Guide to Food Safety and Quality during Transportation: Controls, Standards and Practices

Guide to Food Safety and Quality During Transportation

Controls, Standards and Practices

Second Edition

John M. Ryan, PhD, PCQI

Ryan Systems, Inc., Palm Bay, FL, United States

Table of Contents

Cover

Title page

Copyright

Dedication

Background

Chapter 1: Introduction to transporter container sanitation, traceability, and temperature controls

Abstract

Inspection as the primary basis for food quality and safety

The need for technology and hard data to enter the certification arena

Moving to measurement and causal analysis

Prevention

Risk factors in real time

The forgotten element: food on the move

Some definitions

International guidance related to food safety in transportation processes

Exclusions to the rules

Chapter 2: Current and emerging transportation food safety models

Abstract

Return on investment and financial benefits for emerging transportation monitors

Basic traceability and monitoring models

Examples of transportation process quality measurement

Inter- and intrastate shipping

Air and ocean food shipments

Emerging monitoring models: intelligent delivery control systems, RFID, ILC, and RH

ILC devices

RFID systems

Other radio frequency systems

Sanitation issues

Automation in interior wash and sanitation

Intermodal

Summary

Chapter 3: Introduction to in-transit food safety auditing and standards

Abstract

Quality in food safety transportation

Internal audits and teams: organizing for system implementation

Continuous improvement team concepts

Internal audit team causal analysis and management reporting

External audits and auditors

In-transit standards: introduction and organization

Certification rules

Chapter 4: System management and record keeping

Abstract

Management system (M)

Ambient atmosphere pick and delivery times and procedures

Shipper record retention manual

TransCert compliance standards and record keeping

Temperature control and traceability component documentation

Appendices

Chapter 5: In-transit preventive control & HACCP planning and implementation: concepts and standards

Abstract

Contaminant migration through the supply chain

HACCP exclusions in the transportation maintenance sector

New hazard prevention thinking: short transportation processes

Preventive planning

HACCP planning, implementation and certification

HACCP 101 plan

Preliminary HACCP planning

Flowcharts and zones

Planning food transportation controls

Moving the preliminary plan to the HACCP forms

HACCP 102 HACCP plan is supported by procedures

HACCP 103 support team

HACCP 104 training

HACCP 105 location-specific information

HACCP 106 identification of hazards

HACCP 107 identification of critical control points

HACCP 108 establish critical limits

HACCP 109 monitoring procedures

HACCP 110 corrective action

HACCP 111 record keeping

HACCP 112 verification activities

HACCP 113 monitoring record-keeping procedures

HACCP 114 signatures and dates

HACCP implementation standards and requirements

HACCP 115 monitoring and record keeping procedures

HACCP 116 records contain actual readings

HACCP 117 data are recorded in a timely manner

HACCP 118 records and recording timeframes are reviewed

HACCP 119 record formats

HACCP 120 record reviews are performed and documented

HACCP 121 corrective action

HACCP 122 design of corrective actions

HACCP 123 documentation of corrective actions

HACCP 124 corrective action reviews

HACCP 125 preventive actions

HACCP 126 preventive action documentation

HACCP 127 preventive action records are reviewed within timelines

HACCP 128 record completeness review

HACCP 129 instrument calibration

HACCP 130 calibration procedures

HACCP 131 calibration records

HACCP 132 calibration activities match procedures

HACCP 133 verification activities

HACCP 134 verification completeness

HACCP 135 verification documentation

HACCP 136 verification of corrective actions

HACCP 137 maintenance of HACCP records

HACCP 138 record maintenance period

HACCP 139 availability of HACCP records for duplication

HACCP for in-transit food

A focused preventive controls approach: causal analysis and validation

Chapter 6: In-transit container sanitation standards: packaging and control of packaging

Abstract

Holes in the research base

Container sanitation (S)

Standard S 101 container adulteration preventive planning

Preventing cross-contamination

Food supply chain cross-contamination and distribution of contaminants during food transportation operations

Summary

Chapter 7: In-transit temperature control monitoring and traceability standards

Abstract

Traceability system considerations

Container temperature control monitoring and traceability standards

Standard T 101 plan

T 103 standard: temperature monitoring and traceability procedures exist and match the planned system

ILC container or pallet-tracker procedures

Recording training events

Preventive system components

The US FBI on cargo theft

Summary

Chapter 8: System implementation

Abstract

Ten rules for guiding food transportation management

Required training

Applying through-put thinking

Addressing container maintenance issues at an early date

How should we start implementing food safety and quality controls for food movement processes?

Considerations for data systems

Controlling risk and liability: a vertically integrated vision of the supply chain

Risk analysis

Electronic traceability

Recall controls

Ranking transportation suppliers: reducing risk using cause and effect thinking

Putting an integrated transportation food safety system together

Useful forms

Preparing for certification audits

External auditor readiness checklist

Notes on external audit scoring

The importance of corrective and preventive actions

Summary

Chapter 9: The future

Abstract

One-up and one-down is dead

A path

Some new technologies

Tests and monitoring: the dilemma

Aluminum pallets on the rise

New needs for the food transportation sector record keeping

Seaports

Trade groups take the lead

The use of statistical procedures for analysis of mega databases

Calibration

FSMA impact on the International Food Safety Community

Homeostasis: achieving stability in food transportation processes

References

Index

Copyright

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Dedication

For Robin

Background

If you open your refrigerator and look at all the food inside, do you have any idea of the average distance that your food traveled to get to you?

In the United States, on an average, food travels around 2000 or more miles to get into your refrigerator.

Although the United States Food and Drug Administration (FDA) has recently passed final Food Safety Modernization Act (FSMA) rules on the Sanitary Transportation of Human and Animal Foods [1], it should surprise you to know that there are no established sanitation, traceability, or temperature control food safety standards that perishable food carriers must comply with during the transportation process. The almost simultaneous finalization of the FDA FSMA Preventive Controls rules, while almost completely ignoring the transportation sector, clearly lays the groundwork for the need to begin to understand and implement preventive systems regardless of the supply chain sector.

Food safety standards, inspection and audit programs, and organizations exist for farms, packinghouses, distribution centers, wholesalers, retailers, restaurants, and food processors; but not for the companies that physically move the food from one place to another. Your food goes in and out of those facilities, in and out of trucks and on and off ships and airplanes, but there is no set of standards established for in-transit carriers of perishable foods.

This lack of standards means that anything goes as long as the food gets through the supply chain within the product’s shelf life and at a cost that makes the shippers, carriers, and receivers happy. In this book, the in-transit phase covers all food movements—from the field to the consumer, from the harvest bin, or tractor trailer to your plate.

This book is not specific to any particular type of food or country, but it is intended to provide professionals and advanced students with a sound foundation for the improvement of the transportation sector responsible for the movement of perishable food. It focuses primarily on the food at load and unload operations, in-transit, food movers, container sanitation, maintenance and traceability, food safety and quality controls. The book is intended to outline delivery monitoring and control solutions and to provide a standard approach for protecting the food transportation industry, those paying for quality transportation practices, and consumers.

While food safety agencies and certifying bodies have been focused on producer, processor, retail, and restaurant food safety, the industry that moves the food has been overlooked by many shippers, carriers, and receivers while others have established company controls. Millions of dollars are spent annually on food safety systems and visual audits for farms, packinghouses, distribution centers, harvest crews, retail outlets, processors and restaurants, but except for a few proactive companies, little has been spent on pressuring food movers to adhere to any set of standards.

Trucks and containers used to move food are often also used to move chemicals and other adulterants during back-haul operations. Truck drivers desiring to save on fuel costs turn off refrigeration units until they are needed. Trans-Pacific shipping containers are held up by incoming customs inspectors because of a lack of proper paperwork, leaving the food inside to age beyond usefulness. Truck trailers used on farms are not cleaned after moving produce from the field to the packinghouse. Harvest bins are never cleaned or sanitized after being stacked in the field once the harvest is over.

Such food safety abuses are the result of generations of practice that have focused on how the food looks, in order to make it sell, rather than a concern for consumer health. Food recall data highlighted over the past 10 or so years has increasingly brought food supply safety to the attention of consumers and others. This as well as lack of government oversight has resulted in multiple but nonstandardized approaches to food safety that are inspection dependent, and that largely ignore the technologies and practices that need to be brought into the solution set.

While the food transportation sector was previously governed by the Sanitary Transportation of Human and Animal Foods Act [1], many food transportation companies are acutely unaware of or unwilling to comply with the Act’s sanitation, record-keeping, and shipment control requirements. The cold chain transportation industry commonly overlooks these requirements (defined in the newly enacted Sanitary Food Transportation Act [1]) and Department of Homeland Security administrative rules. This book covers these requirements and other international compliance issues, and moves through vicarious liability and the ever-evolving buyer requirements. Produce precooling operations are explored as a preliminary input to possible sources of adulteration that leave transporters liable for shelf life and product losses. Short versus extended supply chains are further explored as potentially contributing to a lack of supply chain control. International food transportation solutions are discussed because of similar food transportation control requirements in other regions of the world, and as a result of tendencies to blame foreign food producers for a lack of control over food adulteration.

The advances in technological testing, sanitation, monitoring, and traceability that have provided the industry with ample cost-effective solutions are highlighted. Such advances, and a sound understanding of responsibilities and liabilities, provide food transporters with the planning mechanisms needed to move into solid standardized delivery control solutions in line with food safety needs as well as government compliance.

Armed with a foundation of legal, liability, practical solutions and common standards, food shippers, transporters and buyers will have a solid foundation that enables them to structure company wide business practices as a part of their overall food safety and quality agenda. For students of food safety and quality, this book provides much needed insight into a critical but overlooked aspect of the food safety and quality spectrum. This food transporter piece of the overall food safety and quality puzzle provides a much needed link to improve the supply chain communication and interdependence sought by governmental and industry executives.

From a prevention perspective, the revised book provides explanations of Hazard Analysis and Critical Control Points (HACCP) and adds preventive process control structures intended to keep safe quality food moving in a more holistic, integrated manner. The transportation sector is treated as a measurable and manageable process that forms the links critical to an integrated food safety system.

All transportation food safety standards presented in the first edition have been updated to comply with new FSMA food transportation requirements.

This revision also includes a review of the final United States Food and Drug Administration’s final Food Safety Modernization Act rules on the sanitary transportation of human and animal foods. New requirements for mandatory training and all food transportation operations are reviewed.

A system for food transportation food safety planning that relies on teams, flowcharts, and Excel spreadsheets is included in this revision along with a new technological approach to collecting temperature, sanitation, traceability, maintenance, and other data critical to record keeping and transportation system management.

New considerations for cross- and contact contamination, food theft is included since all food transportation processes are subjected to such hazards.

There are perhaps thousands of different types of food transported around the world: frozen living, canned, fresh, fish and meat, milk, cheese, eggs, sprouts, avocados, processed, packaged, clean, dirty, adulterated, contaminated, from Chile to Europe, from the United States to Korea, and from South Africa to Florida. Food transportation and control over it is taken quite seriously by some companies in some countries, whereas in other countries fresh produce is transported to the morning market in bags slung over a carrier’s back.

Some long-distance food carriers have established extremely sophisticated real-time location and temperature measurement systems designed to control food safety and quality, whereas others would rather dump a truckload of overripe tomatoes on the side of the road because the road was rained out and impassable for several days.

No single book could cover such diversity.

Regardless, a system can be established that provides guidance on planning, implementation, and standards, and is designed to satisfy both internal management needs and external certification audit requirements.

This book is intended to help begin providing visibility into these areas, and to provide a basis for those companies and food logistics professionals in need of modern guidance on food safety and quality during transportation processes.

Chapter 1

Introduction to transporter container sanitation, traceability, and temperature controls

Abstract

Outbreaks due to food adulteration have resulted in extensive needs for food safety improvement in all food supply chain sectors. The need for improved measurement, analysis, and reporting has increased the food supply chain’s need to move to preventive and risk reducing strategies based on causal analysis. The transportation sector has been basically ignored as a key factor in the delivery of safe and quality food.

To improve food transportation processes, especially sectors handling perishable foods, new definitions, and more preventive controls for shippers, carriers, containers, maintenance stations, and transportation operations personnel need to be established and managed as other critical operational functions are managed. This lack of transportation food safety and quality controls leaves the entire food supply chain in jeopardy of falling to recalls, product liability, vicarious liability, lack of sales, and an inability to meet established international and evolving transportation food safety and quality requirements.

Keywords

adulteration

prevention

causal analysis

food containers

food carriers

traceability

cold chain

liability

food safety laws

logistics

transportation operations

preventive controls

Food and Drug Administration (FDA)

Food Safety Modernization Act (FSMA)

Food supply chains are subject to the vagaries of a number of regional and international food safety procedures. Distribution centers, farms, processors, retailers, restaurants, and packers are besieged by hundreds of different standards, all purporting to certify the operation to whatever food safety audit standards have been developed by compliance bodies and approved by government agencies. Because of costs, the slowness of analysis and the need to generate business, other than processors following hazard analysis critical control point (HACCP)-type systems, many certification audit practices exclude such basics as testing for hazardous biocontaminants or chemicals, and instead rely on visual inspection by auditors and documentation reviews.

Most people are acutely aware of the numerous recent adulteration outbreaks in the food supply chain and the resulting illnesses and deaths. Spinach, green onions, carrots, peanuts, hamburger, and juices are only a few of the publicly reported carriers over the past few years. What most people are not aware of is the extent to which these and similar problems go publicly unreported. For instance, the USDA Food Safety and Inspection Service (FSIS) reported that for the calendar year up to October 2006 there was 29 separate meat recalls across the country [3]. What is interesting about the spinach Escherichia coli outbreak is that the retail industry, not the government, voluntarily removed the spinach from the shelves to prevent its sale.

The author recently moved from implementing quality systems in high-technology electronics manufacturing companies throughout the United States and Asia into a position responsible for implementing a quality system at the Hawaii State Department of Agriculture. When I began my career in technology in 1984, the company where I was a director of quality relied solely on inspection and sorting to assure the quality of their products. The factory the company owned in South Korea was operating in a batch-manufacturing mode. Each process step in the product build was followed by a wall of inspectors responsible for sorting the good from the bad, with the bad going to rework or scrap and the good going on to the next process step. Return rates for the final product were at 49%. I have long forgotten the rework rates, but I do remember many shelves piled with materials awaiting rework. The scrap piles were also something to be proud of. There was no corrective action, and incoming materials were purchased based solely on price. Management was convinced that they were doing a good job because the company was making money.

Inspection as the primary basis for food quality and safety

Readers might have gained a clue to this situation by carefully rereading the first paragraph. The USDA Food Safety and Inspection Service is just that: an inspection service. It relies heavily on inspection, certification, and audits. During my 25-year career I have never knew that those activities to positively affect outgoing quality or cost savings, except where results were used for causal analysis and to drive improvements. Organizations that rely on visual inspection are rarely knowledgeable about prevention. Further, the use of inspection data to drive preventive action is rare. Preventive action is not the same as what is commonly referred to as corrective action.

Here is a list of Deming’s 14 points first published in Out of the Crisis [4]. It is interesting to consider how they apply to the food supply and our control over how food is transported from one place to another.

Deming’s 14 points

1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs.

2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.

3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place.

4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.

5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.

6. Institute training on the job.

7. Institute leadership. The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.

8. Drive out fear, so that everyone may work effectively for the company.

9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service.

10. Eliminate slogans, exhortations, and targets for the workforce, asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the workforce.

• Eliminate work standards (quotas) on the factory floor. Substitute leadership.

• Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.

11. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality.

12. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective.

13. Institute a vigorous program of education and self-improvement.

14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody’s job.

Clearly the 14 points are focused on management and management’s ability and willingness to implement systematic changes to what he called common causes. Common causes of quality and, in this case, food safety problems are management caused problems. Deming points out the fact that throughout his career, he estimates that up to 85% of all quality problems are caused by the system implemented (or not implemented) by management. Common or system causes are clearly management’s responsibility and with the newly established final rules on the sanitary transportation of human and animal foods, the liability associated with the failure to establish preventive transportation controls makes all transportation operations personnel personally responsible and open to legal action.

Take, for example, point number 3 Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place. This is particularly important and applicable in our circumstance. Bacteria and chemical hazards cannot be detected using inspection strategies.

There is a good deal of discussion nowadays about food quality versus safety. Deming is well known for helping to improve quality, but is that the same as food safety? The 14 points listed before show that our food supply chain is in need of exactly the types of changes he recommended 30 years ago. Food safety and food quality go hand in hand. Both rely on and can be seriously affected by the transportation industry and its ability to improve services.

State, local, and federal level governments rely heavily on inspection when involved in food enforcement activities. They believe they will achieve quality with visual inspection, audits, and enforcement. Interestingly, with literally thousands of inspections going on, there are few focused on measurement mechanisms that might be established to collect and analyze data or to drive change.

This government reliance on what is commonly called verification represents a focus on inspection and audit and is an anachronism that demonstrates a basic lack of understanding of how to resolve the complex problems of food quality and safety. In short, verification simply means that the food safety plan has been implemented as determined by a documentation review. Verification activities ignore the need to establish any level of proof that the plan and the implementation of the plan actually work. Verification, by itself is meaningless.

Within the new preventive framework, validation requirements mean that a company must establish a quantitative, scientific approach to identify causes of problems and must establish a continuous improvement system to lessen and eliminate identified hazards. Of equal importance, validation efforts are based on hard or objective data not on subjective inspection and audit observations. Objective data is obtained from sampling and laboratory reports not from food safety audits.

In more modern organizations, the terms currently in use include six-sigma, supply chain management, leadership, teamwork, customer focus, data-driven decision-making, traceability, and so on. These terms are only sometimes used in agricultural and food supply organizations. Statistical process control (SPC) is relatively unknown, as is the idea that one could actually use statistics to control assignable causes in a process. Remember the comments about Deming aforementioned. While management causes create 85% of our quality and food safety problems, assignable causes (those controlled everywhere except at management levels) contribute some 15% to the overall food safety and food quality failure rate.

Although SPC and six-sigma tool kits might be used effectively depending on the particular situation, they rarely have been thought of or applied in the transportation sector with the exception of a few forward-thinking companies. In spite of current food safety outbreaks, this gap is probably due partly to the lack of knowledgeable quality professionals moving into the food safety industry, as there is little demand for such people. Furthermore, current coursework in food science colleges focuses primarily on inspection and compliance audit requirements as a means of achieving quality and safety. This leaves the college-educated food science and food safety communities with a 100-year-old gap in quality improvement practices.

The weak legal framework for food quality and safety is based on weak inspection standards that often intentionally exclude hard and more objective data. With regard to our current interest—the transportation sector—there is virtually no oversight, no measurement, little data, no analysis and no preventive action. Without such data and management, prevention is nearly impossible.

Whereas many laws are enacted with the intention of improving produce quality, implementation, and enforcement, except in the case of recalls, are virtually nonexistent. The National Organic Program (NOP) [5] is a good example of quality avoidance. The Organic Foods Production Act of 1990 [6] levies perhaps the greatest burden of compliance on organic farmers by establishing national standards governing the marketing of certain agricultural products as organically produced products. The Act relies heavily on certification, and on certification of the certifiers. Those familiar with the International Standards Organization (ISO) approach to quality systems understand what this means. Food safety certification, as implemented today, neither implies nor assures safety or quality. Typically, auditors with extensive training in procedural implementation analysis will visit an operation and go through a set of questions and review activities to determine the level to which the organization has implemented or attempted to control hundreds of items. The final score determines whether the business is certified. Certification is generally handled by a certifying agency responsible for training and certifying the auditors, and for the scoring system and documentation strategy. A great deal of certification takes place at all levels, at great expense in terms of time and money. Usually, only larger organizations can afford to become certified, but some smaller certifying agencies will work with smaller companies for a reasonable fee. Many food supply businesses cannot afford to become certified, or do not wish to be bothered by government regulations and interference. Many others simply cut costs that are negative to delivering safe food. This is known as economically motivated adulteration.

Currently, no standards, inspection, certification, auditing, or testing for hazards are required for containers that actually hold the food during transportation processes.

The problem is that, like ISO, implementation of standards and guided improvement practices and certification are top-down driven. Many (most) larger retailers (e.g., Safeway, Wal-Mart) have fallen into the certification trap and require their suppliers to be safety certified to enter the supply chain. If Safeway stores want a distributor to be safety certified, the distributor quickly requires its supplier farms also to be safety certified. The assumption is that auditing and certification will improve things.

Moving away from organic products, readers might wish to review good agricultural practices (GAP) [7], good handling practices (GHP) [8], and good manufacturing practices (GMP) [9], which are all inspection- and certification-based initiatives, all written to establish armies of certifying agencies responsible for certifying armies of certified inspectors out to certify thousands of farms, distributors, and producers. What is really interesting about many of the standards set up by certifying agencies that have interpreted these codes are the standards they have established for certified inspectors to follow. The following are four examples from the USDA Good Agricultural Practices and Good Handling Practices Audit Verification Matrix November 1, 2006 revision [10]:

1. Water quality is known to be adequate for the crop irrigation method and/or chemical application.

2. If necessary, steps are taken to protect irrigation water from potential contamination.

3. The farm sewage treatment system is functioning properly and there is no evidence of leaking or runoff.

4. Processing water is sufficiently treated to reduce microbial contamination.

(Source: USDA Good Agricultural Practices and Good Handling Practices Audit Verification Matrix November 1, 2006 revision.)

Most food safety or quality initiatives would more likely be inclined to establish standards that actually mean something. For instance, what is adequate water quality? What is a properly functioning sewage treatment system? Number 4 is the best one: just what is sufficiently treated water?

Standards like these are simply not standards. Interpretations left open to certifying agencies and individual inspectors are unreliable, prone to failure, and an utter waste of time and money—but this is the best we have!

Like the company I referred to at the beginning of this section, agriculture, the US Department of Agriculture, the FDA, certifying agencies, and the inspectors, after decades of worry and handwringing, are still in batch-processing mode. They insist on following the assumption that food safety and quality can be inspected into the product, container, transporter, produce, food, farm, or outdoor facilities. But inspection, and in particular subjective inspection, as a primary quality or safety tool has never and will never meet food safety needs satisfactorily.

It is time for the food transportation sector to begin to wake up to the 21st century. Many transporters are currently employing higher quality and safer standards and tools than the government or the certifying agencies, and they are doing so on their own account, in their own time, and without the help of university, state, or federal enforcement agencies.

The need for technology and hard data to enter the certification arena

Although new applications for statistical process control may need to be developed, a few bright thinkers are moving to bridge the gap between inspection and preventive process controls. Writers for Northwest Analytical (John G. Surak), in The Future of Food Regulations [11] and Surak et al. in Integrating HACCP and SPC [12] spark the imagination. For anyone who might be unfamiliar, HACCP contains a set of recommended procedures for maintaining process controls in the food production (factory) environment. These authors note that a good HACCP program cannot depend on microbiological tests as the means to prevent a hazard because they are too slow to provide the real-time information needed to maintain process control properly.

This statement illustrates the lack of understanding of the problem. We have to depend on microbiological tests as the means of preventing a hazard: inspectors cannot see, smell, taste, or feel biological contaminants. And HACCP is representative of advanced thinking in the food supply chain. HACCP is considered advanced because the vast majority of food suppliers and handlers cannot understand what it is all about or what it means—but HACCP is very far behind the food safety and food quality systems we need today. Jokingly, the FDA Backgrounder [13] notes that HACCP is Space-age technology designed to keep food safe in outer space [and] may soon become standard here on Earth.

We are in dire need of help. Maybe someone in outer space can give us a hand.

While HACCP has been doodling along for some time now, an attempt by the US FDA was made to do something to clarify whatever the heck they want. So, along came the preventive control rules that clearly call for environmental monitoring and, at first glance, move in the direction of objectivity. Alas, such is not the case. Under preventive control rules the food safety plan must be approved by a qualified individual who has been trained in preventive controls that include validation. Unfortunately, the preventive control rules focus solely on HACCP while minimizing validation (hard, objective, scientific evidence that the plan works). One would have to guess that the food side of the FDA could not understand what the drug and medical side of the FDA means when they call for causal analysis and a reliance on more objective data than that provided by inspection and audits.

This oversight is symptomatic of a lack of understanding of common causes (85% management controllable = FDA controllable) and represents a significant failure on the part of those who apparently spent a lot of energy and time fighting against the definition of a system that would prevent food safety problems. We should have more respect for those people managing food transportation operations than that. Many of them are actually competent problem solvers and are clearly more dedicated to food safety during transportation processes than the new rules might lead us to believe.

Rapid, low-cost tests are needed for food suppliers to determine, beyond visual audits, what is really going on with their products. Such testing could be applied to farm harvests, distribution, transportation, and virtually any place in the food supply chain. The hard and objective data supplied by testing could support quality and food safety control, management decision-making, and preventive and corrective actions. And electronic traceability systems should become mandatory—required, and not the subject of guidance. Using manual, paper-based traceability systems in this day and age when laptop computers cost less than $300 is an indication of resistance to change, not concern for consumer safety. Traceability technology is available to measure temperatures, humidity, and tampering throughout all transportation processes, and the application of these technologies can be shown to provide not only return on investment but also marketing leverage.

However, such is not yet the case, especially with regard to many types of container used to transport food. Since such containers are rarely cleaned,