[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
