[Federal Register: October 30, 2003 (Volume 68, Number 210)]
[Proposed Rules]               
[Page 61943-61985]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30oc03-34]                         


[[Page 61943]]

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Part IV





Department of Agriculture





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Agricultural Marketing Service



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7 CFR Part 60



Mandatory Country of Origin Labeling of Beef, Lamb, Pork, Fish, 
Perishable Agricultural Commodities, and Peanuts; Proposed Rule


[[Page 61944]]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 60

[No. LS-03-04]
RIN 0581-AC26

 
Mandatory Country of Origin Labeling of Beef, Lamb, Pork, Fish, 
Perishable Agricultural Commodities, and Peanuts

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Farm Security and Rural Investment Act of 2002 (Farm Bill) 
and the 2002 Supplemental Appropriations Act (Appropriations Act) 
amended the Agricultural Marketing Act of 1946 (Act) to require 
retailers to notify their customers of the country of origin of covered 
commodities beginning September 30, 2004. The law also requires the 
Department of Agriculture (USDA) to issue regulations to implement a 
mandatory country of origin labeling (COOL) program not later than 
September 30, 2004. 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 (fresh and frozen fruits and 
vegetables); and peanuts. This proposed rule contains definitions, the 
requirements for consumer notification and product marking, and the 
recordkeeping responsibilities of both retailers and suppliers.

DATES: Comments must be submitted on or before December 29, 2003 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 e-mail to cool@usda.gov. State that 
your comments refer to Docket No. LS-03-04. Comments received will be 
posted to the AMS Web site at: http://www.ams.usda.gov/cool/. 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: Robert Keeney, Deputy Administrator, 
Fruit and Vegetable Programs, AMS, USDA, by telephone on 202/720-4722, or via e-mail at: robert.keeney@usda.gov; or 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:

Questions and Answers Concerning This Proposed Rule

What Are the General Requirements of Country of Origin Labeling?

    The Farm Bill (Public Law 107-171) and the Appropriations Act 
(Public Law 107-206) amended the Act (7 U.S.C. 1621 et seq.) to require 
retailers to notify their customers of the country of origin of beef 
(including veal), lamb, pork, fish, perishable agricultural 
commodities, and peanuts beginning September 30, 2004. The law also 
requires USDA to issue regulations to implement this program no later 
than September 30, 2004. The law defines the terms ``retailer'' and 
``perishable agricultural commodity'' as having the meanings given 
those terms in the Perishable Agricultural Commodities Act of 1930 
(PACA)(7 U.S.C. 499 et seq.). Food service establishments are 
specifically excluded. In addition, the law specifically outlines the 
criteria a covered commodity must meet to bear a ``United States 
country of origin'' label.

Why Can't 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. For beef, pork, and lamb, for 
example, U.S. origin can only be claimed if derived from animals that 
are born, raised, and slaughtered in the United States. 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, 
imported or domestic. 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.

The Internal Revenue Service Essentially Uses Self-Certification, 
Backed Up by Selective Audits, for Those of Us Who File Income Taxes. 
Why Couldn't Self-Certification Work for COOL?

    The COOL law requires firms or individuals that supply covered 
commodities to retailers to provide information indicating the 
product's country of origin. This information must address the 
production steps included in the origin claim (i.e., born, raised, and 
slaughtered or produced). Self-certification documents or affidavits 
may play a role in assuring that auditable records are available 
throughout the chain of custody, but the auditable records must 
themselves also be available to ensure credibility of country of origin 
labeling claims.

With a Number of Covered Commodities, Particularly Produce Items, 
Already Labeled as to Country of Origin at Retail, How Big a Burden 
Will Mandatory Country of Origin Labeling Actually Cause?

    It is certainly true that some covered commodities, particularly 
produce items, are already being labeled as to country of origin at 
retail establishments. It is also the case that existing Federal law 
and regulation (e.g., PACA) help ensure the truthfulness of such 
labels. At the same time, the labeling of such commodities with country 
of origin information is neither mandatory nor universal at the current 
time. Thus, while the burden of implementing country of origin labeling 
for those commodities should be lessened, some additional effort may 
still be required. For example, suppliers will need to ensure that 
documentation is complete and properly maintained. Retailers will need 
to manage their product displays to ensure country of origin 
information is being properly conveyed to their customers.

Why Can't USDA Use The Same System To Verify Compliance With Country of 
Origin Labeling That It Uses for Meat Products Under USDA's Commodity 
Procurement Program?

    There are several reasons why the systems must be different. First, 
the requirements for origin are not the same. The COOL law for U.S. 
origin requires meat products to be from cattle, hogs, and sheep that 
are born, raised, and slaughtered in the United States. USDA's 
commodity procurement program requires meat products to come from U.S.-
produced livestock. The definition of U.S.-produced livestock excludes 
only imported meat and meat

[[Page 61945]]

from livestock imported for direct slaughter.
    The system for verifying compliance with USDA's commodity 
procurement program is a ``command and control'' type system. USDA, 
through various certification or audit programs, confirms the 
applicable claim at the beginning of the process, then tracks and 
controls the movement of the product throughout the rest of the 
marketing chain. A similar system for COOL would require USDA to verify 
that livestock were born in the United States, then track and control 
the movement of those livestock and resulting meat products through the 
marketing chain to retail. However, the COOL law specifically precludes 
USDA from imposing this type of control.

How Will the Mandatory Country of Origin Labeling Requirements Impact 
Existing U.S. Cow and Bull Herds?

    The law requires country of origin labeling for all covered 
commodities sold at retail beginning September 30, 2004, and does not 
contain a grandfathering provision that would exclude meat from these 
animals from the mandatory labeling requirements. If records as to 
where these animals were born, raised, and slaughtered do not exist, 
retailers could not substantiate a country of origin claim that would 
comply with the law.

Are Cattle, Hogs, and Sheep Covered Commodities?

    No. However, the law requires suppliers to provide country of 
origin information to retailers, including the ``born, raised, and 
slaughtered'' information required to make U.S. origin claims for the 
covered commodities beef, pork, and lamb. The records needed to 
substantiate this information can only be created by persons having 
first-hand knowledge of the country designation for each production 
step declared in the country of origin claim. Thus, livestock producers 
will need to create and/or maintain these records to enable retail 
suppliers to provide retailers with correct country of origin 
information.
    This proposed rule is issued pursuant to the Farm Bill and the 
Appropriations Act, 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.
    In response to these requests for comment, AMS received over 2,400 
written comments. In addition, as another means to receive public input 
with respect to this rulemaking action, AMS held 12 formal educational 
and listening sessions throughout the United States to afford 
interested parties the opportunity to provide comments and ideas on the 
mandatory COOL program's development. Over 3,300 people attended the 
listening sessions and approximately 580 people provided oral 
testimony.
    AMS has considered all of the comments received to date in 
developing this proposed rule. Several key concepts have emerged from 
both the written comments and the public testimony from the listening 
and educational sessions:
    [sbull] General opinions of the law (i.e., both pro and con).
    [sbull] Conflicting testimony regarding the costs that will be 
incurred by the industry in complying with the law.
    [sbull] Opinion that the law will improve the food safety of 
covered commodities.
    [sbull] Conflicting testimony as to whether there will be 
improvement in the marketplace because of consumers' willingness to pay 
for U.S. origin of covered commodities.
    [sbull] Opinion that poultry will be placed at a competitive 
advantage because it is exempt from labeling under COOL.
    [sbull] Opinion that significant pricing disparity will exist 
between retailers required to label under COOL and those that are 
exempt such as fish markets and butcher shops.
    [sbull] Opinion that the law requiring mandatory COOL should be 
repealed and the program should be made permanently voluntary.
    [sbull] Opinions that COOL should be implemented immediately due to 
the Canadian BSE incident.
    [sbull] Considerable testimony that presumption of U.S. origin 
should be allowed.
    [sbull] Considerable testimony that only imported products should 
be tracked and controlled.
    [sbull] Considerable testimonies that COOL should be implemented in 
the least costly manner possible.
    [sbull] Conflicting testimony on how to interpret the scope of 
covered commodities.
    [sbull] Considerable testimony that producers should be allowed to 
self-certify the origin of their animals.
    [sbull] Considerable testimony that required recordkeeping should 
be minimized and should allow for the use of existing records to the 
maximum extent possible.
    [sbull] Testimony that this law may violate United States trade 
obligations under the World Trade Organization.
    AMS has accepted many of the commenters' recommendations in 
developing this proposed rule. However, several of the recommendations 
provided by the commenters are not in conformance with the law and were 
therefore not adopted. Further discussion on the key concerns raised by 
the commenters can be found in each applicable section. AMS has also 
included a ``Questions and Answers'' section to address a few of the 
more common questions posed by the commenters.

Background

    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. It is not a 
food safety or animal health measure. COOL is a retail labeling program 
and as such does not address food safety or animal health concerns. 
Food products, both imported and domestic, must meet the food safety 
standards of FSIS and/or the Food and Drug Administration (FDA), as 
applicable. In addition, all food products must also meet FDA labeling 
standards as well as all other applicable FDA regulations and 
standards.
    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 (fresh and frozen fruits and 
vegetables); and peanuts. The law defines the terms ``retailer'' and 
``perishable agricultural commodity'' as having the meanings given 
those terms in PACA.
    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 beef, lamb, and pork, the covered

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commodity must be derived from an animal that was exclusively born, 
raised, and slaughtered in the United States. In the case of beef, this 
definition also includes cattle exclusively born and raised in Alaska 
or Hawaii and transported for a period not to exceed 60 days through 
Canada to the United States and slaughtered in the United States. 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 the country of origin declaration to 
distinguish between wild and farm-raised fish and shellfish. In the 
case of perishable agricultural commodities and peanuts, the products 
must be produced in the United States.
    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 PACA 
as the meaning of ``retailer'' for the application of the labeling 
requirements under the COOL law. Under PACA, a retailer is any person 
who is a dealer engaged in the business of selling any perishable 
agricultural commodity solely at retail when the invoice cost of all 
purchases of produce exceeds $230,000 during a calendar year. This 
definition excludes butcher shops, fish markets, and small grocery 
stores that either sell fruits and vegetables at a level below this 
dollar volume threshold or do not sell any fruits and vegetables at 
all.
    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 (Secretary) 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.

Key Components of the Law

Defining Covered Commodities

    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.

Exclusion for Ingredient in a Processed Food Item

    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.'' However, Public Law 107-171 does not define a ``processed 
food item.'' Therefore, AMS must define what constitutes a ``processed 
food item'' for each covered commodity in the context of Public Law 
107-171 for the purposes of this proposed regulation.
    In defining ``processed food item'' in the voluntary guidelines (67 
FR 63367), AMS recognized that the term ``processed'' has been 
previously defined in other regulations promulgated by AMS, such as 
those issued in conjunction with the National Organic Program. AMS also 
stated that it did not believe that these definitions were suitable for 
use in the COOL program because using such a broad definition would 
exempt commodities that Congress clearly intended to be governed under 
this law.
    AMS received numerous comments relating to the definition of a 
``processed food item.'' Many commenters suggested that the definition 
of processed food item published in the voluntary guidelines (67 FR 
63367) resulted in significantly reducing the number of food items 
Congress intended to be covered by the Act. These commenters contend, 
for example, that a roast remains a muscle cut of beef even if cooked, 
salted, or flavored.
    Conversely, many other commenters suggested that the definition 
published in the voluntary guidelines (67 FR 63367) was too narrow and 
resulted in the inclusion of products that Congress did not intend to 
be covered by the Act. These commenters contend that any item bearing 
an ingredient statement should not be required to be labeled under 
COOL.
    As this is a retail labeling law, to help guide AMS in determining 
how to define a ``processed food item,'' AMS viewed the scope of 
covered commodities in the context of how these products are marketed 
at the retail level. For example, most peanuts sold at retail are 
shelled and roasted. To interpret the law as only applying to green 
peanuts would result in the exclusion of most peanuts sold at retail. 
Similarly, to exclude canned fish would result in the exclusion of a 
large share of the fish products sold at retail.
    To address the concerns raised by the commenters, AMS has chosen to 
define a ``processed food item'' utilizing a 2-step approach. First, a 
retail item derived from a covered commodity that has undergone a 
physical or chemical change, causing the character to be different from 
that of the covered commodity is deemed to be a processed food item. 
Examples include oranges that have been squeezed and made into orange 
juice, a fresh leg of pork that has been cured and made into a ham, 
peanuts that have been ground and made into peanut butter, or flesh of 
a fish that has been restructured and made into a fish stick. These 
retail items have undergone a physical or chemical change such that 
they no longer retain the characteristics of the covered commodity and 
thus consumers would not use the items in the same manner as they would 
the covered commodities. Second, a retail item derived from a covered 
commodity that has been combined with either (1) other covered 
commodities, or (2) other substantive food components (e.g., chocolate, 
stuffing) resulting in a distinct retail item that is no longer 
marketed as a covered commodity. Examples include a salad mix that 
contains lettuce and tomatoes, peanuts in a candy bar, a stuffed pork 
chop, or seafood medley.
    Alternatively, some commenters suggested that a processed food item 
could be defined as to exclude any product that bears an ingredient 
statement. These commenters contend that this would establish a bright 
line standard that would enable companies throughout the marketing 
chain to readily determine whether the commodities they produce or sell 
would be covered commodities. Utilizing such a definition would result 
in the exclusion of many products, including those products in which 
the ingredient statement lists only the commodity itself. Accordingly, 
AMS invites further

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comment on the practicality of this alternative definition.
    Similarly, some commenters suggested that any covered commodity 
that has undergone processing as defined by other existing Federal 
regulations (e.g., PACA, National Organic Program, and AMS Processed 
Fruit and Vegetable Inspection Program) should be defined as an 
ingredient in a processed food item, thereby being excluded from 
country of origin labeling under this law. Under this alternative any 
food item that represents additional transformation (e.g., canning, 
cooking, dehydration, drying, fermentation, milling, the addition of 
chemical substances, etc.) of a covered commodity would be considered a 
processed food item. In addition, a covered commodity that has been 
combined with other covered commodities or other ingredients would also 
be considered an ingredient in a processed food item and excluded from 
labeling. Utilizing such a definition could result in the exclusion of 
many retail products. Accordingly, AMS invites further comment on the 
practicality of this alternative definition.
    As another alternative, some commenters suggested that a covered 
commodity that is further processed (i.e., cured, restructured, etc.) 
should not be excluded unless the covered commodity is mixed with other 
commodities to create a distinct food item such as a pizza or TV 
dinner. Accordingly, AMS also invites further comment on the 
practicality of this alternative definition.
    AMS invites further comment on its preferred approach, the three 
identified alternatives, or any other alternative to the statutory 
exclusion for an ingredient in a processed food item.

Muscle Cuts of Beef, Lamb, and Pork

    All muscle cuts of beef (including veal), lamb, and pork whether 
chilled, frozen, raw, cooked, seasoned, or breaded are covered 
commodities and would be subject to these regulations unless they are 
an ingredient in a processed food item.
    In cases where a retail item is derived from a muscle cut of beef, 
lamb, or pork that has undergone a physical or chemical change, causing 
the character to be different than that of the covered commodity, that 
item is considered a processed food item and would be excluded from 
needing to bear a country of origin declaration under these 
regulations. For example, products such as restructured steaks and 
cured products like hams, corned beef briskets, and bacon would be 
considered processed food items as they no longer retain the 
characteristics of the covered commodity and thus consumers would not 
use them in the same manner as they would the covered commodity. A 
consumer who desires a fresh pork leg for roasting would not substitute 
a cured product such as ham for the same purpose. In addition, these 
products also are not typically marketed with muscle meats at a retail 
establishment, but are generally marketed with other excluded meat 
products.
    In cases where a retail item is derived from a covered commodity 
that has been combined with non-substantive components, and the 
character of the covered commodity is retained, the resulting product 
would not be considered a processed food item and would be subject to 
these regulations. Examples include products such as needle-tenderized 
steaks; fully-cooked entrees containing beef pot roast with gravy; 
seasoned, vacuum-packaged pork loins; and water-enhanced case ready 
steaks, chops, and roasts. These items would not be considered 
processed food items because the combination of non-substantive 
components and a muscle cut of beef, lamb, or pork does not result in a 
retail item with characteristics that are different from that of the 
covered commodity and would generally be used by consumers in the same 
manner.
    In cases where a retail item consists of a muscle cut of beef, 
lamb, and pork and another covered commodity or other substantive food 
components resulting in a distinct retail item that is no longer 
marketed as a covered commodity, such an item is considered a processed 
food item and would be excluded from these regulations. An example 
includes an item such as a shish kabob containing beef and lamb, which 
would not be marketed as a muscle cut of beef or lamb, but would 
instead be marketed as a shish kabob.

Ground Beef, Lamb, and Pork

    Under the law, ground beef, ground lamb, and ground pork are 
required to bear a country of origin declaration. FSIS rules and 
regulations specifically define the requirements for products to be 
labeled as ``ground beef,'' ``ground pork,'' and ``ground lamb.'' As 
such, only those products that meet FSIS requirements to be labeled as 
``ground beef,'' ``ground pork,'' or ``ground lamb,'' must bear a 
country of origin declaration in accordance with this proposed rule.

Fresh and Frozen Fruits and Vegetables

    Under the law, perishable agricultural commodities as defined by 
PACA are required to bear a country of origin declaration. PACA defines 
perishable agricultural commodities as ``any of the following, whether 
or not frozen or packed in ice: Fresh fruits and vegetables of every 
kind and character; and * * * includes cherries in brine as defined by 
the Secretary in accordance with trade usages.'' Therefore, frozen 
fruits and vegetables (e.g., a package of frozen strawberries or frozen 
french fried potatoes made from sliced potatoes) would be covered 
commodities subject to these regulations; however, cooked and canned 
fruits and vegetables would be exempt.
    In order to maintain consistency with PACA, a frozen fruit or 
vegetable would be a covered commodity as long as it is not an 
ingredient in a processed food item and thus its ``kind or character'' 
has not been altered. For example, a retail item derived from a 
perishable agricultural commodity that has undergone a physical or 
chemical change, causing the character to be different from that of the 
covered commodity, is considered to be a processed food item and would 
be excluded from these regulations. For example, oranges that have been 
squeezed and made into orange juice or apples that have been mashed and 
made into fresh apple sauce would be considered processed food items as 
they no longer retain the characteristics of the covered commodity and 
thus consumers would not use them in the same manner as they would the 
covered commodity.
    In cases where a retail item is derived from a perishable 
agricultural commodity combined with non-substantive components and the 
character of the covered commodity is retained, the resulting product 
is not considered a processed food item and would be subject to these 
regulations. Examples include products such as strawberries packaged 
with sugar, a preservative, or other flavoring. These items would not 
be considered processed food items because the addition of non-
substantive components does not result in a retail item with 
characteristics that are different from that of the covered commodity 
and would generally be used by consumers in the same manner as the 
covered commodity.
    In cases where a retail item is derived from a perishable 
agricultural commodity that has been combined with another covered 
commodity or other substantive food components resulting in a distinct 
retail item that is not marketed as a covered commodity, such an item 
is considered a processed food item and would be excluded from

[[Page 61948]]

these regulations. Examples include a frozen prepared pie that includes 
frozen sliced apples, a fruit cup containing cantaloupe, honeydew, and 
watermelon, or a vegetable tray containing both carrots and celery.

Peanuts

    All peanuts, whether raw, roasted, in-shell, shelled, salted, 
seasoned, or canned are subject to these regulations unless they are an 
ingredient in a processed food item. Under the law, the term ``covered 
commodity'' includes ``peanuts.'' Because the vast majority of peanuts 
sold at retail are shelled, roasted, and salted, AMS believes these 
products were intended to be covered by the law. Accordingly, shelled 
and/or roasted peanuts would be subject to these regulations as these 
retail items do not have characteristics that are different from that 
of a covered commodity. Further, peanuts that have been combined with 
other non-substantive ingredients such as oil, salt, or other 
flavorings would also be subject to these regulations. However, peanut 
products such as candy coated peanuts, peanut brittle, and peanut 
butter would not be subject these regulations as they are processed 
food items with a character that is different than that of the covered 
commodity. In addition, in cases where the peanuts are ingredients in 
other food products (e.g., peanuts in a candy bar), they would also be 
excluded from these regulations as they are not marketed as a covered 
commodity.

Wild and Farm-Raised Fish and Shellfish

    All fish and shellfish, whether chilled, frozen, raw, cooked, 
breaded, or canned would be subject to these regulations unless they 
are an ingredient in a processed food item. This includes fillets, 
steaks, nuggets, and other flesh from wild or farm-raised fish and 
shellfish.
    In cases where a retail item is derived from fish or shellfish that 
has undergone a physical or chemical change, causing the character to 
be different than that of the covered commodity, that item is 
considered a processed food item and would be excluded from these 
regulations. For example, items such as restructured shrimp or fish 
sticks and smoked and cured products would be considered processed food 
items because they no longer retain the characteristics of the covered 
commodity and thus consumers would not use them in the same manner as 
they would the covered commodity.
    In cases where a retail item is derived from a fish or shellfish 
that has been combined with non-substantive ingredients such as 
seasonings, preservatives, or breading, that item would not be 
considered a processed food item as it does not result in a retail item 
with characteristics that are different from that of the covered 
commodity and would generally be used by consumers in the same manner 
as the covered commodity.
    In cases where a retail item is derived from a fish or shellfish 
that has been combined with another covered commodity or other 
substantive ingredients, that item would be considered a processed food 
item and would not be subject to these regulations as it results in a 
distinct retail item that is no longer marketed as a covered commodity. 
Examples include a bag of seafood medley, stuffed salmon, or surimi.

Labeling Country of Origin for Products Produced Exclusively in the 
United States

    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) Beef--covered commodities must be derived exclusively from an 
animal that was born, raised, and slaughtered in the United States 
(including from an animal exclusively born and raised in Alaska or 
Hawaii and transported for a period not to exceed 60 days through 
Canada to the United States and slaughtered in the United States).
    (b) Lamb and Pork--covered commodities must be derived exclusively 
from an animal that was born, raised, and slaughtered in the United 
States.
    (c) Farm-raised Fish and Shellfish--covered commodities must be 
derived exclusively from fish or shellfish hatched, raised, harvested, 
and processed in the United States.
    (d) 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.
    (e) Fresh and Frozen Fruits and Vegetables, and Peanuts--covered 
commodities must be derived exclusively from perishable agricultural 
commodities or peanuts grown in the United States.
    Products otherwise meeting the requirements of ``United States 
country of origin'' may retain that designation after export for 
further processing in a foreign country and reentry into the United 
States for retail sale provided a verifiable recordkeeping audit trail 
is maintained. However, in the case of meat and meat products, 
additional labeling information may be required by other Federal 
agencies.

Labeling Country of Origin for Imported Products (i.e., Produced 
Entirely Outside of the United States)

    Currently, under the Tariff Act of 1930, as amended (19 U.S.C. 
1304)(Tariff Act), most imported items, including food items, are 
required to be marked to indicate the ``country of origin'' to the 
``ultimate purchaser.'' The U.S. Bureau of Customs and Border 
Protection (CBP), which administers the Tariff Act, generally defines 
``ultimate purchaser'' as the last person in the United States who will 
receive the article in the form in which it was imported and defines 
``country of origin'' as the country of manufacture, production, or 
growth of any article of foreign origin entering the United States.
    For example, under the Tariff Act, containers (e.g., cartons and 
boxes) holding imported fresh fruits and vegetables must bear a country 
of origin declaration (as defined by current CBP regulations) when 
entering the United States. However, under current law, a retailer may 
remove loose produce from a labeled container and display it in an open 
bin, selling each individual piece of produce without a country of 
origin declaration. In contrast, this proposed rule would require the 
retailer to notify the consumer as to the country of origin of all 
covered commodities whether individually packaged or displayed in a 
bin.
    Currently, under the Federal Meat Inspection Act (FMIA)(21 U.S.C. 
601 et seq.), all meat products imported into the United States are 
required to bear the country of origin on the labeling of the container 
in which the products are shipped. If imported meat or meat products 
are intended to be sold intact to a grocer or household consumer (i.e., 
consumer-ready packaging), the country of origin is conveyed to those 
recipients. For example, if a bulk shipping container imported from 
country X, consists of pre-packaged and labeled meat cuts that are 
intended to be sold to grocers or at retail to household consumers as 
they are packaged, each package would bear a country of origin 
declaration (e.g., product of country X).
    Currently, under the Tariff Act, if an article is destined for a 
U.S. processor or manufacturer in which it will undergo ``substantial 
transformation,'' that processor or manufacturer is generally 
considered the ``ultimate

[[Page 61949]]

purchaser.'' As such, products that have been substantially transformed 
by a U.S. processor generally are not required to bear a country of 
origin declaration. Similarly, under current FSIS policies and 
directives, imported meat and meat products that are further processed 
in the United States are not required to bear country of origin 
declarations on the newly produced products or subsequent products made 
from them as these products are now considered to be domestic.
    Under this proposed rule, imported covered commodities for which 
origin has already been established as defined by this regulation 
(e.g., born, raised, and slaughtered in the case of meat products or 
grown in the case of peanuts), shall retain their origin, as determined 
by CBP at the time the product entered the United States, through 
retail sale. For example, if an imported lamb carcass derived from an 
animal that was born, raised, and slaughtered in country X, was further 
processed in the United States, the resulting products derived from 
that carcass would be labeled as ``product of the country X.'' However, 
in this example, additional labeling information may be required by 
FSIS.
    Products imported in consumer-ready packages, including food 
products (e.g., frozen green beans or canned ham), are currently 
required to bear a country of origin declaration on each individual 
package under both the Tariff Act and FMIA. This proposed rule would 
not change these requirements.

Labeling Country of Origin When the Product Has Entered the United 
States During the Production Process (i.e., Mixed Origin That Includes 
the United States)

    The law specifically defines the requirements for covered 
commodities to bear a ``United States country of origin'' declaration. 
However, the law is less specific for products produced completely or 
in part outside of the United States. In these instances, the law 
requires only that retailers inform consumers as to the country of 
origin of a covered commodity at the final point of sale.

Beef, Lamb, and Pork

    The law states that only covered commodities derived from animals 
that were born, raised, and slaughtered in the United States may bear a 
``United States country of origin'' declaration. AMS recognizes that a 
number of animals born in foreign countries are raised and slaughtered 
in the United States. In addition, some animals born in the United 
States are raised in foreign countries and then either slaughtered in 
that foreign country or returned to the United States for slaughter.
    The requirements for products to bear a ``Product of the United 
States'' declaration do not permit products derived from animals that 
were born, raised, or slaughtered in a foreign country to be labeled as 
``Product of the United States.'' However, AMS recognizes that to label 
products of an animal that was only born in country X, but raised and 
slaughtered in the United States solely as ``Product of country X'' 
does not reference the significant production steps that occurred in 
the United States. Therefore, under this proposed rule, products that 
were produced in both a foreign country and the United States would be 
labeled at retail as being imported from the foreign country and also 
for the production steps that occurred in the United States. For 
example, pork products derived from a pig that was born in country X, 
raised and slaughtered in the United States would be labeled as 
``Imported from country X, Raised and Slaughtered in the United 
States.'' Alternatively, products may also be labeled to specifically 
identify the production step(s) that occurred in the country other than 
the United States if the animal's identity was maintained along with 
records to substantiate the origin claims. For example, products 
derived from a pig that was born and raised in country X and 
slaughtered in the United States could either be labeled as ``Imported 
from country X, Slaughtered in the United States'' or ``Born and Raised 
in country X, Slaughtered in the United States.'' AMS invites further 
comment on the use of alternative terms for the term ``slaughtered.''
    AMS also recognizes that in some cases, an animal will undergo 
production steps in two or more foreign countries prior to entering the 
United States for additional processing or a final process such as 
slaughter. In these cases, the meat products derived from an animal 
that was born in country X, raised in country Y, and slaughtered in the 
United States would be labeled at retail as being imported from country 
Y and for any production steps occurring in the United States. For 
example, if a calf was born in country X and raised in country Y before 
being imported for slaughter in the United States, the resulting meat 
products derived from this animal would be labeled as ``Imported from 
country Y, Slaughtered in the United States.'' Alternatively, if the 
animal's identity was maintained along with the records to substantiate 
the origin claims, the product could be labeled to specifically 
identify the production step(s) (e.g., born, raised) occurring in the 
country(ies) other than the United States. In the example cited above, 
the product could be labeled ``Born in country X, Raised in country Y, 
Slaughtered in the United States.''
    AMS invites further comment on this approach to the labeling of 
beef, lamb and pork, and requests identification of alternative 
approaches to labeling such products.

Wild and Farm-Raised Fish and Shellfish

    In the case of wild fish and shellfish, the law states that a 
covered commodity can only bear a ``United States country of origin'' 
declaration if it is harvested in the waters of the United States or 
aboard a U.S. flagged vessel and processed in the United States or 
aboard a U.S. flagged vessel. In the case of farm-raised fish and 
shellfish, the law states that a covered commodity can only be labeled 
as ``Product of the U.S.'' if it is hatched, raised, harvested, and 
processed in the United States. However, the law does not define the 
term processed.
    AMS received numerous comments requesting that the regulations for 
the mandatory COOL program conform to existing regulations of CBP 
wherever possible to eliminate redundancies, costs, and conflicts. As 
such, for wild and farm-raised fish and shellfish, AMS has defined 
``processed'' as any process that effects substantial transformation as 
defined by CBP Rules of Origin.
    In the case of wild fish and shellfish, if a covered commodity was 
harvested in the waters of the U.S. or by a U.S. flagged vessel and 
processed in country X or aboard a country X flagged vessel, the 
covered commodity shall be labeled at retail as ``Product of country 
X.'' For example, if a fish was caught in U.S. waters and processed 
into individually quick-frozen fillets in country Y, such product would 
be labeled as ``Product of country Y'' because it has been 
substantially transformed as defined by CBP and thus does not meet the 
requirements to bear a U.S. origin declaration. Alternatively, the 
product may also be labeled to include the production step occurring in 
the United States if the product's identity was maintained along with 
records to substantiate the origin claims. In the example provided 
above, the product could be labeled as ``product of country Y, 
harvested in the United States.''
    If a covered commodity was harvested in country Y and processed in 
the United States or aboard a U.S. flagged vessel, the product shall be 
labeled at retail as ``Imported from country Y, processed in the United 
States.'' In all cases, the covered commodity must also

[[Page 61950]]

be labeled to indicate that it was derived from wild fish and/or 
shellfish.
    In the case of farm-raised fish, if a covered commodity was hatched 
in country X, and raised, harvested and/or processed in the United 
States, the product would be labeled as being imported from country X 
and for the production step(s) occurring in the United States. For 
example, if a fish was hatched in country X and processed in the United 
States, the product would be labeled as ``Imported from country X, 
Processed in the United States.''
    If a covered commodity was hatched, raised, and harvested in the 
United States and processed in country X, the product shall be labeled 
at retail as ``Product of country X.'' Alternatively, the product may 
also be labeled to include the production step(s) occurring in the 
United States if the product's identity was maintained along with 
records to substantiate the origin claims. In the example given above, 
the product could be labeled as ``Product of country X, hatched, 
raised, and harvested in the United States.'' In all cases, the covered 
commodity must also be labeled to indicate that it was derived from 
farm-raised fish and/or shellfish. Farm-raised fish means fish or 
shellfish that have been harvested in controlled or selected 
environments, including ocean-ranched (e.g., penned) fish and shellfish 
confined in managed beds; and fillets, steaks, nuggets, and any other 
flesh from a farm-raised fish or shellfish. For example, mussels on 
rope culture and oysters on leased land would be considered farm-
raised.
    AMS invites further comment on this approach to the labeling of 
wild and farm-raised fish and shellfish and requests identification of 
alternative approaches to labeling such products.

Defining Country of Origin for Blended Products

    Many of the covered commodities required to bear a country of 
origin declaration under the law are commingled or blended products 
that were prepared from raw material sources having different origins 
(e.g., bagged lettuce, ground beef, shrimp, etc.). However, the law 
does not specify how these products should be labeled.
    In defining country of origin for blended or mixed products in the 
voluntary guidelines (67 FR 63367), AMS recognized that it could be 
misleading to consumers if only a small percentage of a covered 
commodity mixture met the definition of United States origin and yet 
the mixture could list the United States first ahead of other countries 
in the country of origin declaration on the package. As such, under the 
voluntary guidelines, the country of origin declaration was to reflect 
the country of origin for each raw material source of the mixed or 
blended retail item by order of predominance by weight. In addition, 
under the voluntary guidelines, containers of mixed or blended products 
in which the individual constituents could be separately identified, 
would have to bear a country of origin declaration individually 
identifying the country of origin of each constituent.
    AMS received numerous comments on this issue stating that to 
require labeling in the order of predominance by weight and for each 
individual constituent would be cumbersome, impractical, and costly.
    In response to these comments, under this proposed rule, the 
country of origin declaration of blended or mixed retail food items 
comprised of the same covered commodity (e.g., bag of lettuce or 
package of ground beef) that are prepared from raw material sources 
having different origins must list alphabetically the countries of 
origin for all of the raw materials contained therein. For example, a 
bag of red and green leaf lettuce from country A and country B would be 
labeled as ``Product of country A, Product of country B.'' However, 
under this proposed rule, items such as a salad mix or a fruit cup 
would not be required to bear a country of origin declaration because 
these items would be considered processed food items and would be 
excluded from these regulations.

Method of Notification

    The law states that the country of origin declaration may be 
provided to consumers by means of 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.
    Under this proposed rule, market participants can utilize a variety 
of different labeling nomenclatures to denote the country of origin of 
a covered commodity. For example, ``U.K.'' and ``United Kingdom of 
Great Britain and Northern Ireland'' would both be allowed under this 
proposed rule.
    AMS received numerous comments requesting acceptance for labels 
containing only the name of the country such as ``USA'' due to the 
limited amount of space on many retail items. Therefore, under this 
proposed rule, country of origin declarations may be in the form of a 
statement such as ``Product of USA,'' ``Grown in Mexico,'' or they may 
only contain the name of the country such as ``USA'' or ``Mexico'' 
provided it is in conformance with other existing Federal laws. 
However, the labeling requirements under this proposed rule do not 
supercede any existing labeling requirements, unless otherwise 
specified, and any such country of origin notification must not obscure 
other labeling information required by existing regulatory 
requirements.
    For those entities that are regulated by FSIS, all country of 
origin labels must be submitted to FSIS for pre-approval as required by 
current FSIS regulations.
    In order to provide the industry with as much flexibility as 
possible, this proposed rule does not contain specific requirements as 
to the exact placement or size of the country of origin declaration. 
However, such declaration must be conspicuous and allow consumers to 
determine the country of origin when making their purchases and 
provided that existing Federal labeling requirements must be followed.

State and Regional Labeling Programs

    The law requires retailers to notify consumers of the country of 
origin of covered commodities. Therefore, State and regional labeling 
programs such as ``Washington apples,'' ``Idaho potatoes,'' and 
``California Grown'' do not meet this requirement and cannot be 
accepted in lieu of country of origin labeling.

Existing State-Level Country of Origin Labeling Laws

    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 particular meat products. In addition, the 
State of Florida and the State of Maine have origin labeling 
requirements for fresh produce items.
    AMS received several comments asserting that these State programs, 
particularly the State of Florida's program, should serve as models for 
the Federal mandatory COOL program. AMS has reviewed these existing 
programs and concluded that most of these programs do not meet the 
requirements of the Act. Accordingly, AMS has determined that, in 
general, these programs are not suitable models on which to base the 
regulations for the Federal mandatory COOL program.
    With regard to enforcement activities, while some of these States 
actively enforce their respective origin labeling

[[Page 61951]]

laws and impose fines on those found to be in violation and/or seize 
product found to be mislabeled, other States conduct no such 
enforcement activities. With respect to the Florida law that is 
actively enforced by the State, verification of a product's origin 
generally consists of the inspector observing the primary container the 
product was packaged in to determine if the retailer has accurately 
characterized the origin of the product on the shelf. This enforcement 
program is based on a presumption of truthfulness that allows the 
retailer to rely on the information printed either on the shipping 
container or on the product itself. Therefore, AMS does not believe 
this type of enforcement program could serve as a model for enforcement 
of the Federal program.

Remotely Purchased Products

    Many consumers are now purchasing products from retailers prior to 
having an opportunity to observe the final package (e.g., Internet 
sales, home delivery sales, etc.). In the voluntary guidelines (67 FR 
63367), AMS stated its belief that consumers should be made aware of 
the country of origin of a covered commodity before the purchase is 
made. Thus, under the voluntary guidelines retailers were required to 
provide the country of origin information on the sales vehicle (i.e., 
Internet site, home delivery catalog, etc.) as part of the information 
describing the covered commodity for sale.
    Numerous commenters stated that it would be nearly impossible and 
extremely impractical to have current country of origin information on 
an Internet site or catalog as this information changes rapidly 
depending on the store location or warehouse at which an order is 
processed and filled. Therefore, under this proposed rule, retailers 
must provide notification of country of origin at the time the product 
is delivered to the customer.

Recordkeeping Requirements

    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, if 
applicable, designations of wild or farm-raised, are necessary in order 
to provide retailers with credible information on which to base origin 
declarations.
    Under this proposed rule, any person engaged in the business of 
supplying a covered commodity to a retailer, whether directly or 
indirectly (i.e., distributors, handlers, etc.), would be required to 
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, for 
a period of 2 years from the date of the transaction. The supplier of a 
covered commodity that is responsible for initiating a country of 
origin declaration and, if applicable, designation of wild or farm-
raised, must possess or have legal access to records that substantiate 
that claim. For an imported covered commodity, the importer of record 
as determined by CBP, must ensure that records: (1) Provide clear 
product tracking from the U.S. port of entry to the immediate 
subsequent recipient, and (2) substantiate country of origin claims, 
and, if applicable, designations of wild or farm-raised and maintain 
such records for a period of 2 years from the date of the transaction. 
To the extent that existing records contain the necessary information 
to substantiate an origin declaration and, if applicable, designations 
of wild or farm-raised, it is not necessary to create or maintain 
additional records.
    AMS invites comment on all aspects of recordkeeping requirements. 
In particular, comment is invited on whether a shorter record retention 
requirement would still afford adequate time to conduct compliance 
activities. For example, FDA proposed a 1-year record retention 
requirement for perishable goods in their proposed rule, published on 
May 9, 2003, implementing sections of the Bioterrorism Act of 2002, and 
many firms would have to retain records for both this rulemaking and 
the FDA recordkeeping rule. At the same time, retailers and others in 
the marketing chain subject to PACA must continue to comply with its 2 
year record retention requirement.
    For suppliers that handle similar covered commodities from more 
than one country, the supplier must be able to document that the origin 
of a product was separately tracked, while in their control, during any 
production or packaging processes to demonstrate that the identity of 
the product wasmaintained.
    Under this proposed rule, retailers also have recordkeeping 
responsibilities. AMS received numerous comments requesting 
clarification of the types of records that must be kept at the retail 
level. Many of these commenters also suggested that a 2-year 
requirement for maintaining records at the store level was too onerous 
and unnecessary given the relatively short amount of time a product is 
on the shelf before it is sold. Therefore, under this proposed rule, 
records and other documentary evidence relied upon at the point of sale 
by the retailer to establish a product's country of origin and, if 
applicable, designation of wild or farm-raised, must be maintained at 
the point of sale or otherwise be reasonably available to any duly 
authorized representatives of USDA for at least 7 days following the 
retail sale of the product. Records that identify the retail supplier, 
the product unique to that transaction, and the country of origin 
information, and, if applicable, designation of wild or farm-raised, 
must be maintained for a period of 2 years 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 
off-site location.
    AMS invites comment on all aspects of recordkeeping requirements. 
In particular, comment is invited on whether a shorter record retention 
requirement would still afford adequate time to conduct compliance 
activities. For example, FDA proposed a 1-year record retention 
requirement for perishable goods in their proposed rule, published on 
May 9, 2003, implementing sections of the Bioterrorism Act of 2002, and 
many firms would have to retain records for both this rulemaking and 
the FDA recordkeeping rule. At the same time, retailers and others in 
the marketing chain subject to PACA must continue to comply with its 2 
year record retention requirement.
    AMS also received numerous comments from retailers emphasizing the 
need to hold retail suppliers accountable as the retailer would be 
unable to determine a product's country of origin in the absence of 
credible information from thesupplier. Under the statute, suppliers of 
covered commodities are required to supply country of origin 
information to retailers and sanctions may be assessed against 
retailers only for willful violations.
    However, to help address the concerns of retailers, AMS invites 
further 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 farm-raised, being made are truthful and that 
the required records are being maintained.

[[Page 61952]]

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 suppliers 
subject to these regulations. USDA would coordinate the scheduling and 
determine the procedures for 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, 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 and provide any necessary 
facilities for such inspections.
    AMS invites further comment on all aspects of enforcement of this 
retail labeling rule. Specific comment is requested on the implications 
of the statutory mandate for retail labeling beginning September 30, 
2004, relative to the amount of lead time necessary for firms in the 
supply chain to comply with this rule.

Violations

    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.
    AMS received numerous comments requesting a clarification as to how 
AMS will apply the standard of willfulness. These commenters urge USDA 
to recognize that if a majority of covered commodity items bear a label 
indicating the product's country of origin, the retailer has met their 
obligation under these regulations. AMS recognizes that many suppliers, 
particularly in the case of produce, will apply stickers to individual 
covered commodities indicating the country of origin and that such 
labeling technology does not result in a 100 percent adhesion level. 
AMS also recognizes that consumers may separate hands of bananas that 
may only have one or two stickers per hand or otherwise move an item 
from one bin to another as they make their selections. AMS will take 
these and all other circumstances into account in determining whether 
or not a retailer has committed a willful violation.
    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, if a firm misrepresents the 
State, country, or region of origin of a perishable agricultural 
commodity, the firm is in violation of PACA. In addition, both FMIA and 
the Federal Food, Drug, and Cosmetic Act prohibit labeling that is 
false or misleading. Thus, inaccurate country of origin labeling of 
covered commodities may lead to additional penalties under these 
statutes as well.

Executive Order 12988

    The contents of this proposed 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. Further, the Act does not restrict or modify the 
authority of the Secretary to administer or enforce FMIA(21 U.S.C. 601 
et seq.) or PACA (7 U.S.C. 499 et seq.). There are no administrative 
procedures that must be exhausted prior to any judicial challenge to 
the provisions of this rule.

Civil Rights Review

    AMS has 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 proposed rule does not require affected entities to 
relocate or alter their operations in ways that could adversely affect 
such persons or groups. Further, this proposed rule would not deny any 
persons or groups the benefits of the program or subject any persons or 
groups to discrimination.

Executive Order 13132

    This proposed 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 proposed 
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. 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, State officials were 
invited to attend, and in many cases did participate in, the 12 
educational and listening sessions AMS held across the United States. 
Further, States are expressly invited to comment on this proposed rule 
as it relates to existing State programs.

Executive Order 12866

    USDA has examined the economic impact of this proposed rule as 
required by Executive Order 12866. USDA has determined that this 
regulatory action is economically significant, as it is likely to 
result in a rule that would have an annual effect on the economy of 
$100 million or more and therefore has been reviewed by OMB. Executive 
Order

[[Page 61953]]

12866 requires that a regulatory cost-benefit assessment be performed 
on all economically significant regulatory actions. In accordance with 
Executive Order 12866, this preliminary economic impact assessment 
contains a statement of need for the proposed rule, an examination of 
alternative approaches, and an analysis of benefits and costs.

Summary of the Economic Analysis

    The estimated benefits associated with this rule are likely to be 
negligible. The estimated first-year incremental cost for growers, 
producers, processors, wholesalers, and retailers ranges from $582 
million to $3.9 billion. The estimated cost to the U.S. economy in 
higher food prices and reduced food production in the tenth year after 
implementation of the rule ranges from $138 million to $596 million.
    Note that this analysis does not quantify certain costs of the 
proposed rule such as the cost of the rule after the first year, or the 
cost of any supply disruptions or any other ``lead-time'' issues. 
Except for the recordkeeping requirements, there is insufficient 
information to distinguish between first year start up and maintenance 
costs versus ongoing maintenance costs for this proposed rule. 
Maintenance costs beyond the first year are expected to be lower than 
the combined start up and maintenance costs required in the first year. 
AMS invites further comment on start up costs and maintenance costs for 
the first year and beyond for firms directly affected by this proposed 
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 do not have a strong preference 
for country of origin.

Statement of Need

    This proposed 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, 
country of origin labeling is not universally required for covered 
commodities. In particular, labeling of U.S. origin is not mandatory, 
and labeling of imported products at the consumer level is required 
only in certain circumstances.
    The Tariff Act, FMIA, and other legislation require most imports to 
bear labels informing the ``ultimate purchaser'' of the country of 
origin. ``Ultimate purchaser'' is defined as the last U.S. person who 
will receive the article in the form in which it was imported. The 
Tariff Act requires country of origin declarations on containers (e.g., 
cartons and boxes) holding imported fresh fruits and vegetables when 
entering the United States. Under the provisions of this statute, loose 
produce in a labeled container can be displayed and sold in an open bin 
at retail outlets without country of origin labels on each individual 
piece of produce. A placard or other bin label indicating country of 
origin is not required. If the produce in a shipping container is 
packed in consumer-ready packaging, however, those packages must bear a 
country of origin declaration. For example, grapes packaged in bags or 
shrink-wrapped English cucumbers must have country of origin labels on 
each consumer-ready package. Further, if the food item is destined for 
a U.S. processor or manufacturer where it will undergo ``substantial 
transformation,'' that processor or manufacturer is considered the 
ultimate purchaser. As a result, under the Tariff Act, these covered 
commodities are not required to carry a country of origin mark after 
processing in the United States.
    The strongest case for establishing a market failure justification 
for mandatory COOL is inadequate or asymmetric information. Country of 
origin is clearly a credence attribute, which means that consumers 
cannot observe the attribute before or after purchasing the product. 
Without labeling, there is no way for consumers to know the country of 
origin of a covered commodity. If the country of origin of the 
commodities covered by this proposed rule is an attribute desired by 
consumers and there is market failure that impedes the voluntary 
provision of this information, then market efficiency could be improved 
by providing credible information to consumers. With credible country 
of origin information, consumers could select products based on their 
preferences for country of origin, and the food industry could respond 
to consumer demand signals by providing products according to the 
expressed demands of consumers.
    Consumer surveys indicate that some consumers desire country of 
origin information on foods (Refs. 1, 2, and 3). The consumer surveys 
also indicate that consumers may desire COOL not out of any intrinsic 
value they place knowing the country of origin, but because it 
represents to them a proxy for product safety or quality, serves as an 
indicator of desirable environmental or labor practices, or represents 
a means for them to support U.S. or another country's producers.
    An important question to consider in weighing the economic basis 
for mandatory COOL is whether there are any barriers to the voluntary, 
private provision of the optimal level of country of origin 
information. Private costs incurred by firms in the supply chain 
represent the primary barrier to the voluntary provision of country of 
origin information. There are no significant regulatory barriers to the 
voluntary provision of this information.
    For the market to voluntarily provide credible country of origin 
declarations, information regarding country of origin must flow between 
firms involved in all stages of the food supply chain. Just as it is 
for consumers, country of origin information is a credence attribute 
for firms in the food supply chain. Firms must incur costs to provide 
credible country of origin information. If the increase in price firms 
in the supply chain expect to receive for providing consumers with 
country of origin information is less than the cost of providing it, 
then firms will not voluntarily incur the costs of providing this 
information.
    If there were profits to be made from country of origin labeling, 
there would be strong incentives for firms to advertise and market 
country of origin labeled foods. Firms in the food supply chain would 
not be expected to forgo opportunities for additional profits. 
Retailers would demand that food manufacturers supply them with 
products having verifiable origin information. If consumers favored 
product by origin, food manufacturers would demand food commodities 
specifying origin and verifiable origin information.
    U.S. farmers and fish harvesters could benefit financially from 
country of origin labels if consumers prefer domestic products to 
imports. In this

[[Page 61954]]

case labels would allow consumers to distinguish between imports and 
domestic products and make their choices accordingly. As a result, 
demand for domestic food products in the United States would rise along 
with domestic food prices. Further, domestic products would increase 
their market share relative to imports. However, if consumers do not 
generally prefer domestic products, labeling would confer little to no 
economic benefits to domestic producers.
    Overall, there does not appear to be a compelling market failure 
argument regarding the provision of country of origin information. 
There appear to be no barriers to the provision of this information 
other than private costs to firms in the supply chain and low expected 
returns. Firms that would incur private costs to provide country of 
origin information would also enjoy the private benefits, if any, from 
consumer demand for the information. Thus, from the point of view of 
society, market mechanisms would ensure that the optimal level of 
country of origin information would be provided.

Alternative Approaches

    Many aspects of the mandatory COOL provisions of Pub. L. 107-171 
are prescriptive and provide little regulatory discretion for this 
proposed rulemaking. The law requires a statutorily defined set of food 
retailers to label covered commodities regarding their country of 
origin. The law also prohibits USDA from using a mandatory 
identification system to verify the country of origin of covered 
commodities. In its guidance for conducting analyses of regulatory 
benefits and costs, OMB suggests several categories of alternative 
approaches that agencies should consider during their analysis. 
Applicable categories of alternative approaches for this proposed rule 
are discussed below.
    Different requirements for different segments of the regulated 
population: The mandatory COOL law explicitly defines the retailers 
required to provide country of origin labeling for covered commodities 
(namely, retailers as defined by PACA). Thus, there is no discretionary 
authority for designating which retailers are subject to the COOL 
labeling requirements. The law also requires that any person supplying 
a covered commodity to a retailer provide information to the retailer 
indicating the country of origin of the covered commodity. Again, the 
law provides no discretionary authority to this requirement.
    Neither the law nor the proposed rule requires that any entity that 
produces or supplies covered commodities must market those commodities 
to retailers as defined by the law. Suppliers of covered commodities 
could completely avoid the requirements of this proposed rule by 
distributing their products through channels other than to the 
retailers subject to the law. Examples include retailers not subject to 
the law, foodservice firms, or exports.
    The proposed rule does not require specific types of recordkeeping 
systems. Thus, retailers and suppliers of covered commodities 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.
    Alternative levels of stringency: USDA interprets the law as 
providing essentially no discretionary authority for providing 
alternative levels of stringency regarding the provision of country of 
origin information for covered commodities by retailers as defined by 
the statute. That is, retailers either provide the required country of 
origin information to their customers or they do not, which provides no 
scope for alternative levels of stringency. There is, however, some 
degree of discretionary authority with regard to how the required 
information may be substantiated and how USDA may enforce the law and 
ensure compliance with this proposed rule.
    USDA received numerous comments suggesting self-certification as a 
means to identify country of origin, particularly for producers. USDA 
does not consider self-certification alone, absent records to 
substantiate the information, as a viable or credible alternative for 
compliance with this proposed rule. In addition, with no mechanism to 
verify compliance, such a system could be highly vulnerable to 
misrepresentation. USDA believes that some type of certification could 
be used as a means to transfer country of origin information from one 
level of the supply chain to the next, but such certification would 
need to be supported by adequate documentation to verify country of 
origin claims.
    An alternative to the proposed recordkeeping requirements would be 
to supplement the recordkeeping requirements with required affidavits 
attesting to the veracity of country of origin claims. Suppliers could 
be required 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 farm-raised, being 
made are truthful and that the required records are being maintained. 
This system of providing affidavits could provide enhanced assurance 
that each participant in the supply chain is fully accountable for 
providing valid country of origin claims.
    Alternative effective dates of compliance: The law states that 
country of origin labeling shall apply to the retail sale of a covered 
commodity beginning September 30, 2004. USDA interprets this 
requirement as providing no discretionary authority for alternative 
effective dates of compliance.
    Alternative methods of ensuring compliance: Country of origin 
labeling is, by its very nature, an information-based activity. Thus, 
USDA believes that there are essentially no alternatives for verifying 
compliance other than through the use of an audit-based system to 
review the information which is both generated to substantiate country 
of origin claims and passed along the supply chain. USDA is precluded 
by law from implementing any mandatory system that might be used to 
verify country of origin information.
    In terms of compliance activities, the law states that USDA shall, 
to the maximum extent practicable, enter into partnerships with States 
having enforcement infrastructure to assist in the administration of 
the law. USDA will seek to enter into such partnerships with States 
where possible to conduct compliance activities at retail 
establishments. Because suppliers of covered commodities are often 
located outside of a particular State's boundaries and jurisdictions, 
USDA concludes that it would be most practicable for States to focus 
their enforcement activities on entities in the supply chain within 
their boundaries.
    Informational measures: Providing information to consumers is the 
intent of this proposed rule and is the chosen regulatory alternative.
    More market-oriented approaches: There is no regulatory alternative 
to implementation of mandatory COOL by the statutorily specified 
retailers. The proposed rule, however, provides flexibility in allowing 
market participants to decide how best to implement mandatory COOL in 
their operations.
    Considering specific statutory requirements: Within the parameters 
established by the legislation, one area which allows for regulatory 
discretion relates to the definition of an ingredient in a processed 
food item. The legislation provides that the term ``covered commodity'' 
does not include an item

[[Page 61955]]

``if the item is an ingredient in a processed food item.'' The 
legislation does not, however, define a processed food item, nor what 
constitutes an ingredient in a processed food item. Therefore, 
alternative definitions of a processed food item are possible. The 
scope of commodities, or number of items, covered by the proposed rule 
changes under alternative definitions of a processed food item.

Analysis of Benefits and Costs

    The baseline for this analysis is the present state of the affected 
industries absent mandatory COOL. USDA recognizes that some directly 
affected firms have already begun to implement changes in their 
operations to accommodate the law and the expected requirements of this 
proposed rule. The benefits and costs examined in the analysis 
represent incremental impacts relative to their state prior to any 
changes resulting from the mandatory COOL statute or this proposed 
rule. If consumers would pay extra for the certainty that their food 
was produced in a particular country, and if labeling is relatively 
inexpensive, there is an economic incentive to make consumers aware of 
this product characteristic. Retailers, food manufacturers, and 
producers would share the increased net revenues and have an incentive 
to voluntarily label. Given that retailers and food manufacturers have 
the greatest incentive to be informed about what consumers desire, the 
fact that they do not currently provide country of origin information 
to consumers on a widespread basis suggests that they believe that the 
costs of labeling outweigh the returns.
    Some analysts argue that country of origin information does not 
matter to U.S. consumers (See, for example, Ref. 4). Freshness, 
quality, price, and other factors may be more important to consumers 
than country of origin. If country of origin does not influence demand, 
there is no incentive to provide country of origin labels. Retailers or 
food manufacturers providing country of origin labels would incur 
labeling costs (including the cost of segregating domestic and imported 
products) but receive no corresponding benefits. Even if consumers do 
favor labeled products over unlabeled products, labeling costs may 
outweigh the increase in market returns from increased demand and 
prices.
    In any event, economic efficiency of mandatory COOL will be 
maximized by implementing the program so that it reduces the cost of 
providing this information as much as possible.
    Benefits: The expected benefits from implementation of this rule 
are difficult to quantify. However, we believe that the benefits will 
be small and will accrue mainly to those consumers who desire country 
of origin information. We find little evidence to support the notion 
that consumers' stated preferences for country of origin labeling will 
lead to increased demands for covered commodities bearing the U.S.-
origin label.
    There is considerable research indicating that a majority of 
consumers have at least some interest in their food's origin, and a 
smaller but significant proportion of consumers that have a strong 
desire to know where their food was produced. However, this research 
indicates that consumer desire for country of origin labeling stems 
primarily from their concerns about the safety of the food they eat. To 
a lesser extent, this research indicates that consumer desire for 
country of origin labeling stems from concerns about the quality and 
freshness of products and a preference to support U.S. producers.
    There is less research on how much consumers would pay to know the 
origin of the food they eat. Some recently conducted surveys, however, 
report that 71 percent to 73 percent of consumers are willing to pay 
more to know the origin of their food (Refs. 1 and 2). Measures of 
willingness to pay, however, do not necessarily translate directly into 
measures of what consumers would actually pay when faced with 
marketplace decisions.
    One frequently cited study, Umberger, et al. (Ref. 2) assessed 
consumers' willingness to pay for labeled beef of U.S. origin. They 
found that 73 percent of survey participants in Denver, Colorado, and 
Chicago, Illinois, were willing to pay premiums of 11 percent or more 
for steak and 24 percent or more for ground beef when labeled as beef 
of U.S.-origin. These findings have been cited by others as an 
indicator of the potential benefits that would accrue from country of 
origin labeling.
    For example, using the average amounts that consumers were willing 
to pay for U.S.-labeled beef from the Umberger, et al. study, 
VanSickle, et al. (Ref. 5) estimated that benefits to consumers for 
country of origin labeling of fresh beef muscle cuts and ground beef 
would equal $5.8 billion per year based on recent per-capita 
consumption figures and price data for January and February 2003. We 
believe, however, that this estimate is based on an inappropriate use 
of the results from the Umberger, et al. study.
    There are several limitations with the willingness-to-pay studies 
that call into question the appropriateness of using this approach to 
make determinations about the benefits of this proposed rule. First, 
consumers in such studies often overstate their willingness to pay for 
a product. This typically happens because survey participants are not 
constrained by their normal household budgets when they are deciding 
which product or product feature they most value. In the case of the 
Umberger, et al. study, consumers ranked the importance of country of 
origin information 8th out of 17 factors, with food safety and 
freshness receiving the highest rankings. This suggests that, when 
faced with a real budget constraint, consumers might actually be 
willing to pay considerably less for the country of origin information 
than they indicate when surveyed.
    Second, in most of these willingness-to-pay studies, consumers are 
not faced with the actual choices they would face at retail outlets. 
For example, consumers in the Umberger, et al. study were only faced 
with making a hypothetical choice between U.S. beef and generic beef. 
Under the proposed rule, however, they may be faced with choosing 
between U.S. beef, beef from several other specific countries, and beef 
from a mixture of countries including the United States. In addition, 
the labels they see in the store will contain information about price 
and quality that may also affect the value they place on country of 
origin information. Visual characteristics and presentation of products 
in the store would also influence choice in addition to label 
information.
    Third, consumers' willingness-to-pay as elicited from a survey is a 
function of the questions asked. Different questionnaires will yield 
different results. For example, if consumers were told that nearly all 
of the beef they currently consume came from the United States before 
they were asked about their willingness to pay for U.S.-labeled beef, 
the strength of their preference for origin information would probably 
be less than if consumers were not told about the correct origin of the 
beef they consume.
    Finally, the results reported from these studies do not take into 
account changes in consumers' preferences for a particular product or 
product attribute over time. While consumers may be willing to pay more 
for a given attribute initially, as time goes on and they gain more 
experience with the product attribute, they may be less willing to pay 
for products with this attribute.
    The authors of the Umberger, et al. study acknowledge many of these 
limitations (Ref. 6). They state that the

[[Page 61956]]

results obtained from these types of surveys do not always predict 
consumer behavior. They also state that because of the limitations 
inherent in willingness-to-pay studies, the results of their study 
should not be used to determine the economic impact of COOL.
    This is not to say that willingness-to-pay studies, such as the 
study conducted by Umberger, et al., are not useful. They are valuable 
for improving our understanding of consumer preferences for product 
characteristics. The results of these studies support the notion that 
at least some consumers desire this information and are willing to pay 
some amount for it.
    With respect to agricultural producer benefits, even if consumers 
are willing to pay more for U.S.-labeled products, this does not 
necessarily mean that U.S. producers would benefit from an increase in 
the demand for their products. U.S. producers will only benefit if the 
country of origin labeling increases demand and ultimately the farm 
price enough to cover producers' costs of labeling itself. Current 
evidence on country of origin labeling, however, does not suggest that 
U.S. producers will receive sufficiently higher farm prices for U.S.-
labeled products to cover the costs of labeling. Moreover, it is even 
possible that producers could face lower farm prices as a result of 
labeling costs being passed back from retailers and processors.
    For the past 3 years, FSIS and AMS have offered a voluntary program 
by which suppliers can place U.S.-origin declarations (certified to be 
accurate by USDA) on many of the meat products covered by this rule. 
However, no suppliers of these covered commodities have participated in 
this program.
    The lack of participation in government-provided programs for 
labeling products of U.S. origin provides evidence that consumers do 
not have a strong preference for country of origin labeling. At the 
very least it indicates that retailers and food manufacturers do not 
believe consumer preferences for country of origin information are 
strong enough to cause demand and prices for labeled products to 
increase sufficiently to pay for the costs of implementing a labeling 
program.
    We can see what happens when consumers do have a strong desire for 
labeling by contrasting the lack of participation in the U.S.-origin 
labeling programs to the high level of participation in the organic 
labeling program. Labeling provided under the organic program provides 
compelling evidence that processors and retailers will provide 
consumers with the information they desire when they believe that 
consumers have a strong preference for this information and are willing 
to pay for it.
    Some may point to the fact that many of the commodities covered by 
this rule are already labeled as to country of origin as proof that 
consumers do desire this information. The existence of country of 
origin information by itself, however, does not indicate that consumers 
place any value on this information. For many covered commodities, the 
cost of identifying country of origin is minimal, and producers and 
processors face little added expense in differentiating their product 
from others by country of origin.
    The primary indication of the strength of consumer preference for 
country of origin information would be whether processors and retailers 
were able to extract a price premium for promoting this information. 
While many products sold by retailers have country of origin labels, 
there appear to be far fewer of these products that retailers attempt 
to sell based on this information. Even when they do, there is little 
evidence that they are able to extract a premium for country of origin 
information.
    The results from consumer surveys provide additional evidence that 
country of origin labeling may not lead to higher demand and prices for 
U.S.-labeled products. The results from these surveys indicate that the 
number of consumers with strong preferences for U.S.-origin labeled 
products is not sufficient for U.S. producers to benefit from labeling. 
This occurs because the supply of U.S.-origin products is likely to 
exceed the total quantity demanded by those who would pay a higher 
price for U.S. origin products (see, for example, Ref. 7).
    While consumers often state a preference for country of origin 
information, they also indicate that they desire this information 
because they believe it provides them with important information about 
the safety of their food. This suggests that consumers may use country 
of origin labeling as a proxy for food safety information.
    Country of origin labeling, as formulated under the proposed rule, 
does not provide valid information regarding food safety. This is 
because the proposed rule does not provide the traceability required to 
permit the government to rapidly respond to a contamination or disease 
outbreak.
    Furthermore, the country of origin information provided under this 
rule could cause some consumers to incorrectly attribute greater risks 
to products from a specific country than is justified. If this 
sentiment causes enough consumers to avoid this product and 
consequently pay a higher price for a competing country's product, the 
result would lead to a decline in consumer welfare.
    Costs: To estimate the costs of this proposed rule, USDA employed a 
two-pronged approach. First, USDA estimated implementation costs for 
firms in the industries directly affected by the proposed 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 proposed 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. USDA 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 
proposed rule.
    To develop its estimates of implementation costs, USDA drew upon 
available studies, comments and testimony received on the voluntary 
COOL guidelines and this rulemaking, and its knowledge of the affected 
industries. USDA developed a range of estimated implementation costs to 
reflect the likely range of first-year costs for directly affected 
firms. At a minimum, all directly affected firms will need to comply 
with the recordkeeping requirements of the proposed rule. Thus, the 
lower range of incremental cost estimates reflect the costs to modify 
and maintain current recordkeeping systems. USDA believes, however, 
that firms will incur other capital and operational costs to comply 
with the proposed rule. For example, firms may need to modify their 
production, storage, distribution, and handling systems to enable 
country of origin information to be tracked and maintained from start 
to finish. Thus, the upper range of 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 proposed rule.
    Estimated first-year incremental costs for directly affected firms 
range from $582 million to $3.9 billion. Estimated costs per firm range 
from $180 to $443 for producers, $4,048 to $50,086 for intermediaries 
(such as handlers,

[[Page 61957]]

importers, processors, and wholesalers), and $49,581 to $396,089 for 
retailers. Although the estimated incremental costs represent 
additional payments individual firms will incur to comply with the 
proposed rule, the sum of such payments does not represent the overall 
impacts of the proposed rule on the entire U.S. economy.
    In effect, these incremental costs represent increases in the costs 
of production for the affected firms. Firms will need to recover these 
costs to stay in business in the long run. To do this, firms will 
either pass the higher costs back to their suppliers by paying lower 
prices for inputs or pass the higher costs forward to their customers 
by charging higher prices for outputs. The directly affected industries 
as well as other, indirectly affected sectors of the economy will thus 
adjust over the longer run to the higher costs imposed by the proposed 
rule.
    To estimate the overall impacts of the higher costs of production 
resulting from the proposed rule, USDA used a model of the entire U.S. 
economy. USDA 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 USDA's 
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.
    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 to range from $138 million to $596 million. 
Domestic production for all of the covered commodities at the producer 
and retail levels is estimated to be lower and prices to be higher. In 
percentage terms, however, the production declines are larger than the 
price increases, so estimated industry revenue declines for all of the 
covered commodities. In addition, U.S. exports are estimated to 
decrease for all covered commodities, and U.S. imports also are 
estimated to decrease for all covered commodities except fish, which 
shows no change to a slight increase.
    It may appear counterintuitive to have first-year incremental costs 
ranging from $582 million to $3.9 billion for directly impacted firms, 
but smaller overall costs ranging from $138 million to $596 million in 
reduced consumers' purchasing power after 10 years of adjustment. 
Nonetheless, these results are consistent with each other.
    Directly affected firms incur additional costs to implement the 
requirements of the proposed rule, which take the form of additional 
payments for capital, labor, and other operating expenses. For the most 
part, however, such additional expenses for directly affected firms 
ultimately return to the economy. For example, additional human 
resource costs incurred to develop and maintain recordkeeping systems, 
segregate and display product properly, and so forth are also wages 
that will be spent on food, transportation, housing, and other goods 
and services in the economy. Likewise, capital costs for warehouse 
reconfiguration or changes in processing plants involve equipment and 
supplies purchased from firms that pay wages, purchase raw materials, 
and supply goods and services. Thus, the implementation costs incurred 
by directly affected firms are not entirely lost to the economy, but 
these incremental costs do increase the costs of production and 
decrease the productivity of the affected industries.
    The findings indicate that directly affected industries recover the 
higher costs imposed by the proposed rule through slightly higher 
prices for their products. With higher prices, the quantities of their 
products demanded also decline to the extent that total industry 
revenues also decline. Consumers pay slightly more for the products and 
purchase less of the covered commodities. Overall, however, the covered 
commodities account for a comparatively small portion of the U.S. 
economy and of consumers' budgets. Thus, the ``deadweight'' economic 
burden of the proposed rule is considerably smaller than the 
incremental costs to directly affected firms. The remainder of this 
section describes in greater detail how USDA developed the estimated 
direct, incremental costs and the overall costs to the U.S. economy.
    Cost assumptions: The industries directly affected by this proposed 
rule are those responsible for producing and marketing the covered 
commodities at retail stores as defined by the law. Consumers of the 
covered commodities at these retail outlets are also directly affected 
by this proposed rule.
    This proposed rule directly regulates the activities of retailers 
(as defined by the law) and their suppliers. Retailers are required by 
the proposed rule to provide country of origin information for the 
covered commodities that they sell, and firms that supply covered 
commodities to these retailers must provide them with this information. 
In addition, all other firms in the supply chain for the covered 
commodities are potentially affected by the proposed rule because 
country of origin 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.
    In general, the supply chains for the covered commodities consist 
of farm or fishing operations, processors, wholesalers, and retailers. 
Table 1 contains a listing of the number of entities in the supply 
chains for each of the covered commodities.
    The total cost of this proposed rule will depend on the number of 
entities affected and the incremental cost to each affected firm in the 
supply chain for the covered commodities. The proposed rule requires 
that retailers provide consumers with country of origin information for 
the covered commodities and also requires that their suppliers provide 
them with the information needed to substantiate these country of 
origin claims. To provide credible country of origin claims, firms in 
the supply chain will need to create, maintain, and transfer 
information from one level of the chain to the next. The proposed rule 
allows industry participants to determine the recordkeeping and 
information transfer mechanisms needed for compliance. Consequently, 
firms will modify existing recordkeeping systems and business practices 
as necessary to ensure compliance with the proposed rule.
    Number of firms and number of establishments affected: USDA 
estimates that approximately 1,377,000 establishments owned by 
approximately 1,339,000 firms would be either directly or indirectly 
affected by this rule. In general, the supply chain for each of the 
covered commodities includes agricultural producers or fish harvesters, 
processors, wholesalers, and retailers. Imported products may be 
introduced at any level of the supply chain. Other intermediaries, such 
as auction markets, may be involved in transferring products from one 
stage of production to the next. Table 1 provides estimates of the 
affected firms and establishments.

[[Page 61958]]



             Table 1.--Estimated Number of Affected Entities
------------------------------------------------------------------------
                    Type                        Firms     Establishments
------------------------------------------------------------------------
Beef, Lamb, and Pork:
    Cattle and Calves......................    1,032,670      1,032,670
    Sheep and Lambs........................       64,170         64,170
    Hogs and Pigs..........................       67,150         67,150
    Stockyards, Dealers & Market Agencies..        7,775          7,775
    Livestock Processing & Slaughtering....        3,098          3,358
    Meat & Meat Product Wholesale..........        3,185          3,305
Fish:
    Farm-Raised Fish and Shellfish.........        3,540          3,540
    Fishing................................       76,499         76,452
    Seafood Product Preparation & Packaging          741            823
    Fish & Seafood Wholesale...............        2,897          2,980
Perishable Agricultural Commodities:
    Fruits & Vegetables....................       47,986         47,986
    Frozen Fruit, Juice & Vegetable Mfg....          163            257
    Fresh Fruit & Vegetable Wholesale......        9,026         12,879
Peanuts:
    Peanut Farming.........................       12,221         12,221
    Roasted Nuts & Peanut Butter Mfg.......          140            159
    Peanut Wholesalers.....................           83             83
General Line Grocery Wholesalers...........        3,183          3,993
Retailers..................................        4,512         37,176
                                            --------------
          Totals:
              Producers....................    1,303,846      1,303,799
              Intermediaries...............       30,291         35,612
              Retailers....................        4,512         37,176
                                            --------------
                   Grand Total.............    1,338,649      1,376,587
------------------------------------------------------------------------

    Supply chains for the covered commodities are mostly specialized 
from farm production through manufacturing levels. After manufacturing, 
the degree of specialization diminishes, until products reach retail 
outlets where most affected retailers sell many of the covered 
commodities. Even after manufacturing, however, there are specialized 
wholesalers who distribute the products to retail outlets. Firms and 
establishments that specialize in the production and distribution of 
each covered commodity are listed within each group. General-line 
wholesalers and retailers that handle several of the covered commodity 
groups are listed separately at the bottom of the table.
    For all covered commodities, the numbers of manufacturing and 
wholesaling establishments are estimated from the 2001 County Business 
Patterns (Ref. 8) and the 2000 Statistics of U.S. Businesses (Ref. 9). 
An establishment is a single physical location where business is 
conducted or where services or industrial operations are performed. A 
firm is a business organization consisting of one or more domestic 
establishments in the same industry that was specified under common 
ownership or control. The firm and the establishment are the same for 
single-establishment firms. County Business Patterns and Statistics of 
U.S. Businesses report data for companies with at least one paid 
employee.
    Nonemployer Statistics are also reported by the U.S. Census Bureau 
(Ref. 10). Nonemployer Statistics reports data for companies with no 
paid employees, such as independent contractors. Because nonemployer 
businesses are generally very small, we assume that nonemployer 
manufacturing and wholesaling businesses do not supply commodities to 
retailers of the size covered by this proposed rule (i.e., retailers 
selling fresh and frozen fruits and vegetables with an invoice value of 
at least $230,000). Such small businesses likely are engaged in 
localized specialty operations that would not supply larger retailers. 
Therefore, nonemployer businesses are not included in the assessment of 
the firms and establishments impacted by the proposed rule. We invite 
comments on the validity of this assumption.
    We assume that all firms and establishments identified in Table 1 
will be impacted by the proposed rule, although some may not produce or 
sell products ultimately within the scope of the proposed rule. While 
this assumption likely overstates the number of affected firms and 
establishments, we believe that the assumption is reasonable. Detailed 
data on the number of entities categorized by the marketing channels in 
which they operate and the specific products that they sell are not 
available.
    Beef, lamb, and pork: USDA estimates that there are 1,032,670 
operations with cattle and calves (Ref. 11), 64,170 operations with 
sheep and lambs (Ref. 12), and 67,150 operations with hogs and pigs 
(Ref. 13). For farming operations, the firm and the establishment are 
considered to be one and the same. We assume that all of these 
livestock production operations are affected by the proposed rule, even 
though we recognize that substantial portions of the covered 
commodities produced from the livestock of these operations will fall 
outside of the proposed rule. Covered commodities sold at foodservice 
establishments, exported, used as ingredients in processed food items, 
or sold at retail outlets not covered by the proposed rule are outside 
the scope of the proposed rule. When livestock are born, the producer 
typically does not know the ultimate destination for the final product. 
We assume that all producers will seek to keep their market options 
open, whether the final product moves to a covered retailer or to 
another marketing outlet. In addition, there are 7,775 posted 
stockyards, bonded dealers and market agencies that are involved in

[[Page 61959]]

buying, selling, and marketing livestock (Ref. 14). Some of these 
stockyards, dealers, and market agencies may deal exclusively with 
other species such as horses, but that number is small and expected to 
minimally impact the estimated number of firms and establishments.
    We estimate that there are 3,358 livestock slaughtering and 
processing establishments and operated by 3,098 firms. These numbers 
may be slightly overstated, since businesses that do not slaughter or 
process cattle, sheep, or hogs are included in these totals. For 
example, a plant that slaughtered only bison would be included in the 
totals, but the number of such businesses is very small. Also, some 
plants that process beef, lamb, or pork may produce only processed 
products that are excluded from the scope of the proposed rule. The 
number of such firms and establishments is unknown, but expected to be 
small. The number of meat and meat product wholesale firms is estimated 
to be 3,185 and the number of establishments is estimated to be 3,305.
    Fish. Fish production includes both farm-raised or aquaculture 
production and wild-caught fishing operations. Aquaculture operations 
include those producing food fish, crustaceans, and mollusks, and the 
estimated number of operations is 3,540 (Ref. 15). Most wild fish 
harvesting operations are nonemployer businesses. Census Bureau data 
are used to estimate the number of fishing, seafood product preparation 
and packaging, and fish and seafood wholesale establishments and firms 
(Refs. 8, 9, and 10). As with the beef, lamb, and pork firms and 
establishments, some of these fish and seafood firms and establishments 
may not produce or sell covered commodities. While the number of such 
entities is unknown, we assume that all firms and establishments will 
be impacted by the proposed rule.
    Perishable agricultural commodities: Census of Agriculture data 
provide estimates of the number of fruit and vegetable farming 
operations (Ref. 16). The total number of fruit farms is estimated at 
81,956 and the total number of vegetable farms at 31,030. USDA 
estimates that 34.6 percent of fruit production and 62.0 percent of 
vegetable production is used for fresh and frozen products. USDA 
assumes that fruit and vegetable producers generally know whether their 
production is destined for fresh or processing use, meaning that some 
producers will be unaffected by the proposed rule depending upon the 
marketing channels for which they produce. Data on the number of 
farming operations categorized by the ultimate end uses of the products 
do not exist. Therefore, USDA assumes that the number of farms 
producing fruits and vegetables for fresh and frozen use is 
proportional to the production of fresh and frozen fruits and 
vegetables relative to total production. Hence, the number of affected 
fruit farms is estimated at 28,357 and the number of vegetable farms at 
19,339, for a total of 47,696 farming operations producing fruits and 
vegetables that will be impacted by this proposed rule.
    Businesses that process frozen fruits and vegetables and fresh 
fruit are estimated from Census Bureau data (Refs. 8, 9, and 10), and 
are estimated to include 163 firms operating 257 establishments. These 
estimates may be overstated by the inclusion of businesses that produce 
frozen juice and businesses that produce frozen fruits and vegetables 
in forms not covered by the proposed rule. Businesses wholesaling 
frozen fruits and vegetables are included in packaged frozen food 
wholesale firms and include 9,026 firms operating 12,878 
establishments.
    Peanuts: Census of Agriculture data provide an estimate of 12,221 
peanut farming operations (Ref. 16). Businesses that roast nuts and 
manufacture peanut butter are estimated from Census Bureau data to 
include 140 firms operating 159 establishments (Refs. 8, 9, and 10). 
These numbers include companies that produce only peanut butter (not a 
covered commodity) or that may roast nuts not covered by the proposed 
rule, but the number of such operations is unknown. Businesses that 
wholesale peanuts are estimated from peanut marketing agreement data 
(Ref. 17) to include 83 firms and the same number of establishments.
    General-line wholesalers and retailers: 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. We 
assume that these general-line wholesalers likely handle at least one 
and possibly all of the covered commodities. Therefore, we include the 
number of general-line wholesale businesses among entities affected by 
the proposed rule. This includes 3,183 firms operating 3,993 
establishments.
    Retailers covered by this proposed rule must meet the definition of 
a retailer as defined by PACA. The number of such businesses is 
estimated from PACA data (Ref. 18). 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 food retailers nationwide. Census Bureau data show that there 
were 92,383 food store firms and 102 warehouse club and superstore 
firms in 2000 (Ref. 9). There were 127,566 food store establishments 
and 2,051 warehouse club and superstore establishments in 2001 (Ref. 
8). Thus, we estimate that there are 92,485 retail firms and 129,617 
retail establishments that account for most of the retail sales of the 
covered commodities. However, only 4,512 retail firms operating 37,176 
retail establishments are included under the statutory definition of a 
PACA retailer.
    Source of cost estimates: Data on costs to implement mandatory COOL 
are largely unavailable. There are State programs for country of origin 
labeling of some products, CBP and regulations specify labeling 
requirements for imported products, and some companies choose to 
provide country of origin labels for marketing purposes. There are, 
however, no mandatory programs with similar requirements and coverage 
that would provide substantive guidance for estimating the costs of 
this proposed rule.
    On October 11, 2002, USDA published voluntary guidelines (67 FR 
63367) for country of origin labeling of the covered commodities. USDA 
invited public comments on the utility of these guidelines, including 
the costs and benefits of the program. USDA also prepared an estimate 
of the information collection burden that would be associated with 
implementation of the voluntary guidelines and invited comments on the 
estimated information collection burden. In addition, USDA also sought 
comments on this rulemaking for mandatory COOL and held 12 public 
listening and information sessions across the country. We also met with 
many industry groups and individuals to discuss this rulemaking and 
visited facilities at all levels of the supply chain to learn about 
current industry practices and changes that would be required to 
implement mandatory COOL. In addition, a number of studies have been 
produced to address various issues relating to the economic impacts 
associated with implementation of mandatory COOL.
    To develop estimates of the cost of implementing this proposed 
rule, we reviewed the comments received on the voluntary guidelines, 
the comments received regarding this rulemaking for mandatory COOL, and 
available economic studies. No single source of information, however, 
provided

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comprehensive coverage of all economic benefits and costs associated 
with mandatory COOL for all of the covered commodities. We applied our 
knowledge about the operation of the supply chains for the covered 
commodities to synthesize the available information about the proposed 
rule's potential costs.
    Cost drivers: This proposed rule is a retail labeling requirement. 
Retail stores subject to this proposed rule will be required to inform 
consumers as to the country of origin of the covered commodities that 
they sell. To accomplish this task, individual package labels or other 
point-of-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 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 and likely will entail additional computer hardware. We 
expect that retail stores will also undertake efforts to ensure that 
their operations are in compliance with the proposed rule.
    Prior to reaching retailers, most covered commodities move through 
distribution centers or warehouses. Direct store deliveries (such as 
when a local truck farmer delivers fresh produce directly to a retail 
store) are an exception. Distribution centers will be required to 
provide retailers with country of origin 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 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.
    Packers and processors of covered commodities will also need to 
inform retailers and wholesalers as to the country of origin of the 
products that they sell. To do so, their suppliers will need to provide 
documentation regarding the country of origin of the products that they 
sell. Maintaining country of origin identity through the packing or 
processing phase is more complex if products from more than one country 
are involved. For example, the identity of fresh kiwi fruit from 
California and New Zealand entering the same packing house would need 
to be maintained throughout the packing operation. The efficiency of 
operations may be affected as products are segregated in receiving, 
storage, processing, and shipping operations. For packers and 
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 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 may have lower implementation costs compared 
with processors handling products from multiple origins. A processor 
that already sources products from a single country of origin would not 
face additional costs associated with product segregation and tracking. 
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 of origin may choose to limit its source to a single 
country of origin 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.
    At the production level, agricultural producers and fish harvesters 
will need to create and maintain records to establish country of origin 
information for the products they sell. This information will need to 
be transferred and maintained as the products move through the supply 
chains. In general, additional producer costs include the cost of 
establishing and maintaining a recordkeeping system for country of 
origin information, animal or product identification, and labor and 
training.
    Recordkeeping burden: On November 21, 2002, USDA published in the 
Federal Register a Notice of Request for Emergency Approval of a New 
Information Collection (67 FR 70205) for the interim guidelines for 
Voluntary Country of Origin Labeling for Beef, Lamb, Pork, Fish, 
Perishable Agricultural Commodities, and Peanuts that were published on 
October 11, 2002 (67 FR 63367). The Notice provided USDA's estimate of 
the recordkeeping burden imposed by voluntary COOL, under the 
requirements of PRA. That PRA cost estimate related solely to the 
recordkeeping burden and did not consider other costs imposed by COOL. 
Also, PRA requirements do not address the benefits of a program. Thus, 
PRA recordkeeping burden published by USDA did not reflect the full 
costs and benefits of voluntary COOL.
    Cost analyses: Despite the numerous comments that USDA has received 
on the voluntary guidelines and on this rulemaking, there is 
surprisingly little quantitative evidence on the likely costs of 
mandatory COOL. The proposed rule does not specify the systems that 
affected entities must put in place to implement mandatory COOL. 
Instead, market participants will be given flexibility to develop their 
own systems to comply with the proposed rule. There are many ways in 
which the proposed rule's requirements may be met, and this contributes 
to the difficulty in arriving at a quantitative assessment of cost 
impacts. Nonetheless, a number of studies and submitted comments shed 
light on the potential costs of mandatory COOL. Generally, comments 
addressed costs for a particular firm or a segment of a particular 
supply chain for a given covered commodity. Of the studies on potential 
economic impacts of mandatory COOL, only a handful developed estimated 
incremental implementation costs for market participants. We use the 
results of these studies, comments received, and knowledge of the 
affected industries to develop a range of the estimated incremental 
cost impacts of this proposed rule.

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    Estimated costs from the studies considered by USDA are summarized 
in Table 2. The studies are VanSickle, McEowen, Taylor, Harl, and 
Connor (Ref.5); Sparks Companies Inc. (Ref. 19); Hayes and Meyer (Ref. 
20); and Davis (Ref. 21). All of the studies report annual costs, and 
the costs shown in Table 2 are assumed to represent first-year costs 
for mandatory COOL. In those cases in which the studies do not state so 
explicitly, USDA infers from the construction of the estimates that 
they represent first-year costs.

BILLING CODE 3410-02-P
[GRAPHIC] [TIFF OMITTED] TP30OC03.005

BILLING CODE 3410-02-C

[[Page 61962]]

    At a minimum, mandatory COOL will entail the transfer of 
information through the respective supply chains, from production 
through retail sales. While information currently flows through the 
system as products move through the supply chains, there is little 
evidence that country of origin information typically is a component of 
this information flow. Thus, we believe that transfer and maintenance 
of records to establish COOL claims will be accomplished through 
modification of the current recordkeeping and systems used for 
accounting, purchasing, sales, production, and related operations.
    VanSickle, et al. (Ref. 5) address the recordkeeping cost to 
producers in their critique of USDA's estimate of the recordkeeping 
burden for the voluntary COOL guidelines. This study notes that 
producers currently maintain a variety of records for taxes, health 
rules, and other programs and they conclude that producers would 
require no new recordkeeping. As part of their critique of USDA's 
recordkeeping burden estimates, VanSickle, et al. recalculated the 
recordkeeping burden using different producer numbers and different 
labor costs. Although the study does not separately show calculations 
for each t