Label Submission and Approval System

LSAS

Webinar Presentation

March 20, 2013

Labeling and Program Delivery Division

USDA, FSIS, OPPD
• Introduction

• Prior Webinars Highlights

• Managing Establishment Information for 

LSAS Temp Numbers

• Helpful Tips

• Resources

• Questions

Agenda

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• Submitter benefits

• LSAS account requirements

• FSIS Enrollment Wizard

• Establishing your profile name in LSAS

• Navigating your dashboard

• Managing establishments under your profile

• Creating a label submission

• Status check

• Generic Label Advisor

Highlights Covered in the January 23, 2013 

Webinar

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• Review of creating a label submission

• How to respond to a return

• Formula Examples

• Claims and Supporting Document requirements

• Appeals

• Miscellaneous Tips (e-auth credentials, updating your 

establishment profile with corrections, Extraordinary 

Circumstances and Draft, and contacting the LSAS 

Administrator if you permanently leave)

Highlights Covered in the February 20, 

2013 Webinar

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• When creating a label submission in LSAS, establishment information should 

ALWAYS reflect a valid establishment number, name, and address. Utilize the 

selection of the PHIS button.

• In cases where an establishment is pending a Grant of Inspection, and a valid 

establishment number has not yet been assigned, LSAS allows the creation of a 

label submission by utilizing the feature: “Include Temporary Establishment.” 

• Once, the Grant of Inspection has been approved and a permanent establishment 

number assigned, it is the submitter’s responsibility to update their establishment 

profile in LSAS to reflect the valid establishment information.

• If you find it necessary to include a temporary establishment number, the next 

several slides will demonstrate how to proceed. Additionally, you will see how to 

manage and update the establishment profile once a permanent establishment 

number has been assigned. 

The importance of ensuring your establishment profile in LSAS is up-to-date, is the 

submitters responsibility. 

Managing Establishment Information

for LSAS Temp Numbers

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Include Temporary Establishment

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Select ONLY if you DO NOT have 

permanent Establishment Number (i.e., 

Pending Grant of Inspection)
Creating Temporary Establishment Profile

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Select Domestic or International

Complete required fields

Select Create and Include

Select Domestic or International

Complete required fields

Select Create and Include
Example of LSAS_Temp Establishment

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Below LSAS has automatically assigned an 

LSAS_Temp Establishment Number as you 

are waiting on your permanent number 

assignment

LSAS has automatically assigned an 

LSAS_Temp Establishment Number , 

allowing you start creating your label 

submission.
Add New Establishment

Once a valid/permanent establishment number 

has been assigned, use “Manage 

Establishments” to Add the new establishment 

information to your LSAS profile.

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Add New Establishment (Continued)

Make use of “Add 

Establishment from 

PHIS” for consistency.

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Add New Establishment (Continued)

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Enter Search Criteria either 

by name or number
Add New Establishment (Continued)

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Select Valid 

Establishment 

Results of Search:
Current Establishment(s) Under Your Profile

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This example shows the 

LSAS_Temp originally 

created, and the official 

establishment information 

you just added using PHIS. 

Select “Remove” to eliminate 

the LSAS_Temp Establishment 

information from your profile. 

Note: You may not use “Update” to correct the Establishment Number 

on an LSAS_TEMP number.
Remove Establishment

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Select “Submit” to 

Remove the LSAS_Temp 

Establishment from your 

profile
Removal Confirmation

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Manage Establishments/Removal Confirmation

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Using “Manage Establishments” 

provides a visual confirmation of 

the removal of the LSAS_Temp, 

and the correct establishment 

information.

Keep your Establishment 

information updated at all times. 

This ensures that you and LPDD 

can effectively utilize LSAS for 

searches and reports.
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Formula Examples

Component Formula

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Formula Examples (Continued)

Composite Formula

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• When listing your ingredients, DO NOT include bullets, special 

characters, or numbered listing, (e.g., # cheddar cheese, 109. Ham, 

**Parsley,

- -Tomato paste, etc.).

• List all ingredients first. Perform search and reconcile error message. 

Then indicate the percentage or weight amounts. 

• Example of “Less than 2% Statement” in formula:

My Made Up Sauce (vegetable oil [soybean, canola], vinegar, egg yolk, water, 

corn syrup, Contains less than 2% of: salt, garlic, onion, dried portabella mushroom, 

natural smoke flavor, red bell peppers, maltodextrin, sugar, natural flavor)

Formula Tips

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• For complex formulations, or difficulty with 

ingredient and OOP, do the following:

√ Remove all ingredients (deselect)

√ Type “See Attached” In the ingredients box

√ Search and “Accept Anyway”

√ Indicate 100 % or total weight

√ Be sure to upload formula on the “Label 

Documentation” page (select “other” for type)

√ Include a Comment that you have attached the 

formula as a separate document

Formula Tips (Continued)

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• Which claims need supporting documents and what specific 

documentation is required?

– See the February 20, 2013 Label Approval Submission System

Webinar presentation (Slides 52-56) for requirements.

Note: The chart included in the February 20, 2013 is not all inclusive and should not 

be relied upon solely. When in doubt, contact LPDD for further guidance.

Claims & Supporting Documentation

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• Selection of an appeal is not a means to “resubmit” a returned application, 

Example: reviewer request a legible copy of label. Use “Edit” under available 

actions to address reviewer’s comments.

• The “appeal” function should only be used if an establishment disagrees with 

a specific modification or reason for rejection. 

• Written arguments supporting the basis for the appeal must be enclosed with 

the appeal. In addition, all uncontested modifications to labeling must be 

made prior to the submission of an appeal. 

• When prior approvals are mentioned in your argument, provide complete 

legible copies of the prior approval. If multiple prior approvals are involved, 

provide a listing.

Difference in Appeal vs. Return

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• Never share your e-Authentication credentials with anyone. This account 

is specific to you as an individual. 

• If you permanently leave your company or establishment, contact the 

LSAS Administrator immediately to ensure that your account is properly 

closed. If other employees in your company will need access to your 

labels, instructions will be provided. 

• Label image should be 300 dpi resolution to avoid having it returned as 

illegible

• If you are using a temporary establishment number, (example: 

LSAS_Temp123) be sure that you update your establishment profile with 

the correct establishment number and address. This is particularly 

important as it ensures consistent information that both LPDD and the 

submitter can utilize while performing searches and reports.

Miscellaneous Tips

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• If you have requested an Extraordinary Circumstance (EC), and your submission 

remains in Draft, be sure you have uploaded your supporting documentation . The 

documentation should include why you are requesting an EC review; e.g., describing an 

economic hardship, or the product is on hold.

• If you have requested a Temporary Approval, and your submission remains in Draft, be 

sure you have completed the prior approval information (prior approval number, date 

of prior approval, etc.). You may also attach documentation that includes the reason(s) 

for the temporary.

• Where is the Approval Number? Once a submission has been given an adjudicated 

status (Sketch, Sketch Modified, or Temporary), the label application number becomes 

the actual approval number. When you select Summary from Available Actions, you will 

observe this information as stated above. However, if you download the summary, it 

indicates a four digit number, which is incorrect. If you require a corrected copy of the 

Summary showing the correct approval number, send your request to the LSAS 

Administrator (lynn.yoder@fsis.usda.gov ) and a copy will be provided as time permits. 

Note: LPDD is working closely with our IT support to resolve this issue.

Miscellaneous Tips

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• Label System and Approval System (LSAS):

http://www.fsis.usda.gov/Regulations_&_Policies/Label_Submission_Approval_System/ind

ex.asp

• Industry User Guide:

http://www.fsis.usda.gov/PDF/LSAS_Industry_User_Guide_052112.pdf

• LPDD Labeling Guidance: 

http://www.fsis.usda.gov/About_FSIS/labeling_&_consumer_protection/index.asp

• Child Nutrition (CN) Labeling Program:

http://www.fns.usda.gov/cnd/cnlabeling/default.htm

• Generic Labeling:

http://www.fsis.usda.gov/Regulations_&_Policies/Generic_Labeling/index.asp

Additional Resources

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• LSAS Administrator:

LSAS@fsis.usda.gov 

(Use to report your issue only. Include your phone number. Please note that due to the 

volume of emails received, an email response may not always be provided).

lynn.yoder@fsis.usda.gov or call: (301) 504-0837

• askFSIS:

http://askfsis.custhelp.com/

• Labeling and Program Delivery Division:

Office: (301) 504-0878

Additional Resources (Continued)

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