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

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the

Federal poultry products 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. This final rule

requires that raw poultry products whose internal temperature has ever

been below 26 deg. F, but above 0 deg. F, must be labeled with

the descriptive term ``hard chilled.'' The word ``previously'' may be

used with the term ``hard chilled'' on an optional basis. The rule also

provides for the relabeling of raw poultry products. This action will

help ensure that raw poultry products distributed to consumers are not

labeled in a false or misleading manner.

EFFECTIVE DATE: August 26, 1996.

FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product

Assessment Division, Regulatory Programs, Food Safety and Inspection

Service, U.S. Department of Agriculture, Washington, DC 20250, (202)

254-2565.

SUPPLEMENTARY INFORMATION:

Background

The current poultry products inspection regulations prescribe

freezing procedures for poultry products and the labeling of products

that are rapidly changed from a non-frozen state to a frozen state. The

regulations (9 CFR 381.66(f)(2)) state that ``ready-to-cook poultry

shall be frozen in a manner so as to bring the internal temperature of

the birds at the center of the package to 0 deg. F or below within 72

hours from the time of entering the freezer.'' Under the poultry

products labeling regulations (9 CFR 381.129(b)(3)), poultry that is

not quick-frozen according to certain permitted procedures may be

labeled ``frozen'' only if it has undergone prescribed 0 deg. F or

below freezing procedures.

On January 11, 1989, FSIS issued Policy Memo No. 022C that allowed

raw poultry to be labeled as ``fresh'' if its internal temperature is

above 0 deg. F and below 40 deg. F, and it has not been previously

frozen at or below 0 deg. F. The policy memorandum states that ``it is

not practical, under existing marketing strategies and distribution

patterns, to define `fresh' in terms of internal temperature beyond the

scope of current regulations, nor is it practical to define consumer

expectations for poultry products labeled as `fresh.' '' In

establishing this policy in 1989, FSIS concluded that the consumer is

the best judge of preference in chilling temperatures for raw poultry

products labeled as ``fresh,'' and that the marketplace is best suited

for making these distinctions.

The State of California enacted a law (Section 26661 of the

California Food and Agriculture Code) on September 27, 1993,

restricting the use of the term ``fresh'' on the labels of poultry

products. Section 26661 prohibited, among other things, poultry

wholesalers from labeling or otherwise marketing as ``fresh'' any

poultry product whose internal temperature ever has been equal to or

below 25 deg. F or that ever has been stored in the aggregate for 24

hours or more at an average ambient temperature of 25 deg. F or below,

regardless of the temperature of the product itself. That law was to

have taken effect January 1, 1994. However, three trade associations

filed suit in the U.S. District Court for the Eastern District of

California to prevent enforcement of the California statute, claiming

that it was preempted by the Poultry Products Inspection Act (PPIA)

(National Broiler Council, et al. v. Voss (E.D.Cal. Civil No. CV-S-93-

1882 DFL/JFM)). At the request of the Court, USDA filed a brief on

February 14, 1994, as amicus curiae, on the question of whether the

California law was preempted by Federal law. In its decision of April

8, 1994, a U.S. District Judge held that the PPIA preempts state

labeling requirements that are ``in addition to, or different than''

Federal requirements and declared that the labeling provision of the

California law was preempted by Federal law.1

\1\ The District Court's Memorandum of Decision and Order as

well as other documents and pleadings related to the lawsuit are

available for public inspection under Docket Number 94-022F at the

office of the FSIS Docket Clerk, Room 4352, South Building, Food

Safety and Inspection Service, U.S. Department of Agriculture,

Washington, DC 20250, from 8:30 a.m. to 1:00 p.m., and from 2:00

p.m. to 4:30 p.m., Monday through Friday.

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California appealed this decision to the U.S. Court of Appeals for

the Ninth Circuit, and USDA filed an amicus brief. On June 16, 1994,

the State of California amended its statute by removing the reference

to the ``ambient temperature'' of the poultry and prohibiting use of

the term ``fresh'' on the labeling of any poultry or poultry meat whose

internal temperature has been below 26 deg. F. On December 14, 1994,

the Court of Appeals for the Ninth Circuit upheld the District Court's

judgment that the labeling provision of the California statute was pre-

empted by the PPIA, but ruled that other portions of the amended

statute, such as those governing the advertising of ``fresh'' poultry,

could stand.2

\2\ The Ninth Circuit's ruling is also on file at the office of

the FSIS Docket Clerk.

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Reassessment of FSIS' Policy on ``Fresh''

Because of the issues raised by the California law, the Secretary

of Agriculture on February 10, 1994, directed FSIS to reexamine its

policy on the use of the term ``fresh'' on the labeling of raw poultry

products. The Secretary stated that this reexamination of policy was

necessary to ensure that the policy ``is reasonable and meets today's

consumer expectations.'' The Secretary directed FSIS to ``make sure

that any policy change does not open the door to problems like the

growth of bacteria that could cause foodborne illness.''

On June 16, 1994, two subcommittees of the U.S. House of

Representatives Committee on Government Operations held a joint hearing

on the issue of ``fresh'' labeling of poultry products. Representatives

from USDA, the poultry industry, and consumer groups presented their

views on the ``fresh'' labeling issue. Subsequently, on July 27, 1994,

Senator Barbara Boxer of California, together with Congressman Gary

Condit of California, introduced H.R. 4839, the Truth in Poultry

Labeling Act of 1994. This bill would have prohibited use of the term

``fresh'' on labeling of poultry that has ever been frozen below

26 deg. F.

In response to the Secretary's direction and the events described

above, FSIS initiated the following action. On August 26, 1994, it

published a notice in the Federal Register (59 FR 44089) announcing

three public hearings on the use of the term ``fresh'' on the labeling

of raw poultry products. The hearings were held during September 1994

in Modesto, CA, Atlanta, GA, and Washington, DC. The hearings focused

on issues relating to current industry practices and controls and

consumer expectations and perceptions regarding the term ``fresh'' on

the labeling of raw poultry products. Also in September 1994, FSIS

conducted an informal survey of callers

[[Page 44397]]

to the USDA Meat and Poultry Hotline to determine their attitudes,

perceptions, and expectations regarding poultry that is to be labeled

as ``fresh.'' FSIS also reviewed the scientific literature to determine

and resolve any scientific or technical time- and temperature-related

issues concerning the safety of poultry products during shipment and

storage. Transcripts of the public hearings and copies of information

submitted during the hearings, a copy of the informal survey entitled

``Consumer Views on Fresh Chicken--Results of a Hotline Survey,'' and a

copy of the literature review entitled ``Effects of Temperature on the

Microbiological Profile and Quality Characteristics of Raw Poultry''

were made available for review at the office of the FSIS Docket Clerk.

FSIS also requested USDA's Agricultural Research Service (ARS) to

conduct research studies on sensory, chemical, and microbial properties

of raw poultry products that have been exposed to and held at

temperatures from 0 deg. F to 40 deg. F for different storage periods.

The ARS report entitled ``Characteristics of Chilled Poultry,'' dated

December 20, 1994, was subsequently placed on file in the office of the

FSIS Docket Clerk. The ARS report found that there was no clear-cut

pattern of change in the sensory characteristics of cooked, deboned

chicken breasts over the temperature range tested (40 deg. F, 32 deg.

F, 26 deg. F, 10 deg. F, and 0 deg. F). Slight changes that were noted

were sample dependent, and it is unlikely that the average consumer

would detect the differences found by the highly trained taste panel.

All shear values were in a range that would be translated as

``tender.'' Near infrared reflectance spectroscopy (NIR) can be used

for the determination of temperature, drip loss, and to classify

storage temperature of deboned chicken breasts. However, classification

of the 26 deg. F storage temperature is not, at present, sufficiently

accurate to permit NIR to be used as a regulatory enforcement tool to

detect if a product was chilled to temperatures in the mid 20-

Fahrenheit range. ARS also reported that microorganisms were not killed

or significantly reduced by exposure to temperatures as low as 0 deg.

F; however, Salmonella and other enterobacteriaceae do not grow below

40 deg. F. Spoilage type bacteria can grow at temperatures as low as

26 deg. F but will not grow at 10 deg. F or 0 deg. F.

The Proposal

After reviewing the information provided at the public hearings,

the results of the Meat and Poultry Hotline survey, the literature

review, the U.S. District Court proceedings in California on ``fresh,''

and other information, FSIS issued in the Federal Register on January

17, 1995 (60 FR 3454), a proposed rule to amend the Federal poultry

products inspection regulations to establish the conditions that would

govern the use of the term ``fresh'' on the labeling of raw poultry

products and the language that would apprise consumers when such

products do not meet FSIS' proposed criteria for ``fresh.'' FSIS stated

that the current policy on the use of the term ``fresh'' on the

labeling of raw poultry products has considerable potential to mislead

consumers about the products they seek to buy as ``fresh,'' and that

the potential for economic deception is great when a product offered

for sale as ``fresh'' is not the product the consumer expects to

purchase. FSIS also stated that there should be no increased

microbiological safety risks associated with raw poultry that is

maintained at 40 deg. F or below.

FSIS proposed that raw poultry products whose internal temperature

has ever been below 26 deg. F, but above 0 deg. F, may not bear a label

declaration of ``fresh'' and must be labeled with the descriptive term

``previously frozen.'' The term ``previously frozen'' was chosen

because FSIS believed that this term would be the most readily

understood by consumers based upon comments from the public hearings.

FSIS also proposed that raw poultry products whose internal temperature

has ever been at or below 0 deg. F may not bear a label declaration of

``fresh'' and must be labeled with either the descriptive term

``frozen'' or ``previously frozen,'' except when such labeling

duplicates or conflicts with the products' special handling labeling

instructions, e.g., ``keep frozen'' or ``shipped/stored and handled

frozen for your protection,'' as required by 9 CFR 381.125. FSIS stated

that it would continue to permit use of terms such as ``fresh frozen''

and ``frozen fresh,'' as currently provided by 9 CFR 381.129(b)(3), to

describe products that are frozen rapidly to an internal temperature of

0 deg. F or below in accordance with the provisions of 9 CFR

381.66(f)(1).

FSIS also identified several additional issues regarding the use of

the term ``fresh'' on the labeling of raw poultry products and

solicited comments on whether these issues should also be addressed in

the final rule. While FSIS proposed the use of the descriptive term

``previously frozen,'' it invited comments on alternate descriptive

terms. FSIS indicated that it would consider alternate terms if

information submitted during the comment period demonstrated greater

consumer understanding and acceptability. In addition, FSIS discussed

the advantages and disadvantages, which it identified, of the terms

``previously frozen,'' ``previously held at ______ deg. F,'' ``thawed

for your convenience,'' ``freshly frozen,'' and ``previously freshly

frozen.'' FSIS invited comments regarding procedures for monitoring

compliance with the fresh labeling requirements. FSIS also sought

comments on its position that the term ``fresh'' can be used in brand

names, company names, sensory modifiers, etc., on the labeling of raw

poultry product in a manner that does not cause the purchaser to assume

the product itself is unprocessed and, consequently, not ``fresh.''

FSIS described its labeling policy expressed in Policy Memo No. 022C

that the term ``fresh'' may not be used on the labeling of any cured,

canned, hermetically sealed shelf stable, dried, or chemically

preserved poultry product and invited comments on whether it would be

useful and desirable to initiate rulemaking to establish regulatory

requirements for all uses of the term ``fresh'' on the labeling of

poultry products.

Extension of Comment Period; Solicitation of Comments

During the comment period on the proposed rule, FSIS received two

requests from trade associations to extend the comment period in order

to allow the public time to obtain and review the findings of the ARS

evaluation on chilled poultry. The ARS report was not available for

public review in the FSIS Docket Clerk's office at the time the

proposed rule was published. Previously, FSIS had stated its intention

to seek comment from the National Advisory Committee on Microbiological

Criteria for Foods on FSIS' conclusion stated in the preamble to the

proposed rule that ``there should be no increased microbiological

safety risks associated with the growth of pathogenic microorganisms''

by changing the labeling definition for ``fresh'' poultry. At that

time, the next meeting of the Committee was scheduled to begin April

17, 1995. FSIS also received a comment noting the conflict between the

proposed use of the term ``previously frozen'' and the existing

regulatory definition of ``frozen.'' In order to allow adequate time

for public comment on the ARS report, allow the National Advisory

Committee on Microbiological Criteria for Foods the opportunity to

comment on FSIS's conclusion that product safety is not an issue should

FSIS change the

[[Page 44398]]

definition of ``fresh'' from 0 deg. F to a value less than 28 deg. F,

and solicit public comments on options for reconciling dual use of the

term ``frozen,'' FSIS announced in the Federal Register on March 20,

1995 (60 FR 14668), that it was extending the comment period for an

additional 60 days until May 19, 1995.

In the notice of extension of comment period and solicitation of

comments, FSIS discussed three possible options to resolve the

inconsistency between the proposed use of the term ``previously

frozen'' and the preexisting regulatory definition of ``frozen.'' The

first option on which FSIS solicited comments involved using

descriptive terms that do not include the word ``frozen'' or the

unqualified word ``frozen,'' e.g., ``previously semi-frozen,'' ``held

semi-frozen,'' ``previously partially frozen,'' ``previously chilled to

a semi-solid state,'' ``shipped/stored/handled semi-frozen (insert

optional statement, e.g., to preserve quality),'' or ``previously

frosted.'' The second option was to eliminate the requirement that

poultry products labeled as ``frozen'' be brought to an internal

temperature of 0 deg. F or below and to require use of the term

``frozen'' to identify all poultry products whose internal temperature

has ever been below 26 deg. F. The third option described would use the

proposed term ``previously frozen'' on labeling of products with

internal temperatures between 0 deg. F and 26 deg. F and would create

an additional qualifier for products with an internal temperature of

0 deg. F or below, such as ``frozen for long-term preservation,'' in

order to differentiate between these two types of products.

Discussion of Comments

FSIS received 26,208 comments in response to the January 17, 1995

proposed rule and the March 20, 1995 solicitation of comments. The

comments were from a range of sources as follow: 25,530 from

individuals; 611 from poultry processors and growers; 23 from trade

associations; 12 from state government agencies; 6 from academia; 6

from consumer organizations; 5 from congressional members; 3 from

chefs; 2 from Federal government agencies; 2 from professional

associations; 2 from food consultants; 2 from food retailers; and 4

from other sources. Many of the individual commenters who identified

themselves as consumers also indicated that they were employed by the

poultry industry. Some of the comments included issues beyond the scope

of the proposed rule. For example, some commenters raised questions

about the difference in meaning of the term ``fresh'' as proposed for

poultry products and its meaning for red meat and fish products. In

addition, 7 other comments addressed only issues outside the proposal,

e.g., water uptake during the chilling process. Since these issues do

not come within the scope of the proposed regulation, they are not

addressed in this final rule. FSIS also received 3,990 letters in

support of the proposal, which carried typed signature blocks but were

unsigned. A summary of the comments submitted with respect to the

proposed rule and FSIS' response to the comments follows.

Use of the Term ``Fresh''

Numerous commenters agreed that the proposed rule is necessary to

provide consumers with information they need to make informed

purchasing decisions. Many commenters indicated that they often freeze

poultry at home for later use and that they want to avoid inadvertently

refreezing poultry that has been previously frozen and thawed out. Many

expressed surprise that the practice of marketing thawed poultry

existed and was allowed under Federal regulations. Some of these

commenters suggested that a twice-frozen, twice-thawed product might be

dry and tough, more likely to spoil, or be unsafe. Most supporting

commenters expressed the opinion that the issue is one of labeling a

product for what it is, that ``fresh'' is the opposite of ``frozen,''

and that, to consumers, ``frozen'' means a product was rock hard or

previously in that condition. While some of these commenters associated

the term ``fresh'' with other factors in addition to temperature

history, such as recent slaughter or age, freedom from bacteria, and

superior flavor, texture, and juiciness, they insisted that ``fresh''

and ``frozen'' are, nonetheless, mutually exclusive.

In contrast, a large number of commenters who opposed the proposed

rule contended that it is based on perceptions and that selection of a

temperature threshold level of 26 deg. F below which a product could

not be labeled as ``fresh'' was arbitrary and lacked a scientific

foundation. Large poultry processors stated that they had received no

or extremely few complaints from consumers that made any reference to

temperature as it relates to freshness of the product. They interpreted

the lack of complaints to mean that the ``fresh'' versus ``frozen''

issue is a very minor consumer concern. Others commenters suggested

that consumers have demonstrated their satisfaction with broiler meat

through an unparalleled increase in per capita consumption in the last

50 years. Opponents of the proposal further argued that consumers

demand a product that does not require thawing, but, instead, is ready-

to-cook, and that most consumers know that the colder the temperature,

the higher the quality of the product. With respect to concerns about

refreezing thawed poultry, one processor noted that, since this has

been the general practice for years, there are obviously no problems.

Many of the commenters who objected to the proposed rule suggested

that temperature alone is not a reasonable basis for labeling poultry

products as ``fresh'' because freshness diminishes with time, e.g., a

product kept at 26 deg. F and held for 3 months is not ``fresh.'' These

commenters argued that ``fresh'' means ``wholesome'' and that ``fresh''

is not the opposite of ``frozen'' because fresh poultry is

characterized by a variety of factors, including appearance, smell,

taste, texture, whether the product will spoil relatively quickly,

among others. Some opponents charged that FSIS attempted to define

``fresh'' by default, thereby creating a currently non-existent product

category, which FSIS proposed to call ``previously frozen,'' and which

was not requested by either consumers or industry. These commenters

expressed the opinion that consumer expectations do not include

changing current free enterprise markets by creating non-market-

demanded new product categories that affect both labeling and current

practices concerning handling statements.

Quality Issues

A number of the commenters, including chefs, who wrote in support

of the proposal, stated that frozen poultry can taste good but that

fresh poultry has a better taste and texture. Many consumers remarked

that they do not mind paying a premium price for a fresh product, which

they perceive to be of high quality; however, they do mind paying a

premium price for a product labeled as ``fresh'' that has been frozen

for shipment and then thawed for sale. Opponents of the proposal argued

that there is no clear and easily discernable quality difference

between products brought to different temperature levels. They pointed

to the conclusion of the ARS study where an expert taste panel found

``that there was no clear-cut pattern of change in the sensory

characteristics over the temperatures tested'' and that ``all shear

values were in the `tender' range.'' The temperatures tested ranged

from 0 deg. F to 40 deg. F and included refrozen product. These

opponents interpreted the ARS results to show that ``fresh'' cannot be

based on,

[[Page 44399]]

or solely defined by, a single temperature threshold. In contrast,

supporters of the proposal suggested that it would be premature to draw

conclusions about the ARS sensory results without further evaluation

and peer review of the findings.

Opponents of the proposal were very concerned that it would

jeopardize product wholesomeness. They stated that appropriate

temperature control is a good manufacturing practice designed to

maximize shelf life and minimize growth of microorganisms to ensure

consistent high quality and freshness to the consumer. The commenters

believed that the proposed rule would not provide for an improved

product, but would cause consumers to purchase a product of lesser

quality or to pay more for poultry without any change in product

quality.

Trade Issues

Numerous opponents, including congressional members, expressed the

opinion that the proposed rule would inhibit the interstate shipment of

poultry. Many stated that the ``fresh'' issue is not a consumer issue

but, rather, a marketing issue in which FSIS should not be involved.

They believed that the proposed rule would certainly mean higher prices

for local products through a forced reduction in competition and deny

free trade in those states enforcing the regulation. On the other hand,

supporting commenters believed that it is wrong for producers who

compete against truly fresh products to call frozen and thawed poultry

``fresh,'' and characterized such a merchandizing practice as

fraudulent. Several commenters asserted that national processors

shipping interstate would not be precluded from any markets, and, if

they wanted to sell fresh poultry, they could do so successfully. One

commenter noted that most of the perishable food consumed in the U.S.

is the subject of interstate commerce and that poultry is no more or

less perishable than many other items in the American market-basket.

Other opponents argued that the proposed rule was inequitable. For

example, a trade association contended that the Food and Drug

Administration (FDA) permits the term ``fresh'' to be used so long as

``the term does not suggest or imply that the product is unprocessed or

unpreserved,'' as described in the introductory paragraph to 21 CFR

101.95. They suggested that poultry products would be ``fresh'' under

FDA's definition because poultry products kept at temperatures below

26 deg. F (i.e., 23 deg. F or 24 deg. F) are not preserved because they

will spoil. Similarly, they questioned why poultry chilled below

26 deg. F could not be thawed and sold as ``fresh'' when fresh milk has

been pasteurized, fresh bread has been baked, and fresh crab has been

cooked and picked.

Many poultry producers and growers were concerned with the

potential effect of the proposal on the poultry industry. Some were

concerned that it could open the door to opportunism by creating an

adverse relationship between the manufacturer and the customer who

might claim a product to be ``frozen'' and expect a price adjustment of

the bill of lading. Others contended that the proposal could adversely

affect small companies or create loss of sales, shortages of product,

possible loss of jobs, and decrease the demand for poultry. A number of

opponents considered the task of monitoring the proposed rule

throughout distribution channels to be monumental. They stated that

enforcement would require the expenditure of substantial resources,

which is not justified because no food safety issue exists.

FSIS Response

The large volume of comments expressed widely diverse opinions

about the meaning of the term ``fresh'' as applied to poultry. FSIS

agrees that there can be numerous perceptions associated with the term

``fresh,'' including one of higher quality. However, the comments and

information gathered at the public hearings held last summer on the

``fresh'' issue show that neither consumers' expectations about fresh

products nor their willingness to pay more for such products is

affected by whatever quality differences may exist between poultry

products subjected to different temperatures.

FSIS has concluded that the ``fresh'' labeling issue is an

important consumer protection issue about false and misleading

labeling. FSIS has the authority to regulate the labeling of poultry

products based upon the statutory provisions concerning misbranding in

the PPIA (21 U.S.C. 453(h)(1)) in order to prevent the distribution of

misbranded products in commerce. Under these statutory provisions, an

article is misbranded if its labeling is false or misleading in any

particular. Because the ``fresh'' issue is a labeling issue, it is not

relevant to this rulemaking whether or not the ``fresh'' issue is also

a trade or marketing issue as many commenters suggested. Generally, the

commenters' concerns about loss of trade opportunities and markets

appear to be driven by factors that relate to how products will have to

be labeled under the regulations and how FSIS will enforce these

regulations. FSIS has addressed these concerns in the sections of this

document that pertain to descriptive labeling and compliance

procedures.

After evaluating all of the comments and other data in the

rulemaking record, FSIS has concluded that consumers equate the term

``fresh'' with a product that has never been chilled until it is hard-

to-the-touch. Rather than simply refrigerated, consumers consider such

a hard-to-the-touch product to be frozen. Based on the comments, FSIS

concludes that use of the term ``fresh'' on the labeling of products

that have been chilled to the point where they appear to consumers to

be frozen but are presented for sale in a thawed condition without

revealing the fact that they had been chilled to a hard-to-the-touch

state, is misleading. In addition, the available information suggests

that many consumers want to know the history of the poultry product

they buy, as related to temperature, so that they can handle the

product accordingly if they choose to do so, e.g., with respect to

refreezing. FSIS does not believe that ``frozen'' and ``fresh'' are

synonymous or that a product which has been chilled until it is hard-

to-the-touch is the same as a product which has not been so chilled. A

product that has been chilled until it is hard has been processed for

purposes of preservation regardless of whether or not all of the water

in the product is in a frozen state.

FSIS does not agree with the argument that it defined ``fresh'' by

default and created a new product category. The category of product

that has been chilled until the product is hard-to-the-touch but not

frozen to an internal temperature of 0 deg. F or below has been in

existence for many years, during which time it was often labeled as

``fresh,'' when, in fact, it was chilled for preservation. FSIS does

not consider fresh milk, fresh bread, or fresh crab to be analogous to

fresh poultry because the use of the term ``fresh'' in this context is

generally not misleading. On the other hand, the comments and other

information in the rulemaking record show that there is confusion among

consumers with respect to poultry labeling, and that consumers were not

aware that poultry products sold as ``fresh,'' and pliable at retail

display, may have once been hard and then thawed. Moreover, an

unprocessed, unpreserved form of poultry, which has never been chilled

to render the product hard-to-the-touch, is available in the

marketplace.

[[Page 44400]]

Safety Issues

In its proposed rule, FSIS explained that it does not believe that

imposing a temperature requirement for use of the term ``fresh'' on the

labeling of poultry products will increase microbiological safety risks

as long as the product is held at 40 deg. F or lower. The National

Advisory Committee on Microbiological Criteria for Foods was asked to

review and comment on this matter. The Committee discussed the issue

and concluded that: ``The available scientific data on the microbial

characteristics of poultry products and growth of bacterial foodborne

pathogens below 40 deg. F were considered in our evaluation. This

information leads us to conclude that changing the temperature that

defines labeling of poultry as `fresh' from 0 deg. F to a value less

than 28 deg. F should not cause any increased risks to public health.

This issue is related to labeling and quality rather than

microbiological safety.'' FSIS agrees with the determination of the

Committee on this issue.

Accordingly, for the reasons stated above, FSIS concludes that a

temperature-related requirement for use of the term ``fresh'' is

necessary to preclude misleading consumers about the nature of the

poultry products they purchase.

Temperature Threshold

The vast majority of the commenters writing in support of the

proposed rule agreed that the minimum temperature for fresh poultry

should be set at the proposed temperature of 26 deg. F. Some of these

commenters expressed the opinion that 26 deg. F is not an arbitrary

number but a temperature below which poultry is hard-to-the-touch and

appears frozen to the consumer. Other commenters stated that, since

most ice crystal formation occurs within a narrow temperature range

between 27 deg. F and 25 deg. F, it makes sense to use 26 deg. F as the

dividing line between ``fresh'' and ``frozen'' poultry. A few

commenters recommended 32 deg. F or 33 deg. F as the cutoff threshold

because 32 deg. F is the freezing point of water. One commenter

suggested that any product stored for prolonged periods at or below

32 deg. F will become hard-to-the-touch and, thus, in the customer's

view, would be a frozen product.

Many opponents of the proposed rule argued that there was no

scientific evidence that poultry products freeze at 26 deg. F. They

noted that the freezing of food is a process involving a change in the

product's moisture from a liquid to a solid state over a wide

temperature range, generally from 28 deg. F to -4 deg. F. Given this

range, they argued that the selection of a single temperature cannot be

justified. A few commenters requested additional research to determine

the freezing point of poultry. Some members of the turkey industry

argued that the proposal's analysis of the ``fresh'' versus ``frozen''

issue focused on chicken. They suggested that more research be

conducted before the proposal is applied to turkeys, which might

possibly freeze at a lower temperature. Some commenters suggested that

an attempt to define complex processes by an oversimplified and

arbitrary temperature is scientifically unsound and may actually have a

negative impact on the application of new technologies, improvement of

product quality, and purchasing options for consumers.

Need for a Lower Temperature

Numerous commenters from industry called for a lower and more

reasonable temperature than 26 deg. F as the definition for ``fresh''

because colder temperatures provide for a higher quality, better

tasting, and safer product. Congressional members also noted that there

are other temperatures below 26 deg. F that preserve the ``fresh''

characteristics consumers seek while giving poultry products the longer

shelf life necessary for transportation over long distances. Many

poultry processors indicated that the proposed limit would force them

to process and ship their products at higher temperatures in order to

ensure that product labeled as ``fresh'' does not fall below 26 deg. F

in order to avoid costly relabeling procedures. They believed that a

practice of using higher temperatures would shorten shelf life,

increase incidence of spoilage, and adversely affect product quality

and/or safety. Industry also expressed the belief that temperatures

colder than 26 deg. F provide a safety margin in the distribution

chain. In addition, commenters argued that a temperature of 26 deg. F

would create extensive operational problems in order to control

temperatures, e.g., ensuring that small packages do not go below

26 deg. F while ensuring that large packages receive adequate

protection, or achieving a consistent 26 deg. F temperature in very

thick products like turkey carcasses.

With respect to lower temperatures, a number of commenters stated

that existing research shows that growth of psychrophilic bacteria

normally associated with product spoilage begins to approach a state of

inactivity at a temperature close to 14 deg. F or 15 deg. F. They

argued that a temperature of 14 deg. F or 15 deg. F would recognize

that at least part of the distinction between ``fresh'' and ``frozen''

is the difference between continuous bacterial degradation of the

product and product in which it has been halted. On the other hand,

some supporters of the proposal challenged this suggestion that the

point at which spoilage bacteria cease to grow be considered as the

dividing line between ``fresh'' and ``frozen'' because spoilage

bacteria do not cause foodborne illness.

Industry commenters stated that there is no indication that any

consumer defined ``fresh'' as being tied to 26 deg. F, and that they

would support 20 deg. F as a practical temperature that would not

disrupt commercial practices, which have proven themselves over 25

years of use. One commenter urged FSIS to determine whether there

exists any distinguishable palpability or quality differential between

poultry chilled at 20 deg. F and that chilled at 26 deg. F, and, if

not, requested FSIS to change its temperature standard to 20 deg. F so

as to impose the least burden on the regulated community. Other

commenters contended that ``fresh'' could easily be product that is

22 deg. F or above, as well as the proposed level of 26 deg. F,

considering that FSIS terminology for ``frozen'' is 0 deg. F. Yet

others supported a temperature of 23 deg. F, which has been considered

by some researchers to be the freezing point of poultry. Commenters

also noted that it has been shown that keeping product as low as even

24 deg. F will reduce bacterial growth, thus enhancing the quality of

the product. In addition, a few commenters asked whether the upper end

temperature limitation of 40 deg. F would be voided should the proposed

regulation replace Policy Memo No. 022C.

FSIS Response

FSIS believes there is adequate information on which to limit the

use of the term ``fresh'' on the labeling of raw poultry products to

product whose internal temperature has never been below 26 deg. F. The

effect of various temperatures on the physical and shelf life

properties of poultry has been studied extensively since the 1920's.

Many reference books on the preservation of foods by freezing and

engineering textbooks, such as the 1994 ASHRAE Handbook on

Refrigeration, I-P Edition, Chapter 12, Poultry Products, published by

the American Society of Heating, Refrigerating, and Air-Conditioning

Engineers, Inc., Atlanta, GA, state that 27 deg. F is the highest

temperature at which poultry

[[Page 44401]]

begins to freeze.3 At 27 deg. F, ice crystals begin to form in

poultry flesh. Below 26 deg. F, poultry products become hard-to-the-

touch because much of the free water is changing to ice. At 25 deg. F,

the literature suggests that approximately half of the water in the

poultry is frozen. By 23 deg. F, approximately 80 to 85 percent of the

free water in the product is frozen, and the product appears to be

frozen solid. FSIS notes that one commenter stated that it is very

difficult to insert a temperature probe by hand into a product at

22 deg. F.

\3\ A copy of Chapter 12 from the 1994 ASHRAE Handbook is

available for public inspection in the FSIS Docket Clerk's office.

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

Pliability of Product

At 26 deg. F, the product is still pliable in that it yields to the

thumb. This characteristic is described by various commenters on the

proposed rule and participants at the public hearings and last year's

court proceedings. A temperature of 26 deg. F as the threshold for

product to be labeled as ``fresh'' is also supported by the National

Institute of Standards and Technology (NIST). NIST's Handbook 133,

``Checking the Contents of Packaged Goods,'' Supplement 3, October

1992, states in part: ``Fresh Poultry.--For net weight determinations

only, fresh poultry is defined as poultry above 26 deg. F. This is

product that yields or gives when pushed with a person's thumb.''

4 While NIST defines fresh poultry for the purpose of net weight

determinations only, FSIS believes that it is pertinent to this issue

that another Federal agency recognizes that poultry is pliable down to

a temperature of 26 deg. F. FSIS does not believe that consumers would

consider a product to be frozen or in some other state as opposed to

``fresh'' when it is pliable, i.e., when it is not hard-to-the-touch.

The recognition by NIST that poultry is pliable down to 26 deg. F lends

further support to the selection of 26 deg. F as the temperature

threshold for an FSIS labeling definition for ``fresh'' poultry

products.

\4\ A copy of the page from the NIST Handbook 133 containing

this entry is available for public viewing in the FSIS Docket

Clerk's office.

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

Based on the scientific evidence that most of the free water in raw

poultry products freezes over a 4-degree temperature range between

27 deg. F and 23 deg. F, FSIS believes that the selection of 26 deg. F

as the lower limit for a product to be called ``fresh'' is reasonable.

The selection of 26 deg. F is also supported by the comments and other

information and documents in the rulemaking record, as discussed above.

A product that has not been held below 26 deg. F should meet consumer

expectations that ``fresh'' products have not been chilled until they

are hard. Accordingly, FSIS is adopting 26 deg. F as the temperature at

or above which a poultry product must have been continually held in

order to be labeled as ``fresh.'' FSIS does not believe that it is

necessary to incorporate an upper limit of 40 deg. F into the labeling

provision because the 40 deg. F internal temperature pertains to

chilling and holding requirements as described in 9 CFR 318.66 (b),

(c), and (d).

Product Coverage

With respect to comments that turkey should not be covered by this

final rule because it might have a different freezing point than

chicken, FSIS disagrees that turkey should be exempted while more

research is conducted to determine its freezing point. There is an

abundance of information on the freezing of turkey products--from

reference books on the freezing preservation of foods and engineering

textbooks, including the 1994 ASHRAE Handbook on Refrigeration--which

shows that turkey freezes over the same temperature range as chicken.

In addition, references to scientific studies on the freezing of turkey

are cited in FSIS' literature review entitled ``Effects of Temperature

on the Microbiological Profile and Quality Characteristics of Raw

Poultry,'' which was discussed in its proposed rule, and in the paper

entitled ``Superchilling of Poultry Meat'' by W. J. Stadelman.5

\5\ These documents are available for public inspection in the

office of the FSIS Docket Clerk.

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

In FSIS' view, the various studies do not show significant

differences between turkey and chicken with respect to the effects of

freezing on the products. FSIS notes that the ASHRAE Handbook on

Refrigeration refers to 27 deg. F as the point at which poultry

starts to freeze. This temperature is not restricted to chicken but,

rather, refers to all poultry, including turkey. Moreover, FSIS has not

been presented with any evidence from the public hearings, the U.S.

District Court proceedings, or comments on its proposed rule that

suggests the effect of various temperatures on the physical and shelf

life properties of turkey differs from chicken to an extent sufficient

to warrant a temperature threshold other than 26 deg. F as an

appropriate threshold for the labeling of ``fresh'' turkey. With

respect to pliability, FSIS notes that the NIST Handbook 133 refers to

``fresh poultry,'' rather than specifically to ``fresh chicken,'' when

defining poultry products for the purpose of net weight determinations

as those that are pliable down to 26 deg. F. Therefore, for these

reasons, FSIS will not exempt turkey from the requirements of this

final rule.

Descriptive Labeling

Those commenters who favored regulating use of the term ``fresh''

on the labeling of poultry products generally supported requiring use

of a descriptive term on the labeling of products whose internal

temperature has ever been below the 26 deg. F minimum temperature

defining ``fresh.'' These commenters also contended that if the

labeling says nothing, many consumers will likely assume product in a

retail case is ``fresh,'' i.e., has never been frozen, because it is

soft-to-the-touch. They argued that consumers should not be subjected

to either the affirmative, deceptive verbal representation that a

product is ``fresh'' when it has been frozen or the deception implied

by the unfrozen condition of a product presented for retail sale that

it is ``fresh'' when, in fact, it has been frozen and thawed.

In contrast, many poultry processors and trade associations

asserted that industry should not be required to use any descriptive

term for product that is not declared to be either ``fresh'' or

``frozen.'' These commenters believed that a regulation governing the

use of the term ``fresh'' should be handled in the same manner as other

affirmative marketing claims such as nutrient content claims.

Specifically, they suggested that FSIS should establish the criteria

for the use of the term and allow all manufacturers the option to make

the claim or not as they see fit. At the minimum, the commenters stated

that descriptive labeling for product between 0 deg. F and 26 deg. F

should be optional.

The Term ``Previously Frozen''

A large majority of commenters who supported use of descriptive

labeling to describe the nature of the product favored the term

``previously frozen,'' which FSIS proposed to require. They expressed

the opinion that the simple phrase ``previously frozen'' was adequate

because, in general, consumers only want to distinguish between fresh

and thawed poultry. A trade association submitted results of a national

telephone survey of consumers, conducted in November 1994, which

consisted of a minimum of 1,000 interviews. Results showed that 87

percent of those interviewed said they want a properly descriptive

label on poultry that was frozen and then thawed. When the respondents

who wanted a descriptive label were asked to rate seven terms on the

basis of accuracy to describe such product, the

[[Page 44402]]

percentages of those surveyed rating the terms as ``most accurate''

were as follows: 49.7 percent for ``do not refreeze''; 48.4 percent for

``previously frozen''; 35.5 percent for ``previously frozen for your

convenience''; 26.9 percent for ``thawed''; 21.6 percent for

``previously thawed for your convenience''; 18.3 percent for ``fresh'';

and 10.2 percent for ``chill-pack.'' The commenter interpreted these

results as showing that ``previously frozen'' was a preferred choice

for a descriptive label.

Without exception, opponents of the proposed rule voiced strong

objection to use of the proposed term ``previously frozen'' on the

labeling of poultry products brought to temperatures between 0 deg. F

and 26 deg. F. They stated that products that have experienced

temperatures below 26 deg. F cannot be characterized accurately as

``previously frozen.'' These commenters noted that the proposal was

internally inconsistent because it would require products to be

identified as ``previously frozen'' when they could never be labeled

legally as ``frozen'' based on FSIS' regulations (9 CFR 381.66(f)(2)),

which provide that poultry may only be labeled as ``frozen'' if it

reaches a temperature of 0 deg. F or below. They argued that, because

the shelf life of raw poultry products held below 26 deg. F is not the

same as for those held at 0 deg. F or below, the labeling would be very

misleading and confusing to the consuming public who have an

expectation that frozen product should not spoil and has a long shelf

life. These commenters also argued that requiring use of the term

``previously frozen'' would be confusing to facets of the industry

because they would handle product labeled as ``previously frozen'' in

the same manner as they would handle fresh frozen or frozen product,

thereby resulting in increased product mishandling.

Additionally, numerous opponents of the term ``previously frozen''

considered it to be a negative or punitive description that connotates

undesirable handling and implies that the products are inferior,

although they consider the products to be superior from a shelf life

and microbiology standpoint. They expressed concern that the proposed

labeling would make it harder to market poultry because consumers would

not want to buy a previously frozen product. These commenters contended

that the proposal establishes a double standard which could cause

consumers to discriminate against certain products. For example, the

proposal would require that product reaching temperatures below 26 deg.

F be labeled as ``previously frozen,'' while products that are frozen

rapidly (within 48 hours after initial chilling) may be labeled as

``fresh frozen'' or ``frozen fresh,'' in accordance with 9 CFR

381.66(f)(1). In their opinion, use of ``previously frozen'' on

labeling suggests the product is not ``fresh'' when, in all likelihood,

it could be fresher than a fresh frozen product.

Some supporters of the term ``previously frozen'' did not agree

that the term might be confusing. They stated that the designation of

``frozen'' for poultry below 0 deg. F is not in conflict with the

designation of ``previously frozen'' for product in the temperature

range between 0 deg. F and 26 deg. F because the latter is a labeling

designation that accurately reflects consumers' perceptions that hard-

to-the-touch poultry is frozen poultry. They noted that the freezing

regulations describe a process for handling poultry products that

allows them to remain in good condition for an extended period of time.

They suggested that labeling thawed poultry as ``previously frozen''

would not impede or contradict that important processing requirement,

but would alert consumers that the poultry they are buying was once in

a short-term frozen state and should not be refrozen at home.

Because the regulatory definition of ``frozen'' describes a

condition of the product which makes it suitable for long-term storage

and subsequent use and/or for consumer education purposes, some

commenters who favored use of the term ``previously frozen'' suggested

that the term could be clarified in the regulations to alleviate any

possible confusion. For example, one commenter suggested that the term

``previously frozen'' be defined as ``defrosted or thawed raw poultry

products which have been chilled (internal temperature has ever been

below 26 deg. F) or frozen (internal temperature of 0 deg. F or

below).'' Similarly, another commenter suggested that terms could be

numerically defined in the regulations such as ``frozen (0 deg. F or

below)''; ``previously frozen (1 deg. F to 25 deg. F)''; and ``fresh

(26 deg. F to 40 deg. F).''

Alternate Terms

FSIS reviewed numerous comments on the four possible alternate

terms discussed in the proposed rule, i.e., ``previously held at

______ deg. F,'' ``thawed for your convenience,'' ``freshly frozen,''

and ``previously freshly frozen.'' FSIS also received numerous comments

on the use of a phrase which either does not include the word

``frozen'' or does not include the unqualified word ``frozen,'' as

discussed in the notice soliciting comments to reconcile dual use of

the word ``frozen.'' Some commenters stated that all the terms convey

basically the same information and clearly alert the consumer that the

product has not been kept at fresh temperatures. These commenters

argued that individual processors should be permitted to select from a

group of terms that accurately depict the product in order to

accommodate different marketing approaches. A number of commenters who

supported descriptive labeling recognized the difficulty of identifying

the best terminology.

A few supporters disliked the phrase ``previously held at

______ deg. F'' on the basis that it might not give consumers the

information they need because many might not know that poultry freezes

below 26 deg. F. A commenter also stated that this particular phrase,

if used, should specify a time period in days or weeks, i.e.,

``previously held at ______ deg. F for less than (insert time

period).''

Some supporters of descriptive labeling opposed the term ``thawed

for your convenience'' on the basis that the product is frozen for the

convenience of the producer and/or retailer rather than the consumer,

or that it is an unnecessarily confusing way of saying ``previously

frozen.'' Similarly, some commenters opposed use of the phrase

``previously frozen for your protection'' on the basis that freezing

does not make the product safer but, rather, extends its shelf life.

Other commenters preferred the phrase ``previously frozen and thawed

for your convenience,'' while yet others preferred the simple word

``thawed.'' To avoid confusion over dual use of the word ``frozen,'' a

consumer organization also suggested ``thawed,'' but was concerned that

some consumers might not understand that the product had been held in a

frozen state.

Concerning terms using the word ``freshly,'' some supporters

contended that ``freshly frozen'' implies that the poultry is still in

the frozen state, which would not likely be the case, and that it might

be confused with the term ``fresh frozen,'' which is used for certain

poultry frozen to 0 deg. F or below. Others expressed opposition to any

language that permits manufacturers to market a product as ``freshly

frozen'' or ``previously freshly frozen'' on the basis that ``fresh''

and ``frozen'' are diametrically opposed terms. Some commenters

considered the phrase ``previously freshly frozen'' to be little

different than ``previously frozen,'' except that it adds an

unnecessary word. Generally, commenters indicated that terms that

avoided the word ``frozen,'' e.g., ``previously chilled to a semi-solid

state,'' or that avoided the unqualified word ``frozen,'' e.g.,

``previously semi-frozen,'' were

[[Page 44403]]

awkward and would be disregarded by consumers.

Industry commenters and trade associations who objected to the term

``previously frozen'' also objected to the alternative terms discussed

in the proposed rule and the notice. They stated that all the

alternatives, like ``previously frozen,'' are based on the dichotomy

that if a product is not fresh, it must be frozen. The commenters

argued further that requiring wholesome product to be labeled with

terms such as ``previously partially frozen'' and ``previously chilled

to a semi-solid state,'' which FSIS acknowledged will be viewed

negatively by consumers, is unprecedented and wholly unnecessary. They

alleged that such terms are awkward, unclear, impractical or

inaccurate.

In its notice seeking further comments to reconcile the existing

definition of ``frozen'' and the proposed use of the term ``previously

frozen'' (60 FR 14668), FSIS discussed an option to eliminate the

current requirement that poultry products labeled as ``frozen'' must be

brought to an internal temperature of 0 deg. F or below and to require

use of the term ``frozen'' to identify all products whose internal

temperature has ever been below 26 deg. F. This option found no support

among commenters whether or not they supported or opposed the intent of

the proposal. Commenters stated that, not only would the option require

more work for the industry and local governments, it would simply shift

the confusion from ``fresh'' to those who understand and rely on the

meaning of ``frozen.'' Some noted that the temperature range from above

0 deg. F to 26 deg. F is not ideal for freezing poultry for storage and

suggested that time limits should be set on this type of storage.

In the same notice, FSIS also discussed an option to create an

additional qualifier for products frozen to 0 deg. F or below,

specifically, ``frozen for long-term preservation,'' to distinguish

them from chill pack products whose temperatures are often between

20 deg. F and 26 deg. F. This option also found virtually no support

among any of the commenters. They stated that the phrases ``frozen for

long-term preservation'' or, similarly, ``frozen for long-term

storage'' imply a difference between the current labeling for

``frozen'' and proposed labeling for ``long term'' when there is no

difference. Others saw no need for ``frozen for long-term . . .'' and

did not understand what additional benefit to the consumer this term

could provide compared to the current labeling requirement of ``keep

frozen.'' As with the preceding options, the commenters contended that

requiring such terms only serves to create confusion for existing

products and implies the existence of a new product when there has been

no change in product quality and safety.

Other Suggested Terms

Some supporting commenters offered other terms to reconcile the

definitions of ``frozen'' and the proposed term ``previously frozen.''

Those who found ``previously frozen'' to be confusing suggested that

``defrosted for your convenience'' and ``defrosted'' would be

acceptable because, like ``thawed for your convenience'' and

``thawed,'' they have been used on seafood and accepted by grocery

store customers. A trade association suggested that use of the term

``fresh, previously frozen'' would sufficiently harmonize the labeling

of the products. Poultry processors and other trade associations

believed that manufacturers should be able to use any number of

optional, meaningful terms such as ``chilled,'' ``very chilled,''

``iced,'' or ``frosted,'' which, they suggested, meet the physical

characteristics of poultry in the semi-frozen state that the consumer

could understand. A number of these commenters suggested ``deep

chilled'' or a similar term to suggest to the consumer more than

adequate chilling analogous to ``deep frozen'' as a method of freezing

that was more than adequate. Likewise, a number of these commenters

stated that ``hard chilled'' would be an appropriate designation

analogous to ``hard frozen.'' In support of such terminology, a poultry

farmer submitted a copy of descriptive terms from a 1937 publication,

Marketing Poultry Products, 3rd. ed., E. Benjamin and H. Pierce, John

Wiley & Sons, Inc., New York.6 The commenter suggested that what

we do today has already been done and the terms and accepted practices

now under discussion were standard in the past. The chilling

descriptions from the publication are: Fresh, dressed--poultry that is

cooled but has not been hard chilled or frozen; fresh, hard chilled--

fresh, dressed poultry that has been frozen only hard enough to allow

it to be carried in good condition to market; and frozen--poultry that

has been frozen solid.

\6\ A copy of the page from the publication containing the

descriptive terms is available for review in the office of the FSIS

Docket Clerk.

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

FSIS Response

After carefully considering the many comments on the proposed

requirement that poultry products whose temperature has ever been below

26 deg. F, but above 0 deg. F, be labeled with a descriptive term, FSIS

continues to believe that such a requirement is necessary to prevent

consumers from being misled about the nature of the products they

purchase. Without such labeling, there is no way for a consumer to know

that a product was at some time in a hard condition because once that

product has been thawed for presentation in the fresh retail case it

may be commingled with product that has never been below 26 deg. F,

which may or may not bear a designation of ``fresh.'' As stated

previously, FSIS believes that consumers do not equate poultry products

that have been chilled to the point where they are hard-to-the-touch

with fresh poultry products. Therefore, to present such chilled

products to consumers in a thawed state, without alerting them to the

fact that the product was at some time in a partly frozen state,

misleads those consumers into assuming that the product was always in

an unfrozen condition and is a fresh product.

However, after thorough consideration of the volume of comments

that expressed concerns with the negative aspects of the proposed term

``previously frozen'' and concerns about confusing consumers into

assuming that chill pack products are identical to deep frozen

products, i.e., products frozen to internal temperatures of 0 deg. F or

below, with which they are long familiar, as well as other information

in the rulemaking record, FSIS has decided not to use the proposed

descriptive term ``previously frozen.'' FSIS has been persuaded that

the proposed term ``previously frozen'' is not the most appropriate

term to convey the accurate message about the chill pack products to

consumers considering the different qualities that partially and

completely frozen products possess across the freezing range. FSIS

recognizes that consumers might confuse chill pack products with deep

frozen products, i.e., those whose internal temperature has been

brought to 0 deg. F or below, and vice versa, under the proposed

labeling scheme. Instead, FSIS will require that poultry product whose

internal temperature has ever been below 26 deg. F, but above 0 deg. F,

be labeled with the descriptive term ``hard chilled.''

Based on information provided in the comments on the proposed rule,

the public hearings, the U.S. District Court proceedings, and other

information in the rulemaking record, FSIS has concluded that there are

differences in poultry products at different internal temperatures. The

chill pack products that are brought to the lower 20-degree Fahrenheit

range will spoil in a matter

[[Page 44404]]

of weeks. A product chilled to 14 deg. F to 15 deg. F, where most of

the free water is in a frozen state and where bacterial growth has

stopped, will develop off-flavors due to chemical oxidation after

several months. A product frozen to 0 deg. F or below, where almost all

of the free water is in a frozen state, has an expected shelf life of a

year or more depending on packaging and storage temperature. Thus,

while products with internal temperatures in the lower 20-degree

Fahrenheit range and those at about 15 deg. F and at 0 deg. F or below

have the same hard physical appearance, they do not have the same

attributes in terms of stability for preservation. According to the

available information, some poultry processors bring certain products

to internal temperatures in the range of 15 deg. F to 20 deg. F, but

most do not take product below 20 deg. F due to the cost of

refrigeration, unless they take the product to 0 deg. F or below for

long-term preservation.

The objective of the labeling requirements adopted in this final

rule is to apprise consumers whether certain poultry products may have

been partly frozen to a hard-to-the-touch state at some time. FSIS

believes that such descriptive labeling should not conflict with the

long-established regulatory definition for ``frozen,'' nor should it

disparage the high quality, wholesome products that consumers have been

purchasing for many years. Having clearly stated the objective of the

descriptive labeling and qualifying conditions, FSIS could choose not

to require use of any one specific term or terms on an industry-wide

basis. Rather, FSIS could require that individual processors select

terms or phrases that meet the objective of descriptive labeling.

However, the disadvantage of this approach is that not all potential

terms convey the message equally well. Use of multiple terms to

communicate an identical message could be a source of confusion for

consumers. FSIS believes that consumers would be better served by use

of a single term that promotes name recognition of the type of chilling

process to which the bulk of the products in question have been

subjected and their resulting physical condition.

Assessment of Terms

FSIS has reviewed and considered the comments regarding the various

descriptive terms to determine how well each conveys the fact that

products had at one time been brought to a very hard physical state.

FSIS believes that the terms containing the word ``frozen'' pose

potential conflicts with the regulatory definition of ``frozen'' and

may well imply that products are of a lesser quality or that they had

been in a frozen condition for some length of time, e.g., months, after

slaughter. In fact, poultry products are typically of high quality and

recently slaughtered, e.g., usually within one or two weeks, when

presented for sale. Similarly, phrases that use terms like ``semi-

frozen,'' ``semi-solid,'' and ``partially frozen'' may be awkward and

confusing to consumers and may also imply that the products have been

mishandled or are inferior. FSIS considers the terms ``chilled,''

``very chilled,'' ``chilled pack,'' ``iced,'' and ``frosted'' to convey

only ordinary refrigeration, packaging in ice above 26 deg. F, or an

ice crust on the surface. The phrase ``previously held at ______ deg.

F'' might convey a hard condition because most consumers know that

water freezes at 32 deg. F and would assume temperatures in the lower

20-degree Fahrenheit range are freezing temperatures for foods;

however, consumers might also assume the products are frozen solid. The

terms ``thawed'' and ``defrosted'' are also commonly understood words

that convey the message that products were frozen, but FSIS believes

that these terms also pose potential conflicts with the Agency's

existing definition of ``frozen.''

The Term ``Hard Chilled''

FSIS carefully considered the term ``deep chilled'' because it

might convey the notion of exceptional coldness extending to the

interior of the product or excessive coldness such as is suggested by

terms like ``deep frozen'' or ``deep freeze.'' In addition, according

to some commenters, the term ``deep chilled'' is one often used by

processors as a trade term to describe poultry that is processed by the

chill pack cooling system. FSIS believes that one of the central issues

in this rulemaking is selection of a descriptive term that will convey

that the subject products had at one time been brought to a very hard

physical state, which consumers equate with products that are frozen.

FSIS does not believe that the term ``deep chilled'' adequately conveys

such information. FSIS does believe, however, that the term ``hard

chilled'' is a reasonably precise and understandable term that conveys

accurate information about both the physical condition of a product and

the chilling process to which it has been subjected. Thus, FSIS has

concluded that the term ``hard chilled'' is superior to ``deep

chilled,'' and will achieve the objective of accurate, descriptive

labeling for use by consumers and industry. FSIS has also determined

that the term ``hard chilled'' will promote name recognition of the

type of chilling process to which the bulk of the products in question

have been subjected and their resulting physical condition.

While FSIS will not require qualification of the term ``hard

chilled'' with the word ``previously'' on the labeling of poultry

products whose internal temperature has ever been between 0 deg. F and

26 deg. F when that product reaches an internal temperature of 26 deg.

F or above prior to sale or during display for sale, this labeling

option will be permitted under this final rule. A commenter, who

identified himself as a meat cutter for a grocery chain, informed FSIS

that, in the commenter's particular situation, the retail walk-in box

is maintained typically at about 32 deg. F, while the retail fresh meat

case is maintained at about 35 deg. F. These approximate temperatures

for retail situations are substantiated by information provided by

other commenters and by participants at the public hearings. Because

the temperatures of the retail cases are above 27 deg. F, which, as

FSIS has previously discussed, is the point at which poultry begins to

freeze, FSIS has concluded that most poultry offered for sale in a

retail setting will be pliable to the touch.

FSIS does not believe that consumers would be confused by a product

labeled as ``hard chilled'' that is no longer hard-to-the-touch. The

term ``hard chilled'' simply conveys that the product has been

subjected to a cooling process that lowered its temperature below

26 deg. F and became hard-to-the-touch. The term ``hard chilled'' could

imply that poultry is still in a hard state, even though the product

may no longer be hard when it is offered for sale in a retail setting.

Because FSIS does not believe that consumers would be confused by a

product labeled as ``hard chilled'' that is no longer hard-to-the-

touch, this final rule does not make a regulatory distinction between

the terms ``hard chilled'' and ``previously hard chilled'' because both

terms describe the cooling process to which the product was subjected.

Therefore, FSIS is providing in this final rule that the word

``previously'' may be used on poultry labeling contiguous to the term

``hard chilled'' on an optional basis. This added flexibility allows

processors and retailers the option to select either ``hard chilled''

or ``previously hard chilled.''

Based on all the considerations set forth in the preceding

discussion, FSIS is revising its proposed provision at 9 CFR

381.129(b)(6)(i). FSIS is providing in this final rule that raw poultry

product whose internal temperature has

[[Page 44405]]

ever been below 26 deg. F, but above 0 deg. F, must be labeled with the

descriptive term ``hard chilled'' or in order to inform consumers and

other end users that the product was subjected to a chilling process

sufficient to render the product hard-to-the-touch. This final rule

also provides for use of the word ``previously'' with the term ``hard

chilled'' on an optional basis.

Products Frozen to 0 deg. F

FSIS does not believe that requiring descriptive labeling in the

form of ``hard chilled'' on poultry products whose temperature has ever

been below 26 deg. F, but above 0 deg. F, conflicts with the long-

established regulatory definition of ``frozen.'' Therefore, FSIS has

decided that it is not necessary to require an additional qualifier,

e.g., ``frozen for long-term preservation,'' for products frozen to

0 deg. F or below. FSIS also agrees with commenters that an additional

qualifier on products frozen to 0 deg. F might confuse consumers about

the existing products and lead them to believe they are in some way

different when, in fact, they are not. In addition, FSIS no longer

believes that it is necessary to require use of the term ``previously

frozen'' for the same reasons discussed above with respect to use of

the word ``previously'' in conjunction with the term ``hard chilled.''

However, FSIS will allow the use of the word ``previously'' with the

term ``frozen'' on an optional basis. Accordingly, FSIS is revising the

requirement in its proposal by adding a provision that the word

``previously'' may be used contiguous to the term ``frozen'' on an

optional basis, and is adopting the requirement that 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 special handling labeling

requirements in 9 CFR 381.125.

The requirement to identify that the product is or was ``frozen''

is not negated under any circumstance. Even if the product is frozen to

an internal temperature at or below 0 deg. F and thawed by the

processor before distribution, the fact that the product was frozen at

one time must be revealed by use of the descriptive term ``frozen'' or

by appropriate handling statements prescribed in 9 CFR 381.125. The

term ``frozen'' may always be qualified with appropriate statements,

e.g., ``frozen, thawed for your convenience,'' at the manufacturer's

discretion, when frozen product is destined to be thawed prior to sale

or during display for sale. However, the product may not be labeled

solely with a handling statement of ``keep refrigerated,'' which would

not suffice to reveal that the product was once frozen to a temperature

at or below 0 deg. F.

Optional Statements

With respect to optional statements used in conjunction with

descriptive labeling, FSIS will continue to allow the use of phrases

such as ``for your convenience'' or ``to preserve quality.''

Compliance Procedures

In the proposed rule, FSIS stated its belief that processors,

transporters, wholesalers, and retailers would establish appropriate

controls to ensure that their poultry products comply with FSIS'

proposed labeling requirements in designing and following good

manufacturing practices. Therefore, FSIS did not believe that it was

necessary to propose detailed procedures to be followed by the Agency

in monitoring compliance with the rule governing the use of the term

``fresh'' on raw poultry products. FSIS did, however, invite comments

regarding such procedures.

Many commenters sought clarification about the procedures for

measuring compliance with ``fresh'' labeling requirements. Others

requested that specific conditions be incorporated into FSIS compliance

instructions. A number of commenters from industry stated that

flexibility needs to be provided in enforcement because of the inherent

practical problems in maintaining product temperature adequate to

ensure its quality. These commenters cited situations where variations

in equipment, product, and other factors might cause products

unavoidably to fall below 26 deg. F, including the following: (a)

typical commercial and retail refrigeration units experience operating

variances of 2 deg. F and 4 deg. F, respectively; (b) refrigerated

trailers experience fluctuations from 3 deg. F to 10 deg. F from front-

to-back and/or top-to-bottom; (c) brief mechanical stops and product

spills in a blast chiller can result in product temperatures below

26 deg. F even if the blast is set correctly; (d) temperature variances

occur during chilling operations and storage between large and small

products due to density, e.g., breasts versus wings or whole birds

versus small trays; (e) physical position in a refrigeration unit

causes temperature variation, e.g., product closest to the air

circulation fans will be measurably colder than product in the middle

or on the far side of a pallet; and (f) variation in product

temperature occurs during storage due to insertion of product with

higher or lower temperature than ambient cooler temperature, relative

humidity, or the act of opening and closing a cooler or truck

compartment to gain access to product. Many commenters also contended

that typical thermometers are only accurate to 2 deg. F.

A trade association, which supported the proposal, countered the

arguments that there are difficulties in maintaining a steady

temperature in refrigerated trucks. The commenter expressed the opinion

that, if poultry is loaded into the cargo cooler at 26 deg. F, air

temperature inside the cooler would have to be kept much lower than

26 deg. F for a very long period of time for it to have an effect on

the internal temperature of the poultry itself. The commenter further

contended that it is not difficult to maintain a steady temperature in

a refrigerated truck because thermostats can control temperatures

within a range of 1.5 to 2 degrees.

Temperature Tolerances

Numerous commenters called for a temperature tolerance, noting that

FSIS has established tolerances in other areas such as net weight

determinations. They argued that a tolerance should reflect recognition

of the physical realities and limitations of product processing and

distribution and represent good manufacturing practices. Some poultry

processors suggested that they be permitted to target a 2 deg. F

window, i.e., a temperature range of 24 deg. F to 26 deg. F, as opposed

to a single temperature of 26 deg. F. Many suggested that product

temperature be regulated to allow a 3 deg. F variance on any given

check unless there is a consistent pattern of abuse. Other commenters

asserted that it would be reasonable to accept a cumulative effective

variance of 4 deg. F assuming the more salient variances to be

represented by commercial refrigeration units and temperature measuring

devices. Still other processors stated that, since neither food safety

nor product quality is at risk, a tolerance of 5 deg. F would be

practical in commercial operations as long as it can be proven that the

raw poultry did reach its optimum temperature for its state, e.g., a

fresh condition, before being shipped. In addition, a trade association

suggested that the regulatory option which FSIS discussed in the

preamble to its proposed rule be used as an alternative compliance

system, i.e., a two-step process control system in which temperatures

between 23 deg. F and 26 deg. F would be attributed to normal effective

variances in refrigeration units and temperature measuring devices;

temperatures between 20 deg. F and 23 deg. F would require process

control

[[Page 44406]]

adjustments; and temperatures below 20 deg. F would require product

relabeling. The commenters further suggested that the first step be set

at 22 deg. F in recognition of the 4 deg. F cumulative effective

variance mentioned previously.

Commenters supporting the proposed rule were divided as to whether

FSIS should modify compliance procedures to provide for a temperature

tolerance. Some of these commenters contended that FSIS should provide

for a minimal range of flexibility throughout processing, storage, and

transportation. On the other hand, some supporters of the proposal

argued against a rule providing for a tolerance because they saw this

as undercutting the proposed rule to establish the 26 deg. F

temperature as the most appropriate standard.

Testing and Sampling Procedures

Some commenters said that the proposal did not address the issue

regarding which location within a package or container, e.g., the

perimeter or center, a sample for testing would be drawn. Commenters

also wanted to know at what anatomical location of the product the

temperature would be measured. Several commenters stated that products

such as chicken wings, which are less dense than other products, should

be excluded from temperature measurements. Also, commenters requested

that sampling procedures should be more precisely defined to provide

for a representative sample. One trade association requested that the

intended sampling scheme be modified to monitor the warmest area of a

designated ``lot,'' rather than the overall lot average, because

products most at risk, i.e., those products furthest away from the

cooling elements of a refrigerated chamber, could be plus 4 deg. F

higher than the target temperature, i.e., over 30 deg. F.

A professional organization, which agreed that the proposed action

would meet consumer expectations, expressed concern about temperature

abuse in light of the prevalence of Salmonella in broilers and turkeys.

The commenter stated that the present practice of chilling poultry to

temperatures between 0 deg. F and 26 deg. F provides a greater margin

of safety, as compared to poultry transported and stored at

temperatures above 26 deg. F, because temperature abuse during storage

or transportation might raise the temperature of the poultry to

dangerous levels above 40 deg. F. The commenter suggested that, until

HACCP systems are implemented throughout the transportation, retail,

and food service industries, temperature sensing and indicating devices

should be used on poultry packaging that will alert retailers, food

service workers, and consumers if temperature abuse has occurred.

Concerns About Responsibility for Compliance

Generally, commenters opposed to the proposed rule objected to the

fact that the rule was too narrowly focused on the original processor

because the proposed requirements would apply to products in all stages

of commerce. Many processors expressed concern that products in

compliance at the time of processing could subsequently become

misbranded through no fault of their own. Some supporters of the

proposal, including congressional members, commented that the vast

majority of poultry processors do their own packaging, storing, and

shipping, and, therefore, would not lose a ``fresh'' designation

through no fault of their own. They contended that one company is

responsible for maintaining the temperature of the product at all

points. In contrast, a number of processors reported that they shipped

on non-company carriers. They stated that the processor, as the

producer of the product, assumes liability for that product, yet is

unable to ensure against potentially varying product conditions during

distribution and sale that would be deemed non-compliant under the

proposal. Other processors insisted that once the product is sold and

title passes it should be the responsibility of that party

(distributor, wholesaler, or retailer), and not the original processor,

to ensure proper temperature or, if the product's temperature moves out

of compliance, to relabel it. Some commenters suggested that, in order

not to disrupt marketing and distribution of products, whether a

product is in compliance should be determined at time of shipment.

Relabeling of Product

Trade associations and processors contended that poultry is

packaged such that it would be impossible to change labels on a

particular product that may inadvertently fall below the temperature

designated as ``fresh.'' They stated that, if products are chilled to a

temperature below 26 deg. F while in distribution and are deemed

``misbranded'' and unable to proceed in commerce until relabeled, the

distributors are not equipped to relabel product. They asserted that

under existing regulatory requirements, it would be unlawful to affix

new labels different from the labeling affixed at the inspected

establishment.

A number of commenters argued that there needs to be an opportunity

for relabeling of product at the retail level if a product accurately

labeled at the point of packaging has been abused during shipment,

storage, and handling after leaving the plant. Others expressed concern

that relabeling could result in food safety problems due to the

additional handling that would occur. One processor suggested use of a

tag on product originating as ``fresh'' which has a tear off that can

be removed if product falls below 26 deg. F. Some commenters noted that

wholesalers or retailers may freeze product labeled as ``fresh'' due to

excessive inventory and would need to repackage and relabel or apply

appropriate stickers to products with FSIS-approved labels. These

commenters encouraged FSIS not to require prior label approval of such

stickers.

FSIS Response

FSIS is confident that processors, transporters, wholesalers, and

retailers will be able to maintain the appropriate controls to ensure

that their poultry products comply with the requirements of this final

rule. FSIS does not intend, therefore, to adopt a temperature tolerance

below 26 deg. F, such as 24 deg. F, as was suggested by many

commenters. FSIS believes that such a tolerance would allow a

significant percentage of poultry products which had fallen below

26 deg. F, and thus rendered hard-to-the-touch, to nevertheless be

labeled as ``fresh,'' thereby misleading consumers.

FSIS acknowledges that there may be instances where poultry product

labeled as ``fresh'' may fall below the minimum temperature that

defines ``fresh'' despite the efforts of manufacturers, distributors,

retailers, and others to keep the product in a ``fresh'' condition.

FSIS, therefore, intends to design a practical compliance policy that

will maintain the integrity of the 26 deg. F standard while providing

the flexibility to deal with the problems that occur despite the

adoption of good manufacturing practices.

FSIS expects that the primary focus of its compliance efforts will

be on products labeled as ``fresh'' or bearing no descriptive term.

FSIS resources will be focused on ensuring that such products meet the

requirements of this regulation when they leave the FSIS-inspected

plant. The policy will also seek to avoid condemnation or relabeling of

entire lots of product if only a small number of units within the lot

have fallen below the standard. FSIS expects that its compliance policy

will take into account the good manufacturing practices that producers

[[Page 44407]]

have adopted to maintain compliance with the requirements of this rule.

FSIS intends to avoid the prescriptive command-and-control approach as

to how companies achieve the performance standards in this final rule.

FSIS shares the concerns of the many commenters about the need for

clarification of product testing and sampling procedures and about the

need for practical compliance procedures throughout processing,

storage, and distribution. To provide instructions to FSIS employees

and to assist producers in complying with this rule, FSIS intends to

issue an FSIS Directive explaining the compliance policy, including

product testing and sampling procedures, as soon as possible. Because

of the complexity of the testing and sampling issue, FSIS intends to

obtain further public input on this matter prior to issuing the

Directive so that its procedures will be both practical and reasonable

while ensuring the integrity of the standards contained in this final

rule. FSIS is also interested in obtaining input on other aspects of

the compliance policy, including the allocation of Agency and industry

resources.

Obviously, product in the possession of or under the control of an

official establishment remains the responsibility of the establishment.

Establishments must, therefore, take reasonable precautions to ensure

that their product is maintained in accord with these regulations, even

when it is in a transport vehicle or otherwise not physically at the

establishment. Generally, the establishment's responsibility for

compliance ends when ownership passes; compliance then becomes the

responsibility of the buyer. However, any person or firm who causes a

product to become misbranded can be held responsible for causing it to

become misbranded whether or not they owned the product at that time.

Moreover, any person or entity that produces product or handles

product in commerce is responsible for ensuring that products remain

properly labeled. If a producer, handler or commercial buyer determines

that products covered by these regulations and labeled as ``fresh,'' or

bearing no descriptive term, have been chilled to an internal

temperature below 26 deg. F, that person will be responsible for

ensuring that the product is brought into compliance. Such a producer,

handler, or buyer must report the fact to FSIS to ensure that remedial

action is taken.

If an Agency official discovers product which is not in compliance

with these regulations, the product will be retained or detained. The

product would be required to be relabeled or, if not relabeled, the

product would be condemned. The Agency would take such additional

compliance or enforcement measures as are warranted under the facts and

circumstances of each case.

Labeling procedures for product found to require relabeling before

it leaves the official establishment are covered under subpart N of the

poultry products inspection regulations. Also, existing regulations (9

CFR 381.140) specify procedures for the relabeling of products in

commerce found to require relabeling. Generally, such products are

relabeled under the supervision of an inspector and FSIS is reimbursed

for the cost of that supervision. However, under the ``fresh''

regulations, such an enforcement approach would place a demand on

scarce FSIS resources and cause delays in bringing product into

compliance. This area is one of considerable concern to many

commenters. FSIS anticipates that the circumstances requiring

relabeling to correct misbranding where the temperature of the product

labeled as ``fresh'' or bearing no descriptive term has dropped below

26 deg. F after leaving the official establishment will be relatively

infrequent. Therefore, this final rule will permit an alternative and

simple relabeling procedure.

Relabeling Options

The relabeling procedures established by this final rule provide

flexibility for relabeling inspected and passed product that was

heretofore unavailable under the poultry products inspection

regulations when product became misbranded after leaving a federally

inspected establishment. Owners of product will now have the option of

notifying the Area Office of the FSIS Compliance Program that the

product outside an establishment has become misbranded under this rule.

The Compliance Program will authorize the movement of the product to an

official establishment for relabeling or to a retail entity where it

can be relabeled without an inspector's supervision, or to another end

user. Relabeling may be accomplished by prominently applying stickers

disclosing that the product has been ``hard chilled'' or ``frozen'' to

the packages, provided any claim such as ``fresh'' is obliterated,

covered or removed. Removal could be accomplished by removal of a hang

tag or a tear off from such a tag as suggested by one commenter. At

retail, relabeling may also be accomplished by completely removing the

inspected establishments's label and applying the retail store's label.

The Compliance Program will monitor such product movement and

relabeling. The issue of who bears the cost of such relabeling is a

contractual matter between buyers and sellers of the product.

Accordingly, FSIS is adding a paragraph at 9 CFR 381.129(b)(6)(iii)

to incorporate procedures for the handling and relabeling of products

as described above. FSIS is also adding a provision at 9 CFR (b)(6) (i)

and (ii) to specify that, if additional labeling containing a

descriptive term required under paragraph (b)(6) (i) or (ii) of this

section, as appropriate, is used, it shall be prominently affixed

thereon with such conspicuousness (as compared with other words,

statements, designs or devices in the labeling) as to render it likely

to be read and understood by the ordinary person under customary

conditions of purchase and use. FSIS has concluded that it would not be

possible for such additional labeling to be placed in such fashion to

be read and understood by the ordinary person unless the false claim is

obliterated, covered or removed.

FSIS also agrees with the commenter who stated that appropriate

stickers for relabeling of product that has become misbranded should

not require prior label approval. Because these regulations prescribe

the exact language of descriptive labeling, this final rule provides

that the processor may apply the descriptive labeling, or that the

authorized retail entity or other end user may apply the descriptive

labeling to approved labels. Furthermore, this rule provides that the

descriptive labeling may be approved under the provisions for generic

label approval. Such action will minimize loss of product shelf life by

eliminating any delay involved in securing prior label approvals.

Accordingly, FSIS is adding a paragraph at 9 CFR 381.134 to this

effect.

Brand Names

While some commenters stated that FSIS should maintain its current

stance of non-restrictive use of the term ``fresh'' in trademarked

names, company names, fanciful names, logos, and sensory modifiers,

others contended that the proposed rule contained a loophole with

respect to such uses. They stated that companies should not be allowed

to incorporate the word ``fresh'' within a brand name, etc., on the

labeling of frozen poultry products because the term would be

inherently misleading. The commenters alleged that producers will

continue to use and may even change their brand names so as to

indirectly represent their products as ``fresh.'' They noted that FDA's

fresh labeling policy does not permit such

[[Page 44408]]

allowances for brand names, sensory modifiers, etc., and urged FSIS not

to create an inconsistency between the two agencies' labeling

regulations without some compelling reason. One commenter stated that

if use of the word ``fresh'' is permitted in brand names and sensory

modifiers, FSIS should require a specific disclaimer of equal size to

the effect that the product had been frozen below 26 deg. F.

FSIS does not agree that use of the word ``fresh'' as part of a

brand name, etc., or in sensory modifiers on the labeling of a raw

poultry product necessarily suggests or implies that the product has

not been processed or preserved. FSIS believes that it should evaluate

use of the term ``fresh'' within the context of the entire product

labeling to determine if it is used to imply that a product has not

been subjected to a chilling or freezing process, i.e., used in a false

or misleading manner. If such an implication is made, the product would

have to comply with the FSIS definition of ``fresh.'' This final rule

on use of the term ``fresh'' on the labeling of poultry products

provides for clear descriptive labeling, i.e., ``hard chilled'' or

``frozen'' to alert consumers about the nature of products that have

ever been brought to internal temperatures below 26 deg. F. FSIS

believes that such labeling will prevent consumers from being misled

about whether a product has been processed or preserved.

This policy is consistent with FDA's policy with respect to use of

the term ``fresh'' in a brand name or use as a sensory modifier. In the

preamble to its final rule entitled ``Food Labeling: Nutrient Content

Claims, General Principles, Petitions, Definition of Terms; Definitions

of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol

Content of Food'' published in the Federal Register on January 6, 1993

(58 FR 2302), FDA states at 58 FR 2405 that ``[i]f, however, a use of

the term ``fresh'' as part of a brand name does not imply or suggest

that the food is unprocessed, and the use is not otherwise false and

misleading, there is nothing in this final rule that would prevent this

use of the term.'' For these reasons, FSIS has not adopted specific

regulatory language that governs use of the term ``fresh'' as part of a

brand name or as a sensory modifier.

In response to the comment that, if use of the word ``fresh'' is

permitted in brand names and sensory modifiers, FSIS should require a

specific disclaimer of equal type size to the effect that the product

had been frozen below 26 deg. F, FSIS does not agree that a type size

requirement is warranted. The special handling statements required at 9

CFR 381.125(a), e.g., ``keep refrigerated'' or ``keep frozen,'' do not

have specific type size requirements although they must be prominently

displayed on the principal display panel of the label. After many years

of use, FSIS has no information that the requirements for special

handling statements are not adequate to inform consumers about the

products. Therefore, FSIS rejects the suggestion to add a type size

requirement for descriptive labeling. However, in order to ensure that

the descriptive labeling is clearly visible on packages, FSIS is

revising proposed 9 CFR 381.129(b)(6)(i) to provide that the

information shall be prominently displayed on the principal display

panel of the label. This requirement is consistent with the treatment

of special handling label statements for frozen products as provided in

9 CFR 381.125(a).

Economic Impact

Several commenters suggested that FSIS, in assessing the costs and

benefits of the proposed rule, should have quantified the benefits of

appropriate labeling. In making its cost estimate, FSIS assumed that a

price difference might develop between affected chill pack products and

``fresh'' products so that the chill pack products might decrease in

price in an amount totaling between $60 to $140 million annually. The

commenters asserted that, considering the projected potential cost

impact for some producers, there is likely to be a corresponding

benefit of the same magnitude or larger to consumers who save money or

get better value for their poultry purchases. Another commenter noted

that FSIS listed as an unquantified consumer benefit the fact that

consumers ``would be assured that the poultry products they purchase

would not be labeled in a false or misleading manner.'' The commenter

suggested that, because the proposed rule removes no products from the

market, requires no changes in products, and leaves the choice among

products to consumers, the estimated $60 to $140 million is a ``cost''

neither to the seller nor the buyer, but is a measure of the potential

benefit to the consumer should all consumers who previously purchased

thawed product shift their preference to fresh product. Additional

amounts voluntarily paid by consumers place a monetary value on the

exercise of informed choice. The commenter further asserted that the

loss of opportunity to commit unlawful business acts such as fraud,

deception, and misleading representation should not be accounted for as

a cost of regulation.

FSIS believes the latter commenter assumes that the $60 to $140

million cost estimate reflects an increase in the price of fresh

product. In making this particular cost estimate, FSIS assumed that the

price of fresh product under the proposed rule would remain constant

while the affected product, specifically 1.4 billion pounds of long-

distance-shipment chill pack product, would be priced down. FSIS made

this assumption based on information presented at the public hearings

and in the U.S. District Court proceedings which indicated that

consumers generally would expect products bearing labeling with terms

such as ``frozen'' or ``previously frozen'' to be lower priced. In this

case, the theoretical ``cost'' represents loss of current revenues for

producers who did not act in an unlawful manner, but in accordance with

existing Federal policy. FSIS agrees that a price saving, which could

be quantified, would be conferred to consumers who continue to buy the

lower priced product as FSIS noted in its discussion of the benefits of

the proposed rule.

Some opponents of the proposal suggested that FSIS did not fully

address the economic impact on product that may fall between ``fresh''

and ``frozen'' and for which there would not be a premium market. Many

contended that the proposed rule, as written, could be devastating to

the poultry industry and, especially, to tray pack operations. Some

stated that labor costs for applying pressure sensitive stickers,

redesigning permanent labels, costs for reapproval of labels, etc.,

will also have an economic impact. A few commenters asserted that there

is a cost factor associated with decreased shelf life of poultry, which

could result in increased product waste and/or more frequent deliveries

for poultry retailers.

FSIS has fully considered these comments on the economic impact,

but, considering the difficulty of predicting future dollar values of

future sales, FSIS continues to believe that it has made the most

reasonable cost analysis possible with the information available, as is

discussed under Executive Order 12866. The commenters provided no data

or further information to aid FSIS in a reassessment of the costs and

benefits of the rulemaking than were available at the time FSIS

developed its proposal. FSIS weighed all commenters' expressed concerns

about the economic impact of a final rule and has attempted to mitigate

those concerns by providing flexibility through compliance procedures

and descriptive labeling.

[[Page 44409]]

FSIS believes that changing the requirement for what was perceived as

very negative labeling in the form of the term ``previously frozen'' to

the term ``hard chilled'' will enable processors to develop marketing

strategies that promote the high quality of their products without

misleading consumers about the products' history.

FSIS also received a comment regarding the impact of the proposed

rule on small entities. The commenter disagreed with FSIS'

certification that the proposal would not have a significant impact on

a substantial number of small entities. The commenter noted that FSIS

stated that most smaller poultry processors use ice or dry ice packs to

chill poultry to temperatures between 32 deg. F to 35 deg. F so that

the proposed rule will not apply to most small processors. However, the

commenter insisted that this assumption ignores about 1,000 small

poultry wholesalers and retailers. The commenter contended that,

hypothetically, if a poultry shipment leaves the processing plant in a

``fresh'' state, but temperatures subsequently drop below 26 deg. F

during shipment, the wholesaler or retailer has several choices as

follows: (1) Accept the delivery and risk the sanctions for selling

misbranded poultry, (2) accept the delivery and relabel each branded

package with a generic label and sell the product at a loss because a

brand name commands a higher price, or (3) refuse the shipment and send

customers to other retail establishments to purchase poultry.

FSIS disagrees that this rulemaking will have an impact on a

substantial number of small wholesalers and retailers. The commenter

provided no data to support such an argument but, rather, speculated

about possible adverse impacts on this constituent group. Under its

discussion on compliance procedures, FSIS has provided guidance and

flexibility regarding actions wholesalers and retailers may take in the

event that product labeled as ``fresh'' is found upon receipt to be

below the minimum temperature defining ``fresh.'' FSIS believes that

its guidance and provisions for practical relabeling options for

wholesalers and retailers are sufficient to prevent disruption at the

wholesale or retail level. In addition, and as noted in response to the

preceding comments, the terminology that FSIS is providing in the form

of the term ``hard chilled'' for the products in question should

minimize potential lost revenues.

Other Issues

1. Cured and Processed Poultry Products

FSIS received only two responses to its request for comments on

whether it would be useful and desirable to initiate rulemaking to

establish regulatory requirements for all uses of the term ``fresh'' on

the labeling of poultry products. One commenter expressed the opinion

that it would make sense to incorporate in the regulations the

prohibition on use of the term ``fresh'' on the labeling of cured,

canned, hermetically sealed shelf stable, dried, or chemically

preserved poultry, as described in Policy Memo No. 022C. The commenter

contended that the policy is not controversial, and it would be

desirable to make the regulatory requirements for use of the term

``fresh'' as comprehensive as possible. Another commenter stated,

without further elaboration, that it is not appropriate for FSIS to

initiate rulemaking to establish regulatory requirements for all uses

of the term ``fresh'' on the labeling of poultry products.

FSIS has concluded that it is not necessary to establish regulatory

requirements for all uses of the term ``fresh'' on the labeling of

poultry products. FSIS continues to believe that Policy Memo No. 022C

and the current poultry products inspection regulations (9 CFR 381.129)

are sufficient to preclude the false and misleading use of the term

``fresh'' on poultry products that are processed or preserved by

methods other than freezing. For clarity, FSIS is restating its policy

on other uses of ``fresh'' on the labeling of poultry products as

follows. The term ``fresh'' may not be used on the labeling of poultry

products which are cured, canned, hermetically sealed shelf stable,

dried, or chemically preserved because such use would be inappropriate

and misleading. Chemical treatments include, but are not limited to,

use of antioxidants, antimicrobial agents, or preservatives that

introduce chemically active substances that remain in or on the

product. FSIS notes that, with regard to raw poultry or poultry parts,

no substances are permitted to be added by the poultry products

inspection regulations for the purpose of shelf life extension.

FSIS will allow raw poultry products to be labeled as ``fresh''

that had been treated with ionizing radiation at an absorbed

pasteurization dose of 1.5 to 3.0 kiloGrays as provided for in 9 CFR

381.147(f)(4). The treatment of raw poultry products with low dose

irradiation causes no changes in the products that FSIS believes would

affect consumer perceptions that they are raw and unprocessed (55 FR

18538, May 2, 1990). In addition, the products are required to be

labeled with a unique logo and the statement ``treated with radiation''

or ``treated by irradiation'' in accordance with 9 CFR 381.135, which

distinguishes them from non-irradiated products.

Because the term ``fresh'' has acquired acceptance when used to

identify further processed products, i.e., products whose chemical

composition has been changed by processes such as heating or by the

addition of functional ingredients, that are sold in the refrigerated

state, FSIS permits the term ``fresh'' to be used on the labeling of

such products. Examples of such products are poultry nuggets and

dinners sold in the refrigerated state even when they are made from

components that are processed by procedures such as curing, canning,

etc. as described above. In these instances, the term ``fresh'' is used

to describe the final products, i.e., the nuggets and dinners, and to

identify that they are refrigerated products. When used in this manner,

the term does not imply that the components or ingredients in the final

products, e.g., the poultry meat, are themselves unprocessed. Another

example of this category of refrigerated product that may be labeled as

``fresh'' while containing ingredients that could not be labeled as

``fresh'' is a poultry salad sold in the refrigerated section of a

grocery store. The salad might contain cured or previously frozen

chicken or turkey meats but the term ``fresh,'' when used on such

products, suggests a freshly made salad and does not imply that the

ingredients are unprocessed.

FSIS does not preclude further processed poultry products from

bearing the term ``fresh'' on their labeling when they are in sealed

packages or containers, which are designed to assure freshness, but are

not shelf stable, and which are sold in the refrigerated state.

Examples include vacuum packed products, products packaged in modified

atmosphere packaging, and products packaged in thermoformed oxygen

barrier multi-layer films. Further processed poultry products which

themselves do not qualify to be labeled as ``fresh,'' but which are

made with fresh ingredients (including non-meat and non-poultry

ingredients), may also bear label statements stating this fact provided

such statements clearly refer to the ingredients and do not imply that

the products themselves are unprocessed. An example is canned gravy

made with fresh mushrooms. With respect to ground poultry products sold

in the fresh retail case that have

[[Page 44410]]

been made from frozen and thawed hand deboned or mechanically deboned

poultry, FSIS does not believe that such ground products should bear

the term ``fresh'' on their labeling. However, FSIS does not see any

need for the labeling of such products to disclose the fact that the

products were made from meats that were at one time frozen. FSIS would

not object if such products were labeled with the statement ``freshly

ground'' when the products had, in fact, been recently ground.

As with products subjected to freezing processes, FSIS believes the

word ``fresh,'' when used as part of trademarked names, company names,

fanciful names, logos, and sensory modifiers on the labeling of poultry

products that are cured, canned, hermetically sealed shelf stable,

dried, chemically preserved, or are refrigerated further processed

products of the type previously described, does not necessarily suggest

or imply that the products have not been processed or preserved. FSIS

believes that it should evaluate the term within the context of the

entire labeling to determine if it is used to imply that the product

has not been subjected to such processes, i.e., used in a false or

misleading manner.

2. Other Products

FSIS also received comments on several issues beyond the scope of

the proposed rule. Some commenters raised questions about the

difference in the meaning of the term ``fresh'' as proposed for poultry

products and its meaning for other products. Some commenters asserted

that the proposed policy for poultry products highlights a lack of

uniformity between the regulations for poultry and those for red meat,

and that it would provide a marketing advantage to the red meat

industry. Commenters also raised concerns about the apparent

inconsistencies the proposed rule would leave between poultry and fish

because FDA does not define a specific temperature at which a fish

product would be deemed to be frozen. Commenters argued that the

``fresh'' labeling rules for poultry products should also be applied to

these other products. Since these issues do not come within the scope

of the proposed regulations, they are not addressed in this final rule.

In contrast to the poultry industry's marketing practices addressed

by this rule, whole cuts of red meat are not frozen, thawed, and

marketed as ``fresh.'' The term ``fresh'' has typically been used to

identify those red meat products that are uncured and uncooked or

otherwise not thermally processed or made shelf stable. The use of the

term ``fresh'' on the labeling of red meat products has not caused

consumer confusion. The labeling of fish and fish products is an issue

within FDA's jurisdiction and cannot be addressed in this docket.

3. Implementation Date

FSIS did not receive any comments on its proposed rule concerning

an effective date or implementation period. However, the provisions of

this final rule will require the relabeling of those products currently

on the market whose manufacturers elect to chill, store, and ship at

internal temperatures below 26 deg. F, but above 0 deg. F. Based on its

review of the comments, FSIS realizes that the provisions may cause

some processors to make operational changes so they can continue to

supply ``fresh'' poultry. Such changes might include alternate methods

of chilling dedicated to small trays, close adjustments of temperature

controls in coolers and transport vehicles, modification in or purchase

of new equipment to more precisely control temperatures, and

development of contingency plans for products that fall below 26 deg. F

after leaving the processing establishment.

Therefore, FSIS has decided that sufficient time should be allotted

for processors and handlers to make any changes necessary to comply

with this rule. FSIS believes that processors may need to establish new

policies and procedures, formulate methods for compliance, and exhaust

label inventories to the extent possible. A survey of meat and poultry

companies for FSIS' final rule on nutrition labeling indicated that

firms carry an average label inventory of 5 to 6 months. While FSIS

will permit use of stickers with descriptive labeling, many firms will

likely not want to use that avenue because of the added step of

applying the stickers and the chance that they may become dislodged.

Therefore, many firms may want to redesign their permanent labels.

Providing adequate time to accomplish the operational activities

described above and to prevent inventory losses will minimize the

impact of the final rule on affected parties. After considering the

factors mentioned above and recognizing that product safety is not a

concern, FSIS has determined that this final rule will be implemented

12 months from the date of its promulgation.

Executive Order 12866

FSIS has determined that this final rule is significant within the

meaning of Executive Order 12866. The final rule requires all poultry

processors and handlers to maintain the internal temperature of raw

poultry at 26 deg. F or above if the term ``fresh'' is used on the

labeling of such products. In addition, the final rule requires that

poultry products whose internal temperature has ever been below 26 deg.

F be labeled with a descriptive term reflecting this fact.

Regulatory Options

FSIS could have chosen to prohibit the use of the term ``fresh'' on

the labeling of raw poultry products whose internal temperature has

ever been below 20 deg. F. Many commenters on the proposed rule stated

that they would support 20 deg. F as a practical temperature that would

not disrupt commercial practices and suggested that temperatures in the

lower 20-degree Fahrenheit range were best for the preparation and

distribution of the highest quality product. Others favored a two-step

process control system in which temperatures between 23 deg. F and

26 deg. F would be attributed to normal effective variances from

refrigeration units and temperature measuring devices; temperatures

between 20 deg. F and 23 deg. F would require process control

adjustments; and temperatures below 20 deg. F would require product

relabeling. If FSIS had chosen 20 deg. F as the temperature at or above

which product could be labeled as ``fresh,'' the impact on the poultry

industry would be minimal because few processors chill products below

that temperature due to the cost of refrigeration unless they take the

product to 0 deg. F or below for long-term storage. However, poultry is

very solid and very hard at 20 deg. F, because much of the free water

in the product is in a frozen state. Consumers perceive such products

to be frozen rather than fresh, and their expectations for the products

would not be met.

Impacts of the Final Rule

In the preamble to its proposed rule, FSIS examined possible

sources of market price changes which could result in transferring

economic value from producers to consumers if it adopts the proposed

rule as a final rule. FSIS stated that Americans consumed approximately

17.9 billion pounds of chicken (retail weight) in 1993, of which

approximately 8.9 billion pounds were purchased at retail. Based on a

survey of broiler marketing practices, FSIS reported that 27 percent of

chicken destined for the retail market was shipped in containers filled

with shaved or crushed ice (ice pack) or solid carbon dioxide (dry ice

pack); 57 percent was shipped using the chill-pack method of

refrigeration; 3 percent was frozen (i.e.,

[[Page 44411]]

below 0 deg. F); and 13 percent was marketed in miscellaneous forms.

Because the internal temperature of poultry products that are

refrigerated by ice pack or dry ice pack methods ranges from about

32 deg. F to 35 deg. F, FSIS assumed that the final rule will not

affect this portion of the market. Also, most smaller processors use

ice or dry ice packs because they do not have the production volume or

chilling equipment to store and ship poultry products using the chill-

pack cooling system. For this reason, the economic impact of a final

rule on small poultry processors should be minimal. FSIS believes that

the final rule will not affect the 3 percent of chicken that is

marketed at retail as frozen (i.e., below 0 deg. F). The final rule

might have an economic impact on the 13 percent of chicken that is

marketed in miscellaneous refrigerated forms, but FSIS has no

information on what such an impact might be.

In its proposed rule, FSIS stated that most turkey is prepared and

shipped as product that is frozen to 0 deg. F or below, and, thus, most

turkey will be unaffected by the proposal. However, FSIS received a

number of comments from the turkey industry indicating that many of

their products, e.g., boneless tray-pack turkey products, would be

affected by the rule. FSIS also recognizes that, under this final rule,

``whole bagged'' turkeys that are frozen at or below an internal

temperature of 0 deg. F can no longer be thawed at the establishment

before distribution and be labeled solely with a handling statement of

``keep refrigerated.'' Rather, the labeling on these products must

reveal that the products were at one time in a frozen condition by use

of an appropriate statement such as ``frozen, thawed for your

convenience.'' Therefore, FSIS has examined the market share of turkey

compared to chicken as shown by production and per capita consumption

data contained in USDA's Agricultural Statistics 1994 published by the

U.S. Government Printing Office. Based on that information, FSIS

concludes that incorporation of cost estimates for turkey would raise

the potential cost estimate for this final rule by approximately 25

percent.

FSIS continues to believe that the final rule could potentially

affect a portion of the 57 percent (5.1 billion pounds) of the 8.9

billion pounds of chicken marketed domestically at retail as chill pack

product, specifically, chill pack products with internal temperatures

ranging from 20 deg. F to 25 deg. F that are destined to be transported

long distances. FSIS examined interstate shipping distances for ready-

to-cook chicken and estimated that about 72 percent of chill pack

products are shipped 800 miles or less. Such trips do not take more

than two days. FSIS believes that products shipped 800 miles or less

with proper refrigerated transportation could be labeled as ``fresh.''

FSIS does not believe that poultry processors using the chill-pack

cooling system would change current procedures for products shipped

long distances of over 800 miles. It may well be desirable to chill and

ship poultry on long-distance hauls at temperatures in the lower 20-

degree Fahrenheit range. FSIS estimates that 28 percent (1.4 billion

pounds) of the 5.1 billion pounds of chill pack product sold at retail

falls into the long-distance-shipment category and might be affected by

this final rule because it could not be labeled as ``fresh.''

Based on information presented at the public hearings and in the

U.S. District Court proceedings, and confirmed by commenters on the

proposed rule, consumers generally expect frozen products to be lower

priced than fresh products. Using a conservative estimate of price

difference at 4 cents per pound (based on a difference in price between

fresh and frozen turkey) and a less conservative estimate of price

difference at 10 cents per pound, FSIS calculated a potential economic

transfer of about $60 million to $140 million from producers to

consumers. Adding the impacts for potentially affected turkey products

to these amounts, the potential economic transfer becomes about $75

million to $175 million. This impact assumes affected product would

decrease in price and, as such, this impact represents an extreme

scenario.

FSIS is convinced that the extreme scenario presented will not

actually develop considering the modifications it has made in this

final rule in response to expressed concerns from commenters on the

proposal. This final rule provides processors with an appropriate

descriptive term in the form of ``hard chilled'' that does not

disparage the products, while the term conveys to consumers the

temperature history of the products, i.e., relates information about

the cooling process to which the products were subjected, as well as

their physical state after undergoing that process. Furthermore, FSIS

is firmly committed to providing a practical and reasonable compliance

strategy. FSIS has also provided for viable options for relabeling of

product should that become necessary and for generic approval of such

labeling. In addition, FSIS has provided adequate time for processors

to come into compliance with the final rule.

Most of the poultry products affected by this rule are branded

products that consumers have come to recognize for their high quality.

FSIS does not believe that all customers will turn away from the

products they have been buying because the quality of the products will

remain unchanged. Thus, there is no reason for the products to be

priced down to the extent in the extreme scenario.

It can also be argued that, under this rule, producers of fresh

product could command even higher prices than they do now or a larger

share of the market, which would represent a cost to the buyer. FSIS

considers this to be quite speculative and subject to supply and demand

and market forces. Such a situation may occur in certain areas, but, in

general, there is no basis to assume that all consumers will pay more

or are even willing to pay more than they do now for truly fresh

product or would choose fresh products over those affected by this

final rule.

Under this final rule, affected products will also require

relabeling with an appropriate descriptive term. About half of all

labels submitted to FSIS each year for approval are for label changes

on existing products. Thus, relabeling costs for printed labels arising

from the final rule would decrease as companies incorporate the

mandated changes with regularly scheduled label redesigns. The average

costs of redesigning and printing new labels and inventory losses fall

significantly as the implementation period increases. FSIS has provided

for a 12 month implementation period so that relabeling costs for

printed labels may approach zero taking into consideration that

stickers may also be used as needed and generic approval of descriptive

labeling is authorized. Stickers could always be used in those cases

where label inventory stocks exceed a 1-year supply.

As stated in the proposed rule, FSIS believes relabeling costs can

be minimized considerably by use of pressure sensitive stickers until

firms make routine label changes for existing products or exhaust label

inventories. While this feature may not be of particular interest to

processors on a routine basis, it is of interest to processors and

retailers when relabeling of product becomes necessary, e.g., when

product labeled as ``fresh'' or bearing no descriptive term falls below

26 deg. F in commerce. FSIS estimates the cost of pressure sensitive

stickers to be about $0.01 each. Assuming the potentially affected 1.4

billion pounds

[[Page 44412]]

of chill pack product were packaged in 2-pound packages, and all

required relabeling, FSIS estimates that use of the stickers to bring

such product into compliance, whether applied at the plant or retail

level, would cost about $7 million, excluding the cost for labor,

during any one year period.

Consumers will benefit from the final rule because they would be

assured that the poultry products they purchase would not be labeled in

a false or misleading manner. Information from the public hearings held

by FSIS, the informal survey conducted by the FSIS Meat and Poultry

Hotline staff, and many comments on the proposed rule indicate that

consumers place considerable value on knowing how poultry products were

handled prior to being offered for sale. The quality of the products

offered for sale would not be changed because their shelf life would

not be adversely affected. However, consumers would not be led to pay a

higher price for products that have been chilled to temperatures below

26 deg. F because the informative labeling would advise them of that

fact. Any price decreases that might occur for products that were so

chilled would result in a savings for consumers who purchase those

products. Thus, if a price differential results in an impact on the

industry of $75 to $175 million, as discussed under the impact

estimate, it is viewed as a transfer to consumers from producers.

If products chilled below 26 deg. F do not suffer a loss in price

or market share, it is possible that ``fresh'' products could command

increased prices and revenues for producers of fresh poultry, who will

be benefitted as a result of the final rule. Consumers would benefit

because they expressed a willingness to pay more for truly fresh

poultry that was accurately labeled as ``fresh.'' With or without an

increased price for fresh products, consumers would be assured that

products they buy would meet their expectations even if they elect to

exercise their choice by paying more for the products. Truthful

labeling information about the nature of poultry products would improve

consumer knowledge about the products and aid them in purchasing

decisions. FSIS believes that the benefits of labeling that is not

false or misleading would be greater than actual costs associated with

the final rule considering the reality of the marketplace. The labeling

strategy then offers consumers a true purchasing option that accurately

reflects their expressed expectations.

Executive Order 12778

This final rule has been reviewed under Executive Order 12778,

Civil Justice Reform. States and local jurisdictions are preempted

under section 23 of the Poultry Products Inspection Act (PPIA) (21

U.S.C. 467E) from imposing any marking, labeling, packaging, or

ingredient requirements on federally inspected poultry products that

are in addition to, or different than, those imposed under the PPIA.

States and local jurisdictions may, however, consistent with

requirements of the PPIA, exercise concurrent jurisdiction over poultry

products that are outside official establishments for the purpose of

preventing the distribution of poultry products that are misbranded or

adulterated under the PPIA, or, in the case of imported articles, which

are not at such an establishment, after their entry into the United

States. Under the PPIA, states that maintain poultry inspection

programs must impose requirements that are at least equal to those

required under the PPIA. The states may, however, impose more stringent

requirements on such state inspected products and establishments.

No retroactive effect will be given to this rule. The

administrative procedures specified in 9 CFR 381.35 must be exhausted

prior to any judicial challenge of the application of the provisions of

this final rule, if the challenge involves any decision of an inspector

relating to inspection services provided under the PPIA. The

administrative procedures specified in 9 CFR part 381, subpart W, must

be exhausted prior to any judicial challenge of the application of the

provisions of this final rule with respect to labeling decisions.

Effect on Small Entities

The Administrator has determined that this final rule will not have

a significant effect on small entities, as defined by the Regulatory

Flexibility Act (5 U.S.C. 601). The small entities that could be

affected by the final rule would be small processors of raw poultry.

However, the economic impact of the final rule on such poultry

processors (small plants operating single-inspector processing lines)

should be minimal because such processors currently ship poultry in ice

pack or dry ice pack containers. The internal temperature of products

refrigerated by these methods does not fall below 26 deg. F, and

products handled in this manner could be labeled as ``fresh'' according

to the regulatory requirements. FSIS is aware that there are

approximately 1,000 small wholesalers and retailers who potentially

could be affected by this final rule. However, FSIS does not believe

they will be impacted because this final rule provides realistic

relabeling options for this group as discussed in the section of this

document dealing with compliance procedures.

Paperwork Requirements

The final rule specifies the regulations permitting the use of the

term ``fresh'' on the labeling of raw poultry products. The final rule

requires many manufacturers to revise their labeling and submit such

labeling to FSIS for approval. However, this final rule also provides

that descriptive labeling may be approved under the provisions for

generic label approval so as to minimize paperwork requirements.

Paperwork requirements contained in this final rule were 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.

Final Rule

For the reasons set forth in the preamble, FSIS is amending 9 CFR

part 381 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

2.17, 2.55.

2. Section 381.66 is amended by adding a sentence at the end of

paragraph (f)(2) to read as follows:

Sec. 381.66 Temperatures and chilling and freezing procedures.

* * * * *

(f) * * *

(2) * * * Such procedures shall not apply to raw poultry product

described in Sec. 381.129(b)(6)(i) of this subchapter.

3. Section 381.129 is amended by adding a new paragraph (b)(6) 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, but above 0 deg. F, may not bear a label declaration

of ``fresh'' and must be labeled with the descriptive term ``hard

chilled.'' The word ``previously'' may be used contiguous to the term

``hard chilled'' on an optional

[[Page 44413]]

basis. The descriptive term shall be prominently displayed on the

principal display panel of the label. If additional labeling containing

the descriptive term is affixed to the label, it shall be prominently

affixed thereon with such conspicuousness (as compared with other

words, statements, designs or devices in the labeling) as to render it

likely to be read and understood by the ordinary individual under

customary conditions of purchase and use. Product as 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 may not bear a label declaration of ``fresh'' and

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 used

contiguous to the term ``frozen'' on an optional basis. The descriptive

term shall be prominently displayed on the principal display panel of

the label. If additional labeling containing the descriptive term is

affixed to the label, it shall be prominently affixed thereon with such

conspicuousness (as compared with other words, statements, designs or

devices in the labeling) as to render it likely to be read and

understood by the ordinary individual under customary conditions of

purchase and use. Product as described in this paragraph is subject to

the freezing procedures required in Sec. 381.66(f)(2) of this

subchapter.

(iii) Handling and relabeling of products. (A) Except as provided

under paragraph (b)(6)(iii)(C) of this section, when any inspected and

passed product has become misbranded under this subpart after it has

been transported from an official establishment, such product may be

transported in commerce to an official establishment after oral

permission is obtained from the Area Supervisor of the area in which

that official establishment is located. The transportation of the

product may be to the official establishment from which it had been

transported or to another official establishment designated by the

person desiring to handle the product. The transportation shall be

authorized only for the purpose of the relabeling of the product. The

Area Supervisor shall record the authorization and other information

necessary to identify the product and shall provide a copy of the

record to the inspector at the establishment receiving the product. The

shipper shall be furnished a copy of the authorization record upon

request.

(B) Upon the arrival of the shipment at the official establishment,

a careful inspection shall be made of the product by the inspector, and

if it is found that the product is not adulterated, it may be received

into the establishment; but if the product is found to be adulterated,

it shall at once be condemned and disposed of in accordance with

Sec. 381.95 of this subchapter. Wholesome product will be relabeled in

accordance with paragraph (b)(6) (i) or (ii) of this section, as

appropriate.

(C) When any inspected and passed product has become misbranded

under this subpart after it has been transported from an official

establishment, the owner may transport the product in commerce to a

retail entity for relabeling in accordance with paragraph (b)(6) (i) or

(ii) of this section, as appropriate, or to other end users, such as

hotels, restaurants or similar institutions; or, relabel the product in

accordance with paragraph (b)(6) (i) or (ii) of this section, as

appropriate if the product is already at a retail entity. A hotel,

restaurant or similar institution is not required to relabel product

misbranded under this subpart; Provided, That the product is prepared

in meals or as entrees only for sale or service directly to individual

consumers at such institutions, and that the mark of inspection is

removed or obliterated. Oral permission shall be obtained from the Area

Officer-in-Charge of the Compliance Program for the area in which the

product is located prior to such transportation or relabeling. The Area

Officer-in-Charge shall record the authorization and other information

necessary to identify the product, and shall furnish a copy of the

authorization record upon request. Before being offered for sale at a

retail entity, such product shall be relabeled.

4. Section 381.134 is amended by adding a new paragraph (b)(15) to

read as follows:

Sec. 381.134 Generically approved labeling.

* * * * *

(b) * * *

(15) The addition of a descriptive term as required by

Sec. 381.129(b)(6) of this subchapter.

* * * * *

Done at Washington, DC, on: August 21, 1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95-21233 Filed 8-24-95; 8:45 am]

BILLING CODE 3410-DM-P