Prior Labeling Approval System

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.

[[Page 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-in-charge (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.

[[Page 67446]]

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 all-generic 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 8\1/2\ 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

[[Page 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.

[[Page 67448]]

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 sketch-only 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

[[Page 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., 8\1/2\ 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 8\1/2\ 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

[[Page 67450]]

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

generically-approved 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

[[Page 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

[[Page 67452]]

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

[[Page 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

[[Page 67454]]

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:

Sec. 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 Sec. 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 Sec. 317.4(d), for all products,

except as provided in Sec. 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 Sec. 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 Sec. 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.

[[Page 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 Sec. 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 Sec. 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:

Sec. 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 Sec. 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

Sec. 317.4, to determine compliance with labeling requirements. Any

finding of false or misleading labeling shall institute the proceedings

prescribed in Sec. 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 inspector-in-charge;

(4) Labeling for shipping containers which contain fully labeled

immediate containers, provided such labeling complies with Sec. 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 Sec. 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

[[Page 67456]]

statements, provided that the change is consistent with Sec. 317.2(k);

(xvii) The addition of safe handling instructions as required by

Sec. 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.''

Sec. 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:

Sec. 320.1 Records required to be kept.

* * * * *

(b) * * *

(11) Records of all labeling, along with the product formulation

and processing procedures, as prescribed in Sec. 317.4 and Sec. 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:

Sec. 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.

Sec. 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:

Sec. 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:

Sec. 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 Sec. 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 Sec. 381.132(d), for all

products, except as provided in Sec. 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 Sec. 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 Sec. 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 Sec. 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;

[[Page 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 Sec. 381.134, and

Sec. 381.134 is redesignated as Sec. 381.133 and revised to read as

follows:

Sec. 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

Sec. 381.132, to determine compliance with labeling requirements. Any

finding of false or misleading labeling shall institute the proceedings

prescribed in Sec. 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 inspector-in-charge;

(4) Labeling for shipping containers which contain fully labeled

immediate containers, provided such labeling complies with

Sec. 381.127;

(5) Labeling for products not intended for human food, provided

they comply with Secs. 381.152(c) and 381.193, and labeling for poultry

heads and feet for export for processing as human food if they comply

with Sec. 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 Sec. 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

Sec. 381.125(a);

(xvii) The addition of safe handling instructions as required by

Sec. 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 Sec. 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;

[[Page 67458]]

(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

Sec. 381.129(b)(6).

16. Section 381.137 is revised to read as follows:

Sec. 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.

Sec. 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:

Sec. 381.175 Records required to be kept.

* * * * *

(b) * * *

(6) Records of all labeling, along with the product formulation and

processing procedures, as prescribed in Secs. 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:

Sec. 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:

Sec. 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 Secs. 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:

Sec. 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