[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]


_______________________________________________________________________

Part X





Department of Agriculture





_______________________________________________________________________



Food Safety and Inspection Service



_______________________________________________________________________



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                    
----------------------------------------------------------------------------------------------------------------
                                                                                    Attributable                
                                                                                     to meat and                
                                                                    Annual medical     poultry                  
             Pathogen\1\                   Cases          Deaths    & productivity --------------    Costs\2\   
                                                                         costs       Percent of                 
                                                                                        cases                   
----------------------------------------------------------------------------------------------------------------
                                               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
                                     ---------------------------------------------------------------------------
      Total.........................  ...............  ...........     5,162-6,076  ............     3,880-4,330
----------------------------------------------------------------------------------------------------------------
\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