[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Proposed Rules]
[Pages 75809-75825]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2011-30992]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 316, 317, 320, 331, 354, 355, 381, 412, and 424
[Docket No. 99-021P; FDMS Docket Number FSIS-2005-0016]
RIN 0583-AC59
Prior Label Approval System: Generic Label Approval
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the meat and poultry products inspection regulations to expand
the circumstances in which FSIS will generically approve the labels of
meat and poultry products. The Agency also is proposing to combine the
regulations that provide for the approval of labels for meat products
and poultry products into a new CFR part.
DATES: Comments must be received on or before February 3, 2012.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by either of the following
methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including diskettes or CD-ROMs, and hand- or
courier-delivered items: Send to U.S. Department of Agriculture (USDA),
FSIS, OPPD, RIMD, Docket Room, Patriots Plaza 3, 1400 Independence
Avenue SW., Mailstop 3782, 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2005-0016. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information provided, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8 a.m. and
4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Jeff Canavan, Food Technologist,
Labeling and Program Delivery Division, Office of Policy and Program
Development, Food Safety and Inspection Service, U.S. Department of
Agriculture, Beltsville, MD 20705-5273; Telephone (301) 504-0879; Fax
(301) 504-0872.
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
product 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 or poultry food 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 to 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
[[Page 75810]]
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)).
The Department's longstanding interpretation of these provisions is
that they require that the Secretary of Agriculture or his or her
representative approve all labels to be used on federally inspected and
passed, and imported, meat and poultry products before the products are
distributed in commerce. Without approved labels, meat and poultry
products may not be sold, offered for sale, or otherwise distributed in
commerce.
These prior label approval provisions also apply to establishments
that do business solely within designated States (see 21 U.S.C. 451 and
602). 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 at which their carcasses
or products are prepared for use as human food solely for distribution
within such State, requirements at least equal to those contained in
titles I and IV of the FMIA and specified sections of the PPIA (21
U.S.C. 454(c)(1) and 661(c)(1)). Once a State is designated, the
inspection requirements of the FMIA and PPIA apply to establishments
that slaughter livestock and poultry, and prepare or process meat or
poultry products, solely for distribution within the State.
Current Label Regulations
There are up to eight features required on most meat and poultry
labels. The mandatory features are designed to ensure that meat and
poultry products are accurately and truthfully labeled, and that they
provide the necessary product information for consumers to make an
informed purchasing decision. These required features of meat and
poultry product labels must appear on the immediate containers of
domestic products (9 CFR part 317, subpart A, and 9 CFR part 381,
subpart N) and imported products (9 CFR part 327 and 9 CFR part 381,
subpart T). The meat inspection regulations define an ``immediate
container'' as the receptacle or other covering in which any product is
directly contained or wholly or partially enclosed (9 CFR 301.2). The
poultry products inspection regulations define an ``immediate
container'' as any consumer package or any other container in which
poultry products, not consumer packaged, are packed (9 CFR 381.1(b)).
The required features include: (1) The standardized, common or
usual, or descriptive name, of the product (9 CFR 317.2(e) and
381.117); (2) an ingredients statement containing the common or usual
name of each ingredient of the product listed in descending order of
predominance (9 CFR 317.2(f) and 381.118); (3) the name and place of
business of the manufacturer, packer, or distributor (9 CFR 317.2(g)
and 381.122); (4) an accurate statement of the net quantity of contents
(9 CFR 317.2(h) and 381.121); (5) the inspection legend, including the
number of the official establishment (9 CFR 317.2(i) and 381.123); (6)
a safe handling statement if the product is perishable; e.g., ``Keep
Frozen'' or ``Keep Refrigerated'' (9 CFR 317.2(k) and 381.125(a)); (7)
nutrition labeling for applicable meat and poultry products; \1\ and
(8) safe handling instructions if the meat or poultry component of the
product is not ready-to-eat (9 CFR 317.2(l) and 381.125(b)). In
addition, imported meat and poultry products must bear the country of
origin under the product name in accordance with 9 CFR 327.14(b)(1) and
381.205(a).
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\1\ Nutrition labeling is required for heat-treated and multi-
ingredient meat and poultry products. New nutrition labeling
requirements for ground or chopped meat and poultry products will
take effect January 1, 2012 (75 FR 82148, Dec. 29, 2010).
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These mandatory features must be prominently and informatively
displayed on the principal display panel, the information panel, or
other surface of the product label. The first six features described
above, including the labeling of country of origin for imported
products in accordance with 9 CFR 327.14 and 381.205, have been
required by the meat and poultry inspection regulations for decades.
FSIS implemented regulations that require the nutrition labeling of
cooked or heat-treated multi-ingredient meat and poultry products and
the display of safe handling instructions in 1993 and 1994,
respectively. Therefore, industry has had a significant amount of
experience complying with the regulations for all required label
features.
The regulations contain other provisions to ensure that no
statement, word, picture, design, or device that is false or misleading
in any particular, or that conveys any false impression, or that gives
any false indication of origin, identity, or quality, appears in any
marking or other labeling (9 CFR 317.8 and 381.129). 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)), the Administrator, FSIS,
may withhold the use of any marking or labeling that is false or
misleading, within the meaning of the FMIA or the PPIA and the
implementing regulations.
Current Prior Label Approval System and the Procedures the Agency
Employs To Implement It
In order to ensure that meat and poultry products comply with the
FMIA and PPIA and their implementing regulations, FSIS conducts a prior
approval program for labels that are to be used on federally inspected
meat and poultry products and imported products (see 9 CFR 317.4,
317.5, 327.14, 381.132, 381.133, 381.134, and 381.205).
Under the current program, FSIS evaluates sketches of labels for
approval. A ``sketch label'' is a printer's proof or other version that
clearly shows all required label features, size, location, and
indication of final color. To obtain sketch label approval, domestic
meat and poultry establishments and certified foreign establishments,
or their representatives, submit sketch labels to FSIS for evaluation,
except when the label is generically approved by the Agency under 9 CFR
317.5 or 381.133.
Meat and poultry establishments and certified foreign
establishments submit sketch labels accompanied by FSIS Form 7234-1
(01/08/2008), ``Application for Approval of Labels, Marking or
Device,'' to the Agency for evaluation. In addition to the required
label information, any special claims or statements that the
establishment intends to make (e.g., quality claims, animal production
raising claims, product origin claims, or nutrient content claims) must
be included on the label, along with documentation supporting the
claim. The label application must contain the basic information about
the establishment and the product, including:
1. Establishment number;
2. Product name;
3. Product formulation;
4. Processing procedures and handling information;
4. Firm name and address;
5. Total available labeling space of the container;
6. Size of the principal display panel; and
7. The Hazard Analysis and Critical Control Point category under
which the establishment is producing the meat or poultry product.
All such information is evaluated by a technical labeling policy
expert in FSIS, who is responsible for verifying that sketch labels
comply with the applicable requirements. A ``final label''
[[Page 75811]]
does not have to be submitted to the Agency for evaluation and
approval. Since July 1, 1996, meat and poultry establishments and
certified foreign establishments have been responsible for ensuring
that the labels that they apply to their meat and poultry products
comply with Federal regulations. All labels are subject to FSIS
verification for compliance with Agency regulations to ensure that they
are accurate, truthful, and not misleading. The management of the
official establishment or establishment certified under a foreign
inspection system must maintain a copy of all labels and labeling used,
along with the product formulation and processing procedures. Such
records must be made available to any duly authorized representative of
the Secretary upon request.
Generic Label Approval
Generic label approval refers to the prior approval of labels or
modifications to labels by the Agency without submitting such labels to
FSIS for sketch approval. Generic label approval requires that all
mandatory label features be in conformance with FSIS regulations (9 CFR
317.5(a)(1) and 381.133(a)(1)). Although such labels are not submitted
to FSIS for approval, they are deemed to be approved and, therefore,
may be applied to product in accordance with the Agency's prior label
approval system.
In 1983, FSIS estimated that it evaluated approximately 130,000
label submissions a year. That year, the Agency promulgated regulations
that granted limited label approval authority to the Inspector-In-
Charge (IIC) at official establishments and provided generic approval
to limited types of labels (e.g., labels for raw, single ingredient
meat and poultry products) (48 FR 11410, March 18, 1983). This generic
approval did not extend to the labels of the products of certified
foreign establishments. The rulemaking was intended to reduce the
number of labels and other labeling submitted for evaluation by FSIS
and to lessen the paperwork burden on official establishments. The
general goal was to improve the efficiency of the label approval system
by streamlining the review process.
Even with the changes made by the rule, however, the number of
labels and other labeling submitted to the Agency continued to grow.
During fiscal year 1991, the Agency processed approximately 167,500
labels. Of these, 87,500 were final labels, and 60,000 were sketch
labels that were approved. Approximately 20,000 labels were not
approved. The Agency did not maintain records on the number of
temporary approvals or other types of labeling (e.g., insert labeling
applied at retail) that were evaluated and acted upon by the Agency.
On March 25, 1992, FSIS published an Advance Notice of Proposed
Rulemaking (ANPRM) (57 FR 10300, Mar. 25, 1992) on the Agency's prior
label approval system. The ANPRM presented two options for making
additional changes to the prior label approval system: (1) Revise the
system by significantly reducing the scope of review through expansion
of the categories of generically approved labels and replacing the
general requirement of FSIS approval of sketch and final labels with
one for sketch labels only; or (2) replace the system with a system in
which all labels are generically approved and used without prior
submission to FSIS for evaluation and approval.
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 generically approved labels authorized for
use on meat and poultry products by official establishments in the
United States and foreign establishments certified under foreign
inspection systems. The rule was proposed as a first step in the
gradual streamlining and modernization of the label approval system. In
the proposal, the Agency sought comment on a long-term plan to
implement a system in which all labels are generically approved. After
reviewing the comments received in response to the proposed rule, and
in light of FSIS's ongoing reassessment of its labeling policies, FSIS
decided to proceed with a gradual streamlining and modernization of the
label approval system.
On December 29, 1995 (effective July 1, 1996), FSIS published a
final rule titled ``Prior Label Approval System'' (60 FR 67334). The
implementing regulations, 9 CFR 317.5 and 381.133, outline the types of
labels and modifications to labels that are deemed to be approved
without submission to FSIS, provided that the label displays all
mandatory label features in conformance with applicable Federal
regulations.
FSIS permits 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 evaluation and approval by FSIS:
1. Labels for a product that has a standard of identity or
composition as specified in 9 CFR part 319 or part 381, subpart P, or
is consistent with an informal standard that the Agency has laid out in
the Food Standards and Labeling Policy Book; does not bear any special
claims, such as quality claims, nutrient content claims, health claims,
negative claims, geographical origin claims (except as provided by 9
CFR 317.5(b)(9)(xxv) and 381.133 (b)(9)(xxviii)), or guarantees; and is
not a product that is not domestic and labeled in a foreign language;
2. Labels for raw, single-ingredient products (such as beef steak,
lamb chops, chicken legs, or turkey breasts) that do not bear special
claims, such as quality claims, nutrient content claims, health claims,
negative claims, geographical origin claims, or guarantees, and are not
products that are not domestic and labeled with a foreign language;
3. Labels 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 that the contract specifications include specific
requirements with respect to labeling that is made available to the
IIC;
4. Labels for shipping containers that contain fully labeled
immediate containers, provided that the outside container's labels
comply with 9 CFR 316.13 or 381.127;
5. Labels for products not intended for human food, provided that
they comply with 9 CFR part 325 or 9 CFR 381.152(c) and 381.193; and
labels for poultry heads and feet for export for processing as human
food if they comply with 9 CFR 381.190(b);
6. Meat and poultry inspection legends that comply with 9 CFR parts
312 and 316, and 9 CFR part 381, subpart M;
7. Inserts, tags, liners, posters, 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. Labels for consumer test products not intended for sale; and
9. Labels that were previously approved by FSIS as sketch labels,
and the final labels were prepared without modification or with the
following modifications:
a. All features of the label are proportionately enlarged or
reduced, provided that all minimum size requirements specified in
applicable
[[Page 75812]]
regulations are met, and the label is legible;
b. A 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.'';
c. A master or stock label that 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);
d. Wrappers or other covers bearing pictorial designs, emblematic
designs, or illustrations, e.g., floral arrangements, illustrations of
animals, fireworks, etc., are used with approved labels (the use of
such designs will not make necessary the application of labeling not
otherwise required);
e. A change in the language or the arrangement of directions
pertaining to the opening of containers or the serving of the product;
f. 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;
g. Any change in the name or address of the packer, manufacturer,
or distributor that appears in the signature line;
h. Any change in net weight, provided the size of the net weight
statement complies with 9 CFR 317.2 or 381.121;
i. The addition, deletion, or amendment of recipe suggestions for
the product;
j. Any change in punctuation;
k. Newly assigned or revised establishment numbers for a particular
establishment for which use of the label has been approved by FSIS;
l. The addition or deletion of open dating information;
m. A change in the type of packaging material on which the label is
printed;
n. 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;
o. The deletion of the word ``new'' on new product labels;
p. 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);
q. The addition of safe handling instructions as required by 9 CFR
317.2(l) and 381.125(b);
r. 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, 319, 424, subpart C, and
381, subpart P;
s. Changes in the color of the label, provided that sufficient
contrast and legibility remain;
t. The addition, deletion, or substitution of the official USDA
grade shield on labels of poultry products;
u. A change in the product vignette, provided the change does not
affect mandatory label information or misrepresent the content of the
package;
v. A change in an establishment number by a corporation or parent
company for an establishment under its ownership;
w. 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;
x. Deletion of any claim, and the deletion of non-mandatory
features or non-mandatory information;
y. The addition or deletion of a direct translation of the English
language into a foreign language for products marked ``for export
only''; and
z. A country of origin statement on any product label described in
9 CFR 317.8(b)(40) and 381.129(f) that complies with the requirements
in these paragraphs.
With the implementation of the 1995 final rule on July 1, 1996,
FSIS transferred the responsibility for maintaining labeling records
from IICs to official establishments in the United States and to
foreign establishments certified by officials of a foreign inspection
system. Each record must include a copy of the labeling, the product
formulation, and processing procedures (9 CFR 320.1(b)(11)). This
transfer of responsibility was done to be consistent with the record
keeping requirements of other production related areas, e.g.,
Sanitation (9 CFR 416.16) and Hazard Analysis and Critical Control
Point (HACCP) Systems (9 CFR 417.5). For example, establishments are
required to maintain copies of their HACCP plan, hazard analysis,
records documenting the monitoring of critical control points, and
sanitation operating procedures. These records must be made available
to FSIS personnel upon request. Establishments are required to maintain
records for product formulation and labeling similar to HACCP and
Sanitation Standard Operating Procedure (SOP) records because
establishments are responsible for ensuring the accuracy of all final
labels applied to product.
To facilitate Agency verification of compliance with regulatory
labeling requirements, FSIS requires that establishments make labeling
records available to any authorized USDA official upon request (9 CFR
320.4). The Agency published FSIS Directive 7221.1, Amendment 1, titled
``Prior Labeling Approval,'' on August 19, 1996, to provide
instructions to Federal inspectors on their responsibilities in
verifying that the modifications to the FSIS food labeling prior
approval program regulations were implemented effectively and without
disruption of the inspection process.
As part of the 1995 final rule, FSIS stated that it intended to
proceed with the gradual streamlining and modernization of the prior
label approval system. FSIS anticipated making additional changes after
it completed an assessment of the modified system.
FSIS announced that it would sample labels applied by
establishments under the generic label approval regulations to assess
compliance with the FMIA and the PPIA (9 CFR 317.5(a)(2) and
381.133(a)(2)). To effect this sampling, the Agency issued FSIS
Directive 7221.1, Amendment 1, which instituted a nationally directed
surveillance plan. Following implementation of the surveillance plan,
FSIS assessed whether establishments were applying the generic label
regulations correctly. The Agency brought label discrepancies to the
attention of establishments for correction when it found them.
The Agency has used its surveillance to assess compliance trends
and to determine whether any new labeling regulations or guidance
materials are needed. FSIS assembled a taskforce of employees to: (1)
Develop criteria and methods to select labels for sampling; (2) develop
the appropriate compliance activity to respond to labeling errors; (3)
develop tracking and reporting systems; and (4) design and implement a
survey of the effects of the limited generic approvals.
The results of a survey \2\ showed that 685 of the 1,107
establishments
[[Page 75813]]
operating at the time of the survey (193 establishments that were
selected to be surveyed were no longer operating) used generically
approved labels. Of the 1,513 labels that inspection program personnel
submitted to FSIS headquarters, 538 were in compliance with all Federal
regulations and policies, 896 had minor labeling errors (for example,
insufficient spacing around the declaration of net weight or an error
in the name of the manufacturer, packer, or distributor) that were not
of public health or economic significance, and 79 had labeling errors
that could not be granted a temporary approval without modification
(e.g., an incomplete product name). Sections 317.4(f) and 381.132(f) of
Title 9 of the CFR provide for the temporary use of final labels that
may be deficient under the following conditions: (1) The product label
does not misrepresent the product; (2) the use of the label does not
present any potential health, safety, or dietary problems to the
consumer; (3) denial of use would create an undue economic hardship;
and (4) an unfair competitive advantage would not result from the
granting of the temporary approval.
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\2\ Generic Label Audit System Project (1997-1998).
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Survey Conclusions
Although 79 of the 1,513 labels that were surveyed had deficiencies
that could not be granted temporary approval without modification
(e.g., through the use of pressure sensitive stickers to correct label
features not in compliance with Federal regulations), FSIS concluded
that the survey showed that the great majority of establishments
surveyed could effectively use generically approved labels without
first submitting sketch labels to FSIS for evaluation and approval.
Furthermore, the Agency concluded that the results showed enough
acceptable compliance by establishments for FSIS to confirm that the
gradual implementation of generic label provisions under the 1995 final
rule was effective.
Trends Toward Increased Guidance and Transparency of Labeling Policies
for Industry
In the years since the survey was conducted and the last major
change to the generic label regulations was made, the Agency has
emphasized the importance of providing guidance and outreach to
industry, trade groups, and consumers. FSIS has posted most of its
labeling policy information on the Agency's Web site to increase
accessibility to industry, particularly small businesses. The Labeling
and Consumer Protection Reference Center was launched as a Web page in
February 1999. The Web page includes a PowerPoint presentation titled
``Labeling 101,'' which is used by the Agency as a teaching tool at
workshops on meat and poultry label requirements. In addition, FSIS has
on its Web page guidance on animal production claims and on nutrition
labeling, a glossary of meat and poultry labeling terms, the Food
Standards and Labeling Policy Book, and questions and answers on
various topics, such as irradiation and the labeling of ingredients.
The Web page also includes FSIS Form 7234-1, Application for Approval
of Labels, Marking and Device, and detailed instructions to assist
establishments in preparing label applications for submission to FSIS.
In addition, the Agency's labeling policy Web page contains a guidebook
that provides information on FSIS labeling requirements, including
generic approval. Due to these efforts, and because no other evidence
has been submitted to FSIS to suggest that generically approved
labeling cannot be successfully applied, FSIS has concluded that
expanding the types of labeling that is generically approved is
appropriate at this time.
Proposed Rule
The provisions of the generic label regulations appear to be
comprehensive. However, in practical application, they are restrictive
regarding the types of labels and labeling changes that are considered
by the Agency to be approved without submitting such labeling to the
Agency. For example, the label for a non-standardized product, such as
a pepperoni pizza (bearing no special statements or claims) that was
sketch approved by FSIS would need to be resubmitted for sketch
approval if the establishment makes a minor formula change that affects
the order of predominance in the ingredients statement. This need to
resubmit exists because the generic label regulations only provide for
changes to the product formula for non-standardized meat or poultry
products that have been sketch approved if the order of predominance in
the ingredients statement does not change. Consequently, the current
label regulations require industry to submit for approval a significant
amount of labeling that the Agency believes could successfully be
generically approved. Expanding the types of labels that can be
generically approved would lessen the burden on industry to submit
labels to the Agency, while allowing the Agency to better focus on, and
direct its resources to, other consumer protection and food safety
activities.
FSIS is proposing to amend the meat and poultry products inspection
regulations (9 CFR 317.5 and 381.133) to expand the circumstances in
which the labels of meat and poultry products will be deemed to be
generically approved by FSIS. If adopted, the new generic label
regulations for meat and poultry will be placed in a new part 412 in
Title 9. The Agency is proposing to combine the regulations that
provide for the approval of labels for meat products and for poultry
products (9 CFR 317.4 and 381.132) into part 412. This proposal, if
adopted, will modernize the regulations by expanding the types of
labels that FSIS considers generically approved without prior
submission to the Agency. This rulemaking will also streamline the
regulations by placing all the label approval regulations for meat and
poultry products in one part in Title 9.
Under the proposed rule, establishments that apply generically
approved labels without prior submission to the Agency will have the
responsibility of ensuring that all basic required label features
(i.e., product name, safe handling statement, ingredients statement,
address line, net weight, legend, safe handling instructions, nutrition
labeling for multi-ingredient products, as well as the country of
origin and mark of inspection of the foreign system for imported
products) appear on their meat or poultry product labels in accordance
with Federal regulations.
If this proposal is adopted, FSIS will require establishments to
submit for evaluation only certain types of labeling, e.g., labels for
temporary approval, labels for products produced under religious
exemption, labels for export with labeling deviations, and claims and
special statements intended for use on labels. FSIS will continue to
require the submission of such labels and special statements and claims
because they are more likely to present significant policy issues that
have health or economic significance. Examples of labeling that will
need to be submitted for evaluation and approval before use if this
proposal is adopted are: (1) Labels for chicken produced under Buddhist
exemption; (2) labels for beef intestine produced for export to China
that identify the product as ``beef casings,'' and (3) labels for
temporary use that do not list all ingredients in the correct order of
predominance.
Examples of special statements and claims for use on labels are:
(1) Claims relating a product's nutrient content to a health or a
disease condition; (2) statements that identify a product as
``organic'' or containing organic
[[Page 75814]]
ingredients; (3) claims regarding meat and poultry production
practices; (4) claims that are undefined in FSIS regulations, such as
``gluten free;'' and (5) instructional or disclaimer statements
concerning pathogens, e.g., ``for cooking only'' or ``not tested for E.
coli O157:H7;'' and (6) statements that identify a product as
``natural.'' A special statement or claim may be submitted to the
Agency for approval in the context of a final label; however, FSIS will
not evaluate the mandatory features (e.g., handling statement and net
weight) that are generically approved by the Agency. FSIS will only
evaluate the special statement or claim that is presented on the label.
Under the proposal, statements on labels that are defined in FSIS's
regulations or policy guidance, e.g., a statement that characterizes a
product's nutrient content, such as ``low fat;'' that has geographical
significance, such as ``Italian Style;'' or that makes a country of
origin statement on the label of any meat or poultry product ``covered
commodity,'' will not need to be submitted to FSIS for evaluation.
Similarly, if this proposal is adopted, FSIS will not view the addition
of an allergen statement (e.g., ``contains soy'') applied in accordance
with the Food Allergen Labeling and Consumer Protection Act as a
special statement or claim that requires sketch approval. The
application of statements of this type are clearly prescribed in an
FSIS compliance policy guide (http://www.fsis.usda.gov/Regulations_&_Policies/Labeling_Allergens/index.asp).
Through its prior label approval system, FSIS is aware that most
establishments are voluntarily applying allergen statements to meat and
poultry product labels in accordance with the Agency's compliance
policy guide on the use of statements of this type.\3\ FSIS plans to
continue to monitor the application of allergen statements, but as long
as the Agency continues to observe the widespread application of
allergen statements on a voluntary basis, FSIS will not initiate
rulemaking to make allergen statements a required label feature. FSIS
intends to continue to use its post-market surveillance activities to
ensure that labels containing statements of this type are not false or
misleading and comply with all applicable Federal regulations.
---------------------------------------------------------------------------
\3\ Source: FSIS Labeling and Program Delivery Division, Label
Audit, 2010.
---------------------------------------------------------------------------
The proposed rule will affect several other sections in the meat
and poultry inspection regulations that reference label approval or
generically approved labels. 9 CFR 317.8(b)(32)(ii) requires the
submission of labels bearing calendar dates, e.g., ``sell by date.''
FSIS is proposing to amend this section by removing the reference to 9
CFR 317.4 for submitting labels for approval because FSIS no longer
believes that labels with these types of phrases need to be submitted
before use. The use of phrases relating to calendar dates is prescribed
in FSIS regulations, and industry has been applying these types of
labeling statements for years.
FSIS is proposing to revise the recordkeeping requirements for
product labels, formulation, and processing procedures that are
described in 9 CFR 320.1(b)(11) by removing the references to 9 CFR
317.4 and 317.5 and replacing them with a reference to the new label
approval regulations for meat and poultry found in 9 CFR part 412.
9 CFR 327.14(c) in FSIS's regulations on meat imports references
label approval by FSIS in accordance with 9 CFR part 317. FSIS is
proposing to revise 9 CFR 327.14(c) to reference the new label approval
regulations in 9 CFR part 412.
FSIS is proposing to remove the reference to 9 CFR 317.4 in 9 CFR
331.3(e) and to replace it with a reference to 9 CFR part 412. The
Agency is also proposing replace the outdated references to the
``Labels and Packaging Staff, Meat and Poultry Inspection'' in these
regulations with ``FSIS labeling program at headquarters.''
In regard to the poultry label regulations and the use of the term
``fresh,'' FSIS is proposing to amend 9 CFR 381.129(b)(6)(i) to remove
the reference to the current generic label regulations. Because the
requirements for the use of the term ``fresh'' are prescribed in FSIS's
regulations, and the term has been used by industry for a number of
years, FSIS does not consider it any longer to be a special statement
or claim. Therefore, under the proposed rule, establishments will be
able to use the term on labels without submitting the labels for
evaluation, provided the use of this term is consistent with the
provisions of 9 CFR 381.129(b)(6)(i).
Similar to the meat inspection regulations, 9 CFR 381.129(c)(2)
requires the approval of phrases with regard to calendar dates on
poultry products. FSIS is proposing to amend this regulation by
removing the reference to 9 CFR 381.132 for label approval because FSIS
considers it no longer necessary to require pre-market approval of the
labels on which these types of phrases appear. The use of phrases
relating to calendar dates is prescribed in FSIS poultry regulations,
and FSIS published several years ago a comprehensive set of guidance
material on poultry dating (http://www.fsis.usda.gov/PDF/Labeling_Guide_on_Poultry_Food_Dating.pdf). Thus, ample guidance exists for
manufacturers to ensure that the labels on which such information is
placed are truthful and not misleading without the need to submit such
labels to FSIS first for pre-market evaluation.
FSIS is proposing to eliminate the requirement that any label
bearing the USDA approved quality control system logo, and any wording
or explanation with respect to the logo, be approved. The logo is
illustrated clearly in the regulations, and its use is prescribed as
well. As such, FSIS does not believe that labels bearing the logo need
to be submitted for approval. If this proposal is adopted, 9 CFR
318.4(f) and 381.145(f) will be amended to remove the references to
``parts 316 and 317 of this chapter'' and ``subparts M and N,''
respectively.
FSIS is proposing to revise the recordkeeping requirements for
product labels, formulation, and processing procedures described in 9
CFR 381.175(b)(6) to remove the references to 9 CFR 381.132 and
381.133. These references will be replaced with a reference to the new
label approval regulations found in 9 CFR part 412.
For the same reason, FSIS is proposing to replace the references to
9 CFR 381.132 and 381.133, which discuss the approval of marks and
other labeling for use on immediate containers of imported products, in
9 CFR 381.205(c) with a reference to 9 CFR part 412.
The Agency is also proposing to amend 9 CFR 381.222(d)(1) to remove
the reference to 9 CFR 381.132 for label approval and to replace it
with a reference to 9 CFR part 412. As with 9 CFR 331.3(e) and
331.3(e)(1), the Agency is proposing to replace the outdated references
to the ``Labels and Packaging Staff, Meat and Poultry Inspection'' in 9
CFR 381.222(d)(2) and (3) with one to the ``FSIS labeling program at
headquarters.''
In regard to other FSIS regulations, FSIS is proposing to amend
footnote 3 in the table of approved substances (9 CFR 424.21(c)) to
replace the old references for label approval to 9 CFR 317.4 and 381.32
(which should have actually been 9 CFR 381.132) with a reference to 9
CFR part 412.
Finally, FSIS is proposing to amend 9 CFR 424.22(c)(4), which
discusses the need for the approval of labels of irradiated meat and
poultry products, by removing the references for label approval in 9
CFR 317.4 and subparts M and N in part 381. Because the requirements
for the labels of irradiated
[[Page 75815]]
products are prescribed in FSIS's regulations, and the term has been
used by industry for a number of years, FSIS no longer considers it to
be a special statement or claim that requires submitting such labels
for approval.
Options Considered for This Proposal
FSIS considered several options in developing this proposed rule.
The first option FSIS considered was to maintain the current prior
label approval system. Under this option, FSIS would not modernize its
regulations by increasing the types of labels that the Agency considers
generically approved and would not streamline its regulations by
combining the label approval regulations for meat and poultry into one
location in Title 9. Under this option, establishments and certified
foreign establishments would not have to change any procedures and
could continue to apply certain types of generically approved labels as
provided for in the regulations. Therefore, FSIS would not need to
allocate its resources to conduct rulemaking.
However, there are several major disadvantages to this option.
First, the option would not be consistent with the Agency's commitment
to enable manufacturers to make decisions and assume more
responsibility concerning whether products that they produce are
compliant with FSIS labeling regulations. Our current generic label
rule was intended to reduce the number of labels and other labeling
that are submitted for evaluation by FSIS and to lessen the paperwork
burden on official establishments. The goal was to improve efficiency
by streamlining the label evaluation and approval process. Streamlining
and modernizing the prior label approval process is important to the
Agency so that it can better focus on and direct its resources to other
consumer protection and food safety activities.
Second, the regulations for the mandatory label features have been
in place for decades, and FSIS believes that, as a result of its
verification activities, establishments and certified foreign
establishments can effectively apply labels with the mandatory label
features without submitting them for approval to the Agency.
Consequently, under this option, industry would continue to need to
submit a significant number of labels for evaluation and approval
because parts of the generic label regulations are unnecessarily
restrictive. Specifically, the regulations require establishments to
submit labels for evaluation that do not present policy issues from the
standpoint of food safety, health, economic adulteration, or
misbranding.
The second option that FSIS considered was: (1) Amending its
regulations so that all labels, including labels for temporary approval
and labels bearing claims, would be considered generically approved by
the Agency; and (2) streamlining its regulations by combining the label
approval regulations for meat and poultry in one location in Title 9.
The primary advantages of this option are that it would streamline the
Agency's label approval regulations and eliminate the burden on
industry to submit labels to the Agency for approval. However, a major
disadvantage of this option is that it would likely result in
misbranded products in the marketplace. While the results of the
generic labeling survey showed success in establishments applying
certain types of labels (e.g., the mandatory features that have been
required by the meat and poultry inspection regulations for decades),
the results of the survey cannot be used to support the generic
approval of all labels because certain types of labels, e.g., labels
with special statements and claims, present significant policy issues
and are not defined in FSIS regulations. Consequently, establishments
may not be familiar with the Agency's requirements for the support or
application of certain special statements or claims, which could result
in increased labeling errors and misbranded product.
Industry is familiar with the requirements for mandatory label
features, but the Agency believes that it needs to continue to provide
pre-market evaluation and approval of certain types of labels (e.g.,
temporary approvals and labels for product produced under a religious
exemption). Further, FSIS needs to continue to provide pre-market
evaluation and approval of special label statements and claims (e.g.,
animal production raising claims and ``natural'') that present
significant and evolving policy issues. The pre-market evaluation and
approval of certain types of labels, and special statements and claims
intended for use on labels, are needed for the Agency to verify that
all labels are accurate, truthful, and not misleading before products
enter commerce.
The third option FSIS considered was to: (1) Expand the types of
labels that would be subject to generic approval; and (2) streamline
its regulations by combining the label approval regulations for meat
and poultry in one location in Title 9 of the CFR. Under this option,
FSIS would expand the types of labels that the Agency considers
generically approved (i.e., any labels that bear mandatory features
without special statements or claims). The Agency would continue to
require the submission of certain types of label, e.g., labels for
temporary approval, labels for export products with label deviations,
and products produced under religious exemptions.
Under this option, Federal establishments and certified foreign
establishments would be responsible for ensuring that the basic
required features on labels are applied in accordance with all
applicable regulations. Temporary approvals, labels for export products
that deviate from domestic labeling requirements, and labels for
products produced under religious exemption, however, would represent
exceptions that FSIS would need to evaluate on a case by case basis.
Therefore, these limited types of labels would have to be submitted to
FSIS for evaluation and approval before use. In addition, manufacturers
would be required to submit special statements and claims intended to
be used on labels to the Agency for approval under this option.
A major advantage of the third option is that establishments would
be responsible for developing labels that include the basic mandatory
features (i.e., product name, safe handling statement, ingredients
statement, signature line, net weight, legend, safe handling
instructions, and nutrition labeling) in accordance with Federal
regulations. This option would thus allow Agency personnel to focus
their efforts on evaluating claims or special statements that have
consumer safety or economic implications and on labels that cannot be
generically approved, e.g., requests for temporary approval to use
labeling that is deficient in some manner. It would substantially
reduce the types of labels that would need to be submitted to the
Agency, thus reducing, although not entirely eliminating, the burden
for industry to submit labels to FSIS for approval.
FSIS would continue to perform verification and post-market
surveillance activities in commerce to ensure that meat and poultry
product labels comply with all applicable regulations. Specifically,
FSIS would select samples of generically approved labels from the
records maintained by official establishments and establishments
certified under foreign inspection systems, in accordance with part 327
and part 381, subpart T, to determine compliance with label
requirements. If the Agency found that an establishment is using a
false or misleading label, it would institute the proceedings
prescribed in 9 CFR 500.8
[[Page 75816]]
to revoke the approval for the label. FSIS's surveillance activities
would ensure that the consumer is protected under this option.
Therefore, FSIS concludes that the third option is the most
feasible for rulemaking. It is an approach that will effectively
enhance implementation of a generic label system that imposes less
burden on industry. It promotes effective use of Agency resources. The
option will not adversely affect consumer protection because FSIS will
continue to evaluate labeling, e.g., special statements and claims and
requests for temporary approval, that have consumer safety or economic
implications. Moreover, FSIS will continue its verification and
compliance activities to ensure that establishments are labeling their
products in conformance with Agency regulations. Finally, it will
streamline FSIS regulations by putting the meat and poultry prior label
approval regulations in one part in Title 9.
We invite public comment on these options as well as on other
options not discussed above.
Executive Orders 12866 and 13563
Executive Orders (EOs) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if a
regulation is necessary, to select the regulatory approach that
maximizes net benefits (including potential economic, environmental,
public health and safety, and other advantages, distributive impacts,
and equity). Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This action has been reviewed for
compliance with EOs 12866 and 13563.
This rule has been designated a ``significant regulatory action,''
although not economically significant, under section 3(f) of EO 12866.
Accordingly, the rule has been reviewed by the Office of Management and
Budget.
The Agency has determined that this proposed rule maximizes net
benefits to consumers and establishments by expanding the types of
labels that are approved generically under the FMIA and the PPIA.
I. Need for the Rule
The purpose of the proposed rule is to expand the circumstances in
which the labels of meat and poultry products will be deemed to be
generically approved by FSIS and to combine the regulations that
provide for the generic approval of labels for meat products into a new
part 412 in Title 9, Chapter III, of the CFR. The proposed rule is the
next step in the Agency's gradual streamlining and modernizing of the
prior label approval system.
This rulemaking's intent is to reduce the number of labels
evaluated by FSIS that only bear basic features (e.g., product name,
ingredients statement, net weight) and to reduce the amount of
paperwork filed by establishments with FSIS. If finalized, these
actions will improve the efficiency of the label approval system by
streamlining the evaluation process for specific types of labels and
making the label approval system more convenient and cost-effective for
industry. As for consumers, this new process will enhance market
efficiency by promoting a faster introduction of new products into the
marketplace to meet demand while not negatively affecting consumer
protection from misbranded product.
II. Historical Record of FSIS's Prior Label Approval System
In 1983, when FSIS established limited types of generically
approved labels, the Agency evaluated 130,000 labels. In 1991, the
number of labels evaluated peaked at 167,500 labels. The 1995 final
rule that amended the prior label approval system expanded the types of
labels and label changes that may be applied in accordance with the
generic label regulations. As a result, the number of labels evaluated
by FSIS decreased by 74 percent to 43,255 in 2003, as depicted in
Figure 1. From 2003 to 2010, the number of labels evaluated per year
averaged 57,457, with a minimum of 43,255 (2003) and a maximum of
66,061 (2010).
[GRAPHIC] [TIFF OMITTED] TP05DE11.000
Source: FSIS, Labeling and Program Delivery Division (LPDD),
Labeling Information System (LIS) Database
Under the current prior label approval system, FSIS evaluates and
approves meat and poultry labels for temporary or sketch approval.
Labels are not approved when they do not comply with Federal
regulations, or when they have claims and special statements that are
not substantiated or supported with sufficient documentation. As
depicted in Figure 2, sketch labels make up over 50 percent of the
volume of labels evaluated and approved by FSIS, while
[[Page 75817]]
the approval of temporary labels makes up only about 9 percent of the
total volume.
[GRAPHIC] [TIFF OMITTED] TP05DE11.001
Source: FSIS, LPDD, LIS Database
During 2003-2010, FSIS reviewed and evaluated a total of 459,656
labels. As depicted in Figure 3, the number of labels reviewed and
evaluated by FSIS LPDD increased 53 percent, from 43,255 labels in 2003
to 66,061 labels in 2010. Each year the number of labels increased,
except between 2004 and 2005, when labels decreased 4 percent, from
56,344 labels to 54,100 labels, but then increased 4 percent to 56,102
labels in 2006.
[GRAPHIC] [TIFF OMITTED] TP05DE11.002
Source: FSIS, LPDD, LIS Database
When looking at the data of the Agency approval of Temporary Labels
(See Table 1), we find that the approval level was at 13 percent in
2003 (5,831 labels approved), which then declined to 6 percent in 2010
(4,101 labels approved). The approval level was at its lowest in 2010
(6.2%), when the Agency approved 4,101 labels out of 66,061 labels.
Since 2003, the Agency has approved 45 percent more sketch labels and
30 percent fewer temporary labels.
[[Page 75818]]
Table 1--Label Evaluation and Approval Process, 2003-2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agency action 2003 2004 2005 2006 2007 2008 2009 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
Temporary Approval.............................. 5,831 6,124 5,036 4,763 4,404 4,369 4,575 4,101
(13%) (11%) (9%) (8%) (7.5%) (8.8%) (7.2%) (6.2%)
Sketch Approval................................. 25,870 36,967 32,795 32,956 32,588 21,693 35,588 37,465
Unapproved...................................... 11,554 13,252 16,269 18,383 21,250 23,456 23,284 24,495
-------------------------------------------------------------------------------------------------------
Total....................................... 43,255 56,343 54,100 56,102 58,242 49,518 63,447 66,061
--------------------------------------------------------------------------------------------------------------------------------------------------------
Examining the data closer, the number of sketch labels approved
increased 64 percent, from 21,693 labels in 2008 to 35,588 labels in
2009, while the number not approved remains the same and the number of
temporary slightly increased. The number of labels not approved has
climbed steadily from 2003, when it was at its lowest at 11,554 labels
unapproved, to its high of 24,495 labels not approved in 2010. Between
2005 and 2007, as the number of sketch label approvals leveled off in
the 32,000 range, the number of labels not approved increased 30
percent, from 16,269 labels to 21,250. FSIS attributes this increase in
labels not approved to the increase in special claims, statements that
were not substantiated, and sketch labels that Agency personnel could
not approve as modified because the labels contained several errors or
major discrepancies. During this timeframe, FSIS placed much of its
labeling guidance on its Web site and conducted many labeling
workshops.
III. Industry Profile
A. Establishments
Based on the Agency's Performance Based Inspection System
databases, in 2011, there were about 6,099 Federal establishments. FSIS
estimates that there were approximately 266,061 approved meat and
poultry product labels used by these establishments. FSIS evaluated
66,061 of them in 2010; the remaining 200,000 were approved under the
Prior Label Approval System because they met the standards for generic
approval.
B. Label Consultant Firms
There are about 12 firms that submit labels to LPDD on behalf of
Federal establishments. These firms provide label courier service,
information, and training to their clients on FSIS labeling policies.
All of the firms in this industry are small, usually having one to four
employees. Many of these firms now offer consulting services, such as
ensuring that import and export labels to be reviewed for compliance
with USDA regulations receive expedited service and providing label
outsourcing, in which a firm handles all of an establishment's food
labeling needs.
IV. Benefits
A. Industry
If adopted, the proposed rule will continue the streamlining and
modernization of the Agency's prior label approval system. The proposed
rule will permit establishments to realize an estimated cost savings of
a minimum of $8.7 million (discounted over a 10-year period) for
generically approving about 584,486 additional labels over a 10-year
period at about $25 per label submission.\4\ In the absence of the
proposed rule, establishments will not realize any cost savings because
Federal regulations will continue to require establishments to submit a
significant number of labels to LPDD for evaluation.\5\ Establishments
will also realize an increase in the number of generically approved
labels over a 10-year period under the proposed rule.
---------------------------------------------------------------------------
\4\ The cost per label is the cost of submitting a label for
review to FSIS, which averages about $25.00 per submission. This
amount will be used as a proxy to estimate the cost savings to
establishments that prepare their labels for review using FSIS Form
7234-1 ``Application for approval of Labels, Markings, or Device''
and preparing a printer's proof of the label for evaluation and
approval by LPDD.
\5\ See Table 2.
Table 2--Estimated Establishment Cost Savings (in 2010 Dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(A) (B) (C) (D) (E) (F) (G)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in
Total number number of Total number Total cost
of labels labels of labels savings
developed and developed and developed and Col.(C) x *$25 To apply Discounted
Year applied by applied by applied by from reduced discount rate total cost
establishments establishments establishments need for FSIS of 7.00% savings col.
that do not that would not that would not label (E) x Col. (F)
require FSIS require FSIS require FSIS evaluation
evaluation evaluation evaluation
Before rule After rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
0....................................................... 200,000 0 200,000 $0 1.00 $0
1....................................................... 250,985 50,985 301,970 $1,274,625 0.93 $1,185,401
2....................................................... 253,495 52,515 306,009 $1,312,864 0.86 $1,129,063
3....................................................... 256,030 54,090 310,120 $1,352,250 0.79 $1,068,277
4....................................................... 258,590 55,713 314,303 $1,392,817 0.72 $1,002,828
5....................................................... 261,176 57,384 318,560 $1,434,602 0.65 $932,491
6....................................................... 263,788 59,106 322,893 $1,477,640 0.58 $857,031
7....................................................... 266,426 60,879 327,304 $1,521,969 0.51 $776,204
8....................................................... 269,090 62,705 331,795 $1,567,628 0.44 $689,756
9....................................................... 271,781 64,586 336,367 $1,614,657 0.37 $597,423
10...................................................... 274,499 66,524 341,022 $1,663,097 0.30 $498,929
-----------------------------------------------------------------------------------------------
[[Page 75819]]
Total............................................... 2,825,858 584,486 3,410,344 $14,612,147 .............. $8,737,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
Description:
Col A: Estimate is for a 10-year period. Year ``0'' is the year before the enactment of the rule.
Col B: Total number of labels developed and applied by official establishments that do not currently require FSIS evaluation.
Col C: Increase in the number of labels generically developed and applied by establishments as a result of the rule (i.e., would not need FSIS
evaluation.
Col D: Total number of labels developed and applied by establishments after the rule was enacted.
Col E: Total cost savings realized to establishments, using an estimated $25 as the cost per label submission to LPDD.
Col F: Discount rate of 7 percent.
Col G: Discount cost savings over 10 years.
Source: FSIS Policy Analysis Division Calculations.
Because fewer labels will need to be submitted to the Agency for
evaluation, establishments will realize a cost savings because they
will no longer need to incur costs to have certain types of labels
evaluated by FSIS.
B. Agency
The proposed rule should reduce the number of labels submitted to
FSIS for evaluation and enable the Agency to reallocate the staff hours
saved from evaluating fewer labels towards the development of labeling
policy, the evaluation of new and novel labeling policy issues, and
involvement in other food safety and consumer protection activities.
The proposed rule would streamline the approval process by amending the
regulations to provide that, except in certain specified circumstances,
the label of a meat or poultry product is deemed to be approved
generically.
Table 3 shows the chronological progression of streamlining and
modernizing the prior label approval system through various
rulemakings.
Table 3--Comparison of FSIS Prior Label Approval System Rulemakings
------------------------------------------------------------------------
1983 1995 2011
------------------------------------------------------------------------
Prior label approval Proposed prior label
Prior label approval system system approval system
------------------------------------------------------------------------
Establishments granted Expanded the types Proposed to expand
limited labeling approval of labels and all types of labels
to the IIC. modifications to and of
labels that the modifications to
Agency deemed labels that the
generically Agency deems
approved. generically
approved except in
certain specified
circumstances.
Label records maintained by Label records Label records
IIC. maintained by the maintained by the
establishments. establishments.
Agency conducts all Agency conducts all Agency conducts all
evaluation and approval of evaluations and evaluations and
temporary, sketch, and approvals of approvals of
final labels. temporary and special statements
sketch labels only.. and claims, labels
for temporary
approval, labels
for products
produced under a
religious
exemption, and
labels for products
for export with
labeling
deviations.
------------------------------------------------------------------------
Source: FSIS, LPDD
Table 4--Estimated FSIS Cost Savings (in 2010 Dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(A) (B) (C) (D) (E) (F) (G) (H)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total number Total number
of labels of labels Annual salary Annual salary Annual salary To apply Discounted
Year evaluated and evaluated and cost ($) of cost ($) of difference (D)- discount rate cost savings
approved by approved by LPDD \1\ LPDD \2\ (E) of 7.00% (F) * (G)
LPDD LPDD
Before rule After rule Before rule After rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
0....................................... 66,061 66,061 538,710 538,710 0 1.00 0
1....................................... 68,043 17,011 554,871 134,677 420,194 0.93 390,781
2....................................... 70,084 17,521 571,517 138,717 432,800 0.86 372,208
3....................................... 72,187 18,047 588,663 142,879 445,784 0.79 352,169
4....................................... 74,352 18,588 606,323 147,165 459,158 0.72 330,594
5....................................... 76,583 19,146 624,513 151,580 472,932 0.65 307,406
[[Page 75820]]
6....................................... 78,880 19,720 643,248 156,128 487,120 0.58 282,530
7....................................... 81,247 20,312 662,545 160,811 501,734 0.51 255,884
8....................................... 83,684 20,921 682,422 165,636 516,786 0.44 227,386
9....................................... 86,195 21,549 702,894 170,605 532,290 0.37 196,947
10...................................... 88,780 22,195 723,981 175,723 548,258 0.30 164,477
---------------------------------------------------------------------------------------------------------------
Total............................... 846,096 261,070 6,899,688 2,082,631 4,817,057 .............. 2,880,382
--------------------------------------------------------------------------------------------------------------------------------------------------------
Description:
Col A: Estimate is for a 10 year period. Year ``0'' is the year before the enactment of the rule.
Col B: Total number of labels evaluated and approved by LPDD prior to rule enactment assuming a 3 percent growth factor.
Col C: Total number of labels evaluated and approved by LPDD after rule enactment, assuming a 3 percent growth factor.
Col D: Annual salary cost of LPDD staff who evaluate labels, prior to enactment of rule, assuming a 3 percent growth factor.
Col E: Annual salary cost of LPDD personnel who evaluates labels, after rule enactment, assuming a 3 percent growth factor.
Col F: Annual salary difference between salary before rule enactment and after rule enactment, assuming a 3 percent growth factor.
Col G: Discount rate of 7 percent.
Col H: Discount cost savings.
Footnotes:
\1\ Total salary is based on a staff of 11 personnel paid at the average rate of a GS-13, step 4 of $47.09 per hour: 11 staff persons would review
labels at a cost of $538,710 per year ($47.09 an hour x 4 hours a day x 11 persons x 5 days a week = $10,359.80. $10,359.80 x 52 weeks = $538,710).
\2\ Total salary is based on a staff of 11 personnel paid at the average rate of a GS-13, step 4 at $47.09 per hour: 11 staff persons would review
labels at a cost of $134,677.40 per year ($47.09 an hour x 1 hour a day x 11 persons x 5 days a week = $2,589.95 x 52 weeks = $134,677.40.
Source: FSIS Policy Analysis Division calculations.
If this proposed rule becomes final, in the year before the
effective date of the rule FSIS will continue to review 66,061 labels
because of the lag time between the publication of the rule and
industry compliance with it. In years 1-10, FSIS will experience a 69
percent reduction in the volume of labels submitted for evaluation.
Currently, FSIS employs eleven labeling policy experts to evaluate
labels.\6\ FSIS staff members are organized into teams based on special
claims or issues, such as amenability, organic, or country of
origin,\7\ and evaluate labeling four hours per day, five days a week,
at a cost of $10,360 per week. FSIS assumes that it will evaluate
labels and labeling for one hour per day, five days a week, as a result
of the reduction in the volume of labels or labeling submitted to FSIS.
Thus, the proposed rule would permit the Agency to realize an estimated
discounted cost savings of $2.9 million over 10 years \8\ from
evaluating labels because FSIS is expected to review a total of 261,070
labels under the proposed rule as compared with 846,096 under the
current system.\9\ This cost savings from fewer staff hours being
allocated towards label evaluation can be redirected towards other food
safety and consumer protection activities.
---------------------------------------------------------------------------
\6\ The average General schedule (GS) level grade of the staff
is a GS-13, step 4.
\7\ Each team will have a member who is knowledgeable about
certain special claims.
\8\ See Table 4.
\9\ Ibid.
---------------------------------------------------------------------------
V. Costs
The proposed rule would not impose any new costs on meat and
poultry establishments that submit labels for review to FSIS and it
minimizes the regulatory burden on establishments that submit labels
for review. The proposed rule does not change the requirement that
establishments maintain copies of all labeling records, along with the
product formulations and a description of the processing procedures
used to formulate the products in accordance with 9 CFR 320.2 and part
381, subpart Q. These labeling records must be made available to any
authorized Agency official within 24 hours upon request.
The proposed rule also does not impose any additional cost burden
on establishments because first, establishments are already applying
generically approved labels and maintaining all labeling records, and
second, establishments are experienced in submitting labels to FSIS for
evaluation. If this proposal is adopted, establishments will continue
label production, once the labels are approved by FSIS. The cost of
label design and products is not a part of this proposed rule.
VI. Summary
If this proposed rule is adopted, it will be net beneficial because
it will streamline the generic label approval process, while imposing
no additional cost burden on establishments. FSIS estimates that
establishments will realize a discounted cost savings of $8.7 million
as a result of their ability to generically approve an additional
584,486 labels over a 10-year period. Furthermore, the Agency will
realize a discounted cost savings of $2.9 million for evaluating
584,486 fewer labels over a 10-year period. This cost savings in fewer
staff hours being spent evaluating labels can be redirected towards
other Agency initiatives. Therefore, the net benefit derived from the
proposed rule is $11.6 million ($8.7 million in establishment savings
plus $2.9 million in Agency savings), discounted at 7 percent, over a
10-year period.
Preliminary Regulatory Flexibility Analysis
The FSIS Administrator has determined that this proposed rule would
not have a significant impact on a substantial number of small
entities, as defined by the Regulatory Flexibility
[[Page 75821]]
Act (5 U.S.C. 601). The proposed changes will affect those entities in
the United States that submit labels for review to FSIS. There are
6,099 meat and poultry establishments that could possibly be affected
by this proposed rule since all are eligible to submit labels for
review and 12 small label consulting firms that are involved in various
labeling activities, such as submitting labels to FSIS for evaluation
on the behalf of meat and poultry establishments. Of the 6,099
establishments, there are about 2,616 small federally inspected
establishments (with more than 10 but less than 500 employees) and
3,103 very small establishments (with fewer than 10 employees) based on
HACCP Classification. Therefore, a total of 5,719 small and very small
establishments could be possibly affected by this rule. These small and
very small establishments, like the large establishments, would be
permitted to generically approved labels as long as there are no
special claims. Small entities would not be disadvantaged because the
proposed rule would minimize the regulatory burden on all
establishments. The proposed rule would not have a significant impact
on a substantial number of label consulting firms. Since the expanded
use of generically approved labels in 1995, these firms have modified
their consulting services to specialize in certain policy areas, e.g.,
the production and labeling of organic products and animal production
raising practices. Therefore, the Agency believes that the proposed
rule will not have a significant economic impact on a substantial
number of small entities (establishments and labeling consulting
firms).
In making its determination, the Agency considered two alternatives
to the proposed rule: the status quo and making all labels candidates
for generic labeling. Keeping the status quo would mean that the Agency
would continue to commit limited resources to a process that
establishments can assume, if the proper guidance was available.
Therefore the Agency rejects this alternative. The second alternative,
making all labels generically approved, would mean that some products
may be misbranded because of misleading statement and claims on the
labels. Therefore the Agency rejects this alternative as well.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule except as
discussed below.
Paperwork Requirements
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501, et seq.), the information collection requirement associated with
this proposed rule on prior labeling has been submitted for approval to
OMB.
Title: Marking, Labeling, and Packaging of Meat, Poultry, and Egg
Products.
OMB No.: 0583-0092.
Expiration Date of Approval:
Type of Request: Revision of a currently approved information
collection.
Abstract: FSIS has been delegated the authority to exercise the
functions of the Secretary as specified in the Federal Meat Inspection
Act (FMIA) (21 U.S.C. 601, et seq.), the Poultry Products Inspection
Act (PPIA) (21 U.S.C. 451, et seq.), and the Egg Products Inspection
Act (EPIA) (21 U.S.C. 1031, et seq.).
FSIS protects the public by verifying that meat, poultry, and egg
products are safe, wholesome, unadulterated, and properly labeled and
packaged. FSIS is requesting a revision of a currently approved
information collection addressing paperwork requirements specified in
the regulations related to marking, labeling, and packaging of meat,
poultry, and egg products.
FSIS is proposing to expand the circumstances in which FSIS will
generically approve the labels of meat and poultry products. Under this
proposed rule, more official and foreign establishments would be able
to use the generic approval of product labels that would also result in
a reduced number of regular label approvals. Hence, FSIS is requesting
a revision of the Marking, Labeling, and Packaging of Meat, Poultry,
and Egg Products information collection. The total number of hours for
this information collection will decrease 31,091 hours because of the
increased use of generic labeling.
Estimate of Burden: FSIS estimates that it will take establishments
on the average of 0.33 hours per response.
Respondents: Official establishments, plants, and foreign
establishments.
Estimated Number of Respondents: 6,418.
Estimated Number of Responses per Respondent: 45.7.
Estimated Total Annual Burden on Respondents: 97,176 hours.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083,
South Building, Washington, DC 20250.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to both John O'Connell, Paperwork Reduction
Act Coordinator, at the address provided above, and the Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253. To be most effective,
comments should be sent to OMB within 60 days of the publication date
of this proposed rule.
E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.
FSIS believes that by proceeding with this rulemaking, the Agency
could potentially accept the electronic submission of requests for the
evaluation of claims or special statements, which will significantly
streamline the approval process.
National Environmental Policy Act
The expected environmental effects: The use of labels by meat and
poultry product establishments that have been deemed to be generically
approved by FSIS is an activity that will not have a significant
individual or cumulative effect on the human environment. Therefore,
this proposed rule is appropriately subject to the categorical
exclusion from the preparation of an environmental assessment or
environmental impact statement provided under 7 CFR 1b.4(6) of the U.S.
Department of Agriculture regulations.
[[Page 75822]]
Executive Order 13175
This final rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on Tribal governments and
will not have significant Tribal implications.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.) Persons with disabilities who require
alternative means for communication of program information (Braille,
large print, or audiotape) should contact USDA's Target Center at (202)
720-2600 (voice and TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
Additional Public Notification
FSIS will announce this proposed rule online through the FSIS Web
page located at http://www.fsis.usda.gov/regulations_&_policies/ProposedRules/index.asp.
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. In addition, FSIS offers an electronic mail subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range
from recalls to export information to regulations, directives and
notices. Customers can add or delete subscriptions themselves, and have
the option to password protect their accounts.
List of Subjects
Food labeling, Food packaging, Meat inspection, Poultry and poultry
products, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR, Chapter III, as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. Sec. 317.4 and 317.5 [Removed and Reserved]
2. Sections 317.4 and 317.5 are removed and reserved.
3. In Sec. 317.8, revise paragraph (b)(32)(ii) to read as follows:
Sec. 317.8 False or misleading labeling or practices generally;
specific prohibitions and requirements for labels and containers.
* * * * *
(b) * * *
(32) * * *
(ii) Immediately adjacent to the calendar date will be a phrase
explaining the meaning of such date, in terms of ``packing'' date,
``sell by'' date, or ``use before'' date, with or without a further
qualifying phrase, e.g., ``For Maximum Freshness'' or ``For Best
Quality.''
* * * * *
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
4. The authority citation for part 318 continues to read as
follows:
Authority: 7 U.S.C. 138, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
5. In Sec. 318.4, revise paragraph (f) introductory text to read
as follows:
Sec. 318.4 Preparation of products to be officially supervised;
responsibilities of official establishments; plant operated quality
control.
* * * * *
(f) Labeling Logo. Owners and operators of official establishments
having a total plant quality control system approved under the
provisions of paragraph (c) of this section may only use, as a part of
any label, the following logo.
* * * * *
PART 320--RECORDS, REGISTRATION, AND REPORTS
6. The authority citation for part 320 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.
7. In Sec. 320.1, revise paragraph (b)(11) to read as follows:
Sec. 320.1 Records required to be kept.
* * * * *
(b) * * *
(11) Records of labeling, product formula, processing procedures,
and any additional documentation needed to support that the labels are
consistent with the Federal meat and poultry regulations and policies
on labeling, as prescribed in Sec. 412.1 of this chapter.
PART 327--IMPORTED PRODUCTS
8. The authority citation for part 327 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
9. In Sec. 327.14, revise paragraph (c) 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 412 of these regulations 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.
PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES;
AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH
AND FOR SUCH DESIGNATED ESTABLISHMENTS
10. The authority citation for part 331 is revised to read as
follows:
[[Page 75823]]
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.53.
11. Amend Sec. 331.3 by revising paragraphs (e) introductory text,
(e)(1), and (e)(3) to read as follows:
Sec. 331.3 States designated under paragraph 301(c) of the Act;
application of regulations.
* * * * *
(e) Sections 316.7, 317.3, and 412.1 will apply to such
establishments, except as provided in this paragraph (e).
(1) The operator of each such establishment will, prior to the
inauguration of inspection, identify all labeling and marking devices
in use, or proposed for use, (upon the date of inauguration of
inspection) to the Front Line Supervisor of the circuit in which the
establishment is located. Temporary approval, pending formal approval
under Sec. Sec. 316.7, 317.3, and 412.1, will be granted by the Front
Line Supervisor for labeling and marking devices that he determines are
neither false nor misleading, provided the official inspection legend
bearing the official establishment number is applied to the principal
display panel of each label, either by a mechanical printing device or
a self-destructive pressure sensitive sticker, and provided the label
shows the true product name, an accurate ingredient statement, the name
and address of the manufacturer, packer, or distributor, and any other
features required by section 1(n) of the Act.
* * * * *
(3) The operator of the official establishment shall promptly
forward a copy of each item of labeling and a description of each
marking device for which temporary approval has been granted by the
Front Line Supervisor (showing any modifications required by the Front
Line Supervisor) to the FSIS labeling program at headquarters, Food
Safety and Inspection Service, USDA, 5601 Sunnyside Ave., Stop 5476,
Beltsville, MD 20705-5476, accompanied by the formula and details of
preparation and packaging for each product. Within 90 days after
inauguration of inspection, all labeling material and marking devices
temporarily approved by the Front Line Supervisor must receive approval
as required by Sec. Sec. 316.7, 317.3, and 412.1, or their use must be
discontinued.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
12. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 451-470; 7
CFR 2.18, 2.53.
13. Amend section 381.129 by revising paragraphs (b)(6)(i) and
(c)(2) to read as follows:
Sec. 381.129 False or misleading labeling or containers.
* * * * *
(b) * * *
(6)(i) A raw poultry product whose internal temperature has ever
been below 26[deg]F may not bear a label declaration of ``fresh.'' A
raw poultry product bearing a label declaration of ``fresh'' but whose
internal temperature has ever been below 26[deg]F is mislabeled. The
temperature of individual packages of raw poultry product within an
official establishment may deviate below the 26[deg]F standard by 1
deg. (i.e., have a temperature of 25[deg]F) and still be labeled
``fresh.'' The temperature of individual packages of raw poultry
product outside an official establishment may deviate below the
26[deg]F standard by 2 deg. (i.e., have a temperature of 24[deg]F) and
still be labeled ``fresh.'' The average temperature of poultry product
lots of each specific product type must be 26[deg]F. Product described
in this paragraph is not subject to the freezing procedures required in
section 381.66(f)(2) of this subchapter.
* * * * *
(c) * * *
(2) Immediately adjacent to the calendar date will be a phrase
explaining the meaning of such date in terms of ``packing'' date,
``sell by'' date, or ``use before'' date, with or without a further
qualifying phrase, e.g., ``For Maximum Freshness'' or ``For Best
Quality.''
* * * * *
Sec. Sec. 381.132 and 381.133 [Removed and Reserved]
14. Sections 381.132 and 381.133 are removed and reserved.
15. In Sec. 381.145, revise paragraph (f) introductory text to
read as follows:
Sec. 381.145 Poultry products and other articles entering or at
official establishments; examination and other requirements.
* * * * *
(f) Labeling Logo. Owners and operators of official establishments
having a total plant quality control system approved under the
provisions of paragraph (c) of this section may only use, as a part of
any label, the following logo.
* * * * *
16. In Sec. 381.175, revise 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 formula,
processing procedures, and any additional documentation needed to
support that the labels are consistent with the Federal meat and
poultry regulations and policies on labeling, as prescribed in Sec.
412.1.
17. In Sec. 381.205, revise paragraph (c) 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 part 412 of this chapter before products
bearing such marks and other labeling will be permitted for entry into
the United States.
18. In Sec. 381.222, revise paragraph (d) to read as follows:
Sec. 381.222 States designated under paragraph 5(c) of the Act;
application of regulations.
* * * * *
(d) Subpart N of this part shall apply to such establishments
except as provided in this paragraph (d).
(1) The operator of each such establishment shall, prior to the
inauguration of inspection, identify all labeling and marking devices
in use, or proposed for use (upon the date of inauguration of
inspection) to the Front Line Supervisor in which the establishment is
located. Temporary approval, pending formal approval under Sec. 412.1,
will be granted by the Front Line Supervisor for labeling and marking
devices that he determines are neither false nor misleading, provided
the official inspection legend bearing the official establishment
number is applied to the principal display panel of each label, either
by a mechanical printing device or a self-destructive pressure
sensitive sticker, and provided the label shows the true product name,
an accurate ingredient statement, the name and address of the
manufacturer, packer, or distributor, and any other features required
by section 4(h) of the Act.
(2) The Front Line Supervisor will forward one copy of each item of
labeling and a description of each marking device for which he has
granted temporary approval to the FSIS labeling program at headquarters
and will retain one copy in a temporary approval file for the
establishment.
(3) The operator of the official establishment shall promptly
forward a
[[Page 75824]]
copy of each item of labeling and a description of each marking device
for which temporary approval has been granted by the Front Line
Supervisor (showing any modifications required by the Front Line
Supervisor) to the FSIS labeling program at headquarters, accompanied
by the formula and details of preparation and packaging for each
product. Within 90 days after inauguration of inspection, all labeling
material and marking devices temporarily approved by the Front Line
Supervisor must receive approval as required by Sec. 412.1 or their
use must be discontinued.
(4) The Front Line Supervisor will also review all shipping
containers to ensure that they do not have any false or misleading
labeling and are otherwise not misbranded. Modifications of
unacceptable information on labeling material by the use of pressure
sensitive tape of a type that cannot be removed without visible
evidence of such removal, or by blocking out with an ink stamp will be
authorized on a temporary basis to permit the maximum allowable use of
all labeling materials on hand. All unacceptable labeling material
which is not modified to comply with the requirements of the
regulations must be destroyed or removed from the official
establishment.
* * * * *
19. Add part 412 to read as follows:
PART 412--LABEL APPROVAL
Sec.
412.1 Label approval.
412.2 Approval of Generic Labels.
Authority: 21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53.
Sec. 412.1 Label approval.
(a) No final label shall be used on any product unless the label
has been submitted for approval to the FSIS labeling program at
headquarters, accompanied by FSIS Form 7234-1, Application for Approval
of Labels, Marking, and Devices, and approved by such division, except
for generically approved labels authorized for use in Sec. 412.2. The
management of the official establishment or establishment certified
under a foreign inspection system, in accordance with parts 327 and
381, subpart T, must maintain a copy of all labels used, in accordance
with parts 320 and 381, Subpart Q, of this subchapter. Such records
shall be made available to any duly authorized representative of the
Secretary upon request.
(b) All labels required to be submitted for approval as set forth
in Sec. 412.1(a) will be submitted to the FSIS labeling program at
headquarters, in duplicate. A parent company for a corporation may
submit only one label application for a product produced in other
establishments that are owned by the corporation.
(c) The Food Safety and Inspection Service requires the submission
of labeling applications for the following:
(1) Sketch label as defined in Sec. 412.1(d) for products which
are produced under a religious exemption;
(2) Sketch labels for products for foreign commerce whose labels
deviate from FSIS regulations, with the exception of printing labels in
foreign language or printing labels that bear a statement of the
quantity of contents in accordance with the usage of the country to
which exported as described in section 317.7 and part 381, subpart M.
(3) Special statements and claims as defined in Sec. 412.1(e) and
presented in the context of a final label.
(4) Requests for the temporary use of final labels as prescribed in
Sec. 412.1(f).
(d) A ``sketch'' label is the concept of a label. It may be a
printer's proof or equivalent that is sufficiently legible to clearly
show all labeling features, size, and location. The Food Safety and
Inspection Service will accept sketches that are hand drawn or computer
generated, or other reasonable facsimiles that clearly reflect and
project the final version of the label.
(e) ``Special statements and claims'' are claims, logos,
trademarks, and other symbols on labels that are not defined in the
Federal meat and poultry products inspection regulations, such as
health claims, negative claims (e.g., gluten free), ingredient and
processing method claims (e.g., high pressure processing), structure-
function claims, animal production and raising claims, organic claims,
natural claims, and instructional or disclaimer statements concerning
pathogens (e.g., ``for cooking only'' or ``not tested for E. coli
O157:H7''). Examples of logos and symbols include graphic
representations of hearts and geographic landmarks.
(f)(1) Temporary approval for the use of a final label that may be
deemed deficient in some particular may be granted by the FSIS labeling
program at headquarters. Temporary approvals may be granted for a
period not to exceed 180 calendar days, under the following conditions:
(i) The proposed label would not misrepresent the product;
(ii) The use of the label 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
FSIS labeling program at headquarters provided that the applicant
demonstrates that new circumstances, meeting the above criteria, have
developed since the original temporary approval was granted.
Sec. 412.2 Approval of generic labels.
(a)(1) An official establishment, or an establishment certified
under a foreign inspection system in accordance with part 327, or part
381, subpart T of this subchapter, is authorized to use generically
approved labels, as defined in paragraph (b) of this section, and thus
is free to use such labels without submitting them to the Food Safety
and Inspection Service for approval, provided the label, in accordance
with this section, displays all mandatory features in a prominent
manner in compliance with part 317 or part 381, and is not otherwise
false or misleading in any particular.
(2) The Food Safety and Inspection Service will select samples of
generically approved labels from the records maintained by official
establishments and establishments certified under foreign inspection
systems, in accordance with part 327 or part 381, subpart T, to
determine compliance with label requirements. If the Agency finds that
an establishment is using a false or misleading label, it will
institute the proceedings prescribed in Sec. 500.8 of this chapter to
revoke the approval for the label.
(b) Generically approved labels are labels that bear all applicable
mandatory labeling features (i.e., product name, safe handling
statement, ingredients statement, the name and place of business of the
manufacturer, packer or distributor, net weight, legend, safe handling
instructions, and nutrition labeling) in accordance with Federal
regulations. Labels that bear claims and statements that are defined in
FSIS's regulations (e.g., a statement that characterizes a product's
nutrient content, such as ``low fat,'' or has geographical
significance, such as ``German Brand''), and that comply with those
regulations are also deemed to be approved by the Agency without being
submitted for evaluation and approval.
PART 424--PREPARATION AND PROCESSING PROCEDURES
20. The authority citation for part 424 continues to read as
follows:
[[Page 75825]]
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695;
7 CFR 2.18, 2.53.
19. In Sec. 424.21, revise footnote 3 in the table in paragraph
(c) to read as follows:
Sec. 424.21 Use of food ingredients and sources of radiation.
* * * * *
(c) * * *
\3\ Provided that its use is functional and suitable for the
product and it is permitted for use at the lowest level necessary to
accomplish the desired technical effect as determined in specific cases
prior to label approval under part 412.
* * * * *
22. In Sec. 424.22, revise paragraph (c)(4)(i) introductory text
to read as follows:
Sec. 424.22 Certain other permitted uses.
* * * * *
(c) * * *
(4) * * *
(i) The labels on packages of meat food and poultry products
irradiated in their entirety, in conformance with this section and with
21 CFR 179.26(a) and (b), must bear the logo shown at the end of this
paragraph. Unless the word ``Irradiated'' is part of the product name,
labels also must bear a statement such as ``Treated with radiation'' or
``Treated by irradiation.'' The logo must be placed in conjunction with
the required statement, if the statement is used. The statement is not
required to be more prominent than the declaration of ingredients
required under Sec. 317.2(c)(2).
Done in Washington, DC, on November 29, 2011.
Alfred V. Almanza
Administrator.
[FR Doc. 2011-30992 Filed 12-2-11; 8:45 am]
BILLING CODE 3410-DM-P