36C25618Q9633-0002001.pdf

Transporting Infectious Substances Safely

Infectious Substances Safely

Infectious Substances Guide

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Objective

• Provide a general overview of the regulatory requirements for transporting Division 6.2 materials:

– Definitions and Package Selection

– Marking and Labeling

– Shipping Papers and Emergency

Response Information

– Security and Training

• Identify requirements for Regulated Medical Waste

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U.S. DOT Hazardous Materials Regulations (HMR)

The HMR govern the packaging and safe transportation of hazardous materials by air, highway, rail, and water (except bulk transportation onboard vessel).

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Other Federal Regulations Governing Safe Transport of Infectious Substances

• Department of Health and Human Services (HHS)

42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

• Department of Labor/0SHA 29 CFR, Section 1910.1030 – Bloodborne Pathogens

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International Regulations

• The International Civil Aviation

Organization (ICAO)

– ICAO Technical Instructions for the

Safe Transport of Dangerous Goods

• The International Maritime

Organization (IMO)

– International Maritime Dangerous

Goods Code (IMDG Code)

• The HM226A Final Rule on Infectious

Substances

– brought the HMR in harmonization with international documents

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HM226A Final Rule

• Hazardous Materials: Infectious Substances; Harmonization With United Nations Recommendations

– Published: Federal Register

Vol. 71, No. 106 – June 2, 2006

– Effective: October 1, 2006

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Significant Changes

• New Classification System

– Category A and Category B

• NO MORE RISK GROUPS

• New and Revised Definitions

– Modified Division 6.2 material

– Modified Biological Product

– Modified Regulated Medical

Waste

– Modified Culture

– New Patient Specimen

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Significant Changes (cont’d)

• Hazardous Materials Table Changes

– Removed Diagnostic Specimen

– Added Biological Substance

Category B

• Security Plans

• Packing and Labeling

• Carriage by Aircraft

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Division 6.2 Materials

• Infectious Substance

• Biological Product

• Cultures and Stocks

• Regulated Medical Waste

§173.134

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Infectious Substance Definition

• A material known or suspected to contain a pathogen:

– a microorganism (including bacteria, viruses, parasites, fungi) or other agent, that can cause disease in humans or animals.

• Infectious substances must be assigned to one of four UN Identification numbers.

§173.134(a)(1)

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Category A Infectious Substance

• A form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposed

• Classification based on:

– known medical history or symptoms of source patient or animal

– endemic local conditions or professional judgment

§173.134(a)(1)(I)

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Category A Infectious Substance

• Identified as:

– Infectious substances, affecting animals only, UN2900; and

– Infectious substances, affecting humans, UN2814

§171.101

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Category B Infectious Substance

• A form that is not generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposed.

• Identified as:

– Biological substance, Category B, UN3373

§§173.134(a)(1)(ii); 172.101

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Biological Product Definition

• Virus, serum, toxin, antitoxin, vaccine, blood, blood component, allergenic product used in prevention, diagnosis, treatment of disease

• Includes materials manufactured in accordance with FDA, USDA regulations

• Excepted if subject to federal approval, permit or license requirements (FDA, USDA)

§173.134(a)(2)

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Biological Product Identification

• When known or expected to contain pathogens of Category A or Category B (unless excepted):

• Category A

– UN 2814

– UN 2900

• Category B

– UN 3373

§173.134(a)(2)

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Culture Definition

• An infectious substance containing a pathogen that is intentionally propagated

• Does not include human or animal patient specimens

§173.134(a)(3)

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Patient Specimen Definition

• Human or animal material (excreta, secreta, blood, tissue, tissue swabs) transported for diagnostic or investigational purposes

• Transported as Category B infectious substances

– not considered capable of causing permanent disability or life-threatening or fatal disease in healthy humans or animals if exposure occurs

§173.134(a)(4)

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Regulated Medical Waste Definition

• Waste or reusable material, other than Category A,

– derived from medical treatment of humans or animals including diagnosis and immunization; or

– from biomedical research

• includes production and testing of biological products

§173.134(a)(5)

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Regulated Medical Waste Identification

• Contains or suspected to contain Category A substance

– must be identified as a Category

A infectious substance UN 2814 or UN 2900, as applicable.

• Contains Category B

– identified as Regulated Medical

Waste, UN 3291

§173.134(a)(5)

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Exceptions

• A material that is unlikely to cause disease in humans or animals

• Non-infectious biological materials from humans, animals, or plants

• A material containing neutralized or inactivated pathogens and no longer pose a health risk

• Blood collected for transfusion or preparation of blood products sent for testing (unless believed to contain an infectious substance)

§173.134(b)

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Exceptions (cont’d)

• Laundry, medical equipment conforming to OSHA regs 29 CFR 1910.1030

• Any waste or recyclable material, other than RMW

• Corpses, remains, and anatomical parts intended for interment, cremation, or medical research

§173.134(b)

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Packaging Requirements

6.2 Packaging Tests178.609

Category B Infectious Substance173.199

Regulated Medical Waste173.197

Category A Infectious Substance173.196

Exceptions for:

Division 6.2 Packaging Regulated Medical Waste

173.134(b) 173.134(c)

General Packaging Requirements for all HAZMAT Changes regarding Infectious Substances and mixed contents

173.24 173.24a 173.24a(c)

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Category A Packaging

§173.196

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UN Packaging – Division 6.2 Category A un

4GU/CLASS 6.2/06

USA/+AA1869/APSS

• Manufacturer’s Code

• Different Primary Receptacle Allowed

• Country

• Test Facility’s Code

• Fiberboard

• Box

• United Nations Symbol

• Infectious Substance Package

• Year Manufactured

§ 178.503(f)

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Category B Packaging

§173.199

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Used Health Care Products

• Products not conforming to CFR1910.1030 returned to manufacturer

• Triple non-spec package

• BIOHAZARD mark on primary and secondary packaging

• Itemized list

• No shipping paper, label, or emergency response information

§173.134(b)(12)(ii)

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Regulated Medical Waste (RMW) Packaging

• Rigid

• Leak resistant

• Impervious to moisture

• Burst, tear, and break resistant

• Puncture resistant for sharps

• Sealed to prevent leaks

• Meets UN PG II specs of Part 178

§173.197

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Regulated Medical Waste

• Bulk packaging

– Large packaging (UN spec)

– BOP (non-spec)

– Biohazard Mark

– CART – requires drop test at PG II level

• Inner packaging

– Solids: plastic film bag (ASTM performance tests)

– Liquids: rigid, general packaging requirements in Part 173

– Sharps: puncture-resistant, PG II performance level if over 20 gallons; closure procedures

§173.197

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Regulated Medical Waste Exceptions

• Non-bulk RMW transported by private or contract carrier

– No label if OSHA BIOHAZARD mark

– Non-spec packaging and OSHA packaging (other than waste concentrated stock culture of an infectious substance)

• Cultures/stocks in OSHA packaging and vehicle used exclusively to transport RMW (Category B infectious substance)

§173.134(c)

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Once sterilized, regulated medical waste is no longer considered a Division 6.2 material.

RMW entering autoclave unit

From Regulated to Non-Regulated

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Marking Requirements Marking requirements for packages include:

– Proper shipping name and technical name when applicable

– Identification number

– Consignee or consignor name and address

– DOT Special Permit (if applicable)

– Orientation arrows (if applicable)

– Net quantity of dry ice

(if applicable) Part 172, Subpart D

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Proper Shipping Names and Identification Numbers

• Biological substance, Category B, UN3373

• Category A infectious substance:

– Infectious substances, affecting animals, only, UN2900

– Infectious substances, affecting humans, UN2814

• Regulated medical waste, n.o.s., UN3291

§172.101

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Marking and Label Requirements

• Category A

– Proper shipping name, UN 2814 or UN 2900 (as applicable)

– Shipper or Consignee identification

– Infectious Substance Label

– Orientation arrows (as applicable)

• Category B

– Proper shipping name

– UN 3373 marking

– Name and telephone number of responsible person (may be placed on separate document such as air waybill

– Orientation arrows (as applicable)

§172, Subparts D and E

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Marking and Label Requirements (cont’d)

• Regulated medical waste

– Proper shipping name

– UN 3291

– Consignor or Consignee name and address

– Infectious substance label

– Orientation arrows (as applicable)

§172, Subparts D and E

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Biological Substance, Category B Marking

UN3373

§173.199(a)(5)

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Division 6.2 Label

• Required label for:

– Category A Infectious Substance

– Regulated Medical Waste (unless excepted)

§172.432

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Shipping Papers

• Category A

– Identification Number

– Proper Shipping Name

• "suspected Category A infectious substance” (technical name as applicable)

– Hazard Class/Division

– Packing Group

– Total Quantity

– Shipper’s Certification

– Emergency Response Telephone Number

• Category B (unless excepted)

– No shipping papers required

Part 172, Subpart C

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Shipping Papers – Regulated Medical Waste

• Shipping description:

– Proper Shipping Name

– Hazard Class/Division

– Identification Number

– Packing Group

– Total Quantity

– Shipper’s Certification

– Emergency Response

Telephone Number

§173.134.(c)

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Emergency Response Information

• Requirements for providing and maintaining emergency response information identified in Part 172, Subpart G

• May be on shipping paper or other document

• Exception: not required if a shipping paper is not required

Photo: Lawrence Berkeley National Lab

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Division 6.2 Materials of Trade

(MOTS)

• Definition

– Hazmat on private motor carrier in direct support of principal business that is other than transportation

• Examples:

– Home health care products, biological product or regulated medical waste

§§171.8; 173.6(a)(4)

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MOTS Exception

• A Division 6.2 other than Category A contained in human or animal samples transported as:

– Research, diagnosis, investigation activities; or disease treatment or prevention, i.e.

• Blood and its components

• Tissue and tissue fluids

• Body parts; or

– Biological product

– Regulated medical waste (RMW)

§173.6(a)(4)

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MOTS Exception (cont.)

• Non-spec combination packagings with quantity limits

• Aggregate gross weight of all MOTS on motor vehicle may not exceed 200 kg (440 lbs)

§173.6(a)(4) and (d)

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Other Requirements – Security Plan

• A security plan is required for:

– Select agent or toxin regulated by

CDC under 42 CFR part 73

– By April 1, 2007 for select agent or toxin regulated by USDA under 9 CFR part 121

• The plan must include:

– Assessment of security risks

– Address personnel security, unauthorized access, and en route security

§172.800(b) (6)

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Other Requirements – Training

• Federal hazardous materials transportation law requires training of all hazmat employees.

These requirements are found in 49 CFR, Part 172, Subpart H

• Hazmat employee training must include:

– General Awareness / Familiarization

– Safety

– Function Specific

– Security Awareness

– In-depth Security (when applicable)

• Anyone shipping infectious substances must have “knowledge and training”

§ §172.704(a); 173.134(b); 173.199(e)

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Where to Find More Information . . .

http://hazmat.dot.gov

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How Can You Reach Us?

– Obtain answers to HMR questions

– Request copies of Federal Register, special permits or training materials

– Report HMR violations

– Fax on Demand

E-mail: infocntr@dot.gov

DOT/PHMSA Photo

Hazardous Materials

INFO-LINE

1-800-HMR49-22

(1-800-467-4922) Hours of Operation: 9 am – 5 pm ET

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