Allegheny Airlines, Inc — Hazardous Materials Safety Interpretation

Page 1U.S.Department of Transportation 100 Seventh Street, S. Vashinaton. D.C. 2059 Special Programs Research and Administration MAR 2 4 1999 Mr. Wayne S. Lester Reference No. 99-0037 Manager, Safety Programs Allegheny Airlines, Inc. 1000 Rosedale Avenue Middletown, PA 17057 Dear Mr. Lester: This is in response to your recent letter concerning differences in the text accompanying the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label in our DOT Chart 10 (1994) and DOT Chart 11 (1998), entitled "Hazardous Materials Marking, Labeling & Placarding Guides." You asked if placing this label on a package in transportation indicates the package . contains a Division 6.2 (infectious substance) hazardous material. The answer is yes. Under 49 CFR 173.134(a)(1) of the DOT Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180), a material meeting the definition of an etiologic agent in 42 CFR 72.3 of the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) regulations also meets the definition of an infectious substance under the HMR. The ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label, depicted in 42 CFR 72.3(d)(1), is required by CDC to be displayed on the outside of a package containing an etiologic agent. Such a package is also required to display the INFECTIOUS SUBSTANCE label depicted in 49 CFR 172.432, unless otherwise excepted. For example, under § 173.134(b), an etiologic agent that is a biological product or a diagnostic specimen is not subject to any of the requirements in the HMR. You also stated that sometimes your company is offered packages of donor organs for transport that display the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label but do not display the INFECTIOUS SUBSTANCE label. You asked if these shipments are subject to the HMR. Shipment of a donor organ is not subject to the HMR unless the item as packaged contains a material that is otherwise subject to regulation, such as "Carbon dioxide, solid" (dry ice). For questions concerning the display of the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label on such packages, I suggest you contact Jonathan Y. Richmond, PhD., Director, Office of Health and Safety, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Atlanta, GA 30333, (404) 639-2453.#

Page 2"" • Mack 1240 NI Allegheny 99-0037 Airlines, Inc. Wayne S. Lester Mgr. Safety Programs Mr. Edward Mazzullo Director OHMS 400 7h Street, SW U.S. Department of Transportation Washington, DC 20590 Re: DOT Chart 10 Confusion Dear Mr. Mazzullo: I am writing to ask for a written clarification on a placard, which appears in the DOT Chart 10. I am told that there is a new DOT Chart 11 available and I have ordered these charts, but in the meantime I need your assistance. The DOT Chart 10 (dated February 1994) shows two labels under Class 6, Division 6.2. One is the Infectious Substance label and the other is a Biomedical Material label. • The Biomedical Material label is the one giving our company trouble. Our Flight Training Department instructs our pilots on the carriage of hazardous materials using the DOT Chart 10. Because the Biomedical Material label appears on the chart with the Infectious Substance label, our pilots believe this label to be a hazardous materials label. We have explained that this is an OSHA label and the mere appearance of the Biomedical Material label (or the Biohazard label) on a package does not indicate that the package is a hazardous material. This has not swayed the opinion of our flight crews and they continue to reject the shipment of donor organs simply because of the Biomedical Material label. We have reviewed 49 CFR 173.134, where the regulation talks about exceptions, however this does not satisfy our Flight Training Department concerning the appearance of the Biomedical Material label on the DOT Chart 10 It would help us greatly if we could receive written confirmation from the DOT indicating that, although the Biomedical Material label does appear on the DOT Chart 10, this label appearing by itself on a package does not constitute a hazardous material Please reply to the attention of: Wayne Lester, Manager of Safety Programs, Allegheny Airlines, Inc., 1000 Rosedale Ave., Middletown, PA, 17057. Your help in dealing with this matter is greatly appreciated Sincerely, Navne S. Leste#

Page 3Interpretation Letters Requester Wayne S. Lester Date Received: 2/9/99 Company Allegheny Airlines, Inc. Tracking Number: 99-0037 Phone 717-948-5411 Revision Date: 2/9/99 Date Assigned 2/9/99 Date of Letter 2/9/99 Staff Mack First Draft Due: 3/2/99 Section 1240NI First Draft Date: Subject Labeling Concurrence Status Status Date Sign Date Signor HBPE Copy to Docket Copy to DHM-60 Comment sir Alley deceit cornermat ma normat constitutte onuper. - Danororgans bood mail products-not infections Itut comes form lab it well have osHA maro 14 141 45°#

Page 4TELEPHONIC CONVERSATION RECORD Specialist Placing Call: Eileen Mack ROUTING Date of Call: 2/23/99, 9:45 a.m. SYMBOL INT Person (s) Contacted: (1) Jerry Davis, Consumer Safety Officer; (2) Mary Ganikos, PhD., Chief, Public and Professional Education Branch, Their Organization: (1)Office of Compliance, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 400 South, Rockville, MD, 20852, (301) 827-6220, (2) Division of Transplantation, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Rockville, MD, 20857, (301) 443-7577 Date of Incoming Letter: Re: Letter from Wayne Lester, Allegheny Airlines, Inc., 100 Rosedale, Ave., Middletown, PA 17057, (717) 948-5411, No date (Received 2/9/99) Specific Subject (including section #'s and key words): Are donor organs biological products? Does any agency within the Department of Health and Human Services regulate the transport of donor organs? Summary: While preparing the response to Mr. Lester's letter on whether donor organs with the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label are regulated by DOT in transportation, the question came up as to whether donor organs were excepted from regulation as a biological product. Mr. Davis said the answer is no and that the FDA does not regulate donor organs. He referred me the HRSA. I spoke to Dr. Ganikos, who explained her agency was concerned with organ procurement and information outreach but had no regulations regarding how they are to be transported. On 2/22/98, I placed a call to Dr. Jonathan Richmond, Centers for Disease Control and Prevention, to learn if CDC has any regulations regarding donor organs. I am awaiting his response. Comments for Further Action: Revise the draft to refer Mr. Lester to Jonathan Richmond and Jerry Davis. Include the recent phone report. Forward the draft for concurrence and signature. Specialist Signature: Giler Mack Date: 2/23/99#

Page 5TELEPHONIC CONVERSATION RECORD Specialist Placing Call: Eileen Mack ROUTING Date of Call: 2/18/99, 3:45 p.m. SYMBOL INT Person (s) Contacted: Wayne Lester, Manager, Safety Programs Their Organization: Allegheny Airlines, Inc., 1000 Rosedale Ave., Middletown, PA 17057, (717) 948-1910 Date of Incoming Letter: No date (Received 2/9/99) Specific Subject (including section #'s and key words): Is placing the ETIOLOGIC AGENTS- BIOMEDICAL MATERIAL label on a package an indication that this package contains a Division 6.2 (infectious substance) material? Summary: Mr. Lester says Allegheny does not carry hazardous materials. They move company mail and donor organs. Occasionally, donor organs come in with the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label and the pilots refuse to carry them. When they consult the DOT Charts 10 and 11, shippers and carriers are confused as to whether the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label belongs to OSHA or CDC and if the item is infectious or not. DOT Chart 10 says the label is from CDC's regulations. DOT Chart 11 says the label is from OSHA's. I informed Mr. Lester that if the ETIOLOGIC AGENTS--BIOMEDICAL MATERIAL label is used, the item is infectious. I also explained that the reference in DOT Chart 11 to OSHA regulations is incorrect. I explained that OSHA's symbol is a trefoil with the words BIOHAZARD written underneath it. I also explained that it is used to express OSHA's universal precautions regulations, which provide relief for materials containing human blood only when it is known they do not contain a blood borne pathogen. Comments for Further Action: Forward the draft for concurrence and signature. The incoming letter is not dated, do not include a letter date in response. Specialist Signature: Giler 6. Mack Date: 2/18/99#

Page 6DOT CHART 10 Transportation U.S. Department of Hazardous Materials Marking, Research and Special Programs Administration Labeling & Placarding Guide lerkeral mgulations Refer to 49 CFR, Part 172: Marking - Subpart D Labeling - Subpart E Placarding - Subpart F Emergency Response - Subpart G NOTE:#

Page 7Hazardous Materials Warning Labels CLASS 1 Explosive 1.1 CLASS 1 Explosive 1.2 1.4 CLASS 1 Explosive 1.5 CLASS 1 Explosive 1.8 CLASS 2 Division 2.1 CLASS 2 Division 2.2 CLASS 2 Division 2.2 1.3 FLANIIABLE GAS < NON-FLAMILIABLE GAS? OXYGEN *Include appropriste compatiblilty group latter. division number and *Include appropriate compatiblilty group letter. *Include appropriate compatibillty group letter. *Include appropriale compatibillty group letter. Flammable gas Non-flammable gas Oxygen CLASS 2 Division 2.3 CLASS 3 CLASS 4 CLASS 4 Division 4.2 CLASS 4 Division 4.3 CLASS 5 Division 5.1 CLASS 5 Division 5.2 POISON GAS •FLAMMABLE LIQUID DANGEROUS OXIDIZER ORGANIC PEROXIDE Poison gas Flammable liquid Flammable solld Spontansously Combuslible Dangerous when wet Oxidizer Organic peroxide CLASS 6 Division 6.1 CLASS 6 Division 6.1 CLASS 6 Division 6.2 CLASS 7 CLASS 7 " CLASS 7 IlI POISON HARMFUL STOW AWAY INFECTOUS SUBSTANCE RADIOACTIVE I RADIOACTIVE II RADIOACTIYEMI Polson-Packing Group I and Il Polson-Packing III Infectious substance agent label may apply. 42 CFR 72.3 Etiological CLASS 8 CLASS 9 SUBSIDIARY RISK LABELS FOR AIRCRAFT Explosive Flammable liquid Flammable gas Cargo Aircraft Only CORROSIVE Flammable solid Oxidizer Corrosive EMPTY Polson Spontaneously Combustible Dangerous when wet MASTERIKED label (see Section 172.402). The class number may not be displayed on a subsidiary Corrosive TRANSITION-2001 TRANSITION-2001 TRANSITION-2001 TRANSITION-2001 Empty TRANSITION-2001 TRANSITION-2001 TRANSITION-2001 CHLORINE FLAMMABLE SOLID IRRITANT INNER PACKAGES HAZARDOUS MATERIALS PACKAGE MARKINGS PRESCRIBED COMPLY WITH CONSUMER COMMODITY SPECIFICATIONS DAPOKA i car hao bees ORM-D §173.25(a)(4) MARINE POLLUTANT vita $172.322 its or poison lesto, sia INHALATION §172.316(a) HAZARD CONSUMER COMMODITY 11 11 HOT ORM-D-AIR §173.9 $172.313(a) §172.312(a) $172.325 §172.316(a)(1) Keep a copy of the DOT Emergency Response Guidebook handy!#

Page 8nazaraons Malerais Varking, Special Programs Administration Labeling & Placarding Guide 100 regulati feeleral Refer to 49 CFR, Part 172: Marking - Subpart D Labeling - Subpart E Placarding - Subpart F Emergency Response - Subpart G NOTE:#

Page 9Hazardous Materials Warning Labels CLASS 1 Explosive 1.1 CLASS 1 Explosiva 55 1.4 CLASS 1 Explosive 1.5 CLASS 1 Explosive 1.6 CLASS 2 Division 2.1 CLASS 2 Division 2.2 CLASS 2 Division 2.2 FLAMMABLE GAS NON-FLAMMABLE GAS OXYGEN division number and *Include appropriate compatibilty group letter. *Include appropriate compatibllty group letter. *Include appropriate compatiblty group letter. *Include appropriate compatibility group letter. Flammable gas Non-flammable gas Dxygen CLASS 2 Division 2.3 CLASS 3 CLASS 4 Division 4.1 CLASS 4 Division 4.2 CLASS 4 Division 4.3 CLASS 5 Division 5.1 CLASS 5 Division 5.2 INHALATION HAZARD FLAMMABLE LIQUID DANGEROUS ™ OXIDIZER ORGANIC PEROXIDE 2 3 Polson gas Flammable liquid Flammable solid Spontaneously Combustible Dangerous when wet Oxidizer Organic peroxide CLASS 6 Division 6.1 CLASS 6 Division 6.1 CLASS 6 Division 6.1 CLASS 6 Division 6.2 CLASS 7 CLASS 7 INHALATION HAZARD POISON HARMFUL NFECTIOUS SUBSTANCE HONCHCAL MATERIAL TOW AWA RADIOACTIVE T RADIOACTIVEN POISON only, Zone A or B. Poison-Inhalation Hazard more of PG I or I!, other than Placard 454 kg (1,001 ibs) or 29 CFR 1910.1030 BIOHAZARD marking may be used for Zone A or B, inhalation hazard. Poison-PG III Infectious substance Ragulated Medical Waste SUBSIDIARY RISK LABELS (RhW). Radioactive WHITE-I Radioactive YELLOW-II CLASS 7 CLASS 8 CLASS 9 FOR AIRCRAFT Flammable gas Explosive Flammable solld Flammable guid RADIOACTIVE MI CORROSIVE Oxidizer Corrosiva EMPTY MATERIE Poison Dangerous when wet Spontaneously Combustible Cargo Aircraft Only Radioactive YELLOW-HII TRANSITION-2001 Corrosive TRANSITION-2001 Miscellaneous he class number may not be displayed on a subsidia TRANSITION-2001 bel (see Section 172.402 TRANSITION-2001 TRANSITION 2001 Empty-Radloactive TRANSITION-2001 FLAMMABLE SOLID IRRITANT HAZARDOUS MATERIALS MARKINGS INNER PACKAGES PRESCRIBED COMPLY WITH CONSUMER COMMODITY SPECIFICATIONS DANGER ORM-D §173.25(a)(4) MARINE POLLUTANT §172.322 INHALATION §172.316(a) PIES ON HAZARD CONSUMER COMMODITY 11 11 HOT DO NOT ENTER ORM-D-AIR $172.302(g) and §173.9 §172.312(a) §172.325 8172.313(a) §172.316(a)(1) Keep a copy of the North American Emergency Respons#

Page 10- Bloodbonie pathogens. - 1910.1030 • ' • http://www.osha-slc.gov/OshStd_data/1910_1030.html OSHA Dacupatist Satcty is Health Administration 15. Orparturot of Laloes OSHA Regulations (Standards - 29 CFR) Bloodborne pathogens. - 1910.1030 • OSHA Regulations (Standards - 29 CFR) - Table of Contents • Standard Title: Bloodborne pathogens. • Standard Number: 1910.1030 • SubPart Number: Z • SubPart Title: Toxic and Hazardous Substances Interpretation(s) (a) infectious materials as defined by paragraph (b) of this section. Scope and Application. This section applies to all occupational exposure to blood or other potentially (b) Definitions. For purposes of this section, the following shall apply: "signated representatives the Assistant Secretary of Labor for Occupational Safety and Health, or "Blood" means human blood, human blood components, and products made from human blood. cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) "Bloodborne Pathogens" means pathogenic microorganisms that are present in human blood and can and human immunodeficiency virus (HIV). "Clinical Laboratory" means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. "Contaminated" means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. "Contaminated Laundry" means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. "Contaminated Sharps" means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. "Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy transmitting infectious particles and the surface or item is rendered safe for handling, use, or bloodborne pathogens on a surface or item to the point where they are no longer capable of disposal. 1 of 25 2/17/1999 8:39 AM#

Page 11http://www.osha-slc.gov/OshStd_gif/10ZBHSC.gif BIOHAZARD 1 of 1 2/17/1999 8:39 AM#