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Cool Law
1. Thursday,
January 15, 2009
Part II
Department of
Agriculture
Agricultural Marketing Service
7 CFR Parts 60 and 65
Mandatory Country of Origin Labeling of
Beef, Pork, Lamb, Chicken, Goat Meat,
Wild and Farm-Raised Fish and Shellfish,
Perishable Agricultural Commodities,
Peanuts, Pecans, Ginseng, and Macadamia
Nuts; Final Rule
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2. 2658 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations
marking, and the recordkeeping mandatory COOL for all covered
DEPARTMENT OF AGRICULTURE
responsibilities of both retailers and commodities except wild and farm-
Agricultural Marketing Service suppliers for covered commodities. raised fish and shellfish until September
30, 2008.
DATES: This final rule is effective March
7 CFR Parts 60 and 65 On October 11, 2002, AMS published
16, 2009.
Guidelines for the Interim Voluntary
FOR FURTHER INFORMATION CONTACT: Erin
[Docket No. AMS–LS–07–0081]
Country of Origin Labeling of Beef,
Morris, Associate Deputy Administrator,
RIN 0581–AC26 Lamb, Pork, Fish, Perishable
Poultry Programs, AMS, USDA, by
Agricultural Commodities, and Peanuts
telephone on 202–720–5131, or via e-
Mandatory Country of Origin Labeling (67 FR 63367) providing interested
mail at: erin.morris@usda.gov.
of Beef, Pork, Lamb, Chicken, Goat parties with 180 days to comment on
SUPPLEMENTARY INFORMATION: The
Meat, Wild and Farm-Raised Fish and the utility of the voluntary guidelines.
information that follows has been
Shellfish, Perishable Agricultural On November 21, 2002, AMS
divided into three sections. The first
Commodities, Peanuts, Pecans, published a notice requesting
section provides background
Ginseng, and Macadamia Nuts emergency approval of a new
information about this final rule. The
information collection (67 FR 70205)
second section provides a discussion of
Agricultural Marketing Service,
AGENCY:
providing interested parties with a 60-
the rule’s requirements, including a
USDA.
day period to comment on AMS’ burden
summary of changes from the October 5,
Final rule.
ACTION:
estimates associated with the
2004, interim final rule for fish and
recordkeeping requirements as required
SUMMARY: The Farm Security and Rural shellfish and the August 1, 2008,
by the Paperwork Reduction Act of 1995
interim final rule for the remaining
Investment Act of 2002 (2002 Farm
(PRA). On January 22, 2003, AMS
covered commodities as well as a
Bill), the 2002 Supplemental
published a notice extending this
summary of the comments received in
Appropriations Act (2002
comment period (68 FR 3006) an
response to the relevant prior requests
Appropriations), and the Food,
additional 30 days.
for comments associated with this
Conservation and Energy Act of 2008
On October 30, 2003, AMS published
rulemaking and the Agency’s responses
(2008 Farm Bill) amended the
the proposed rule for the mandatory
to these comments. The prior requests
Agricultural Marketing Act of 1946 (Act)
COOL program (68 FR 61944) with a 60-
for comments include: The interim final
to require retailers to notify their
day comment period. On December 22,
rule for fish and shellfish published in
customers of the country of origin of
2003, AMS published a notice
the October 5, 2004, Federal Register
covered commodities. Covered
extending the comment period (68 FR
(69 FR 59708); the reopening of the
commodities include muscle cuts of
71039) an additional 60 days. On June
comment period (for costs and benefits)
beef (including veal), lamb, chicken,
20, 2007, AMS reopened the comment
for the interim final rule that was
goat, and pork; ground beef, ground
period for the proposed rule for all
published in the November 27, 2006,
lamb, ground chicken, ground goat, and
covered commodities (72 FR 33917).
Federal Register (71 FR 68431); the
ground pork; wild and farm-raised fish
On October 5, 2004, AMS published
reopening of the comment period for all
and shellfish; perishable agricultural
the interim final rule for fish and
aspects of the interim final rule that was
commodities; macadamia nuts; pecans;
shellfish (69 FR 59708) with a 90-day
published in the June 20, 2007, Federal
ginseng; and peanuts. The
comment period. On December 28,
Register (72 FR 33851); and the interim
implementation of mandatory country
2004, AMS published a notice
final rule for the remaining covered
of origin labeling (COOL) for all covered
extending the comment period (69 FR
commodities that was published in the
commodities, except wild and farm-
77609) an additional 60 days. On
August 1, 2008, Federal Register (73 FR
raised fish and shellfish, was delayed
November 27, 2006, the comment
45106). The last section provides for the
until September 30, 2008.
period was reopened on the costs and
required impact analyses including the
The 2008 Farm Bill contained a
benefits aspects of the interim final rule
Regulatory Flexibility Act, the
number of provisions that amended the
(71 FR 68431). On June 20, 2007, the
Paperwork Reduction Act, Civil Rights
COOL provisions in the Act. These
comment period was reopened for all
Analysis, and the relevant Executive
changes included the addition of
aspects of the interim final rule (72 FR
Orders.
chicken, goat, macadamia nuts, pecans,
33851).
and ginseng as covered commodities, I. Background On August 1, 2008, AMS published
the addition of provisions for labeling
an interim final rule for covered
Prior Documents in This Proceeding
products of multiple origins, as well as
commodities other than fish and
a number of other changes. However, This final rule is issued pursuant to
shellfish (73 FR 45106) with a 60-day
the implementation date of September the 2002 Farm Bill, the 2002
comment period.
30, 2008, was not changed by the 2008 Appropriations, and the 2008 Farm Bill,
Farm Bill. Therefore, in order to meet which amended the Act to require II. Summary of Changes From the
the September 30, 2008, implementation retailers to notify their customers of the Interim Final Rules
date and to provide the newly affected origin of covered commodities. In
Definitions
industries the opportunity to provide addition, the FY 2004 Consolidated
comments prior to issuing a final rule, Appropriations Act (Pub. L. 108–199) In the regulatory text for fish and
on August 1, 2008, the Department delayed the implementation of shellfish (7 CFR part 60), a definition for
published an interim final rule with a mandatory COOL for all covered ‘‘commingled covered commodities’’
request for comments for all of the commodities except wild and farm- has been added for clarity and to
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covered commodities other than wild raised fish and shellfish until September conform to the regulatory text for the
and farm-raised fish and shellfish. The 30, 2006. The Agriculture, Rural other covered commodities.
Agency is issuing this final rule for all Development, Food and Drug In the regulatory text for the
covered commodities. This final rule Administration, and Related Agencies remaining covered commodities (7 CFR
contains definitions, the requirements Appropriations Act of 2006 (Pub. L. part 65), the definition of ‘‘ground beef’’
for consumer notification and product 109–97) delayed the applicability of has been modified in response to
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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations
comments. Under this final rule, the processed in another country such that commodities that are derived from
a substantial transformation (as animals that are imported into the
term ‘‘ground beef’’ has the meaning
determined by CBP) does not occur. In United States for immediate slaughter as
given that term in 9 CFR § 319.15(a), i.e.,
addition, to the extent that additional defined in § 65.180, the origin may be
chopped fresh and/or frozen beef with
information about the production steps designated as Product of the United
or without seasoning and without the
that occurred in the U.S. is permitted States, Country X, and (as applicable)
addition of beef fat as such, and
under existing Federal regulations (e.g., Country Y.
containing no more than 30 percent fat,
In all of the cases above, the countries
CBP, FSIS), nothing in this final rule
and containing no added water,
of origin may be listed in any order. In
precludes such information from being
phosphates, binders, or extenders, and
addition, if animals are raised in
included. A full explanation of this
also includes products defined by the
another country and the United States,
change is discussed in the Comments
term ‘‘hamburger’’ in 9 CFR 319.15(b). A
provided the animals are not imported
and Responses section.
full explanation of this change is
for immediate slaughter as defined in
discussed in the Comments and Country of Origin Notification for § 65.180, the raising that occurs in the
Responses section. Muscle Cuts United States takes precedence over the
In 7 CFR part 65, the definition of
Under the August 1, 2008, interim minimal raising that occurred in the
‘‘lamb’’ has been modified in response
final rule, if an animal was born, raised, animal’s country of birth.
to comments to include mutton. Under
and/or slaughtered in the United States A full explanation of these changes is
this final rule, the term ‘‘lamb’’ means
and was not imported for immediate discussed in the Comments and
meat produced from sheep.
slaughter as defined in § 65.180, the Responses section.
In 7 CFR part 65, the definition of
origin of the resulting meat products
‘‘NAIS-compliant system’’ has been Markings
derived from that animal could have
deleted in response to comments
Under the October 5, 2004, interim
been designated as Product of the
received as it is no longer needed.
final rule for fish and shellfish and the
United States, Country X, and/or (as
A definition of ‘‘pre-labeled’’ has been
August 1, 2008, interim final rule for the
applicable) Country Y, where Country X
added to both 7 CFR part 60 and 7 CFR
remaining covered commodities, only
and Country Y represent the actual or
part 65 for clarity in response to
those abbreviations approved for use
possible countries of foreign origin.
comments received. Under this final
under CBP rules, regulations, and
During the comment period, the
rule, the term ‘‘pre-labeled’’ means a
policies were acceptable. The 2008
Agency received extensive feedback
covered commodity that has the
Farm Bill and the August 1, 2008,
from livestock producers, members of
commodity’s country of origin, and, as
interim final rule expressly authorized
Congress, and other interested parties
applicable, method of production
the use of State, regional, or locality
expressing concern about the provision
information, and the name and place of
label designations in lieu of country of
in the interim final rule that allowed
business of the manufacturer, packer, or
origin for perishable agricultural
U.S. origin product to be labeled with a
distributor on the covered commodity
commodities, peanuts, pecans, ginseng,
mixed origin label. It was never the
itself, on the package in which it is sold
and macadamia nuts. In response to
intent of the Agency for the majority of
to the consumer, or on the master
comments received, under this final
product eligible to bear a U.S. origin
shipping container. The place of
rule, abbreviations may be used for
declaration to bear a multiple origin
business information must include at a
state, regional, or locality label
designation. The Agency made
minimum the city and state or other
designations for these commodities
additional modifications for clarity.
acceptable locale designation. Under this final rule, for muscle cut whether domestically harvested or
In 7 CFR part 65, the definition of covered commodities derived from imported using official United States
‘‘produced’’ has been modified for animals that were born in Country X or Postal Service abbreviations or other
clarity in response to comments. Under (as applicable) Country Y, raised and abbreviations approved by CBP. A full
this final rule, the term ‘‘produced’’ in slaughtered in the United States, and explanation of this change is discussed
the case of perishable agricultural were not derived from animals imported in the Comments and Responses
commodities, peanuts, ginseng, pecans, for immediate slaughter as defined in section.
and macadamia nuts means harvested. § 65.180, the origin may be designated
Recordkeeping
as Product of the U.S., Country X, and
Country of Origin Notification
The 2008 Farm Bill made changes to
(as applicable) Country Y.
Labeling Covered Commodities of the recordkeeping provisions of the Act.
For muscle cut covered commodities
United States Origin Specifically, the 2008 Farm Bill states
derived from animals born, raised, and
The August 1, 2008, interim final rule that records maintained in the course of
slaughtered in the U.S. that are
contained an express provision allowing the normal conduct of the business of
commingled during a production day
U.S. origin covered commodities to be such person, including animal health
with muscle cut covered commodities
further processed or handled in a papers, import or customs documents,
derived from animals that were raised
foreign country and retain their U.S. or producer affidavits, may serve as
and slaughtered in the United States,
origin. The Agency received numerous such verification. Under the 2008 Farm
and were not derived from animals
comments requesting further Bill, the Secretary is prohibited from
imported for immediate slaughter as
clarification of this provision as well as requiring the maintenance of additional
defined in § 65.180, the origin may be
comments requesting that it be deleted. records other than those maintained in
designated, for example, as Product of
Accordingly, under this final rule, this the normal conduct of business. In
the United States, Country X, and (as
provision has been deleted. To the addition to the changes made as a result
applicable) Country Y.
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extent that it is allowed under existing For muscle cut covered commodities of the 2008 Farm Bill, other changes
Customs and Border Protection (CBP) derived from animals that are born in were made in the August 1, 2008,
and Food Safety and Inspection Service Country X or Country Y, raised and interim final rule to reduce the
(FSIS) regulations, U.S. origin covered slaughtered in the United States, that recordkeeping burden. Further changes
commodities may still be eligible to bear are commingled during a production are being made in this final rule in
a U.S. origin declaration if they are day with muscle cut covered response to comments received.
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For retailers, this rule requires records other than the U.S. (i.e., ‘‘CAN’’ or ‘‘M’’) the character of the covered commodity
and other documentary evidence relied may use that information as a basis for includes cooking (e.g., frying, broiling,
upon at the point of sale by the retailer a U.S. origin claim. In addition, packers grilling, boiling, steaming, baking,
to establish a covered commodity’s that slaughter animals that are part of roasting), curing (e.g., salt curing, sugar
country(ies) of origin and method of another country’s recognized official curing, drying), smoking (cold or hot),
production (wild and/or farm-raised), as system (e.g. Canadian official system, and restructuring (e.g., emulsifying and
applicable, to be either maintained at Mexico official system) may also rely on extruding).
With regard to determining what is
the retail facility or at another location the presence of an official ear tag or
considered an ‘‘other covered
for as long as the product is on hand and other approved device on which to base
commodity’’ with respect to fruits and
provided to any duly authorized their origin claims.
vegetables, the Agency will generally
representative of USDA, upon request,
Highlights of This Final Rule rely on U.S. Grade Standards for fruits
within 5 business days of the request.
Covered Commodities and vegetables to make the distinction
For pre-labeled products, the label itself
of whether or not the retail item is a
is sufficient information on which the As defined in the statute, the term
combination of ‘‘other covered
retailer may rely to establish the ‘‘covered commodity’’ includes: Muscle
commodities’’. For example, different
product’s origin and method of cuts of beef, lamb, pork, chicken, and
colored sweet peppers combined in a
production, as applicable, and no goat; ground beef, ground lamb, ground
package will require country of origin
additional records documenting origin pork, ground chicken, and ground goat;
notification because there is one U.S.
and method of production information wild and farm-raised fish and shellfish;
Grade Standard for sweet peppers,
are necessary. Under the August 1, perishable agricultural commodities
regardless of the color. As another
2008, interim final rule, retailers were (fresh and frozen fruits and vegetables);
example, there are separate U.S. Grade
required to maintain these records for a peanuts; pecans; ginseng; and
Standards for iceberg lettuce and
period of 1 year. macadamia nuts.
Under this final rule, upon request by romaine lettuce. Therefore, this type of
Exemption for Food Service
USDA representatives, suppliers and salad mix will not be required to be
Establishments
retailers shall make available to USDA labeled with country of origin
representatives, records maintained in information. While the Agency
Under the statute and therefore this
the normal course of business that verify previously used this example in the
final rule, food service establishments
an origin and method of production preamble of the August 1, 2008, interim
are exempt from COOL labeling
(wild and/or farm-raised) claim, as final rule and concluded that such a
requirements. Food service
applicable. Such records shall be salad mix would be subject to COOL,
establishments are restaurants,
provided within 5 business days of the the Agency now believes the use of U.S.
cafeterias, lunch rooms, food stands,
request and may be kept in any location. Grade Standards in determining when a
saloons, taverns, bars, lounges, or other
Under this final rule, producer perishable retail item is considered a
similar facilities operated as an
affidavits shall also be considered processed food item provides a bright
enterprise engaged in the business of
acceptable records that suppliers may line to the industry and is an easy and
selling food to the public. Similar food
utilize to initiate origin claims for all straightforward approach as regulated
service facilities include salad bars,
covered commodities, provided it is entities are already familiar with U.S.
delicatessens, meal preparation stations
made by someone having first-hand Grade Standards.
in which the retailer sets out ingredients
There are limited exceptions to this
knowledge of the origin of the covered for different meals and consumers
policy. One exception occurs when
commodity and identifies the covered assemble the ingredients into meals to
there are different grade standards for
commodity unique to the transaction. take home, and other food enterprises
the same commodity based on the
located within retail establishments that
Responsibilities of Retailers and
region of production. For example,
provide ready-to-eat foods that are
Suppliers
although there are separate grade
consumed either on or outside of the
With regard to the ‘‘safe harbor’’ standards for oranges from Florida,
retailer’s premises.
language that was contained in the Texas, and California/Arizona,
Exclusion for Ingredient in a Processed
October 30, 2003, proposed rule and the combining oranges from these different
Food Item
October 5, 2004, interim final rule, regions would not be considered
which allowed retailers and suppliers to combining ‘‘other covered
Items are excluded from labeling
rely on the information provided unless commodities’’ and therefore, a container
under this regulation when a covered
they could have been reasonably with oranges from Texas and Florida is
commodity is an ingredient in a
expected to have knowledge otherwise, required to be labeled with country of
processed food item. Under this final
based on comments received, similar origin information.
rule, a ‘‘processed food item’’ is defined
As examples of processing steps that
‘‘safe harbor’’ language has been as: A retail item derived from a covered
are considered to further prepare
included in this final rule. A complete commodity that has undergone specific
product for consumption, meat products
discussion is contained in the processing resulting in a change in the
that have been needle-tenderized or
Comments and Responses section of this character of the covered commodity, or
chemically tenderized using papain or
final rule. that has been combined with at least
With regard to the recordkeeping other similar additive are not
one other covered commodity or other
provision concerning livestock that are considered processed food items.
substantive food component (e.g.,
part of a NAIS-compliant system, in Likewise, meat products that have been
chocolate, breading, tomato sauce),
response to comments received, the injected with sodium phosphate or
except that the addition of a component
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Agency has clarified that packers who other similar solution are also not
(such as water, salt, or sugar) that
slaughter animals that are tagged with considered processed food items as the
enhances or represents a further step in
an 840 Animal Identification Number solution has not changed the character
the preparation of the product for
device without the presence of any of the covered commodity. In contrast,
consumption, would not in itself result
additional accompanying marking meat products that have been marinated
in a processed food item. Specific
indicating the origin as being a country processing that results in a change in with a particular flavor such as lemon-
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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations
pepper, Cajun, etc. have been changed derived from animals exclusively born, X and substantially transformed (as
in character and thus are considered raised, and slaughtered in the United established by CBP) in the United States
processed food items. States; from animals born and raised in or aboard a U.S. flagged vessel, the
While the definition of a processed Alaska or Hawaii and transported for a product shall be labeled at retail as
food item does exclude a number of period of time not more than 60 days ‘‘From [country X], processed in the
products from labeling under the COOL through Canada to the United States and United States.’’ Alternatively, the
program, many imported items are still slaughtered in the United States; or from product may be labeled as ‘‘Product of
required to be marked with country of animals present in the United States on country X and the United States’’. The
origin information under the Tariff Act or before July 15, 2008, and once covered commodity must also be
of 1930 (19 U.S.C. 1304) (Tariff Act). For labeled to indicate that it was derived
present in the United States, remained
example, while a bag of frozen peas and from wild fish or shellfish.
continuously in the United States.
carrots is considered a processed food In the case of farm-raised fish, if a
(b) Perishable agricultural
item under this final rule, if the peas covered commodity was imported from
commodities, peanuts, pecans, ginseng,
and carrots are of foreign origin, the country X at any stage of production
and macadamia nuts—covered
Tariff Act requires that the country of and substantially transformed (as
commodities must be from products
origin information be marked on the established by CBP) in the United
exclusively produced in the United
bag. Likewise, while roasted peanuts, States, the product shall be labeled at
States.
pecans, and macadamia nuts are also (c) Farm-raised fish and shellfish— retail as ‘‘From [country X], processed
considered processed food items under in the United States.’’ Alternatively, the
covered commodities must be derived
this final rule, under the Tariff Act, if product may be labeled as ‘‘Product of
exclusively from fish or shellfish
the nuts are of foreign origin, the country X and the United States’’. The
hatched, raised, harvested, and
country of origin information must be covered commodity shall also be labeled
processed in the United States, and that
indicated to the ultimate purchaser. to indicate that it was derived from
has not undergone a substantial
This also holds true for a variety of fish farm-raised fish or shellfish.
transformation (as established by CBP)
and shellfish items. For example, outside of the United States. Labeling Muscle Cut Covered
salmon imported from Chile that is (d) Wild fish and shellfish—covered
Commodities of Multiple Countries of
smoked in the United States as well as commodities must be derived
Origin (That Includes the United States)
shrimp imported from Thailand that is exclusively from fish or shellfish either
Under this final rule, for muscle cut
cooked in the United States are also harvested in the waters of the United
covered commodities derived from
required to be labeled with country of States or by a U.S. flagged vessel and
animals that were born in Country X or
origin information under the Tariff Act. processed in the United States or aboard
(as applicable) Country Y, raised and
In addition, items such as marinated a U.S. flagged vessel, and that has not
slaughtered in the United States, and
lamb loins that are imported in undergone a substantial transformation
were not derived from animals imported
consumer-ready packages would also be (as established by CBP) outside of the
for immediate slaughter as defined in
required to be labeled with country of United States.
§ 65.180, the origin may be designated,
origin information as both CBP and FSIS
Labeling Country of Origin for Imported for example, as Product of the U.S.,
regulations require meat that is
Products County X, and (as applicable) Country
imported in consumer-ready packages to
Y. The countries of origin may be listed
Under this final rule, a fish or
be labeled with origin information on
in any order.
shellfish imported covered commodity
the package.
For muscle cut covered commodities
Examples of items excluded from shall retain its origin as declared to CBP
derived from animals born, raised, and
country of origin labeling include at the time the product enters the
slaughtered in the U.S. that are
teriyaki flavored pork loin, meatloaf, United States, through retail sale,
commingled during a production day
roasted peanuts, breaded chicken provided it has not undergone a
with muscle cut covered commodities
tenders, breaded fish sticks, flank steak substantial transformation (as
derived from animals that were raised
with portabella stuffing, steakhouse established by CBP) in the United
and slaughtered in the United States,
sirloin kabobs with vegetables, cooked States. Similarly, for the other covered
and were not derived from animals
and smoked meats, blue cheese angus commodities, an imported covered
imported for immediate slaughter as
burgers, cured hams, bacon, corned beef commodity for which origin has already
defined in § 65.180, the origin may be
briskets, prosciutto rolled in mozzarella been established as defined by the Act
designated as, for example, Product of
cheese, a salad that contains iceberg and (e.g., born, raised, slaughtered or
the United States, Country X, and (as
romaine lettuce, a fruit cup that harvested) and for which no production
applicable) Country Y. The countries of
contains cantaloupe, watermelon, and steps have occurred in the United States
origin may be listed in any order.
honeydew, mixed vegetables, and a shall retain its origin as declared to CBP
If an animal was imported into the
salad mix that contains lettuce and at the time the product enters the
United States for immediate slaughter as
carrots and/or salad dressing. United States, through retail sale.
defined in § 65.180, the origin of the
Covered commodities imported in
Labeling Covered Commodities of resulting meat products derived from
consumer-ready packages are currently
United States Origin that animal shall be designated as
required to bear a country of origin
Product of Country X and the United
The law prescribes specific criteria declaration on each individual package
States.
that must be met for a covered under the Tariff Act. This final rule does
For muscle cut covered commodities
commodity to bear a ‘‘United States not change these requirements.
derived from animals that are born in
country of origin’’ declaration.
Labeling Fish and Shellfish Imported
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Country X or Country Y, raised and
Therefore, covered commodities may be
Products That Have Been Substantially slaughtered in the United States, that
labeled as having a United States origin
Transformed in the United States are commingled during a production
if the following specific requirements
Under this final rule, in the case of day with muscle cut covered
are met:
commodities that are derived from
(a) Beef, pork, lamb, chicken, and wild fish and shellfish, if a covered
animals that are imported into the
goat—covered commodities must be commodity was imported from country
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