[Federal Register Volume 60, Number 165 (Friday, August 25, 1995)]
[Rules and Regulations]
[Pages 44396-44413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21233]
[[Page 44395]]
_______________________________________________________________________
Part IV
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 381
Use of the Term ``Fresh'' on the Labeling of Raw Poultry Products;
Final Rule
Federal Register / Vol. 60, No. 165 / Friday, August 25, 1995 / Rules
and Regulations
[[Page 44396]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. 94-022F]
RIN 0583-AB86
Use of the Term ``Fresh'' on the Labeling of Raw Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
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
