{"operation":"document","citation":"02-0129","title":"Patton Boggs, L.L.P. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1997-02-21","effective_on":null,"summary":"02-0129 response to Patton Boggs, L.L.P. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0129.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0129.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0129","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2002/020129.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n400 Seventh Street, S.W\nWashington, D.C.\n20590\nResearch and\nspecial Programs\nIdministration\nFEB 2 1 1997\nMs. Carolina L. Mederos\nRef. No.: 02-0129\nTransportation Policy Consultant\nPatton Boggs, L.L.P.\n2550 M Street, N. W.\nWashington, D.C. 20037-1350\nDear Ms. Mederos:\nThis is in response to your letter to Alan I. Roberts, Associate Administrator for Hazardous\nMaterials Satety, dated January 17, 1997, concerning the proper classification of unbuffered\nlactic acid under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). In\nparticular, you requested confirmation that a lactic acid product is not a corrosive material and,\nassuming no other potentially hazardous attributes, is not a hazardous material under the HMR.\nThe letter was sent via FAX transmission.\nBased on the definition for \"corrosive material\" at 49 CFR 173.136, test criteria to determine\nthe packing group of Class 8 material at 49 CFR. 173.137, and test data and other information\nyou submitted, it is our opinion that the lactic acid product, as tested, is not a corrosive\nmaterial. Furthermore, if the material does not meet the definition for any other hazard class,\nit would not be subject to the HMR.\nIf we can be of further assistance, please contact us.\nSincerely,\nEdward T.\nDirector, Office of Hazardous\nMaterials Standards\n173.134\n020129\n\n<<<PAGE 2>>>\n\nID:7\nJAN 17'97\n17:26 No.037 P.02\nPATTON BOGGS. L.L.P.\n173,136\n2550 M STREET, N.W.\nWASHINGTON. D.C. 20037-1350\n02-0129\n(202) 457-6000\nFACSIMILE: 12021 457-6315\nWHICH'S DIRECT DIAL\n(202) 457-5653\n...\nJanuary 17, 1997\nAlan I. Roberts\nAssociate Administrator for Hazardous Materials Safety (DHM-1)\nRoom 8420\nResearch and Special Programs Administration\nU.S. Department of Transportation\n400 7th Streel, S.W.\nWashington, D.C. 20590\nRe:\nRequest for Clarification\nDear Al:\nI am writing to request guidance as to the proper classification of unbuffered lactic\nacid under U.S. Department of Transportation (\"DOT\") rules governing transportation of\nhazardous materials. 49 C.F.R. Parts 171-180. Lactic acid is marketed in the United States\nfor a variety of uses, including as a preservative in foods. Based on the results of animal\ntesting in accordance with OECD Guideline No. 404, the product does not have corrosive\neffects that would render it a \"corrosive material\" within the meaning of 49 C.F.R.\n$173.136(a). We request confirmation that the lactic acid product is not a \"corrosive\nmaterial\" and, assuming no other potentially hazardous attributes, is not a \"hazardous\nmaterial\" within the meaning of DOT's regulations.\nDOT's regulations define \"corrosive material\" as: \"[A] liquid or solid that causes full\nthickness destruction of human skin at the site of contact within a specified period of\ntime. \"I Corrosive effect on human skin is to be inferred from testing on animals in\naccordance with the 1992 OECD Guideline for Testing of Chemicals, Number 404, \"Acute\nDermal Irritation/Corrosion.\" 49 C.F.R. §173.136.\"\nAlternatively, a material is corrosive\n/ A liquid is classified as \"corrosive material\" if it causes observable destruction of intact skin\ntissue (1) within 60 minutes after exposure time of three minutes or less; (2) within 14 days after\nexposure time of between three minutes and 60 minutes; or (3) wilhin 14 days after exposure time\nof between 60 minutes and four hours. 49 C.F.R. §9173.136(a), (b), (c)(1).\n22\nBefore October 1, 1995, DOT's regulations did not incorporate OECD Guideline 404.\nInslead, a material was considered \"corrosive\" if, when tested on the intact skin of an albins rabbit\n\n<<<PAGE 3>>>\n\nID :7\nJAN 17'97\n17:26 No.037 P.03\nPATTON BOGGS, L. L.P.\nMr. Alan I. Roberts\nJanuary 17, 1997\nPage 2\nif its corrosion rate exceeds 6.25 mm a year on specified grades of steel or aluminum. 49\nC.F.R. $173.136(a).\"\nThe Netherlands Organization for Applied Scientific Research (\"TNO\") has tested\nunbuffered lactic acid (88%) for corrosive or irritative properties under Guideline 404.\nPigs were dermally exposed 10 the acid at exposure intervals of 3 minutes, 60 minutes and\n4 hours in accordance with Guideline 404.4l\nTNO reported that no irritation or corrosion\nwas observed to any exposed animal during the 21 day observation period. Id. at 8.\"\nTNO concluded that, on the basis of these results, \"lactic acid (88%) is not irritating or\ncorrosive to skin\" within the meaning of Guideline 404, Id. at 5.\"\nby a protocol set forth in the regulations, \"the structure of the lissue at the site of contact is\ndestroyed or changed irreversibly after an exposure period of 4 hours or less.\". 49 C.F.R. §\ntime periods discussed above, deleting the prescribed testing protocol using albino rabbits, and\n173.136(a)(1) [Oct. 1, 1994 ed.] In late 1994, DOT amended the regulation, establishing the three\nincorporating the OECD Guideline as the required test methodi, effective October 1, 1995. See 59\nFederal Register 67508 (Dec. 29, 1994).\n3/\nResearch demonstrated that 80% lactic acid has corrosion rales an order of magnitude lower than\nTesting by the Metaalinstitut of the Netherlands Organization for Applied Scientific\nthe DOT limits - 0.15 mm/year on steel and 0.1mm/year on aluminium. See TNO Report No.\n55° C\" (19 Nov. 1995) (unpublished). We see no basis for inferring that 88% lactic acid would\n85M/014560/WIJ/RAN, \"The Corrosion Resistance of Steel and Aluminium in 80% Lactic Acid at\nsubmitted to your office copies of the other scientific materials cited in this letter.)\nhave materially greater corrosion rates. (A copy of this study is enclosed; we have previously\nTNO Report No. V 87.405/270419, \"Acute Dermal Irritation/Corrosion Study With Lactic\nAcid (88%) In Pigs (Nov. 1987) (unpublished) at 7.\nThe 1981 Guideline required that a single patch containing the test substance be applied to\nthe skin of each of three test animals for four hours, and that the exposed areas then be examined\nfor sighs of irritation at intervals of 30-60 minutes, 24 hours, 48 hours after patch removal. The\n1992 Guideline requires that three patches be applied to the test animal, to be remover\nsequentially after 3 minutes, one hour and four hours. TNO's 1987 test followed this latter\nprocedure, with the exposed locations being cxamined 60 minutes, 1 day, 2 days, 3 days, 7 days,\n14 days and 21 days after patch removal. 1987 TNO Report at 7.\nIn 1986 Inversk Research International (\"IRI\") exposed guinea pigs to 88% lactic acid,\nin Guinea Pigs,\" Inversk Research International, IRI Report No. 3625 ( Sept. 1986) (unpublished).\nwithout corrosive effects. J.A. Cuthbert and S.M.A. Carr, \"Lactic: Acid Q88: A Skin Corrosivity Test\nUnlike the 1987 TNO testing, the 1986 IRI test report does not specifically reference OECD\nGuideline 404 as the lest prolocol followed. However, our review of the IRI report indicates that\nconna deman botan oment nn...\n\n<<<PAGE 4>>>\n\nID :7\nJAN 17'97\n17:27 No.037 P.04\nPATTON BOGGS, L. L.P.\nMr. Alan I. Roberts\nJanuary 17, 1997\nPage 3\nTNO performed this study under the 1981 version of Guideline 404. However,\nbased on our review of the 1981 and 1992 versions of Guideline 404, the principal\nversion requires sequential rather than simultaneous testing of three animals and cautions\nsubstantive changes in the 1992 version relate solely to animal welfare issues, i.e., the new\nvalid for purposes of 49 C.F.R. §173.136.\nagainst in vivo testing of very low pH liquids. Therefore, TNO's 1987 findings appear\nAlthough both the 1981 and 1992 versions of OECD Guideline 404 state that the\nalbino rabbit is \"the preferred species\" for use in skin exposure testing, the Guideline says\nthat \"several mammalian species may be used.\" The skin of the albino rabbit is, in fact,\nsignificantly more susceptible to corrosive effects than that of humans, whereas pig skin is\nquite similar țo human skin. Surveying a number of studies on the permeability of human\nskin and that of various animal species, Wester and Maibach (1977) conclude:\n\"Comparative studies in vivo on percutaneous absorption have shown the\nskin of monkey and pig to be most relevant to the skin of man. The skin of\nthe rabbit and rat was highly permeable when compared to human skin.\" 7\nThey note further that \"especially in the rabbit, skin penetration is greater than that\nobserved in man.\" Id. at 116-117. As observed by Winter (1971), \"porcine skin\nresembles human skin more closcly than does the skin of any of the common small\nlaboratory animals.\" * Thus, pig skin provides more representative results than does rabbit\nskin in modeling the effects of lactic acid on human skin.\nIn conclusion, we believe that the TNO test, in which pigs exposed to lactic acid\nshowed no adverse effects, deonstrates that this product is not a \"corrosive material\" within\nthe meaning of 49 C.F.R. $173.136(a). If you agree with our conclusion, we ask that you\ncontinuat\nthe exposure times - 3 minutes, 1 hour, and 4 hours - and the observation intervals - 1, 24, 48 and\n72 hours after patch removal - wore substantially identical to those in the TNO test, and thus\nclosely replicated Guideline 404. Id. at 4-5. Based on its observations, IRI concluded that \"Lactic\npages\nAcid Q88 is not corrosive to guinea pig skin.\" Id. at 6.\n71\nWester, R.C. and H.l. Maibach, Percutaneous Absorption in Man and Animal: A\nNew York 1977), at 125.\nPerspective, in Cutaneous Toxicity 111-126 (V.A. Drill and P. Lazar eds., Academic Press Inc.,\nWinter, G., Epidermal Regeneration Studied in the Domestic Pig, in Epidermal Wound\nHealing 71-112 (H.l. Maibach and D.T. Rovee eds., Yearbook Medical Publishers, Chicago 1971),\nat 71.\n\n<<<PAGE 5>>>\n\nID:?\nJAN 17'97\n17:27 No.037 P.05\n:\nPATTON BOGGS, L. L.P.\nMr. Alan I. Roberts\nJanuary 17, 1997\nPage 4\nprovide confirmation that the material would not be a hazardous material, assuming no\nother hazardous attributes. Please do not hesitate to contact me if you have questions\nthis matter.\nabout this letter or require further information. We greatly appreciate your assistance in\nSincerely,\nCarolina L. Mederos\nTransportation Policy Consultant","truncated":false,"body_characters":10045}