[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7217]
[Federal Register: March 28, 1994]
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Part X
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
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9 CFR 317 and 381
Mandatory Safe Handling Statements on Labeling of Raw Meat and Poultry
Products; Final Rule
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. 93-026F]
RIN 0583-AB67
Mandatory Safe Handling Statements on Labeling of Raw Meat and
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 meat and poultry products inspection regulations to make safe
handling instructions mandatory on all raw meat and poultry product
labeling. The handling instructions include a rationale statement and
address safe storage of raw product, prevention of cross-contamination,
cooking of raw product, and handling of leftovers. The rule provides
additional safeguards to protect consumers from exposure to possible
bacterial contaminants found in raw meat and poultry products. This
action is being taken in an effort to reduce the risk of foodborne
illness.
DATES: This regulation is effective May 27, 1994. The compliance date
for comminuted meat and poultry products is May 27, 1994, and the
compliance date for all other meat and poultry products is July 6,
1994.
FOR FURTHER INFORMATION CONTACT: Patrick J. Clerkin, Director,
Evaluation and Enforcement Division, Regulatory Programs, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250, (202) 254-2537.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
In publishing the proposal on November 4, 1993 (58 FR 58922), the
Agency stated that it had determined that the proposed rule was a
significant regulatory action under Executive Order 12866 because the
action would likely raise policy issues arising out of the principles
set forth in the Executive Order. The proposal advocated a significant
new policy direction that would require safe handling instructions on
raw and partially cooked meat and poultry products to further combat
foodborne illness.
The Agency published an economic analysis for comment in the
preamble to the proposed rule. That analysis incorporated comments
received in response to an earlier interim rule (58 FR 43478). As
discussed in the proposal, a preliminary economic analysis was
published for comment in the preamble of that interim rule. Most
comments addressed the cost of the rule.
In contrast to the earlier interim rule, the proposal generated
relatively few comments that criticized the analysis and the
assumptions behind the analysis. Presumably, the fewer critical
comments reflected the modifications that were made in response to data
supplied in comments on the preliminary analysis published with the
interim rule. Comments on the modified analysis published with the
proposal are discussed in the following paragraphs.
At least one commenter misunderstood the statement that: ``The
Department also anticipates that stores will utilize point-of-purchase
materials that will minimize any labor costs.'' The commenter stated
that the assertion was inaccurate because the proposed rule does not
allow for point-of-purchase information except as a supplement to the
label on each package. This statement was referring to the period after
the effective date and before April 15, 1994. Under the proposal,
before April 15, 1994, official establishments and retailers would be
allowed alternative approaches, such as point-of-purchase materials,
for affected products other than comminuted products. The Agency
included the above statement to acknowledge that there would be some
labor costs associated with point-of-purchase materials, but that such
costs could easily minimized.
The same commenter pointed out that many stores, especially smaller
ones, do not have label application guns and questioned basing the
estimate for labor costs on the use of label application guns. The
Agency was not implying that it believes that most retail stores
currently have label guns. However, since hand-held label application
guns are low cost option for applying safe handling instructions, the
Department would expect to see widespread use of such equipment.
One commenter stated that USDA has dismissed, based upon non-public
information, the cost estimates provided by the regulated industry
regarding label costs. The reference to non-public information is
related to the statement in the proposal that ``Discussions with label
manufacturers indicate that the lower prices are available for even
small quantities.''
The proposal points out that the preliminary analysis (published
with the interim rule) estimated that the cost of an additional
pressure-sensitive label would range from $.01 to $.025. That estimate
was based on discussions with label manufacturers and/or wholesale
distributors. Most of the comments on the interim rule suggest that the
preliminary estimate was accurate. In fact, the most frequent response
was that the labels would cost $.01 each. The proposal acknowledged
that some comments including one from the U.S. Small Business
Administration suggested that some retail firms were paying more.
Because the comments on the interim rule are more compelling evidence
than provided by the earlier discussions with label manufacturers, the
quoted sentence would have been better stated as ``Comments on the
interim rule support the preliminary estimate that the lower prices are
available for even small quantities.''
With respect to the comment on non-public information, the process
of conducting a preliminary regulatory cost analysis involves a wide
mix of formal surveys and informal information gathering. In this case
the preliminary estimate was based on informal discussions with 4 or 5
manufacturers and/or wholesale distributors of pressure-sensitive
labels and the fact that pressure-sensitive address labels are widely
advertised at costs ranging from $.01 to $.025. Because the details of
the specific label were not available the discussions were limited to
general questions concerning the range of costs and the relationship
between label size and cost. The information collected was not recorded
by name of firm. Individual firm confidentiality is also a standard
practice for more formal cost surveys. For example, in conducting the
regulatory impact analysis for the nutrition labeling rule, a survey
was mailed to 650 meat and poultry firms. Confidentiality of individual
responses was assured.
A comment from a meat industry trade association noted the lack of
``hard numbers'' used in the cost-vs-benefit section. This commenter
specifically questioned why the Department estimated that annual deaths
attributable to Escherichia coli 0157:H7 could range from 146 to 389.
The estimate referred to was published in Agricultural Outlook,
Economic Research Service, USDA, AO-197, June 1993. The discussion in
the preamble stated that ``the estimates in Table 1 were developed
after the epidemic outbreak of foodborne illness attributed to E. coli
0157:H7 in undercooked hamburgers from a fast-food chain in 1993.
Although the States have voted to make foodborne illness from E. coli
0157:H7, a disease that must be reported to the Center for Disease
Control and Prevention (CDC), such reporting will not be effective for
some time. Thus, cost estimates for E. coli should be reviewed as
preliminary.'' Table 1 from the proposal is repeated here also as Table
1.
Table 1.--Estimated Annual Costs for Selected Foodborne Pathogens, 1992
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Attributable
to meat and
Annual medical poultry
Pathogen\1\ Cases Deaths & productivity -------------- Costs\2\
costs Percent of
cases
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Number Number $ million Percent $ million
Bacteria:
Salmonella...................... 1,920,000 960-1,920 1,188-1,588 50 600-800
Campylobacter jejuni or coli.... 2,100,000 120-360 907-1,016 50 450-500
Escherichia coli 0157:H7........ 7,668-20,448 146-389 229-610 50 100-300
Listeria monocytogenes.......... 1,526-1,581 378-433 209-233 50 100
Parasites:
Toxoplasma gondii\3\............ 2,090 42 2,628 100 2,630
Trichinella spiralis............ 131 0 0.8 100 0
Taenia saginata................. 894 0 0.2 100 0
Taenia solium\4\................ 210 0 0.1 100 0
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Total......................... ............... ........... 5,162-6,076 ............ 3,880-4,330
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\1\Analysis assumes 100% of human illnesses are foodborne for Campylobacter, Escherichia coli, Trichinella, and
the Taenias and assumes 96% of Salmonella cases, 85% of Listeria cases, and 50% of Toxoplasma cases are
foodborne. Meat and poultry are assumed to be responsible for 100% of foodborne parasitic diseases and 50% of
foodborne bacterial diseases.
\2\Estimates rounded.
\3\Productivity losses are high for survivors who develop mental retardation or blindness as a result of
toxoplasmosis. These costs exclude toxoplasmic encephalitis infections in 2,250 to 10,200 AIDS patients
annually which are a significant cause of premature death (50% of cases may also have a foodborne origin).
\4\Costs are estimated at less than $0.1 million, although estimates do not include costs for cysterlcercosis
which may have an indirect foodborne transmission.
Reference: Agricultural Outlook, Economic Research Service, USDA, AO-197 (June 1993), pp 32-36.
The Agricultural Outlook publication (which was available in the
FSIS Hearing Clerk's office) states that ``CDC researchers estimate
that between 7,668 and 20,448 persons became ill from exposure to E.
coli 0157:H7 annually in the U.S.'' The range in estimated deaths is
directly related to the range in the CDC estimate for number of cases.
CDC researchers have estimated that 1.9 percent of the 7,668 to 20,448
cases result in death.
Several comments point out that costs are affected by the effective
date, especially in view of the upcoming implementation date for
nutrition labeling. The Department agrees that costs are affected by
the implementation schedule. However, it is beyond the scope of the
cost analysis to be able to differentiate or estimate the cost savings
that would be attributable to processors and retailers having an
additional 30 or 60 days to comply. The issue of effective date is
discussed elsewhere under comments related to the implementation
schedule.
One comment alleged that the Department did not make sufficient
supporting material available to the public, particularly in the area
of the cost and benefit analysis. The data from Table 1 represents the
latest and best estimates of the cost of foodborne illness prepared by
the Department's Economic Research Service (ERS). ERS has been
publishing articles on their cost of foodborne illness research for
more than a decade. The methodology has been refined and updated over
time. From the perspective of Executive Order 12866, the relevant
information is the available data on costs and benefits that is based
on the latest methodology. The Department is not obligated to identify
all the materials that have been published during the development and
refinement of these methods.
Another comment stated that USDA failed to place on the record any
studies or other information relied upon by USDA regarding foodborne
illnesses other than E. coli 0157:H7. The Agricultural Outlook article
summarizes CDC findings for all foodborne diseases caused by bacterial
and parasitic agents.
While recognizing that in the majority of cases, the cause is
unknown, CDC has found that when a source or likely source is
identified, approximately 50 percent of cases of all foodborne diseases
are associated with meat or poultry products. The CDC analysis supports
the ERS estimates that meat and poultry are associated with
approximately 50 percent of foodborne bacterial diseases.
A supermarket chain commented that scale upgrades would cost almost
$500,000, or approximately $9,700 per store. While this cost is
slightly outside the estimate of $6,000 to $9,000 used in the analysis,
changing the range from $6,000 to $10,000 would not have an effect on
the net benefit conclusions.
The same commenter pointed out that upgrading equipment does not
eliminate labor costs, since there would always be some items that were
not compatible with automated equipment and would have to be done by
hand. The Department agrees, but accounting for this in the analytical
model would have minimal effect on net benefits.
A large processor commented that the Agency did not include in its
cost estimate many of the significant costs associated with label
redesign. The analysis did recognize that the cost of revising a label
varies widely and that variation is included in the estimate of a one-
time cost for processors of $50 to $100 million. The Agency is aware
that some firms spend several thousand dollars on label revisions.
Other firms spend far less. The Department considers an average cost of
$1,000 per label to be a reasonable estimate for an average cost for a
label revision of this type.
A supermarket chain from a large urban area submitted a detailed
estimate of its costs using a labor rate of $24.00 per hour. The cost
analysis used a labor rate of approximately $10.00 per hour. The
Department recognizes that wages will vary widely. Aggregate cost and
benefit analyses must, however, be based on national averages.
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirement on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA or PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat and poultry products that are misbranded or
adulterated under the FMIA or PPIA, or, in the case of imported
articles, which are not at such an establishment, after their entry
into the United States. Under the FMIA and PPIA, States that maintain
meat and poultry inspection programs must impose requirements that are
at least equal to those required under the FMIA and 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 306.5 and 381.35 must be
exhausted prior to any judicial challenge of the application of the
provisions of this rule, if the challenge involves any decision of an
inspector relating to inspection services provided under the FMIA or
PPIA. The administrative procedures specified in 9 CFR 335 and 381,
Subpart W, must be exhausted prior to any judicial challenge of the
application of the provisions of this rule with respect to labeling
decisions.
Effect on Small Entities
The Administrator has determined that this final rule will not have
a significant economic impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
The rule will affect a substantial number of small entities, but the
economic impact on such small entities will not be significant.
The final rule affects both retail stores and inspected
establishments. In 1991, USDA estimated there were 253,000 foodstores
in the United States. These stores are categorized as follows:
Supermarkets................................................. 23,813
(Sales >$2.5 million each)
Superettes................................................... 94,647
(Sales <$2.5 million each)
Convenience Stores........................................... 51,700
Specialty stores............................................. 82,895
Total.................................................. 253,055
Most of the small businesses affected would be superettes and
specialty stores, such as meat markets, butcher shops, and locker
plants. The specialty store category includes a large number of small
businesses that do not sell meat and poultry products, e.g.,
confectionery stores. Most convenience stores do not sell raw or
partially cooked meat and poultry products.
The Department recognizes that small retail firms would experience
the greatest relative ongoing costs because they may not be able to
afford new or modified equipment that can minimize costs. However, the
public health risks do not allow for alternative small business
considerations. At least one of the recent foodborne illness incidents
described in the interim rule referred to earlier involved ground beef
sold through a small market in a small community.
Background
Introduction
The Secretary of Agriculture has statutory authority to require
meat and poultry products to bear labels including such ``information
as the Secretary may require * * * to assure that * * * the public will
be informed of the manner of handling required to maintain the article
in a wholesome condition.'' Federal Meat Inspection Act, 21 U.S.C. 601
(n) (12); Poultry Products Inspection Act, 21 U.S.C. 453 (h) (12). The
Secretary issued an interim final rule on August 16, 1993, requiring
raw and partially cooked meat and poultry products to carry safe
handling instructions, effective October 15, 1993 (58 FR 43478), and
solicited comments for 30 days. In light of these comments, the
Secretary issued a final rule on October 12, 1993, which made
significant changes in response to the comments (58 FR 52856). Due to
continued outbreaks of foodborne illness involving meat and poultry
products which resulted in serious illness and death, the Secretary
invoked the ``good cause'' exception to the notice and comment
requirement of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)(13)(B)).
On September 23, 1993, the Texas Food Industry Association, the
National American Wholesale Grocers' Association, the International
Foodservice Distributors Association, and the National Grocers
Association filed a complaint in the United States District Court for
the Western District of Texas (District Court) alleging that the
issuance of the interim rule violated the APA and requested that the
Court issue a preliminary injunction.
On October 14, the District Court granted plaintiffs' request for a
preliminary injunction and enjoined the Department from enforcing or
implementing the interim or final regulations against the plaintiffs or
any other affected entities or individuals. The Department filed a
motion with the United States Court of Appeals for the Fifth Circuit on
October 15 to stay the preliminary injunction and allow the safe
handling regulations to take effect. This motion was denied on October
19, 1993.
While the Department believed it would prevail on the APA issue in
further litigation, it recognized that a notice and comment rulemaking
would take less time than further litigating the APA issue with the
plaintiffs. Due to the importance of protecting public health and the
related need to provide this crucial information to consumers as
quickly as possible, the Department published simultaneously on
November 4, 1993, a proposal to amend the regulations to require safe
handling instructions on raw and partially cooked meat and poultry
products, and a final rule withdrawing the provisions of the interim
and final rules (58 FR 43478 and 58 FR 52856).
Authority
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.)
direct the Secretary of Agriculture to maintain meat and poultry
inspection programs designed to assure consumers that meat and poultry
products distributed to them (including imports) are wholesome, not
adulterated, and properly marked, labeled, and packaged.
Section 2 of the FMIA (21 U.S.C. 602) and section 2 of the PPIA (21
U.S.C. 451) state that unwholesome, adulterated, or misbranded meat or
meat food products and poultry products are injurious to the public
welfare, destroy markets for wholesome, not adulterated, and properly
marked, labeled, and packaged products, and result in sundry losses to
producers and processors of meat and poultry products, as well as
injury to consumers. Therefore, Congress has granted the Secretary
authority to regulate meat, meat food products, and poultry products to
protect consumers' health and welfare. Subsection 1(n)(12) of the FMIA
(21 U.S.C. 601(n)(12)) and subsection 4 (h)(12) of the PPIA (21 U.S.C.
453(h)(12)) state that the term ``misbranded'' applies to any product
if it fails to bear, directly thereon or on its container, as the
Secretary may be regulations prescribe, the inspection legend, and
unrestricted by any of the foregoing, such information as the Secretary
may require in such regulations to assure that it will not have false
or misleading labeling and that the public will be informed of the
manner of handling required to maintain the article in a wholesome
condition. Section 7(d) of the FMIA (21 U.S.C. 607(d)) states: ``No
article subject to this title shall be sold or offered for sale by any
person, firm, or corporation, in commerce, under any name or other
marking or labeling which is false or misleading, or in any container
of a misleading form or size, but established trade names and other
marking and labeling and containers which are not false or misleading
and which are approved by the Secretary are permitted.'' The PPIA
contains similar language in section 8(c) (21 U.S.C. 457(c)).
Safe Handling Labeling Instructions
In 1972, the American Public Health Association, individual
consumers, and six other public health and consumer interest groups
brought suit in the U.S. District Court for the District of Columbia
against the U.S. Department of Agriculture alleging that labels placed
on meat and poultry products were false and misleading because they
failed to warn consumers against the dangers of foodborne illness
caused by Salmonella and other bacteria in such products. The Court of
Appeals affirmed the District Court's order dismissing the action, and
ruled that the Secretary of Agriculture did not abuse his discretion by
choosing to undertake a consumer education program instead of requiring
labeling instructions for meat and poultry products. Since that ruling,
USDA has conducted a massive and increasingly targeted food safety
campaign to inform consumers about safe handling and cooking of meat
and poultry products. FSIS has offered a toll-free nationwide hotline,
staffed by food safety specialists, and conducted campaigns, directed
at such specialized audiences as food handlers, institutions, health
professionals, and at-risk populations, as well as food handlers in the
home. Additionally, FSIS has permitted the voluntary labeling of
poultry products with safe handling instructions since 1987. FSIS does
not monitor participation in voluntary labeling; however, one trade
association has said that 75 percent of its members offer handling
instructions on their labels.
New Policy Direction
In recent years, FSIS has been aware that a growing percentage of
the U.S. population consists of persons lacking experience in food
preparation and knowledge of safe food handling and storage methods.
Studies of foodborne illness outbreaks have repeatedly shown improper
food handling to be the frequent cause of foodborne illnesses. Improper
cooling of cooked foods has been ranked as the leading factor. Other
factors cited included inadequate cooking, cross-contamination, and
inadequate reheating.
Studies of consumer knowledge and practices indicate that a
significant number lack basic food safety information and skills,
particularly with respect to the relationship between temperature and
foodborne illness.
Information from the CDC revealed that: (1) Undercooking was a
factor in 108 of 345 (31.3 percent) home outbreaks of foodborne illness
that occurred between 1973 and 1982 (data include all foods); and (2)
cooking foods ahead, i.e., 12 hours or more before serving, was a
factor in 12.8 percent of the home outbreaks.
While the Agency has long been committed to a program of consumer
education to help prevent foodborne illness, as exemplified by its
distribution of publications for consumers and its Meat and Poultry
Hotline, it has become convinced of the need for more direct methods of
placing food safety information in the hands of consumers. Thus, Agency
officials in early January 1993 began to advocate in their speeches and
writings that the mandatory safe handling instructions on the labeling
of meat and poultry products was a necessary component of a program to
combat foodborne illness.
The Agency's new policy direction gained additional impetus
following the January 1993 outbreaks of a severe foodborne illness that
led to four deaths among approximately 500 confirmed cases in
Washington, Idaho, California, and Nevada. The outbreaks were linked to
the pathogenic bacterial strain E. coli 0157:H7. Because most of the
cases were attributed to undercooked hamburgers served at a fast-food
restaurant chain, Federal and local authorities have intensified their
regulatory activities. In June and July of 1993, the Department became
aware of nine separate incidents where E. coli 0157:H7 was the direct
or suspected cause of illness or death. The incidents led the
Department to conclude that it was time to immediately require safe
handling information on raw and partially cooked meat and poultry
products. On August 16, 1993, FSIS published in the Federal Register an
interim rule (58 FR 43478) mandating safe handling instructions on all
raw and partially cooked meat and poultry product labeling. Also, FSIS
established a permanent liaison position with the CDC. The
responsibilities of this position include monitoring and tracking all
E. coli epidemics reported to the CDC. Preliminary data for 1993 from
CDC indicates 17 reported clusters of E. coli 0157:H7 infections. Many
of these cases occurred after publication of the interim rule.
Several noteworthy developments in previously cited cases of
foodborne illness and new incidents, not reported in the prior
rulemaking publication, which reinforce the exigent need for safe
handling instructions are summarized below:
Reading, CT
The Connecticut Department of Health investigated an outbreak of E.
coli 0157:H7 that appeared to be linked to a country club. Four cases
of E. coli 0157:H7 were positively linked to undercooked hamburger
patties served at the Reading Country Club. E. coli 0157:H7 was
isolated by the Connecticut State Lab and the FSIS Beltsville Lab.
Ft. Bragg, CA
The Mendocino County Health Department reported confirmed cases of
E. coli 0157:H7 in a 13 year old girl and an 84 year old woman in Ft.
Bragg. The two cases appeared unrelated except that both victims
consumed home-cooked hamburgers which may have been made from ground
beef purchased at the same supermarket during the same time period.
FSIS isolated E. coli 0157:H7 from ground beef returned to the market
as well as a patty from the residence where the 13 year old girl had
eaten.
Texas
A total of 10 separate cases E. coli 0157:H7 occurring over a 6-
week period in the autumn of 1993 are being investigated by the Texas
Health Department. These included three cases that resulted in
hemolytic uremic syndrome and one death. No common source has been
identified.
Parameters of Good Safety
After reviewing available information, FSIS in conjunction with the
Food and Drug Administration (FDA) identified the following parameters
of safe handling by consumers: How to safely store raw product and thaw
frozen product; how to avoid cross-contamination during preparation;
how to cook for optimal safety and palatability; and, how to store
leftovers after preparation. For institutions, hot holding of prepared
food is an additional parameter. (The term institutions as used
throughout this preamble includes hotels, restaurants, or similar
institutions.) In addition, the Agency proposed that the safe handling
instructions include a rationale statement specifying the reason why it
is important to follow such instructions. The Agency believes that
consumers will pay more attention to the safe handling instructions if
they understand that mishandling will lead to the growth of bacteria
and possibly to illness.
Labeling
Various methods have been used in the past to inform consumers of
handling instructions. Such methods have included putting the
instructions on the product label, on inserts, on tags attached to the
product, and on point-of-purchase materials displayed near the product
at the point of sale. FSIS has concluded that the outside label is the
most appropriate location for safe handling instructions.
The Agency considered three options for presenting safe handling
information on the label. These options included long word messages,
short word messages, and short word messages with symbols or graphic
representations to accompany the message. To collect information on
which format would most effectively influence consumer behavior, FSIS
initiated consumer focus-study research.
In the FSIS initiated consumer focus-study, most participants
wanted to see safe handling instructions on raw meat and poultry
products. Consumers in the study expressed a preference for the safe
handling instructions to be on the package label and felt that other
labeling, such as pamphlets or in-store signs, should only be used to
supplement package labels. Instructions with graphic illustrations were
generally preferred to those without graphic illustrations and the
short word messages were preferred to the long word messages. Also,
most participants of the focus-study research felt that the rationale
statement was a necessary part of the safe handling instructions.
Current Regulations
The Federal meat and poultry products inspection regulations
currently require the placement of safe handling statements on packaged
products that require special handling to maintain their wholesome
condition. Sections 317.2 and 381.125 of the Federal meat and poultry
products inspection regulations (9 CFR 317.2(k) and 9 CFR 381.125,
respectively) provide that packaged products which require special
handling to maintain their wholesome condition shall have prominently
displayed on the principal display panel of the label the statement:
``Keep Refrigerated,'' ``Keep Frozen,'' ``Perishable Keep Under
Refrigeration,'' or such similar statement as the Administrator may
approve in specific cases.
Proposal
FSIS proposed to amend the Federal meat and poultry products
inspection regulations to mandate the inclusion of safe handling
instructions on the labeling of raw and partially cooked meat and
poultry products along with a rationale statement to indicate the
reason why it is important to follow such handling instructions. The
Department has established required cooking temperatures for certain
beef, poultry, and patty products. These requirements are set forth at
9 CFR 318.17, 381.150, and 318.23, respectively. The proposed rule
applied the beef temperature requirements to beef, swine, sheep, goat,
horse, and other equine. The Department has also established processing
requirements for the curing or other treatment of certain meat products
to control microbial activity. Some of these products are identified in
part 319 of the meat inspection regulations. These cooked products,
e.g., cooked sausage, and some products that have been otherwise
further processed so as to render them ready-to-eat, e.g., dry
fermented sausage, are not considered to be at sufficient risk of
microbial contamination to warrant the application of safe handling
labels. However, some products that are traditionally considered ready-
to-eat receive no lethal heat treatment and may not be pathogen free.
FSIS is reevaluating its policies and regulations governing these
products and plans to propose a regulation requiring that these
products either bear the safe handling instructions or be processed in
such a manner as to assure the destruction of pathogens.
FSIS proposed to permit official establishment and retailers to use
alternate approaches to deliver the safe handling instructions until
April 15, 1994, except for comminuted products. For comminuted
products, FSIS proposed to require that safe handling instructions be
included on the label within 30 days after publication of the final
rule.
The alternate approaches presented in the proposed rule are: (1)
Official establishments may include in the shipping container either
pressure-sensitive labels containing the safe handling instructions for
retailers to apply to packages or leaflets containing a facsimile of
the safe handling instructions in lettering no smaller than one one-
sixteenth of an inch for retailers to place in close proximity to the
packages to ensure that leaflets are likely to be seen and taken home
by consumers; and (2) retailers may distribute leaflets containing the
facsimile described above.
In some cases, it was expected that retailers might prefer
pressure-sensitive labels or leaflets of their own design and
manufacture to those that an official establishment would provide under
the permitted alternative. FSIS proposed that if a retailer notifies an
official establishment in writing that it intends to supply its own
labels or labeling, the official establishment would not be required to
supply the materials in the shipping container.
The following rationale statement was proposed for products
prepared from inspected and passed meat and/or poultry: This product
was prepared from inspected and passed meat and/or poultry. Some food
products may contain bacteria that could cause illness if the product
is mishandled or cooked improperly. For your protection, follow these
safe handling instructions.
FSIS proposed the following rationale statement for poultry
slaughtered under exemptions specified in 9 CFR 381.10: Some food
products may contain bacteria that could cause illness if the product
is mishandled or cooked improperly. For your protection, follow these
safe handling instructions.
FSIS proposed the following four safe handling statements for use
on the label of both red meat and poultry products distributed to both
household consumers and institutions: (1) Keep refrigerated or frozen.
Thaw in refrigerator or microwave. (Any portion of this statement that
is in conflict with the product's specific handling instructions, may
be omitted.) (A graphic illustration of a refrigerator shall be
displayed next to the statement.); (2) Keep raw meat and poultry
separate from other foods. Wash working surfaces (including cutting
boards), utensils, and hands after touching raw meat or poultry. (A
graphic illustration of soapy hands under a faucet shall be displayed
next to the statement.); (3) Cook thoroughly. (A graphic illustration
of a skillet shall be displayed next to the statement.); and (4) Keep
hot foods hot. Refrigerate leftovers immediately or discard. (A graphic
illustration of a thermometer shall be displayed next to the
statement.)
The label for safe handling instructions is shown in Exhibit 1.
BILLING CODE 3410-DM-M
EXHIBIT 1
TR28MR94.001
BILLING CODE 3410-DM-C
FSIS proposed that safe handling instructions may appear anywhere
on the label where they would likely to be read. The proposal also
required the safe handling instructions to be set off by a border and
to one color type printed on a single color contrasting background.
FSIS proposed to exempt products intended for further processing by
an inspected establishment from mandatory safe handling labeling
requirements. Since products for further processing by another Federal
or State establishment will not be available to consumers or food
service institutions, FSIS did not believe that it was necessary to
require safe handling instructions on such packaging.
FSIS proposed to allow safe handling instructions to be added to
labels by the manufacturer and to be approved under the provisions of
generic label approval since the regulations prescribe the exact
language of the safe handling instructions.
Discussion of Comments
The FSIS Hearing Clerk received 60 comments on the proposed rule.
Commenters included consumers, representatives of consumer and other
interest groups, State meat and poultry inspection officials,
representatives and associations of retail stores, representatives and
associations of official meat and poultry establishments, two U.S.
Department of Agriculture Agencies, and others.
The following discussion of comments follows the general structure
of the proposed rule. General concerns are addressed in the context of
specific features of the rule. Where the concerns cannot be logically
addressed in the context of specific sections of the rule, they are
presented under a ``Miscellaneous Issues'' section. Changes made in the
final rule are described so that it is apparent how they address the
concerns of commenters. Where the Agency addresses the meat
regulations, conforming changes are also made in the poultry
regulations. Any changes unique to either the meat or poultry
regulations are identified.
Miscellaneous Issues
One commenter suggested that the comment period should be extended
and that additional information that FSIS used in formulating and
supporting the regulation should be placed on the regulatory record. We
disagree with this comment and not that FSIS had made publicly
available, as part of this rulemaking proceeding, all relevant data
upon which the regulation is based, including: the August 16, 1993
interim rule and all comments received in response thereto; the studies
referenced in the interim rule; the October 12, 1993 final rule;
questions and answer papers formulated in response to questions raised
by the interim rule; the November 4, 1993 Notice of Proposed Rulemaking
and all comments received in response thereto; all studies referenced
in the Notice of Proposed Rulemaking, including the Focus-Study
Research and Agricultural Outlook (June, 1993); and documentation of
oral presentations made in the course of the rulemaking proceeding.
The majority of commenters supported the labeling of products with
safe handling instructions. Several commenters objected to mandatory
labeling stating either that other methods of educating consumers would
be more appropriate, that the required labeling would be ineffective,
that labeling is not a substitute for proper training of safe food
handling, that requiring a simple label can not guarantee any consumer
will follow that label, or that some products currently include
sufficient safe handling instructions which make the proposed safe
handling label unnecessary. Seven commenters stated that many existing
products contain much more helpful and meaningful handling and
preparation information than that required by the proposed regulation.
One also questioned whether the information contained in the proposed
statements is so demonstrably more effective than the safe handling
instructions currently in use on meat and poultry so as to justify the
millions of dollars in conversion costs. They also suggest that to
prohibit alternative language is unnecessarily restrictive and may
preclude a more effective way of conveying the message intended. Five
commenters suggested that labeling is only one option and point-of-
purchase materials or other types of signs may be equally effective or
more effective in instructing the consumer about safe food handling.
FSIS does not agree with these comments. The focus-study research
asked participants about other alternatives for safe handling
instructions. Participants in the focus-study research expressed a
preference for safe handling instructions to be on the package label
and felt other labeling, such as pamphlets or in-store signs, should
only be used to supplement package labels, but not replace the package
labels. The safe handling instructions are not meant to substitute for
comprehensive training of safe handling procedures either in the home
or food service setting. The instructions primarily alert food
preparers that there is a risk of illness if products are mishandled or
improperly cooked, and it addresses four broad parameters of food
safety. Finally, FSIS does not believe that current handling
instructions on labels will make safe handling instructions
unnecessary. The safe handling instructions are not meant to replace
more comprehensive cooking instructions found on products. In addition,
current labeling may cover the four broad parameters of food safety,
but does not include a rationale statement explaining to food preparers
why it is important to follow the instructions. The focus-study
research found that the rationale statement was an essential feature of
the label.
Officials from two retail stores and two retail associations
suggested that the regulations have a sunset provision and that the
effectiveness of the regulation be studied periodically. Five
additional commenters suggested that the effectiveness of the
regulation be evaluated. Several suggested annual reports be sent to
the Secretary of Agriculture for review and one requested that FSIS
publish a method to measure the effectiveness of the regulation as part
of the final rule. There are no changes in the final rule in response
to these comments. The Regulatory Flexibility Act already provides that
Agencies will periodically review regulations. While this does not have
the same effect as a sunset provision, it does insure that the
continuing appropriateness of regulations will be assessed. Further,
there is no way to quantify the effectiveness of the regulation. It is
impossible to determine how many cases of foodborne illness were
prevented by the inclusion of these instructions on the labels of raw
and partially cooked meat and poultry products.
Twelve commenters addressed the four sets of ``Questions and
Answers (Q&A's)'' that FSIS disseminated between August 20 and
September 15, 1993. Suggestions included codifying the Q&A's as part of
the final rule, adding the Q&A's to the proposal and reopening the
comment period to allow all interested parties an opportunity to
comment on the Q&A's, and including specific responses either in the
regulatory language or the preamble of the final rule. Four issues
specifically cited were the status of export products, retroactive
labeling of products, placement of information on hang tags and on the
bottom of trays, and safe handling information requirements for multi-
component products which include a meat or poultry portion that is
fully cooked or otherwise processed so as to render it ready-to-eat.
FSIS does not believe that these Q&A's need to be part of the
regulatory language of the final rule. The Q&A's either cited other
regulations within Title 9 or provided interpretations of how the safe
handling regulation would be applied in specific situations.
In addition, the Q&A's, in large part, related to the interim rule,
which was withdrawn. However, we will address the specific questions
raised by the commenters. Regarding the need for export products to
carry safe handling instructions, the condition under which deviations
from labeling requirements are permitted are already set out in 9 CFR
317.7 and 9 CFR 381.128. FSIS will not require retroactive labeling of
products, products labeled on or after the effective date will be
required to carry safe handling instruction on the label. Products
labeled prior to the effective date will not require the addition of
safe handling instructions. For example, products in frozen storage,
labeled prior to the effective date but shipped afterwards, will not be
required to add the safe handling instructions. Regarding the placement
of safe handling instructions on hang tags or the bottom of trays, FSIS
has considered hang tags to be an extension of the label and
consequently they may contain required label features such as safe
handling instructions. Also, the instructions may be placed on the
bottom of trays as long as they are visible at time of purchase. This
is evident in the language of the proposed and final rules that state
the safe handling instructions, ``shall be prominently placed 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 consumer under customary conditions of
purchase and use.'' Finally, as to whether safe handling instructions
need to be on products that include a fully cooked meat filling but
where the total product requires cooking, e.g., a fully cooked meat
filling in uncooked dough: the rule does not require safe handling
instructions on products where the meat or poultry portion is fully
cooked or otherwise processed to render that portion ready-to-eat.
However, while such products do not require safe handling instructions
they are not considered ready-to-eat products.
One commenter suggested that FSIS implement appropriate compliance
procedures for safe handling labels, stating the hope that ``after all
the commotion and rhetoric accompanying this present rule that more
effort will be made to assure not only compliance with it but with all
the other regulatory initiatives that are sorely in need of the
Department's attention.'' FSIS appreciates the concern of this
commenter. It is envisioned that the monitoring of compliance with
these requirements will follow the current model of enforcement of
misbranding of products at the retail level. Jurisdiction is primarily
exercised by State and local food regulatory agencies. Local codes
generally require that food be fully labeled in conformance with
requirements of agencies having jurisdiction over the product. FSIS and
State meat and poultry inspection programs also monitor meat and
poultry products in commerce. If products are found out of compliance
with these requirements, they generally require that the specific
product be brought into compliance or other appropriate action is
taken. FSIS anticipates that initial compliance monitoring of this
labeling requirement will have an educational focus. Where
noncompliance is found, FSIS Compliance and other enforcement officials
will provide guidance on these labeling requirements. Where it is
apparent that businesses are making a good faith effort to comply with
these requirements, they will not be subject to enforcement action.
One commenter suggested that FSIS replace the term ``comminuted''
with a different term such as ``non-whole muscle'' products because
historically, ``comminuted'' has been used to include only very finely
ground meat and poultry products produced from by-products of other
whole muscle operations. FSIS does not agree with this comment. Other
FSIS regulations, including the August 2, 1993, pattie regulation (58
FR 41138), have defined ``comminuted'' as a processing term used to
describe the reduction in size of pieces of meat or poultry, and
includes chopping, flaking, grinding, and mincing.
One commenter was concerned that styrofoam trays are sometimes
reused in children's crafts and that such a use poses risks. The
commenter suggested that these trays should include a message saying to
discard them. Meat packed in styrofoam trays could pose a potential
health risk if ready-to-eat food products are stored in an unwashed
tray. Use of these materials by school children has not resulted in any
reported foodborne illness. FSIS believes that most consumers either
discard the trays or wash them before giving them to their children to
use. On this basis, FSIS does not believe a message is needed to
address this concern.
One commenter suggested that the Department introduce two new
categories of product that could be sold in addition to the current
products that are labeled ``USDA Inspected and Passed (or For
Wholesomeness).'' The first category would be ``USDA Inspected for
Cosmetics and Marketing Defects Only--Not Health Hazards,'' and the
second category would be ``Uninspected.'' Both of the new categories
would be required to include safe handling information on the label.
Products meeting the criteria to be labeled ``USDA Inspected and Passed
(or For Wholesomeness)'' would not be required to include safe handling
information.
The Agency does not agree with this commenter. The ``USDA Inspected
and Passed'' logo represents an assurance that products are derived
only from animals slaughtered under inspection; contain only
ingredients from approved sources; are processed in a sanitary
environment; and, are processed in accordance with accepted Good
Manufacturing Practices. All these assurances are of health and safety
concern. The Agency does not agree with an assertion that failure to
assure that raw meat and poultry products are sterile reduces
inspectional efficacy to assuring only the absence of cosmetic and
marketing defects. Inspection of the processing of cooked products is
designed to assure a commercially sterile product. Requiring safe
handling instructions on the labels of raw and partially cooked meat
and poultry products is the appropriate step to alert consumers to the
practical limits of the assurance represented by the ``USDA Inspected
and Passed'' logo.
Some commenters suggested that the focus-study research results
were misused. Specifically, they state that FSIS is mandating a
nationwide labeling plan based on the input of 86 individuals. They
also cited a statement in the final report on the focus-study research
that cautioned that the findings of focus-study research should not be
generalized to a larger population in any statistical sense. FSIS does
not believe that its use of the focus-study research findings was
inappropriate. Consumers have an important role in assuring meat and
poultry are safe to eat. Safe handling labels are a part of the
Agency's consumer education campaign. The focus-study research was used
to obtain consumer feedback on three label formats proposed by FSIS.
The process used was consistent with generally recognized focus group
methodology. Focus-study research provides a richness of detail not
possible in more structured quantitative research. Focus groups are
highly effective for developing understanding and insight into consumer
behavior and thinking. The Agency was responsive to focus-study
research suggestions as well as public comments in formulating the
previous final regulation on safe handling instructions. As previously
cited, participants in the focus-study research expressed a preference
for safe handling instructions to be on the package label and felt
other labeling, such as pamphlets or in-store signs, should only be
used to supplement package labels, but not replace the package labels.
Implementation Date
Representatives from many official establishments and their
associations, retail stores and their associations, as well as
officials of State meat and poultry inspection programs strongly
recommended that the effective date of the rule be extended. The most
frequently mentioned date was July 6, 1994, to coincide with the
effective date for nutrition labeling. Many noted that a 30 day
implementation time was not feasible. Retailers state that it will take
a minimum of 60 days to either receive and install new equipment or
receive new labels, taking into account the lag time from publication
of a final rule to receiving the new regulation, and ordering and
delivery of equipment or labels. Federally inspected establishments and
trade associations commenting on the 30-day implementation timeframe
offered varied estimates of the time required to make label changes.
These ranged from 4 weeks to 4 months. In addition, several commenters
stated that pressure-sensitive stickers pose feasibility problems,
including inability of the stickers to remain on the product through
processing, lack of adequate space on the current label to place the
sticker without obscuring other mandatory features, and extremely high
labor costs due to the need to add a labor intensive manual process
step where businesses currently use high speed equipment that cannot be
easily or economically retrofitted to apply the stickers.
The National Association of State Departments of Agriculture states
that ``FSIS should consider delaying the implementation to July 6,
1994, to provide an opportunity to educate not only the public, but
also those who must enforce the requirement and encourage the public to
follow the guidelines. It is essential that FSIS provide a lead time to
furnish state officials with accurate and reliable information before
the regulation is implemented.'' One retail store also stated that 30
days did not provide the time necessary to properly train employees.
Regarding FSIS's suggestion that companies revise their nutrition
labeling timetable to coincide with safe handling, one official
establishment wrote, ``it is not practical to simply `revise our
timetable for nutrition labeling' as FSIS has stated. There is a great
deal of analysis, planning, and designing that goes into each nutrition
panel. It is simply not a case of printing information that is already
dictated as is the case for the handling instructions.'' Additionally,
one commenter questioned whether the incremental cost of complying with
the label requirement versus the pamphleting option during the April 15
and July 6 period for noncomminuted products could be justified by any
demonstrable benefit. However, one consumer group requested that
implementation of these requirements not be delayed for any reason,
because of the risks of foodborne illness associated with raw meat and
poultry.
FSIS has been persuaded by the comments that in some cases it might
be impractical to achieve compliance with a 30-day implementation
requirement for comminuted products and an April 15 requirement for
other products. However, the Agency does not agree that businesses will
require 4 months to comply. A commenter that calculated 4 months as a
minimum included time for sketch approval by FSIS in its calculation.
That step is not required for these generically approved labels. They
also included a period of time to exhaust preexisting label
inventories. This is not a factor that impacts on the feasibility of
obtaining complying labels. Additionally, they did not consider such
alternatives to complete label redesign as pressure-sensitive labels.
The latter approach could obviate both time concerns and concerns over
utilization of existing label inventories. Finally, many firms
demonstrated the ability to make the required label changes within the
2 months following the publication of the interim rule on August 16,
1993. Their performance certainly belies the notion that 4 months is a
minimum required to achieve compliance.
FSIS will extend the implementation requirement for the labeling of
comminuted products to 60 days after publication and the labeling of
other products to July 6, 1994. The Agency believes that the high level
of voluntary compliance before these required dates will minimize the
impact of extending the timeframes for implementation and eliminating
the pamphleting requirement. The Agency believes that these extended
timelines will provide retailers as well as establishments the needed
time for those companies having difficulty obtaining the necessary
labeling. Additionally, it will allow some businesses to make one label
change to incorporate both safe handling instructions and nutrition
labeling at a cost savings. Many retailers as well as official
establishments have already voluntarily complied with this regulation
by providing safe handling labels, brochures and other point of sale
information. In addition, the Department's educational efforts to
inform the public of the need to safely handle and prepare meat and
poultry as well as other food products along with publicity surrounding
the rule has increased the public's awareness of the necessity and
requirements of safe food handling. A major joint voluntary effort to
educate consumers began last year. The Food Marketing Institute, the
American Meat Institute and the National Livestock and Meat Board, in
cooperation with the USDA and FDA, developed ``A Consumer Guide to Safe
Handling and Preparation of Ground Meat and Ground Poultry.'' The
brochures are for consumers and for food service operators. Each
brochure discusses proper handling, preparation and storage methods for
ground meat and ground poultry and emphasizes three key points (the
three C's): keep it cold; keep it clean; and cook it. These interim
measures should minimize the impact of extending the timelines for
implementation of these labeling requirements.
Three commenters suggested that FSIS permit companies up to 18
months to exhaust supplies of labels that do not include the safe
handling instructions since it would be an economic and environmental
burden to discard packaging materials. One commenter cited the
nutrition regulation which gave an 18 month implementation time and
suggested a similar implementation time. Three additional commenters
requested that FSIS permit companies up to 1 year after the effective
date of the regulation to use labels with safe handling instructions
required by the interim rule. They state that materials were ordered in
good faith to comply with the interim rule and it would be an economic
burden to destroy such materials. Commenters stated that due to low
volume sales of certain products, they expect to have over a year's
supply of labels with the original safe handling instructions.
FSIS does not believe that 18 months or even 1 year should be given
to exhaust packaging materials that do not include the safe handling
instructions. Implementation time required for the nutrition
regulations cannot be compared to the safe handling regulations since
the two are very different. The safe handling regulations prescribe the
exact language required on the label and do not require time consuming
laboratory analysis or interpretation of extensive rules regarding
formats, serving sizes, claims, etc. However, FSIS has been persuaded
by the comments to permit safe handling instructions provided in both
the August 16, 1993, interim rule and the October 12, 1993, final rule
to be used for 1 year past the effective date of this final rule. The
label required under this final rule is unchanged from the label
required in the October 12, 1993, final rule.
Product Appropriateness and Inclusiveness
Eleven commenters suggested that we narrow the focus of the
regulation making safe handling instructions mandatory on ground meat
and poultry products and voluntary on all other meat and poultry
products. Many stated that the proposed rule was overly broad and that
no evidence was presented to support the requirement of safe handling
instructions on products other than ground products. They suggested the
labeling effort would be more effective if ground products were
targeted so that the information would have a proper impact with
consumers. In addition, they stated that to blanket every package in
the meat case with the same message would in effect make the message
invisible because it would be so repetitive.
Several commenters questioning the scope of the regulation cited
information from the preamble of the August 2, 1993, Uncured Meat
Pattie regulation which stated ``The likelihood of foodborne illness is
not the same in all beef products or all hamburger-type products.
Ground meat presents a different risk than whole muscle cuts such as
steaks, roasts, or chops * * * the production process for ground meat
assures that any present pathogens will be distributed throughout the
product, including the interior, while bacteria tend to remain on the
surface of steaks, roasts, and chops. This factor has major
implications for the cooking process. Because a rare steak is
thoroughly cooked at the surface, one can presume that pathogenic
bacteria present are killed.'' They proposed limiting this labeling to
ground products. One additional commenter objected to pork products in
9 CFR 318.10(a) being suddenly drawn into the proposed regulation.
FSIS agrees that comminuted products present a greater potential
threat to public health than whole muscle cuts. For this reason, FSIS
is requiring that comminuted products be labeled with safe handling
instructions within 60 days after publication of this final rule. As
cited elsewhere in this preamble, many outbreaks of E. coli 0157:H7
food poisoning in the past year have been epidemiologically linked to
the consumption of comminuted products. However, E. coli 0157:H7 is not
the only pathogen targeted in this rulemaking proceeding. The proposed
rule also cited statistics relating to illness, death, and medical and
productivity cost due to other bacteria, including Salmonella,
Camphylobacter jejuni or coli, Listeria monocytogenes, and parasites,
including Toxoplasma gondii, Trichinella spiralis, Taenia saginata, and
Taenia solium.
The safe handling instructions were designed to cover the four
broad parameters of food safety and to prevent outbreaks of foodborne
illness resulting from all sources, not just E. coli 0157:H7 in ground
beef. Meat and poultry products are known carriers of the pathogenic
bacteria and parasites identified in the proposed rule and compliance
with the safe handling instructions will prevent some foodborne
illnesses and deaths. To require safe handling instructions exclusively
on ground meat and poultry might lead consumers to mistakenly believe
that other raw or partially cooked meat and poultry products are
without risk, and ignores the concern for public health arising from
the presence of pathogenic organisms on all types of raw and partially
cooked meat and poultry products. It is important to remember that the
safe handling instructions include parameters of safe handling beyond
cooking instructions. In addition, the scope of the proposed regulation
is supported by one official establishment which stated that all types
of meat and poultry products should be required to have safe handling
instructions since bacterial contamination can take place on any cut or
type of meat and one meat trade association which stated that even
products traditionally well cooked in the home need to carry safe
handling instructions due to the possibility of cross contamination.
Regarding the inclusion of certain pork products in 9 CFR
318.10(a), these products have not suddenly been drawn into the safe
handling regulation. These products were included in the interim rule
as products needing safe handling instructions. The commenter
misinterpreted this section.
One meat trade association questioned the fact that FSIS has taken
no initiative to seek FDA efforts to have foods under FDA jurisdiction
similarly labeled. FSIS will advise the Food and Drug Administration of
the concerns expressed by commenters.
Nine commenters recommended that safe handling instructions not be
required for products such as frozen dinners and entrees. Several
reasons were given as to why such products do not need safe handling
instructions. Commenters stated that FSIS has provided no evidence that
such products present a meaningful health risk to consumers. In
addition, they state that the four safe handling instructions either
appear on the labels already or are unnecessary for frozen dinners and
entrees. The commenters state that other regulations require a handling
statement on the label, thus the refrigeration statement is redundant
and unnecessary. Most of the products are not handled directly by
consumers and there is no contact between the products and working
surfaces, making the cross contamination statement unnecessary. Frozen
dinners and entrees already contain very specific cooking instructions
which are far superior to ``cook thoroughly.'' Lastly, most products
are single serve items making the statement on leftovers inapplicable,
however, many manufacturers currently include statements such as
``Promptly refrigerate any unused portion'' on their labels.
FSIS disagrees with these comments. While frozen dinners and
entrees probably pose a relatively lower risk of foodborne illness than
fresh meat and poultry products, these products are vulnerable to the
same mishandling risks associated with fresh product. Freezing is not
considered a pathogen destruction step, but will only slow their
growth. The Agency believes it is prudent to require the safe handling
instructions on these types of frozen products if the meat portion is
either uncooked or partially cooked. Since current instructions for
handling frozen dinners and entrees varies from manufacturer to
manufacturer the safe handling instructions will provide a consistent
and uniform message. In addition, none of the current handling
instructions include a rationale statement which explains to consumers
why it is important to follow the prescribed instructions and the
focus-study research indicated that the rationale statement was an
integral part of the safe handling instructions.
The Texas Department of Health recommended that the exemption for
custom slaughter products be eliminated. They state that these products
are as likely to contain harmful or pathogenic bacteria that could
cause illness if mishandled. However, they suggest that labeling each
individual package is not necessary since the product goes back to the
owner for use. One meat trade association suggested that we retain the
custom exemption since elimination of the exemption could cause more
owners to do their own farm slaughter and processing which would result
in a greater danger of meat and poultry contamination.
FSIS is not persuaded by the comments to eliminate the exemption of
custom slaughtered products. While the Agency encourages the
distribution of safe handling information with products slaughtered
under the exemption, labeling is not required for such products if they
are marked ``not for sale.''
Location of Information on Label
One official establishment and two meat trade associations misread
the proposal as requiring that the labels be placed on either the
principal display panel or the information panel. One poultry trade
association on behalf of an official establishment requested FSIS to
permit the safe handling instructions to appear on the back of an
insert label with a referral statement on the front informing consumers
that the instructions were on the back.
One consumer group stated that placement of the safe handling
instructions anywhere on the label as to render it likely to be read is
ambiguous and will likely result in lengthy disputes regarding its
meaning. They recommended that FSIS revert to the original requirement
from the interim regulation on the placement, i.e., on the principal
display panel or information panel, which will have the same result
while avoiding unnecessary disputes and litigation.
FSIS is not persuaded by the comments to make any changes in the
placement of the safe handling instructions. The instructions may be
placed anywhere on the outside label where they will be visible at the
time of purchase. Several of the commenters must have misread the
proposal when they objected to placement of the instructions on the
principal display panel or the information panel. The interim rule
required such placement but comments persuaded FSIS to allow
flexibility in the placement of the safe handling instructions. We do
not believe that the current language is ambiguous or will lead to
lengthy disputes.
Several commenters stated that FSIS ignored the previous comments
that packages would be too small to carry all mandatory information. As
stated in the previous final regulation, FSIS is not aware of labels
smaller than those on 12 ounce chubs that would likely require safe
handling instructions. FSIS believes that labels will be large enough
to accommodate all mandatory information due to the flexibility
provided by the safe handling and nutrition regulations. FSIS received
no comments which provided examples of packages that could not
accommodate both features.
Rationale Statement
Five commenters suggested changes to the rationale statement. One
retail store, one grocers association and one meat association
recommended that since all meat and poultry sold in commerce was
inspected and passed by either Federal or State authorities, FSIS
should permitted the following on all products, ``This product was
inspected for your safety.'' These groups suggested the second sentence
be changed to ``Food products must be handled and prepared properly to
prevent potential illness.'' This would emphasize the positive rather
than negative aspects of proper food handling. In addition one
commenter suggested the option of a singular ``meat'' or ``Poultry''
label. Two consumer groups suggested that the rationale statement did
not appraise consumers of the true threat bacterial contamination poses
and may even give consumers a false sense of confidence about the
safety of the product. Suggested change included eliminating the first
sentence of the rationale, the use of a ``warning,'' mentioning the
possibility of death, and adding descriptions of the symptoms of
foodborne illness. FSIS concluded that the proposed rationale statement
strikes a good balance that will neither scare consumers away from meat
and poultry products nor cause them to ignore risks of foodborne
illness. Given that, and the overwhelming acceptance of the single
label message which will reduce the likelihood of errors, no changes
are made or further flexibility permitted in the final rule.
Additionally, one commenter stated that a different rationale
statement should be permitted for irradiated product. They suggested
that a reference should be made to the reductions in bacterial counts
that irradiation produces. While FSIS does not agree with this comment,
it anticipates addressing the issue of label claims related to emerging
pathogen reduction treatments in the future. However, these statements
should not be a substitute for the required safe handling instructions
since the handling statements also apply to treated products.
Handling Statements
Some commenters suggested allowing flexibility on the cross
contamination, cooking, and leftover statements similar to the
flexibility permitted in the proposal for the refrigeration statement.
Three commenters suggested that deviations in the statements could be
approved through the prior approval system.
FSIS does not agree with these comments. In the long term,
differences between label messages would work against consumer
recognition of the one label message. In addition, this is supported by
five commenters who recommended that FSIS make no changes in the text
of the safe handling statements and one commenter that stated that it
was in the best interest of both consumers and the industry to have
only one set of safe handling instructions since the existence of more
than one statement would only contribute to consumer and industry
confusion.
One commenter suggested that we require the FSIS Hotline number
with the label. The Meat and Poultry Hotline telephone number may be
included on other parts of the label. FSIS does not have enough
information about the impact of including this phone number on the
label. Requiring it on 15 billion packages of product per year might
easily overwhelm the Hotline resources.
One fast-food restaurant chain suggested that FSIS permit
deviations in the refrigeration statement, as well as in other
statements, if they conflicted with company policy or other printed
company materials including operating manuals. FSIS is not persuaded by
this comment to make any changes in the regulation. FSIS believes that
the flexibility provided for the refrigeration statement is adequate to
accommodate the only significant area of concern identified.
Two commenters suggested that FSIS add a recommendation for
disinfecting or sanitizing hard surfaces because washing cutting boards
with soap and water will not guarantee elimination of pathogens. One of
the commenters suggested that this be included in leaflets containing
other expanded information, such as cooking temperatures. They
recommend that the leaflets be required to be available at the point-
of-sale in addition to the safe handling labels on the products.
Washing of working surfaces has been found to be an effective means
of reducing pathogens on cutting boards, utensils, etc. Use of a
sanitizing agent would add another margin of safety, however, FSIS
believes that the current message conveys the importance of washing
working surfaces that have contacted raw product. This was further
supported by the focus-study research. Participants preferred short
word messages, and indicated that the longer the messages, the less
likely consumers would be to read them. While FSIS encourages programs
to provide additional information on safe handling at the point-of-
sales, it believes that additional verbiage might detract from the
efficacy of the label.
One commenter suggested that the cross contamination statement be
revised to include washing before and after contact with raw meat and
poultry. While FSIS agrees that this is a good practice, the focus of
these statements is avoidance of contamination of other ready-to-eat
foods with raw meat and poultry products. This change will not be
incorporated.
Six commenters stated that more explicit cooking instructions were
necessary. The commenters suggested that visual signs of doneness and/
or internal temperatures be required or at least allow the flexibility
in the cooking statement to include such information. One commenter
recommended that FSIS provide the proscribed internal cooking
temperatures for each type of raw meat and poultry that would be
labeled as well as a descriptive statement to accompany the internal
cooking temperature. One suggested that a descriptive visual definition
will provide safeguards for any consumer who is unable or unwilling to
measure the internal temperature of their meat. One consumer group
suggested that visual keys were preferable to the use of internal
temperatures, as consumers may misunderstand the internal temperature
to be a cooking temperature. They stated that it is critical to provide
more specific cooking instructions since there is no single definition
of ``thoroughly cooked'' among consumers. One meat trade association
stated that the cooking instructions were adequate for the safe
handling label because consumers want simple accurate information. In
addition, they stated that it would be more appropriate to include more
detailed handling information in a brochure or pamphlet which could be
distributed at the point-of-purchase.
FSIS does not believe it would be appropriate to add either an
endpoint temperature or more comprehensive cooking directions because
cooking temperatures and other visual indications of doneness vary by
product. As stated above, this labeling is not intended to replace
comprehensive cooking statements that accompany many products.
Additionally, as cited earlier, more complex messages might reduce the
likelihood of consumer use of the label.
A consumer group suggested that FSIS include a time limit with the
leftover statement, such as the two hours mentioned in the interim
regulation. Another commenter representing a restaurant chain suggested
that the leftover statement be eliminated in situations where company
policy strictly controls holding time for products and the sale of
leftover meat and poultry products is not permitted.
FSIS is not persuaded by these comments to make any changes in the
leftover statement. The Agency believes that current language conveys
appropriate information on the importance of prompt refrigeration of
leftovers. In addition, the leftover statement is broad enough so as
not to conflict with the described company policy.
Symbols
Six retailers and their associations commented on the symbols
required by the proposed regulation. They stated the symbols were
possibly misleading, do not effectively enhance the message and are
meaningless without the word message. In addition, the commenters
stated that the symbols were likely to confuse those who can read the
label as well as those who cannot read. A specific example cited was
that the frying pan may suggest that frying is the preferred method of
cooking. In addition, the use of symbols also substantially increases
costs to retailers. The commenters recommended that the symbols be
eliminated.
One consumer group and one meat trade association supported the use
of the symbols. The consumer group stated that the symbols provide
important information to those who cannot read English and serve as a
reminder of the written instructions to those who have read them. The
symbols also draw attention to the labels and convey the instructions
to the consumers instantaneously. However, they do not believe the
symbol for the cross contamination message is clear or effectively
illustrated the need to keep raw meat and poultry separate from other
foods.
One USDA Agency suggested that the frying pan be replaced by a pot.
This Agency believes that the skillet might be interpreted as a
suggestion that the meat be fried, which is inconsistent with
nutritional recommendations of the Department. Our focus-study research
on labels has indicated that short messages with visual symbols are
more acceptable to consumers as a means of alerting them to actions
they should take. Symbols convey messages to individuals who have
difficulty reading English. The symbols provide visual reminders of
actions consumers should take to handle food safely. The symbols were
modified from those originally considered to reflect suggestions from
participants of the focus-study research and public comments. Regarding
the cross contamination symbol, FSIS agrees that the symbol addresses
the cleaning portion of the message. However, since no feasible
alternatives were offered for the symbol of the soapy hands under a
faucet, FSIS will not make any changes in the symbol. Finally,
regarding the objections to the skillet symbol, FSIS believes that the
skillet is a more recognizable symbol than a pot, given the scale of
its representation. Additionally, the Agency considers the likelihood
of resulting confusion over preferred cooking method to be low.
Therefore, FSIS is retaining the skillet symbol as proposed.
FSIS is adopting the proposed rule as a final rule with the changes
as discussed above. Labels prepared in accordance with the August 16,
1993, interim rule may be used for 1 year past the effective date of
this final rule.
List of Subjects
9 CFR 317
Food labeling, Meat inspection.
9 CFR 381
Food labeling, Poultry inspection.
Final Rule
For the reasons discussed in the preamble, FSIS is amending 9 CFR
parts 317 and 381 of the Federal meat and poultry products inspection
regulations to read as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
2. Section 317.2 is amended by adding a new paragraph (1) to read
as follows:
Sec. 317.2 Labels; definition; required features.
* * * * *
(l) Safe handling instructions shall be provided for: All meat and
meat products of cattle, swine, sheep, goat, horse, or other equine not
heat processed in a manner that conforms to the time and temperature
combinations in the Table for Time/Temperature Combination For Cooked
Beef, Roast Beef, and Cooked Corned Beef in Sec. 318.17, or that have
not undergone other further processing that would render them ready-to-
eat; and all comminuted meat patties not heat processed in a manner
that conforms to the time and temperature combinations in the Table for
Permitted Heat-Processing Temperature/Time Combinations For Fully-
Cooked Patties in Sec. 318.23; except as exempted under paragraph
(l)(4) of this section.
(1)(i) Safe handling instructions shall accompany every meat or
meat product, specified in this paragraph (l) destined for household
consumers, hotels, restaurants, or similar institutions and shall
appear on the label. The information shall be in lettering no smaller
than one-sixteenth of an inch in size and shall be prominently placed
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.
(ii) The safe handling information shall be presented on the label
under the heading ``Safe Handling Instructions'' which shall be set in
type size larger than the print size of the rationale statement and
handling statements as discussed in paragraphs (l)(2) and (l)(3) of
this section. The safe handling information shall be set off by a
border and shall be one color type printed on a single color
contrasting background whenever practical.
(2) The labels of the meat and meat products specified in this
paragraph (l) shall include the following rationale statement as part
of the safe handling instructions, ``This product was prepared from
inspected and passed meat and/or poultry. Some food products may
contain bacteria that could cause illness if the product is mishandled
or cooked improperly. For your protection, follow these safe handling
instructions.'' This statement shall be placed immediately after the
heading and before the safe handling statements.
(3) Meat and meat products, specified in this paragraph (l), shall
bear the labeling statements:
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave.
(Any portion of this statement that is in conflict with the product's
specific handling instructions, may be omitted, e.g., instructions to
cook without thawing.) (A graphic illustration of a refrigerator shall
be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash
working surfaces (including cutting boards), utensils, and hands after
touching raw meat or poultry. (A graphic illustration of soapy hands
under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall
be displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or
discard. (A graphic illustration of a thermometer shall be displayed
next to the statement.)
(4) Meat or meat products intended for further processing at
another official establishment are exempt from the requirements
prescribed in paragraphs (l)(1) through (l)(3) of this section.
3. Section 317.5 is amended by deleting the word ``or'' following
the semicolon at the end of paragraph (b)(12), replacing the period at
the end of paragraph (b)(13) with a semicolon followed by the word
``or'', and adding a new paragraph (b)(14) to read as follows:
Sec. 317.5 Generically approved labeling.
* * * * *
(b) * * *
(14) The addition of safe handling instructions as required by
Sec. 317.2 of this subchapter.
4. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 2.17, 2.55.
5. Section 381.125 is amended by designating the current paragraph
as (a) and adding a new paragraph (b) to read as follows:
Sec. 381.125 Special handling label requirements.
* * * * *
(b) Safe handling instructions shall be provided for all poultry
products not heat processed in accordance with the provisions of
Sec. 381.150(b) or that have not undergone other further processing
that would render them ready-to-eat, except as exempted under paragraph
(b)(4) of this section.
(1) (i) Safe handling instructions shall accompany the poultry
products, specified in this paragraph (b), destined for household
consumers, hotels, restaurants, or similar institutions and shall
appear on the label. The information shall be in lettering no smaller
than one-sixteenth of an inch in size and shall be prominently placed
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.
(ii) The safe handling information shall be presented on the label
under the heading ``Safe Handling Instructions'' which shall be set in
type size larger than the print size of the rationale statement and
handling statements as discussed in paragraphs (b)(2) and (b)(3) of
this section. The safe handling information shall be set off by a
border and shall be one color type printed on a single color
contrasting background whenever practical.
(2) (i) The labels of the poultry products, specified in this
paragraph (b) and prepared from inspected and passed poultry, shall
include the following rationale statement as part of the safe handling
instructions, ``This product was prepared from inspected and passed
meat and/or poultry. Some food products may contain bacteria that could
cause illness if the product is mishandled or cooked improperly. For
your protection, follow these safe handling instructions.'' This
statement shall be placed immediately after the heading and before the
safe handling statements.
(ii) The labels of the poultry products, specified in this
paragraph (b) and prepared pursuant to Sec. 381.10(a) (2), (5), (6),
and (7), shall include the following rationale statement as part of the
safe handling instructions, ``Some food products may contain bacteria
that could cause illness if the product is mishandled or cooked
improperly. For your protection, follow these safe handling
instructions.'' This statement shall be placed immediately after the
heading and before the safe handling statements.
(3) Poultry products, specified in this paragraph (b), shall bear
the labeling statements.
(i) Keep refrigerated or frozen. Thaw in refrigerator or microwave.
(Any portion of this statement that is in conflict with the product's
specific handling instructions may be omitted, e.g., instructions to
cook without thawing.) (A graphic illustration of a refrigerator shall
be displayed next to the statement.);
(ii) Keep raw meat and poultry separate from other foods. Wash
working surfaces (including cutting boards), utensils, and hands after
touching raw meat or poultry. (A graphic illustration of soapy hands
under a faucet shall be displayed next to the statement.);
(iii) Cook thoroughly. (A graphic illustration of a skillet shall
be displayed next to the statement.); and
(iv) Keep hot foods hot. Refrigerate leftovers immediately or
discard. (A graphic illustration of a thermometer shall be displayed
next to the statement.)
(4) Poultry products intended for further processing at another
official establishment are exempt from the requirements prescribed in
paragraphs (b)(1) through (b)(3) of this section.
6. Section 381.134 is amended by deleting the word ``or'' following
the semicolon at the end of paragraph (b)(12), replacing the period at
the end of paragraph (b)(13) with a semicolon followed by the word
``or'', and adding a new paragraph (b)(14) to read as follows:
Sec. 381.134 Generically approved labeling.
* * * * *
(b) * * *
(14) The addition of safe handling instructions as required by
Sec. 381.125 of this subchapter.
Done at Washington, DC, on March 23, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-7217 Filed 3-25-94; 8:45 am]
BILLING CODE 3410-DM-M