Role of Testing to Ensure FSMA and Global Safety
Compliance for Functional Food and Dietary
Ingredients
Douglas L. Marshall, Ph.D., CFS
Chief Scientific Officer
Eurofins Microbiology Laboratories
douglasmarshall@eurofinsus.com
The Food Drug and Law Institute Conference
Safeguarding the Functional Food and Dietary Ingredient Supply
Chain
Washington, DC
September 10, 2013
Eurofins’ Mission is Health and Safety
Food
#1 worldwide
Environment
#1 worldwide
Our Mission:
Pharmaceuticals
#1 or 2 worldwide
To contribute to global health and safety by providing our
customers with high-quality laboratory and advisory services
while creating opportunities for our employees and
generating sustainable shareholder value
2
Growing Network of World-Class
Laboratories
Worldwide >180 laboratories in 35 countries
U.S. Laboratory Competence Centers
metals
supplements
dairy,
microbiology
seed
nutritional,
microbiology,
auditing
grain
mid- and near IR
microbiology
Microbiology,
filth/extraneous
seed
chemical
contaminants,
GMO,
allergens
microbiology
Disclaimer
• I do not work for or represent FDA or the Federal
Government
• I have no current or previous relationship with FDA
• The opinions expressed here are based on an analysis
of publically available information
• I have a potential conflict of interest as an employee of
Eurofins, which provides food and supplement
analytical, auditing, and consulting services
4
Old School Pillars of Food Safety
• Current Good Manufacturing Practices (CGMPs)
• Sanitation Standard Operating Procedures (SSOPs)
• Hazard Analysis Critical Control Point Program
(HACCP)
5
New School Pillars of Food Safety
• Environmental Monitoring Program (EMP) – pathogens
& allergens
• Supplier Verification Programs – don’t inherit your
suppliers problems
• Audits – naivety in use
6
CGMP/Hazard Analysis/Preventative
Control Proposed Rule
• 21 CFR part 110 Current Good Manufacturing Practices
are updated
• 21 CFR part 117 updates to mandate formal
identification and analysis of food safety hazards
reasonably likely to occur during processing,
packaging, and holding of food
• Implement risk-based preventative controls to
minimize or prevent hazards reasonably likely to occur
• Details required elements of a written food safety plan
• Mandates a “qualified individual” to develop and
manage food safety plan – formally trained or on-job
experience
7
FSMA CGMPs
• Manufacturing processes are clearly defined and
controlled
• Changes in manufacturing processes are carefully
evaluated
•
•
•
•
•
•
•
Written operational procedures
Trained employees
Adequate record keeping
Batch history
Product quality maintained during distribution
Recall plan
Recurrence prevention plan
8
Required Food Safety Plan Elements
Hazard Analysis
Preventive Controls
Reanalysis
Validation
Records
Verification
Monitoring
Corrective Actions
9
Which Contaminants are Important to Me?
Contaminants potentially can be found in
ANY food, supplement, or ingredient at ANY
time!
Preventive Control Programs
• Training programs for managers and/or workers
• Written records, e.g., batch records, sanitation
records, critical control point records
•
•
•
•
Validation of control measures
Written sanitation SOPs
Food label review and control program
Testing of in-coming raw materials, in-process
materials, finished products, and processing
environment
11
Required Preventive Controls
•
•
•
•
Process Controls
Food Allergen Controls
Sanitation Controls
Recall Plan
• Supplier Approval and Verification Program – not
required in proposed rule, but FDA believes this is an
important element and is seeking comments
12
Allergen Control Program
• Training of processing and supervisory personnel
• Segregation of food allergens during storage & handling
• Validated cleaning procedures for food contact
equipment
• Prevention of cross contact during processing through
measures such as:
 Scheduling of production runs
 Control or rework
 Use of dedicated production lines
• Product label review and label usage and control
• Supplier control program for ingredients and labels
13
Know What You’re Doing
Validation
• Science-based evidence used to support decision
making
Verification
• Are you doing what you say you should do?
• Are your suppliers providing you with what you
desire?
14
Required Verification Activities
• Prove that preventive controls are implemented and
working effectively
• Validate the adequacy of preventive controls for their
purpose and effectiveness in controlling the hazard
• Verify that controls are operating as intended and
review of monitoring records
• Requires reassessment of the food safety plan at least
every three years and at other times as needed
15
Suggested Verification Activities
• Product and environmental testing programs are not
required in proposed rule but FDA believes these are
important science-based verification activities
• Review of customer and other complaints
16
Required Recordkeeping
•
•
•
•
•
Written food safety plan, including the hazard analysis
Preventive controls
Monitoring
Corrective actions
Verification
17
Records
• Employee training programs related to food safety and
GMPs. Such records should include a description of
the training program(s) and evidence of successful
completion of the training for each affected employee
• Allergen control plans and records documenting
compliance with the provisions of that plan
• Listeria monocytogenes control plans and records
documenting compliance with the provisions of that
plan
• Written sanitation procedures
• HACCP plan documents and records demonstrating
process control of CCPs
18
Additional Suggested Activities
• Required training for employees and supervisors,
including a requirement for records that document
training
• Require, rather than recommend, cleaning non-foodcontact surfaces of equipment as frequently as
necessary to protect against contamination of food and
food-contact surfaces
19
Motivation for Supplement CGMPs
• Dietary supplements that contain ingredients in
amounts that are greater than those listed on the label
• Dietary supplements that contain ingredients in
amounts that are less than those listed on the label
• Wrong ingredient
• Presence of contaminants (e.g., bacteria, pesticides,
glass, lead, foreign material)
• improper packaging
• Mislabeling
20
Supplement CGMPs
• Design and construction of physical plants that
facilitate maintenance
•
•
•
•
Cleaning
Proper manufacturing operations
Quality control procedures
Testing final product or incoming and inprocess
materials
• Handling consumer complaints
• Maintain records
21
Supplement CGMPs
• Employ qualified employees and supervisors
• Design and construct their physical plant in a manner
to protect dietary ingredients and dietary supplements
from becoming adulterated during manufacturing,
packaging, labeling and holding
• Use equipment and utensils that are of appropriate
design, construction, and workmanship for the
intended use
• Establish and use master manufacturing and batch
production records
• Establish procedures for quality control operations
22
Supplement CGMPs
• Hold and distribute dietary supplements and materials
used to manufacture dietary supplements under
appropriate conditions of temperature, humidity, light,
and sanitation so that the quality of the dietary
supplement is not affected
• Keep a written record of each product complaint
related to CGMPs
• Retain records for 1 year past the shelf life date, if shelf
life dating is used, or 2 years beyond the date of
distribution of the last batch of dietary supplements
associated with those records
23
Role of Testing
Monitor Ingredient and Finished Product Specifications
•
•
•
•
Identity
Purity
Strength
Composition
Monitor Products and Process Environment for
Contaminants
• Pathogens
• Heavy Metals
• Pesticides
24
Why Test?
•
•
•
•
•
•
Brand protection
Liability reduction
Regulatory expectation
Validate effectiveness of control plans
Validate purchase specifications by our your customer
Outbreak investigations
25
FSMA New Testing Requirements
• All affected food must be evaluated for safety – final
product and environmental testing
• Monitoring requirements must verify that controls are
working correctly
26
Additional Motivation
Liability Insurers
Auditors
Investigators
Manufacturers
Competitors
Lawyers
Customers
27
Cost of Not Testing
•
•
•
•
•
Potential for injuring or killing your customer
Intrinsic and extrinsic costs associated with recalls
Damaged brand reputation
Loss of customer confidence in your products
No liability protection
28
Key Points on Testing
• If a sample tests positive for a pathogen or harmful
chemical, the entire lot/batch is considered positive
• Subsequent negatives do not negate a positive result
• Have in advance a plan of action in the event of a
positive result
• Refuse
• Divert – no direct human contact and no pathogenic
strains
• Destroy
• Recondition
29
30
Thank you for the opportunity to provide this overview
We look forward to working with you in the future
www.eurofinsus.com