DOT Hazmat Training for Nuclear Medicine Technologists: Rules of the Road

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1 DOT Hazmat Training for Nuclear Medicine Technologists: Rules of the Road Presented by Charles W. Beasley, Ph.D., DABSNM

2 Regulatory History Regulations to control the transport of radioactive materials were started in 1935 by the U.S. Postal Service. Over the years, the Interstate Commerce Commission (ICC), now the Surface Transportation Board, became involved. There are at least five groups developing rules governing the transport of radioactive materials. These include the Nuclear Regulatory Commission, the Department of Transportation, the Postal Service, the Department of Energy, and the States. Of these agencies, the DOT and NRC are the primary ones issuing regulations based on standards set by the International Atomic Energy Agency (IAEA).

3 Pipeline And Hazardous Materials Safety Administration, Department of Transportation Title 49 CFR Part Subchapter C-Hazardous C Materials Regulations General Information, Regulations, and Definitions Hazardous Materials Table, Special Provisions, Hazardous Materials Communications, Emergency Response Information, and Training Requirements Shippers General Requirements for Shipments and Packagings Carriage by Rail Carriage by Aircraft Carriage by Vessel Carriage by Public Highway Specifications for Packagings Specifications for Tank Cars Continuing Qualification and Maintenance of Packagings

4 Training Requirements 49 CFR The Department of Transportation (DOT) requires that any employee who: Prepares packages of hazardous (radioactive) materials for shipment; Transports and delivers hazardous (radioactive) materials; and/or Is responsible for the safe preparation and transport of packages containing hazardous (radioactive) materials receive specific training.

5 Training Requirements 49 CFR (a) The DOT training requirements include: General awareness and familiarization of the employee with the requirements of the Hazardous Materials Regulations (HMR) subchapter. Safety measures to protect the employee from radioactive materials, methods and procedures to avoid accidents and emergency response information. Security awareness employee training. Function-specific training for those tasks that the employee performs (e.g. packaging, labeling).

6 Training Requirements (c) New employees may perform hazmat functions prior to completion of training provided the employee performs those functions under the direct supervision of a properly trained and knowledgeable hazmat employee. Initial training must be completed within 90 days after employment. Hazmat employee must receive training at least once every three years. Relevant training received from a previous employer or other source may be used to satisfy the requirements provided a current record of training is obtained from the hazmat s previous employer.

7 Training Requirements (c) and (d) Each hazmat employer is responsible for compliance with the training requirements. A record of current training, including the past three years, shall be created and retained by each employer for each hazmat employee. The record shall include: Hazmat employee s name; Completion date of most recent training; Description or copy of the training material used; Name and address of the hazmat trainer; and Certification that the hazmat employee has been trained and tested

8 Sample Certificate

9 Training Program The training program must be a systematic approach to assure the hazmat employee can perform hazmat functions properly. Compliance testing can be written, verbal or performance based. DOT does not review or certify training programs. Employer must determine a trainer s qualifications based on the employer s need. Self-training is acceptable provided all training requirements of 49 CFR are met.

10 General Awareness/Familiarization Training directed toward the hazmat employee being able to recognize and identify radioactive (hazardous) materials consistent with the hazard communication standards of 49 CFR Part 172. Training should also include a basic orientation on: DOT shipping papers Package marking Package labeling Emergency response

11 General Awareness/Familiarization DOT has prepared training modules that meet the requirements for general awareness training which may be found at:

12 Training must cover: Safety Required emergency response information Measures to protect the employee from hazards such as: Basic Basic radiation safety principles (TDS) Methods Methods to avoid radioactive contamination Methods for avoiding accidents, such as proper handling procedures

13 Security Awareness After September 11, 2001, the DOT has required hazmat employees to receive training to increase their security awareness associated with the transportation of hazardous material and to recognize and respond to possible security threats. They encourages facilities to include security considerations in all operations to manage the potential security risks associated with the transportation of hazardous (radioactive) materials.

14 Security Awareness Radioactive Material Security All radioactive material should be stored within a restricted area. Incoming packages should be moved to the restricted area as soon as possible. Outgoing packages should be held in restricted area until ready to be shipped.

15 Security Awareness Restricted Area Security Doors to restricted area require a lock. Never block doors open. Limit who gets code or key. Report suspicious activity/persons.

16 Training Requirements Reviewed General Awareness/Familiarization Safety Security Awareness Function Specific

17 Function Specific Training The DOT requires training that is specifically applicable to activities (functions) the hazmat employee performs. A nuclear medicine technologist may perform some or all of these function specific tasks listed. Preparing package containing Limited Quantity radioactive materials Preparing a package containing radioactive materials Marking and labeling a package containing radioactive materials Preparing shipping papers for radioactive shipments

18 Return of Spent and/or Unused Doses Most nuclear medicine departments take advantage of the waste return services offered by local radiopharmacies. In these instances, the licensee is the designed shipper and responsible for DOT compliance. Three shipping scenarios are most common: Spent (used) syringes are returned Empty shields are returned Unopened, unused doses are returned

19 Spent (Used) Syringe Return The The most likely scenario is returning used syringes and vials to the local radiopharmacy as biohazardous waste. These These items will be returned to shielding and placed within the delivery case. The The next step is to determine if the package meets the requirements for Limited Quantity (LQ) shipment.

20 Limited Quantity (49 CFR ) Defined as the maximum amount of hazardous material for which there is a specific labeling or packaging exception Also known as excepted package No shipping papers required Package need only be strong, tight and in good condition Wipe test is required (<22 dpm/cm 2 over 300 cm 2 ) Survey is required (surface < 0.5 mr/hr) Inside package labeled Radioactive Labeled UN2910 on outside container Must meet certain activity limits

21 Package Limited Quantities 49 CFR Limited Quantity activity is a function of the radionuclide and its physical form (solid, liquid or gas). Tabulated below are some of the calculated common nuclear medicine radionuclide Limited Quantities. If these limits are exceeded, the package is a Normal Form shipment (shipping papers and Type A container required). Your radiopharmacy can supply a more detailed radionuclide list. Isotope Tc-99m Xe-133 I-131 I-131 I-123 Form Liquid Gas Liquid Solid Liquid Activity 11 mci 270 mci 1.9 mci 19 mci 8.1 mci Isotope Tl-201 Ga-67 In-111 P-32 F-18 Form Liquid Liquid Liquid Liquid Liquid Activity 11 mci 8.1 mci 8.1 mci 1.4 mci 2 mci

22 Preparing a Limited Quantity Package Ensure the activity limits do not exceed the specified limits for Limited Quantity shipments. Survey the external package surface. Reading can not exceed 0.5 mrem/hour. Wipe an area equal to 300 cm 2 of the external package surface. The wipe cannot exceed 6,600 dpm of removable contamination. If the three conditional above are met, the package may be shipped as a limited quantity shipment.

23 Preparing a Limited Quantity Package Continued The outside of the package must be marked Radioactive, UN No shipping papers are required. Many radiopharmacies use a reversible DOT warning card on the delivery cases. Note that used syringes are considered a biohazard and a label is required if returning used syringes.

24 Empty Shield Return Some nuclear medicine departments manage radioactive and biohazardous waste internally and do not return used materials to the pharmacy. Empty shields are returned to the delivery case. DOT Specific definition of empty implies the contents have been tested for residual radioactivity and biohazard. For simplicity assume the shields are contaminated and return as a limited quantity.

25 Unused Dose Return Occasionally, a patient no show or cancellation will result in unused dose of a radiopharmaceutical. To return this material to the radiopharmacy, first estimate the activity that will be remaining at the anticipated time the courier will retrieve the case. Check Check if this estimated activity is below the Limited Quantity.

26 Unused Dose Return If the estimated activity at time of pickup is less that limited quantity for that radionuclide, ship as Limited Quantity. When the dose activity is more that the Limited Quantity (Normal Form) value the dose must be packaged in a DOT marked, labeled and certified package. Shipping paper must be prepared.

27 Warning about Returning Unused Doses as Limited Quantity Package 3 Tc-99m unit doses of 30 mci each calibrated for 12 noon cannot be returned on the next morning pickup. 150 mci Tc-99m calibrated for 12 noon should not be returned in the next morning pickup. Returning non-tc Tc-99m products such as Ga-67 or Tl-201 unit doses although usually under the Limited Quantity values may have a surface reading over 0.5 mr/h.

28 Danger Ahead Proceed at Your Own Risk

29 Functional Specific Training for Above Limited Quantity Package The DOT requires specific training for hazmat employees who perform any function with preparing a package for shipment including: marking and labeling of a delivery container for the shipment of Normal Form radioactive materials. The DOT requires that all packages of RAM be marked and labeled in accordance with 49 CFR Subpart B Parts 172 and 173.

30 Packaging Requirements Normal Form hazardous material (most radiopharmaceuticals) must be shipped in a TYPE A container. These containers must be certified as having passed a free drop test, a water test spray test, a compression test, and a penetration test. Documentation of the certification must be available. TYPE A containers are not required for Limited Quantity shipments A Limited Quantity package need only to be strong, tight and in good condition

31 Marking and Labeling Requirements 49 CFR (b) requires that the package include the markings USA DOT 7A TYPE A. Packages containing liquid radioactive materials must be marked with orientation (directional) markings on two opposing sides. The proper shipping name of the hazardous material, Radioactive Material, Type A Package and the UN identification number (UN2915) must be marked on each package.

32 Marking and Labeling Requirements The The DOT requires special Reportable Quantity (RQ)markings if limits in Appendix A, Table 2 are exceeded. Shipments of more than 10 mci of I-131 I or I-125 need to be marked RQ. The The RQ must be placed before or after the proper shipping name. Each Each package must have the name and address of both the shipper and recipient.

33 Marking and Labeling Requirements Each TYPE A package containing radioactive material must include two hazard warning labels located on opposing sides of the package. There are three radioactive materials categories: White I Yellow II Yellow III Each category has unique information associated with it regarding: Type and quantity or radioactive material Safety information and Emergency response

34 Selecting the Proper Hazard Warning Labels The label depends on: the highest radiation level measured from any surface of the package and The radiation level measured at one meter from the highest surface reading The second measurement, also called the transportation index (TI), is not required if the maximum surface reading is less than 0.5 mrem per hour

35 Selecting the Proper Hazard Warning Labels Label Surface Radiation Level Radiation Level at 1 Meter (TI) White Does not exceed 0.5 mrem/hr Not applicable Yellow II Does not exceed 50 mrem/hr AND Does not exceed 1 mrem/hr Yellow III Exceeds 50 mrem/hr OR Exceeds 1 mrem/hr

36 Completing the Hazard Warning Labels Contents List radionuclides by authorized abbreviation Activity Enter the activity in units of Becquerel (1 mci = 37 MBq) Transport Index (TI) Enter the 1 meter reading (if > 0.5 mrem/hr) rounded up to one decimal point

37 Securing the Package Normal Normal Form packages require a security seal. The The security seal can be a nylon, paper tape or other device that would show when the integrity of the package has been breach. Limited Limited Quantity packages do not require a security seal.

38 Normal Form Package Summary Package markings include: USDOT 7A Radioactive Material, TYPE A Package UN2915 Directional arrows Shipper name and address Consignee (receiver) name and address Package labels include: Hazard warning (White I, Yellow II and Yellow III) indicating radionuclide, activity and possibly transport index Security seal

39 Package Wipe Test Wipe tests must be performed to determine the level of contamination. Use an alcohol swab or other material to wipe the surface of the shipping package Wipe area of at least 300 square centimeters. Sample all surfaces of the package. Use a single or multi-channel analyzer preferably with a well detector Collect a background count. Count the wipe sample. Determine the net count by subtracting the background count from the wipe count. Apply correction factor to convert net counts (cpm) to disintegration per minute (dpm). Compare the net count to action level.

40 Wipe Test Results Compare the net corrected to an action level for wipes. DOT action level is 6600 dpm over a 300 cm 2 area. Each facility may have a lower action level. If the corrected wipe sample is greater than the action level repeat test. If action level is exceeded on repeat wipe stop and notify your radiation safety officer.

41 Functional Specific Training for Preparing Shipping Papers for Ground Delivery A shipping paper or bill of lading, must accompany every shipment of hazardous material. The shipping paper contains: Names and addresses Classification and identification of material being transported, Emergency contact information and Shipper s certificate. Shipper must retain a copy of the completed bill of lading for two years.

42 Preparing Shipping Papers Items listed on a shipping paper: Names and Addresses of shipper and receiver (consignee) Proper shipping name and classification RADIOACTIVE MATERIAL, TYPE A PACKAGE 7A UN 2915 Radionuclide Chemical form/physical state Activity in Becquerels Hazardous label category 24/7 emergency phone number Signed shipper certification

43 Shipper Certification and Emergency Contact Information The Shipper s Certificate is a signed statement that the package has been prepared in accordance with DOT regulations. The emergency contact phone number listed is required to be answered by a person 24/7 during the time period the shipment is in transit. You cannot list the phone number of Chemtrack unless your facility subscribes to Chemtrack. Providing a cell phone number for emergency contact is a simple solution.

44 Functional Specific Training for Preparing Dangerous Goods Air Bill Packages containing radioactive material transported by air must comply with the International Air Transport Association (IATA) Dangerous Goods Regulations (DGR). Shipments by air must be accompanied by three typed or computer generated copies of a Shipper s Declaration of Dangerous Goods Nuclear medicine technologists do not typically ship packages that require a Declaration of Dangerous Goods.

45 Help with Declaration of Dangerous Goods Carriers such as Federal Express have extensive on line material to help complete the paperwork. IATA Dangerous Goods regulations can be used as a reference. The 49CFR specifies the requirements for transportation of packages of radioactive material by air.

46 Conditions for Shipping by Air The DOT allows the transport of radioactive material by air if: The material is intended for use in research, medical diagnosis or treatment The package is appropriately marked and labeled in accordance with DOT regulations The transport index (TI) can not exceed 3.0 for passenger carrying aircraft and packages can not be carried in passenger compartments The TI can not exceed 10.0 for cargo only aircraft Shipments by air must be accompanied by three typed or computer generated copies Shipper s Declaration of Dangerous Goods. Shipper and generator of declaration assume all responsibility for compliance with all applicable laws and regulations pertaining to shipment

47 Air Carrier Check List Many carriers of dangerous goods routinely use a check list to determine the acceptance of a package of dangerous goods.

48 Office of Hazardous Material Enforcement Top 7 violations: Failing to train hazmat employees Failure to get recurring training after three years Failing to have proper TYPE A package documentation Using improper shipping names and ID numbers Failing to recognize for any amount of I-131 I over 10 mci requires shipping paper and package to be marked with the letters RQ Failure of required information on the shipping paper to be in the proper format and order Not responding satisfactory when emergency contact listed called

49 Suggested Route Review and categorize the activities and surface exposure rates shipped: Only Limited Quantity (LQ) Normal Form decayed to LQ Normal Form (>LQ) If you ship Normal Form collect documentation on TYPE A containers from radioisotope suppliers Develop training and testing program based on your facility: Return to pharmacy LQ Return to pharmacy Normal Form Return of sealed sources or generator by air carrier Provide certificates to staff that satisfactory complete program

50 The