Handbook of farm, dairy and food machinery engineering (2nd ed)(gnv64)

1. Handbook of FARM, DAIRY AND FOOD MACHINERY ENGINEERING SECOND EDITION

2. Handbook of FARM, DAIRY AND FOOD MACHINERY ENGINEERING SECOND EDITION MYER KUTZ Myer Kutz Associates, Inc., Delmar, New York Amsterdam Boston Heidelberg London New York Oxford Paris San Diego San Francisco Singapore Sydney Tokyo Academic Press is an imprint of Elsevier

3. Academic Press is an imprint of Elsevier 32 Jamestown Road, London NW1 7BY, UK 225 Wyman Street, Waltham, MA 02451, USA 525 B Street, Suite 1800, San Diego, CA 92101-4495, USA First edition 2010 Second edition 2013 Copyright r 2013 Elsevier Inc. All rights reserved No other part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise without the prior written permission of the publisher Permissions may be sought directly from Elseviers Science & Technology Rights Department in Oxford, UK: phone (144) (0) 1865 843830; fax (144) (0) 1865 853333; email: [email protected]. Alternatively, visit the Science and Technology Books website at www.elsevierdirect.com/rights for further information Notice No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verification of diagnoses and drug dosages should be made British Library Cataloguing-in-Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN: 978-0-12-385881-8 For information on all Academic Press publications visit our website at elsevierdirect.com Typeset by MPS Limited, Chennai, India www.adi-mps.com Printed in the United States of America 13 14 15 16 17 10 9 8 7 6 5 4 3 2 1

4. To Alan for all the good times at Ichiban

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6. CONTENTS Preface to the Second Edition xv Preface to the First Edition xvii List of Contributors xxi 1. The Food Engineer 1 Felix H. Barron 1. Nature of Work and Necessary Skills 1 2. Academic and Industry Preparation 2 3. Work Opportunities for a Food Engineer 5 4. Engineering Jobs 9 5. Future Opportunities 9 6. Conclusions 10 Reference 12 Further Reading 12 2. Food Regulations 13 Kevin M. Keener 1. Background 13 2. Federal Register 14 3. Code of Federal Regulations 15 4. United States Code 15 5. State and Local Regulations 16 6. USDAFSIS Sanitation Programs 16 7. FDA Sanitation Programs 18 8. Food Safety Modernization Act 20 9. Hazard Analyses and Critical Control Point Program (HACCP) 22 10. Meat Processing 24 11. Shell Eggs 26 12. Seafood Processing 27 13. Fruits, Vegetables, and Nuts 29 14. Beverages 30 15. Canned Foods 34 16. Food Service/Restaurants 35 17. Export Foods 35 18. Imported Foods 37 19. Conclusions 38 20. Acronyms 38 References 39 vii

7. 3. Food Safety Engineering 43 Raghupathy Ramaswamy, Juhee Ahn, V.M. Balasubramaniam, Luis Rodriguez Saona and Ahmed E. Yousef 1. Introduction 43 2. Intervention Technologies 44 3. Control/Monitoring/Identification Techniques 52 4. Packaging Applications in Food Safety 57 5. Tracking and Traceability 58 6. Byproducts of Processing 59 7. Conclusions 61 Acknowledgment 61 References 61 4. Farm Machinery Automation for Tillage, Planting Cultivation, and Harvesting 67 Brian T. Adams 1. Introduction 67 2. Vehicle Guidance 68 3. Implement Guidance Systems 75 4. Guidance Methods 75 5. Challenges Facing Autonomous Vehicles 81 6. Summary 83 References 84 Other Contacts 85 5. Air Seeders for Conservation Tillage Crop Production 87 John Nowatzki 1. Opener Design Options 87 2. Managing Crop Residue 89 3. Soil Disturbance and Environmental Impacts 93 4. Seed/Fertilizer Placement, Row Spacing 94 5. Depth Control and Packing 97 6. Varying Conditions 98 7. Precision Agriculture 99 8. Energy Requirements 101 9. Commercial Options 101 Reference 101 Further Reading 101 6. Grain Harvesting Machinery 103 H. Mark Hanna and Graeme R. Quick 1. General 103 2. History 103 viii Contents

8. 3. Pre-Harvest Issues that Affect Machine Design 104 4. Performance Factors 105 5. Heads: Grain Platforms, Corn Heads, and Strippers 106 6. Feederhouse 109 7. Cylinder or Rotor and Concave 109 8. Separation: Straw Walkers or Rotary Separation 112 9. Cleaning Shoe 114 10. Elevators: Clean Grain and Tailings 116 11. Grain Bin and Unloading Auger 116 12. Other Attachments 118 13. Operators Station, Adjustments, and Monitoring Systems 118 14. Field Performance 119 15. Grain Damage 120 16. Combine Trends 120 References 121 7. Grain Storage Systems Design 123 Ray Bucklin, Sid Thompson, Michael Montross and Ali Abdel-Hadi 1. Materials 124 2. Drying 126 3. Structural Loads 132 4. Grain Handling 153 5. Testers for Measuring Flow Properties 165 References 171 8. Milking Machines and Milking Parlors 177 Douglas J. Reinemann 1. Introduction 177 2. The Milking Machine 178 3. Milking Parlors 189 References 197 9. Dairy Product Processing Equipment 199 H. Douglas Goff 1. Introduction 199 2. Clarification, Separation, and Standardization 200 3. Pasteurization 202 4. UHT Sterilization 208 5. Homogenization 209 6. Membrane Processing 211 7. Evaporation 212 ixContents

9. 8. Drying 213 9. Ice Cream Manufacturing Equipment 216 10. Butter Manufacturing Equipment 218 11. Cheese Manufacturing Equipment 219 References 220 10. Grain Process Engineering 223 Imran Ahmad and Athapol Noomhorm 1. Drying 223 2. Pre-Storage Grain Treatments 228 3. Post-Harvest Value Addition 233 4. Cooking and Processing 239 5. Quality Evaluation 246 References 251 11. Technology of Processing of Horticultural Crops 259 Conrad O. Perera and Bronwen Smith 1. Introduction 259 2. Properties of Fruits and Vegetables 261 3. Biological Deterioration and Control 269 4. Methods for Minimizing Deterioration 272 5. General Methods of Fruit and Vegetable Preservation 275 6. Some Important Methods of Processing of Fruits and Vegetables 282 7. Quality Control/Assurance 301 8. Fruit and Vegetable Processing Units 303 References 309 12. Food Drying and Evaporation Processing Operations 317 William L. Kerr 1. Introduction 317 2. Water in Foods 317 3. Types of Water in Foods 319 4. Food Stability and Moisture Relationships 321 5. Drying: Describing the Process 323 6. Types of Dryers 329 7. Quality Changes During Drying 340 8. Evaporation 342 9. The Basic Evaporator 344 10. Tube Evaporators 345 11. Single Effect Evaporators 348 12. Multi-Effect Evaporators 350 x Contents

10. 13. Mechanical Vapor Recompression 351 14. Quality Changes During Evaporation 352 15. Conclusion 352 Further Reading 353 13. Food Freezing Technology 355 Chenchaiah Marella and Kasiviswanathan Muthukumarappan 1. Introduction 355 2. Freezing Point Depression 356 3. Freezing Process 356 4. Phase Change and Ice Crystal Formation 359 5. Product Heat Load 360 6. Freezing Time Estimations 361 7. Freezing Equipment 364 8. Effect of Freezing and Frozen Storage on Foods 372 9. Developments in Freezing Techniques 375 10. Energy Conservation in Freezing 376 11. Scope for Future Work 376 References 377 14. Heat and Mass Transfer in Food Processing 379 Mohammed Farid 1. Basic Concepts of Heat and Mass Transfer 379 2. Case Study 1: Thermal Sterilization Using Computational Fluid Dynamics 384 3. Case Study 2: New Approach to the Analysis of Heat and Mass Transfer in Drying and Frying 389 4. Case Study 3: Microwave Thawing of Frozen Meat 393 Nomenclature 397 Greek Symbols 400 References 400 15. Food Rheology 403 Qixin Zhong and Christopher R. Daubert 1. Introduction 403 2. Basic Concepts in Rheology 403 3. Rheology of Fluids 407 4. Rheology of Semi-Solid Materials 414 5. Interfacial Rheology 422 6. Conclusions 425 References 425 xiContents

11. 16. Food Extruders 427 Mian N. Riaz 1. Role of an Extruder 429 2. Typical Components of an Extruder 430 3. Types of Extruders 431 4. Sources for More Information for Extrusion Technology 439 References 439 Further Reading 440 17. Thermal Processing for Food Sterilization and Preservation 441 Arthur A. Teixeira 1. Introduction 441 2. Retort Systems 441 3. Automated Materials Handling Systems 454 4. Aseptic Process Equipment Systems 457 5. Low-Acid Canned Food Regulations 459 References 466 18. Artificial Neural Network (ANN) Based Process Modeling 467 Gauri Shankar Mittal 1. Basics 467 2. Examples 468 3. Meatball Cooking Example in Detail 469 References 472 19. Design of Food Process Controls Systems 475 Mark T. Morgan and Timothy A. Haley 1. Introduction 475 2. Benefits of Automation 475 3. Computer Integrated Manufacturing 476 4. Automation Components and Terminology 478 5. Control System Objectives 480 6. Controllers 493 7. Sensor Fundamentals 502 8. Actuators 531 Further Reading 540 xii Contents

12. 20. Ohmic Pasteurization of Meat and Meat Products 541 James G. Lyng and Brian M. McKenna 1. Introduction 541 2. Conventional Thermal Methods for the Preservation of Meats 543 3. Basic Principle of Ohmic Heating 544 4. Microbial Inactivation during Ohmic Heating 552 5. Quality of Ohmically Heated Meat Products 553 6. Economics of Ohmic Processing 557 7. Ohmic Heating for Commercial Scale Production of Cooked Meats 559 8. Conclusion and Future Work 564 Acknowledgements 564 Abbreviations 565 References 565 21. Food Processing Facility Design 571 Timothy J. Bowser 1. Introduction 571 2. Background 571 3. Key Facility Issues 572 4. Project Phases 579 5. Conclusion 595 References 595 22. Sanitary Pump Selection and Use 599 Timothy J. Bowser 1. Introduction 599 2. Sanitation Standards for Pumps 600 3. Sanitary Pump Classification 600 4. Selecting Sanitary Pump Type 604 5. Installation 614 6. Cleaning and Maintenance 615 7. Conclusion 617 References 617 23. Agricultural Waste Management in Food Processing 619 Conly L. Hansen and Dae Yeol Cheong 1. Introduction 619 2. Common Unit Processes Employed in Food Waste Treatment 621 xiiiContents

13. 3. Characteristics of Wastes and Treatment Types 623 4. Physical-Chemical Treatment Process 628 5. Biological Treatment Process 639 6. Land Treatment of Waste 650 7. Bioprocess Technology from Waste 652 8. Conclusions 659 References 662 Further Reading 666 24. Food Packaging Machinery 667 Harold A. Hughes 1. Introduction 667 2. Filling Machines 670 3. Volumetric Fillers 670 4. Weight Filling 673 5. In-Line or Rotary Fillers 676 6. Cap Application Machines 677 7. Induction Cap Sealing 680 8. Flexible Packaging 681 9. FormFillSeal Equipment 681 10. Canning Machinery 684 11. Carton Filling and Closing Machinery 687 12. Metal Detectors 689 25. Damage Reduction to Food Products During Transportation and Handling 691 Jay Singh and S. Paul Singh 1. Introduction 691 2. Functions of Packaging 691 3. Food Product Categories 696 4. Food Product Distribution Environment 702 5. Major Causes of Food Spoilage/Damage in Supply Chain 704 6. Packaging Materials 705 7. Smart Packaging 711 8. Trends in Protective Food Packaging of 2000 and Beyond 713 References 719 Index 721 xiv Contents

14. PREFACE TO THE SECOND EDITION The Preface (reprinted here) to the First Edition of the Handbook of Farm, Dairy, and Food Machinery, published in 2007, made the case for the handbooks importance. The case remains as forceful now as it did then, so I will not update it in this Preface. Instead, I will focus on the changes made for the new edition. While the changes are substantial, the overall arrangement of the Second Edition follows the arrangement of the First Edition. As in the First Edition, the Second Edition begins with three introductory chapters on The Food Engineer, Food Regulations, and Food Safety Engineering. The first two chapters have been updated, while the third remains unchanged. The handbooks next section, on Farm Machinery Design, now has five chapters, one more than in the first edition. The new chapter covers Air Seed Openers for Proper Seed & Fertilizer Placement. Three chapters have been updated-Grain Harvesting Machinery Design, Grain Harvesting Machinery Design, and Milking Machines and Milking Parlors. One chapter remains unchanged-Farm Machinery Automation. The handbooks third and by far largest section, on Food Processing Operating Systems and Machinery Design, has been expanded from 13 to 15 chapters. The two new chapters cover Food Extruders and Sanitary Pump Selection/Application. Ten chapters have been updated: Dairy Product Processing Equipment, Grain Processing Engineering, Technology of Processing of Horticultural Crops, Food Drying and Evaporation Processing Operations, Food Freezing Technology, Food Rheology, Thermal Processing for Food Sterilization and Preservation, Food Process Modeling, Simulation and Optimization, Ohmic Pasteurization of Meat and Meat Products, and Food Processing Facility Design. Just three chapters remain unchanged-Heat and Mass Transfer in Food Processing, Design of Food Processing Controls Systems, and Agricultural Waste Management in Food Processing. The two chapters comprising the handbooks final section, Food Packaging Systems and Machinery Design, are unchanged. I would like to thank all contributors to both editions of the handbook for their efforts. I know how busy their lives are, and it is a miracle that they could find the time to write their erudite and comprehensive chapters. I salute them. xv

15. Thanks also to my editor, Nancy Maragioglio, and to Carrie Bolger, the editorial project manager, for shepherding the new edition from concept through to publication. And to my wife, Arlene: thank you for keeping me healthy and hearty. Myer Kutz Delmar, NY October, 2012 xvi Preface to the Second Edition

16. PREFACE TO THE FIRST EDITION The food industry, which includes farming and food production, packaging and distribution, and retail and catering, is enormous. The Wikipedia states that in the United States, consumers spend approximately US$1 trillion annually for food, or nearly 10% of the Gross Domestic Product (GDP). Over 16.5 million people are employed in the food industry. In 2004, processed food sales worldwide were approximately US$3.2 trillion. According to Reuters, food processing is one of the largest manufacturing sectors in the United States, accounting for approximately 10% of all manufacturing shipments (by value). The processed food industry has grown by over 10% between 1998 and 2004, and in 2004, the value of processed food shipments was approximately $470 billion. The largest sectors of the industry, in terms of value, are meat, dairy, fruit and vegetable preservation, and specialty foods. Other niche sectors include bakeries and tortilla manufacturing, grain and oilseed milling, sugar and con- fectionery, animal food manufacturing, and seafood products. The size of the machinery component of the food processing industry is hardly static, and it is an area where engineers can have a major effect. The U.S. Department of Labor, Bureau of Labor Statistics, states: Fierce competition has led food manufacturing plants to invest in technologically advanced machinery to be more productive. The new machines have been applied to tasks as varied as packaging, inspection, and inventory control. . . . Computers also are being widely implemented throughout the industry. . . . Food manufacturing firms will be able to use this new automation to better meet the changing demands of a growing and increasingly diverse population. As convenience becomes more important, consumers increasingly demand highly-processed foods such as pre-marinated pork loins, peeled and cut car- rots, microwaveable soups, or ready-to-heat dinners. Such a shift in consumption. . .will lead to the development of thousands of new processed foods. Domestic producers also will attempt to market these goods abroad as the volume of international trade continues to grow. The increasing size and diversity of the American population has driven demand for a greater variety of foods, including more ethnic foods. The combination of expanding export markets and shifting and increasing domestic consumption. . .will lead to significant changes throughout the food manufacturing industry. During 2004, according to data compiled by the U.S. Census Bureau, factory shipments of farm equipment and machinery, including parts and attachments, produced by original equipment manufacturers (OEM) totaled US$6.9 billion. The total includes dairy, planting, seeding, fertilizing, harvesting, and haying machinery, among xvii

17. other products. It seems safe to say that the farm machinery component of the food industry is in the same growth and development mode as the food processing component. Clearly, these two components of the food industryfarm machinery and food processing machineryare of great interest to engineers in a variety of disciplines, including food and agricultural, mechanical, chemical, materials, and computer engineering. At least four major technical publishers address food engineering, with as many as several dozen titles in their lists. But when my editor at William Andrew Publishing, Millicent Treloar, and I reviewed these lists, none of the titles appeared to us to take the broad approach that we were interested inan approach that her informal market research at industry meetings seemed to justify. So one of the main ideas that drove development of the Handbook of Farm, Dairy, and Food Machinery to con- form to the needs of engineers, was to provide coverage from farm to market. Our intent from the outset was to cover, in a single comprehensive volume, those aspects of the food industry of interest to engineers who design and build farm machinery, food storage facilities, food processing machinery, and food packaging machinery. This is a handbook written for engineers by engineers. Most of the contributors are based in the United States. Of the handbooks 22 chapters, 16 are from U.S. Contributors. But over a quarter of the chapters are from contributors based else- wheretwo in Canada, one in Ireland, one in Thailand, and two in New Zealand. The targeted audience for the handbook is practising engineers. Because the handbook is not only practical, but is also instructive, students in upper-level undergradu- ate and graduate courses will also benefit. While some chapters deal with the design of farm and food processing machinery and facilities, other chapters provide the theo- retical basis for determining and predicting the behavior of foods as they are handled and processed. In order for the handbook to be useful to engineers, coverage of each topic is comprehensive enough to serve as an overview of the most recent and relevant research and technology. Numerous references are included at the ends of most chapters. Like any of my handbooks (I am also the editor of the Mechanical Engineers Handbook, which is now in its third edition, the Handbook of Materials Selection, the Standard Handbook of Biomedical Engineering and Design, the Transportation Engineers Handbook, and the Handbook of Environmental Degradation of Materials), the Handbook of Farm, Dairy, and Food Machinery is meant not only to be used as a print reference, but also to serve as the core of a knowledge spectrum. In this Internet age, a broad-based publication, such as this handbook, does not exist in isolation. Instead, each part of iteach sentence, paragraph, item of data, reference, etc.may be linked to information on a multiplicity of web sites. So this handbook, with its own store of knowledge, is also a gateway to a wider world of knowledge about farm and food processing machinery and facilities. xviii Preface to the First Edition

18. The handbook opens with three introductory chaptersFelix Barrons chapter about food engineering curricula; a chapter on food regulations by Kevin Keener; and a chapter on food safety engineering by V.M. (Bala) Balasubramaniam and colleagues Raghupathy Ramaswamy, Juhee Ahn, Luis Rodriguez Saona, and Ahmed E. Yousef. There are then four chapters about farm machinery, facilities, and processes, including Brian Adams chapter on automating planting machinery, Graeme Quick and Mark Hannas chapter on designing grain harvesting machinery, a chapter by Ray Bucklin and colleagues Sidney Thompson, Ali Abdel-Hadi, and Michael Montross on designing grain storage facilities, and a chapter by Conley Hansen and Dae-Yeol Cheong on managing agricultural waste. The next section of the handbook deals with milk and dairy products. There are two chapters, the first on milking machines and milking parlors by Douglas Reinemann, and the second on dairy product processing equipment by Doug Goff, from Canada. (Unless otherwise noted, contributors are from the United States.) The largest section of the handbook, with a dozen chapters, covers food processing. This section begins with a chapter on rice processing by Athapol Noomhorm and Imran Ahmad, both from Thailand. The next chapter, by Conrad Perera and Bronwen Smith, both from New Zealand, is an overview of food processing operations. These operations are covered in more detail in the next half-dozen chapters food drying and evaporation by William Kerr; food freezing by Kasiviswanathan Muthukumarappan and Chenchaiah Marella; heat and mass transfer by Mohammed Farid, from New Zealand; rheology by Qixin Zhong; thermal processing by Arthur Teixeira; and food process modeling, simulation, and optimization by Gauri Mittal, from Canada. The section continues with a chapter on designing food process controls by Mark Morgan; a forward-looking chapter on ohmic pasteurization of meat and meat products by James Lyng and Brian McKenna, both from Ireland; a chapter on food safety engineering by V.M. (Bala) Balasubramaniam and colleagues Raghupathy Ramaswamy, Juhee Ahn, Luis Rodriguez Saona, and Ahmed E. Yousef; and, finally, a chapter on food processing facilities design by Timothy Bowser. The final section of the handbook contains two chapters on packaging, the first on packaging materials and processing by Jay Singh and Paul Singh (who are not related and are at different universities), and the second on packaging machinery by Harold Hughes. While my own training as a mechanical engineer was crucial in conceiving the Handbook of Farm, Dairy, and Food Machinery, and while my publishing history with engineering handbooks in a wide variety of disciplines was certainly useful in bringing the handbook to fruition, it was the contributors who did the real heavy lifting. It is a miracle, as it is for any handbook with many contributors, that so many found the time and energy to create their scholarly and practical chapters. xixPreface to the First Edition

19. Their professionalism is remarkable, and they have my utmost appreciation and admi- ration. My thanks also to my wife Arlene, whose love. encouragement, and patience help me immeasurably. Myer Kutz Delmar, NY xx Preface to the First Edition

20. LIST OF CONTRIBUTORS Ali Abdel-Hadi Tuskegee University, AL, USA Brian T. Adams University of Missouri-Columbia, MO, USA Imran Ahmad Asian Institute of Technology, Thailand Juhee Ahn Ohio State University, OH, USA V.M. Balasubramaniam Ohio State University, OH, USA Felix H. Barron Clemson University, SC, USA Timothy J. Bowser Oklahoma State University, OK, USA Ray Bucklin University of Florida, FL, USA Christopher R. Daubert North Carolina State University, NC, USA Mohammed Farid University of Auckland, Auckland, New Zealand H. Douglas Goff University of Guelph, ON, Canada Timothy A. Haley Iowa State University, Ames, IA, USA H. Mark Hanna Iowa State University, IA, USA Conly L. Hansen Utah State University, UT, USA Harold A. Hughes Michigan State University, MI, USA Kevin M. Keener Purdue University, NY, USA xxi

21. William L. Kerr University of Georgia, GA, USA James G. Lyng University College Dublin, Ireland Chenchaiah Marella South Dakota State University, SD, USA Brian M. McKenna University College Dublin, Ireland Gauri Shankar Mittal University of Guelph, Ontario, Canada Michael Montross University of Kentucky, KY, USA Mark T. Morgan Purdue University, West Lafayette, IN, USA Kasiviswanathan Muthukumarappan South Dakota State University, SD, USA Athapol Noomhorm Asian Institute of Technology, Pathum Thani, Thailand John Nowatzki North Dakota State University, Fargo, ND, USA S. Paul Singh Michigan State University, MI USA Conrad O. Perera University of Auckland, Auckland, New Zealand Graeme R. Quick Fellow ASABE, Fellow IEAust., Peachester, Queensland, Australia Raghupathy Ramaswamy Ohio State University, OH, USA Douglas J. Reinemann University of Wisconsin, Madison, WI, USA Mian N. Riaz Texas A&M University College Station, TX, USA Luis Rodriguez Saona Ohio State University, OH, USA Jay Singh California Polytechnic State University, CA, USA xxii List of Contributors

22. Bronwen Smith University of Auckland, Auckland, New Zealand Arthur A. Teixeira University of Florida, FL, USA Sid Thompson University of Georgia, GA, USA Dae Yeol Cheong Utah State University, UT, USA Ahmed E. Yousef Ohio State University, OH, USA Qixin Zhong University of Tennessee, TN, USA xxiiiList of Contributors

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24. CHAPTER 11 The Food Engineer Felix H. Barron Clemson University, SC, USA 1. NATURE OF WORK AND NECESSARY SKILLS Food engineering is considered a specialized engineering field. In general, engineers are trained in the application of science principles and mathematics in order to provide economical solutions to technical problems; usually fulfilling social, commercial, or similar needs. Product design and development are typical activities that an engineer may be asked to perform. The engineer must specify the functional requirements of the product, design, and testing and final evaluation to check for overall efficiency, cost, safety, and reliability if necessary. Overall, these principles may be applied to product design, no matter what the product is, for example a machine, a food, or a chemical. Engineers may also work in testing, production, or maintenance areas, supervising production in factories, determining the causes of component failure, and testing manufactured products to maintain quality. Costing and scheduling for project completion are other duties typical of an engineer. Some engineers may become managers or salespersons. A background in sales engineering gives an individual the knowledge and experience required to discuss technical aspects and assist in product planning, installation, and use of equipment. A supervising engineer is responsible for major components or entire projects. Food engineers use computers extensively to produce and analyze products, processes, or plant designs; to simulate and test how a machine or food system operates; and to generate specifications for foods, machinery, or packaging. Food engineers may also use computers to monitor product quality, safety, and to control process efficiency. Food nanotechnology, which involves control or manipulation of a product on the atomic scale, is introducing innovative principles to product and process design. Seventeen engineering related specialties are covered in the Federal Governments Standard Occupational Classification system. Food engineering is recognized by 1 Handbook of Farm, Dairy and Food Machinery Engineering DOI: http://dx.doi.org/10.1016/B978-0-12-385881-8.00001-X 2013 Elsevier Inc. All rights reserved.

25. professional societies such as the Institute of Food Technologists, the American Society of Agricultural Engineers, and the American Institute of Chemical Engineers. 2. ACADEMIC AND INDUSTRY PREPARATION As a specialized professional, the food engineer obtains his/her skills mainly through a university degree or industrial experience. Several universities across the USA offer formal academic training in food engineering. Agricultural engineering departments are a common avenue to specialization in the engineering aspects of food processing; however, it is not uncommon for graduates in food science to pursue the engineering specialization also. In fact, it is a requirement that food science students take a course in the principles of food process engineering; however, food scientists generally lack rigorous training in applied mathematics such as the use of differential equations to solve heat and mass transfer problems, plant design, or simulation of systems. Internationally, food engineering training may be obtained through colleges of agriculture, chemical engineering departments, or schools of applied sciences. International degrees obtained through engineering programs, which also offer tradi- tional engineering degrees such as chemical or mechanical, likely are the most similar to the typical USA degree, especially with regards to mathematical training. Table 1.1 shows a typical course work program to obtain an engineering degree specializing in food engineering. Tables 1.2 and 1.3 show typical course work in chemical and mechanical engineering, respectively. Comparing the three programs, it can be con- cluded that the major academic preparation difference lies in the specialized topics or Table 1.1 A Typical List of Courses for an International B.S. Program in Food Engineering Food Engineering B. S. Program: an International Example Mathematics I, II, III Food Analysis Physics I, II Food Biotechnology Chemistry Heat Transfer Organic Chemistry Product Development Computer Science Milk and Milk Products Thermodynamics for the Food Industry Mass Transfer Food Chemistry Meat Processing Transport Phenomena Fruits and Vegetables Processing Numerical Methods Cereal Processing Human Nutrition Quality Assurance Food Technology Food Plant Design Microbiology Design of Experiments Food Microbiology Differential Equations Other electives Biochemistry Probability and Statistics Other Electives and Laboratories 2 Felix H. Barron

26. Table 1.2 Chemical Engineering; a Curriculum (USA) Example First Semester Second Semester Freshman Year 2Engineering Disciplines and Skills 3Chemical Engineering Tools 4General Chemistry 4General Chemistry 3Accelerated Composition 3Physics with Calculus I 4Calculus of One Variable I 4Calculus of One Variable II 3Arts and Humanities Requirement or 3Social Science Requirement 3Arts and Humanities Requirement or 3Social Science Requirement Total: 16 hours Total: 17 hours Sophomore Year 3Organic Chemistry 3Organic Chemistry 4Intro. to Chemical Engineering 1Organic Chemistry Lab 4Calculus of Several Variables 4Intro. to Ord. Diff. Equations 3Physics with Calculus II 4Fluids/Heat Transfer 3Arts and Humanities Requirement 3Chemical Engineering Thermodynamics I Total: 17 hours Total: 15 hours Junior Year 3Molecular Biochemistry 3Physical Chemistry 1Physical Chemistry Lab 1Physical Chemistry Lab 3Unit Operations Lab I 4Mass Transfer and Separation Processes 3Engineering Materials 3Chemical Engineering Thermodynamics II 2Basic Electrical Engineering 3Emphasis Area 1Electrical Engineering Lab I 3Arts and Humanities Requirement or 3Social Science Requirement3Arts and Humanities Requirement or 3Social Science Requirement Total: 16 hours Total: 17 hours Senior Year 3Unit Operations Lab II 3Process Dynamics and Control 3Process Development, Design, and Optimization of Chemical Engineering Systems I 3Process Design II 1Chemical Engineering Senior Seminar I 1Chemical Engineering Senior Seminar II 3Chemical Reaction Engineering 3Industrial Microbiology 3Emphasis Area 3Emphasis Area 3Arts and Humanities Requirement or 3Social Science Requirement Total: 16 hours Total: 13 hours 127 total semester hours. 3The Food Engineer

27. areas of fundamentals of food processing and food microbiology. Other areas such as food chemistry, applied mass and energy balances to foods, or food unit operations can be learned from a general engineering degree such as chemical engineering. Table 1.3 Mechanical Engineering; a Curriculum (USA) Example First Semester Second Semester Freshman year 2Engineering Disciplines and Skills 2Engr. Graphics with Computer Appl. 3General Chemistry 3Programming and Problem Solving in Mechanical Engineering 3Accelerated Composition 4Calculus of One Variable II 4Calculus of One Variable I 3Physics with Calculus I 1Physics Lab. I 3Humanities/Social Science Requirement or 3Social Science Requirement 3Humanities/Social Science Requirement or 3Social Science Requirement Total: 16 hours Total: 16 hours Sophomore Year 5Statics and Dynamics for Mech. Engr 2Basic Electrical Engineering 2Mechanical Engineering Lab. I 1Electrical Engineering Lab. I 4Calculus of Several Variables 3Engineering Mechanics: Dynamics 3Physics with Calculus II 3Foundations of Thermal and Fluid Systems 35Science Requirement 4Intro. To Ord. Diff. Equations 3Numerical Analysis Requirement Total: 1719 hours Total: 16 hours Junior Year 3Mechanics of Materials 3Heat Transfer 3Thermodynamics 3Fundamentals of Machine Design 3Model. And Analysis of Dynamics Syst. 3Manufacturing Proc. And Their Appl. 3Fluid Mechanics 3Advanced Writing Requirement 2Mechanical Engineering Lab. II 3Statistics Requirement 3Arts and Humanities Requirement or 3Social Science Requirement Total: 17 hours Total: 15 hours Senior Year 3Mechanical Engineering Design 1Senior Seminar 3Control and Integration of Multi-Domain Dynamic Systems 3Internship in Engineering Design 2Mechanical Engineering Lab. III 6Arts and Humanities Requirement or 3Social Science Requirement 6Technical Requirement 3Technical Requirement Total: 14 hours Total: 13 hours 124126 total semester hours. 4 Felix H. Barron

28. A mechanical or electrical engineer requires training in mass balances and unit operations for easier adaptation to the food engineering area. Bachelors degree programs in engineering typically are designed to last 4 years, but many students find that it takes between 4 and 5 years to complete their studies. In a typical 4-year college curriculum, the first 2 years are spent studying mathematics, basic sciences, introductory engineering, humanities, and social sciences. During the last 2 years, most courses are in engineering, usually with a concentration in one specialty, such as food engineering or biotechnology. Some programs offer a general engineering curriculum; students then specialize on the job or in graduate school. Some 5-year or even 6-year cooperative plans combine classroom study and practical work, permitting students to gain valuable experience and to finance part of their education. 3. WORK OPPORTUNITIES FOR A FOOD ENGINEER All 50 US states and the District of Columbia require licensure for engineers who offer their services directly to the public. Engineers who are licensed are called professional engineers (PE). This licensure generally requires a degree from an Accreditation Board for Engineering and Technology (ABET) accredited engineering program, 4 years of relevant work experience, and successful completion of a state examination. An informal collection of job descriptions for engineers gathered through the years (20092011) from various resources including: http://www.engineers.com, http:// www.indeed.com, and http://www.foodrecruiters.com reveals some of the necessary skills companies, universities, or government agencies are looking for in a food engineer. 3.1 Job Description Sample 1 A Process Design Engineering Manager has engineering responsibility for root cause analysis and correcting process issues within a beverage, pharmaceutical, or food plant. This includes existing plant opportunities and new state of the art solutions to process packaging in a high speed plant. It is important that the candidate can demon- strate, with examples, his/her strength in visualizing complete projects at the concep- tual stage. Specific accountabilities include: Conducting fundamental research related to optimization of a process and product. Independently designing and performing laboratory testing directed at problem solving with commercial scale-up capability. Planning and executing medium-term research and development activities of mod- erate to complex scope. 5The Food Engineer

29. Demonstrating technical competence in several areas of food-related chemistry and engineering practice. Specific skills and qualifications include: Ph.D. in Food Science or Food Engineering. Expertise in areas of natural organic polymers, carbohydrate chemistry, physical science, food science, and food process engineering. The ability to apply scientific/engineering theory to the execution of projects related to process or product development. Sound problem solving and project leadership skills, with emphasis on designing or conducting laboratory testing and pilot scale simulations. The ability to conduct literature searches and compile comprehensive, clear sum- maries of findings. Working knowledge of applied statistics and statistical design of experiments. Good oral, written, technical, and general communication skills. 3.2 Job Description Sample 2 3.2.1 Essential Functions Develop written policies and procedures for the organized and profitable development of new meat products. Such procedures should have distinct mechanisms for the timely completion of: new product concept approval, development, shelf-life testing, package design, and final product approval. Follow concepts identified by sales and marketing: work closely with sales, marketing, quality assurance, operations, finance, purchasing, and engineering to develop new meat products that meet internal and/or external specifications. Develop and implement cost reduction products to improve operating efficiency and maximize profitability. Write project protocols, collect and analyze data, prepare reports. 3.3 Job Description Sample 3 This position will manage the engineering functions needed to support manufacturing, R&D, quality assurance, and logistics. The Project Engineer will manage contractors and in-plant personnel in the completion of capital projects, and also manage the capital plan. 3.4 Job Description Sample 4 3.4.1 Food Engineering Research This facility is a high-speed/high-volume, 24/7 operation, which is currently going through an expansion. This position will support the production of newly developed 6 Felix H. Barron

30. products, and current production lines, purchase and install new equipment, upgrade existing equipment, and develop efficiency improvements. Working in a team-based manufacturing environment, process engineers lead, develop, and execute solutions to improve process system performance and product quality. Serving as a dedicated technical system resource, process engineers also lead problem solving and problem prevention efforts directed at current and future processes and products, assure that new product and process tests and start-ups are designed and executed effectively, and develop and direct training in system operations. 3.4.2 Requirements B.S. in Engineering (Chemical, Mechanical, Electrical, or Food Engineering pre- ferred), and 48 years of process or packaging engineering experience in a food, consumer products, pharmaceutical, chemical, or other continuous process manufacturing environment. Strong technical skills are required, including demonstrated understanding of unit operations, analytical methods, and statistical process control, as well as troubleshooting skills. 3.5 Job Description Sample 5 Our client seeks a process improvement engineer with food manufacturing experience for their dynamic company. In this role, you will analyze new product formulations and pilot plant productions and provide recommendations for process flow modifications, equipment modifications, operations changes, and new equipment requirements. You will define issues, collect data, establish facts, and draw valid conclusions as well as manage teams to ensure effective transition from product conception to full- scale production. The position requires a degree in engineering and 5 or more years of work experience. Of this work experience, 3 years must be within the food industry. Experience in product development is desired. Experience as a process engineer, production manager, production supervisor or research and development engineer is highly desirable. Up to 50% domestic travel is required. Based on these job descriptions, the following engineering key words were found with major frequency in descending order: engineering, development, manage, design, analysis, concept, solving and scale. These key words can be compared with knowledge and skills to be taught at universities offering engineering degree majors, including food engineering. Take for example the following: Students specializing in food engineering learn to apply engineering principles and concepts to handling, storing, processing, packaging, and distributing food and related products. 7The Food Engineer

31. Students specializing in agricultural engineering integrate engineering analysis and design with applied biology to solve problems in production, transportation, and processing of agricultural products. Agricultural engineers design machinery, processes, and systems for managing the environment, nutrients, and waste associated with productive plant and animal culture. Figure 1.1 demonstrates a general flow diagram illustrating unit operations or processing steps typical of a food processing facility. The knowledge and skills of a food Liquid Foods in Solid Foods in Fluid flow Solid transport Separation Separation Grinding Heating Mixing Evaporation Dehydration Concentrated liquid Dried solid Liquid Cooling Solid Freezing Packaging Packaging materials Storage Distribution Figure 1.1 General flow in a food processing plant. (Adapted from Heldman and Singh, 1981) 8 Felix H. Barron

32. engineer can be applied in an integrated approach or in a more specific way such as heat transfer in heating and cooling operations. As food is received into the food processing plant, it may be in a liquid or solid form; if it is a liquid, one of the primary considerations may be its classification as a Newtonian or non-Newtonian liquid; therefore the field of rheology should be part of the knowledge base of the food engineer. Rheological studies could provide information necessary for the design of mixing machinery, piping, and even cleaning and sanitation of tubes and pipes used in transporting a fluid from one location to another. Dehydration and evaporation of foods involve heat and mass transfer. The food engineer, with his/her knowledge in the theory of diffusion, mass and energy balances, would be capable of designing processes, equipment, and even costing in feasi- bility studies. In addition to the heating and cooling section (Figure 1.1), the canning operation can be placed into the category of thermal processing. Thermal processing gives engineers and food scientists the opportunity to make significant contributions to the safety of processing canned products. Typical engineering skills required by a thermal processor include knowledge of thermobacteriology and mathematical calculations in order to design a safe thermal- sterilization process. The thermal-sterilization process is industrially recognized as a commercial sterilization process. A Process Authority is a federally recognized food professional who is typically responsible for creating a thermal process. 4. ENGINEERING JOBS According to a 2008 survey distribution of employment by the Department of Labor (Table 1.4), engineers specialize within key industries, for example, 40% of agricultural engineers specialize in food manufacturing, and 29% of chemical engineers specialize in chemical manufacturing. Overall, job opportunities for engineers are expected to increase (Table 1.5) over the next 5 years. Biomedical engineers should experience the highest growth by 2018, while electronics engineers, except computer engineers, should experience zero growth. 5. FUTURE OPPORTUNITIES The food processing industry may be facing a challenge by consumers and health care government agencies to provide healthy foods that can contribute to a decrease in the obesity problem in the USA and around the world. In general, designing such 9The Food Engineer

33. foods could become a critical factor for the food industry in order to expand markets and profitability. It may be necessary for food engineers to work more closely with molecular nutritionists in order to design so-called medical foods. Food biotechnology and food nanotechnology and their applications to food safety are areas in which food engineers may find new opportunities. 6. CONCLUSIONS Overall, it appears that specialism in food engineering is becoming more common via on-the-job training in the food industry, rather than being an entry-level requirement Table 1.4 Percent Concentration of Engineering Specialty Employment in Key Industries, 2008 Specialty Industry Percent Aerospace Aerospace product and parts manufacturing 49 Agricultural Food manufacturing and other engineering 40 Biomedical Scientific research and development services 20 Medical supplies 20 Chemical Chemical manufacturing 29 Architectural, engineering, and related services 15 Civil Architectural, engineering, and related services 49 Computer hardware Computer and electronic product manufacturing 41 Computer systems design and related services 19 Electrical Architectural, engineering, and related services 21 Navigational, measuring, electromedical, and control instruments manufacturing 10 Electronics, except computer Manufacturing 26 Telecommunications 15 Environmental Architectural, engineering, and related services 29 State and local government 21 Health and safety, except mining safety State and local government 10 Industrial Machinery manufacturing 8 Transportation equipment manufacturing 18 Marine engineers and naval architects Architectural, engineering, and related services 29 Materials Primary metal and semiconductor manufacturing 20 Mechanical Architectural, engineering, and related services 22 Machinery manufacturing 14 Mining and geological, including mining safety Mining 58 Nuclear Electric power generation, transmission and distribution 57 Petroleum Oil and gas extraction 43 10 Felix H. Barron

34. by food processing companies. This may be the reason some universities have modi- fied their curricula by decreasing the number of food engineering-related courses and changing instead to areas considered hot such as biotechnology, bioengineering, or biomedical engineering. Non-food engineers, such as mechanical, electrical, or chemical engineers who wish to work in the food processing industry can obtain the necessary training on- the-job or through professional development workshops, which are abundant. Many universities and consulting groups offer this type of training. Basic food microbiology, food safety, food quality, and food processing form a good knowledge base for non- food engineers. Table 1.5 Projections Data from the National Employment Matrix Occupational Title SOC Code Employment 2008 Project Employment 2018 Change 20082018 Number Percent Engineers 172000 1,571,900 1,750,300 178,300 11 Aerospace engineer 172011 71,600 79,100 7,400 10 Agricultural engineers 172021 2,700 3,000 300 12 Biomedical engineers 172031 16,000 27,600 11,600 72 Chemical engineers 172041 31,700 31,000 2600 22 Civil engineers 172051 278,400 345,900 67,600 24 Computer hardware engineers 172061 74,700 77,500 2,800 4 Electrical and electronics engineers 172070 301,500 304,600 3,100 1 Electrical engineers 172071 157,800 160,500 2,700 2 Electronics engineers, except computer 172072 143,700 144,100 400 0 Environmental engineers 172081 54,300 70,900 16,600 31 Industrial engineers, including health and safety 172110 240,400 273,700 33,200 14 Marine engineers and naval architects 172121 8,500 9,000 500 6 Materials engineers 172131 24,400 26,600 2,300 9 Mechanical engineers 172141 238,700 253,100 14,400 6 Mining and geological engineers, including mining safety engineers 172151 7,100 8,200 1,100 15 Nuclear engineers 172161 16,900 18,800 1,900 11 Petroleum engineers 172171 21,900 25,900 4,000 18 (NOTE) Data in this table are rounded. 11The Food Engineer

35. REFERENCE Heldman, D.R., Singh, P.R., 1981. Food Process Engineering, second ed. Van Nostrand Reinhold, New York. FURTHER READING Bureau of Labor Statistics, US Department of Labor, Occupational Outlook Handbook, 20082009 Edition, Engineers. ,http://www.bls.gov/oco/ocos027.htm/. (Last accessed 28.03.12.). Clemson University, on the internet at ,http://www.clemson.edu.. Food and Drug Administration. ,http://fda.cfsan.gov.. Institute of Food Technologists. ,http://ift.org.. Instituto Tecnologico de Monterrey. ,http://cmportal.itesm.mx/wps/portal.. 12 Felix H. Barron

36. CHAPTER 22 Food Regulations Kevin M. Keener Purdue University, NY, USA 1. BACKGROUND In the USA an estimated 48 million illnesses (one in six), 128,000 hospitalizations, and 3,000 deaths are caused by foodborne disease. Three pathogenic bacteria Salmonella, Listeria, and Toxoplasma are responsible for approximately 30% of deaths (CDC, 2011). Foodborne illness and disease is a major cause of morbidity worldwide, resulting in substantial costs to individuals, food processors, national, and international economics. Thus, there is a need to ensure that food processing is conducted in a sanitary environment, performed in a sanitary manner, and every appropriate consideration given to produce safe food of high quality. The purpose of this chapter is to provide process engineers with an understanding of food regulations in the USA. This chapter is by no means comprehensive, and regulations are constantly changing as a result of advances in science and changes in per- ceived threats. Therefore, it is recommended that individuals interested in producing food machinery, starting a food business, or producing a food product contact the appropriate regulatory agencies prior to commencing production. Food produced and sold without proper regulatory inspection is not in compliance with federal, state, and local laws, and may be deemed adulterated. Producing adulterated food is a serious crime and persons found guilty may be subject to civil and criminal penalties, including prison. Food regulations in the USA are a patchwork of rules and regulations that have developed over time. For a single food, there are numerous government agencies that have inspection roles. At the federal level, the primary agencies with regulatory responsibilities are the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, and the Food Safety Inspection Service (FSIS) an agency within the United States Department of Agriculture. The FDA has responsibility to ensure safety of all foods under the Federal Food Drug and Cosmetic Act (FFDCA) of 1938 with the exceptions of meat, poultry, and egg products. The FFDCA Section 201(f) defines food as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles. 13 Handbook of Farm, Dairy and Food Machinery Engineering DOI: http://dx.doi.org/10.1016/B978-0-12-385881-8.00002-1 2013 Elsevier Inc. All rights reserved.

37. The FSIS has primary responsibility for meat, poultry, and egg products under the Meat Product Inspection Act (1906) (FSIS, 2011a), Poultry Product Inspection Act (1957) (FSIS, 2011b) and Egg Product Inspection Act (1970) (FSIS, 2010a). Other agencies have supporting roles in various commodities and provide grading and export inspection services. These will be identified in the proceeding commodity sections as appropriate. Prior to producing any food it is recommended that one contact the local health department and/or state health department to ensure compliance with food regulations. FDA notification is required of any individuals producing low-acid or acidified canned foods. This notification is referred to as a process filing, which will contain a description of the food, packaging, and the proposed manufacturing process. FDA will review the submitted information and may respond with a letter asking additional questions. Historically, FDA has provided a non-rejection letter for filings. A non- rejection letter is where FDA acknowledges in writing that they have reviewed the proposed food manufacturing process including equipment, packaging, etc., and do not have any concerns (e.g. objection) at that point in time. Recent communications with FDA indicate that they no longer provide non-rejection letters except for new processes and equipment. If a food manufacturer needs documentation regarding out- come of a filing review they must contact FDA. Further details on process filings may be found on the FDA website (FDA, 2011a). Additionally, any company that produces or distributes foods must register with FDA as required in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (FDA, 2010). 2. FEDERAL REGISTER The Federal Register is the daily newspaper of the US government. It publishes all proposed, interim, and final rules on federal regulations from all federal agencies (Federal Register, 2011). Development of new regulations starts with the US Congress. In general the US Congress passes a bill (Act), e.g. the Meat Product Inspection Act. The President agrees and signs this bill into a new law. This Act assigns regulatory responsibility to a specific person or department, e.g. the Secretary of the United States Department of Agriculture (USDA). The Secretary (USDA) then determines what federal agency within their department will oversee regulatory inspection, e.g. the FSIS. That agency is responsible for proposing rules (regulations) regarding the assigned regulatory responsibility. Initially, the designated agency will announce a proposed rule and a comment period, e.g. 30, 60, or 90 days, in which interested parties (consumers, processors, industry associations, etc.) will provide 14 Kevin M. Keener

38. feedback to the designated agency on the proposed rule. These comments will include both the technical merits and scientific merits. The federal agency will then respond, as required by law, to all comments received, and modify or abandon the proposed rule, or issue a final rule. Final rules usually have an implementation period after which enforcement will begin. It is very important that affected parties participate in this rule making process because non-response is treated as acceptance of the proposed rule. 3. CODE OF FEDERAL REGULATIONS Federal agencies compile and publish current regulatory requirements every year in the Code of Federal Regulations. This compendium of federal regulations is published and maintained by the United States Government Printing Office and can be pur- chased in hard copy or viewed in electronic form at their website (CFR, 2011a). This document contains 50 volumes (referred to as Titles) and includes all federal agencies. For example, USDA-Agricultural Marketing Service (AMS) Regulations are listed in Title 7; USDA-FSIS Animal and Animal Products Regulations are listed in Title 9; HHS-FDA Food and Drug Regulations are listed in Title 21; and US-Environmental Protection Agency (EPA) Protection of Environment Regulations are listed in Title 40. 4. UNITED STATES CODE The United States Code is the codification by subject matter of the general and per- manent laws (Acts) of the USA. It is meant to be an organized, logical compilation of the laws passed by Congress. At its highest level, it divides the legislation into 50 topic areas called Titles. Each Title is further subdivided into any number of logical subto- pics. The United States Code is published every 6 years, with the most recent being the 2006 version with annual updates added (US Code, 2011a). Any law or individual provisions within a law passed by Congress are classified in the Code. However, legislation often contains many unrelated provisions that collectively respond to a particular public need or problem. For example, a Farm Bill, might contain provisions that affect the tax status of farmers, their land management practices, and a system of price supports. Each of these individual provisions would belong to a different section in the Code. Thus, different parts of a law will be found within different Titles. Typically, an explanatory note will indicate how a particular law has been classified into the Code. It is usually found in the Note section attached to a relevant section of the Code, usually under a paragraph identified as the Short Title. 15Food Regulations

39. 5. STATE AND LOCAL REGULATIONS Many states have a department of agriculture and/or an environmental and natural resources departments that regulate many aspects of food processing facilities. Many states have an administrative code similar to the Code of Federal Regulations (usually adopted by reference) that states requirements for administrative responsibilities, inspection frequency, and permitting requirements for food processors operating in a particular state. In addition, some states allow local regulations/zoning requirements to be developed that can also impact food processing facilities. The local rules are not usually on-line, but can be located by contacting the county and/or city services department for the respective location of the food processing facility. These local rules often deal with waste discharges, noise, and odors, and other neighbor concerns. 6. USDAFSIS SANITATION PROGRAMS All meat, poultry, and egg processing plants are required to have a written sanitation program. Sanitation is the creation and maintenance of hygienic and healthful conditions in food processing plants. Sanitation involves an applied science that has the overall goal of providing a clean environment and preventing food product contamination during processing. The universal goal of sanitation is to protect the food supply. An effective sanitation program includes benefits such as: 1. Microbial and chemical monitoring. 2. Control of food spoilage and lower consumer complaints. 3. Increased storage life of the product. 4. Improved employee morale. 5. Reduced public health risks. Specific sanitation requirements vary for each commodity. FSIS has sanitation requirements for meat poultry and egg products in Title 9 Part 416 of the Code of Federal Regulations (CFR, 2011b). 6.1 Sanitation Sanitation requirements for meat, poultry and egg products are listed in Title 9 Part 416 and subdivided into two parts. Sections 416.1416.6 are referred to as the Sanitation Performance Standards (SPS) and Sections 416.11416.17 are referred to as the Sanitation Standard Operating Procedures (SSOPs). Note: There are no sections between 416.7 and 416.10. 6.1.1 Sanitation Performance Standards Sanitation performance standards describe specific areas evaluated by inspection personnel regarding sanitation performance. Establishments must comply with the 16 Kevin M. Keener

40. regulatory performance standards for sanitation cited below, but may do so by what- ever means they determine to be appropriate. No specific sanitary practices are required; FSIS inspection personnel will verify that official establishments comply with the performance standards. Section 416.1 is known as the General Rules and requires that each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated. Section 416.2 describes specific concerns regarding buildings and grounds and pest control. The information on buildings and grounds includes criteria for construction, ventilation, lighting, plumbing, sewage disposal, and water. In addition, the facility must be designed to allow management of pests (flies, rodents, birds, etc.). It should be noted that pest control substances must be approved by EPA for use in food processing environments and be used in a manner that does not adulterate the product or create insanitation. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA reviews pesticides, cleaners, sanitizers, antimicrobials, etc., formulations, intended use, and other information; registers all pesticides, sanitizers, antimicrobials, etc., for use in the USA; and prescribes labeling, use, and other regulatory requirements to prevent unreasonable adverse effects on the environment, including humans, wildlife, plants, and property. Any meat or poultry establishment using a pesticide, cleaner, sanitizer, antimicrobial, etc., must follow the FIFRA requirements. Section 416.3 describes the appropriate selection of equipment and utensils, and their respective installation and maintenance. Section 416.4 details the requirements for cleaning and sanitizing of food contact, non-food contact, and utensils. Section 416.5 describes the requirements for management of employee hygiene practices including the person and their respective practices to prevent product adulteration. If any equipment, utensils, rooms, or compartments are found to be insanitary, then the inspector (FSIS/state) will place a tag on the equipment (US rejected). The equipment, utensil, room, or compartment cannot be used until corrective action has taken place to produce sanitary conditions. 6.1.2 Sanitation Standard Operating Procedures (SSOPs) Minimum requirements for sanitation operating procedures are stated in Title 9 Sections 416.11416.17 (CFR, 2011b). Each official establishment is required (shall) to develop, implement, and maintain written standard operating procedures for sanitation (Section 416.11). The SSOPs shall describe all procedures an official establishment will conduct daily, before and during operations, sufficient to prevent direct contamination or adulteration of product(s) (Section 416.12). The SSOPs cover the entire establishment and all shifts of operation. These procedures include at a minimum frequency of cleaning, cleaning procedures, and designated plant personnel. SSOPs must be signed and dated by the overall authority usually the owner or plant 17Food Regulations

41. manager. The FSIS also requires (shall) perform preoperational SSOPs prior to production and other SSOPs as written. Monitoring procedures will be established by plant personnel to verify implementation of the SSOPs (Section 416.13). The written SSOPs must be routinely reviewed and effectiveness assessed. Revision is required (shall) as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel (Section 416.14). The establishment must also maintain daily records sufficient to document the implementation and monitoring of the SSOPs and any corrective action taken (416.16). The establishment is required to maintain 6 months of written records, and they must be available to FSIS upon request, if within last 48 hours of plant operation, or within 24 hours. It is the establishments responsibility to implement the procedures as they are written in the SSOPs. If the establishment or FSIS determines that the SSOPs fail to prevent direct contamination or adulteration of product, the establishment must implement corrective actions that include the appropriate disposition of product, res- toration of sanitary conditions, and measures to prevent recurrence. It is also required that SSOPs should describe the procedures that the establishment will take to prevent direct contamination or adulteration of product (Section 416.15). FSIS has responsibility to verify that the establishment is conducting the SSOPs as written. Specifically they will verify the adequacy and effectiveness of the SSOPs and the procedures specified therein by determining that they meet the requirements of this part (416). Such verification may include: 1. Reviewing the SSOPs. 2. Reviewing the daily records documenting the implementation of the SSOPs and the procedures specified therein, and any corrective actions taken or required to be taken. 3. Direct observation of the implementation of the SSOPs and the procedures specified therein, and any corrective actions taken or required to be taken. 4. Direct observation or testing to assess the sanitary conditions in the establishment. 7. FDA SANITATION PROGRAMS For FDA inspected food processors (all foods excluding meat, poultry, and egg products) there are also sanitation requirements. These are detailed in the current Good Manufacturing Practices (cGMP). The cGMP regulations are printed in Title 21 Part 110 of the Code of Federal Regulations (CFR, 2011c). In addition, FDA has developed specific GMPs for some food processing such as bottled water, baby food, and seafood. These regulations are minimum sanitation requirements and many food processors exceed these requirements. 18 Kevin M. Keener

42. The cGMP regulations are general sanitation requirements that apply to all foods. They are subdivided into specific plant requirements. Within Title 21 CFR 110, defi- nitions of food processes and products (Section 110.3) along with the specific definition of adulteration are stated. Specific requirements for plant personnel are found in Section 110.10, and plant and grounds in Section 110.20. In brief, these specific regulations dictate that plant personnel, plant (building) and grounds, must be constructed and managed in a sanitary manner so as not to lead to adulteration of food processed in the facility. Section 110.35 describes sanitary operation requirements for the facility such as required cleaning of food contact and non-food contact surfaces, cleaners, and sanitizers. Sanitary facilities and controls (Section 110.39) describes requirements for sanitary water, plumbing, toilet and hand washing station requirements, floor drain requirements, and placement of signs instructing employees in required hygiene practices. Design of equipment and utensils (Section 110.40) for food contact are required to be constructed of non-toxic, corrosive-resistant materials. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. Each freezer and cold storage cooler is required to have a thermometer with an auto- matic control system or alarm system if under manual operation. All instruments and controls must be designed and maintained so as to not adulterate food. Any gases (air, nitrogen, etc.) introduced into the food or used to clean food contact surfaces or equipment must be appropriately treated so as to not adulterate the food. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles (Section 110.80). Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. (CFR, 2011c) All food that has become contaminated to the extent that it is adulterated shall be rejected, or if permissible, treated or processed to eliminate the contamination. Finished food products should be stored and transported appropriately so as to protect against product adulteration or container damage (Section 110.93). Some foods when processed under cGMP contain natural or unavoidable defects that are at low levels and are not hazardous to health. FDA establishes a maximum level of each defect in a food produced under cGMP that is called the defect action level (DAL) (Section 110.110). DALs are established as needed and change as new technology and processing practices become available. DALs do not excuse the food from 19Food Regulations

43. being adulterated by non-compliance with cGMP, even when their effects produce defects below the DAL. In addition, mixing of food exceeding a DAL with food below the DAL is not allowed; even if the final product does not exceed the DAL, it would be deemed adulterated (CFSAN, 2000). A complete list of current DALs for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Note that maximum levels for pesticide residues in raw agricultural products are determined by the EPA under FIFRA. FDAs DAL for pesticide residues follow EPAs limits, unless an allowance for a higher level is made. Many food processes concentrate food products, and thus pesticides may cause the product to be considered adulterated if the DAL of pesticide residue is exceeded in the finished product. In addition, if the product is a ready-to-eat product, it may not be blended to lower the pesticide residue. For example, the DAL for aflatoxin (a carcinogen produced by certain molds) in peanuts and peanut products is 20 ppb. A finished peanut or peanut product must contain less than 20 ppb aflatoxin if it is to be sold for human consumption. If the amount of aflatoxin exceeds 20 ppb in dry roasted peanuts, they cannot be sold for human consumption. Also, these dry roasted peanuts cannot be blended with dry roasted peanuts containing a lower level of aflatoxin to lower the overall level of aflatoxin. In addition, if peanuts containing less than 20 ppb aflatoxin were used to produce peanut butter and the peanut butter (finished product) had an aflatoxin level above 20 ppb then this product could not be sold for human consumption. Also, this peanut butter could not be blended with peanut butter containing less than 20 ppb aflatoxin to lower the overall concentration below 20 ppb. 8. FOOD SAFETY MODERNIZATION ACT The signing of the Food Safety Modernization Act by the President on January 4, 2011 provides increased regulatory authority to FDA. FDA is currently developing new regulations based on this increased authority. Although the complete scope of these new regulations and their impact on food safety is unknown, it is apparent that additional requirements on food manufacturers will result. Five key areas of emphasis in the FSMA include: prevention, inspection and compliance, response, imports, and enhanced partnerships (FDA, 2011b). 8.1 Prevention Under the FSMA, FDA has authority to mandate companies across the entire food supply to implement comprehensive, preventive control systems including establishing science-based, minimum standards for safe production and harvest of food. These standards will take into consideration naturally occurring hazards and those that may 20 Kevin M. Keener

44. be unintentionally or intentionally introduced. Factors such as soil contact, employee hygiene, packaging processes, temperature controls, water quality, and animal access to fields or growing areas will be considered. Implementation of these preventive controls requires development of a (HACCP- like) written plan that includes the following: 1. Evaluation of hazards that could affect food safety in the processing plant. 2. Specific identification of preventive steps and/or controls that will be put in place to prevent or significantly reduce the hazards identified. 3. Indication of how the preventive steps and controls will be monitored to ensure effectiveness. 4. Routine record-keeping of previously identified monitoring procedures. 5. Detailed actions that will be taken to correct any problems that arise. Additional regulations will be issued to establish mitigation strategies to prepare and protect the food supply for intentional adulteration of food at points of vulnera- bility in the supply chain. 8.2 Inspection and Compliance Under the FSMA, FDA will be increasing inspection and monitoring using the following methods: Mandated inspection frequencyFDA will determine for each food facility (both domestic and foreign) an inspection frequency based on the food safety risk of all products handled or manufactured. Access to recordsFDA will have access to all records related to the preventive controls system put in place. Accredited laboratory testingFDA is working to establish a laboratory accreditation program. 8.3 Response Under FSMA, FDA has the following new authorities: Mandatory recallFDA has the authority to issue mandatory food safety recalls. Previously, FDA would strongly request that companies make voluntary recalls of products. Product detentionFDA has the authority to detain (prevent movement or ship- ment) products that are believed to be adulterated or misbranded for up to 30 days. Registration suspensionif FDA determines that a food product has reasonable probability of serious adverse health consequences or death, FDA has the authority to suspend the registration of a facility to prevent product distribution. Enhanced product traceabilityFDA has the authority to develop and implement a food product traceability system to track and trace domestic and imported foods. 21Food Regulations

45. 8.4 Imports Under FSMA, FDA has the following new authorities for imported products: Importer accountabilityverification of food importers adequacy in preventive controls in their foreign suppliers and assurance of the safety of the imported product. Third party certificationFDA will establish a program to identify qualified third parties that will be able to certify compliance of foreign food facilities to US standards. Certification for high-risk foodsFDA has the authority to require all imported high-risk foods have certification by one of the identified third parties mentioned above as a requirement of entry to the USA. Authority to deny entryFDA has the authority to deny entry of products from any foreign facility that denies FDA access to the facility or the country in which the facility is located. It should be noted that until specific regulations are developed, vetted, and published by FDA as final rules in the Federal Register no specific guidance can be provided on compliance. In addition, there will likely be phased implementation over a number of years based on company size. 9. HAZARD ANALYSES AND CRITICAL CONTROL POINT PROGRAM (HACCP) HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards. It is a regulatory requirement for many areas of food processing including meat (FSIS), poultry (FSIS), egg products (FSIS), seafood (FDA), and juice processing (FDA). With the passage of the FSMA, HACCP or HACCP-like programs will likely be developed by FDA to cover all manufactured food. HACCP requirements are unique for each food process. The unique requirements are dictated by the responsible regulatory agency. From a scientific perspective, HACCP is a proactive approach to food safety and is based on seven principles: Principle 1: Conduct a hazard analysis. Principle 2: Determine the critical control points (CCP). Principle 3: Establish critical limits. Principle 4: Establish monitoring procedures. Principle 5: Establish corrective action. Principle 6: Establish verification procedures. Principle 7: Establish record-keeping and documentation procedures. When combined, these principles form a flexible food safety program that is adjustable as processing conditions change. The goal of HACCP is to eliminate, control, and/or prevent food safety hazards at the processing plant with an ultimate goal of protecting the consumer. 22 Kevin M. Keener

46. 9.1 Prerequisite Programs The production of safe food products requires that the HACCP system be built on a solid foundation of prerequisite programs. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. These programs include sanitation (GMPs), preventative maintenance, ingredient receiving, recall, biosecurity, etc. Many of the requirements for these programs are specified in federal, state, and local regulations and guidelines. The HACCP program is built on the prerequisite programs. In developing a HACCP program, preliminary information on the products, processes, and prerequisite programs must be collected and a process flow diagram developed detailing specific practices within the food processing facility. The preliminary steps must be completed before development of the HACCP plan. Principle 1: Conduct a hazard analysis. Each process step is assessed for potential physical, chemical, and biological hazards. Hazards are defined as those things that cause injury or illness. Physical hazards may include broken glass, wood, or bone shards. Chemical hazards may include cleaner, sanitizer, and pesticide residues. Biological hazards include pathogenic bacteria such as Salmonella enteritidis (SE) or E. coli 0157:H7. Principle 2: Determine the critical control points (CCP). For each process step in which potential hazards exist there is an assessment of existing control measures. If control measures exist that prevent the introduction of a potential hazard (e.g. prerequisite programs), then no CCP is needed. But, when a potential hazard exists and no control measures are present, then a CCP must be implemented. Principle 3: Establish critical limits. Once a CCP has been identified then critical limits must be developed based on scientific evidence. The critical limits are the conditions under which one can control, reduce, or eliminate the potential hazard. For example, if it was determined that SE might be present in ready-to-eat (RTE) chicken breast and no existing control measures prevented its introduction, then a CCP might consist of specifying a minimum cooking time and temperature to eliminate any potential SE from RTE chicken breast. Principle 4: Establish monitoring procedures. Once a CCP has been established with appropriate critical limits, it is necessary to ensure proper operation. This requires establishment of monitoring procedures and generation of records that document that critical limits have been met. For example, if one were required to cook chicken breast for a minimum time and a minimum temperature to eliminate any potential SE present, then records would document oven temperature and cooking time for each batch of chicken breast. 23Food Regulations

47. Principle 5: Establish corrective action. If a deviation (not meeting critical limit or monitoring procedures inadequate) has been found to occur in the CCP, corrective action must be taken. Corrective action requires an assessment of what went wrong, what to do with the suspect product (product produced when the deviation occurred), how to fix the problem, and how to prevent the problem happening again. Principle 6: Establish verification procedures. These are established practices periodically performed to ensure that the hazard analysis, established CCP, established critical limits, and established corrective actions are appropriate to ensure elimination, reduction, and/or control of all known hazards for the particular food product in question. Principle 7: Establish record-keeping and documentation procedures. Written records of all HACCP activities must be kept and provided as appropriate for regulatory inspection of the food processing facility. Further details on HACCP requirements for particular food processing may be found in the Code of Federal Regulations and under the appropriate regulatory agency. Further information on the scientific approach of HACCP can be located in the National Advisory Committee Microbiological Criteria in Food Document (NACMCF, 2009). 10. MEAT PROCESSING Meat processing includes animals such as beef, pork, chicken, turkey, goat, and other minor animal species. Responsibility of meat inspection is delegated to the Secretary of the USDA under the Meat Products Inspection Act (1906) and Poultry Products Inspection Act (1968). Within USDA, the enforcement of meat processing regulations is the sole responsibility of the FSIS. Many states also have (federal equivalent) state inspection programs that enforce federal food processing regulations (adopted by reference) for products produced and sold within a state. If a company ships product over state lines, it must be inspected by federal inspectors. Federal regulations (FSIS) for all meat processors are listed under Title 9 of the Code of Federal Regulations (CFR, 2011b). Since 2000, all meat processing facilities are required to have a written sanitation program and a HACCP program. The goal of the sanitation and HACCP program is to prevent adulterated product from enter- ing the food supply. A food is adulterated under Section 601(m) of the FMIA If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance does not ordinarily render it injurious to health. . .. There are a total of nine parts to this 24 Kevin M. Keener

48. definition. Adulteration under FDA inspection is similarly defined under Section 402 of the FFDCA. Meat slaughter plants are required by regulation to have an FSIS/state inspector on-site during processing to ensure that the product is being produced in a sanitary manner and no unfit (diseased or contaminated) meat is being processed. Further meat processing facilities (ready-to-eat meat, hot dogs, hamburger, etc.) are required to have all processed meat products inspected to ensure the sanitary conditions of the facility and that only wholesome food products are being produced. In addition to the required inspection, optional product grading may be requested. Grading of meat products is done by the USDA-AMS Meat Grading and Services Branch. The grading service is a voluntary, fee-based service, although is required for many customers including hospitals, schools, and public institutions. Product grading is a visual assessment of qualities such as tenderness, juiciness, and flavor. Quality grades for beef, veal, and lamb are word labels such as prime, choice, good, etc., and vary slightly for each product, although the grades are based on nationally uniform standards within a product category. Beef carcasses also are graded indicating the yield from the carcass. Pork is not graded. Poultry is graded A, B, or C, where B and C are usually used in further processed products. The mandatory inspections by FSIS have no relationship to the AMS voluntary meat grading service. Product labels for meat products include the name of the product, ingredients, quantity, inspection insignia, the companys name and address, and qualifying phrases such as cereal added or artificially colored. Product dating is voluntary, but if included must identify what the date means, stated as sell by, use by, best if used before, or expiration date. The Fair Packaging and Labeling act of 1967 makes it illegal to mislead or mislabel the product (FTC, 2011). Standards of identity for meat products are prescribed by regulation (USDA) so that the common or usual name for a product can only be used for products of that standard. The FSIS and FDA collaborate on the standards for meat and meat products. Some are defined easily in a couple of sentences, whereas others are complicated by involved ingredients, formulations, or preparation processes. For example, the definition of a hotdog (skinless variety): . . . have been stripped of their casings after cooking. Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve curing ingredients. The finished products may not contain more than 30% fat or no more than 10% water, or a combination of 40% fat and added water. Up to 3.5% non-meat binders and extenders (such as non-fat dry milk, cereal or dried whole milk) or 2% isolated soy protein may be used, but must be shown in the ingredients statement on the products label by its common name. Beef franks or pork franks are cooked and/or smoked sausage products made according to the specifications above, but with meat from a single species and do not include byproducts. Turkey franks or chicken franks can contain turkey or chicken and turkey or chicken skin and fat in 25Food Regulations

49. proportion to a turkey or chicken carcass. Mechanically separated meat (beef, pork, turkey, or chicken) may be used in hotdogs, and must be so labeled. MSM is minced meat paste produced from meat scraps removed from bones (FSIS, 2010b). 11. SHELL EGGS FDA and agencies of the USDA (FSIS, AMS, APHIS) carry out regulation, safety efforts, inspection, and grading of eggs in cooperation. FSIS and FDA share authority for egg safety. FDA has authority for shell egg production and processing facilities, and FSIS has responsibility for egg product inspection. FDA also has responsibility for res- taurant and foodservice and is working to strengthen egg handling requirements in the Food Code (food service regulations) and encourage its adoption by states and local jurisdictions. FDA and FSIS work together on the Egg Safety Action Plan to identify the systems and practices that must be carried out to meet the goal of elimi- nating Salmonella illnesses associated with the consumption of eggs (FSIS, 2011c). USDA works to educate consumers on the safe handling of egg products. The Animal and Plant Health Inspection Service (APHIS) conducts activities to reduce the risk of disease in flocks of laying hens. APHIS administers the voluntary National Poultry Improvement Plan (NPIP) which certifies that poultry breeding stock and hatcheries are free of certain diseases. Participation is required for producers that ship interstate or internationally. The APHIS National Animal Health Monitoring System monitors the prevalence of Salmonella in layer flocks. Egg production and egg processing facilities are inspected by FDA under the authority of the Secretary of Health and Human Services to inspect food manufacturing facilities. Inspections of premises (including farms), storage facilities, inventory, manufacturing operations, and required records are done as deemed appropriate. Shell egg packers are inspected at least once per calendar quarter. In addition, eggs must be packaged according to the Fair Packaging and Labeling Act. AMS administers voluntary egg-quality grading programs for shell eggs paid for by processing plants. AMS is responsible for the shell egg surveillance program to assure that eggs in the marketplace are equal to the assigned grade by visiting egg handlers and hatcheries four times per year. A USDA shield on the egg carton means that the plant processed the eggs according to AMS sanitation requirements and that the eggs were graded for quality and weight. Sanitation regulations require that eggs be washed and sanitized, and the egg coated with a tasteless natural mineral oil to protect it (AMS, 2007). State Departments of Agriculture monitor compliance with official US standards, grades, and weight classes by packers not using the voluntary AMS shell egg grading service. Eggs monitored by a state agency will not have the USDA shield, but will be marked with a grade. State and local regulations (quality, condition, weight, quantity 26 Kevin M. Keener

50. or grade, or labeling) are required to be at least equal to federal regulations, and often have increased requirements. There are three shell egg grades: Grade AA have whites that are thick and firm; yolks that are high, round, and practically free from defects; clean unbroken shells; and Haugh unit measurement above 72. Grade A have the same characteristics as Grade AA except that the whites are reasonably firm and the Haugh unit measurement is above 60. Grade A is the quality most often sold in stores. Grade B eggs have whites that may be thinner and yolks that may be wider and flatter than eggs of higher grades. The shells must be unbroken, but may show slight stains. Grade B eggs are usually used to make liquid, frozen, and dried egg products. Eggs are weighed individ- ually and grouped based on weight. Egg weights per dozen are identified on the package: Jumbo (30 oz/doz), Extra Large (27 oz/doz), Large (24 oz/doz), Medium (21 oz/doz), Small (18 oz/doz), and Peewee (15 oz/doz). Shell Egg cartons with the USDA shield must display the pack date in a three digit code starting with January 1 as 001 through December 31

Handbook of farm, dairy and food machinery engineering (2nd ed)(gnv64)

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Transcript of Handbook of farm, dairy and food machinery engineering (2nd ed)(gnv64)