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FDA Warning Letters Focus on HACCP Issues

Still not sure if the Food & Drug Administration is interested in Hazard Analysis and Critical
Control Point, or HACCP? Well, as one politician might say to an opponent during a debate, Quality Management &
Regulatory Compliance
“Let’s look at the record.”
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The FDA has already issued nearly 30 HACCP – pronounced “hassip” -- warning letters issued info@assurx.com
through the first four months of 2006. That accounts for the bulk of the food-related
warning letters issued by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN)
and other offices.

But that shouldn’t be surprising. In 2005 HACCP warning letters accounted for more than 80
of the approximately 100 issued by the agency. The pattern was similar in 2004, when more
than 100 of the approximately 130 food-related warning letters focused on HACCP.

In fact, HACCP warning letters tend to account for about 80% of those issued each year by
the FDA’s CFSAN and food-related letters from other offices. And you’ll have a long search
indeed if you are looking for an expert to tell you that that pattern is likely to change
anytime soon.

Clearly, HACCP remains a significant part of the FDA’s food enforcement focus. Now that
we’ve established that HACCP is important to the FDA and its inspectors, let’s take a quick
look at what those inspectors expect to find at a regulated site.

FDA Embraces HACCP

“Space-age technology designed to keep food safe in outer space may soon become
standard here on Earth,” the agency declared back in October 2001 when it significantly
expanded the HACCP program. The FDA adopted this food safety program developed nearly
30 years ago for astronauts and is applying it to seafood and juice. The agency intends to
eventually use it for much of the U.S. food supply. The program for the astronauts focuses on
preventing hazards that could cause food-borne illnesses by applying science-based controls,
from raw material to finished products. FDA’s new system will do the same.
Traditionally, industry and regulators have depended on spot-checks of manufacturing
conditions and random sampling of final products to ensure safe food. This approach,
however, tends to be reactive, rather than preventive, and can be less efficient than the new
system, the FDA says.

HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius
Commission (an international food standard-setting organization), and the National
Advisory Committee on Microbiological Criteria for Foods.

A number of U.S. food companies already use the system in their manufacturing processes,
and it is in use in other countries, including Canada.
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What is HACCP?

HACCP involves seven principles:

n Analyze hazards. Potential hazards associated with a food and measures to control those hazards are identified.
The hazard could be biological, such as a microbe; chemical, such as a toxin; or physical, such as ground glass or
metal fragments.
n Identify critical control points. These are points in a food’s production--from its raw state through processing
and shipping to consumption by the consumer--at which the potential hazard can be controlled or eliminated.
Examples are cooking, cooling, packaging, and metal detection.
n Establish preventive measures with critical limits for each control point. For a cooked food, for example, this
might include setting the minimum cooking temperature and time required to ensure the elimination of any
harmful microbes.
n Establish procedures to monitor the critical control points. Such procedures might include determining how
and by whom cooking time and temperature should be monitored.
n Establish corrective actions to be taken when monitoring shows that a critical limit has not been met--for
example, reprocessing or disposing of food if the minimum cooking temperature is not met.
n Establish procedures to verify that the system is working properly--for example, testing time-and-temperature
recording devices to verify that a cooking unit is working properly.
n Establish effective recordkeeping to document the HACCP system. This would include records of hazards and
their control methods, the monitoring of safety requirements and action taken to correct potential problems.
Each of these principles must be backed by sound scientific knowledge: for example, published microbiological
studies on time and temperature factors for controlling foodborne pathogens.

Need for HACCP

New challenges to the U.S. food supply have prompted the FDA to consider adopting a HACCP-based food safety
system on a wider basis. One of the most important challenges is the increasing number of new food pathogens. For
example, between 1973 and 1988, bacteria not previously recognized as important causes of food-borne illness--such as
Escherichia coli O157:H7 and Salmonella enteritidis--became more widespread.

There also is increasing public health concern about chemical contamination of food: for example, the effects of lead in
food on the nervous system.

Another important factor is that the size of the food industry and the diversity of products and processes have grown
tremendously--in the amount of domestic food manufactured and the number and kinds of foods imported. At the
same time, FDA and state and local agencies have the same limited level of resources to ensure food safety.
The need for HACCP in the United States, particularly in the seafood and juice industries, is further fueled by the
growing trend in international trade for worldwide equivalence of food products and the Codex Alimentarious
Commission’s adoption of HACCP as the international standard for food safety.

HACCP Advantages

HACCP offers a number of advantages over the current system. Most importantly, HACCP:
n focuses on identifying and preventing hazards from contaminating food
n is based on sound science
n permits more efficient and effective government oversight, primarily because the recordkeeping allows
investigators to see how well a firm is complying with food safety laws over a period rather than how well it is
doing on any given day
n places responsibility for ensuring food safety appropriately on the food manufacturer or distributor
n helps food companies compete more effectively in the world market
n reduces barriers to international trade.
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How FDA Inspectors Work

There is some good news for FDA-regulated firms out there wondering how to get in the shoes of an FDA Inspector:
The agency publicly publishes the instructions it gives to inspectors.

For food-related inspections, the FDA tells inspectors, “Regardless of the resource limitations you may have, you can still
use the principles of HACCP to guide your inspections.”

The agency defines “hazards” as the specific biological, chemical, or physical properties or agents that, if uncontrolled,
may lead to illness or injury. Risk factors are the poor conditions, procedures, or practices that result in out-of-control
food safety hazards.

Risk factors include -

n Food from Unsafe Sources
n Inadequate Cooking
n Improper Holding Temperature
n Contaminated Equipment
n Poor Personal Hygiene

Focus of Risk-Based Inspections

“Conducting a risk-based inspection requires you to focus on

evaluating the degree of active managerial control that an operator CFSAN’s ROLE IN FOOD SAFETY
has over risk factors,” the agency instructs inspectors. “In order
for you to properly assess active managerial control, you will need The FDA’s Center for Food Safety and
to spend the majority of your time observing the practices and Applied Nutrition (CFSAN) oversees
procedures that are likely to lead to out-of-control risk factors and
the safety and security of about 80%
of the U.S. food supply. It is responsible
asking food workers questions to assess the operation.”
for cosmetics, too. However, meat
and poultry do not come under its
Retail and food service operators implement “control measures”
jurisdiction; those are regulated by the
to ensure food safety. Control measures are actions or activities
U.S. Department of Agriculture.
that are used to prevent, eliminate, or reduce food safety hazards.
Instructors are told they’ll need to determine the control measures Since 9/11, CFSAN has ramped up its
that should be implemented to prevent the occurrence of risk efforts to protect the nation’s food
factors in each food preparation process. “In order to determine supply from terrorism. Much of its work
the risk factors common to each operation, it is important for you in this area centers on the Bioterrorism
to understand that the food preparation processes and all the Act of 2002. In 2005, the FDA published
associated control measures initiated by a retail or food service the final rule requiring registration of all
operator represent a food safety management system. It will be domestic and foreign facilities providing
necessary for you to ask questions in order to gain information food and feed for the U.S. market. Some
about the system already in place. Once you have done this, you 116,000 domestic and 155,000 foreign
will be able to determine the degree of active managerial control facilities have already complied with the
present in the facility and will be able to assist the operator in requirement.
strengthening the system.” By setting priorities early in the
inspection, observations attributed to out-of-control risk factors can be distinguished from those related to general
sanitation and maintenance, the agency tells its inspectors.

They are advised to set priorities by completing four activities early in their inspection:
n Establishing an open dialogue with the person in charge
n Reviewing previous inspection records
n Conducting a menu or food list review
n Conducting a quick walk-though 3
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Inspectors Look for the Boss

Remember: If you are in charge, the FDA inspector is likely to train their sites on you. “Having an open dialogue with the
person in charge during all phases of your inspection gives you an opportunity to learn important information about the
existing food safety management system,” the FDA instructs its inspectors. “It is important to know both the strengths
and weaknesses of the existing food safety management system early in your inspection so that you can focus your
inspection on weak areas.”

Asking the person in charge questions about important activities such as receiving, cooling, and preparation is also
important in relating the seriousness of out-of-control risk factors, the FDA tells inspectors.

Reviewing Previous Inspection Reports

And FDA inspectors will carefully examine your compliance record before they make a site visit. “If the same risk factor is
out-of-control during more than one inspection, it is strongly recommended that the operator develop an intervention
strategy to prevent its recurrence. Knowledge of what has been corrected from the last inspection also gives you the
opportunity to provide some positive feedback to the operator and allows you to track corrected violations in accordance
with your jurisdiction’s policy.”

Conclusion

The FDA makes it crystal clear that HACCP is critically important. As we have seen, it is one of the first issues an inspector
will focus on during an inspection. The evidence is obvious; the vast majority of food-related warning letters issued by
the agency focus on HACCP. It’s been that way for years and isn’t likely to change any time soon.

It is equally important for FDA regulated entities to understand HACCP and develop a proactive, strategic compliance
plan for their operation. That means developing a plan, identifying the tools and committing to training your people to
help your company avoid the sting of an FDA warning letter.

RESOURCES:

m The FDA has an excellent HACCP overview available for download at:

http://www.cfsan.fda.gov/~lrd/haccp.html

m The FDA’s “Playbook” for Inspectors, “Managing Food Safety: A Regulator’s Manual For Applying HACCP
Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary Food Safety
Management Systems,” is available at:

http://www.cfsan.fda.gov/~dms/hret3toc.html

m To keep up with the latest warning letters and spot any new enforcement trends, go to the FDA’s warning
letter database at:

http://www.fda.gov/foi/warning.htm

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please call 408-778-1376, ext. 705.

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