Cytyc Corporation — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 400 Seventh St., S.W. Research and Washington, D.G. 20590 Special Programs Administration JAN 2 3 2003 Mr. Jeffrey Joaquim Manager Ref. No. 02-0302 Environmental Health and Safety 85 Swanson Rd Cytyc Corporation Boxborough, MA. 01719 Dear MI. Joaquim: This is in response to your letter dated November 22, 2002 requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you are asking if $ 173.24 (f) (1) (ii) requires the closure on a one its gallon plastic container to have a safety seal over or around screw cap. Section 173.24(f) (1) (ii) states that closures on packagings shall be so designed and closed that under conditions normally There is no requirement in S 173.24(f) (1) (ii) to attach a incident to transportation they are secure and leakproof. safety seal to a packaging that has been deemed secure and leakproof without a safety seal.. However, for transportation vibration or substantial temperature change. secured to such an extent that it will not loosen due to I hope this satisfies your request. Sincerely, Transportation Regulations Specialist Office of Hazardous Materials Standards 173,24 020302 140919280207/4#

Page 2Page 1 of 1 3,24 (f) INFOCNTR From: Joaquim, Jeffrey [Jeffrey. Joaquim@cytyc.com] tackaging Sent: Friday, November 22, 2002 12:47 PM 02-0302 To: Subject: Formal Interpretation of 49 CFR 173.24 (7) (i) Infocntr, Infocntr < RSPA> 85 Swanson Rd, Boxborough, MA 01719. My phone number is 978-929-3354. My fax is 978-929-3346. I am seeking a formal written interpretation of 49 CFR 173.24 (f) (i). I am the EHS Mgr for Cytyc Corporation, Cytyc offers laboratories a cytology stain in a 1-gallon plastic screw capped containers. The contain wall closure is secure and leak proof." Independent lab tests have demonstrated that the container does not leak. thickness exceeds minimum requirements. My question deals with 49 CFR 173.24 (f) (ii) which states "The (The cap is torqued down after the container is filled. The separate safety seal is not placed over the cap.) Is it acceptable to ship a 1-gallon plastic container of hazardous material under 173.24 General Requirements for Packaging without a safety seal device over or around the cap? Again, the closure and container design temperature and vibration testing. pass all applicable testing requirements including those associated with cap security when exposed to I would appreciate a formal letter of interpretation. Sincerely. Jeffrey J. Joaquim, MS. CIH, CSP EHS Manager Cytyc Corporation 11/22/02#