Inmark — Hazardous Materials Safety Interpretation

Page 11200 New Jersey Ave., S.E. U.S. Department Washington, DC 20590 of Transportation Pipeline and Hazardous Materials Safety Administration SEP 2 1 2011 Jay Johnson, DGSA Regulatory Compliance Manager Inmark 675 Hartman Road, Suite 100 Austell, GA 30168 Reference No. 11-0227 Dear Mr. Johnson: This is in response to your August 3,2011, and September 1,2011 e-mails to Mr. Dehner Billings, Senior Regulatory Advisor, Standards and Rulemaking Division, Pipeline and Hazardous Materials Safety Administration (PHMSA). He directed your e-mail to my branch for response. A member of my staff responded to you informally bye-mail on September 19, 2011. This is our official response to your inquiry. You ask when PHMSA plans to revise § 173.199(a)( 4) to remove the steel rod puncture test from the requirements for Category B infectious substance packagings. We cannot provide you with a specific time frame, but can tell you that this revision is currently under consideration for inclusion in a future rulemaking. You also ask if a Category B, Division 6.2 (infectious substance) must be capable of surviving the conditioning requirements prescribed in §§ 1 78.609(e) (water spray), 178.609(t) (coldconditioned), and I 78.609(g) (dry ice dissipation) to demonstrate that it is capable ofpassing the drop test in § 178.609(d). The answer is no. See page 32247, first paragraph, ofthe preamble of the final rule PHMSA issued under Docket No. PHMSA-2004-16895 (HM-226A; 71 FR 32244; http://edocket.access.gpo.gov/2006/pdf/06-4992.pdf), where PHMSA stated a § 173.199 packaging need not be capable ofpassing a puncture or other performance tests. I hope this satisfies your request. Sincerely, rY~71-~~ T. Glenn Foster Chief, Regulatory Review and Reinvention Standards and Rulemaking Division#

Page 2Edmonson, Ei leen Subject: FW: Question about Category B Infectious Packaging -X;tf'~~hI)UJ 5 tdas tan~· 11-02/1-7 From: Jay Johnson [mailto:jayj@inmarkinc.com] Sent: Thursday, September 01, 2011 9:40 AM To: Billings, Delmer (PHMSA) Subject: RE: Question about Category B Infectious Packaging Good Morning Del, testing? Thanks I was wondering if you had had a chance to look at the two questions I had sent you concerning UN3373 package Jay Johnson DGSA, Regulatory Compliance Manager Iinmark 1 675 Hartman Road, Suite 100, Austell, GA 301681 main: 770.373.3300 1 direct: 770.373.33561 direct fax: 770.373.33571 cellular: 770.377.0205 jayj@inmarkinc.com I www.inmarkinc.com . Confidentiality Notice: This communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain confidential information. If you are not the intended reCipient, any disclosure, copying, distribution or use of any of the information contained in or 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 transmission and its attachments without reading or saving in any manner. -----~--------. From: Jay Johnson Sent: Wednesday, August 03, 2011 12:21 PM To: 'delmer,billings@dot.gov' 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 ofhazardous 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 §§17B.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 100 mm by 100 mm (3.9 inches). PHMSA clarified this requirements in an interpretation (PHIVISA Interpretation #07-0018) that: 1#

Page 3A packaging used to transport a Category B infectious substance must be capable ofpassing the drop test prescribed in § 178.609(d). The packaging is not required to also be capable ofpassing 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) ofthis 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 ofremoval from that atmosphere be subjected to the test described in paragraph (d) ofthis section. Where the sample contains dry ice, the conditioning period may be reduced to 4 hours. §§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 Iinmark 1675 Hartman Road, Suite 100, Austell, GA 301681 main: 770.373.3300 1 direct: 770.373.33561 direct fax: 770.373.33571 cellular: 770.377:0205 jaYi@inmarkinc.com I www.inmarkinc.com Confidentiality Notice: This communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain confidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or 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 transmission and its attachments without reading or saving in any manner. 2#