Inmark Packaging — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Avenue, SE Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration MAR 022016 Jay Johnson, DGSA Inmark Packaging Regulatory Compliance Manager 675 Hartman Road, Suite 100 Austell, GA 30168 Ref. No.: 15-0092 Dear Mr. Johnson: This letter is in response to your e-mail and attached letter requesting the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to closure instructions for Category B infectious substance packagings. Specifically, you ask if the closure instructions on filling and closing a Category B packaging that are prescribed in § 173.199(a)(10) differ from the closure instruction requirements prescribed in § 178.2(c). While the packaging closure instructions prescribed in §§ 173.199(a)(10) and 178.2(c) use similar language, the instructions differ in that those prescribed in § 178.2(c) apply to hazardous materials subject to the requirements of 49 CFR Subtitle B, Chapter I, Subchapter C. The HMR excepts Category B infectious substances prepared and offered for transportation in conformance with the requirements prescribed in § 173.199 from having to conform to the remainder of 49 CFR Subchapter C, except those requirements specifically prescribed in § 173.199 (see § 173.199(a)). Therefore, the packaging closure instructions prescribed in § 173.199(a)(10) apply only to Category B infectious substances. You also refer to a letter the Pipeline and Hazardous Materials Safety Administration (PHMSA) issued under Reference No. 14-0060 that stated the HMR does not require closure instructions for Category B infectious substances that conform to § 173.199. For clarification, the HMR does require closure instructions under § 173.199(a)(10) for Category B infectious substances but does not require these materials to conform to the closure instructions prescribed in § 178.2(c). I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, ern taster T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 2Edmonson • 5173.199 B Irfectious sab Dodd, Alice (PHMSA) From: INFOCNTR (PHMSA) Sent: To: Tuesday, May 05, 2015 4:22 PM Hazmat Interps Subject: FW: Question regarding 173.199 Attachments: Interp Request on 173.199.pdf Dear Shante & Alice, please assign to Eileen Edmonson. Thanks, Sent: Tuesday May 5, 2015 9:45 AM From: Jay Johnson [mailto:jayj@inmarkinc.com] To: PHMSA HM InfoCenter Subject: Question regarding 173.199 Please see attached document for a request for a formal letter of interpretation of 49 CFR 173.199. Kind Regards, Jay Johnson, DGSA 675 Hartman Road, Suite 100 Regulatory Compliance Manager Austell GA 30168 Confidentiality Notice: and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain This communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510, confidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or transmission and its attachments without reading or saving in any manner. attached to this transmission is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original 1#

Page 3Mr. Charles E. Betts U.S. DOT/PHMSA (PHH-10) Director, Standards and Rulemaking Division Washington, DC 20590 1200 New Jersey Avenue, SE East Building, 2nd Floor Dear PHMSA: In your recent interpretation (Reference No. 14-0060) you stated that 173.199 do not require closure instructions. standard packagings that comply with the requirements in 49 CFR Part 178 (see § 178.2(c)(1) (ii) (B)). The A3. The answer is no. The HMR requires packaging closure instructions for DOT specification and UN HMR does not require closure instructions for packagings that comply with § 173.199. transport a Category B infectious" differ from the closure requirements found in § 178.2(c)? How do the requirements in § 173.199(a)(10) for "Clear instructions on filling and closing a packaging used to infectious substance must be provided by the packaging manufacturer and subsequent distributors to the -§173.199(a)(10) Clear instructions on filling and closing a packaging used to transport a Category B consignor or person who prepares the package to enable the package to be correctly prepared for subsequent distributors for at least one year from the date of issuance, and made available for inspection transport. A copy or electronic image of these instructions must be retained by the manufacturer and by a Federal or state government representative upon request. Packagings must be filled and closed in accordance with the information provided by the packaging manufacturer or subsequent distributor. -§178.2(c) (1) (i)(B) With information specifying the type(s) and dimensions of the closures, including the applicable performance tests. This information must include any procedures to be followed, including gaskets and any other components needed to ensure that the packaging is capable of successfully passing closure instructions for inner packagings and receptacles, to effectively assemble and close the packaging BELE for the purpose of preventing leakage in transportation. Closure instructions must provide for a consistent it was tested. For packagings sold or represented as being in conformance with the requirements of this and repeatable means of closure that is sufficient to ensure the packaging is closed in the same manner as subchapter applicable to transportation by aircraft, this information must include relevant guidance to ensure that the packaging, as prepared for transportation, will withstand the pressure differential requirements in $173.27 of this subchapter. -§178.2(c)(1)(iii) Make copies of all written notifications available for inspection by a representative of the -§178.2(c)(1)(ii) Retain copies of each written notification for at least one year from date of issuance; and Department. Kind Regards, Jay Johnson, DGSA | Regulatory Compliance Manager Austell GA 30168 675 Hartman Road, Suite 100 770-373-3300 770-373-3356 770-377-0205 770-373-3357 jayi@inmarkpackaging.com SAFA PAK™ Inmark* AN InmarkS COMPANY ĐGS EXAKT PAK® DO SUPPLIES AN INMARK BRAND#

Page 4Follow us at: t in Visit our website or InmarkPackaging.com to learn more about our products and services. Please consider the environment before printing this e-mail. Confidentiality Notice: U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, This communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 or use of any of the information contained in or attached to this transmission is STRICTLY PROHIBITED. Please contact us and any attachments, may contain confidential information. If you are not the intended recipient, any disclosure, copying, distribution saving in any manner. immediately by return e-mail or at +1-770-373-3300 and destroy the original transmission and its attachments without reading or#