Medical Courier Details:
HISTORICAL INFORMATION
OVERVIEW OF INTRASTATE REGULATIONS
TITLE 49 CFR - SURFACE SHIPMENT OF INFECTIOUS SUBSTANCES
&
OTHER HAZARDOUS MATERIALS
Subject: New Federal Intrastate Regulation of Hazardous Material Shipments - Effective October 1, 1998
Private Sector Shipments under Intrastate Regulation--
On October 1, 1998, the U.S. Department of Transportation ("DOT") commenced intrastate regulation of hazardous materials shipments, including (1) etiologic agents ("Infectious Substances") and (2) regulated medical waste, under the federal Hazardous Materials Regulations ("HMR").
Jurisdiction. Previously, the authority of the federal government over hazardous materials shipments was restricted primarily to shipments intended for air transport or interstate shipments. Under its new authority, DOT may audit or inspect shippers, freight forwarders, common carriers, and couriers (including both air and surface) for compliance with the HMR.
The types of shipments now regulated include, without limitation, the following:
(1) shipment of etiologic agents ("Infectious Substances") which are intended for commercial air transport (these shipments have been regulated since January 1, 1995),
(2) intrastate shipment of Infectious Substances which are transported by common carrier or third party courier and where such shipments utilize the public streets and highways (effective October 1, 1998),
(3) intrastate shipment of Infectious Substances which are transported by employees of a health care organization as shippers or reference laboratory employee couriers, using the public streets and highways (effective October 1, 1998),
(4) other hazardous materials, including regulated medical waste shipments, which are now regulated under the HMR.
Government Exemption from the HMR
Recently our company requested information from DOT concerning a clarification of exemptions from regulation under the HMR which are granted to governmental entities.
In 1994, the Resource and Special Programs Administration ("RSPA") drafted a response to issues raised by the University of California and U.S. Congressman Ronald Dellums in Washington. In these letters RSPA, a division of the DOT in Washington, summarized the ground rules for governmental exemptions from the federal HMR.
After studying the RSPA letters, the HMR, and reviewing the issues, we have confirmed that certain shipments from government facilities are regulated under the HMR, and these include:
(1) etiologic agents ("Infectious Substances") which are transported from exempt health care facilities, such as county, municipal, military, or veterans hospitals by private reference laboratory couriers,
(2) Infectious Substance shipments which are carried from exempt health care organizations by third party private couriers,
(3) Infectious Substances which are carried from exempt health care facilities by third party couriers or common carriers,
(4) Infectious Substance shipments which are carried from exempt health care facilities by FedEx and other air transporters, and
(5) all other hazardous material shipped as in 1 through 4 above.
Except for air transport, shipments from exempt organizations which are directly associated with (1) a government purpose and (2) are transported by government employees are exempt from the HMR.
It is important to note that ALL of the above types of shipments are fully regulated by DOT if they originate from private sector health care organizations or laboratories, even if the transport is carried-out by employees of the organization utilizing their own private automobiles.
Additional areas of federal regulation could be established, with respect to specific shipments of hazardous materials, if:
(1) government institutions perform compensated laboratory services for private health care providers (and exempt organization employees provide the transportation), or
(2) a government hospital provides transportation and laboratory services for a controlled HMO, established to compete in the private sector for Medicare patients.
Federal Regulation of Intrastate Transportation of Dangerous Goods--
The extension of the HMR to intrastate shipments applies to commercial carriers, including couriers, and licensed medical waste transporters in carriage of hazardous materials anywhere within the states using the public streets and highways. HM200 represents a vast expansion of the authority of federal regulators over transporters and, therefore, shippers. [U.S. law holds the shipper responsible in virtually all circumstances because of their control over the materials before transport.]
Under the HMR, the Federal Highway Administration, the Federal Aviation Administration, or the Resource and Special Programs inspectors may audit carriers. If a probable violation has been determined under Title 49 CFR or the ICAO Technical Instructions, the appropriate agency may further investigate the shipper/health care organization or laboratory.
Since October 1998, DOT inspectors have been visiting laboratories and hospitals throughout the U.S., issuing tickets for violations related to required UN performance packaging for "Live Cultures & Stocks". As a waste material, DOT requires these substances to be packaged in certified and tested UN Packaging Group II medical waste containers. These containers must be tested under Subchapter C, Subpart M, including certain packaging tests contained in paragraphs 178.600 to 178.609 and as stated elsewhere in the HMR.
The fines for violations of the Packaging Group II requirement range from $200 per violation to $25,000 per violation and can carry a criminal penalty of up to five years in a federal jail.
This new regulation, taken together with the letters to Congressman Dellums and to Michael Shepard of the University of California legal staff, is important to both government and private sector health care organizations and their transport program.
Further, each organization is required to designate "hazmat" employees and to train and certify each employee in package preparation as well as "hazmat" driver training. Records must be maintained.
Under the federal HMR, a shipper ("a person") may not offer for transportation in commerce and a carrier ("a person") may not accept a hazardous material for shipment in commerce which is not in compliance with the HMR.
Private Sector Health Care Providers--
The new policy of United Parcel Service on October 1, 1998, the date the intrastate rules went into effect, was:
(1) to discontinue acceptance of hazardous material shipments at all UPS customer counters nationwide, (2) to require each customer to utilize UPS computer software in preparing documentation, (3) to require each customer to prove that each hazmat employee has been trained and certified under the HMR, and (4) to accept a "three strikes and you are out" policy from UPS, whereby DOT can be notified to assess fines and penalties if probation and retraining results in failure.
While UPS has carried hazardous materials for many years, it is corporate policy that UPS does not carry Infectious Substances. Other private courier companies such as FedEx and the airlines, in-house couriers of reference laboratories, and in-house couriers of private hospitals, actively participate in transport of these substances.
These facts about UPS and its recent policy change suggests that a sober and deliberate response to these regulations was considered warranted by a giant corporation. Other transporters and couriers may take the same posture and ask each health care shipper to sign a manifest which affirms that there are no Infectious Substances or other hazardous materials contained in any shipping packages.
Health care organizations and their carriers which are covered under the new intrastate HMR include, without limitation:
blood banks, hospitals, microbiology laboratories,
pharmaceutical research companies,
biotechnology companies, physician offices,
veterinary medicine,
government research organizations (non-exempt),
universities (non-exempt), zoos,
coroners, military hospitals (non-exempt),
animal research facilities (non-exempt),
medical & clinical reference laboratories,
courier companies, licensed medical waste transporters, and
other common carriers
Regulated Medical Waste--
Under the HMR, U.S. Centers for Disease Control ("CDC") Biosafety Level 1 through 3 defined waste cultures and stocks must be packaged under Title 49 CFR Packing Group II. THE CONTAINERS UTILIZED TO TRANSPORT LIVE CULTURES AND STOCKS AS A WASTE MATERIAL MUST BE TESTED, CERTIFIED, MARKED AS CERTIFIED, LABELED WITH THE UN NUMBER 3291, AND PRESENT ALL OTHER LABELING REQUIREMENTS OF OSHA & STATE AGENCIES, AND BE PROPERLY DOCUMENTED PRIOR TO BEING OFFERED FOR TRANSPORTATION. Unless previously disinfected or incinerated before being transported, Biosafety Level 4 waste cultures and stocks must be packaged in Division 6.2, and these packagings must be tested, certified, marked, labeled, and documented. ALL LIVE CULTURES AND STOCKS OF INFECTIOUS AGENTS THAT ARE SHIPPED AS SPECIMENS MUST COMPLY WITH UN 4G/CLASS 6.2 REQUIREMENTS OF TITLE 49CFR, IATA, ICAO, OR U.S. POSTAL SERVICE REGULATIONS.
The containers for Level 4 "Live Cultures & Stocks" (as a waste material) are identical to the Un 4G/Class 6.2 containers required for shipping Infectious Substances by surface or air. The testing requirements are established in Title 49 CFR, Subchapter C, Subpart M, 178.609.
All other regulated medical waste containers must be capable of passing the UN Packaging Group II performance oriented packaging standards as set forth in Title 49 CFR. These packages must also be marked with the UN number 3291 and be labeled "REGULATED MEDICAL WASTE".
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