This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

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examples of documents appearing in this

section.

Notices Federal Register

60228 

Vol. 73, No. 198 

Friday, October 10, 2008 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2008–0026] 

Product Labeling: Use of the Animal 

Raising Claims in the Labeling of Meat 

and Poultry Products 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is issuing this 

notice to initiate a public process to 

review its policies regarding the 

approval of animal raising claims in the 

labeling of meat and poultry products. 

FSIS evaluates animal raising claims by 

considering information on animal 

production practices submitted by 

companies as part of their label 

approval requests. The Agency approves 

these claims if the animal production 

information submitted with the label 

application supports the claims being 

made and the claim is truthful and not 

misleading. 

The Agency’s recent experience with 

labeling claims related to the raising of 

poultry have led FSIS to initiate a 

review of its evaluation and approval 

process for labels of meat and poultry 

products that contain animal raising 

claims. The Agency is publishing this 

notice to solicit public input and to 

announce that FSIS and the Agricultural 

Marketing Service will jointly hold a 

public meeting to discuss these issues. 

DATES: The public meeting will be held 

on October 14, 2008. Comments on this 

notice and the issues discussed at the 

public meeting must be received by 

November 14, 2008. 

ADDRESSES: The public meeting will be 

held from 8:30 a.m. to 12:30 p.m. at the 

L’Enfant Plaza Hotel, 480 L’Enfant 

Plaza, SW., Washington, DC 20024, 

(202) 484–1000. 

FSIS will finalize an agenda on or 

before the meeting date and will post it 

on the FSIS Internet Web page http:// 

www.fsis.usda.gov/News? Meetings_

& _ Events/. 

The official transcript of the meeting 

will be available for viewing by the 

public in the FSIS docket room and on 

the FSIS Web site http:// 

www.fsis.usda.gov/ News? Meetings_

&_ Events/ when it becomes available. 

FSIS invites interested persons to 

submit comments on this notice. 

Comments may be submitted by one of 

the following methods: 

Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions at that site for 

submitting comments. 

Mail, including floppy disks or CD– 

ROMs, and hand- or courier-delivered 

items: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, FSIS Docket 

Room, 1400 Independence Avenue, 

SW., Room 2534, Washington, DC 

20250. 

All submissions received must 

include the Agency name and docket 

number FSIS–2008–0026. Documents 

referred to in this notice, and all 

comments submitted in response to this 

notice, will be available for public 

inspection in the FSIS Docket Room at 

the address listed above between 8:30 

a.m. and 4:30 p.m., Monday through 

Friday, except Federal holidays. 

Comments also will be posted on the 

Agency’s Web site at http:// 

www.fsis.usda.gov/ 

regulations_&_policies/ 

2008_Notices_Index/index.asp. 

Individuals who do not wish FSIS to 

post their personal contact 

information—mailing address, e-mail 

address, telephone number—on the 

Internet may leave this information off 

of their comments. 

FOR FURTHER INFORMATION CONTACT: For 

technical information: Charles Gioglio, 

Director, Labeling and Program Delivery 

Division, Office of Policy and Program 

Development, USDA, FSIS, 1400 

Independence Avenue, SW., 

Washington, DC 20250, (202) 205–3625, 

e-mail: Charles.Gioglio@fsis.usda.gov. 

Pre-registration for this meeting is 

recommended. To pre-register, please 

contact Sheila Johnson by telephone at 

(202) 690–6498 or by e-mail at 

Sheila.Johnson@fsis.usda.gov. Persons 

requiring a sign language interpreter or 

special accommodations should contact 

Sheila Johnson as soon as possible. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS is the public health regulatory 

agency in the USDA that is responsible 

for ensuring that the nation’s 

commercial supply of meat, poultry, 

and egg products is safe, wholesome, 

and accurately labeled and packaged. 

FSIS develops and implements 

regulations and policies to ensure that 

meat, poultry, and egg product labeling 

is truthful and not misleading. Under 

the Federal Meat Inspection Act (FMIA) 

(21 U.S.C. 601, 607) and the Poultry 

Products Inspection Act (PPIA) (21 

U.S.C. 451, 457), the labels of meat and 

poultry products must be approved by 

the Secretary of Agriculture, who has 

delegated this authority to FSIS, before 

these products can enter commerce. 

Section 203(c) of the Agricultural 

Marketing Act (AMA) of 1946, as 

amended (7 U.S.C. 1622), directs and 

authorizes the Secretary of Agriculture 

‘‘to develop and improve standards of 

quality, condition, quantity, grade, and 

packaging, and recommend and 

demonstrate such standards in order to 

encourage uniformity and consistency 

in commercial practices.’’ The 

Agricultural Marketing Service (AMS) 

has played a lead role in achieving the 

objectives of the AMA in part through 

the development of voluntary standards 

for agricultural products. 

As part of its prior approval process 

for label claims, FSIS has been asked to 

evaluate and approve label claims that 

highlight certain aspects of the way 

animals used as the source for meat and 

poultry products are raised. Examples of 

animal raising claims that the Agency 

has approved include ‘‘raised without 

antibiotics,’’ ‘‘not fed animal byproducts,’’ ‘‘free range,’’ ‘‘vegetarian fed 

diet,’’ and ‘‘raised without added 

hormones.’’ FSIS typically evaluates 

such claims by reviewing testimonials, 

affidavits, animal production protocols, 

and other relevant documentation 

provided by animal producers. 

When FSIS evaluates a meat or 

poultry product label that includes an 

animal raising claim, it reviews the 

animal production protocol submitted 

in support of the label claim to ensure 

that it describes practices that are 

accurately reflected in the claim being 

made. Supporting documentation may 

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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices 60229 

be submitted directly by the 

establishment seeking approval of the 

label or by producers, growers, or others 

on the establishment’s behalf. If a 

company submits information that 

demonstrates that an animal production 

claim is truthful and not misleading, 

FSIS allows products derived from 

animals raised according to the protocol 

to bear the raising claim on their labels. 

In addition to producer testimonials 

and affidavits, establishments or animal 

producers may also submit certifications 

from a certifying organization or entity 

to support animal raising claims. FSIS 

accepts these certifications if the 

Agency has evaluated the certifying 

entity’s animal raising standards and 

determined that they are truthful and 

not misleading and accurately reflect 

the claim being made. FSIS also allows 

the label of a meat or poultry product 

to bear a certified claim if the claim 

clearly identifies the certifying entity, 

e.g., ‘‘certified free range by * * * 

(name of certifying entity),’’ and the 

Agency determines, based on its review 

of the entity’s standards, that the 

standards truthfully define the claim. 

FSIS makes this determination in 

consultation with AMS and other 

agencies with relevant expertise. 

Issues Associated With Animal Raising 

Claims 

It has become clear, however, that the 

use of animal raising claims in the 

labeling of meat and poultry products 

presents issues that can be difficult for 

FSIS to address through its pre-market 

label approval process. 

As discussed above, FSIS assesses 

animal raising claims by evaluating 

supporting documentation that 

companies submit as part of their label 

approval requests. However, because 

FSIS does not regulate food animal 

production, the Agency may not always 

have all the relevant information 

necessary to the proper evaluation of the 

animal raising practices described in a 

producer’s animal production protocol. 

In addition, while FSIS’ approval of 

an animal raising claim depends on 

submissions that describe how the 

source animals were raised, animal 

producers and certifying entities may 

have different views on the specific 

animal production practices that qualify 

a product to bare a given animal raising 

claim on its label. Thus, the same 

animal raising claim may reflect 

different animal raising practices, 

depending on how an animal producer 

or certifying entity defines the basis for 

the claim. 

For example, FSIS approves ‘‘free 

range’’ raising claims on the labels of 

poultry products if the producer 

demonstrates that the birds were 

allowed continuous, free access to the 

outside for over 51% of their lives 

through a normal growing cycle. Under 

this standard, some producers or 

certifying organizations may support a 

‘‘free range’’ labeling claim if the source 

birds for the poultry products were 

allowed access to a yard outside, 

regardless of whether the birds actually 

use the yard. On the other hand, other 

producers or certifying entities may 

establish stricter standards for 

themselves and request that FSIS 

approve a ‘‘free range’’ claim only if the 

source birds actually use the yard. 

As with animal producers and 

certifying entities, consumers often have 

a wide variety of views regarding the 

meaning of specific animal raising 

claims. 

Policy Review and Public Meeting 

FSIS has decided to initiate a review 

of its policies for evaluating and 

approving animal raising claims on 

labels. FSIS will carry out this policy 

review in cooperation with AMS. 

To facilitate this review, FSIS is 

publishing this Federal Register notice 

to solicit public input on ways to 

improve the Agency’s label approval 

policies and practices with respect to 

raising claims and to continue to ensure 

that approved labels are truthful and not 

misleading. 

In addition, FSIS and AMS will hold 

a public meeting on October 14, 2008, 

to discuss the development, evaluation, 

and proposed process for animal raising 

claims. FSIS is collaborating with AMS 

on these issues because AMS has taken 

a lead in establishing voluntary 

standards and in developing programs, 

such as Quality System Verification 

Programs (QSVPs) to verify or certify 

marketing claims that relate to animal 

raising practices. 

Certification by Certifying Entities, 

Request for Comments 

The use of animal raising claims in 

the labeling of meat and poultry 

products is an important issue for 

members of the industry that want to 

use these claims to differentiate their 

meat or poultry products from other 

similar products in the marketplace. It 

is also an important issue for consumers 

that prefer to purchase products derived 

from animals raised under certain 

conditions. 

FSIS wants to ensure that its policies 

for evaluation and approval of animal 

raising claims will create a level playing 

field for companies that want to use 

such claims in marketing their products 

and that will allow consumers to use 

animal raising claims information to 

assist in their purchase decisions. 

One approach under consideration is 

to rely on outside certifying entities. A 

certifying entity would evaluate a 

company’s animal production protocol 

to determine whether those practices 

meet the certifying entities standards for 

certifying the claim. The certifying 

entity would define and publish its 

standards. FSIS would review the 

certifying entities standards to 

determine whether they would in any 

way render the claim false or 

misleading. For example, poultry 

‘‘raised without antibiotics’’ claims 

certified by a certifying entity whose 

standards covered only on the period 

post-hatch, and allowed the 

administration of antibiotics in ovo 

would be considered misleading by the 

Agency and not approved for label use. 

The certifying entity would also 

conduct audits to verify that the animals 

used as the source for meat and poultry 

products bearing the raising claims were 

raised according to those standards. 

Companies interested in using animal 

raising claims in the labeling of their 

meat or poultry products would submit 

documentation of the certification as 

part of their label approval requests. 

If FSIS were to adopt this approach, 

companies could use the services of a 

private certifying entity or request that 

USDA’s AMS establish a voluntary 

audit-based program on specific animal 

raising claims. For example, AMS’s 

Livestock and Seed (LS) Program offers 

verification services through QSVPs to 

substantiate claims that cannot be 

determined by direct examination of 

livestock, their carcasses, or component 

parts, thus allowing the product to be 

labeled as ‘‘Verified by USDA’’ (http:// 

www.ams.usda.gov/ARCaudits). One 

specific QSVP is the USDA Process 

Verified Program, which allows a 

supplier to make marketing claims 

about feed practices or other raising 

practices, and then label and market 

their product as ‘‘USDA Process 

Verified’’. 

FSIS and AMS are interested in 

comments on the use of certification 

provided by certifying entities to verify 

animal raising claims and other possible 

approaches for approving the use of 

such claims in the labeling of meat and 

poultry products. The agencies plan to 

discuss this and the other issues related 

to animal raising claims at the October 

14, 2008, public meeting. 

The agencies are interested in public 

input on the following questions 

concerning the use of certifying entities 

in evaluating and approving animal 

raising claims in the labeling of meat 

and poultry products. 

mstockstill on PROD1PC66 with NOTICES

60230 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices 

1. Should FSIS continue to approve 

label claims based on animal raising 

standards developed by private 

certifying entities and by companies 

themselves if FSIS has reviewed the 

standards and determines that they 

would not render a claim false or 

misleading? 

2. Should FSIS establish any 

performance criteria or standards for 

private certifying entities? Should the 

Agency require that private certifying 

entities be reviewed and approved by 

AMS? 

3. Should FSIS establish minimum 

standards that companies would have to 

achieve to qualify to use certain animal 

raising claims? 

4. For those animal raising claims for 

which AMS has adopted standards, 

should FSIS adopt the AMS standards 

as the minimum standards? 

5. Would the approach outlined in 

this document create any inequities or 

create any problems for companies 

interested in using animal raising claims 

on the labels of their meat or poultry 

products? 

6. What other approaches should FSIS 

consider for evaluating and approving 

animal raising claims? 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and, in particular, 

minorities, women, and persons with 

disabilities, are aware of this notice, 

FSIS will announce it on-line through 

the FSIS Web page located at http:// 

www.fsis.usda.gov/ 

regulations_&_policies/ 

2008_Notices_Index/index.asp. 

FSIS also will 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 our constituents and 

stakeholders. The Update is 

communicated via Listserv, a free e-mail 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The Update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, 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 account. 

Done at Washington, DC, on: October 7, 

2008. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. E8–24191 Filed 10–7–08; 4:15 pm] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety Inspection Service 

[Docket No. FSIS 2008–0035] 

Sampling and Testing Procedures for 

Escherichia coli O157:H7 in Beef 

Manufacturing Trimmings 

AGENCY: Food Safety and Inspection 

Service (FSIS), USDA. 

ACTION: Notice of public meeting. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is announcing 

that it will hold a public meeting on 

October 14 and 15, 2008, to discuss 

sampling and testing procedures used 

by FSIS and industry for Escherichia 

coli (E. coli) O157:H7 in beef 

manufacturing trimmings and draft 

guidance to industry concerning this 

pathogen. Copies of the guidance 

materials are available on the FSIS Web 

site. 

DATES: The public meeting will be held 

on October 14 and 15, 2008. 

ADDRESSES: The public meeting will be 

held from 1 p.m. to 4:30 p.m. on 

October 14 and from 8:30 a.m. to 4 p.m. 

on October 15 at: L’Enfant Plaza Hotel, 

480 L’Enfant Plaza, SW., Washington, 

DC 20024, (202) 484–1000. FSIS invites 

interested persons to submit comments 

on the issues addressed at the public 

meeting. FSIS will finalize an agenda on 

or before the meeting date and will post 

it on the FSIS Web page http:// 

www.fsis.usda.gov/ 

News?Meetings_&_Events/. The official 

transcript of the meeting will be 

available for viewing by the public in 

the FSIS Docket Room and on the FSIS 

Web site http://www.fsis.usda.gov/ 

News?Meetings_&_Events/ when it 

becomes available. 

Comments may be submitted by either 

of the following methods: 

Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

online instructions at that site for 

submitting comments. 

Mail, including floppy disks or CD– 

ROMs, and hand- or courier-delivered 

items: Send to Docket Clerk, U.S. 

Department of Agriculture, Food Safety 

and Inspection Service, FSIS Docket 

Room, 1400 Independence Avenue, 

SW., Room 2534, Washington, DC 

20250. 

All submissions received must 

include the Agency name and docket 

number FSIS–2008–0035. Documents 

referred to in this notice, and all 

comments submitted in response to this 

notice will be available for public 

inspection in the FSIS Docket Room at 

the address listed above between 8:30 

a.m. and 4:30 p.m., Monday through 

Friday, except Federal holidays. 

Comments also will be posted on the 

Agency’s Web site at http:// 

www.fsis.usda.gov/ 

regulations_&_policies/ 

2008_Notices_Index/index.asp. 

Individuals who do not wish FSIS to 

post their personal contact 

information—mailing address, e-mail 

address, telephone number—on the 

Internet may leave this information off 

of their comments. 

FOR FURTHER INFORMATION CONTACT: Preregistration for this meeting is 

recommended. To pre-register, go to the 

FSIS Web site at http:// 

www.fsis.usda.gov/News_&_Events/ 

Reg_Ecoli_101408/index.asp. 

For additional information, please 

contact Keith Payne by telephone at 

(202) 690–6522 or by e-mail at 

keith.payne@fsis.usda.gov. Persons 

requiring a sign language interpreter or 

special accommodations should contact 

Keith Payne as soon as possible. 

SUPPLEMENTARY INFORMATION: 

Background 

The presence of E. coli O157:H7 in 

raw beef products continues to be a 

concern to FSIS. Based on E. coli 

O157:H7 test results from FSIS, other 

Federal and State entities, and industry, 

E. coli O157:H7 continues to 

contaminate finished product. Controls 

in food safety systems, including 

sanitary dressing procedures, do not 

consistently prevent, eliminate, or 

reduce E. coli O157:H7 to an 

undetectable level. Therefore, testing 

may be a means to ensure that 

contaminated product does not enter 

commerce. The meeting will focus on 

sampling and testing of beef 

manufacturing trimmings for E. coli 

O157:H7. 

Issues To Be Discussed at the Public 

Meeting 

FSIS will discuss the issues 

associated with the uniformity and 

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