A. The industry sectors, as categorized by the North American Industry Classification System (NAICS), potentially affected by this rule are: Affected Industries NAICS Code Industry Description for NAICS Code 31193 Flavoring Syrup and Concentrate Manufacturing 312111 Soft Drink Manufacturing 325199 All Other Basic Organic Chemical Manufacturing [manufacturers of saccharin] 32541 Pharmaceutical and Medicine Manufacturing 325411 Medicinal and Botanical Manufacturing 325412 Pharmaceutical Preparation Manufacturing 32562 Toilet Preparation Manufacturing 49311 General Warehousing and Storage 5417 Scientific Research and Development Services 54171 Research and Development in the Physical, Engineering, and Life Sciences 61131 Colleges, Universities, and Professional Schools Note: Saccharin and its salts are used in personal-care products such as mouthwash, dental cleaners, and lipstick, which come under Toilet Preparation Manufacturing (NAICS Code 32562).
A. EPA’s regulations, under 40 CFR 260.20, set out a procedure and standards by which any person may petition the EPA Administrator to modify or revoke any provision in Parts 260 through 266, 267, 268, and 273 of 40 CFR.
Q. Why did EPA remove saccharin and its salts from its lists of hazardous constituents, hazardous wastes, and hazardous substances?
A. EPA received a petition from the Calorie Control Council (CCC) to remove saccharin and its salts from the mentioned hazardous lists. The CCC cited the removal of saccharin as a potential human carcinogen by the National Toxicology Program and International Agency for Research on Cancer as justification to remove saccharin and its salts from hazardous listings. EPA reviewed the evaluations conducted by the National Toxicology Program and the International Agency for Research on Cancer concerning the carcinogenic and other potential toxicological effects of saccharin and its salts. Based on the conclusions by these public health agencies that saccharin and its salts are not reasonably expected to be human carcinogens, as well as EPA’s own assessment of the waste generation and management information, EPA issued a proposed rule in April 2010 proposed granting CCC’s petition. As no objections were received during the public comment period, EPA finalized the proposal on December 17, 2010.
Q. Why were saccharin and its salts on EPA’s lists of hazardous constituents, hazardous wastes, and hazardous substances?
A. Saccharin was identified by EPA’s Carcinogen Assessment Group as a potential human carcinogen. This lead to its inclusion on EPA’s list of hazardous constituents (40 CFR Part 261Appendix VIII) and, as a result, list of hazardous wastes (EPA Hazardous Waste No. U202 in 40 CFR 261.33(f)) in May 1980. The Agency added “and salts” to the saccharin listing in November 1980, since normal commercial use includes both forms. The substances listed on 40 CFR 261.33(f) are commercial chemical products, manufacturing chemical intermediates, or off-specification commercial chemical products that are hazardous wastes if and when they are discarded or intended to be discarded. EPA’s listing of saccharin and its salts as hazardous substances under 40 CFR 302.4 is based solely upon these substances being listed as U202 hazardous wastes under 40 CFR 261.33(f)).
A. This rule allows generators to manage saccharin and its salt wastes as nonhazardous. The nonhazardous waste management regulations under RCRA Subtitle D, while still protective of human health and the environment, reduce paperwork and reporting requirements for generators and decrease the cost of waste management.
A. Saccharin is used primarily as non-nutritive sweeteners. The most common uses are in diet soft drinks, as a table-top sweetener, and in products, such as juices, sweets, chewing gum and jellies. Saccharin is also used in cosmetics (e.g., toothpaste, mouthwash, and lipstick), pharmaceuticals (e.g., for coatings on pills), and electroplating (e.g., as a brightener in nickel-plating baths).
A. Saccharin is a white crystalline powder, approximately 300 times sweeter than sucrose or sugar. It is typically available commercially either in the acid form (saccharin) or as salts (sodium saccharin or calcium saccharin). All three forms of this chemical are commonly referred to as saccharin.