Transportation and Storage Requirements for Potentially Hazardous Foods

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

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\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.

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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.

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\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.)

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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