[Federal Register Volume 74, Number 53 (Friday, March 20, 2009)]
[Rules and Regulations]
[Pages 11837-11839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6127]



[[Page 11837]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. FSIS-2008-0027]
RIN 0583-AD38


Mandatory Country of Origin Labeling of Muscle Cuts of Beef 
(Including Veal), Lamb, Chicken, Goat, and Pork; Ground Beef, Ground 
Lamb, Ground Chicken, Ground Goat, and Ground Pork

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Affirmation of interim final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is affirming, 
without change, its interim final rule requiring a country of origin 
statement on the label of any meat or poultry product that is a covered 
commodity, as defined by the Agricultural Marketing Service (AMS), and 
that is to be sold by a retailer, also as defined by AMS, in accordance 
with the regulations set out in AMS' final rule, ``Mandatory Country of 
Origin Labeling of Beef, Pork, Lamb, Chicken, Goat Meat, Perishable 
Agricultural Commodities, Peanuts, Pecans, Ginseng, and Macadamia 
Nuts.'' FSIS is also affirming, without change, the provisions of the 
interim final rule that amended its regulations to provide that it will 
consider the addition of compliant country of origin statements to the 
labels of covered meat or poultry products to be generically approved. 
FSIS is thus conforming its regulations to the AMS final rule. FSIS is 
not amending its regulations or labeling policies for meat or poultry 
products that are non-covered commodities.

DATES: This final rule is effective on March 20, 2009.

FOR FURTHER INFORMATION CONTACT: Rosalyn Murphy-Jenkins, Acting 
Director, Labeling and Program Delivery Division, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250-3700; (202) 205-0279.

SUPPLEMENTARY INFORMATION:

FSIS' Interim Final Rule

    On August 28, 2008 (73 FR 50701), FSIS published an interim final 
rule conforming its regulations to the AMS interim final country of 
origin labeling (COOL) rule, published August 1, 2008 (73 FR 45106). As 
FSIS explained in its interim final rule, the Farm Security and Rural 
Investment Act of 2002 (Section 10816 of Public Law 107-171) and the 
Food, Conservation and Energy Act of 2008 (Section 11002 of Public Law 
110-246) amended the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 
et seq.) to require that retailers notify their customers of the 
country of origin of covered commodities. Under the law, covered 
commodities include muscle cuts of beef (including veal), lamb, 
chicken, goat, and pork; ground beef, ground lamb, ground chicken, 
ground goat, and ground pork; as well as other non-meat covered 
commodities.
    The law defines ``retailer'' as having the meaning given that term 
in section 1(b) of the Perishable Agricultural Commodities Act of 1930 
(PACA) (7 U.S.C. 499 et seq.). In addition, the law states that any 
person engaged in the business of supplying a covered commodity to a 
retailer shall provide information to the retailer about the country of 
origin of the covered commodity.
    The law exempts covered commodities from mandatory COOL if they are 
ingredients in processed foods. The law also prescribes specific 
criteria that must be met for a covered commodity to bear a ``United 
States country of origin'' declaration. Furthermore, the law requires 
that country of origin labeling for ground beef, ground lamb, ground 
pork, ground goat, and ground chicken include a list of all the 
countries of origin contained therein or reasonably contained therein.
    The Agricultural, Rural Development, Food and Drug Administration, 
and Related Agencies Appropriations Act of 2006 (Pub. L. 109-97) 
delayed the applicability of mandatory COOL for all covered commodities 
except wild and farm-raised fish and shell fish until September 30, 
2008. Therefore, FSIS' interim final COOL regulations were effective 
September 30, 2008. The requirements of the interim final rule did not 
apply to meat or poultry product covered commodities produced or 
packaged before September 30, 2008. FSIS' interim final rule remains in 
effect until this final rule becomes effective.

AMS Final Rule

    AMS's final COOL regulations were published on January 15, 2009 (74 
FR 2658). The preamble to AMS final COOL regulations summarizes the 
contents of the final rule and highlights changes from the interim 
final rule.
    AMS made two changes to the definitions of meat product covered 
commodities in 7 CFR part 65, subpart A. AMS changed the definition of 
``ground beef'' in the final rule in response to comments. The revised 
definition excludes ``beef patties,'' as defined in 9 CFR 319.15(c), 
from the definition of ``covered commodity.'' Under AMS' final rule, 
the term ``ground beef'' includes products defined in 9 CFR 319.15(a), 
i.e., chopped fresh or frozen beef, with or without seasoning and 
without the addition of beef fat as such, containing no more than 30 
percent fat, and containing no added water, phosphates, binders, or 
extenders. The term ``ground beef'' also includes products defined by 
the term ``hamburger'' in 9 CFR 319.15(b) (7 CFR 65.155).
    In response to comments, AMS also changed the definition of 
``lamb'' in the final rule to include mutton. Under AMS' final rule, 
the term ``lamb'' means meat produced from sheep (7 CFR 65.190).
    AMS' country of origin regulations in 7 CFR 65.300 include 
requirements for labeling covered commodities of United States origin 
(7 CFR 65.300(d)). AMS' interim final rule contained a provision 
allowing U.S. origin covered commodities to be further processed or 
handled in a foreign country and to retain their U.S. origin. In 
response to comments, AMS deleted this provision. To the extent that it 
is allowed under existing Department of Homeland Security Customs and 
Border Protection (CBP) or FSIS regulations, U.S. origin covered 
commodities may still be eligible to bear a U.S. origin declaration if 
they are processed in another country such that a substantial 
transformation (as determined by CBP) does not occur. Below, FSIS has 
included a discussion of the effect of the COOL regulations on U.S. 
meat and poultry products exported for processing.
    The effective date of AMS's January 15, 2009, final regulation is 
March 16, 2009. In its final rule, AMS explained that it had provided a 
six month education and outreach period following the effective date of 
its interim final rule to allow the regulated industries to adapt to 
the changes in its COOL regulations. AMS provided in its final rule 
that this period of education and outreach would continue through March 
2009.

FSIS Final Rule

    This final rule will conform its final rule to AMS' final rule. In 
this final rule, FSIS made no changes to its interim final rule in 
response to comments. Therefore, consistent with FSIS' interim final 
rule, FSIS is amending 9 CFR 317.8(b) and 381.129 to require that a 
country of origin statement on the label of a meat or poultry product 
that is a ``covered commodity,'' as defined in 7 CFR part 65, subpart 
A, that is to be sold by a ``retailer,'' as defined in 7 CFR 65.240, 
comply with the country of origin notification and markings

[[Page 11838]]

requirements in 7 CFR 65.300 and 65.400.
    Also, consistent with its interim final rule, FSIS is amending its 
generic approval labeling regulations (9 CFR 317.5 and 381.133) to 
specify that the addition of country of origin statements on the labels 
of meat or poultry product covered commodities that are to be sold by 
retailers and that comply with COOL requirements will be considered to 
be generically approved. FSIS is providing that such country of origin 
statements will be generically approved to facilitate implementation of 
COOL. Under the Federal meat and poultry products inspection 
regulations, country of origin statements on non-covered meat or 
poultry products generally are not generically approved labeling. FSIS 
generally considers country of origin statements on non-covered 
commodities to be special claims that require sketch approval from FSIS 
(9 CFR 317.4 and 381.132).
    The Federal meat and poultry product inspection regulations require 
country of origin statements on the immediate containers of imported 
products (9 CFR 327.14 and 381.205). These regulations require that the 
country of origin statement be immediately under the name or 
descriptive designation of the product. AMS' final regulations do not 
affect these requirements.
    This action is authorized under the Federal Meat Inspection Act and 
the Poultry Products Inspection Act and is consistent with the 
Agricultural Marketing Act of 1946.
    The AMS final rule was effective March 16, 2009. Because it is 
important that AMS and FSIS have consistent regulations, the 
Administrator has determined under 5 U.S.C. 533 that it is in the 
public interest to make this final rule effective on the date of 
publication. Making this rule effective on the date of publication is 
in the public interest because it will minimize confusion among 
industry and consumers. For this reason, FSIS's final rule will be 
effective on the date of publication.

Responses to Comments

    FSIS received 33 comments in response to the interim final rule. 
Several commenters supported FSIS conforming its regulations to AMS' 
regulations and supported FSIS providing for generic approval of 
country of origin statements that comply with AMS' regulations.
    Many of the comments raised issues concerning the requirements and 
effects of AMS' interim final COOL regulations, including recordkeeping 
requirements, acceptable abbreviations, costs and benefits, 
international effects, and health effects. These comments were directed 
to the AMS interim final regulations, did not specifically address 
FSIS' interim final rule, and are considered to be outside the scope of 
this rulemaking. Furthermore, AMS has addressed the issues these 
comments raised in the preamble to its final rule. Therefore, FSIS has 
not responded to these comments in the discussion below.
    Comments: Many of the comments recommended that COOL be required on 
all products, including processed food products.
    Response: The COOL statute specifically defines the commodities 
covered by the mandatory COOL program. The COOL statute specifically 
exempts covered commodities from mandatory COOL if they are an 
ingredient in a processed food item. These comments are outside the 
scope of this FSIS rulemaking.
    Comments: One company recommended more guidance on what is 
considered a ``processed food item.'' Specifically, the commenter 
questioned whether FSIS generic approval for COOL will be available 
when the product is marinated, enhanced or injected with tenderizers 
such as papain, bromelin, or ficin or with ingredients such as lemon 
juice concentrates, chicken broth, dried beef stock, natural flavor and 
spices.
    Response: AMS' final rule defines a ``processed food item'' as a 
retail item derived from a covered commodity that has undergone 
specific processing resulting in a change in the character of the 
covered commodity, or that has been combined with at least one other 
covered commodity or other substantive food component (e.g., chocolate, 
breading, tomato sauce). The ``processed food item'' definition also 
provides that the addition of a component (such as water, salt, or 
sugar) that enhances or represents a further step in the preparation of 
the product for consumption, would not in itself result in a processed 
food item (7 CFR 65.220). Furthermore, in the preamble to its final 
rule, AMS stated that enhancement with enzymatic tenderizers, such as 
ficin and bromelain, do not by themselves change the character of the 
covered commodity. Therefore, the use of the ingredients listed in the 
comment would not, by themselves, result in a covered commodity 
becoming a processed food item. Based on AMS' regulations, if an 
establishment used such ingredients in a covered commodity and did not 
process the product in a way that resulted in a change in the character 
of the product, the product would continue to be a covered commodity. 
In this situation, the required compliant country of origin statements 
on the product label could be generically approved.
    Comments: One commenter questioned whether FSIS or another Federal 
agency would use a COOL noncompliance as a basis to recall product.
    Response: AMS provided a six month education and outreach period 
following the effective date of its interim final COOL regulations. As 
FSIS explained in a notice to inspection program personnel, FSIS will 
follow AMS enforcement policy during this same period. After this 
period has elapsed, if noncompliance with COOL regulations is disclosed 
on meat or poultry product labeling, FSIS will consult with AMS and 
consider appropriate enforcement action. If FSIS enforcement action is 
necessary, FSIS will consider rescinding label approval (9 CFR 500.8), 
requesting a recall, or taking such other enforcement action as is 
appropriate in light of the facts involved in the particular situation.
    Comments: One industry association recommended that FSIS work with 
AMS to convey information concerning COOL requirements. The commenter 
also recommended that FSIS provide additional guidance on COOL as it 
relates to FSIS' labeling requirements.
    Response: FSIS will continue to consult closely with AMS concerning 
COOL requirements. FSIS is working with AMS to develop additional COOL 
guidance for meat and poultry establishments.
    Comments: One commenter questioned whether establishments can use 
up existing label stocks or are required to have new labels printed 
immediately to be compliant with the COOL rule.
    Response: AMS' and FSIS' final rules do not require that covered 
commodities be individually labeled with COOL information. Retailers 
can use placards and other signage to convey origin information.
    Comments: One commenter questioned how beef trim co-mingled from 
different countries is to be labeled when it leaves the establishment.
    Response: As is noted above, the establishment is not required to 
label the product. Rather, in this situation, the establishment is 
required to make available to the purchasers of the trim information 
about the countries of origin of the beef trim (7 CFR 65.500(b)).

COOL for U.S. Products Exported for Processing

    In addition to the comments discussed above, an industry 
association

[[Page 11839]]

has questioned how United States origin meat or poultry products that 
are exported to a foreign country for processing prior to re-
importation back to the United States should be labeled under the final 
COOL regulations. To the extent that existing CBP or FSIS regulations 
allow for products that have been minimally processed in a foreign 
country to reenter the United States as ``Product of the U.S.,'' 
nothing in the AMS final rule precludes this practice.
    It should be noted, however, that FSIS meat and poultry product 
inspection regulations require country of origin statements on the 
immediate containers of imported products (9 CFR 327.14 and 381.205). 
Therefore, if a U.S. country of origin meat or poultry product is 
transported to be minimally processed (e.g., marinated) in Canada prior 
to re-importation back to the United States, the immediate containers 
of the finished product would have to be labeled with the statement, 
``product of Canada.'' Notwithstanding this requirement, FSIS 
regulations allow such product to be repackaged for sale at retail. If 
such product is repackaged for sale at retail, the retailer could 
provide labeling indicating that the product is of U.S. origin if the 
product otherwise meets the criteria in 7 CFR 65.260.

Executive Order 12988

    This final rule has been reviewed under the Executive Order 12988, 
Civil Justice Reform. Under this final rule: (1) All State and local 
laws and regulations that are inconsistent with this rule will be 
preempted; (2) no retroactive effect will be given to this rule; and 
(3) no retroactive proceedings will be required before parties may file 
suit in court challenging this rule.

Executive Order 12866 and the Regulatory Flexibility Act

    This final rule has been reviewed under Executive Order 12866. The 
rule has been determined to be not significant for the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget (OMB). All costs and benefits 
associated with this rule are accounted for in AMS' final rule economic 
analysis.

Effect on Small Entities

    AMS' final rule includes a final regulatory flexibility analysis. 
AMS believes that its regulations will have a significant economic 
impact on a substantial number of small entities. FSIS' conforming 
regulations will not have any additional impact on small entities.

Paperwork Reduction Act

    AMS' final rule includes an estimate of the annual recordkeeping 
burden associated with COOL requirements. FSIS' final rule has been 
reviewed under the Paperwork Reduction Act and imposes no additional 
paperwork or recordkeeping requirements.

Government Paperwork Elimination Act (GPEA)

    FSIS is committed to compliance with the GPEA, which requires 
Government agencies, in general, to provide the public the option of 
communicating electronically with the government to the maximum extent 
possible. The Agency will ensure that all forms used by the 
establishments are made available electronically.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
final rule, FSIS will announce it online through the FSIS Web page 
located at http://www.fsis.usda.gov/Regulations_&_Policies/2009_Interim_&_Final_Rules_Index/index.asp. FSIS will also make copies 
of this Federal Register publication available through the FSIS 
Constituent Update, which is used to provide information regarding FSIS 
policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to constituents and stakeholders. The Update is 
communicated via Listserv, a free electronic mail subscription service 
for industry, trade groups, consumer interest groups, health 
professionals, and other individuals who have asked to be included. The 
Update is also available on the FSIS Web page. Through the Listserv and 
Web page, FSIS is able to provide information to a much broader and 
more diverse audience. In addition, FSIS offers an e-mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password protect their accounts.

List of Subjects

9 CFR Part 317

    Food labeling, Meat inspection.

9 CFR Part 381

    Food labeling, Poultry and poultry products.


0
For the reasons discussed in the preamble, FSIS adopts the interim rule 
published August 28, 2008 (73 FR 50701) as final without change.

    Done in Washington, DC, on March 17, 2009.
Alfred V. Almanza,
Administrator.
[FR Doc. E9-6127 Filed 3-19-09; 8:45 am]
BILLING CODE 3410-DM-P