Food Safety and Inspection Service:

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Food Safety and Inspection Service:

FSIS Labeling Overview and 

Generic Label Approval

Labeling and Program Delivery Staff (LPDS)

October 21, 2014

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Food Safety and Inspection Service:

 Background information

 Required labeling features

 New generic labeling regulations

 Sample labels

 Label submission

 Labeling record

 Useful resources

Webinar Overview

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Food Safety and Inspection Service:

Background Information

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Food Safety and Inspection Service:

Introduction

 U.S. Department of Agriculture (USDA) assures that 

meat and poultry products in interstate or foreign 

commerce are wholesome, not adulterated, and 

properly marked, labeled and packaged

 USDA’s Food Safety and Inspection Service (FSIS) is 

responsible for the development and application of 

labeling requirements applicable to meat and poultry 

products

 FSIS is charged with developing the labeling policy by 

which it is determined if a meat or poultry product is 

misbranded or adulterated 

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Food Safety and Inspection Service:

Labeling and Program Delivery Staff (LPDS)

 Staff within the Office of Policy and Program Development (OPPD) of FSIS

 LPDS Functions include

– Administering the Agency’s prior label approval program

– Responding to inquiries (e.g., askFSIS and phone calls) on FSIS labeling 

regulations and policies 

– Performing amenability determinations for FSIS and developing compliance 

policy guidance for special statements and claims (e.g., animal production 

raising claims)

– Writing regulations, FSIS Directives, FSIS Notices, and other policy guidance 

documents for meat, poultry, and egg product labeling and standards issues

– Providing labeling-related training for stakeholders, including FSIS personnel

– Developing and managing Agency research to explore consumer use and 

understanding of labeling features (e.g., cooking instructions, safe food 

handling)

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Food Safety and Inspection Service:

Prior Label Approval

 Federal Meat Inspection Act (FMIA) and Poultry 

Products Inspection Act (PPIA) require food 

manufacturers to obtain prior approval for 

labels of meat and poultry products before 

products may be marketed

 Prior approval is granted one of two ways:

– Sketch approval which is approved by the Labeling and 

Program Delivery Staff (LPDS)

– Generic approval which is approved by being in 

compliance with applicable regulations

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Food Safety and Inspection Service:

Types of Label Approval

Sketch

 Label review process by LPDS

 Printer’s proof or equivalent that is 

sufficiently legible to clearly show all 

labeling features, size, and location

 May be hand drawn, computer generated 

or other reasonable facsimile

 Must clearly reflect and project the final 

version of the label

 Specific categories of labels require sketch 

approval

 Sketch approved labels reviewed by LPDS 

are either “approved” or “approved as 

modified”

 A “Sketch” label is the concept of a label 

while “Final” label is the label that is 

applied to product before distribution in 

commerce

NOTE: Establishments are responsible for ensuring final 

labels applied to product are in compliance with FSIS 

regulations, including making modifications noted by 

LPDS during sketch review

Generic

 The approval of labeling or 

modifications to labeling prior 

approved by the Agency without 

submitting such labeling to FSIS for 

sketch approval

 Requires that all mandatory labeling 

features are in conformance with FSIS 

regulations 

 Although not submitted to FSIS for 

approval, generically approved labels 

are approved by being in compliance 

with applicable regulations 

NOTE: FSIS Inspectors do not generically approve labels. 

Establishments do not generically approve labels. FSIS 

approves labels through generic labeling regulations.

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Food Safety and Inspection Service:

Required Labeling Features

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Food Safety and Inspection Service:

Required Labeling Features

 Labels have up to eight (8) required features

 Regulations specify where on the label some 

of the features must be located

– Principal Display Panel (PDP)

• 9 CFR 317.2(c) and (d), 9 CFR 381.116

– Information Panel (IP)

• 9 CFR 317.2 (m), 9 CFR 381.116(c)

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Food Safety and Inspection Service:

Principal Display Panel and Information Panel

 PDP is the part of the label most likely to be 

displayed, presented...when offered for sale 

under customary conditions

 IP is any portion of a label not on the PDP that is 

displaying certain mandatory features

PDP

Information 

Panel 

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Food Safety and Inspection Service:

Required Labeling Features

Four features are required on the principal display panel (PDP):

(1) Product name 

9 CFR 317.2(e)/381.117(a)

(2) Handling Statement, if product is perishable

9 CFR 317.2(k)/381.125(a) 

(3) Inspection Legend/Est. number

9 CFR 312.2(b)/381.96 &381.123(b)(2) 

(4) Net weight for product sold at retail (except variable net weight products)

9 CFR 317.2(h)/381.121

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Food Safety and Inspection Service:

Required Labeling Features

The remaining four features may be located on the 

PDP or on the information panel:

(5) Name and place of business of the manufacturer, packer or distributor

9 CFR 317.2(g)(2)/381.122

(6) Ingredients statement displaying all ingredients in descending order of 

predominance

9 CFR 317.2(c)(2)/381.118

(7) Nutrition labeling (unless an exemption applies)

9 CFR 317.300-400/381.400-500

(8) Safe Handling Instructions if the product is not ready-to-eat (may be located 

on any panel)

9 CFR 317.2(l)/381.125(b)

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Food Safety and Inspection Service:

Required Labeling Features: Summary Table

Feature Reference Location Applies to 

Product Name 9 CFR 317.2(c)(1) or 

381.117

Principal display panel All products

Inspection Legend 9 CFR 317.2(c)(5) or 

381.123

Principal display panel All products

Handling Statement 

(e.g. “Keep Frozen”)

9 CFR 317.2(k) or 

381.125(a)

Principal display panel Products requiring special 

handling to maintain 

wholesomeness

Net Weight Statement 9 CFR 317.2(h) or 

381.121

Principal display panel Product sold at retail, unless the 

net weight is applied at retail

Ingredients Statement* 9 CFR 317.2(f) or 

381.118

Information panel or 

Principal display panel

Products with multiple 

ingredients

Address Line 9 CFR 317.2(g) or 

381.112

Information panel or 

Principal display panel

All products

Nutrition Facts Panel by 9 CFR 317.300 or 

381.400

Information panel or 

Principal display panel

Products not exempted by 9 

CFR 317.400 or 381.500

Safe Handling 

Instructions

9 CFR 317.2(l) or 

381.125(b)

Information panel or 

Principal display panel

Products with a not-ready-toeat meat or poultry component 

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Food Safety and Inspection Service:

Sample Label

GROUND BEEF

Keep Frozen

Net Wt. 16 oz. (1 lb.) 

Ingredients: Beef, salt, pepper, garlic powder

Distributed by: Felix’s Kitchen, 

Frederick, MD 21701

Serving Suggestion

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Food Safety and Inspection Service:

Mindy’s Meatloaf

Net Weight: 26 oz (1.625 lbs.)

Serving 

Suggestion

Keep 

Refrigerated

Ingredients: Beef, Pork, Veal, 

Bread Crumbs (flour, wheat 

flour, salt, pepper and 

seasoning), flavorings, natural 

flavorings, spices, sugar, 

dextrose, water

Distributed by:

Mallon Industries, West Seneca, NY 14224

Heating Instructions:

Remove from package

Put in pan

Preheat oven to 350 degrees

Heat for 60 minutes or it reaches 

an internal temperature of 165 

degrees as measured by a meat 

thermometer. 

Sample Label

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Food Safety and Inspection Service:

New Generic Labeling 

Regulations

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Food Safety and Inspection Service:

New Generic Labeling Final Rule

 Effective January 6, 2014, the final rule amended 

FSIS regulations to combine the previous 

regulations that provided for labeling approval (9 

CFR 317.4 and 381.132) and generically approved 

labeling (9 CFR 317.5 and 381.133) for meat and 

poultry products into one new section

 New label approval regulations for meat and

poultry products now in 9 CFR 412.1; approval of 

generic labels now in 9 CFR 412.2

– Current regulations found online at www.ecfr.gov

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Food Safety and Inspection Service:

Generic Approval

 Final rule amended the meat and poultry products inspection 

regulations to expand the circumstances under which the labels of 

meat and poultry products are generically approved by the Agency

 Prior to issuance of the Generic Final Rule

– FSIS regulations specified when a generic approval could be 

undertaken by an establishment (9 CFR 317.5 and 381.133)

– specific labels were eligible for generic approval AND

– certain changes could be made generically to sketch approved labels

 NOW, four categories of labels REQUIRE LPDS review. 

 ALL OTHER labels that do not fit into one of the four categories do 

not require sketch approval by LPDS

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Food Safety and Inspection Service:

New Generic Labeling Final Rule

 Only certain types of labeling require submission for 

evaluation by LPDS 

– labels for temporary approval (9 CFR 412.1(c)(4))

– labels for products produced under religious exemption (9 

CFR 412.1(c)(1))

– labels for products for export with labeling deviations (9 

CFR 412.1(c)(2))

– labels with special statements and claims (9 CFR 

412.1(c)(3))

 FSIS will continue to require the submission of such 

labels because they are more likely to present 

significant policy issues that have health or economic 

significance 20
Food Safety and Inspection Service:

LPDS Approval Required: Temporary Label Approval (9 CFR 412.1(c)(4))

 A temporary label approval may be granted for labels with a regulatory 

deviation that does not pose any potential health, safety or dietary 

problems to the consumer

 Temporary approval not to exceed 180 days

– Plant transfers are granted for up to 60 days

– Additional 60-day extension may be granted

 Granted on a case-by-case basis

 Four conditions for temporary approval described in the regulations

 (9 CFR 412.1(f)(1)) must be met

 Approval process unchanged by the new generic labeling rule

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Food Safety and Inspection Service:

Temporary Label Approval Submission

 Address all four components of 9 CFR 412.1(f)(1)

 Clearly explain the specific labeling deviations that are 

present on the label

 Ingredients statement deficiencies must clearly list which 

ingredients are on the label but not in the product and 

which ingredients are in the product but not on the label

 Complete previously approved label information in Box 6b 

of Form 7234-1 or in the “Approval Information” section 

of LSAS

 If requesting extension of a temporary approval, explain 

in detail why the extension is necessary

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Food Safety and Inspection Service:

Temporary Label Approval: Examples

 Incorrect legend on label (e.g. poultry legend on a 

meat label)

 Order of predominance of ingredients has changed

 Specific multi-ingredient item has changed resulting in 

incorrect sublisting of some ingredient (e.g. spice mix)

 New ingredient has been added to formulation but is 

not on the label

 Address of the establishment has changed

 Incomplete product name (e.g. “smoke flavor added” 

qualifier missing)

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Food Safety and Inspection Service:

LPDS Sketch Approval Required:

Religious Exemption Statements (9 CFR 412.1(c)(1))

 Religious-exempt product (poultry) does not 

receive the mark of inspection and, therefore, 

deviates from the general labeling requirements 

for meat and poultry products

 Labels for religious-exempt product must be 

submitted to LPDS for sketch approval

 Ritually-slaughtered meat and poultry products 

receive the mark of inspection (Kosher, Halal) 

and may be approved generically provided that 

they don’t meet one of the other labeling 

categories requiring LPDS approval

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Food Safety and Inspection Service:

Religious Exemption: Examples

Poultry processed in accordance with:

 Buddhist religious beliefs (head and feet remain on eviscerated 

poultry)

 Confucian religious beliefs (poultry is not eviscerated, head and 

feet intact)

 Islamic (or Halal) religious beliefs (poultry is eviscerated, head- on, with or without the feet intact, in ready-to-cook form)

 Kosher processed and handled, non-eviscerated, head and feet 

intact 

Ritually slaughtered meat and poultry products (Halal, 

Kosher) are produced under Federal inspection and are not

included in this category

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Food Safety and Inspection Service:

LPDS Sketch Approval Required: 

Export Labels Bearing Labeling Deviations (9 CFR 412.1(c)(2))

 Exports of U.S. meat and poultry products occur under agreements 

between the U.S. government and foreign governments

 Agreements require U.S. government approval of labels on exported 

meat and poultry products which bear labeling deviations

 Includes ensuring that any changes made to labels on meat and poultry 

products are allowed per the importing country’s laws (9 CFR 317.7 and 

381.128)

 Most labels marked “for export only” that bear labeling deviations 

cannot be used domestically must be sketch approved by LPDS

 412.1(c)(2) allows for export only labels with only changes to the net 

weight in metric units and required features entirely in a foreign 

language to be approved generically

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Food Safety and Inspection Service:

Common Deviations on Export Labels that require label submission 

 No Safe Handling Instructions

 Nutrition Facts Panels in formats not 

permitted on domestic labels

 Different/alternate spelling of ingredient 

names

 Not sublisting of certain standardized foods, 

e.g., cheeses or enriched flour 

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Food Safety and Inspection Service:

Export Label Deviations which do not require LPDS sketch approval

 Net Weight in metric units

 Required features entirely in a foreign 

language

 9 CFR 412.1(c)(2)

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Food Safety and Inspection Service:

LPDS Sketch Approval Required:

Special Statements and Claims Defined in 9 CFR 412.1(e)

 Detailed list of special statements and claims requiring 

LPDS approval and examples of claims eligible for 

generic approval is available on FSIS website

http://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-

4a2d-8f86-940c2698e2c5/Comp-Guide-Labeling-EvaluationApproval.pdf?MOD=AJPERES

 List includes commonly used special statements and 

claims

 List will be periodically updated to reflect commonly 

asked questions regarding special statements and 

claims

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Food Safety and Inspection Service:

Special Statements and Claims: LPDS Approval Required 

o 3rd party raising claims or programs (i.e. Global Animal partnership, 

AMS Process verified or certified programs, American Heart 

Association (AHA) claims)

o Claims regarding meat and poultry production practices (i.e. claims 

regarding the raising of animals such as “no antibiotics administered” 

or “vegetarian fed”)

o Breed claims (Berkshire, Angus, Hereford, etc)

o Certified claims, Certified Halal

o Gluten free: both certified and non certified 

o Health claims defined in 21 CFR Subpart E, e.g. dietary saturated fat 

and cholesterol and risk of coronary heart disease (21 CFR 101.75)

Implied Nutrition Claims for example Heart Smart, Baked Not Fried, 

Made without Butter

o Instructional or disclaimer statements concerning pathogens, such as 

“for cooking only”; “not tested for E. coli O157:H7”; or “For high 

pressure pasteurization at establishment ABC”

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Food Safety and Inspection Service:

Special Statements and Claims: Sketch Approval Required (continued) 

o Natural claims, e.g. “All Natural”, “100% Natural”

o Negative claims or “free” claims (no MSG, no MSG added, no 

preservatives)

o Statements that identify a product as “organic” or containing organic 

ingredients

o Omega 3 factual statements

o “Whole Grain”, “Made with Whole Grains”, “Made with whole wheat” 

claims

o Nutritional Front of Pack statements, for example “0 grams trans fat per 

serving”, Nutrition facts Up Front

o Claims of the use of non-genetically engineered ingredients

o Claims that are undefined in FSIS regulations or the Food Standards and 

Labeling Policy Book (Note: natural and negative claims are defined in 

the policy book but will continue to be required to be submitted for 

approval). 

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Food Safety and Inspection Service:

Statements: Generic Approval Permitted

 Some statements and claims are not 

considered “special” under 9 CFR 412.1 (e), 

e.g. statements of fact

 Statements and claims of this type may be 

approved generically (9 CFR 412.2(b))

 The next two slides review examples of 

statements that are not considered special 

and may be approved generically

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Food Safety and Inspection Service:

Statements: Generic Approval Permitted

o All, 100%, pure 

o Allergen or “Contains (name of ingredient)” statements 

(e.g., contains soy) 

o AMS Grading (Prime, choice, grade A)

o Child Nutrition Boxes

o Flavor Profiles (e.g. made with fennel, teriyaki flavored, 

made with real cheese, only white meat)

o Foreign Language on domestic products

o Geographic claims (refer to 9 CFR 317.8(b)(1))

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Food Safety and Inspection Service:

Statements: Generic Approval Permitted

o Green Claims/Environmental Claims

o Halal, Kosher (not certified)

o Hand pulled style/hand pinched style 

o Handcrafted, handmade, hand slaughtered, hand crafted 

style

o Home Style

o For HRI only, Institutional use only, etc

o Nutrition Claims (defined)

o Ready in/Cooks in (number of minutes or seconds)

o Oven roasted or similar statements

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Food Safety and Inspection Service:

Points of Clarification

 Generic Rule does not apply to egg products

– Expanding the generic labeling criteria for processed egg 

products is being considered as a separate rule

 Generic Rule also does not apply to exotic species under 

voluntary inspection

– All labels for exotic species products must be approved by LPDS, 

including any changes to sketch approved labels (e.g. buffalo 

jerky)

– Amenable products with exotic species used as an ingredient 

may be generically approved if they do not fall into any of the 

four categories of labels requiring LPDS approval (e.g. bison 

jerky, beef added)

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Food Safety and Inspection Service:

 FSIS Inspectors do not generically approve labels

 FSIS in-plant inspection personnel will continue to 

verify labels as part of the General Labeling task

 Labels will be generically approved if they meet 

the criteria listed in 9 CFR 412.2(b)

 Establishments do not generically approve labels. 

Generically approved labels are approved by FSIS

Points of Clarification

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Food Safety and Inspection Service:

Label Examples

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Food Safety and Inspection Service:

Special Statements and Claims: Sketch Approval Required 

Special 

Statements 

and Claims

A Good Win! Farms©

est 2010 

Net Weight: 48 oz (3 lbs)

Keep Refrigerated

Distributed By:

20101Beltsville Rd

Sunnyside, MD 12345

Certified Organic by 

LPDD Organic 

Certifying

*Minimally Processed, No 

Artificial Ingredients

Without Added Antibiotics 

Barn Roaming, Never Confined to a Lot 

Grass Fed 

Organic 

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Food Safety and Inspection Service:

Statements and Claims: Generic Example

NEW!

Chicken Kabobs

Serving suggestion

Keep Refrigerated Net Wt. 32 oz. (2 lbs.)

Packed for: House of Kabob, Houston, TX 77252

Grilled White Chicken Chunks 

on a wooden skewer

Ingredients: chicken breast, 

salt, pepper

Fully Cooked Generic 

statements 

and claims

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Food Safety and Inspection Service:

All 

Natural* Chicken Kabobs

Serving suggestion

Keep Refrigerated Net Wt. 32 oz. (2 lbs.)

Packed for: House of Kabob, Houston, TX 77252

Grilled White Chicken Chunks 

on a wooden skewer

Ingredients: chicken breast, 

salt, pepper

Fully Cooked

*Minimally Processed, no artificial ingredients

Special 

Statements 

and Claims

Special Statements and Claims: Sketch Approval Required 

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Food Safety and Inspection Service:

Black Forest Ham

Hand-rubbed with spices

Keep Refrigerated

Cured with water, salt, contains 2% or less of 

dextrose, sodium nitrite, sodium erythorbate, 

sodium lactate, sodium phosphate, sodium 

diacetate

97% Fat Free

Distributed by Birchwood Farms, Nashua, NH 03060

Made in New Hampshire

Generic 

statements 

and claims

Net Wt. 6 oz.

Statements and Claims: Generic Example

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Food Safety and Inspection Service:

Sliced Black Forest Ham

Keep Refrigerated

Cured with water, salt, contains 

2% or less of dextrose, sodium 

nitrite, sodium erythorbate, 

sodium lactate, sodium 

phosphate, sodium diacetate

0 g Trans fat per serving

Distributed by Birchwood Farms, Nashua, NH 03060

Special 

Statements 

and Claims

Made in 

New 

Hampshire

Net Wt. 6 oz.

Special Statements and Claims: Sketch Approval Required 

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Food Safety and Inspection Service:

Label Submission 

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Food Safety and Inspection Service:

Label Review Process

 Labels that do not fit into one or more of the four categories of labels 

requiring LPDS approval are generically approved by their compliance with 

applicable regulations

 If an establishment elects to submit a generically approved label to LPDS 

for review, the label will be assigned a lower priority than those labels that 

require approval by LPDS

 Labels classified as “first priority” or “second priority” based on whether 

or not labels require LPDS review

 Generic Final Rule referenced a higher priority given to those labels 

requiring review

 Establishments note claims on label applications on paper labels and in 

LSAS

 LPDS staff also verify that labels are categorized correctly 

44
Food Safety and Inspection Service:

First and Second Priority Labels

First Priority

 Labels which require LPDS 

evaluation as per 9 CFR 412.1: 

– Temporary labels

– Religious-Exempt product

– Labels for Export bearing 

labeling deviations

– Labels bearing special 

statements or claims

 Reviewed in the order in which 

they are received

 Wait time for review has 

decreased significantly since the 

generic changes took effect

Second Priority (Voluntary Evaluation)

 Labels which do not require 

LPDS evaluation as per 9 CFR 

412.2

 Establishments may request 

voluntary evaluation by LPDS 

of generically approved 

labels

 Applications for voluntary 

evaluation will be placed in a 

second priority queue and 

may take longer to be 

reviewed

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Food Safety and Inspection Service:

Second Priority (Voluntary Evaluation): Paper

 Type “Generic” after “Other claims” in Block 10 of FSIS Form 7234-1

 Paper labels that may be generically approved which are not marked as 

“Generic” in Block 10 will be placed in the second priority queue

Check the “Other 

Claims” box and 

type “generic” 

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Food Safety and Inspection Service:

Second Priority (Voluntary Evaluation): LSAS

 *New* question in Step 2: Product Information: “Are you 

requesting a voluntary review of a submission which can be 

generically approved?”

– Required field

– Select “yes” or “no”

 In Step 3: Special Claims Information, check the “Other Claims” box 

and type “generic” in the box entitled “Other claim description”

 LSAS labels with requests for voluntary review will be added to the 

second priority queue

 Generic labels incorrectly marked with the “No” button selected 

will be moved by LPDS Staff Officer to the second priority queue

 

47
Food Safety and Inspection Service:

LSAS Special Claims Information

To request a Voluntary Review of a Generic 

label, check the “Other Claims” box and 

type “Generic” in the “Other Claim 

Description” box

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Food Safety and Inspection Service:

Generic Label Advisor

 Updated to reflect the new generic regulations

 The GLA is a tool, not a requirement for generic 

approval

– GLA guides applicants through a series of questions to 

determine if a label requires submission

– Use of the GLA is not required to submit a label 

through LSAS

– Use of the GLA is not required to verify that a label is 

generically approved

49
Food Safety and Inspection Service:

Note on Second Priority (Voluntary) Review

 LPDS will assess all labels to determine if label review 

is required

 LPDS determination that a label may be generically 

approved is NOT a label approval

 The establishment is responsible for ensuring that the 

final label meets all applicable labeling regulations

 Generically approved labels awaiting voluntary review 

do not require approval by LPDS

– may be used provided that the labels are in compliance with applicable 

regulations

– labels placed in the second priority queue may take longer to be 

reviewed

50
Food Safety and Inspection Service:

Label Review Process

First Priority Review

Paper and LSAS labels reviewed by LPDS will 

be marked as either:

 Sketch Approved

 Sketch Modified, with required 

changes noted

 Returned

– Returned first priority labels 

must be resubmitted to LPDS 

for approval

– Resubmitted first priority will 

be reviewed when they are 

received and will not be “requeued”

Second Priority (Voluntary) Review

Paper and LSAS labels reviewed by LPDS will 

be marked as either:

 Sketch Approved

 Sketch Modified, with required 

changes noted

 Returned

– Returned labels are NOT required 

to be resubmitted to LPDS for 

approval since they are approved 

generically once the noted 

changes are made

– Returned labels resubmitted to 

LPDS will be placed at the 

bottom of the second priority 

queue on the day they are 

received 

– There is no resubmittal priority 

for labels that may be generically 

approved

51
Food Safety and Inspection Service:

Extraordinary Circumstances

 Labels that may be generically approved and are voluntarily 

submitted for review do not qualify as an extraordinary 

circumstance

 Any label that may be generically approved does not require LPDS 

approval to enter commerce, therefore emergency review will not 

be granted

 Special note on final product labels “Tagged” for labeling noncompliance

– Final label must be brought in to compliance by correcting the noncompliance

– Requests for the temporary use of final labels not in compliance with 

FSIS regulations and policies must be submitted to LPDS for review. 

(Emergency reviews may be requested in this instance.)

52
Food Safety and Inspection Service:

“Blanket” Approval

 Blanket approval allows certain information to be added to other products without 

having to submit each individual label bearing the same type of information for 

approval

 Refers to an approval that covers multiple labels or product lines

– e.g. Front of Pack nutrition statements, Certified State programs 

 Application for a blanket approval includes:

– completed application form 7234-1

– copy of at least one of the product labels

– attachment that indicates a list of products or line of products to which the 

same information will be applied, e.g. FOP nutrition

53
Food Safety and Inspection Service:

Blanket Approval: Example 

 In this example, if the establishment references in the application that the FOP 

statements will be applied to other products:

– Calories, saturated fat and sodium values may be removed or updated 

generically on other products to match the nutrition values for each individual 

product

– Any new FOP statements (e.g. protein, sugar) must be submitted to LPDS for 

approval

Pepperoni Pizza

Keep Refrigerated Chloe’s House of Pizza, Pittsburgh, PA 15232

Per 1/5 pizza

54
Food Safety and Inspection Service:

Labeling Record

55
Food Safety and Inspection Service:

Labeling Record 

 Establishments are required to keep records of all labeling

 Labeling record must include:

– Final label applied to product

– Product formulation

– Processing procedures

– Supporting documentation, including prior sketch approval from LPDS (if applicable)

 Required records prescribed by 9 CFR 320.1(b)(11), 381.175(b)(6), and 412.1

 The final rule added the requirement establishments maintain as part of the 

labeling record, supporting documentation needed to show that the label is 

consistent with the Federal meat and poultry regulations and policies on 

labeling as described in 9 CFR 412.1

 Labeling record for any label generically approved must include a complete 

copy of the original LPDS approval (if the original required LPDS approval)

56
Food Safety and Inspection Service:

Supporting Documentation: Examples

 AMS Schedule G for breed claims such as Angus

 Support for the use of State approved agricultural logos such as “Go 

Texan” or “Kentucky Proud” 

 Description in the processing procedures that the product is “hand 

tossed” for a “hand tossed” claim

 Prior approved label with FOP keys to support FOP keys on a different 

product

 Third party verification for geographic style such as from a culinary 

institute supporting the use of “Mongolian Style”

 Organic certificate from the National Organic Program for both the 

slaughter facility and the animal grower

 Certificate from a specific regional Halal certifying entity to support a 

“Certified Halal” claim 

 Documentation that ink used for printing the label is made from 100% soy 

ink

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Food Safety and Inspection Service:

Resources

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Food Safety and Inspection Service:

Food Standards and Labeling Policy Book

 Available online at:

http://www.fsis.usda.gov/OPPDE/larc/Policies/Labeling_Policy_Book_082005.pdf

 Provides additional guidance regarding FSIS standards 

outside of the regulations

 Used in conjunction with the Meat and Poultry 

Inspection Regulations and FSIS Directives and Notices

 Composite of policy and day-to-day labeling decisions 

 Claims found in the Policy Book may be approved 

generically except: natural claims, negative claims

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Food Safety and Inspection Service:

Food Standards and Labeling Policy Book

 FSIS has decided to stop adding policy guidance to the Food 

Standards and Labeling Policy Book

 FSIS will continue to amend or remove items in the book, as 

necessary, but it will no longer add new material to it

The Agency will convey new labeling policy by other means, 

such as compliance policy guides

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Food Safety and Inspection Service:

http://www.fsis.usda.gov

 TopicsRegulatory ComplianceLabeling/Label Approval

Home page 

for all generic 

labeling 

resources

Note: Other labeling resources may also be found on this page

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Food Safety and Inspection Service:

Generic Labeling Home Page

Generic labeling resources

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Food Safety and Inspection Service:

Available Resources

FSIS Main Labeling Website:

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling

Generic Labeling Resources:

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/Labeling-Policies

Allergens - Voluntary Labeling Statements:

http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/ingredients-guidance/allergensvoluntary-labeling-statements

Submit questions through askFSIS http://askfsis.custhelp.com

Call LPDS at (800) 233-3935

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Food Safety and Inspection Service:

Questions?

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