[Federal Register Volume 60, Number 10 (Tuesday, January 17, 1995)]
[Proposed Rules]
[Pages 3454-3462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1001]




[[Page 3453]]

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Part II





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Part 381



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

  Federal Register / Vol. 60, No. 10 / Tuesday, January 17, 1995 / 
Proposed Rules   
[[Page 3454]] 

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 381

[Docket No. 94-022P]
RIN 0583-AB86


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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the 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. The proposal 
would require such poultry products to be labeled with a descriptive 
term reflecting this fact. FSIS is proposing such action to ensure that 
poultry products distributed to consumers are not labeled in a false or 
misleading manner. Such action would also meet consumer expectations 
that the term ``fresh'' should not be applied to raw poultry products 
that have been subjected to processes that would cause such products to 
become frozen (i.e., below 26 deg. F).

DATES: Comments must be received on or before March 20, 1995.

ADDRESSES: Written comments should be sent, in triplicate, to Policy, 
Evaluation and Planning Office, ATTN: Diane Moore, FSIS Docket Clerk, 
Room 3171, South Building, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Washington, DC 20250. Oral comments should 
be directed to Mr. Charles R. Edwards at (202) 254-2565. (See also 
``Comments'' under Supplementary Information.)

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 Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) 
authorizes the Secretary of Agriculture to establish and maintain 
inspection programs designed to assure consumers that poultry products 
distributed to them (including imports) are wholesome, not adulterated, 
and are properly marked, labeled, and packaged. The PPIA prohibits the 
shipment in commerce of poultry products that are misbranded (21 U.S.C. 
458). Under the PPIA (21 U.S.C. 453(h)(12)), a product is misbranded if 
it fails to bear, directly thereon or on its container, as the 
Secretary may by regulations prescribe, the inspection legend, and 
``such other information as the Secretary may require in * * * 
regulations to assure that it will not have false or misleading 
labeling and that the public will be informed of the manner of handling 
required to maintain the article in a wholesome condition.'' The PPIA 
also states (21 U.S.C. 457(c)): ``No article subject to this Act shall 
be sold or offered for sale by any person in commerce, under any name 
or other marking or labeling which is false or misleading, or in any 
container of a misleading form or size, but established trade names and 
other marking and labeling and containers which are not false or 
misleading and which are approved by the Secretary are permitted.''
    General requirements governing the marking and labeling of 
federally inspected poultry products are set forth in subparts M and N 
of the poultry products inspection regulations (9 CFR 381 subparts M 
and N). The regulations also prescribe the processing procedures to be 
followed and the standards of identity and composition for products 
that are to be labeled in a certain manner (9 CFR 381 subparts I, O, 
and P).
    At present, FSIS' poultry products inspection regulations do not 
define a non-frozen state. The 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. This proposal would not alter the current 
requirements governing the freezing of poultry that is to be labeled 
``frozen.''

Current FSIS Policy on ``Fresh'' Labeling of Raw Poultry

    From time to time, FSIS issues policy memoranda concerning 
significant or novel interpretations of the Federal Meat Inspection Act 
(21 U.S.C. 601 et seq.), the PPIA, and/or departmental policy that 
affect product labeling. FSIS' current policy on the use of the term 
``fresh'' on the labeling of raw poultry products, which is contained 
in Policy Memo No. 022C, dated January 11, 1989, allows 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 the opinion 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. Thus, Policy Memo 022C establishes a broad range of 
temperatures for which the term ``fresh'' can be used.
    In addition to limiting the use of the term ``fresh'' on raw 
poultry products based on internal temperature, FSIS Policy Memo No. 
022C states that the word ``fresh'' may not be used in conjunction with 
the product name of any poultry product that is cured, canned, 
hermetically sealed shelf stable, dried, or chemically preserved. 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.

Other Policies on ``Fresh'' Labeling

    While the term ``fresh'' has been used historically to describe raw 
poultry carcasses and parts of carcasses that have not been previously 
frozen to 0 deg. F, the term has commonly been used by FSIS and 
industry to describe red meat products that have not been cured. The 
Federal meat inspection regulations at 9 CFR 317.8(b)(6) state that the 
word ``fresh'' shall not be used on labels to designate product which 
contains any sodium nitrate, sodium nitrite, potassium nitrate, or 
potassium nitrite, or which has been salted for preservation. In 
addition, FSIS Policy Memo No. 022C precludes use of the word ``fresh'' 
on any canned, hermetically sealed shelf stable, dried, or chemically 
preserved meat product. Thus, the use of the term ``fresh,'' as applied 
to meat products, is not related to temperature. Red meat may be frozen 
and thawed, and then presented for sale to consumers as ``fresh.''
    The Food and Drug Administration (FDA) regulations at 21 CFR 101.95 
provide for use of the term ``fresh'' on [[Page 3455]] the label or in 
the labeling of foods regulated by FDA. The requirements of the section 
also pertain to use of the term ``fresh'' in a brand name and use as a 
sensory modifier, for example, ``fresh tasting.'' According to the 
provision at 21 CFR 101.95(a), the term ``fresh,'' when used on the 
label or in labeling of a food in a manner that suggests or implies 
that the food is unprocessed, means that the food, including 
refrigerated food, is in its raw state and has not been frozen or 
subjected to thermal processing or other methods of preservation, with 
certain exceptions, for example, surface treatments such as waxing of 
produce. Thus, fish that is caught, cleaned, and displayed for sale 
under refrigeration may be labeled ``fresh.'' If the fish was frozen 
aboard a fishing vessel, then thawed and prepared for sale in a central 
facility, it could not be labeled as ``fresh'' because it has been 
processed by freezing. However, FDA does not specify a precise 
temperature at which the product would be deemed to be frozen. FDA also 
permits use of the term ``fresh'' as a descriptor on foods if use of 
the term does not suggest or imply that a product is unprocessed or 
unpreserved, as described in the introduction to 21 CFR 101.95. For 
example, use of the term ``fresh'' as a descriptor for crabmeat that is 
traditionally cooked and picked is acceptable to distinguish it from 
pasteurized crabmeat that has a lower price and requires special 
handling.
    At the international level, the Codex Alimentarius Commission of 
the Food and Agriculture Organization of the United Nations (FAO)/World 
Health Organization, in its Draft Code on Hygienic Practice for Fresh 
Meat, defines ``fresh meat'' (including poultry) as a product that has 
not been treated by any other means than by modified atmosphere 
packaging or vacuum packaging to ensure its preservation, except that 
if it has been subjected only to refrigeration it continues to be 
considered ``fresh'' for the purpose of the code. (Codex Alimentarius 
Commission, FAO, 20th Session, Geneva, Switzerland, 28 June-7 July 
1993: Alinorm 93/16A: Report of the 7th Session of the Codex Committee 
on Meat Hygiene, Rome, 29 March-2 April 1993.)
    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. 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, among other 
things, that it was preempted by the PPIA. 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. 
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 Appeals Court 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.

Current Policies on Use of the Term ``Fresh Frozen''

    Both FSIS and FDA have regulations governing the use of the term 
``fresh frozen.'' The FSIS poultry products inspection regulations at 9 
CFR 381.129(b)(3) specify that the terms ``fresh frozen,'' ``quick 
frozen,'' ``frozen fresh,'' and terms of similar import apply only to 
ready-to-cook poultry (raw poultry) processed in accordance with the 
freezing regulations described at 9 CFR 381.66(f)(1). These freezing 
regulations specify that these labeling terms imply a rapid change from 
a fresh state to a frozen state, and that any product to be labeled 
with such descriptive terms shall be placed into a freezer within 48 
hours after initial chilling in accordance with 381.66(b). During this 
period, if such poultry is not immediately placed into a freezer after 
chilling and packaging, it shall be held at 36 deg. F or lower. Under 
FDA's regulations at 21 CFR 101.95(b), the terms ``fresh frozen'' and 
``frozen fresh'' may be used to describe a food that was quickly frozen 
while still fresh, for example, recently harvested, by a freezing 
system such as blast-freezing (sub-zero Fahrenheit temperature with 
fast moving air directed at the food). The process should ensure that 
the food is frozen quickly, even to the center of the food, and that 
virtually no deterioration has taken place. Blanching of food such as 
vegetables before blast-freezing does not preclude use of the terms.

Reassessment of FSIS' Policy on ``Fresh''

    Because of the issues raised by the California law and the 
litigation that arose in its wake, 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 also 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. As a result of newspaper 
articles and the publicity surrounding the hearings, FSIS received 
7,500 letters from consumers asking the Agency to reevaluate its policy 
on ``fresh'' labeling.
    Subsequent to the hearing, Senator Barbara Boxer of California, 
together with Congressman Gary Condit of California, introduced H.R. 
4839, the Truth in Poultry Labeling Act of 1994, on July 27, 1994. This 
bill would prohibit use of the term ``fresh'' on labeling of poultry 
that has been frozen, or previously frozen below 26 deg. F.
    FSIS is committed to achieving the Secretary's objectives by 
considering both the scientific bases for the labeling policy and 
consumer expectations regarding the use of the term ``fresh'' as it is 
applied to raw poultry. In response to the Secretary's direction and 
the significant events described above, FSIS pursued the following 
courses of action: (1) On August 26, 1994, FSIS 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; 
[[Page 3456]] (2) FSIS surveyed callers to the USDA Meat and Poultry 
Hotline to determine their attitudes, perceptions, and expectations 
regarding poultry that is to be labeled as ``fresh''; (3) FSIS 
conducted a review of the scientific literature to determine and, if 
necessary, to resolve any scientific or technical time- and 
temperature-related issues concerning the safety of poultry products 
during shipment and storage; and (4) FSIS requested USDA's Agricultural 
Research Service (ARS) to conduct research studies on sensory and 
quality characteristics of poultry exposed to various time and 
temperature combinations, to examine general microbial properties of 
poultry, and to develop a spectroscopic analytical model to measure the 
temperature to which poultry has been chilled.

Public Hearings

    The public hearings on use of the term ``fresh'' were held on 
September 12 in Modesto, CA; September 16 in Atlanta, GA; and September 
20 in Washington, DC. At these hearings, consumers, processors, 
producers, industry representatives, state and local government 
officials, members of Congress and their staffs, restaurant and hotel 
chefs, health officials, and other interested parties had the 
opportunity to present oral and written views on the ``fresh'' poultry 
labeling issue. The results of these hearings are presented below. 
Transcripts of the public hearings and copies of data and information 
submitted during the hearings are available for review under Docket 
Number 94-022P at the office of the FSIS Docket Clerk, Room 3171, 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.
    The hearings focused on issues relating to industry practices and 
controls and consumer expectations and perceptions regarding the term 
``fresh'' on the labeling of raw poultry products. Discussions centered 
on current practices and controls used by industry (e.g., processors, 
wholesalers) for packaging, storing, and transporting raw poultry 
products; practices and controls used by retailers for packaging, 
storing, and handling raw poultry products; and the time which elapses 
between slaughter and the sale to consumers of raw poultry products 
labeled as ``fresh.'' Participants also discussed consumers' 
expectations when purchasing poultry labeled as ``fresh'' and the 
usefulness of descriptive terms on the labeling of poultry products 
that have been previously frozen to an internal temperature below 
26 deg. F. A total of 79 individuals from five constituent groups 
representing consumers, industry, academia, government, and 
professional organizations presented comments.
    At the Modesto hearing, consumer and industry representation was 
even, but the proportion of participants who were elected state and 
federal officials and their staffs was larger than at the other public 
hearings. The predominant theme expressed by the participants was the 
issue of truth in labeling and the consumers' right to know what they 
are purchasing. Participants contended that consumers feared there 
might be health hazards associated with home refreezing of poultry that 
had been chilled, frozen, and thawed before being displayed as 
``fresh'' in the supermarket. Many participants considered the labeling 
of a product as ``fresh,'' when to all appearances it was hard-to-the-
touch, to be mislabeled, and a few characterized such labeling as 
fraudulent.
    In Atlanta, the industry and consumer representation was 
proportionally higher than in Modesto, and, of the two groups, the 
industry presence was slightly larger. The majority of speakers stated 
that if a product is not really fresh, it should not be labeled as 
such. Some argued that the word ``fresh'' should be left off the 
product entirely, while others thought that the use of the phrase 
``previously frozen'' would be a truthful statement on a label of a 
product that had been previously frozen (i.e., below 26 deg. F) and 
then thawed. Participants expressed an interest in seeing more 
scientific research before a decision is made. Some participants 
maintained that temperature was not the only indication of a ``fresh'' 
product, but that other characteristics, such as smell, color, and 
texture, should be considered. Participants asserted that temperature 
cannot be controlled once a product leaves a plant. Some participants 
emphasized the importance of allowing products to move freely in 
interstate commerce. For example, they stated that the California law 
(specifically, the ``ambient temperature'' provision that has since 
been removed from the law) made it difficult, if not impossible, for 
fresh poultry processed in other States to be shipped into California 
because the temperature to which a product is subjected and maintained 
during storage and distribution affect its freshness. These 
participants maintained that poultry products shipped in interstate 
commerce must be subject to a uniform set of requirements developed by 
the Federal government, and not subject to requirements of individual 
or different states which may seek to protect their local markets from 
out-of-state competition.
    At the hearing in Washington, DC, the main themes discussed were 
labeling misrepresentation and the definition of ``fresh'' versus that 
of ``frozen.'' Almost half the presenters were consumer 
representatives, including chefs, restaurant owners, and members of 
consumer advocacy groups. Additionally, Minnesota Congressman David 
Minge attended the hearing, while Congressman Gary A. Condit and 
Senator Diane Feinstein, both of California, submitted written 
comments. Arkansas' Senators Dale Bumpers and David Pryor submitted a 
joint comment opposing the California law as discriminating against 
out-of-state products. The consensus among participants was that 
poultry at an internal temperature of 26 deg. F or less should be 
considered frozen.
    Additional comments regarding industry practices and consumer 
expectations and perceptions that were presented at the three public 
hearings are discussed below.

Industry Practices

    Industry participants reported at the public hearings that it is a 
common practice of the poultry industry to ship product across the 
country in a deep-chilled state with internal temperatures ranging from 
20 deg. F to 26 deg. F depending on the type of product, for example, 
whole birds or parts for slicing. According to the industry 
participants, poultry generally is cooled to the lower 20 deg. F range 
when the chill-pack cooling system is used. Because cooling is costly, 
poultry that is not ``frozen'' according to the regulatory definition 
(at or below 0 deg. F) is rarely cooled below 20 deg. F. The product 
cooled to the lower 20 deg. F range is often labeled as ``fresh'' in 
accordance with current regulations and appears in supermarket 
refrigerated display cases, which hold poultry in the range of 35 deg. 
F to 45 deg. F, feeling soft-to-the-touch. The industry participants 
indicated that the product may be priced from $0.10 to $1.00 or more 
per pound below locally produced product whose temperature has never 
been below the range of 26 deg. F to 28 deg. F.
    According to California poultry producers' presentations at the 
public hearings, 98 percent of California product sold on the West 
Coast has not been brought to temperatures below 26 deg. F to 28 deg. 
F. They contended that the temperature range of 26 deg. F to 28 deg. F 
is safe, the product remains pliable as expected by consumers, and the 
product has an expected shelf life of 11 to 14 [[Page 3457]] days. It 
was reported at the public hearings that at least two large poultry 
companies maintain product in the 26 deg. F to 28 deg. F range, and use 
that range in defining ``fresh'' on the label. Several industry 
participants define ``fresh'' to mean not stale or spoiled and contends 
that freshness encompasses numerous factors, including taste, aroma, 
bacterial quality, nutritional characteristics, temperature, and shelf 
life.
    The majority of the poultry industry participants at the public 
hearings maintained that the poultry industry has the capability of 
transporting product nationwide at 22 deg. F to 26 deg. F. However, the 
participants suggested that 20 deg. F to 26 deg. F is the best range 
for maintaining product quality and limiting microbiological activity 
during storage and transportation. Many commenters from all 
constituency groups believed that industry can readily maintain a safe 
temperature of 26 deg. F or above. They contended that some large 
companies do this now, and that small producers can market product 
within 24 hours of slaughter at 32 deg. F.
    The poultry industry participants recognize that temperatures 
inside cargo compartments of trucks transporting poultry products over 
long distances are likely to vary during transport. The participants 
stated that to ensure that the quality of poultry products is 
maintained and that spoilage is retarded, that is, by keeping the cargo 
compartment temperature at or below 28 deg. F, it is necessary to set 
truck thermostats at temperatures as low as 21 deg. F. According to the 
poultry industry participants truck cargo compartments are more 
difficult to control than a room inside a plant that has giant 
insulated walls and multiple refrigeration units. The participants 
contended that commercial coolers generally have a plus or minus 2 
degree range, and if industry targets 26 deg. F, a cooler could 
fluctuate down to 24 deg. F. They stated that, in some instances, the 
coolers can fluctuate as much as 4 degrees. They also stated that 
generally, temperature variations in a truck would not be expected to 
be more than 10 degrees. FSIS has no data with which to confirm or 
refute that these are common temperature fluctuations in cargo 
compartments and coolers.

Consumer Expectations and Perceptions

    Most consumer representatives at the public hearings viewed the 
term ``fresh,'' as it applies to poultry, to mean that the product has 
never been frozen to an internal temperature below 26 deg. F. Consumer 
representatives used terms such as ``native state,'' ``native 
condition,'' or ``recently killed'' to describe poultry just after 
slaughter, dressing, and packaging. Although industry commenters did 
not make frequent distinctions between fresh and frozen, most consumer 
representatives believe that for raw poultry to be considered 
``fresh,'' it must never have been chilled to a solid or hard-to-the-
touch state during any of the processes involved in its preparation, 
packaging, shipping, storage, or retail sale. Consumer representatives 
also viewed chicken that was not in its ``native state'' (i.e., frozen, 
thawed, or refrozen) as being different from ``fresh'' chicken in 
taste, texture, moistness, and shelf life.
    Consumer representatives frequently cited 26 deg. F and above as 
the handling limit for poultry they deemed to be ``fresh.'' Poultry 
that was hard-to-the-touch (or described as below 26 deg. F) was viewed 
by consumers to be a frozen product in an altered state and, therefore, 
a processed product. They expressed the opinion that only fresh 
products should be labeled as ``fresh'' and anything frozen, i.e., 
hard-to-the-touch, should be labeled as ``frozen.'' Consumer 
representatives noted that, at fish counters, some fish are clearly 
marked as ``fresh,'' while other fish are labeled as ``previously 
frozen'' or as ``flash-frozen.'' Several consumer representatives 
expressed a willingness to pay more for truly fresh poultry that was 
accurately labeled as ``fresh.'' Overall, consumer representatives 
emphasized the need to identify and define key terms in poultry 
freshness and handling so that these terms could be reflected in 
poultry labeling. Consumer representatives see better labeling as a 
means to improve consumer knowledge about the product and to help 
consumers make purchasing decisions.

Survey of Meat and Poultry Hotline Callers

    Survey participants were those people who were calling the Hotline 
seeking information on topics of interest to them. There was no attempt 
to geographically balance the callers surveyed or to get any socio-
economic information. However, FSIS sought to learn more about consumer 
perceptions and expectations concerning the term ``fresh'' when 
associated with raw chicken or turkey. The Meat and Poultry Hotline 
staff conducted an informal survey using a sample comprised of 200 
individuals who called the Hotline during the last two weeks of 
September 1994. A copy of the survey entitled ``Consumer Views on Fresh 
Chicken--Results of a Hotline Survey'' is available for public viewing 
at the office of the FSIS Docket Clerk.
    Survey participants were pre-qualified to include only food 
shoppers who purchase raw chicken. Qualifying participants were asked 
six open-ended questions about what the terms ``fresh,'' ``frozen,'' 
and ``previously frozen'' mean as applied to raw chicken. They were 
asked about whether they prefer ``fresh'' over ``frozen'' product and, 
if so, why they prefer to buy ``fresh chicken.'' The shoppers were also 
asked if they would respond in the same way for raw turkey as for raw 
chicken.
    The responses of these 200 individuals indicated that the term 
``fresh'' is generally associated with product not being frozen, i.e., 
hard-to-the-touch. About 50 percent of the respondents directly related 
``fresh'' to never frozen or recently slaughtered. Eighty-five percent 
of the respondents said ``previously frozen'' does not equate with 
``fresh.'' Seventy-five percent of the shoppers try to buy fresh 
chicken, and many prefer it because they perceive its quality to be 
better than frozen, for example, tastier or more moist. Other 
respondents prefer ``fresh'' chicken because they think frozen chicken 
is older and more likely to have been mishandled and less safe. 
Nonetheless, many consumers opt for frozen turkey and perceive it as 
safer than fresh turkey.

Literature Review

    As a first step in assuring that any policy change on use of the 
term ``fresh'' on poultry labeling would not result in conditions 
causing foodborne illness, FSIS conducted a review of the literature on 
temperature-related factors that could affect the safety of poultry 
products during shipment and storage. A copy of the review entitled 
``Effects of Temperature on the Microbiological Profile and Quality 
Characteristics of Raw Poultry'' is available for public viewing at the 
office of the FSIS Docket Clerk.
    The review, which covered scientific and technical studies on 
microbial safety and physiological factors regarding perishable poultry 
products, also confirms that product safety is not jeopardized if raw 
poultry is maintained at 40 deg. F or below.
    Temperature is a key factor that determines both what bacteria can 
grow in a food product and how fast they grow. Each bacterium has its 
own characteristic temperature range for growth. As a general class, 
there are spoilage bacteria that can grow in the temperature range of 
28 deg. F to 40 deg. F. Even at 28 deg. F, some species of this class 
will grow slowly and ultimately spoil [[Page 3458]] the product. 
However, almost all pathogens of food safety concern have minimum 
growth temperatures that exceed 40 deg. F. For example, the two most 
important pathogens associated with raw poultry, Salmonella and 
Campylobacter jejuni, have minimum growth temperatures of approximately 
50 deg. F and 85 deg. F, respectively.
    There are a limited number of foodborne pathogens that are capable 
of growth under refrigerated conditions. The most important is Listeria 
monocytogenes, which under ideal conditions has minimum growth 
temperature in the range of 30 deg. F to 34 deg. F. This species can 
occur on raw poultry products; surveys suggest that it may be present 
on approximately 18 percent of broiler carcasses. However, while the 
microorganism can grow under refrigeration conditions in certain 
circumstances, extensive studies have indicated that the pathogen does 
not grow on adequately refrigerated meat and poultry products. This 
reflects the fact that raw meat and poultry do not provide the ideal 
conditions for growth, with both the depressed pH associated with these 
products and the presence of a competing microflora depressing the 
potential for growth. For example, competing microorganisms such as 
Pseudomonas, Corynebacterium, and Lactobacillus have a much greater 
growth rate than L. monocytogenes at refrigeration temperatures, and 
have been shown to help depress the growth of the pathogen. Even 
without this inhibitory effect, the more actively growing spoilage 
organisms would likely cause the product to be unpalatable before L. 
monocytogenes began to multiply.
    Yersinia enterocolitica, the other major foodborne pathogen capable 
of growth at refrigeration temperatures, is similarly unlikely to grow 
in adequately refrigerated raw poultry products. While keeping 
refrigerated raw poultry products as close to 28 deg. F as possible 
will help delay microbial spoilage, extend shelf life, and provide a 
small safety margin against transitory temperature abuse, as long as 
the product is maintained at 40 deg. F or less, there should be no 
increased microbiological safety risks associated with the growth of 
pathogenic microorganisms.

Scientific Research

    In order to provide FSIS with additional information in support of 
its rulemaking on the definition of ``fresh'' as applied to raw 
poultry, ARS engaged in research on important quality factors, such as 
flavor, texture, and juiciness, that influence consumer preference for 
fresh or frozen poultry. ARS is conducting studies to evaluate the 
sensory, chemical, and physical properties of raw poultry products that 
have been exposed to and held at temperatures from 0 deg. F to 40 deg. 
F from the time of post-slaughter chilling to 48 hours and to 7 days. 
ARS is also examining poultry that has been exposed to these conditions 
and subsequently frozen to temperatures below 0 deg. F. In addition, 
microbiological data are being collected and the research will seek to 
develop a spectroscopic analytical model to measure the temperature to 
which poultry has been chilled. The findings of this research effort 
will be incorporated into the record of this rulemaking.

The Proposal

    After carefully reviewing the information provided at the public 
hearings, the results of the Meat and Poultry Hotline survey, the 
literature review, and other information generated during the 
significant events discussed in the preamble, FSIS has determined that 
its 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.'' FSIS believes that 
consumers are willing to pay more for a product that they perceive to 
be ``truly'' 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 does not believe that product 
safety is an issue with raw poultry that is maintained at 40 deg. F or 
below. Furthermore, because the shelf life of the product is determined 
by temperature, poultry is stored and transported at temperatures that 
are well below 40 deg. F. FSIS believes that the definition of 
``fresh'' is a labeling issue, as was stated by many participants at 
the public hearings. Therefore, FSIS is proposing to establish by 
regulation, the conditions that will 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 the Agency's 
proposed criteria for ``fresh.''
    FSIS is proposing to amend 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. The proposed rule would not allow raw poultry products whose 
internal temperature has ever been below 26 deg. F to bear a label 
declaration of ``fresh,'' and would require such products to be labeled 
in a manner that reflects that fact. Such products would not be called 
by their common or usual name without further descriptive labeling. Raw 
poultry products whose internal temperature has never been below 
26 deg. F may be labeled as ``fresh,'' and such products could also be 
called by their common or usual name, for example, chicken breast, 
without further description. FSIS 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 in 
accordance with the provisions of 9 CFR 381.66(f)(1) to an internal 
temperature of 0 deg. F or below.
    While FSIS continues to hold its position, as stated in Policy Memo 
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, it is not proposing to establish regulatory 
requirements for these products in this rulemaking. FSIS believes that 
use of the term ``fresh'' on the labeling of such products is not 
controversial. Also, FSIS believes that Policy Memo 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. However, FSIS invites 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.
    FSIS is aware that, in some instances, the term ``fresh'' could be 
incorporated into brand names, firm names, etc., or used in sensory 
modifiers, e.g., fresh tasting, on the labeling of raw poultry products 
whose internal temperature has been below 26 deg. F. In the past, as 
described in Policy Memo 022C, FSIS generally has not restricted use of 
the word ``fresh'' when incorporated in trademarked names, company 
names, fanciful names, logos, and sensory modifiers on labeling of 
poultry products that are frozen, previously frozen, cured, or 
preserved because, in many instances, it would be unlikely that 
consumers would be led to believe they were purchasing a fresh product. 
However, this allowance is not consistent with FDA's application of its 
``fresh'' labeling policy which extends to use in a brand name and use 
as a sensory modifier as described in 21 CFR 101.95. While FSIS 
believes that the term ``fresh'' can be used in brand names, company 
names, sensory [[Page 3459]] modifiers, etc., on the labeling of raw 
poultry products whose internal temperature has been below 26 deg. F in 
a manner that makes it clear to the purchaser that the product is not 
fresh, FSIS seeks comments on this position. FSIS will consider 
disallowing such label statements if information provided in the 
comment period shows that such uses have the potential to mislead.

Descriptive Labeling

    FSIS is proposing that further descriptive labeling on raw poultry 
products sold in a thawed condition whose internal temperature has been 
below 26 deg. F would be accomplished through the use of a descriptive 
term. FSIS considered a number of terms to describe the nature of the 
product. These included ``previously frozen,'' ``previously held at 
____ deg. F,'' ``thawed for your convenience,'' ``freshly frozen,'' or 
``previously freshly frozen.'' FSIS is proposing to require use of the 
term ``previously frozen'' because it believes that this term would be 
the most readily understood by consumers based upon comments from the 
public hearings. Raw poultry products that have been frozen to an 
internal temperature of 0 deg. F or below in accordance with the 
freezing procedures required in 9 CFR 381.66(f)(2) could have the 
option to use the descriptive term ``frozen'' in lieu of the term 
``previously frozen.'' In addition, to avoid confusion or errors in 
handling, FSIS would not require use of either the term ``frozen'' or 
``previously frozen'' on the labeling of products that have been frozen 
to an internal temperature of 0 deg. F or below when such labeling 
duplicates or conflicts with products' special handling labeling 
instructions, e.g., ``keep frozen'' or ``shipped/stored and handled 
frozen for your protection,'' as required in 9 CFR 381.125.
    FSIS is aware of certain advantages and disadvantages associated 
with the use of the proposed descriptive term ``previously frozen,'' as 
well as the others it considered. For these reasons, FSIS invites 
comments on descriptive terms and will consider another term or terms 
if information submitted during the comment period demonstrates greater 
consumer understanding and acceptability of the terms. The advantages 
and disadvantages of the terms, which FSIS has identified, are 
discussed below.
    Labeling a product with the term ``previously frozen'' would 
provide information that the product so labeled had been frozen to an 
internal temperature below 26 deg. F at one time or another and, for 
that reason, could be distinguished from product whose internal 
temperature has never been below 26 deg. F. Such labeling terminology 
would also be consistent with that used currently in the marketing of 
fish and seafood as described by participants at the public hearings.
    However, the term ``previously frozen'' does not convey information 
on how long or at what temperature below 26 deg. F the product was kept 
frozen. Furthermore, a product labeled with the term ``previously 
frozen'' whose internal temperature had been kept in the range above 
0 deg. F but below 26 deg. F could be confused with product that had 
been frozen at 0 deg. F or below in accordance with the FSIS regulatory 
requirement in 9 CFR 381.66(f)(2) for the proper freezing of poultry. 
However, based on comments received during the public hearings, FSIS 
does not believe that most consumers are aware that a temperature of 
0 deg. F or below is associated with the regulatory definition of 
``frozen.'' FSIS believes most consumers believe that a ``frozen'' 
product is one that is ``hard-to-the-touch,'' which consumer 
representatives at the public hearings often described as below 26 deg. 
F.
    The term, ``previously held at ____  deg. F,'' would provide 
consumers with information on the temperature at which product had been 
stored. It would also enable them to distinguish the product from 
product whose internal temperature had not been below 26 deg. F. 
However, labeling with this term would not provide information on how 
long the product had been held at the stated temperature. It would not 
provide information on the significance of holding a product at the 
stated temperature. Also, some consumers might find the words 
``previously held'' to be confusing. They might form the impression 
that after they purchased the product, they would have to handle it in 
some special way.
    ``Thawed for your convenience'' would clearly imply that the 
product had been frozen. The term is considered to be easily understood 
by consumers, and would reflect industry good manufacturing practices 
as applied to temperature fluctuations. In other words, the term would 
not reflect any commitment by the industry to maintaining the product 
in a particular temperature range. The disadvantages to use of this 
term include the fact that it would not provide information on how long 
the product had been thawed prior to sale. It also would not state the 
temperature at which product had been held in a frozen state.
    Labeling poultry with the term ``freshly frozen'' would convey 
truthful information that the product had been frozen to an internal 
temperature below 26 deg. F. The term ``freshly ____________'' does not 
imply that a food product is actually fresh in terms of being 
unprocessed. The use of the word ``freshly'' before frozen would also 
convey the notion that the product had been frozen while in a fresh 
state and had recently been in a frozen state. However, the term 
``freshly frozen'' does not provide information on how long and at what 
temperature the product to which it is applied may have been held in a 
frozen state. Also, the term might be a source of confusion to the 
consumer buying the product at a supermarket where it is kept in a 
fresh poultry display case at a temperature higher than 26 deg. F. Use 
of the term on raw poultry sold at ``fresh'' temperatures would be 
inconsistent with application to other food products that are retailed 
as frozen foods. The term might also be confused with the term ``fresh 
frozen'' that is used in connection with poultry that has been frozen 
at 0 deg. F in accordance with the FSIS poultry freezing regulation.
    Use of the term ``previously freshly frozen'' would have the 
advantage of providing factual information that the poultry had indeed 
been frozen to an internal temperature below 26 deg. F. It would also 
convey the notion that the product had been frozen while fresh and that 
it had recently been in a frozen state. On the other hand, the term 
would not inform the consumer of the length of time and the temperature 
at which the product had been kept frozen. Nor would use of the term 
provide industry with a mechanism to distinguish among the multiple 
temperatures between 0 deg. F and 26 deg. F at which the product was 
held. Also, product labeled with this term could be confused with 
product labeled as ``fresh frozen'' that had been frozen for long-term 
storage at 0 deg. F in accordance with the FSIS poultry freezing 
regulation.

Compliance Procedures

    FSIS believes that processors, transporters, wholesalers, and 
retailers will maintain controls to ensure that their poultry products 
comply with the Agency's proposed requirements as part of their good 
manufacturing practices. Therefore, the Agency believes that it is 
unnecessary to propose compliance procedures for use of the term 
``fresh'' on raw poultry products. FSIS inspection and compliance 
staffs monitor compliance with labeling requirements at inspected 
plants and in commerce for the purpose of preventing the distribution 
of poultry products that are misbranded. In specific instances, the 
Agency provides instructions to its [[Page 3460]] inspectors and 
compliance staff for enforcing compliance. Such instructions typically 
will include collection of randomly selected samples of consumer units, 
representative of a lot, either at the inspected plant or in commerce. 
In the case of poultry products covered by this proposal, a lot might 
consist of the contents of all like product contained in a cooler, 
cargo compartment, or other area used for cold storage or transport of 
products. Like product would be defined as similar kinds of whole birds 
and similar kinds of the same cut-up or disjointed poultry parts. If 
the mean temperature at the central part of the samples is below 
26 deg. F, the lot would be out of compliance with the proposed 
``fresh'' labeling requirements. If any lot is found to be not in 
compliance, it could be deemed to be misbranded and could not enter or 
proceed in commerce until the product is relabeled to accurately 
reflect its nature. FSIS invites comments regarding procedures for 
monitoring compliance with the ``fresh'' labeling requirements.

Executive Order 12866

    FSIS has determined that this proposed rule is significant within 
the meaning of Executive Order 12866. The proposed rule would require 
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 proposal 
would require that poultry products whose internal temperature has ever 
been below 26 deg. F to be labeled with a descriptive term reflecting 
this fact.

Regulatory Option

    FSIS could choose 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. Some industry participants at the public hearings 
held by FSIS suggested that, if designing a program for control for the 
industry for precooling temperatures that maintain physical attributes 
of freshness, one could use 23 deg. F as the first lower control limit, 
and 20 deg. F as the second-step lower limit for taking corrective 
action. They suggested these temperatures as best for the preparation 
and distribution of the highest quality fresh product. Should FSIS 
alternatively choose 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. Information from the hearings suggests that 
few processors chill product lower than 20 deg. F because the 
refrigeration process is expensive. Generally, product is not cooled 
below 20 deg. F unless it is being frozen to 0 deg. F or below for 
long-term storage. However, other participants noted that poultry is 
very solid at 23 deg. F and 80 percent of the water is in a frozen 
state. There is little discernable physical difference between a 
product frozen to 23 deg. F and one frozen to 0 deg. F, where almost 
all of the water is in a frozen state. Therefore, products at a 
temperature of 20 deg. F would be perceived by consumers to be frozen 
and not fresh.

Costs of the Proposed Rule

    FSIS has examined possible sources of costs associated with the 
proposed rule. Americans consumed approximately 17.9 billion pounds of 
chicken (retail weight) in 1993, of which approximately 8.9 billion 
pounds were purchased at retail. According to a recent survey of 
broiler marketing practices, 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). Broilers 
represent the majority of chicken grown and slaughtered in the U.S. The 
survey also showed that 57 percent of the chicken was shipped using the 
chill-pack method of refrigeration, which was described under industry 
practices at the public hearings; 3 percent was frozen (i.e., below 
0 deg. F); and 13 percent was marketed in other miscellaneous forms.
    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. Therefore, the proposed rule would not affect this portion 
of the market. 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 the proposed rule on small poultry 
processors should be minimal. The proposed rule would not affect the 3 
percent of chicken that is marketed at retail as frozen (i.e., below 
0 deg. F). Most turkey is prepared and shipped as product that is 
frozen to 0 deg. F or below, and, thus, most turkey would be unaffected 
by the proposal.
    The proposed 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. FSIS believes 
that the proposed rule could 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. Chill pack product is 
sold in the fresh retail case and either is labeled as ``fresh'' or 
bears no temperature-related labeling other than special handling 
instructions. Some of the chill pack product has been frozen to 
internal temperatures below 26 deg. F and is thawed prior to 
presentation in the retail case.
    Under the chill pack refrigeration method, raw poultry products are 
said to be cooled to a range of 28 deg. F to 32 deg. F. However, 
according to information presented in the public hearings held by FSIS 
and in the U.S. District Court proceedings, processors currently using 
the chill pack method often target an internal temperature range of 
26 deg. F to 28 deg. F. Other processors of chill pack products 
commonly target internal temperatures ranging from 20 deg. F to 25 deg. 
F, and transport products across the country in this temperature range. 
Most processors using the chill pack cooling system aim to keep the 
product at or below 28 deg. F during storage and shipment to maintain 
an optimum shelf life of about 3 weeks from slaughter.
    The information presented in the public hearings and U.S. District 
Court proceedings also indicates that, in commercial practice, it is 
difficult to maintain all product in a storage area at an exact target 
temperature of 26 deg. F to 28 deg. F. For example, the temperature in 
storage rooms at poultry plants, which are commonly maintained at 
26 deg. F to 28 deg. F, may have cold spots, such as by a blower, that 
are as low as 22 deg. F. Poultry is typically transported from 
processing plants to wholesalers and purchasers by refrigerated trucks. 
The temperature inside the storage compartments of these trucks is 
reported to vary about 5 to 7 degrees Fahrenheit. Thus, the temperature 
near the refrigeration unit at the front of the truck could be at 
21 deg. F while the top of the truck compartment is at 28 deg. F.
    Because products that have been chilled to internal temperatures of 
26 deg. F to 28 deg. F require time to equilibrate with different 
surrounding air temperatures, such as those produced by the temperature 
dispersions in truck cargo compartments, FSIS examined interstate 
shipping distances for ready-to-cook chicken. FSIS estimates that about 
72 percent of chill pack products are shipped 800 miles or less. Such 
trips would not take more than 2 days, and products chilled at the 
plant to internal temperatures of 26 deg. F to 28 deg. F and stored 
near cold spots in the truck cargo compartments would be less likely to 
fall below 26 deg. F. If truck thermostats were adjusted so as to 
maintain the highest cargo temperature at 32 deg. F, as opposed to 
28 deg. F, in order to prevent product from becoming frozen (i.e., 
[[Page 3461]] below 26 deg. F) in colder sections of the compartments, 
FSIS does not believe that the shelf life or market quality of products 
shipped 800 miles or less would become unsatisfactory. FSIS expects 
that industry will find market incentives to closely control storage 
and shipping temperatures of products destined for hauls of durations 
of 2 days or less so that none of the cargo falls below 26 deg. F, and 
the products could be labeled as ``fresh.''
    FSIS does not believe that it is likely that chicken processors 
using the chill-pack cooling system would change current procedures for 
products shipped long distances of over 800 miles because the shelf 
life of the products might become unsatisfactory. FSIS believes these 
products include chicken deep-chilled to internal temperatures in the 
lower 20 deg. F range and chicken whose internal temperatures 
processors want to keep at or below 28 deg. F at all times during 
storage and shipment to maintain optimum shelf life. For example, to 
maintain all product in a truck at 26 deg. F or higher, would mean that 
poultry in the warmest part of the truck on a long haul could be stored 
for as many as 4 days at 32 deg. F. Participants at the public hearings 
reported shelf life of poultry from time of slaughter is about 2 weeks 
when it is held at 32 deg. F. Processors and purchasers of poultry 
shipped long distances may not find such decreases in shelf life to be 
acceptable.
    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 proposed 
rule because it could not be labeled as ``fresh.'' Consumers generally 
pay slightly more for fresh poultry than for frozen poultry. A 
conservative estimate of the price difference is 4 cents per pound 
(based on a difference in price between fresh and frozen turkey). The 
difference could range up to 10 cents per pound (a conservative 
estimate presented by knowledgeable persons at the public hearings held 
by FSIS). Should such a price differential develop between fresh and 
previously frozen poultry, FSIS estimates that the impact would range 
from about $60 million to $140 million.
    Under the proposed rule, the products would also require relabeling 
with the descriptive term ``previously frozen.'' However, FSIS believes 
these costs could be minimized considerably by use of pressure 
sensitive stickers until firms make routine label changes for existing 
products or exhaust label inventories. FSIS estimates the cost of 
pressure sensitive stickers to be about $0.01 each. Assuming the 
potentially affected 1.4 billion pounds of chill pack product were 
packaged in 2-pound packages, FSIS estimates use of the stickers would 
cost about $7 million, excluding the cost for labor, during the first 
year of implementation if the proposed rule is adopted. About half of 
all labels submitted to FSIS each year for approval are for label 
changes on existing products. Thus, relabeling costs arising from the 
proposed rule would decrease as companies incorporate the proposed 
mandated changes with regularly scheduled label redesigns.

Benefits of the Proposed Rule

    Consumers would benefit from the proposal 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 and the survey conducted by the FSIS Meat and Poultry Hotline 
staff both 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 
previously frozen because the informative labeling would advise them of 
that fact. Any price decreases that might occur for products that were 
previously frozen would result in a savings for consumers who purchase 
those products.
    If a price differential should develop between fresh and previously 
frozen chicken, then part of that differential will reflect increased 
prices and revenues for producers of fresh chicken, who will be 
benefitted as a result of the proposed rule. Consumers would also 
benefit because they expressed a willingness to pay more for truly 
fresh poultry that was accurately labeled as ``fresh.'' Consumers would 
be assured that products they buy would meet their expectations. 
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 any costs associated 
with the proposed rule. The proposed labeling strategy then offers 
consumers a true purchasing option that accurately reflects their 
expressed expectations.

Executive Order 12778

    This proposed 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 proposed 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 proposed rule with respect to labeling decisions.

Effect on Small Entities

    The Administrator has determined that this proposed rule would 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 proposed rule would be small processors of raw 
poultry. However, the economic impact of the proposed 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 proposed requirements.

Paperwork Requirements

    The proposed rule would specify the regulations permitting the use 
of the term ``fresh'' on the labeling of raw poultry products. The 
proposed rule [[Page 3462]] would require many manufacturers to revise 
their labeling and submit such labeling to FSIS for approval. The 
paperwork requirements contained in this proposed rule have been 
submitted to the Office of Management and Budget for approval under the 
Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Comments on the 
paperwork burden of this proposed rule should be sent to: Office of 
Management and Budget, Desk Officer for FSIS, Office of Information and 
Regulatory Affairs, Room 3208, New Executive Office Building, 
Washington, DC 20503, and to the Clearance Office, Room 404-W, 
Administration Building, Washington, DC 20250.

Comments

    Interested persons are invited to submit written comments 
concerning this proposal. Submit comments in triplicate to Diane Moore, 
FSIS Docket Clerk, Room 3171, South Building, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC 
20250. Any person desiring an opportunity for an oral presentation of 
views should make such request to Mr. Charles R. Edwards so that 
arrangements can be made for such views to be presented. A record will 
be made of all views orally presented. All comments submitted in 
response to this proposal will be available for public inspection in 
the Policy, Evaluation and Planning Office from 8:30 a.m. to 1:00 p.m., 
and from 2:00 p.m. to 4:30 p.m., Monday through Friday.

List of Subjects in 9 CFR Part 381

    Food labeling, Poultry and poultry products.

Proposed Rule

    For the reasons set forth in the preamble, FSIS is proposing to 
amend 9 CFR part 381 as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    1. The authority citation for part 381 would continue 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 would be 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.


Sec. 381.129   [Amended]

    3. Section 381.129 would be amended by adding a new paragraph 
(b)(6) to read as follows:
* * * * *
    (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 ``previously 
frozen.'' 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 either the descriptive term ``frozen'' or 
``previously frozen,'' except when such labeling duplicates or 
conflicts with the labeling requirements in Sec. 381.125. Product as 
described in this paragraph is subject to the freezing procedures 
required in Sec. 381.66(f)(2) of this subchapter.
* * * * *
    Done at Washington, DC, on: January 10, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 95-1001 Filed 1-11-95; 8:45 am]
BILLING CODE 3410-DM-P