{"operation":"document","citation":"16-0116","title":"UL Supply Chain & Sustainabilty — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2019-05-29","effective_on":null,"summary":"16-0116 response to UL Supply Chain & Sustainabilty concerning 172.101, 173.132.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0116.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0116.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0116","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/71481/160116.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMay 29, 2019\nMr. Kevin Skerrett\nSenior Regulatory Specialist\nUL Supply Chain & Sustainability\n23 British American Boulevard\nLatham, NY 12110\nReference No. 16-0116\nDear Mr. Skerrett:\nThis letter is in response to your June 29, 2016, email and subsequent telephone conversation\nwith a member of my staff requesting clarification of the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180) applicable to methanol solutions when shipped domestically and\ninternationally.\nIn your email, you note that methanol has two entries in the Hazardous Materials Table (HMT):\n• The first entry describes methanol as a Class 3, PG II material. The letter \"D\" in Column\n1 of the HMT identifies this material as being suitable for domestic transportation.\n• The second entry describes methanol as a Class 3, (6.1), PG II material. Column 1 of the\nHMT depicts both the letter \"I\" and the \"plus\" ( +) sign. The letter \"I\" identifies proper\nshipping names appropriate for describing materials in international transportation. The\n(+) sign fixes the proper shipping name, hazard class, and packing group for that entry\nwithout regard to whether the material meets the definition of that class, packing group,\nor any other hazard class definition.\nYou ask a series of questions related to the applicability of the Division 6.1 (Toxic) subsidiary\nhazard to methanol. Your questions are paraphrased and answered below:\nQ 1. You ask whether human health experience takes precedent over the classification criteria\ndetermined by animal testing presented in § 1 73 .13 2( a)( 1) through ( c).\nAl. The answer is yes. Animal testing data obtained in accordance with§ 173.132 may be\nused when there is an absence of data on human toxicity. For the purposes of the HMR, a\nDivision 6.1 (Toxic) material is a material, other than a gas, which is known to be so\ntoxic to humans as to afford a hazard to health during transportation, or which, iv the\nabsence of adequate data on human toxicity is presumed [ emphasis added] to be toxic to\nhumans because it falls within any of the categories presented in§ 173.132 when tested\non laboratory animals.\n\n<<<PAGE 2>>>\n\nQ2. A2. Q3. A3. Q4. A4. Q5. AS. You ask whether the International Maritime Dangerous Goods Code (IMDG Code), the\nInternational Civil Aviation Organization Technical Instructions for the Safe Transport of\nDangerous Goods by Air (ICAO Technical Instructions), and the United Nations Model\nRegulations on the Transport of Dangerous Goods (UN Model Regulations) concur with\nthe HMR with respect to the use of human health experience over animal testing data.\nThe answer is yes. The IMDG Code in 2.6.2.2.2, the ICAO Technical Instructions in\n2.6.2.2.2, and the UN Model Regulations in 2.6.2.2.2 state that in making packing group\nassignments, account shall be taken of human experience in instances of accidental\npoisoning and special properties possessed by any individual substance, such as liquid\nstate, high volatility, any special likelihood of penetration, and special biological effects.\nParagraph 2.6.2.2.3 of all three standards further states that in the absence of human\nexperience the groupings shall be based on data obtained from animal experiments.\nYou ask whether the statements in§ l 73.132(a) and 2.6.2.2.2 of the IMDG Code, the\nICAO Technical Instructions, and the UN Model Regulations apply only to the listed\n\"pure\" material or is it implied for all mixtures and solutions of the material.\nThe statements in§ 173.132(a) and 2.6.2.2.2 of the IMDG Code, the ICAO Technical\nInstructions, and the UN Model Regulations regarding the use of human experience is not\nspecific to a listed \"pure\" material and can be applied to materials listed in the HMT and\ntheir solutions.\nIn your email, you note that no experimental oral, dermal, or inhalation human toxicity\nvalues exist for methanol. You ask if a shipper can apply animal testing data for a\nmixture or solution of a listed substance, such as methanol, for which there is no human\nexperience data for a specific concentration.\nIt is the shipper's responsibility to properly classify and describe a hazardous material.\nThe international entry for methanol is assigned a(+) sign in Column 1 of the HMT, and\nthis means that the material is known to pose a risk to humans. The ( +) sign no longer\nneeds to be considered when the mixture or solution does not exhibit the same hazard to\nhumans. In this example, the material may be described using an alternative proper\nshipping name that represents the hazards posed by the material. See § 172.101 (b )(1 ).\nYou ask what constitutes acceptable evidence that a mixture or solution is significantly\ndifferent or poses no hazard to humans.\nTo make that determination, you must identify available human toxicity data for\nmethanol and use that data to determine if a mixture or solution is still toxic. If you find\nthat the hazards to humans are significantly different from that of the pure methanol or\n\n<<<PAGE 3>>>\n\nthat no hazard to humans is posed, the material may be described using an alternative\nshipping name that represents the hazards posed by the material.\nQ6. You ask whether§ 172.1 0l(b)(l) allows the shipper to omit the Division 6.1 (Toxic)\nsubsidiary hazard or only select an alternative shipping name that describes the material\nas toxic.\nA6. See A5.\nQ7. A 7. Q8. A8. Q9. A9. You ask whether a shipper must describe a solution that contains methanol and assigned .\nan alternate proper shipping name with a Division 6.1 (Toxic) subsidiary hazard.\nA solution containing methanol must be described by an appropriate proper shipping\nname from the HMT that reflects the hazards of the solution. If you find that the hazards\nto humans are significantly different from that of the pure methanol or that no hazard to\nhumans is posed, the material may be described using an alternative shipping name that\nrepresents the hazards posed by the material. In this instance, the most appropriate\ndescription for the material shall be determined in accordance with § 172.101 ( c )(10).\nYou ask whether an approval from the Associate Administrator is required to use an\nalternate proper shipping name.\nThe approval from the Associate Administrator to use an alternate proper shipping name\nis required for instances when a ( +) sign is assigned to a mixture or solution according to\n§ 172.l0l(b)(l). In the case of methanol, the(+) sign is affixed to a pure substance. If\nyou were to dilute that pure substance in a solution to a point at which the hazard to\nhumans is significantly different than the pure substance or where no hazard to humans is\nposed, the ( +) sign would no longer be applied to that material, and the shipper would be\nrequired to assign a new proper shipping name to the material based on its current\nproperties and hazard characteristics.\nYou ask whether the answers to A6 through A8 differ if the material is offered for\ninternational transport.\nThe answer is no. The IMDG Code in 3.1.3, the ICAO Technical Instructions in 3.1.3,\nand the UN Model Regulations in 3.1.3 state that a mixture or solution is not subject to\nthe regulations if the characteristics, properties, form or physical state of the mixture or\nsolution are such that it does not meet the criteria, including human experience criteria,\nfor inclusion in any class.\nQlO. In your email, you note that in 2003 the United States submitted a proposal to the United\nNations Sub-Committee of Experts on the Transport of Dangerous Goods (the Sub-\n\n<<<PAGE 4>>>\n\nAl 0. Q 11. Al 1. Q12. Al 2. Committee) to amend the existing entries for methanol to add a PG III entry for methanol\nand methanol solutions without the Division 6.1 (Toxic) subsidiary hazard. You further\nnoted that this proposal was not adopted because the Sub-Committee determined that the\nDivision 6.1 (Toxic) subsidiary hazard label was justified by human experience not only\nfor the pure substance, but also for dilute solutions. Based on this, you ask whether\ndilution is an acceptable method to omit the Division 6.1 (Toxic) subsidiary hazard from\nmethanol solutions in international transport.\nThe criteria for assigning a UN number and a proper shipping name are outlined in\nChapter 2 of the IMDG Code, the ICAO Technical Instructions, and the UN Model\nRegulations. As described in 2.0.2.6 in both the UN Model Regulations and the IMDG\nCode (2.0.3.6 in the ICAO Technical Instructions), for a solution or mixture when the\nhazard class, the physical state or the packing group is changed in comparison with the\nlisted substance, the appropriate n.o.s. entry shall be used including its packaging and\nlabelling provisions. A solution or mixture of methanol may not be subject to the IMDG\nCode, the ICAO Technical Instructions, or the UN Model Regulations if the\ncharacteristics, properties, form or physical state of the mixture or solution are such that it\ndoes not meet the criteria, including human experience criteria, for inclusion in any class.\nThe fact that the Sub-Committee did not adopt the 2003 proposal has no impact on how\nmixtures or solutions should be classified.\nYou ask whether there is a negligible or de minimis concentration of methanol below\nwhich the toxic hazard has dropped to a negligible risk.\nThere is no definitive concentration that would except a mixture or solution containing\nmethanol from the HMR; however, if the concentrations are so low that the material no\nlonger meets the criteria for any hazard class, the material may no longer be considered\nhazardous. Each mixture or solution must be evaluated in the form it will be shipped to\ndetermine whether it should be considered a hazardous material.\nYou ask whether there was any indication from the Sub-Committee, including approval,\nfor calculating or testing to omit the Division 6.1 (Toxic) subsidiary hazard for mixtures\nor solutions containing methanol.\nThe criteria for assigning a UN number and a proper shipping name are outlined in\nChapter 2 of the IMDG Code, the ICAO Technical Instructions, and the UN Model\nRegulations. As described in 2.0.2.6 in both the UN Model Regulations and the IMDG\nCode (2.0.3.6 in the ICAO Technical Instructions), for a solution or mixture when the\nhazard class, the physical state or the packing group is changed in comparison with the\nlisted substance, the appropriate n.o.s. entry shall be used including its packaging and\nlabelling provisions. A solution or mixture of methanol inay not be subject to the IMDG\nCode, the ICAO Technical Instructions, or the UN Model Regulations if the\n\n<<<PAGE 5>>>\n\nQ 13. A 13. Q14. A14. Q 15. Al 5. Q 16. A16. characteristics, properties, form or physical state of the mixture or solution are such that it\ndoes not meet the criteria, including human experience criteria, for inclusion in any class.\nYou ask whether the Sub-Committee has further discussed the classification of mixtures\nand solutions of methanol since 2003.\nThe answer is no. Since 2003 there have been no further discussions specific to the\ntransport of mixtures or solutions of methanol.\nYou ask whether a shipper can use calculations and methods authorized by the Globally\nHarmonized System of Classification and Labelling of Chemicals (GHS).\nThe answer is no. When an entry is assigned a(+) sign in Column 1 of the HMT, the\nhazard class and packing group are fixed, regardless of whether that material meets the\ndefinition of that hazard class, packing group, or any other hazard class definition. For\nmaterials not assigned a(+) sign in Column 1 of the HMT, transport classification\ndecisions must utilize the criteria described in § 1 73 .13 2 of the HMR and Chapter 2 of\nthe IMDG Code, the ICAO Technical Instructions, and the UN Model Regulations.\nParagraph 2.2.61.1.14 of the European Agreement Concerning the International Carriage\nof Dangerous Goods by Road (ADR) includes a provision that exempts certain\nsubstances, mixtures and solutions from consideration as a Division 6.1 (Toxic) material.\nYou ask whether this rationale is appropriate for the classification of methanol mixtures\nor solutions.\nParagraph 2.2.61.1.14 of the ADR references two European Council directives. It is the\nopinion of this Office that provided those directives specifically address methanol\nmixtures and solutions it may be appropriate to utilize these directives in making\nclassification decisions for transport between ADR contracting parties. However, the\nU.S. is not a contracting party to the ADR and we recommend directing this question to\nan appropriate ADR contracting party. A List of Competent Authorities for the\napplication of ADR is available through the following URL:\nhttp://www.unece.org/trans/danger/publi/adr/country-info e.html (last visited May 16,\n2019).\nYou ask whether there have been any proposals to provide a similar reference in the GHS\nor the UN Model Regulations.\nWe are not aware of any proposals to extend references to these European Council\nDirectives to the GHS or the UN Model Regulations.\n\n<<<PAGE 6>>>\n\nQ 17. Al 7. Ql8. Al 8. In letter of interpretation (LOI) 04-0204 PHMSA agreed that the concentration of\nmethanol in various mixtures described in LOI 04-0134 was sufficiently diluted such that\nthe mixture posed no toxicity hazard to humans. You ask what was the methanol\nconcentration in the product discussed in LOI 04-0134.\nThe product described in LOI 04-0134 contains various concentrations of hydrogen\nperoxide (20%- 39%), methanol (4%-13%), and water (48%- 76%).\nYou ask what was the rationale for agreeing that the mixture described in LOI 04-0134\ndid not pose a hazard to humans.\nThe review of the mixtures described in LOI 04-0134 (i.e., that they did not pose a hazard\nto humans) was based on our assessment of the information provided for that product at\nthat time.\nI hope this information is helpful. If you have further questions, please do not hesitate to contact\nthis office.\nSincerely,\nShane C. Kelley\nDirector,\nStandards and Rulemaking Division\n\n<<<PAGE 7>>>\n\nGoodall, Shante CTR (PHMSA)\nFrom:\nSent:\nTo:\nSubject: I -0 11eo\nRivera, Jordan CTR (PHMSA)\nWednesday, June 29, 2016 5:20 PM\nHazmat Interps\nFW: PHMSA Interpretation request - International classification of methanol mixtures\nHi Shante/Alice,\nPlease submit this as a letter of interpretation. Mr. Skerrett has spoken multiple individuals in the Info Center on this\nissue.\nPlease let me know if you have any questions.\nThanks,\nJordan\nFrom: Skerrett, Kevin [mailto:Kevin.Skerrett@ul.com]\nSent: Wednesday, June 29, 2016 3:41 PM\nTo: PHMSA HM InfoCenter\nSubject: PHMSA Interpretation request - International classification of methanol mixtures\nWe are looking for some guidelines regarding the dilution of the toxicity of methanol for dilutions and solutions shipped\ninternationally.\nSince we currently have reviews on hold for these issues, which can block shipping of product, we would like to request\nan informal response (by phone or email) as quickly as possible, followed by a formal letter of interpretation in your\nnormal timeframe.\nWe review supplier classifications for the benefit of downstream users, and this issue has been increasingly difficult to\ndeal with.\nSuppliers provide a variety of rationales for why their product dilution does not require the 6.1 subsidiary hazard for\nmethanol shipped internationally.\nWe want to know which of these are acceptable, and whether acceptability requires an approval or other authorization\nfrom a Competent Authority (CA), such as PHMSA, or if the supplier's professional judgment alone is sufficient.\nThe problem is the \"human experience\" indicated for methanol by the \"plus sign\" in column A (DOT), Special Provision\nA113 (ICAO/IATA) and Special Provision 279 {IMDG and UN Model Regs).\n173.132 (a) appears to indicate that human health experience is precedent over the LDSO calculations presented in the\nrest of 173.132- but provides no means of calculating packing group, or dilution of the hazard to a non-regulated level,\nwhen \"human experience\" is involved.\nThis is a problem for all 20+ materials carrying this indication, but methanol is particularly a concern, since:\n1) DOT allows a domestic alternative that does NOT include the 6.1 subsidiary hazard\n2) Methanol is very common in many consumer and retail products, in a wide variety of concentrations.\nWe are primarily interested in the international shipment methanol, but if the answers to any of the questions below\nwould differ for methanol relative to the other \"human experience\" case, please do indicate that if possible.\nBelow are the questions we believe would help us understand this better:\n1\n\n<<<PAGE 8>>>\n\nA) B) C) D) 173.132 (a) indicates that 6.1 applies to a material \" ... which is known to be so toxic to humans as to afford a\nhazard to health during transportation, or which, in the absence of adequate data on human toxicity:\"\n, it then\nprovides the LOSO definitions and calculations.\na. This appears to indicate that human health experience is precedent over the LOSO calculations\npresented in the rest of 173.132 - is that correct?\nb. c. d. Do the international regs (specifically IMDG and !CAO and TDG) have this same understanding?\nDoes this only apply to the listed (pure) material, or is it implied for 2'.l dilutions and solutions of it?\nSuppliers correctly point out that there is no human LDS0 data for methanol - nor should there be. For\na solution of a material listed by its technical name (like methanol), if there is no human experience data\nfor the specific concentration, can the animal LDS0 calculations then be applied?\ne. It is clear that in the absence of human experience, no approval by PHMSA or other CA is required for a\nshipper to apply the LOSO calculations. Is that still true if \"human experience\" is involved? Can a LDS0\nrationale be allowed without approval, or only with it?\n172.101 (b)(l) defines the \"plus sign\" in Column A of the 172.101 table. It is clear that this locks in the\nclassification for the listed material - but less clear for dilutions and other solutions. It indicates 'When a plus\nsign is assigned to mixtures or solutions containing a material where the hazard to humans is significantly\ndifferent from that of the pure material or where no hazard to humans is posed, the material may be described\nusing an alternative shipping name that represents the hazards posed by the material. An appropriate alternate\nproper shipping name and hazard class may be authorized by the Associate Administrator.\"\na. What is considered acceptable evidence that the hazard to humans is \"significantly different\" or \"no\nhazard\"? No guidance for this appears in 173.132.\nb. This appears to allow dropping the 6.1 subsidiary hazard, as opposed to just selecting an alternate name\nthat continues to carry the 6.1 hazard - is that correct?\nc. Suppliers have told us that this (the plus sign) does not apply if a different UN# must be selected based\non other hazards the material presents - is this correct? Or does the 6.1 carry through unless specifically\naddressed?\nd. Is an approval or authorization by the Associate Administrator required for use of an alternate shipping\nname? The word \"may\" makes this appear optional, and thus not necessary for the supplier to pursue.\ne. Do the answers to these questions differ for international shipment vs. domestic?\nOn 14 April 2003 the expert from the US submitted to the UN a request (ST/SG/AC.10/C.3/2003/23) to add,\ninternationally, a Methanol PG Ill listing that would drop the 6.1 subsidiary hazard based on dilution. The UN\nresponse (ST/SG/AC.10/C.3/46 of 16 July 2003) indicated, in part, \"76. Many experts said that they could not\nsupport the proposal because it was well known that methanol was responsible for numerous deaths due to\ningestion of adulterated alcohol and therefore they considered that the Division 6.1 label was justified by human\nexperience not only for pure methanol but also its solutions.\" The US expert then withdrew the proposal.\na. This appears to indicate that the international community does not consider dilution to be acceptable\nfor dropping the 6.1 subsidiary, at least not without an approval - is that correct?\nb. \"Common sense\" is often quoted by suppliers as a rationale for declassification by dilution - is there at\nleast a \"deminimis\" threshold below which the international experts agree that the hazard has dropped\nto negligible risk?\nc. In these negotiations, was ANY route, including approval, indicated for calculating or testing to a\nreduction of the 6.1 hazard?\nd. Has anything further occurred along these lines with the UN?\nGHS calculations are increasingly used as justification for dropping the 6.1 subsidiary hazard for methanol\nsolutions- including aspects that are not in the HMR. Can these be used, or only with approval, or not at all?\na. Since Rat LD50 values might not reflect human toxicity, ATE values are drawn from Table 3.1.1 (GHS 5th\ned.) and then used in the calculations. It is felt that this would address human toxicity, since the 6.1\nwould be assigned based on \"human toxicity\" - effectively a stand-in for \"human LOSO\". Analogy is\nmade between GHS Category 3 and HMR PG 111, and so then Category 3 ATEs are used to calculate the\nsolution's LDS0 and this is used to determine PG . Is this an acceptable approach? With or without\napproval?\nb. Given methanol's flashpoint (12°C) and the precedence table (173.2(b)), it is possible that the toxicity of\nmethanol could have been assigned as PG II - we cannot tell on what basis the 6.1 was assigned to\nMethanol - could the Category 2 ATEs be used as a \"worst case\" calculation instead?\n2\n\n<<<PAGE 9>>>\n\nE} F) c. GHS (5th ed.) includes 3.1.3.6.2.l(b), which appears to specifically address the \"human toxicity\" issue. It\nspecifies that the tox roll-up calculation (similar to 173.132(c)(3) may use ATEs in cases when: \"(b)\nEvidence from human exposure that indicates toxic effects but does not provide lethal dose data\". Does\nthis provide an acceptable rationale for transport classification by ATEs? Is this under consideration for\nthe HMR or other transport regs?\nADR (and RID and ADN) include a clause in their 6.1 classification sections as 2.2.61.1.14 that addresses using\nthe EU DSD and DPD classifications in transport: \"Substances, solutions and mixtures, with the exception of\nsubstances and preparations used as pesticides, which do not meet the criteria of Directives 67 /548/EEC3 or\n1999/45/EC4 as amended and which are not therefore classified as highly toxic, toxic or harmful according to\nthese directives, as amended, may be considered as substances not belonging to Class 6.1.\" ·\na. This appears to be specific to EU regs, and I do not find similar wording elsewhere. Is this a valid\nrationale for declassifying 6.1 for methanol mixtures?\nb. Has there been any discussion of extending this to GHS and the UN Model regs?\nPHMSA interpretation 04-0204 appears to be an example of PHMSA agreeing with the dropping of the 6.1\nsubsidiary for methanol for international shipment based on dilution.\na. No concentrations were given - were these available on the original request (04-0134}? I could not find\na copy of that.\nb. No rationale or calculation was given by the requester or by PHMSA - was any determined, and could\nthis be the basis of guidance?\nI apologize for the degree of detail, but these are all rationales that we have been presented with.\nAfter verbal discussion with the HMIC, our understanding was that an approval or authorization would be necessary for\nany of the above - but we would be happy to be wrong about that!\nAlthough we recognize that a receiver is entitled to reship material as received from a supplier per 171.2(b), as long as\nthere is no reason to believe it is incorrect, we believe that due diligence regarding this issue requires that it be clarified.\nI can be reached by cellphone at (518) 229-7302 or by email at kevin.skerrett@ul.com\nThank you very much for your attention to this request!\nKevin Skerrett\nSenior Regulatory Specialist, Chemicals & Formulated Products\nUL Supply Chain & Sustainability\nUL\n23 British American Blvd.\nLatham, NY 12110, USA\nM: +15182297302\nW: www.ul.com\nwww.thewercs.com\nThis e-mail may contain privileged or confidential information. 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