By Joseph L. Baumert, Ph.D., and Steve L. Taylor, Ph.D.
Best Practices with
Allergen control is becoming an increasingly important component of the overall food safety programs for the food industry. The recent proposal by the U.S. Food and Drug Administration (FDA) on preventive controls
indicates, in part, that allergens should be identified
as hazards in situations where undeclared allergens are
reasonably likely to occur in the absence of appropriate controls. Thus, allergens become part of the overall
Hazard Analysis and Critical Control Points program
for many food processing facilities. Accordingly, Critical Control Points must be identified and critical limits
must be established. Allergen control approaches must
be validated and verified.
Even before the FDA proposal, auditing organizations were evaluating the adequacy of allergen control
plans within food manufacturing facilities. The Safe
Quality Food (SQF) Institute stated in its 2000 code that
“verification of the effectiveness of cleaning and sanitizing of areas and equipment in which allergen-causing
agents are used shall be part of the requirements....” The
SQF code goes on to indicate “the responsibility and
methods used to verify the effectiveness of the cleaning
procedures shall be documented and implemented” and
that “a verification schedule shall be established.” The
general SQF approach does not specify how allergen
control practices should be validated and verified.
Similarly, the British Retail Consortium (BRC) global
standard for food safety states “based on risk assessment,
documented equipment or area cleaning procedures
shall be undertaken to remove or reduce to acceptable
Allergen control depends
on an effective food safety
levels any potential cross-contamination
in compliance with finished product
specifications.” BRC further indicates
that cleaning methods should be validated. Again, the specific approaches to
validation are not provided.
Historically, the food industry began
to develop allergen control programs in
the early 1990s. At that time, the food
industry lacked analytical test methods
for the detection of residues of allergenic foods with the exception of the so-called Skerritt method to detect gluten.
Pragmatically, visual cleanliness became
the industry standard for the assessment
of the effectiveness of Sanitation Standard Operating Procedures (SSOPs) on
shared equipment. Despite its subjective
nature, visually clean turned out to be
an excellent approach and remains part
of the industry’s approach today. Where
particulate contamination of shared
equipment can occur, sampling for analytical testing can be quite challenging.
In those cases, the visually clean standard is appropriate and efficient.
Testing to Verify Allergen Control
Beginning in the mid-1990s, analytical test methods were developed that
can be used for the validation and verification of allergen control programs.
A wide variety of analytical approaches
have since emerged, including enzyme-linked immunosorbent assays (ELISAs)
for specific allergen residues, ATP detection, general protein detection, polymerase chain reaction (PCR) to detect
DNA fragments from the allergenic
food and mass spectrometry methods
to detect specific target peptides from
allergenic sources. PCR and mass spectrometry require expensive, specialized
equipment plus laboratories and highly
trained personnel to conduct the analysis and analyze the large quantity of
data generated (for mass spectrometry).
Accordingly, these methods primarily
serve as confirmatory procedures that