Alden Medical LLC — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 AUG 2 8 2018 Mr. Chris Corridan Alden Medical LLC 360 Cold Spring Avenue West Springfield, MA 01089 Reference No. 18-0055 Dear Mr. Corridan: This letter is in response to your April 9, 2018, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the use of United Nations (UN) specification packaging. You explain that your company has UN specification packagings that underwent performance testing by a certified third party facility, and the resulting test report suggested a periodic retest date of every 24 months. Specifically; you ask if you can continue to use a packaging beyond the periodic retest date provided no changes are made to the approved packaging design. The answer is yes. An unused UN certified packaging can be manufactured, maintained in inventory for an indefinite amount of time, and then used without being retested. There are no retesting procedures that a shipper must conduct for an unused UN certified packaging. The periodic retest procedures described in§ 178.601(e) are design requalifications that must be performed by the manufacturer to demonstrate that their design types still pass performance tests. I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 2~~ -:p~~~ l~-oo5S- January, lkeya CTR (PHMSA) From: Sent: To: Subject: INFOCNTR (PHMSA) Monday, April 09, 2018 4:58 PM Hazmat Interps FW: Interpretation Question Hi Alice & lkeya, Below is a request for a letter of interpretation. Mr. Corridan spoke with Jonathon. Please let me know if you have any questions. Thanks, Jodi From: Chris Corridan [mailto:chris@aldenmedical.com] Sent: Monday, April 09, 201812:48 PM To: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov> Subject: Interpretation Question Good afternoon, I work for Alden Medical LLC, a manufacturing facility which occasionally ships out a hazmat product. Specifically, that product consists of plastic bottles of a liquid disinfectant inside cardboard boxes. The net volume in each box is about three gallons, and the package's gross weight is about 35 pounds. The packaging had successfully undergone performance testing by a certified third party facility. The testing report has a "periodic retest date" suggesting that the packaging should be retested 24 months after the testing date. · We have a sizeable quantity of packaging (empty bottles and boxes) which should last us well beyond the retesting date on the report. Provided that no changes are being made to the approved design or the manufacture of the packaging, I wanted to know if the DOT requires us to have the packaging retested on a periodic basis. If it is not required by the DOT, then we would prefer not to spend money on unnecessary re-testing. I spent some time searching through 49 CFR §178, and I could not locate any regulation which requires retesting for this type of packaging. On Friday morning, I called the toll-free phone number 1-800-HMR-4922 (1-800-467-4922) as suggested by your web site. I spoke at length with a representative named Jonathan. (I was told that the representatives' last names are not shared for these calls.) Jonathan was very helpful. He reviewed the regulations and found that there are some retesting requirements which apply to "chemical cylinders" and to refurbished drums. However, it appeared to both of us no retesting requirements apply to the packaging used by Alden Medical. Jonathan explained that he only provides informal guidance, and that a binding answer could be obtained by sending an email and including a mailing address. If retesting is unnecessary, we would prefer to continue using our inventory of packaging materials beyond the retesting date. 1#

Page 3• If retesting is required, then we would have the materials retested. Please advise. I can be reached by phone at 413-747-9717. My mailing address is as follows: Alden Medical LLC 360 Cold Spring Avenue West Springfield, MA 01089 Thank you and have a nice day, Regards, Chris Corridan RA/QA Manager Alden Medical LLC 413.747.9717 2#