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Small Plant News: Volume 6, Number 10


Small Plant News Archive Page. This is an archive page. No new content is being added. While these newsletters remain available for reference purposes, the documents do not reflect changes to Agency policy that may have been instituted since the newsletters were published. Also note that resources and websites mentioned in older issues may have moved or may no longer be available. Points of contact for various initiatives may have changed.

In This Issue:

Labeling Policy - Determining Fact From Fiction

By Arial Thompson, DVM 
Have you ever been unsure of labeling policy? Perhaps you think you remember someone saying, once upon a time, that something was true about labeling. Are you remembering correctly, or is what you’re remembering even still true? In this article, we’ll explore some common labeling issues to separate fact from fiction.

Fact or Fiction?
Generic label approval must be approved by the in-plant FSIS personnel before being used on product.

Fiction. According to regulations found in Title 9 of the Code of Federal Regulations (CFR) 412.2, companies can use generically approved labels without submitting them first to FSIS provided they meet certain criteria. The 1996 final rule that amended FSIS’ prior label approval system eliminated the authority for inspectors to grant label approvals.

Fact or Fiction?
If a company hires a label expediter to deliver the label to FSIS, it will be given priority over labels submitted through other means (mailed or faxed).

Fiction. Labels which require LPDS sketch approval are processed in the order in which they are received, no matter the submission route. It’s also important to remember that labels which require LPDS sketch approval that have been returned for corrections or clarifications will be handled as resubmittals. Resubmittals are normally reviewed the day they are returned to FSIS and are not handled as a new label submission.

Fact or Fiction?
If the label is returned with modifications that I do not like, I just have to deal with it and use it anyway.

Fiction. While there are some points that are non-negotiable when it comes to labeling regulations, others can be appealed. If you receive a label approval with modifications that you do not want, or feel are unfair, you should contact the Labeling and Program Delivery Staff (LPDS) by phone or through askFSIS to discuss these findings with the staff officer who reviewed your application. The labeling staff can also provide direction if you then choose to submit an appeal. To save time and frustration, if you are strongly opposed to having even minor changes made to your label, state this in the application. If a label is determined not to be in compliance with FSIS regulations or policies, the staff officer will reject the label, explaining the reasons for rejection rather than making modifications.

Fact or Fiction?
Since I sent in my label for sketch approval to Washington, I do not need to maintain the records myself.

Fiction. It’s the establishment’s responsibility to create and maintain labeling records that include a copy of the final labeling applied to product. A labeling record includes the final label, the product formulation, processing procedure, sketch approvals if needed and any supporting documentation necessary to support any special statements or claims on the label. A sketch approval is required for any labels that fall into one or more of the categories of labels listed in 9 CFR 412.1: labels for temporary approval, labels for religious exempt product, export labels which bear labeling deviations from domestic requirements, and labels bearing special statements or claims as defined in 9 CFR 412.1(e).

Fact or Fiction?
Temporary approvals are only given to big companies.

Fiction. Temporary approvals may be granted by the labeling staff for a period not to exceed 180 calendar days, under the following conditions:

  1. The proposed labeling would not misrepresent the product;
  2. The use of the labeling would not present any potential health, safety, or dietary problems to the consumer;
  3. Denial of the request would create undue economic hardship; and
  4. An unfair competitive advantage would not result from the granting of the temporary approval.

When submitting for a temporary approval, it’s critical to state the reason clearly. If there is an ingredient change, it’s most important to identify all ingredients that are in the product and not on the label and those ingredients removed from the product.

As an alternative to submitting for temporary approval, corrections to labeling (e.g., covering an error with indelible ink, using a corrected pressure sensitive sticker, or cutting off a portion of the label) may be done to bring a label into compliance with FSIS’ labeling regulations and policies.

Fact or Fiction? 
I can speed up the approval process if I both fax and mail in my label to FSIS’ Labeling and Program Delivery Staff.

Fiction. Sending in the same label via multiple delivery routes will not speed up the approval process. In fact, it may slow it down because the labeling staff will have to take time to review both labels against each other and possibly contact you to see why you sent in duplicate labels for approval.

Fact or Fiction? 
If I’m using an inspected facility to process my product for me, I’m required to have its address on the label.

Fiction. Although an address line is a required feature on a label for compliance with 9 CFR 317.2(g)(1) and 381.122, the name and address of the Federal establishment that prepared the product is not necessarily required. The label may include a “Distributed by___” or ‘Manufactured for___” statement in the address line. The actual manufacturer can be traced through the establishment number on the label. If the name and address on the label is not preceded by a phrase such as “Distributed by,” “Manufactured for,” “Packed for,” or a similar phrase, the name and address on the product label must be that of the actual manufacturer, or a “DBA” (doing business as) name that has been granted to the official establishment.

Fact or Fiction?
If I have fully labeled product packed inside another shipping container, then the outer shipping container must also bear a full label as well. 

Fiction. In accordance with 9 CFR 316.13 and 9 CFR 381.127, a shipping container for products sold in domestic commerce that hold fully labeled packaged products is only required to include the inspection legend and establishment number.

Additionally, a handling statement is required on shippers that contain perishable products. All other labeling features are optional.

Fact or Fiction?
A new client wants our company to begin producing and packaging product for it. It has a copy of the sketch approval for a Federal establishment under different ownership that used to make the product for the client. Because the label has been sketch approved for the other company, and the only information that will be changing is the address line and establishment number, I don’t believe I need to submit for sketch approval to begin producing the product at my establishment.

Fiction. A sketch label approval is valid for the specific establishment listed on the label application. If the client wants to change establishments, he or she may resubmit the label to LPDS for prior approval if the label falls into any of the categories of labels listed in 9 CFR 412.1. However, if the new establishment has a complete copy of the original sketch label approval on file, including any and all associated supporting documentation necessary to support any special statements or claims on the original label, then the new plant may change the establishment number and address line on the label to their own number and address. In this case the information contained within the labeling application would be expected to remain the same (e.g. HACCP category, product formulation, and processing procedures). Note that this generic change of an establishment number would not apply to certain claims, such as organic claims, since the supporting documentation for organic claims is specific to the establishment and therefore would not support the claim of organic made by the new establishment. Of course, if a label meets the criteria for generic approval in 9 CFR 412.2, then a new label with the new establishment address line and establishment number may be applied generically.

Fact or Fiction?
The labeling staff of FSIS has moved within the past year.

Fact. The labeling staff has indeed been steadily working through a move this past year, and its contact information has changed.  The new contact information is:

Label Applications sent via U.S. Postal Service (including regular mail, U.S. Priority):
Labeling Distribution Unit 
Stop Code 3786, Patriots Plaza III, 8-168
1400 Independence Avenue, SW
Washington, DC 20250-3700

Label Applications sent via UPS, FedEx, or Courier:
Labeling Distribution Unit
Patriots Plaza III, 8-168
355 E Street, SW
Washington, DC 20024-3221

By phone:

  • For labeling policy questions: (301) 504-0879
  • For label application and compliance questions: (301) 504-0878
  • To check the status of a previously submitted label, call (301) 504-0883.

By fax:

  • (202) 245-4795; or (202) 245-4796


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Commonly Asked Questions & Answers

Q. Can an establishment use ultraviolet light (UV radiation) as an antimicrobial treatment applied to the surface of primals/subprimals cuts of meat or poultry product?

A. Yes. The United States Department of Health and Human Services’ Food and Drug Administration has determined conditions of use for UV radiation as a surface antimicrobial treatment for food [21 CFR 179.39]. When UV radiation sources consist of low-pressure mercury lamps, they can be safely used as a surface antimicrobial treatment. See 21 CFR 179.39.

Q. If I need guidance on FSIS Policy, whom should I contact?

A. For guidance on FSIS Policy, you may contact the FSIS Policy Development Staff (PDS).

They may be contacted through one of two ways:

  1. Submit the question through askFSIS at http://askfsis.custhelp.com/. Then it can automatically be routed to the best place for an answer via our normal process; or
  2. Contact the PDS at 1-800-233-3935, and then press extension 6.

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Small Plant News

Editorial Staff 

Editor in Chief: Daniel P. Puzo 
Editor: Keith Payne
Managing Editor: Jane Johnson, DVM
Manager: Sally Fernandez 
Layout/Design: Gordon E. Wilson, Duane Robinson 
Contributing Writer: Jeff Tarrant, Commander, U.S. Public Health Service 
Office of Outreach, Employee Education and Training: Michael G. Watts, Assistant Administrator

Contact Information

Small Plant News, USDA/FSIS, Patriots Plaza III, Rm. 9-267A, Mailstop 3778, 1400 Independence Ave., SW, Washington, DC 20250. (800) 336-3747; E-mail: SmallPlantNews@fsis.usda.gov

FSIS Small Plant Help Desk

Last Modified Jan 12, 2017