Saccharin from China - USITC

and monkeys, evidence strongly supported the conclusion that saccharin does not cause cancer in humansand the FDA delisted saccharin and on December 21, 2000, President Clinton signed the SWEETESTAct, which removed the warning label on all products using saccharin. 16The large packaged-soft-drink manufacturers, such as Coca Cola and Pepsi, switched fromsaccharin to aspartame in their products that were bottled for retail sale in 1983, 6 years after theSaccharin Study and Labeling Act of 1977 requiring a warning label on products containing saccharintook effect. However, because of the limited shelf life of aspartame, the large packaged-soft-drinkmanufacturers continued to use saccharin in their products for use in beverage dispensing equipment.With the lifting of the warning label and the growing use of blends, petitioner states that food formulatorshave used saccharin with other sweeteners to create cost-effective taste profiles in products prepared forretail sale. 17 Adding saccharin to blends reduces the total cost of the sweetener product since mostsweeteners are more expensive than saccharin. 18 The amount of saccharin used in the blends varies fromproduct to product depending on the desired food taste requirements. PMC stated that roughly 20 percentof its total sales of saccharin are used in products that contain blends. 19Manufacturing ProcessesTwo production processes are currently in use worldwide: the Maumee process, a continuousproductionmethod which was developed in the United States and is the only process used domestically,and the older Remsen-Fahlberg process, a batch-production method using different starting materials, 20that is the predominant method used worldwide. Both processes are used in China. The Maumee processwill be discussed presently.Beginning in 2007, PMC underwent a major renovation in their process for making saccharin.For that reason, the original Maumee process and its modifications will be discussed in some detail.During the Commission plant trip, the company representatives referred to the overall process of makingsaccharin as consisting of a “front end” and a “back end.” The front end refers to the chemical reactionsthat make the crude saccharin (irrespective of the process), and the back end refers to the process ofpurifying and crystallizing the crude product (irrespective of the process) 21 .The following discussion will refer primarily to the front end of the process used by PMC.“***.” 22The company stated that important advantages of the process (relative to the Remsen-Fahlbergprocess) included:15(...continued)Assessment Report, AFSSA, May 7, 2002, p. 12.16Hearing transcript of the final investigation, p. 20. The SWEETEST Act is an acronym for the SaccharinWarning Elimination via Environmental Testing Employing Science and Technology Act. See “Congress GivesSaccharin a Clean Bill of Health” press release of the Calorie Control Counsel obtained on line athttp://www.caloriecontrol.org/pr12-22-00.html dated December 22, 2000.17Hearing transcript of the final investigation, pp. 35-38.18Ibid., pp. 36 and 40.19Ibid., p. 51.20Ortho-toluene sulfonamide is the starting material for the Remsen-Fahlberg process. Hearing transcript, p. 21;petition, p. 4. The discussion of the Maumee process which follows will contain a flow chart of the Remsen-Fahlberg process.21Commission PMC Plant Trip, February 3, 2009. During the initial discussion, the company representativesdiscussed the chemical reactions (using a chemical flow chart, figure I-1) used to make saccharin by theRemsen-Fahlberg process, the Maumee process (and early modifications), and the latest Maumee modification.However, the plant tour followed the Maumee modification and its purification.22The actual chemical reactions for the Maumee process are as follows: ***.I-10