Daniels Sharpsmart, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Wash ngton, D.C. 20590 400 Seventh Street, S.W. Pipeline and Administration Hazardous Materials Safety JUN 7 2006 Mr. Terry Grimmond Daniels Sharpsmart, Inc. Clinical Director Reference No. 05-0182 3 Tarbett Road Hillcrest Hamilton 2001, New Zealand Dear Mr. Grimmond: Q1. May packages complying with the Packing Group II performance criteria under the mported into the United States from other countries to be cleaned and refurbishe IMR and containing contaminated medical equipment, including sharps, br by Food and Drug Administration-approved companies? Are such devices regulated medical waste (RMW) regardless of whether or not they meet the medical waste. Is this correct? Al. for disposal, that is known or suspected of being contaminated with a Division 6.2 In accordance with § 173.134(b)(7), medical equipment, excluding that transported or teal anisit essentially sucianis a reuths mendelete the components provided the equipment conforms to the Occupational Safety and Health Administration's (OSHA's) bloodborne pathogen requirements prescribed in 29 CFR 1910.1030. Medical equipment known or suspected of containing a Division be transported in accordance with the HMR requirements applicable to the 6.2 material that does not conform to the requirements in 29 CFR 1910.1030 must transportation of RMW. Medical equipment that previously contained an infectious substance that has been decontaminated is not subject to the HMR. 173-1341631) 050182#

Page 2Q2. If contaminated medical equipment is not subject to the HMR's Division 6.2. transport, or labeling? requirements, is it subject to any other requirements under the HMR for packaging, A2. Medical equipment transported in commerce that contains a material meeting the requirements contained within the HMR for that hazard class. definition of any hazard class under the HMR is subject to the applicable Q3. May any state within the United States impose transportation requirements for medical equipment that are more stringent than those in the HMR? A3. transportation law (Federal hazmat law; 49 U.S.C. 5101 et seq.), a requirement of a Generally, the answer is no. In accordance with the Federal hazardous materials state, local, or tribal government is preempted, unless otherwise author. zed by another Federal statute or DOT issues a waiver of preemption, under the conditions specified in § 171.1(f) of the HMR. Note, however, that PHMSA makes preemption determinations applicable to specific non-Federal requirements on a case-by-case basis. Q4. If blood-stained medical equipment is imported into the United States for cleaning and refurbishment and meets FDA and OSHA requirements, is it excepted from complying with the HMR for Division 6.2 materials? A4. See Al above. Q5. What other United States agencies regulate imported medical waste devices? A5. Imported medical equipment may be subject to regulations issued by the U.S. Postal Service; the Department of Health and Human Services' Centers for Disease Control and Prevention, and Food and Drug Administration; the Department of abor's Occupational Safety and Health Administration; the U.S. Department of Iomeland Security' Transportation Security Administration and U.S. Coast Guard or the U.S. Department of Agriculture's Animal Plant and Health Inspection Service. You may wish to contact those agencies directly. Q6. May a state enact regulations reclassifying non-infectious medical equipment as RMW making these items subject to the HMR? A6. No. See A3 above. Q7. Is it correct that medical equipment transported for reprocessing is not subject to equipment is excepted from regulation under § 173.134(b)(7) of the HMR? the requirements for used health care products in § 173.199 because medical A7. products being returned to the manufacturer or the manufacturer's designee. Yes. Note that the requirements for used health care products in § 173.199 apply to#

Page 3Is it correct that medical equipment cleaned prior to shipment for refurbishment may be transported both internationally and domestically as general goods not leakproofness, or BIOHAZARD labeling? subject to OSHA requirements, including those for puncture resistance, A8. Medical equipment cleaned to the point that it no longer meets the definition of a not cleaned medical equipment would be subject to OSHA requirements, you may HMR hazard class not subject to regulation under the HMR. To learn whether or wish to contact OSHA directly at: U.S. Department of Labor, Occupational Safety Washington, D.C. 20210, (202) 693-2222. & Health Administration, Safety Standards Division, 200 Constitution Avenue, I hope this information is helpful. Sincerely, Hallu z. mitcheli Hattie L. Mitchell, Chief Office of Hazardous Materials Standards Regulatory Review and Reinvention#

Page 4Page 1 of 2 Edmonson, Eileen <PHMSA> Edmonson From: Terry Grimmond [TGrimmond@danielsinternational.com] §/73.134 (b)(1) Sent: Tuesday, August 02, 2005 7:14 AM To: Edmonson, Eileen <PHMSA> Regulated Medical liose Subject: RE: Shipping RMW to USA Exceptions Hi Eileen, 05-0182 Thanks for confirmation that RMW coming into US comes under DOT jurisdiction. My specific Q is: Can containers (PG2 compliant) of non-decontaminated medical devices, which may include "sharps", be received in US from other countries so as to be cleaned and refurbished by FDA-approved companies? This is a rapidly growing industry in US. In US, expensive, disposable Medical Equipment/Devices are sent back to mfg or third party for reprocessing and resale. irrespective of whether they were decontaminated before shipping. Can you advise DOT's regulations on this? Somewhere, I thought I saw such devices were NOT classed as RMW irrespective of whether they were sharp, and ind not classified as RMW - do I read this. correctly ara 173.134 (b) (7) refers to medical equipment being shipped for "..cleaning or refurbishment" as being an exceptio Kind regards, Terry From: Edmonson, Eileen <RSPA> [mailto:eileen.edmonson@RSPA.dot.gov] To: Terry Grimmond Sent: Friday, 11 February 2005 9:39 AM Cc: Gorsky, Susan <RSPA> Subject: RE: Shipping RMW between counties Hi Terry, transportation to the United States or one of its territories. The answer is yes to both questions when RMW is being transported in commerce in, through, or intended for See § 171.1(a) of 49 CFR Parts 171-180, and 49 U.S.C. 5101 Eileen Edmonson Regulatory Review and Reinvention, DHM-12 Transportation Regulations Specialist Office of Hazardous Materials Standards Research and Special Programs Administration (main office) 202-366-8553 (w-direct) 202-366-4481 (fax) 202-366-3012 From: Terry Grimmond [mailto:terry.grimmond@sharpsmart.com -----Original Message----- To: Edmonson, Eileen <RSPA> Sent: Monday, February 07, 2005 11:42 PM Subject: Shipping RMW between counties 08/02/2005#

Page 5Page 2 of 2 Hi Eileen, Does DOT have jurisdiction over: RMW shipped to USA from other countries - eg Canada, UK, Europe? Kind regards, RMW generated in USA but shipped to other countries - eg Canada, UK, Europe? Terry 08/02/2005#