Inmark Packaging, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Avenue SE Washington. DC 20590 Pipeline and Hazardous Administration Materials Safety FEB 01. 2015 Mr. Jay Johnson Regulatory Compliance Manager Inmark Packaging, Inc. 675 Hartman Road, Suite 100 Austell, GA 30168 Reference No. 15-0154 Dear Mr. Johnson: This is in response to your July 27, 2015 email and subsequent telephone conversation with a member of my staff concerning packaging requirements for Category B infectious substances contained in the Hazardous Materials Regulations (HMR: 49 CFR Parts 171-180). Specifically, you ask whether a Category B packaging is required to meet the conditions specified in §S 178.609(e) and 178.609(f) for water spray and cold conditioning, respectively, before subjecting the packaging to the drop test in § 178.609(d). As specified in § 173.199(a)(4), a Category B packaging must be capable of successfully passing the drop test in § 178.609(d) at a drop height of at least 1.2 meters (3.9 feet) but is not required to be tested using this method. Further, as stated in the preamble to a final rule issued under Docket No. PHMSA-2004-16895 (71 FR 32244), a § 173.199 packaging need not be capable of passing a puncture or other performance tests. Therefore, the HMR do not require that a Category B infectious substance packaging be subjected to the conditions prescribed in §§ 178.609(e) and 178.609(f) in preparation for the drop test prescribed in § 178.609(d). I hope this information is helpful. Please contact this office if we can be of further assistance. Sincerely, Done A. Pad Duane A. Pfund International Standards Coordinator Standards and Rulemaking Division#

Page 2". Suchat $/73.199 Dodd, Alice (PHMSA) Catagory В сприном substances From: Foster, Glenn (PHMSA) 15-0154 Sent: Tuesday, July 28, 2015 8:33 AM To: Dodd, Alice (PHMSA); Goodall, Shante CTR (PHMSA) Subject: Question about Category B Infectious Packaging Alice and Shante, Please check in the email below as a request for letter of interpretation. Thanks, Glenn From: Foster, Glenn (PHMSA) Sent: Tuesday, July 28, 2015 7:40 AM To: 'Jay Johnson' Cc: Betts, Charles (PHMSA); Supko, Ben (PHMSA) Subject: RE: Question about Category B Infectious Packaging Hello Jay, Your inquiry below will be logged in as a request for Interpretation and responded accordingly. Thanks, Glenn From: Jay Johnson [mailto:jayj@inmarkinc.com] Sent: Monday, July 27, 2015 4:42 PM To: Foster, Glenn (PHMSA) Cc: Betts, Charles (PHMSA); Supko, Ben (PHMSA) Subject: RE: Question about Category B Infectious Packaging Hello Glenn, While you are working on this, I have another question on 173.199 package performance capability. Does Category B packaging that is being dropped according to 178.609(d) subject to the cold conditioning and water spray conditioning as defined in 178.609(b) and 178.609(c)? Kind Regards, Jay Johnson, DGSA | Regulatory Compliance Manager SAF\PAK™ Inmark i AN Inmarkyl COMPANY 1#

Page 3E EXAKT-PAK® DO SUPPLIES AN INMARK BRAND 675 Hartman Road, Suite 100 Austell GA 30168 0 770-373-3300 | d 770-373-3356 | m770-377-0205 | f770-373-3357 | e jayi@inmarkpackaging.com Follow us at: 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: transmission and its attachments without reading or saving in any manner. From: Glenn.Foster@dot.gov [mailto:Glenn.Foster@dot.gov] To: Jay Johnson Sent: Wednesday, June 24, 2015 11:48 AM Cc: charles.betts@dot.gov; Ben. Supko@dot.gov Subject: RE: Question about Category B Infectious Packaging Jay, In the meantime, here is a PDF of the NPRM under HM-218 "Miscellaneous Amendments" where the revision was proposed. I will have the final rule forwarded to you when it is published, as well. Thanks, Glenn From: Foster, Glenn (PHMSA) To: 'Jay Johnson' Sent: Wednesday, June 24, 2015 10:56 AM Cc: Betts, Charles (PHMSA); Supko, Ben (PHMSA) Subject: FW: Question about Category B Infectious Packaging Hello Jay, Thanks for the follow-up. Our plan is to include this revision in an upcoming rulemaking. We will send you a notification/link to the rule when it is published. Thanks, Glenn From: Jay Johnson [mailto:jayj@inmarkinc.com] Sent: Wednesday, June 24, 2015 6:21 AM To: Betts, Charles (PHMSA); Supko, Ben (PHMSA) Subject: FW: Question about Category B Infectious Packaging Hello Ben and Charles, 2#

Page 4I am curious how things are progressing with two questions | asked Del Billings back in 2011 Has there been any changes regarding this topic? Thanks Jay Johson Inmark From: Jay Johnson To: 'delmer.billings@dot.gov' Sent: Wednesday, August 03, 2011 12:21 PM Subject: Question about Category B Infectious Packaging Hello Del, I have two questions about the package testing for Biological Substance, Category B and I hope you can help me with this. Currently §§173.199(a)(4) states that packages must be capable of successfully passing the drop tests in §§178.609(d) and (h) of this subchapter. 173.199(a)(4) The completed package must be designed, constructed, maintained, filled, its contents limited, and closed so that under conditions normally encountered in transportation, including removal from a pallet or overpack for subsequent handling, there will be no release of hazardous material into the environment. Package effectiveness must not be substantially reduced for minimum and maximum temperatures, changes in humidity and pressure, and shocks, loadings and vibrations normally encountered during transportation. The packaging must be capable of successfully passing the drop tests in §§178.609(d) and (h) of this subchapter at a drop height of at least 1.2 meters (3.9 feet). Following the drop tests, there must be no leakage from the primary receptacle, which must remain protected by absorbent material, when required, in the secondary packaging. At least one surface of the outer packaging must have a minimum dimension of 100mm by 100 mm (3.9 inches). PHMSA clarified this requirements in an interpretation (PHMSA Interpretation #07-0018 ) that: A packaging used to transport a Category B infectious substance must be capable of passing the drop test prescribed in § 178.609(d). The packaging is not required to also be capable of passing the steel rod impact test in § 178.609(h). We will correct this error in a future rulemaking. Question 1: Do you know when the rulemaking to correct this error is going to occur? Question 2: When conduction the drop testing in §§178.609(d) to establish if the packages are capable of passing the drop test, do the samples have to be conditioned as described in the requirements of §$178.609(e), §§178.609(f), and §$178.609(g)? §§178.609(e) The samples must be subjected to a water spray to simulate exposure to rainfall of approximately 50 mm (2 inches) per hour for at least one hour. They must then be subjected to the test described in paragraph (d) of this section. §§178.609(f) The sample must be conditioned in an atmosphere of -18 [deg]C (0 [deg]F) or less for a period of at least 24 hours and within 15 minutes of removal from that atmosphere be subjected to the test described in paragraph (d) of this section. Where the sample contains dry ice, the conditioning period may be reduced to 4 hours. 3#

Page 5§$178.609(g) Where packaging is intended to contain dry ice, a test additional to that specified in paragraph (d) or (e) or (f) of this section must be carried out. One sample must be stored so that all the dry ice dissipates and then be subjected to the test described in paragraph (d) of this section. Thanks for your clarification on the matter. Best regards, Jay Johnson DGSA, Regulatory Compliance Manager | Inmark | 675 Hartman Road, Suite 100, Austell, GA 30168| www.inmarkinc.com main: 770.373.3300 | direct: 770.373.3356| direct fax: 770.373.3357| cellular: 770.377.0205 jayi@inmarkinc.com | This communication constitutes an electronic communication within the meaning of the Electronic Communications Confidentiality Notice: Privacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this recipient, any disclosure, copying, distribution or use of any of the information contained in or attached to this transmission message. This transmission, and any attachments, may contain confidential information. If you are not the intended is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original transmission and its attachments without reading or saving in any manner.#