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  1. 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 mstockstill on PROD1PC66 with RULES2 VerDate Nov<24>2008 18:41 Jan 14, 2009 Jkt 217001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:FRFM15JAR2.SGM 15JAR2
  2. 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 mstockstill on PROD1PC66 with RULES2 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 VerDate Nov<24>2008 18:41 Jan 14, 2009 Jkt 217001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:FRFM15JAR2.SGM 15JAR2
  3. 3. 2659 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. mstockstill on PROD1PC66 with RULES2 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. VerDate Nov<24>2008 18:41 Jan 14, 2009 Jkt 217001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:FRFM15JAR2.SGM 15JAR2
  4. 4. 2660 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Rules and Regulations 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 mstockstill on PROD1PC66 with RULES2 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- VerDate Nov<24>2008 18:41 Jan 14, 2009 Jkt 217001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:FRFM15JAR2.SGM 15JAR2
  5. 5. 2661 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 mstockstill on PROD1PC66 with RULES2 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 VerDate Nov<24>2008 18:41 Jan 14, 2009 Jkt 217001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:FRFM15JAR2.SGM 15JAR2

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