[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