Food GMP

Modernization
Don L. Zink, Ph.D.
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Why Modernize Food CGMPs?
„ Originally written in 1969, last revised in 1986
„ Revolutionary new understanding of the causes
of foodborne illness compared to 20 years ago
„ Evolutionary changes in the food industry and
farm practices since 1986
„ Increased sales and consumption of fresh produce
items
„ More refrigerated ready-to-eat foods
„ More meals consumed outside the home
„ Fewer meals prepared from “scratch”
 Revolutionary Changes in Our
Understanding of Food Safety
„ Listeria monocytogenes is now recognized as
a significant hazard that can become
established in the food manufacturing
environment
„ Expanded view of food safety
„ Food allergens are now recognized as a hazard
„ We now have a Farm-to-Table view of food
safety
„ Salmonella control in fresh eggs
„ Fresh produce as a source of Salmonella, E. coli
O157:H7, Cyclospora, and HAV
Approach to CGMP Modernization
„ How can we amend the regulation to
make it “risk-based”
„ Involve stakeholders early in the process
„ Keep what has worked well in the past
„ Modernize the regulation in “phases” if
necessary
 GMP Research
„ Literature review
„ Examined other approaches to GMPs
„ Expert Elicitation
„ Identified the most significant problems and
most needed preventive controls
„ Class I and II recall analysis
„ Characterized the causes of processing
failures that led to recalls
 Expert Elicitation
„ Most significant food safety problems:

„ Deficient employee training

„ Contamination of raw materials

„ Poor plant and equipment sanitation

„ Poor plant design and construction

 Research Results
„ Expert Elicitation:
„ Need for GMP requirements for:
„ Training – Ongoing and targeted training
„ Audits – Periodic inspections by in-house or
external auditors
„ SOPs/SSOPs
„ Documentation of sanitation and key controls
„ Validation/Evaluation – prove the effectiveness of
controls, sanitation and training
 Recall Analysis
„ Reviewed class I and class II recalls for
1999 – 2003
„ Determined which recalls could have been
prevented by a GMP-type preventive
control
„ Two food scientists examined each recall
file to identify the likely root cause
 Recall Analysis
„ 1,307 recalls were class I or II during the
5 year period
„ 684 (50%) were class I and 649 (50%)
were class II
„ 1,146 recalls (88%) occurred because of a
GMP-related problem (including labeling
problems)
 Recall Analysis
Figure 1: Recall actions by specific processor-level problems*
(N=1146)

Unknown
4%
Ineffective use of sanitation principles
8%
Excess/mistaken addition of chemicals/ingredients
9%
Contamination of raw materials
8%
Failure to follow processing SOP
26%
Ineffective employee training
32%

Incorrect packaging/labeling
68%

0% 10% 20% 30% 40% 50% 60% 70% 80%

 Public Comments
„ Most common themes in comments:
„ The need to maintain flexibility
„ The need for guidance

„ Training

„ Food allergen controls

„ Environmental monitoring

„ Written sanitation procedures

„ Temperature controls
 Modernization Opportunities
„ Training for supervisors and workers to
ensure that they have the necessary
knowledge and expertise in food hygiene,
food protection, employee health and
personal hygiene to produce safe food
products.
 Modernization Opportunities
„ Allergen control plans for food processing
establishments that produce foods
containing allergens.
 Modernization Opportunities
„ Written environmental pathogen control
program for food processors that produce
ready-to-eat foods that support the
growth of Listeria monocytogenes.
 Modernization Opportunities
„ Written sanitation procedures that define
the scope, sanitation objective,
management responsibility, monitoring,
corrective action and record keeping
associated with the sanitation procedure.
 Modernization Opportunities
„ 21 CFR Part 110.19(a) excludes “establishments
engaged solely in the harvesting, storage, or
distribution of one or more ‘raw agricultural
commodities,’ ... which are ordinarily cleaned,
prepared, treated, or otherwise processed
before being marketed to the consuming public”
from compliance with the regulations in Part
110. Part 110.19(b) states “FDA, however, will
issue special regulations if it is necessary to
cover these excluded operations.”
 Modernization Opportunities
„ “…manufacturers must keep certain types of
processing records to document that controls
and systems that ensure food safety are being
carried out properly, and that the agency needs
to be able to review these records in order to
verify that a food establishment is in compliance
with the regulations.”
„ Training
„ Allergen Control Plan
„ Listeria monocytogenes control plan
„ Sanitation procedures
 Modernization Opportunities
„ Amend 21 CFR 110.80(b)(3) which lists
specific temperature requirements for hot
and cold storage of foods, and instead
issue guidance for temperature control
 Current Status
„ During the past year, staff resources have been
devoted to fresh produce issues and the citizen’s
petition on a “tolerance” for Listeria
monocytogenes in foods that do not support
growth
„ We are now putting some staff resources back
into the CGMP Modernization effort and we are
in the early stages of drafting a proposed rule
„ GMP research questionnaire