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Food Allergies: Why It's Important To Double Check Your Labels
By Jane Johnson, DVM
As the owner and/or operator of a small or very small plant, you are very much aware of
the importance of proper labeling, and not just because the U.S. Department of Agriculture's (USDA) Food Safety
and Inspection Service (FSIS) requires it. (All ingredients used to formulate a meat, poultry, or processed egg product
must be declared in the ingredients statement on product labeling.) Product labels are where your customers get
most of their information about your products. Many consumers make their decisions about which products
to buy based on a product's label. This is especially true for people who suffer from food intolerances and food allergies.
Food intolerance is an abnormal response to eating a food. The problem occurs within the digestive tract
(stomach and intestines). A particular food may irritate the person's digestive tract, or the person may have a medical
condition that prevents him or her from properly breaking down or absorbing the food. Although the reaction to the
food may be unpleasant (bloating, gas, diarrhea, nausea), it isn't usually life threatening.
A food allergy involves a person's immune system. The body uses the immune system to fight off invasions
by bacteria, viruses, fungi, parasites, and anything else that enters the body but doesn't belong there. Allergic
reactions may consist of one or a combination of these symptoms: hives, tingling in the mouth, swelling
in the tongue and throat, difficulty breathing, abdominal cramps, vomiting or diarrhea, eczema
or rash, coughing or wheezing, loss of consciousness, or dizziness. Allergic reactions may be merely annoying or can
be severe and life threatening.
When an allergic reaction is life threatening, it is known as anaphylaxis. Anaphylaxis may result in constricted
airways in the lungs, severe lowering of blood pressure and shock ("anaphylactic shock"), and suffocation by swelling
of the throat. Symptoms that seem mild at first can progress to anaphylaxis. The amount of an allergen in a food is
irrelevant. For someone with a severe allergy, even a tiny amount of the allergen in his or her food is enough to cause
a potentially fatal anaphylactic reaction.
There are eight foods (or food groups) that are known to cause 90 percent of all food allergies. Collectively
categorized as "major food allergens" or the "big eight," they consist of milk, eggs, fish, Crustacean shellfish, tree
nuts, wheat, peanuts, and soybeans. According to the U.S. Centers for Disease Control and Prevention's Web site, "the
prevalence of food allergies and associated anaphylaxis appears to be on the rise. Risk factors associated with food
allergy include a family history of asthma and allergies, genetic predisposition to allergic disease, elevated allergen-specific
serum immunoglobulin levels (IgE concentrations), and being younger than 3 years of age. While 3.3 million
are allergic to peanuts or tree nuts, 6.9 million are allergic to seafood. Combined, food allergies cause
30,000 cases of anaphylaxis, 2,000 hospitalizations, and 150 deaths annually."
Therefore, food allergies can lead to death, and more and more people seem to be suffering from them. These
two facts alone make it obvious that the proper labeling of food products containing or potentially containing food
allergens is critical. FSIS has posted a compliance guide, "A Guide to Federal Food Labeling Requirements for Meat
and Poultry Products," on its Web site at www.fsis.usda.gov/PDF/Labeling_Requirements_Guide.pdf.
Also, "Allergens – Voluntary
Labeling Statements" may be found at www.fsis.usda.gov/Regulations_&_Policies/
Since FSIS requires that all ingredients used in a product be declared in the ingredients statement of the
label, the Agency does not require that you provide wording specific to a known allergen that may be present in the
product. However, FSIS supports practices that promote accurate and informative product labeling, including
voluntary statements on labels that alert people who have sensitivities or intolerances to the presence of specific ingredients.
For example, a phrase such as "Contains: milk, wheat gluten, soy" has been accepted by the Agency on
labeling immediately following the ingredients statement. Additionally, further clarification, using parentheses, of the
source of a specific ingredient in the ingredients statement, e.g., "whey (from milk)," is encouraged as a means of
informing consumers who may be alerted to a more recognizable term.
To ensure that any potential food allergen is declared on the label, always double check your labels prior to
sending them to your label manufacturer whenever you get a new shipment of labels at your plant from your label
manufacturer, whenever you change formulations, whenever you change label designs, or whenever you change label
manufacturers. It's also a good idea to routinely audit the labels you have in stock just in case something is missed
during one of the checks mentioned previously. Of course, having everything declared on the label won't do much
good if it's placed on the wrong product, so always double check that the label you're using matches the product to
which it is being attached.
Proper labeling is important for both you and your customers. It helps your customers make informed choices
about the food they eat, and it protects you from a recall and potential lawsuit. For more information or questions
regarding food allergens and labeling of product, please contact the Small Plant Help Desk at 1-877-374-7435 or
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Business Planning Guidebook Available for Small Meat Processors
By Lauren Gwin, Ph.D, Oregon State University, and Jane Johnson, DVM
Every business needs a plan, whether you're just getting started or changing course after many years.
The Niche Meat Processor Assistance Network (NMPAN) has announced that its guidebook, "Small
Meat Processors Business Planning Guidebook," is now available for download at
www.extension.org/pages/17166/meat-processor-business-development. You may also visit
NMPAN's Web site at www.nichemeatprocessing.org,
click on "Tools for Businesses," and select "Business Planning."
This short guide walks you through a basic business plan using an actual plan written by a processor looking to
upgrade and expand his or her facility.
- Section I lists and briefly describes the basic components of a business plan.
- Section II walks you through the business plan for a specific meat processing business, a custom-exempt
slaughter and processing facility proposing to build a new building three times its current size, become
USDA-inspected, and expand its retail operation. In each part of this business plan, you'll find questions you
need to answer and suggestions for finding information to answer those questions.
- In Section III, you'll see how your plan may change for two alternative plant configurations: first, as a custom-exempt
facility, and second, by adding an inspected mobile slaughter unit.
- Section IV lists other useful resources for business planning.
- Section V concludes the guide with a few final thoughts on planning this kind of business. A companion
spreadsheet offers a modifiable cashflow template based on the model plan in the guide.
NMPAN is a national network of people and organizations assisting niche meat processors, as well as the
livestock producers and the niche meat buyers who depend on them. The organization's goal is to strengthen and
expand the slaughter and processing capacity of the meat processing sector serving niche markets. If you do not have
computer access, you may contact NMPAN co-coordinators Dr. Arion Thiboumery at (515) 294-2882 or Dr. Lauren
Gwin at (510) 388-4720.
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Small Plant News Guidebook Series Launched
By Jane Johnson, DVM
FSIS is pleased to announce that the Small Plant News team is producing a series of guidebooks
that will provide useful information on a variety of topics including, but not limited to, dealing with plant
emergencies, developing a recall plan, introduction to microbiology, and obtaining a grant of inspection.
The intended audience for the series is the owner and/or operator of small and very small plants.
The first guidebook in the series, Help for Dealing with Plant Emergencies (PDF Only), is available for viewing on, or
downloading from, the FSIS Web site at www.fsis.usda.gov/News_&_Events/
This guidebook provides useful information and tips that will assist you in preparing for, responding to, and recovering
from some of the most common emergencies that you may encounter at your plant.
Future guidebooks will be posted on FSIS' Web site at www.fsis.usda.gov and available on a CD. For more
information, please contact the Small Plant Help Desk at 1-877-374-7435. If you prefer, you may send an email to
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Commonly Asked Questions & Answers
Q. Can an establishment refuse to provide access to inspection program personnel
(IPP) to its Hazard Analysis and Critical Control Point (HACCP) plans or other establishment data due to concerns with the
potential release of its proprietary data? If the establishment does, how would the agency proceed?
A. No. An establishment is obligated to provide access to HACCP plans or
other establishment data by 9 Code of Federal Regulations (CFR) Part 417.5(f), which states: "All records required by
this part (Part 417) and all plans and procedures required by this part shall be available for official
review." If an establishment refuses to provide access to its HACCP plan or other supporting
documentation for review and recording of information into the Public Health Information System (PHIS), IPP must record a noncompliance,
citing 9 CFR 417.5(f). IPP are then to discuss this noncompliance with establishment management at the next weekly meeting, and document
that fact and any establishment response in the memorandum of interview (MOI) that is routinely generated from the weekly meeting.
If the establishment continues in its refusal, IPP are to immediately contact their Frontline Supervisor, who will, in turn, inform the District
Manager (DM) of the establishment's refusal. The DM, or designee, will contact the establishment management and discuss the issue. If the
establishment continues to refuse, the DM will instruct the IPP to take an official control action by withholding inspection, as defined under 9 CFR
500.1(b). The DM will then document the incident in a letter to the establishment, officially informing it that FSIS has withheld inspection under 9
CFR 500.3(a)(6) because the establishment has interfered with an FSIS inspector performing his/her inspection duties. The DM will lift the
withholding action when the establishment has provided its HACCP plan and supporting documentation to the IPP.
Q. Are establishments required to provide electronic copies of their HACCP
plans, Sanitation Standard Operating Procedures, or supporting data to the IPP to enter into PHIS?
A. No. Data to be input into PHIS is to be keyed in by IPP based on their review
of the establishment documents and knowledge of establishment's operations. 9 CFR 417.5(f) states: "All records required by
this part (9 CFR Part 417) and all plans and procedures required by this part shall be available for official review." The establishment is required
to provide access to the plans and procedures even if the plans and procedures are maintained electronically (9 CFR 417.5(d)). IPP will be
afforded access; however, IPP should not request copies of any plans or programs.
Q. Will there be special directives related to the implementation and use of PHIS? If so,
where can inspectors find them?
A. Under PHIS, FSIS inspectors will use directives with the heading "FSIS PHIS
Directive." The PHIS directives mirror many of the current directives, but have directions related to PHIS and not PBIS. The
PHIS directives are found at www.fsis.usda.gov/regulations_&_policies/
Q. When an establishment employee documents a time on the official HACCP
record, would the employee document the time the HACCP event started or the time the HACCP event ended?
A. 9 CFR 417.2(c)(6) allows an establishment to develop any type of recordkeeping
system it wishes to document the monitoring of its critical control point to ensure compliance with its critical limit. Therefore,
it should not matter whether the monitoring start time or end time is used, as long as the time is
consistently documented per the establishment's HACCP recordkeeping system.
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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