[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Proposed Rules]
[Pages 59372-59382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29837]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 61, No. 227 / Friday, November 22, 1996 / 
Proposed Rules  

[[Page 59372]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 325, 381

[Docket No. 95-049A]
RIN 0583-AC05

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
21 CFR Part 110


Transportation and Storage Requirements for Potentially Hazardous 
Foods

AGENCIES: Food Safety and Inspection Service, USDA; Food and Drug 
Administration, DHHS.

ACTION: Advance notice of proposed rulemaking; request for comments.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and 
Drug Administration (FDA) are seeking information and comments on 
approaches the two Agencies might take to foster food safety 
improvements that may be needed in the transportation and storage of 
potentially hazardous foods. Potentially hazardous foods, including 
meat, poultry, eggs and egg products, fish, seafood, and dairy 
products, are those that are capable of supporting the rapid 
multiplication of microorganisms that cause foodborne illness. This 
notice seeks comments and information on various issues and 
alternatives for ensuring the safety of potentially hazardous foods 
during transportation and storage.

DATES: Comments must be received before: February 20, 1997.

ADDRESSES: Please send an original and two copies of written comments 
to: FSIS Docket Clerk, DOCKET #95-049A, Room 3806, South Agriculture 
Building, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Washington, DC 20250. All comments submitted will be 
available for public inspection in the Docket Clerk's Office between 
8:30 a.m. and 1:00 p.m. and 2:00 p.m. and 4:30 p.m., Monday through 
Friday. To review the publications and other background information 
cited in this document, interested persons may visit the Docket Clerk's 
Office during the times listed above.

FOR FURTHER INFORMATION CONTACT: Mr. Ralph Stafko, Office of the 
Administrator, Room 3835, South Agriculture Building, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Washington, DC, 
20250, (202) 720-7773, in regard to meat, poultry, and egg products.
    Ms. Shellee Davis, Center for Food Safety and Applied Nutrition 
(HFS-306), Food and Drug Administration, U.S. Department of Health and 
Human Services, 200 C Street SW., Washington, DC 20204, (202) 205-4681, 
in regard to seafood, whole (shell) eggs, dairy products, and other 
potentially hazardous foods, other than those listed above for which 
Mr. Ralph Stafko should be contacted.

SUPPLEMENTARY INFORMATION: FSIS and FDA maintain regulatory programs to 
help ensure that foods distributed in interstate commerce are not 
adulterated or misbranded. FSIS's programs, which cover meat, poultry, 
and egg products, include continuous in-plant inspection of livestock 
and poultry slaughtering, and processing of products therefrom, and egg 
product processing activities. FDA, which is responsible for ensuring 
the safety of foods in most other circumstances, operates a regulatory 
program that includes unannounced inspection of the domestic food 
industry and sample analysis. FSIS conducts its inspections at meat, 
poultry, and egg product processing establishments. FDA inspects 
establishments that process other types of foods. FSIS and FDA conduct 
examinations of warehouses and transshipment points, including points 
of entry of imported foods into the United States. They also conduct 
Federal-State cooperative programs, and consumer education.
    Both FSIS and FDA, in recent rulemakings, have adopted a new food 
safety regulatory strategy, the framework of which is a science-based 
system known as the hazard analysis and critical control points (HACCP) 
system. HACCP is a process control system designed to identify and 
prevent chemical, physical, and biological hazards in food production. 
On December 18, 1995, FDA published a final rule, ``Procedures for the 
Safe and Sanitary Processing and Importing of Fish and Fishery 
Products'' (60 FR 65096), mandating the development and implementation 
of HACCP systems to ensure the safe and sanitary processing and 
importation of fishery products. FSIS promulgated a final rule 
``Pathogen Reduction; HACCP Systems'' for meat and poultry on July 25, 
1996 (61 FR 38806) mandating implementation of HACCP systems and 
standard operating procedures (SOP) for sanitation, and pathogen 
reduction performance standards and testing for meat and poultry.
    Both Agencies have come to recognize that, if they are to reduce 
foodborne illness to the maximum extent possible, they must broadly 
approach their food safety missions, addressing potential hazards that 
arise throughout the food production and delivery system. They and the 
industries they regulate must work toward preventing, minimizing, and 
eliminating hazards that may arise before raw products or animals enter 
manufacturing plants or FSIS-inspected establishments and after food 
products leave those businesses. There is widespread agreement among 
food safety experts that ensuring food safety requires taking steps to 
prevent hazards and to reduce the risk of foodborne illness throughout 
the chain of production, processing, sale, storage, and transportation.
    Post-harvest (seafood) and post-processing transporters, storage 
operators, and retail stores, restaurants, and other food service 
sectors are important links in the chain of responsibility for food 
safety. In these areas, FSIS, FDA, and State and local governments 
share authority and responsibility for oversight of food products. FSIS 
and FDA do not have programs that address the handling of food by these 
industry sectors, as they do for federally inspected processing 
establishments. However, both Agencies have become increasingly 
concerned about the public health impact of diseases associated with 
potentially hazardous foods and about what happens to food at the 
stages through which it passes on the way to consumers.
    This notice addresses hazards attributable to the transportation 
and

[[Page 59373]]

storage of potentially hazardous foods outside of the establishments 
where they are processed.

Transportation and Storage of Potentially Hazardous Foods: Current 
Regulatory Coverage and Guidance

    Foods are susceptible to contamination from a wide variety of 
agents--physical, microbial, or chemical. Some foods, most notably 
animal food products like meat, poultry, eggs, seafood, and dairy 
products are particularly susceptible to microbiological hazards 
because their moisture, pH levels, and high protein content provide 
ideal environments for the growth of bacteria. For these reasons, these 
products must be carefully monitored to prevent their exposure to 
microbiological, as well as other hazards.
    No matter how carefully prepared, however, most any raw food 
product of animal origin may potentially have some bacteria present, 
including pathogens, and, thus, must be handled in a manner that 
minimizes the opportunity for bacteria to multiply. Furthermore, like 
other foods, these foods may become contaminated through direct abuse 
such as damaged packaging, exposure to filth or harmful chemicals, or 
contact with a contaminated surface. Sometimes, contamination is caused 
by direct or indirect contact with contaminated foods--a process known 
as cross-contamination. For example, salad components prepared on a 
cutting board used previously for raw poultry could become contaminated 
by pathogens that were on the poultry.
    Food safety protection can be improved by the control of 
microbiological and other hazards through the use of preventive methods 
such as HACCP, good sanitation and manufacturing practices, and food 
safety performance standards, as appropriate, throughout the food 
production and distribution chain. Currently, however, most Federal 
regulatory measures are directed at slaughtering and food processing 
plants. State and local authorities have also directed their regulatory 
oversight at certain categories of food processors, generally small 
firms, as well as retail stores and food service establishments.
    Despite increasing concern about the risks that may be created in 
the transportation and storage of potentially hazardous foods, 
government agencies at all levels do not have comprehensive regulatory 
programs for those segments of the farm (or harvest)-to-table food 
continuum that are comparable to that for slaughtering and processing 
establishments. Additional information is needed on the extent and 
severity of food safety problems that may be attributable to the 
transportation and storage of potentially hazardous food products from 
harvesting or production to processing plants and from processing 
plants to the consumer for FSIS and FDA to determine whether there is a 
need for additional government regulation to address risks that may be 
created during these stages of food distribution.

1. FSIS

    All ingredients used in meat and poultry products prepared in 
establishments where FSIS maintains inspection (``official 
establishments'') are subject to examination upon their arrival at the 
official establishment. Substances and ingredients used in the 
preparation of egg products at FSIS-inspected plants (``official 
plants'') are also subject to inspection. Meat and poultry carcasses 
and parts that enter official establishments are inspected before they 
may be used in the preparation of meat or poultry food products at such 
establishments, regardless of whether they previously have been 
inspected and passed by FSIS, even if returned to the original 
establishment. Similarly, previously inspected egg products are subject 
to reinspection upon arrival at an official egg products processing 
plant.
    The safety and wholesomeness of meat and poultry products being 
transported in interstate commerce, or being held in storage, are 
governed by various regulatory and statutory provisions. Certain 
regulations (9 CFR part 325 and part 381 subpart S) require meat and 
poultry products being transported to be ``wrapped, packaged, or 
otherwise enclosed'' so as to prevent their adulteration by air 
contaminants, unless the means of conveyance in which the product is 
transported is completely enclosed with tight-fitting doors or other 
covers for all openings. The means of conveyance must be reasonably 
free of foreign matter (such as dust, dirt, rust, or other articles or 
residues) and free of chemical residues, so that the products placed in 
it will not become adulterated. Any cleaning compound, lye, soda 
solution, or other chemical used in cleaning a means of conveyance must 
be thoroughly removed from the means of conveyance prior to its use. 
Means of conveyance onto which meat or poultry products are loaded, 
being loaded, or intended to be loaded are subject to inspection at an 
official establishment. If a means of conveyance, upon inspection, is 
found to be in a condition such that meat or poultry products placed in 
it could become adulterated, it is not to be used until the condition 
that could cause adulteration is corrected. Meat and poultry products 
found by an inspector to be in such a condition that they may have 
become adulterated are subject to inspection.
    A guide for inspectors, the FSIS Sanitation Handbook, also presents 
details on acceptable conditions for transport vehicles and storage 
facilities of meat and poultry products.
    FSIS monitors and enforces compliance with the adulteration and 
misbranding provisions of the Federal Meat Inspection Act (FMIA) and 
Poultry Products Inspection Act (PPIA) during transportation to and 
among inspected establishments and allied industries, such as 
renderers, pet food processors, retail stores, and restaurants. Meat 
and poultry products are considered to be adulterated for various 
reasons including if they are unsound, unhealthful, unwholesome, or 
otherwise unfit for human food (21 U.S.C. 453(g), 601(m)). Misbranding 
of meat and poultry products occurs, if among other reasons, their 
labeling is false or misleading. (21 U.S.C. 453(h), 601(n).) Similar 
adulteration and misbranding provisions apply to egg products. (21 
U.S.C. 1033(a), 1033(l), 1036.)
    FSIS also investigates complaints received from consumers and 
others alleging that adulterated or misbranded meat, poultry, and egg 
products have been sold or distributed in commerce.
    FSIS has exercised its statutory authority over meat and poultry 
products outside official establishments in various instances, 
including in its promulgation of safe-handling labels on raw meat and 
poultry products (9 CFR 317.2(l) and (m), and 381.125(b)). However, 
FSIS does not have a comprehensive regulatory program that covers the 
handling of meat, poultry, and egg products outside of official 
establishments that is comparable to its program of regulating such 
products during their production in official establishments. FSIS's 
regulatory role regarding such products has generally been a reactive 
one. FSIS generally responds on a case by case basis to instances of 
adulteration and misbranding of products outside official 
establishments. FSIS has not focused directly on conditions and 
practices that occur after meat, poultry, and egg products leave 
official establishments that contribute to products being exposed to 
pathogenic contaminants, or that contribute to the multiplication of 
pathogenic microbes.
    FSIS-inspected product that is in distribution channels and is not 
at an

[[Page 59374]]

establishment where FSIS maintains inspection may be examined by FSIS 
if the product is suspected of being adulterated or misbranded. At this 
point, the Agency focuses on the condition of the product, not on the 
conditions under which the product was produced. Product found in 
distribution channels that is adulterated or misbranded is subject to 
detention. In certain circumstances, if the product is reprocessed, 
repackaged, or relabeled under inspection, it may be sold in commerce.
    FSIS also checks product for evidence of breaking of bulk packages 
and repackaging or reshipment without reinspection, for evidence that 
the product has been processed without inspection, and for spoilage. If 
such evidence is found, the facility in which the product is found may 
be subject to a thorough inspection for sanitation, product processing, 
and storage conditions. For example, discovery of rodent fecal matter 
in a product could lead to an investigation of the storage warehouse in 
which the product has been held.
    In carrying out its investigations, FSIS does not stop trucks or 
other transportation vehicles, but rather examines products at key 
points during distribution. At cold storage warehouses, FSIS examines 
specific conditions to determine the adequacy of warehouse procedures 
for preventing the adulteration of meat and poultry products, including 
the adequacy of sanitation at the warehouse and the other controls 
utilized to reduce hazards, such as pests, to meat and poultry 
products.
    Post-processing transportation and storage of meat and poultry 
products was also a subject of concern to commenters on FSIS's February 
3, 1995, Pathogen Reduction/HACCP proposal. Various commenters stated 
that the majority of hazards consumers face from raw meat and poultry 
products stem from mishandling the products after they have left the 
official establishments. They stated that to be effective, any 
regulatory controls contemplated by FSIS must include those industry 
segments that handle products after they leave official establishments 
as well as slaughter and processing establishments. Commenters further 
stated that FSIS should expand its inspection program to include all 
segments of the food production and transportation industries. Some 
commenters noted that, although there is not a sufficient number of 
FSIS (and FDA) employees to inspect businesses outside official 
establishment on a regular basis, there must be some additional 
regulatory efforts to ensure proper controls are maintained throughout 
the food chain.
    Other commenters stated that they believed that transportation and 
storage entities should not be subject to regulatory controls. They 
stated that warehousing and food distribution operations do not pose 
the same levels of risk as processing operations. Still others felt 
that FDA and DOT should develop voluntary guidelines for transport 
conveyance, not mandatory requirements.

2. FDA

    FDA routinely inspects food processing plants and examines food 
products transported in interstate commerce. The examination and 
inspectional aspects of FDA's program are carried out by its field 
force as part of its compliance program for foods. FDA covers the full 
range of potential food safety problems, including microbial hazards, 
chemical contaminants, pesticides, filth, and food additives. FDA 
provides similar coverage for imported foods.
    FDA's requirements for the conditions under which food is to be 
transported and stored are contained in FDA's good manufacturing 
practice regulations (21 CFR Part 110). The conditions under which food 
is received, inspected, transported, segregated, prepared, 
manufactured, packaged, and stored of food must be such as to ensure 
that the food will not become contaminated with filth or rendered 
injurious to health. Storage and transportation of finished food must 
be under conditions that will protect food against physical, chemical, 
and microbial contamination, as well as against the deterioration of 
the food and its container (21 CFR 110.93).
    FDA's final rule on seafood, which mandates the application of 
HACCP principles to the processing of seafood, is designed to ensure 
that the hazards that are presented at all stages of the food 
processing and distribution chain, including transportation, are 
identified, and appropriate control measures are put in place to 
address them. Thus, for example, a processor could require, as part of 
its HACCP plan, that a certain temperature be maintained during the 
transport of raw materials to its facility.
    FDA is evaluating whether to require a comprehensive preventive 
regulatory program, similar to its seafood regulatory program, for food 
products other than seafood in commerce. On August 4, 1994, FDA 
published an advance notice of proposed rulemaking entitled 
``Development of Hazard Analysis Critical Control Points for the Food 
Industry'' (59 FR 39888), which sought public comment on whether and 
how FDA should develop regulations to establish requirements for a new, 
comprehensive, food safety assurance program for both domestically 
produced and imported foods. Further regulatory action by FDA on this 
matter is pending.

3. Department of Transportation

    The Department of Transportation (DOT) has promulgated a number of 
regulations affecting the conditions under which edible products can be 
transported in commerce. For example, a carrier can not transport 
hazardous material required to be labeled poison in the same motor 
vehicle with material that is marked or known to be a foodstuff, feed, 
or any edible material intended for consumption by humans or animals 
unless packaged in specifically prescribed packages (49 CFR 173.25(c) & 
177.841(e).) A rail car that has held poisonous materials in packages 
showing any evidence of leakage, must be thoroughly cleaned after 
unloading before the car is returned to service. After any poisonous 
materials are unloaded from a rail car, that car must be thoroughly 
cleaned unless that car is used exclusively in the carriage of 
poisonous materials (49 CFR 174.615(b)).

4. Food Code

    Finally, the transportation and storage of food products is dealt 
with in the model Food Code, which is published by FDA. This model code 
contains provisions that specifically address the storage and 
preparation of foods at retail stores, restaurants, and institutions. 
It also contains recommended holding temperatures for a variety of 
foods. Most State and local food statutes, regulations, and ordinances 
are based on some edition of FDA's model food code.

Risk of Contamination and Disease From Food Transportation

1. Current Transportation Vehicles and Conditions

    There are three basic types of transport: air transport; sea 
transport, including conventional refrigerator ships and container 
ships; and land transport, which consists of rail cars and trucks. Of 
the approximately 47 million tons of food shipped between continents 
each year, about 60 percent goes by sea, 35 percent by land, and 5 
percent by air. Approximately 22 million tons of meat and poultry, 
fish, and dairy products are exported intercontinentally each year, 
with 40 percent of that total moving by sea transport.

[[Page 59375]]

    Within a continent, most perishable cargoes are hauled by trucks. A 
lesser amount is transported by rail. Rail shipments may be by self-
contained refrigerated rail cars or by flatcars carrying sea containers 
known as ``piggyback'' trailers. Over-the-road hauling involves 
refrigerated trucks or flatbed trailers used to haul sea containers, 
with most of the refrigerated freight moving in refrigerated trailers. 
Refrigerated trailers are a necessary method of transportation for the 
distribution of perishable foods from seaports and rail heads to the 
ultimate consumer. Thus, it is assumed that most refrigerated food 
cargo, whether originating overseas or within the U.S., ultimately 
travels by truck transport.

2. Safeguarding Food Under Conditions of Transport, e.g., the ``Cold 
Chain''

    The logistics of moving perishable, potentially hazardous products 
generally involves cooling after processing to achieve adequate 
temperatures before shipping. This means that perishable foods must be 
refrigerated or frozen after processing and before shipment to inhibit 
spoilage or growth of pathogens. During transportation and storage, the 
challenge is to maintain proper refrigeration temperatures and to keep 
the ``cold chain'' from breaking during steps such as palletization, 
staging, loading and unloading of containers, movement into storage, 
and time spent in storage.
    For example, post-harvesting temperature control is especially 
important in preventing illness from consuming certain marine fish and 
certain raw Gulf-harvested oysters. Improper handling of some marine 
fish, most notably tuna, mahi mahi, and bluefish can lead to histamine 
(scombrotoxin) formation, resulting in illness and death. Similarly, 
the Interstate Shellfish Sanitation Conference has adopted post-
harvesting temperature controls to reduce the proliferation of the 
marine bacterium Vibrio vulnificus in oysters harvested from the Gulf 
of Mexico during warm weather. To date, temperature controls from time 
of harvest to consumption remain the most practical means of reducing 
the risk of illness and death for medically compromised consumers of 
raw Gulf oysters.

3. Technical Analysis Group (TAG) Report on Transportation

    When FSIS proposed the Pathogen Reduction/HACCP rule in February 
1995 (60 FR 6774), FSIS stated its commitment to develop standards to 
help ensure the safe handling of meat and poultry products during 
transportation and storage. FSIS stated it would: (1) Ask a group of 
experts to provide data on the hazards to food safety and the controls 
that currently exist in the industry to address such hazards; (2) 
develop practical standards of performance for establishments and 
carriers with respect to the transport of food; (3) develop a list of 
good manufacturing practices and various options for encouraging their 
use; (4) initiate, where feasible, joint rulemaking with FDA to 
establish appropriate standards to ensure the safety of meat and 
poultry products and other foods during transport, and (5) along with 
FDA, work with the DOT to implement the Sanitary Food Transportation 
Act of 1990, as revised, and determine whether additional authority is 
needed to carry out the shared food safety mission of FDA and FSIS. 
(Id., at p. 6828)
    In April 1995, FSIS and DOT contracted with a Transportation 
Technical Analysis Group (TAG) to identify the primary hazards 
associated with the transport of perishable foods and recommend 
reasonable controls that might be employed by industry to ensure food 
safety. The 10-member TAG was composed of representatives from 
academia, the transportation and food industries, and DOT. The TAG's 
tasks were to identify hazards associated with the transportation of 
perishable foods; identify practical controls to prevent, reduce, or 
eliminate the risks involved; and outline the cost implications and 
desired results of applying the controls. The TAG's analysis was 
intended to provide basic information FSIS could use in formulating 
good manufacturing practices (industry guidance) or regulations, or 
both, dealing with the transportation of meat, poultry, and egg 
products.
    Tasks of the TAG for meat, poultry, and egg products included: (1) 
Identifying and describing the steps comprising the transportation of 
these foods, from the live animal to the consumer; (2) identifying all 
hazards to these foods that can pose a risk to public health; (3) 
estimating the potential impact of each hazard by considering its 
prevalence in these foods, and the severity of the adverse effect of 
the hazard; (4) identifying practical controls to prevent, eliminate, 
or reduce each hazard to an acceptable level; (5) noting any 
scientifically valid procedures for verifying the effectiveness of each 
control; (6) identifying the desired results of applying the controls; 
and (7) identifying any research and development activities needed to 
better define the hazards or improve on the identified controls. The 
TAG identified hazards associated with the transportation and storage 
of potentially hazardous foods, control points for addressing such 
hazards, and procedures needed to eliminate, minimize, or reduce the 
hazards.
    Because its members considered trucks to be the predominant mode of 
transportation for potentially hazardous foods, the TAG focused its 
initial attention on this mode of transportation. Limitations of time 
and money kept the TAG from inquiring much into the state of perishable 
food transport by air, sea, or rail. Therefore, FSIS would appreciate 
having information and comments from those who are familiar with 
transport operations in these industries on factors that affect the 
safety and wholesomeness of perishable foods shipped by plane, rail, or 
ocean or freshwater vessel.
    The TAG found that how trucks are loaded has a very direct relation 
to the likelihood of food contamination and abuse. A less-than-full-
load (LTL) is a truck that has available space as it begins its 
journey, and to which additional freight may be loaded during the 
journey. A mixed load is a truck that is fully loaded at the time it 
begins its journey, but whose load consists of different types of 
freight. According to available information, a disproportionate number 
of product handling problems, resulting in claims for product losses, 
are associated with LTL's and mixed loads. In addition, TAG members 
believed that LTL product handling problems are more likely to occur 
among smaller carriers which are more likely to haul smaller, mixed 
cargoes.
    LTL and mixed loads may be troublesome from the food safety 
standpoint for several reasons. First, such a load may consist of foods 
with different holding temperature requirements. The temperature of the 
trailer or container with the load may be suitable for one food but not 
for another. An extreme example of this problem would be an LTL or 
mixed load maintained at a refrigeration temperature but in which part 
of the food cargo must be kept frozen. Some freight companies have 
solved this problem by using partitioned trailers; each storage space 
between the partitions can be maintained at a different temperature, so 
the LTL holding temperature problem does not arise.
    Another hazard to which food carried in LTL containers may be 
exposed is the failure to maintain the proper storage temperature 
throughout the transit. Because LTL or mixed load carriers tend to be 
loaded and unloaded more frequently during a trip, it is

[[Page 59376]]

technologically more difficult to consistently maintain food cargo at 
the correct temperature than it is for uniform food cargo carried to a 
single destination. Each time freight is loaded or unloaded, the 
opportunity exists, even under the best of handling conditions, for a 
temperature fluctuation that may cause food safety problems.
    A further problem that can arise is potential adulteration of food 
cargoes by incompatible food or non-food cargoes. For example, some 
cargoes may release gases or odors that are absorbed by other cargoes.
    The TAG identified other concerns involving the transportation of 
perishable foods by truck. These included the cleaning and precooling 
of trucks, proper packaging of foods, loading patterns and partial 
loading or unloading of trucks, adequacy of refrigeration units, air 
circulation, humidity, insulation of trucks, and the time taken to 
transport the food.
    The TAG concluded that good controls are essential to ensuring safe 
transportation of perishable foods. They noted that ``The focus needs 
to be on establishing control points that will monitor temperatures and 
times en route and at the loading and storage facilities. Time, 
temperature, and sanitation are the three elements of any control 
plan.'' (Transportation TAG Report, at p. 14)
    The TAG identified six critical control points, points at which 
loss of control may result in an unacceptable health risk. They are: 
(1) Inspecting the truck trailer before loading; (2) ensuring that the 
temperature of the product intended to be loaded is not above 40 
deg.F; (3) proper configuration of the load; (4) maintenance of a 40 
deg.F temperature while awaiting additional product to be loaded; (5) 
maintaining the temperature of the food during transit; and (6) 
maintaining the inside temperature of the food during unloading and 
movement to storage. For each of these critical control points, the TAG 
identified interventions that would address the hazards at each 
critical control point, the frequency of monitoring needed to ensure 
the interventions are carried out, who should monitor the critical 
control points, actions to be taken if deficiencies or deviations are 
noted, how corrective actions should be documented, and who should 
verify the corrective actions taken.

4. FSIS and FDA Concerns: Evidence of a Problem

    FSIS and FDA are concerned about whether reliable procedures are 
being used by all sectors of the food production and delivery chain to 
combat the invisible threats to safety and health posed by microbial 
pathogens. Control of microbial pathogens is difficult even in those 
areas where inspection and other regulatory and public health measures 
are applied most intensively, as in slaughterhouses, and food 
processing facilities.
    Agencies concerned with food safety have devoted relatively few 
resources to the transportation and storage sectors of the food chain. 
There is an absence of data and information about whether adequate and 
appropriate food safety controls are being employed while food is being 
transported and stored. This lack of information does not by itself 
indicate the existence of a problem warranting regulatory intervention. 
However, FSIS and FDA need information about the transportation and 
storage of food if they are going to assure that the food safety risks 
associated with transportation and storage are properly identified and 
adequately addressed.
    The United States annually experiences an estimated 6.5 to 33 
million foodborne illness cases. These are largely associated with 
potentially hazardous foods that have become contaminated. In most 
cases of foodborne illness, post-processing temperature abuse or other 
mishandling contributed to the food hazard implicated in the illness. 
Such mishandling of potentially hazardous foods frequently occurs in 
food-service establishments and homes. However, food product abuse also 
may occur at earlier stages. In processing establishments, for example, 
equipment breakdowns, failure to adhere to appropriate time and 
temperature requirements, cross-contamination between raw and cooked 
product, and physical contamination by chemicals or foreign matter may 
render foods unsafe.
    Although there is little empirical data on the extent to which 
conditions under which food is transported and stored contribute to 
safety hazards, there is anecdotal evidence. For example, a 1994 
salmonellosis outbreak reported to have affected 224,000 people is 
believed by public health authorities to have been caused by cross-
contamination of a pasteurized ice cream premix during transportation 
in tanker trailers that had previously hauled nonpasteurized liquid 
eggs.1
---------------------------------------------------------------------------

    \1\ Thomas W. Hennessy, M.D., et al. 1996. A National Outbreak 
of Salmonella enteritidis Infections from Ice Cream. N. Engl. J. 
Med. 334:1281-1286.
---------------------------------------------------------------------------

    FSIS, in its continuous inspection of meat and poultry 
establishments, has found that some food spoilage can be attributed to 
mishandling during transportation, based on examination by inspectors 
of meat and poultry products returned to official establishments 
(``returned product'') that have been refused by a buyer or consignee. 
The amount of returned product may serve as an index of the amount of 
spoiled foods that may be in transportation channels, but the Agencies 
do not know how much potentially hazardous food that is spoiled is 
returned or otherwise handled.
    Only a very small percentage of meat or poultry product that is 
shipped from a federally inspected establishment is returned to the 
establishment. FSIS staff officers estimate that perhaps one-tenth of 
this returned product was returned because of a problem that developed 
during transportation. This seems generally true for imported meat and 
poultry products, as well as domestically produced products. In 1994, 
FSIS rejected nearly 14 million pounds (0.5 percent) of imported meat 
and poultry products, most commonly for processing defects, 
contamination, unsound condition, and transportation damage. This 
rejection rate is roughly equivalent to the rejection rate of product 
produced in the United States.
    Returned product must go back to the establishment where it was 
prepared and must be received in a designated area for reinspection. 
Although many plants are permitted to handle such products under their 
own quality-control program, inspectors routinely evaluate 
establishment records on returned product to ensure they are complete 
and accurate, and show that the establishment has sorted and otherwise 
taken all corrective action necessary to ensure proper disposition of 
the product. The inspectors also supervise condemnation of unwholesome 
or misbranded product.
    From time to time, foreign countries to which U.S. meat and poultry 
exports are sent have rejected U.S. product that has become spoiled 
because of transportation or storage failures. Such problems have the 
potential to cause, or contribute to, serious trade disruptions. In 
1994, Russia refused to accept shipments of United States-produced 
poultry alleged to be ``off-condition'' and unfit for food purposes. 
The poultry had apparently been allowed to thaw at some point between 
shipment from the processing plant and receipt by the importer. Similar 
cold storage problems involving pork shipments to the same country had 
occurred some years earlier.

[[Page 59377]]

    Similarly, there have been occasional, documented instances of 
careless handling and transportation of meat and poultry within the 
U.S. These generally involve inadequate refrigeration or exposure to 
physical hazards.
    There appears to be increasing public awareness of the possibility 
that food might become contaminated during shipment. From time to time, 
Congress has expressed concern that gaps in the regulatory coverage of 
food during transportation in commerce ought to be filled. For example, 
in 1990 Congress passed the ``Sanitary Food Transportation Act'' that 
required the Secretary of Transportation, in consultation with the 
Secretaries of Agriculture and Health and Human Services and the 
Administrator of the Environmental Protection Agency, to issue 
regulations with respect to the transportation of food products in 
motor vehicles or rail vehicles that are also used to transport nonfood 
products that could make food subsequently shipped in the vehicles 
unsafe.2 (Pub. L. 101-500; 49 U.S.C. app. section 2801 et seq.) 
Although information on the extent of the practice was scarce, there 
were press accounts of trucks carrying food from the Midwest to both 
the East and the West Coasts and returning with garbage for Midwest 
landfills. It was feared that food products could become contaminated 
and unfit for human consumption if irresponsible vehicle operators 
failed to prevent contamination of food products in vehicles that had 
been previously used to haul waste or other non-food materials.
---------------------------------------------------------------------------

    \2\ In July 1994, Congress passed Public Law 103-272, which 
revised Title 49 of the U.S. Code, including provisions for Sanitary 
Food Transportation (Chapter 57--Sanitary Food Transportation. (49 
U.S.C. 5701 to 5714.)
---------------------------------------------------------------------------

    On May 21, 1993, DOT proposed regulations to implement the new law. 
The proposal addressed the safe transportation of food products during 
highway and rail transportation (58 FR 29698). Further action on the 
proposal is pending.

5. Data and Information Needed

    FSIS and FDA are now attempting to develop better information on 
the nature and scope of food safety risks posed by transportation and 
storage practices. The Agencies would like, among other things, to 
develop reliable estimates of the number of cases of foodborne illness 
that are attributable to the abuse of potentially hazardous foods 
during transportation. Also needed are better data to determine whether 
current estimates of the annual number of shipments of potentially 
hazardous foods are accurate and to determine what types and amounts of 
such foods are transported by truck, rail car, airplane, or ship. FSIS 
and FDA would also like to obtain information about what controls are 
currently being used to ensure the safety of potentially hazardous food 
during transportation, for truck, rail car, airplane, or ship 
transports.
    Additionally, the Agencies would like to know whether there are any 
special concerns relating to transportation of imported products. 
Further, the Agencies seek information from owners or operators of cold 
storage facilities, warehouses, depots, and similar kinds of businesses 
regarding the types and volumes of potentially hazardous foods that 
they handle and the controls that they use to ensure the safe storage 
of foods.
    The Agencies have addressed some of these matters in the 
preliminary work on which this ANPR is based, but more precise 
information is needed.

Information and Accountability; Failure of the Market

    Most large food companies conduct rigorous quality control 
operations to ensure, among other things, that the foods and food 
ingredients they purchase match contract specifications and will be 
suitable for use in the manufacture of their products. Many companies 
already operate HACCP systems to ensure the safety of the food products 
that they deliver to consumers.
    Such companies enforce their own criteria for foods and food 
ingredients delivered to them. If refrigerated or frozen foods arrive 
at the receiving departments of these companies in an ``off'' 
condition, if they are spoiled or damaged, or if they fail lot 
acceptance inspections, the companies will not accept delivery. The 
company that shipped the product or the transporter may be liable for 
the costs of the unaccepted product, or the company that insured the 
shipment may be called upon to satisfy a claim.
    However, to the extent that firms do not take actions that provide 
consumers with products of the level of safety that they desire, there 
exists a market failure. The most significant element of this market 
failure is lack of information for purchasers. Purchasers of 
potentially hazardous food products may lack information about products 
other than their appearance. Signs of spoilage, such as unpleasant odor 
or discoloration, may not be present to warn of possible safety 
concerns.
    When foodborne illness does occur, it may often be difficult or 
impossible to trace the cause back to a specific source because some 
pathogens do not cause illness until several days or weeks after 
exposure. Thus, food safety attributes are often not apparent to 
consumers either before purchase or immediately after consumption of 
food. This information deficit also applies to wholesalers and 
retailers who generally rely on sensory tests--sight and smell--to 
determine whether a food is safe to sell or serve. Therefore, if food 
became contaminated because of a problem in transportation or storage, 
the receivers of the food might not know about it and might not be able 
to relate a resultant outbreak of foodborne illness to the problem.

Applicable Legal Authorities

    Both the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) 
and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) 
give the Secretary of Agriculture authority to regulate meat and 
poultry products in commerce. Specifically, the FMIA and PPIA authorize 
the Secretary to prescribe regulations covering the storage or other 
handling of meat or poultry products whenever the Secretary determines 
that regulations are necessary to assure that meat or poultry products 
are not adulterated or misbranded when they are delivered to the 
consumer (21 U.S.C. 624, 463). The statutes further state that no 
person may ``sell, transport, offer for sale or transportation, or 
receive for transportation'' in commerce any meat or poultry product 
that is capable of use as human food and is ``adulterated or misbranded 
at the time of such sale, transportation, offer for sale or 
transportation, or receipt for transportation * * *'' (21 U.S.C. 
610(c), 661(c) and 454(c), 458(a)(2).) The statutes also prohibit any 
act with respect to such products, while they are being transported in 
commerce or held for sale after such transportation, ``which is 
intended to cause or has the effect of causing such articles to be 
adulterated or misbranded.'' (21 U.S.C. 610(d), 661(c) and 454(c), 
458(a)(3).) These prohibitions, and Federal regulation and inspection 
generally, are applicable to operations and transactions conducted in 
commerce and to those conducted wholly within a state in those states 
that have been ``designated'' by the Secretary. See 21 U.S.C. 454(c) 
and 661(c). For a list of such states, see 9 CFR 331.2, 381.221. The 
Egg Products Inspection Act also has provisions concerning the sale and 
transportation in commerce of adulterated or misbranded eggs or egg 
products (21 U.S.C. 1037).
    The Federal Food, Drug, and Cosmetic Act (FFD&C Act), administered 
by FDA,

[[Page 59378]]

prohibits the adulteration or misbranding of food in interstate 
commerce (21 U.S.C. 331(b)). The FFD&C Act also prohibits the 
introduction or delivery for introduction into interstate commerce, and 
the receipt in interstate commerce, of adulterated or misbranded food 
(21 U.S.C. 331(a) and (c)). Section 402(a)(4) provides that a food is 
deemed to be adulterated if it has been prepared, packed, or held under 
insanitary conditions whereby it may have become contaminated with 
filth, or whereby it may have been rendered injurious to health (21 
U.S.C. 342(a)). Section 701(a) authorizes FDA to promulgate regulations 
for the efficient enforcement of the FFD&C Act (21 U.S.C. 371(a)).
    The Public Health Service Act (PHSA) authorizes the Secretary of 
Health and Human Services and, by delegation, FDA, to make and enforce 
such regulations as ``are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the States * * * or from one State * * * into any other State.'' 
(42 U.S.C. 264(a).) Communicable diseases are defined by FDA as 
illnesses due to infectious agents or their toxic products, which may 
be transmitted from a reservoir to a susceptible host either directly 
as from an infected person or animal or indirectly through the agency 
of an intermediate plant or animal host, vector, or the inanimate 
environment (21 CFR 1240.3(b)). With respect to food as a vector 
(carrier), infectious agents include Listeria monocytogenes, Salmonella 
enteritidis, Vibrio vulnificus, and similar pathogens. Moreover, FDA 
may take such measures as may be necessary to prevent the spread of 
communicable diseases, including inspection, fumigation, disinfection, 
sanitation, pest extermination, and destruction of animals or articles 
believed to be sources of infection (42 U.S.C. 264(a)).
    These statutes give FDA the authority to establish regulations 
concerning foods in interstate commerce, including regulations 
governing the transportation and storage of such foods.
    The Sanitary Food Transportation provision also provides authority 
to regulate the transportation of food (49 U.S.C. 5701 to 5714). 
However, FSIS and FDA regard some of the potential food safety issues 
associated with previous cargoes as involving more than just nonfood 
products regulated by DOT. It seems clear that all types of prior 
cargoes need to be addressed, not just nonfood products. Thus, this 
ANPR seeks information on the appropriate mechanism for addressing 
prior food cargoes. FSIS and FDA seek comment on how DOT requirements 
for food transportation conveyances that also haul nonfood items, under 
its Sanitary Food Transportation statutory provisions, might be 
complemented by additional FSIS/FDA requirements.
    FSIS and FDA believe existing statutory authorities are ample to 
support the regulatory initiative being considered to regulate the safe 
and sanitary transportation of potentially hazardous foods.

Alternatives Considered

    Because transportation and storage are vital links in the farm (or 
seafood harvest)-to-table food chain, the success of a comprehensive, 
farm (or harvest)-to-table food protection strategy requires that 
effective preventive measures be taken to ensure the safe 
transportation and storage of food. FSIS and FDA are considering 
several alternatives for addressing the safety of potentially hazardous 
foods during transportation and storage. These alternatives include 
specific requirements, such as temperature standards, performance 
standards, recordkeeping to ensure that food safety controls are 
maintained, mandatory HACCP-type systems, voluntary guidelines, and 
combined approaches.
    Regardless of the alternative, one constant is the need for 
personnel who understand the importance of handling food cargoes safely 
and who know how to do it. All persons involved in transporting and 
storing foods need to recognize that contaminated foods can cause 
illness and that microbes can spoil or poison foods. It is important 
that they recognize that vehicles must be adequately cleaned, and they 
should know how to accomplish this task. They should understand the 
influence of temperature on product quality and microbial growth and 
the importance of controlling insects and rodents. Government and 
industry can both play a role in ensuring that essential knowledge is 
provided to those who need it.

1. Temperature Performance Standards

    One approach is the promulgation of a performance standard that 
would require that potentially hazardous foods be cooled to and 
maintained at or below a specific temperature during transportation and 
storage from the food processing plant to the retail outlet, 
restaurant, or other establishment serving the consumer. If this 
approach is adopted, all potentially hazardous foods being transported 
to retail or food service establishments would have to be maintained at 
or below such a maximum temperature.
    In its February 1995 Pathogen Reduction/HACCP proposal, FSIS 
proposed various requirements for chilling and cooling meat and poultry 
products. The proposal included specific time and temperature 
parameters for the rate of cooling meat and poultry carcasses in 
slaughtering establishments and a maximum shipping temperature of 40 
deg.F for raw meat and poultry products leaving FSIS-inspected 
establishments. FSIS agreed with commenters that keeping raw products 
cooled after they leave the establishment and during transportation, 
storage, distribution, and sale to consumers is essential to prevent 
growth of pathogenic microorganisms on raw products.
    The Agencies have considered at least two possible maximum 
temperatures as appropriate for this kind of performance standard. The 
first is 41  deg.F. This standard is consistent with the temperature 
recommended by the 1995 Food Code for cooling and holding (including 
during transportation) potentially hazardous food. It would provide a 
margin of safety to prevent the multiplication of pathogenic bacteria, 
which generally will not proliferate at temperatures below 50  deg.F.
    A second temperature limit being considered is 45  deg.F. This 
temperature would provide a smaller margin of safety but would comport 
with the temperature established by the European Union 3 for the 
transportation, in commerce, of raw meat products. This temperature is 
increasingly accepted as a standard for potentially hazardous foods 
during storage and transportation by other countries and appears to be 
an emerging standard for international trade. Comments are invited on 
these potential performance standards and on any other appropriate 
temperature standard applicable to specific commodities.
---------------------------------------------------------------------------

     3 ``Agreement on International Carriage of Perishable 
Foodstuffs and on the Special Equipment to be Used for Such Carriage 
(ATP)'' (Geneva, September 1, 1970) (Annex III).
---------------------------------------------------------------------------

    Relevant to this discussion is the 1991 Farm Bill legislation that 
provided for a 45  deg.F ambient air shipping and storage temperature 
requirement for shell eggs. USDA proposed, but has not promulgated, 
regulations to implement that requirement. FSIS is concerned that the 
rule as proposed could impose significant costs, especially on small 
business entities, but achieve no clear public gains in food safety 
protection. Available evidence indicates that the key factor in 
determining bacterial

[[Page 59379]]

growth in shell eggs is how long eggs leaving laying farms stay warm. 
The effect of cool ambient air temperatures on packed and crated shell 
eggs during transport and distribution is difficult to ascertain, even 
if the ambient temperature is 45  deg.F (however measured). FSIS's 
approach to temperature requirements for shell eggs is similar to its 
approach to the cooling of red meat carcasses. FSIS has decided that 
before it can impose temperature requirements, it must have better data 
and information on the food safety effects of temperature controls at 
all phases of production and distribution.
    Temperature-based performance standards might include the use of a 
recording thermometer or other means to ensure compliance with the 
standard. A temperature performance standard might be complemented by 
some requirement that would permit processors to determine the 
acceptability of a food transport vehicle for the transport of bulk 
foods that pose a risk of communicable disease, as discussed below. 
This might be based on a review of transporters' prior cargo records.
    FSIS and FDA anticipate that Federal standards governing proper 
transportation and storage for potentially hazardous foods and other 
food safety practices would be, to some extent, self-enforcing. In the 
view of FSIS and FDA, large commercial purchasers of such foods, such 
as retail grocery store chains, are likely to incorporate such 
standards in their purchasing specifications and would enforce them 
through routine quality assurance and product acceptance procedures. 
The Agencies request comment on the extent to which such Federal 
standards are likely to achieve and safeguard public food safety 
objectives with a minimal enforcement effort.
    The merits of any temperature standards, and alternative approaches 
for preventing temperature abuse and achieving appropriate product 
temperature controls during transportation and storage of all 
potentially hazardous foods, are topics for discussion at the joint 
FSIS-FDA technical conference held November 18-20, 1996, in Washington, 
D.C.

2. Shipper Recordkeeping

    The Agencies might also consider recordkeeping requirements with 
respect to the conditions under which foods that pose a risk of being 
vectors for the spread of communicable disease are transported 
interstate, to help prevent contamination and cross- contamination of 
certain food cargoes. Relying on the relevant statutory authorities, 
the Agencies may consider requiring carriers of potentially hazardous 
foods that are shipped in bulk (foods which directly contact a food 
conveyance) to provide food shippers with records that identify the 
last three cargoes for any conveyance being offered to the food shipper 
for use in transporting the food and that disclose the data of the most 
recent cleaning of the conveyance.
    FDA and FSIS request comments on the feasibility and effectiveness 
of this approach for ensuring the availability of information needed to 
assess potential contamination from prior cargoes in a transportation 
vehicle.

3. Mandatory HACCP-type Systems

    Another approach that could be taken would be to require that a 
HACCP system be established specifically with respect to the 
transportation and storage of potentially hazardous foods to prevent 
the contamination of these foods, although, as noted earlier, comments 
on the FDA and FSIS HACCP rulemakings were negative on requiring HACCP 
for transportation and storage. Such requirements could be modeled on 
the regulations recently adopted by FSIS and FDA that apply to 
establishments that process meat, poultry, and seafood.
    Such HACCP-type systems would probably be relatively simple. 
Essentially, they would likely require that potentially hazardous foods 
be maintained at a particular refrigeration temperature or frozen 
temperature, and that the temperature be recorded using a recording 
thermometer. The use of a temperature performance standard would allow 
processors to determine the acceptability of a food transport vehicle 
for the transport of certain bulk foods, i.e., those that pose a risk 
of communicable disease, based on cargo records.
    Personnel involved in the implementation of the HACCP-type systems 
would have to be knowledgeable about product vulnerabilities and be 
trained in HACCP principles, the development, reassessment, and 
modification of HACCP plans, and record review. If this option were 
pursued, the Agencies would consider the development of model HACCP 
plans or other guidelines that could be used by transportation and 
storage companies in developing their own HACCP plans.

4. Voluntary Guidelines

    Another approach under consideration is to make more use of 
voluntary guidelines. FSIS and FDA are aware that some government 
agencies, industry groups, and other organizations have published 
guidelines or recommended practices that address the transportation and 
storage of potentially hazardous foods, whether fresh or frozen. Such 
guidelines could serve as the basis for developing joint Government-
industry guidelines for food transportation and storage.
    For example, the Association of Food and Drug Officials (AFDO), a 
voluntary organization of State and local food regulatory officials, in 
its publication entitled ``Guideline for the Transportation of Food,'' 
states that during transportation, potentially hazardous food should be 
maintained at 45  deg.F or below. The AFDO guideline states that frozen 
food should be held at an air temperature of 0  deg.F or below and 
should not exceed a product temperature of 10  deg.F for more than a 
short period of time during transportation. The use of an easily 
accessible temperature-recording device is recommended for measuring 
air temperature in the transportation vehicle. Maintaining the proper 
food temperature is one of AFDO's four major food transportation 
measures for ensuring food safety. The remaining measures cover the use 
of good sanitation practices, good personal hygiene of food employees, 
and adequate transportation equipment.
    The Frozen Food Round Table, a trade organization, in its 
publication entitled ``Frozen Food Handling and Merchandizing'' 
presents several recommended practices for transporting and storing 
frozen foods. These practices include maintaining product temperature 
at 0  deg.F or colder and use of a recording device to accurately 
measure the air temperature inside the transportation vehicle.
    In September 1995, USDA's Agricultural Marketing Service (AMS) 
published a revised version of its handbook ``Protecting Perishable 
Foods During Transport by Truck.'' The handbook contains 
recommendations for loading and transporting various food commodities. 
In the handbook, AMS states that maintaining the desired or ideal 
holding temperature is a major factor in protecting perishable foods 
against quality loss during transportation and storage. The handbook 
also presents recommended temperatures for holding meat, poultry, fresh 
fish, and other commodities during transportation.
    The Interstate Shellfish Sanitation Commission also has published a 
manual that provides appropriate temperatures for shipping shellfish.
    The International Dairy Foods Association (IDFA) is carrying out a

[[Page 59380]]

long-term strategy for ensuring product safety that focuses primarily 
on HACCP but that also depends for its effectiveness on a series of 
prerequisite good manufacturing practices (GMP's). The association has 
developed a manual that is product-oriented and product-specific and 
contains model HACCP programs for such product categories as fluid 
milk, ice cream, cheese, and yogurt.
    Finally, the HACCP systems that have been implemented voluntarily 
by some major food service companies provide time, temperature, 
sanitation, and contamination critical limits to be applied at critical 
control points such as at shipping and receiving locations and aboard 
transport vehicles. For example, there are temperature critical limits 
for trailers that haul refrigerated and frozen foods, procedures for 
daily monitoring of compliance with these criteria, and documentation 
of findings and any necessary corrective action.
    All these organizations could participate in the development of 
guidelines for various products. The Federal Government, possibly in 
cooperation with the States, could provide technical advice and 
assistance in the development of such guidelines. Since the 
transportation and storage ``gap'' in regulatory coverage is similar at 
the Federal and the State levels, such an approach might be useful.

5. Combination of Approaches

    The Agencies intend also to consider some combination of the above-
discussed approaches. For example, time/temperature performance 
standards could be required along with mandatory HACCP-type systems. By 
specifying critical limits--such as the maximum temperature--to be met 
in handling, storage, and shipping potentially hazardous foods, there 
would be some degree of uniformity among processors in measures that 
they take to ensure the safety and quality of that food while it is 
being transported and stored.
    The combination of a performance standard, such as a time-
temperature standard, with voluntary transport and storage ``good 
practice'' guidelines on how to achieve that standard would probably be 
regarded as the most flexible option, though not necessarily the least 
burdensome of the approaches that involve regulation. Some of the 
voluntary guidelines mentioned above, such as the IDFA and the AFDO 
guidelines, make specific time/temperature recommendations or cargo 
handling procedures intended to prevent physical, biological, or 
chemical contamination. Some involve the voluntary implementation of 
HACCP systems. The voluntary guidelines therefore cover many of the 
recommendations considered in this ANPR as possible regulatory 
requirements.
    Thus, the use of voluntary guidelines would not necessarily be less 
burdensome to the industry than regulation-based alternatives. The 
major disadvantage is the reduced ability of the agencies to assure 
uniformly effective adoption of the guidelines by transportation and 
storage facilities and the consequent achievement of food safety goals.

6. Alternative of No Federal Regulatory Initiative

    This alternative would mean that the Agencies would rely only on 
enforcement of current laws and regulations. Both Agencies have the 
authority to detain or seize adulterated and misbranded food products 
that are in interstate commerce. The Agencies could, for example, take 
action on a cargo of potentially hazardous food that is found to be in 
an off-condition, that is contaminated with some deleterious substance, 
or that is being held at too high a temperature. Depending on the type 
of cargo, the food could be detained based on evidence of adulteration 
and be allowed to be returned to the establishment that produced it, or 
it could be subject to Government seizure. However, actions of this 
sort are inefficient ways to encourage safe food handling practices and 
can involve the Agencies and food companies in costly court actions. 
Worse, they are merely reactive. Although they may have some deterrent 
effect on the mishandling of foods, they do not address the underlying 
causes of the problem.
    The Agencies could, and would, continue to promote food safety 
practices through public information and consumer education, directing 
their efforts, to the extent possible and appropriate, to food 
transporters and storage facility operators. The effectiveness of these 
efforts, however, would depend on the industry also being an advocate 
for good food storage and handling practices and comprehensive 
preventive approaches.

Comparison of Alternatives

    FSIS and FDA would appreciate comments on the following: Which of 
the alternatives presented seem most likely to contribute to achieving 
the goal of reducing the risk of foodborne illness associated with the 
consumption of potentially hazardous foods? Which of the alternatives 
is both feasible and is most likely to prevent food safety hazards from 
arising during transportation and storage? Which would be most 
effective and which least? Which would allow industry the greatest 
flexibility in adopting technologies or developing other means to 
prevent food safety hazards or reduce the likelihood they will occur? 
Which would be most likely to encourage the adoption of new 
technologies, such as improved refrigeration methods, more efficient 
insulated trailers, more accurate thermography, and state-of-the art 
vehicle tracking and communications?

1. Approach to Regulatory Compliance

    FSIS and FDA also seek comments on what roles the Federal, State, 
and local jurisdictions should play in regulating the transportation 
and storage of potentially hazardous foods. This is particularly 
important in light of increasingly tight budgets affecting FSIS, FDA, 
the States, and local jurisdictions, and the consequent need to ensure 
that all public resources devoted to the common goal of food safety are 
used in a coordinated way that maximizes public health protection while 
minimizing public costs.

2. Balancing of Interests and Limitations

    Any option involving additional regulation of the conditions under 
which potentially hazardous foods are transported and stored will 
necessarily involve investment of a larger proportion of the Agencies' 
resources to monitoring the transportation and storage of food, 
compared with resources presently allocated to those activities. 
Assuming at best no real growth in the Agencies' budgets, it may be 
necessary to shift resources from in-plant inspection and other 
activities to the examination of food transportation and storage. 
Reallocations of personnel would entail judgments on the benefits of 
making new assignments. Ideally, the Agencies believe, judgments on how 
best to allocate static or declining resources would be based primarily 
on assessments of relative risks to public health. Therefore, any such 
shift of resources would require careful analysis of relative risks to 
consumers that derive from transportation and storage operations, 
compared with the risks that derive from food processing and other 
activities.
    Thus, for example, new information may dictate that FDA and FSIS 
inspectors and FSIS compliance officers be assigned to new tasks to 
verify compliance with any requirements that apply to the conditions 
under which potentially hazardous food is

[[Page 59381]]

transported by land, air, or sea, or is stored.
    Therefore, the agencies would appreciate comments on how best to 
balance competing demands on Government resources. That is, assuming 
that the general goal of the Agencies is to achieve maximum food safety 
protections throughout the farm (pre-harvest)-to-table continuum, is it 
reasonable for the Agencies to redeploy their personnel and other 
resources to achieve such additional coverage?
    Alternatively, if an option not involving regulation were chosen, 
such as industry agreements to abide by voluntary guidelines, should 
the Agencies nonetheless redeploy resources to increase the monitoring 
of potentially hazardous foods during transportation and storage under 
their existing authorities to prevent the distribution in commerce of 
adulterated or misbranded foods?
    Of course, Government regulation is rarely more than a part of the 
solution. The primary responsibility for protecting the safety of food 
products in distribution channels rests with those in that business--in 
this case, those who buy and sell, handle, and store, and are 
responsible for the shipment of potentially hazardous foods.
    This responsibility argues for an alternative that involves a 
strengthening, by industry itself, of the control systems that they 
utilize. An alternative that induced a more widespread application of 
available technologies, such as improved refrigeration, thermography, 
and vehicle tracking and communication systems, could result in 
efficiency gains to industry and reduced risk to consumers.

3. Costs and Benefits

    Companies that institute a HACCP-type system or other control 
system where such systems are not already in operation would incur one-
time direct costs to implement a control system. These costs would 
include those of setting up the needed documentation, tracking, 
inventory control, or other systems, and one-time costs of training 
personnel to operate them. For temperature monitoring, the cost of 
acquisition of thermometric equipment and temperature recording devices 
could also occur.
    For any alternative that might involve the application of new 
technologies, the cost to industry of implementing the technologies 
would have to be considered. Such direct costs could be offset by the 
benefits of such technology gains as those from: improved thermography, 
improved temperature control; trailers made with lighter and more 
effective insulating materials, more fuel-efficient refrigeration; 
improved thermographic equipment, more accurate temperature monitoring 
and control; and from improved vehicle tracking and communication, more 
efficient and effective delivery with less product loss. The benefits 
of these technologies can reduce transit time and risk and provide 
shippers, receivers, and consumers with fresher, higher quality 
products.
    Because of the Agencies' interest in reducing foodborne illness, 
the Agencies would appreciate data or information on the control or 
reduction in microbial populations that the application of new 
technologies could produce. Of special value would be information 
relating to predictive modeling of time, temperature, and microbial 
growth under conditions in which the technologies might be applied.
    The costs to the Agencies of increased oversight over food 
transportation and storage would include costs associated with 
increases in personnel travel, costs for training of personnel in 
oversight techniques, and costs (mostly one-time) related to personnel 
reassignments.
    The ultimate beneficiaries of a regulatory or non-regulatory 
initiative in the transportation and storage area would be the general 
public, to the extent that the initiative resulted in a reduction of 
foodborne illness. There would be additional tangible and intangible 
benefits. For some companies, increased reliance on quality control or 
HACCP-type systems could result in improved product tracking and 
inventory control, reduction in product loss, and overall efficiency 
gains. An intangible benefit, increased confidence in the food supply 
among both domestic and foreign purchasers, could lead to indirect 
tangible benefits for processors, distributors, and producers, in the 
form of increased sales.

Information Needed for Regulatory Analyses

    As a general matter, when developing new regulations, regulatory 
agencies take into consideration many factors. FDA and FSIS consider, 
among other things, the costs of enforcement and compliance (to the 
Government, regulated entities, and the public) of new regulations. 
FSIS and FDA also consider, where appropriate, alternative ways of 
achieving an objective and where applicable, the risks addressed by an 
intended regulation. The factors the Agencies consider are set forth in 
statutes and other authorities.
    Executive Order 12866 provides that to the extent permitted by law 
and where applicable, agencies should adhere to certain principles of 
regulation. These principles include considering to the extent 
reasonable, in setting regulatory priorities, the degree and nature of 
the risks posed by various activities within an Agency's jurisdiction. 
Under the Executive Order, agencies also examine whether an intended 
regulatory action would be significant. A regulatory action could be 
considered to be significant for a number of reasons, including if it 
were determined to have an annual effect on the economy of $100 million 
or more.
    The Regulatory Flexibility Act (RFA), recently amended by the Small 
Business Regulatory Enforcement Fairness Act (SBREFA, PL 104-121; 5 
U.S.C. 601 et seq.), requires assessment of a proposed regulation's 
economic impact on small entities, which includes small businesses and 
other small entities, including local governmental units. Agencies are 
required under the RFA to determine whether a proposed regulatory 
action would have a significant economic effect on a substantial number 
of small entities. If it is determined that it would have such an 
impact, an initial regulatory flexibility analysis is published that 
discusses various issues including an estimate of the number of small 
entities to which the proposed rule will apply, the rule's projected 
reporting, recordkeeping, and compliance requirements, and significant 
alternatives that would accomplish the stated objectives of an 
applicable statute which minimize any significant economic impact of 
the proposed rule on small entities. At the final rule stage, a final 
regulatory flexibility analysis is published.
    The Unfunded Mandates Reform Act (UMRA, 2 U.S.C. 1531 et seq.) 
requires consideration of the possibility that regulatory or other 
resource-intensive burdens are being imposed by the Federal government 
without providing for funding to accomplish the mandated function.
    FSIS also is required to conduct a risk analysis under the Federal 
Crop Insurance Reform Act and Department of Agriculture Reorganization 
Act of 1994 (Pub. L. 103-354, 7 U.S.C. 2204e) to ensure adequate risk 
assessment and cost benefit analysis for major proposed regulations 
whose primary purpose is to regulate issues of human health, human 
safety, or the environment. Under this Act, a major rule is defined as 
a rule that is likely to have an annual impact on the economy of the 
United States of $100 million.

[[Page 59382]]

    Therefore, the Agencies would also use the information requested 
earlier in this document to help them conduct any risk assessment that 
may be needed. Especially useful would be information on the following 
for potentially hazardous foods: (1) The probability of occurrence of 
hazards in potentially hazardous foods at the beginning of 
transportation; (2) the hazards that could be introduced or spread 
during transportation, and the magnitude of these hazards; (3) the 
occurrence of factors such as improper cooling and temperature 
maintenance that could increase the probability and/or magnitude of 
microbial hazards; (4) the probability of occurrence of hazards in 
potentially hazardous foods at the end of the transportation segment; 
and (5) the probability of occurrence and magnitude of human foodborne 
illnesses that can be directly or indirectly attributed to the 
transportation of potentially hazardous food.
    The Agencies also need information about the businesses that may be 
affected by any of the alternatives being considered in order to assess 
their potential costs and benefits on small entities under the RFA. 
Businesses of concern would include establishments that process and 
ship meat, poultry, eggs, seafood, and other potentially hazardous 
foods, motor freight companies, food storage warehousing operations, 
air freight companies, and water transport firms.
    Under the Small Business Administration regulations, a small entity 
in the motor freight and warehousing category is one whose annual 
receipts are no greater than $18.5 million. A small entity in the 
category that includes air freight or railroad transportation is one 
with no more than 1,500 employees. A small entity in the categories of 
water transportation or food processing is one that employs no more 
than 500 people.
    Finally, the agencies are requesting relevant environmental 
information because under the National Environmental Policy Act (42 
U.S.C. 4332), the individual or cumulative effect of regulations on the 
human environment needs to be considered. The agencies do not now 
possess the data that would permit detailed analysis of any 
environmental impacts of the alternatives described in this document. 
Therefore, information on potential environmental impacts is also 
requested, including: (1) the potential for increased energy 
consumption that may result either from the need to increase 
refrigeration during transportation of food or from the use of more 
trucks to avoid transporting food in trucks that had previously held 
cargoes that could affect food safety, (2) increased disposal of 
defective foods, (3) new or increased use and disposal of sanitizing 
products, and (4) a description of measures that could be taken to 
avoid or mitigate adverse environmental impacts that might result from 
this action.

    Done at Washington, DC, on: November 18, 1996.
Thomas J. Billy,
Administrator, Food Safety and Inspection Service.
William B. Schultz,
Deputy Commissioner for Policy, Food and Drug Administration.
[FR Doc. 96-29837 Filed 11-18-96; 5:08 pm]
BILLING CODE 3410-DM-P