Sacramento Blood Center — Hazardous Materials Safety Interpretation

Page 1U.S. Department 400 Seventh Street, S.W. of Transportation Washington, D.C. 20590 Special Programs Research and NOV 2 - 1999 Administration Ms. Catherine J. Feiock Ref. No. 99-0065 QA Manager for Hospital Services Sacremento Blood Center 1625 Stockton Boulevard Sacramento, CA 95816-7089 Dear Ms. Feiock: This is in response to your letter, and subsequent telephone conversations with members of this Office, concerning the air transportation of blood and blood components, packed with dry ice, under the International Air Transport Associations Dangerous Goods Regulations and the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). In telephone conversations with members of this Office, you stated the materials are biological products that are used for transfusions or for research purposes. Your questions are paraphrased and answered as follows: Q1. Are absorbent materials (e.g., wipes) required for blood and blood components that have been tested and found not to contain an infectious substance? Al. Blood and blood components that do not contain an infectious substance or any other hazard class are not subject to the HMR or the international regulations, regardless of the quantity being shipped. However, blood and blood components may be subject to other Federal regulations, such as those for biological products administered by the Department of Health and Human Services' Food and Drug Administration. You should contact that agency for information on those requirements. Q2. What is the maximum volume of tested donor blood that can be shipped that is known to be non-infectious? A2. See above response under A1: Q3. What is the maximum volume of "Dry ice, 9, UN 1845, PG III" that may be included with a shipment of non-infectious frozen red blood cells? 172.101j 990065#

Page 2A3. With certain exceptions, the HMR authorize compliance with the International Civil Aviation Organization's (ICAO) Technical Instructions if the hazardous material is intended for transportation by aircraft, and by motor vehicle, either before or after being transported by aircraft. See 49 CFR 171.11. The entry "Carbon dioxide, solid or Dry ice" is listed in the § 172.101 Hazardous Materials Table of the HMR and the Dangerous Goods List in the ICAO Technical Instructions. Under these regulations, the maximum net amount of dry ice that may be offered in one package for transportation by aircraft is 200 kg (441 pounds). Advance arrangements must be made between the shipper and each carrier for shipments exceeding 2.3 kg (5 pounds) per package. See 49 CFR 173.217. Dry ice is subject to regulation only when transported by aircraft or vessel. I hope this satisfies your request. Sincerely, Hathe 2. Mattel Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 3SACRAMENTO MEDICAL FOUNDATION Blood Centers George $172.101g) March 5, 1999 - 99-0065 US Department of Transportation, Research Special Programs Administration Edward Mazzullo 400 Seventh Street, South West, Room 8102 Route DHM 10 Washington, DC 20590-0001 Dear Mr. Mazzullo: This letter is to confirm my understanding of answers received regarding lATA SACRAMENTO BLOOD CENTER regulations: 1625 Stockton Boulevard Sacramento, CA 95816-7089 Q. Are absorbent wipes required for blood and blood components tested for FAX 916/452-9232 TEL. 916/456-1500 infectious disease, non-reactive, transported via air? A. No, tested blood and blood components are not regulated, only known NORTH STATE BLOOD CENTER pathogens. 188o Park Marina Drive Redding, CA goo Q. What is the maximum volume of tested blood which can be shipped? TEL 530/243-0160 A. No maximum volume, tested blood and blood components are not FAX 530/243-0580 regulated. 285 Cohasset Road NORTH VALLEY BLOOD CENTER Q. What is the maximum volume of dry ice that can be included with tested Chico, CA 95926 frozen blood component shipments (ORM UN1845) TEL 530/893-5433 A. 200 Kilograms per package or 440 Ibs. (2.2 Ibs. per kilogram) FAX 530/893-2537 CENTER FOR BLOOD RESEARCH 1631 Stockton Boulevard Thank you for your prompt response and clarification of the requirements. Sacramento, CA 95816-7089 TEL 916/456-1500 Sincerely, FAX 916/456-2414 Catherine f. Feiock Catherine J. Feiock QA Manager for Hospital Services#