[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Rules and Regulations]
[Pages 67444-67458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31392]
[[Page 67443]]
_______________________________________________________________________
Part IV
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 301, et al.
Meat and Poultry Inspection; Final Rule and Proposed Rules
Federal Register / Vol. 60, No. 250 / Friday, December 29, 1995 /
Rules and Regulations
[[Page 67444]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 306, 317, 320, 327, and 381
[Docket No. 92-012F]
RIN 0583-AB92
Prior Labeling Approval System
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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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
