[Federal Register Volume 61, Number 243 (Tuesday, December 17, 1996)]
[Rules and Regulations]
[Pages 66198-66201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31971]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. 94-022F-2]
RIN 0583-AC24


Use of the Term ``Fresh'' on the Labeling of Raw Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
poultry product inspection regulations to prohibit the use of the term 
``fresh'' on the labeling of raw poultry products whose internal 
temperature has ever been below 26 deg.F. Raw poultry products whose 
internal temperature has ever been below 26 deg.F, but is above 
0 deg.F, are not required to bear any specific, descriptive labeling 
terms, including ``hard chilled'' or ``previously hard chilled.'' These 
products may contain optional, descriptive labeling, provided the 
optional, descriptive labeling does not cause the raw poultry products 
to be misbranded. Products whose internal temperature has ever been at 
or below 0 deg.F will continue to be labeled with the term ``frozen.'' 
The rule also establishes a temperature tolerance below the 26 deg.F 
standard for labeling product as ``fresh.''
    FSIS is taking this action in response to legislation enacted by 
the United States Congress directing FSIS to issue a revised final rule 
about the labeling of raw poultry products.

EFFECTIVE DATE: Effective upon December 17, 1996 9 CFR 381.129(b)(6) is 
stayed through December 16, 1997. The amendatory changes in this rule 
will be effective December 17, 1997.

FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, 
Facilities, Equipment, Labeling & Compounds Review Division; (202) 418-
8900.

SUPPLEMENTARY INFORMATION:

Background

    On January 17, 1995, FSIS published a proposed rule in the Federal 
Register

[[Page 66199]]

(60 FR 3454) to amend the poultry products inspection regulations to 
prohibit the use of the term ``fresh'' on the labels of raw poultry 
products whose internal temperature has ever been below 26 deg.F. The 
proposal would have required that poultry products whose internal 
temperature had ever been below 26 deg.F, but above 0 deg.F, be labeled 
with the descriptive term ``previously frozen.'' Raw poultry products 
whose internal temperature had ever been at or below 0 deg.F would have 
had to be labeled with the descriptive term ``frozen'' or ``previously 
frozen,'' except when such labeling would have duplicated or conflicted 
with the products'' special handling instructions.
    FSIS sought comments on a variety of issues raised in the proposal, 
including alternative descriptive terms and the use of the term 
``fresh'' in brand names, company names, sensory modifiers, etc., on 
the labels of raw poultry products. FSIS received more than 26,000 
comments in response to the proposal. The comments expressed widely 
diverse opinions about a variety of issues, such as the meaning of the 
term ``fresh'' as applied to poultry, safety issues, including a 
temperature threshold, descriptive labeling and alternate terms, and 
the relabeling of product and relabeling options. FSIS modified the 
proposed rule in response to the comments and, on August 25, 1995, 
published a final rule in the Federal Register (60 FR 44396).
    As proposed, the final rule amended the poultry products inspection 
regulations to prohibit the use of the term ``fresh'' on raw poultry 
product labels if the internal temperature of the poultry product had 
ever been below 26 deg.F. However, rather than requiring that poultry 
products whose internal temperature has ever been below 26 deg.F, but 
above 0 deg.F, be labeled with the descriptive term ``previously 
frozen,'' the final rule required that those products be labeled with 
the descriptive term ``hard chilled'' or ``previously hard chilled.'' 
The final rule also added requirements for the handling and relabeling 
of misbranded raw poultry products. The final rule's intent was to 
require clear, descriptive labeling on raw poultry products so that 
consumers would know if raw poultry products have ever been held at 
temperatures where the flesh becomes hard-to-the-touch, i.e., an 
internal temperature below 26 deg.F.
    The final rule was to become effective on August 26, 1996. However, 
on October 21, 1995, Congress passed the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Act, 1996, Public Law 104-37, 109 Stat. 299 (1995). 
Section 726 of that Act prevented FSIS's ``Use of the Term ``Fresh'' on 
the Labeling of Raw Poultry Products'' final rule from taking effect 
and prohibited FSIS from using any funds appropriated or otherwise made 
available by the Act to develop compliance guidelines, implement, or 
enforce the final rule.
    On August 8, 1996, the Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies Appropriations Act, 1997, 
Public Law 104-80, 110 Stat. 1569 (1996) (1996 Appropriations Act) was 
signed. Section 732(b) of this Act, entitled ``Labeling of Raw Poultry 
Products,'' instructed the Secretary of Agriculture to issue, within 90 
days, a revised final rule related to the labeling of raw poultry 
products which would replace certain, specified provisions of FSIS's 
original August 25, 1995, ``Use of the Term ``Fresh'' on the Labeling 
of Raw Poultry Products'' final rule with provisions stipulated by 
Congress.
    The law specifies that the revised final rule (1) maintain the 
requirement promulgated in FSIS's original final rule that the term 
``fresh'' may only be used to describe raw poultry products whose 
internal core temperature has never fallen below 26 deg. F and (2) 
delete the requirement in the original final rule that poultry products 
whose internal core temperature has ever been less than 26 deg. F, but 
more than 0 deg. F, be labeled ``hard chilled'' or ``previously hard 
chilled.'' The law also declares that poultry products whose internal 
core temperature has ever been between 0 deg. F and 26 deg. F may not 
be required to bear any specific alternative labeling. The law does not 
alter the requirement that poultry products whose internal core 
temperature has ever been at or below 0 deg. F be labeled ``frozen'' or 
``previously frozen.''
    To be in compliance with the law and this revised final rule, those 
raw poultry products that are labeled ``fresh'' but are found to have 
an internal temperature below 26 deg. F will have to be correctly 
relabeled by having the ``fresh'' designation deleted from the package. 
The ``fresh'' designation may be deleted from packages of raw poultry 
products by any method consistent with the poultry products inspection 
regulations, including the use of pressure-sensitive stickers. Under 9 
CFR 381.133(b)(9)(xxiv), the deletion of any claim, non-mandatory 
features, or non-mandatory information which was previously approved by 
FSIS is generically approved. FSIS Policy Memo 115, which currently 
requires the temporary approval of pressure sensitive stickers before 
they may be used to cover any information on an approved label, is 
being amended to permit the generic approval of pressure sensitive 
stickers. Official establishments will be permitted to cover labels of 
packages of raw poultry products incorrectly labeled ``fresh'' with 
pressure sensitive stickers. The stickers must be the type which 
destroy the underlying label or package if removed or be self-
destructive.
    The 1997 Appropriations Act establishes a temperature tolerance 
from the 26 deg. F labeling standard for ``fresh.'' A temperature 
tolerance of 1 deg. F is established for poultry products within an 
official processing establishment and 2 deg. F for poultry products in 
commerce. FSIS has interpreted the temperature tolerance to mean that 
the temperature of individual packages of raw poultry products labeled 
``fresh'' can vary as much as 1 deg. below 26 deg. F (i.e., 25 deg. F) 
while such product is within an official establishment or 2 deg. below 
26 deg. F (i.e., 24 deg. F) after such product leaves an official 
establishment. The law exempts ``wings, tenders, hearts, livers, 
gizzards, necks, and products that undergo special processing, such as 
sliced poultry products,'' from temperature testing.
    Further, the law requires FSIS to issue a compliance directive for 
the enforcement of the labeling standards established by the revised 
final rule. The law requires the compliance directive to include 
provisions for measuring temperature at the center of the deepest 
muscle being tested and a sampling plan designed to ``ensure that the 
average of individual temperatures within poultry product lots of each 
specific product type (such as whole birds, whole muscle leg products, 
and whole muscle breast products) meet the standards.''
    The compliance directive will include a sampling plan that ensures 
that the average temperature of poultry product lots of each specific 
product type (such as whole birds, whole muscle leg products, and whole 
muscle breast products) meet the 26 deg. F standard for ``fresh.'' The 
compliance directive will be used by FSIS to monitor establishment, 
processor, and retailer compliance with the labeling requirements in 
the revised final rule. Poultry products not in compliance with the 
requirements for ``fresh'' shall be handled and relabeled in accordance 
with the provisions of the August 25, 1995 final rule, as amended by 
this action. FSIS will publish the compliance directive no later than 
60 days after publication of this revised final rule, as directed by 
Congress.

[[Page 66200]]

Implementation Date

    Based on its review of the comments submitted in response to the 
proposed rule, FSIS recognized that some poultry processors might need 
to make operational changes so they could continue to supply ``fresh'' 
poultry under the provisions of the original final rule. FSIS therefore 
decided to allot processors and handlers sufficient time to make any of 
these operational changes, which might have included establishing new 
policies and procedures needed to market ``fresh'' poultry, formulating 
methods for compliance with the rule, and exhausting label inventories 
to the extent possible. Recognizing that product safety was not a 
concern, FSIS established an implementation date for the original final 
rule of 12 months from the date of its promulgation. As noted above, 
however, Congress prevented that rule from taking effect.
    The 1997 Appropriations Act states that ``the Secretary of 
Agriculture shall issue a revised final rule related to the labeling of 
raw poultry products that * * * in all other terms and conditions 
(including the period of time permitted for implementation) is 
substantively identical'' to the final rule promulgated by FSIS on 
August 25, 1995. The law also stipulates that the revised final rule 
cannot be effective during fiscal year 1997.
    Therefore, FSIS is establishing an implementation date for all 
provisions of this revised final rule, as well as the provisions of the 
August 25, 1995 final rule which are not being amended by this revised 
final rule, of 12 months from the date of promulgation. This is the 
same period of time provided for implementation in the original final 
rule and the corresponding effective date will not fall during fiscal 
year 1997.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. (1) All state and local laws and regulations that 
are inconsistent with this rule are preempted; (2) this rule has no 
retroactive effect; and (3) administrative proceedings will not be 
required before parties may file suit in court challenging this rule.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been determined to be significant and was reviewed by 
OMB under Executive Order 12866.
    In the preambles to the proposed (60 FR 3454) and final (60 FR 
44396) rules, FSIS examined possible sources of costs to consumers and 
the poultry industry if it adopted the proposed rule as a final rule. 
Except for the costs associated with relabeling raw poultry products 
that had originally been labeled ``fresh'' but must be relabeled to 
remove that designation (because the product's internal temperature has 
fallen below 26 deg.F), all other costs and the assumptions upon which 
they were based remain the same in this revised final rule as they were 
in the original final rule. FSIS believes that the relabeling costs to 
the poultry industry will either remain the same or decrease from those 
estimated in the original final rule.
    Under this revised final rule, those raw poultry products that are 
labeled ``fresh'' but are ever found to have had an internal 
temperature below 26 deg.F will have to be correctly relabeled by 
having the ``fresh'' designation deleted from the package. However, 
they will not have to be relabeled with any specific alternative 
descriptive term (unless their temperature should fall to or below 
0 deg.F, at which point they will have to be relabeled with the 
descriptive term ``frozen''). Raw poultry products with an internal 
temperature below 26 deg.F that were never labeled ``fresh'' will not 
have to be relabeled.
    FSIS believes that relabeling costs can be minimized considerably 
by the use of pressure sensitive stickers, rather than brand new labels 
containing optional, descriptive terms. The stickers may be used as 
needed and are generically approved. Stickers may also be used in those 
circumstances where label inventory stocks exceed a 1-year supply. This 
feature will be of interest to processors and retailers when relabeling 
of product becomes necessary, i.e., when the temperature of product 
labeled ``fresh'' falls below the permissible temperature tolerance. 
Though that product will no longer have to be relabeled ``hard 
chilled,'' the ``fresh'' label will have to be covered or removed from 
the package under this revised final rule.
    In the original final rule, FSIS stated that the new labeling 
strategy offers consumers a true purchasing option that accurately 
reflects their expressed expectations. FSIS believes that consumers 
will continue to benefit from improved consumer knowledge about poultry 
products under the provisions of this revised final rule. However, 
there may be some decrease in consumer benefits because the revised 
final rule will not require specific labeling on poultry products with 
temperatures between 0 deg.F and 26 deg.F.
    The Administrator has determined that this revised final rule will 
not have a significant economic impact on a substantial number of small 
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). 
The small entities that might be affected by this revised final rule 
would be small processors of raw poultry (small establishments 
operating single-inspector processing lines). However, the economic 
impact of the revised final rule on these poultry processors should be 
minimal because they currently ship poultry in ice pack or dry ice pack 
containers. The internal temperature of products refrigerated by these 
methods does not generally fall below 26 deg.F, and products handled in 
this manner which remain at or above 26 deg.F may be labeled as 
``fresh'' according to the regulations.

Paperwork Requirements

    This revised final rule specifies the regulations permitting the 
use of the term ``fresh'' on the labeling of raw poultry products. 
Paperwork requirements contained in this revised final rule have not 
changed significantly and are approved by the Office of Management and 
Budget under control number 0583-0102.

List of Subjects in 9 CFR Part 381

    Food Labeling, Poultry and poultry products.

    For the reasons set forth in the preamble, 9 CFR part 381 is 
amended as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    1. The authority citation for part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 
2.18, 2.53.

    2. Effective December 17, 1996 Sec. 381.129(b)(6) is stayed 
effective stayed through December 16, 1997.
    3. Effective December 17, 1997 Sec. 381.129 is amended by revising 
paragraphs (b)(6)(i) and (ii), and by redesignating (b)(6)(iii) as 
(b)(6)(iv) and adding a new paragraph (b)(6)(iii) to read as follows:


Sec. 381.129  False or misleading labeling or containers.

* * * * *
    (b) * * *
    (6) (i) Raw poultry product whose internal temperature has ever 
been below 26 deg.F may not bear a label declaration of ``fresh.'' Raw 
poultry product bearing a label declaration of ``fresh'' but whose 
internal temperature has never been below 26 deg.F is mislabeled. The 
``fresh'' designation may be deleted from such product in accordance 
with Sec. 381.133(b)(9)(xxiv).

[[Page 66201]]

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 
Sec. 381.66(f)(2) of this subchapter.
    (ii) Raw poultry product whose internal temperature has ever been 
at or below 0 deg.F must be labeled with the descriptive term 
``frozen,'' except when such labeling duplicates or conflicts with the 
labeling requirements in Sec. 381.125 of this subchapter. The word 
``previously'' may be placed next to the term ``frozen'' on an optional 
basis. The descriptive term must be prominently displayed on the 
principal display panel of the label. If additional labeling containing 
the descriptive term is affixed to the label, it must be prominently 
affixed to the label. The additional labeling must be so conspicuous 
(as compared with other words, statements, designs, or devices in the 
labeling) that it is likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use. Product 
described in this paragraph is subject to the freezing procedures 
required in Sec. 381.66(f)(2) of this subchapter.
    (iii) Raw poultry product whose internal temperature has ever been 
below 26 deg.F, but is above 0 deg.F, is not required to bear any 
specific descriptive term. Raw poultry product whose internal 
temperature has ever been below 26 deg.F, but is above 0 deg.F, may 
bear labeling with an optional, descriptive term, provided the 
optional, descriptive term does not cause the raw poultry product to 
become misbranded. If used, an optional, descriptive term must be 
prominently displayed on the principal display panel of the label. If 
additional labeling containing the optional, descriptive term is 
affixed to the label, it must be prominently affixed on the label. The 
additional labeling must be so conspicuous (as compared with other 
words, statements, designs, or devices in the labeling) that it is 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use.
    (iv) * * *
* * * * *
    4. Effective December 17, 1997 Sec. 381.133 is amended by revising 
paragraph (b)(9)(xxvi) and by adding a new paragraph (b)(9)(xxvii) to 
read as follows:


Sec. 381.133  Generically approved labeling.

* * * * *
    (b) * * *
    (9) * * *
    (xxvi) The use of the descriptive term ``fresh'' in accordance with 
Sec. 381.129(b)(6)(i) of this subchapter.
    (xxvii) The use of the descriptive term ``frozen'' as required by 
Sec. 381.129(b)(6)(ii) of this subchapter.

    Done at Washington, DC, on December 11, 1996.
Thomas J. Billy,
Administrator.
[FR Doc. 96-31971 Filed 12-16-96; 8:45 am]
BILLING CODE 3410-DM-P