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Part I: Implementing the Public Health Information System (PHIS): An Overview of Its Purpose
By Jane Johnson
The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) is implementing an enhanced public health data infrastructure
system to replace FSIS' previous arrangement of multiple data systems. This system is a more efficient tool to enhance its public health mission. Small Plant
News examines PHIS in a special two-part series.
FSIS collects a significant amount of information and data every day in order to fulfill its mission of ensuring that the Nation's
commercial supply of meat, poultry, and processed egg products are safe, wholesome, and correctly labeled and
packaged. But collecting data is only the beginning. How the data is stored, processed, and accessed is just as
important. Collectively, such activities are accomplished through what is known as a data infrastructure. FSIS is
actively strengthening its public health data infrastructure in order to enhance the Agency's ability to better protect
public health. This enhanced data infrastructure system is known as the Public Health Information System (PHIS).
PHIS is a Web-based, user-friendly application that will not add additional requirements or new regulations for
domestic plants. Nor will it change existing requirements or regulations for domestic plants. It will, however, allow FSIS
to better capture the data associated with the results of FSIS inspection verifications and improve the management of the
"PHIS is basically a system that provides information for action to prevent food safety breakdowns," said Dr.
Kenneth Petersen, FSIS Assistant Administrator for the Office of Field Operations. "FSIS will use PHIS data
to identify potential problems and focus inspection activities appropriately. With the integrated system, we
can accomplish this without changing the ability of inplant personnel to address urgent situations."
How can PHIS do all that?
First, PHIS will be able to access many data sources and store the collected data in an FSIS "data warehouse."
All of the functions of many of FSIS' individual systems will be integrated into PHIS, which means that much of
the data that FSIS inspection personnel collect will be put into one system and will be available from that one system.
PHIS also will allow FSIS to collect more information about the U.S. domestic and international food safety
systems producing FSIS-regulated products so the Agency can better identify food safety risks before they result in
outbreaks or recalls. In the future, PHIS is even expected to be able to incorporate data from external sources—such
as the Agricultural Research Service's VetNet and the U.S. Centers for Disease Control and Prevention's PulseNet and
National Antimicrobial Resistance Monitoring System—and to integrate these data with FSIS-generated data for use in
analysis, scheduling, and decisionmaking.
Second, PHIS data will be available for use by FSIS in near real time. FSIS will analyze PHIS data for trends
and will adjust domestic and import inspection and sampling accordingly. The Agency also will notify field and
headquarters personnel about potential public health threats. The new system will guide inplant inspection personnel to
focus their attention on the specific aspects of their plants' food safety systems and supporting documentation that
have the most significant impact on public health. Thus, PHIS will enable plant owners and/or operators, as well
as inspection personnel, to identify shortcomings in their plants' food safety systems more quickly and to anticipate
problems before they result in adulterated products.
More specifics regarding the advantages of PHIS for small and very small plant owners and/or operators will be
featured in an upcoming issue. If you have any questions regarding PHIS, contact FSIS' Office of Policy and Program
Development via askFSIS on the FSIS Web site at www.fsis.usda.gov or
call 1-800-233-3935. You can also call the Small Plant Help Desk at 1-877-374-7435 or send an email
(Part II of this series will continue in the Volume 4, Number 7 issue of Small Plant News.)
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Food Safety Resources
By Kurtis Calhoun
Some types of influenza (flu) occur mostly in pigs. Other types, such as the 2009 H1N1 virus, cause illness mainly in people. Flu viruses can sometimes
spread from people to pigs and from pigs to people. It's important to protect yourself and prevent the spread of the flu.
To do this, familiarize yourself with the OSHA Quick Card: Protecting Swine Production Workers from
Influenza, produced by the U.S. Department of Labor's Occupational Safety and Health Administration (OHSA).
This laminated card is a handy reference tool that provides an overview of flu symptoms in humans and pigs as well
as safety measures for swine production workers. One side of the card is in English and the other side is translated into Spanish.
To order free copies of these materials, fax your order request to (202) 690-6519 or call the Small Plant Help Desk at 1-877-374-7435.
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Review Your Prerequisite Program
By CDR Jeff Tarrant, U.S. Public Health Service
The World Health Organization defines prerequisite programs as "practices and conditions needed prior
to, and during, the implementation of Hazard Analysis and Critical Control Point (HACCP) systems, and which are
essential for food safety." In essence, prerequisite programs provide the solid foundation for a well-designed and
administered HACCP system by encompassing the programs and procedures in your food processing operation.
Prerequisite programs deal with the "good housekeeping" elements of your establishment, such as
environmental and operating conditions, whereas an HACCP plan manages specific process hazards. It's important to
point out that there's a difference between an HACCP plan and HACCP system. An HACCP plan is a written document
that describes your plant's specific food safety processes and procedures and how you manage and control food safety
hazards. On the other hand, an HACCP system looks at the "big picture" of your food safety process and encompasses
your HACCP plan and prerequisite programs.
Prerequisite programs set the stage for a successful HACCP system and provide ongoing support for your food
safety system by reducing or eliminating the likelihood that a potential food safety hazard will occur in a process.
Examples of prerequisite programs include: pest control programs, Good Manufacturing Practices (GMPs), raw
material control (e.g., receiving and storage, purchase specifications, Certificates of Analysis, residue control,
etc.), production control (e.g., foreign material detection and removal programs, rework practices, etc.), and sanitation and
Once established, you should revise your prerequisite program, as necessary, to ensure its effectiveness, and
you should take appropriate corrective actions when you determine that your programs may have failed to prevent
contamination or adulteration of product. For example, if you address Escherichia coli (E. coli) O157:H7 in your
prerequisite program but not in your HACCP plan, and produce an E. coli O157:H7-positive product, this event
would be considered a "deviation not covered by a specific corrective action" or an "unforeseen hazard" according to
Part 417.3 (b) of the Code of Federal Regulations. Therefore, you would be required to take corrective actions, including
reassessment, because your prerequisite program was not effective in reducing the likely risk of product adulteration.
In addition, prerequisite programs must be implemented and have documentation, such as records, to verify
implementation if referenced in your hazard analysis, HACCP plan, or Sanitation Standard Operating Procedures
(SSOPs). Records generated from prerequisite programs should be reviewed regularly by you or other plant personnel
and must be made available to FSIS inspectors upon request.
By designing and implementing a solid prerequisite program in your establishment, you lay the foundation for a
strong HACCP system. And, this is the first step in producing and distributing safe food products in a clean and sanitary
For more information on prerequisite programs, please review FSIS Directive 5000.1, Revision 3, Verifying an
Establishment's Food Safety System, or visit www.fsis.usda.gov. You can also contact the Agency's Policy Development
Division at 1-800-233-3935.
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Commonly Asked Questions & Answers
Q. When an establishment uses a continuous monitoring device to monitor a critical limit, is the
establishment expected to perform a direct observation verification activity in accordance with Title 9, Part 417.4 (a)(2)(ii)
of the Code of Federal Regulations (CFR) for this device?
A. No. The use of continuous monitoring devices and data loggers to monitor a critical limit is common
and encouraged. The establishment does not need to observe the device. The establishment needs to observe
its employees performing procedures associated with monitoring the critical control point (CCP). Inspection program personnel (IPP)
need to be familiar with the HACCP plan's list of monitoring procedures, the frequency at which monitoring is to occur, and the
documents supporting the monitoring and frequency to determine whether the establishment needs to perform an ongoing verification per
9 CFR 417.4(a) (2)(ii). For example, there may be specific instructions for the setup and startup of the device used by the establishment.
The establishment may also have documentation that makes clear that the placement of the probe is critical to the design of the CCP and
critical limit. IPP need to verify that the establishment is appropriately performing its procedures associated with the CCP. As part
of the verification that IPP perform, they are to ensure that the procedure is being followed per the HACCP plan. When applicable,
IPP will review the results associated with establishment verification (i.e., calibration of the process monitoring instrument per
9 CFR 417.4(a) (2)(i) and observations made to verify that the monitoring procedure as written and supported is being performed per
the HACCP plan per 9 CFR 417.4(a)(2)(ii)) are documented per 9 CFR 417.5(a)(3).
Q. What are the HACCP record retention requirements for ready-to eat products?
A. HACCP records for refrigerated ready-to-eat products are required to be retained for at least 1 year.
HACCP records for ready-to-eat frozen, preserved, or shelf-stable products are required to be retained for at least 2 years [9 CFR 417.5(e)].
Q. Is a solution that is captured and reused by a plant to inject flavoring into raw poultry or meat products
considered water reuse under 9 CFR 416.2(g)(3)?
A. No. Only water, ice, or solutions reused for the express purpose of chilling or washing raw
product are subject to the water reuse requirements in 9 CFR 416.2(g)(3). Solutions that are injected to tenderize product,
impart flavor, or to add similar ingredients, are not subject to the water reuse regulatory requirements.
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Small Plant NEWS
Editor: Keith Payne
Managing Editor: Jane Johnson, DVM
Production: Joan Lindenberger, Sally Fernandez
Design: Gordon Wilson
Contact: Small Plant News, USDA/FSIS, Aerospace Building,
3rd Floor-Room 405, 14th and Independence Ave., SW, Washington,