{"operation":"document","citation":"05-0175","title":"Kaivac, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2005-08-23","effective_on":null,"summary":"05-0175 response to Kaivac, Inc. concerning 173.137.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0175.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0175.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0175","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2005/050175%20Vitro%20Guidance%20PDF.pdf","body":"<<<PAGE 1>>>\n\nGuidance Relative to the Classification of Corrosive Materials\nBased on recent revisions to the U.S. Hazardous Materials Regulations (HMR; 49 CFR Parts 171-\n180) of in vitro skin corrosion testing protocols, the Pipeline and Hazardous Materials Safety\nAdministration’s (PHMSA) Office of Hazardous Materials Safety is working to ensure that all\ninformation relevant to the use of such test methods is available immediately to stakeholders\nvia its website.\nThe attached guidance issued in conjunction with a Final Rule published in the Federal Register\non January 19, 2011 [76 FR 3308] under Docket No. PHMSA-2009-0126 (HM-215K) is the most\ncurrently available and is provided for the benefit of all concerned parties.\n\n<<<PAGE 2>>>\n\nsrobinson on DSKHWCL6B1PROD with MISCELLANEOUS\nFederal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations\n3333\noverpack. Additionally, an overpack\ncontaining packages of excepted\nquantities is not required to be marked\nwith the word ‘‘OVERPACK.’’\nSection 173.4b\nSection 173.4b prescribes the\nrequirements for de minimis quantities\nof hazardous materials offered for\ntransportation and transported by all\nmodes, domestic or international.\nConsistent with the international\nstandards, PHMSA is adding a new\nparagraph (b) to except non-infectious\nspecimens (e.g., museum specimens)\npreserved with small amounts of certain\nClass 3 (flammable liquid) materials for\nscientific purposes from the\nrequirements of the HMR. This\namendment is consistent with previous\ninterpretations we have issued on this\nmatter indicating these specimens do\nnot pose a risk to safety during the\ncourse of transportations.\nOne commenter (AVMA) expressed\nsupport for the adoption of this\nexception as essential to the conduct of\nprofessional work of veterinarians.\nTherefore, in this final rule, we are\nadopting the exception from full\nregulation under the HMR for non-\ninfectious specimens preserved with\nsmall amounts of certain Class 3\n(flammable liquid) material for scientific\npurposes.\nSection 173.25\nSection 173.25 prescribes the\nrequirements for certain authorized\npackagings and overpacks. Consistent\nwith the international standards,\nPHMSA is requiring an overpack\ncontaining packages of limited quantity\nmaterial marked with the new limited\nquantities marking required by this final\nrule (see the Section 172.315\ndiscussion) to be marked with the word\n‘‘OVERPACK’’ if the markings are not\nvisible, in addition to all other required\npackage markings. This mark is an\nindication that the packages contained\nwithin the overpack are in accordance\nwith the HMR. Additionally, for\nexcepted quantities (see the Section\n173.4a discussion) where the required\npackage markings are not visible inside\nan overpack, the excepted quantities\nmarking must also be placed on the\noverpack. An overpack containing\npackages of excepted quantities is not\nrequired to be marked with the word\n‘‘OVERPACK.’’\nSection 173.27\nSection 173.27 prescribes the general\nrequirements for packaging offered or\nintended for air transportation. In this\nfinal rule, PHMSA is amending\nparagraph (f) by adding a new Table 3\nthat outlines the requirements for\nlimited quantities intended for air\ntransportation consistent with the 2011–\n2012 ICAO Technical Instructions,\nwhere appropriate. See the limited\nquantity, consumer commodity and\nICAO Technical Instructions alignment\nNPRM comment discussion in Section\nIII.A.5 of this rule.\nSection 173.40\nSection 173.40 specifies the general\npackaging requirements for toxic\nmaterials packaged in cylinders.\nPHMSA is amending paragraph (c)(1)\nconcerning closure requirements by\nrequiring the valve connections on UN\nSpecification cylinders to be made by a\ntaper thread or some other means in\naccordance with ISO Standard 10692–\n2:2001.\nSection 173.58\nSection 173.58 outlines the\nassignment of class and division for new\nexplosives. Based on a recommendation\nfrom comments provided by IME, we\nare revising paragraph (a)(5) to include\na reference to the Type 6(d) test for\ndetermination of Division 1.4S\nclassification for consistency with the\nadoption of the new test.\nSection 173.59\nSection 173.59 provides definitions of\nexplosive terms that are intended for\ninformation only. The UN Committee of\nExperts (COE) recently defined the term\n‘‘phlegmatized’’ to meaning the addition\nof a substance to an explosive to\nenhance its safety in handling and\ntransport. One commenter indicated\nsupport for adoption of the proposed\ndefinition of ‘‘phlegmatized,’’ therefore,\nin this final rule PHMSA is adopting the\ndefinition in the HMR as proposed.\nSection 173.63\nSection 173.63 specifies packaging\nexceptions for limited quantities of\ncertain Division 1.4S explosive articles\nauthorized for reclassification and\ntransport as ORM–D material. Prior to\noffering for transportation by aircraft,\n‘‘Cartridges, power devices, ORM–D–\nAIR’’ (UN0323), must have been\nsuccessfully tested in accordance with\nthe new UN Test Series Type 6(d) test\nbeginning July 1, 2011. See the Section\n172.102, Special Provision 347\ndiscussion. This requirement is a\ncondition for the continuation of a\nDivision 1.4S classification and for\nreclassification to ORM–D for limited\nquantities of such articles intended for\ntransportation by international highway,\nrail and vessel and domestic vessel\neffective January 1, 2012. Limited\nquantities of such articles approved as\nDivision 1.4S prior to January 1, 2012,\nmay continue to be reclassed as ORM–\nD and offered for domestic highway and\nrail transportation only until January 1,\n2014.\nSection 173.120\nSection 173.120 defines Class 3\n(flammable liquid) material. PHMSA is\nrevising paragraph (c) to add new\ntesting methods for determining the\nflash point of a liquid. See Section 171.7\nfor a listing of materials incorporated by\nreference pertaining to § 173.120.\nSection 173.121\nSection 173.121 prescribes the\npacking group assignment for flammable\nliquids. The HMR do not specify a test\nmethod for determining the boiling\npoint of a liquid which may be\nnecessary for liquids with very low flash\npoints. PHMSA is revising paragraph (a)\nto add new testing methods for\ndetermining the boiling point of a\nliquid. See Section 171.7 for a listing of\nmaterials incorporated by reference\npertaining to § 173.121.\nSection 173.124\nSection 173.124 defines Class 4\nmaterial. For consistency with a\nrevision adopted in the UN Model\nRegulations, PHMSA is amending the\ndefinition of ‘‘self-heating’’ in\n§ 173.124(b)(2) of the HMR to read:\n‘‘Self-heating of a substance is a process\nwhere the gradual reaction of that\nsubstance with oxygen (in air) generates\nheat. If the rate of heat production\nexceeds the rate of heat loss, then the\ntemperature of the substance will rise\nwhich, after an induction time, may\nlead to self-ignition and combustion.’’\nSection 173.137\nSection 173.137 establishes test\ncriteria and packing group assignments\nfor Class 8 (corrosive) material. Since\n1993, PHMSA has authorized under the\nterms of a special permit (i.e., DOT–SP\n10904) an in vitro test method (available\ncommercially as Corrositex®) as an\nalternative form of testing to that\nspecified in the HMR, which is based on\nlive animal test results, to determine the\ncorrosivity of certain materials.\nMaterials authorized for analysis using\nthe alternative test method include\nacids (and their derivatives), acyl\nhalides, alkylamines and\npolyalkylamines, bases, chlorosilanes,\nmetal halides, and oxyhalides.\nThe UN COE recently recognized and\nadopted in vitro test methods in the UN\nModel Regulations as an alternative\nform of testing to that specified in OECD\nGuideline for Testing of Chemicals,\nNumber 404, ‘‘Acute Dermal Irritation/\nVerDate Mar<15>2010 18:10 Jan 18, 2011 Jkt 223001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 E:\\FR\\FM\\19JAR3.SGM 19JAR3\n\n<<<PAGE 3>>>\n\nsrobinson on DSKHWCL6B1PROD with MISCELLANEOUS\n3334 Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations\nCorrosion.’’ The following alternative in\nvitro test methods include OECD\nGuidelines for the Testing of Chemicals:\n• No. 430, ‘‘In Vitro Skin Corrosion:\nTranscutaneous Electrical Resistance\nTest (TER)’’ (2004);\n• No. 431, ‘‘In Vitro Skin Corrosion:\nHuman Skin Model Test’’ (2004); and\n• No. 435, ‘‘In Vitro Membrane Barrier\nTest Method for Skin Corrosion’’ (2006).\nA positive test result under in vitro\nmethods 430 and 431 may be used to\ndetermine corrosivity for transportation\npurposes but cannot be used to\ndetermine the PG assignment. A\nnegative result for corrosivity under in\nvitro methods 430 and 431 can preclude\nfurther testing to determine PG\nassignment using method 404, the\ncurrent OECD Guideline involving in\nvivo testing, or method 435, the newly\nadopted OECD Guideline involving in\nvitro testing.\nBased on the adoption of three new\nOECD guidelines for the in vitro testing\nof materials for corrosivity in the UN\nModel Regulations and through\nencouragement from PETA to adopt\nthese new test methods in a petition for\nrulemaking (P–1550), we proposed to\nadopt such guidelines as matter\nincorporated by reference (IBR) in\n§§ 171.7 and 173.137 of the HMR.\nIn response to our proposal to\nincorporate several in vitro test methods\nfor determination of corrosivity,\nPHMSA has received over 900\ncomments supporting the proposal,\nincluding a comment from PETA. We\nreceived no opposition. Therefore, we\nare adopting the OECD Guideline Test\nNos. 430, 431, and 435, and revising\nTest No. 404 as proposed. Further,\nPETA urged PHMSA to facilitate access\nto DOT–SP 10904 through our Web site\nuntil such a time that this final rule\nbecomes effective, and requested that\nPHMSA remove letters of interpretation\nthat they believe recommend the use of\nin vivo testing even though alternative\nin vitro testing is available.\nWith regard to PETA’s additional\nrequests, they are beyond the scope of\nthis rulemaking. However, we note that\nin prior correspondence with PETA,\nPHMSA has indicated that information\nabout DOT–SP 10904 can be obtained\nby entering ‘‘Corrositex’’ in the search\nfeature of the PHMSA Office of Hazmat\nSafety Web site. Also, the special permit\nmay be accessed by entering ‘‘10904’’ in\nthe search feature on our special permits\nWeb site or by conducting a group\nnumber search.\nWe agree with PETA that non-live\nanimal testing should be used where\navailable and encourage shippers to use\nthe in vitro test methods to determine\nthe classification of a material as\ncorrosive and assignment of a packing\ngroup. We also remind shippers that\nhistorical data may also be used to\nclassify a material in accordance with\n§ 173.136(c). Thus, in this final rule we\nare revising § 173.136(a) to codify the\nauthorization to use in vitro test\nmethods and to highlight the\navailability of classifying a material\nbased on historical data.\nSections 173.150, 173.151, 173.152,\n173.153, 173.154 and 173.155\nSections 173.150 through 173.155\nprescribe the exceptions for certain\nClass 3, 8 and 9 and Division 4.1, 4.2,\n4.3, 5.1, 5.2, 6.1 hazardous materials\nunder the HMR. In this final rule,\nPHMSA is revising each of these\nsections to recognize the UN Model\nRegulations and IMDG Code package\nquantity limits for the highway, rail, and\nvessel transportation of limited\nquantities. No limited quantity limits\ndecrease and two increase slightly to\nmaintain alignment with the\ninternational standards for transport by\nother than aircraft. Additionally, the\npackaging provisions for ‘‘Polyester\nresin kits’’ are removed from § 173.152,\nas proposed, and placed in new\n§ 173.165 for clarity.\nWhen PHMSA lowered the quantity\nlimits for Division 6.1 (poisonous)\nmaterials of PG II (primary or\nsubsidiary) authorized as a limited\nquantity in a final rule published under\nDocket HM–215G (70 FR 34065, June\n13, 2005), it did not authorize the\nlabeling exception for such packages\nwhen intended for transportation by\nhighway, rail and vessel, nor did it\nauthorize renaming and reclassification\nas ‘‘Consumer commodity, ORM–D’’ for\nsuch materials. In this final rule, except\nfor transportation by aircraft, we are\nauthorizing the labeling exception for\npackages of limited quantity material\nwith a Division 6.1, PG II primary or\nsubsidiary hazard and, until December\n31, 2013, we are authorizing renaming\nand reclassification as ‘‘Consumer\ncommodity, ORM–D’’. Additionally,\nuntil December 31, 2012, a consumer\ncommodity as defined in § 171.8 in\neffect on October 1, 2010 may continue\nto be packaged, reclassed and marked\n‘‘ORM–D–AIR’’ either in accordance\nwith the new Table 3 of § 173.27(f) or\n§§ 173.150 through 173.155 and\n173.306, as applicable. PHMSA fully\nbelieves this eventual alignment with\ninternational standards will improve\nclarity, promote regulatory compliance,\nreduce employee training costs and\nenhance safety overall.\nSection 173.161\nSection 173.161 prescribes packaging\nrequirements for chemical kits and first\naid kits containing small amounts of\nhazardous materials. In this final rule,\nPHMSA is editorially revising the\nsection. In addition, PHMSA is\nauthorizing transport of dry ice in\naccordance with § 173.217 in packaging\nauthorized under this section when\nused as a refrigerant for the contents of\na kit.\nSection 173.165\nA new section 173.165 is added to\nprescribe packaging and other\nrequirements for ‘‘Polyester resin kits,\nUN3269’’ formerly contained in\n§ 172.102, special provision 40 and\n§ 173.152(b)(4) of the HMR. This\namendment is intended to provide\nclarification of existing requirements\nwhile also harmonizing the HMR with\ninternational standards.\nSection 173.167\nA new section 173.167 is added to\nindicate authorized materials and\nquantity limits for articles and\nsubstances that may be described as\n‘‘ID8000, Consumer commodity,’’ when\nintended for transportation by all modes\nof transport provided all or some of the\ntransportation is by aircraft. Such\narticles and substances eligible for\nclassification or reclassification to Class\n9 are Class 2 materials (non-toxic\naerosols only), Class 3 materials\n(Packing Group II and III only), Division\n6.1 (Packing Group III only), UN/\nNA3077, UN/NA3082, and UN3175,\nprovided such materials do not have a\nsubsidiary risk and are authorized\naboard a passenger-carrying aircraft.\nInner and outer packaging quantity\nlimits are based on Packing Instruction\nY963 of the 2011–2012 ICAO TI.\nSpecification outer packagings are not\nrequired under the conditions\nprescribed in this section. Additionally,\nthe pressure differential capability of\nthe inner packagings of a combination\npackaging intended to contain liquids is\nreduced from 95 kPa to 75 kPa for\nmaterials offered for transportation and\ntransported by aircraft under the\nprovisions of this section.\nSection 173.220\nSection 173.220 provides exceptions\nfrom regulation under the HMR for the\ntransport of internal combustion\nengines, self-propelled vehicles,\nmechanical equipment containing\ninternal combustion engines, and\nbattery-powered vehicles or equipment.\nThis section is revised to include\nengines, vehicles, and equipment\npowered by fuel cells consistent with\nVerDate Mar<15>2010 18:10 Jan 18, 2011 Jkt 223001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\\FR\\FM\\19JAR3.SGM 19JAR3","truncated":false,"body_characters":15146}