{"operation":"document","citation":"16-0143R","title":"Mark Hawk — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2017-11-09","effective_on":null,"summary":"16-0143R concerning 173.415, 173.461, 173.465.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0143r.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0143r.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0143r","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/56081/160143r.pdf","body":"<<<PAGE 1>>>\n\nMark B. Hawk\nPackaging Management Council Coordinator\n49 Palisades Parkway\nOak Ridge, TN 37830\nReference No. 16-0143R\nDear Mr. Hawk:\nThis letter revises our March 30, 2017, response to your August 29, 2016, letter in which you\nrequested clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180)\napplicable to DOT Specification 7A Type A (Type A) packagings. Specifically, you ask about\nchanges made to documentation requirements for Type A packagings as a result of the HM-250\nfinal rule (July 11, 2014; 79 FR 40596).\nWe have paraphrased and answered your questions as follows:\nQ1.\nYou ask if an offeror may satisfy the requirements of § 173.415(a)(1)(i) by documenting\na \"good faith effort\" to obtain missing elements of the test documentation information for\nType A packagings that were in existence prior to the changes made under the HM-250\nfinal rule if they prove to be unobtainable.\nAl.\nThe answer is no. No provisions in the HMR state that a \"good faith effort\" may serve as\na substitute for compliance with HMR requirements.\nQ2. You ask if an offeror may use other (non-testing) methods in accordance with § 173.461\nto provide the missing testing documentation information required by § 173.415(a)(1)(i)\nfor existing Type A packagings that had been subjected to the physical tests of § 173.465.\nA2. The answer is yes. For demonstration of compliance, the HMR permit the use of non-\ntesting methods in § 173.461.\nQ3. You ask if it was PHMSA's intent in HM-250 to require retroactive retesting of Type A\n• packagings that had already successfully passed testing under § 173.415(a)(1)(i).\nA3. PHMSA's intent was to hold all Type A packaging documentation to the same\nrequirements. PHMSA allowed for a transition period for the new documentation\nrequirements with a compliance date of January 1, 2017, instead of the July 13, 2015,\n\n<<<PAGE 2>>>\n\nparagraph (a)(1)(i) when one or more elements therein are found to be unobtainable for\nexisting previously tested Type A packagings.\nA4.\nThe documentation requirements are not limited to packagings that were constructed and\ntested after January 1, 2017. All Type A packagings that are offered for shipment after\nJanuary 1, 2017, must meet the documentation provisions required by HM-250.\nElements of the documentation requirements in § 173.415 may be supplemented by\nproviding a detailed analysis as described in § 173.415(a)(1)(ii). If any elements of the\ndocumentation requirements cannot be fulfilled by analysis, then additional testing may\nbe required.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerel\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\n1200 New Jersey Avenue, SE\nWashington, DC 20590-0001\nSubject: Docket No. PHMSA-2009-0063 (HM-250)'\nTo Whom It May Concern:\nThe subject docket introduced a change to 49 CFR § 173.415 \"to include more detailed language\ndescribing the kinds of information expected to be included as part of the Type A package\ndocumentation\" (40596). Upon review, the test documentation information of § 173.415(a)(1)(i) has\nbeen deemed problematic enough to warrant asking the following questions:\nQ1.\nWhen an offeror has made a good faith effort to retroactively obtain the test documentation\ninformation in the new § 173.415(a)(1)(i) for existing previously-tested DOT Specification 7A\nType A packagings, and found one or more elements to be unobtainable, may the offeror satisfy\nthe regulation by documenting a good faith effort to obtain the unobtainable elements and\ncertifying that no such record exists for those particular unobtainable elements? This logic\nwould be similar to the allowance granted to motor carriers under § 391.23 when they find\nthemselves unable to obtain driving records or safety performance history information after\nmaking a good faith effort.\n02.\nMay the offeror use other (non-testing) methods under § 173.461 to satisfy the missing\nelements of the new § 173.415(a)(1)(i) for existing Type A packagings that had actually been\nsubjected to the physical tests of § 173.465 prior to HM-250? Please keep in mind that, in some\ncases, offerors lack the expertise to demonstrate compliance through non-testing means such as\nengineering evaluations and do not possess a manufacturer's certification that contains all the\nnew elements of § 173.415(a)(1)(I).\nQ3.\nWas it PHMSA's intent to require retroactive retesting of Type A packagings--that had already\nsuccessfully passed testing under § 173.465 prior to publication of HM-250—in order to satisfy\nthe missing elements of the new § 173.415(a)(1)(i)? If so, then why did the HM-250 preamble\nnot discuss the issue of retesting in the context of § 173.415(a)(1)(i) or provide any associated\ncost analysis?\nQ4.\nWould PHMSA (1) limit the scope of § 173.415(a)(1)(i) to packagings constructed and tested\nafter January 1, 2017, or (2) advise on the best pathway to achieve relief from (a)(1)(i) when one\nor more of the elements therein are found to be retroactively unobtainable for existing\npreviously-tested Type A packagings?\n\" Federal Register, 79 FR 40590, July 11, 2014 (also 76 FR 50332, August 12, 2011).\n\n<<<PAGE 4>>>\n\nMark's Hawk\nMark B. Hawk\nPackaging Management Council Coordinator\n49 Palisades Parkway\nOak Ridge, TN 37830\nPhone: 865-250-3300\n\n<<<PAGE 5>>>\n\nAnalysis of 49 CFR § 173.415 as Amended by Docket HM-250\nA WHITE PAPER\nPackaging Management Council\n\n<<<PAGE 6>>>\n\nwe8 ciosale alla clusure\nmaterials (including gaskets, tape, etc.) of each item of the containment system, shielding and packing\nmaterials used in normal transportation. Those elements should be reasonably accessible to, and\nrecordable by, each offeror of a Specification 7A package. There may be some minor challenges here,\nbut the new documentation elements in this region of the new regulations are straightforward (i.e.,\nimprove and standardize the description of the packaging configuration which is being shipped). Other\nthan the time needed to \"review and upgrade documentation\" (40596), the retroactive effect of this\nportion of the new requirements is of relatively low consequence.\nThe problem, however, is in § 173.415(a)(1)(i) where (for packagings tested under § 173.465) the testing\ndocumentation will be required to include the following elements:\n•\nDate\n• Place of test\n• Signature of testers\n• A detailed description of each test performed\n• Equipment used\n• Damage to each item of the containment system resulting from the tests\nThe retroactive effect of this portion of the new requirements-which, as written, appears to make no\ndistinction between packagings tested before or after HM-250—will have a significant adverse effect\nupon shipper/offerors to the extent that it will be difficult or even impossible in some cases to comply\nwith these new rules for existing previously-tested packagings (in the absence of retesting or shifting to\na non-testing method to demonstrate compliance under § 173.461).\nBelow are some examples whereby it would be partially or completely impossible to retroactively\ncomply with § 173.415(a)(1)(i) for packagings tested prior to HM-250 under § 173.465.\n• The date and/or place was never recorded by the manufacturer who tested the packaging.\n• The signature of the tester was not recorded and is impossible to obtain because the tester has\nretired, passed away, or otherwise become unreachable. We know of at least one case where\nthis situation currently exists for a packaging still in active use.\n• No additional descriptive detail of each test performed is available. This could also be true for\nadditional details of containment system damage resulting from historical tests of still-in-use\npackagings.\n• Equipment and personnel may have long since been replaced with different equipment and new\npersonnel (who have no record or memory of the original equipment used to perform a\nparticular test, since they never used it). This situation also currently exists.\n• The manufacturer has gone out of business and no longer exists. This situation also currently\nexists.\n1\n\n<<<PAGE 7>>>\n\nretroactively acquiring this information generally goes down in proportion to how long ago the testing\nwas conducted, which can be significant in some cases (e.g., decades).\nOn page 40608 of the final rule, under Extension of package documentation retention requirement and\nclarification of information required to be maintained, it states \"new clarification on types of information\nrequired to be retained for certain packages used to ship radioactive materials is provided in this final\nrule. PHMSA expects modest positive environmental gains due to a projected increase in appropriately\ntested and constructed packages\" [underlining added for emphasis].\nThe phrase \"projected increase in appropriately tested and constructed packages\" is a noteworthy\nforward-looking claim of benefits that would obviously be yielded proactively-for packagings\nconstructed and tested after the inception of HM-250'—not retroactively for packagings constructed\nand tested prior to HM-250. The proof is in the fact that the relatively simple act of \" reviewing and\nupgrading documentation\" (40596) would have zero effect on the appropriateness with which existing\n_rading socere constunted or tested libate to fie\nBased on the above concerns, a survey of various member organizations within the Department of\nEnergy (DOE) sponsored Packaging Management Council (MC) was administered to evaluate the\neffects of the revised § 173.415(a) documentation requirements on their operations.\nFigure 1 below depicts the responses-by § 173.415(a) criterion-for 24 existing previously-tested Type\nA packaging designs in use by the respondents.\n2 After (or in anticipation of) the effective date of the revised § 173.415(a) (i.e., January 1, 2017).\n2\n\n<<<PAGE 8>>>\n\nDimensions\n2\nTILLA 22\nPackage Description\nWeight\nIZA 23\n§ 173.415(a)(1)\nClosure and closure materials (including gaskets,\ntape, etc.) of each item of the containment system\n1A 20\nShielding\n15\nPacking materials used in normal transportation\nDate of test\n14\nTIZ 20\nPlace of test\n12\n12\nSignature of tester(s)\nIlIA\nTest Documentation\n§ 173.415(aX1)()\nDetailed descripfon of each test perfored\n2\nEquipment used\n13\nDamage to each item of the containment\nsystem resulting from the tests\nDemonst ation of compliance (173.461)\n173.415(aX1Хii)\n8\nManufacturer Certification\n173.415(a)(2)\nпиши 15\nBefore proceeding further, there are a few caveats to acknowledge regarding Figure 1:\n• Although there were 15 reported instances (the highest apparent number for missing data)\nwhere discussions of shielding were found to be absent from the package description, it\nappeared shielding was not relevant to the package design in at least 13 of those instances (in\nterms of the presence of any distinct shielding components). So although the data appears\nnegatively skewed toward missing data, it is probably more accurate to view the majority of the\nabsent data as implicitly reflecting the non-applicability of shielding.\n• The \"demonstration of compliance\" (§ 173.461) criterion shows eight cases of apparently\nmissing data. It is believed that some respondents may have interpreted this criterion—at least\nfor the purpose of the survey-to denote solely methods of demonstrating compliance in lieu of\nphysical testing. So although the data appears to be more negatively skewed toward missing\ndata than it should be, evidence suggested that physical testing was conducted on every Type A\npackaging for which the respondents provided feedback.\n3\n\n<<<PAGE 9>>>\n\nanalyze to that depth, it is worth considering the possibility that the manutacturer s\ndocumentation may contain package description and/or test documentation gaps similar to\nthose seen during this survey. If so, then this criterion in Figure 1 would be positively skewed\ntoward the presence of data that isn't fully there.\n• Given their level of specificity, the remaining criteria in Figure 1 can be taken at face value, with\nthe understanding that whereas it is relatively easy to obtain missing package description\nelements [§ 173.415(a)(1)], it will be difficult in some cases-and impossible in some cases (as\nindicated in the bullet list on pages 1 and 2)-to obtain missing test documentation elements [S\n173.415(a)(1)(i)]. It is for this reason that Figure 1 is organized to enable clear differentiation\nbetween these two prominent groupings, the latter of which is the primary focus of this white\npaper.\nThe data summarized in Figure 1 clearly confirms that gaps exist in both the package description and\ntest documentation elements of Type A package documentation.\n• Package Description: Out of 144 total data points (6 package description criteria × 24 package\ndesigns), 111 (77%) responses were \"yes\" (information present) and 33 (23%) were \"no\"\n(information not present). As mentioned previously, these data are not generally anticipated to\nbe difficult to obtain, and therefore are considered to have a relatively low retroactive burden\non offerors of DOT Specification 7A Type A packagings.\n• Test Documentation: Responses to this topic also generated 144 data points, of which 102\n(71%) were \"yes\" and 42 (29%) were \"no\". This is of course the area of highest concern, because\nof the aforementioned difficulties in retroactively obtaining this information.\nSo what is an offeror to do? Figure 2 below offers a hypothetical process, from an offeror perspective, to\nexplore potential options upon which the questions in this paper's cover letter are based.\n3 § 173.415(a)(2), as revised in HM-250, states \"If the offeror has obtained the packaging from another person\nwho meets the definition of 'packaging manufacturer' in §178.350(c) of this subchapter, a certification from the\npackaging manufacturer that the package meets all the requirements of §178.350 for the radioactive contents\npresented for transport and a copy of documents maintained by the packaging manufacturer that meet the\nrequirements of paragraph (a)(1) of this section\" [underlining added for emphasis].\n4\n\n<<<PAGE 10>>>\n\nObtain the missing elements\nCan\nAll new\nand couple with the rest of he -Yes-\nmissing elements\n§ 173.415(a)(1)i)\n§ 173.415(a) documentation\nbe retroactively\n+-No-\ntest documentation\nobtained?\nelements\npresent?\nNo\nAdd supplemental document to\n§ 173.415(a) documentation\nDemonstrate compliance\nstating un obtainable and why\nor\nthrough means other than\ntesting ($ 173.461)\nor\nConduct new testing\nYes\nSTOP\nOption C is viewed as a worst-case scenario, because it would presumably be the most costly. Survey\nrespondents were able to provide replacement cost data for about 42 percent (10 out of 24) of their\nType A package designs. Although admittedly incomplete, these data points at least provide a glimpse of\nthe financial impacts that might arise from the provision of test samples for destructive testing. Table 1\nand 2 below provide the list of known package replacement costs and some descriptive statistics\nassociated with them. This data might be useful to perform various extrapolations regarding the entire\npopulation of 24 Type A packagings identified by the respondents.\nIt is noted, however, that neither retesting nor associated costs were discussed in the HM-250 preamble\nin the context of § 173.415(a)(1)(i). Ideally, this would mean PHMSA did not intend for offerors of\nexisting previously-tested Type A packaging to have to retest them in order to establish compliance with\nthe amended § 173.415(a). Non-ideally, this would mean there was a failure to account for retesting and\nassociated costs in the preamble for the rulemaking.\n5\n\n<<<PAGE 11>>>\n\n$10,000\nMode\nN/A\n$13,500\nStandard Deviation\n$23,055\n$20,000\nRange\n$58,300\n$45,000\nMinimum\n$500\n$50,000\nMaximum\n$58,800\n$54,000\nSum\n$314,300\n$55,000\nCount\n10\n$58,800\nOption B appears as a sort of middle-of-the-road scenario, because it is somewhat unclear if it would be\nconsidered acceptable to use \"other [non-testing] methods\" under § 173.461 to satisfy the missing\nelements of the revised § 173.415(a)(1)(i) for an existing Type A packaging that had actually been\nsubiected to the physical tests of § 173.465. Even if so, it must be recognized that not every organization\npossesses the expertise necessary to demonstrate compliance through non-testing methods such as\nengineering evaluations, etc.\nOption A appears to be the best-case scenario to deal with retroactive effects that are unresolvable [i.e.,\n§ 173.415(a)(1)(i) test documentation elements that are unobtainable as described in the bullet list on\npages 1 and 2].\nThe HM-250 preamble alludes that the time to \"review and upgrade documentation\" (40596) is all that\nis needed to acquire the new elements of 415(a)(1) and (a)(1)(i). The analysis in this white paper shows\nthat this assumption will not always be true-at least with respect to the test documentation elements\nof § 173.415(a)(1)(i)—for existing previously-tested Type A packagings.\n6","truncated":false,"body_characters":16965}