59708 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service 

7 CFR Part 60

[No. LS–03–04] 

RIN 0581–AC26 

Mandatory Country of Origin Labeling 

of Fish and Shellfish

AGENCY: Agricultural Marketing Service, 

USDA.

ACTION: Interim final rule with request 

for comments. 

SUMMARY: The Farm Security and Rural 

Investment Act of 2002 (Farm Bill) and 

the 2002 Supplemental Appropriations 

Act (2002 Appropriations) amended the 

Agricultural Marketing Act of 1946 (Act) 

to direct the Secretary of Agriculture to 

promulgate regulations by September 

30, 2004, requiring retailers to notify 

their customers of the country of origin 

of covered commodities. Covered 

commodities include muscle cuts of 

beef (including veal), lamb, and pork; 

ground beef, ground lamb, and ground 

pork; farm-raised fish and shellfish; 

wild fish and shellfish; perishable 

agricultural commodities; and peanuts. 

The FY 2004 Consolidated 

Appropriations Act (2004 

Appropriations) (Public Law 108–199) 

delayed the applicability of mandatory 

country of origin labeling (COOL) for all 

covered commodities except wild and 

farm-raised fish and shellfish until 

September 30, 2006. After issuance of a 

proposed rule, the Department has 

decided to provide further opportunity 

to comment due to the changes made as 

a result of comments received and the 

costs associated with this rule. This 

interim final rule contains definitions, 

the requirements for consumer 

notification and product marking, and 

the recordkeeping responsibilities of 

both retailers and suppliers for fish and 

shellfish covered commodities. 

Regulatory provisions for the other 

covered commodities will be provided 

in a separate regulatory action as 

appropriate.

DATES: This interim final rule is 

effective April 4, 2005. The 

requirements of this rule do not apply 

to frozen fish or shellfish caught or 

harvested before December 6, 2004. 

Comments must be submitted on or 

before January 3, 2005, to be assured of 

consideration.

ADDRESSES: Send written comments to: 

Country of Origin Labeling Program, 

Room 2092–S; Agricultural Marketing 

Service (AMS), USDA; STOP 0249; 1400 

Independence Avenue, SW., 

Washington, DC 20250–0249, or by 

facsimile to (202) 720–3499, or by email to cool@usda.gov. State that your 

comments refer to Docket No. LS–03–

04. Comments may also be submitted 

electronically through http://

www.regulations.gov. All comments 

received will be posted to the AMS Web 

site at: http://www.ams.usda.gov/cool/.

Comments may also be inspected at the 

above location between 8 a.m. and 4:30 

p.m., Monday through Friday, except 

holidays. Comments sent to the above 

location that specifically pertain to the 

information collection and 

recordkeeping requirements of this 

action should also be sent to the Desk 

Officer for Agriculture, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB), New Executive Office Building, 

725 17th Street, NW., Room 725, 

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

William Sessions, Associate Deputy 

Administrator, Livestock and Seed 

Program, AMS, USDA, by telephone on 

202/720–5705, or via e-mail at: 

william.sessions@usda.gov.

SUPPLEMENTARY INFORMATION: The 

information that follows has been 

divided into three sections. The first 

section provides background 

information including questions and 

answers about this interim final rule, a 

summary of the history of this 

rulemaking, and a general overview of 

the law. The second section provides a 

discussion of the rule’s requirements, 

including a summary of the comments 

received in response to the proposed 

rule published in the October 30, 2003, 

Federal Register (68 FR 61944) and the 

Agency’s responses to these comments. 

The last section provides for the 

required impact analyses including the 

Regulatory Flexibility Act, the 

Paperwork Reduction Act, Civil Rights 

Analysis, and the relevant Executive 

Orders. 

I. Background 

Questions and Answers Concerning This 

Interim Final Rule 

What Are the General Requirements of 

Country of Origin Labeling? 

The Farm Bill (Public Law 107–171) 

amended the Act (7 U.S.C. 1621 et seq.) 

to direct the Secretary of Agriculture to 

issue regulations by September 30, 

2004, to require retailers to notify their 

customers of the country of origin of 

beef (including veal), lamb, pork, fish, 

shellfish, perishable agricultural 

commodities, and peanuts beginning 

September 30, 2004. The 2004 

Appropriations Act (Public Law 107–

206) delayed the applicability of 

mandatory COOL for all covered 

commodities except wild and farmraised fish and shellfish until September 

30, 2006. The law defines the terms 

‘‘retailer’’ and ‘‘perishable agricultural 

commodity’’ as having the meanings 

given those terms in section 1(b) of the 

Perishable Agricultural Commodities 

Act of 1930 (PACA)(7 U.S.C. 499 et 

seq.). Food service establishments are 

specifically excluded as are covered 

commodities that are ingredients in a 

processed food item. In addition, the 

law specifically outlines the criteria a 

covered commodity must meet to bear a 

‘‘United States country of origin’’ label.

How Do I Find Out if My Product Is 

Considered a Covered Commodity or if 

It Is Labeled Accurately Under the 

COOL Law? 

Questions regarding whether a 

product is considered a covered 

commodity or is labeled accurately 

under this regulation may be e-mailed to 

cool@usda.gov.

What Is the Definition of a Processed 

Food Item and What Types of Products 

Are Considered Processed Food Items? 

Fish and shellfish covered 

commodities are exempt from COOL 

under this rule if they are an ingredient 

in a processed food item. An ingredient 

is a component either in part or in full 

of a finished retail food product. A 

processed food item is a retail item 

derived from fish or shellfish 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 components (e.g., 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 (cold or hot), and restructuring 

(e.g., emulsifying and extruding, 

compressing into blocks and cutting 

into portions). Examples of fish and 

shellfish combined with different 

covered commodities or other 

substantive food components include 

scallops and shrimp in a seafood 

medley, breaded shrimp, breaded fish 

fillets, coated shrimp, and marinated 

fish fillets. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59709

What Requirements Must Be Met for a 

Retailer To Label a Covered Commodity 

as Being of U.S. Origin? 

The law prescribes specific criteria 

that must be met for a covered 

commodity to bear a ‘‘United States 

country of origin’’ declaration. The 

specific requirements for fish and 

shellfish covered commodities are as 

follows: Farm-raised fish and shellfish—

covered commodities must be derived 

exclusively from fish or shellfish 

hatched, raised, harvested, and 

processed in the United States, and that 

has not undergone a substantial 

transformation (as established by U.S. 

Customs and Border Protection) outside 

of the United States; wild fish and 

shellfish—covered commodities must be 

derived exclusively from fish or 

shellfish either harvested in the waters 

of the United States or by a U.S. flagged 

vessel and processed in the United 

States or aboard a U.S. flagged vessel, 

and that has not undergone a substantial 

transformation (as established by U.S. 

Customs and Border Protection) outside 

of the United States. 

How Should I Label a Retail Product 

That Contains a Covered Commodity 

(Such as a Bag of Shrimp) Commingled 

From More Than One Country of 

Origin? 

For imported covered commodities 

that have not subsequently been 

substantially transformed in the United 

States that are commingled with other 

imported and/or U.S. origin 

commodities, the declaration shall 

indicate the countries of origin for all 

covered commodities in accordance 

with existing Federal legal 

requirements. For imported covered 

commodities that have subsequently 

undergone substantial transformation in 

the United States that are commingled 

with other imported covered 

commodities that have subsequently 

undergone substantial transformation in 

the United States (either prior to or 

following substantial transformation in 

the United States) and/or U.S. origin 

covered commodities, the declaration 

shall indicate the countries of origin 

contained therein or that may be 

contained therein. 

What Are the Requirements for 

Maintaining Country of Origin 

Information for Blended Covered 

Commodities That Contain Products 

From More Than One Country of 

Origin? 

The labeling requirements are 

consistent with other Federal legal 

requirements under which facilities are 

not required to separately track 

throughout the process, and ultimately 

into each individual retail package, the 

country source of the commodities that 

are found within each individual retail 

package. Rather, the declaration of the 

retail product can indicate the several 

countries of origin that are represented 

in the overall blending process, without 

being required to verify which specific 

countries of origin are found within 

each individual retail package. 

Why Can’t the Department of 

Agriculture (USDA) Track Only 

Imported Products and Consider All 

Other Products To Be of ‘‘U.S. Origin?’’

The COOL provision of the Farm Bill 

applies to all covered commodities. 

Moreover, the law specifically identifies 

the criteria that products of U.S. origin 

must meet. The law further states that 

‘‘Any person engaged in the business of 

supplying a covered commodity to a 

retailer shall provide information to the 

retailer indicating the country of origin 

of the covered commodity.’’ And, the 

law does not provide authority to 

control the movement of product. In 

fact, the use of a mandatory 

identification system that would be 

required to track controlled product 

through the entire chain of commerce is 

specifically prohibited. 

When Will the Requirements of This 

Regulation Be Enforced? 

The effective date of this regulation is 

six months following the date of 

publication of this interim final rule. 

The requirements of this rule do not 

apply to frozen fish or shellfish caught 

or harvested before December 6, 2004. 

The country of origin statute provides 

that ‘‘not later than September 30, 2004, 

the Secretary shall promulgate such 

regulations as are necessary to 

implement this subtitle.’’ Many of the 

covered commodities sold at retail are 

in a frozen or otherwise preserved state 

(i.e., not sold as ‘‘fresh’’). Thus, many of 

these products would already be in the 

chain of commerce prior to September 

30, 2004, and the origin/production 

information may not be known. 

Therefore, it is reasonable to delay the 

effective date of this interim final rule 

for six months to allow existing 

inventories to clear through the 

channels of commerce and to allow 

affected industry members to conform 

their operations to the requirements of 

this rule. During this time period, AMS 

will conduct an industry education and 

outreach program concerning the 

provisions and requirements of this 

rule. AMS also will focus its resources 

for the six months immediately 

following the effective date of this 

interim final rule on industry education 

and outreach. After a careful review of 

all its implications, AMS has 

determined that its allocation of 

enforcement resources will ensure that 

the rule is effectively and rationally 

implemented. This AMS plan of 

outreach and education, conducted over 

a period of one year, should 

significantly aid the industry in 

achieving compliance with the 

requirements of this rule.

How Will the Requirements of This 

Regulation Be Enforced? 

USDA will seek to enter into 

partnerships with States having existing 

enforcement infrastructure to assist in 

the administration of this law. USDA 

will determine the scheduling and 

procedures for the compliance reviews. 

Only USDA will be able to initiate 

enforcement actions against a person 

found to be in violation of the law. 

USDA may also conduct investigations 

of complaints made by any person 

alleging violations of these regulations 

when the Secretary determines that 

reasonable grounds for such 

investigation exist. In addition, the 

Agency plans to publish a compliance 

guide that will provide the industry 

with information on compliance and the 

phasing in of active enforcement. 

What Are the Recordkeeping 

Requirements of This Regulation? 

Any person engaged in the business of 

supplying a covered commodity to a 

retailer, whether directly or indirectly, 

must maintain records to establish and 

identify the immediate previous source 

(if applicable) and immediate 

subsequent recipient of a covered 

commodity, in such a way that 

identifies the product unique to that 

transaction by means of a lot number or 

other unique identifier, for a period of 

1 year from the date of the transaction. 

For retailers, records and other 

documentary evidence relied upon at 

the point of sale by the retailer to 

establish a product’s country(ies) of 

origin and method(s) of production 

(wild and/or farm-raised) must be 

available during normal business hours 

to any duly authorized representatives 

of USDA for as long as the product is 

on hand. For pre-labeled products, the 

label itself is sufficient evidence on 

which the retailer may rely to establish 

a product’s origin and method(s) of 

production (wild and/or farm-raised). 

Records that identify the supplier, the 

product unique to that transaction by 

means of a lot number or other unique 

identifier, and for products that are not 

pre-labeled, the country of origin and 

method of production (wild and/or 

farm-raised) information must be 

59710 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

maintained for a period of 1 year from 

the date the origin and production 

designations are made at retail. 

How Does This Regulation Impact 

Existing State Country of Origin 

Labeling Programs? 

To the extent that State country of 

origin labeling programs encompass 

commodities which are not governed by 

this regulation, the States may continue 

to operate them. For those State country 

of origin labeling programs that 

encompass commodities that are 

governed by this regulation, these 

programs are preempted. 

Can Food Products That Are Not 

Covered by This Regulation Be 

Voluntarily Labeled With COOL 

Information? 

Yes. Such voluntary claims must be 

truthful and accurate and adhere to 

existing Federal labeling regulations.

Prior Documents in This Proceeding 

This interim final rule is issued 

pursuant to the Farm Bill, the 2002 

Appropriations, and the 2004 

Appropriations, which amended the 

Act. 

On October 11, 2002, AMS published 

Guidelines for the Interim Voluntary 

Country of Origin Labeling of Beef, 

Lamb, Pork, Fish, Perishable 

Agricultural Commodities, and Peanuts 

(67 FR 63367) providing interested 

parties with 180 days to comment on 

the utility of the voluntary guidelines. 

On November 21, 2002, AMS 

published a notice requesting 

emergency approval of a new 

information collection (67 FR 70205) 

providing interested parties with a 60-

day period to comment on AMS’ burden 

estimates associated with the 

recordkeeping requirements as required 

by the Paperwork Reduction Act of 1995 

(PRA). On January 22, 2003, AMS 

published a notice extending this 

comment period (68 FR 3006) an 

additional 30 days. 

On October 30, 2003, AMS published 

the proposed rule for the mandatory 

COOL program (68 FR 61944) with a 60-

day comment period. On December 22, 

2003, AMS published a notice 

extending the comment period (68 FR 

71039) an additional 60 days. 

Overview of the Law 

Section 10816 of Public Law 107–171 

(7 U.S.C. 1638–1638d) amended the Act 

(7 U.S.C. 1621 et seq.) to require 

retailers to inform consumers of the 

country of origin of covered 

commodities beginning September 30, 

2004. 

The intent of this law is to provide 

consumers with additional information 

on which to base their purchasing 

decisions. COOL is a retail labeling 

program and as such does not provide 

a basis for addressing food safety. 

Seafood products, both imported and 

domestic, must meet the food safety 

standards of the Food and Drug 

Administration (FDA). The law defines 

the term ‘‘covered commodity’’ as 

muscle cuts of beef (including veal), 

lamb, and pork; ground beef, ground 

lamb, and ground pork; farm-raised fish 

and shellfish; wild fish and shellfish; 

perishable agricultural commodities; 

and peanuts. The law excludes items 

from needing to bear a country of origin 

declaration when a covered commodity 

is an ‘‘ingredient in a processed food 

item.’’ The law defines the terms 

‘‘retailer’’ and ‘‘perishable agricultural 

commodity’’ as having the meanings 

given those terms in PACA. The law 

defines the term ‘‘wild fish’’ as 

naturally-born or hatchery-raised fish 

and shellfish harvested in the wild and 

excludes net-pen aquacultural or other 

farm-raised fish. 

The law specifically outlines the 

criteria a covered commodity must meet 

in order to bear a ‘‘United States country 

of origin’’ declaration. In the case of 

farm-raised fish and shellfish, the 

covered commodity must be derived 

from fish or shellfish hatched, raised, 

harvested, and processed in the United 

States. In the case of wild fish and 

shellfish, the covered commodity must 

be derived from fish or shellfish 

harvested in the waters of the United 

States or by a U.S. flagged vessel and 

processed in the United States or aboard 

a U.S. flagged vessel. In addition, the 

law also requires that fish and shellfish 

covered commodities be labeled to 

indicate whether they are wild or farmraised. 

To convey the country of origin 

information, the law states that retailers 

may use a label, stamp, mark, placard, 

or other clear and visible sign on the 

covered commodity or on the package, 

display, holding unit, or bin containing 

the commodity at the final point of sale 

to consumers. Food service 

establishments, such as restaurants, 

cafeterias, food stands, and other similar 

facilities are exempt from these labeling 

requirements. 

The law makes reference to the 

definition of ‘‘retailer’’ in section 1(b) of 

PACA as the meaning of ‘‘retailer’’ for 

the application of the labeling 

requirements under the COOL law. 

Under this interim final rule, a retailer 

is any person engaged in the business of 

selling any perishable agricultural 

commodity at retail. Retailers are 

required to be licensed when the 

invoice cost of all purchases of produce 

exceeds $230,000 during a calendar 

year. Since fish markets and similar 

specialty shops do not generally sell 

fruits and vegetables, they do not meet 

the PACA definition of a retailer and 

therefore are not covered by this rule. 

The law requires any person engaged 

in the business of supplying a covered 

commodity to a retailer to provide the 

retailer with the product’s country of 

origin information. In addition, the law 

states the Secretary of Agriculture may 

require that any person that prepares, 

stores, handles, or distributes a covered 

commodity for retail sale maintain a 

verifiable recordkeeping audit trail. The 

law prohibits the Secretary from using 

a mandatory identification system to 

verify the country of origin of a covered 

commodity and provides examples of 

existing certification programs that may 

be used to certify the country of origin 

of a covered commodity. The law 

contains enforcement provisions for 

both retailers and suppliers that include 

civil penalties of up to $10,000 for each 

violation. The law also encourages the 

Secretary to enter into partnerships with 

States with enforcement infrastructure 

to the extent possible to assist in the 

program’s administration. 

II. Highlights of This Interim Final Rule 

Covered Commodities 

The term ‘‘covered commodity’’

includes: farm-raised fish and shellfish 

(including fillets, steaks, nuggets, and 

any other flesh) and wild fish and 

shellfish (including fillets, steaks, 

nuggets, and any other flesh).

Exclusion for Ingredient in a Processed 

Food Item 

Items are excluded from labeling 

under this regulation when a covered 

commodity is an ingredient in a 

processed food item. Under this interim 

final rule, a ‘‘processed food item’’ is 

defined as: a retail item derived from 

fish or shellfish 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 (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, 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59711

roasting), curing (e.g., salt curing, sugar 

curing, drying), smoking (cold or hot), 

and restructuring (e.g., emulsifying and 

extruding, compressing into blocks and 

cutting into portions). Examples of 

items excluded include fish sticks, 

surimi, mussels in tomato sauce, 

seafood medley, coconut shrimp, soups, 

stews, and chowders, sauces, pates, 

salmon that has been smoked, 

marinated fish fillets, canned tuna, 

canned sardines, canned salmon, crab 

salad, shrimp cocktail, gefilte fish, 

sushi, and breaded shrimp. 

Labeling Covered Commodities of 

United States Origin 

The law prescribes specific criteria 

that must be met for a covered 

commodity to bear a ‘‘United States 

country of origin’’ declaration. The 

specific requirements for each 

commodity are as follows: 

(a) Farm-raised Fish and Shellfish—

covered commodities must be derived 

exclusively from fish or shellfish 

hatched, raised, harvested, and 

processed in the United States, and that 

has not undergone a substantial 

transformation (as established by U.S. 

Customs and Border Protection) outside 

of the United States. 

(b) Wild Fish and Shellfish—covered 

commodities must be derived 

exclusively from fish or shellfish either 

harvested in the waters of the United 

States or by a U.S. flagged vessel and 

processed in the United States or aboard 

a U.S. flagged vessel, and that has not 

undergone a substantial transformation 

(as established by U.S. Customs and 

Border Protection) outside of the United 

States. 

Labeling Country of Origin for Imported 

Products That Have Not Been 

Substantially Transformed in the United 

States 

Under this interim final rule, an 

imported covered commodity shall 

retain its origin as declared to U.S. 

Customs and Border Protection at the 

time the product enters the United 

States, through retail sale, provided it 

has not undergone a substantial 

transformation (as established by U.S. 

Customs and Border Protection) in the 

United States. 

Covered commodities imported in 

consumer-ready packages are currently 

required to bear a country of origin 

declaration on each individual package 

under the Tariff Act of 1930 (Tariff Act). 

This interim final rule does not change 

these requirements. 

Labeling Imported Products That Have 

Been Substantially Transformed in the 

United States 

Under this interim final rule, in the 

case of wild fish and shellfish, if a 

covered commodity was imported from 

country X and substantially transformed 

(as established by U.S. Customs and 

Border Protection guidelines and 

policies) in the United States or aboard 

a U.S. flagged vessel, the product shall 

be labeled at retail as ‘‘From [country 

X], processed in the United States.’’ The 

covered commodity must also be 

labeled to indicate that it was derived 

from wild fish or shellfish. 

In the case of farm-raised fish, if a 

covered commodity was imported from 

country X at any stage of production 

and substantially transformed (as 

established by U.S. Customs and Border 

Protection guidelines and policies) in 

the United States, the product shall be 

labeled at retail as ‘‘From [country X], 

processed in the United States.’’ The 

covered commodity shall also be labeled 

to indicate that it was derived from 

farm-raised fish or shellfish.

Defining Country of Origin for Blended 

Products 

Under this interim final rule, the 

country of origin declaration of blended 

or commingled retail food items 

comprised of the same covered 

commodity (e.g., bag of shrimp) having 

different origins, shall indicate the 

countries of origin for covered 

commodities in accordance with 

existing Federal legal requirements 

when the commingled product contains 

imported covered commodities that 

have not subsequently been 

substantially transformed in the United 

States. When the retail product contains 

imported covered commodities that 

have subsequently undergone 

substantial transformation in the United 

States commingled with other imported 

covered commodities that have 

subsequently undergone substantial 

transformation in the United States 

(either prior to or following substantial 

transformation in the United States) 

and/or U.S. origin covered commodities, 

the declaration shall indicate the 

countries of origin contained therein or 

that may be contained therein. 

Remotely Purchased Products 

For sales of a covered commodity in 

which the customer purchases a covered 

commodity prior to having an 

opportunity to observe the final package 

(e.g., Internet sales, home delivery sales, 

etc.) the retailer may provide the 

country of origin and method of 

production information (wild and/or 

farm-raised), either on the sales vehicle 

or at the time the product is delivered 

to the consumer. 

Markings 

Under this interim final rule, the 

country of origin declaration and 

method of production (wild and/or 

farm-raised) designation may be 

provided to consumers by means of a 

label, stamp, mark, placard, band, twist 

tie, pin tag, or other clear and visible 

sign on the covered commodity or on 

the package, display, holding unit, or 

bin containing the commodity at the 

final point of sale to consumers. The 

country of origin declaration and 

method of production (wild and/or 

farm-raised) designation may be 

combined or made separately. Except as 

provided in § 60.200(g) and § 60.200 

(h)(2) of this regulation, the declaration 

of the country(ies) of origin of a product 

shall be listed according to existing 

Federal legal requirements. 

Abbreviations and variant spellings that 

unmistakably indicate the country of 

origin, such as ‘‘U.K.’’ for ‘‘The United 

Kingdom of Great Britain and Northern 

Ireland’’ are acceptable. The adjectival 

form of the name of a country may be 

used as proper notification of the 

country(ies) 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. 

With respect to the production 

designation, various forms of the 

production designation are acceptable, 

including ‘‘wild caught,’’ ‘‘wild,’’ ‘‘farmraised,’’ ‘‘farmed,’’ or a combination of 

these terms for blended products that 

contain both wild and farm-raised fish 

or shellfish provided it can be readily 

understood by the consumer and is in 

conformance with other Federal labeling 

laws. Designations such as ‘‘ocean 

caught,’’ ‘‘caught at sea’’, ‘‘line caught,’’

‘‘cultivated,’’ or ‘‘cultured’’ do not meet 

the requirements of this regulation. 

Alternatively, the method of production 

(wild and/or farm-raised) designation 

may also be in the form of a check box. 

However, the labeling requirements 

under this rule do not supersede any 

existing Federal legal requirements, 

unless otherwise specified, and any 

such country of origin and method of 

production (wild and/or farm-raised) 

notification must not obscure or 

intervene with other labeling 

information required by existing 

regulatory requirements. 

In order to provide the industry with 

as much flexibility as possible, this rule 

does not contain specific requirements 

59712 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

as to the exact placement or size of the 

country of origin or method of 

production (wild and/or farm-raised) 

declaration. However, such declarations 

must be conspicuous and allow 

consumers to determine the country(ies) 

of origin and method(s) of production 

(wild and/or farm-raised) when making 

their purchases and provided that 

existing Federal labeling requirements 

must be followed. For example, under 

FDA labeling regulations (21 CFR 101.2) 

it is not permissible to include the 

method of production (wild and/or 

farm-raised) designation in either the 

ingredient statement or as part of the 

common or usual name of a product. 

Recordkeeping Requirements and 

Responsibilities 

The law states that the Secretary may 

require any person that prepares, stores, 

handles, or distributes a covered 

commodity for retail sale to maintain a 

verifiable recordkeeping audit trail that 

will permit the Secretary to verify 

compliance. As such, records and other 

documentary evidence to substantiate 

origin declarations and designations of 

wild and/or farm-raised are necessary in 

order to provide retailers with credible 

information on which to base origin 

declarations. 

Under this interim final rule, any 

person engaged in the business of 

supplying a covered commodity to a 

retailer, whether directly or indirectly 

(i.e., harvesters, producers, distributors, 

handlers, etc.), must make available 

information to the subsequent purchaser 

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 it identifies 

the product and its country(ies) of origin 

and method(s) of production, unique to 

that transaction by means of a lot 

number or other unique identifier. If 

after October 6, 2005, a frozen fish or 

shellfish covered commodity caught or 

harvested before December 6, 2004, is 

offered for retail sale and for which 

origin and/or method of production 

information is not known, the supplier 

must possess records to substantiate the 

date of harvest or capture of the fish or 

shellfish. 

Any person engaged in the business of 

supplying a covered commodity to a 

retailer, whether directly or indirectly, 

must maintain records to establish and 

identify the immediate previous source 

(if applicable) and immediate 

subsequent recipient of a covered 

commodity, in such a way that 

identifies the product unique to that 

transaction by means of a lot number or 

other unique identifier, for a period of 

1 year from the date of the transaction. 

In addition, the supplier of a covered 

commodity that is responsible for 

initiating a country of origin declaration 

and method of production (wild and/or 

farm-raised) designation must possess 

records necessary to substantiate the 

claim.

For an imported covered commodity, 

the importer of record as determined by 

CBP, must ensure that records: provide 

clear product tracking from the U.S. port 

of entry to the immediate subsequent 

recipient and accurately reflect the 

country(ies) of origin and method(s) of 

production (wild and/or farm-raised) of 

the item as identified in relevant CBP 

entry documents and information 

systems; and maintain such records for 

a period of 1 year from the date of the 

transaction. 

Any intermediary supplier (i.e., not 

the supplier responsible for initiating a 

country of origin declaration and 

method of production (wild and/or 

farm-raised) designation) handling a 

covered commodity that is found to be 

designated incorrectly for country of 

origin and/or 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 

intermediary supplier could not have 

been reasonably expected to have had 

knowledge of the violation. 

Under this interim final rule, retailers 

also have recordkeeping 

responsibilities. Records and other 

documentary evidence relied upon at 

the point of sale by the retailer to 

establish a product’s country(ies) of 

origin and method(s) of production 

(wild and/or farm-raised), or, if 

applicable, date of harvest or capture 

designation, must be available during 

normal business hours to any duly 

authorized representatives of USDA for 

as long as the product is on hand. For 

pre-labeled products (i.e., labeled by the 

manufacturer/first handler) the label 

itself is sufficient evidence on which the 

retailer may rely to establish a product’s 

origin and method(s) of production 

(wild and/or farm-raised). Records that 

identify the retail supplier, the product 

unique to that transaction by means of 

a lot number or other unique identifier, 

and for products that are not prelabeled, the country of origin and 

method of production (wild and/or 

farm-raised) information must be 

maintained for a period of 1 year from 

the date the origin declaration is made 

at retail. Such records may be located at 

the retailer’s point of distribution, 

warehouse, central offices, or other offsite location. 

Any retailer handling a covered 

commodity that is found to be 

designated incorrectly as to country of 

origin and/or the method of production 

(wild and/or farm-raised) shall not be 

held liable by reason of the conduct of 

another if the retailer could not have 

been reasonably expected to have had 

knowledge of the violation. 

Enforcement 

The law encourages the Secretary to 

enter into partnerships with States to 

the extent practicable to assist in the 

administration of this program. As such, 

USDA will seek to enter into 

partnerships with States that have 

enforcement infrastructure to conduct 

retail compliance reviews. 

Routine compliance reviews may be 

conducted at retail establishments and 

associated administrative offices, and at 

supplier establishments subject to these 

regulations. USDA will coordinate the 

scheduling and determine the 

procedures for compliance reviews. 

Only USDA will be able to initiate 

enforcement actions against a person 

found to be in violation of the law. 

USDA may also conduct investigations 

of complaints made by any person 

alleging violations of these regulations 

when the Secretary determines that 

reasonable grounds for such 

investigation exist. 

Retailers and suppliers, upon being 

notified of the commencement of a 

compliance review, must make all 

records or other documentary evidence 

material to this review available to 

USDA representatives in a timely 

manner during normal hours of business 

and provide any necessary facilities for 

such inspections. 

The law contains enforcement 

provisions for both retailers and 

suppliers that include civil penalties of 

up to $10,000 for each violation. For 

retailers, the law states that if the 

Secretary determines that a retailer is in 

violation of the Act, the Secretary must 

notify the retailer of the determination 

and provide the retailer with a 30-day 

period during which the retailer may 

take necessary steps to comply. If upon 

completion of the 30-day period the 

Secretary determines the retailer has 

willfully violated the Act, after 

providing notice and an opportunity for 

a hearing, the retailer may be fined not 

more than $10,000 for each violation. 

For suppliers, the law states that 

section 253 of the Act shall apply to a 

violation of this subpart. This section 

states in part that in determining the 

amount of a civil penalty to be assessed 

for violations of this subpart, the 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59713

Secretary must consider the gravity of 

the offense, the size of the business 

involved, and the effect of the penalty 

on the ability of the person that has 

committed the violation to continue in 

business. The Act also states that the 

Secretary shall consider whether there 

has been a pattern of errors in the 

violation of this subtitle in determining 

whether to assess a civil penalty. This 

section also provides that in addition to 

or in lieu of a civil penalty, the 

Secretary may issue a cease and desist 

order from continuing any violation. In 

addition, section 253 also contains the 

administrative process that must be 

followed in assessing a civil penalty or 

cease and desist order. As with retailers, 

if the Secretary determines that a 

supplier is in violation of the Act, the 

Secretary will notify the supplier of the 

determination and provide the supplier 

with a 30-day period during which the 

supplier may take necessary steps to 

comply.

In addition to the enforcement 

provisions contained in the Act, 

statements regarding a product’s origin 

must also comply with other existing 

Federal statutes. For example, the 

Federal Food, Drug, and Cosmetic Act 

prohibits labeling that is false or 

misleading. Thus, inaccurate country of 

origin labeling of covered commodities 

may lead to additional penalties under 

this statute as well. 

In order to provide regulated parties 

with additional information relative to 

the enforcement of this program, AMS 

will issue a compliance guide. This 

compliance guide will contain 

additional information about the audit 

process, the types of records that may be 

useful in verifying compliance with this 

regulation, examples of instances that 

would be considered violations, as well 

as other information that may be useful 

in complying with this regulation. 

Comments and Responses 

On October 30, 2003, AMS published 

the proposed rule for the mandatory 

COOL program (68 FR 61944) with a 60-

day comment period. On December 22, 

2003, AMS published a notice 

extending the comment period (68 FR 

71039) an additional 60 days. AMS 

received over 5,600 timely comments 

from consumers, retailers, foreign 

governments, producers, wholesalers, 

manufacturers, distributors, members of 

Congress, trade associations and other 

interested parties. The majority of the 

comments received were from 

consumers expressing support for the 

requirement to label the method of 

production of fish and shellfish as either 

wild and/or farm-raised. Numerous 

other comments related to the definition 

of a processed food item, the 

recordkeeping requirements for both 

retailers and suppliers, and the 

enforcement of the program. In addition, 

over 100 late comments were received 

which generally reflected the substance 

of the timely comments received. 

Specific comments are discussed in 

detail below. As this interim final rule 

contains the requirements for labeling 

fish and shellfish covered commodities, 

to the extent practicable, only those 

comments that pertain to fish and 

shellfish covered commodities and to 

the general requirements of this 

regulation are discussed herein. In some 

cases, the summary of comments and 

Agency response encompass both fish 

and shellfish covered commodities and 

other covered commodities. These 

comments and the Agency response are 

included in this interim final rule in 

cases where their inclusion facilitates 

the reader’s understanding of the 

changes that were made in this rule 

based on the commenters’

recommendations.

Definitions 

Covered Commodity 

Summary of Comments: Numerous 

commenters suggested that the 

definition of covered commodity should 

be amended to include poultry. 

Agency Response: Section 281(2)(A) 

of the Act defines the term ‘‘covered 

commodity’’ as ‘‘muscle cuts of beef, 

lamb, and pork; ground beef, ground 

lamb, ground pork; farm-raised fish; 

wild fish; a perishable agricultural 

commodity; and peanuts.’’ Accordingly, 

this recommendation is not adopted. 

Processed (for Fish and Shellfish) 

Summary of Comments: One 

commenter recommended that USDA 

adopt a clearer definition of determining 

a country of origin’s location of 

processing if USDA is unable to clearly 

articulate what substantial 

transformation means in this rule. Other 

commenters recommended that the 

definition of processed be modified so 

that imported products subjected to 

processing beyond repackaging but less 

than substantial transformation should 

be eligible to voluntarily be labeled as 

processed in the United States. 

Agency Response: Because of changes 

made by the Agency in the regulatory 

text in § 60.200(g) to simplify the 

labeling of imported products that have 

been substantially transformed in the 

United States, the Agency no longer 

believes that a separate definition of 

processed is necessary. With respect to 

allowing imported products that have 

been subjected to processing beyond 

repackaging but less than substantial 

transformation to voluntarily be labeled 

as processed in the United States, such 

labeling would not conform to U.S. 

Customs and Border Protection 

requirements. Accordingly, because the 

definition of processed has been deleted 

no changes have been made as a result 

of these comments. 

Processed Food Item 

Summary of Comments: AMS 

received numerous comments on the 

definition of a processed food item. 

Some commenters offered specific 

recommendations as to what should be 

considered a processed food item such 

as canned fish, breaded products, all 

products that have been substantially 

transformed, and all seafood products 

made from block derivatives. Other 

commenters offered specific 

recommendations as to what products 

should not be considered a processed 

food item such as smoked fish, cured 

products, and simple mixtures of 

covered commodities. Several 

commenters recommended that the first 

alternative definition provided in the 

proposed rule should be utilized which 

would exclude any product that bears 

an ingredient statement. Several other 

commenters recommended that the 

second alternative definition provided 

in the proposed rule should be utilized 

which would exclude any covered 

commodity that has undergone 

processing as defined by other existing 

Federal regulations. Other commenters 

recommended that the third alternative 

definition provided in the proposed rule 

should be utilized which would only 

exclude a covered commodity if it is 

mixed with other commodities to create 

a distinct food item such as a pizza or 

TV dinner. Another commenter 

recommended that a processed food 

item be defined as ‘‘transformation of a 

covered commodity that results in a 

finished product that has a distinct 

character from the covered commodity 

so that consumers do not use the item 

in the same fashion as they would use 

the covered commodity itself.’’ Another 

commenter stated his belief that 

Congress intended for COOL to cover 

only those products not currently 

covered under existing tariff laws. Other 

commenters expressed general concern 

about the proposed definition, but did 

not offer any alternatives. Some 

commenters stated that the definition as 

proposed will result in USDA deciding 

on a case by case basis which food 

products must be labeled. Other 

commenters expressed concern that the 

concept of substantial transformation 

which is the basis for determining origin 

under both CBP regulations and the 

59714 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

World Trade Organization’s Rules of 

Origin is being overwritten. 

Agency Response: In an effort to make 

the definition of a processed food item 

clearer, the Agency has modified the 

language in the proposed rule to provide 

specific examples of the types of 

processing that would result in a 

product being considered a processed 

food item. In addition, the Agency has 

determined that the application of the 

definition and thus the scope of covered 

commodities should be modified. 

Accordingly, under this interim final 

rule, all cooked (e.g., canned fish, 

cooked shrimp) and breaded products, 

which in the case of shrimp can account 

for up to 50 percent of the finished 

product, are considered processed food 

items and are excluded from labeling 

under this regulation. In addition, retail 

items that have been given a distinct 

flavor (e.g., Cajun marinated catfish) are 

also considered processed food items. 

Further, to provide additional guidance 

to the industry, the Agency has added 

additional examples of the types of 

products that would be excluded in the 

Questions and Answers section of this 

rule. With respect to the issue of 

substantial transformation, the law 

specifically defines the criteria for a 

covered commodity to be labeled as 

having a United States country of origin. 

Thus, under this regulation, imported 

products that have been subsequently 

substantially transformed in the United 

States are not eligible to bear a ‘‘product 

of the U.S.’’ declaration. 

Raised 

Summary of comments: One 

commenter recommended that the 

definition of raised for farm-raised fish 

and shellfish be modified to include 

farm-raised fish and shellfish originally 

obtained from the wild. 

Agency Response: The Agency 

defined ‘‘raised’’ in the case of farmraised fish and shellfish in the context 

of defining the production steps 

contemplated by the law for this 

commodity (hatched, raised, harvested, 

and processed). The Agency separately 

defined the term ‘‘farm-raised fish’’ to 

include farm-raised fish and shellfish 

originally obtained from the wild. 

However, the Agency has modified the 

definition of ‘‘raised’’ to clarify that it is 

defined in context of the production 

steps defined by the law (hatched, 

raised, harvested, and processed). 

Retailer 

Summary of comments: Numerous 

commenters recommended that the 

definition of retailer be modified to 

include specialty shops such as fish 

markets. 

Agency Response: The law 

specifically defines the term retailer as 

having the meaning given that term in 

section 1(b) of PACA. Accordingly, fish 

markets or any other retail entities that 

either invoice fruits and vegetables at a 

level below the $230,000 threshold or 

do not sell any fruits and vegetables at 

all are not included. Therefore, this 

recommendation is not adopted. 

United States Country of Origin

Summary of comments: One 

commenter expressed concern that the 

definition of United States country of 

origin departs from the relevant 

international standard in which the 

country of origin is defined as the 

country where substantial 

transformation occurred. 

Agency Response: The law 

specifically defines the criteria a 

covered commodity must meet to bear a 

United States country of origin 

declaration. As such, the Agency is 

unable to modify this definition in the 

manner recommended by the 

commenter. However, the Agency has 

modified the definition to clarify that 

products otherwise meeting the 

definition of U.S. origin that are 

subsequently substantially transformed 

outside of the United States are not 

eligible to bear a U.S. origin declaration. 

Country of Origin Notification 

General 

Summary of comments: One 

commenter recommended that 

§ 60.200(a) of the proposed rule should 

be deleted as it could be construed as 

requiring each individual commodity to 

bear a label indicating its country of 

origin. 

Agency Response: The Agency agrees 

with the commenter that the language 

could be interpreted as requiring each 

individual covered commodity to bear a 

label. However, the Agency does not 

agree that this section should be 

deleted. The Agency has modified the 

language in this section to clarify that 

the regulation does not require each 

covered commodity to be individually 

labeled. 

Designation of Wild Fish and FarmRaised Fish 

Summary of Comments: Several 

commenters recommended the Agency 

clarify that the designation of the 

method of production for fish and 

shellfish as either wild or farm-raised is 

a separate requirement from the 

requirement to provide notice of a 

covered commodity’s country of origin. 

Agency Response: The Agency agrees 

with the commenters’ recommendation 

and has modified § 60.200(d) 

accordingly. 

Labeling Covered Commodities When 

the Product Has Entered the United 

States During the Production Process 

Summary of Comments: Several 

commenters recommended alternative 

methods of labeling products that have 

entered the United States during the 

production process. Several commenters 

recommended that mixed origin 

products should be labeled to reflect 

each country involved in the production 

process (e.g., capture/farming country, 

processing country). Other commenters 

recommended that the Agency should 

delete any requirement to display the 

origin where processing occurred for 

any of the covered commodities. Several 

other commenters expressed support for 

the provisions contained in the 

proposed rule. Another commenter 

recommended that all countries 

involved in the production of a covered 

commodity be listed alphabetically. In 

addition, one commenter recommended 

that the words ‘‘by a vessel other than 

a U.S. flagged vessel’’ be inserted after 

the phrase ‘‘was harvested in country 

X’’ in § 60.200(2)(ii). 

Agency Response: The Agency has 

made modifications to § 60.200(g) in 

order to harmonize the requirements of 

this regulation with current Federal 

legal requirements. No additional 

changes have been made as a result of 

these comments.

Blended Products 

Summary of Comments: Numerous 

commenters recommended alternative 

methods for labeling products 

comprised of the same commodity that 

are prepared from raw material sources 

having different origins. Several 

commenters recommended that 

companies should be allowed to list the 

countries either alphabetically or by 

weight. Numerous other commenters 

recommended that companies be 

allowed to use labels that indicate what 

countries may be contained within the 

package. Several commenters 

recommended that AMS consider using 

general rather than specific labels for 

products involving more than one 

country such as ‘‘mixed origin.’’

Another commenter recommended that 

labels should list all of the countries but 

in no particular order. Another 

commenter recommended that the label 

should indicate the percentage of each 

country contained within the package 

(e.g., 65% country Y, 35% country X). 

Finally, one commenter expressed 

concern as to whether listing the 

countries alphabetically is acceptable 

under FDA and CBP regulations. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59715

Agency Response: The law requires 

all covered commodities to be labeled 

with country of origin information. As 

such, the use of ‘‘mixed origin’’ labels 

does not provide consumers with the 

required information and are therefore 

unacceptable. However, USDA is 

concerned about the burden imposed by 

the rule on facilities that produce a 

blended retail product. The proposed 

rule would have required such facilities 

to document that the origin of a product 

was separately tracked, while in their 

control, during production and 

packaging. The proposed rule also 

would have required that the labeling of 

all blended products specify precisely 

the countries of origin represented 

within each individually-packaged 

retail product. In this interim final rule, 

the provision to separately track the 

product has been removed, and the 

labeling requirements have been made 

consistent with other Federal legal 

requirements. Therefore, this interim 

final rule does not impose any 

additional burden with respect to the 

labeling of blended products for which 

labeling is also required under U.S. 

Customs and Border Protection legal 

requirements. For imported covered 

commodities that have not subsequently 

been substantially transformed in the 

United States that are commingled with 

other imported or U.S. origin covered 

commodities, the declaration shall 

indicate the countries of origin for all 

covered commodities in accordance 

with existing Federal legal 

requirements. For imported covered 

commodities that have subsequently 

undergone substantial transformation in 

the United States that are commingled 

with other imported covered 

commodities that have subsequently 

undergone substantial transformation in 

the United States (either prior to or 

following substantial transformation in 

the United States) and/or U.S. origin 

covered commodities, the declaration 

shall indicate the countries of origin 

contained therein or that may be 

contained therein. 

Remotely Purchased Products 

Summary of Comments: Some 

commenters recommended that 

consumers be notified of a product’s 

country of origin prior to the purchase 

being made. Other commenters 

recommended that the country of origin 

notification should be allowed to be 

made either on the sales vehicle or at 

the time the product is delivered to the 

consumer. 

Agency Response: The Agency 

believes that companies should be 

allowed flexibility in providing the 

notice of country of origin and method 

of production (wild and/or farm-raised). 

As such, under this interim final rule, 

companies can provide the required 

notification either on the sales vehicle 

or at the time the product is delivered 

to the consumer. 

Markings 

Section 60.300(a) 

Summary of Comments: Several 

commenters recommended that the 

method of production (wild and/or 

farm-raised) designation should be 

allowed to be made separately from the 

country of origin declaration. Another 

commenter requested flexibility in 

labeling commingled similar wild and 

farm-raised products. Several other 

commenters recommended that the 

Agency specifically allow the use of 

check boxes to convey both the country 

of origin and method of production 

(wild and/or farm-raised) information. 

Agency Response: The Agency 

believes that the law provides the same 

flexibility in providing the method of 

production (wild and/or farm-raised) 

designation as it does the country of 

origin notification. As such, § 60.300(a) 

has been modified to clarify that various 

forms of the method of production (wild 

and/or farm-raised) designation are 

permissible and that the country of 

origin declaration and method of 

production (wild and/or farm-raised) 

designation can be combined or made 

separately. In addition, § 60.300(d) has 

been modified to clarify that a bulk 

container used at the retail level to 

present product to consumers may 

contain products comprised of both 

wild and farm-raised fish or shellfish 

provided all possible origins and/or 

method(s) of production are listed. In 

addition, § 60.300(a) has been modified 

to clarify that products may contain 

both wild and farm-fish provided the 

label identifies both methods of 

production. With respect to check 

boxes, the Agency has added language 

in § 60.300(a) to specifically authorize 

the use of check boxes as an acceptable 

method of notification.

Section 60.300(b) 

Summary of Comments: Several 

commenters recommended that the 

conspicuous location requirement 

should include any place on the 

package or product. Another commenter 

recommended that the preamble 

recognize that conspicuous may be 

provided in a broad number of ways, 

including signs adjacent to a bulk 

display, pin tags for seafood, etc. 

Agency Response: The Agency 

believes the current explanation of a 

conspicuous location as being likely to 

be read and understood by a customer 

under normal conditions of purchase is 

sufficient. In addition, the proposed rule 

adequately clarified that the country of 

origin and method of production (wild 

and/or farm-raised) declarations can be 

made in a multitude of ways (e.g., 

placard, sign, label, sticker, band, twist 

tie, etc.). However, the Agency will add 

pin tags as a specific example. 

Accordingly, these recommendations 

have been adopted in part. 

Section 60.300(d) 

Summary of Comments: One 

commenter recommended that bulk 

commodities should be allowed to be 

commingled in bins as long as the 

signage indicates the countries of origin 

of the contents of the bin. Another 

commenter requested that the words 

‘‘that a substantial amount of’’ be 

inserted after the word provided. 

Another commenter expressed concern 

that requiring individual stickering may 

result in the elimination of bulk 

displays and in packaged products 

displacing fresh displays. 

Agency Response: The Agency has 

modified § 60.300(d) such that a bulk 

container used at the retail level may 

contain a covered commodity from more 

than one origin and/or method of 

production provided that all possible 

origins and/or methods of production 

are listed. No additional changes have 

been made as a result of these 

comments. 

Section 60.300(e) 

Summary of Comments: Several 

commenters recommended that the 

Agency define acceptable standard 

country abbreviations. One commenter 

recommended that the three letter 

format accepted by the International 

Olympic Committee be used while the 

other commenter expressed concern that 

if the International Organization for 

Standardization country codes were 

utilized, abbreviations for many of the 

countries exporting to the United States 

will not be recognized by consumers. 

Another commenter requested 

clarification on whether ‘‘Brazilian 

product’’ would be accepted as proper 

country of origin notification. Another 

commenter recommended that the 

language allowing the use of the 

adjectival form of the name of a country 

be modified to delete the reference to 

‘‘region/city’’ since the Agency 

expressly prohibited the use of State or 

regional label designations in lieu of 

country of origin notification. 

Agency Response: The Agency 

believes that the language regarding 

abbreviations as proposed that allows 

abbreviations and variant spellings that 

59716 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

unmistakably indicate the country of 

origin is appropriate. This is the same 

language contained in U.S. Customs and 

Border Protection laws and regulations, 

which will minimize the burden on the 

industry by allowing them to continue 

to follow existing regulations. With 

respect to the clarification on the use of 

‘‘Brazilian product’’ as country of origin 

notification, the adjectival form of the 

name of a country is specifically 

authorized as long as it does not refer to 

a kind or species of product (e.g., Brazil 

nuts). With respect to the commenter’s 

recommendation to delete the reference 

to ‘‘region/city,’’ the Agency agrees with 

the commenter’s recommendation and 

has deleted the reference to ‘‘region/

city.’’ Accordingly, these 

recommendations have been adopted in 

part. 

Section 60.300(f) 

Summary of Comments: Numerous 

commenters recommended that the 

Agency accept State and regional label 

designations in lieu of country of origin 

labeling. 

Agency Response: The Act 

specifically requires that all covered 

commodities be labeled with country of 

origin information. Thus, allowing State 

and regional label designations in lieu 

of country designations would not meet 

the requirements of the statute. 

Accordingly, this recommendation is 

not adopted. 

Recordkeeping 

General 

Summary of Comments: Several 

commenters recommended that the 

Agency list the specific records that it 

will use to determine the validity of 

origin claims. Other commenters 

recommended that the Agency cite the 

examples of records that can be used to 

substantiate origin and method of 

production (wild and/or farm-raised) 

claims that the Agency has posted on its 

website in the preamble of the final rule. 

Other commenters recommended that 

the Agency require no additional 

records beyond those mandated by the 

Tariff Act, PACA, and FDA. Several 

other commenters requested that the 

Agency provide guidance on what 

records could be used to substantiate 

method of production (wild and/or 

farm-raised) claims for imported 

products and asked what AMS would 

require of foreign suppliers. Another 

commenter expressed concern that the 

preamble provides no explanation of the 

records that would be necessary to 

establish the chain of custody of a 

product. The commenter further 

contends that this requirement is higher 

than the standard set forth in FDA’s 

recordkeeping authority under the 

Bioterrorism Act and suggested that it 

be deleted.

Agency Response: With regard to 

identifying records that may be useful in 

verifying origin and method of 

production (wild and/or farm-raised) 

claims, the Agency has included some 

examples of records in the regulation 

and additional examples will be 

included in the compliance guide. In 

addition § 60.400(b)(4) has been 

modified to clarify the responsibilities 

of importers. With respect to using 

existing records mandated by the Tariff 

Act, PACA, and FDA to verify 

compliance with this regulation, it is 

not necessary that additional records be 

created to comply with this regulation 

to the extent that existing records 

contain the necessary information. With 

respect to establishing the chain of 

custody of a product, the Agency has 

deleted this language from this rule. The 

requirement in the interim final rule 

that retail suppliers maintain records to 

establish and identify the immediate 

previous source and immediate 

subsequent recipient of a covered 

commodity, in such a way that 

identifies the product unique to that 

transaction by means of a lot number or 

other unique identifier, is sufficient 

documentation to allow the Agency to 

track a product back through the 

marketing chain in order to verify 

compliance with this regulation. 

Recordkeeping Retention 

Summary of Comments: The Agency 

received numerous comments regarding 

the recordkeeping retention 

requirement. The majority of 

commenters recommended a shorter 

record retention time for both retailers 

and suppliers. Specifically, most 

commenters recommended that a oneyear record retention requirement for 

suppliers and for the centrally-located 

retail records. Several other commenters 

recommended alternate retention times 

including, for the reasonable life of the 

product (and that for most perishable 

items 30 days would be sufficient), six 

months for perishable items, and 90 

days for both retailers and slaughter 

facilities. Other commenters suggested 

various recordkeeping retention 

requirements at the store level 

including, limiting it to the time that the 

products are located at the store, 

lengthening it to 30 days, reducing it to 

2 days or eliminating it all together. 

Another commenter requested that the 

preamble include language specifying 

that the ‘‘date the origin declaration was 

made at retail’’ with respect to retaining 

the centrally located retail records that 

identify the retail supplier is the date 

that the product is received at the retail 

store. Another commenter expressed 

concern that it may be impossible for 

retailers to determine when the 

proposed recordkeeping retention 

requirement of 7 days after retail sale 

has elapsed. One commenter 

recommended that the regulations 

should expressly recognize that a 

document that identifies the country of 

origin and method of production (wild 

and/or farm-raised) of a covered 

commodity provided by the supplier 

that accompanies the product from the 

supplier all the way to the retail store 

would serve as an adequate record upon 

which the retailer could justifiably rely 

at the point of retail sale to establish a 

covered commodity’s origin and method 

of production (wild and/or farm-raised). 

The commenter also recommended that 

pre-labeled products should not require 

additional documentation at the retail 

level as the label itself is the 

documentary evidence on which the 

retailer is relying. 

Agency Response: The Agency 

believes that a 1-year record retention 

requirement for suppliers and centrally 

located retail records as recommended 

by many of the commenters is 

appropriate. This requirement would be 

consistent with the recordkeeping 

retention time proposed by FDA under 

the Bioterrorism Act and would allow 

the Agency ample time to conduct 

enforcement reviews to verify 

compliance with this regulation. With 

respect to the recordkeeping retention 

requirement for store-level records, the 

Agency agrees with the commenters’

recommendation that records only need 

to be available while the product is on 

hand. As one commenter pointed out, it 

would be difficult for the retail facility 

to determine when the 7 day time 

period after retail sale had elapsed. In 

addition, generally retail enforcement 

activities would not encompass 

products that have already been sold. 

With respect to a commenter’s request 

to clarify that the date the origin 

declaration is made at retail is the date 

the product is received at the retail 

store, the Agency does not believe such 

a clarification is appropriate. In the case 

of nonperishable products, the retailer 

may receive products at the store that 

are not actually displayed for sale for 

some time. Accordingly, this 

recommendation is not adopted. With 

respect to the commenter’s 

recommendation that pre-labeled 

products should not require any 

additional documentation at the retail 

level and that a document containing 

country of origin and method of 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59717

production (wild and/or farm-raised) 

information that accompanies the 

product through retail sale should be 

adequate documentation on which a 

retailer can rely, the Agency agrees and 

has modified § 60.400(b)(1) and 

§ 60.400(c)(1) accordingly. 

Responsibilities of Suppliers and 

Retailers

Summary of Comments: One 

commenter recommended that the final 

rule should clarify that only USDA has 

the authority to verify, audit, and 

administer the labeling program. 

Another commenter recommended that 

the Agency clarify that suppliers of 

covered seafood products must also 

separately track and document the 

method of production (wild and/or 

farm-raised). The commenter also 

recommended that the preamble should 

expressly state that suppliers such as 

wholesalers who simply distribute prepackaged product are not required to 

document that the product was 

separately tracked. Another commenter 

recommended that importers be 

required to maintain adequate records to 

reconcile purchase, inventories, and 

sales of imported and domestic 

commodities. One commenter stated 

their belief that the safe harbor 

provision for retailers and intermediary 

suppliers does not have a specific 

statutory basis in the Act and expressed 

an interest in understanding the 

application of the PACA standard to 

claims required under the Act. The 

commenter also recommended that the 

safe harbor provision for retailers 

should also extend to misstatements of 

the method of production (wild and/or 

farm-raised). The commenter also 

requested that the preamble should 

articulate that retailers can accept 

information provided by suppliers 

without liability and without 

obligations to investigate the 

declarations or systems put in place to 

ensure the accuracy of declarations. 

Several commenters requested that the 

‘‘reasonable knowledge’’ language 

contained in the safe harbor provision 

be deleted as the commenters contend it 

is difficult to determine what someone 

should have been reasonably expected 

to be known. 

Agency Response: With respect to 

clarifying that only USDA has the 

authority to verify, audit, and 

administer the labeling program, the 

Enforcement section of the preamble 

states that only USDA may initiate 

enforcement actions against a person 

found to be in violation of the law. 

Thus, the Agency believes no further 

clarification is necessary. With respect 

to clarifying that suppliers of covered 

seafood products must also separately 

track and document the method of 

production (wild and/or farm-raised), 

the Agency has deleted § 60.400(b)(5) as 

it is duplicative and unnecessary given 

the requirement in the regulation that 

suppliers provide country of origin and 

method of production information for 

all covered commodities. No additional 

changes as a result of these comments 

have been made. With respect to the 

recommendation to require importers to 

maintain adequate records to reconcile 

purchases, inventories, and sales of 

imported and domestic commodities, 

the law does not provide the Agency 

with the authority to require such 

detailed information nor is such 

information necessary to substantiate 

origin and method of production claims. 

Accordingly, this recommendation is 

not adopted. With respect to the safe 

harbor provision, the Agency agrees 

with the commenters’ recommendations 

to extend the safe harbor to 

misstatements of the method of 

production (wild and/or farm-raised) 

and has modified § 60.400(b)(2) 

accordingly. With respect to the 

statutory basis for the ‘‘safe harbor’’

provision, the basis for providing 

regulatory protection for retailers in 

instances where they receive inaccurate 

COOL information and/or method of 

production (wild and/or farm-raised) 

information is based on the language 

contained in sections 253 and 283 of the 

Act. Section 283 speaks of specific 

enforcement procedures and penalties 

for retailers, while enforcement 

procedures and penalties as to other 

persons are found in section 253. 

Because the penalty as to retailers 

requires a willful violation, where a 

retailer acting in good faith relies on 

statements or records given by others, 

we do not believe it was Congress’

intent to hold retailers responsible for 

violations when they relied upon false 

and/or inaccurate information provided 

by a supplier. However, the Agency 

believes the ‘‘reasonable knowledge’’

language is necessary as there are 

instances in which a retailer would 

likely have had knowledge that the 

country of origin information provided 

to them by the supplier was not correct 

and should be held accountable. For 

example, a retailer that receives fresh 

wild salmon from Alaska in January 

labeled as product of the U.S. should 

have known that such a declaration was 

inaccurate. With respect to the issue of 

retailers accepting information provided 

by suppliers without liability and 

without requiring third-party 

verification of the information, the 

Agency believes that because the 

penalty as to retailers specifically 

requires a willful violation and the final 

regulation contains a safe harbor 

provision, there is no additional 

language needed. 

Use of Affidavits and Self-Certification 

Summary of Comments: In the 

proposed rule, the Agency invited 

comment on the practicality of requiring 

suppliers to provide an affidavit for 

each transaction to the immediate 

subsequent recipient certifying that the 

country of origin claims and, if 

applicable, designations of wild or farmraised, being made are truthful and that 

the required records are being 

maintained. Numerous commenters 

recommended that such affidavits not 

be required as they believe it would be 

expensive, onerous, unnecessary, and 

does nothing to alleviate knowing 

violations of the law. Another 

commenter supported the use of 

affidavits as they believe it would 

provide a level of insurance that the 

retailer can rely on the information 

provided by the supplier. One 

commenter suggested that providing an 

affidavit with each transaction would be 

helpful, but legal requirements for such 

a legally binding document may vary by 

State. Numerous other commenters 

interpreted allowing the use of affidavits 

as allowing self-certification. These 

commenters recommended that 

suppliers should be allowed to selfcertify the origin of their product. 

Agency Response: Self-certification 

documents or affidavits may play a role 

in assuring that auditable records are 

available throughout the marketing 

chain, but the auditable records must 

themselves also be available to ensure 

credibility of country of origin labeling 

claims. However, in view of the 

marketing practices of the fish and 

shellfish industries and the probable 

cost impacts, the Agency has concluded 

that requiring affidavits is not 

practicable or necessary.

Enforcement 

Summary of Comments: The Agency 

received numerous comments on the 

issue of enforcement. Several 

commenters recommended that the 

Agency incorporate a grace period in 

which enforcement of this regulation 

would be delayed and implement a 

program emphasizing compliance rather 

than enforcement for the first year. 

Numerous other commenters requested 

that the Agency clearly define the 

process of enforcement including 

recognizing the circumstances under 

which retailers will be considered to 

have willfully violated the statute. 

Several commenters suggested that 

59718 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

retailers should not be found in willful 

violation of the statute unless the 

retailer intentionally removed or 

changed the information provided by 

the supplier. Another commenter 

recommended that willful be defined as 

any act resulting in misinformation that 

was a deliberate and intentional act for 

the purpose of misstating the COOL 

label. Several other commenters 

recommended that the Agency should 

expressly recognize that if the majority 

of covered commodity items bear a 

label, the retailer has met their 

obligation. Several commenters 

requested additional information on the 

process the Agency will employ to 

fulfill the mandate to partner with 

States. Other commenters recommended 

that the Agency expressly prohibit 

third-party audits from being required of 

any party subject to this regulation. 

Another commenter expressed concern 

that the Agency does not define what 

type of information will be sufficient to 

withstand third-party audits which the 

commenter believes will lead to a lack 

of uniformity exposing all participants 

to unnecessary legal liability. Another 

commenter recommended that the final 

regulation clearly describe or at least 

reiterate the statutory standards for nonretailers. Another commenter 

recommended that AMS establish a 

sliding scale for penalties. 

Agency Response: Many of the 

covered commodities sold at retail are 

in a frozen or otherwise preserved state 

(i.e., not sold as ‘‘fresh’’). Thus, many of 

these products would already be in the 

chain of commerce prior to September 

30, 2004, and the origin/production 

information may not be known. 

Accordingly, the effective date of this 

regulation is six months following the 

date of publication of this interim final 

rule. The requirements of this rule do 

not apply to frozen fish or shellfish 

caught or harvested before December 6, 

2004. Further, AMS will focus its 

activities on industry education and 

outreach for an additional six months 

from the effective date of this interim 

final rule. This will allow a total of 12 

months for AMS to conduct an industry 

education and outreach program 

concerning the provisions contained 

within this rulemaking. With respect to 

the issue of acts that will constitute 

‘‘willful’’ violations of this subpart, 

determinations will be made on a case 

by case basis. However, the Agency will 

take into consideration the facts and 

circumstances regarding the situation 

before initiating an enforcement action. 

In addition, the Agency will issue a 

compliance guide similar to the guide 

published by FDA in promulgating 

regulations under the Bioterrorism Act 

of 2002 to provide the industry with 

further information on compliance and 

enforcement. With respect to 

partnerships with States, following 

publication of the interim final rule, 

USDA will seek to enter into 

cooperative agreements with States that 

have existing infrastructure to conduct 

audits at the retail level. USDA will 

provide States with a schedule 

identifying the stores that should be 

audited and with what frequency, 

identify the products to be audited, and 

outline the audit procedures that will be 

followed. If a noncompliance is 

identified by the State, the State will 

notify USDA. USDA will then proceed 

with the appropriate enforcement 

action. With regard to third-party audits, 

the law does not require third-party 

audits of any party subject to these 

regulations. However, the law does not 

prohibit any party subject to this 

regulation from requiring a third-party 

audit of another party as part of their 

contractual arrangement if they so 

choose. With respect to penalties for 

non-retailers, the Farm Bill incorporates 

by reference section 253 of the Act as 

applying to violations of this subpart by 

non-retailers. This section details the 

penalties that may be assessed as well 

as other enforcement mechanisms (e.g., 

cease and desist orders) and the 

administrative process that must be 

followed. Therefore, it is not necessary 

to fully restate the penalties for nonretailers. However, the Agency has 

added additional information regarding 

enforcement of non-retailers to the 

provisions regarding enforcement in the 

Highlights of the Interim Final Rule 

section. With respect to establishing a 

sliding scale for penalties, the Agency 

will determine the appropriate penalty 

on a case by case basis depending on the 

circumstances surrounding the 

violation. 

Existing State Programs 

Summary of Comments: The Agency 

invited comment on the proposed rule 

as it relates to existing State programs. 

One commenter recommended that the 

Agency reiterate the conclusion that this 

regulation preempts State law. No 

comments from States were received on 

this issue. 

Agency Response: In the discussion 

on Executive Order 13132, Federalism, 

the Agency has added additional 

language clarifying that State programs 

that encompass commodities that are 

subject to this regulation are preempted. 

Miscellaneous

Summary of Comments: Numerous 

commenters recommended that 

mandatory COOL be repealed and 

replaced with a voluntary program and 

recommended that USDA seek 

administrative relief from Congress. 

Another commenter requested that 

USDA promulgate an interim final 

regulation instead of a final rule. Other 

commenters stated their belief that 

COOL is a nontariff trade barrier 

intended to discriminate against 

imported products and questioned 

whether this regulation is in 

conformance with various WTO 

agreements. 

Agency Response: The Agency could 

not implement a voluntary program 

without legislative changes. With 

respect to promulgating an interim final 

regulation, the Agency believes that 

because of the changes made as a result 

of comments received and the costs 

associated with this rule, additional 

public input should be obtained and is 

issuing this regulation as an interim 

final rule. However, the Agency is not 

making final provisions that concern 

other covered commodities at this time. 

With respect to the commenters’

concern regarding WTO agreements, the 

Agency has considered these obligations 

throughout the rulemaking process and 

concludes that this regulation is 

consistent with these international 

obligations. 

Preliminary Economic Impact Analysis 

(Executive Order 12866) 

Summary of Comments: A commenter 

stated that USDA did not consider any 

of its alternative approaches viable and 

that AMS failed to consider an array of 

obvious alternatives. The commenter 

suggested that AMS could reduce the 

recordkeeping requirement for retailers 

from 7 days to 2 days at the point of sale 

and reduce the overall recordkeeping 

requirement from 2 years to 1 year. The 

commenter also suggested that AMS 

could consider using general rather than 

specific labels for products involving 

more than one country (e.g., ‘‘mixed 

origin’’). 

Agency Response: The proposed rule 

identified limited discretionary 

authority for alternative regulatory 

approaches, but alternative approaches 

were considered. The preliminary 

economic impact assessment considered 

alternative definitions of the term 

‘‘processed food item,’’ which change 

the scope of commodities required to be 

labeled with country of origin and 

method of production (wild and/or 

farm-raised) information. This interim 

final rule includes a revised definition 

of a processed food item that leads to 

lower costs of implementation for the 

affected industries. The Agency also 

considered the impacts of the use of 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59719

affidavits to transmit country of origin 

information along the food production 

and marketing chain. 

The interim final rule reduces the 

recordkeeping burden at the retailer’s 

point of sale from 7 days following retail 

sale of the product to the length of time 

the product is on hand. The interim 

final rule also reduces the 

recordkeeping burden for suppliers and 

retailers of covered commodities from 2 

years to 1 year. 

The Agency disagrees that the law 

provides discretionary authority to use 

general rather than specific labels for 

products involving more than one 

country. The law requires a retailer of a 

covered commodity to inform 

consumers of the country of origin of a 

covered commodity. A label such as 

‘‘mixed origin’’ does not fulfill this 

requirement because it provides no 

information regarding the country of 

origin of the commodity, other than the 

fact that the origin involves more than 

one country. 

Summary of Comments: A commenter 

observed that AMS argued in the 

proposed rule that if COOL was really 

desirable to consumers, the marketplace 

would provide the information on a 

voluntary basis. The commenter further 

noted that some retailers do label 

seafood as to its source. In addition, the 

commenter noted that such labeling is 

erratic and can be inconsistent, and said 

that seafood is far less likely to be 

labeled for foreign than domestic origin. 

On this basis, the commenter concluded 

that mandatory COOL requirements are 

essential. 

Agency Response: The Agency 

concluded in its preliminary economic 

impact assessment that there was no 

compelling market failure argument 

regarding the provision of country of 

origin information. This conclusion 

stemmed from a lack of evidence of 

barriers to private provision of 

voluntary COOL should consumer 

demand support the increased costs of 

such labeling. The fact that some 

retailers already label seafood as to its 

source indicates that market 

participants will provide country of 

origin information in response to market 

demand. 

Summary of Comments: A commenter 

stated that the preliminary economic 

impact analysis depended heavily on a 

study, Umberger, et al., concerning beef 

labeling. The commenter said that 

Umberger et al.’s and other analyses 

may not apply to seafood, which the 

commenter noted is far more likely than 

beef to be imported from other 

countries—and, unlike beef, comes from 

two distinct types of production systems 

(wild capture and fish farming). 

Agency Response: The Umberger, et 

al. study was referenced as one of the 

available studies on consumer response 

to country of origin labeling. The 

Agency agrees that there are differences 

in terms of consumer demand 

characteristics for beef versus seafood 

products. Therefore, the transfer of 

estimates from Umberger, et al. may be 

a source of uncertainty. Based on the 

numerous comments received on the 

issue, the Agency also concludes that 

wild capture versus farm-raised is an 

important distinction for many seafood 

consumers. 

Summary of Comments: A commenter 

said that when determining the actual 

value of COOL regulations, USDA needs 

to consider the importance of consumer 

education, small U.S. based producers 

and their inability to mount extensive 

lobbying campaigns, the importance of 

progressive regulations, and 

discouraging fraudulent information in 

the marketplace.

Agency Response: The Agency agrees 

that consumer education will be vital to 

firms’ abilities to derive benefits from 

mandatory COOL. While the Agency 

will make available to the public 

information about the requirements of 

this rule, industry will need to 

undertake any initiatives to educate 

consumers with an eye toward using 

COOL as a promotional tool. The 

Agency also recognizes the importance 

of discouraging fraudulent information 

in the marketplace, which underlies the 

rationale for much of this rule. That is, 

this rule is designed to ensure that 

mandatory country of origin claims 

made at retail are credible and verifiable 

back through the supply chain. 

Summary of Comments: A number of 

commenters expressed concern about 

USDA’s preliminary analysis of benefits 

for the proposed rule, and many 

claimed that USDA failed to identify or 

acknowledge any benefits of the COOL 

law. One commenter noted results of a 

poll of 900 people conducted in January 

2004—82 percent of respondents said 

that food should be labeled with 

country of origin information, 85 

percent would be more inclined to buy 

food produced in U.S., and 81 percent 

said they would be willing to pay a few 

cents more for food products of U.S. 

origin. Another commenter reported 

results of a survey conducted by Fresh 

Trends in 2002, in which 86 percent of 

respondents favored the concept of 

COOL. This commenter also cited a 

study by North Carolina State 

University, in which 68 percent of 

respondents indicated willingness to 

pay more for U.S. food products. 

Another commenter said that there is 

little factual support for USDA’s finding 

that there is ‘‘little evidence that 

consumers are willing to pay a price 

premium for country of origin labeling.’’

Agency Response: In the preliminary 

economic impact analysis, the Agency 

did identify and acknowledge benefits 

from the proposed rule. The Agency 

noted that surveys show that a majority 

of consumers state at least some interest 

in knowing where their food was 

produced, and a smaller but significant 

number indicate a strong desire to know 

where their food was produced. The 

Agency also cited results of studies that 

found substantial degrees of 

willingness-to-pay for country of origin 

information by consumers. The 

comment period did not elicit 

additional evidence sufficient to change 

the Agency’s conclusion that such 

professed interest in country of origin 

labels would result in increased 

demands or higher prices for U.S.-origin 

covered commodities. 

The January 2004 poll commissioned 

by the National Farmers Union 

reconfirms that consumers, when 

prompted, indicate an interest in 

country of origin information for food. 

The poll also indicates that respondents 

would be ‘‘willing to pay a few cents 

more’’ for food products grown and/or 

raised in the U.S. This poll does not 

overcome limitations of previous 

surveys and willingness-to-pay studies, 

namely, that there is little basis to 

support the notion that these prompted 

responses will carry over into actual 

purchasing behavior. No comments 

brought forth evidence that there are 

barriers to the voluntary provision of 

country of origin information by firms 

that produce and market the covered 

commodities. In addition, the Agency 

did not receive any information that 

indicated an increased demand for U.S.-

origin products in States that currently 

require country of origin labeling for 

some of the covered commodities. 

Therefore, the Agency continues to 

conclude that in the presence of 

demand for U.S.-origin products, food 

companies would respond by sourcing 

such products and providing consumers 

with the information. 

Summary of Comments: One 

commenter believes there are a number 

of scenarios where consumer preference 

would shift to U.S. products, creating a 

one to five percent shift in consumer 

demand, thus recovering 

implementation costs of the proposed 

rule. 

Agency Response: This commenter 

did not specify the scenarios under 

which consumer preference would shift 

to U.S. products. Neither this 

commenter nor other commenters 

provided evidence sufficient to 

59720 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

conclude that there would be a shift in 

consumer demand for U.S.-origin 

products of one to five percent.

Summary of Comments: One 

commenter stated that USDA needs to 

address the direct cost of administering 

this program and where the funds 

would come from (not from user fees). 

Agency Response: The Agency 

intends to use funds that may be 

appropriated for administration of this 

program. The Agency estimates the 

costs for a minimal level of enforcement 

to be $2.8 million per year. About five 

percent of covered retailers would be 

audited each year under this scenario. 

Summary of Comments: A commenter 

stated that the preliminary economic 

impact assessment is inadequate due to 

the broad range of implementation costs 

presented. 

Agency Response: In its preliminary 

economic impact assessment, the 

Agency estimated a range of direct, 

incremental costs to reflect uncertainty 

about steps that affected entities would 

need to take to implement the proposed 

rule. Comments on the voluntary 

country of origin labeling guidelines (67 

FR 63367) and feedback that the Agency 

received through its outreach efforts 

during development of the proposed 

rule painted two very different pictures 

of the costs and difficulty of 

implementing mandatory COOL. One 

viewpoint suggested that 

implementation and operational costs 

would be relatively low and would 

consist of primarily additional 

recordkeeping costs. The other 

viewpoint suggested that 

implementation and operational costs 

would be relatively high and would 

consist of not only additional 

recordkeeping, but would entail 

substantial changes to operations, 

systems development, and capital 

expenditures. Thus, the Agency’s 

estimated range of direct costs reflected 

the different viewpoints expressed 

about costs of implementing mandatory 

COOL. 

Taking into account comments 

received on the proposed rule, the 

Agency concludes in its interim final 

economic impact assessment that 

implementation costs will exceed the 

lower range estimates presented in the 

preliminary economic impact 

assessment published with the proposed 

rule. Affected firms and trade 

associations noted that implementation 

costs will involve costs and operational 

changes beyond recordkeeping practices 

alone. Therefore, in its interim final 

economic impact assessment, the 

Agency no longer presents a range of 

costs. 

Summary of Comments: A commenter 

said that the preliminary economic 

impact assessment is incomplete 

because it fails to explain in detail the 

components underlying each of the cost 

estimates. The commenter said that the 

analysis should have included cost 

estimate subcategories for each type of 

covered commodity. 

Agency Response: As described in the 

preliminary economic impact 

assessment, the Agency derived its 

direct, incremental cost estimates from 

publicly available sources of data and 

studies. These sources are fully 

referenced in the proposed rule. The 

Agency presented details about cost 

components to the extent that such 

information was provided in the 

available studies. Lack of available 

information precludes further subcategorization of costs. 

Summary of Comments: One 

commenter stated that USDA’s 

preliminary cost estimates do not take 

into account industry infrastructure and 

current labeling practices and do not 

consider existing regulations such as 

PACA. Similarly, another commenter 

stated that the preliminary regulatory 

impact assessment fails to net out the 

cost of complying with existing 

regulations such as the Tariff Act and 

PACA and does not take into account 

existing signage. 

Agency Response: The Agency’s 

preliminary cost estimates did take into 

account existing industry infrastructure, 

labeling practices, and statutes such as 

PACA. The Agency sought to estimate 

the incremental cost of implementing 

the proposed rule. The Agency assumed 

that incremental changes would be 

made to affected firms’ operations and 

recordkeeping systems to implement the 

requirements of the rule. The Agency’s 

assumptions recognized the existence of 

existing Federal regulations such as 

those promulgated under PACA. PACA 

does not require that retailers provide 

country of origin information to 

consumers, or that producers, 

processors, dealers, and other industry 

participants provide country of origin 

information to their customers. Instead, 

PACA would require records to 

substantiate any transaction or product 

claim made by entities subject to PACA, 

such as a claim that a perishable 

agricultural commodity had a certain 

country of origin. 

PACA requires maintenance of 

records and firms subject to PACA have 

developed recordkeeping systems to 

comply with the requirements of PACA. 

The existence of such infrastructure and 

recordkeeping systems reduces the 

incremental costs of additional 

informational requirements, including 

mandatory COOL. The Agency’s 

preliminary cost estimates reflected 

these existing conditions, which is one 

reason that per-unit costs were 

estimated generally to be less for 

perishable agricultural commodities 

than for other covered commodities not 

covered by PACA, its regulations, and 

recordkeeping requirements. 

Summary of Comments: A commenter 

noted that the preliminary economic 

impact assessment does not consider or 

discuss similar voluntary State labeling 

programs, such as the ‘‘Buy California’’

or ‘‘Go Texan’’ programs. 

Agency Response: Voluntary State 

labeling programs have limited 

application to the analysis of the 

impacts of the rule. First and foremost, 

State labeling programs are voluntary, 

while this rule is mandatory. Under 

these types of voluntary State programs, 

there is no requirement for any firms to 

participate, and firms will not choose to 

participate unless it is in their economic 

interest to do so. Even when firms do 

participate in these types of voluntary 

State programs, they are not required to 

label everything that they sell. 

Conversely, this rule is mandatory, and 

retailers and their suppliers must adhere 

to the requirements of the rule for 100 

percent of the sales of the covered 

commodities that must be labeled at 

retail. Second, these voluntary State 

programs do not have the same types of 

requirements for recordkeeping and 

tracking as contained in this mandatory 

rule. Third, State labeling programs 

such as ‘‘Buy California’’ and ‘‘Go 

Texan’’ generally involve a more 

comprehensive program of marketing 

and promotional tools beyond just 

labeling, while this mandatory rule 

addresses labeling but does not address 

marketing and promotional activities. 

For example, some State programs 

require certain minimum quality 

standards for participation in the 

program. Most State programs also 

include promotional and marketing 

activities by the State. Such voluntary 

quality standards and promotional 

activities imply different market effects 

compared to this rule, which addresses 

only labeling requirements.

Summary of Comments: A commenter 

said that seafood labeling should not be 

costly because the National Oceanic and 

Atmospheric Administration (NOAA) 

already has recordkeeping requirements 

for fishing vessels that are pertinent to 

COOL. 

Agency Response: The Agency 

believes that costs for seafood producers 

(wild fish harvesters and fish farmers) 

will be relatively low. The Agency’s 

interim final regulatory impact analysis 

estimates first-year implementation 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59721

costs for fish producers at $241 per 

producer. The difficulty, however, lies 

in passing the relevant information 

along through the food production and 

marketing chain so that credible and 

verifiable information is made available 

to consumers at retail. The additional 

costs throughout the production and 

marketing chain are not embodied in 

current NOAA recordkeeping 

requirements for fishing vessels. 

Summary of Comments: A commenter 

noted that potential costs include 

additional equipment for printing codes, 

significant computer programming, and 

complete label review and redesign. 

Agency Response: The Agency 

believes that these types of costs will be 

incurred to implement the rule. Both the 

preliminary upper-range cost estimates 

published with the proposed rule and 

the interim final economic impact 

assessment reflect these added costs. 

Summary of Comments: A commenter 

said that USDA’s cost estimates are 

substantially understated because they 

fail to recognize complexity of the 

industry, and that USDA’s upper-range 

cost estimates are too low. 

Agency Response: The Agency 

disagrees with this comment. The 

upper-range estimates presented in the 

preliminary economic impact 

assessment sought to reflect the full 

range of direct, incremental costs that 

affected entities would incur during the 

first year of implementation. Likewise 

in this interim final rule, the Agency’s 

cost estimates seek to reflect the full 

implementation costs that will be faced 

by industry. 

Summary of Comments: One 

commenter observed that the proposed 

rule will impact the canned seafood 

production process by requiring the 

segregation of both raw materials and 

frozen stock, requiring multiple lids, 

and requiring the processing line to be 

shut down to switch to another origin. 

Agency Response: Although canned 

seafood is exempt from the interim final 

rule, the Agency believes that these 

types of adjustments to operational 

procedures will be incurred by affected 

firms to comply with the rule. The 

estimated implementation costs 

presented in the interim final economic 

impact assessment reflect these types of 

costs. 

Summary of Comments: A commenter 

noted that about three-fourths of fish 

and shellfish consumed in the U.S. is 

imported and about one-fourth is 

farmed-raised.

Agency Response: The greater the 

potential number of countries of origin 

from which to source a given product, 

the more complicated will be the task of 

making, maintaining, and transferring 

country of origin claims as the product 

moves through the production and 

marketing chain. For example, a product 

that is sourced from only one country 

would require only one production line 

along with a sufficient recordkeeping 

trail. A product that is sourced from 

more than one country likely would 

require some type of segregation plan, 

additional storage, and perhaps 

additional production lines along with 

the requisite recordkeeping 

requirements. The fact that fish must 

also be labeled as wild caught or farmraised represents another piece of 

information that must be maintained 

and transferred throughout the system. 

Summary of Comments: Several 

commenters noted the anticipated costs 

of the proposed rule for their 

businesses. For example, one growercooperative estimated that costs for its 

growers alone would exceed $3.5 

million. A grocery store chain noted that 

the proposed rule would cost its 

company $3.5 million per year. 

Agency Response: These comments 

confirm the Agency’s conclusion that 

implementation of this regulation is a 

complex matter for the affected 

industries and that costs will be 

substantial for many affected entities. In 

these examples, the retailer estimate 

appears to be consistent with the upper 

range cost estimates presented in the 

preliminary economic impact 

assessment. The grower-cooperative 

estimate appears to be lower than the 

Agency’s upper range cost estimate per 

pound, although the comment does not 

provide much detail about how the total 

was computed and whether the total 

includes both grower costs and 

intermediary costs. 

Summary of Comments: A seafood 

processor noted that it already includes 

country of origin information on all 

imported canned crabmeat as required 

by U.S. Customs and Border Protection, 

and said that to indicate whether it is 

wild or farm-raised will impose huge 

financial and administrative burden. 

This commenter stated that it already 

has a substantial amount of inventory of 

cans that will be unusable and to make 

design changes to the packaging will 

take about 1 year, and that it will not 

have time to implement by September 

30, 2004. 

Agency Response: Canned seafood 

products are exempt from the interim 

final rule. Nevertheless, the Agency 

recognizes that labeling of wild versus 

farm-raised fish and fish products will 

entail additional costs, even in cases in 

which country of origin information is 

already maintained. In addition, many 

of the covered commodities sold at 

retail are in a frozen or otherwise 

preserved state (i.e., not sold as ‘‘fresh’’). 

Thus, many of these products would 

already be in the chain of commerce 

prior to September 30, 2004, and the 

origin/production information may not 

be known. Accordingly, the effective 

date of this regulation is six months 

following the date of publication of this 

interim final rule. Further, AMS will 

focus its activities for the six months 

immediately following the effective date 

of this interim final rule on industry 

education and outreach. This will allow 

a total of 12 months for existing product 

to clear through the channels of 

commerce and for AMS to conduct an 

industry education and outreach 

program concerning the provisions 

contained within this rulemaking. 

Additionally, this will permit existing 

inventories of labels and packaging 

materials to be exhausted. 

Summary of Comments: A commenter 

observed that the preliminary economic 

impact analysis of costs on the fish and 

seafood sector derive from the findings 

of one study, namely Sparks/CBW. This 

commenter stated that in the proposed 

rule, USDA argues that the Sparks/CBW 

estimates are too low without providing 

detailed rationale. 

Agency Response: For fish and 

seafood producers, the Agency estimates 

costs per pound of $0.0025 per pound 

for a total of $19 million, compared to 

the Sparks/CBW total estimate of $1 

million. Fish harvesters and farmers 

already maintain many of the types of 

records sufficient to substantiate 

country of origin and wild caught versus 

farm-raised claims. For example, it is 

USDA’s expectation that the 

information contained in records 

typically kept by fish and shellfish 

harvesters and farmers will provide the 

necessary information to substantiate 

these claims. These records include but 

are not limited to hatching records, site 

maps, feeding records, vessel records, a 

U.S. vessel identification number, 

spawning records, and import permits. 

Additional examples of the types of 

records that may be used to substantiate 

origin and method of production claims 

will appear in the compliance guide. 

However, the basis for arguing higher 

costs is that systems need to be 

implemented to ensure that this 

information is transferred from 

producers to the next buyers of their 

products, and that the information is 

maintained for the required amount of 

time. Currently, this type of information 

exchange does not necessarily take 

place. The Agency believes that its 

estimated first-year implementation 

costs of $241 per producer are within 

reason.

59722 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

In the case of fish and seafood 

intermediaries and retailers, the Agency 

adopted the upper range of the Sparks/

CBW estimated costs per pound. 

However, the Agency estimated that 

greater total units of fish and seafood 

production would be affected by 

mandatory COOL. In the case of both 

intermediaries and retailers, the 

Agency’s preliminary estimates for fish 

and seafood intermediaries included 

canned product, while the Sparks/CBW 

estimates included only fresh and 

frozen product. The Agency’s revised 

estimates exclude canned product, as 

well as fish sticks, fish portions, and 

breaded shrimp, due to the change in 

the definition of a processed food item. 

In addition, Sparks/CBW estimated that 

one-third of fish and seafood products 

would move through retail, compared to 

the Agency’s estimate that 41.4 percent 

of the domestic disappearance of the 

covered commodities would be sold 

through retailers covered by this rule. 

The Agency received no comments to 

refute its initial estimated share of 

production that would be sold through 

retailers covered by this rule, but the 

share estimates are revised to reflect the 

lower proportion of fish and shellfish 

consumed at home relative to other food 

products. 

Summary of Comments: A commenter 

observed that USDA did not provide a 

cost comparison for development of a 

compliance system with the new FDA 

recordkeeping requirement under the 

Bioterrorism Act. 

Agency Response: There are several 

reasons that the Agency did not take 

into consideration the requirements of 

the FDA rules being promulgated under 

the Bioterrorism Act. Of the rules 

proposed by FDA, only the rule relating 

to the establishment and maintenance of 

records likely would have much, if any, 

impact on firms’ initiatives to comply 

with mandatory COOL. FDA’s proposed 

rule on records maintenance is not yet 

final, and the Agency cannot anticipate 

how the final rule may differ from the 

proposed rule. Also, the covered 

commodities beef, pork, and lamb are 

exempt from the FDA rulemaking as the 

FDA rules do not cover food regulated 

exclusively by USDA. Finally, as with 

PACA’s regulations and similar existing 

Federal rules, the FDA rules would not 

require that country of origin 

information be provided to consumers 

by retailers, or that firms’ in the supply 

chain provide country of origin 

information. 

Summary of Comments: A commenter 

said that U.S. farmers will be required 

to absorb a majority of the costs, 

marginalizing any profits attributed to 

increased demand for U.S. commodities. 

Agency Response: The Agency 

assumes that in the longer run, higher 

costs will be passed onto consumers in 

the form of higher prices for the covered 

commodities. In the short run, however, 

increased costs incurred by 

intermediaries and retailers may lead to 

lower demand at the farm level. Lower 

market demand may in turn translate 

into lower farm-level prices for 

producers. 

Summary of Comments: Several 

commenters pointed out potential traderestricting impacts of the proposed rule, 

especially for ground beef processing. 

One commenter noted that a meat 

grinder looking for product of least cost 

would tend to seek domestic U.S. 

product at the disadvantage of imported 

product. Another commenter stated that 

the increased cost of mandatory COOL 

will cause suppliers to cease selling to 

customers in the U.S, as the cost 

associated with multiple sources will 

force distributors to source from a single 

country. Another commenter said that 

mandatory COOL will restrict trade by 

restricting flexibility of ground beef 

processors. 

Agency Response: Both importers and 

domestic suppliers will be required to 

meet the requirements of the rule. In the 

long run, the Agency believes that firms 

will find efficient ways to comply with 

the requirements of the rule. Resulting 

small trade impacts as estimated by the 

Economic Research Service (ERS) 

computable general equilibrium (CGE) 

model stem from general increases in 

production costs for the covered 

commodities, rather than any provision 

of the rule. 

Summary of Comments: A number of 

commenters stated that mandatory 

COOL will restrict trade. One 

commenter said that COOL is a nontariff 

trade barrier intended to discriminate 

against imported products on the basis 

of nationality. 

Agency Response: As previously 

mentioned, both importers and 

domestic suppliers will be required to 

meet the requirements of the rule, 

which is meant to provide accurate 

information to consumers with respect 

to the country of origin and the method 

of production of the fish and shellfish 

products they purchase. The Agency 

estimates that exports of fish and 

shellfish will decline slightly and 

imports will increase slightly after 10 

years of adjustment to the rule. This is 

a result of increased production costs 

for the covered fish and shellfish 

commodities regardless of origin, rather 

than any provision of the rule.

Summary of Comments: A commenter 

noted that the proposed rule will make 

domestic seafood canners less 

competitive with foreign producers of 

low-priced imports by increasing 

production costs and complicating the 

production process. The commenter 

said that plants must regularly use 

herring that are caught in both the U.S. 

and Canada to provide enough supplies, 

and that the rule will make processing 

sardines in Maine less competitive. 

Agency Response: Because the interim 

final rule does not require labeling of 

canned fish and seafood products, these 

concerns have been addressed. 

Summary of Comments: A commenter 

stated that mandatory COOL will add 

costs and reduce the abilities of U.S. 

industries to compete in international 

markets. 

Agency Response: The Agency agrees 

that mandatory country of origin 

labeling will add costs to the covered 

commodities. The Agency assumes that 

producers and processors of the covered 

commodities will seek to maintain 

flexibility in marketing decisions. Thus, 

the Agency assumes that producers and 

processors will incur recordkeeping and 

associated operational costs to make and 

substantiate country of origin claims for 

most, if not all, of their production even 

though most of the product ultimately 

will enter channels of distribution not 

covered by this rule. Higher costs will 

be passed forward in the form of higher 

prices, with the result that U.S. exports 

of the covered commodities are 

expected to decline slightly after 10 

years of adjustment to the rule. 

Summary of Comments: A commenter 

observed that implementation of 

mandatory COOL will add costs and 

complexities to all covered commodities 

regardless of where they are marketed. 

Agency Response: The Agency agrees 

that mandatory COOL will add costs 

and complexities to the covered 

commodities regardless of where the 

products ultimately are marketed. First, 

the Agency expects that producers and 

intermediaries will seek to keep their 

marketing options flexible, and thus 

will take the steps necessary to 

implement COOL to allow their 

products to be labeled and sold at retail 

establishments covered by this rule. 

Second, covered commodities for which 

there is no verifiable country of origin 

information will no longer be fully 

fungible. That is, these products will not 

be able to be sold at retail 

establishments covered by this rule. 

These products will need to be 

segregated in the production and 

marketing chain, resulting in reduced 

system wide efficiency and higher costs. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59723

Preliminary Regulatory Flexibility 

Analysis 

Summary of Comments: A commenter 

said that recordkeeping and other costs 

of compliance will fall 

disproportionately on smaller, 

independent farmers. Another 

commenter noted that the position of 

small, independent farmers may be 

weakened. 

Agency Response: In the initial 

regulatory flexibility analysis, the 

Agency noted that costs of 

implementation may be proportionately 

higher for smaller versus larger firms 

given the potential scale economies 

associated with the operation of systems 

to comply with the requirements of 

mandatory country of origin labeling. In 

particular, larger firms would have the 

ability to spread fixed costs of 

implementation over a greater number 

of units of production, thereby incurring 

lower average costs per unit. 

Conversely, smaller farmers and other 

firms may have some implementation 

cost advantages over larger firms. 

Smaller farms and firms likely have 

simpler recordkeeping systems, and 

thus would incur lower development 

costs relative to larger firms. The rule 

does not prescribe a particular 

recordkeeping system; so for example, a 

small fishing operation likely would be 

able to maintain records in hardcopy 

form rather than developing a 

complicated electronic recordkeeping 

system. 

Summary of Comments: A commenter 

stated that USDA’s suggestion that a 

supplier could market covered 

commodities to other channels 

illustrates that mandatory COOL is an 

attempt to affect some supplier market 

preference with a discriminatory effect 

against the supermarket industry. 

Agency Response: The intent of 

mandatory COOL is not to discriminate 

against the retailers subject to the law 

and the rule. Nonetheless, some retailers 

are required to provide country of origin 

information for the covered 

commodities, while foodservice 

establishments and other retailers not 

subject to the rule are not required to 

provide such information. The Agency’s 

suggestion makes the point that 

producers and intermediaries could 

seek regulatory relief by selling their 

products through alternative marketing 

channels. As explained in the economic 

impact assessment, however, the 

Agency assumes that producers and 

intermediaries will seek to provide 

country of origin information for 

virtually all of their production so as to 

maintain maximum marketing 

flexibility. 

Summary of Comments: A commenter 

said that requiring only PACA-licensed 

retailers to label may provide economic 

incentive for retailers not to be PACA 

licensed. Another commenter said that 

the exclusion of fish markets creates an 

un-level playing field.

Agency Response: PACA licensing is 

mandatory for retailers that purchase 

perishable agricultural commodities 

with an invoice value in excess of 

$230,000 in a calendar year at retail. 

Adoption of this definition will assure 

that the vast majority of covered 

commodities will be subject to this rule 

without unduly burdening small 

businesses. 

Fish markets and other retailers not 

subject to mandatory COOL may have a 

cost advantage over retailers subject to 

the rule, but the law defines explicitly 

which retailers are required to provide 

country of origin information. 

Summary of Comments: A commenter 

said that the preliminary regulatory 

flexibility analysis is inadequate as the 

proposed alternatives will not decrease 

the burden on small entities. Another 

commenter said that AMS should 

further study its economic analysis and 

consider alternatives to minimize 

impacts on small entities. 

Agency Response: The Agency’s 

initial regulatory flexibility analysis 

examined potential viable alternatives 

for small entities, but found relatively 

little discretionary authority to provide 

additional regulatory relief. This interim 

final rule decreases the length of time 

that records are required to be kept, 

providing some relief to affected entities 

both large and small. The number of 

products required to be labeled is 

reduced because the definition of a 

processed food item has been 

broadened, thus providing additional 

regulatory relief. The Agency will 

prepare a compliance guide to assist 

firms, both small and large, to comply 

with the requirements of the rule. 

Summary of Comments: A commenter 

said that it is not reasonable for market 

participants to sell their products 

through other channels not subject to 

the proposed rule. 

Agency Response: The Agency 

assumes that most entities will seek to 

maintain maximum marketing 

flexibility by complying with the 

requirements of this rule. Nonetheless, 

the Agency disagrees with the assertion 

that it would not be reasonable for some 

market participants to sell their 

products through channels other than 

retailers expressly required to provide 

country of origin information. As 

detailed in the economic impact 

assessment, the Agency estimates that 

58 percent of fresh and frozen fish and 

38 percent of shellfish are eaten at 

home, and that 65.8 percent of that athome consumption of the covered 

commodities would be sold by retailers 

subject to the rule. Hence, most of the 

domestic market (62 percent for fish and 

75 percent for shellfish) does not require 

country of origin information for the 

covered commodities, which includes 

retailers not subject to the rule and 

foodservice establishments. In addition, 

fish and shellfish defined as ingredients 

in a processed food item and export 

sales are not subject to the requirements 

of this rule. 

Summary of Comments: A commenter 

said that the notion is flawed that the 

proposed rule offers flexibility because 

it is a performance standard rather than 

a design standard. 

Agency Response: The Agency’s 

conclusion is based on the notion that 

each firm will be able to develop its 

own least-cost solution for complying 

with the rule, rather than having to meet 

a rigid design standard. This continues 

to be the case in this interim final rule, 

and the Agency continues to conclude 

that the performance standards of the 

rule allow firms to comply in the most 

cost effective way for their operations. 

Nonetheless, retailers, processors, and 

other affected firms may develop 

differing requirements for their 

suppliers. The Agency will issue a 

compliance guide to assist market 

participants in complying with the 

requirements of the rule. 

Summary of Comments: A commenter 

questioned the assertion in the 

preliminary regulatory flexibility 

analysis that number of affected small 

entities is significantly reduced by the 

PACA definition of retailer. 

Agency Response: The Agency 

disagrees with this comment. As 

detailed in the preliminary regulatory 

flexibility analysis, there were 67,916 

food stores, warehouse clubs, and 

superstores operated the entire year 

according to the 1997 Economic Census, 

and 66,868 of these firms are small. 

Based on PACA data, the Agency 

estimates that 4,512 retailers would be 

subject to this rule, with 3,464 of these 

being small. Thus, 63,404 smaller 

retailers, or 94.8 percent of all small 

food store retailers would not be 

affected. These are estimates of the 

number of firms and not the number of 

establishments. The Small Business 

Administration defines size standards 

based on the size of the business or firm, 

not the size of the establishments 

operated by the firm. 

The Agency recognizes that all 

producers and intermediaries choosing 

to sell through marketing channels 

supplying the covered retailers would 

59724 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

need to meet the requirements of the 

rule. The Agency did not assert that the 

number of small entities in these sectors 

would be reduced by the definition of 

a retailer. As noted previously, however, 

the majority of the sales of the covered 

commodities are through channels not 

affected by this rule, which provides 

substantial marketing opportunities for 

product without verifiable country of 

origin claims. 

Summary of Comments: A commenter 

questioned the Agency’s conclusion that 

costs for producers will be limited and 

will generally include costs involved in 

establishing and maintaining a 

recordkeeping system.

Agency Response: In its preliminary 

regulatory impact analysis, the Agency 

estimated a range of implementation 

costs. The lower-range estimates 

reflected the costs of implementing and 

maintaining a recordkeeping system. 

The upper-range costs reflected 

additional operational costs that would 

be incurred to comply with the rule. In 

the preliminary analysis, the Agency 

concluded that direct incremental costs 

likely would fall in the middle to upper 

end of the estimated range. In the 

interim final regulatory impact analysis, 

the Agency presents a single cost 

estimate to reflect its conclusion that 

costs for affected entities will be higher 

than the preliminary lower-range costs 

for recordkeeping activities alone. 

Summary of Comments: A commenter 

said that the Agency should expand its 

analysis to take into consideration that 

the rule will likely impact all entities 

along the supply chain, not just those 

PACA licensed retailers. 

Agency Response: The Agency’s 

initial regulatory impact and regulatory 

flexibility analyses considered all 

potentially affected firms, from 

producer through intermediaries 

through retailers subject to this rule. 

Summary of Comments: A commenter 

stated that the flexibility provided is not 

particularly helpful to small entities. 

Agency Response: The Agency has 

provided as much regulatory relief for 

small entities as possible, within the 

limits of the discretionary authority 

provided by the law. The requirements 

of the rule flow from the law that 

requires retailers to inform consumers of 

the country of origin of the covered 

commodities. Information must flow 

throughout the supply chain to enable 

retailers to provide the required 

information to consumers, regardless of 

the size of the businesses participating 

in the supply chain. To ensure 

compliance and integrity of the 

program, the Agency has determined 

that these claims must be supported by 

a recordkeeping trail that can be 

audited. 

Summary of Comments: A commenter 

noted that the Small Business 

Regulatory Enforcement Fairness Act 

requires publication of a compliance 

guide that explains the rule, provides 

compliance scenarios to illustrate and 

clarify any complexities, lessens small 

businesses’ anxiety about complying 

with the rule, and provides suggestions 

on how to structure data collection and 

recordkeeping systems. 

Agency Response: The Agency will 

develop a compliance guide to assist 

firms in complying with the rule. 

Preliminary Paperwork Reduction Act 

Summary of Comments: A commenter 

stated that wholesalers will have to 

develop new recordkeeping systems and 

that substantial labor costs will be 

incurred because wholesalers are 

responsible for tracking the identity of 

both the prior seller and the subsequent 

buyer. 

Agency Response: In the proposed 

rule, the Agency estimated the initial 

costs associated with recordkeeping, 

which includes the costs of maintaining 

country of origin information of the 

covered commodities purchased and 

subsequently furnishing that 

information to the next participant in 

the supply chain. For products that are 

not pre-labeled, this action would 

require adding information to a firm’s 

bills of lading, invoices, or other records 

associated with movement of covered 

commodities from purchase to sale. The 

Agency believes that most wholesalers 

already have functioning recordkeeping 

systems and will require only 

modification of existing recordkeeping 

systems rather than the development of 

new systems. The Label Cost Model 

developed for FDA is used to estimate 

the cost of including additional country 

of origin information to an operation’s 

records. The costs of labor in 

establishing and maintaining these 

records are included in these cost 

estimates. The Agency concludes that 

these costs will be substantial and will 

involve substantial labor costs. 

Summary of Comments: A commenter 

strongly disagrees with the assumption 

that the recordkeeping for retailers and 

others will be accomplished primarily 

by electronic means. According to the 

commenter’s survey, 75 percent of 

retailers and wholesalers would have to 

keep manual records. 

Agency Response: The Agency has 

made a number of visits to retailer and 

wholesaler facilities. Retailers covered 

by this rule must meet the definition of 

a retailer as defined by PACA. The 

PACA definition of a retailer includes 

only those retailers handling fresh and 

frozen fruits and vegetables with an 

invoice value of at least $230,000 

annually. Most small food store firms, 

which may keep manual records, have 

been excluded from mandatory COOL 

based on the PACA definition of a 

retailer. The Agency believes that most 

wholesalers and retailers covered by 

mandatory COOL already have 

established electronic recordkeeping 

systems and will only require the 

modification of existing recordkeeping 

systems rather than the development of 

new systems. Conceptually, the task of 

modifying a paper-based recordkeeping 

system is no different than the task of 

modifying an electronic recordkeeping 

system. Therefore, the Agency believes 

that its estimation represents a 

reasonable approximation of the variety 

of solutions that firms will undertake to 

comply with the rule. 

Summary of Comments: A commenter 

said that if USDA is using the ‘‘FDA one 

pager’’ as a model, USDA should make 

it public and publish it in the Federal 

Register.

Agency Response: A more complete 

discussion of the Label Cost Model is 

available in the FDA proposed rule on 

‘‘Establishment and Maintenance of 

Records Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002’’ (68 FR 

25187). 

Summary of Comments: A commenter 

noted that USDA uses contradictory 

assumptions—on the one hand USDA 

says industry will do electronic 

recordkeeping and on the other it bases 

cost estimates on a paper-based system. 

Agency Response: As noted 

previously, the Agency believes that the 

task of modifying a recordkeeping 

system is similar conceptually 

regardless of whether the system is 

electronic or paper based. Therefore, the 

Agency believes that its approach to 

estimating costs adequately represents 

the variety of recordkeeping systems 

currently in place. 

Summary of Comments: A commenter 

said that USDA has wrongly decreased 

the estimated recordkeeping costs for 

intermediaries like wholesalers (from 

the recordkeeping burden estimated for 

the voluntary guidelines). 

Agency Response: In response to the 

estimated PRA burden published for the 

voluntary country of origin labeling 

guidelines, the Agency received 

numerous comments on its estimated 

costs and the number of enterprises 

impacted by the guidelines. As a result, 

the Agency carefully reconsidered its 

estimates in preparing the preliminary 

paperwork burden estimate for the 

proposed rule. As a result of these 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59725

revisions, the Agency has refined its 

estimates of the numbers of affected 

entities and the costs per entity. In 

addition, a further improvement from 

the voluntary country of origin 

recordkeeping cost estimates is the use 

of Bureau of Labor Statistics wage rates 

for tasks required by producers, 

distributors, handlers, packers, 

processors, wholesalers, and retailers for 

recordkeeping. Similarly, a more 

appropriate estimate is added to the 

wage rate to account for total benefits. 

All of this resulted in the reduction of 

the total estimated recordkeeping costs 

under mandatory COOL in comparison 

to the voluntary guidelines, and the 

Agency believes this is a more accurate 

assessment. 

Summary of Comments: A commenter 

said that the assumed administrative 

hourly rate of $16.05 ignores 

supervisory, professional, and 

management time required at the 

wholesale and retail level. This 

commenter further stated that if 

overhead costs are to equate fringe 

benefits, the rate should be 30–35 

percent, not 25 percent. 

Agency Response: The Agency 

believes that the administrative support 

occupations category represents a 

reasonable composite of the labor skills 

that will be involved in recordkeeping 

activities for wholesalers and retailers. 

The Agency believes these 

responsibilities would be assumed 

under the current supervisory and 

management structure. For handlers, 

processors, wholesalers, and other 

intermediaries as well as retailers the 

Agency believes the maintenance 

activities for recordkeeping will include 

inputting, tracking, and storing country 

of origin information for each covered 

commodity. While the Agency 

acknowledges that supervisory and 

management input will be required, the 

Agency also notes that some labor will 

be supplied by workers receiving lower 

wages. In some of our visits to retailers, 

it was indicated that these firms were 

employing more high school and college 

students than in the past to reduce their 

costs. 

Bureau of Labor Statistics (BLS) data 

are used for both the wage and for 

overhead costs (which include social 

security, unemployment insurance, 

workers compensation, and other 

benefits). In this interim final rule, the 

wage rates and fringe benefits rate are 

both updated to 2002 BLS figures, 

which results in increased wage rates 

and benefits. The Agency believes this 

is the most accurate and documented 

estimate of wages and additional 

employer paid benefits. 

Summary of Comments: A commenter 

said that USDA has underestimated the 

number of hours needed for 

recordkeeping, noting that one hour per 

week for wholesalers is too low because 

it will take more than one hour per day. 

This commenter also stated that one 

hour per day for retailers is also too low. 

Agency Response: For fish and 

seafood wholesalers, the Agency 

estimates the maintenance burden for 

country of origin recordkeeping to be 52 

hours per year per establishment, or one 

hour per week. The Agency recognizes 

that some of these wholesalers may 

require more than one hour a week to 

maintain country of origin information. 

However, a number of smaller 

wholesalers and those that do not 

operate continuously throughout the 

year will likely require less than an 

average of one hour per week. 

Therefore, the Agency believes an 

average of one hour per week per 

establishment is a reasonable estimate 

for these wholesalers. In the case of 

general line grocery wholesalers, the 

Agency reduced the maintenance 

burden from 52 to 12 hours annually per 

establishment because fish and shellfish 

represent only a portion of the 

commodities handled by these 

establishments. 

Taking into account Agency reviews 

of retailers’ operations, the Agency 

believes that an additional hour of 

recordkeeping activities for country of 

origin information will be incurred 

daily at each retail establishment. The 

Agency’s estimate of one hour per day 

for retailers is only for the maintenance 

portion of the recordkeeping of country 

of origin information. Maintenance 

activities will include inputting, 

tracking, and storing country of origin 

information for each covered 

commodity.

In summary, this interim final rule 

adopts the fish and shellfish provissions 

of the October 30, 2003 (68 FR 61944), 

proposed rule with the changes 

discussed herein and with other 

changes made for purposes of clarity 

and accuracy. 

III. Impact Analysis 

Executive Order 12866—Interim Final 

Regulatory Impact Analysis 

USDA has examined the economic 

impact of this interim final rule as 

required by Executive Order 12866. In 

its Preliminary Regulatory Impact 

Assessment (PRIA), USDA determined 

that the regulatory action was 

economically significant, as it was likely 

to result in a rule that would have an 

annual effect on the economy of $100 

million or more. Although the estimated 

annual effect on the economy of this 

interim final rule for fish and shellfish 

is less than $100 million, it remains an 

economically significant regulatory 

action because it would adversely affect 

in a material way a sector of the 

economy and therefore has been 

reviewed by the Office of Management 

and Budget (OMB). Executive Order 

12866 requires that a regulatory benefitcost analysis be performed on all 

economically significant regulatory 

actions. 

This interim final regulatory impact 

assessment reflects revisions to the 

PRIA (68 FR 61952). Revisions to the 

PRIA were made as a result of changes 

to this rule relative to the proposed rule, 

in responses to comments on the PRIA 

itself, and as a result of narrowing the 

scope of covered commodities affected 

by the rule. Specifically, this interim 

final rule defines covered commodities 

as farm-raised and wild fish and 

shellfish. 

The Comments and Responses section 

lists the comments received on the PRIA 

and provides the Agency’s responses to 

the comments. Where substantially 

unchanged, results of the PRIA are 

summarized herein, and revisions are 

described in detail. Interested readers 

are referred to the text of the PRIA for 

a more comprehensive discussion of the 

assumptions, data, methods, and results. 

Summary of the Economic Analysis 

The estimated incremental benefits 

associated with this interim final rule 

are difficult to quantify, but current 

information indicates that they are not 

likely to be large. The estimated firstyear incremental costs for fish and 

shellfish harvesters, producers, 

processors, wholesalers, and retailers 

are $89 million. Maintenance costs 

beyond the first year are expected to be 

lower than the combined start up and 

maintenance costs required in the first 

year. The estimated cost to the U.S. 

economy in higher food prices and 

reduced food production (deadweight 

loss) in the tenth year after 

implementation of the rule is $6.2 

million, or about two cents per person 

annually based on the current U.S. 

population. In other words, the U.S. 

economy would be worse off after 

implementing this rule. 

Note that this analysis addresses 

implementation of labeling 

requirements for fish and shellfish 

destined for human consumption only. 

Note also that this analysis does not 

quantify certain costs of the interim 

final rule such as the cost of the rule 

after the first year, or the cost of any 

supply disruptions or any other ‘‘leadtime’’ issues. Except for the 

59726 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

recordkeeping requirements, there is 

insufficient information to distinguish 

between first year start up and 

maintenance costs versus ongoing 

maintenance costs for this interim final 

rule. 

USDA finds little evidence that 

consumers are willing to pay a price 

premium for country of origin labeling. 

USDA also finds little evidence that 

consumers are likely to increase their 

purchase of food items bearing the U.S. 

origin label as a result of this 

rulemaking. Current evidence does not 

suggest that U.S. producers will receive 

sufficiently higher prices for U.S.-

labeled products to cover the labeling, 

recordkeeping, and other related costs. 

The lack of participation in voluntary 

programs for labeling products of U.S. 

origin provides evidence that consumers 

currently are unwilling to pay price 

premiums sufficient to recoup the costs 

of labeling.

Statement of Need 

Justification for this interim final rule 

remains unchanged from the PRIA. This 

rule is the direct result of statutory 

obligations to implement the COOL 

provisions of the Farm Bill, which 

amended the Act by adding Subtitle D—

Country of Origin Labeling. There are no 

alternatives to Federal regulatory 

intervention for implementing this 

statutory directive. 

The country of origin labeling 

provisions of the Farm Bill change 

current Federal labeling requirements 

for muscle cuts of beef, pork, and lamb; 

ground beef, ground pork, and ground 

lamb; farm-raised fish; wild fish; 

perishable agricultural commodities; 

and peanuts (hereafter, covered 

commodities). Under current Federal 

laws and regulations, COOL is not 

universally required for covered 

commodities. Provisions concerning 

labeling requirements for farm-raised 

and wild fish are provided herein. 

Labeling requirements for the remaining 

covered commodities become effective 

on September 30, 2006. Therefore, this 

rule and economic impact analysis 

address requirements and impacts for 

farm-raised and wild fish and shellfish 

only. 

As described in the PRIA, the 

conclusion remains that there does not 

appear to be a compelling market failure 

argument regarding the provision of 

country of origin information. 

Comments received on the PRIA elicited 

no evidence of significant barriers to the 

provision of this information other than 

private costs to firms in the supply 

chain and low expected returns. Thus, 

market mechanisms likely would lead to 

the provision of the optimal level of 

country of origin information. 

Alternative Approaches 

The PRIA noted that many aspects of 

the mandatory COOL provisions of Pub. 

L. 107–171 are prescriptive and provide 

little regulatory discretion for this 

rulemaking. Some commenters 

suggested that USDA explore more 

opportunities for less costly regulatory 

alternatives. Specific suggestions 

focused on methods for identifying 

country of origin, recordkeeping 

requirements, and the scope of products 

required to be labeled. 

A number of comments on the PRIA 

suggested that USDA adopt a 

‘‘presumption of U.S. origin’’ standard 

for identifying commodities of U.S. 

origin. Under this standard, only 

imported covered commodities would 

be required to be identified and tracked 

according to their respective countries 

of origin. Any covered commodity not 

so identified would then be considered 

by presumption to be of U.S. origin. A 

presumption of origin standard would 

require mandatory identification of 

products not of U.S. origin. The law, 

however, specifically prohibits USDA 

from using a mandatory identification 

system to verify the country of origin of 

a covered commodity. In addition, as 

discussed in the proposed rule (68 FR 

61944), the Agency does not believe that 

a presumption of U.S. origin standard 

provides a means of providing country 

of origin information that is credible 

and can be verified. Comments on the 

proposed rule did not identify how to 

overcome these obstacles. Thus, a 

presumption of U.S. origin standard is 

not a viable alternative. 

A number of commenters suggested 

that USDA reduce the recordkeeping 

burden for the rule. In this interim final 

rule, the recordkeeping retention period 

for retailers is reduced from 7 days 

following the retail sale of the product 

to the length of time the product is on 

hand. In addition, the overall 

recordkeeping retention period for 

retailers and suppliers is reduced from 

2 years to 1 year. 

The interim final rule also 

‘‘streamlines’’ the required 

recordkeeping for items that are prelabeled (i.e., labeled by the 

manufacturer/first handler) with the 

required country of origin and method 

of production (wild and/or farm raised) 

information. Records that demonstrate 

the chain of custody (immediate 

previous source and/or subsequent 

recipient, as applicable) for all covered 

items must be maintained, but the 

underlying records (e.g., invoices, bills 

of lading, production and sales records, 

etc.) do not need to identify the country 

of origin and method of production 

(wild and/or farm-raised) of these prelabeled products. For example, if a 

processor labels the country of origin 

and method of production on a package 

of salmon steaks, and the salmon steaks 

ultimately are sold in that package at 

retail, then that label may serve as 

sufficient evidence on which the retailer 

may rely to establish the product’s 

origin and method of production. Thus, 

the retailer’s records would not need to 

show country of origin and method of 

production information for that package 

of salmon, but the retailer’s records 

would need to include information to 

allow the source of those salmon steaks 

to be tracked back through the system to 

allow the country of origin and method 

of production claims to be verified at 

the point in the system at which the 

claims were initiated. Under the 

proposed rule, the retailer would have 

also have been required to identify the 

country of origin and method of 

production of the package of salmon 

within its recordkeeping system; the 

information provided on the package 

itself would not have been sufficient. 

This change in recordkeeping 

requirements should lessen the number 

of changes that entities in the 

distribution chain need to make to their 

recordkeeping systems and should 

lessen the amount of data entry that is 

required.

The interim final rule changes the 

definition of a processed food item such 

that a greater number of products are 

now exempt from country of origin 

labeling requirements. The fewer the 

number of products that must be 

labeled, the lower are implementation 

and maintenance costs for many 

affected entities. 

Analysis of Benefits and Costs 

As in the PRIA, the baseline for this 

analysis is the present state of the 

affected industries absent mandatory 

COOL. USDA recognizes that some 

affected firms have already begun to 

implement changes in their operations 

to accommodate the law and the 

expected requirements of this interim 

final rule. 

Benefits: The expected benefits from 

implementation of this rule are difficult 

to quantify. The Agency’s conclusion 

remains unchanged, which is that the 

estimated economic benefits will be 

small and will accrue mainly to those 

consumers who desire country of origin 

and method of production information. 

There clearly is some level of interest by 

consumers in the country of origin of 

food. In addition, the Agency received 

numerous comments expressing an 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59727

interest in labeling of fish and shellfish 

as wild or farm-raised. The rule will 

provide benefits to these consumers. 

However, commenters provided no 

additional substantive evidence to alter 

the Agency’s conclusion that the 

measurable economic benefits of 

mandatory COOL will not be large. 

Additional information and studies 

cited by commenters were of the same 

type identified in the PRIA—namely, 

consumer surveys and willingness-topay studies. The Agency does not 

believe that these types of studies 

provide a sufficient basis to estimate the 

quantitative benefits, if any, of COOL. 

A number of commenters pointed to 

recent food safety incidents, suggesting 

that mandatory COOL would provide 

food safety benefits to consumers. As 

discussed in the PRIA, mandatory 

COOL does not address food safety 

issues. Appropriate preventative 

measures and effective mechanisms to 

recall products in the event of 

contamination incidents are more 

comprehensive means of protecting the 

health of the entire consuming public 

regardless of the form in which a 

product is consumed or where it is 

purchased. In addition, foods imported 

into the U.S. must meet food safety 

standards equivalent to those required 

of products produced domestically. 

Costs: To estimate the costs of this 

rule, we employed a two-pronged 

approach. First, we estimated 

implementation costs for firms in the 

industries directly affected by the rule. 

The implementation costs on directly 

affected firms represent increases in 

capital, labor, and other input costs that 

firms will incur to comply with the 

requirements of the rule. These costs are 

expenses that these particular firms 

must incur, but are not necessarily costs 

to the U.S. economy as measured by the 

value of goods and services that are 

produced. We then applied the 

implementation cost estimates to a 

general equilibrium model to estimate 

overall impacts on the U.S. economy 

after a 10-year period of economic 

adjustment. The model provides a 

means to estimate the change in overall 

consumer purchasing power after the 

economy has adjusted to the 

requirements of the rule. 

Details of the data, sources, and 

methods underlying the cost estimates 

are provided in the PRIA. This section 

provides the interim final cost estimates 

and describes revisions made to the 

PRIA. 

In the PRIA, we developed a range of 

estimated implementation costs to 

reflect the likely range of first-year costs 

for directly affected firms to comply 

with the proposed rule. The lower range 

of incremental cost estimates reflected 

the costs to modify and maintain 

current recordkeeping systems, while 

the upper range of estimates reflected 

other capital and operational costs to 

comply with the proposed rule. We 

concluded in the PRIA that costs likely 

would fall in the middle to upper end 

of the range of estimated costs. Taking 

into account comments received on the 

proposed rule and the PRIA, this 

interim final regulatory impact 

assessment presents only a single set of 

estimates for anticipated costs. 

Comments representing affected entities 

clearly described that compliance with 

the rule would require changes beyond 

recordkeeping alone. Thus, the revised 

incremental cost estimates reflect not 

only additional recordkeeping costs, but 

also additional payments by the directly 

affected firms for capital, labor, and 

other expenses that will be incurred as 

a result of operational changes to 

comply with the rule. 

First-year incremental costs for 

directly affected firms are estimated at 

$89 million. The large change relative to 

the estimate of $3.9 billion for the 

proposed rule is attributable to the fact 

that this interim final rule covers only 

fish and shellfish. Costs per firm are 

estimated at $241 for fish and shellfish 

harvesters and producers, $1,890 for 

intermediaries (such as handlers, 

importers, processors, and wholesalers), 

and $12,600 for retailers. 

To estimate the overall impacts of the 

higher costs of production resulting 

from the interim final rule, we used a 

model of the entire U.S. economy. We 

adjusted the model by imposing the 

estimated implementation costs on the 

directly impacted segments of the 

economy in a computable general 

equilibrium model developed by the 

Economic Research Service (ERS). The 

model estimates changes in prices, 

production, exports, and imports as the 

directly impacted industries adjust to 

higher costs of production over the 

longer run (namely, 10 years). Because 

the model covers the whole U.S. 

economy, it also estimates how other 

segments of the economy adjust to 

changes emanating from the directly 

affected segments and the resulting 

change in overall productivity of the 

economy.

This general equilibrium analysis is 

developed from the standpoint that only 

farm-raised and wild fish and shellfish 

products will be directly affected by the 

interim final rule. Implementation and 

economic costs for the other covered 

commodities are not included in this 

analysis. Thus, this analysis illustrates 

the relative scale of the overall impacts 

of this rule on the U.S. economy, but 

does not represent the impacts of 

mandatory COOL requirements for all 

covered commodities. 

Note that a general equilibrium 

analysis differs from a partial 

equilibrium analysis in that a partial 

equilibrium analysis would examine the 

effects of the mandatory COOL on 

consumers and producers of fish and 

shellfish. The general equilibrium 

approach is a more encompassing 

analytic approach. However, the gains 

and losses to consumers and producers 

of fish and shellfish are not identified 

separately from the rest of the economy. 

Annual costs to the U.S. economy in 

terms of reduced purchasing power 

resulting from a loss in productivity 

after a 10-year period of adjustment are 

estimated at $6.2 million. Domestic 

production of fish and shellfish at the 

producer and retail levels is estimated 

to be lower and prices to be higher. U.S. 

exports of fish and shellfish are 

estimated to decrease, while U.S. 

imports of fish and shellfish are 

estimated to increase. 

The findings indicate that directly 

affected industries recover the higher 

costs imposed by the rule through 

slightly higher prices for their products. 

With higher prices, the quantities of 

their products demanded also decline. 

Consumers pay slightly more for the 

products and purchase less fish and 

shellfish. Overall, however, the fish and 

shellfish account for a small portion of 

the U.S. economy and of consumers’

budgets. Thus, the ‘‘deadweight’’

economic burden of the rule is 

considerably smaller than the 

incremental costs to directly affected 

firms. 

Estimated impacts of this interim final 

rule are subject to uncertainties inherent 

in this type of prospective economic 

analysis. Firms directly affected by this 

interim final rule differ considerably in 

size and in their operational 

characteristics. Actual impacts on 

individual firms and on the overall 

economy resulting from the interim 

final rule may vary from the average 

estimated impacts presented herein. 

The remainder of this section 

describes in greater detail how we 

developed the estimated direct, 

incremental costs and the overall costs 

to the U.S. economy. 

Cost assumptions: This interim final 

rule directly regulates the activities of 

retailers (as defined by the law) and 

their suppliers. Retailers are required by 

the rule to provide country of origin and 

method of production (wild and/or 

farm-raised) information for fish and 

shellfish products that they sell, and 

firms that supply these products to 

these retailers must provide them with 

59728 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

this information. In addition, all other 

firms in the supply chain for the 

relevant fish and shellfish products are 

potentially affected by the rule because 

country of origin and method of 

production (wild and/or farm-raised) 

information will need to be maintained 

and transferred along the entire supply 

chain to enable retailers to correctly 

label the products at the point of final 

sale. 

Number of firms and number of 

establishments affected: We estimate 

that approximately 125,000 

establishments owned by approximately 

91,000 firms would be either directly or 

indirectly affected by this rule. Table 1 

provides estimates of the affected firms 

and establishments.

TABLE 1.—ESTIMATED NUMBER OF AFFECTED ENTITIES

Type Firms Establishments 

Fish: 

Farm-Raised Fish and Shellfish ......................................................................................................................................... 3,540 3,540 

Fishing ................................................................................................................................................................................ 76,499 76,452 

Fresh & Frozen Seafood Processing ................................................................................................................................. 582 653 

Fish & Seafood Wholesale ................................................................................................................................................. 2,897 2,980 

General Line Grocery Wholesalers .................................................................................................................................... 3,183 3,993 

Retailers .............................................................................................................................................................................. 4,512 37,176 

Totals: 

Producers ........................................................................................................................................................................... 80,039 79,992 

Intermediaries ..................................................................................................................................................................... 6,662 7,626 

Retailers .............................................................................................................................................................................. 4,512 37,176 

Grand Total ......................................................................................................................................................................... 91,213 124,794 

In contrast to the PRIA, the beef, pork, 

lamb, perishable agricultural 

commodity and peanut sectors are no 

longer directly affected by this interim 

final rule. Thus, entities in these sectors 

are removed from the estimated number 

of affected entities. In addition, the 

numbers of affected entities in the 

seafood processing industry are 

lowered. Canned seafood products 

would have required labeling under the 

proposed rule, but are exempt under the 

interim final rule because of the revised 

definition of a processed food item. 

While there may be fishing operations 

that harvest fish destined exclusively for 

canning, data on the number of such 

operations are unavailable. In addition, 

fishing vessels that target a particular 

species destined for canning often have 

a by-catch of other species that would 

be destined for fresh or frozen end uses. 

Thus, we believe that keeping the 

estimated number affected fishing 

operations unchanged is a reasonable 

assumption. In the PRIA, the seafood 

product preparation and packing 

industry included fresh and frozen 

seafood processing and seafood canning. 

Because the interim final rule exempts 

canned seafood products, the number of 

affected seafood processing firms is 

reduced from 741 to 582 and the 

number of establishments from 823 to 

653. We assume that all of these 

remaining fresh and frozen seafood 

processing firms prepare at least some 

covered commodities, although there 

may be some firms that prepare fish and 

shellfish exclusively into items that 

would be exempt from this rule under 

the definition of a processed food item. 

For example, a firm that produces only 

breaded shrimp would not be subject to 

the requirements of this interim final 

rule.

We assume that all firms and 

establishments identified in Table 1 will 

be impacted by the rule, although some 

may not produce or sell products 

ultimately within the scope of the rule. 

While this assumption likely overstates 

the number of affected firms and 

establishments, we believe that the 

assumption is reasonable. Detailed data 

are not available on the number of 

entities categorized by the marketing 

channels in which they operate and the 

specific products that they sell. 

Source of cost estimates: To develop 

estimates of the cost of implementing 

this rule, we reviewed the comments 

received on the voluntary guidelines (67 

FR 63367), the comments received on 

the proposed rule for mandatory COOL 

(68 FR 61944), and available economic 

studies. No single source of information, 

however, provided comprehensive 

coverage of all economic benefits and 

costs associated with mandatory COOL. 

We applied available information and 

our knowledge about the operation of 

the supply chains for the covered 

commodities to synthesize the findings 

of the available studies about the rule’s 

potential costs. 

Cost drivers: This interim final rule is 

a retail labeling requirement. Retail 

stores subject to this rule will be 

required to inform consumers as to the 

country of origin and method of 

production (wild and/or farm-raised) of 

the covered fish and shellfish products 

that they sell. To accomplish this task, 

individual package labels or other pointof-sale materials will be required. If 

products are not already labeled by 

suppliers, the retailer will be 

responsible for labeling the items or 

providing the country of origin and 

method of production (wild and/or 

farm-raised) information through other 

point-of-sale materials. This may require 

additional retail labor and personnel 

training. A recordkeeping system will be 

required to ensure that products are 

labeled accurately and to permit 

compliance and enforcement reviews. 

For most retail firms of the size defined 

by the statute (i.e., those retailing fresh 

and frozen fruits and vegetables with an 

invoice value of at least $230,000), we 

assume that recordkeeping will be 

accomplished primarily by electronic 

means. Modifications to recordkeeping 

systems will require software 

programming, but in most cases should 

not entail additional computer 

hardware. We expect that retail stores 

will also undertake efforts to ensure that 

their operations are in compliance with 

the interim final rule.

Prior to reaching retailers, most 

covered fish and shellfish products 

move through distribution centers or 

warehouses. Direct store deliveries are 

an exception. Distribution centers will 

be required to provide retailers with 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59729

country of origin and method of 

production (wild and/or farm-raised) 

information. This will require 

additional recordkeeping processes to 

ensure that the information passed from 

suppliers to retail stores permits 

accurate product labeling and permits 

compliance and enforcement reviews. 

Additional labor and training may be 

required to accommodate new processes 

and procedures needed to maintain the 

flow of country of origin and method of 

production (wild and/or farm-raised) 

information through the distribution 

system. There may be a need to further 

segregate products within the 

warehouse, add storage slots, and alter 

product stocking, sorting, and picking 

procedures. 

Processors of covered fish and 

shellfish products will also need to 

inform retailers and wholesalers as to 

the country of origin and method of 

production (wild and/or farm-raised) of 

the products that they sell. To do so, 

their suppliers will need to provide 

documentation regarding the country of 

origin and method of production (wild 

and/or farm-raised) of the products that 

they sell. Maintaining country of origin 

and method of production (wild and/or 

farm-raised) identity through the 

processing phase is more complex if 

products from more than one country or 

from more than one method of 

production are involved. For example, 

the identity of wild shrimp from the 

U.S. and farm-raised shrimp from 

Thailand entering the same processing 

facility would need to be maintained 

throughout the packing operation. The 

efficiency of operations may be affected 

if products are segregated in receiving, 

storage, processing, and shipping 

operations. For processors handling 

products from multiple origins, there 

may also be a need to separate shifts for 

processing products from different 

origins, or to split processing within 

shifts. In either case, costs are likely to 

increase. Records will need to be 

maintained to ensure that accurate 

country of origin and method of 

production (wild and/or farm-raised) 

information is retained throughout the 

process and to permit compliance and 

enforcement reviews. 

Processors handling only domestic 

origin products or products from a 

single country of origin and a single 

method of production may have lower 

implementation costs compared with 

processors handling products from 

multiple origins and methods of 

production. A processor that already 

sources products from a single country 

would not face additional costs 

associated with product segregation and 

tracking, provided that the products also 

have the same method of production 

(wild or farm-raised). Procurement costs 

also may be unaffected in this case, if 

the processor is able to continue 

sourcing products from the same 

suppliers. Alternatively, a processor that 

currently sources products from 

multiple countries may choose to limit 

its source to a single country to avoid 

costs associated with product 

segregation and tracking. In this case, 

such cost avoidance would be partially 

offset by additional procurement costs 

to source supplies from a single country 

of origin. Additional procurement costs 

may include higher transportation costs 

due to longer shipping distances and 

higher acquisition costs due to supply 

and demand conditions for products 

from a particular country of origin, 

whether domestic or foreign, and having 

the same method of production, 

whether wild or farm-raised. 

At the production level, fish 

producers and harvesters will need to 

create and maintain records to establish 

country of origin and method of 

production (wild and/or farm raised) 

information for the products they sell. 

Country of origin and method of 

production (wild and/or farm-raised) 

information will need to be transferred 

to the first handler of their products, 

and records sufficient to allow the 

source and method of production of the 

product to be traced back will need to 

be maintained as the products move 

through the supply chains. In general, 

additional producer and harvester costs 

include the cost of establishing and 

maintaining a recordkeeping system for 

country of origin and method of 

production (wild and/or farm-raised) 

information, product identification, and 

labor and training. 

Incremental cost impacts on affected 

entities: To estimate direct costs of this 

rule, we focus on units of production 

that are impacted (Table 2). Relative to 

the PRIA, estimated quantities are 

reduced for fish and shellfish at the 

intermediary and retailer levels.

TABLE 2.—ESTIMATED ANNUAL UNITS OF FISH AND SHELLFISH PRODUCTION AFFECTED BY MANDATORY COUNTRY OF

ORIGIN LABELING

Million 

pounds 

Producer .................................................................................................................................................................................................. 7,707 

Intermediary—

Fresh and Frozen Fish: 

U.S. Food Disappearance ......................................................................................................................................................... 1,617 

Adjustments for Fish Sticks & Portions: 

U.S. Production .................................................................................................................................................................. ¥232 

Imports ............................................................................................................................................................................... ¥16 

Exports ............................................................................................................................................................................... 5 

Adjusted Subtotal ........................................................................................................................................................... 1,374 

Fresh and Frozen Shellfish: 

U.S. Food Disappearance ......................................................................................................................................................... 1,304 

Adjustments for Breaded Shrimp: 

U.S. Production .................................................................................................................................................................. ¥152 

Imports ............................................................................................................................................................................... ¥7 

Adjusted Subtotal ........................................................................................................................................................... 1,145 

Total, Intermediary ...................................................................................................................................................... 2,519 

Retailer—

At-Home Consumption: 

Fish ............................................................................................................................................................................................ 797 

59730 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

TABLE 2.—ESTIMATED ANNUAL UNITS OF FISH AND SHELLFISH PRODUCTION AFFECTED BY MANDATORY COUNTRY OF

ORIGIN LABELING—Continued

% Million 

pounds 

Shellfish ..................................................................................................................................................................................... 435 

Total ....................................................................................................................................................................................... 1,232 

Total, Affected Retailers ..................................................................................................................................................... 811 

For fish producers, production is 

measured by round weight (live weight) 

pounds of fish, except mollusks, which 

excludes the weight of the shell. Wild 

caught fish and shellfish production is 

measured by U.S. domestic landings for 

fresh and frozen human food. The PRIA 

estimate inadvertently omitted landings 

of fish for canned human food, which 

would have required labeling under the 

proposed rule. Canned fish, however, is 

exempt from this interim final rule. We 

assume that fish harvesters generally 

know whether their catch is destined for 

fresh and frozen markets, canning, or 

industrial use. Fish production also 

includes farm-raised fish. Total 

estimated fish production is unchanged 

from the PRIA. 

We assume that all sales by 

intermediaries such as handlers, 

packers, processors, wholesalers, and 

importers will be impacted by the rule. 

Although some product is destined 

exclusively for foodservice or other 

channels of distribution not subject to 

the interim final rule, we assume that 

these intermediaries will seek to keep 

their marketing options open for 

possible sales to subject retailers. 

Among other adjustments, fish and 

shellfish production at the intermediary 

level is reduced by 1.2 billion pounds 

from the PRIA estimate to account for 

the removal of canned fish and shellfish 

(Ref. 1). 

Further adjustments to intermediary 

volume are made to remove other major 

categories of products exempt from 

labeling—fish sticks, fish portions, and 

breaded shrimp. Fish sticks and 

portions are shaped masses of cohering 

fish flesh, and are thus defined as a 

processed food item. The volume of 

affected fish production is computed 

separately from shellfish production. As 

shown in Table 2, U.S. disappearance of 

fresh and frozen fish is estimated at 

1,617 million pounds in 2001 (Ref. 1), 

which includes imports but excludes 

exports. This figure is reduced by the 

estimated U.S. production of fish sticks 

and portions (232 million pounds, Ref. 

2) and by imports of fish sticks (16 

million pounds, Ref. 3), as these items 

would be exempt from the requirements 

of this rule. Exports of fish sticks (5 

million pounds, Ref. 3) are added back 

to U.S. production to estimate net U.S. 

supplies of these exempt products (i.e., 

domestic production plus imports 

minus exports). Similar calculations are 

applied to fresh and frozen shellfish to 

account for breaded shrimp. In the case 

of shellfish, however, U.S. trade data 

(Ref. 3) do not identify exports of 

breaded shrimp. Accordingly, exports of 

breaded shrimp are treated as zero for 

purposes of the calculations shown in 

Table 2. 

PRIA estimates of the volume of affect 

product at the retail level are revised to 

reflect changes in the definition of a 

processed food item and to improve the 

accuracy of the estimates. First, 

estimated fish and shellfish retailer 

volume is reduced by 493 million 

pounds from the PRIA estimate to 

remove canned fish and shellfish (Ref. 

1), which is exempt from the 

requirements of this rule under the 

revised definition of a processed food 

item. Second, revised factors are used to 

estimate the volume of product 

requiring labeling at retailers subject to 

this rule. 

In the PRIA, food disappearance 

figures were multiplied by 0.414 to 

represent the estimated share of 

production sold through retailers 

covered by the proposed rule. To derive 

this share, the factor of 0.629 was used 

to remove the 37.1 percent food service 

quantity share of total food in 2002. 

This factor was then multiplied by 

0.658, which was the share of sales by 

supermarkets, warehouse clubs and 

superstores of food for home 

consumption in 2002. In other words, 

we assumed supermarkets, warehouse 

clubs and superstores represent the 

retailers as defined by PACA, and these 

retailers were estimated to account for 

65.8 percent of retail sales of the 

covered commodities. 

Compared to other food products, 

greater proportions of fish and shellfish 

are eaten away from home, and smaller 

proportions are eaten at home. We 

estimate that 58 percent of fresh and 

frozen fish and 38 percent of shellfish 

are eaten at home. These proportions are 

based on estimated at-home and awayfrom-home the National Seafood 

Consumption Survey conducted by the 

National Marine Fisheries Service (Ref. 

4). Based on these percentages, at-home 

consumption is estimated at 797 million 

pounds for covered fresh and frozen fish 

products and 435 million pounds for 

covered shellfish products (Table 2). 

Total at-home consumption of covered 

fresh and frozen shellfish products is 

estimated at 1.2 billion pounds. As in 

the PRIA, 65.8 percent of at-home 

consumption is estimated to be sold by 

retailers subject to this rule. As a result, 

the total volume of fresh and frozen fish 

and shellfish products affected by this 

rule is estimated to be 811 million 

pounds at retail. Total fish and shellfish 

volume at retail is thus reduced 891 

million pounds from the PRIA estimate. 

Table 3 summarizes the direct, 

incremental costs that we believe firms 

will incur during the first year as a 

result of this interim final rule. These 

estimates are derived primarily from the 

available studies that addressed cost 

impacts of mandatory COOL, coupled 

with our estimates of the volume of 

affected production at each level of the 

supply chain.

TABLE 3.—ESTIMATES OF FIRST-YEAR

IMPLEMENTATION COSTS FOR FISH

AND SHELLFISH, PER AFFECTED INDUSTRY SEGMENT

Million 

dollars 

Producer ....................................... 19 

Intermediary .................................. 13 

Retailer ......................................... 57 

Total ....................................... 89 

Assumptions and procedures 

underlying the cost estimates are 

described fully in the discussion of the 

upper range estimates presented in the 

PRIA. Changes from the PRIA estimates 

are highlighted herein.

As in the PRIA (68 FR 61952), we 

estimate costs to fish and shellfish 

producers at $0.0025 per pound. Total 

costs for fish and shellfish producers are 

thus estimated at $19 million, 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59731

unchanged from the PRIA upper range 

estimate. As mentioned previously, the 

PRIA estimated of fish landings 

inadvertently omitted U.S. domestic 

landings used for canned human food. 

Thus, the estimated volume of fish is 

unchanged at the producer level even 

though the interim final rule now 

exempts canned fish. With the same 

estimate of the number of affected 

producers, the estimated cost per 

producer remains unchanged. 

Consistent with the PRIA (68 FR 

61952), we adopt $0.005 per pound as 

an estimate of costs for intermediaries in 

the fish and shellfish sector. Processors 

will need to collect country of origin 

and method of production (wild and/or 

farm-raised) information from 

producers, maintain this information, 

and supply this information to other 

intermediaries or directly to retailers. In 

addition, there may need to be 

segregation of the product before and 

after processing to facilitate tracking of 

country of origin and method of 

production (wild and/or farm-raised) 

identity. There will also be labeling 

costs associated with providing country 

of origin and method of production 

(wild and/or farm-raised) information 

on consumer-ready packs of frozen and 

fresh fish that are labeled by processors. 

Total costs for fish and shellfish 

intermediaries are thus estimated at $13 

million, a reduction of $8 million from 

the upper range PRIA estimate. The 

reduction is attributable to the lowered 

estimate of the volume of production 

affected by the rule. 

As discussed in the PRIA (68 FR 

61952), we adopt $0.07 per pound as an 

estimate of costs for retailers of fish and 

shellfish. This estimate results in total 

costs of $57 million for retailers of fish 

and shellfish, a reduction of $62 million 

from the PRIA upper range estimate. As 

with intermediaries, the reduction stems 

from the lowered estimate of the volume 

of production affected by the rule. 

Total costs for fish and shellfish are 

estimated at $89 million, $70 million 

less than the PRIA upper range estimate. 

We estimate total incremental costs 

for this interim final rule of $19 million 

for fish producers and harvesters, $13 

million for intermediaries, and $57 

million for retailers for the first year. 

Total incremental costs for all supply 

chain participants are estimated at $89 

million for the first year. The large 

reduction from the PRIA upper range 

estimate of $3.9 billion is attributable to 

the fact that this interim final rule 

covers only wild and farm-raised fish 

and shellfish products. The proposed 

rule also covered beef, pork, lamb, 

fruits, vegetable, and peanuts.

There are wide differences in average 

estimated implementation costs for 

individual entities in different segments 

of the supply chain (Table 4). With the 

exception of a small number of fishing 

operations, producer operations are 

single-establishment firms. Thus, 

average estimated costs per firm and per 

establishment are the same after 

rounding to the nearest dollar. In 

contrast, retailers subject to the rule 

operate an average of just over eight 

establishments per firm. As a result, 

average estimated costs per retail firm 

also are just over eight times larger than 

average costs per establishment.

TABLE 4.—ESTIMATED FIRST-YEAR IMPLEMENTATION COSTS PER FIRM

AND ESTABLISHMENT

Firm 

Establishment 

Producer ........................... $241 $241 

Intermediary ...................... 1,890 1,650 

Retailer ............................. 12,600 1,530 

Average estimated implementation 

costs per fish and shellfish producer are 

relatively small at $241. Costs per fish 

operation are lowered slightly from the 

PRIA upper-range estimates due to a 

correction in the number of fishing 

operations used to calculate the average 

cost per operation (the estimated 

number of operations is unchanged from 

the PRIA). Estimated costs for 

intermediaries are substantially larger, 

averaging $1,890 per firm and $1,650 

per establishment. The average cost per 

firm is much less than the PRIA upper 

range estimated cost, with the lower 

cost attributable to the sharp reduction 

in the volume of production subject to 

this interim final rule. Similarly, the 

average cost per intermediary 

establishment is considerably less than 

PRIA the upper range estimate. At an 

average of $12,600 retailers have the 

highest average estimated costs per firm. 

This is much less than the PRIA upper 

range estimate because of the reduction 

in the estimated volume of production 

subject to the interim final rule. 

Retailers also have the highest average 

estimated costs per establishment, 

$1,530. 

The costs per firm and per 

establishment represent industry 

averages for aggregated segments of the 

supply chain. Large firms and 

establishments likely will incur higher 

costs relative to small operations due to 

the volume of commodities that they 

handle and the increased complexity of 

their operations. In addition, different 

types of businesses within each segment 

are likely to face different costs. Thus, 

the range of costs incurred by individual 

businesses within each segment is 

expected to be large, with some firms 

incurring only a fraction of the average 

costs and other firms incurring costs 

many times larger than the average. 

We believe that the major cost drivers 

for the rule occur when covered 

commodities are transferred from one 

firm to another, when covered 

commodities are commingled in the 

production or marketing process, and 

when products are assembled and then 

redistributed to retail stores. In part, we 

believe that some requirements of the 

rule will be accomplished by firms 

using essentially the same processes and 

practices as are currently used, but with 

information on country of origin and 

method of production (wild and/or 

farm-raised) claims added to the 

processes. This adaptation generally 

would require relatively small marginal 

costs for recordkeeping and 

identification systems. In other cases, 

however, firms may need to revamp 

current operating processes to 

implement the rule. For example, a 

processing plant may need to sort 

incoming products by country of origin 

and method of production (wild and/or 

farm-raised) in addition to weight, size, 

color, or other quality factors. This may 

require adjustments to plant operations, 

line processing, product handling, and 

storage. Ultimately, we anticipate that a 

mix of solutions will be implemented by 

industry participants to effectively meet 

the requirements of the rule. Therefore, 

we anticipate that direct, incremental 

costs for the interim final rule likely 

will fall within a reasonable range of the 

estimated total of $89 million. 

In the PRIA, one regulatory alternative 

considered by AMS would be to narrow 

the definition of a processed food item, 

thereby increasing the scope of 

commodities covered by the rule. This 

alternative is not adopted in this interim 

final rule. An increase in the number of 

commodities that would require COOL 

would increase implementation costs of 

the rule with little expected economic 

benefit. Additional labeling resulting 

from fewer exempted items may also 

slow some of the innovation that is 

occurring with various types of valueadded, further processed products. 

A converse regulatory alternative 

would be to broaden the definition of a 

processed food item, thereby decreasing 

the scope of commodities covered by 

the rule. Accordingly, such an 

alternative would decrease 

implementation costs for the rule. At the 

retail level and to a lesser extent at the 

intermediary level, cost reductions 

would be at least partly proportional to 

59732 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

the reduction in the volume of 

production requiring retail labeling. 

Start-up costs for retailers and many 

intermediaries likely would be little 

changed by a narrowing of the scope of 

commodities requiring labeling because 

firms would still need to modify their 

recordkeeping, production, 

warehousing, distribution, and sales 

systems to accommodate the 

requirements of the rule for those 

commodities that would require 

labeling. Ongoing maintenance and 

operational costs, however, likely would 

decrease in some proportion to a 

decrease in the number of items covered 

by the rule. On the other hand, 

implementation costs for the vast 

majority of fish and shellfish harvesters 

and producers would not be affected by 

a change in the definition of a processed 

food item. This is because we assume 

that virtually all affected producers 

would seek to retain the option of 

selling their products through supply 

channels for retailers subject to the rule.

The definition of a processed food 

item developed for this interim final 

rule has taken into account comments 

from potentially affected entities and 

has resulted in excluding products that 

would be more costly and troublesome 

for retailers and suppliers to provide 

country of origin and method of 

production (wild and/or farm-raised) 

information. Total incremental costs for 

this interim final rule are estimated at 

$70 million less than the upper range 

costs estimated in the PRIA for fish and 

shellfish because of the exemption of 

canned items under the revised 

definition of a processed food item. 

Another alternative considered by 

AMS would be to require that suppliers 

provide an affidavit for each transaction 

to the immediate subsequent recipient 

certifying that the country of origin and 

method of production (wild and/or 

farm-raised) claims being made are 

truthful and that the required records 

are being maintained. We do not have 

an estimate of the number of 

transactions that would be impacted. 

Assuming, however, costs of just $0.001 

per pound of product sold by producers 

and intermediaries, and assuming that 

commodities are transferred at least 

twice between intermediaries, costs for 

fish and shellfish would increase by 

nearly $13 million, or almost 15 

percent, compared to the alternative of 

having no affidavits. Taking into 

consideration probable cost impacts, 

comments received on the proposed 

rule, and the structure and needs of the 

industry, we rejected this alternative. 

Effects on the economy: The previous 

section estimated the direct, 

incremental costs of the interim final 

rule to the affected firms in the supply 

chains for the covered commodities. 

While these costs are important to those 

directly involved in the production, 

distribution, and marketing of covered 

commodities, they do not represent net 

costs to the U.S. economy or net costs 

to the affected entities for that matter. 

With respect to assessing the effect of 

this rule on the economy as a whole, it 

is important to understand that a 

significant portion of the costs directly 

incurred by the affected entities take the 

form of expenditures for additional 

production inputs, such as payments to 

others whether for increased hours 

worked or for products and services 

provided. As such, these direct, 

incremental costs to affected entities do 

not represent losses to the economy but 

rather transfers of money from one 

economic agent to another. As a result, 

the direct costs incurred by the 

participants in the supply chains for the 

covered commodities do not measure 

the impact of this rule on the economy 

as a whole. Instead, the relevant 

measure is the extent to which the 

interim final rule reduces the amount of 

goods and services that can be produced 

throughout the U.S. economy from the 

available supply of inputs and 

resources. 

Even from the perspective of the 

directly affected entities, the direct, 

incremental costs do not present the 

whole picture. Initially, the affected 

entities will have to bear the full cost of 

implementing the interim final rule. 

However, over time as the economy 

adjusts to the requirements of the 

interim final rule, the burden facing 

suppliers will be reduced as their 

production level and the prices they 

receive change. What is critical in 

assessing the effect of this rule on the 

affected entities over the longer run is 

to determine the extent to which the 

entities are able to pass these costs on 

to others and consequently how the 

demand for their commodities is 

affected. 

Conceptually, suppose that all the 

increases in costs from this rule were 

passed on to consumers in the form of 

higher prices and that consumers 

continued to purchase the same 

quantity of the affected commodities 

from the same marketing channels. 

Under these conditions, the suppliers of 

these commodities would not suffer any 

net loss from the rule even if the 

increases in their operating costs were 

quite substantial. However, other 

industries might face losses as 

consumers may spend less on other 

commodities. It is unlikely, however, 

absent the rule leading to changes in 

consumers’ preferences for the covered 

commodities, that consumers will 

maintain their consumption of the 

covered commodities in the face of 

increased prices. Rather, many or most 

consumers will likely reduce their 

consumption of the covered 

commodities. The resulting changes in 

consumption patterns will in turn lead 

to changes in production patterns and 

the allocation of inputs and resources 

throughout the economy. The net result, 

once all these changes have occurred, is 

that the total amount of goods and 

services produced by the U.S. economy 

will be less than before. 

To analyze the effect of the changes 

resulting from the rule on the total 

amount of goods and services produced 

throughout the U.S. economy in a global 

context, we utilized a computable 

general equilibrium (CGE) model 

developed by ERS. In the PRIA, the ERS 

CGE model includes all the covered 

commodities and the products from 

which they are derived, as well as noncovered commodities that would be 

indirectly affected by the proposed rule, 

such as poultry and feed grains. For 

purposes of this interim final rule, the 

same model structure is used, but direct, 

incremental cost increases are assumed 

to occur for fish and shellfish products 

only. 

The ERS CGE model traces the 

impacts from an economic ‘‘shock,’’ in 

this case an incremental increase in 

operating costs, through the U.S. 

agricultural sector and the U.S. 

economy to the rest of the world and 

back through the inter-linking of 

economic sectors. By taking into 

account the linkages among the various 

sectors of the U.S. and world 

economies, a comprehensive assessment 

can be made of the economic impact on 

the U.S. economy of the rule 

implementing COOL. The model reports 

resulting economic changes after a tenyear period of adjustment.

The results of this analysis indicate 

that the interim final rule implementing 

COOL after the economy has had a 

period of ten years to adjust will have 

a more limited impact on the overall 

U.S. economy than the direct costs for 

the first year, alone, would suggest. 

Under the assumption that COOL will 

not change consumers’ preferences for 

the covered fish and shellfish 

commodities, we estimate that the 

overall costs to the U.S. economy of the 

interim final rule, in terms of a 

reduction in consumers’ purchasing 

power, will be $6.2 million. This 

represents the cost to the U.S. economy 

after all transfers and adjustments in 

consumption and production patterns 

have occurred. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59733

Overall costs to the U.S. economy 

after a decade of adjustment are 

significantly smaller than the first-year 

implementation costs to directly 

affected firms. This result does not 

imply that the implementation costs for 

directly affected firms have been 

substantially reduced from the initial 

estimates. While some of the increase in 

their costs will be offset by reduced 

production and higher prices over the 

longer term, the suppliers of the covered 

commodities will still bear direct 

implementation costs. Prior to full 

economic adjustment, economic 

impacts on directly affected firms in the 

short term are expected to be larger than 

impacts on the economy after 

adjustment has taken place. 

Our estimates of the overall costs to 

the U.S. economy are based on our 

estimates of the incremental increases in 

operating costs to the affected firms. The 

model does not permit supply channels 

for covered commodities that require 

country of origin and method of 

production information to be separated 

from supply channels for the same 

commodities that do not require COOL. 

Thus, the direct cost impacts must be 

adjusted to accurately reflect changes in 

operating costs for all firms supplying 

covered commodities. Table 5 reports 

these adjusted estimates in terms of 

their percentage of total operating costs 

for each of the directly impacted sectors. 

The percentages used are based on our 

estimate of the percentage change in 

operating costs for the entire supply 

channel and are adjusted between the 

various segments of the fish and 

shellfish supply chain (harvesters and 

producers, processors, importers, and 

retailers) based on our estimate of how 

the costs of the regulation will be 

distributed among them. As a result, the 

cost changes shown in Table 5 only 

approximate the direct cost estimates 

previously described.

TABLE 5.—ESTIMATED INCREASES IN

FISH AND SHELLFISH INDUSTRY OPERATING COSTS BY SUPPLY CHAIN

SEGMENT

Percent 

change 

Farm Supply: 

Domestic .................................. 0.6 

Imported .................................. 0.6 

Processing: 

Domestic .................................. (1) 

Imported .................................. (1) 

Retail: 

Domestic .................................. 0.4 

TABLE 5.—ESTIMATED INCREASES IN

FISH AND SHELLFISH INDUSTRY OPERATING COSTS BY SUPPLY CHAIN

SEGMENT—Continued

Percent 

change 

Imported .................................. 0.4 

1 Due to the structure of the model, costs increases for the processing segment are included in the retail segment. 

In addition, we assume that domestic 

and foreign suppliers of the affected 

commodities located at the same level 

or segment of the supply chain face the 

same percentage increases in their 

operating costs. In reality, imported 

covered commodities likely would 

enjoy some measure of competitive 

advantage as a portion of those products 

already enter the United States with 

country of origin labels. Labeling and 

country of origin notification necessary 

to satisfy existing U.S. Customs and 

Border Protection requirements could be 

used to implement the country of origin 

requirements of this rule, but importers 

also would need to provide method of 

production information (wild and/or 

farm-raised) for covered fish and 

shellfish commodities destined for 

retail. 

The percentage changes in operating 

costs reported in Table 5 differ from the 

percentage changes in operating costs 

reported for the High Cost scenario as 

listed in Table 8 in the PRIA. The 

differences in percentage changes 

reported in the PRIA and those reported 

here are attributable to changes in 

implementation costs of the interim 

final rule as well as recalibration of our 

estimates of total operating costs for the 

various segments of the supply channels 

of the directly impacted sectors. 

As discussed above, consumption and 

production patterns will change as the 

incremental increases in operating costs 

outlined above are passed on, at least 

partially, to consumers in the form of 

higher prices by the affected firms. The 

increases in the prices of the covered 

fish and shellfish commodities will in 

turn cause exports and domestic 

consumption and ultimately domestic 

production to fall. 

The costs of the interim final rule will 

not be shared equally by all suppliers of 

the covered commodities. The 

distribution of the costs of the rule will 

be determined by several factors in 

addition to the direct costs of complying 

with the rule. These are the availability 

of substitute products not covered by 

the rule and the relative 

competitiveness of the affected 

suppliers with respect to other sectors of 

the U.S. and world economies.

Table 6 contains the percentage 

changes in prices, production, exports, 

and imports for the three main segments 

of the marketing chain for fish and 

shellfish. Results for potential substitute 

products are not shown in Table 6 

because impacts of the interim final rule 

on these products are estimated to be 

minimal. Percentage changes in U.S. 

production, prices, exports, and imports 

of cattle and sheep, broilers, hogs, beef 

and lamb, chicken, and pork are 

estimated to be 0.001 percent or less. 

Because of the negligible impacts on 

these other commodities, Table 6 shows 

results for fish and shellfish only.

TABLE 6.—ESTIMATED IMPACT OF INTERIM FINAL RULE ON U.S. PRODUCTION, PRICES AND TRADE OF

FISH AND SHELLFISH

Item 

Percent 

Change 

from the 

Base 

Year 

Price ................................................ 0.36 

Production ....................................... ¥0.46 

Exports ............................................ ¥0.56 

Imports ............................................ 0.18 

The rule increases operating costs for 

the supply chains for the covered fish 

and shellfish commodities. As shown in 

Table 6, the increased costs result in 

higher prices for these products. The 

quantity demanded at these higher 

prices falls, with the result that the U.S. 

production of fish and shellfish 

decreases. 

Demand for U.S. fish production is 

particularly sensitive to increases in 

prices in the model, suggesting that U.S. 

fish suppliers face a degree of 

competitive disadvantage relative to 

their foreign counterparts. As a result, 

fish imports increase as a result of the 

estimated cost increases, while U.S. 

production falls. Evidently, U.S. 

domestic suppliers of fish respond more 

to changes in their operating costs than 

do foreign suppliers. The resulting gap 

between the supply response of U.S. 

and foreign producers provides foreign 

suppliers of fish with a competitive 

advantage in U.S. markets that enables 

them to increase their exports to the 

U.S. even though they face similar 

increases in operating costs. 

To put these impacts in more 

meaningful terms, the percentage 

changes reported in Table 6 were 

converted into changes in current prices 

and quantities produced, imported, and 

exported (Table 7). The base values in 

Table 7 differ from those reported in 

59734 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

Table 2 above because they are derived 

from projected levels reported in the 

USDA Agricultural Baseline for 2003, 

while values in Table 2 represent actual 

reported values for 2002 as compiled by 

USDA’s National Agricultural Statistical 

Service. Baseline values were used to 

accommodate the structure of the 

model.

TABLE 7.—ESTIMATED CHANGES IN U.S. PRODUCTION, PRICES, AND TRADE FOR FISH AND SHELLFISH

Indicator Units Base Change 

U.S Production a ............................................................................................................................................. Mil. Lbs. 10,204 ¥46.94 

U.S. Price b ..................................................................................................................................................... $/Lb. 0.41 0.0015 

U.S. Exports ................................................................................................................................................... Mil. Lbs. 2,565 ¥14.36 

U.S. Imports ................................................................................................................................................... Mil. Lbs. 4,102 7.38 

Sources: Changes are derived from applying percentage changes obtained from the ERS CGE model to the base values. 

aBase values for fish come from Fisheries of the United States, 2001. National Marine Fisheries Service, National Oceanic and Atmospheric 

Administration, U.S. Department of Commerce, 2002. bFish price derived by dividing total value of commercial and aquaculture production, excluding other, by total commercial and aquaculture 

production. 

U.S. prices for covered fish and 

shellfish commodities increase by a very 

small amount, less than two-tenths of a 

cent per pound. U.S. production 

declines by 47 million pounds. The 

estimated changes in prices and 

production cause revenues for the fish 

industry to fall by $4 million. The 

increase in the price of the affected fish 

and shellfish commodities cause exports 

to decline by about 14 million pounds. 

Imports of fish and shellfish increase 

and as costs imposed on importers are 

relatively less than those imposed on 

domestic producers. 

The ERS CGE model assumes that 

firms behave as though they have no 

influence on either their input or output 

prices. On the other hand, for example, 

a model that assumed that processors 

could influence their input and output 

prices could find that prices received by 

agricultural producers decreased 

because processors passed their cost 

increases down to their suppliers rather 

than increase the price they charged 

their customers. 

The estimates of the economic impact 

of the interim final rule on the United 

States are based on the assumption that 

country of origin and method of 

production (wild and/or farm-raised) 

labeling does not shift consumer 

demand toward the covered fish and 

shellfish commodities of U.S. origin. 

This assumption is based on the earlier 

finding that there was no compelling 

evidence to support the view that 

mandatory COOL will increase the 

demand for U.S. products. An increase 

in the demand for commodities of U.S. 

origin increase would have to occur to 

offset the costs imposed on the economy 

by the interim final rule. 

As previously mentioned, our 

estimates of the overall economic effects 

of the interim final rule are derived from 

a CGE model developed by ERS. The 

results from this model show the 

changes in production and consumption 

patterns after the economy has adjusted 

to the incremental increase in costs 

(medium run results). In reality, such 

changes occur over time and the 

economy does not adjust 

instantaneously. 

The results of this analysis describe 

and compare the old production and 

consumption patterns to the new ones, 

but do not reflect any particular 

adjustment process. In addition, these 

results assume that the only changes 

that are occurring in the agriculture 

sector or the economy as a whole are 

those that are driven by COOL. The 

purpose of using the ERS CGE model is 

not to forecast what prices and 

production will be over any particular 

time frame, but to explore the 

implications of COOL on the U.S. 

economy and capture the direction of 

the changes.

The ERS CGE model is global in the 

sense that all regions in the world are 

covered. Production and consumption 

decisions in each region are determined 

within the model following behavior 

that is consistent with economic theory. 

Multilateral trade flows and prices are 

determined simultaneously by world 

market clearing conditions. This permits 

prices to adjust to ensure that total 

demand equals total supply for each 

commodity in the world. 

The general equilibrium feature of the 

model means that all economic 

sectors—agricultural and nonagricultural—are included. Hence, 

resources can move among sectors, 

thereby ensuring that adjustments in the 

feed grains and livestock sectors, for 

example, are consistent with 

adjustments in the processed sectors. 

The model is static and this implies 

that gains (or losses) from stimulating 

(or inhibiting) investment and 

productivity growth are not captured. 

The model allows the existing resources 

to move among sectors, thereby 

capturing the effects of re-allocation of 

resources that results due to policy 

changes. However, because the model 

fixes total available resources it 

underestimates the long-run effects of 

policies on aggregate output. 

Regulatory Flexibility Analysis 

This interim final rule has been 

reviewed under the requirements of the 

Regulatory Flexibility Act (RFA)(5 

U.S.C. 601 et seq.). The purpose of RFA 

is to consider the economic impact of a 

rule on small businesses and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the marketplace. The 

Agency believes that this rule will have 

a significant economic impact on a 

substantial number of small entities. As 

such, the Agency has prepared the 

following interim final regulatory 

analysis of the rule’s likely economic 

impact on small entities pursuant to the 

RFA. The Comments and Responses 

section lists the comments received on 

the preliminary RFA and provides the 

Agency’s responses to the comments. 

The interim final rule is the direct 

result of statutory obligations to 

implement the COOL provisions of the 

Farm Bill, which amended the Act by 

adding Subtitle D—Country of Origin 

Labeling. The COOL provisions of the 

Farm Bill require covered fish and 

shellfish commodities to be labeled 

beginning September 30, 2004. The 

intent of this law is to provide 

consumers with additional information 

on which to base their purchasing 

decisions. Specifically, the law imposes 

additional Federal labeling 

requirements for covered commodities 

sold by retailers subject to the law. 

Covered commodities included in this 

interim final rule are farm-raised fish 

and shellfish and wild fish and 

shellfish. 

Under preexisting Federal laws and 

regulations, COOL is not universally 

required for the commodities covered by 

this rule. In particular, labeling of U.S. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59735

origin and method of production (wild 

and/or farm-raised) is not mandatory, 

and labeling of imported products at the 

consumer level is required only in 

certain circumstances. Thus, the Agency 

has not identified any Federal rules that 

would duplicate or overlap with this 

interim final rule. 

Many aspects of the mandatory COOL 

provisions are prescriptive and provide 

little regulatory discretion in 

rulemaking. The law requires a 

statutorily defined set of food retailers 

to label the country of origin and 

method of production (wild and/or 

farm-raised) of covered commodities. 

The law also prohibits USDA from using 

a mandatory identification system to 

verify the country of origin of covered 

commodities. However, the interim final 

rule provides flexibility in allowing 

market participants to decide how best 

to implement mandatory COOL in their 

operations. Market participants other 

than those retailers defined by the 

statute may decide to sell products 

through marketing channels not subject 

to the rule. Taking into account 

comments received on the proposed 

rule, the interim final rule decreases the 

length of time that records are required 

to be kept, providing some relief to 

affected entities both large and small. A 

complete discussion of the information 

collection and recordkeeping 

requirements and associated burdens 

appears in the Paperwork Reduction Act 

section below. In addition, the number 

of products required to be labeled is 

reduced because the definition of a 

processed food item has been 

broadened, thus providing additional 

regulatory relief. 

The objective of the interim final rule 

is to regulate the activities of retailers 

(as defined by the law) and their 

suppliers so that retailers will be able to 

fulfill their statutory obligations. The 

interim final rule requires retailers to 

provide country of origin and method of 

production (wild and/or farm-raised) 

information for all of the covered fish 

and shellfish commodities that they sell. 

It also requires all firms that supply 

covered commodities to these retailers 

to provide the retailers with the 

information needed to correctly label 

the covered commodities. In addition, 

all other firms in the supply chain for 

the covered commodities are potentially 

affected by the rule because country of 

origin and method of production (wild 

and/or farm-raised) information will 

need to be maintained and transferred 

along the entire supply chain. In 

general, the supply chains for the 

covered fish and shellfish commodities 

consist of farms, fishing operations, 

processors, wholesalers, and retailers. A 

listing of the number of entities in the 

supply chains for the covered fish and 

shellfish commodities can be found in 

Table 1 above in the Interim Final 

Regulatory Impact Analysis (IFRIA).

Retailers covered by this interim final 

rule must meet the definition of a 

retailer as defined by PACA. The PACA 

definition includes only those retailers 

handling fresh and frozen fruits and 

vegetables with an invoice value of at 

least $230,000 annually. Therefore, the 

number of retailers impacted by this 

rule is considerably smaller than the 

total number of retailers nationwide. In 

addition, there is no requirement that 

firms in the supply chain must supply 

their products to retailers subject to the 

interim final rule. 

Because country of origin and method 

of production (wild and/or farm-raised) 

information will have to be passed along 

the supply chain and made available to 

consumers at the retail level, we assume 

that each participant in the supply 

chain as identified in Table 1 will likely 

encounter recordkeeping costs as well 

as changes or modifications to their 

business practices. Absent more 

detailed information about each of the 

entities within each of the marketing 

channels, we assume that all such 

entities will be affected to some extent 

even though some fish and shellfish 

harvesters, producers and suppliers may 

choose to market their products through 

channels not subject to the requirements 

of this interim final rule. Therefore, we 

estimate that nearly 125,000 

establishments owned by approximately 

91,000 firms will be either directly or 

indirectly impacted by this rule. 

Changes from the PRIA are reductions 

in the numbers of affected firms and 

establishments due to the exclusion of 

covered commodities other than wild 

and farm-raised fish and shellfish in this 

interim final rule. 

This interim final rule potentially will 

have an impact on all participants in the 

supply chain, although the nature and 

extent of the impact will depend on the 

participant’s function within the 

marketing chain. The rule likely will 

have the greatest impact on retailers and 

intermediaries (handlers, processors, 

wholesalers, and importers), while the 

impact on individual fish and shellfish 

harvesters and producers is likely to be 

relatively small. 

As shown in Table 3 and discussed in 

the Costs section of the IFRIA, we 

estimate direct incremental costs for the 

interim final rule at approximately $89 

million. The decrease in the direct 

incremental cost in the interim final 

rule as compared to the proposed rule 

is the result of excluding commodities 

other than fish and shellfish from this 

interim final rule. In addition, 

broadening the definition of a processed 

food item exempts items such as canned 

fish and shellfish, fish sticks, and 

breaded shrimp from the labeling 

requirements of the rule. 

There are two measures used by the 

Small Business Administration (SBA) to 

identify businesses as small: Sales 

receipts or number of employees. In 

terms of sales, SBA classifies as small 

those grocery stores with less than $23 

million in annual sales and specialty 

food stores with less than $6 million in 

annual sales (13 CFR 121.201). 

Warehouse clubs and superstores with 

less than $23 million in annual sales are 

also defined as small. SBA defines as 

small those agricultural producers with 

less than $750,000 in annual sales and 

fishing operations with less than $3.5 

million in annual sales. Of the other 

businesses potentially impacted by the 

interim final rule, SBA classifies as 

small those manufacturing firms with 

less than 500 employees and 

wholesalers with less than 100 

employees. 

Retailers: While there are many 

potential retail outlets for the covered 

commodities, food stores, warehouse 

clubs, and superstores are the primary 

retail outlets for food consumed at 

home. In fact, food stores, warehouse 

clubs, and superstores account for 82.5 

percent of all food consumed at home 

(Ref. 5). Therefore, the number of these 

stores provides an indicator of the 

number of entities potentially impacted 

by this interim final rule. The 1997 

Economic Census (Ref. 6) shows there 

were 67,916 food store, warehouse club, 

and superstore firms operated for the 

entire year. Most of these firms, 

however, would not be subject to the 

requirements of this interim final rule. 

Retailers covered by this interim final 

rule must meet the definition of a 

retailer as defined by PACA. The 

number of such businesses is estimated 

from PACA data (Ref. 7). A PACA 

license is required for all retailers 

having an invoice cost of fresh and 

frozen fruits and vegetables exceeding 

$230,000 in a calendar year. Licensee 

data is entered and maintained in 

USDA’s PACA database. Among other 

required information, the PACA license 

application includes the name of the 

business and the number of branches 

where the business handles fruits and 

vegetables. In the case of retailers, most 

branch locations represent retail stores. 

There is an active USDA compliance 

program to ensure compliance with 

licensing requirements, and the industry 

is monitored to keep the licensing data 

current when there are changes in firms’

operations (such as the opening of new 

59736 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

branch locations). Thus, the PACA data 

provide a reliable estimate of the 

number of retail firms that would be 

affected by this regulatory action. 

Because the PACA definition of a 

retailer includes only those retailers 

handling fresh and frozen fruits and 

vegetables with an invoice value of at 

least $230,000 annually, the number of 

retailers impacted by this rule is 

considerably smaller than the number of 

food retailers nationwide. USDA data 

indicate that there are 4,512 retail firms 

as defined by PACA that would thus be 

subject to the interim final rule. As 

explained below, most small food store 

firms have been excluded from 

mandatory COOL based on the PACA 

definition of a retailer. 

The 1997 Economic Census data 

provide information on the number of 

food store firms by sales categories. Of 

the 67,916 food store, warehouse club, 

and superstore firms, we estimate that 

there are 66,868 firms with annual sales 

meeting the SBA definition of a small 

firm and 1,048 other firms. USDA has 

no information on the identities of these 

firms, and the PACA database does not 

identify firms by North American 

Industry Classification System code that 

would enable matching with Economic 

Census data. USDA assumes, however, 

that all or nearly all of the 1,048 large 

firms would meet the definition of a 

PACA retailer because most of these 

larger food retailers likely would handle 

fresh and frozen fruits and vegetables 

with an invoice value of at least 

$230,000 annually. Thus, we estimate 

that 77 percent (3,464 out of 4,512) of 

the retailers subject to the interim final 

rule are small. However, this is only 5.2 

percent of the estimated total number of 

small food store retailers. In other 

words, an estimated 94.8 percent of 

small food store retailers would not be 

subject to the requirements of this 

interim final rule.

As discussed in the Costs section of 

the IFRIA, we estimate retailer costs 

under this interim final rule at 

approximately $57 million (Table 3). 

Costs are estimated at $12,600 per retail 

firm and $1,530 per retail establishment 

(Table 4). These estimated costs are 

lower than the PRIA upper range 

estimates because of the exclusion of 

commodities other than fish and 

shellfish from this interim final rule and 

because of the exemption of additional 

products under the revised definition of 

a processed food item. 

Retailers will face recordkeeping 

costs, costs associated with supplying 

country of origin and method of 

production (wild and/or farm-raised) 

information to consumers, costs 

associated with segmenting products by 

country of origin and method of 

production (wild or farm-raised), and 

possibly additional handling costs. 

These cost increases may result in 

changes to retailer business practices, 

such as additional time devoted to 

labeling and signage needed to provide 

required information for products sold 

from in-store seafood department 

operations. The interim final rule does 

not specify the systems that affected 

retailers must put in place to implement 

mandatory COOL. Instead, retailers will 

be given flexibility to develop their own 

systems to comply with this rule. There 

are many ways in which the interim 

final rule’s requirements may be met 

and firms will likely choose the least 

cost method in their particular situation 

to comply with the interim final rule. 

Wholesalers: Any establishment that 

supplies retailers with one or more of 

the covered commodities will be 

required by retailers to provide country 

of origin and method of production 

(wild and/or farm-raised) information so 

that retailers can accurately supply that 

information to consumers. Of 

wholesalers potentially impacted by the 

interim final rule, SBA defines those 

having less than 100 employees as 

small. Importers of covered 

commodities will also be impacted by 

the interim final rule and are 

categorized as wholesalers in the data. 

The 2000 Statistics of U.S. Businesses 

(Ref. 8) provides information on 

wholesalers by employment size. For 

fish and seafood wholesalers there are a 

total of 2,897 firms. Of these, 2,837 

firms have less than 100 employees. 

Therefore, approximately 98 percent of 

the fish and seafood wholesalers could 

be considered as small firms. 

In addition to specialty wholesalers 

that primarily handle a single covered 

commodity, there are also general-line 

wholesalers that handle a wide range of 

products. For purposes of this analysis, 

we assume that these general-line 

wholesalers handle at least some of the 

covered fish and shellfish commodities. 

Therefore, we include the number of 

general-line wholesale businesses 

among entities affected by the interim 

final rule. The 2000 Statistics of U.S. 

Businesses provides information on 

general-line grocery wholesalers by 

employment size. There were 3,183 

firms in total, and 2,983 firms had less 

than 100 employees. This results in 

approximately 94 percent of the generalline grocery wholesalers being classified 

as small businesses. 

In general, 5,820 of 6,080 or 96 

percent of the wholesalers are classified 

as small businesses. This indicates that 

most of the wholesalers impacted by 

this interim final rule may be 

considered as small entities as defined 

by SBA. 

As discussed in the Costs section of 

the IFRIA, we estimate that 

intermediaries (importers and domestic 

wholesalers, handlers, and processors) 

will incur costs under the interim final 

rule of approximately $13 million 

(Table 3). Costs are estimated at $1,890 

per intermediary firm and $1,650 per 

establishment (Table 4). These costs are 

lower than the upper range costs 

estimated in the PRIA because of the 

omission of commodities other than fish 

and shellfish from this interim final rule 

and because of the revised definition of 

a processed food item. 

Wholesalers will encounter increased 

costs in complying with this interim 

final rule. Wholesalers will likely face 

increased recordkeeping costs, costs 

associated with supplying country of 

origin and method of production (wild 

and/or farm-raised) information to 

retailers, costs associated with 

segmenting products by country of 

origin and method of production (wild 

or farm-raised), and possibly additional 

handling costs. Some of the comments 

received from wholesalers and retailers 

on the proposed rule and voluntary 

guidelines indicated that retailers may 

choose to source covered commodities 

from a single supplier that procures the 

covered commodity from only one 

country in an attempt to minimize the 

costs associated with complying with 

mandatory COOL. In the case of fish and 

shellfish, this type of change in 

procurement practices could extend to 

sourcing products having only one 

method of production (wild or farmraised). These changes in business 

practices could lead to the further 

consolidation of firms in the 

wholesaling sector. The interim final 

rule does not specify the systems that 

affected wholesalers must put in place 

to implement mandatory COOL. Instead, 

wholesalers will be given flexibility to 

develop their own systems to comply 

with the interim final rule. There are 

many ways in which the rule’s 

requirements may be met. In addition, 

wholesalers have the option of 

supplying covered commodities to 

retailers or other suppliers that are not 

covered by the interim final rule.

Manufacturers: Any manufacturer 

that supplies retailers or wholesalers 

with a covered commodity will be 

required to provide country of origin 

and method of production (wild and/or 

farm-raised) information to retailers so 

that the information can be accurately 

supplied to consumers. Most 

manufacturers of covered commodities 

will likely print country of origin and 

method of production (wild and/or 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59737

farm-raised) information on retail 

packages supplied to retailers. Of the 

manufacturers potentially impacted by 

the interim final rule, SBA defines those 

having less than 500 employees as 

small. 

The 2000 Statistics of U.S. Businesses 

(Ref. 8) provides information on 

manufacturers by employment size. For 

seafood product preparation and 

packaging there is a total of 741 firms. 

Of these, 714 have less than 500 

employees and thus, 96 percent are 

considered to be small firms. This 

indicates that most of the manufacturers 

of covered commodities impacted by the 

interim final rule would be considered 

as small entities as defined by SBA. 

Manufacturers are included as 

intermediaries and additional costs for 

these firms are discussed in the 

previous section addressing 

wholesalers. Manufacturers of covered 

commodities will encounter increased 

costs in complying with this interim 

final rule. Like wholesalers, 

manufacturers will likely face increased 

recordkeeping costs, costs associated 

with supplying country of origin and 

method of production (wild and/or 

farm-raised) information to retailers, 

costs associated with segmenting 

products by country of origin and 

method of production, and possibly 

additional handling costs. Some of the 

comments received from manufacturers 

on the proposed rule and the voluntary 

guidelines indicated that they may limit 

the number of sources from which they 

procure raw products. These changes in 

business practices could lead to 

decreased operational efficiency and the 

further consolidation of firms in the 

manufacturing sector. The interim final 

rule does not specify the systems that 

affected manufacturers must put in 

place to implement mandatory COOL. 

Instead, manufacturers will be given 

flexibility to develop their own systems 

to comply with the rule. There are many 

ways in which the interim final rule’s 

requirements may be met. 

Producers: Harvesters and producers 

of the covered fish and shellfish 

commodities are directly impacted by 

this interim final rule. These harvesters 

and producers will more than likely be 

required by handlers and wholesalers to 

create and maintain country of origin 

and method of production (wild and/or 

farm-raised) information and transfer it 

to them so that they can readily transfer 

this information to retailers. 

SBA defines a small agricultural 

producer as having annual receipts less 

than $750,000. Based on 1998 Census of 

Aquaculture data (Ref. 9), we estimate 

that at least 90 percent of the 3,540 fish 

and shellfish farming operations are 

small. The manner in which the data are 

reported, however, does not allow the 

precise number of small producers to be 

calculated. Similar information on the 

size of fishing operations is not known 

to exist. However, it is assumed that the 

majority of these producers would be 

considered small businesses. We 

estimate that there are 76,499 firms 

engaged in fishing (Refs. 8 and 10). 

At the production level, fish and 

shellfish producers and harvesters will 

need to create, if necessary, and 

maintain records to establish country of 

origin and method of production (wild 

and/or farm-raised) information for the 

products they sell. This information will 

need to be conveyed as the products 

move through the supply chains. In 

general, additional producer costs 

include the cost of establishing and 

maintaining a recordkeeping system for 

the country of origin and method of 

production (wild and/or farm-raised) 

information, product identification, and 

labor and training. Based on our 

knowledge of the affected industries as 

well as comments received on the 

proposed rule and the voluntary 

guidelines, we believe that producers 

and harvesters already have much of the 

information available that could be used 

to substantiate country of origin and 

method of production (wild and/or 

farm-raised) claims. 

The costs for producers and 

harvesters are expected to be relatively 

limited and should not have a larger 

impact on small producers than large 

producers. As discussed in the Costs 

section of the IFRIA, producer costs are 

estimated at $19 million (Table 3), or an 

estimated $241 per firm (Table 4). In the 

case of producers, the firm and the 

establishment are considered as one and 

the same, with the exception of a small 

number of fishing operations. Thus, 

costs per firm and per establishment are 

the same after rounding to the nearest 

dollar. 

Economic impact on small entities:

Information on sales or employment is 

not available for all firms or 

establishments shown in Table 1. 

However, it is reasonable to expect that 

this interim final rule will have a 

substantial impact on a number of small 

businesses. At the wholesale and retail 

levels of the supply chain, the efficiency 

of these operations may be impacted if 

products are segregated in receiving, 

storage, processing, and shipping 

operations. For processors handling 

products sourced from multiple 

countries and multiple methods of 

production (wild and/or farm-raised), 

there may also be a need to operate 

separate shifts for processing products 

from different origins, or to split 

processing within shifts. In either case, 

costs are likely to increase. Records will 

need to be maintained to ensure that 

accurate country of origin and method 

of production (wild and/or farm-raised) 

information is retained throughout the 

process and to permit compliance and 

enforcement reviews. A complete 

discussion of the recordkeeping burden 

associated with this rule is contained in 

the Paperwork Reduction Act section 

below.

Even if only domestic origin products 

or products from a single country of 

origin are handled, there may be 

additional procurement costs to source 

supplies from a single country of origin. 

In the case of fish and shellfish, such 

‘‘single-sourcing’’ of products extends to 

method of production (wild or farmraised) in addition to country of origin. 

Additional procurement costs may 

include higher transportation costs due 

to longer shipping distances and higher 

acquisition costs due to supply and 

demand conditions for products from a 

particular country of origin, whether 

domestic or foreign, and with a 

particular method of production (wild 

or farm-raised). 

These additional costs may result in 

a number of consolidations within the 

processor, manufacturer, and wholesaler 

sectors for these covered fish and 

shellfish commodities. Also, to comply 

with the interim final rule, retailers may 

seek to limit the number of entities from 

which they purchase covered 

commodities as a means to simplify 

recordkeeping and labeling tasks. 

Additional alternatives considered:

As previously mentioned, the COOL 

provisions of the Farm Bill leave little 

regulatory discretion in defining who is 

directly covered by this rule. The law 

explicitly identifies those retailers 

required to provide their customers with 

country of origin and, if applicable, 

method of production (wild and/or 

farm-raised) information for covered 

commodities (namely, retailers as 

defined by PACA). 

The law also requires that any person 

supplying a covered commodity to a 

retailer provide information to the 

retailer indicating the country of origin 

and, in the case of fish and shellfish 

products, method of production (wild 

and/or farm-raised) of the covered 

commodity. Again, the law provides no 

discretion regarding this requirement for 

suppliers of covered commodities to 

provide information to retailers. 

The interim final rule has no 

mandatory requirement, however, for 

any firm other than statutorily defined 

retailers to make country of origin and 

method of production (wild and/or 

farm-raised) claims. In other words, no 

59738 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

harvester, producer, processor, 

wholesaler, or other supplier is required 

to make and substantiate a country of 

origin and method of production (wild 

and/or farm-raised) claim provided that 

the commodity is not ultimately sold in 

the form of a covered commodity at the 

establishment of a retailer subject to the 

interim final rule. Thus, for example, a 

processor and its suppliers may elect 

neither to maintain country of origin 

and method of production (wild and/or 

farm-raised) information nor to make 

country of origin and method of 

production (wild and/or farm-raised) 

claims, but instead sell products 

through marketing channels not subject 

to the interim final rule. Such marketing 

alternatives include foodservice, export, 

and retailers not subject to the interim 

final rule. We estimate that about 38 

percent of U.S. fresh and frozen fish and 

about 25 percent of fresh and frozen 

shellfish sales occur through retailers 

subject to the interim final rule, with the 

remainder sold by retailers not subject 

to the interim final rule or sold as food 

away from home. Additionally, 

producers and intermediaries may have 

opportunities to market their products 

to export markets, which are not subject 

to the provisions of the interim final 

rule. The majority of product sales are 

not subject to the rule, and there are 

many current examples of companies 

specializing in production of 

commodities for foodservice, export 

markets, and other channels of 

distribution that would not be directly 

affected by the rule. 

The effective date of this regulation is 

six months following the date of 

publication of this interim final rule. 

The country of origin statute provides 

that ‘‘not later than September 30, 2004, 

the Secretary shall promulgate such 

regulations as are necessary to 

implement this subtitle.’’ Many of the 

covered commodities sold at retail are 

in a frozen or otherwise preserved state 

(i.e., not sold as ‘‘fresh’’). Thus, many of 

these products would already be in the 

chain of commerce prior to September 

30, 2004, and for these products, origin/

production information may not be 

known. Therefore, it is reasonable to 

delay the effective date of this interim 

final rule for six months to allow 

existing inventories to clear through the 

channels of commerce and to allow 

affected industry members to conform 

their operations to the requirements of 

this rule. During this time period, AMS 

will conduct an industry education and 

outreach program concerning the 

provisions and requirements of this 

rule. AMS also plans to focus its 

enforcement resources for the six 

months immediately following the 

effective date of this interim final rule 

on industry education and outreach. 

After a careful review of all its 

implications, AMS has determined that 

its allocation of enforcement resources 

will ensure that the rule is effectively 

and rationally implemented. This AMS 

plan of outreach and education, 

conducted over a period of one year, 

should significantly aid the industry in 

achieving compliance with the 

requirements of this rule. 

The interim final rule does not dictate 

systems that firms will need to put in 

place to implement the requirements of 

the rule. Thus, different segments of the 

affected industries will be able to 

develop their own least-cost systems to 

implement COOL requirements. For 

example, one firm may depend 

primarily on manual identification and 

paper recordkeeping systems, while 

another may adopt automated 

identification and electronic 

recordkeeping systems.

The interim final rule has no 

requirements for firms to report to 

USDA. Compliance audits will be 

conducted at firms’ places of business. 

As stated previously, required records 

may be kept by firms in the manner 

most suitable to their operations and 

may be hardcopy documents, electronic 

records, or a combination of both. In 

addition, the interim final rule provides 

flexibility regarding where records may 

be kept. If the product is pre-labeled 

with the necessary country of origin and 

method of production (wild and/or 

farm-raised) information, records 

documenting the immediate previous 

source and immediate subsequent 

recipient are sufficient as long as the 

source of the claim can be tracked and 

verified. Such flexibility should reduce 

costs for small entities to comply with 

the interim final rule. 

In effect, the interim final rule is a 

performance standard rather than a 

design standard. The interim final rule 

requires that covered fish and shellfish 

commodities at subject retailers be 

labeled with country of origin and 

method of production (wild and/or 

farm-raised) information, that suppliers 

of covered commodities provide such 

information to retailers, and that 

retailers and their suppliers maintain 

records and information sufficient to 

verify all country of origin and method 

of production claims. The interim final 

rule provides flexibility regarding the 

manner in which the required 

information may be provided by 

retailers to consumers. The interim final 

rule provides flexibility in the manner 

in which required country of origin and 

method of production (wild and/or 

farm-raised) information is provided by 

suppliers to retailers, and in the manner 

in which records and information are 

maintained to substantiate country of 

origin and method of production claims. 

Thus, the interim final rule provides the 

maximum flexibility practicable to 

enable small entities to minimize the 

costs of the interim final rule on their 

operations. 

Paperwork Reduction Act 

Pursuant to PRA (44 U.S.C. 3501–

3520) the information collection 

provisions contained in this interim 

final rule have not yet been approved by 

OMB and will not take effect until such 

approval is received. The Comments 

and Responses section lists the 

comments received on the preliminary 

PRA analysis and provides the Agency’s 

responses to the comments. A 

description of these provisions is given 

below with an estimate of the annual 

recordkeeping burden. 

Title: Recordkeeping and Records 

Access Requirements for Producers and 

Food Facilities. 

OMB Number: 0581–new. 

Type of Request: New collection. 

Expiration Date: Three years from the 

date of approval. 

Abstract: The COOL provision in the 

Farm Bill requires that specified 

retailers inform consumers as to the 

country of origin and, in the case of fish 

and shellfish, method of production 

(wild and/or farm-raised) of covered 

commodities. This interim final rule 

requires that records and other 

documentary evidence used to 

substantiate an origin and method of 

production (wild and/or farm-raised) 

claim must, upon request, be made 

available to USDA representatives in a 

timely manner during normal business 

hours and at a location that is 

reasonable in consideration of the 

products and firm under review. Any 

person engaged in the business of 

supplying a covered commodity to a 

retailer (i.e., including but not limited to 

harvesters, producers, distributors, 

handlers, packers, and processors), 

whether directly or indirectly, must 

make country of origin and method of 

production (wild and/or farm-raised) 

information available to the retailer and 

must maintain records to establish and 

identify the immediate previous source 

and immediate subsequent recipient of 

a covered commodity, in such a way 

that identifies the product unique to 

that transaction by means of a lot 

number or other unique identifier, for a 

period of one year from the date of the 

transaction. For an imported covered 

commodity, the importer of record as 

determined by CBP must ensure that 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59739

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 farm-raised) 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. Records and 

other documentary evidence (e.g., 

shipping receipt from central 

warehouse) relied upon at the point of 

sale to establish a product’s country of 

origin and designation of production 

method (wild and/or farm-raised) must 

be available during normal business 

hours to any duly authorized 

representative of USDA at the facility 

for as long as the product is on hand. 

In addition, records that identify the 

retail supplier, the product unique to 

that transaction by means of a lot 

number or other unique identifier, and 

for products that are not pre-labeled the 

country of origin and method of 

production (wild and/or farm-raised) 

information, must be maintained for a 

period of one year from the date the 

origin declaration is made at retail. Such 

records may be located at the retailer’s 

point of distribution, or at a warehouse, 

central office or other off-site location. 

Description of Recordkeepers:

Individuals who supply covered fish 

and shellfish commodities, whether 

directly to retailers or indirectly through 

other participants in the marketing 

chain, are required to establish and 

maintain country of origin and method 

of production (wild and/or farm-raised) 

information for the covered 

commodities and supply this 

information to retailers. As a result, 

producers, handlers, manufacturers, 

wholesalers, importers, and retailers of 

covered fish and shellfish commodities 

will be impacted by this interim final 

rule.

Burden: We estimate that nearly 

125,000 establishments owned by 

approximately 91,000 firms would be 

either directly or indirectly impacted by 

this rule. Changes from the PRIA are 

reductions in the numbers of affected 

entities due to the omission of 

commodities other than fish and 

shellfish in this interim final rule. 

In general, the supply chain for the 

covered fish and shellfish commodities 

includes fish and shellfish producers 

and harvesters, processors, wholesalers, 

importers, and retailers. Imported 

products may be introduced at any level 

of the supply chain. Other 

intermediaries, such as markets, may be 

involved in transferring products from 

one stage of production to the next. We 

estimate that the interim final rule’s 

paperwork burden will be incurred by 

the number and types of firms and 

establishments listed in Table 8.

TABLE 8.—PAPERWORK BURDEN ESTIMATES

Type Firms Initial costs Establishments 

Maintenance 

costs Total costs 

Producers: 

Farm-Raised Fish & Shellfish ....................................................... 3,540 245,895 3,540 466,876 712,772 

Fishing .......................................................................................... 76,499 5,313,774 76,452 3,360,983 8,674,756 

Intermediaries: 

Fresh & Frozen Seafood Processing ........................................... 582 761,838 653 580,571 1,342,409 

Fish & Seafood Wholesale ........................................................... 2,897 3,792,173 2,980 2,649,467 6,441,640 

General Line Grocery Wholesalers .............................................. 3,183 4,166,547 3,993 819,256 4,985,80 

Retailers: .............................................................................................. 4,512 5,906,208 37,176 16,526,275 22,432,483 

Totals: 

Producers ...................................................................................... 80,039 5,559,669 79,992 3,827,859 9,387,528 

Handlers, Processors, & Wholesalers .......................................... 6,662 8,720,558 7,626 4,049,294 12,769,852 

Retailers ........................................................................................ 4,512 5,906,208 37,176 16,526,275 22,432,483 

Grand Total ............................................................................ 91,213 20,186,435 124,794 24,403,428 44,589,863 

The impacted firms and 

establishments will broadly incur two 

types of costs. First, firms will incur 

initial or start-up costs to comply with 

the interim final rule. We assume that 

initial costs will be borne by each firm, 

even though a single firm may operate 

more than one establishment. Second, 

enterprises will incur additional 

recordkeeping costs associated with 

storing and maintaining records on an 

ongoing basis. We assume that these 

activities will take place in each 

establishment operated by each affected 

business. 

Compared to the proposed rule, this 

interim final rule reduces the length of 

time that records must be kept and 

revises the recordkeeping requirements 

for pre-labeled products. Any person 

engaged in the business of supplying a 

covered commodity to a retailer, 

whether directly or indirectly, must 

maintain records to establish and 

identify the immediate previous source 

and immediate subsequent recipient of 

a covered commodity, in such a way 

that identifies the product unique to 

that transaction by means of a lot 

number of other unique identifier, for a 

period of 1 year from the date of the 

transaction. Under the proposed rule, 

records would have been required to be 

kept for 2 years. For retailers, this 

interim final rule requires records and 

other documentary evidence relied 

upon at the point of sale by the retailer 

to establish a product’s country of origin 

and method of production, to be 

available to any duly authorized 

representatives of USDA for as long as 

the product is on hand. Under the 

proposed rule, retailers would have to 

have maintained these records for 7 

days following the sale of the product. 

For pre-labeled products, the interim 

final rule provides that the label itself is 

sufficient evidence on which the retailer 

may rely to establish a product’s origin 

and method of production (wild and/or 

farm-raised). The proposed rule would 

not have provided for this method of 

substantiation. Under the interim final 

rule, records that identify the supplier, 

the product unique to that transaction 

by means of a lot number or other 

unique identifier, and for products that 

are not pre-labeled, the country of origin 

and the method of production (wild 

and/or farm-raised) information must be 

59740 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

maintained for a period of 1 year from 

the date the origin and production 

designations are made at retail. Under 

the proposed rule, these records would 

have been required to be maintained for 

2 years. 

With respect to initial recordkeeping 

costs, we believe that most fish and 

shellfish harvesters and producers 

currently maintain many of the types of 

records that would be needed to 

substantiate country of origin and 

method of production (wild and/or 

farm-raised) claims. However, 

harvesters and producers are not 

typically required to pass along country 

of origin and method of production 

(wild or farm-raised) information to 

subsequent purchasers. Therefore, 

harvesters and producers will incur 

some additional incremental costs to 

record, maintain, and transfer country of 

origin and method of production (wild 

or farm-raised) information to 

substantiate required claims made at 

retail. Because much of the necessary 

recordkeeping is already developed 

during typical fishing and aquaculture 

operations, we estimate that the 

incremental costs for harvesters and 

producers to supplement existing 

records with country of origin and 

method of production (wild or farmraised) information will be relatively 

small per firm. Examples of initial or 

start-up costs would be any additional 

recordkeeping burden needed to record 

the required country of origin and 

method of production (wild or farmraised) information and transfer this 

information to handlers, processors, 

wholesalers, or retailers.

We estimate that producers will need 

4 hours to establish a system for 

organizing records to carryout the 

purposes of these regulations. This 

additional time would be required to 

modify existing recordkeeping systems 

to incorporate any added information 

needed to substantiate country of origin 

claims. Although not all fish and 

shellfish products ultimately will be 

sold at retail establishments covered by 

this interim final rule, we assume that 

virtually all producers will wish to keep 

their marketing options as flexible as 

possible. Thus, we assume that all 

harvesters and producers of covered fish 

and shellfish commodities will establish 

recordkeeping systems sufficient to 

substantiate country of origin and 

method of production claims. We also 

recognize that some operations will 

require substantially more than 4 hours 

to establish their recordkeeping systems. 

Overall, we believe that 4 hours 

represents a reasonable estimate of the 

average additional time that will be 

required across all types of harvesters 

and producers. 

In estimating initial recordkeeping 

costs, we used 2001 wage rates and 

benefits published by the Bureau of 

Labor statistics from the National 

Compensation Survey. Subsequently, 

the National Compensation Survey has 

been updated and 2002 wage rates and 

benefits are now available. These 

updated wage rates and benefits are 

used in estimating the interim final 

recordkeeping costs and results in an 

increase in the estimated costs. 

For harvesters and producers, we 

assume that the added work needed to 

initially set up a recordkeeping system 

for country of origin and method of 

production (wild or farm-raised) 

information is primarily a bookkeeping 

task. This task may be performed by 

independent bookkeepers, or in the case 

of operations that perform their own 

bookkeeping, will require equivalent 

skills. The Bureau of Labor Statistics 

(BLS) (Ref. 11) publishes wage rates for 

bookkeepers, accounting, and auditing 

clerks. We assume that this wage rate 

represents the cost for producers to hire 

an independent bookkeeper. In the case 

of producers who currently perform 

their own bookkeeping, we assume that 

this wage rate represents the 

opportunity cost of the producers’ time 

for performing these tasks. The July 

2002 wage rate, the most recent data 

available, is estimated at $13.62 per 

hour. For this analysis, an additional 

27.5 percent is added to the wage rate 

to account for total benefits which 

includes social security, unemployment 

insurance, workers compensation, etc. 

The estimate of this additional cost to 

employers is published by the BLS (Ref. 

11). At 4 hours per firm and a cost of 

$17.37 per hour, initial recordkeeping 

costs to harvesters and producers are 

estimated at approximately $5.6 million 

to modify existing recordkeeping 

systems in order to substantiate country 

of origin and method of production 

(wild or farm-raised) claims. 

The recordkeeping burden on 

handlers, processors, wholesalers, and 

retailers is expected to be more complex 

than the burden most producers face. 

These operations will need to maintain 

country of origin and method of 

production (wild and/or farm-raised) 

information on the covered 

commodities purchased and 

subsequently furnish that information to 

the next participant in the supply chain. 

This will require adding additional 

information to a firm’s bills of lading, 

invoices, or other records associated 

with movement of covered commodities 

from purchase to sale. Similar to 

harvesters and producers, however, we 

believe that most of these operations 

already maintain many of the types of 

necessary records in their existing 

systems. Thus, we assume that country 

of origin and method of production 

(wild and/or farm-raised) information 

will require only modification of 

existing recordkeeping systems rather 

than development of entirely new 

systems. 

The Label Cost Model Developed for 

FDA by RTI International (Refs. 12 and 

13) is used to estimate the cost of 

including additional country of origin 

and method of production (wild and/or 

farm-raised) information to an 

operation’s records. We assume a 

limited information, one-color redesign 

of a paper document will be sufficient 

to comply with the interim final rule’s 

recordkeeping requirements. The 

number of hours required to complete 

the redesign is estimated to be 29 with 

an estimated cost at $1,309 per firm. 

While the cost will be much higher for 

some firms and lower for others, we 

believe that $1,309 represents a 

reasonable estimate of average cost for 

all firms. We thus estimate that the 

initial recordkeeping costs to 

intermediaries such as handlers, 

processors, and wholesalers (importers 

are included with wholesalers) will be 

approximately $8.7 million, and initial 

recordkeeping costs at retail will be 

approximately $5.9 million. The initial 

recordkeeping cost to intermediaries 

declines from the initial recordkeeping 

cost estimate in the proposed rule due 

to the reduction in the number of 

affected intermediaries associated with 

commodities other than fish and 

shellfish. The total initial recordkeeping 

costs for all firms are thus estimated at 

approximately $20 million. 

In addition to these one-time costs to 

establish recordkeeping systems, 

enterprises will incur additional 

recordkeeping costs associated with 

storing and maintaining records. These 

costs are referred to as maintenance 

costs in Table 8. Again, the marginal 

cost for harvesters and producers to 

maintain and store any additional 

information needed to substantiate 

country of origin and method of 

production (wild or farm-raised) claims 

is expected to be relatively small.

For wild fish harvesters, country of 

origin and method of production (wild) 

generally is established at the time that 

the product is harvested, and thus there 

is no need to track country of origin and 

method of production information 

throughout the production lifecycle of 

the product. This group of producers is 

estimated to require an additional 4 

hours a year, or 1 hour per quarter, to 

maintain country of origin and method 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59741

of production information. Maintenance 

costs for fish harvesters are estimated to 

be $3.4 million. 

Compared to wild fish harvesters, we 

expect that fish farmers will incur 

higher costs to maintain country of 

origin and method of production (farmraised) information. Wild fish are 

generally harvested once and then 

shipped by the producer to the first 

handler. In contrast, farm-raised fish 

and shellfish can and often do move 

through several geographically 

dispersed operations prior to final sale 

for processing. Fish and shellfish may 

be acquired from other countries by U.S. 

producers, complicating the task of 

tracking country of origin and method of 

production information. Because farmed 

fish and shellfish may change 

ownership several times prior to 

harvest, will need to be maintained to 

substantiate country of origin 

information as the animals move 

through their lifecycle. Thus, we expect 

that the recordkeeping burden for fish 

and shellfish farmers will be higher than 

it will be for harvesters of wild fish and 

shellfish. We estimate that these 

producers will require an additional 12 

hours a year, or 1 hour per month, to 

maintain country of origin and method 

of production records. Again, this is an 

average for all enterprises. Some will 

require substantially more time, while 

others will require little additional time 

to maintain country of origin and 

method of production information. 

We assume that farm labor will 

primarily be responsible for maintaining 

country of origin information at 

producers’ enterprises. NASS data (Ref. 

14) are used to estimate average farm 

wage rates—$8.62 per hour for livestock 

workers. (Wage rates for fish workers 

were unavailable, so the average wage 

rate for livestock workers is used.) 

Applying the rate of 27.5 percent to 

account for benefits results in an hourly 

rate of $10.99 for livestock workers. 

Assuming 12 hours of labor per year for 

farmed fish operations results in 

estimated annual maintenance costs to 

producers of $467,000 which is slightly 

higher than the estimated maintenance 

costs in the proposed rule for this group 

of producers. The increase in the 

estimated maintenance cost is due to the 

higher estimated benefits. 

We expect that intermediaries such as 

handlers, processors, and wholesalers 

will face higher costs per enterprise to 

maintain country of origin and method 

of production (wild and/or farm-raised) 

information compared to costs faced by 

producers. Much of the added cost is 

attributed to the larger average size of 

these enterprises compared to the 

average producer enterprise. In 

addition, these intermediaries will need 

to track products both coming into and 

going out of their businesses. 

We estimate the maintenance burden 

hours for country of origin and method 

of production (wild and/or farm-raised) 

recordkeeping to be 52 hours per year 

per establishment for fresh and frozen 

seafood processors and fish and seafood 

wholesalers. For general line grocery 

wholesalers, we estimate the 

maintenance burden hours to be 12 

hours per year per establishment. The 

burden estimate for general line grocery 

wholesalers is reduced from the 52 

hours estimated in the proposed rule 

because fish and shellfish represent 

only a portion of the commodities 

handled by these establishments. 

Maintenance activities will include 

inputting, tracking, and storing country 

of origin and method of production 

(wild and/or farm-raised) information 

for each covered fish and shellfish 

commodity. Since this is mostly an 

administrative task, we estimate the cost 

using the July 2002 BLS wage rate from 

the National Compensation Survey for 

administrative support occupations 

($13.41 per hour with an additional 27.5 

percent added to cover overhead costs 

for a total of $17.10 per hour). This 

occupation category includes stock and 

inventory clerks and record clerks. 

Coupled with the assumed hours per 

establishment, the resulting total annual 

maintenance costs to handlers, 

processors, and wholesalers and other 

intermediaries are estimated at 

approximately $4.0 million. 

Retailers will need to supply country 

of origin and method of production 

(wild and/or farm-raised) information 

for each covered fish and shellfish 

commodity sold at each store. 

Therefore, additional recordkeeping 

maintenance costs are believed to 

impact each establishment. Because fish 

and shellfish represent only a portion of 

the covered commodities included in 

the proposed rule, estimated 

recordkeeping maintenance burden is 

lowered from 365 hours to 26 hours per 

year per retail establishment. This 

represents 30 minutes per week. Using 

the BLS wage rate for administrative 

support occupations ($13.41 per hour 

with an additional 27.5 percent added 

to cover overhead costs for a total of 

$17.10 per hour) results in total 

estimated annual maintenance costs to 

retailers of $16.5 million. 

The total maintenance recordkeeping 

costs for all producer, intermediary, and 

retail enterprises are thus estimated at 

approximately $24.4 million.

The total first-year recordkeeping 

burden is calculated by summing the 

initial and maintenance costs. The total 

recordkeeping costs are estimated for 

harvesters and producers at 

approximately $9.4 million; for 

handlers, processors, and wholesalers at 

approximately $12.8 million; and for 

retailers at approximately $22.4 million. 

We estimate the total recordkeeping cost 

for all participants in the supply chain 

for covered fish and shellfish 

commodities at $44.6 million for the 

first year, with subsequent maintenance 

costs of $24.4 million per year. 

Annual Reporting and Recordkeeping 

Burden for the First Year (Initial): Public 

reporting burden for this initial 

recordkeeping set up is estimated to 

average 7.1 hours per year per 

individual recordkeeper. 

Estimated Number of Firms 

Recordkeepers: 91,213. 

Estimated Total Annual Burden:

644,202 hours. 

Annual Reporting and Recordkeeping 

Burden (Maintenance):

Public reporting burden for this 

recordkeeping storage and maintenance 

is estimated to average 12.4 hours per 

year per individual recordkeeper. 

Estimated Number of Establishments 

Recordkeepers: 124,794. 

Estimated Total Annual Burden:

1,551,696 hours. 

AMS is committed to implementation 

of the Government Paperwork 

Elimination Act (GPEA) to provide the 

public with the option to submit or 

transact business electronically to the 

extent practicable. This new 

information collection has no forms and 

is only for recordkeeping purposes. 

Therefore, the provisions of an 

electronic submission alternative is not 

required by GPEA. 

AMS is soliciting comments from all 

interested parties concerning these 

recordkeeping requirements. Comments 

are specifically invited on: (1) Whether 

the recordkeeping is necessary for the 

proper operation of this program, 

including whether the information 

would have practical utility; (2) the 

accuracy of USDA’s estimate of the 

burden of the recordkeeping 

requirements, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the records to be 

maintained; and (4) ways to minimize 

the burden of the recordkeeping on 

those who are to maintain and/or make 

the records available, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

recordkeeping techniques or other forms 

of information technology. Comments 

concerning the recordkeeping 

requirements contained in this interim 

final rule should reference the date and 

page number of this issue of the Federal 

59742 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

Register and should be sent to Country 

of Origin Labeling Program, Room 

2092–S; Agricultural Marketing Service 

(AMS), USDA; STOP 0249; 1400 

Independence Avenue, SW., 

Washington, DC 20250–0249, or by 

facsimile to (202) 720–3499, or by email to cool@usda.gov.

Comments sent to the above location 

should also be sent to the Desk Officer 

for Agriculture, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget, New 

Executive Office Building, 725 17th 

Street, NW., Room 725, Washington, DC 

20503. All responses to this action will 

be summarized and included in the 

request for OMB approval. All 

comments will become a matter of 

public record. 

References

1. ERS, USDA. Food Consumption (Per 

Capita) Data System, http://

www.ers.usda.gov/data/FoodConsumption/.

2. NMFS, NOAA, U.S. Dept. of Commerce. 

Fisheries of the United States 2001. 

September 2002. 

3. FAS, USDA. U.S. Trade Internet System, 

http://www.fas.usda.gov/ustrade/.

4. NMFS, NOAA, U.S. Dept. of Commerce. 

National Seafood Consumption Survey. 

5. ERS, USDA. Food CPI, Prices and 

Expenditures: Sales of Food at Home by Type 

of Outlet, www.ers.usda.gov/Briefing/

CPIFoodAndExpenditures/Data/table16.htm.

6. U.S. Census Bureau. 1997 Economic 

Census. Retail Trade Subject Series. 

Establishment and Firm Size. EC97R44S–SZ. 

Issued October 2000. 

7. AMS, USDA. Perishable Agricultural 

Commodities Act database. 

8. U.S. Census Bureau. 2000 Statistics of 

U.S. Businesses. 

9. NASS, USDA. 1998 Census of 

Aquaculture. 

10. U.S. Census Bureau. 2000 

Nonemployer Statistics. 

11. Bureau of Labor Statistics, Department 

of Labor, National Compensation Survey, 3rd 

quarter 2003, Employer Cost for Employee 

Compensation. 

12. Food and Drug Administration. 

‘‘Establishment and Maintenance of Records 

Under the Public Health Security and 

Bioterrorism Preparedness and Response Act 

of 2002,’’ proposed rule. May 9, 2003. 

13. RTI, International 2000. FDA Labeling 

Cost Model: Final Report. Revised April 

2002. 

14. NASS, USDA. Farm Labor, August 15, 

2003.

Executive Order 12988 

The contents of this rule were 

reviewed under Executive Order 12988, 

Civil Justice Reform. This rule is not 

intended to have a retroactive effect. 

States and local jurisdictions are 

preempted from creating or operating 

country of origin labeling programs for 

the commodities specified in the Act 

and these regulations. With regard to 

other Federal statutes, all labeling 

claims made in conjunction with this 

regulation must be consistent with other 

applicable Federal requirements. There 

are no administrative procedures that 

must be exhausted prior to any judicial 

challenge to the provisions of this rule. 

Civil Rights Review 

AMS considered the potential civil 

rights implications of this rule on 

minorities, women, or persons with 

disabilities to ensure that no person or 

group shall be discriminated against on 

the basis of race, color, national origin, 

gender, religion, age, disability, sexual 

orientation, marital or family status, 

political beliefs, parental status, or 

protected genetic information. This 

review included persons that are 

employees of the entities that are subject 

to these regulations. This interim final 

rule does not require affected entities to 

relocate or alter their operations in ways 

that could adversely affect such persons 

or groups. Further, this rule will not 

deny any persons or groups the benefits 

of the program or subject any persons or 

groups to discrimination. 

Executive Order 13132 

This rule has been reviewed under 

Executive Order 13132, Federalism. 

This Order directs agencies to construe, 

in regulations and otherwise, a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence to conclude that 

the Congress intended preemption of 

State law, or where the exercise of State 

authority conflicts with the exercise of 

Federal authority under the Federal 

statute. This rule is required by the 

Farm Bill. While this statute does not 

contain an express preemption 

provision, it is clear from the language 

in the statute that Congress intended 

preemption of State law. 

Several States have implemented 

mandatory programs for country of 

origin labeling of certain commodities. 

For example, Alabama, Arkansas, 

Mississippi, and Louisiana have origin 

labeling requirements for certain 

seafood products. Other States 

including Wyoming, Idaho, North 

Dakota, South Dakota, Louisiana, 

Kansas, and Mississippi have origin 

labeling requirements for certain meat 

products. In addition, the State of 

Florida and the State of Maine have 

origin labeling requirements for fresh 

produce items.

To the extent that these State country 

of origin labeling programs encompass 

commodities which are not governed by 

this regulation, the States may continue 

to operate them. For those State country 

of origin labeling programs that 

encompass commodities which are 

governed by this regulation, these 

programs are preempted. In most cases, 

the requirements contained within this 

rule are more stringent and prescriptive 

than the requirements of the State 

programs. With regard to consultation 

with States, as directed by the law, AMS 

has consulted with the States that have 

country of origin labeling programs. 

Further, States were expressly invited to 

comment on the proposed regulation as 

it related to existing State programs. No 

States submitted any comments 

pertaining to this issue. 

This interim final rule contains those 

provisions of the October 30, 2003, (68 

FR 61944) proposed rule that pertain to 

fish and shellfish covered commodities. 

Modifications to these provisions have 

been made as discussed herein. The 

implementation of mandatory COOL for 

all covered commodities except wild 

and farm-raised fish and shellfish has 

been delayed until September 30, 2006. 

The provisions for the other covered 

commodities, including muscle cuts of 

beef (including veal), lamb, and pork; 

ground beef, ground lamb, and ground 

pork; perishable agricultural 

commodities; and peanuts are not made 

final in this action. In view of the 

changes made in this interim final rule 

to fish and shellfish covered 

commodities, interested persons should 

examine provisions concerning their 

respective covered commodities in light 

of these changes. Assuming that 

provisions of the interim final rule 

would be applied to all covered 

commodities, the Agency specifically 

invites comments on the issues 

described below. 

In this regard, particular attention is 

drawn to the changes made for fish and 

shellfish with respect to definition of a 

processed food item and recordkeeping. 

Under this interim final rule, all cooked 

products (e.g., canned fish) are 

considered processed food items and are 

excluded from labeling under this 

regulation. Cooked products have a 

character that is different than that of 

the covered commodity and have a 

somewhat limited functionality. Also 

excluded under this interim final rule 

are breaded products, which in the case 

of shrimp can account for up to 50 

percent of the finished product. In 

addition, retail items that have been 

given a distinct flavor (e.g., Cajun 

marinated catfish) are also considered 

processed food items. The Agency 

believes that these exclusions are 

consistent in that these products all 

have a limited range of use. 

AMS has reduced the recordkeeping 

retention requirement for suppliers and 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59743

centrally-located retail records to one 

year and reduced the retail level record 

retention requirement to while the 

product is on hand. In addition, the 

interim final rule clarifies that only 

those suppliers responsible for initiating 

an origin and method of production 

claim would have to possess records to 

substantiate those claims (e.g., where it 

was harvested). Intermediate suppliers 

and retailers would be required to have 

documentation that identifies the 

product with either a lot number or 

other unique identifier and illustrates 

the immediate previous supplier and 

subsequent recipient (as applicable) of 

that uniquely identified product. Thus, 

only origin/production identification 

must travel with the product either on 

the product itself, on the shipping 

container, or in some other fashion. In 

performing an audit, AMS would be 

able to track that product back through 

the marketing chain to the supplier 

responsible for initiating the origin/

production designation claims. 

With respect to costs, modifications in 

this interim final rule resulted in lower 

estimates of first-year implementation 

costs for affected entities in the fish and 

shellfish sector, relative to the upper 

range estimates of first-year 

implementation costs presented in the 

proposed rule. If applied to the other 

covered commodities, corresponding 

changes to the proposed rule would 

result in lowered estimates of first-year 

implementation costs for those 

commodities relative to the upper-range 

estimates presented in the PRIA. In the 

PRIA, upper-range first-year 

implementation costs for all covered 

commodities (including fish and 

shellfish) were estimated at $3.9 billion. 

Preliminary analysis suggests that 

requirements in this interim final rule, 

if applied to all covered commodities, 

would result in a reduction on the order 

of 20 to 30 percent in estimated firstyear implementation costs relative to 

the PRIA upper-range estimate. 

This interim final rule is made 

effective 180 days after the date of 

publication in the Federal Register. The 

requirements of this rule do not apply 

to frozen fish or shellfish caught or 

harvested before December 6, 2004. This 

will allow existing product to clear 

through the channels of commerce and 

permit AMS to conduct an industry 

education and outreach program 

concerning the provisions contained 

within this rulemaking. 

Further, pursuant to 5 U.S.C. 553, it 

is found and determined upon good 

cause that it is impractical, unnecessary, 

and contrary to the public interest to 

give preliminary notice prior to putting 

this rule into effect. This action is 

authorized under the Agricultural 

Marketing Act of 1946, as amended. 

After issuance of a proposed rule, the 

Department has decided to provide 

further opportunity to comment due to 

the changes made as a result of 

comments received and the cost 

associated with this rule. Further, this 

rule provides for a 90-day comment 

period.

List of Subjects in 7 CFR Part 60 

Agricultural commodities, Fish, Food 

labeling, Reporting and recordkeeping 

requirements.

■ For the reasons set forth in the 

preamble, 7 CFR chapter I is amended by 

adding part 60 to read as follows:

PART 60—COUNTRY OF ORIGIN 

LABELING FOR FISH AND SHELLFISH

Subpart A—General Provisions 

Definitions 

Sec. 

60.101 Act. 

60.102 AMS. 

60.103 [Reserved] 

60.104 Consumer package. 

60.105 Covered commodity. 

60.106 Farm-raised fish. 

60.107 Food service establishment. 

60.108–60.110 [Reserved] 

60.111 Hatched. 

60.112 Ingredient. 

60.113 [Reserved] 

60.114 Legibly. 

60.115 [Reserved] 

60.116 Person. 

60.117 [Reserved] 

60.118 [Reserved] 

60.119 Processed food item. 

60.120 [Reserved] 

60.121 [Reserved] 

60.122 Production step. 

60.123 Raised. 

60.124 Retailer. 

60.125 Secretary. 

60.126 [Reserved] 

60.127 United States. 

60.128 United States country of origin. 

60.129 USDA. 

60.130 U.S. flagged vessel. 

60.131 Vessel flag. 

60.132 Waters of the United States. 

60.133 Wild fish and shellfish. 

Country of Origin Notification 

60.200 Country of origin notification. 

60.300 Markings. 

Recordkeeping 

60.400 Recordkeeping requirements. 

Appendix A to Subpart A—Exclusive 

Economic Zone and Maritime 

Boundaries; Notice of Limits

Subpart B—[Reserved]

Authority: 7 U.S.C. 1621 et seq.

Subpart A—General Provisions 

Definitions

§ 60.101 Act. 

Act means the Agricultural Marketing 

Act of 1946, (7 U.S.C. 1621 et seq.).

§ 60.102 AMS. 

AMS means the Agricultural 

Marketing Service, United States 

Department of Agriculture.

§ 60.103 [Reserved]

§ 60.104 Consumer package. 

Consumer package means any 

container or wrapping in which a 

covered commodity is enclosed for the 

delivery and/or display of such 

commodity to retail purchasers.

§ 60.105 Covered commodity. 

(a) Covered commodity means: 

(1) [Reserved]

(2) [Reserved] 

(3) Farm-raised fish and shellfish 

(including fillets, steaks, nuggets, and 

any other flesh); 

(4) Wild fish and shellfish (including 

fillets, steaks, nuggets, and any other 

flesh); 

(5) [Reserved] 

(6) [Reserved] 

(b) Covered commodities are excluded 

from this part if the commodity is an 

ingredient in a processed food item as 

defined in § 60.119.

§ 60.106 Farm-raised fish. 

Farm-raised fish means fish or 

shellfish that have been harvested in 

controlled environments, including 

ocean-ranched (e.g., penned) fish and 

including shellfish harvested from 

leased beds that have been subjected to 

production enhancements such as 

providing protection from predators, the 

addition of artificial structures, or 

providing nutrients; and fillets, steaks, 

nuggets, and any other flesh from a 

farm-raised fish or shellfish.

§ 60.107 Food service establishment. 

Food service establishment means a 

restaurant, cafeteria, lunch room, food 

stand, saloon, tavern, bar, lounge, or 

other similar facility operated as an 

enterprise engaged in the business of 

selling food to the public. Similar food 

service facilities include salad bars, 

delicatessens, and other food enterprises 

located within retail establishments that 

provide ready-to-eat foods that are 

consumed either on or outside of the 

retailer’s premises.

§ 60.108–60.110 [Reserved]

§ 60.111 Hatched. 

Hatched means emerged from the egg.

59744 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

§ 60.112 Ingredient. 

Ingredient means a component either 

in part or in full, of a finished retail food 

product.

§ 60.113 [Reserved]

§ 60.114 Legibly. 

Legibly means text that can be easily 

read by a consumer.

§ 60.115 [Reserved]

§ 60.116 Person. 

Person means any individual, 

partnership, corporation, association, or 

other legal entity.

§ 60.117 [Reserved]

§ 60.118 [Reserved]

§ 60.119 Processed food item. 

Processed food item means a retail 

item derived from fish or shellfish 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., 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, 

compressing into blocks and cutting 

into portions). Examples of items 

excluded include fish sticks, surimi, 

mussels in tomato sauce, seafood 

medley, coconut shrimp, soups, stews, 

and chowders, sauces, pates, salmon 

that has been smoked, marinated fish 

fillets, canned tuna, canned sardines, 

canned salmon, crab salad, shrimp 

cocktail, gefilte fish, sushi, and breaded 

shrimp.

§ 60.120 [Reserved]

§ 60.121 [Reserved]

§ 60.122 Production step. 

Production step means in the case of: 

(a) [Reserved] 

(b) Farm-raised Fish and Shellfish: 

Hatched, raised, harvested, and 

processed. 

(c) Wild Fish and Shellfish: Harvested 

and processed.

§ 60.123 Raised. 

Raised means in the case of: 

(a) [Reserved] 

(b) Farm-raised fish and shellfish as it 

relates to the production steps defined 

in § 60.122: the period of time from 

hatched to harvested.

§ 60.124 Retailer. 

Retailer means any person licensed as 

a retailer under the Perishable 

Agricultural Commodities Act of 1930 

(7 U.S.C. 499a(b)).

§ 60.125 Secretary. 

Secretary means the Secretary of 

Agriculture of the United States or any 

person to whom the Secretary’s 

authority has been delegated.

§ 60.126 [Reserved]

§ 60.127 United States. 

United States means the 50 States, the 

District of Columbia, the 

Commonwealth of Puerto Rico, the U.S. 

Virgin Islands, American Samoa, Guam, 

the Northern Mariana Islands, and any 

other Commonwealth, territory, or 

possession of the United States, and the 

waters of the United States as defined in 

§ 60.132.

§ 60.128 United States country of origin. 

United States country of origin means 

in the case of: 

(a) [Reserved]

(b) [Reserved] 

(c) Farm-raised fish and shellfish: 

from fish or shellfish hatched, raised, 

harvested, and processed in the United 

States, and that has not undergone a 

substantial transformation (as 

established by U.S. Customs and Border 

Protection) outside of the United States. 

(d) Wild-fish and shellfish: from fish 

or shellfish harvested in the waters of 

the United States or by a U.S. flagged 

vessel and processed in the United 

States or aboard a U.S. flagged vessel, 

and that has not undergone a substantial 

transformation (as established by U.S. 

Customs and Border Protection) outside 

of the United States. 

(e) [Reserved] 

(f) [Reserved]

§ 60.129 USDA. 

USDA means the United States 

Department of Agriculture.

§ 60.130 U.S. flagged vessel. 

U.S. flagged vessel means: 

(a) Any vessel documented under 

chapter 121 of title 46, United States 

Code; or 

(b) Any vessel numbered in 

accordance with chapter 123 of title 46, 

United States Code.

§ 60.131 Vessel flag. 

Vessel flag means the country of 

registry for a vessel, ship, or boat.

§ 60.132 Waters of the United States. 

Waters of the United States means 

those fresh and ocean waters contained 

within the outer limit of the Exclusive 

Economic Zone (EEZ) of the United 

States as described in Department of 

State Public Notice 2237 published in 

the Federal Register volume 60, No. 

163, August 23, 1995, pages 43825–

43829. The Department of State notice 

is republished in appendix A to this 

subpart.

§ 60.133 Wild fish and shellfish. 

Wild fish and shellfish means 

naturally-born or hatchery-originated 

fish or shellfish released in the wild, 

and caught, taken, or harvested from 

non-controlled waters or beds; and 

fillets, steaks, nuggets, and any other 

flesh from a wild fish or shellfish. 

Country of Origin Notification

§ 60.200 Country of origin notification. 

In providing notice of the country of 

origin as required by the Act, the 

following requirements shall be 

followed by retailers: 

(a) General. Labeling of covered 

commodities offered for sale whether 

individually, in a bulk bin, display case, 

carton, crate, barrel, cluster, or 

consumer package must contain country 

of origin and method of production 

information (wild and/or farm-raised) as 

set forth in this regulation. 

(b) Exemptions. Food service 

establishments as defined in § 60.107 

are exempt from labeling under this 

subpart. 

(c) Exclusions. A covered commodity 

is excluded from this subpart if it is an 

ingredient in a processed food item as 

defined in § 60.119. 

(d) Designation of Method of 

Production (Wild and/or Farm-Raised).

Fish and shellfish covered commodities 

shall also be labeled to indicate whether 

they are wild and/or farm-raised as 

those terms are defined in this 

regulation. 

(e) Labeling Covered Commodities of 

United States Origin. A covered 

commodity may only bear the 

declaration of ‘‘Product of the U.S.’’ at 

retail if it meets the definition of United 

States Country of Origin as defined in 

§ 60.128. 

(f) Labeling Imported Products That 

Have Not Undergone Substantial 

Transformation in the United States. An 

imported covered commodity shall 

retain its origin as declared to U.S. 

Customs and Border Protection at the 

time the product entered the United 

States, through retail sale, provided that 

it has not undergone a substantial 

transformation (as established by U.S. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59745

Customs and Border Protection) in the 

United States.

(g) Labeling Imported Products That 

Have Subsequently Been Substantially 

Transformed in the United States.

(1) [Reserved] 

(2) Wild and Farm-Raised Fish and 

Shellfish: If a covered commodity was 

imported from country X and 

subsequently substantially transformed 

(as established by U.S. Customs and 

Border Protection) in the United States 

or aboard a U.S. flagged vessel, such 

product shall be labeled at retail as 

‘‘From [country X], processed in the 

United States.’’

(h) Blended Products (Commingling of 

the same covered commodity).

(1) For imported covered commodities 

that have not subsequently been 

substantially transformed in the United 

States that are commingled with other 

imported covered commodities that 

have not been substantially transformed 

in the United States, and/or covered 

commodities of U.S. origin and/or 

covered commodities as described in 

§ 60.200(g), the declaration shall 

indicate the countries of origin for 

covered commodities in accordance 

with existing Federal legal 

requirements. 

(2) For imported covered commodities 

that have subsequently undergone 

substantial transformation in the United 

States that are commingled with other 

imported covered commodities that 

have subsequently undergone 

substantial transformation in the United 

States (either prior to or following 

substantial transformation in the United 

States) and/or U.S. origin covered 

commodities, the declaration shall 

indicate the countries of origin 

contained therein or that may be 

contained therein. 

(i) Remotely Purchased Products. For 

sales of a covered commodity in which 

the customer purchases a covered 

commodity prior to having an 

opportunity to observe the final package 

(e.g., Internet sales, home delivery sales, 

etc.), the retailer may provide the 

country of origin notification and 

method of production (wild and/or 

farm-raised) designation either on the 

sales vehicle or at the time the product 

is delivered to the consumer.

§ 60.300 Markings. 

(a) Country of origin declarations and 

method of production (wild and/or 

farm-raised) designations can either be 

in the form of a placard, sign, label, 

sticker, band, twist tie, pin tag, or other 

format that provides country of origin 

and method of production information. 

The country of origin declaration and 

method of production (wild and/or 

farm-raised) designation may be 

combined or made separately. Except as 

provided in § 60.200(g) and 60.200(h) of 

this regulation, the declaration of the 

country(ies) of origin of a product shall 

be listed according to applicable Federal 

legal requirements. Country of origin 

declarations may be in the form of a 

check box provided it is in conformance 

with other Federal legal requirements. 

Various forms of the production 

designation are acceptable, including 

‘‘wild caught’’, ‘‘wild’’, ‘‘farm-raised’’, 

‘‘farmed’’, or a combination of these 

terms for blended products that contain 

both wild and farm-raised fish or 

shellfish, provided it can be readily 

understood by the consumer and is in 

conformance with other Federal labeling 

laws. Designations such as ‘‘ocean 

caught’’, ‘‘caught at sea’’, ‘‘line caught’’, 

‘‘cultivated’’, or ‘‘cultured’’ are not 

acceptable substitutes. Alternatively, 

method of production (wild and/or 

farm-raised) designations may be in the 

form of a check box. 

(b) The declaration of the country(ies) 

of origin and method(s) of production 

(wild and/or farm-raised) (e.g., placard, 

sign, label, sticker, band, twist tie, pin 

tag, or other display) must be placed in 

a conspicuous location, so as to render 

it likely to be read and understood by 

a customer under normal conditions of 

purchase. 

(c) The declaration of the country(ies) 

of origin and the method(s) of 

production (wild and/or farm-raised) 

may be typed, printed, or handwritten 

provided it is in conformance with other 

Federal labeling laws and does not 

obscure other labeling information 

required by other Federal regulations. 

(d) A bulk container (e.g., display 

case, shipper, bin, carton, and barrel), 

used at the retail level to present 

product to consumers, may contain a 

covered commodity from more than one 

country of origin and/or more than one 

method of production (wild and farmraised) provided all possible origins 

and/or methods of production are listed.

(e) Abbreviations and variant 

spellings that unmistakably indicate the 

country of origin, such as ‘‘U.K.’’ for 

‘‘The United Kingdom of Great Britain 

and Northern Ireland’’ are acceptable. 

The adjectival form of the name of a 

country may be used as proper 

notification of the country(ies) 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. 

(f) State or regional label designations 

are not acceptable in lieu of country of 

origin labeling. 

Recordkeeping

§ 60.400 Recordkeeping requirements. 

(a) General. 

(1) All records must be legible and 

may be maintained in either electronic 

or hard copy formats. Due to the 

variation in inventory and accounting 

documentary systems, various forms of 

documentation and records will be 

acceptable. 

(2) Upon request by USDA 

representatives, suppliers and retailers 

subject to this subpart shall make 

available to USDA representatives, 

records and other documentary 

evidence that will permit substantiation 

of an origin claim and method(s) of 

production (wild and/or farm-raised), in 

a timely manner during normal hours of 

business and at a location that is 

reasonable in consideration of the 

products and firm under review. 

(b) Responsibilities of Suppliers. 

(1) Any person engaged in the 

business of 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, unique to 

that transaction by means of a lot 

number or other unique identifier. In 

addition, 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. 

(2) Any intermediary supplier (i.e., 

not the supplier responsible for 

initiating a country of origin declaration 

and designation of wild and/or farmraised) handling a covered commodity 

that is found to be designated 

incorrectly for country of origin and/or 

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 intermediary 

supplier could not have been reasonably 

expected to have had knowledge of the 

violation. 

(3) Any person engaged in the 

business of 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 

59746 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

1The limits of the U.S. exclusive economic zone 

from points 1 to 12 in areas adjacent to Canada do 

not correspond to limits of the Canadian fishery 

zone as defined in the Canada Gazette of January 

1, 1977, due to the dispute between the United 

States and Canada relating to the sovereignty over 

Machias Seal Island and North Rock. The line 

defined by points 12 through 15 reflects the 

International Court of Justice Award of October 14, 

1984, establishing a United States-Canada maritime 

boundary, pursuant to t he Treaty between the 

Government of Canada and the Government of the 

United States of America to Submit to Binding 

Dispute Settlement the Delimitation of the Maritime 

Boundary in the gulf of Maine Area, TIAS 10204.

2The line defined by points 113 through 139 is 

that line delimited in the maritime boundary treaty 

signed with Cuba December 16, 1977, Senate 

Executive H, 96th Cong., 1st Sess. The treaty has 

been applied provisionally since January 1, 1978.

identify the immediate previous source 

(if applicable) and immediate 

subsequent recipient of a covered 

commodity, in such a way that 

identifies the product unique to that 

transaction by means of a lot number or 

other unique identifier, for a period of 

1 year from the date of the transaction. 

(4) For an imported covered 

commodity (as defined in § 60.200(f)), 

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 farm-raised) 

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.

(c) Responsibilities of Retailers. 

(1) Records and other documentary 

evidence relied upon at the point of sale 

to establish a covered commodity’s 

country(ies) of origin and designation of 

wild and/or farm-raised, must be 

available during normal business hours 

to any duly authorized representative of 

USDA at the facility for as long as the 

product is on hand. For pre-labeled 

products, the label itself is sufficient 

evidence on which the retailer may rely 

to establish the product’s origin and 

method(s) of production (wild and/or 

farm-raised). 

(2) Records that identify the retail 

supplier, the product unique to that 

transaction by means of a lot number or 

other unique identifier, 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. Such records may be 

located at the retailer’s point of 

distribution, warehouse, central offices 

or other off-site location. 

(3) Any retailer handling a covered 

commodity that is found to be 

designated incorrectly as to country of 

origin and/or the method of production 

(wild and/or farm-raised), or for frozen 

fish and shellfish covered commodities 

caught or harvested before December 6, 

2004, for the date of harvest, shall not 

be held liable for a violation of the Act 

by reason of the conduct of another if 

the retailer could not have been 

reasonably expected to have had 

knowledge of the violation.

Subpart B—[Reserved]

Appendix A to Subpart A—Exclusive 

Economic Zone and Maritime 

Boundaries; Notice of Limits

Note: The following notice was originally 

published at 60 FR 43825–43829, August 23, 

1995.

Department of State 

[Public Notice 2237] 

Exclusive Economic Zone and Maritime 

Boundaries; Notice of Limits 

By Presidential Proclamation No. 5030 

made on March 10, 1983, the United States 

established an exclusive economic zone, the 

outer limit of which is a line drawn in such 

a manner that each point on it is 200 nautical 

miles from the baseline from which the 

breadth of the territorial sea is measured. 

The Government of the United States of 

America has been, is, and will be, engaged 

in consultations and negotiations with 

governments of neighboring countries 

concerning the delimitation of areas subject 

to the respective jurisdiction of the United 

States and of these countries. 

The limits of the exclusive economic zone 

of the United States as set forth below are 

intended to be without prejudice to any 

negotiations with these countries or to any 

positions which may have been or may be 

adopted respecting the limits of maritime 

jurisdiction in such areas. Further, the limits 

of the exclusive economic zone set forth 

below are without prejudice to the outer limit 

of the continental shelf of the United States 

where that shelf extends beyond 200 nautical 

miles from the baseline in accordance with 

international law. 

The following notices have been published 

which have defined the United States 

maritime boundaries and fishery 

conservation zone established March 1, 1977: 

Public Notice 506, Federal Register, Vol. 41, 

No. 214, November 4, 1976, 48619–20; Public 

Notice 526, Federal Register, Vol. 42, No. 44, 

March 7, 1977, 12937–40; Public Notice 544, 

Federal Register, Vol. 42, No. 92, May 12, 

1977, 24134; Public Notice 4710–01, Federal 

Register, Vol. 43, No. 7, January 11, 1978, 

1658; Public Notice 585, Federal Register, 

Vol. 43, No. 7, January 11, 1978, 1659; Public 

Notice 910, Federal Register, Vol. 49, No. 

155, August 9, 1984, 31973. 

This Public Notice supersedes all limits 

defined in the above Public Notices. 

Therefore, the Department of State on 

behalf of the Government of the United States 

hereby announces the limits of the exclusive 

economic zone of the United States of 

America, within which the United States will 

exercise its sovereign rights and jurisdiction 

as permitted under international law, 

pending the establishment of permanent 

maritime boundaries by mutual agreement in 

those cases where a boundary is necessary 

and has not already been agreed. 

Publication of a notice on this subject 

which is effective immediately upon 

publication is necessary to effectively 

exercise the foreign affairs responsibility of 

the Department of State. (See Title 5 U.S.C. 

553(a)(1)(B).) 

Unless otherwise noted, the coordinates in 

this notice relate to the Clarke 1866 Ellipsoid 

and the North American 1927 Datum (‘‘NAD 

27’’). Unless otherwise specified, the term 

‘‘straight line’’ in this notice means a 

geodetic line. 

U.S. Atlantic Coast and Gulf of Mexico 

In the Gulf of Maine area, the limit of the 

exclusive economic zone is defined by 

straight lines connecting the following 

coordinates: 1

1. 44 deg. 46′35.346′′ N., 66 deg. 54′11.253’’

W. 

2. 44 deg. 44′41′′ N., 66 deg. 56′17′′ W. 

3. 44 deg. 43′56′′ N., 66 deg. 56′26′′ W. 

4. 44 deg. 39′13′′ N., 66 deg. 57′29′′ W. 

5. 44 deg. 36′58′′ N., 67 deg. 00′36′′ W. 

6. 44 deg. 33′27′′ N., 67 deg. 02′57′′ W. 

7. 44 deg. 30′38′′ N., 67 deg. 02′38′′ W. 

8. 44 deg. 29′03′′ N., 67 deg. 03′42′′ W. 

9. 44 deg. 25′27′′ N., 67 deg. 02′16′′ W. 

10. 44 deg. 21′43′′ N., 67 deg. 02′33′′ W. 

11. 44 deg. 14′06′′ N., 67 deg. 08′38′′ W. 

12. 44 deg. 11′12′′ N., 67 deg. 16′46′′ W. 

13. 42 deg. 53′14′′ N., 67 deg. 44′35′′ W. 

14. 42 deg. 31′08′′ N., 67 deg. 28′05′′ W. 

15. 40 deg. 27′05′′ N., 65 deg. 41′59′′ W.

Between points 15 and 16, the limit of the 

exclusive economic zone is 200 nautical 

miles seaward from the baseline from which 

the territorial sea is measured. 

In the area of the Blake Plateau, the Straits 

of Florida, and Eastern Gulf of Mexico, the 

limit of the exclusive economic zone shall be 

determined by straight lines connecting the 

following coordinates: 2

16. 28 deg. 17′10′′ N., 76 deg. 36′45′′ W. 

17. 28 deg. 17′10′′ N., 79 deg. 11′24′′ W. 

18. 27 deg. 52′54′′ N., 79 deg. 28′36′′ W. 

19. 27 deg. 26′00′′ N., 79 deg. 31′38′′ W. 

20. 27 deg. 16′12′′ N., 79 deg. 34′18′′ W. 

21. 27 deg. 11′53′′ N., 79 deg. 34′56′′ W. 

22. 27 deg. 05′58′′ N., 79 deg. 35′19′′ W. 

23. 27 deg. 00′27′′ N., 79 deg. 35′17′′ W.

24. 26 deg. 55′15′′ N., 79 deg. 34′39′′ W. 

25. 26 deg. 53′57′′ N., 79 deg. 34′27′′ W. 

26. 26 deg. 45′45′′ N., 79 deg. 32′41′′ W. 

27. 26 deg. 44′29′′ N., 79 deg. 32′23′′ W. 

28. 26 deg. 43′39′′ N., 79 deg. 32′20′′ W. 

29. 26 deg. 41′11′′ N., 79 deg. 32′01′′ W. 

30. 26 deg. 38′12′′ N., 79 deg. 31′33′′ W. 

31. 26 deg. 36′29′′ N., 79 deg. 31′07′′ W. 

32. 26 deg. 35′20′′ N., 79 deg. 30′50′′ W. 

33. 26 deg. 34′50′′ N., 79 deg. 30′46′′ W. 

34. 26 deg. 34′10′′ N., 79 deg. 30′38′′ W. 

35. 26 deg. 31′11′′ N., 79 deg. 30′15′′ W. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59747

3The lines defined by points 140–142 and 143–

146 reflect the exchange of Notes Effecting 

Agreement on the provisional Maritime Boundary 

with Mexico done on November 24, 1976, TIAS 

8805, 29 UST 196. The U.S.-Mexico Maritime 

Boundary Treaty, signed on May 4, 1978, Senate 

Executive F, 96th Congress, 1st Sess., defines 

boundary using the same turning points.

4The limit of the U.S. exclusive economic zone 

from points 1 to 17 adjacent to Canada in the area 

seaward of the Strait of Juan de Fuca do not 

correspond to limits of the Canadian fishery zone 

as defined in the Canada Gazette of January 1, 1977.

5The line defined by points 18 through 21 reflect 

the Exchange of Note Effecting Agreement on the 

Provisional Maritime Boundary with Mexico done 

on November 24, 1976. The U.S.-Mexico Maritime 

Boundary Treaty, signed on May 4, 1978, defines 

the boundary using the same turning points.

6The limit of the U.S. exclusive economic zone 

in areas adjacent to Canada in the Beaufort Sea do 

Continued

36. 26 deg. 29′04′′ N., 79 deg. 29′53′′ W. 

37. 26 deg. 25′30′′ N., 79 deg. 29′58′′ W. 

38. 26 deg. 23′28′′ N., 79 deg. 29′55′′ W. 

39. 26 deg. 23′20′′ N., 79 deg. 29′54′′ W. 

40. 26 deg. 18′56′′ N., 79 deg. 31′55′′ W. 

41. 26 deg. 15′25′′ N., 79 deg. 33′17′′ W. 

42. 26 deg. 15′12′′ N., 79 deg. 33′23′′ W. 

43. 26 deg. 08′08′′ N., 79 deg. 35′53′′ W. 

44. 26 deg. 07′46′′ N., 79 deg. 36′09′′ W. 

45. 26 deg. 06′58′′ N., 79 deg. 36′35′′ W. 

46. 26 deg. 02′51′′ N., 79 deg. 38′22′′ W. 

47. 25 deg. 59′29′′ N., 79 deg. 40′03′′ W. 

48. 25 deg. 59′15′′ N., 79 deg. 40′08′′ W. 

49. 25 deg. 57′47′′ N., 79 deg. 40′38′′ W. 

50. 25 deg. 56′17′′ N., 79 deg. 41′06′′ W. 

51. 25 deg. 54′03′′ N., 79 deg. 41′38′′ W. 

52. 25 deg. 53′23′′ N., 79 deg. 41′46′′ W. 

53. 25 deg. 51′53′′ N., 79 deg. 41′59′′ W. 

54. 25 deg. 49′32′′ N., 79 deg. 42′16′′ W. 

55. 25 deg. 48′23′′ N., 79 deg. 42′23′′ W. 

56. 25 deg. 48′19′′ N., 79 deg. 42′24′′ W. 

57. 25 deg. 46′25′′ N., 79 deg. 42′44′′ W. 

58. 25 deg. 46′15′′ N., 79 deg. 42′45′′ W. 

59. 25 deg. 43′39′′ N., 79 deg. 42′59′′ W. 

60. 25 deg. 42′30′′ N., 79 deg. 42′48′′ W. 

61. 25 deg. 40′36′′ N., 79 deg. 42′27′′ W. 

62. 25 deg. 37′23′′ N., 79 deg. 42′27′′ W. 

63. 25 deg. 37′07′′ N., 79 deg. 42′27′′ W. 

64. 25 deg. 31′02′′ N., 79 deg. 42′12′′ W. 

65. 25 deg. 27′58′′ N., 79 deg. 42′11′′ W. 

66. 25 deg. 24′03′′ N., 79 deg. 42′12′′ W. 

67. 25 deg. 22′20′′ N., 79 deg. 42′20′′ W. 

68. 25 deg. 21′28′′ N., 79 deg. 42′08′′ W. 

69. 25 deg. 16′51′′ N., 79 deg. 41′24′′ W. 

70. 25 deg. 15′56′′ N., 79 deg. 41′31′′ W. 

71. 25 deg. 10′38′′ N., 79 deg. 41′31′′ W. 

72. 25 deg. 09′50′′ N., 79 deg. 41′36′′ W. 

73. 25 deg. 09′02′′ N., 79 deg. 41′45′′ W. 

74. 25 deg. 03′53′′ N., 79 deg. 42′30′′ W. 

75. 25 deg. 02′58′′ N., 79 deg. 42′57′′ W. 

76. 25 deg. 00′28′′ N., 79 deg. 44′06′′ W. 

77. 24 deg. 59′01′′ N., 79 deg. 44′49′′ W. 

78. 24 deg. 55′26′′ N., 79 deg. 45′58′′ W. 

79. 24 deg. 44′16′′ N., 79 deg. 49′25′′ W. 

80. 24 deg. 43′02′′ N., 79 deg. 49′39′′ W. 

81. 24 deg. 42′34′′ N., 79 deg. 50′51′′ W. 

82. 24 deg. 41′45′′ N., 79 deg. 52′58′′ W. 

83. 24 deg. 38′30′′ N., 79 deg. 59′59′′ W. 

84. 24 deg. 36′25′′ N., 80 deg. 03′52′′ W. 

85. 24 deg. 33′16′′ N., 80 deg. 12′44′′ W. 

86. 24 deg. 33′03′′ N., 80 deg. 13′22′′ W. 

87. 24 deg. 32′11′′ N., 80 deg. 15′17′′ W. 

88. 24 deg. 31′25′′ N., 80 deg. 16′56′′ W. 

89. 24 deg. 30′55′′ N., 80 deg. 17′48′′ W. 

90. 24 deg. 30′12′′ N., 80 deg. 19′22′′ W. 

91. 24 deg. 30′04′′ N., 80 deg. 19′45′′ W. 

92. 24 deg. 29′36′′ N., 80 deg. 21′06′′ W. 

93. 24 deg. 28′16′′ N., 80 deg. 24′36′′ W. 

94. 24 deg. 28′04′′ N., 80 deg. 25′11′′ W. 

95. 24 deg. 27′21′′ N., 80 deg. 27′21′′ W. 

96. 24 deg. 26′28′′ N., 80 deg. 29′31′′ W. 

97. 24 deg. 25′05′′ N., 80 deg. 32′23′′ W. 

98. 24 deg. 23′28′′ N., 80 deg. 36′10′′ W. 

99. 24 deg. 22′31′′ N., 80 deg. 38′57′′ W. 

100. 24 deg. 22′05′′ N., 80 deg. 39′52′′ W. 

101. 24 deg. 19′29′′ N., 80 deg. 45′22′′ W. 

102. 24 deg. 19′14′′ N., 80 deg. 45′48′′ W. 

103. 24 deg. 18′36′′ N., 80 deg. 46 deg. 50′′

W. 

104. 24 deg. 18′33′′ N., 80 deg. 46′55′′ W. 

105. 24 deg. 09′49′′ N., 80 deg. 59′48′′ W. 

106. 24 deg. 09′46′′ N., 80 deg. 59′52′′ W. 

107. 24 deg. 08′56′′ N., 81 deg. 01′08′′ W. 

108. 24 deg. 03′28′′ N., 81 deg. 01′52′′ W. 

109. 24 deg. 08′24′′ N., 81 deg. 01′58′′ W. 

110. 24 deg. 07′26′′ N., 81 deg. 03′07′′ W. 

111. 24 deg. 02′18′′ N., 81 deg. 09′06′′ W. 

112. 23 deg. 59′58′′ N., 81 deg. 11′16′′ W. 

113. 23 deg. 55′30′′ N., 81 deg. 12′55′′ W. 

114. 23 deg. 53′50′′ N., 81 deg. 19′44′′ W. 

115. 23 deg. 50′50′′ N., 81 deg. 30′00′′ W. 

116. 23 deg. 50′00′′ N., 81 deg. 40′00′′ W. 

117. 23 deg. 49′03′′ N., 81 deg. 50′00′′ W. 

118. 23 deg. 49′03′′ N., 82 deg. 00′12′′ W. 

119. 23 deg. 49′40′′ N., 82 deg. 10′00′′ W. 

120. 23 deg. 51′12′′ N., 82 deg. 25′00′′ W. 

121. 23 deg. 51′12′′ N., 82 deg. 40′00′′ W. 

122. 23 deg. 49′40′′ N., 82 deg. 48′54′′ W. 

123. 23 deg. 49′30′′ N., 82 deg. 51′12′′ W. 

124. 23 deg. 49′22′′ N., 83 deg. 00′00′′ W. 

125. 23 deg. 49′50′′ N., 83 deg. 15′00′′ W. 

126. 23 deg. 51′20′′ N., 83 deg. 25′50′′ W. 

127. 23 deg. 52′25′′ N., 83 deg. 33′02′′ W. 

128. 23 deg. 54′02′′ N., 83 deg. 41′36′′ W. 

129. 23 deg. 55′45′′ N., 83 deg. 48′12′′ W. 

130. 23 deg. 58′36′′ N., 84 deg. 00′00′′ W. 

131. 24 deg. 09′35′′ N., 84 deg. 29′28′′ W. 

132. 24 deg. 13′18′′ N., 84 deg. 38′40′′ W. 

133. 24 deg. 16′39′′ N., 84 deg. 46′08′′ W. 

134. 24 deg. 23′28′′ N., 85 deg. 00′00′′ W. 

135. 24 deg. 26′35′′ N., 85 deg. 06′20′′ W. 

136. 24 deg. 38′55′′ N., 85 deg. 31′55′′ W. 

137. 24 deg. 44′15′′ N., 85 deg. 43′12′′ W.

138. 24 deg. 53′55′′ N., 86 deg. 00′00′′ W. 

139. 25 deg. 12′25′′ N., 86 deg. 33′12′′ W.

Between points 139 and 140, the limit of 

the exclusive economic zone is 200 nautical 

miles seaward from the baseline from which 

the territorial sea is measured. 

In the central Gulf of Mexico, the limit of 

the exclusive economic zone is determined 

by straight lines connecting the following 

coordinates: 3

140. 25 deg. 41′56.52.88′′ N., 88 deg. 

23′05.54′′ W. 

141. 25 deg. 46′52.00′′ N., 90 deg. 29′41.00′′

W. 

142. 25 deg. 42′13.05′′ N., 91 deg. 05′24.89′′

W.

Between points 142 and 143, the limit of 

the exclusive economic zone is 200 nautical 

miles seaward from the baseline from which 

the territorial sea is measured. 

In the western Gulf of Mexico, the limit of 

the exclusive economic zone is determined 

by straight lines connecting the following 

coordinates:

143. 25 deg. 59′48.28′′ N., 93 deg. 26′42.19′′

W. 

144. 26 deg. 00′30.00′′ N., 95 deg. 39′26.00′′

W. 

145. 26 deg. 00′31.00′′ N., 96 deg. 48′29.00′′

W. 

146. 25 deg. 58′30.57′′ N., 96 deg. 55′27.37′′

W.

From point 146, the limit of United States 

jurisdiction is the territorial sea boundary 

with Mexico established by the United States 

of America and the United Mexican States in 

Article V(A) and annexes of the Treaty to 

Resolve Pending Boundary Differences and 

Maintain the Rio Grande and Colorado River 

as the International Boundary, signed at 

Mexico City, November 23, 1970, and entered 

into force April 18, 1972, TIAS No. 7313, 23 

UST 371. 

U.S. Pacific Coast (Washington, Oregon, and 

California) 

In the area seaward of the Strait of Juan de 

Fuca, the limit of the exclusive economic 

zone shall be determined by straight lines 

connecting the points with the following 

coordinates: 4

1. 48 deg. 29′37.19′′ N., 124 deg. 43′33.19′′

W. 

2. 48 deg. 30′11′′ N., 124 deg. 47′13′′ W. 

3. 48 deg. 30′22′′ N., 124 deg. 50′21′′ W. 

4. 48 deg. 30′14′′ N., 124 deg. 54′52′′ W. 

5. 48 deg. 29′57′′ N., 124 deg. 59′14′′ W. 

6. 48 deg. 29′44′′ N., 125 deg. 00′06′′ W. 

7. 48 deg. 28′09′′ N., 125 deg. 05′47′′ W. 

8. 48 deg. 27′10′′ N., 125 deg. 08′25′′ W. 

9. 48 deg. 26′47′′ N., 125 deg. 09′12′′ W. 

10. 48 deg. 20′16′′ N., 125 deg. 22′48′′ W. 

11. 48 deg. 18′22′′ N., 125 deg. 29′58′′ W. 

12. 48 deg. 11′05′′ N., 125 deg. 53′48′′ W. 

13. 47 deg. 49′15′′ N., 126 deg. 40′57′′ W. 

14. 47 deg. 36′47′′ N., 127 deg. 11′58′′ W. 

15. 47 deg. 22′00′′ N., 127 deg. 41′23′′ W. 

16. 46 deg. 42′05′′ N., 128 deg. 51′56′′ W. 

17. 46 deg. 31′47′′ N., 129 deg. 07′39′′ W.

Between point 17 and 18, the limit of the 

exclusive economic zone is 200 nautical 

miles seaward from the baseline from which 

the breadth of the territorial sea is measured. 

In the area off the Southern California coast, 

the limit of the exclusive economic zone 

shall be determined by straight lines 

connecting the following points: 5

18. 30 deg. 32′31.20′′ N., 121 deg. 51′58.37′′

W. 

19. 31 deg. 07′58.00′′ N., 118 deg. 36′18.00′′

W. 

20. 32 deg. 37′37.00′′ N., 117 deg. 49′31.00′′

W. 

21. 32 deg. 35′22.11′′ N., 117 deg. 27′49.42′′

W.

From point 21 to the coast, the limit of 

United States jurisdiction is the territorial sea 

boundary with Mexico established by the 

United States of America and the United 

Mexican States in Article V(B) and annexes 

of the Treaty to Resolve Pending Boundary 

Differences and Maintain the Rio Grande and 

Colorado River as the International 

Boundary, signed at Mexico City, November 

23, 1970, and entered into force April 18, 

1972. 

Alaska 

Off the coast of Alaska, in the area of the 

Beaufort Sea, the limit of exclusive economic 

zone shall be determined by straight lines, 

connecting the following coordinates: 6

59748 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

not correspond to limits of the Canadian fishery 

zone, as defined in the Canada Gazette of January 

1, 1997.

7The line defined by points 22–59 and 59–87 is 

that line delimited in the maritime boundary treaty 

signed with the former Soviet Union (now 

applicable to Russia) June 1, 1990, Senate Treaty 

Doc. 102–22, and applied provisionally pending the 

exchange of instruments of ratification, by an 

exchange of notes effective June 15, 1990.

8The limit of the U.S. exclusive economic zone 

in, and seaward of, the Dixon Entrance do not 

correspond to the limits of the Canadian fishery 

zone, as defined in the Canada Gazette of January 

1, 1977. Where the claimed boundaries published 

by the United States and Canada leave an 

unclaimed area within Dixon Entrance, the United 

States will exercise fishery management jurisdiction 

to the Canadian claimed line where that line is 

situated southward of the United States claimed 

line, until such time as a permanent maritime 

boundary with Canada is established in the Dixon 

Entrance.

9The line defined by points 1–50 is that line 

delimited in the maritime boundary treaty signed 

with the United Kingdom (for the British Virgin 

Islands) at London on November 4, 1993, Senate 

Treaty Doc. 103–23, and entered into force on June 

1, 1995. The line defined by points 50–51 is that 

line delimited in the maritime boundary treaty 

signed with the United Kingdom (for Anguilla) at 

London on November 4, 1993, Senate Treaty Doc. 

103–23, and entered into force June 1, 1995. The 

line from point 1 to point 51 is on the North 

American Datum 1983 (NAD 83). The line defined 

by points 57–78 is that line delimited in the 

maritime boundary treaty signed with Venezuela at 

Caracas on March 28, 1978; the treaty entered into 

force on November 24, 1980, TIAS 9890, 32 UST 

3100.

1. 69 deg. 38′48.88′′ N., 140 deg. 59′52.7′′

W. 

2. 69 deg. 38′52′′ N., 140 deg. 59′51′′ W. 

3. 69 deg. 39′37′′ N., 140 deg. 59′01′′ W 

4. 69 deg. 40′10′′ N., 140 deg. 58′34′′ W. 

5. 69 deg. 41′30′′ N., 140 deg. 57′00′′ W. 

6. 69 deg. 46′25′′ N., 140 deg. 49′45′′ W.

7. 69 deg. 47′54′′ N., 140 deg. 47′07′′ W. 

8. 69 deg. 51′40′′ N., 140 deg. 42′37′′ W. 

9. 70 deg. 09′26′′ N., 140 deg. 19′22′′ W. 

10. 70 deg. 11′30′′ N., 140 deg. 18′09′′ W. 

11. 70 deg. 29′07′′ N., 140 deg. 09′51′′ W. 

12. 70 deg. 29′19′′ N., 140 deg. 09′45′′ W. 

13. 70 deg. 37′31′′ N., 140 deg. 02′47′′ W. 

14. 70 deg. 48′25′′ N., 139 deg. 52′32′′ W. 

15. 70 deg. 58′02′′ N., 139 deg. 47′16′′ W. 

16. 71 deg. 01′15′′ N., 139 deg. 44′24′′ W. 

17. 71 deg. 11′58′′ N., 139 deg. 33′58′′ W. 

18. 71 deg. 23′10′′ N., 139 deg. 21′46′′ W. 

19. 72 deg. 12′18′′ N., 138 deg. 26′19′′ W. 

20. 72 deg. 46′39′′ N., 137 deg. 30′02′′ W. 

21. 72 deg. 56′49′′ N., 137 deg. 34′08′′ W.

Between point 21 and point 22, the limit 

of the exclusive economic zone is 200 

nautical miles seaward from the baseline 

from which the territorial sea is measured. In 

the Chukchi Sea, Bering Strait, and northern 

Bering Sea, the limit of the exclusive 

economic zone shall be determined by 

straight lines connecting the following 

coordinates: 7

22. 72 deg. 46′29′′ N., 168 deg. 58′37′′ W. 

23. 65 deg. 30′00′′ N., 168 deg. 58′37′′ W. 

24. 65 deg. 19′58′′ N., 168 deg. 21′38′′ W. 

25. 65 deg. 09′51′′ N., 169 deg. 44′34′′ W. 

26. 64 deg. 59′41′′ N., 170 deg. 07′23′′ W. 

27. 64 deg. 49′26′′ N., 170 deg. 30′06′′ W. 

28. 64 deg. 39′08′′ N., 170 deg. 52′43′′ W. 

29. 64 deg. 28′46′′ N., 171 deg. 15′14′′ W. 

30. 64 deg. 18′20′′ N., 171 deg. 37′40′′ W. 

31. 64 deg. 07′50′′ N., 172 deg. 00′00′′ W. 

32. 63 deg. 59′27′′ N., 172 deg. 18′39′′ W. 

33. 63 deg. 51′01′′ N., 172 deg. 38′13′′ W. 

34. 63 deg. 42′33′′ N., 172 deg. 55′42′′ W. 

35. 63 deg. 34′01′′ N., 173 deg. 14′07′′ W. 

36. 63 deg. 25′27′′ N., 173 deg. 32′27′′ W. 

37. 63 deg. 16′50′′ N., 173 deg. 50′42′′ W. 

38. 63 deg. 08′11′′ N., 174 deg. 08′52′′ W. 

39. 62 deg. 59′29′′ N., 174 deg. 26′58′′ W. 

40. 62 deg. 50′44′′ N., 174 deg. 44′59′′ W. 

41. 62 deg. 41′56′′ N., 175 deg. 02′56′′ W. 

42. 62 deg. 33′06′′ N., 175 deg. 20′48′′ W. 

43. 62 deg. 24′13′′ N., 175 deg. 38′36′′ W. 

44. 62 deg. 15′17′′ N., 175 deg. 56′19′′ W. 

45. 62 deg. 06′19′′ N., 176 deg. 13′59′′ W. 

46. 61 deg. 57′18′′ N., 176 deg. 31′34′′ W. 

47. 61 deg. 48′14′′ N., 176 deg. 49′04′′ W. 

48. 61 deg. 39′08′′ N., 177 deg. 06′31′′ W. 

49. 61 deg. 29′59′′ N., 177 deg. 23′53′′ W. 

50. 61 deg. 20′47′′ N., 177 deg. 41′11′′ W. 

51. 61 deg. 11′33′′ N., 177 deg. 58′26′′ W. 

52. 61 deg. 02′17′′ N., 178 deg. 15′36′′ W. 

53. 60 deg. 52′57′′ N., 178 deg. 32′42′′ W. 

54. 60 deg. 43′35′′ N., 178 deg. 49′45′′ W. 

55. 60 deg. 34′11′′ N., 179 deg. 06′44′′ W. 

56. 60 deg. 24′44′′ N., 179 deg. 23′38′′ W. 

57. 60 deg. 15′14′′ N., 179 deg. 40′30′′ W. 

58. 60 deg. 11′39′′ N., 179 deg. 46′49′′ W.

Between points 58 and 59 the limit of the 

exclusive economic zone is 200 nautical 

miles seaward from the baseline from which 

the territorial sea is measured. In the 

southern Bering Sea and north Pacific Ocean, 

the limit of the exclusive economic zone 

shall be determined the straight lines 

connecting the following coordinates:

59. 56 deg. 16′31′′ N., 174 deg. 00′19′′ E. 

60. 56 deg. 15′07′′ N., 173 deg. 56′56′′ E. 

61. 56 deg. 04′34′′ N., 173 deg. 41′08′′ E. 

62. 55 deg. 53′59′′ N., 173 deg. 25′22′′ E. 

63. 55 deg. 43′22′′ N., 173 deg. 09′37′′ E. 

64. 55 deg. 32′42′′ N., 172 deg. 53′55′′ E. 

65. 55 deg. 21′59′′ N., 172 deg. 38′14′′ E. 

66. 55 deg. 11′14′′ N., 172 deg. 22′36′′ E. 

67. 55 deg. 00′26′′ N., 172 deg. 06′59′′ E. 

68. 54 deg. 49′36′′ N., 171 deg. 51′24′′ E. 

69. 54 deg. 38′43′′ N., 171 deg. 35′51′′ E. 

70. 54 deg. 27′48′′ N., 171 deg. 20′20′′ E. 

71. 54 deg. 16′50′′ N., 171 deg. 04′50′′ E. 

72. 54 deg. 05′50′′ N., 170 deg. 49′22′′ E. 

73. 53 deg. 54′47′′ N., 170 deg. 33′56′′ E. 

74. 53 deg. 43′42′′ N., 170 deg. 18′31′′ E. 

75. 53 deg. 32′46′′ N., 170 deg. 05′29′′ E. 

76. 53 deg. 21′48′′ N., 169 deg. 52′32′′ E. 

77. 53 deg. 10′49′′ N., 169 deg. 39′40′′ E. 

78. 52 deg. 59′48′′ N., 169 deg. 26′53′′ E. 

79. 52 deg. 48′46′′ N., 169 deg. 14′12′′ E. 

80. 52 deg. 37′43′′ N., 169 deg. 01′36′′ E. 

81. 52 deg. 26′38′′ N., 168 deg. 49′05′′ E. 

82. 52 deg. 15′31′′ N., 168 deg. 36′39′′ E. 

83. 52 deg. 04′23′′ N., 168 deg. 24′17′′ E. 

84. 51 deg. 53′14′′ N., 168 deg. 12′01′′ E. 

85. 51 deg. 42′03′′ N., 167 deg. 59′49′′ E. 

86. 51 deg. 30′51′′ N., 167 deg. 47′42′′ E. 

87. 51 deg. 22′15′′ N., 167 deg. 38′28′′ E.

From point 87 to point 88, the limit of the 

exclusive economic zone is 200 nautical 

miles from the baseline from which the 

territorial sea is measured. From point 88, the 

southern limit of the exclusive economic 

zone off the coast of Alaska shall be 

determined by straight lines connecting the 

following coordinates: 8

88. 53 deg. 28′27′′ N., 138 deg. 45′20′′ W. 

89. 54 deg. 00′01′′ N., 135 deg. 45′57′′ W. 

90. 54 deg. 07′30′′ N., 134 deg. 56′24′′ W. 

91. 54 deg. 12′45′′ N., 134 deg. 25′03′′ W. 

92. 54 deg. 12′57′′ N., 134 deg. 23′47′′ W. 

93. 54 deg. 15′40′′ N., 134 deg. 10′49′′ W. 

94. 54 deg. 20′33′′ N., 133 deg. 49′21′′ W. 

95. 54 deg. 22′01′′ N., 133 deg. 44′24′′ W. 

96. 54 deg. 30′06′′ N., 133 deg. 16′58′′ W. 

97. 54 deg. 31′02′′ N., 133 deg. 14′00′′ W. 

98. 54 deg. 30′42′′ N., 133 deg. 11′28′′ W. 

99. 54 deg. 30′10′′ N., 133 deg. 07′43′′ W. 

100. 54 deg. 30′03′′ N., 133 deg. 07′00′′ W. 

101. 54 deg. 28′32′′ N., 132 deg. 56′28′′ W. 

102. 54 deg. 28′25′′ N., 132 deg. 55′54′′ W. 

103. 54 deg. 27′23′′ N., 132 deg. 50′42′′ W. 

104. 54 deg. 27′07′′ N., 132 deg. 49′35′′ W. 

105. 54 deg. 26′00′′ N., 132 deg. 44′12′′ W. 

106. 54 deg. 24′54′′ N., 132 deg. 39′46′′ W. 

107. 54 deg. 24′34′′ N., 132 deg. 38′16′′ W. 

108. 54 deg. 24′39′′ N., 132 deg. 26′51′′ W. 

109. 54 deg. 24′41′′ N., 132 deg. 24′35′′ W. 

110. 54 deg. 24′41′′ N., 132 deg. 24′29′′ W. 

111. 54 deg. 24′52′′ N., 132 deg. 23′39′′ W. 

112. 54 deg. 21′51′′ N., 132 deg. 02′54′′ W. 

113. 54 deg. 26′41′′ N., 131 deg. 49′28′′ W. 

114. 54 deg. 28′18′′ N., 131 deg. 45′20′′ W. 

115. 54 deg. 30′32′′ N., 131 deg. 38′01′′ W. 

116. 54 deg. 29′53′′ N., 131 deg. 33′48′′ W. 

117. 54 deg. 36′53′′ N., 131 deg. 19′22′′ W. 

118. 54 deg. 39′09′′ N., 131 deg. 16′17′′ W. 

119. 54 deg. 40′52′′ N., 131 deg. 13′54′′ W. 

120. 54 deg. 42′11′′ N., 131 deg. 13′00′′ W. 

121. 54 deg. 46′16′′ N., 131 deg. 04′43′′ W. 

122. 54 deg. 45′39′′ N., 131 deg. 03′06′′ W. 

123. 54 deg. 44′12′′ N., 130 deg. 59′44′′ W. 

124. 54 deg. 43′46′′ N., 130 deg. 58′55′′ W. 

125. 54 deg. 43′00′′ N., 130 deg. 57′41′′ W. 

126. 54 deg. 42′34′′ N., 130 deg. 57′09′′ W. 

127. 54 deg. 42′27′′ N., 130 deg. 56′18′′ W. 

128. 54 deg. 41′26′′ N., 130 deg. 53′39′′ W. 

129. 54 deg. 41′21′′ N., 130 deg. 53′18′′ W. 

130. 54 deg. 41′05′′ N., 130 deg. 49′17′′ W. 

131. 54 deg. 41′06′′ N., 130 deg. 48′31′′ W. 

132. 54 deg. 40′46′′ N., 130 deg. 45′51′′ W. 

133. 54 deg. 40′41′′ N., 130 deg. 44′59′′ W. 

134. 54 deg. 40′42′′ N., 130 deg. 44′43′′ W. 

135. 54 deg. 40′03′′ N., 130 deg. 42′22′′ W. 

136. 54 deg. 39′48′′ N., 130 deg. 41′35′′ W. 

137. 54 deg. 39′14′′ N., 130 deg. 39′18′′ W. 

138. 54 deg. 39′54′′ N., 130 deg. 38′58′′ W. 

139. 54 deg. 41′09′′ N., 130 deg. 38′58′′ W. 

140. 54 deg. 42′22′′ N., 130 deg. 38′26′′ W. 

141. 54 deg. 42′47′′ N., 130 deg. 38′06′′ W. 

142. 54 deg. 42′58′′ N., 130 deg. 37′57′′ W. 

143. 54 deg. 43′00′′ N., 130 deg. 37′55′′ W. 

144. 54 deg. 43′15′′ N., 130 deg. 37′44′′ W. 

145. 54 deg. 43′24′′ N., 130 deg. 37′39′′ W. 

146. 54 deg. 43′30.15′′ N., 130 deg. 

37′37.01′′ W. 

Caribbean Sea 

The seaward limit of the exclusive 

economic zone around the Commonwealth of 

Puerto Rico and the Virgin Islands of the 

United States is a line 200 nautical miles 

from the baseline from which the breadth of 

the territorial sea is measured, except that to 

the east, south, and west, the limit of the 

exclusive economic zone shall be determined 

by straight lines connecting the following 

coordinates: 9

1. 21 deg. 48′33′′ N., 65 deg. 50′31′′ W. 

2. 21 deg. 41′20′′ N., 65 deg. 49′13′′ W. 

3. 20 deg. 58′05′′ N., 65 deg. 40′30′′ W. 

4. 20 deg. 46′56′′ N., 65 deg. 38′14′′ W. 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 59749

10The line defined by points 1–12 constitutes the 

line of delimination between the maritime zones of 

the United States and Japan as reflected in an 

Exchange of Notes effective July 5, 1994. Points 1–

12 are on the World Geodetic System 1984 (WGS 

84). In this regard, users should be aware that the 

Government of Japan defines points 1–12 on the 

Tokyo Datum and the coordinate values will differ 

slightly from those published in this Notice.

11The line defined by points 1–8 is that line 

delimited in the maritime boundary treaty with 

New Zealand (for Tokelau) signed at Atafu on 

December 2, 1980; this treaty entered into force on 

September 3, 1983, TIAS 10775. The line defined 

by points 8–32 is that line delimited in the 

maritime boundary treaty with the Cook Islands 

signed at Rarotonga on June 11, 1980; this treaty 

entered into force on September 8, 1983, TIAS 

10774. Points 1–32 are on the World Geodetic 

System 1972 (WGS 72).

5. 19 deg. 57′29′′ N., 65 deg. 27′21′′ W. 

6. 19 deg. 37′29′′ N., 65 deg. 20′57′′ W. 

7. 19 deg. 12′25′′ N., 65 deg. 06′08′′ W. 

8. 18 deg. 45′14′′ N., 65 deg. 00′22′′ W. 

9. 18 deg. 41′14′′ N., 64 deg. 59′33′′ W. 

10. 18 deg. 29′22′′ N., 64 deg. 53′50′′ W. 

11. 18 deg. 27′36′′ N., 64 deg. 53′22′′ W. 

12. 18 deg. 25′22′′ N., 64 deg. 52′39′′ W. 

13. 18 deg. 24′31′′ N., 64 deg. 52′19′′ W. 

14. 18 deg. 23′51′′ N., 64 deg. 51′50′′ W. 

15. 18 deg. 23′43′′ N., 64 deg. 51′23′′ W. 

16. 18 deg. 23′37′′ N., 64 deg. 50′18′′ W. 

17. 18 deg. 23′48′′ N., 64 deg. 49′42′′ W. 

18. 18 deg. 24′11′′ N., 64 deg. 49′01′′ W. 

19. 18 deg. 24′29′′ N., 64 deg. 47′57′′ W. 

20. 18 deg. 24′18′′ N., 64 deg. 47′00′′ W. 

21. 18 deg. 23′14′′ N., 64 deg. 46′37′′ W. 

22. 18 deg. 22′38′′ N., 64 deg. 45′21′′ W.

23. 18 deg. 22′40′′ N., 64 deg. 44′42′′ W. 

24. 18 deg. 22′42′′ N., 64 deg. 44′36′′ W. 

25. 18 deg. 22′37′′ N., 64 deg. 44′24′′ W. 

26. 18 deg. 22′40′′ N., 64 deg. 43′42′′ W. 

27. 18 deg. 22′30′′ N., 64 deg. 43′36′′ W. 

28. 18 deg. 22′25′′ N., 64 deg. 42′58′′ W. 

29. 18 deg. 22′27′′ N., 64 deg. 42′28′′ W. 

30. 18 deg. 22′16′′ N., 64 deg. 42′03′′ W. 

31. 18 deg. 22′23′′ N., 64 deg. 40′59′′ W. 

32. 18 deg. 21′58′′ N., 64 deg. 40′15′′ W. 

33. 18 deg. 21′51′′ N., 64 deg. 38′22′′ W. 

34. 18 deg. 21′22′′ N., 64 deg. 38′16′′ W. 

35. 18 deg. 20′39′′ N., 64 deg. 38′32′′ W. 

36. 18 deg. 19′16′′ N., 64 deg. 38′13′′ W. 

37. 18 deg. 19′07′′ N., 64 deg. 38′16′′ W. 

38. 18 deg. 17′24′′ N., 64 deg. 39′37′′ W. 

39. 18 deg. 16′43′′ N., 64 deg. 39′41′′ W. 

40. 18 deg. 11′34′′ N., 64 deg. 38′58′′ W. 

41. 18 deg. 03′03′′ N., 64 deg. 38′03′′ W. 

42. 18 deg. 02′57′′ N., 64 deg. 29′35′′ W. 

43. 18 deg. 02′52′′ N., 64 deg. 27′03′′ W. 

44. 18 deg. 02′30′′ N., 64 deg. 21′08′′ W. 

45. 18 deg. 02′31′′ N., 64 deg. 20′08′′ W. 

46. 18 deg. 02′01′′ N., 64 deg. 15′39′′ W. 

47. 18 deg. 00′12′′ N., 64 deg. 02′29′′ W. 

48. 17 deg. 59′58′′ N., 64 deg. 01′02′′ W. 

49. 17 deg. 58′47′′ N., 63 deg. 57′00′′ W. 

50. 17 deg. 57′51′′ N., 63 deg. 53′53′′ W. 

51. 17 deg. 56′37′′ N., 63 deg. 53′20′′ W. 

52. 17 deg. 39′48′′ N., 63 deg. 54′54′′ W. 

53. 17 deg. 37′15′′ N., 63 deg. 55′11′′ W. 

54. 17 deg. 30′28′′ N., 63 deg. 55′57′′ W. 

55. 17 deg. 11′43′′ N., 63 deg. 58′00′′ W. 

56. 17 deg. 05′07′′ N., 63 deg. 58′42′′ W. 

57. 16 deg. 44′49′′ N., 64 deg. 01′08′′ W. 

58. 16 deg. 43′22′′ N., 64 deg. 06′31′′ W. 

59. 16 deg. 43′10′′ N., 64 deg. 06′59′′ W. 

60. 16 deg. 42′40′′ N., 64 deg. 08′06′′ W. 

61. 16 deg. 41′43′′ N., 64 deg. 10′07′′ W. 

62. 16 deg. 35′19′′ N., 64 deg. 23′39′′ W. 

63. 16 deg. 23′30′′ N., 64 deg. 45′54′′ W. 

64. 15 deg. 39′31′′ N., 65 deg. 58′41′′ W. 

65. 15 deg. 30′10′′ N., 66 deg. 07′09′′ W. 

66. 15 deg. 14′06′′ N., 66 deg. 19′57′′ W. 

67. 14 deg. 55′48′′ N., 66 deg. 34′30′′ W. 

68. 14 deg. 56′06′′ N., 66 deg. 51′40′′ W. 

69. 14 deg. 58′27′′ N., 67 deg. 04′19′′ W. 

70. 14 deg. 58′45′′ N., 67 deg. 05′17′′ W. 

71. 14 deg. 58′58′′ N., 67 deg. 06′11′′ W. 

72. 14 deg. 59′10′′ N., 67 deg. 07′00′′ W. 

73. 15 deg. 02′32′′ N., 67 deg. 23′40′′ W. 

74. 15 deg. 05′07′′ N., 67 deg. 36′23′′ W. 

75. 15 deg. 10′38′′ N., 68 deg. 03′46′′ W. 

76. 15 deg. 11′06′′ N., 68 deg. 09′21′′ W. 

77. 15 deg. 12′33′′ N., 68 deg. 27′32′′ W. 

78. 15 deg. 12′51′′ N., 68 deg. 28′56′′ W. 

79. 15 deg. 46′46′′ N., 68 deg. 26′04′′ W. 

80. 17 deg. 21′30′′ N., 68 deg. 17′53′′ W. 

81. 17 deg. 38′01′′ N., 68 deg. 16′46′′ W. 

82. 17 deg. 50′24′′ N., 68 deg. 16′11′′ W. 

83. 17 deg. 58′07′′ N., 68 deg. 15′52′′ W. 

84. 18 deg. 02′28′′ N., 68 deg. 15′40′′ W. 

85. 18 deg. 06′10′′ N., 68 deg. 15′27′′ W. 

86. 18 deg. 07′27′′ N., 68 deg. 15′33′′ W. 

87. 18 deg. 09′12′′ N., 68 deg. 14′53′′ W. 

88. 18 deg. 17′06′′ N., 68 deg. 11′28′′ W. 

89. 18 deg. 19′20′′ N., 68 deg. 09′40′′ W. 

90. 18 deg. 22′42′′ N., 68 deg. 06′57′′ W. 

91. 18 deg. 24′39′′ N., 68 deg. 04′58′′ W. 

92. 18 deg. 25′25′′ N., 68 deg. 04′09′′ W. 

93. 18 deg. 28′08′′ N., 68 deg. 00′59′′ W. 

94. 18 deg. 31′27′′ N., 67 deg. 56′57′′ W. 

95. 18 deg. 32′58′′ N., 67 deg. 55′07′′ W. 

96. 18 deg. 34′34′′ N., 67 deg. 52′53′′ W. 

97. 18 deg. 54′37′′ N., 67 deg. 46′21′′ W. 

98. 19 deg. 00′42′′ N., 67 deg. 44′25′′ W. 

99. 19 deg. 10′00′′ N., 67 deg. 41′24′′ W. 

100. 19 deg. 19′03′′ N., 67 deg. 38′19′′ W. 

101. 19 deg. 21′20′′ N., 67 deg. 38′01′′ W. 

102. 19 deg. 59′45′′ N., 67 deg. 31′52′′ W. 

103. 20 deg. 00′59′′ N., 67 deg. 31′35′′ W. 

104. 20 deg. 01′17′′ N., 67 deg. 31′29′′ W. 

105. 20 deg. 02′49′′ N., 67 deg. 31′04′′ W. 

106. 20 deg. 03′30′′ N., 67 deg. 30′52′′ W. 

107. 20 deg. 09′28′′ N., 67 deg. 29′11′′ W. 

108. 20 deg. 48′18′′ N., 67 deg. 17′50′′ W. 

109. 21 deg. 22′48′′ N., 67 deg. 02′34′′ W. 

110. 21 deg. 30′18′′ N., 66 deg. 59′05′′ W. 

111. 21 deg. 33′47′′ N., 66 deg. 57′30′′ W. 

112. 21 deg. 51′24′′ N., 66 deg. 49′30′′ W.

Navassa Island. The limits of the exclusive 

economic zone around Navassa Island 

remain to be determined. 

Central and Western Pacific 

Northern Mariana Islands and Guam. The 

seaward limit of the exclusive economic zone 

is 200 nautical miles from the baseline from 

which the breadth of the territorial sea is 

measured, except that to the north of the 

Northern Mariana Islands, the limit of the 

exclusive economic zone shall be determined 

by straight lines connecting the following 

points: 10

1. 23 deg. 53′35′′ N., 145 deg. 05′46′′ E. 

2. 23 deg. 44′32′′ N., 144 deg. 54′05′′ E. 

3. 23 deg. 33′52′′ N., 144 deg. 40′23′′ E.

4. 23 deg. 16′11′′ N., 144 deg. 17′47′′ E. 

5. 22 deg. 50′13′′ N., 143 deg. 44′57′′ E. 

6. 22 deg. 18′13′′ N., 143 deg. 05′02′′ E. 

7. 21 deg. 53′58′′ N., 142 deg. 35′03′′ E. 

8. 21 deg. 42′14′′ N., 142 deg. 20′39′′ E. 

9. 21 deg. 40′08′′ N., 142 deg. 18′05′′ E. 

10. 21 deg. 28′21′′ N., 142 deg. 03′45′′ E. 

11. 20 deg. 58′24′′ N., 141 deg. 27′33′′ E. 

12. 20 deg. 52′51′′ N., 141 deg. 20′54′′ E.

and, except that to the south of Guam, the 

limit of the exclusive economic zone shall be 

determined by straight lines connecting the 

following points:

13. 11 deg. 38′25′′ N., 147 deg. 44′42′′ E. 

14. 11 deg. 36′53′′ N., 147 deg. 31′03′′ E. 

15. 11 deg. 31′48′′ N., 146 deg. 55′19′′ E. 

16. 11 deg. 27′15′′ N., 146 deg. 25′34′′ E. 

17. 11 deg. 22′13′′ N., 145 deg. 52′36′′ E. 

18. 11 deg. 17′31′′ N., 145 deg. 22′38′′ E. 

19. 11 deg. 13′32′′ N., 144 deg. 57′26′′ E. 

20. 11 deg. 13′23′′ N., 144 deg. 56′29′′ E. 

21. 10 deg. 57′03′′ N., 143 deg. 26′53′′ E. 

22. 10 deg. 57′30′′ N., 143 deg. 03′09′′ E. 

23. 11 deg. 52′33′′ N., 142 deg. 15′28′′ E. 

24. 12 deg. 54′00′′ N., 141 deg. 21′48′′ E. 

25. 12 deg. 54′17′′ N., 141 deg. 21′33′′ E. 

26. 12 deg. 57′34′′ N., 141 deg. 19′17′′ E. 

27. 13 deg. 06′32′′ N., 141 deg. 12′53′′ E.

Hawaii and Midway Island. The seaward 

limit of the exclusive economic zone is 200 

nautical miles from the baselines from which 

the territorial sea is measured. 

Johnston Atoll. The seaward limit of the 

exclusive economic zone is 200 nautical 

miles from the baselines from which the 

territorial sea is measured. 

American Samoa. The seaward limit of the 

exclusive economic zone shall be determined 

by straight lines connecting the following 

points: 11

1. 11 deg. 02′17′′ S., 173 deg. 44′48′′ W. 

2. 10 deg. 46′15′′ S., 173 deg. 03′53′′ W. 

3. 10 deg. 25′26′′ S., 172 deg. 11′01′′ W. 

4. 10 deg. 17′50′′ S., 171 deg. 50′58′′ W. 

5. 10 deg. 15′17′′ S., 171 deg. 15′32′′ W. 

6. 10 deg. 10′18′′ S., 170 deg. 16′10′′ W. 

7. 10 deg. 07′52′′ S., 169 deg. 46′50′′ W. 

8. 10 deg. 01′26′′ S., 168 deg. 31′25′′ W. 

9. 10 deg. 12′44′′ S., 168 deg. 31′02′′ W. 

10. 10 deg. 12′49′′ S., 168 deg. 31′02′′ W. 

11. 10 deg. 52′31′′ S., 168 deg. 29′42′′ W. 

12. 11 deg. 02′40′′ S., 168 deg. 29′21′′ W. 

13. 11 deg. 43′53′′ S., 168 deg. 27′58′′ W. 

14. 12 deg. 01′55′′ S., 168 deg. 10′24′′ W. 

15. 12 deg. 28′40′′ S., 167 deg. 25′20′′ W. 

16. 12 deg. 41′22′′ S., 167 deg. 11′01′′ W. 

17. 12 deg. 57′51′′ S., 166 deg. 52′21′′ W. 

18. 13 deg. 11′25′′ S., 166 deg. 37′02′′ W. 

19. 13 deg. 14′03′′ S., 166 deg. 34′03′′ W. 

20. 13 deg. 21′25′′ S., 166 deg. 25′42′′ W. 

21. 13 deg. 35′44′′ S., 166 deg. 09′19′′ W. 

22. 13 deg. 44′56′′ S., 165 deg. 58′44′′ W. 

23. 14 deg. 03′30′′ S., 165 deg. 37′20′′ W. 

24. 15 deg. 00′09′′ S., 165 deg. 22′07′′ W. 

25. 15 deg. 14′04′′ S., 165 deg. 18′29′′ W. 

26. 15 deg. 38′47′′ S., 165 deg. 12′03′′ W. 

27. 15 deg. 44′58′′ S., 165 deg. 16′36′′ W. 

28. 16 deg. 08′42′′ S., 165 deg. 34′12′′ W. 

29. 16 deg. 18′30′′ S., 165 deg. 41′29′′ W. 

30. 16 deg. 23′29′′ S., 165 deg. 45′11′′ W. 

31. 16 deg. 45′30′′ S., 166 deg. 01′39′′ W. 

32. 17 deg. 33′28′′ S., 166 deg. 38′35′′ W. 

33. 17 deg. 31′45′′ S., 166 deg. 42′07′′ W. 

34. 16 deg. 56′20′′ S., 168 deg. 26′05′′ W. 

35. 16 deg. 37′55′′ S., 169 deg. 18′19′′ W. 

36. 16 deg. 37′36′′ S., 169 deg. 19′12′′ W. 

37. 16 deg. 34′58′′ S., 169 deg. 55′59′′ W. 

38. 16 deg. 39′17′′ S., 170 deg. 19′09′′ W. 

39. 16 deg. 48′46′′ S., 171 deg. 12′29′′ W. 

40. 16 deg. 49′33′′ S., 171 deg. 17′03′′ W. 

41. 16 deg. 13′29′′ S., 171 deg. 37′41′′ W. 

42. 16 deg. 04′47′′ S., 171 deg. 42′37′′ W.

59750 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Rules and Regulations 

43. 15 deg. 58′20′′ S., 171 deg. 46′06′′ W. 

44. 15 deg. 50′48′′ S., 171 deg. 50′23′′ W. 

45. 15 deg. 50′12′′ S., 171 deg. 50′44′′ W. 

46. 15 deg. 14′19′′ S., 171 deg. 37′37′′ W. 

47. 15 deg. 01′58′′ S., 171 deg. 31′37′′ W. 

48. 14 deg. 46′48′′ S., 171 deg. 24′21′′ W. 

49. 14 deg. 27′02′′ S., 171 deg. 14′46′′ W. 

50. 14 deg. 06′18′′ S., 171 deg. 04′48′′ W. 

51. 14 deg. 03′28′′ S., 171 deg. 03′06′′ W. 

52. 14 deg. 03′27′′ S., 171 deg. 03′05′′ W. 

53. 14 deg. 03′05′′ S., 171 deg. 02′53′′ W. 

54. 13 deg. 56′54′′ S., 170 deg. 59′34′′ W. 

55. 13 deg. 54′30′′ S., 170 deg. 58′20′′ W. 

56. 13 deg. 53′43′′ S., 170 deg. 57′57′′ W. 

57. 13 deg. 50′40′′ S., 170 deg. 56′24′′ W. 

58. 13 deg. 13′56′′ S., 170 deg. 44′20′′ W. 

59. 13 deg. 09′05′′ S., 170 deg. 42′39′′ W. 

60. 12 deg. 36′18′′ S., 170 deg. 30′44′′ W. 

61. 12 deg. 36′11′′ S., 170 deg. 31′35′′ W. 

62. 12 deg. 35′21′′ S., 170 deg. 36′26′′ W. 

63. 12 deg. 29′47′′ S., 171 deg. 08′24′′ W.

64. 12 deg. 27′27′′ S., 171 deg. 17′25′′ W. 

65. 12 deg. 23′34′′ S., 171 deg. 25′18′′ W. 

66. 12 deg. 17′36′′ S., 171 deg. 37′14′′ W. 

67. 12 deg. 14′01′′ S., 171 deg. 44′25′′ W. 

68. 12 deg. 13′49′′ S., 171 deg. 44′47′′ W. 

69. 12 deg. 05′27′′ S., 172 deg. 00′55′′ W. 

70. 11 deg. 54′06′′ S., 172 deg. 22′53′′ W. 

71. 11 deg. 53′57′′ S., 172 deg. 23′09′′ W. 

72. 11 deg. 40′49′′ S., 172 deg. 48′17′′ W. 

73. 11 deg. 26′56′′ S., 173 deg. 08′46′′ W. 

74. 11 deg. 22′08′′ S., 173 deg. 15′50′′ W. 

75. 11 deg. 02′28′′ S., 173 deg. 44′37′′ W. 

76. 11 deg. 02′17′′ S., 173 deg. 44′48′′ W.

Palmyra Atoll-Kingman Reef. The seaward 

limit of the exclusive economic zone is 200 

nautical miles from the baseline from which 

the territorial sea is measured, except that to 

the southeast of Palmyra Atoll and Kingman 

Reef the limit of the exclusive economic zone 

shall be determined by straight lines 

connecting the following points:

1. 7 deg. 55′04′′ N., 159 deg. 22′29′′ W. 

2. 7 deg. 31′05′′ N., 159 deg. 39′30′′ W. 

3. 7 deg. 09′43′′ N., 159 deg. 54′35′′ W. 

4. 6 deg. 33′40′′ N., 160 deg. 19′51′′ W. 

5. 6 deg. 31′37′′ N., 160 deg. 21′18′′ W. 

6. 6 deg. 25′31′′ N., 160 deg. 25′40′′ W. 

7. 6 deg. 03′05′′ N., 160 deg. 41′42′′ W. 

8. 5 deg. 44′12′′ N., 160 deg. 55′13′′ W. 

9. 4 deg. 57′25′′ N., 161 deg. 28′19′′ W. 

10. 4 deg. 44′38′′ N., 161 deg. 37′18′′ W. 

11. 3 deg. 54′25′′ N., 162 deg. 12′56′′ W. 

12. 2 deg. 39′50′′ N., 163 deg. 05′14′′ W.

Wake Island. The seaward limit of the 

exclusive economic zone is 200 nautical 

miles from the baseline from which the 

territorial sea is measured, except that to the 

south of Wake Island the limit of the 

exclusive economic zone shall be determined 

by straight lines connecting the following 

points:

1. 17 deg. 56′15′′ N., 169 deg. 54′00′′ E. 

2. 17 deg. 46′02′′ N., 169 deg. 31′18′′ E. 

3. 17 deg. 37′47′′ N., 169 deg. 12′53′′ E. 

4. 17 deg. 11′18′′ N., 168 deg. 13′30′′ E. 

5. 16 deg. 41′31′′ N., 167 deg. 07′39′′ E. 

6. 16 deg. 02′45′′ N., 165 deg. 43′30′′ E.

Jarvis Island. The seaward limit of the 

exclusive economic zone is 200 nautical 

miles from the baseline from which the 

territorial sea is measured, except that to the 

north and east of Jarvis Island, the limit of 

the exclusive economic zone shall be 

determined by straight lines connecting the 

following points: 

1. 2 deg. 01′00′′ N., 162 deg. 22′00′′ W. 

2. 2 deg. 01′42′′ N., 162 deg. 01′35′′ W. 

3. 2 deg. 03′20′′ N., 161 deg. 41′33′′ W. 

4. 2 deg. 02′30′′ N., 161 deg. 36′20′′ W. 

5. 2 deg. 00′13′′ N., 161 deg. 22′24′′ W. 

6. 1 deg. 50′18′′ N., 160 deg. 20′42′′ W. 

7. 1 deg. 45′46′′ N., 159 deg. 52′59′′ W. 

8. 1 deg. 43′31′′ N., 159 deg. 39′27′′ W. 

9. 0 deg. 58′53′′ N., 158 deg. 59′04′′ W. 

10. 0 deg. 46′58′′ N., 158 deg. 48′24′′ W. 

11. 0 deg. 12′36′′ N., 158 deg. 18′06′′ W. 

12. 0 deg. 00′17′′ S., 158 deg. 07′27′′ W. 

13. 0 deg. 24′23′′ S., 157 deg. 49′44′′ W. 

14. 0 deg. 25′44′′ S., 157 deg. 48′43′′ W. 

15. 0 deg. 58′15′′ S., 157 deg. 24′52′′ W. 

16. 2 deg. 13′26′′ S., 157 deg. 49′01′′ W. 

17. 3 deg. 10′40′′ S., 158 deg. 10′30′′ W.

Howland and Baker IslandS., The seaward 

limit of the exclusive economic zone is a line 

200 nautical miles from the baseline from 

which the territorial sea is measured, except 

to the southeast and south of Howland and 

Baker Islands the limit of the exclusive 

economic zone shall be determined by 

straight lines connecting the following 

points:

1. 0 deg. 14′30′′ N., 173 deg. 08′00′′ W. 

2. 0 deg. 14′32′′ S., 173 deg. 27′28′′ W. 

3. 0 deg. 43′52′′ S., 173 deg. 45′30′′ W. 

4. 1 deg. 04′06′′ S., 174 deg. 17′41′′ W. 

5. 1 deg. 12′39′′ S., 174 deg. 31′02′′ W. 

6. 1 deg. 14′52′′ S., 174 deg. 34′48′′ W. 

7. 1 deg. 52′36′′ S., 175 deg. 34′51′′ W. 

8. 1 deg. 59′17′′ S., 175 deg. 45′29′′ W. 

9. 2 deg. 17′09′′ S., 176 deg. 13′58′′ W. 

10. 2 deg. 32′51′′ S., 176 deg. 38′59′′ W. 

11. 2 deg. 40′26′′ S., 176 deg. 51′03′′ W. 

12. 2 deg. 44′49′′ S., 176 deg. 58′01′′ W. 

13. 2 deg. 44′53′′ S., 176 deg. 58′08′′ W. 

14. 2 deg. 56′33′′ S., 177 deg. 16′43′′ W. 

15. 2 deg. 58′45′′ S., 177 deg. 26′00′′ W.

Dated: August 10, 1995. 

David A. Colson,

Deputy Assistant Secretary for OceanS.,

Dated: September 30, 2004. 

A.J. Yates, 

Administrator, Agricultural Marketing 

Service.

[FR Doc. 04–22309 Filed 9–30–04; 3:00 pm] 

BILLING CODE 3410–02–P