# Presentation: 001003

## USDA Food Safety and Inspection Service

**Labeling of FSIS-Regulated Foods**

## Required Information on a Label (9 CFR 317.2/381 Subpart N)

- Up to 8 required features
- Product name
- Inspection legend and est. number
- Handling statement
- Net weight statement
- Ingredients statement
- Address line
- Nutrition facts
- Safe handling instructions

## A Food is Misbranded if

- Its labeling is false or misleading in any particular
- It is offered for sale under the name of another food
- It is an imitation of another food without proper labeling

## Prior Approval: Traditionally Required For All Product Labels

- Meat and poultry plants submit labels for approval
- Labeling “Policy Book” precedents become *de facto* regulation
- FSIS inspection force monitors label usage and product formulation

## Sketch

- Company submits a printer’s proof showing all labeling material (including graphics)
- Avoids unnecessary expense of printing incorrect labels

## Temporary

- Temporary approval of noncomplying labels may be granted under extenuating circumstances, for _up to_ 6 months, only if:
- The label is not misleading
- The label does not pose a health, safety or dietary problem
- Approval would not give an unfair competitive advantage
- Denial would cause undue economic hardship

## July 1996 Labeling Regulation 

- FSIS returned all label files to plants
- Generic approved labels
- Plants are not required to submit certain types of labels for approval
- FSIS only approves sketch and temporary labels
- Inspector’s task performed periodically
- Verify presence of mandatory label features
- Ensure label is accurate representation of product

## Company Responsibilities - Labeling

- Create a record of _all_ final labeling including sketch approved labels
- Modifications per sketch approval are made to label before final printing
- Maintain labeling records
- Final labeling
- Temporary approvals

## Generic Approvals - New Labels9 CFR 317.5/381.133

- Standardized products without special claims, guarantees or foreign language
- Single ingredient products without special claims, guarantees or foreign language
- Products with contract specification for Federal Government agencies
- Shipping containers
- Inspection legends

## Generic Approvals - New Labels

- Products not intended for human food
- Poultry heads and feet *for export* for processing as human food
- Consumer test products not for sale
- Inserts, tabs, liners, pasters, etc. that make no reference to the product
- Prior approved sketch labeling or labeling with generic modifications

## Generic Modifications

- Proportionate enlargement or reduction
- Abbreviations for unit of measurement
- Master or stock label
- Holiday designs
- Opening instructions or serving directions
- Coupons, cents-off statements, cooking instructions, packer product code information or UPC information

## Generic Modifications

- Address of packer, manufacturer or distributor
- Net weight statement
- Recipe suggestions
- Punctuation
- Newly assigned or revised establishment number for a particular establishment
- Open dating information

## Generic Modifications

- Packaging material
- Brand name changes
- Deletion of the word “new”
- Handling statements
- Safe handling instructions
- A change in the quantity of an ingredient without order of predominance change

## Generic Modifications

- Color changes
- Vignette changes
- Addition, deletion or substitution of USDA poultry grade shield
- Deletion of a claim or non-mandatory information or features
- Deletion or addition of English language translated into foreign language  -  *for export only*

## Generic Modifications

- Quantitative adjustments to the nutrition facts except for serving size
- A change in establishment number by a corporation for a plant under its ownership
- The use of the term *fresh* on poultry carcasses or parts
- The use of the term *frozen* on poultry carcasses or parts

## FSIS Promotes and Strictly Enforces Product Standards of Identity

- Examples:
- Ham; Ham with Natural Juices; Ham Water Added; Ham and Water Product
- Hot Dogs/Frankfurters: maximum 40% fat and water
- Ground Beef:  May contain no more than 30% fat
- Veal Cutlet:  Single slice of veal from the round

## Labeling Terms: Meat

- “ ‘**Meat**’: muscle that is skeletal, or in the tongue, diaphragm, heart or esophagus...”  (9 CFR 301.2(rr))
- Includes product recovered from “_advanced_” meat recovery systems (AMRS) machinery
- Does not include “_mechanically_ _separated_” meat

## Labeling Terms: Fresh

- May not be used to designate a product that contains sodium/potassium nitrate/nitrite or has a brine concentration of 10% or more
- May not be used to describe poultry carcasses or parts when the internal temperature has ever been below 26o F

## Labeling Terms: Spring Lamb

- Carcasses of new-crop lambs slaughtered in the Northern Hemisphere
- During the period beginning in March and ending the close of the week containing the first Monday in October

## Labeling Terms: Production

- “Farm” or “country” should not be used on labels if the products are not prepared in the farm or country
- Sausage containing cereal should not be labeled “farm style” or “country style”

## Labeling Terms: Production

- Free range
- Farm raised
- No added hormones
- No antibiotics administered
- Not fed animal by-products
- “Certified organic by (name of certifying entity)” -- until 8/20/2002

## Mandatory Handling Statements

- Perishable product preserved by chilling
- “Keep Frozen”; “Keep Refrigerated”
- “Keep Refrigerated or Frozen”
- Perishable cooked product shipped hot
- Product receives a heat lethality treatment
- “This product must either be maintained at no less than 1400 F during shipment or discarded”

## Safe Handling Instructions

- Mandatory when meat and poultry product is  raw or partially cooked
- Specific format for word size
- Graphics mandated

## Labeling - Not Ready to Eat Products

- A product containing a meat or poultry component that has received a lethality treatment for pathogens
- Can also include dry cured products, e.g., country ham
- Also contains non-meat/poultry component in need of a lethality treatment
- Includes meals, dinners and frozen entrees
- Cooking and preparation instructions on the product are sufficient to destroy pathogens

## Labeling - Not Ready to Eat Products

- Terms required on principal display panel displayed in a _prominent_ manner in product name, in a starburst or elsewhere on  principal display panel
- Uncooked
- Ready to cook
- Cook before eating
- Cook and serve
- Needs to be fully cooked
- Safe handling instructions are recommended

## Examples of Packaging Requirements

- Packages for sliced bacon need a transparent opening for viewing the cut surface of a representative slice
- Transparent or semi-transparent coverings shall not give a false impression of leanness to raw meat or cured meat

## Protective CoveringsProcessed Meat Products

- Immediate packaging exempt from labeling requirements
- No marking or labeling permitted except for limited situations
- Shipper must include all mandatory features since it is the immediate container
- Statement of limited use required on shipper
- Entire contents consumed on premises of hotel, restaurant or institution - no further distribution

## Protective CoveringsUnprocessed Meat Cuts

- Shipper must include all mandatory features since it is the immediate container
- Products may be removed for resale if product or covering includes mark of inspection and establishment number

## Protective CoveringsPoultry

- Product in protective coverings for export or sold to hotels, restaurants or institutions are exempt from the mandatory labeling of immediate containers
- No marking or labeling permitted except for limited situations
- Shipper must include all mandatory features since it is the immediate container
- Shipper does **not** require a statement of limited use

## FSIS-FDA Jurisdiction Determined by Meat / Poultry Content of Product

- FSIS regulates products containing
- 2% or more cooked meat or poultry meat
- 3% or more raw meat or poultry meat
- FDA regulates “meat flavored”sauces and soups with less than 2% meat or poultry meat

## Marking

- Applying of lettering or affixing of tags directly onto product
- Branding is a form of marking

## Branding

- U.S. Inspected & Passed Brand
- Minimum of one required on each separate piece (side, quarter, primal part, etc.)
- Size and/or shape identify species
- U.S. Inspected & Condemned Brand
- Applied to carcasses and parts that have been inspected and found to be adulterated and condemned under the regulations
- U.S. Passed for Cooking Brand

## Carcass Misbranding

- If a mark of inspection is applied to uninspected adulterated or unwholesome carcasses
- If a mark of inspection for one species of livestock is applied to another species