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State of FDA’s Food Additives Program
Dennis Keefe, PhD
Director, Office of Food Additive Safety
U.S. Food and Drug Administration
October 14, 2015
Food Packaging Law Seminar
Washington, DC
1
Office of Food Additive Safety
• Our Mission
• Who We Are
• What We Regulate
• What We Have Accomplished
• Where We Are Going: Stewardship Challenges
• Bridge Building
2
Our Mission
To assure that the use of food ingredients is safe by:
Evaluating new applications efficiently & effectively
Expediting applications that mitigate food hazards
Meeting high performance standards with strong science and modern infrastructure
Directing resources to issues of greater public health importance while anticipating future trends
Maintaining data to monitor safety over time
Conducting research that supports the FDA regulatory agenda
3
Who We Were: The People
4
Who We Are: The People
5
Who We Are: Organizational Structure
6
Our Numbers: OFAS Human Capital: FTEs 1998-2015
0
20
40
60
80
100
120
140
160
180
7
What We Regulate: The Food “Ingredient” Universe
• Added Directly to Food for an Intended Effect
– Direct Additives: Sweeteners; preservatives;
nutrients; fat substitutes; texturizers (e.g., thickeners,
emulsifiers); flavors
– Color Additives: In food (also includes animal feed,
drugs, cosmetics, and medical devices (e.g., sutures,
contact lenses))
8
The Food “Ingredient” Universe (continued)
9
• Indirect Additives
– Food Contact Substances: Coatings (paper, metal,
etc.); new/recycled plastics including polymers and
monomers; paper; adhesives; colorants,
antimicrobials, and antioxidants in packaging;
packaging materials used during food irradiation;
packaging “formulations”
– Processing Aids: Antimicrobials (meat
and poultry processing); defoamers;
ion exchange resins
The Food “Ingredient” Universe (continued)
• Other “Ingredients”:
– Food Irradiation Equipment: To Process food or to
inspect food
– GRAS Substances: Enzymes; fibers; proteins; lipids;
sugars; MSG; antimicrobials; phytosterols/stanols;
flavors; infant formula ingredients
– Foods/Ingredients Produced Via Biotechnology:
Plants w/ herbicide resistance or insect resistance;
delayed ripening, etc.
10
Accomplishments Since 1958
• Food Additive Petitions > 4800
• Color Additive Petitions > 300
• GRAS Affirmation Petitions > 400
• Food Contact Notifications > 1550
• GRAS Notifications ~600 (since 1998)
Total: >7700 petitions/notifications
11
What We’ve Accomplished: Code of Federal Regulation Listings
• Regulations/Effective Notifications
– Food Additive >700
– Affirmed GRAS ~ 350
– Color Additive > 200
– FCNs > 1170
– Total: ~2500
• Substances
– Direct Food Additives > 800
– Indirect Food Additives ~ 3500
– GRAS Substances > 1000
– Color Additives ~ 300
– Total: > 5600 12
Submissions Completed by Fiscal Year
0
20
40
60
80
100
120
140
2007 2008 2009 2010 2011 2012 2013 2014 2015
FCN
C/FAP
GRN
BNF
13
Submissions Completed by Fiscal Year
14
0
20
40
60
80
100
120
140
160
180
200
2007 2008 2009 2010 2011 2012 2013 2014 2015
BNF
GRN
C/FAP
FCN
15
ChallengesScience
• Validating in silico, in vitro, and high throughput screening assays in
risk assessment.
• Applying emerging methodologies for risk assessments (e.g., read
across, AOPs, threshold approaches).
• Role of epidemiology studies in risk assessments.
• Utilization of risk factors for chronic disease vs frank organ/tissue
lesions as endpoints
• Updating risk assessments based on new data and information
(e.g., cyclic review)
• Updating Redbook Guidance
16
ChallengesPolicy
• Public Health Protection Priorities
– Reduction of Foodborne Illnesses
– Chronic disease and food ingredients (e.g., PHOs,
sugar, sodium, saturated fats)
• Science-based cyclic review of approved uses
– Priority ranking
– Access to supporting information
– Creation of administrative record to support action
• Resources/Priorities
17
ChallengesLaw
• Statutory Timeframes for Premarket Review– Food Additive and Color Additive Petitions
– Food Contact Notifications
• Implementation of the GRAS Exclusion
• Safety Standard: Reasonable Certainty of No Harm
• Delaney Clause: “. . .no additive shall be deemed to be safe if
it is found to induce cancer when ingested by man or animal, or if it
is found, after tests which are appropriate for the evaluation of the
safety of food additives, to induce cancer in man or animal. . .”
18
ChallengesRecent Events of Note
• GAO: “Food Safety: FDA Should Strengthen Is Oversight of Food Ingredients
Determined to Be Generally Recognized as Safe” (GAO-10-246) (2010)
• Citizen Petitions to initiate FDA rulemaking to amend existing food additive or color
additive regulations (e.g., BPA, BHA, certified color additives) or to prohibit the use of
a food ingredient (e.g., PHOs).
• Litigation to compel FDA to respond to Citizen Petitions (e.g., BPA, PHOs) or to
finalize proposed rules (e.g., FSMA, GRAS Notification program).
• Food Additive Petitions (2) to revoke food additive regulations based on
abandonment (e.g., BPA).
• Food Additive Petitions to revoke food additive regulations based on safety (e.g.,
perfluoroalkyl ethyl compounds and perchlorate, 7 synthetic flavoring agents).
• Color Additives: Increased interested in biological vs. coal tar starting materials
19
ChallengesPublic Perception/Confidence
20
ChallengesPublic Perception/Confidence
21
ChallengesPublic Perception/Confidence
22
ChallengesPublic Perception/Confidence
23
Stewardship
“. . . conducting, supervising, or managing of
something; especially: the careful and responsible
management of something entrusted to one's
care”
Miriam Webster
24
Food Safety Stewardship It is Important to All of Us
25
Food Safety StewardshipWho is Responsible?
26
FDA
Industry Stakeholders
Advocates
Consumers
All of the Above!
Food Safety StewardshipAssuring Food Safety through Action
27
Communication
• FDA
• Food Industry
• Advocates
• Consumers
Food Safety
• Adherence to Regulations
• New Products and Technologies
• New Uses
Transparency
• Clear Processes
• Data Sharing
Regulatory Stewardship
• “Cleaning up” 21 CFR
• Voluntary Submissions
Stewardship
StewardshipFood Ingredient Oversight Expectations
Consumers: Accessible, Safe and Affordable Food
– Access to affordable food
– Access to safe food
– Access to truthful labeling
– Able to make informed choices
– Confidence that FDA is neutral, science-based arbiter of food
safety
– Full disclosure of ingredients added to food.
• “Clean labels”
• “Chemicals” in food
• “Natural” ingredients
28
StewardshipFood Ingredient Safety Expectations
FDA: Rigorous, Responsive, Science-based, Process
Premarket
– Regulations should reflect industry’s current best practices
– Regulations should be based on the best available science
Postmarket
– Allows for post-market resources to focus on actual vs.
hypothetical or perceived chemical risks
– Enhances FDA’s ability to focus its finite resources on public
health priorities
29
StewardshipFood Ingredient Safety Expectations
Industry: Science-based, Efficient, Predictable,
Consistent
– Safe food
– Market access
– Level playing field
– Promotes technical innovations
– Promotes use of best available technology
– Demonstrates responsible corporate citizenship
30
StewardshipFood Ingredient Oversight Expectations
Advocates: Transparency, Independent assessments
– Safe food
– Predictable, science-based process
– Diverse interests that may or may not be directly related to food
safety (e.g., sustainability, production practices - organic, animal
welfare, antibiotic use, pesticide use, nutritional quality,
marketing practices)
31
StewardshipWhere Are We Going?
32
StewardshipGoing Forward
33
StewardshipPremarket Needs:
Update Regulations
– Science-based
– Reflect current market practice
– Systematic/efficient process
– Maximize resource allocations
34
StewardshipPostmarket Needs:
Food Chemical Knowledgebase:
– Food ingredient use information (foods & levels)
– Food consumption information
– Updated toxicology information
– Integration of in silico risk assessment tools based on QSAR,
Mode of Action, high throughput screening data, in vitro assays,
etc. to prioritize hazards.
Food Chemical Safety Communications
35
StewardshipProviding Data to FDA: Rewards
Create Public Value
– Continued assurance that use is safe
– FDA is better informed, and thereby better able to
timely respond to real and imagined safety concerns
– Increases likelihood for evidence-based risk
assessments, decision-making, dialogue and policy
– Finite resources can be focused on ensuring the safe
use of chemicals in food and premarket review
program.
36
Bridge Building I: Information Sharing MOUs
• OFVM/FDA and EPA’s Office of Chemical Safety and
Pollution Prevention
(http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-
2003-0004-0095)
• Updated MOU/SOP on interactions between OFAS and
FSIS/USDA
(http://www.fda.gov/aboutfda/partnershipscollaborations/memorand
aofunderstandingmous/domesticmous/ucm441552.htm)
37
Bridge Building II: E-submissions
Advantages of Electronic Submission
Secure and more efficient processing
Less wasted energy
Reduced physical storage
Fast delivery - same day upload
No cost for paper, binding and delivery
For a more comprehensive list of advantages visit the FDA Web Site:
FDA Electronic Submission Gateway: Impact of the Gateway
38
Resources for Electronic Submissions
FDA Electronic Submissions Gateway:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
OFAS Guidance:
http://www.fda.gov/FoodIngrPkgSubmissions
OFAS Training videos:
http://www.fda.gov/Food/IngredientsPackagingLabeling/ucm368958.htm
OFAS Quick links to forms, instructions and downloadable folders:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf
ormation/IngredientsAdditivesGRASPackaging/ucm199174.htm
39
Bridge Building III:Redbook
• Public Docket and Meeting (Dec. 9, 2014) soliciting
comment on our update of Redbook1. What components of the Redbook should receive priority for review and update?
2. What aspects of the safety and risk assessment of food ingredients or other
CFSAN-regulated products are not addressed and should be considered for
incorporation in the Redbook?
3. How can the Redbook be updated to more fully support the development and
submission of safety assessments for substances introduced into food?
4. How should we balance the desire for transparency and consistency in risk
assessment as described in the Redbook, with the goal of flexibility in applying
the most appropriate analysis for specific contexts?
• Outreach plans for professional meetings in 2016.
40
Questions?
41