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What to Do if Your Product Needs to be Recalled
By Jeff Tarrant, LCDR, U.S. Public Health Service
In the last issue of Small Plant News, we provided
steps that you can take to develop your own facility's food recall plan. This month we go one step
further—what to do if your product needs to be recalled.
Before we start, we need to determine how a recall is initiated. Generally speaking, most recalls
are identified by the facility, U.S. Department of Agriculture's (USDA) Food Safety and Inspection
Service (FSIS) or other sources. In this scenario, let's assume you identified the problem.
So, in the event you are involved in a food recall, what should you do? First, FSIS recommends you read
FSIS Directive 8080.1, Revision 4, Attachment 1, Product Recall Guidelines for Firms (PDF Only).
It provides step-by-step actions FSIS "expects a firm to take to ensure that the maximum amount of
product is recovered in the shortest amount of time." In addition, the directive provides valuable
communication information including model press releases and recall notification letters.
Get the Facts
Next, you need to collect information that will allow you to characterize the issue properly and
communicate with FSIS, consignees and the public in a timely manner. FSIS' inspector-in-charge,
district office and Recall Management Staff will need clear and concise documentation including the following:
- Complete and accurate product identity, including product labels (e.g., digital images);
- Reason for recall and details about the time and discovery of the defect or deficiency;
- Your determination and risk assessment of product consumption;
- Timeframe and volume of the product's production;
- Estimate of how much product is in distribution and for how long;
- Area of geographical distribution of product by state and/or country;
- Distributor and customer information;
- Copies of any firm correspondence with distributors, brokers or consignees related to recall actions and a copy of any proposed press release; and
- The name, title and telephone number of your facility's recall coordinator.
Initially this information may be provided orally. However, FSIS recommends you submit confirmation
information on a data sheet to the recall management staff once it's collected. Shortly thereafter,
FSIS will typically send one of its employees to your facility to review and verify the information.
Communicate Early and Regularly
Once you have the facts, contact your consignees, distributors or brokers (if you haven't yet) by telephone,
FAX, e-mail or special delivery and provide them the following information:
- The suspect product subject to a recall;
- The immediate cessation of distribution or use of any remaining product;
- Notification of your consignees of the recall; and
- Your contact information (e.g., name and number).
If your facility provides notice of the recall by telephone or personal contact, FSIS expects
you to document it and follow up with a written communication. Furthermore, follow up communications
should be sent to those who did not respond to the initial product removal communication within
a specified timeframe.
Next, you need to notify the public. Typically, FSIS develops press releases for class I and II recalls.
The agency will develop the recall press release based on information you previously provided them.
They, in turn, will give you 30 minutes to review and comment on it for accuracy. Then, they will
distribute the release to the media, interested constituents and finally post it to FSIS' Web site.
According to Lisa Volk, director of FSIS' recall management staff, plants are encouraged to issue
their press releases in conjunction with FSIS.
In addition, your facility is expected to report regularly, and in
a timely manner, ongoing efforts to retrieve recalled product to FSIS in a recall status report.
The frequency of updates is determined by the degree of public health hazard. The recall status
report should include:
- Number of consignees notified of the recall;
- Dates notifications were made and the method used;
- Number of consignees responding to recall communications;
- Quantity of product each customer had on hand when communication was received;
- Number and identity of consignees who did not respond;
- Quantity of product returned or held by each customer; and
- Estimated time of recall completion.
Effectiveness Checks
FSIS also plays a strong role in the conduct of effectiveness checks. This is a process where the
agency verifies the effectiveness of the establishment in carrying out its recall by statistically
sampling a percentage of consignees throughout the distribution chain.
Recall Termination
A recall is terminated when FSIS has completed its effectiveness checks and determined that the
firm has made all reasonable efforts to recall the product, and that it has either disposed
of the recovered product or it is under documented control. In addition, FSIS expects that
the firm will notify the agency when the recall is complete through a closeout memorandum
containing a list of consignees, the amount of product retrieved and actions taken.
Once a recall action has been completed, you should notify your consignees, thank them for their
assistance and provide assurances that the problem has been corrected. In addition, your recall
team should evaluate the recall process and determine if changes should be made to your recall plan.
In a future issue of Small Plant News, we'll address different food products and the other Federal
agencies that may be involved in a recall. For more information on food recalls, visit the FSIS Web site at
www.fsis.usda.gov/Fsis_Recalls/index.asp or call (202) 690-6520
if you need assistance in obtaining FSIS Directive 8080.1, Revision 4, Attachment 1, Product Recall
Guidelines for Firms.
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Food Safety Resources
By Mary Gioglio
Are you setting up a new plant and need guidance to comply with Federal regulations? Or do you want
to find a unique way to orient new managers and employees at your plant?
Turn to the New Plant Orientation: Safe and Easy, a DVD designed to introduce Sanitation Standard
Operating Procedures (SSOPs) and the Hazard Analysis and Critical Control Point (HACCP) system to owners
and operators of new meat plants. This informative DVD, developed by New Mexico State University in
partnership with FSIS, describes daily activities that occur in meat plants including pre-operational,
processing, monitoring and verification procedures. Not only is this a good resource for new plant owners
and operators but it can also be used as an orientation for newly hired employees.
To request this item or any other food safety resource, fax the order form found on FSIS'
Food Safety Resources Brochure to (202) 690-6519, or complete an online version of the form and send it to
FoodSafetyResources@fsis.usda.gov.
The online form can be found at www.fsis.usda.gov/Science/
HACCP_Resources_Order_Form/index.asp.
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Commonly Asked Question & Answer
Q. Can a noncompliance report be issued for failing to label product "For export only" when required?
A. Yes, "For Export Only" or a similar term is a statement of limited
distribution required when the labeling does not fully meet FSIS labeling regulations but has been
determined to meet the labeling regulations of the receiving country. It's required when a deviation
is approved under Title 9 Code of Federal Regulations, Parts 317.7 or 381.128 and when generic approval
of a direct translation is exercised under Parts 317.5 or 381.133. The term "For Export Only" or a
similar term may not be used when the container bears no other label other than an English-only label that
meets all domestic requirements.
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Briefs
By Sheila Johnson
Public Meetings
FSIS held a public meeting titled E. coli 0157:H7 - Addressing the Challenges, Moving Forward with Solutions
on April 9 and 10 in Washington, DC Presentations and the transcript from this meeting are now available at
www.fsis.usda.gov/News_&_Events/Past_Events/index.asp. To obtain
information on any other public meetings, visit FSIS' Web site at www.fsis.usda.gov or call (202) 690-6520.
Web Seminars
As part of FSIS' initiative to enhance outreach to assist small and very small plants outlined in the
FSIS Strategic Implementation Plan for Strengthening Small and Very Small Outreach, the agency is holding
a series of regulatory education workshops. The workshops include a walk-through of a variety of topics,
which may include HACCP system, Sanitation Performance Standards, SSOPs, Rules of Practice, food defense
strategies, E. coli O157:H7 workshops and FSIS Notices 65-07, 66-07 and 68-07. Online registration
forms are provided. Pre-registration helps FSIS plan for the meetings, but is not required.
An upcoming workshop will focus on E. coli O157:H7, and the sessions will cover prerequisite
programs and FSIS Notices 65-07, 66-07 and 68-07. The workshop will be held in Raleigh, North Carolina,
on July 15 from 6:30 a.m. to 8:30 p.m. at the Holiday Inn Crabtree Valley, located at 4100 Glenwood Avenue.
For more information and assistance in registering, call FSIS' Office of Outreach, Employee Education and Training
at (800) 336-3747.
Feedback
Small Plant News is also posted on FSIS' Web site at www.fsis.usda.gov. If you or your colleagues would
like to receive an electronic copy, visit FSIS' Web site today and sign up for a complimentary e-mail subscription.
Please continue to submit your comments to SmallPlantNews@fsis.usda.gov
or call (202) 690-6389. We look forward to hearing from you on how we can provide the resources you need.
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Measuring Your Needs: FSIS Examines Communication Methods
By Jeff Tarrant, LCDR, U.S. Public Health Service
For over 25 years, FSIS has been searching for ways to communicate better with meat, poultry and processed
egg products establishments under its regulatory purview. During that time, industry demographics have
changed tremendously.
In an effort to keep up with the ever-changing industry landscape, the agency participated in an informal
study in 2005 to help it find more effective ways to communicate with underserved owners, operators and
employees of small and very small meat, poultry and processed egg products facilities, in particular African
Americans, Hispanics/Latinos, American Indians/Alaska Natives, or Asians/Pacific Islanders.
The informal study was based on interviews of 22 subject matter experts from around the country. These
included trade association representatives, government officials, academics and extension agents with experience
in getting food safety and regulatory messages across to small and very small plants in communities with
special language or cultural needs. The subject matter experts were asked a series of questions about
the effectiveness of different vehicles that may be used for FSIS communication. The responses were
informative. A sampling of these includes:
How do you think small and very small businesses become aware of FSIS messages related to new
regulations and other food safety initiatives?
- FSIS inspection program personnel (55%)
- Rural Development/University Extension programs (45%)
- Trade associations (28%)
- State inspection programs (23%)
- Postal mail/Fax (18%)
What do you think are the best ways for FSIS to get information to small and very small businesses?
- Postal mail (50%)
- E-mail (41%)
- Direct contact between FSIS inspectors and plant owners/operators (41%)
- Fax (36%)
- Regional workshops (32%)
- Workshop webcasts (27%)
- University Extension Service (18%)
- FSIS Web site (18%)
A number of respondents expressed concerns with FSIS' reliance on computer-based communication
methods (e.g., e-mail, webcasts, etc.). One interviewee stated, "Many small and very small operators
don't have computers and are small family-owned businesses. Direct contact is still the best way to
communicate with them." A commonly conveyed phrase was, "All the examples are important,
because there is no one-size-fits-all approach to reach the businesses."
Any comments on the best ways for FSIS to communicate?
Fifty percent of interviewees stated that they would like FSIS to develop and foster positive working
relationships between its inspectors and the owners and operators of small and very small plants.
One respondent stated, "Since industry is a non-homogeneous population, there is no one-size-fits-all
approach for communicating with operators. For some, seminars work well. For others, face-to-face interaction
is necessary. Combination methods work best."
Another interviewee commented, "Some of these plants are the primary source of income in their
communities. We need to find a way to help them out. The local community and economy depends on it."
FSIS could not agree more. In keeping with the goals set out in the FSIS Strategic Implementation
Plan for Strengthening Small and Very Small Outreach released in May 2006, the agency is committed to
listening to, identifying and addressing the needs of small and very small plant owners and operators
across the country. And, that's a promise we plan to keep.
For more information on FSIS small and very small plant outreach efforts, visit FSIS' Web site at:
www.fsis.usda.gov/Science/
Small_Very_Small_Plant_Outreach/index.asp#plan
or call FSIS' Office of Outreach, Employee Education and Training at (800) 336-3747.
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Small Plant NEWS
Editor: Keith Payne
Production: Jeff Tarrant, LCDR, U.S. Public Health Service
Design: Rowena M. Becknel
Contact: Small Plant News, USDA/FSIS, Aerospace Building,
3rd Floor-Room 405, 14th and Independence Ave., SW, Washington,
DC 20250. (202) 690-6520
E-mail: SmallPlantNews@fsis.usda.gov |
