Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Rules and Regulations 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 

11838 Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Rules and Regulations 

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 

Federal Register / Vol. 74, No. 53 / Friday, March 20, 2009 / Rules and Regulations 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 reimportation 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 email 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. 

■ 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 

DEPARTMENT OF ENERGY 

10 CFR Part 820 

RIN 1990–AA30 

Procedural Rules for DOE Nuclear 

Activities 

AGENCY: Office of Health, Safety and 

Security, Department of Energy. 

ACTION: Final rule. 

SUMMARY: The Department of Energy 

(DOE) is today publishing a final rule to 

amend its Procedural Rules for DOE 

Nuclear Activities at Part 820 to be 

consistent with section 610 of the 

Energy Policy Act of 2005, Public Law 

109–58 (EPAct of 2005), signed into law 

by President Bush on August 8, 2005. 

Section 610 amends provisions in 

section 234A. of the Atomic Energy Act 

of 1954 (AEA) concerning civil penalty 

assessments against certain DOE 

contractors, subcontractors and 

suppliers. Specifically, this final rule 

revises DOE regulations at section 

820.20 to be consistent with the changes 

under section 610 of the EPAct of 2005. 

DATES: Effective Date: This rulemaking 

is effective on April 20, 2009. 

FOR FURTHER INFORMATION CONTACT: John 

S. Boulden III, Acting Director (HS–40), 

Office of Enforcement, Office of Health, 

Safety and Security, U.S. Department of 

Energy, 19901 Germantown Road, 

Germantown, Maryland 20874, (301) 

903–2178; or Sophia Angelini, Attorney 

Advisor (GC–52), Office of the General 

Counsel, U.S. Department of Energy, 

1000 Independence Ave., SW., 

Washington, DC 20585, (202) 586–6975. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. DOE’s Response to Comments 

III. Procedural Requirements 

A. Review Under Executive Order 12866