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 Labels9 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

Safe Handling 

This product was prepared from inspected and passed meat and/or poultry.  Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly.  For your protection, follow these safe handling instructions.

Keep refrigerated or frozen.  Thaw in refrigerator or microwave.

Keep raw meat and poultry separate from other foods.  Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry.

Cook thoroughly.

Keep hot foods hot.  Refrigerate leftovers immediately or discard.

Instructions

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 CoveringsProcessed 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 CoveringsUnprocessed 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 CoveringsPoultry
        - 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