Mandatory Safe Handling Statements on Labeling of Raw Meat and Poultry Products

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 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