[Federal Register Volume 63, Number 166 (Thursday, August 27, 1998)]
[Rules and Regulations]
[Pages 45663-45675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22890]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 63, No. 166 / Thursday, August 27, 1998 / 
Rules and Regulations  

[[Page 45663]]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

7 CFR Part 59

[Docket No. 97-069F]
RIN 0583-AC04


Refrigeration and Labeling Requirements for Shell Eggs

AGENCY: Food Safety and Inspection Service.

ACTION: Final rule and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is revising its 
regulations governing the inspection of eggs and egg products to 
implement 1991 amendments to the Egg Products Inspection Act (EPIA). 
These amendments require that shell eggs packed for consumer use be 
stored and transported under refrigeration at an ambient temperature 
not to exceed 45 deg.F (7.2 deg.C). In addition, the amendments require 
that these packed shell eggs be labeled to state that refrigeration is 
required. Finally, the amendments require that any shell eggs imported 
into the United States packed for consumer use include a certification 
that the eggs, at all times after packing, have been stored and 
transported at an ambient temperature of no greater than 45 deg.F 
(7.2 deg.C).

DATES: Effective Date: The effective date of the final rule is August 
27, 1999.
    Comment Date: As noted below, the proposed rule concerning 
refrigeration and labeling requirements for shell eggs was published on 
October 27, 1992. Because the proposed rule was published approximately 
six years ago, FSIS is requesting comments on this final rule. FSIS 
requests comments on the economic impact analysis in these regulations 
and on options for monitoring compliance with the refrigeration and 
labeling requirements. Comments must be received on or before October 
26, 1998.

ADDRESSES: Send an original and two copies of comments to: FSIS Docket 
Clerk, Docket #97-069F, Room 102, Cotton Annex, 300 12th Street, SW, 
Washington, DC 20250-3700. Reference material cited in the document and 
any comments received will be available for public inspection in the 
FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Ms. Patricia F. Stolfa, Assistant 
Deputy Administrator, Regulations and Inspection Methods, Food Safety 
and Inspection Service, U.S. Department of Agriculture (202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

    In 1991, as part of the Food, Agriculture, Conservation and Trade 
Act Amendments of 1991 (Pub.L. 102-237) (hereafter referred to as ``the 
1991 EPIA amendments''), Congress amended the EPIA to require that egg 
handlers store and transport shell eggs destined for the ultimate 
consumer under refrigeration at an ambient temperature of no greater 
than 45 deg.F (7.2 deg.C) (21 U.S.C 1034(e)(1)(A)). (See also 21 U.S.C. 
1037(c)). The 1991 EPIA amendments specify that these refrigeration 
requirements apply to shell eggs after they have been packed into a 
container destined for the ultimate consumer. The 1991 EPIA amendments 
also require that egg handlers label the shell egg containers to 
indicate that refrigeration is required (21 U.S.C. 1034(e)(1)(B)). In 
addition, these amendments require that any eggs packed into a 
container destined for the ultimate consumer and imported into the 
United States include a certification that the eggs have, at all times 
after packaging, been stored and transported at an ambient temperature 
that is no greater than 45 deg.F (7.2 deg.C) (21 U.S.C. 1046(a)). The 
1991 EPIA amendments specify that these requirements become effective 
12 months after promulgation of final regulations implementing the EPIA 
amendments (21 U.S.C. 1034 note).
    The Agricultural Marketing Service (AMS) proposed a rule in 1992 to 
implement the 1991 EPIA amendments (57 FR 48569, October 27, 1992); 
however, AMS never published a final rule incorporating these 
amendments into the regulations governing the inspection of eggs and 
egg products. Following enactment of the Federal Crop Insurance Reform 
and Department of Agriculture Reorganization Act of 1994 (Pub.L. 103-
354; 7 U.S.C. 2204e), food safety issues were consolidated in FSIS. 
Because these statutorily mandated requirements are intended to improve 
food safety, FSIS, rather than AMS, is promulgating this final rule to 
revise the regulations governing the inspection of eggs and egg 
products to implement the 1991 EPIA amendments. By January 1, 1999, 
FSIS and AMS will publish revisions to the regulations transferring the 
provisions concerning refrigeration and labeling of shell eggs from 7 
CFR, Chapter I, to 9 CFR, Chapter III, so that these provisions will be 
in the same title as the Federal meat and poultry products inspection 
regulations.
    The 1998 Appropriations for Agriculture, Rural Development, Food 
and Drug Administration, and Related Agencies (1998 Appropriations) 
(Pub.L. 105-86) provides that $5 million of FSIS' annual appropriation 
will be available for obligation only after the Agency promulgates a 
final rule to implement the refrigeration and labeling requirements 
included in the 1991 EPIA amendments. The Agency is thus revising its 
regulations to implement these requirements. FSIS is adopting the 
proposed regulations published in 1992 concerning refrigeration and 
labeling of shell eggs with some technical changes based on its review 
of the proposed rule and the comments on that proposal.
    In addition to the refrigeration and labeling requirements, AMS's 
proposed rule included revisions to 7 CFR Part 56, Grading of Shell 
Eggs and U.S. Standards, Grades, and Weight Classes for shell eggs. 
FSIS is publishing this final rule on the refrigeration and labeling 
requirements but is not revising part 56.
    Under the 1991 EPIA amendments, USDA is responsible for enforcing 
the refrigeration and labeling requirements at storage facilities and 
transport vehicles of shell egg packers (21 U.S.C. 1034(e)(1) and (2)). 
The Secretary of Health and Human Services is responsible for enforcing 
the labeling and refrigeration requirements at food manufacturing 
establishments, institutions, and restaurants, other than plants 
packing eggs (21 U.S.C. 1034(e)(3)).

[[Page 45664]]

    On May 19, 1998 (63 FR 27502), FSIS and the Food and Drug 
Administration (FDA) published an advance notice of proposed rulemaking 
(ANPR) concerning Salmonella enteritidis (SE) in eggs. Through this 
notice, the Agencies are seeking to identify farm-to-table actions that 
will decrease the food safety risks associated with shell eggs. The 
ANPR may result in additional Agency actions concerning shell eggs. 
Although this final rule may bring about a small reduction in SE risk, 
it does not address many of the underlying food safety problems posed 
by eggs. These problems can only be dealt with in the context of a 
broader process that examines a variety of food safety issues in 
addition to ambient air temperatures. Through the ANPR, FSIS and FDA 
are looking at how best to address the food safety concerns of shell 
eggs as part of their mutual farm-to-table HACCP strategy. Any 
additional actions that may result from this process will be considered 
in light of identified public health risks and available alternatives.
    On June 12, 1998, FSIS completed a risk assessment concerning SE in 
shell eggs and egg products in response to an increasing number of 
human illnesses associated with consumption of shell eggs (FSIS, 
Salmonella Enteritidis Risk Assessment, Washington, DC, June 12, 1998). 
The objectives of this risk assessment are to: establish the 
unmitigated risk of foodborne illness from SE, identify and evaluate 
potential risk reduction strategies, identify data needs, and 
prioritize future data collection efforts. This risk assessment 
developed a model to assess risk throughout the egg and egg products 
continuum. The risk assessment model was used to estimate the possible 
benefits of this rule, as discussed below.

Comments

    One hundred and fifty-nine comments were submitted in response to 
the proposed rule. Thirty-one commenters, including private citizens, 
State departments of agriculture, several trade associations, and 
several members of the egg industry, supported the proposal. The 
remainder of commenters opposed the proposed rule or suggested 
alternatives to it. Commenters opposed to the rule included private 
citizens, trade associations, and members of the egg industry. The 
majority of comments from the egg industry opposed the rule and 
suggested alternatives to it. Six comments were received after the 
close of the comment period. All of these comments were generally 
opposed to the proposed rule.

Size of Establishments Required to Comply With the Rule

    Several small producers recommended exempting from the 
refrigeration and labeling requirements producers with flocks of 5,000, 
10,000, or 50,000 hens, or exempting producers that marketed a 
specified number of cases of eggs or a specified number of eggs per 
week, such as 500 cases per week or 1,200 eggs per week. These 
producers wanted an exemption from the refrigeration requirements 
because, they stated, the high costs of complying with the 
refrigeration requirements would effectively force them out of 
business. In contrast to these comments from small producers, several 
other producers and several associations stated that all egg industry 
members should be treated equally, and that no producers should be 
exempt from the refrigeration and labeling requirements.
    Several commenters stated that they had flocks of less than 3,000 
layers but packed eggs from other producers. These commenters asked 
whether the refrigeration and labeling requirements would apply to 
them.
    Consistent with current regulations that exempt from inspection egg 
handlers with flocks of 3,000 or fewer birds (see Sec. 59.100), the 
1991 EPIA amendments specify that any egg handler with a flock of 3,000 
layers or less is not subject to inspection for purposes of verifying 
compliance with the refrigeration and labeling requirements (21 U.S.C. 
1034(e)(4)). Given this consistency, FSIS is responding to Congress's 
clear intent and limiting the exemption from the refrigeration and 
labeling requirements in Sec. 59.50 to egg handlers with flocks of 
3,000 or fewer layers (Sec. 59.50(c)).
    In response to the comments suggesting that the refrigeration and 
labeling requirements should apply to all producers, the Agency points 
out that the statute provides that the refrigeration and labeling 
requirements in the 1991 EPIA amendments are not applicable to any egg 
handler with a flock of 3,000 or fewer layers. FSIS concludes that, for 
clarity, it is appropriate to reflect this fact in its regulations with 
an exemption.
    Egg packers who obtain eggs from other producers will not be exempt 
from the refrigeration and labeling requirements. The exemption will 
only apply to egg handlers with a flock of 3,000 or fewer layers who 
pack eggs from their own flock. This exemption is consistent with the 
exemption from registration requirements for producer-packers with an 
annual egg production from a flock of 3,000 hens or less (see 
Sec. 59.690).

Costs of the Rule

    Approximately half the commenters stated that the rule would impose 
major costs on the industry. Many small businesses stated that the 
compliance costs associated with this rule could force them out of 
business.
    Several commenters stated that they believed that the cost 
estimates in the 1992 proposed rule were too low and provided their own 
cost projections. For example, one small producer stated that it would 
cost its family-owned business approximately $200,000 to comply with 
the requirements. One association that represents the poultry, egg, and 
allied industry received information from its members on the price of 
refrigerated trucks: One member estimated that a new 26 foot 
refrigerated tractor trailer would cost $92,000, and another producer 
stated that a used refrigerated trailer portion costs $25,000. The 
association stated that, on the basis of this information, the cost of 
replacing and modifying the industry's fleet might exceed the estimates 
made by the Department.
    In addition, several commenters stated that costs would be 
particularly high because at the time the proposed rule was published, 
the Environmental Protection Agency (EPA) was revising laws concerning 
refrigerants. These commenters believed that, subsequent to purchasing 
new refrigeration equipment to comply with the 45 deg.F refrigeration 
requirements, they would again be required to replace refrigeration 
equipment once the new EPA laws regarding refrigerants went into 
effect.
    Five members of the industry stated that the proposed rule would be 
extremely costly to the entire shell egg industry. These commenters 
stated that the cost analysis included in the 1992 proposed rule 
ignored major costs, such as new higher powered refrigeration units for 
both warehouses and vehicles, greater insulation requirements for 
warehouses and vehicles, ongoing depreciation expenses per year on the 
new refrigeration equipment, replacement costs of new equipment after 
its useful life, yearly maintenance costs, much higher ongoing yearly 
energy costs required for higher powered refrigeration units, and the 
effects of inflation. These commenters stated that compliance costs 
would outweigh any benefits of reducing cases of salmonellosis. In 
addition, these commenters stated that the increased compliance costs 
would force smaller producers and smaller distributers out of business, 
resulting in layoffs and

[[Page 45665]]

higher rates of unemployment. In addition, they stated that the higher 
cost of compliance would result in higher consumer prices for eggs.
    The same five commenters discussed in the preceding paragraph 
stated that the requirements for imported eggs could also have a 
negative impact on international trade. These commenters stated that 
food products prepared with shell eggs abroad may not meet the U.S. 
refrigeration requirements for shell egg production. Thus, they 
maintained, the refrigeration requirements would lead to restrictions 
on imports of foreign food items prepared with shell eggs if 
refrigeration requirements in a particular country did not meet U.S. 
standards.
    Finally, one association suggested costs to the industry might 
increase because of increased taxes on energy consumption.
    Although the Agency agrees this rule is likely to result in an 
increase in costs to the industry, the 1991 EPIA amendments and the 
1998 Appropriations require that FSIS promulgate this final rule. The 
Agency's current cost impact analysis is discussed below, under the 
heading, ``Incremental Social Costs.'' The original analysis of the 
costs of the regulation was conducted in 1992. The current analysis 
updates the 1992 cost estimates for inflation and changes in the State 
regulatory environment. The comments submitted in response to the 
analysis in the proposed rule were based on 1992 costs. For these 
reasons, the Agency is providing opportunity for comment on the updated 
economic impact analysis.
    In the discussion of the cost to the industry, the Agency notes 
that many States already have enacted laws that require ambient 
temperatures of 45 deg.F for shell egg storage and transportation. As 
explained below, producers in these States may not incur any 
significant costs as a result of this rule. In the other States, there 
is likely to be some increase in costs to the industry.
    In regard to EPA laws concerning refrigerants, FSIS notes that 
those laws are in effect. At this time, the industry will have met 
these EPA requirements. Therefore, these regulations will not affect 
industry compliance with EPA requirements.
    In response to the comments on international trade, it should be 
noted that the requirements in these regulations apply to imported 
shell eggs that are not imported under disease restriction and are 
destined for the ultimate consumer. The requirements do not apply to 
other imported processed food products containing eggs.
    Finally, with regard to costs that may be imposed due to taxes on 
energy consumed, no significant new taxes have been imposed based on 
energy consumed.

Transportation

    Many comments from members of the egg industry concerned problems 
with complying with the proposed transportation requirements. Some 
commenters stated that the cost of complying with the transportation 
requirements would be extremely high for them. Others stated that 
maintaining 45 deg.F during transportation would not be possible. For 
example, one company stated that its trucks average sixteen deliveries 
per load, and, in certain situations, the truck doors remain open for 
ten to fifteen minutes during delivery. Therefore, the company 
explained, on a warm day, it is impossible to maintain the 45 deg.F 
temperature in the truck. Another commenter stated that producers 
servicing family-owned markets and restaurants use a truck with less 
than one ton capacity, and that a truck of this size is not made with a 
refrigeration unit with enough cooling capacity to maintain 45 deg.F. 
One association explained that many of its members believed that the 
constant opening and closing of the truck's storage compartment during 
local deliveries would prevent the truck from reaching an ambient 
temperature of 45 deg.F.
    About 20 commenters offered a variety of alternative options for 
exempting small producers from the requirement that shell eggs remain 
refrigerated during transportation. These alternative options included 
exempting from refrigeration requirements eggs delivered within a 
certain radius of the packing facility, eggs delivered in a certain 
size truck, and eggs delivered within a certain specified delivery 
time.
    The specific requirement of the 1991 EPIA amendments is that shell 
eggs be refrigerated at 45 deg.F during transportation. Other than the 
exemption for egg handlers with 3,000 or fewer layers, the statute does 
not provide any exemptions from the requirement that shell eggs be 
refrigerated during transportation. Therefore, the Agency has no 
discretion concerning this requirement and is not making the changes in 
the regulations that were requested by the commenters.

Alternative Temperature Requirements

    About 15 commenters suggested that eggs should be held at 
temperatures above 45 deg.F, such as 50 deg.F, 55 deg.F, or 60 deg.F. 
One commenter noted that the current voluntary grading program 
regulations require that eggs be kept at 60 deg.F, and that a change to 
45 deg.F would be a significant change. Several commenters stated that 
refrigerating eggs at 45 deg.F would cause them to ``sweat'' when they 
are exposed to non-refrigerated conditions. These commenters stated 
that wet eggs can allow the passage of waterborne bacteria into the 
egg.
    Several commenters offered suggestions for additional refrigeration 
requirements. One member of the industry suggested that the rule might 
be enhanced if it specified the time allowed for the shell eggs to 
reach an internal temperature of 45 deg.F. Several other commenters 
recommended establishing refrigeration requirements that would apply to 
eggs prior to packing. For example, one State department of agriculture 
suggested that shell eggs should be refrigerated at 55 deg.F or lower, 
within 24 hours of being laid, until the egg is washed and packed.
    The statute specifically requires that eggs packed for consumer use 
be stored and transported at 45  deg.F. Therefore, the Agency has no 
discretion concerning the required temperature.
    In response to the suggestions concerning additional refrigeration 
requirements, the 1991 EPIA amendments do not specify requirements 
concerning the internal temperature of eggs or an ambient temperature 
requirement for eggs that are not yet packed. However, these actions 
may be considered as part of the review that flows from the joint FSIS/
FDA ANPR. FSIS or FDA may take further action in response to these 
comments at a later time.

Benefits of the Regulation

    Approximately 50 commenters questioned whether this regulation 
would result in any health benefits. Commenters stated that safety 
problems related to eggs are caused by inadequate food preparation in 
restaurants and hotels, and that refrigeration by the producer will not 
remedy this problem. Similarly, several commenters noted that problems 
often arise because of mishandling by the consumer. Other commenters 
stated that the Agency should focus efforts on specific egg production 
establishments or particular regions where Salmonella has been 
detected.
    Five comments from members of the shell egg industry stated that 
there was inadequate scientific evidence to justify the proposal, and 
that available studies show that relatively few salmonellosis cases can 
be attributed directly to shell eggs. Therefore, these commenters 
asserted, there is a need for more complete epidemiological studies and

[[Page 45666]]

documentation of actual salmonellosis cases that are directly linked to 
inadequate refrigeration of shell eggs held by producers and 
distributors. These commenters noted that studies show no growth of SE 
in eggs with an internal temperature of 45  deg.F; however, the 
commenters explained that the internal temperature of eggs will not 
reach 45  deg.F as soon as they are stored under refrigeration. They 
also argued that packed eggs may never reach this temperature 
throughout the distribution process. Similarly, another commenter 
stated that commercial processing plants will be unable to bring eggs 
to 45  deg.F before they are transported, especially when they are 
packed in cartons, cased, and stacked on pallets. This commenter also 
questioned whether the ambient temperature refrigeration requirements 
would improve the safety of shell eggs.
    In contrast, several commenters stated that they believed that 
these regulations would improve the safety of shell eggs. For example, 
one medical association stated that existing scientific evidence 
provides a sufficient basis for requiring that shell eggs be stored and 
transported in refrigerated trucks at an ambient temperature of 45 
deg.F, and that this refrigeration requirement would control the 
replication of SE. This commenter stated that, once the rule is 
effective, reported cases of SE in humans will be markedly reduced. An 
epidemiologist employed by a Federal agency stated that most human 
outbreaks of SE in which shell eggs were the probable source could have 
been prevented if time and temperature abuse had not taken place.
    Although there is no consensus concerning the level of health 
benefits these regulations may achieve, the 1991 EPIA amendments and 
the 1998 Appropriations require that FSIS promulgate this final rule.
    In response to concerns regarding food safety problems because of 
mishandling of eggs at retail establishments, FDA may propose a rule 
addressing refrigeration of eggs at retail, as discussed in the ANPR.
    With regard to public education efforts, the Food Safety Education 
and Communications Staff within FSIS provides information to the public 
concerning numerous food safety issues, including egg-related food 
safety issues. This office provides food safety education information 
through USDA's Toll-Free Meat and Poultry Hotline (1-800-535-4555), 
through public service announcements, printed materials, and a variety 
of communication channels. In addition, FSIS makes this information 
available over the Internet (URL: http://www.fsis.usda.gov/).
    Finally, as noted under the heading, ``Incremental Social 
Benefits,'' the Agency has estimated that these regulations would 
result in a mean reduction of 1.54 percent in salmonellosis cases 
related to SE in shell eggs. To estimate the reduction of the number of 
salmonellosis cases that would result from the implementation of these 
regulations, FSIS's risk assessment model, discussed below, was 
adjusted so that all eggs were exposed to ambient temperatures of 45 
deg.F or lower after packing. The risk assessment predicts that 
additional measures would result in greater benefits than would result 
from the ambient temperature requirements in this rule. For example, 
the risk assessment predicts that maintaining ambient temperatures of 
45  deg.F throughout processing and distribution (that is, from 
processing through retail) will result in an eight percent average 
reduction in human SE illnesses. In addition, the risk assessment model 
predicts that maintaining internal temperatures of eggs at 45  deg.F 
would result in a twelve percent decrease in human SE illnesses (FSIS, 
Salmonella Enteritidis Risk Assessment, Washington, DC, June 12, 1998: 
26-27). The Agency recognizes that requiring an internal shell egg 
temperature of 45  deg.F (7.2  deg.C) would result in greater benefits 
than an ambient temperature requirement; however, the statute provides 
for an ambient temperature requirement only, and any such additional 
requirement will have to be considered in response to the ANPR.

Labeling Requirements

    Approximately 30 commenters were opposed to the labeling 
requirements. Some of the commenters mistakenly believed ``warning 
labels'' would be required. Others stated that the labeling provisions 
were unnecessary because they believed consumers know that eggs should 
be refrigerated. Finally, many of these commenters believed the 
labeling requirements would be costly for producers, and that increased 
costs would be incurred by consumers.
    Several commenters who supported the labeling requirements 
suggested requiring additional information on egg containers, such as a 
``pull date'' or expiration date; a statement identifying the flock 
that produced the eggs in the container; the phrase, ``keep 
refrigerated at 45 deg.F or below''; and the packing date and the 
packing plant number.
    Three comments were from companies promoting time/temperature 
indicators. The companies explained that these indicators are labels 
that act as temperature recording devices and change color to indicate 
the temperature at which the carton is held and the length of time the 
carton is held at a particular temperature. These commenters suggested 
that time/temperature indicators should be affixed to egg cartons.
    Establishments can meet the labeling requirements adopted in this 
rule (see Secs. 59.50(b), 59.410(a), 59.950(a)(4), and 59.955(a)(6)) 
simply by including the phrase, ``Keep Refrigerated,'' or words of 
similar meaning, on the egg containers. Therefore, the labeling 
provisions do not require a warning statement. The Agency has 
determined that adding this phrase to shell egg labeling will result in 
only minimal costs for producers that do not currently include this 
labeling on egg cartons. Furthermore, many producers are currently 
labeling egg cartons to indicate that the product should be kept 
refrigerated.
    With regard to the recommendations for additional labeling 
requirements, the statute does not specify any additional labeling 
provisions, and the Agency is not including additional labeling 
requirements in these regulations.

Implementation Details

    Several commenters questioned how the rule would be implemented and 
provided suggestions concerning methods for measuring the temperature 
in transportation vehicles and storage facilities. For example, several 
commenters questioned the particular location an inspector would use 
inside a cooler or a truck to obtain the ambient temperature. One 
commenter recommended that the temperature should be checked at least 
10 minutes after all doors are closed. One commenter asked what would 
happen during a mechanical breakdown, and whether producers should use 
recording thermometers both in cooler rooms and trucks. One association 
suggested that inspection of coolers be handled on a case-by-case basis 
because, the association explained, no two coolers are alike, and their 
configurations and holding capacities differ. The association also 
recommended that cooler doors be closed for at least five minutes 
before temperature readings are taken, and that readings be taken in at 
least three locations. This same commenter recommended that truck 
inspections be limited to trucks on property not being loaded, and that 
inspection of trucks occur before loading, with the door closed for at 
least five minutes and refrigeration equipment operating. Finally, this 
same commenter stated that when plants are

[[Page 45667]]

found to be out of compliance with the temperature regulations, 
consideration should be given for re-inspection within the annual 
quarter before a citation is issued.
    Several commenters questioned the intent of proposed 
Sec. 59.134(b). They were concerned that the provision stating that 
``the perimeter of each cooler room * * * shall be made accessible'' 
would require that they create a walking aisle around the cooler room, 
or that the entire perimeter would need to be accessible for 
inspection. The commenters explained that to make the entire perimeter 
accessible to an inspector would result in reduced storage capacity and 
increased costs.
    In response to the concerns about accessibility of the perimeter of 
the cooler room, the Agency advises that it does not intend that 
producers would be required to reduce storage space or create a walking 
aisle. The Agency is specifying that the perimeter must be accessible 
because it may often be the warmest area in the cooler, and because the 
center of the cooler room is typically accessible. An establishment 
could comply with the requirement that the perimeter of the cooler room 
be made accessible to inspectors by locating thermometers along the 
perimeter or allowing inspectors to use extension devices with attached 
thermometers to obtain the temperature along the perimeter.
    The rule will not be effective until a year after the publication 
date. The Agency is currently considering various policy options for 
monitoring industry compliance with the rule. In response to the 
question concerning whether producers should use recording devices in 
cooler rooms and trucks, producers may install thermometric equipment 
and temperature recording devices; however, these regulations do not 
require that producers do so. FSIS requests comments on implementation 
of this rule.

Longer Phase-In Period

    Several commenters recommended that the Department implement the 
rule over a phase-in period (two commenters suggested a three-year 
phase-in period), explaining that a phase-in period would provide 
producers adequate time to bring their equipment into compliance. 
Similarly, a small producer that expressed general support for the rule 
argued that the effective date for the final rule should be extended 
beyond a year from publication to allow the industry more time to meet 
the refrigeration requirements.
    The EPIA specifies that the refrigeration and labeling requirements 
become effective 12 months after promulgation of final regulations 
implementing the amendments (21 U.S.C. 1034 note). Therefore, the 
Agency does not have the authority to provide for an extended phase-in 
period.

Technical Suggestions

    A State department of agriculture commented that the proposed 
definition of ``immediate container'' is confusing and recommended 
changing the phrase ``not consumer packaged,'' as used in the proposed 
definition, to ``not packaged by the consumer.''
    In response to the comment concerning the definition of ``immediate 
container,'' the Agency points out that the phrase, ``not consumer 
packaged'' refers to eggs packed for a buyer, such as a restaurant or 
hotel, that buys containers of eggs larger than those for household 
consumers. This definition simply provides that an immediate container 
could be a carton for household consumers or a larger container for a 
restaurant or other institution. To clarify the definition, FSIS has 
revised it to read, ``Immediate container means any package or other 
container in which egg products or shell eggs are packed for household 
or other ultimate consumers.''
    One commenter questioned the intent of the provision in proposed 
Sec. 59.132, which stated that ``access shall not be refused at any 
reasonable time to any representative of the Secretary to any plant, 
place of business, or transport vehicle subject to inspection.'' This 
commenter suggested wording that would provide that access be provided 
to any representative of the Secretary at any time business operations 
are being conducted.
    In Sec. 59.132, as well as in Sec. 59.760, FSIS has removed the 
phrase ``at any reasonable time,'' which the commenter questioned, for 
greater consistency with the EPIA, which does not limit Agency access 
to establishments (see 21 U.S.C. 1034). FSIS is also making these 
changes for greater consistency with the Federal meat and poultry 
inspection regulations (see 9 CFR 381.32 and 9 CFR 306.2), which do not 
restrict Agency access to establishments.

The Final Rule

    When these regulations become effective, egg handlers with flocks 
of more than 3,000 layers will be required to comply with the new 
refrigeration and labeling provisions. Consistent with current 
regulations that exempt from inspection egg handlers with flocks of 
3,000 or fewer birds (see Sec. 59.100), the 1991 EPIA amendments 
specify that any egg handler with a flock of 3,000 layers or less is 
not subject to inspection for purposes of verifying compliance with the 
refrigeration and labeling requirements (21 U.S.C. 1034(e)(4)).
    To monitor temperatures in storage rooms and transport vehicles, 
egg handlers with flocks of more than 3,000 layers may choose to 
install thermometric equipment and temperature recording devices; 
however, these regulations do not prescribe the means by which egg 
handlers are to comply with these provisions or to monitor their 
compliance. These regulations allow establishments the flexibility to 
determine how to meet the statutory requirements and how to monitor and 
ensure their compliance. U.S. Department of Agriculture (USDA) 
inspectors will verify that storage facilities and transport vehicles 
are refrigerated at or below 45 deg.F (7.2 deg.C).
    In Sec. 59.5, FSIS is adding new definitions to the regulations to 
reflect the terminology in the 1991 EPIA amendments. AMS proposed 
adding all of these definitions in the 1992 proposed rule. FSIS has 
added the term ``ambient temperature,'' as used in the 1991 amendments, 
to clarify that the 45 deg.F (7.2 deg.C) refrigeration requirement 
refers to the air temperature maintained in a shell egg storage 
facility or transport vehicle.
    The regulations include a definition for ``ultimate consumer'' that 
reflects how this term is used in the 1991 amendments. The Agency has 
defined the ``ultimate consumer'' as any household consumer, 
restaurant, institution or any other party who has purchased or 
received shell eggs or egg products for consumption. In 1992, AMS 
proposed to define this term as a household consumer, retail store, 
restaurant, institution, food manufacturer or other interested party 
who has purchased or received shell eggs or egg products for use or 
resale. After review of the proposed language, FSIS determined that an 
ultimate consumer should be defined as a party that purchases shell 
eggs or egg products for consumption, rather than for use or resale. 
Therefore, FSIS determined that a retail store or food manufacturer 
would not be considered an ultimate consumer and has modified the 
definition accordingly. The term ``ultimate consumer'' is used in the 
existing regulations, and each time it is used, examples of ``ultimate 
consumers'' follow the term. As was proposed, FSIS has revised 
Secs. 59.28(a)(1) and 59.690 to remove these examples, because the term 
will now be included in the definitions section.

[[Page 45668]]

    The 1991 EPIA amendments specifically refer to eggs that have been 
packed into a ``container'' and establish refrigeration requirements 
for shell eggs after packing (21 U.S.C 1037(c)). To implement these 
amendments, this final rule adds new language to the definition of 
``container or package'' to refer to shell eggs in containers destined 
for the ultimate consumer. The current definition for ``container or 
package'' does not provide specific examples of a container or package 
for shell eggs. Therefore, as was proposed, FSIS has revised the 
definition of ``container or package'' to distinguish between 
containers for egg products and containers for shell eggs. In the 
definition of ``immediate container'', FSIS has modified the language 
proposed in 1992 to clarify that an immediate container means any 
package or other container in which egg products or shell eggs are 
packed for household or other ultimate consumers. The labeling 
requirements would apply to all types of containers (that is, both 
immediate containers and shipping containers).
    As was proposed, FSIS has revised the definition of the term ``egg 
handler'' to clarify that the ultimate consumer is not considered an 
egg handler.
    As was proposed in 1992, FSIS is incorporating the refrigeration 
and labeling requirements prescribed by the 1991 EPIA amendments for 
domestic shell eggs into its regulations by adding Secs. 59.50 and 
59.410(a). In these sections, FSIS has made only minor revisions to the 
provisions proposed in 1992. Section 59.410(a) provides that all shell 
eggs packed into containers destined for the ultimate consumer be 
labeled to indicate that refrigeration is required and includes an 
example of labeling that would meet this requirement, ``Keep 
Refrigerated.'' The provision also allows establishments to use other 
words of similar meaning.
    To reflect the fact that the 1991 amendments specify that egg 
handlers with flocks of 3,000 or fewer layers are not subject to 
inspection for purposes of verifying compliance with refrigeration and 
labeling requirements, Sec. 59.50(c) includes new language that 
clarifies that producers-packers with a flock of this size are exempt 
from these refrigeration and labeling requirements.
    As was proposed in 1992, FSIS is amending Secs. 59.132, 59.134, and 
59.760 to clarify that inspectors must be granted access to transport 
vehicles and cooler rooms to verify that any shell eggs packed into 
containers for the ultimate consumer are stored and transported at an 
ambient temperature of no greater than 45 deg.F (7.2 deg.C). Transport 
vehicles that would be subject to inspection would include containers 
holding eggs that are attached to railroad cars or semi-trailer 
chassis.
    As discussed above, FSIS has revised the provisions proposed in 
1992 under Secs. 59.132 and 59.760 to remove the phrase ``at any 
reasonable time'' for greater consistency with the EPIA and for greater 
consistency with the Federal meat and poultry inspection regulations.
    FSIS has also revised the provision proposed in 1992 under 
Sec. 59.760 to refer to representatives of the ``Secretary'' rather 
than representatives of the ``Administrator.'' In the near future, FSIS 
intends to revise the current definition of ``Administrator'' in this 
part, which refers to the Administrator of AMS, to refer to the 
Administrator of FSIS. Because AMS retains surveillance activities 
under Sec. 59.760, FSIS has revised this section to refer to 
representatives of the ``Secretary'' rather than representatives of the 
``Administrator.'' This revision reflects a change in Agency 
organization made in response to the Federal Crop Insurance Reform and 
Department of Agriculture Reorganization Act of 1994.
    As was proposed in 1992, FSIS has revised Sec. 59.915 to 
incorporate the statutory amendment that imported shell eggs packed 
into containers destined for the ultimate consumer include a 
certification stating that the eggs have, at all times after packing, 
been stored and transported under refrigeration at an ambient 
temperature of no greater than 45 deg.F (7.2 deg.C). In addition, 
Secs. 59.950 and 59.955 require that imported shell egg containers and 
imported egg shipping containers be labeled to indicate that 
refrigeration is required. In each of these sections, FSIS has made 
only minor changes to the language AMS proposed in 1992.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Has no retroactive effect; and (2) 
does not require administrative proceedings before parties may file 
suit in court challenging this rule. Public Law 102-237 provides that 
with respect to the temperature requirements contained therein, no 
State or local jurisdiction may impose temperature requirements 
pertaining to eggs packaged for the ultimate consumer which are in 
addition to, or different from, Federal requirements.

Executive Order 12866

    FSIS is required to publish these regulations to comply with the 
1991 EPIA amendments and the 1998 Appropriations. This rule has been 
designated significant and was reviewed by the Office of Management and 
Budget under Executive Order 12866. Executive Order 12866 requires USDA 
to identify and, to the extent possible, quantify and monetize benefits 
and costs associated with the rule. This section estimates these 
benefits and costs. As discussed below, because of changes in State 
laws concerning the refrigeration of shell eggs, FSIS has changed the 
baseline that was used for determining costs in the 1992 proposed rule. 
If the Agency had used the original baseline, the estimated costs would 
have been higher than the estimates in this rule. In addition, the 
benefits in this rule are based on the recently completed SE risk 
assessment and data that were not available in 1992. The estimated 
annual benefits of this rule are lower than those estimated in 1992 
(see 57 FR 48572).

Incremental Social Benefits

    The incremental social benefits of the rule are the avoidance of 
illnesses and deaths associated with consumption of eggs contaminated 
with SE. SE is a serotype of the family of pathogen Salmonella. When 
the disease affects humans, it causes salmonellosis, which usually 
appears 6 to 72 hours after eating contaminated eggs and egg products 
and lasts up to 7 days. Symptoms of this disease include diarrhea, 
abdominal cramps, fever, nausea, and vomiting (nausea and vomiting 
develop in less than 50 percent of cases). Children, the elderly, and 
people with compromised immune systems are particularly vulnerable to 
SE infection. Deaths from SE disease occur in these vulnerable groups. 
Statistics of outbreaks reported to the Centers for Disease Control and 
Prevention (CDC) on foodborne diseases reveal that an increasing number 
of salmonellosis cases are associated with SE; however, it should be 
noted that the CDC actively contacts each State to obtain information 
concerning SE but does not actively contact the States for information 
on the other Salmonella serotypes.
    From 1985 to 1993, consumption of eggs was associated with 83 
percent of SE-related outbreaks where a food vehicle was identified 
(CDC, ``Outbreak of Salmonella enteritidis Associated with Homemade Ice 
Cream--Florida, 1993,'' Morbidity and Mortality Weekly Report 43(36) 
(September 16, 1994): 669-671). The proportion of cases of 
salmonellosis reported to CDC attributable to SE increased from 5 
percent in 1976 to 26 percent in 1994 (CDC, ``Outbreaks of Salmonella

[[Page 45669]]

Serotype Enteritidis Infection Associated with Consumption of Raw Shell 
Eggs--United States 1994-1995,'' Morbidity and Mortality Weekly Report 
45(34) (August 30, 1996): 737-742). In 1995 and 1996, salmonellosis 
cases attributable to SE represented about 25 percent of salmonellosis 
cases reported to the CDC. Preliminary data from the Foodborne Diseases 
Active Surveillance Network (FoodNet) indicate that SE represented 17% 
of all cases of Salmonella in 1996 (FSIS, FSIS/CDC/FDA Sentinel Site 
Study: The Establishment and Implementation of an Active Surveillance 
System for Bacterial Foodborne Diseases in the United States, February 
1997).
    In the discussion below, FSIS assumes that SE cases associated with 
the consumption of eggs represent 25 percent of all human salmonellosis 
cases. This assumption is based on the percentage of SE cases reported 
to the CDC in recent years. FSIS is using this percentage rather than 
the 17 percent based on FoodNet data because the FoodNet database is 
still being implemented and covers only Minnesota, Oregon, and counties 
in Connecticut, Georgia, and California. In addition, only the first 
year of data is available from the Foodnet. The CDC surveillance system 
has been active for approximately 30 years, all States contribute to 
the CDC surveillance data, and States receive incentives for 
submissions to the CDC surveillance system.
    In 1996, 39,027 confirmed cases of human salmonellosis were 
reported to the CDC by State, local, and Federal departments of health. 
From 1985 through 1996, there have been 508,673 reported cases of 
salmonellosis (Centers for Disease Control and Prevention, Laboratory 
Confirmed Salmonella, Surveillance Annual Summary, 1993-1995 and 1996). 
Based on CDC outbreak data, the three illness-causing serotypes most 
frequently reported--Salmonella typhimurium, Salmonella heidelberg, and 
Salmonella enteritidis--are most often traced to poultry and eggs when 
a food vehicle is found. A food vehicle is found in only about 25 to 30 
percent of cases.
    Since the reporting of outbreak statistics to CDC is voluntary, it 
is estimated that there are an additional 20 to 100 cases of 
salmonellosis for every reported case, or some 800,000 to 4 million 
cases per year (R. Chalker and M. Blaser, ``A Review of Human 
Salmonellosis: III. Magnitude of Salmonella Infection in the United 
States,'' Review of Infectious Diseases 10(1) (1988): 111-124). The 
severity of the underreported cases as well as their statistical 
distribution is unknown and hence this analysis could not adjust for 
such probabilities. The estimate of 800,000 to 4 million is based on 
the number of cases reported to the CDC surveillance system through 
1996 and is confirmed by the data for the 1988-92 period.

      Table 1.--Health and Economic Benefits of Refrigerating Eggs at 45 deg.F Rule: Low Benefits Estimates     
----------------------------------------------------------------------------------------------------------------
                                                                                    Upper bound of health costs 
Annual number of egg-related human SE    Lower bound of health costs associated    associated with column 1 in $
                cases                         with column 1 in $ (1996) \1\                  (1996) \2\         
----------------------------------------------------------------------------------------------------------------
661,633 \3\..........................  $225 million..............................  $900 million.                
----------------------------------------------------------------------------------------------------------------
                  Estimated Reduction in Egg-Related SE Cases due to 45 deg.F Refrigeration \4\                 
----------------------------------------------------------------------------------------------------------------
   Health benefits (number of cases         Lower bound of economic benefits          Upper bound of economic   
               avoided)                    associated with column (1) $ (1996)        benefits associated with  
                                                                                       column (1) in $ (1996)   
----------------------------------------------------------------------------------------------------------------
10,189...............................  $3.47 million.............................  $13.86 million.              
----------------------------------------------------------------------------------------------------------------
\1\ Jean C. Buzby and Tanya Roberts, ``Guillain-Barre Syndrome Increases Foodborne Disease Costs,'' Food Review 
  (September-December 1997): 36-42. This report provides an estimate of costs of total human Salmonella cases   
  from all food sources. The costs estimated in this table assume that egg-related SE cases represent 25% of    
  total human salmonellosis cases. The report estimates the lower bound of the low estimate of health care costs
  at $900 million.                                                                                              
\2\ Ibid. The report estimates the upper bound of the low estimate of health care costs at $3.6 billion.        
\3\ FSIS, Salmonella Enteritidis Risk Assessment, Washington, DC, June 12, 1998. The number shown in the chart  
  is the estimated mean number of salmonellosis cases resulting from the consumption of SE-contaminated eggs.   
  The estimated number of cases per year in the Risk Assessment ranges from 126,374 to 1.7 million.             
\4\ FSIS, Salmonella Enteritidis Risk Assessment, Washington, DC, June 12, 1998. The risk assessment model      
  estimates that refrigeration of eggs at 45 deg.F during storage and transportation will result in a mean      
  reduction of 1.54% in human SE cases.                                                                         


     Table 2.--Health and Economic Benefits of Refrigerating Eggs at 45 deg. F Rule: High Benefits Estimates    
----------------------------------------------------------------------------------------------------------------
                                                                                    Upper bound of health costs 
Annual number of egg-related human SE    Lower bound of health costs associated    associated with column 1 in $
                cases                         with column 1 in $ (1996) \5\                  (1996) \6\         
----------------------------------------------------------------------------------------------------------------
661,633 \7\..........................  $1.2 billion..............................  $3.075 billion.              
----------------------------------------------------------------------------------------------------------------

[[Page 45670]]

                                                                                                                
  Estimated Reduction in Egg-Related SE Cases due to 45 deg.F Refrigeration \8\                                 
----------------------------------------------------------------------------------------------------------------
   Health benefits (number of cases         Lower bound of economic benefits          Upper bound of economic   
               avoided)                    associated with column (1) $ (1996)        benefits associated with  
                                                                                       column (1) in $ (1996)   
----------------------------------------------------------------------------------------------------------------
10,189...............................  $18.48 million............................  $47.355 million.             
----------------------------------------------------------------------------------------------------------------
\5\ Jean C. Buzby and Tanya Roberts, ``Guillain-Barre Syndrome Increases Foodborne Disease Costs,'' Food Review 
  (September-December 1997): 36-42. This report provides an estimate of costs of total human Salmonella from all
  food sources. The costs estimated in this table assume that egg related SE cases represent 25% of all human   
  salmonellosis cases. The report estimates the lower bound of the high estimate of health care costs at $4.8   
  billion.                                                                                                      
\6\ Ibid. The report estimates the upper bound of the high estimate of health care costs at $12.3 billion.      
\7\ FSIS, Salmonella Enteritidis Risk Assessment, Washington, DC, June 12, 1998. The number shown in the chart  
  is the estimated mean number of salmonellosis cases resulting from the consumption of SE-contaminated eggs.   
  The estimated number of cases per year in the Risk Assessment ranges from 126,374 to 1.7 million.             
\8\ FSIS, Salmonella Enteritidis Risk Assessment, Washington, DC, June 12, 1998. The risk assessment model      
  estimates that refrigeration of eggs at 45 deg.F during storage and transportation will result in a mean      
  percent reduction of 1.54% in human SE cases.                                                                 

    Tables 1 and 2 show an estimated number of annual human illnesses 
resulting from consumption of SE-contaminated eggs. This number is 
based on the mean estimated annual number of cases in the Salmonella 
Enteritidis Risk Assessment published by FSIS (June 12, 1998). This 
report estimates that the number of cases of illness resulting from 
consumption of SE-contaminated eggs ranges from 126,374 to 1.7 million 
per year. The Agency is using data from the risk assessment rather than 
the number of reported cases because, as noted above, it is estimated 
that there are an additional 20 to 100 cases of salmonellosis for every 
reported case. Tables 1 and 2 display the mean estimate because the 
mean is not unduly affected by a few moderately small or moderately 
large values, and this stability increases with the sample size. To 
estimate the economic value of the health costs of salmonellosis, the 
USDA's Economic Research Service (ERS) related illnesses and deaths to 
four types of severity groups of patients. The four severity groups 
were: (1) those who did not visit a physician, (2) those who visited a 
physician, (3) those who were hospitalized, and (4) those who died 
prematurely because of their illness (Jean C. Buzby and Tanya Roberts, 
``Guillain-Barre Syndrome Increases Foodborne Disease Costs,'' Food 
Review (September-December 1997): 36-42). Similar severity rates are 
also used in the risk assessment final report, e.g., treatment by a 
physician, hospitalization, and mortality. Both sources use the CDC 
data on severity.
    Based on the avoidance of medical costs, ERS estimated the economic 
values of prevention of these cases. ERS calculated the range of low 
estimate of avoidance of all foodborne human salmonellosis-linked 
diseases and deaths, at $900 million and $3.6 billion respectively (in 
1996 dollars). ERS calculated the range of high estimate of the health 
costs at $4.8 billion and $12.3 billion (in 1996 dollars). The wide 
variation in this range of estimates is attributed both to the wide 
range in estimates of the number of cases and the economic methods used 
for the analysis.
    The economic methods are the human capital method and the labor 
market method. The human capital method yields a lower estimated range 
of $0.9 to $3.6 billion because the cost of premature death in this 
analysis varies with age and ranged from $15,000 to $2,037,000 (in 1996 
dollars). The labor market approach yields the higher range of $4.8 to 
$12.3 billion because it values the cost of premature death at $5 
million per person (in 1996 dollars) (Jean C. Buzby and Tanya Roberts, 
``Guillain-Barre Syndrome Increases Foodborne Disease Costs,'' Food 
Review (September-December 1997): 36-42).
    Since the ranges of estimates for salmonellosis-related costs 
estimated by Buzby and Roberts are based on salmonellosis from all food 
sources, it is necessary to adjust the estimates downwards to obtain 
only the cases of salmonellosis related to consumption of SE-
contaminated eggs. The medical cost data shown in the first rows of 
Tables 1 and 2 represent 25 percent of the ERS estimates because FSIS 
assumes that SE-contaminated eggs are responsible for approximately 25 
percent of salmonellosis cases. This assumption is based on the 
percentage of SE cases reported to the CDC and the fact that eggs are 
responsible for the vast majority of these cases. As noted above, from 
1985 to 1993, consumption of eggs was associated with 83 percent of SE-
related outbreaks where a food vehicle was found. Also noted above, a 
food vehicle is found in only about 25 to 30 percent of cases. Given 
the level of uncertainty in this data, for estimation purposes, the 
Agency believes it is appropriate to assume that SE-contaminated eggs 
are responsible for 25 percent of total salmonellosis cases.
    Humphrey and Whitehead (1993) suggest that an egg's contents can 
become contaminated with SE before the egg is laid. They also note that 
after an infected egg is laid, SE contamination tends to grow inside 
the egg (T. Humphrey and A. Whitehead, ``Egg Age and Growth of 
Salmonella Enteritidis PT4 in Egg Contents,'' Epidemiological Infection 
111 (1993): 209-219). Humphrey suggested that refrigerating during 
storage can prevent such growth (T.J. Humphrey, ``Growth of Salmonella 
in intact shell eggs: Influence of Storage Temperature,'' Veterinarian 
Record (1990): 1236-1292). Other measures for preventing growth include 
refrigeration during transportation and retail sales, reducing shelf 
life of eggs at retail, thorough

[[Page 45671]]

cooking, pasteurization, and processing shell eggs into frozen, liquid, 
or dry egg products (FSIS, Salmonella Risk Assessment, June 12, 1998; 
T. Hammack, et al., ``Research Note: Growth of Salmonella Enteritidis 
in Grade A Eggs During Prolonged Storage,'' Poultry Science 334 (1993): 
1281-1286).
    In order to determine the benefits of refrigerating eggs at 
45 deg.F, it is necessary to determine the percentage of reduction in 
the number of egg-related deaths and illnesses from SE cases referred 
to above. To determine these benefits, this analysis relied on input 
from a risk assessment model. In June 1998, FSIS completed a risk 
assessment concerning shell eggs and egg products in response to an 
increasing number of human illnesses associated with the consumption of 
shell eggs. The risk assessment developed a model to assess risk 
throughout the egg and egg products continuum. The risk assessment 
model consists of five modules. The first module, the Egg Production 
Module, estimates the number of eggs produced that are infected (or 
internally contaminated) with SE. The Shell Egg Module, the Egg 
Products Module and the Preparation and Consumption Module estimate the 
increase or decrease in the number of SE organisms in eggs or egg 
products as they pass through storage, transportation, processing and 
preparation. The Public Health Module then calculates the incidences of 
illnesses and four clinical outcomes (recovery without treatment, 
recovery after treatment, treatment by a physician, hospitalization, 
and mortality) as well as the cases of reactive arthritis associated 
with consuming SE positive eggs.
    Refrigeration of shell eggs at an ambient air temperature of 
45 deg.F or below during storage and transportation will retard growth 
of SE and hence is likely to reduce the associated illnesses and 
deaths. The risk assessment model estimates that refrigeration of shell 
eggs at an ambient temperature of 45 deg.F or below can bring about a 
mean reduction of 1.54 percent in egg-related human illnesses 
associated with SE. This estimate has a 90 percent confidence interval, 
with a lower bound of 0 percent and an upper bound of 7 percent. 
Therefore, there is a range of possible outcomes. Although a 1.54 
percent reduction in illnesses associated with SE is the most likely 
outcome, the regulation could result in no reduction in illnesses or in 
a reduction as high as 7 percent. This estimate and its confidence 
interval are based on a model with the assumption that eggs are 
maintained at an ambient temperature of 45 deg.F after processing 
through transportation to retail, or other, end users. This result also 
assumes complete compliance with the regulation. The effect of the 
regulation was modeled by adjusting the baseline model (consisting of 
the Production, Shell Egg Processing/Transportation, Preparation/
Consumption, and Public Health modules) to reflect the regulation's 
effect. The model adjusted the following temperature variables in the 
Shell Egg Processing/Transportation module: Storage temperature after 
processing at off-line processor, Storage temperature after processing 
at in-line processor, Temperature during transportation to egg users. 
In the baseline model, these variables were modeled as extending from a 
low of 41 deg.F, in the case of the storage temperature after 
processing at in-line processors, to a high of 90 deg.F. The baseline 
model assumes that eggs are handled under a variety of different 
temperatures. In modeling the regulation, these variables' 
distributions were truncated at 45 deg.F. Therefore, all eggs were 
exposed to ambient temperatures of 45 deg.F or less after packing in 
the regulation model. The effect of the regulation was calculated as 
the difference in simulated total human cases between the baseline 
model and the regulation model. The percent reduction in human 
illnesses was then calculated by dividing this difference in human 
cases by the simulated total human cases from the baseline model. It 
must be noted that the estimated mean reduction in SE illnesses of 1.54 
percent referred to above was estimated in a separate run of the model 
for this rule performed by FSIS scientists and is not included in the 
risk assessment final report. As noted above, the risk assessment final 
report estimates the benefits that would result from maintaining an 
ambient temperature of 45 deg.F throughout processing and distribution 
(that is, from pre-packing and through retail) and the benefits of 
maintaining the internal temperature of eggs at 45 deg.F throughout 
processing and distribution.
    The last rows in Tables 1 and 2 show the reductions in SE cases 
associated specifically with refrigeration of shell eggs based on the 
mean value of 1.54 percent reduction in cases referred to above. These 
are the incremental social benefits of the rule. These estimates range 
from a low of $3.47 million to $13.86 million in Table 1 to a range of 
$18.48 million to $47.355 million in Table 2 (in 1996 dollars). 
Requiring refrigeration of eggs at an ambient air temperature of 
45 deg.F does not address all the food safety risks posed by shell 
eggs. Responses to the ANPR will assist FSIS and FDA in the development 
of a comprehensive, farm-to-table food safety strategy that will 
address a variety of food safety measures in addition to ambient air 
temperature. Actions taken subsequent to the analysis of alternatives 
identified in the ANPR may provide additional benefits associated with 
further reductions in foodborne illness associated with the consumption 
of shell eggs.
    As noted above, FSIS and FDA have published an ANPR concerning SE 
in shell eggs (63 FR 27502; May 19, 1998). The number of cases in 
Tables 1 and 2 are larger than those reported in the ANPR (63 FR 27504) 
because the figures in the ANPR are based on outbreaks reported to the 
CDC, while the data on Tables 1 and 2 take into account the fact that 
many of the cases are unreported. In addition, the cost of illnesses in 
Tables 1 and 2 differ from those in the ANPR (63 FR 27504) because the 
estimates in the ANPR were based on 1991 data. FSIS used 1996 data for 
the cost and benefit analysis in these regulations.

Incremental Social Costs

    The incremental social costs associated with the rule include the 
first year fixed capital costs and the annual recurring costs of 
compliance to be incurred by the industry. The first year costs would 
include the costs of replacing or retrofitting refrigeration units, 
compressors, and coils. These capital costs are required for storing 
shell eggs at 45 deg.F or below after washing and packing. The capital 
costs to the industry would also include the costs of replacing or 
retrofitting transportation vehicles that have refrigeration units 
capable of producing air at 45 deg.F or below. The annual recurring 
costs would encompass the energy costs of maintaining ambient 
temperatures in storage facilities and transportation vehicles at 
45 deg.F or below. These capital and recurring costs would be incurred 
either by shell egg producers or by their contractors for storage and 
transportation. When the storage or transportation services are 
contracted out, however, it is very difficult to separate the costs 
associated with shell eggs because these contractors store or haul not 
only shell eggs but also several other products.
    An additional element of the social costs would be the incremental 
budgetary costs, if any, to USDA for enforcing this regulation. The 
Agency has not determined how it will enforce this rule. AMS may check 
the ambient temperature of shell egg storage

[[Page 45672]]

facilities and the labeling of shell egg containers during its 
surveillance of egg handlers and during grading activities. FSIS 
compliance officers may check the ambient temperature of shell egg 
storage facilities and transportation vehicles and the labeling of 
shell egg containers once the eggs leave the plant. For example, while 
compliance officers are checking meat and poultry products in commerce 
outside inspected establishments or at uninspected facilities, if such 
facilities store shell eggs, compliance officers may also check 
temperatures at these locations and verify that the labeling of egg 
containers meets the requirements in this rule.
    Whether AMS or FSIS checks the temperature of shell egg storage 
facilities and transport vehicles and verifies that the labeling of egg 
containers meets the requirements in this rule, these activities are 
likely to be in addition to other Agency activities conducted at the 
same location. Checking temperatures and labeling will increase the 
time required for AMS or FSIS personnel to conduct their oversight 
activities. However, FSIS is unable to determine the amount of 
additional time that will be required. Therefore, the Agency is unable 
to estimate the additional costs (e.g., personnel costs and costs of 
equipment such as thermometers) that will be required for monitoring 
compliance with the requirements in this rule.
    The costs of compliance to the industry are not likely to be 
excessive for three reasons. First, the rule exempts small producers 
with flocks of 3,000 layers or less. There are approximately 80,000 
such small egg producers that would not be required to comply with the 
refrigeration and labeling provisions of this rule.
    Second, of the approximately 700 producers currently registered 
with USDA as of July 1998, 329 are major producers with flocks of 
75,000 or more who produce about 94 percent of U.S. table eggs. Most of 
these producers are members of United Egg Producers (UEP), an 
organization that provides a variety of services to member egg 
producers. The UEP already has a quality assurance program that 
recommends refrigerating eggs at 45 deg.F or below as quickly as 
possible after washing and grading and that the same temperature be 
maintained during transportation. A letter from UEP indicated that many 
of these producers have already started refrigerating at 45 deg.F or 
below. Therefore, these producers are unlikely to incur additional 
costs of compliance. (This aspect is elaborated later in a section on 
the Regulatory Flexibility Act (RFA).) It is likely that most producers 
that are not members of UEP or are not major producers have also begun 
refrigerating shell eggs during storage and transportation because of 
State requirements (discussed below). With regard to producers that are 
not members of the UEP or are not major producers, specific information 
regarding whether they store and transport shell eggs at 45 deg.F is 
not available. The structure of egg industry is changing toward greater 
concentration of large producers. For example, the number of producers 
registered with AMS has declined from about 1,200 in 1992 to 
approximately 700 in July, 1998. The resulting concentration of larger 
producers who refrigerate their supplies is likely to have reduced the 
costs of compliance.
    Third, many States have already enacted laws requiring specified 
ambient air temperatures for shell egg storage and transportation. 
Approximately one-half of all States require 45 deg.F or less for 
storage and transportation. Approximately ten of these States have 
adopted 45 deg.F refrigeration requirements since 1992. Some of these 
States are large producers. Many States also require that shell eggs be 
refrigerated at 45 deg.F at retail. Approximately ten States retain the 
60 deg.F traditionally required under USDA grading standards. 
Approximately one dozen States have no refrigeration requirement for 
shell egg storage and transportation. Costs of compliance for the shell 
egg producers in the States already requiring refrigeration at 45 deg.F 
are not likely to increase significantly. Some of the States that 
require 45 deg.F refrigeration of shell eggs during storage and 
transportation are among States in which major producers are located, 
e.g., Ohio, Pennsylvania, and Georgia. However, there are States with 
major producers and other producers that do not require 45 deg.F 
refrigeration during storage and transportation of shell eggs. The 
Agency requests information concerning the costs these regulations may 
impose on producers who are currently not refrigerating shell eggs at 
45 deg.F during storage and transportation. The Agency also requests 
information concerning the size of these establishments.
    The rule proposed on October 27, 1992 for refrigerating shell eggs 
at 45 deg.F or below estimated the first-year capital investment costs 
at $40.67 million (57 FR 48571). The annual recurring operating costs 
were estimated at $10 million. The capital investment costs involved 
replacing or retrofitting existing refrigeration units with larger 
compressors or coils. The recurring annual operating costs involved the 
energy costs of maintaining ambient air temperatures in storage 
facilities and transport vehicles at 45 deg.F or below. These cost 
estimates were based on data obtained from a survey of 80 (7 percent) 
out of the 1200 shell egg processing plants located throughout the 
country representing about 25 percent of production. 59 plants (75 
percent) responded to the survey. The Agency was unable to evaluate the 
comments regarding the specific large costs of acquiring trucks and 
equipment because the survey did not contain such detailed data.
    The costs to comply with this final rule will be lower than the 
costs estimated for the proposed rule in 1992 because about ten States 
(e.g., Arkansas, Florida, Georgia, Louisiana, Ohio, Oregon, Rhode 
Island, and Texas) have already adopted refrigeration requirements at 
45 deg.F or below for storage and transportation since 1992. These 
States represented 29 percent of shell egg production in 1996. FSIS 
updated the 1992 estimates to account for inflation and changes in 
State laws. The Agency requests specific information concerning costs 
that will be incurred in States that have not enacted refrigeration 
requirements.
    The costs estimated in 1992 were not adjusted upward for any of the 
comments to the proposed rule because about 10 States have implemented 
the 45 deg.F refrigeration requirements since 1992. Since about ten out 
of fifty States representing 29 percent of production have implemented 
the rule since 1992, this analysis reduced the capital and recurring 
costs estimated in 1992 by 29 percent. This adjustment reduced the 
capital and recurring costs to $28.40 million and $7.1 million 
respectively. Therefore, costs were reduced based on shell egg 
production data. FSIS reduced costs based on production data because 
the 1992 costs were estimated and reported on a production basis (see 
57 FR 48571-48572). The fact that the number of producers has declined 
since 1992 may further lower the costs to the industry because a 
smaller number of larger producers tend to have lower costs due to 
scale economies.
    The updated costs referred to above were adjusted upwards because 
of inflation over the last six years. To adjust for this increase, FSIS 
increased the $28.40 million capital costs by 8 percent (based on U.S. 
Department of Commerce, Bureau of Economic Analysis, price index of 
transportation and related equipment index, 1992 = 100, 1997 = 108.5). 
This adjustment increased the capital cost estimate from

[[Page 45673]]

$28.40 million to $30.67 million, or $31 million approximately.
    The updated recurring costs of compliance, estimated at $7 million 
per year in 1992, were assumed to comprise mostly energy costs of 
refrigeration. These estimates were increased for inflation over the 
last six years to $7.63 or $8 million approximately (based on U.S. 
Department of Commerce, Bureau of Economic Analysis, Price Index of 
Electricity and Gas, 1992 = 100, 1997 = 108.98, or by 9 percent). FSIS 
requests alternate cost estimates and data to support these estimates 
from commenters who disagree with the Agency's cost estimates.
    The estimated costs of compliance and the associated social 
benefits of this rule are likely to be realized over the next twenty 
years. Therefore, these costs and benefits were discounted over this 
time span by using a 7 percent mid-year discount rate recommended by 
the Office of Management and Budget.
    Table 3 reports FSIS estimates of the discounted costs and benefits 
of the rule under alternative assumptions about cost of salmonella 
induced foodborne illness. Depending on the assumption used, the 
estimated net benefits range from -$79.6 million to $401.30 million. 
Under the assumption that the cost of foodborne illness varies with 
age, the net benefits from the rule range from -$79.6 million to $34.2 
million. Alternatively, if it is assumed that the cost of premature 
death is $5 million per person, the net benefits from the rule are 
higher, from $84.9 million to $401.3 million. In light of the 
uncertainty surrounding the benefit estimates and refinements to costs, 
FSIS cannot make a definitive statement about the net benefits 
associated with the rule.

                     Table 3.--Discounted Benefit-Cost Estimates of Refrigerating Shell Eggs                    
                              [Fixed Costs=$31 million, Recurring Costs=$8 million]                             
----------------------------------------------------------------------------------------------------------------
                                                                                        Lower bound  Upper bound
                                                              Lower bound  Upper bound    of high      of high  
                                                              of low est.  of low est.      est.         est.   
----------------------------------------------------------------------------------------------------------------
Recurring benefits: ($ million).............................         3.47        13.86        18.48        47.36
Discounted Benefits*: ($ m.)................................        38.03       151.88       202.51       518.93
Discounted Costs*: ($ m.)...................................       117.63       117.63       117.63       117.63
Net Discounted Benefits: (Row 2-Row 3) ($ m.)...............       -79.60        34.17        84.88       401.30
Benefit-Cost Ratio: (Row 2:Row 3)...........................         0.32         1.29         1.72        4.41 
----------------------------------------------------------------------------------------------------------------
*Discount Rate=7%, Time Period=20 years.                                                                        
Source: Tables 1 and 2.                                                                                         

    The preceding costs are likely to be passed on to consumers by the 
industry because of the elasticity of demand and supply of eggs. The 
demand for shell eggs is very inelastic, i.e., an increase in the price 
of shell eggs is not likely to reduce significantly the demand for 
them. For example, Kuo reports that the price elasticity of demand for 
shell eggs is only (-0.11), i.e., an increase in price by one percent 
is associated with only 0.11 percent decrease in quantity of shell eggs 
demanded (Huang S. Kuo, A Complete System of U.S. Demand for Food, 
USDA/Economic Research Service, Technical Bulletin No.1821, 1993, 
Appendix B and C).
    The inelastic demand is due to the fact that there are no good 
substitutes for eggs that consumers might use when prices of shell eggs 
are increased. Also, a typical consumer spends an insignificant 
proportion of the food budget on shell eggs and consumes a limited 
number of eggs.
    The supply of shell eggs is very elastic because this industry has 
hundreds of producers who can increase the supply of eggs with little 
increase in costs. This prevents price increases by any single producer 
and no producer can increase prices without losing significant market 
share. Therefore, egg prices have been stable, if not declining, for 
several years. For example, wholesale egg prices declined from 91.5 
cents/dozen in 1996 to 83.8 cents/dozen in 1997. In the first quarter 
of 1998, this price declined to 82.5 cents/dozen. The average retail 
price of grade A large eggs was $1.1063/dozen in 1997 (U.S. Department 
of Labor/Bureau of Labor Statistics). Per capita consumption of eggs 
increased only slightly, from 237.8 eggs in 1996 to 239.3 eggs in 1997.

Regulatory Flexibility Act (RFA)

    The Administrator has determined that this rule will not have a 
significant economic impact on a substantial number of small entities. 
As noted above, this rule exempts from compliance small producers with 
flocks of 3,000 layers or less. Most of the establishments not exempt 
from this rule are small establishments with employment of 500 or less. 
Also, the compliance costs are likely to be spread over a large volume 
of output that will be produced over the life cycles of these capital 
assets (e.g., refrigeration equipment). For example, according to the 
National Agricultural Statistics Service, 5.456 billion dozen eggs were 
produced between January 1, 1997 and December 31, 1997. During that 
time, the wholesale price for table eggs, estimated by ERS, was 83.8 
cents per dozen, and the gross industry receipts were estimated at 
$3.96 billion. Therefore, the compliance costs would represent less 
than a penny per dozen eggs or less than one percent of revenues. Since 
these first year costs include nonrecurring capital costs for storage 
facilities and refrigerated vehicles, the impact on the industry would 
be substantially less in subsequent years. For example, the recurring 
costs in the subsequent years were estimated at $9 million per year. 
This cost would represent primarily the energy cost of generating 
refrigeration and the maintenance and replacement costs of storage 
facilities. The relative impact on small producers would be 
insignificant also because the current structure of the shell egg 
industry is more concentrated than in 1992. For example, currently 
there are only about 700 producers, compared to about 1,200 producers 
in 1992. The smaller number of producers with increased output is 
likely to have resulted in a greater concentration of larger firms in 
this industry. These larger firms are more likely to absorb the 
compliance costs relative to smaller firms. FSIS notes that increased 
costs will not be evenly distributed across the industry because some 
producers are currently storing and transporting shell eggs at 45 
deg.F, while others are most likely storing and transporting shell eggs 
at higher temperatures.
    The shell egg industry would be able to ``pass through'' this cost 
in the form of higher prices to consumers because, as noted earlier, 
demand for this product is very inelastic and the supply

[[Page 45674]]

of shell eggs is highly elastic. The inelasticity of the demand follows 
from the fact that household expenditures on eggs are a small share of 
household budgets and because substitutes for eggs--at least in some 
applications--are limited. The high elasticity of supply is based on 
the fact that there are hundreds of shell egg producers in the U.S. 
with relatively flat marginal cost curves. Thus, producers expand egg 
production with little increase in average costs.
    The rule would not be burdensome to other small entities such as 
State and local governments because they are not in the business of 
storage and transportation of shell eggs. However, to the extent State 
and local governments are consumers of eggs, they will pay a little 
more for eggs.

Alternatives to the Rule

    FSIS considered several alternatives to this rule. FSIS found the 
alternatives, which are described below, to be inferior to this rule 
because of their expected benefits and costs, administrative burden, 
efficiency, and equity.

No Action

    This alternative would continue the current practice of no Federal 
requirement for refrigeration of shell eggs. The public health benefit 
would be zero because this alternative would not reduce Salmonella 
related illness. FSIS considered and rejected this alternative because, 
as noted above, the EPIA amendments mandate promulgation of this rule. 
In addition, as noted earlier, the Appropriations Committee has 
withheld $5 million of the FSIS appropriated funds for Fiscal Year 1998 
until a final rule is promulgated to implement the refrigeration and 
labeling requirements included in the 1991 EPIA amendments. A loss of 
$5 million in the Agency's appropriation is likely to impair FSIS's 
inspection activities, and degrade food safety in general.

Sliding Scale Approach

    This alternative does not require maintenance of a specific ambient 
temperature, such as the 45 deg.F rule does. Under this approach, a 
specific ``sell-by'' date is mandatory, which would vary depending on 
the temperatures at which eggs are maintained. To provide an incentive 
for processors to chill eggs before shipping, yet retain flexibility to 
accommodate reasonable alternatives to an absolute temperature 
requirement, a regulation might prescribe a range of ``sell-by'' dates 
based on the egg temperature achieved by the packer. Such an approach 
is under consideration by the European Union but is not recommended for 
the U.S. because of differences in climate, and vast distances in the 
U.S. relative to within or even between countries in Europe. This 
alternative would be burdensome to the industry and difficult to 
implement because it would require detailed recordkeeping by the 
industry. Some public health benefits would be expected and would 
depend on the sell-by date/temperature matrix. Industry costs would 
depend on the matrix and which temperatures producers select. Finally, 
this alternative would be very difficult to enforce since USDA 
inspectors would have to keep track of hundreds of shell egg producers 
and billions of dozens of eggs.

State Rules Instead of Federal Rule

    FSIS considered the alternative of actively encouraging State 
governments to promulgate their own laws instead of a Federal rule but 
did not adopt it for several reasons. First, as noted earlier, about 
half of all States currently have laws requiring refrigeration of shell 
eggs at 45 deg.F. On the other hand, some States do not have any 
refrigeration requirements for shell eggs. Other States require 
refrigeration during storage but not during transportation. Some States 
require refrigeration of shell eggs at temperatures greater than 
45 deg.F. In contrast to these inconsistencies and non-uniformities, 
with the exception of shell eggs packed by egg handlers with 3,000 or 
fewer hens, this rule requires that all shell eggs packed in containers 
for the ultimate consumer be refrigerated during storage and 
transportation at 45 deg.F or below. The public health benefits of this 
alternative are expected to be zero, since this alternative is 
essentially the same as no action except that States would be put on 
notice that they should deal with public health risks from eggs.
    In view of the disparities within and across the States, FSIS 
determined that it would not be appropriate to defer to the States.

Summary and Conclusions

    This section analyzed compliance of this rule with Executive Order 
12866. It estimated discounted social benefits of the rule and 
juxtaposed them against discounted capital and operating costs of 
compliance with the rule. The analysis concluded that potential net 
social benefits may result from this rule.
    This section also analyzed compliance of this rule with the 
Regulatory Flexibility Act. It is concluded that the costs of 
compliance are not likely to have a significant economic impact on a 
substantial number of small entities because the industry's cost of 
compliance amounts to less than a penny per dozen eggs, demand for eggs 
is inelastic, and the supply of eggs is highly elastic. In short, the 
egg producers could easily ``pass through'' the costs of compliance to 
consumers without losing their market shares. Other small entities such 
as local and State governments are also not likely to be adversely 
affected by this rule because they are not in the business of 
producing, storing, or transporting shell eggs. To the extent that they 
are large buyers of eggs, they would be adversely impacted by the 
estimated increase in price of a penny per dozen eggs.
    Finally, this section analyzed several alternatives to the rule. 
These alternatives included: (1) no action, (2) sliding scale approach, 
and (3) State rules instead of a Federal rule. These alternatives were 
rejected because of their costs, administrative burden, efficiency, or 
equity.

Paperwork Requirements

    The paperwork and recordkeeping activities associated with this 
rule are approved under OMB control number 0583-0106.

List of Subjects in 7 CFR Part 59

    Eggs and egg products, Exports, Food grades and standards, Food 
labeling, Imports, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, FSIS is amending 7 CFR 
Part 59 as follows:

PART 59--INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS 
INSPECTION ACT)

    1. The authority citation for part 59 continues to read as follows:

    Authority: 21 U.S.C. 1031-1056.

    2. Section 59.5 is amended by adding alphabetically the definitions 
for ``Ambient temperature'' and ``Ultimate consumer'' and revising the 
definitions for ``Container or Package'' and ``Egg handler'' to read as 
follows:


Sec. 59.5  Terms defined.

* * * * *
    Ambient temperature means the air temperature maintained in an egg 
storage facility or transport vehicle.
* * * * *
    Container or Package includes for egg products, any box, can, tin, 
plastic, or other receptacle, wrapper, or cover and for shell eggs, any 
carton, basket, case, cart, pallet, or other receptacle.

[[Page 45675]]

    (a) Immediate container means any package or other container in 
which egg products or shell eggs are packed for household or other 
ultimate consumers.
    (b) Shipping container means any container used in packing an 
immediate container.
* * * * *
    Egg handler means any person, excluding the ultimate consumer, who 
engages in any business in commerce that involves buying or selling any 
eggs (as a poultry producer or otherwise), or processing any egg 
products, or otherwise using any eggs in the preparation of human food.
* * * * *
    Ultimate consumer means any household consumer, restaurant, 
institution, or any other party who has purchased or received shell 
eggs or egg products for consumption.
* * * * *
    3. Section 59.28 is amended by revising the first two sentences in 
paragraph (a)(1) to read as follows:


Sec. 59.28  Other inspections.

    (a) * * *
    (1) Business premises, facilities, inventories, operations, 
transport vehicles, and records of egg handlers, and the records of all 
persons engaged in the business of transporting, shipping, or receiving 
any eggs or egg products. In the case of shell egg packers packing eggs 
for the ultimate consumer, such inspections shall be made a minimum of 
once each calendar quarter. * * *
* * * * *
    4. A new undesignated centerhead and new Sec. 59.50 are added to 
read as follows:

Refrigeration of Shell Eggs


Sec. 59.50  Temperature and labeling requirements.

    (a) No shell egg handler shall possess any shell eggs that are 
packed into containers destined for the ultimate consumer unless they 
are stored and transported under refrigeration at an ambient 
temperature of no greater than 45 deg.F (7.2 deg.C).
    (b) No shell egg handler shall possess any shell eggs that are 
packed into containers destined for the ultimate consumer unless they 
are labeled to indicate that refrigeration is required.
    (c) Any producer-packer with an annual egg production from a flock 
of 3,000 or fewer hens is exempt from the temperature and labeling 
requirements of this section.
    5. Sec. 59.132 is revised to read as follows:


Sec. 59.132  Access to plants.

    Access shall not be refused to any representative of the Secretary 
to any plant, place of business, or transport vehicle subject to 
inspection under the provisions of this part upon presentation of 
proper credentials.
    6. Sec. 59.134 is amended by revising the section heading, 
designating the existing text as paragraph (a), and adding a new 
paragraph (b) to read as follows:


Sec. 59.134  Accessibility of product and cooler rooms.

* * * * *
    (b) The perimeter of each cooler room used to store shell eggs 
packed in containers destined for the ultimate consumer shall be made 
accessible in order for the Secretary's representatives to determine 
the ambient temperature under which shell eggs are stored.
    7. Section 59.410 is amended by revising the section heading, 
designating the existing text as paragraph (b), and adding a new 
paragraph (a) to read as follows:


Sec. 59.410  Shell eggs and egg products required to be labeled.

    (a) All shell eggs packed into containers destined for the ultimate 
consumer shall be labeled to indicate that refrigeration is required, 
e.g., ``Keep Refrigerated,'' or words of similar meaning.
* * * * *
    8. Section 59.690 is amended by revising the first sentence to read 
as follows:


Sec. 59.690  Persons required to register.

    Shell egg handlers, except for producer-packers with an annual egg 
production from a flock of 3,000 hens or less, who grade and pack eggs 
for the ultimate consumer, and hatcheries are required to register with 
the U.S. Department of Agriculture by furnishing their name, place of 
business, and such other information as is requested on forms provided 
by or available from the U.S. Department of Agriculture. * * *
    9. Section 59.760 is revised to read as follows:


Sec. 59.760  Inspection of egg handlers.

    Duly authorized representatives of the Secretary shall make such 
periodic inspections of egg handlers, their transport vehicles, and 
their records as the Secretary may require to ascertain if any of the 
provisions of the Act or this part applicable to such egg handlers have 
been violated. Such representatives shall be afforded access to any 
place of business, plant, or transport vehicle subject to inspection 
under the provisions of the Act.
    10. Section 59.915 is amended by revising the section heading, by 
removing the word ``and'' at the end of paragraph (b)(8), by 
redesignating paragraph (b)(9) as paragraph (b)(10) and by adding a new 
paragraph (b)(9) to read as follows:


Sec. 59.915  Foreign inspection certification required.

* * * * *
    (b) * * *
    (9) A certification that shell eggs which have been packed into 
containers destined for the ultimate consumer have, at all times after 
packing, been stored and transported under refrigeration at an ambient 
temperature of no greater than 45 deg.F (7.2 deg.C); and
* * * * *
    11. In Sec. 59.950, paragraphs (a)(4) through (a)(8) are 
redesignated as paragraphs (a)(5) through (a)(9), respectively, and a 
new paragraph (a)(4) is added to read as follows:


Sec. 59.950  Labeling of containers of eggs or egg products for 
importation.

    (a) * * *
    (4) For shell eggs, the words, ``Keep Refrigerated,'' or words of 
similar meaning;
* * * * *
    12. Section 59.955 is amended by redesignating paragraphs (b) and 
(c) as paragraphs (c) and (d), respectively, by redesignating the last 
sentence of paragraph (a) as new paragraph (b), and by revising 
paragraph (a) to read as follows:


Sec. 59.955  Labeling of shipping containers of eggs or egg products 
for importation.

    (a) Shipping containers of foreign product which are shipped to the 
United States shall bear in a prominent and legible manner:
    (1) The common or usual name of the product;
    (2) The name of the country of origin;
    (3) For egg products, the plant number of the plant in which the 
egg product was processed and/or packed;
    (4) For egg products, the inspection mark of the country of origin;
    (5) For shell eggs, the quality or description of the eggs, except 
as required in Sec. 59.905;
    (6) For shell eggs, the words ``Keep refrigerated'' or words of 
similar meaning.
* * * * *
    Done at Washington, DC, on: August 20, 1998.
Thomas J. Billy,
Administrator, Food Safety and Inspection Service.
[FR Doc. 98-22890 Filed 8-26-98; 8:45 am]
BILLING CODE 3410-DM-P