 Nutritional Facts Panel

43 Heads Up! Nutritional Facts Panel

44 Nutritional Facts Panel Update No more Calories from Fat No more DV chart for 2000 and 2500 diet

45 Nutritional Facts Panel Update

46 Nutritional Facts Panel Update

47 Nutritional Facts Panel Update

48 Nutritional Facts Panel Update Industry Reply to Proposal Regulation becomes Law FDA Proposes NFP Update FDA Publishes NFP Regulation

49 Edible Fats and Oils Update QUESTIONS???