DOCSLIB.ORG

GRAS Notice No. 922, 6'-Sialyllactose Sodium Salt

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
GRAS Notice No. 922, 6'-Sialyllactose Sodium Salt GRAS Notice (GRN) No. 922 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory March 19, 2020 Rachel Morissette, Ph.D. Regulatory Review Scientist Center for Food Safety and Applied Nutrition Office of Food Additive Safety U.S. Food and Drug Administration CPK-2 Building, Room 2092 5001 Campus Drive, HFS-225 College Park, MD 20740 Dear Dr. Morissette: It is our opinion that the enclosed GRAS Determination for the Use of 6’-Sialyllactose Sodium Salt (6’-SL) in Non-Exempt Term Infant Formula constitutes a new notification. Although 6’- SL is the subject of other GRAS Notices, the subject of the enclosed GRAS Notice is produced using a novel production process. We thank you for taking the time to review this GRAS determination. Should you have additional questions, please let us know. Sincerely, Dietrich B. Conze, Ph.D. Managing Partner Enclosure: CD containing Form 3667, cover letter, GRAS Determination for the Use of 6’-Sialyllactose Sodium Salt (6’-SL) in Non-Exempt Term Infant Form, and all references Spherix Consulting Group, Inc. 11821 Parklawn Drive, Suite 310, Rockville, MD 20852 301-557-0375; [email protected] GRAS Determination for the Use of 6’-Sialyllactose Sodium Salt in Non-Exempt Term Infant Formula Prepared for: Jennewein Biotechnologie GmbH Maarweg 32 D-53619 Rheinbreitbach Germany Prepared by: Spherix Consulting Group, Inc. 11821 Parklawn Drive, Suite 310 Rockville, MD 20852 March 19, 2020 GRAS Notification for the Use of 6’-Sialyllactose Sodium Salt March 19, 2020 Prepared for Jennewein Biotechnologie GmbH TABLE OF CONTENTS I. SIGNED STATEMENT OF THE CONCLUSION OF GENERALLY RECOGNIZED AS SAFE (GRAS) AND CERTIFICATION OF CONFORMITY TO 21 CFR §170.205-170.260 .... 1 A. SUBMISSION OF GRAS NOTICE .................................................................................1 B. NAME AND ADDRESS OF THE SPONSOR ................................................................1 C. COMMON OR USUAL NAME .......................................................................................1 D. TRADE SECRET OR CONFIDENTIAL INFORMATION ............................................1 E. INTENDED USE ..............................................................................................................1 F. BASIS FOR GRAS DETERMINATION .........................................................................1 G. PREMARKET APPROVAL ............................................................................................4 H. AVAILABILITY OF INFORMATION ...........................................................................4 I. FREEDOM OF INFORMATION ACT (FOIA) ...............................................................4 J. INFORMATION INCLUDED IN THE GRAS NOTIFICATION...................................4 II. IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT OF THE NOTIFIED SUBSTANCE ........................................................ 1 A. COMMON OR USUAL NAME .......................................................................................1 B. CHEMICAL NAME .........................................................................................................1 C. MOLECULAR FORMULA AND MASS ........................................................................1 D. STRUCTURAL FORMULA ............................................................................................1 E. DESCRIPTION OF 6’-SL ................................................................................................1 F. PRODUCTION PROCESS ...............................................................................................2 1. Description of the Production Strains ........................................................................... 2 2. Manufacturing Process ................................................................................................. 5 G. FINISHED PRODUCT SPECIFICATIONS AND OTHER QUALITY ATTRIBUTES 6 1. 6’-SL Product Specifications and Batch Data Compliance .......................................... 6 2. Other Quality Attributes ............................................................................................... 8 H. STABILITY OF 6’-SIALYLLACTOSE ..........................................................................8 1. Genetic Stability of the Production Strains .................................................................. 8 2. Stability of the 6’-SL .................................................................................................... 9 III. DIETARY EXPOSURE ........................................................................................................ 11 A. INTENDED EFFECT .....................................................................................................11 B. HISTORY OF EXPOSURE ............................................................................................11 C. INTENDED USE ............................................................................................................15 D. ESTIMATED DAILY INTAKE .....................................................................................15 -ii- SPHERIX CONSULTING GROUP, INC. GRAS Notification for the Use of 6’-Sialyllactose Sodium Salt March 19, 2020 Prepared for Jennewein Biotechnologie GmbH IV. SELF-LIMITING LEVELS OF USE .................................................................................... 16 V. COMMON USE IN FOOD BEFORE 1958 ........................................................................... 17 VI. NARRATIVE ON THE CONCLUSION OF GRAS STATUS ............................................ 18 A. SAFETY OF THE PRODUCTION ORGANISM ..........................................................20 B. ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION ...................21 C. TOXICOLOGY ...............................................................................................................22 1. Genotoxicity ............................................................................................................... 23 2. Toxicity Studies on 6’-SL as a Single Ingredient ....................................................... 29 3. Toxicity Studies on Jennewein’s 6’-SL as Part of an HMO Mixture ......................... 32 D. TOLERANCE STUDY IN NEONATAL PIGLETS ......................................................38 1. Introduction ................................................................................................................ 38 2. Materials and Methods ............................................................................................... 38 3. Results ........................................................................................................................ 42 4. Discussion ................................................................................................................... 70 E. CORROBORATIVE ANIMAL STUDIES ....................................................................70 F. CLINICAL STUDIES .....................................................................................................71 G. ALLERGENICITY .........................................................................................................72 H. REGULATORY APPROVALS ACROSS THE WORLD ............................................73 VII. SUPPORTING DATA AND INFORMATION................................................................... 74 A. REFERENCES ................................................................................................................74 B. EXPERT PANEL STATEMENT ...................................................................................87 LIST OF TABLES Table 1. Genetic Manipulations in the Basic Strain ...................................................................... 3 Table 2. Genetic Manipulations in JBT-6SL .................................................................................. 4 Table 3. Product Specifications and Batch Data for 6’-Sialyllactose ............................................ 7 Table 4. Elemental Analysis of 6’-Sialyllactose ............................................................................ 8 Table 5. Stability of 6’-Sialyllactose as a Component of a Mixed Human Milk Oligosaccharide Powder Under Ambient Conditions (25°C, 60% Relative Humidity) .......................................... 10 Table 6. Stability of 6’-Sialyllactose as a Component of a Mixed Human Milk Oligosaccharide Powder Under Accelerated Conditions (40°C, 75% Relative Humidity) ..................................... 10 Table 7. Studies Determining the Concentration of 6’-Sialyllactose in Human Breast Milk ...... 12 Table 8. Comparison of Jennewein’s 6’-Sialyllactose Sodium Salt With the 6’-Sialyllactose Sodium Salt Tested Phipps et al., 2019 and That Supports GRN 881 .......................................... 23 -iii- SPHERIX CONSULTING GROUP, INC. GRAS Notification for the Use of 6’-Sialyllactose Sodium Salt March 19, 2020 Prepared for Jennewein Biotechnologie GmbH Table 9. Bacterial Reverse Mutation Test Performed with an HMO Mixture Containing 4.0% 6- Sialyllactosec ................................................................................................................................. 27 Table 10. In vitro Micronucleus Test in Human Peripheral Blood Lymphocytes Exposed to an HMO Mixture Containing 4.0% 6’-Sialyllactoseb ........................................................................ 29 Table 11. Statistically Significant Differences in Clinical Chemistry Values on Day
Load more

Recommended publications
  • Benjamin Franklin Rum Is a Distilled Alcoholic Beverage Made
    “There cannot be good living where there is not good drinking” -Benjamin Franklin Rum is a distilled alcoholic beverage made from sugarcane byproducts, such as molasses, or directly from sugarcane juice, by a process of fermentation and distillation. The distillate, a clear liquid, is then usually aged in oak barrels. The majority of the world's rum production occurs in the Caribbean and Latin America. Rums are produced in various grades. Light rums are commonly used in cocktails, whereas "golden" and "dark" rums are typically consumed neat or on the rocks. JW Marriott Marco Island Beach Resort | 400 South Collier Boulevard, Marco Island, Florida 34145 | 239-394-2511 1 A RUM TOUR BARBADOS Afrohead 7 Yr- amber 14 molasses and Bourbon wood accents with a ghost of vanilla Afrohead xo 15 Yr- dark 20 creamy and builds to a toffee and caramel Facundo Neo-white 20 vanilla coconut apple banana pepper Facundo Eximo – dark oak 24 walnut and vanilla with a round buttery texture Facundo Exquisito – light Cherrywood 32 vanilla dried raisins and apricots hint of butterscotch Facundo Paraiso- deep amber 38 sweet fruit caramel Mt Gay Eclipse- amber 12 subtle smokiness medium body with a bright finish Mt Gay XO - deep amber 20 ripe banana toast vanilla Plantation 20th Anniversary XO - amber 20 coffee bean notes hearty wood and backing sweetness BRAZIL Leblon Cachaca- white 13 fresh cut sugar cane spices and fruits BERMUDA Goslings Black Seal- black 12 butterscotch vanilla and caramel JW Marriott Marco Island Beach Resort | 400 South Collier Boulevard,
    [Show full text]
  • Images of the Caribbean : Materials Development on a Pluralistic Society
    University of Massachusetts Amherst ScholarWorks@UMass Amherst Doctoral Dissertations 1896 - February 2014 1-1-1982 Images of the Caribbean : materials development on a pluralistic society. Gloria. Gordon University of Massachusetts Amherst Follow this and additional works at: https://scholarworks.umass.edu/dissertations_1 Recommended Citation Gordon, Gloria., "Images of the Caribbean : materials development on a pluralistic society." (1982). Doctoral Dissertations 1896 - February 2014. 2245. https://scholarworks.umass.edu/dissertations_1/2245 This Open Access Dissertation is brought to you for free and open access by ScholarWorks@UMass Amherst. It has been accepted for inclusion in Doctoral Dissertations 1896 - February 2014 by an authorized administrator of ScholarWorks@UMass Amherst. For more information, please contact [email protected]. IMAGES OP THE CARIBBEAN - MATERIALS DEVELOPMENT ON A PLURALISTIC SOCIETY A Dissertation Presented by Gloria Mark Gordon Submitted to the Graduate School of the University of Massachusetts in partial fulfillment of the requirements for the degree of DOCTOR OF EDUCATION May 1 982 School of Education © 1982 GLORIA MARK GORDON All Rights Reserved IMAGES OF THE CARIBBEAN - MATERIALS DEVELOPMENT ON A PLURALISTIC SOCIETY A Dissertation Presented by Gloria Mark Gordon Approved as to style and content by: Georg? E. Urch, Chairperson ) •. aJb...; JL Raljih Faulkinghairi, Member u l i L*~- Mario FanbfLni , Dean School of (Education This work is dedicated to my daughter Yma, my sisters Carol and Shirley, my brother Ainsley, my great aunt Virginia Davis, my friend and mentor Wilfred Cartey and in memory of my parents Albert and Thelma Mark iii . ACKNOWLEDGMENTS This work owes much, to friends and colleagues who provided many elusive forms of sustenance: Ivy Evans, Joan Sandler, Elsie Walters, Ellen Mulato, Nana Seshibe, Hilda Kokuhirwa, Colden Murchinson, Sibeso Mokub.
    [Show full text]
  • Nobu Miami Beverage Drinks Menu
    NOBU'S SAKE SELECTION The Hokusetsu Brewery on Sado Island in the Sea of Japan has been operated by the Hazu family since 1871. The name "Hokusetsu", or “Northern Snow”, was chosen to reflect the ideal sake brewing conditions on the island during the coldest days of winter. Chef Nobu first experienced Hokusetsu sake when his Japanese rock-musician friend brought a bottle to the original Matsuhisa restaurant in Beverly Hills. Impressed by the quality, Nobu obtained exclusive rights to sell Hokusetsu sake in the United States. JUNMAI DAIGINJO TK40 GENSHU ENSHINBUNRI 'HIKARI' The rare hybrid rice grain, Koshitanrei, is polished to 40% of its original size to produce this premium sake. Elegant floral flavors of Orange Blossom, Elderflower, and White Tea are found in this powerful Genshu, or undiluted sake. Bottle 24 oz $680 DAIGINJO YK35 SHIZUKU The most sought-after rice grain, Yamada Nishiki, is polished to 35% of its original size to produce this premium sake. The sake is extracted through a slow drip process that highlights delicate flavors of Lychee, Honeydew, and Pear. Fruit forward and amazingly smooth. Bottle 24 oz $560 DAIGINJO YK35 SHIZUKU JUKUSEI KOSHU This is the YK35 Shizuku, aged for three years. The aging process has added structure to the delicate Nashi Pear flavor becoming highly complex with a deep richness not found in young sake. This is made in extremely limited quantities. Bottle 60 oz $3500 NOBU SAKE SELECTION GINJO NIGORI Unfiltered, dry and creamy Glass Bottle 16 oz $12 $64 Pepino Light-bodied crisp and dry with a
    [Show full text]
  • The Origins and Development of the U.S. Sugar Program, 1934-1959
    The Origins and Development of the U.S. Sugar Program, 1934-1959 Richard Sicotte University of Vermont [email protected] Alan Dye Barnard College, Columbia University [email protected] Preliminary draft. Please do not cite. Paper prepared for the 14th International Economic History Conference August 21-25, 2006 1 Recent trade talks in the WTO indicate that the powerful US sugar lobby continues to be a roadblock to agricultural liberalization. It calls attention to a need for better understanding of the complex quota-based regulations that have governed the US sugar trade for so long. In 1934 the United States shifted its sugar protection policy from emphasizing the tariff to a comprehensive system of quotas. It was revised in 1937. After its suspension for much of World War II, a new Sugar Act was passed in 1948, and further revised in 1951 and 1956. It has been in almost continuous operation since 1934. This paper examines the origins and development of the Sugar Program from 1934 to 1959. Why did the United States adopt sugar quotas? What were the rules set up to implement and govern the policy? How did they function? The sugar quota was adopted after the U.S. government determined that the long-standing policy using the tariff to protect the domestic industry was failing. A principal reason was that the tariff was not raising the price of sugar because, by diminishing the imports of Cuban sugar, it was causing severe decline in wages and costs on that island. In turn, Cuban sugar was being offered at ever lower prices.
    [Show full text]
  • RUM 12-YR, Jamaica
    APPLETONRuM 12-YR, Jamaica ....................................................................................................... BaR 43% nutty, rich & creamyC withaR taste of spicediB molassesbE & biscuitsaN APPLETON SIGNATURE BLEND, Jamaica ......................................................................40% golden, fruity nose, spicy & woodsy flavors with a sweet finish * APPLETON 21-YR, Jamaica ....................................................................................................43% nutty & rich, thick full notes of cocoa, sugar & oak with a long finish RON ATLANTICO RESERVA, Dominican Republic ....................................................40% solera blend, tropical fruit flavors, earthy oak, notes of vanilla ANGOSTURA 7-YR, Trinidad & Tobago .............................................................................40% dark amber hue, robust, flutterings of treacle, chocolate and smokiness BLACKWELL, Jamaica .................................................................................................................40% sweet flavours like caramel, black strap molasses, coconut & hints of vanilla BANKS RUM 5 ISLAND BLEND, Caribbean ....................................................................43% flavorful dry full-bodied white rum blend, vegetal & herbal notes, ginger & black pepper BANKS RUM 7 GOLDEN AGE, Caribbean ........................................................................43% ex-bourbon barrel-aged rum blend, medium body, dry, spicy, complex BACARDI BLACK, Cuba...........................................................................................................37.5%
    [Show full text]
  • Transitioning the Sugarcane Industry to the Circular Economy in Central America
    Transitioning the Sugarcane Industry to the Circular Economy in Central America. Can it lead the transformation in the food sector? Ronald Panameño, Professor & Researcher, Central American University UCA, Operations & Systems department. (corresponding author) [email protected] +(503) 7836 – 4659 Boulevar los próceres, San Salvador, El Salvador,CP 1101 Abstract The sugar industry is one of the leading economic sectors in Central America, as demonstrated by the industry’s output volume, labor utilization, and biomass energy use, all among the most significant in regional economic activity. At the same time, the industry imposes a heavy burden on Central American societies: it requires extensive land use, heavy use of nitrogen-based fertilizers, large amounts of water, and the emissions resulting from the industrial processes are a considerable source of pollution. The sugarcane industry’s current production cycles and machinery (the sugarcane mill being the most emblematic) were developed during the 19th century. Therefore, the industry follows a classic linear production workflow whereby it relies on significant asset investments that cannot be easily adapted to another industrial process; the main goal is usually to maximize production every harvest season disregarding the externalities. How can, then, this sector transforms this anachronistic industrial method to adapt to a framework of circular economic development? This paper analyzes current industrial trends and processes among leading sugar producers in Central América. We use Life Cycle Assessment (LCA) methodology to evaluate an archetypal sugar mill and develop a simulated model of the environmental impacts of the industry using SimaPro software and the International Reference Life Cycle Data System (ILCD) method; the results are applied to estimate sugar production and visualize the impact characterization.
    [Show full text]
  • An Overview of Sugar Cane Cogeneration in Six Central American Countries
    BUN-CA AN OVERVIEW OF SUGAR CANE COGENERATION IN SIX CENTRAL AMERICAN COUNTRIES BUN-CA REGIONAL OFFICE FOR CENTRAL AMERICA DECEMBER, 1997 BUN-CA 1997 Acknowledgment The Central American Regional Office of Biomass Users Network (BUN-CA), wishes to express its appreciation to The Rockefeller Foundation for the financial support provided during the execution of this study. Thanks are also extended to the in-country consultants, who where responsible for the execution of the initial stage of the Central American Sugar Diversification Initiative in six Central American countries, and whose work made possible the task of preparing this regional overview. Ing. José Ma. Blanco, Costa Rica Ing. Orlando Aguilar, Panamá Ing. María Engracia Detrinidad, Nicaragua Ing. Ana María González, El Salvador Ing. Jorge Morazán, Honduras and our highest appreciation to our Regional Project Coordinator, Dr. Oscar Coto Ch., who also prepared the country study for Guatemala. We also wish to extend our thanks to Ms. Ellen Kennedy of Winrock International for making available important publications on Sugarcane Cogeneration. BUN-CA also appreciates the time and patience of many sugar mill owners and plant managers in Central America who shared their experience during our visits to their facilities. Thanks are also extended to representatives of AICA, Azucareros del Istmo Centroamericano, a regional organization that works closely with the sugar mill sector, for their invaluable comments and suggestions to the authors of this Report. BUN-CA 1997 TABLE OF CONTENTS Executive Summary Resumen Ejecutivo I. The Context of the Sugarcane Industry in Central America.............8 II. Central American Sugarcane Processing Overview.........................12 III.
    [Show full text]
  • Sugar Cane Resources—Queensland & International
    Selected Bibliography: Sugar Cane Resources—Queensland & International Formats: A= Video, film, filmstrip. B= Book. C= Calatogue. AMRA (Qld) (1998). Railways of Queensland: an album CD= CD-ROM. F= Fiche. M= Magazine. P= Pamphlet. R= of... Vol 3. Zillmere, Qld: Australian Model Railway Reference. V= Vertical file (loose/stapled). Y= Map. Association Queensland Branch Inc. A C Kalmbach Memorial Library Staff [Eds] (2003). Maple Half page, primarily B&W photos, with captions. Of Leaf 2003: The Clinics at Toronto NMRA Convention). particular interest are two cane railway photos. Format: B, Chattanooga, TN: NMRA. np. Selection of clinic notes from the 2003 NMRA National AMRA (Qld) (1999). Railways of Queensland: an album Convention. Includes Parsons, Stan, 'Sugar: A Sweet of... Vol 4. Zillmere, Qld: Australian Model Railway Industry for your Pike', pp 238-249. Format: B, 336 p. Association Queensland Branch Inc. ABC TV (1992). B&W Cane Harvesting Footage. Brisbane, Half page, primarily B&W photos, with captions. Cover has QLD: ABC TV. cane railway lift bridge (Moreton Mill), etc. Format: B, 48 p. Material from the ABC TV Archives on cane harvesting; AMRA (Qld) (2001). Railways of Queensland: an album restricted circulation. $100. Format: A, of... Vol 5. Zillmere, Qld: Australian Model Railway Association Queensland Branch Inc. AFFC/Look Television (1998). Railway Adventures across Australia: 1 Touching the Pacific. Surrey Hills, NSW: Half page, primarily B&W photos, with captions. Of Reader's Digest. particular interest are several cane railway photos, including Macknade Mill's Hudswell Clarke, Qunabe Mill's John 1 Touching the Pacific: Queensland tropical north to Sydney incl Kuranda, Mossman Mill sugar cane, Orient luxury train, Fowler, dual gauge at Marian Mill and a Bingera Mill Malcolm Moore modified for grass cutting duties.
    [Show full text]
  • Part II: the Sugar Industry
    Mexico & Caribbean Area Series Vol. V No. 8 (CUBA) Unive ASPECTS OF THE CUBAN ECONOMY Part 11: The Sugar Industry by Irving P. Pflaum Havana August 1960 To pass judgment on the Cuban Revolution would be in mid- 1960 improper and untimely: im- proper because most sources of information were biased; untimely because the Revolution was in full motion with its testing periods just ahead. In Cuba, future crises will result from eco- nomic, social, and political forces released by the Revolution as it rolled through 1959 and into 1960, Impelling these forces are 400 years of social de- velopment on the island the revolutionaries took on January 1, 1959, from Fulgencio Batista and the en- trenched elite behind him. To understand the situation one must look to the sugar industry and the influence it has had on the Cuban economy and social structure. The cultiva- tion and processing of sugar cane and the exporta- tion of its derivatives is Cuba's biggest business, dominating the island's economy. Cuba's sugar business is notable for its size, cartelization, inefficiency, apathy, and high profits. It has made many personal and corporate fortunes but has added virtually nothing to man's knowledge of the cane itself, its cultivation, the chemistry of its conversion into sugar, molasses, alcohol, and other by-products, or the usefulness of these deriv- ative s , The technological stagnation of the industry is illustrated by the fact that most of the cane grown in Cuba is of a variety called P.O. J. (Proefstation Oest Java) 2878 developed in Java in the 1920's.
    [Show full text]
  • GEORGE FLETCHER & Co. Ltd
    GEORGE FLETCHER & Co. Ltd. DERBY, ENGLAND. ESTABLISHED 1838 'WORLD' SUGAR P.RODUCTION & ;CONSUMPTION . -,' .'." . AN ECONOMIC-GEOGR~HI~l- ~-oOa'd~i';:-i~ra~ . i Dbananjayara " , '\ \\\\\~ \\\\\ \\\\\ ~\\\ \\\\\ \\\\\ \\\\ \\\\ , . \ GIPE_PUNE-009S92 .By '\ _~ ... --~-~ . C. .J. ROBERTSON,'- B.Sc., M.A.! J,>h.D WiTH ~ FORFWORD, ~y ~OEL . DEERR .. 1onl)on . JOHN BALE, SONS & DANIE~SSON. LTD. ' .•.. .,,' 83'91, GREAT TITCHFI;ELD STREET, W •• 1934 )<j(r 6f~) • ) . G--1 MADa AND PRINTBD IN CT. aRtTAIN BY JOHN BALE, SONSAHDDANrELSSON .. LTD.; 83-91, e"l\ TITCHP1BLD ST•• LONDON. W.I. FOREWORD. WHILE there are numerous books available dealing with the technicalities of the manufacture of sugar, there are few which are concerned with the economics of its production. This is so much so that it has become a matter of routine to design 8; factory to operate on so many "hundr$ or thousands of tons of raw material per day. This alone will not ensure success to any projected scheme; a study of the economics, including therein such matters as labour supply, access to markets and utilization of natural facilities, are of equal or even of more importance. , These'matters are discussed in this book and the. method of their presentation' leaves little to be desired. The effect of climate, density of population, tariffs, the relationship of" research to industry and many other controlling factors are all considered in . detail. Though addreSsed, in the first instance, to . the economist, there is much of interest to the" producer also. NOEL DEED. PREFACE., EXHAUSTIVE treatises on the technical aspects of sugar production have been written, dealing with cane or beet agriculture, with the factory processes.
    [Show full text]
  • Sugar from Mexico
    Sugar from Mexico Investigation Nos. 701-TA-513 and 731-TA-1249 (Preliminary) Publication 4467 May 2014 U.S. International Trade Commission Washington, DC 20436 U.S. International Trade Commission COMMISSIONERS Irving A. Williamson, Chairman Dean A. Pinkert David S. Johanson Meredith M. Broadbent F. Scott Kieff Rhonda K. Schmidtlein Robert B. Koopman Director of Operations Staff assigned Amy Sherman, Investigator Michael Szustakowski, Investigator Douglas Newman, Industry Analyst James Fetzer, Economist Charles Yost, Accountant Russell Duncan, Statistician Darlene Smith, Statistical Assistant Karl von Schriltz, Attorney Elizabeth Haines, Supervisory Investigator Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Sugar from Mexico Investigation Nos. 701-TA-513 and 731-TA-1249 (Preliminary) Publication 4467 May 2014 CONTENTS Page Determinations ............................................................................................................................... 1 Views of the Commission ............................................................................................................... 3 Part I: Introduction ................................................................................................................ I‐1 Background ................................................................................................................................ I‐1 Statutory criteria
    [Show full text]
  • The 1995-1996 Sugar Zafra: Results and Implications—The Machinery Sector
    THE 1995-1996 SUGAR ZAFRA: RESULTS AND IMPLICATIONS—THE MACHINERY SECTOR Alfredo Blanco, Jr. Sugar production in Cuba during the 20th century the various nations, the upshot of the diverse charac- has never been curtailed by the installed industrial ca- teristics of soils, climate and labor. pacity. It is easy to increase the cane grinding rate on It can be concluded that: a short notice in such a manner as to process any ex- pansion of the cane supply within the normal har- • The cost of the raw material—cane—is the vesting season. The communist government was for- most important component of the cost of pro- tunate the mills it seized had an industrial capacity to duction of sugar in Cuba. Also, it determines the crush all the cane it has made available up to the competitiveness in the international export mar- present date. In contrast, augmenting cane quantity ket due to its variation among countries takes years from planting to harvesting, with weather vagaries ever present. • Sugar output in Cuba is limited by the cane sup- ply under current conditions inasmuch as the In certain years, for example in 1930-40 and crushing capacity of the mills greatly exceeds the 1953-60, international marketing agreements set ex- available cane. port quotas for Cuban sugar. After 1960, the Com- munist regime pulled out from, or discarded, quota We raise these points because customarily most of pacts and Cuba has been producing sugar freely, lim- the attention of seminars is devoted to the factory ited only by the available cane.
    [Show full text]