Inova Diagnostics — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Avenue SE Washington. DC 20590 Materials Safety Pipeline and Hazardous Administration Allison E. Fowler EH & S Manager, BSO, CHO Inova Diagnostics 9900 Old Grove Road San Diego, CA 92131 AUG 1 7 2015 Ref. No. 15-0090 Dear Ms. Fowler: This responds to your May 6, 2015 request for clarification on the Hazardous Materials is compliant with § 178.601(g)(1), Variation 1. Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if the following scenario You state that you had a certification for a low density polyethylene (LDPE) plastic inner packaging/bottle that passed the testing/certification criteria and proved capability. This certification has since expired. You have a current certification that tested a high density polyethylene (HDPE) plastic (re: inner packaging bottle type), and it references HDPE, LDPE and PPCO on the certification under materials/bottle type. You ask if you comply with § 178.601(g)(1), Variation 1, using an LDPE bottle type for inner packaging under the current certification. You believe that because the previous certification proved capability of LDPE and the current certification for HDPE proves capability, an equivalent level of performance is maintained on the basis of: (1) the inner packagings are of equivalent size/volume; (2) the inner packagings are of similar design to the tested inner packagings (i.e., shape-round); and (3) the material of construction of the inner packagings (re: plastic) offers resistance to impact and stacking forces equal to or greater than that of the originally tested inner packaging. Therefore, you believe the LDPE plastic inner packaging included under the with § 178.601(g)(1), Variation 1. HDPE certification may be used without further testing of the packaging in accordance Your understanding is correct. Use of the LDPE plastic inner packagings complies with requirements in § 178.601(g)(1), Variation 1. Provided the inner packagings are of similar design (i.e., shape) and the material of construction offers the same or greater impact resistance than that of the originally tested inner packaging, further testing of a tested design type is not necessary and the LDPE inner packagings may be used. Moreover, provided an equivalent level of performance can be ascertained, you may use the LDPE inner packagings instead of the HDPE inner packagings under Variation 1.#

Page 2I hope this answers your inquiry. If you need additional assistance, please contact this Office at 202-366-8553. Sincerely, Not Pite Dirk Der Kinderen Acting Chief, Standards Development Branch Standards and Rulemaking Division#

Page 3Boothe $178.601(1) Dodd, Alice (PHMSA) applicability 15-0090 From: Sent: Geller, Shelby CTR (PHMSA) To: Wednesday, May 06, 2015 3:57 PM Subject: Hazmat Interps Attachments: FW: Inova Diagnostics, Interpretive Letter (HMR; 49 CFR Parts 178.601(1), Variation 1 LDPE_VS_HDPE.Intpretative.Letter_05.05.15_Final.pdf Hi Shante and Alice, Attached is a request for a formal letter of interpretation. Please let me know if you need any more information. Thanks, Shelby From: afowler@inovadx.com [mailto:afowler@inovadx.com] Sent: Wednesday, May 06, 2015 3:28 PM To: INFOCNTR (PHMSA) Cc: Karen.Yoneda@faa.gov; Gary Lindsey - Dangerous Goods; steve@normaninternational.com; sgustafson@inovadx.com; bwaddell@sd.inovadx.com; elorusso@ilww.com; eaustin@inovadx.com Subject: Inova Diagnostics, Interpretive Letter (HMR; 49 CFR Parts 178.601(1), Variation 1 Dear Department of Transportation (DOT) information center, I am Allison Fowler, EH&S Manager with Inova Diagnostics, Inc. Please see attached Interpretative Letter, we are seeking clarification on HMR; 49 CFR Parts 178.601(1), Variation 1. If you have questions or concerns with the letter as written, please feel free to contact me. Thank you so much for your time and help. We look forward to hearing back from you. All the best. Best regards, Allison E. Fowler EH&S Manager, BSO, CHO allison@inovadx.com Inova Diagnostics 9900 Old Grove Road Call +1-358-449-3212 Tel. +1-858-586-9900 San Diego, CA 92131 Ext. 1422 inovadx.com#

Page 4Inova Diagnostics To: : Worfen Company infocntr@dot.gov To whom it may concern, May 05, 2015 Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). This letter is written to request written clarification on 4GV non-bulk combination packaging under the We are asking for your help interpreting § 178.601(g)(1), Variation 1. VS. high density polyethylene (HDPE). This question specifically regards inner packagings of plastic mediums: low density polyethylene (LDPE) criteria and we proved capability. This certification has now expired (re: JOB NO. 12211U, Norman We have a certification in which we tested LDPE for inner packaging/bottle plastic type; LDPE passed the International, March 14, 2012). HDPE, LDPE and PPCO on the certification under materials/bottle type (Job No. 14526U, Norman We have a current certification that tested HDPE plastic (re: inner packaging bottle type), it references International, September 18, 2014). Question: Are we compliant using an LDPE bottle type for inner packaging under this certification? and an equivalent level of performance is maintained, we believe: Because the previous certification proved capability of LDPE, and the HDPE bottles are of similar design • the inner packagings are of equivalent size/volume. the material of construction of the inner packagings (re: plastic) offers resistance to impact and the inner packagings are of similar design to the tested inner packagings (i.e. shaperound). stacking forces equal to or greater than that of the originally tested inner packaging. certification per 49 CFR § 178.601(g)(1), Variation 1. Therefore, we believe that LDPE has been proven to be equivalent to HDPE and is compliant under the Please advise? Sincerely, @ 05/05/15 EH&S Manager, BSO, CHO Inova Diagnostics 9900 Old Grove Road allison@inovadk.com San Dieco CA 92131 Cell +1-858 449-3212 Tel +1 858-586-9900 Ex: 1422 ...-#