{"operation":"document","citation":"12-0227","title":"IQ Products Company — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2012-10-19","effective_on":null,"summary":"12-0227 response to IQ Products Company concerning 171.1, 173.306.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0227.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0227.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0227","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2012/120227.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue SE\nWashington. DC 20590\nOCT 1 9 2012\nMr. P. Yohanne Gupta\nDirector of Research and Development\nCEO\nIQ Products Company\n16212 State Highway 249\nHouston, TX 77086\nReference No.: 12-0227\nDear Mr. Gupta:\nThis is in response to your September 27, 2012 letter requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CPR Parts 171-180) applicable to aerosol\ncontainers. You provide extensive background information and ask two questions relating\nto hot water bath testing of metal aerosol containers. Your questions are paraphrased and\nanswered below:\nQl. During the filling and testing process of the hot water bath test, the flat-cup valve\nassembly permanently deforms. Does this occurrence render the container\nunsuitable for transportation?\nA1. The answer is yes. Section § 173 .306( a )(3 )(v) of the HMR specifies that when\nsubjected to the hot water bath test, no leakage or permanent deformation of a\ncontainer may occur. When the aerosol container is assembled, the valve mounting\ncup becomes part of the container. If the valve mounting cup exhibits permanent\ndeformation as a result of filling and the hot water bath test, the container is not in\ncompliance with§ 173 .. 306(a)(3)(v).\nQ2. If your company knowingly transports non-compliant, defective aerosol cans at the\ncustomer's insistence, would you be considered in violation of the HMR?\nA2. The answer is yes. While non-compliance with the HMR is determined on a case-\nby-case basis, § 171.1( c) provides that the requirements of the HMR apply to the\ntransportation of hazardous material in commerce and to each person who\ntransports hazardous material in commerce. Accordingly, as detailed in your\nincoming letter, you have correctly advised your customer of the safety issues.\n\n<<<PAGE 2>>>\n\nThe continued manufacturing and/or transportation of a defective container\nconstitutes a knowing and possible willful violation of the HMR which could be\nsubject to civil and criminal sanctions that include penalties up to $500,000 and\nimprisonment for not more than 10 years.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\n~~\nirector,\nStan ards and Rulemaking Division\n\n<<<PAGE 3>>>\n\n16212 State Highway 249\nHouston, Texas 77086-1014 U.S.A\nTel: (281) 444-6454\nFax: (281) 444-0185\nWebsite: www.iqproducts.com\nSeptember 27, 2012\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety\nAdministration\nEast Building, 2nd Floor\nMail Stop: E21-317\n1200 New Jersey Ave., SE\nWashington, DC 20590\nOffice of Engineering and Research, PHH -20\nAttn: Dr. Carole LeBlanc, Director\nRichard Boyle, Acting Chief, Sciences, PHH -21\nCheryl West Freeman, Acting Chief, Engineering, PHH -22\nJames Simmons, Acting Chief, R&D, PHH-23 ·\nOffice of Standards and Rulemaking, PHH-10\nAttn: Charles Betts, Director\nBen Supko, Acting Chief, Standards Development, PHH-11\nGlenn Foster, Chief, Regulatory Review, PHH -12\nRe: Specific Clarification of the Testing Methods and Compliance Requirements\nDescribed in 49 CFR 173.306, Limited Quantities of Compressed Gases\nDear Madam/Sir:\nI write you this letter with the utmost sense of urgency and grave concern. IQ Products\nCompany (IQPC) is a major manufacturer and packager of aerosol and non-aerosol\nconsumer products based in Houston, Texas, in continuous business since the late 1950s\nthrough its sister companies.\nA recent Engineering Methods and Manufacturing Process audit that we conducted at\nour facility exposed the use of improperly developed specifications and unacceptable\nmanufacturing practices by one of our third party contract packaging business segment\ncustomers that were resulting in aerosol products that did not meet DOT's minimum\nrequirements. Consequently, immediately upon becoming aware and confirming the\nfacts, we ceased production of the affected products. In my capacity as the Director of\nPage 1 ofs\nBUSINESS CONFIDENTIAL INFORMATION\n(Not for disclosure to any third party without prior written authorization)\n\n<<<PAGE 4>>>\n\nResearch & Development (R&D) at IQPC, I am writing to respectfully request specific\nclarification of the testing methods and compliance requirements described in 49 CFR\n173.306 to affirm the merit in the decision to cease production of said noncompliant\nproducts.\nBackground and Theory\nAerosol containers can be described from a scientific perspective as \"pressurized\nvessels\". Mandatory regulations, such as 49 CFR 173.306 ensure public safety by\nrequiring that a minimum level of established scientific and engineering principles are\nutilized in the design and manufacturing of pressurized vessel (aerosol) products,\nmaking them safe when being transported in commerce and when being used by the\nconsumer.\nFor example, the 130 °F hot water bath equilibrium testing relates to the instances when\ntransporting aerosol products by highway. It is feasible that a transport trailer is\nsubjected to high summer temperatures such that the interior contents are subjected to\nan adiabatic thermal equilibrium condition (ilQ=o) at a constant temperature of 130 °F.\nThis is foreseeable if a transport trailer is parked in the sun on a hot summer day or if an\naerosol container is left in the hatchback of a car wherein the interior car temperature\ncan reach 130 °F or more.\nThe DOT standard was thus established to enhance public safety by preventing aerosol\ncontainers from bursting under normally anticipated conditions. This safety standard is\nachieved by the mandatory requirement that each aerosol container is manufactured\nwith (a) properly developed chemical compositions and (b) properly specified and\nselected package components, to prevent bursting due to internal content pressure that\nexists at 130 °F, as a minimum.\nIQPC Manufacturing Process for IQPC Branded Products\nI. In the beginning Research & Development (R&D) phase for IQPC's Branded\nProducts, we establish the chemical composition of any given product by\nempirically determining the (a) net concentrate to be filled to meet the stated\nlabel claim for weights and measures; (b) selection and amount of the propellant\nrequired to expel said concentrate; (c) the internal fill volume; (d) flammability of\nthe product by testing in accordance to ASTM standards; (e) pressure-\ntemperature profile up to burst (failure) end point for said composition in the\nselected container size, which also determines the 130 °F thermal equilibrium\npressure condition in the laboratory. Our R&D Group then specifies the package\ncomponents such as whether the aerosol container should be 2P or 2Q based on\nempirical data, and whether the aerosol valve should be flat-cup or conical-cup.\nAfter storage stability and requirements of various other tests and protocols have\nbeen met and satisfied, our R&D Group conducts a production line run of a few\nPage 2 ofs\nBUSINESS CONFIDENTIAL INFORMATION\n(Not for disclosure to any third party without prior written authorization)\n\n<<<PAGE 5>>>\n\nII. III. IV. thousand containers to establish \"Product Specifications\" for each new product\nby establishing the (a) chemical composition (weights and measures); (b)\npackage component specifications; and (c) production line manufacturing\nmethods, including Quality Assurance (QA) testing requirements.\nThe R&D Group determines the submerged residence time within the hot water\nbath on any given production line for a given production line speed. It then\ndetermines the hot water bath temperature to achieve the pressure inside each\ncan that would be equivalent to the compositions pressure at 130 °F equilibrium\ncondition that was earlier determined empirically in the laboratory. NOTE:\nDepending on the line speed and submerged residence time, the hot water bath\ntemperature may exceed 130 °F, in most cases.\nIn a test run, the R&D Group confirms whether each aerosol container exiting the\nhot water bath is reaching the 130 op equivalent pressure. While submerged,\ninspectors look for bubbles from leaking cans and promptly remove them, if\nfound. And, each can is visually inspected to ensure the absence of any\ndeformation of any part of the aerosol container including the aerosol valve base\nand the aerosol can bottom, and if found, the cans are rejected. During this test\nrun, if more than 1 or 2 cans are found to fail, the R&D Group stops the test run\nand returns to the laboratory to evaluate the chemical composition and the\npackaging component specifications and selection.\nThe test run is repeated until all concerns are addressed and results are found\nacceptable. After all these R&D exercises are completed satisfactorily, the new\n\"Product Specifications\" are formalized and approved for actual production.\nProduction is scaled up slowly and manufacturing process specifications are\nadjusted, if needed, over the first few production runs, to address unanticipated\nabnormalities unique to each new chemical composition.\nManufacturing Process at IQPC for Third Party Contract Packaging\nUnlike with our own branded products, product composition and packaging component\nspecifications are developed and supplied by our contract packaging customers with\nsaid responsibility confirmed in writing by contract. In such circumstances, our R&D\nGroup is not engaged for establishing Product Specifications, as our scope of work only\ninvolves following customer supplied specifications. IQPC ensures that it follows DOT\nregulations in its role as a packager and shipper of such items, but we rely on the\naffirmative representations of our customers when they affirm product composition and\npackaging component specifications are compliant with existing regulations and\nstatutes.\nPage3of5\nBUSINESS CONFIDENTIAL INFORMATION\n(Not for disclosure to any third party without prior written authorization)\n\n<<<PAGE 6>>>\n\nResults of the Engineering Methods and Manufacturing Process Audit\nThe audit conducted at IQPC was deemed necessary because of unusual and abnormal\nproduction results that occurred using the Customer's specifications over several\nmonths before we made the decision to cease production. The Customer dictated\nproduction composition and packaging component specifications to IQPC for the\npackaging process. In the case of this particular product that we had been\nmanufacturing under contract for the Customer, the liquid concentrate is a flammable\nsolvent and the propellant is Carbon Dioxide (C02) gas. Selection and specifications for\nthe chemical composition and package components were the responsibility of our\nCustomer by written agreement, of which we were repeatedly assured. Furthermore,\nIQPC is indemnified against any damages arising out of product failure, whether\nresulting from defects in the chemical composition or packaging components.\nOur audit revealed that:\n(a) the Customer's Product Specifications have not been properly developed\nusing scientific and engineering principles;\n(b) the Customer's specifications result in internal aerosol container pressures\nthat are too high when tested using minimum DOT standard requirements; and\nmost alarmingly\n(c) that the Customer's selection of\"flat-cup\" aerosol valve in this high-pressure\ncomposition rendered the product defective because during and after the filling\nprocess, the flat-cup of the metal valve was \"deforming permanently\" in violation\nof 49 CFR 173.306Ca)(3)(v), which states \"No leakage or permanent deformation\nof a container may occur.\"\nFirst Request for Clarification from DOT:\nWe submit that in any aerosol container, metal deformation (i) will only occur at the\nweakest structural part of the container; (ii) will be permanent because the pressures\ninside the aerosolized container will always be greater than atmospheric pressure; and\n(iii) will result in metal fatigue at the deformation that, if further stressed, will be the\npoint of rupture (failure). We submit that the high C02 pressure during filling and\ntesting causes the \"flat-cup\" valve to deform permanently, rendering the product\nnoncompliant and unsuitable for transport or sale. Is our interpretation of the\nreferenced DOT standard regarding permanent deformation of the container correct?\nPage4of5\nBUSINESS CONFIDENTIAL INFORMATION\n(Not for disclosure to any third party without prior written authorization)\n\n<<<PAGE 7>>>\n\nSecond Request for Clarification from DOT:\nIQPC has refused to continue packaging our Customer's product that has defective\nspecifications. Although we are indemnified by our Customer, if we were to knowingly\ntransport these noncompliant, defective aerosol cans at the customer's insistence, would\nIQPC be considered in violation of DOT requirements?\nConclusion:\nWe have advised our Customer of our concerns and urged them to advise the DOT and\nthe Consumer Product Safety Commission (CPSC) repeatedly since May 2012, which\nthey have refused to do. Additionally, we have advised our Customer of the DOT\nrequirements and the applicable penalties for knowingly transporting and selling\nnoncompliant products, which they have elected to ignore. It is our understanding that\nour Customer has at least two other contract manufacturers in the United States making\nproducts using the same undeveloped or improperly developed Product Specifications\nwith undoubtedly the same results of noncompliance due to failing the 49 CFR\n173.306(a)(3)(v) \"no permanent deformation\" DOT standard. As a result, millions of\ncans of defective aerosol products continue to be introduced into commerce in the\nUnited States, compromising public safety. A large number of the noncompliant\nproducts previously made by IQPC remain in our warehouses.\nIQPC is not willing to wait any longer out of courtesy to our Customer and we intend to\nmeet and notify the DOT and the CPSC, urgently. In the interest of public safety, if the\nDOT must proactively act, we are willing to come up to Washington, D.C. to meet and\nbring the underlying facts to enable your team to take the next steps as you deem\nnecessary. Please contact us with the earliest date when we can meet in your offices.\nI request and await your prompt response.\nSincerely,\nIQ PRODUCTS COMPANY\nf.'t~~:--\nP. Yohanne Gupta\nDirector of Research & Development\nCEO\nYG/JTB/MY/lc\ncc:TK,MW\nPages ofs\nBUSINESS CONFIDENTIAL INFORMATION\n(Not for disclosure to any third party without prior written authorization)","truncated":false,"body_characters":14390}