Edible Fats and Oils Regulatory Update - NIOP · 2018. 9. 5. · State GMO Labeling efforts continue in 2014 • So far this year, 67 GMO labeling bills introduced in 25 states according

Edible Fats and Oils Regulatory Update

National Institute of Oilseed Products

March 16-18, 2014

San Antonio, TX

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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.

Regulatory Update

Where do I begin???

E Edible Fats and Oils Regulatory Update

Focus on Food Regulations and Initiatives� GMO Labeling� Partially Hydrogenated Oils� Food Safety Modernization Act� Nutrition Labeling

Right to Know or Right to Scare???

OR

Mandatory GMO Labeling State or Federal

State GMO Labeling efforts continue in 2014State GMO Labeling efforts continue in 2014State GMO Labeling efforts continue in 2014State 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

Maine Governor LePage Signs GMO Label LawMaine Governor LePage Signs GMO Label LawMaine Governor LePage Signs GMO Label LawMaine 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.

New Hampshire House kills GMO labeling billNew Hampshire House kills GMO labeling billNew Hampshire House kills GMO labeling billNew Hampshire House kills GMO labeling bill

New Hampshire, House of Representatives voted down its version of the GMO bill by 185-162.

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.

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%

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

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

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

Industry Activities at Federal Level

http://factsaboutgmos.org/

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


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


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

PHOs and the Cayman Islands

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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

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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

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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

– Refrigerated biscuits

– Frostings

– Frozen pizza

– Microwave popcorn

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0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

Grams

Trans Fat Intake 2003 vs. 2010

2003

2010

Trans Fat Intake 2003 vs 2012

2003

2012

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.

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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?

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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)

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FDA Resolve

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“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

Comment Deadline March 8, 2014--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???)

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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)

Food Safety Modernization Act

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

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

INTENTIONALADULTERATION Public Fear/Lost Confidence

Economic LossUnlikely to occur but

Illnesses/Injuries/Deaths


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


Food Defense – Preventing Adulteration, What is Covered?

Yes

No


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?


� Bulk liquid receiving and loading

� Liquid storage and handling

� Secondary ingredient handling

� Mixing and similar activities

Four Key Activities are Determinative:

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

FSMA Update – Sanitary Transport of Food

Dry Vans & Reefers

Bulk Liquid Trailers

Railcars

Proposed February 5, 2014 Comment Deadline May 31, 2014


Cargo Aircraft

Tank Ships

X


“Food”

“Food”

“Food”


“Shipper”

Receiver

Carrier


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


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.


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.


ISEO Bulk Transport Guidance

Nutritional Facts Panel

Nutritional Facts Panel

“Heads Up!”

Nutritional Facts Panel Update

No more “Calories from Fat”

No more DV chart for 2000 and 2500 diet





2016 201820172014 2015

FDA Proposes

NFP Update

Industry Reply to Proposal

FDA Publishes

NFP Regulation

Regulation becomes Law

Edible Fats and Oils Update

QUESTIONS???

Documents

Edible Fats and Oils Regulatory Update - NIOP · 2018. 9. 5. · State GMO Labeling efforts continue in 2014 • So far this year, 67 GMO labeling bills introduced in 25 states according