HACCP: Patrolling for Food-Borne Illness
by Paula Kurtzweil
       Like a cop on the beat, James Reed patrols his assigned food
processing area daily for any wrongdoing. But instead of seeking
out thugs on street corners, he's prowling for broken glass and
other food hazards lurking inside automated food processing lines.
       Reed is a lead person in Heinz USA's Pittsburgh factory, where
he oversees the filling and capping of 900 baby food jars a minute.
Several times a day he fills in for other employees and stops the
processing line, checks the machine for glass, documents findings
via computer, and, if necessary, withdraws the affected food
products for disposal.
       Reed's actions are part of a new food safety system that
focuses on preventing food-borne hazards that can cause illness.
The system is known as Hazard Analysis Critical Control Point, or
HACCP (pronounced hassip), and Heinz is one of a number of U.S.
food manufacturers that have adopted it within the last five years.
The National Food Processors Association estimates that about half
of its 300 member processors use some form of HACCP in their
operations.
       More may soon join them. In August 1994, FDA announced in an
advance notice of proposed rule-making that it was considering
whether to make HACCP mandatory for much of the U.S. food supply.
FDA already requires HACCP for the low-acid canned food industry
and has proposed it for the seafood industry.
       Also, FDA incorporated HACCP into its 1994 Food Code. The Food
Code is FDA's guidance and recommendations to state and territorial
agencies that license and inspect retail food establishments in the
United States and can serve as a model for them. Many restaurants
and retail food establishments already follow HACCP principles,
some because their local regulators mandate it. (See "New Food
Code: A Menu of Modern Safety Standards" in the April 1994 FDA
Consumer.)
       And, the U.S. Department of Agriculture has announced it will
propose HACCP for the meat and poultry industry. (USDA regulates
meat and poultry; FDA all other foods.)
       "This system--though it is simple and based on common sense--
signals one of the broadest food safety policy shifts in the last
50 years," said FDA Commissioner David A. Kessler, M.D.

Old vs. New
       Traditionally, industry and regulators have depended on spot-
checks of manufacturing conditions and random sampling of final
products to ensure safe food. This system is seen as more reactive
than preventive because it finds problems after they have occurred
rather than as the food is being prepared.
       HACCP, on the other hand, focuses on problem prevention.
Companies analyze their food production processes and determine the
"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 hazards can be prevented, controlled or
eliminated.
       At Heinz USA in Pittsburgh, for example, there are several
critical control points on the "capper," the machine that places 
caps on baby food jars. One potential hazard is broken glass. Even
though the machine can automatically detect the presence of broken
glass, employees stop the line and inspect the machine every half
hour for broken glass. This checking is a preventive measure. It
helps ensure that glass does not get into the baby food.
       Cooking, chilling, sanitizing, preventing cross contamination,
and employee hygiene are other examples of critical control points.
       What HACCP doesn't do is replace basic sanitation and good
manufacturing practices that are a part of today's food safety
system, noted Jeffery Rhodehamel, a microbiologist in FDA's
division of HACCP programs. "HACCP works in concert with them," he
said.

HACCP Close Up
       As it does at Heinz, a HACCP program typically involves seven
steps:
fl      Analyze hazards. Potential hazards associated with food are
identified. The hazard could be biological (such as a microbe),
chemical (such as mercury), or physical (such as broken glass or
metal). Also, establish preventive measures to control identified
hazards.
fl      Identify critical control points.
fl      Establish critical limits for each preventive measure
associated with a critical control point. An example for cooked
food might include setting the minimum cooking temperature and time
required to ensure a safe product. The temperature and time are the
critical limits.
fl      Establish procedures to monitor the control points. Such
procedures might include determining how and by whom cooking time
and temperature should be monitored.
fl      Establish corrective actions to be taken when monitoring shows
that a critical limit has not been met. Examples are reprocessing
or disposing of food if the minimum cooking temperature is not met.
fl      Establish effective record keeping to document the HACCP
system. At Heinz USA in Pittsburgh, record keeping is computerized.
fl      Establish procedures to verify the system is working
consistently--for example, auditing records to confirm that all
critical limits have been met during a production run.
       Each of these steps has to be based on sound scientific and
technical knowledge, such as published microbiological studies.

Why HACCP?
       A number of national and international organizations have
endorsed HACCP, including the National Advisory Committee on
Microbiological Criteria for Foods, which includes government and
non-government food safety experts, and the Codex Alimentarius
Commission, an international food standard-setting organization.
       HACCP is viewed favorably because of its potential to help the
United States and other countries cope with new food safety
challenges. Among the challenges most often cited is an increase in
the number of human disease outbreaks due to food-borne microbial
pathogens. For example, between 1973 and 1988, bacteria not 
previously recognized as important causes of food-borne illness in
the United States--such as Escherichia coli O157:H7, Listeria
monocytogenes, and Salmonella enteritidis--became more widespread.
       "Fifty years ago, we were dealing with only a limited number
of food-borne pathogens," said FDA's Rhodehamel, referring to
Clostridium botulinum, Staphylococcus aureus, Salmonella, and the
parasite Trichinella spiralis. "Today, the list of known food-borne
pathogens is much more extensive."
       There also is increasing concern about chemical contamination,
such as the effects of lead on the nervous system.
       Another problem is that processing and packaging systems
designed to prolong shelf life may introduce new food safety risks.
       Also of interest is the increasing size of the U.S. food
industry--both in the amount of domestic food manufactured and the
number and kinds of foods imported. FDA now lists over 30,000 food
manufacturers and processors and more than 20,000 food warehouses
in its inventory, and in 1992 alone dealt with more than 1 million
imported food items. At the same time, FDA and state and local
agencies face severe resource constraints that make it increasingly
difficult to ensure food safety.

Advantages
       Advocates of HACCP believe that it offers a number of
advantages to help deal with these challenges. Most importantly,
HACCP:
fl      focuses on preventing hazards from contaminating food
fl      is based on sound science
fl      places responsibility for ensuring food safety on the food
manufacturer or distributor. Under a HACCP-based inspection system,
the food company develops the HACCP plan, and government's role is
to verify that the company is carrying out its plan. Government
monitoring would ensure that preventive controls are in place and
working properly.
fl      permits more efficient and effective government oversight,
primarily because the record keeping allows government
investigators to see how well a firm is complying with food safety
laws over time rather than how well it is doing on any given day.
Under the proposal FDA envisions, the agency would have access to
critical control point records.
fl      helps food companies compete more effectively in the world
market. Members of the European Union and other countries, such as
Canada, will soon require imported foods and foods made within
their borders to be processed under HACCP requirements.
       At the Heinz plant in Pittsburgh, company officials have
discovered another advantage: a potential savings to the company.
According to Ed Sonnet, technical operations consultant for Heinz
USA, the HACCP system seems to have led to a drop in the number of
stock cases held at the company's Pittsburgh plant. These are cases
of food that are withheld from the market because of poor quality
or safety concerns.
       "We have a very strong feeling in our minds that HACCP is
doing a good job for us," he said. "We think we'll be able to 
quantify it a lot better when we go into our other plants."
       Sonnett said HACCP will be implemented in the company's four
other U.S. manufacturing facilities by April 1995.

What's Ahead
       FDA has begun reviewing comments it received in response to
its August 1994 advance notice of proposed rule-making. At press
time, in late 1994, the agency was planning to begin a pilot HACCP
program with about six food manufacturing companies. FDA will use
information from this program to help decide whether to propose a
HACCP system for industry, and, if so, to what extent.
       If FDA decides to implement HACCP for the seafood industry, it
expects to issue final regulations this year. This program, along
with HACCP programs already in use, will likely lay the groundwork
for future food safety in the United States and the world.

Paula Kurtzweil is a member of FDA's public affairs staff.