FSIS Labeling and Program Delivery Staff (LPDS)

January 14, 2014
 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

2
Label review process by Labeling and Program 

Delivery Staff (LPDS)

May be a 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 facsimiles that clearly reflects and 

projects the final version of the label

Certain types of labels require sketch approval 

(discussed later in this presentation)

3
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. 

Establishments are responsible for ensuring final 

labels applied to product are in compliance with 

FSIS regulations

4
 FSIS regulations approve some labels generically 

 Generic labeling approval refers to the approval of labeling or 

modifications to labeling prior approved by the Agency 

without submitting such labeling to FSIS for sketch approval

 Generic labeling approval requires that all mandatory labeling 

features are in conformance with FSIS regulations 

 Although such labeling is not submitted to FSIS for approval, 

generically approved labels are approved by being in 

compliance with applicable regulations, therefore...

 Generically approved labels applied to product are consistent 

with the Agency’s prior labeling approval system

NOTE: FSIS Inspectors do not generically approve labels. 

Establishments do not generically approve labels. FSIS 

approves labels through generic labeling regulations.

5
 By regulation, FSIS specified when a generic 

approval could be undertaken by an 

establishment (9 CFR 317.5 and 381.133)

 Generic approval forgoes the need to obtain 

sketch approval 

 Prior to the new rule

• specific labels were eligible for generic approval 

AND

• certain changes could be made generically to 

sketch approved labels

6
 On November 7, 2013, FSIS published a final rule 

that amended the meat and poultry products 

inspection regulations to expand the circumstances 

under which the labels of meat and poultry 

products would be deemed to be generically 

approved by the Agency

 Effective January 2014, four categories of labels 

now REQUIRE sketch approval

 ALL OTHER labels that do not fit into one of the 

four categories do not require sketch approval by 

LPDS

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 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

8
 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

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New Generic Labeling Final Rule introduces the 

four categories of labels that require prior 

approval by LPDS:

◦ Temporary labels

◦ Religious exemption

◦ Exports with labeling deviations 

◦ Special statements and claims

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 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

 Approval not to exceed 180 days

• Plant transfers are granted for up to 60 days

 Temporary label approval granted on a caseby-case basis

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 Approval process unchanged by the new generic 

labeling rule

 FSIS assesses the public health risk and 

potential economic adulteration when deciding 

to grant approval for the use of a temporary 

label

 The regulations are not specific enough to 

assist establishments in determining when a 

temporary label may be granted

 For these reasons, FSIS is not expanding the 

scope of generic labeling approval to include 

temporary label approvals and extensions.

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 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 sketch approval

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 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 meat and poultry products to be 

exported bearing 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)

 Labels marked “for export only” that bear 

labeling deviations and therefore cannot be 

used domestically must be sketch approved by 

LPDS

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 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/bf1707

61-33e3-4a2d-8f86-940c2698e2c5/Comp-GuideLabeling-Evaluation-Approval.pdf?MOD=AJPERES

 List includes commonly used special 

statements and claims

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Examples of special statements and claims: 

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) 

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o Implied Nutrition Claims for example Heart 

Smart, Baked Not Fried, Made without Butter

o Statements that identify a product as “organic” 

or containing organic ingredients

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”

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

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

added, no preservatives)

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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). 

18
19

Special 

Claim 

(Breed 

Claim)

Special 

Claim 

(Natural 

Claim)
20

Special Claims 

(Organic Claims 

and logo)
 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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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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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

23
 Expected to be a cost-saving measure for the 

industry: $8.7 million over ten years

 FSIS is committed to providing guidance and 

resources that will help companies take 

advantage of this new rule without needing to 

hire additional personnel

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 Estimate that allowing more labels to be 

generically approved will reduce current label 

approval volume by roughly 70 percent

• decrease from 846,000 submissions to 261,000 

submissions over a 10-year period

• $2.9 million saved over ten years

 Cost savings in fewer staff hours spent 

evaluating labels can be redirected towards 

other Agency initiatives

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 Will enhance market efficiency by promoting 

a faster introduction of new products into the 

marketplace to meet demand 

 Frees up FSIS’ resources so they can be 

redirected to other food safety issues

 In-plant inspection personnel will continue 

on-site labeling evaluations

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 FSIS Inspectors do not generically approve labels

 Labels will be generically approved if they meet the 

criteria listed in 9 CFR 412.2(b)

 FSIS in-plant inspection personnel will continue to 

verify labels as part of the General Labeling task

 Establishments do not generically approve labels. 

Generically approved labels are approved by FSIS

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 Labels that do not fit into one or more of the 

four categories of labels requiring sketch 

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 sketch approval by 

LPDS

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 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

 Will be reviewed in the order in which they are 

received

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 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 of 

generically approved labels will be placed in 

a second priority queue and may take 

longer to be reviewed

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Type “generic” in the box entitled “Other claim description” 

in Step 3: Special Claims Information of the LSAS label 

submission process

Generic-labels not marked as “generic” will be returned via 

LSAS with a note that the label may be generically approved

• Generic-labels may be resubmitted through LSAS for voluntary 

review by noting “generic” in the “other claim description” box

• When a label that may be generically approved is returned 

electronically, no response is necessary if voluntary review is 

not requested

LSAS labels with requests for voluntary review will be added 

to the second priority queue

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 Type “Generic” after “Other claims” in Block 10 of FSIS Form 

7234-1

 Establishments submitting paper labels that may be 

generically approved not marked as “Generic” in Block 10 

will be contacted by LPDS to determine if voluntary review 

is requested

 If voluntary review is requested, the paper label will be placed 

in the second priority queue

 If voluntary review is not requested, the label will be returned 

to the establishment

 If no contact is made with the establishment, the labels will 

be placed in the second priority queue

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 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 review

 Notification by LPDS that a label may be generically approved 

should not be mistaken for LPDS approval of the label 

• It is the establishment’s responsibility to ensure that the final 

label meets all applicable labeling regulations

• Generically approved labels do not require approval by LPDS

• As noted earlier, generically approved labels that are voluntarily 

submitted for approval will be placed in the second priority queue 

and may take longer to be reviewed

• Labels that may be generically approved placed in the second 

priority queue may be used by the establishment provided that 

the labels are in compliance with applicable regulations

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 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

34
 Labels that may be generically approved submitted 

through labeling consultants with no note of 

“generic” in Box 10 will be returned to the 

consultant for confirmation that voluntary review is 

requested

 Labels may be submitted back to LPDS with 

“generic” noted in Box 10 if voluntary review is 

requested

 Labels will be placed in the second priority queue 

on the day that they are received complete with 

“generic” noted in Box 10

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 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 labeling “Tagged” for labeling 

non-compliance

Final label must be brought in to compliance by correcting 

the non-compliance

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.

36
 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

37
 Available online at:

http://www.fsis.usda.gov/wps/wcm/connect/7c48be3e-e516-4ccf-a2d5-

b95a128f04ae/Labeling_Policy_Book_082005.pdf?MOD=AJPERES

 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 

38
 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

39
 Are previously approved labels containing special statements 

or claims eligible for generic approval when the only 

modification involves changes unrelated to the special 

statement or claim?

Yes. Previously approved labels containing special statements 

or claims may be generically approved if the modifications to 

the label are unrelated to the special statement or claim.

40
May the establishment number be changed generically from one 

establishment number to another in the case of a label bearing a 

special statement or claim? For example, may Plant B use an approved 

label from Plant A by simply changing the Establishment number from 

A to B? 

 

Yes, this may be permitted under certain circumstances. If Plant B 

obtains a complete copy of the original label application and all 

associated supporting documentation necessary to support any special 

statements or claims on the original application approved for Plant A, 

then Plant B would have a complete label record on file and would be 

permitted to change the Est. number from A to B. In this case the 

information contained within the labeling application would be 

expected to remain the same (e.g. HACCP category, product 

formulation, processing procedures).

41
 Labels with negative claims must be submitted to FSIS for 

approval. How does FSIS define “negative claims” ?

“Negative” labeling claims are defined in the Food Standards and 

Labeling Policy Book. Negative claims refer to statements 

highlighting the absence of an ingredient or another constituent 

of the food, an example of which, “gluten free,” has been 

codified in 9 CFR 412.1 (e). “No milk” is another example of a 

negative claim that highlights the absence of an ingredient or 

another constituent of a food. A negative claim may also identify 

the absence of certain types of ingredients e.g. “no 

preservatives” or “no artificial coloring” based on the product 

formulation. 

NOTE: Nutrient content claims (e.g. fat free, cholesterol free) are 

not considered negative claims under the Policy Book entry. 

42
 Is the child nutrition (CN) box on a meat or 

poultry product considered a special 

statement or claim and require sketch 

approval?

No. The CN information in CN boxes is 

reviewed and evaluated for approval by the 

Agricultural Marketing Service (AMS), 

removing it from the realm of a special 

statement or claim. 

43
 May statements on labels that are defined in FSIS’s regulations or 

the Food Standards and Labeling Policy Book be generically 

approved? 

With the exceptions of “natural” and negative claims, yes, defined 

statements may be approved generically. Examples of such 

claims that will no longer require sketch approval by FSIS include:

◦ A statement that characterizes a product’s nutrient content 

that is consistent with the applicable Agency regulations, such 

as “low fat”

◦ Addition of a nutrition facts panel to a product sold at retail

◦ A statement that has geographical significance, such as “Italian 

Style”

44
Do non-standardized products still require LPDS Sketch 

approval? 

 

The fact that a product does not have a standard described in 

the FSIS Food Standards and Labeling Policy Book or specified in 

the regulations has no bearing on whether or not the label 

requires sketch approval. A non-standardized meat or poultry 

product may be generically approved provided it does not fall 

into one or more of the four categories of labels requiring 

approval in 9 CFR 412.1(c): temporary approval, labels for 

export with labeling deviations, religious exempt, or labels 

bearing special statements or claims. 

45
 Will allergen statements require approval by 

LPDS staff?

No. FSIS will not view the addition of an 

allergen statement (e.g., “contains soy”) 

applied in accordance with the Food Allergen 

Labeling and Consumer Protection Act 

(FALCPA) as a special statement or claim that 

requires sketch approval.

46
 Will labels containing foreign languages on 

products for sale in the US that do not have special 

statements or claims require prior approval by 

LPDS staff?

No. While the previous meat and poultry inspection 

regulations did not permit the generic approval of 

a label adding or deleting a direct translation of the 

English language into a foreign language for 

product sold in the U.S., this final rule will allow it. 

These types of labels do not fall into any of the 

categories of labels that must be submitted to FSIS 

for evaluation and review.

47
 Do front-of-package labeling statements that meet the 

requirements for nutrient content claims, including 

statements of quantity, qualify for generic approval?

No. FSIS considers certain front-of-pack (FOP) labeling 

statements, such as those highlighting select nutrients from 

the nutrition facts panel placed on the principal display panel, 

to be nutrient content claims. However, unlike traditional 

nutrient content claims, such as “low fat,” that are defined in 

FSIS regulations, there are no guidelines for the multiple 

types of FOP labeling statements on labeling. 

48
 What are the record keeping requirements for generically 

approved label?

Establishments are required to keep records of all labeling, 

both generically approved and approved by FSIS, along with 

the product formulation and processing procedures, as 

prescribed in 9 CFR 320.1(b)(11), 381.175(b)(6), and 412.1. 

The final rule added the requirement that any additional 

documentation needed to support that the labels are 

consistent with the Federal meat and poultry regulations and 

policies on labeling also be kept. 

49
• FSIS Labeling Website:

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

• Guide to Federal Food Labeling Requirements for Meat, Poultry and Egg 

Products:

http://www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16- fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES

• Final Rule:

http://www.fsis.usda.gov/wps/wcm/connect/3b0efaeb-9a81-4532-a1cc- b4d1cdb30f4a/2005-0016F.pdf?MOD=AJPERES

• Questions submitted through askFSIS : http://askfsis.custhelp.com

• Call LPDS at (301) 504-0878

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