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

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.

-----------------------------------------------------------------------

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