AMS Module 2

COOL Regulatory Requirements
Module 2 Lesson Objectives

By the end of this lesson, you will understand: 

• COOL Regulation – Labeling and recordkeeping requirements

• Complex aspects:

• Processed Food Items 

• Commingled vs. Combined

• Adjectival Form of Country of Origin

• State Marketing Programs and State Abbreviations

• Fish and Shellfish Labeling: Substantial Transformation and Method of Production

• Production Steps for Muscle Cuts of Meat

2
Perishable Agricultural Commodities, 

Peanuts, Pecans, Macadamia Nuts and 

Ginseng Labeling
Perishable Agricultural Commodities, 

Peanuts, Pecans, Macadamia Nuts 

and Ginseng - US Origin

• Labeling Covered Commodities of United States Origin. A covered 

commodity may bear a declaration that identifies the United States as 

the sole country of origin at retail only if it meets the definition of 

United States country of origin as defined in § 65.260. 7 CFR 65.300(d)

• United States country of origin means in the case of: Perishable 

agricultural commodities, peanuts, ginseng, pecans, and macadamia 

nuts: from products produced in the United States. 7 CFR 65.260

4
Perishable Agricultural Commodities, 

Peanuts, Pecans, Macadamia Nuts 

and Ginseng - Imported

• Labeling Imported Covered Commodities: Perishable agricultural 

commodities, peanuts, pecans, ginseng, macadamia nuts and 

ground meat covered commodities that have been produced in 

another country shall retain their origin, as declared to U.S. 

Customs and Border Protection at the time the product entered the 

United States, through retail sale. 7 CFR 65.300(d)

5
Perishable Agricultural Commodities, 

Peanuts, Pecans, Macadamia Nuts, and 

Ginseng – Multiple Origins

• Labeling Commingled Covered Commodities. In the case of perishable agricultural commodities; peanuts; pecans; ginseng; and macadamia nuts: For imported covered 

commodities that have not subsequently been substantially transformed in the United 

States that are commingled with covered commodities sourced from a different origin 

that have not been substantially transformed (as established by CBP) in the United 

States, and/or covered commodities of United States origin, the declaration shall 

indicate the countries of origin in accordance with existing Federal legal requirements. 

7 CFR 65.300(g)

• For perishable agricultural commodities, peanuts, pecans, macadamia nuts, and 

ginseng, the declaration shall include all the country of origins contained therein. 7 

CFR 65.400(d) 

6
Fish and Shellfish Labeling
Fish and Shellfish – US Origin

“United States country of origin” for fish and shellfish is at 7 CFR 

60.128. This includes:

• Farm-raised fish and shellfish hatched, raised, harvested, and 

processed in the United States;

• Wild fish and shellfish harvested in waters of the United States 

or by a U.S. flagged vessel; and,

• Farm-raised or wild fish and shellfish that has not undergone 

substantial transformation outside the United States.

8
Fish and Shellfish - Imported

An imported covered commodity shall 

retain its origin as declared to U.S. 

Customs and Border Protection (CBP) 

at the time the product entered the 

United States, through retail sale, if it 

has not undergone a substantial 

transformation (as established by 

CBP) in the United States. 7 CFR 

60.200(f).

9
Fish and Shellfish – Multiple Origins

Fish and Shellfish of the same type presented for retail sale that are 

prepared from raw material sources of different origins shall indicate all the 

countries contained therein. 7 CFR 60.300(d) 

Examples include:

• Product of Argentina, Chile, and USA, Wild caught.

• This means that one species of fish from all three countries is displayed 

together at the store; all are wild caught.

• Product of Vietnam and Indonesia, Farm raised.

• This means one item, such as shrimp, from both countries, is displayed 

together at the store; all are farm raised.

10
Fish and Shellfish - Method of 

Production

Fish and shellfish covered 

commodities must also be 

labeled with the method of 

production that indicates 

whether they are wild or 

farm-raised as those terms 

are defined in the 

regulation. 7 CFR 60.200(d)

Acceptable phrases 

for method of 

production are:

• Farm-raised

• Farmed

• Wild-caught

• Wild

11
Lamb, Goat, and Chicken Labeling
Muscle Cuts of Meat – US Origin 

• United States country of origin means animals exclusively 

born/hatched, raised, and slaughtered/harvested in the 

United States. 7 CFR 65.260

• The United States country of origin designation for muscle cut 

covered commodities shall include all of the production steps (i.e., 

“Born, Raised, and Slaughtered in the United States”). 7 CFR 

65.300(d)

13
Muscle Cuts of Meat: Production 

Steps 

• Born or Hatched: This is the place of birth. 7 CFR 65.115 

• Raised: For commodities raised in the United States, raised is the 

time from birth until slaughter. For commodities imported into the 

United States for immediate slaughter, raised is the time from birth 

until entry into the United States. 7 CFR 65.235

• Slaughtered or Harvested: Slaughtered means the point when a 

livestock animal (including chicken) is prepared into meat 

products (covered commodities) for human consumption. 7 CFR 

65.250

14
Muscle Cuts of Meat – Imported 

Labeling Imported Covered Commodities: Muscle cut covered 

commodities derived from an animal that was slaughtered in another 

country shall retain their origin, as declared to U.S. Customs and 

Border Protection at the time the product entered the United States, 

through retail sale. 7 CFR 65.300(f)(1)

15
Ground Meat: Goat, Lamb, and 

Chicken

• The declaration for ground lamb, ground goat, and ground chicken 

covered commodities shall list all countries of origin contained 

therein or that may be reasonably contained therein. 7 CFR 65.300(h)

• Productions steps (born, raised, harvested) are not required for 

ground meat.

16
Activity 
Recordkeeping Requirements
Recordkeeping Requirements

General

• All records must be legible and may be maintained in either electronic or 

hard copy formats. 7 CFR 60.400(a)(1), 7 CFR 65.500(a)(1)

• Upon request by USDA representatives, suppliers and retailers subject to 

this subpart shall make available to USDA representatives, records 

maintained in the normal course of business that verify an origin claim 

and method of production (wild and/or farm-raised). Such records shall 

be provided within 5 business days of the request and may be maintained 

in any location. 7 CFR 60.400(a)(2), 7 CFR 65.500(a)(2)

19
Recordkeeping Requirements

Suppliers

• Any person supplying a covered commodity to a retailer, whether directly or 

indirectly, must make available information to the buyer about the country(ies) of origin and method(s) of production (wild and/or farm-raised), of the covered commodity. 

• This information may be provided either on the product itself, on the master shipping container, or in a document that accompanies the product 

through retail sale provided that it identifies the product and its country(ies) of origin and method(s) of production.

• The supplier of a covered commodity that is responsible for initiating a 

country(ies) of origin and method(s) of production (wild and/or farm-raised) claim must possess records that are necessary to substantiate that claim for a 

period of 1 year from the date of the transaction. 7 CFR 60.400(b)(1), 7 CFR 65.500(b)(1)

20
Recordkeeping Requirements

Suppliers (cont.)

• A intermediary supplier handling a covered commodity that is found to be 

designated incorrectly as to the country of origin shall not be held liable ... if 

the[y] relied on the designation provided by the[ir] ... supplier, unless the 

intermediary supplier willfully disregarded information establishing that the 

country of origin declaration was false. 7 CFR 65.500(b)(2), 7 CFR 60.400(b)(2)

• Any person ...supplying a covered commodity to a retailer, whether directly or 

indirectly (i.e., including but not limited to harvesters, producers, distributors, 

handlers, and processors), must maintain records to establish and identify the 

immediate previous source (if applicable) and immediate subsequent recipient 

of a covered commodity for a period of 1 year from the date of the transaction.7 

CFR 65.500(b)(3), 7 CFR 60.400(b)(3)

21
Recordkeeping Requirements

Suppliers (cont.)

For an imported covered commodity, the importer of record as 

determined by U.S. Customs and Border Protection, must ensure that 

records: provide clear product tracking from the port of entry into the 

United States to the immediate subsequent recipient and accurately 

reflect the country of origin and method of production (wild and/or farmraised) of the item as identified in relevant CBP entry documents and 

information systems; and must maintain such records for a period of 1 year 

from the date of the transaction.. 7 CFR 65.500(b)(4), 7 CFR 60.400(b)(4)

22
Recordkeeping Requirements

Retailers 

• Retailers are to convey the origin and method of production information 

provided to them by their suppliers. 

• Only if the retailer physically commingles a covered commodity of 

different origins and/or methods of production... can the retailer initiate 

a multiple country of origin and/or method of production designation 

that reflects the actual countries of origin and method of production for 

the resulting covered commodity. 7 CFR 60.400(c)(1), 7 CFR 65.500(c)(1)

23
Recordkeeping Requirements

Retailers (cont.) 

• Records ...relied upon ...to establish a covered commodity's country(ies) of origin 

must either be maintained at the retail facility or at another location for as long as the 

product is on hand and provided to any duly authorized representative of USDA.

• For pre-labeled products, the label itself is sufficient information on which the retailer 

may rely to establish the product's origin and no additional records documenting 

origin information are necessary. 7 CFR 60.400(c)(2), 7 CFR 65.500(c)(2)

• Prelabled means a covered commodity that has the commodity's country of origin and 

method of production and the name and place of business of the manufacturer, 

packer, or distributor on the covered commodity itself, on the package in which it is 

sold to the consumer, or on the master shipping container. The place of business 

information must include at a minimum the city and state or other acceptable locale 

designation. 7 CFR 60.118, 7 CFR 65.218

24
Recordkeeping Requirements

Retailers (cont.) 

• Records that identify the covered commodity, the retail supplier, and for 

products that are not pre-labeled, the country of origin information and the method(s) of production (wild and/or farm-raised) must be maintained for a period of 1 year from the date the declaration is made at retail. 7 CFR 

60.400(c)(3), 7 CFR 65.500(c)(4)

• Any retailer handling a covered commodity that is found to be designated 

incorrectly as to the country of origin and/or the method of production (wild 

and/or farm-raised) shall not be held liable for a violation of the Act by reason of the conduct of another if the retailer relied on the designation provided by 

the supplier, unless the retailer willfully disregarded information establishing 

that the country of origin and/or method of production declaration was false. 7 

CFR 60.400(c)(4), 7 CFR 65.500(c)(3)

25
Complex Aspects of the COOL 

Regulations
Processed Food Items
Processed Food Items

Processed food items are excluded from COOL requirements. 7 CFR 60.200(c), 7 CFR 65.300(c) 

Processed food item means a retail item derived from a covered commodity that has 

undergone specific processing resulting in a change in the character of the covered 

commodity, or that has been combined with at least one other covered commodity or other 

substantive food component (e.g., chocolate, breading, tomato sauce), except that the 

addition of a component (such as water, salt, or sugar) that enhances or represents a further 

step in the preparation of the product for consumption, would not in itself result in a 

processed food item. Specific processing that results in a change in the character of the 

covered commodity includes cooking (e.g., frying, broiling, grilling, boiling, steaming, baking, 

roasting), curing (e.g., salt curing, sugar curing, drying), smoking (hot or cold), and 

restructuring (e.g., emulsifying and extruding). Examples of items excluded include roasted 

peanuts, breaded chicken tenders, and fruit medley. 7 CFR 60.119, 7 CFR 65.220

28
Processed Food Items (cont.)

Let’s examine three parts of the processed food definition:

1. Change of character

2. Combined with another food component

3. Addition of a component (such as water, salt, or sugar) that 

enhances or represents a further step in the preparation of the 

product 

29
Processed Food Items

Change of character

A few examples are:

• Cooked: Deli meats

• Cured: Lutefisk, dried beans

• Smoked: Smoked salmon

• Restructured: Chicken nuggets

30

Specific processing resulting in the 

change of character includes:

• Cooking (frying, broiling, steaming, 

baking, roasting)

• Curing (salt curing, sugar curing, 

drying)

• Smoking (hot or cold)

• Restructuring (emulsifying and 

extruding)
Processed Food Items

Combined with another food component

A covered commodity that is 

combined with another covered 

commodity or substantive food 

component is excluded from COOL. 

31

A few examples are:

• Chocolate covered strawberries

• Mixed vegetables, salad mix

• Chicken cordon bleu

• Teriyaki marinated chicken breast
“...except that the addition of a 

component (such as water, salt, or 

sugar) that enhances or represents a 

further step in the preparation of 

the product for consumption...” 7 

CFR 60.119 and 7 CFR 65.220

These items are not processed food 

items, therefore are still subject to 

COOL. 

32

Processed Food Items

Exception when a component enhances or represents 

a further step in preparation of the product

A common example is chicken muscle cuts 

with an added salt solution. This item is 

subject to COOL.
Not Processed Food Items

The actions below do not change the item’s character therefore do not make 

an item a processed food item. 

Items that have undergone the action below are subject to COOL.

Blanching (Steam or Oil) Polishing

Chopping (riced) Slicing

Cutting Trimming

Dicing Waxing

Removal of a Seed 

(Pit, Stem, Husk, Calyx, Pods, Rind, Skin, Peel, 

Etc.)

Adding Sugar

Peeling Ascorbic Acid (to retard oxidation)

33
Not Processed Food Items cont.

Items that do not have in change of character are not considered 

processed food items, therefore are subject to COOL. 

Examples include: 

• Riced cauliflower

• Diced fruit

• Zucchini noodles

• Sliced apples

• Chopped onions

34
Commingled vs. Combined
Commingled

Commingled covered commodities means covered commodities (of the 

same type) presented for retail sale in a consumer package that have been 

prepared from raw material sources having different origins. 7 CFR 65.125,

7 CFR 60.103

Commingled covered commodities require COOL.

Example: Tomatoes from both USA and Canada.

36
Commingled Examples

More examples of commingled items include:

• Shrimp from both Vietnam and Indonesia.

• Bell peppers from Holland, Norway, and the US 

sold together in a single package. 

Reminder: These do require COOL.

37
Combined

Combined: A covered commodity that has been combined with at least one 

other covered commodity or other substantive food component (e.g., 

chocolate, breading, tomato sauce). 

Combined items are considered a processed food item, therefore excluded 

from COOL. 

Common examples: 

• Fajita mix of sliced onions and peppers.

• Seafood medley of fish and shrimp.

• Fruit platter of strawberries, watermelon, kiwi, grapes, and pineapple.

38
Combined Examples

More examples of combined items include:

• Package of various fresh herbs.

• Package of salad mix with romaine and 

radicchio. 

Reminder: These are excluded from COOL; 

they do not require COOL.

39
Adjectival Form of Country Name
Adjectival Form of Country Name

The adjectival form of the name of a country may be used as proper notification 

of the country of origin of imported commodities provided the adjectival form of 

the name does not appear with other words so as to refer to a kind or species of 

product. Symbols or flags alone may not be used to denote country of origin. 7 

CFR 65.400(e), 7 CFR 60.300(e)

41
Adjectival Form of Country Name

• Adjectival form of a country name is not acceptable when it refers to 

the name of a species, such as Chilean Sea Bass or Japanese 

Eggplant. The country of origin is required.

• Adjectival form of a country name is acceptable when it is not 

related to the name of a species, such as Australian Lamb or 

Scottish Salmon. In this case, Australian means the origin is 

Australia, which is the COOL.

42
Adjectival Form of Country Name 

(cont)

• Geographic names for a species 

or variety do not indicate origin.

• Japanese Eggplant

• Adjectival forms that refer to 

country of origin are allowed.

• Brazilian Papaya

• Uncertain if it is an adjectival form 

of a variety or species? Check the 

PACA Commodities List

43
State Abbreviations and State 

Marketing Programs
State Abbreviations

State abbreviations are acceptable in lieu of COOL only for fruits, 

vegetables, peanuts, pecans, macadamia nuts, and ginseng per 7 

CFR 65.400(f). 

Examples include:

• Grown in AL

• Product of IL

• Proudly grown in WA State

45
State Marketing Programs

State Marketing Programs vary. If the criteria for a State Marketing Program refers to the 

item’s origin and follows the COOL regulation for US origin, then the State Marketing 

Program’s logo can be used for COOL. 

State Marketing Program logos can only be used in lieu of COOL for fruits, vegetables, 

peanuts, pecans, macadamia nuts, and ginseng .

For example, New Jersey’s Jersey Fresh marketing program’s logo can be used in lieu of 

COOL, as this marketing program requires all items be grown in New Jersey.

46
Fish & Shellfish Issues – Substantial 

Transformation and Method of 

Production
Substantial Transformation

• Substantial transformation occurs when a new and different article of 

commerce emerges from a process with a new name, character, or use 

different from that possessed by the article prior to processing.

• “Substantial transformation” is used by the US Customs and Border 

Protection (CBP) to determine country of origin. (7 CFR 60.200 f - h)

• Imported product that has been substantially transformed in the U.S. or 

aboard a US flagged vessel, it must be labeled as “From Country X, 

Processed in U.S.” or “Product of country X and the United States”.

48
Substantial Transformation (cont.)

At times, you may see that there is seemingly 

conflicting country of origin for fish or shellfish on 

the same label or sign. 

• Example is "Alaska Wild" salmon labeled as 

"product of China."

• In many cases it is because the fish was harvested 

in one place and substantially transformed in 

another.

• Country of origin for all imported fish/ shellfish is 

regulated by Customs and Border Protection based 

on where that item was substantially transformed.

49
Method of Production

Acceptable and Unacceptable Phrases

Here are a few examples of unacceptable 

phrases for the method of production :

• Ocean caught, line caught, fresh land raised

• Fresh water caught, WC, FR

50

The only acceptable phrases for the 

method of production are:

• Farm-raised

• Farmed

• Wild-caught

• Wild
Knowledge Check
What is the correct Method of Production?

This picture shows fish being raised in 

controlled environments in the ocean.

Would the fish harvested from these 

controlled environments be farm-raised or 

wild caught?
What is the correct Method of Production?

This picture shows fish being raised in 

controlled environments in the ocean.

Would the fish harvested from these 

controlled environments be farm-raised or 

wild caught?

Farm-raised is correct!

Note: A sign or label could state Ocean FarmRaised. Ocean is merely descriptive and okay 

to include as additional information.
Production Steps for Muscle Cuts 

of Meat
Production Steps

United States Country of Origin

The United States country of origin designation for muscle cut covered 

commodities shall include all of the production steps (i.e., “Born, Raised, and 

Slaughtered in the United States”). 7 CFR 65.300(d)

Production steps may be abbreviated, as long as the consumer can easily 

understand. Here are a few abbreviations:

BRN: Born 

HTCHD: Hatched 

RAISD: Raised 

SLGHTRD: Slaughtered 

HRVSTD: Harvested 

55
Production Steps

Multiple Countries of Origin

• If an animal was born and/or raised in Country X and/or (as applicable) Country Y, 

and slaughtered in the United States, the resulting muscle cut covered commodities shall be labeled to specifically identify the production steps occurring in each 

country (e.g., “Born and Raised in Country X, Slaughtered in the United States”).

• If an animal is raised in the United States as well as another country (or multiple 

countries), the raising occurring in the other country (or countries) may be omitted 

from the origin designation except if the animal was imported for immediate 

slaughter as defined in § 65.180 or where by doing so the muscle cut covered commodity would be designated as having a United States country of origin (e.g., 

“Born in Country X, Raised and Slaughtered in the United States” in lieu of “Born 

and Raised in Country X, Raised in Country Y, Raised and Slaughtered in the United 

States”).

56
Production Steps: Born or 

Hatched

Born means the place of birth. Born, in the case of chicken, 

means hatched from the egg. 7 CFR 65.115

57
Production Steps: Raised

For chicken, goat, and lamb animals, raised means the period of 

time from birth until slaughter. 

For chicken, goat, and lamb animals imported into the United 

States for immediate slaughter, raised means the period from birth 

until entry into the United States. 7 CFR 65.235

58
Production Steps: Slaughter or 

Harvested

Slaughtered means the point when 

a livestock animal (including 

chicken) is prepared into meat 

products (covered commodities) for 

human consumption. For purposes 

of labeling under this part, the word 

harvested may be used in lieu of 

slaughtered. 7 CFR 65.250

59
Production Steps Recap

• Production steps are not required for ground chicken, ground 

lamb or ground goat. Ground items only require county of origin. 

• Production steps are not required for imported muscle cuts of 

meat. They only require country of origin. 

60
Production Steps versus 

Method of Production

• Production steps are only for muscle cuts of goat, lamb and 

chicken. Production steps indicate where the animal was born, 

raised, and slaughtered.

• Method of production is only for fish and shellfish. The method 

of production indicates whether the item was farm raised or wild 

caught. 

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COUNTRY OF ORIGIN LABELING

62

Thank you for completing Module 2!