67444 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 306, 317, 320, 327, and 381

[Docket No. 92–012F]

RIN 0583–AB92

Prior Labeling Approval System

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Final rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is amending

the Federal meat and poultry products

inspection regulations by expanding the

types of labeling, authorized for use on

meat and poultry products by official

establishments in the United States and

foreign establishments certified under

foreign inspection systems, which

would not require submittal to FSIS for

approval prior to use. In addition, FSIS

is amending the Federal meat and

poultry products inspection regulations

to permit the submission of only sketch

labeling, except for temporary

approvals, in those instances where

labeling is required to be submitted for

approval and to require retention of

certain labeling records. This final rule

eliminates unnecessary duplication in

the labeling approval system, and

contributes to President Clinton’s

initiatives for greater efficiency in

government services, (e.g., it is

consistent with the principles of the

National Performance Review to cut red

tape, put customers first, and eliminate

what is not needed).

EFFECTIVE DATE: July 1, 1996.

FOR FURTHER INFORMATION CONTACT: Ms.

Cheryl Wade, Director, Food Labeling

Division, Regulatory Programs, Food

Safety and Inspection Service, U.S.

Department of Agriculture, Washington,

DC 20250, Area Code (202) 254–2590.

SUPPLEMENTARY INFORMATION:

Background

Introduction

The Federal Meat Inspection Act

(FMIA) (21 U.S.C. 601 et seq.) and the

Poultry Products Inspection Act (PPIA)

(21 U.S.C. 451 et seq.) direct the

Secretary of Agriculture to maintain

meat and poultry inspection programs

designed to assure consumers that meat

and poultry products distributed to

them (including imports) are safe,

wholesome, not adulterated, and

properly marked, labeled, and packaged.

Section 2 of the FMIA (21 U.S.C. 602)

and section 2 of the PPIA (21 U.S.C.

451) state that unwholesome,

adulterated, or misbranded meat or meat

food products and poultry products are

injurious to the public welfare, destroy

markets for wholesome, not adulterated,

and properly marked, labeled, and

packaged products, and result in sundry

losses to producers and processors of

meat and poultry products, as well as

injury to consumers. Therefore,

Congress has granted the Secretary

broad authority to protect consumers’

health and welfare. Section 7(d) of the

FMIA (21 U.S.C. 607(d)) states: ‘‘No

article subject to this title shall be sold

or offered for sale by any person, firm,

or corporation, in commerce, under any

name or other marking or labeling

which is false or misleading, or in any

container of a misleading form or size,

but established trade names and other

marking and labeling and containers

which are not false or misleading and

which are approved by the Secretary are

permitted.’’ The PPIA contains similar

language in section 8(c) (21 U.S.C.

457(c)).

Under the latter provisions, the

Department has a longstanding

interpretation of the language to mean

that the Secretary of Agriculture or his

or her representative has the

responsibility to approve all labels or

other labeling to be used on federally

inspected and imported products prior

to the distribution of such products

from establishments that distribute such

products in interstate or foreign

commerce. Without approved labeling,

products may not be sold or offered for

sale or otherwise distributed in

commerce. The term ‘‘labeling,’’ as

defined in section 1(p) of the FMIA and

section 4(s) of the PPIA (21 U.S.C.

601(p) and 453(s), respectively), means

all labels and other written, printed, or

graphic matter (1) upon any article or

any of its containers or wrappers, or (2)

accompanying such article.

The aforementioned provisions also

apply to establishments that operate

solely within designated States. A State

is designated if it does not have or is not

effectively enforcing with respect to

establishments within its jurisdiction at

which livestock or poultry are

slaughtered, or their carcasses, or

products thereof, are prepared for use as

human food solely for distribution

within such State, requirements at least

equal to titles I and IV of the FMIA and

specified sections of the PPIA as

applicable. Once a State is designated,

the inspection requirements of the

FMIA and PPIA apply to establishments

that slaughter livestock and poultry

and/or prepare or process meat and/or

poultry products therefrom, solely for

distribution within the State.

Section 1(m)(8) of the FMIA (21

U.S.C. 601(m)(8)) and section 4(g)(8) of

the PPIA (21 U.S.C. 453(g)(8)) provide

that any carcass, part thereof, meat or

meat food product or any poultry

product is adulterated ‘‘* * * if any

valuable constituent has been in whole

or in part omitted or abstracted

therefrom; or if any substance has been

substituted, wholly or in part therefor;

or if damage or inferiority has been

concealed in any manner; or if any

substance has been added thereto or

mixed or packed therewith so as to

increase its bulk or weight, or reduce its

quality or strength, or make it appear

better or of greater value than it

is* * * .’’ Furthermore, section 1(n)(1)

of the FMIA (21 U.S.C. 601(n)(1)) and

section 4(h)(1) of the PPIA (21 U.S.C.

453(h)(1)) prescribe that any carcass,

part thereof, meat or meat food product

or poultry product is considered

misbranded if its labeling is false or

misleading in any particular.

In order to prevent product

adulteration and misbranding, the FMIA

and PPIA further authorize the Secretary

to prescribe, whenever he or she

determines such action is necessary for

the protection of the public, (1) the

styles and sizes of type to be used with

respect to material required to be

incorporated in labeling to avoid false or

misleading labeling, and (2) definitions

and standards of identity or

composition for meat and poultry

products (section 7(c) of the FMIA, 21

U.S.C. 607(c), and section 8(b) of the

PPIA, 21 U.S.C. 457(b)).

Current Regulations

The labeling provisions of the meat

and poultry products inspection

regulations specify the required features

of meat and poultry product labels for

immediate containers of domestic

product (9 CFR part 317 and 9 CFR part

381, subpart N) and for imported

product (9 CFR part 327 and 9 CFR part

381, subpart T). These include: (1) The

standardized, common or usual, or

descriptive name of the product; (2) an

ingredients statement containing the

common or usual name of each

ingredient listed in descending order of

predominance; (3) the name and place

of business of the manufacturer, packer,

or distributor; (4) an accurate statement

of the net quantity of contents; (5) the

inspection legend; and (6) special

handling instructions if product is

perishable; i.e., ‘‘Keep Frozen’’ and

‘‘Keep Refrigerated.’’ These essential

labeling features must be prominently

and informatively displayed on the

principal display panel or the

information panel of the product label.
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67445

The regulations contain other

provisions to ensure that no statement,

word, picture, design, or device which

is false or misleading in any particular

or conveys any false impression or gives

any false indication of origin, identity,

or quality, appears in any marking or

other labeling (9 CFR 317.8 and

381.129).

Any marking or labeling which is

determined to be false or misleading

within the meaning of the FMIA or the

PPIA and the regulations promulgated

thereunder causes the article to which it

relates to be misbranded, and, pursuant

to the authority contained in section

7(e) of the FMIA (21 U.S.C. 607(e)) and

section 8(d) of the PPIA (21 U.S.C.

457(d)), and 9 CFR 335.12 and 381.233

of the Federal meat and poultry

products inspection regulations, the

Administrator, FSIS, may withhold the

use of such marking or labeling.

In addition to providing substantive

labeling requirements, the Federal meat

and poultry products inspection

regulations provide specific information

regarding permitted and nonpermitted

uses of various substances (9 CFR part

318 and part 381, subpart 0). These

provisions prohibit the use of any food

additive, color additive, pesticide

chemical, or other added poisonous or

deleterious substance, or any other

substance in or on meat and poultry

products that would cause such articles

to be adulterated or misbranded within

the meaning of the FMIA and PPIA.

The Federal meat and poultry

products inspection regulations also

prescribe definitions and standards of

identity or composition for certain meat

and poultry products (9 CFR part 319

and part 381, subpart P). Standards of

composition identify the minimum

amount of meat and/or poultry required

in a product’s recipe. Standards of

identity set specific product

requirements for a product’s makeup.

These standards often specify (1) the

kind and minimum amount of meat

and/or poultry; (2) the maximum

amount of nonmeat ingredients, such as

fat or moisture; and (3) any other

ingredients allowed or expected in the

final product.

Current Prior Label Approval System

In order to assure that meat and

poultry products comply with the FMIA

and PPIA and the regulations

promulgated thereunder, FSIS conducts

a prior approval program for labels and

other labeling as specified in 9 CFR

317.4, 317.5, 327.14, 327.15, 381.132,

381.134, and 381.205 to be used on

federally inspected meat and poultry

products and imported products. This

program is administered by the Food

Labeling Division (FLD), Regulatory

Programs, FSIS, in Washington, DC.

To obtain labeling approval, domestic

meat and poultry processors and

certified foreign establishments, or their

representatives, must submit final labels

and other final labeling, except under

certain conditions. Such foreign

establishments are certified by

responsible officials of foreign meat and

poultry inspection systems, to the

Department, in accordance with parts

327 and 381, subpart T, of the Federal

meat and poultry products inspection

regulations as fully complying with

requirements at least equal to those

imposed on domestic products and

establishments. Such foreign

establishments are then eligible to have

their meat and poultry products

imported into the United States, unless

the Administrator terminates their

eligibility to import products in

accordance with parts 327 and 381,

subpart T, of the Federal meat and

poultry products inspection regulations.

Meat and poultry processors and

certified foreign meat establishments

may submit sketch labeling (a printer’s

proof or other version which clearly

shows all required labeling features,

size, location, and indication of final

color), accompanied by FSIS Form 7234,

‘‘Application for Approval of Labels,

Marking or Device,’’ to FLD for review.

Certified foreign poultry establishments

are required to submit sketch and

finished (final) labels of immediate

containers for review and approval. The

labeling application and sketch or final

printed labeling to be used on domestic

meat and poultry products and on

imported meat products must be

submitted to FLD in triplicate. Certified

foreign poultry establishments must

submit two copies of sketch and four

copies of final labeling to FLD. In

addition to the required information,

any special claims the processor intends

to make (e.g., quality claims or nutrient

content claims) must also be included

on the labeling. The labeling application

must contain the processing procedures

(sufficient to support the accuracy of the

label) and handling information,

including the following as indicated on

the form:

1. Product name;

2. Formulation information;

3. Firm name and address;

4. How the labeling is to be used;

5. Size and type of container; and

6. Size of the principal display panel.

All such information is reviewed by

an FSIS label review specialist who is

responsible for assuring that the labeling

complies with all Federal regulations

and labeling policies.

In 1983, the Agency promulgated

regulations that granted limited labeling

approval authority to the inspector-incharge (IIC) of official establishments

and established limited types of

generically approved labeling for official

establishments (48 FR 11410). This

rulemaking did not establish analogous

provisions for certified foreign

establishments. This rulemaking was

intended to reduce the number of labels

and other labeling reviewed and

processed by FLD, thereby improving

the efficiency of the labeling approval

system by expediting the process for

specific types of labeling and reducing

the paperwork burden on official

establishments. As a result of these

regulations, the IIC currently has

authority to approve the types of

labeling identified in 9 CFR 317.4(e) and

381.132(c), (e.g., labeling for single

ingredient products without additional

claims), provided certain requirements

are satisfied. However, under current

regulations, official establishments are

not required to submit labeling that

comes within the categories of labeling

the IIC can approve to the IIC for

approval, but rather have the option of

submitting the labeling to FLD for

approval.

The regulations also specify limited

types of labeling that can be approved

generically. The generically approved

labeling provisions allow

establishments to make certain

modifications to their previously

approved labeling. These modifications

can be designed, developed, printed,

and applied to a product without

submission for approval to FSIS,

provided the labeling shows all

mandatory information in a sufficiently

prominent manner and is not false or

misleading in any particular.

Generically approved labeling is

labeling which contains one or more of

the modifications identified in 9 CFR

317.5(b) and 381.134(b), (e.g., all

features of the labeling are

proportionately enlarged or reduced).

Under the current regulations, official

establishments may submit labeling that

comes within the generic approval

category, at their option, to FSIS for

approval. The IIC is also currently

authorized to approve those types of

labeling.

Currently, official establishments may

submit sketch labeling to FLD for

approval, but must submit final labeling

to FLD for approval, except for generic

or IIC approvals. Even though the IIC

has the authority to approve certain

final labeling, many official

establishments continue to submit all

final labeling to FLD for approval.
67446 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

During the development of the 1983

rule, FSIS estimated the number of

labels and other labeling reviewed by

FLD at approximately 130,000. During

fiscal year 1991, FLD processed

approximately 167,500 labels—87,500

final labels and 60,000 sketch labels

were reviewed and approved, 20,000

labels were reviewed but not approved,

and about 43,000 labels were approved

by IIC’s. No records are maintained on

numbers of temporary approvals,

generically approved labels, or labeling

inserts.

The continuing increase in the

numbers of labels and other labeling

submitted to FLD and limited Agency

resources led to an Agency assessment

of the prior labeling approval system in

1990. In exploring options for an

improved labeling approval system, the

Agency decided to institute a plan to

automate the labeling review process

and to revise internal procedures.

Advance Notice of Proposed

Rulemaking

On March 25, 1992, FSIS published

an Advance Notice of Proposed

Rulemaking (ANPR) (57 FR 10300) on

the Agency’s prior labeling approval

system. The ANPR presented the

following two options for making

additional changes to the current prior

labeling approval system: (1) Revise the

current system by significantly reducing

the scope of review through expanding

the categories of generically approved

labeling and replacing the current

general requirement of FSIS approval of

sketch and final labeling with one for

sketch labeling only; and (2) replace the

current system with a system in which

all labeling would be generically

approved and used without prior

submission to FSIS.

FSIS sought comments on these two

options and welcomed comments on

other options. FSIS also sought

comments on the role of the IIC with

regard to review or enforcement of

labeling, and on whether generic

approval should be provided for

labeling that includes geographical,

quality, health, nutrient content, or

negative claims, or guarantees.

FSIS received 110 comments in

response to the ANPR. After review and

consideration of the comments received

on the ANPR, FSIS issued a proposed

rule which is discussed in the following

section.

Proposed Rule

On November 23, 1993, FSIS

published a proposed rule (58 FR

62014) to amend the Federal meat and

poultry products inspection regulations

by expanding the types of labeling

currently authorized for use on meat

and poultry products by official

establishments in the United States and

foreign establishments certified under

foreign inspection systems which would

be generically approved. The rule was

proposed as a first step in the gradual

streamlining and modernization of the

labeling approval system. In the

proposal, the Agency sought comments

on a long-term plan to implement an allgeneric system.

Under the proposed rule, official

establishments and establishments

certified by responsible officials of

foreign inspection systems would be

required to submit only sketch labeling

in those instances where labeling was

required to be submitted to FLD for

approval. FSIS proposed to limit the

types of labeling submitted for review

and approval for domestic and imported

products and to revise 9 CFR 317.4,

317.5, 381.132, 381.133, 327.14,

381.205, and 381.206. No final labeling

would be approved by FLD, except

temporary labeling approvals. The

proposal defined a sketch label as a

printer’s proof or equivalent which

clearly shows all labeling features (as set

forth in 9 CFR 317.2 and part 381,

subpart N), as well as size, location, and

indication of final color and is no larger

than 81⁄2 x 14 inches. The proposed size

requirement was a result of the Agency’s

efforts to automate the review process

and to use scanning technology to

record certain information from the

labeling application. The proposal

provided that a parent company for a

corporation need only submit one

labeling application for a product

produced in other establishments which

were owned by the corporation. The

proposal indicated that this provision

for corporations would reduce the

burdens on the industry and the Agency

in submitting and revising such

applications without posing any

apparent risk of misbranding. The

proposal also provided that once a

sketch was approved, the establishment

would have the authority to print a final

copy and use the labeling without any

further authorization from the Agency.

Also, under the proposed rule,

establishments would still be required

to assure that the labeling was not false

or misleading in any particular. If an

establishment chose to modify an

approved sketch, the establishment

would be authorized to use the final

labeling if such labeling complied with

the requirements proposed in 9 CFR

317.5, 327.14, 381.133, and 381.205. If

the labeling was not in accord with

these proposed provisions, the labeling

would be required to be resubmitted as

a sketch for approval by FLD.

FSIS proposed to revise the IIC and

generic approval authorities prescribed

in 9 CFR 317.4(e), 317.5, 381.132(c), and

381.134 to alleviate the burden of

labeling approval imposed upon IIC’s.

The IIC would retain, however, the

authority to approve meat carcass ink

brands and meat food product ink and

burning brands. All other provisions of

9 CFR 317.4(e), 317.5, 381.132(c), and

381.134 would be combined to permit

establishments to use final labeling for

products in certain circumstances

without the submission of a sketch to

FLD and to use final labeling for

products for which a sketch had been

approved. FSIS proposed to add to this

authority a few other provisions

including the permitted use of labeling

for standardized products prescribed in

9 CFR parts 319 and 381, subpart P,

provided such labeling did not contain

special claims, such as quality claims,

nutrient content or health claims,

geographical origin claims, negative

claims, and guarantees, and was not a

domestic product labeled with a foreign

language.

FSIS proposed to permit official

establishments and foreign

establishments certified by officials of

foreign inspection systems to use the

following generically approved labeling

without the submission of sketches for

approval by FSIS:

1. Labeling for a product which has a

standard of identity or composition as

specified in 9 CFR part 319 or part 381,

subpart P, and which does not contain

any special claims, such as quality

claims, nutrient content claims, health

claims, negative claims, geographical

origin claims, or guarantees, or which is

not a domestic product labeled with a

foreign language;

2. Labeling for single-ingredient

products (such as beef steak, lamb

chops, chicken legs, or turkey breasts)

which does not contain special claims,

such as quality claims, nutrient content

claims, health claims, negative claims,

geographical origin claims, or

guarantees, or which is not a domestic

product labeled with a foreign language;

3. Labeling for products marked ‘‘For

Export Only’’ in U.S. establishments

which does not contain any special

claims, such as quality claims, nutrient

content claims, health claims, negative

claims, geographical origin claims, or

guarantees;

4. Labeling for containers of meat and

meat food products and poultry

products sold under contract

specifications to Federal Government

agencies, when such product is not

offered for sale to the general public,

provided the contract specifications

include specific requirements with
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67447

respect to labeling, and are made

available to the IIC;

5. Labeling for shipping containers

which contain fully labeled immediate

containers, provided such labeling

complies with 9 CFR 316.13 or 381.127.

6. Labeling for products not intended

for human food, provided they comply

with 9 CFR part 325 or 9 CFR 381.152(c)

and 381.193, and labeling for poultry

heads and feet for export for processing

as human food if they comply with 9

CFR 381.190(b);

7. Inspection legends, which comply

with 9 CFR parts 312 and 316 and 9 CFR

part 381, subpart M; and

8. Inserts, tags, liners, pasters, and

like devices containing printed or

graphic matter and for use on, or to be

placed within containers, and coverings

of products, provided such devices

contain no reference to product and bear

no misleading feature.

The proposed rule would also permit

official establishments and foreign

establishments certified by officials of

foreign inspection systems to use final

labeling, without further authorization

from FSIS, that was approved by FSIS,

FLD, in sketch form if the final labeling

was prepared without modification or

with the following modifications:

1. All features of the labeling are

proportionately enlarged or reduced,

provided that all minimum size

requirements specified in applicable

regulations are met and the labeling is

legible;

2. A substitution of the abbreviation

‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for ‘‘ounce,’’

or of the word ‘‘pound’’ for ‘‘lb.’’ or

‘‘ounce’’ for ‘‘oz.’’;

3. A master or stock label has been

approved from which the name and

address of the distributor are omitted

and such name and address are applied

before being used (in such case, the

words ‘‘prepared for’’ or similar

statement must be shown together with

the blank space reserved for the

insertion of the name and address when

such labels are offered for approval);

4. During holiday seasons, wrappers

or other covers bearing floral or foliage

designs or illustrations of rabbits,

chicks, fireworks, or other emblematic

holiday designs are used with approved

labeling (the use of such designs will

not make necessary the application of

labeling not otherwise required);

5. A change in the language or the

arrangement of directions pertaining to

the opening of containers or the serving

of the product;

6. The addition, deletion, or

amendment of a dated or undated

coupon, a cents-off statement, cooking

instructions, packer product code

information, or UPC product code

information;

7. Any change in the name or address

of the packer, manufacturer or

distributor that appears in the signature

line;

8. Any change in the net weight,

provided the size of the net weight

statement complies with 9 CFR 317.2 or

381.121;

9. The addition, deletion, or

amendment of recipe suggestions for the

product;

10. Any change in punctuation;

11. Newly assigned or revised

establishment numbers for a particular

establishment for which use of the

labeling has been approved by the FLD;

12. The addition or deletion of open

dating information;

13. A change in the type of packaging

material on which the label is printed;

14. Brand name changes, provided

that there are no design changes, the

brand name does not use a term that

connotes quality or other product

characteristics, the brand name has no

geographic significance, and the brand

name does not affect the name of the

product;

15. The deletion of the word ‘‘new’’

on new product labeling;

16. The addition, deletion, or

amendment of special handling

statements, such as ‘‘Keep Refrigerated’’

or ‘‘Keep Frozen,’’ provided that the

change is consistent with 9 CFR 317.2(k)

or 381.125(a);

17. The addition of safe handling

instructions as required by 9 CFR

317.2(l) or 381.125(b).

18. Changes reflecting a change in the

quantity of an ingredient shown in the

formula without a change in the order

of predominance shown on the label,

provided that the change in quantity of

ingredients complies with any

minimum or maximum limits for the

use of such ingredients prescribed in 9

CFR parts 318 and 319, or 9 CFR

381.147 or 9 CFR part 381, subpart P;

19. Changes in the color of the

labeling, provided that sufficient

contrast and legibility remain;

20. The addition, deletion, or

substitution of the official USDA grade

shield on labels of poultry products;

21. A change in the product vignette,

provided the change does not affect

mandatory labeling information or

misrepresent the content of the package;

or

22. A change in an establishment

number by a corporation or parent

company for an establishment under its

ownership.

Section 327.15 of the Federal meat

inspection regulations (9 CFR 327.15)

requires that all labeling used with

outside containers of foreign meat

product must be approved in

accordance with 9 CFR part 317.

However, 9 CFR 381.206 dealing with

shipping containers of imported poultry

products does not include such a

provision. FSIS proposed to clarify 9

CFR 381.206 to indicate that shipping

containers of imported poultry products

would be approved in accordance with

9 CFR part 381, subpart N of the poultry

products inspection regulations. This is

merely a clarification of our labeling

approval procedures.

FSIS proposed to transfer the

responsibility of maintaining updated

generically approved labeling records

from the IIC to the official establishment

in the United States and to require

establishments certified by officials of a

foreign inspection system to maintain

such records. FSIS also proposed to

require establishments to maintain

records of labeling approved by FLD. In

order to monitor compliance of

regulatory labeling requirements, FSIS

proposed that establishments maintain

records on all labeling used and make

such records available to any authorized

USDA official upon request. Each record

would consist of a copy of the labeling

and the product formulation and

processing procedure. Under the

proposed rule, official establishments

would not have to present to the IIC a

copy of the generically approved

labeling prior to its use, as is currently

required under 9 CFR 317.5 and

381.134.

Sections 306.5, 327.24, 381.35 and

381.202(d) of the meat and poultry

regulations (9 CFR 306.5, 327.24,

381.35, and 381.202(d)) specify the

appeal procedures to be followed for

decisions made by program employees

or inspectors. These sections also state

that denial of a labeling application by

the IIC or inspector is not a basis for

appeal under these sections. Since the

proposed rule would not maintain the

IIC’s authority to approve labeling

applications, there would no longer be

a need to retain this provision.

Therefore, the proposed rule proposed

to remove these provisions from these

sections.

FSIS proposed to randomly select

samples of generically approved

labeling from official establishments

and establishments certified under a

foreign inspection system in order to

determine compliance with labeling

requirements. If the Agency found that

any such labeling was false or

misleading in any particular, FSIS

would initiate the proceedings set forth

in 9 CFR 335.12 and 381.233 for

domestic and imported products.
67448 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

Although FSIS did not propose to

change the general authority for

temporary labeling approvals currently

specified in 9 CFR 317.4(d) and

381.132(b), provisions for temporary

approvals were proposed at 9 CFR

317.4(f)(1) and 381.132(f)(1). FSIS

proposed that final labeling deficient in

some particular could be granted a

temporary approval for up to 180 days,

provided, among other things, that the

product was not misrepresented. FSIS

also proposed that such an approval

could be extended under certain

circumstances. Temporary labeling

approval requests would continue to be

handled the same as sketch labeling

approvals through submission of

labeling applications to FLD.

FSIS also proposed to remove the

provision set forth in 9 CFR 317.4(b)

that required that paper takeoffs of

lithographed labels, in lieu of sections

of the metal containers, be submitted to

the Agency for approval. This provision

was intended to assist producers of

canned products when submitting final

labeling. However, because FLD would

no longer review final labeling, such

provision would no longer be needed.

Alternative Option Considered

In developing the proposal, FSIS

considered the alternative of proposing

a system where all labeling for domestic

and imported products would be

generically approved. Under this

alternative, there would not be any

labeling review and approval conducted

by program employees, either at

headquarters or in the field.

Establishments would be authorized to

design, develop, print, and apply

labeling without any submission to

FSIS, provided that the labeling

complied with existing labeling

regulations. As with generically

approved labeling under the proposed

rule, establishments would be required

to maintain records for all labeling.

These records would include a copy of

the labeling used on the product and a

record of the product formulation and

processing procedure. In addition,

similar to the proposed rule, under this

alternative there would be an enhanced

sampling program to assure that labeling

was accurate and not misleading. It was

envisioned that this sampling program

would supplement, but not replace, the

existing in-plant inspection task that

directs inspectors of official

establishments and analogous personnel

of certified foreign establishments to

check a sample of labeling to determine

if the labeling is correct and used as

intended.

After reviewing the comments

received in response to the proposed

rule (see following discussion), and in

light of FSIS’ ongoing reassessment of

its labeling policies, FSIS has decided to

proceed, at this time, with the gradual

streamlining and modernization of the

prior labeling approval system.

Therefore, FSIS will expand the types of

labeling that will be generically

approved, as opposed to instituting at

this time a system where all labeling

would be generically approved. FSIS

anticipates making further changes after

completing the reassessment of the prior

label approval system.

Discussion of Comments

FSIS received 122 comments in

response to the proposed rule. The

majority of the comments (88) were

submitted by food manufacturers, while

13 were received from industry trade

associations, 12 from food industry

consultants, 5 from consumers, 3 from

foreign governments, and 1 from

another Federal agency. The following

discussion is a summary of the major

issues and comments received.

1. ‘‘Sketch Only’’ System of Approval

Many commenters supported the

streamlining of the current prior

labeling approval process which would

eliminate the need to submit final

labeling for approval, and which, in

turn, would eliminate unnecessary

duplication in the labeling approval

system. However, a few commenters

opposed a ‘‘sketch only’’ system of

approval and wanted to maintain the

existing system of approval. These

commenters appeared to be concerned

about their lack of understanding of all

the existing labeling regulations and

their ability to keep abreast of any future

changes to the regulations. They

expressed concern about the possible

extent of their liability if a product were

misbranded and severity of penalties

that might occur as a result of an

unintentionally misbranded product

entering the marketplace.

FSIS believes that requiring a sketchonly system of approval for most

labeling situations will alleviate

unnecessary duplication in the labeling

approval system. Conformance with

labeling policies and regulations will be

verified when labeling is submitted as a

sketch. FSIS does not believe it is

necessary to reverify conformance of

final labeling in order to prevent

mislabeling of products, and, therefore,

will permit final labeling that has been

approved in sketch form to be used

without further authorization from FSIS,

where the final labeling is prepared

without modification. Final labeling,

however, that is altered from the

approved sketch must be resubmitted as

a ‘‘sketch’’ to FSIS for approval, unless

the changes made to the final labeling

conform with modifications included in

the generic approval category.

A few commenters suggested that a

numbering system, similar to the system

that is currently used to identify final

approved labeling, should be developed

for sketch approvals when the Agency

implements a sketch-only system of

approval. FSIS intends to assign formal

approval numbers to approved sketches.

The numbering system will be similar to

the system currently used for final

approvals. The sketches will be

processed and filed permanently for

future reference.

2. Printer’s Proof for Sketch Approval

While many commenters supported a

sketch-only system of approval, in many

cases, the support was contingent upon

the Agency clarifying its definition for

a sketch as a ‘‘printer’s proof or

equivalent.’’

It was not the intent of the Agency to

limit sketch submittals solely to actual

‘‘printer’s proofs.’’ FSIS believes that the

term ‘‘equivalent,’’ as used in the

proposed definition of ‘‘sketch,’’

conveys that methods of sketch

preparation, other than an actual

‘‘printer’s proof,’’ would also be

acceptable. Accordingly, FSIS will

accept a printer’s proof or equivalent,

such as sketches that are hand drawn or

computer generated or other reasonable

facsimiles that clearly represent the

final version of the labeling. FSIS has

added examples of what would be

considered equivalent to a printer’s

proof in the final regulation. FSIS

believes it is appropriate to leave in the

phrase ‘‘or equivalent’’ in order to

provide the needed flexibility to meet

the requirement of submission of a

sketch. As FSIS moves to a sketch-only

system of approval, the Agency believes

it is necessary to emphasize the

importance of submitting sketches

prepared in a manner that clearly

indicates all labeling features, including

their size, location, and an indication of

final colors so that final printed labeling

will be accurately and correctly

prepared.

3. Final Color Indication on Sketches

A few commenters objected to the

need for an indication of final color on

the sketch. However, after reviewing

these comments, FSIS believes that

these commenters may have believed

that the requirement of indicating final

colors on the sketch meant that FSIS

would accept only color proofs or color

sketches.

FSIS is not requiring that a color proof

or sketch be submitted. However, FSIS
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67449

believes it is necessary to continue to

require an indication of final color to

ensure that the labeling requirements for

proper contrast and legibility will be

met on final printed labeling. In light of

the comments received, FSIS has

clarified the final regulations to make it

clear that the requirement of indicating

final colors can be met in a numbers of

ways. The requirements of indication of

final color may be met by: Submission

of a color sketch, submission of a sketch

which indicates by descriptive language

the final colors, or submission with a

sketch of previously approved final

labeling that indicates the final colors.

4. Size Limitations for Sketch

Submittals

A few commenters objected to the size

limitations for sketch submittals (i.e.,

81⁄2 x 14 inches) that was proposed in

an effort to accommodate the expected

automation and modernization of the

labeling approval process.

Although the Agency continues to

move toward a more automated,

modernized approval system, the

Agency is not yet at the stage of

development that such restrictions are

necessary. Therefore, FSIS will not limit

sketch submittals to the proposed size

requirement of no larger than 81⁄2 x 14

inches.

5. Temporary Approval

Several commenters requested that

temporary labeling approval be

extended beyond 6 months.

FSIS grants and proposed to continue

to grant temporary approval for labeling

deemed deficient in some particular for

a period of time not to exceed 6 months,

provided that (1) the proposed labeling

would not misrepresent the product, (2)

use of the labeling would not present

any potential health, safety, or dietary

problems to the consumer, (3) denial of

the request would create undue

economic hardship, and (4) an unfair

competitive advantage would not result

from granting the temporary approval.

FSIS continues to believe that changes

to labeling that must be made as a result

of these conditions can be accomplished

within a 6-month timeframe. In certain

circumstances, the current and

proposed regulations allow temporary

approvals to be extended beyond the 6-

month timeframe. Therefore, FSIS has

not extended the maximum time

granted to temporary approval requests

beyond that which currently exists in

the regulations.

6. Expansion of the Generic Label

Approval Category

Commenters concurred with the

Agency’s proposed expansion of the

generically approved labeling categories

to include those categories of labeling

presently approved by the IIC. However,

most commenters did not agree that

standardized products should be

included in the generic category.

Commenters stated that not all of the

existing product standards provide

enough guidance to ensure labeling

compliance. In addition, several

commenters stated that few standards

are actually codified in the Federal meat

and poultry products inspection

regulations, and that numerous informal

standards are contained in the

Standards and Labeling Policy Book.

Although FSIS acknowledges the

concerns expressed, FSIS continues to

believe that standardized products

should be included in the generic

approval category. Permitting the

generic approval of labeling for these

products will not affect the safety of the

products. Consumers will continue to

receive the information they need about

the products from the ingredients

statement and the Nutrition Facts panel.

FSIS’ prior review of these labels does

not provide any additional benefits and

requires resources that could be used in

overseeing other areas more directly

related to health and safety. In addition,

including standardized products under

generic approvals streamlines and

makes more efficient the label review

process, without compromising product

safety. Furthermore, this action is

consistent with the Agency’s focus on

using resources to reduce actual risks to

the public as discussed in its February

3, 1995, HACCP proposal.

FSIS has also determined that

standardized products contained in the

Standards and Labeling Policy book

should be eligible for generic approval.

Therefore, FSIS has modified the

provison for generic approval of

standardized products in two ways.

First, FSIS will grant manufacturers the

flexibility to generically approve

labeling for standardized products

found in 9 CFR part 319 or part 381,

subpart P, and the Standards and

Labeling Policy Book, provided such

labeling does not contain any special

claims or the product is not a domestic

product labeled in a foreign language.

Second, FSIS will allow the submission

of sketch labeling for review and

approval if manufacturers so desire.

FSIS believes that the above

modification will alleviate the concerns

expressed by the commenters.

FSIS is currently reassessing the role

of regulatory and policy standards in

promoting meat and poultry products

with better nutritional profiles (e.g.,

lower in fat and cholesterol). FSIS is

also currently reassessing its labeling

regulations. Additionally, an assessment

is planned that will involve public

input regarding modification or

elimination of the informal policy

standards in the Standards and Labeling

Policy Book.

A few commenters expressed concern

that labeling prepared for the Child

Nutrition (CN) Program, conducted by

USDA’s Food and Nutrition Service,

would not receive adequate review

under the proposed approval system

and opposed the inclusion of these

product labels in the generic approval

category. FSIS views CN information on

the labeling as if it were a claim.

Therefore, CN labeling will not be

included in a generic approval category

and will require review and sketch

approval by FSIS.

As stated in the proposal, several

commenters to the ANPR believed that

the generic approval category could be

expanded beyond those situations

specifically identified in the ANPR. In

the past, FSIS had been reluctant to

expand the generic approval category

further, until it could be demonstrated

that this method of labeling approval

would continue to provide the public

with accurate, non-misleading labeling

information. However, these suggestions

were brought up again among the

comments to the proposal. The Agency

is now convinced that its present

position is unnecessarily restrictive and

now agrees that there are some other

labeling categories that should be

included in the generic approval

category which would result in little, if

any, risk of misbranding. Also, FSIS

believes that the scope of some generic

approval categories should be

broadened.

After reviewing the suggestions

presented by the commenters, FSIS

agrees that it is appropriate to include

additional categories of labeling under

the generic approval category and to

broaden the scope of some of the generic

approval categories. Therefore, the

following categories of labeling that will

be generically approved have been

either added or broadened in this final

rule for the reasons explained below.

a. Quantitative adjustments to the

nutrition labeling information, except

for serving sizes, provided the changes

do not affect the accuracy and

consistency of the nutrition labeling

information, (e.g., revising the fat

content from 10 to 7 grams), for labeling

that was previously approved by FLD as

sketch labeling.

Meat and poultry companies will

periodically need to revise nutrition

information on their labeling as a result

of ongoing nutrition monitoring

programs. Several commenters
67450 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

recognized that this particular labeling

situation was not adequately addressed

by the nutrition labeling regulations and

suggested that quantitative nutrition

labeling changes could be included in

the expanded generic approval category.

FSIS never intended to require

manufacturers to resubmit labeling for

approval to make quantitative changes

to the nutrition labeling information.

Since the manufacturers are responsible

for declaring accurate nutrition

information, FSIS believes that

quantitative nutrition information

labeling changes will have little impact

on the accuracy of the labeling.

Requiring such labeling changes to be

resubmitted through the approval

process would undermine the Agency’s

efforts to streamline the approval

process and reduce the volume of

labeling submitted to FSIS for review.

Furthermore, the accuracy of nutrition

labeling will be monitored through the

Agency’s planned compliance, audit,

and sampling activities. However, FSIS

does not believe that it is appropriate to

allow quantitative changes for serving

sizes to be included in the expanded

generic approval category. The need to

maintain uniform serving sizes for

specific products is very critical to the

overall integrity of the nutrient profile

of products. Thus, quantitative nutrition

information labeling changes, except for

serving sizes, may be generically

approved for labeling that was

previously approved by FLD as sketch

labeling, provided the changes in no

way render the labeling false or

misleading in any particular.

b. Labeling for consumer test products

not intended for sale.

Historically, products prepared for

consumer test purposes have not

presented FSIS with regulatory

problems. These products are produced

under controlled conditions and in

limited quantities, and are not broadly

distributed in the marketplace. In

addition, all of the product’s ingredients

must be listed on the labeling and

conform with all regulatory restrictions

on their use. FSIS believes that

permitting the generic approval of

labeling for consumer test products will

allow processors to more expeditiously

develop and produce new, safe,

wholesome products while testing

consumer acceptance. Accordingly,

FSIS will allow generic approval of

labeling for consumer test products that

will not be sold.

c. Deletion of any claim or other

nonmandatory feature or information on

labeling that was previously approved

in sketch form, provided the deletion of

the information will not render the

labeling false or misleading in any

particular.

Companies often delete claims and

other nonmandatory information on the

labeling (e.g., promotional information,

cooking instructions, and recipes) as a

part of their overall marketing strategy.

Some examples of these situations are

already included in the existing generic

approval category (e.g., deletion of the

word ‘‘new’’ and modification of

cooking instructions (9 CFR 317.5 and

381.134)). FSIS believes there is little, if

any, risk of misbranding by broadening

the generic approval category to allow

the deletion of any claim or other

nonmandatory information, for labeling

previously approved in sketch form.

d. The addition or deletion of a direct

translation of the English language into

a foreign language for products marked

‘‘for export only,’’ for labeling

previously approved by FLD as sketch

labeling.

Traditionally, the responsibility of

accurately making a direct translation of

the English language into a foreign

language for products marked ‘‘for

export only’’ has rested with

manufacturers. FSIS believes that the

addition or deletion of a direct

translation of the English language into

a foreign language for products marked

‘‘for export only’’ will not compromise

the accuracy of the labeling of those

products. Furthermore, FSIS is of the

opinion that the inclusion of such

labeling modifications in the generically

approved category is consistent with the

intent of this final rule. Thus, FSIS will

permit generic approval of the addition

or deletion of a direct translation of the

English language into a foreign language

for products marked ‘‘for export only,’’

whose labeling was previously

approved in sketch form.

e. The substitution of any unit of

measurement with its abbreviation or

the substitution of an abbreviation with

its unit of measurement.

In its proposal, FSIS proposed that the

substitution of the abbreviation ‘‘lb.’’ for

‘‘pound,’’ or ‘‘oz.’’ for ‘‘ounce,’’ or the

substitution of the word ‘‘pound’’ for

‘‘lb.,’’ or ‘‘ounce’’ for ‘‘oz.’’ on labeling

would be generically approved. FSIS

now believes, after reviewing the

comments, that broadening the scope of

this category to include the substitution

of any unit of measurement with its

abbreviation or the substitution of an

abbreviation with its unit of

measurement will not compromise the

accuracy of product labeling. Thus, FSIS

will permit the substitution of any unit

of measurement with its abbreviation

and substitution of an abbreviation with

its unit of measurement, e.g., ‘‘lb.’’ for

‘‘pound’’ or ‘‘teaspoon’’ for ‘‘tsp.’’

f. Wrappers or other covers bearing

pictorial designs, emblematic designs or

illustrations, e.g., floral arrangements,

illustrations of animals, fireworks, etc.

are used with approved labeling (the use

of such designs will not make necessary

the application of labeling not otherwise

required);

FSIS had proposed to allow generic

approval during holiday seasons of

wrappers or other coverings bearing

floral or foliage designs, illustrations, or

other emblematic holiday designs.

FSIS now believes, after reviewing the

comments, that allowing the generic

approval of only holiday designs on

wrappers or other covers is too

restrictive. Therefore, FSIS has

broadened the scope of this category to

permit the use of any pictorial or

emblematic design, or illustration on

wrappers or other covers, provided such

design will not render the labeling to be

false or misleading. FSIS is of the

opinion that the inclusion of such

labeling modification in the generically

approved category is consistent with the

intent of this final rule.

7. Voluntary Approval for Labeling

Eligible For Generic Approval

Some of the commenters who

expressed support for the expansion of

the generic approval category wanted to

retain the option of submitting labeling

to FSIS for review and approval, even

when the labeling is eligible for generic

approval.

As previously stated, FSIS is aware

that there are some concerns about the

provision to include standardized

products within the genericallyapproved labeling category. The intent

of this rulemaking is to improve the

overall efficiency of the labeling

approval process by limiting the amount

of labeling submitted to FSIS for review

and approval, which cannot be achieved

if all labeling authorized to be

generically approved were permitted to

be submitted for review and approval.

Further, permitting all labeling

authorized for generic approval to be

submitted for review and approval

would take away from the limited

resources FSIS has at its disposal which

it needs to review those aspects of

labeling requirements that involve

potential public health concerns.

Nonetheless, FSIS has always provided,

and will continue to provide advice and

counsel to the industry and to the

public at-large concerning labeling

issues. To make very clear that FSIS

remains committed to providing needed

advice in appropriate circumstances,

FSIS has modified the proposed rule to

allow manufacturers to voluntarily

submit sketch labeling for standardized
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67451

products for review and approval. Many

of these products have complex

compositional and minimum content

requirements. FSIS is also providing

this option for standardized products

contained in the Standards and Labeling

Policy Book because many of these

products also have complex

compositional and minimum content

requirements. FSIS has determined that

manufacturers should have the option,

at this time, of submitting sketch

labeling for standardized products for

review. However, as FSIS begins a more

indepth review of its labeling

requirements and practices, FSIS may

propose in a future rulemaking to

remove this voluntary submittal option.

This would be consistent with the intent

of this rulemaking, which is to limit the

types of labeling submitted for review so

that FSIS resources can be focused on

issues that bear directly on public

health and food safety.

8. Generic System of Labeling Approval

Under an all-generic system,

establishments would design, develop,

print, and apply labeling without

submission to FSIS for review and

approval. A few commenters supported

the proposed concept of an all-generic

labeling approval system, citing

reductions in costs and improved

efficiency. However, the majority of the

commenters opposed an all-generic

system of approval because of concerns

with their ability to fully understand

and consistently interpret the existing

labeling policies and regulations, the

potential for misbranded product to

enter the marketplace, and concern with

penalties for misbranding and product

recalls.

FSIS is currently reassessing the

proposed all-generic labeling system of

approval as an alternative option in an

effort to streamline and modernize the

label review process.

9. Preemption Concerns

Several commenters expressed

concern that the proposal acknowledged

‘‘concurrent jurisdiction’’ (i.e., the

States and local governments may

exercise concurrent jurisdiction over

meat and poultry products that are

outside official establishments for the

purpose of preventing distribution of

meat and poultry products that are

misbranded or adulterated under the

FMIA or PPIA). The comments

indicated that FSIS should clearly state

that the new labeling requirements will

have a preemptive effect on the

requirements of the various States and

local governments.

The provisions of the FMIA and PPIA

preclude any State or local jurisdiction

from imposing ingredient, marking, or

labeling requirements on products

produced in federally inspected

establishments that are different or in

addition to Federal requirements. In this

regard, State and local jurisdictions

cannot impose different or additional

requirements, regardless of whether the

labeling is approved in sketch form by

FSIS or generically approved by FSIS.

10. The IIC’s Role Under a Generic

Approval System

Many commenters were concerned

about the responsibilities of the IIC with

respect to product packaged in

generically approved labeling.

Commenters repeatedly stated that the

role of the IIC must be clearly defined

for these proposed changes to be

implemented efficiently. Most

commenters contended that the IIC’s

limited knowledge and expertise on

labeling regulations and policies may

lead to unwarranted interference or

retention of product. In addition, some

commenters stated that labeling

interpretations made by individual

inspectors would not contribute toward

uniformity in labeling decisions.

FSIS believes some of the concerns

raised by commenters will be alleviated

since the Agency will issue a notice to

field personnel that will clearly describe

how to respond to and report label

deficiencies.

FSIS is currently conducting a top to

bottom review of how the Agency

defines its regulatory roles, allocates

resources, and is organized (60 FR

32127). The IIC’s role with regard to

monitoring product formulations and

processing procedures will be addressed

in that review but will not change or be

diminished as a result of this regulation.

Inspection personnel will continue to

observe and monitor product

formulations and processing procedures

to assure conformance with general

labeling requirements. If inspection

personnel observe that products are not

being manufactured in accordance with

their formulation or believe that a

situation may have health or safety

significance, they are to take the

appropriate action necessary to ensure

that misbranded and/or adulterated

product does not enter commerce. In

addition, inspection personnel are to

immediately contact FLD, through

appropriate channels, for technical

assistance.

11. Recordkeeping

FSIS proposed that domestic

establishments and establishments

certified by officials of a foreign

inspection system maintain records on

all labeling used, and make such records

available to any authorized USDA

official, upon request. Each record

would consist of the product’s labeling,

formulation, and processing procedure.

Several commenters requested

clarification about the location and

content of the required records.

Manufacturers of meat and poultry

products will be required to maintain

records of all labeling used, along with

the product’s formulation and

processing procedure in accordance

with 9 CFR part 320 of the meat

inspection regulations for meat

products, and in accordance with 9 CFR

part 381, subpart Q of the poultry

products inspection regulations for

poultry products. This means that

records of the actual labeling used on a

product, along with the product’s

formulation and processing procedures

must be maintained.

In regard to where the required

records must be located, i.e.,

maintained, the final regulations, as did

the proposal, require, as previously

stated, the records to be maintained in

accordance with 9 CFR part 320 for

meat products, and in accordance with

9 CFR part 381, subpart Q for poultry

products. In accordance with section

320.2 of the meat inspection regulations

and section 381.176 of the poultry

products inspection regulations,

required records must be maintained by

a person, including a corporation at the

place of business where the business is

conducted, except that if a person,

including a corporation conducts

business at multiple locations, records

may be maintained at the headquarters

office. FSIS does not believe it is

necessary to require all establishments

at multiple locations to maintain copies

of the labeling records required by this

final rule. However, the IIC will retain

his or her authority to request the

labeling records to verify the accuracy of

the labeling of products as it relates to

official business.

Any existing labeling files maintained

by inspection personnel at federally

inspected establishments will be

returned to plant management at the

time this regulation is implemented.

This final rule will eliminate the

requirement that inspection personnel

maintain labeling files. FSIS has

determined, after further examination of

the regulations, that the elimination of

this requirement will necessitate

changes in other related provisions of

the meat and poultry inspection

regulations (9 CFR 317.14, 381.141, and

381.137). FSIS inadvertently omitted

these provisions in the proposed rule

but believes such provisions must be

amended to avoid confusion among

inspection personnel regarding their
67452 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

labeling responsibilities and to make the

regulations consistent. The current

provisions in 9 CFR 317.14 and 381.141

require the inspector, upon notification

of an obsolete label, to return the label

that is in the official labeling file to the

establishment and to forward the label

transmittal to FLD for further data

processing. This procedure will become

unnecessary because the final rule, as

did the proposal, no longer, in general,

requires inspection personnel to

maintain labeling files. Thus, FSIS is

eliminating 9 CFR 317.14 and 381.141

to relieve inspection personnel of the

responsibility of handling obsolete

labeling records. In addition, the

provision in 9 CFR 381.137 states that

no inspector shall authorize the use of

any labeling or device unless he or she

has on file evidence that such labeling

or device has been approved in

accordance with the appropriate

provisions. Because inspection

personnel will no longer maintain

labeling files, the IIC’s responsibility for

authorizing the use of labeling will not

be required. Thus, FSIS is revising 9

CFR 381.137 to delete the IIC’s

responsibility for authorizing the use of

approved labeling based on evidence

maintained in official labeling files.

FSIS believes that amending the

aforementioned provisions is consistent

with the intent of this final rule.

12. Auditing the Accuracy of

Generically Approved Labeling

To monitor compliance with the

Federal meat and poultry products

inspection regulations, FSIS proposed to

select samples of generically approved

labeling.

In addition to routine compliance and

inspection activities, FSIS will develop

and implement a sampling plan for the

expanded types of labeling under the

generic approval category. The sampling

plan will be directed from FSIS

headquarters in Washington. FSIS

inspection personnel will collect all

pertinent labeling records

corresponding to each selected sample.

These samples would be collected and

forwarded to FLD for audit. FLD will

evaluate the samples to determine if

they comply with labeling regulations

and policies.

13. Modernization of the Labeling

Review System

All of the commenters responding to

this issue of modernizing the labeling

review system were in support of the

Agency’s efforts. Such commenters

included those who supported sketch

only approval, as well as those who

supported generic approval. The

commenters stated that an electronic

communications system would be cost

effective by eliminating unnecessary

paperwork and taking advantage of new

information, collection, and storage

technologies.

FSIS will continue to make

incremental improvements in

automation as budget constraints allow.

Furthermore, FSIS believes that its

current efforts to automate its labeling

review system are consistent with the

President’s initiatives for greater

efficiency in government services.

Miscellaneous Changes

The proposal stated that products

labeled ‘‘for export only’’ in U.S.

establishments that do not contain any

special claims would be permitted to be

labeled with generically approved

labeling and thus labeling for such

products would not have to be

submitted in sketch form to FSIS for

approval. However, after further

consideration, FSIS has concluded that

products designated ‘‘for export only’’

and destined to foreign countries should

be reviewed and approved under the

same provisions proposed for other

products manufactured in U.S.

establishments. FSIS acknowledges its

responsibility for ensuring the accuracy

of all labeling of meat and poultry

products manufactured in Federal

establishments, regardless of the

product’s destination. Also, most

countries that receive product from the

United States do not have label review

programs. Therefore, these countries

depend on FSIS review and approval as

their assurance that imported products

are accurately labeled. Thus, FSIS has

decided to withdraw this provision of

its proposal, and to require, as it did

prior to its proposal, that labeling

designated ‘‘for export only’’ be

submitted to FSIS for approval, except

when such labeling comes within the

categories of labeling that will be

generically approved. As FSIS reforms

its prior labeling approval system, more

of these labels will be considered for

inclusion in the generic approval

category. Although FSIS is continuing to

provide labeling review services for

these exporters, it will explore the

possibility of charging user fees in the

future for such services.

As stated in the proposal, where

sketch labeling is required to be

submitted to FLD for review and

approval, a parent company for a

corporation may submit only one

labeling application for a product

produced in other establishments,

which are owned by the corporation.

FSIS has clarified this matter in the

Federal meat and poultry products

regulations.

On August 8, 1994, FSIS published in

the Federal Register a final rule on the

placement of nutrition labeling and

other mandatory labeling on meat and

poultry products (59 FR 40209). That

rule included a provision identifying as

generically approved, final labeling

bearing nutrition labeling information

which was approved in sketch form or

other version that clearly shows all

required features, size, location, and

identification of final color, by FSIS (9

CFR 317.5(c) and 381.134(c)). This final

rule on prior labeling approval, as did

the proposed rule, identifies as

generically approved, final labeling,

which would include labeling bearing

nutrition information, that was

submitted for approval and approved by

FSIS in sketch form. Therefore, the

current provisions in 9 CFR 317.5(c) and

381.134(c) are no longer needed.

Accordingly, FSIS is amending the

Federal meat and poultry products

inspection regulations to eliminate 9

CFR 317.5(c) and 381.134(c).

This final rule, as did the proposal,

will eliminate the need for FSIS

inspection personnel to maintain

labeling records. Consequently, FLD

will no longer need labeling

applications to be submitted in

triplicate form. Accordingly, FSIS is

clarifying this requirement in the

Federal meat and poultry products

inspection regulations 9 CFR 317.4(c)

and 381.132(c) to reflect that labeling

applications only need to be submitted

in duplicate form.

Effective Date

After careful consideration of the

changes necessary to implement the

revised labeling system, FSIS has

decided to make this rule effective 6

months from the date of publication.

The Agency believes that a longer

implementation period will alleviate

unnecessary delays in the labeling

review process. This longer

implementation period will also

minimize burdens related to the transfer

of labeling records from the IIC’s to the

establishments, inspection personnel

and industry orientation to new

procedures, the auditing of generically

approved labels, and various other

miscellaneous changes. In addition, the

longer implementation period will

allow the Agency time to develop and

issue to its inspection personnel, official

guidelines for implementing this

regulation.

Executive Order 12866

The final rule has been reviewed

under Executive Order 12866 and has

been determined to be significant. FSIS

has assessed the impacts of its final rule
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67453

that expands the types of labeling, used

on meat and poultry products, that are

generically approved; i.e.,

establishments will be able to use

certain labeling on meat and poultry

products without submission of the

labeling to FSIS for approval by the IIC

or FLD, in Washington, DC. This rule

eliminates unnecessary duplication in

the labeling approval system.

Benefits of the Final Rule

This regulation will benefit

consumers, the meat and poultry

industry, and the Agency. The final rule

will reduce market inefficiencies caused

by delays in new product introduction

attributable to the labeling application

and review process. Industry will be

able to be more responsive to their

consumers. Consumers will also benefit

because new products will be

introduced into the marketplace faster.

This final rule will reduce

requirements for the submission of

labeling for review and approval by

FSIS. The final rule will streamline the

label submission process from two steps

(sketch and final) to a one step process

(sketch only). Also, meat and poultry

manufacturers will be able to make

numerous labeling modifications

without submitting certain labels for

approval. This streamlined process will

reduce the burden on industry by

making the labeling approval process

more convenient and cost-effective.

Furthermore, those establishments that

use representatives to present their

labels to FLD for review will also save

time and money. These savings will be

realized because fewer labels will be

required to be submitted to FLD. It is

estimated that the reduction in the

submission of labeling will save the

meat and poultry establishments at least

20,000 hours.

This final rule will result in a savings

of approximately $3 million in direct

label application costs to the industry.

This $3 million was derived by

estimating that approximately 82,600

fewer labels, at a cost of $37 per label,

would be submitted to FLD annually as

a result of this final rule. Unknown

additional savings will be realized by

the industry, depending on the degree to

which industry uses the generic

approval authority for labeling for

standardized products. This $3 million

savings estimate differs from the savings

that were attributed to the elimination

of labeling application costs stated in

the proposed rule ($5 million) because

this final rule contains provisions for

either generic approval or voluntary

submission for review and approval of

labeling for standardized products. The

proposed rule contained provisions for

mandatory generic approval of labeling

for standardized products. This rule will

reduce the paperwork burdens of

industry by eliminating the application

process for specific types of labeling.

Shifting responsibility for maintaining

labeling records from the inspector will

enable FSIS to redirect its inspection

resources to areas more directly related

to food safety. In addition, this rule is

consistent with FSIS’ February 3, 1995,

Pathogen Reduction; Hazard Analysis

and Critical Control Point Systems

proposal and FSIS’ other regulatory

reform initiatives that are intended to

focus inspection and other Agency

resources on activities that have a direct

bearing on food safety.

Costs of the Final Rule

This final rule requires that

establishments submit only one labeling

application for FSIS approval (sketch

labeling) instead of two applications in

those instances where labeling must be

approved by FSIS. This final rule also

expands the types of labeling that can be

generically approved. For standardized

products, this rule permits the voluntary

submittal of sketch labeling for review,

if desired by the manufacturer.

FSIS estimates that this final rule will

result in $3 million annual savings in

direct labeling application costs. The

final rule does require, however, that

establishments maintain copies of all

labeling used, along with the product

formulations and a description of the

processing procedures used to formulate

the product in accordance with 9 CFR

320.2 and part 381, subpart Q, for all

labeling submitted for review and

approval by FSIS, as well as for labeling

in the generic approval category. This

requirement should not impose any

additional cost burden on

establishments because most

establishments already maintain copies

of their labeling.

The labeling records maintained by

the establishments must be made

available to Agency officials upon

request. FSIS will conduct periodic

sampling of generically approved

labeling from the records maintained by

the establishments. This sampling will

be conducted to monitor compliance of

generically approved labeling with all

labeling requirements. Activities related

to the generic labeling sampling

program will be absorbed into existing

Agency resources, and, thus, will not

impose additional Agency costs.

Executive Order 12778

This final rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. States and local

jurisdictions are preempted under the

FMIA and the PPIA from imposing any

marking, labeling, packaging, or

ingredient requirements on federally

inspected meat and poultry products

that are in addition to, or different from,

those imposed under the FMIA or PPIA.

States and local jurisdictions may,

however, exercise concurrent

jurisdiction over meat and poultry

products that are outside official

establishments for the purpose of

preventing the distribution of meat and

poultry products that are misbranded or

adulterated under the FMIA or PPIA, or,

in the case of imported articles, which

are not at such an establishment, after

their entry into the United States. Under

the FMIA and PPIA, States that

maintain meat and poultry inspection

programs must impose requirements

that are at least equal to those required

under the FMIA and PPIA. The States

may, however, impose more stringent

requirements on such State inspected

products and establishments.

No retroactive effect will be given to

this final rule. The administrative

procedures specified in 9 CFR 306.5 and

381.35 must be exhausted prior to any

judicial challenge of the application of

the provisions of this rule, if the

challenge involves any decision of an

inspector relating to inspection services

provided under the FMIA or PPIA. The

administrative procedures specified in 9

CFR parts 335 and 381, subpart W, must

be exhausted prior to any judicial

challenge of the application of the

provision of this rule with respect to

labeling decisions.

Effect on Small Entities

The Administrator, FSIS, has

determined that this final rule will not

have a significant economic impact on

a substantial number of small entities.

This rule will affect small meat and

poultry establishments, and other small

entities involved in various label

consulting activities, including those

entities who specialize in obtaining

label approval from FSIS. Most small

meat and poultry establishments will

benefit from the provisions in this rule

as direct costs involved with the

labeling application and approval

process will be reduced. Costs involved

with label design and printing will not

change and would be incurred even

without this final rule.

The affect of this final rule on those

entities known as label expediters will

depend on the percentage of their

business directly involved with

obtaining expedited approvals of

product labels. There are about 13 firms

that are involved on a consistent basis

with obtaining label approvals. Eight of

these 13 firms provide services other
67454 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

than expedited label approvals. A

reduction in the need for this service is

not expected to significantly affect these

entities. In addition, these firms will

likely expand existing services not

related to expediting label approvals.

Also, certain types of labels will

continue to need approval by the Food

Labeling Division before they may be

used. Therefore, firms whose primary

service involves obtaining label

approval will be able to continue

providing this service.

Any impacts of this final rule on

small entities will be mitigated because

the Agency is providing a 6-month

period before the final rule will be

effective. Therefore, affected entities

will be given time to adjust their current

practices and/or to modify their

businesses to lessen any possible

negative affects of the final rule.

Paperwork Requirements

Abstract: This final rule expands the

types of generically approved labeling

currently authorized for use by meat

and poultry establishments and certified

foreign establishments. (Generically

approved labeling is not required to be

submitted to FSIS for review and

approval.) The rule also permits the

submission of only sketch labeling,

except for temporary approvals, in those

instances where labeling is required to

be submitted for approval. The rule also

requires the retention of certain records

at the establishment.

Estimate of Burden: This final rule

substantially reduces ‘‘reporting’’

requirements for official establishments.

FSIS estimates that label submissions

sent to Washington for review and

approval will decrease by about 50

percent. For such submissions, FSIS

estimates that 15 minutes will be the

response time to prepare the label

application form, submit it, along with

the label, to FSIS or to a label expediter

who will deliver the form and label to

FSIS, and to file the records this rule

requires establishments to maintain,

which is approximately the same

amount of time establishments currently

utilize to meet paperwork requirements.

FSIS believes that there will be no

change in the time FSIS estimates, 60

minutes, it takes to design and develop

labels in accordance with the

regulations. In total, the burden

associated with label approval

submissions will decrease by 22,921

hours.

For generically approved labeling,

FSIS estimates the addition of new

generic labeling categories will result in

a 50 percent increase of generically

approved labels. Before this final rule, a

copy of generically approved labeling

was required to be filed with the

inspector, and FSIS had estimated a 1

minute response time for this activity.

The final rule eliminates this

requirement and instead requires that a

copy of the label and supporting

information be maintained at the

establishment. FSIS estimates it will

take 2 minutes for the establishment to

file this information. Therefore, there

will be an increase in burden hours

relating to generically approved labels

by 2,691 hours.

Copies of this information collection

assessment can be obtained from Lee

Puricelli, Paperwork Specialist, Food

Safety and Inspection Service, USDA,

South Agriculture Building, Room 3812,

Washington, DC 20250.

Send comments regarding the need

and usefulness of the requirements, the

accuracy of our burden hour estimate,

ways to minimize the burden, including

through the use of automated collection

techniques or other forms of information

technology, or any other aspect of this

collection of information, to Lee

Puricelli, Paperwork Specialist, see

address above.

All responses to this notice will be

summarized and included in the request

for OMB approval. All comments will

also become a matter of public record.

List of Subjects

9 CFR Part 306

Appeals, Meat inspection.

9 CFR Part 317

Food labeling, Meat inspection,

Reporting and recordkeeping

requirements.

9 CFR Part 320

Reporting and recordkeeping

requirements.

9 CFR Part 327

Food labeling, Imports, and Meat

inspection.

9 CFR Part 381

Appeals, Food labeling, Imports,

Poultry and poultry products, Reporting

and recordkeeping requirements.

For the reasons set forth in the

preamble, FSIS is amending 9 CFR parts

306, 317, 320, 327, and 381 as follows:

PART 306—ASSIGNMENT AND

AUTHORITIES OF PROGRAM

EMPLOYEES

1. The authority citation for part 306

is revised to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

2. Section 306.5 is amended by

removing the last sentence.

PART 317—LABELING, MARKING

DEVICES, AND CONTAINERS

3. The authority citation for part 317

is revised to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

4. Section 317.4 is revised to read as

follows:

§ 317.4 Labeling approval.

(a) No final labeling shall be used on

any product unless the sketch labeling

of such final labeling has been

submitted for approval to the Food

Labeling Division, Regulatory Programs,

Food Safety and Inspection Service, and

approved by such division,

accompanied by FSIS form, Application

for Approval of Labels, Marking, and

Devices, except for generically approved

labeling authorized for use in § 317.5(b).

The management of the official

establishment or establishment certified

under a foreign inspection system, in

accordance with part 327 of this

subchapter, must maintain a copy of all

labeling used, along with the product

formulation and processing procedure,

in accordance with part 320 of this

subchapter. Such records shall be made

available to any duly authorized

representative of the Secretary upon

request.

(b) The Food Labeling Division shall

permit submission for approval of only

sketch labeling, as defined in § 317.4(d),

for all products, except as provided in

§ 317.5(b) (2)–(9) and except for

temporary use of final labeling as

prescribed in paragraph (f) of this

section.

(c) All labeling required to be

submitted for approval as set forth in

§ 317.4(a) shall be submitted in

duplicate to the Food Labeling Division,

Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250. A

parent company for a corporation may

submit only one labeling application (in

duplicate form) for a product produced

in other establishments that are owned

by the corporation.

(d) ‘‘Sketch’’ labeling is a printer’s

proof or equivalent which clearly shows

all labeling features, size, location, and

indication of final color, as specified in

§ 317.2. FSIS will accept sketches that

are hand drawn, computer generated or

other reasonable facsimiles that clearly

reflect and project the final version of

the labeling. Indication of final color

may be met by: submission of a color

sketch, submission of a sketch which

indicates by descriptive language the

final colors, or submission with the

sketch of previously approved final

labeling that indicates the final colors.
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67455

(e) Inserts, tags, liners, pasters, and

like devices containing printed or

graphic matter and for use on, or to be

placed within, containers and coverings

of product shall be submitted for

approval in the same manner as

provided for labeling in § 317.4(a),

except that such devices which contain

no reference to product and bear no

misleading feature shall be used without

submission for approval as prescribed in

§ 317.5(b)(7).

(f)(1) Consistent with the

requirements of this section, temporary

approval for the use of a final label or

other final labeling that may otherwise

be deemed deficient in some particular

may be granted by the Food Labeling

Division. Temporary approvals may be

granted for a period not to exceed 180

calendar days, under the following

conditions:

(i) The proposed labeling would not

misrepresent the product;

(ii) The use of the labeling would not

present any potential health, safety, or

dietary problems to the consumer;

(iii) Denial of the request would create

undue economic hardship; and

(iv) An unfair competitive advantage

would not result from the granting of

the temporary approval.

(2) Extensions of temporary approvals

may also be granted by the Food

Labeling Division provided that the

applicant demonstrates that new

circumstances, meeting the above

criteria, have developed since the

original temporary approval was

granted.

(g) The inspector-in-charge shall

approve meat carcass ink brands and

meat food product ink and burning

brands, which comply with parts 312

and 316 of this subchapter.

5. Section 317.5 is revised to read as

follows:

§ 317.5 Generically approved labeling.

(a)(1) An official establishment or an

establishment certified under a foreign

inspection system, in accordance with

part 327 of this subchapter, is

authorized to use generically approved

labeling, as defined in paragraph (b) of

this section, without such labeling being

submitted for approval to the Food

Safety and Inspection Service in

Washington or the field, provided the

labeling is in accordance with this

section and shows all mandatory

features in a prominent manner as

required in § 317.2, and is not otherwise

false or misleading in any particular.

(2) The Food Safety and Inspection

Service shall select samples of

generically approved labeling from the

records maintained by official

establishments and establishments

certified under foreign inspection

systems, in accordance with part 327 of

this subchapter, as required in § 317.4,

to determine compliance with labeling

requirements. Any finding of false or

misleading labeling shall institute the

proceedings prescribed in § 335.12.

(b) Generically approved labeling is

labeling which complies with the

following:

(1) Labeling for a product which has

a product standard as specified in part

319 of this subchapter or the Standards

and Labeling Policy Book and which

does not contain any special claims,

such as quality claims, nutrient content

claims, health claims, negative claims,

geographical origin claims, or

guarantees, or which is not a domestic

product labeled in a foreign language;

(2) Labeling for single-ingredient

products (such as beef steak or lamb

chops) which does not contain any

special claims, such as quality claims,

nutrient content claims, health claims,

negative claims, geographical origin

claims, or guarantees, or which is not a

domestic product labeled with a foreign

language;

(3) Labeling for containers of products

sold under contract specifications to

Federal Government agencies, when

such product is not offered for sale to

the general public, provided that the

contract specifications include specific

requirements with respect to labeling,

and are made available to the inspectorin-charge;

(4) Labeling for shipping containers

which contain fully labeled immediate

containers, provided such labeling

complies with § 316.13;

(5) Labeling for products not intended

for human food, provided they comply

with part 325 of this subchapter;

(6) Meat inspection legends, which

comply with parts 312 and 316 of this

subchapter;

(7) Inserts, tags, liners, pasters, and

like devices containing printed or

graphic matter and for use on, or to be

placed within containers, and coverings

of products, provided such devices

contain no reference to product and bear

no misleading feature;

(8) Labeling for consumer test

products not intended for sale; and

(9) Labeling which was previously

approved by the Food Labeling Division

as sketch labeling, and the final labeling

was prepared without modification or

with the following modifications:

(i) All features of the labeling are

proportionately enlarged or reduced,

provided that all minimum size

requirements specified in applicable

regulations are met and the labeling is

legible;

(ii) The substitution of any unit of

measurement with its abbreviation or

the substitution of any abbreviation

with its unit of measurement, e.g., ‘‘lb.’’

for ‘‘pound,’’ or ‘‘oz.’’ for ‘‘ounce,’’ or of

the word ‘‘pound’’ for ‘‘lb.’’ or ‘‘ounce’’

for ‘‘oz.’’;

(iii) A master or stock label has been

approved from which the name and

address of the distributor are omitted

and such name and address are applied

before being used (in such case, the

words ‘‘prepared for’’ or similar

statement must be shown together with

the blank space reserved for the

insertion of the name and address when

such labels are offered for approval);

(iv) Wrappers or other covers bearing

pictorial designs, emblematic designs or

illustrations, e.g., floral arrangements,

illustrations of animals, fireworks, etc.

are used with approved labeling (the use

of such designs will not make necessary

the application of labeling not otherwise

required);

(v) A change in the language or the

arrangement of directions pertaining to

the opening of containers or the serving

of the product;

(vi) The addition, deletion, or

amendment of a dated or undated

coupon, a cents-off statement, cooking

instructions, packer product code

information, or UPC product code

information;

(vii) Any change in the name or

address of the packer, manufacturer or

distributor that appears in the signature

line;

(viii) Any change in the net weight,

provided the size of the net weight

statement complies with § 317.2;

(ix) The addition, deletion, or

amendment of recipe suggestions for the

product;

(x) Any change in punctuation;

(xi) Newly assigned or revised

establishment numbers for a particular

establishment for which use of the

labeling has been approved by the Food

Labeling Division, Regulatory Programs;

(xii) The addition or deletion of open

dating information;

(xiii) A change in the type of

packaging material on which the label is

printed;

(xiv) Brand name changes, provided

that there are no design changes, the

brand name does not use a term that

connotes quality or other product

characteristics, the brand name has no

geographic significance, and the brand

name does not affect the name of the

product;

(xv) The deletion of the word ‘‘new’’

on new product labeling;

(xvi) The addition, deletion, or

amendment of special handling
67456 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

statements, provided that the change is

consistent with § 317.2(k);

(xvii) The addition of safe handling

instructions as required by § 317.2(l);

(xviii) Changes reflecting a change in

the quantity of an ingredient shown in

the formula without a change in the

order of predominance shown on the

label, provided that the change in

quantity of ingredients complies with

any minimum or maximum limits for

the use of such ingredients prescribed in

parts 318 and 319 of this subchapter;

(xix) Changes in the color of the

labeling, provided that sufficient

contrast and legibility remain;

(xx) A change in the product vignette,

provided that the change does not affect

mandatory labeling information or

misrepresent the content of the package;

(xxi) A change in the establishment

number by a corporation or parent

company for an establishment under its

ownership;

(xxii) Changes in nutrition labeling

that only involve quantitative

adjustments to the nutrition labeling

information, except for serving sizes,

provided the nutrition labeling

information maintains its accuracy and

consistency;

(xxiii) Deletion of any claim, and the

deletion of non-mandatory features or

non-mandatory information; and

(xxiv) The addition or deletion of a

direct translation of the English

language into a foreign language for

products marked ‘‘for export only.’’

§ 317.4 [Removed and reserved]

6. Section 317.14 is removed and

reserved.

PART 320—RECORDS,

REGISTRATION, AND REPORTS

7. The authority citation for part 320

is revised to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

8. Section 320.1 is amended by

adding a new paragraph (b)(11) to read

as follows:

§ 320.1 Records required to be kept.

* * * * *

(b) * * *

(11) Records of all labeling, along

with the product formulation and

processing procedures, as prescribed in

§ 317.4 and § 317.5.

PART 327—IMPORTED PRODUCTS

9. The authority citation for part 327

is revised to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

10. Section 327.14(c) is revised to

read as follows:

§ 327.14 Marking of products and labeling

of immediate containers thereof for

importation.

* * * * *

(c) All marks and other labeling for

use on or with immediate containers, as

well as private brands on carcasses or

parts of carcasses, shall be approved by

the Food Safety and Inspection Service

in accordance with part 317 of this

subchapter before products bearing such

marks, labeling, or brands will be

entered into the United States. The

marks of inspection of foreign systems

embossed on metal containers or

branded on carcasses or parts thereof

need not be submitted to the Food

Safety and Inspection Service for

approval, and such marks of inspection

put on stencils, box dies, labels, and

brands may be used on such immediate

containers as tierces, barrels, drums,

boxes, crates, and large-size fiberboard

containers of foreign products without

such marks of inspection being

submitted for approval, provided the

markings made by such articles are

applicable to the product and are not

false or misleading.

§ 327.24 [Amended]

11. Section 327.24 is amended by

removing the last sentence.

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

12. The authority citation for part 381

is revised to read as follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 21

U.S.C. 451–470; 7 CFR 2.18, 2.53.

13. Section 381.35 is amended by

revising the last sentence to read as

follows:

§ 381.35 Appeal inspections; how made.

* * *. The poultry or poultry

products involved in any appeal shall

be identified by U.S. retained tags and

segregated in a manner approved by the

inspector pending completion of an

appeal inspection.

14. Section 381.132 is revised to read

as follows:

§ 381.132 Labeling approval.

(a) No final labeling shall be used on

any product unless the sketch labeling

of such final labeling has been

submitted for approval to the Food

Labeling Division, Regulatory Programs,

Food Safety and Inspection Service, and

approved by such division,

accompanied by FSIS Form,

Application for Approval of Labels,

Marking, and Devices, except for

generically approved labeling

authorized for use in § 381.133(b) (2)–

(9). The management of the official

establishment or establishment certified

under a foreign inspection system, in

accordance with subpart T of this part,

must maintain a copy of all labeling

used, along with the product

formulation and processing procedure,

in accordance with subpart Q of this

part. Such records shall be made

available to any duly authorized

representative of the Secretary upon

request.

(b) The Food Labeling Division shall

permit submission for approval of only

sketch labeling, as defined in

§ 381.132(d), for all products, except as

provided in § 381.133(b) (2)–(9) and

except for temporary use of final

labeling as prescribed in paragraph (f) of

this section.

(c) All labeling required to be

submitted for approval as set forth in

§ 381.132(b) shall be submitted in

duplicate to the Food Labeling Division,

Regulatory Programs, Food Safety and

Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250. A

parent company for a corporation may

submit only one labeling application (in

duplicate) for a product produced in

other establishments that are owned by

the corporation.

(d) ‘‘Sketch’’ labeling is a printer’s

proof or equivalent which clearly shows

all labeling features, size, location, and

indication of final color, as specified in

subpart N of this part. FSIS will accept

sketches that are hand drawn, computer

generated or other reasonable facsimiles

that clearly reflect and project the final

version of the labeling. Indication of

final color may be met by: submission

of a color sketch, submission of a sketch

which indicates by descriptive language

the final colors, or submission with the

sketch of previously approved final

labeling that indicates the final colors.

(e) Inserts, tags, liners, pasters, and

like devices containing printed or

graphic matter and for use on, or to be

placed within, containers and coverings

of product shall be submitted for

approval in the same manner as

provided for labeling in § 381.132(a),

except that such devices which contain

no reference to product and bear no

misleading feature shall be used without

submission for approval as prescribed in

§ 381.133(b)(9).

(f)(1) Consistent with the

requirements of this section, temporary

approval for the use of a final label or

other final labeling that may otherwise

be deemed deficient in some particular

may be granted by the Food Labeling

Division. Temporary approvals may be

granted for a period not to exceed 180

calendar days under the following

conditions:

(i) The proposed labeling would not

misrepresent the product;
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations 67457

(ii) The use of the labeling would not

present any potential health, safety, or

dietary problems to the consumer;

(iii) Denial of the request would create

undue economic hardship; and

(iv) An unfair competitive advantage

would not result from the granting of

the temporary approval.

(2) Extensions of temporary approvals

may also be granted by the Food

Labeling Division, provided that the

applicant demonstrates that new

circumstances, meeting the above

criteria, have developed since the

original temporary approval was

granted.

15. Section 381.133 is redesignated as

§ 381.134, and § 381.134 is redesignated

as § 381.133 and revised to read as

follows:

§ 381.133 Generically approved labeling.

(a)(1) An official establishment or an

establishment certified under a foreign

inspection system, in accordance with

subpart T of this part, is authorized to

use generically approved labeling, as

defined in paragraph (b) of this section,

without such labeling being submitted

for approval to the Food Safety and

Inspection Service in Washington or the

field, provided the labeling is in accord

with this section and shows all

mandatory features in a prominent

manner as required in subpart N of this

part, and is not otherwise false or

misleading in any particular.

(2) The Food Safety and Inspection

Service shall select samples of

generically approved labeling from the

records maintained by official

establishments and establishments

certified under foreign inspection

systems, in accordance with subpart T

of this part, as required in § 381.132, to

determine compliance with labeling

requirements. Any finding of false or

misleading labeling shall institute the

proceedings prescribed in § 381.233.

(b) Generically approved labeling is

labeling which complies with the

following:

(1) Labeling for a product which has

a product standard as specified in

subpart 381 of this subchapter or the

Standards and Labeling Policy Book and

which does not contain any special

claims, such as quality claims, nutrient

content claims, health claims, negative

claims, geographical origin claims, or

guarantees, or which is not a domestic

product labeled in a foreign language;

(2) Labeling for single-ingredient

products (such as chicken legs or turkey

breasts) which does not contain any

special claims, such as quality claims,

nutrient content claims, health claims,

negative claims, geographical origin

claims, or guarantees, or which is not a

domestic product labeled with a foreign

language;

(3) Labeling for containers of products

sold under contract specifications to

Federal Government agencies, when

such product is not offered for sale to

the general public, provided that the

contract specifications include specific

requirements with respect to labeling,

and are made available to the inspectorin-charge;

(4) Labeling for shipping containers

which contain fully labeled immediate

containers, provided such labeling

complies with § 381.127;

(5) Labeling for products not intended

for human food, provided they comply

with §§ 381.152(c) and 381.193, and

labeling for poultry heads and feet for

export for processing as human food if

they comply with § 381.190(b);

(6) Poultry inspection legends, which

comply with subpart M of this part;

(7) Inserts, tags, liners, pasters, and

like devices containing printed or

graphic matter and for use on, or to be

placed within containers, and coverings

of products, provided such devices

contain no reference to product and bear

no misleading feature;

(8) Labeling for consumer test

products not intended for sale; and

(9) Labeling which was previously

approved by the Food Labeling Division

as sketch labeling, and the final labeling

was prepared without modification or

with the following modifications:

(i) All features of the labeling are

proportionately enlarged or reduced,

provided that all minimum size

requirements specified in applicable

regulations are met and the labeling is

legible;

(ii) The substitution of any unit of

measurement with its abbreviation or

the substitution of any abbreviation

with its unit of measurement, e.g., ‘‘lb.’’

for ‘‘pound,’’ or ‘‘oz.’’ for ‘‘ounce,’’ or of

the word ‘‘pound’’ for ‘‘lb.’’ or ‘‘ounce’’

for ‘‘oz.’’;

(iii) A master or stock label has been

approved from which the name and

address of the distributor are omitted

and such name and address are applied

before being used (in such case, the

words ‘‘prepared for’’ or similar

statement must be shown together with

the blank space reserved for the

insertion of the name and address when

such labels are offered for approval);

(iv) Wrappers or other covers bearing

pictorial designs, emblematic designs or

illustrations, e.g., floral arrangements,

illustrations of animals, fireworks, etc.

are used with approved labeling (the use

of such designs will not make necessary

the application of labeling not otherwise

required);

(v) A change in the language or the

arrangement of directions pertaining to

the opening of containers or the serving

of the product;

(vi) The addition, deletion, or

amendment of a dated or undated

coupon, a cents-off statement, cooking

instructions, packer product code

information, or UPC product code

information;

(vii) Any change in the name or

address of the packer, manufacturer or

distributor that appears in the signature

line;

(viii) Any change in the net weight,

provided that the size of the net weight

statement complies with § 381.121;

(ix) The addition, deletion, or

amendment of recipe suggestions for the

product;

(x) Any change in punctuation;

(xi) Newly assigned or revised

establishment numbers for a particular

establishment for which use of the

labeling has been approved by the Food

Labeling Division, Regulatory Programs;

(xii) The addition or deletion of open

dating information;

(xiii) A change in the type of

packaging material on which the label is

printed;

(xiv) Brand name changes, provided

that there are no design changes, the

brand name does not use a term that

connotes quality or other product

characteristics, the brand name has no

geographic significance, and the brand

name does not affect the name of the

product;

(xv) The deletion of the word ‘‘new’’

on new product labeling;

(xvi) The addition, deletion, or

amendment of special handling

statements, provided that the change is

consistent with § 381.125(a);

(xvii) The addition of safe handling

instructions as required by § 381.125(b);

(xviii) Changes reflecting a change in

the quantity of an ingredient shown in

the formula without a change in the

order of predominance shown on the

label, provided that the change in

quantity of ingredients complies with

any minimum or maximum limits for

the use of such ingredients prescribed in

§ 381.147 and subpart P of this part;

(xix) Changes in the color of the

labeling, provided that sufficient

contrast and legibility remain;

(xx) A change in the product vignette,

provided that the change does not affect

mandatory labeling information or

misrepresent the content of the package;

(xxi) The addition, deletion, or

substitution of the official USDA

poultry grade shield; (xxii) A change in

the establishment number by a

corporation or parent company for an

establishment under its ownership;
67458 Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 / Rules and Regulations

(xxiii) Changes in nutrition labeling

that only involve quantitative

adjustments to the nutrition labeling

information, except for services sizes,

provided the nutrition labeling

information maintains its accuracy and

consistency;

(xxiv) Deletion of any claim, and the

deletion of non-mandatory features or

non-mandatory information;

(xxv) The addition or deletion of a

direct translation of the English

language into a foreign language for

products marked ‘‘for export only’’; and

(xxvi) The addition of a descriptive

term as required by § 381.129(b)(6).

16. Section 381.137 is revised to read

as follows:

§ 381.137 Evidence of labeling and devices

approval.

No inspector shall authorize the use

of any device bearing any official

inspection legend unless he or she has

on file evidence that such device has

been approved in accordance with the

provisions of this subpart.

§ 381.141 [Removed and reserved]

17. Section 381.141 is removed and

reserved.

18. Section 381.175 is amended by

adding a new paragraph (b)(6) to read as

follows:

§ 381.175 Records required to be kept.

* * * * *

(b) * * *

(6) Records of all labeling, along with

the product formulation and processing

procedures, as prescribed in §§ 381.132

and 381.133.

19. Section 381.202(d) is amended by

removing the last sentence and by

revising the next to the last sentence to

read as follows:

§ 381.202 Poultry products offered for

entry; reporting of findings to customs;

handling of articles refused entry; appeals,

how made; denaturing procedures.

* * * * *

(d) * * *. The poultry or poultry

products involved in any appeal shall

be identified by U.S. retained tags and

segregated in a manner approved by the

inspector pending completion of an

appeal inspection.

* * * * *

20. Section 381.205(c) is revised to

read as follows:

§ 381.205 Labeling of immediate

containers of poultry products offered for

entry.

* * * * *

(c) All marks and other labeling for

use on or with immediate containers

shall be approved for use by the Food

Safety and Inspection Service in

accordance with §§ 381.132 and 381.133

before products bearing such marks and

other labeling will be permitted for

entry into the United States.

21. Section 381.206 is amended by

adding to the end thereof the following

sentence:

§ 381.206 Labeling of shipping containers

of poultry products offered for entry.

* * *. All labeling used with a

shipping container of imported poultry

products must be approved in

accordance with subpart N of this part.

Done at Washington, DC, on: December 21,

1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95–31392 Filed 12–26–95; 3:36 pm]

BILLING CODE 3410–DM–P