{"operation":"document","citation":"01-0106","title":"Antimicrobial Division — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2001-06-13","effective_on":null,"summary":"01-0106 response to Antimicrobial Division concerning 173.4.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0106.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0106.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0106","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2001/010106.pdf","body":"<<<PAGE 1>>>\n\n•\nU.S. Department\nResearch and\nof Transportation\nWashington, D.C. 20590\n400 Seventh St., S.W.\ndministratic\necial Program\nJUN 13 2001\nMr. James P. Ringo\nRef. No. 01-0106\nTechnical and Regulatory Director\nAntimicrobial Division\n1818 West Lindsey, Suite C-180\nNorman, OK 73069\nDear Mr. Ringo:\nThis is in response to your letter and subsequent telephone conversations with Eric Nelson of my staff\nrequesting clarification of the smali quantity exceptions under the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180). Specifically, you ask whether your packaging and inner receptacle\nqualifies for the small quantity provisions of § 173.4. The inner receptacle is comprised of a split-\ncompartment poly-textile pouch that contains sodium chlorite solid in one compartment and anhydrous\ncitric acid in the other compartment. This pouch is placed in a poly/foil/paper pouch, which is then\nplaced in a polyethylene plastic bag.\nA material may be transported under the small quantity exceptions if it is prepared in accordance with\nthe quantity limits and packaging requirements in § 173.4, which includes the requirement that inner .\nreceptacles be made of plastic at least 0.008 inches thick, or glass, earthenware, or metal. Based on\nthe information you submitted, we agree that your package may be transported under the small quantity\nexception provided the quantity of hazardous materials is less than 30 grams (1 ounce) and all other\nprovisions in § 173.4 are met. Packing a nonhazardous material in excess of the 30 grams in the same\npackage is permitted provided the package conforms with the requirements of § 173.21. Based on the\ninformation you submitted, we agree that a mixture of sodium chlorite solid and anhydrous citric acid is\nunlikely to produce dangerous quantities of chlorine dioxide gas under normal shipping conditions, and\nthus, would not be in violation of the prohibition in § 173.21(e).\nI hope this information is helpful.\nSincerely,\nTransportation Regulations Specialist\nOffice of Hazardous Materials Standards\n173.4\n010106\n:3:\n\n<<<PAGE 2>>>\n\nNelson\nFRACTAL HASTECH\n3173.4\nRAVIC\nCORPORATION\ntackaging\nApril 27, 2001\n01-0106\nU.S. Department of Transportation\nAttention: Edward Mizzullo\nOffice of Hazardous Material Standards\nResearch and Special Programs Administration\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nregulations.\nRe: Request for an opinion regarding compliance with hazardous material\nDear Mr. Mizzullo:\nRaytec Corporation requests an opinion regarding the transporting of certain\nhazardous materials. Specifically, is the transporting of sodium chlorite and citric\nacid in the same inner receptacle permitted under the provisions of 49 CFR\nwhich are described below?\n173.4, Small quantity exemptions, under material and packaging conditions\nBackground: The use of an acidified sodium chlorite solution as an antimicrobial\nagent in seafood processing water is permitted by the Food and Drug\nAdministration as described in 21 CFR 173.325, Acidified sodium chlorite\nsolutions. To meet industry demand for this usage Raytec has developed and\napplied for a patent on a novel method to prepare acidified sodium chlorite\nsolutions.\nIn brief, the Raytec development comprises a dual chambered sachet in a\n\"teabag\" configuration. One side of the teabag contains dry 80% technical grade\nsodium chlorite, the other side contains anhydrous food grade citric acid. The\ntwo dry chemicals are separated by an internal barrier. Upon immersion in water\nthe barrier material exhibits a wicking action which draws water into the teabag.\nThe water dissolves the sodium chlorite and citric acid which cross the barrier,\ncombine, and react to form the acidified sodium chlorite solution which is\nsubsequently diluted to the use concentration.\nOne important component of the acidified sodium chlorite solution is chlorine\ndioxide, CAS No. 10049-04-4, which is generally considered to be the efficacious\nantimicrobial component of the system. The generalized reaction of chlorite with\nan acid under agueous conditions iș shown in the following equation:\n5C1Oź + 4H*\n→\n4C102 + 2H2O + Cr\nHEADQUARTERS\nANTIMICROBIAL DIVISION\nNATIONAL SALES OFFICE\nSparks, NV 89431\n958 Spice Islands Drive\n1818 West Lindsey, Suite C-180,\n(800) 729-1443 • Tel. (702) 359-5353\nNorman, OK 73069\n9375 S.W. Commerce Circle, Suite #9\nFax: (702) 359-5370\nFax: (405) 354-3462\n(888) 638-6888 • Tel. (405) 364-7968\n(800) 338-6478 • Tel. (503) 682-9515\nWilsonville, OR 97070\nFax: (503) 682-9636\n\n<<<PAGE 3>>>\n\nChlorine dioxide is a poisonous gas which is listed as forbidden in 49 CFR\nfrozen hydrate.\n172.101 Hazardous Materials Table, and may not be transported except as a\nRaytec corporation believes that sodium chlorite and citric acid can be prepared\nand packaged under conditions which preclude the generation of dangerous\nquantities of chlorine dioxide even if the materials are mixed.\nDescription of the Raytec teabag chemicals and packaging materials:\n1. Sodium chlorite. CAS No. 7758-19-2. Dry 80% technical grade\nsodium chlorite, manufactured by Vulcan Chemicals. An MSDS is provide as\nleast one hour to insure dryness.\nAttachment 1. Prior to packaging the sodium chlorite is heated to 150 °C for at\n2. Citrid acid. CAS No. 77-92-9. Food grade, anhydrous, citric acid\nmanufactured by Tate & Lyle. An MSDS from the distributor is provided as\nAttachment 2.\n3. Teabag. The teabag is comprised of three material layers, heat\nbonded together, which form a two compartment pouch. Samples of the teabag\nare provided and labeled as Attachment 4. The outer layers of the teabag are\nTyvek Style 1079 with the physical characteristics described in Attachment 3. In\naccordance with 173.4 no more than thirty (30) grams of dry sodium chlorite are\nplaced in one side of each bag. A total of four (4) grams of anhydrous citric acid\nare placed in the other pouch of each teabag.\n4. Poly/Foil/Paper over wrap. The filled teabag is heat sealed inside the\nairtight polyfoil over wrap bag. A sample of the printed over wrap bag is provided\nand labeled as Attachment 5.\n5. Polyethylene outer wrap bag. The outer wrap bag is made of 8 mil\n(0.008 in) polyethylene. The teabag and over wrap are heat sealed inside the\npolyethylene outer wrap bag. A sample of the outer wrap bag is provide at\nAttachment 6.\n6. An unsealed assembly of the teabag, over wrap, and outer wrap are\nprovided at Attachment 7 to aid in visualization of the completed inner packaging.\n7. The outer packaging is a fiberboard box which has been tested in\naccordance with and meets all the standards of 49 CER 173.4 A total of 32 of\nthe inner packages are packaged in one fiberboard box outer package. The total\nweight of the completed package is less that eight pounds. A sample of the\nfiberboard box is not included, but will be provided if so requested\n\n<<<PAGE 4>>>\n\nIssue of concern: Raytec believes that the described packaging meets all of the\nrequirements of 49 CFR 173.4 although we have one area of concern,\nspecifically, 173.4 (a) (7) \"Placement of the material in the package or packing\ndifferent materials in the package does not result in a violation of 173.21.\"\nThe issue of concern under 173.21 is (e) which states, \"A material in the same\npackaging, freight container, or overpack with another material, the mixing of\nwhich is likely to cause a dangerous evolution of heat, or flammable or poisonous\ngases or vapors, or to produce corrosive materials\"\nSumman\nRaytec has determined that the dried sodium chlorite and anhydrous citric acid,\neven if mixed, are unlikely to produce dangerous quantities of chlorine dioxide\ndried technical grade sodium chlorite were mixed with four grams of citric acid\ngas under normal shipping conditions. To determine this thirty gram samples of\ninside the polyfoil over wrap bags and stored at ambient temperature for up to\nand placed in one side of test teabags. The teabags were then heat sealed\nfourteen days. At Days 1, 3, 7, and 14 the over wrap bags were opened and\nchlorine dioxide concentration was determined by an Interscan chlorine dioxide\nmonitor used in accordance with the manufacturers instructions. The fourteen\nTherefore, we believe that by using dried sodium chlorite and anhydrous citric\nday sample exhibited the low, but detectable, level of 3.07 pm in the bag.\nacid, packaged as described above, the teabag product can be safely shipped in\naccordance with 49 CFR 173.4 and will not generate dangerous levels of chlorine\ndioxide even if mixed.\nRaytec would appreciate your review and response to this request for an opinion\nto our question. If you have any questions or need for additional information on\nthis subject please do not hesitate to call and let me know.\nSincerely,\njames P. Pingo\njames P. Ringo\nTechnical and Regulatory Director\nAntimicrobial Division\nEnclosures: Seven, as stated\nsupporting da ta","truncated":false,"body_characters":8841}