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Common Food Safety Violations Documented by Federal Regulatory Agencies, Part II
By Commander Jeff Tarrant, U.S. Public Health Service
In July 2011, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) and Agricultural Marketing Service (AMS)
and the U.S. Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) developed a food safety
cross-training program to strengthen communication and collaboration efforts among USDA and HHS agencies on food safety issues
in shared jurisdiction facilities. As part of the program, the agencies devised a method to ensure that any food safety violations
that employees observe while conducting their normal day-to-day duties at federally regulated establishments are reported to the
agency with jurisdiction over the violation.
What were the common violations noted by the three agencies? The Small Plant News editorial staff decided to answer this
question by examining "significant observations" from each agency's training material. What we found is best broken down into the
following categories: General Facility, Processing, Storage, and Employee Health and Hygiene.
In Small Plant News, Volume 5, Number 8, we looked at common food safety
violations documented by Federal regulatory agencies related to General Facility and Processing observations. In this issue,
we'll examine Storage and Employee Health and Hygiene violations.
First, let's review Storage violations. Some common issues that arise during inspections involve the placement of pesticides,
insecticides, and cleaning solutions in storage areas. On numerous occasions, open containers of pesticide bait placed near food
products have been noted by inspectors. During one inspection, for instance, rodent bait was found in apple storage bins and in
the raw-ingredient side of a baby food processing line. If the problem hadn't been detected, infants could have been sickened
and/or killed. This is why pesticides, insecticides, and cleaning supplies must be used and stored properly. Rodent and insect
bait stations should be designed to eliminate spillage into processing and storage areas and placed where they will not contaminate
food or food contact surfaces.
Another observation involves improperly cooling food products in storage areas. For instance, potentially hazardous food items
(e.g., those high in protein or carbohydrates, with a pH above 4.6 and a water activity above 0.85) have been documented as being
held for long periods of time at room temperature (usually more than 2 hours) and not being actively processed. Some of the items
included cooked vegetables and grains, soups, gravy, raw shell eggs, egg products, meat, seafood, and ready-to-eat foods.
Often times, improperly cooked products can be a result of coolers and freezers that are not properly maintained. Remember that
coolers should maintain food at or below 41 °F, and freezers should maintain food in a frozen state, ideally between
0 and 10 °F. Be aware that the air temperature can fluctuate in coolers because of the frequent opening and closing of the doors.
Therefore, collect your readings prior to opening the door or entering the area.
Other observations include the possibility of cross contamination when raw ingredients are stored near finished product in a
manner that exposes them to microbial contamination. An example of this involves storing raw meat above or adjacent to ready-to-eat
foods, such as cooked product or raw vegetables, in a refrigerated storage area. Ideally, facilities should have dedicated coolers
for storing raw meat products. In addition, cross contamination can occur when food products are improperly covered or when
retained/quarantined products are accidentally mixed with products not under quarantine or retention. Products must be covered
or sealed in a container to reduce the likelihood of accidental or intentional contamination, and establishments should segregate
and label damaged and/or retained/quarantined containers of food to ensure that they are not used by mistake.
One issue that should be addressed is the transportation of raw and finished products. Product contamination can occur when
raw materials are transported on unclean or improperly maintained vehicles. As a result, containers can become grossly contaminated,
and frozen or refrigerated ingredients may become contaminated if not held at a cold temperature. Essentially, trucks should be
dedicated to transporting food and not used for waste products and toxic substances. When a vehicle is used to transport both raw
and finished products, they should not be mixed together. The raw products should be transported separately, and the vehicle should
be thoroughly cleaned and sanitized before transporting finished products.
One real-life scenario involved the cross contamination of ready-to-eat food in 1994, which led to a nationwide outbreak of
salmonellosis that was responsible for sickening an estimated 224,000 people in the United States. It was later determined that
the outbreak occurred because the pasteurized ice cream pre-mix was delivered to a facility in a tanker truck that had previously
transported raw, unpasteurized eggs. The tank hadn't been properly washed and sanitized between loads, and the raw egg mix was
contaminated with Salmonella enteritidis bacteria.
Next, we'll look at Employee Health and Hygiene violations that have been documented by Federal inspectors. One of the
gravest violations, and often the simplest to fix, is a lack of accessible hand washing facilities (with soap, water, and a dryer
or towels) within an establishment. Since proper hand washing is a key defense against the spread of pathogens between employees
and product, it is critical and required by law to provide and properly maintain hand washing stations.
Another issue that arises is the lack of an employee health and hygiene training program in food service facilities. Usually,
poor hygienic practices demonstrated by employees indicates a lack of proper training and interest in the quality of products
produced by the establishment. Good hygienic practices include the wearing of clean lab coats, hair nets, arm guards, and intact
gloves. If food service gloves are used as a barrier against contamination, they must be changed when they become soiled or damaged.
In addition, employees must wash their hands prior to putting the gloves on.
When it comes to employee health, Federal inspectors have documented incalculable instances of employees who exhibited symptoms
of infectious disease while handling or processing food products in establishments. After a recent foodborne illness outbreak
investigation in the United States, it was determined that the causative agent, Staphylococcus aureus, was traced back
to an infectious employee at a bakery. Don't allow this to happen in your facility. If employees are diagnosed with or exhibiting
symptoms of an infectious disease while at work, send them home and recommend they visit their primary healthcare facility. Do not
permit them to return to work until cleared by a doctor.
For more information on food safety regulatory requirements, visit the following food safety Web sites:
www.fsis.usda.gov, www.fda.gov, and
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Guidance for Establishments Affected by a Natural Disaster
By Jane Johnson, DVM
If you own or operate a meat, poultry, egg products, or retail and foodservice establishment, you may have asked yourself at some point,
"where on the FSIS Web site can I find guidance that identifies food safety factors that I should consider as I resume
operations in an area affected by a hurricane, flood, natural, or other disaster?" You can find this type of information at
On this Web page, you'll find links to technical guidance such as a checklist outlining the steps to take in the event of flooding;
questions and answers identifying food safety and other issues in areas affected by natural disasters; emergency action food safety
suggestions and information for retail and foodservice establishments resuming business in the aftermath of natural or other disasters;
and guidelines for FSIS personnel that you may also find useful regarding information for discussion to assist in identifying possible
food safety issues in processing and slaughter establishments.
For more information or if you have any questions, feel free to contact the Small Plant Help Desk at 1-877-FSISHelp 1-877-374-7435) or email
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Countertop Food Safety Training Program Provides a Hands-On, Easy Approach for Food Service Workers
By Jane Johnson, DVM
The Countertop Food Safety Training Program for Employees of USDA-Inspected Egg, Meat, and Poultry Establishments is a
bilingual (English and Spanish) training program that provides an educational tool for the processed egg, meat, poultry, and other
food processing industries to train their Spanish-speaking line employees on essential concepts in short periods of time. It is
intended to provide operators an educational tool that recognizes these workers' cultural and linguistic differences.
The following eight modules can be presented to small audiences in informal settings in 20-30 minutes: the ABCs of Food Safety;
Cross Contamination; Personal Hygiene; Hand Washing and Gloves; Sanitation; Allergens; Food Defense; and ABCs of HACCP.
The training program was prepared under a USDA-FSIS cooperative agreement by Cathy Cutter of Pennsylvania State University, in
cooperation with Sergio Nieto-Montenegro of Hispanic Workforce Management, LLC. The modules are posted on FSIS' Web site at
Limited hard copies are also available for distribution. Please contact the Small Plant Help Desk at 1-877-FSISHelp (1-877-374-7435) or email
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Commonly Asked Questions & Answers
Q. Does the agency expect cattle slaughter establishments to determine that Escherichia coli
(E. coli) O157:H7 is a hazard reasonably likely to occur (RLTO)?
A. Yes, the agency expects cattle slaughter establishments to address the food safety hazard of E. coli O157:H7
in their Hazard Analysis and Critical Control Point (HACCP) plans because of the prevalence of the pathogen shed by cattle transported to slaughter.
In 2002, the agency published a Federal Register Notice (Docket No. 00-022N), titled E. coli O157:H7 Contamination of Beef Products, in
which FSIS outlined the agency's position:
"The regulations require that establishments develop HACCP plans that include critical control points (CCPs): points, steps, or procedures
in a food process at which a control can be applied, and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable
levels. FSIS considers an acceptable reduction for E. coli O157:H7 to be a reduction to an undetectable level. Because controls to
reduce the risk of E. coli O157:H7 contamination when the product is still intact may be the best means of controlling the hazard,
FSIS believes that slaughter establishments
should strongly consider putting in place one or more validated CCPs that are designed to eliminate
or reduce E. coli O157:H7 and other pathogens. If such establishments have controls in place to address E. coli O157:H7 specifically,
they cannot conclude that the pathogen is not a hazard reasonably likely to occur in the absence of those controls. FSIS believes that any
interventions that slaughter establishments
use to address E. coli O157:H7 should be incorporated into their HACCP plans. At this time,
FSIS is not aware of any prerequisite programs that are appropriate for use in slaughter
to address E. coli O157:H7."
The agency is not aware of any pre-harvest strategy that can reduce or eliminate the pathogen to non-detectable levels prior to cattle being
transported for slaughtering. Therefore, a cattle slaughter establishment needs to address this known food safety hazard in its cattle slaughter
process with a CCP (9 CFR 417.1). Cattle slaughter establishments need to ensure that the design and execution of the CCP addressing E. coli
O157:H7 ensures that by the end of the slaughter process, the pathogen is reduced to non-detectable levels or is eliminated on the cattle carcasses
that establishments fabricate or ship into commerce. Robust verification testing results from trim manufacturing, applied through appropriate
statistical process control systems, have proven to be an accurate way for slaughter establishments to assess the effectiveness of the slaughter
operation. Published scientific studies have demonstrated that there are effective decontamination methods that can be used for preventing,
eliminating, or reducing E. coli O157:H7. The slaughter establishment may use antimicrobial agents (FSIS Directive 7120.1, Safe and
Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products) or other interventions to ensure its slaughter process
reduces or eliminates the pathogen to nondetectable levels. Posted on FSIS' Web site are resources to assist small and very small
slaughter establishments (www.fsis.usda.gov/Science/
Q. The 2008 Farm Bill provides that establishments selected to participate in the cooperative
interstate shipment program must be "in compliance with" with all Federal standards. Why does the new interstate shipment
program need to operate under standards that are the "same as" those imposed under the Federal program when States already
have programs that are "at least equal to"?
A. The Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA), as amended by
Congress in the 2008 Farm Bill, expressly state that the cooperative interstate shipment program must operate under standards that
are the "same as" those imposed under the Federal program.
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Small Plant NEWS
Editor: Keith Payne
Managing Editor: Jane Johnson, DVM
Production: Joan Lindenberger, Sally Fernandez
Design: Gordon Wilson, Duane Robinson
Contact: Small Plant News, USDA/FSIS, Patriots Plaza III, Rm. 9-267A, Mailstop 3778
1400 Independence Ave., SW, Washington, DC 20250