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Algae Biomass Summit
October 2013
Orlando, FL
Production of food ingredients &
chemicals:
Regulatory considerations for parallel
production and dual channel substances.
Greg Sower, PhD
Meghan McKelvey, MBA, HACCP certified
Gavin Thompson, PhD
2
Sources of Food Additives and
Ingredients
Farms:
Raw Agricultural
Commodities
Facilities:
Processed Foods
Manufactured
Chemicals
Algae production is comparable to farms and facilities.
3
Regulatory Frameworks
The governing framework depends on the intended uses:
1. Industrial chemicals: Toxic Substances Control Act (TSCA) –
administered by the EPA.
2. Foods, feeds, drugs & cosmetics: Federal Food Drug and
Cosmetics Act (FDCA) – administered by the FDA.
3. Pesticides, biocides, antimicrobials: Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) – administered by
EPA (with input from FDA).
Many substances are regulated under TSCA and FDCA.
4
Dual Channel Substances
Example:
Adipic acid – used as a monomer in the production of nylon and as a
direct food ingredient to modify flavor and texture (21 CFR 184.1009).
Many substances can be used either as an industrial
chemical or as a food additive or ingredient.
Food additives
& ingredients
(FDCA)
Industrial
chemicals
(TSCA)
5
Parallel Production
A facility may have separate production lines or manufacturing areas.
Facilities may manufacture both TSCA and FDCA
regulated substances separately.
Food additives
& ingredients
(FDCA)
Industrial
chemicals
(TSCA)
6
21st Century Food Regulations
Substances for food use must comply with the FDCA as
modified by the Food Safety and Modernization Act
(FSMA).
FSMA: intended to expose, mitigate and manage supply
chain weaknesses.
Substances manufactured for non-food uses cannot be
used directly as food additives/ingredients unless
manufactured under FDCA & FSMA regulations.
If intended for food, then substances must meet all
regulatory requirements for food use.
7
• Is the facility registered with FDA?
• Does you use current Good
Manufacturing Practice (cGMP)?
• Do you purchase through a
broker? Do you know the source?
• Do they know the intended use of
the product? Is it food grade?
Questions for Food Facilities
8
20th
Century Supply Chains
Food ingredient production required cGMP.
New chemical substances required PMN; new microbes a MCAN.
9
21st Century Supply Chains
Facility Registration – cGMP – Preventive Controls – Product Tracing
No major changes to TSCA … yet.
10
21st Century Supply Chains
11
Facility Registration
Who must register?
Any facility “manufacturing, processing, packing, or
holding food for consumption in the US” must be
registered with the FDA in accordance with the
Bioterrorism Act of 2002. Under FSMA, these facilities
must update their registration every two years.
Food producers should verify that their ingredient
suppliers’ facilities, foreign and domestic, are
registered with FDA.
12
Preventive Controls
New regulations require a written Hazard Analysis and
Risk-based Preventive Controls plan.
Preventive controls are based on the Hazard Analysis
and Critical Control Point (HACCP) framework that is
required for certain high-risk foods.
Final FDA guidance is pending.
Manufacturers should begin preparing their preventive
controls plans using HACCP as a model and review
those of their suppliers.
13
21st Century Supply Chains
Foreign Supplier Verification Program – Voluntary Qualified Importer Program
14
Foreign Supplier Verification
Importers must verify that a foreign supplier
complies with preventive controls requirements and
that their product is not adulterated (according to US
standards). An “importer” is defined as a US owner,
consignee, or the US agent or representative of a
foreign owner.
The verification responsibility is on the US-based
importer – know your broker and supplier.
15
Voluntary Qualified Importer
Program
Imports to the US may be expedited by eligible,
qualified importers. To be eligible an importer must
use a facility that has been certified by an accredited
third party. FDA guidance for the VQIP program and
for third party accreditation is pending.
Although guidance is pending, food producers and
manufacturers should review their supply chain for
potential weakness.
Imported dual channel substances with only TSCA
compliance will be exposed under these regulations.
16
21st Century Supply Chains
Use as a food ingredient requires adherence to food regulations.
17
Algae-specific Considerations
Are you using “waste” products from other industries?
Water, CO2?
18
• Key Data Elements (KDEs) lot numbers, storage
areas and temperatures, etc.
• Critical Tracking Events (CTEs)
• Standardized Formats & Electronic Records
• Required Audits & Training
Product Tracing will expose the supply chains of
dual channel substances.
New rules for food: Product Tracing
19
Broker/
Storage
Transport #1 Ingredient
Manufacturer #1
Consumer
Food Product
#2
Formulator/
Packager #2
Inputs &
Raw Materials Production
Distribution
& Storage
Transport #2
Formulator/
Packager #1
Food Product
#1
Retail Market
Transport #3
Source #1
Source #2
Source #3
Material #1
Source #1
Source #2
Material #2
Source #1
Source #2
Material #3
Transport #4 Broker/
Storage
Ingredient
Manufacturer #2
Retail #1
Retail #3
Retail #2
CTE
(Critical Tracking Event)
Product Tracing under FSMA
20
Pre-Manufacturing Notice or
Microbial Commercial Activity Notice
1 2 3 4
Complete
PMN/MCAN form
EPA Review
(90 days)
Submit to EPA Objection/
No Objection/
SNUR
To
market
21
New Dietary Ingredient Notification
1 2 3 4
Develop Safety
Dossier
FDA Review
(75 days)
Submit to FDA Objection/
No Objection
To
market
22
GRAS Determination & Notification
1
Develop
Safety
Dossier
3
Submit to FDA
(voluntary)
2
Expert Panel Review
(if GRAS, then to market
to or FDA)
4
FDA Review
(180 days)
5
“No questions”
(or withdrawal)
To market
23
Conclusion
There are many similarities between TSCA and FDCA
regulated substances; however,
due to recent legislation, FDCA products have
increased regulatory obligations that can significantly
impact market access.
24
Getting Your Product to Market
Take home:
Are you making a chemical
or a food ingredient?
Greg Sower, PhD
602-734-7738
Gavin Thompson, PhD
602-734-7704
