Summary The origin of new federal regulation of infectious substance classification, packaging, and transportation occurred because of concern about the the spread of new disease forms such as AIDS, the spread of drug resistant bacteria such as m. tuberculosis and staph aureaus, and the lack of packaging standards for microorganisms being mailed, shipped by FedEx, or transported by ground.  Biological agents used in germ warfare and terrorism, and newly emerging microbes such as Avian "bird flu" are of growing concern due to possible genetic resorting which can occur in nature.

The risk of transmitting infectious disease and the risks to transport, package handlers, and laboratory personnel has grown in recent years. These new regulations affecting the transport of biological specimens are supported by the U.S. Centers for Disease Control and Prevention, as part of its continuing efforts in the promotion of public health.  It is also a significant part of the U.S. CDC's disaster planning efforts in cooperation with the U.S. Department of Transportation and other agencies worldwide.

If your organization ships specimens by courier using the public streets and highways, DOT regulations apply to those shipments, if they contain known infectious substances. If these shipments are loaded aboard aircraft, both DOT and IATA regulations apply. If these shipments utilize packaging supplied by a clinical laboratory, the employees in your send-out department and/or the persons preparing the package and documentation are liable.

If your organization provides packaging to health or research laboratories and that packaging material is used in transporting infectious substances to your laboratories, the shipper--your customer--is the responsible party under the DOT & IATA regulations, but this does not absolve any joint liability claims which might be asserted against your organization if there were ever an accidental exposure connected with such shipments. In operating in this new climate, it is probably better to "err on the side of caution".

Federal Intrastate Regulation of Hazardous Material Shipments - Effective October 1, 1998

Private Sector Shipments under Federal Intrastate Regulations

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.

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 California Environmental Protection Agency 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".

Access to Federal Register Information - WORLD WIDE WEBB

To access the Federal Register announcement of this regulation, please click on "Notice" above.  To Access the Final Rule, please click on Federal Register at the top of this page.

The Final Rule from DOT was published on January 8, 1997 and was entitled "Hazardous Materials in Intrastate Commerce..." Federal Register Vol. 62, No. 5 / Rules & Regulations (RIN 2137-AB37 or Docket HM-200) with technical amendments published on February 18, 1998, Vol 63, No. 32.

THIS AND OTHER REGULATORY INFORMATION IS ALSO AVAILABLE ON THE WORLD WIDE WEBB AT THE FOLLOWING ADDRESS:

http:\\hazmat.dot.gov (click on Current Regulations & Interpretations) Another means of accessing this site is to access a search engine such as Lycos or Yahoo and type in the words: hazmat safety (without quotes). The internet will provide a list of sites, including: www.hazmat.dot.gov listed above.

Please call us if you have any difficulty accessing the information. We can email the document.

NEW POSTAL SERVICE REGULATIONS. In July 1998, the U.S. Postal Service ("the Service") revised its Direct Mail Manual. These new regulations reflect the adoption--by the postal service--of Title 49 CFR performance oriented packagings testing standards for packaging used in  the shipment of hazardous materials, including Infectious Substances. The Service has adopted severe penalties for violations of their regulations.

PROPOSED NEW REGULATIONS. On September 2, 1998, DOT issued a Advance Notice of Proposed Rule-making which proposes the adoption of World Health Organization risk groups as the standard for classification of diagnostic specimens in the U.S. This is a major set of proposals which also covers medical waste issues such as cultures and stocks and other medical waste packaging requirements.  PROPOSED NEW REGULATIONS. On September 2, 1998, DOT issued a Advance Notice of Proposed Rule-making which proposes the adoption of World Health Organization risk groups as the standard for classification of diagnostic specimens in the U.S. This is a major set of proposals which also covers medical waste issues such as cultures and stocks and other medical waste packaging requirements. 

FAA. In July 1997, the Federal Aviation Administration ("FAA") initiated a new program of monitoring and enforcement related to shipment of hazardous materials, including Infectious Substances.FAA. In July 1997, the Federal Aviation Administration ("FAA") initiated a new program of monitoring and enforcement related to shipment of hazardous materials, including Infectious Substances.

For the first time, FAA commenced inspections of shippers and their compliance programs with Title 49 or ICAO Technical Instructions. Packaging, procedures, and training are the issues.

FAA may make written requests to shippers for detailed information on shipments and compliance, but they have the authority to conduct surprise visits. In the last year, FAA has conducted surprise inspections of "hazmat" packaging operations at Los Angeles, Miami, and JFK International airports and has conducted audits of clinical laboratories on the east coast.

FAA has confirmed at least one recent incident involving infectious substances in which transport workers were exposed to dangerous pathogens as defined by the World Health Organization risk groups. This incident was taken very seriously by FAA.

In addition, incidents continue to occur involving exposure of package handlers and emergency response teams to hazardous materials shipped by common carrier and ground couriers.   The passengers aboard an American Airlines international flight became sick when exposed to an insecticide compound which had erupted in the jet cargo hold. The packaging is alleged to have failed to comply with Title 49 and the ICAO Technical Instructions.

The shipper, employed by an import-export concern, was arrested by FAA for possible violation of the ICAO Technical Instructions and Title 49 and may face criminal prosecution.

We have first hand knowledge of shippers, including the academic university and public health sector, receiving letters of inquiry from FAA. It is important to note that these requests for information may be just that: a need for data. In some situations FAA has been known to offer suggestions on improving compliance.

The FAA may issue other types of letters which could include a "Notice of Probable Violation". This would be a more serious indication that an incident may have occurred with a shipment.

In addition to this new program at FAA, the U.S. Department of Transportation ("DOT") is requesting that emergency and law enforcement organizations report any road accidents involving transport of specimens to a special division at DOT, and DOT is enforcing training requirements under HM 126F. The maximum fine for untrained employees is $27,500 per employee.

Shippers Liability & Classification of Specimens

- Typically, medical specimens being sent to a remote clinical laboratory are flown on passenger aircraft or by air cargo services such as Federal Express or Airborne. Ground couriers, United Parcel Service, and the U.S. Postal Service also transport significant volumes of specimens. UPS does not knowingly carry infectious specimens. It is prohibited by UPS management.

- The International Civil Aviation Organization ("ICAO"), the carrier agency of the United Nations and the International Air Transport Association ("IATA") have established new rules with severe penalties in order to protect the traveling public and package handlers from these potentially infectious substances.

- These regulations are enforced by the Federal Aviation Administration ("FAA"), a unit of the U.S. Department of Transportation ("DOT") or other similar enforcement agencies worldwide who can levy significant fines against shippers and carriers who violate the regulations.

- Your send-out department, or others who ship infectious substances are considered the "shipper" when they send specimens to a reference laboratory. Use of surface or air couriers does not transfer the shipper's responsibility to a third party. Under federal DOT regulations, the "shipper" is defined as the "person" who prepares the packaging and manifests. All persons who prepare shipments of hazardous materials (including Infectious Substances) must be trained and certified to prepare such shipments under the Hazardous Materials Transportation Uniform Safety Act of 1990 ("HM126F"). Re-training at periodic intervals is also required.

- If you use ground courier services or other surface transport such as UPS, you must follow DOT regulations. If you use the U.S. Post Office, you must use Postal Service regulations. Postal Service regulations make direct reference to DOT regulations. As a separate set of regulations for air and surface shipments, DOT regulations provide for civil and (in certain situations) criminal penalties: both of which involve exposure to personal liability. A completely separate issue is the potential for civil liability in the event of injury to a third party as a result of shipper's lack of compliance with these regulations.

- DOT regulations are based on the Transportation Safety Act of 1974 which "gives the U.S. Secretary of Transportation the regulatory and enforcement authority to protect the Nation against the risks to life and property which are inherent in the transport of hazardous materials in commerce". This statute authorized DOT to regulate shipments of hazardous materials, by surface and air, by intrastate as well as interstate transport, and to supersede all state and local transport regulations. All federal facilities are regulated equally with the private sector.

- IATA and ICAO have established two groups, each with specific packaging standards designed to protect anyone coming into contact with the package. The two groups are:

1. "Non-Infectious Diagnostic Specimens" &

2. "Infectious Diagnostic Specimens"

- In the past, there has been confusion about the definition of  known infectious substances and non-infectious diagnostic specimens. ICAO and IATA have changed the definition of "Infectious". If you suspect or know that a specimen is Infectious, or the test requested is looking for an antibody or the pathogen, you have to consider the specimen as infectious. It is possible to determine the legal status of a specimen by:

Once the specimen has been classified as either infectious or non-infectious, packaging, documentation, marking, and labeling must be prepared. An Infectious Substance package will include detailed documentation and disclosure requirements, and a violation may consist of an omission in documentation, inadequate package performance, errors in package closure and preparation, or misrepresentation of package contents. Fines are formula based and can accumulate for each violation. A single incident could result in fines of $50,000 or more.

- Training is also a federal requirement under Title 49 CFR, Subpart H, Parts 172.700 to .704, and FAA has been giving shippers 30 days to produce training records, proving that employees meeting the DOT definition of a "hazmat employee" have been trained. The penalty for failure to train employees has a statutory limit of $27,500 per employee. Hospital pathology and microbiology laboratory employees, employees in the send-out department, employees of clinical and references labs, blood banks, universities, coroners, research laboratories, public health departments, and agricultural diagnostic laboratories are all covered by the federal training requirement.

Summary of Current Issues & Regulatory Trends

JCAHO: JCAHO: The Joint Commission on Accreditation of Health Care Organizations and their U.S. military counterparts have recognized the importance of recent regulatory changes in the area of specimen transport and packaging for transportation of hazardous materials and have included the issue of mandatory training and packaging as a substantial area of inquiry in the accreditation review of health care organizations.

1. Enforcement Programs of DOT: 1. Enforcement Programs of DOT: During 1997, the U.S. Department of Transportation ("DOT") commenced an enforcement program which is based upon acquisition of packages manufactured under United Nations package performance rules. These UN packages, including packaging used to transport etiologic agents ("Infectious Substances") are then tested by DOT at a U.S. army base. This U.S. Army testing laboratory is involved in intensive package testing activity. The results of tests have been the basis of fines and litigation filed by the U.S. Department of Transportation against manufacturers and shippers. In addition, the FAA has initiated, for the first time, a program of initiating inspections of shippers. In connection with surface transportation, the Resource and Special Programs Administration ("RSPA") is also requesting law enforcement and emergency professionals to report any road accidents involving transport of specimens. 1. Enforcement Programs of DOT: During 1997, the U.S. Department of Transportation ("DOT") commenced an enforcement program which is based upon acquisition of packages manufactured under United Nations package performance rules. These UN packages, including packaging used to transport etiologic agents ("Infectious Substances") are then tested by DOT at a U.S. army base. This U.S. Army testing laboratory is involved in intensive package testing activity. The results of tests have been the basis of fines and litigation filed by the U.S. Department of Transportation against manufacturers and shippers. In addition, the FAA has initiated, for the first time, a program of initiating inspections of shippers. In connection with surface transportation, the Resource and Special Programs Administration ("RSPA") is also requesting law enforcement and emergency professionals to report any road accidents involving transport of specimens.

1a. As indicated above, on October 1, 1998, DOT commenced intrastate regulation of hazardous materials shipments. Infectious Substances are included in the HMR and are now regulated regardless of the mode of transport. Shippers of Infectious Substances must now document and package all hazardous materials under the HMR.

2. New Specimen Classification Rules From IATA: On January 1, 1999, the International Air Transport Association adopted a new Technical Instruction from the United Nations carrier agency, the International Civil Aviation Organization ("ICAO").  Please click on "Classification" above for a discussion concerning these new rules that were effective January 1, 1999.    This new DGR relates to the classification of diagnostic specimens and biological products shipped aboard IATA member aircraft.   DOT is presently considering new rules making these classification rules a U.S. regulation, even though it is presently enforceable by the FAA for shipments made by air. 2. New Specimen Classification Rules From IATA: On January 1, 1999, the International Air Transport Association adopted a new Technical Instruction from the United Nations carrier agency, the International Civil Aviation Organization ("ICAO").  Please click on "Classification" above for a discussion concerning these new rules that were effective January 1, 1999.    This new DGR relates to the classification of diagnostic specimens and biological products shipped aboard IATA member aircraft.   DOT is presently considering new rules making these classification rules a U.S. regulation, even though it is presently enforceable by the FAA for shipments made by air.

2a. U.S. DOT Advance Notice of Proposed Rule-making ("ANPRM"). On September 3, 1998, the U.S. Department of Transportation's Resource and Special Programs Administration ("RSPA") issued this ANPRM which proposes to modify federal rules concerning transport of Infectious Substances, regulated medical waste, and genetically altered substances. This proposal includes adoption of World Health Organization risk groups, in parallel with the IATA regulations described in 2.0 above and additional packaging requirements for medical waste.

3. Federal Express. 3. Federal Express. On January 1, 1995, Federal Express and the worldwide air transport members of the International Air Transport Association ("IATA") started enforcing tough new packaging standards for shipment of etiologic agents ("Infectious Substances"). Also on that date, the U.S. Department of Transportation issued its Final Rule for the packaging and shipment of Infectious Substances. 3. Federal Express. On January 1, 1995, Federal Express and the worldwide air transport members of the International Air Transport Association ("IATA") started enforcing tough new packaging standards for shipment of etiologic agents ("Infectious Substances"). Also on that date, the U.S. Department of Transportation issued its Final Rule for the packaging and shipment of Infectious Substances.

IATA adopted the requirement that all packages containing Infectious Substances would have to be UN Class 6.2 containers and have passed rigorous package certification testing. These regulations affect thousands of shippers including pharmaceutical research companies, hospitals, laboratories, medical researchers, biotechnology companies, government researchers, blood banks, military installations, and public health departments.

4. U.S. Postal Service Regulations. 4. U.S. Postal Service Regulations. On April 9, 1998, the U.S. Postal Service amended the Domestic Mail Manual to clarify the standards for mailability of hazardous materials. Included in these clarifications are Infectious Substances transported by U.S. Mail. These standards follow closely the packaging requirements of the ICAO Technical Instructions and Title 49 CFR. These new mailing standards require UN performance oriented packaging and labeling for hazard Class 6, and dangerous goods declarations. The July 1998 DMM provides detailed requirements for packaging Infectious Substances and sets forth the legal penalties for improperly packaged hazardous materials including 18 USC. 4. U.S. Postal Service Regulations. On April 9, 1998, the U.S. Postal Service amended the Domestic Mail Manual to clarify the standards for mailability of hazardous materials. Included in these clarifications are Infectious Substances transported by U.S. Mail. These standards follow closely the packaging requirements of the ICAO Technical Instructions and Title 49 CFR. These new mailing standards require UN performance oriented packaging and labeling for hazard Class 6, and dangerous goods declarations. The July 1998 DMM provides detailed requirements for packaging Infectious Substances and sets forth the legal penalties for improperly packaged hazardous materials including 18 USC.

5. United Parcel Service. 5. United Parcel Service. On October 1, 1996, United Parcel Service installed an internal packaging rule requiring all routine diagnostic specimens (including blood) to be packaged in UN Class 6.2 containers. This is the same type of packaging required by Federal Express for shipment of Infectious Substances (Infectious Substance and other hazardous material marking and labeling is prohibited by UPS).

5a. On October 1, 1998, UPS halted the acceptance of hazardous material packages at its customer service counters in the U.S.   In addition, UPS required each hazmat shipper (a) to prove that each hazmat employee has been trained, (b) to sign a separate contract (c) to utilize UPS computer software in generating the required documentation and dangerous goods disclosures which accompany each package, (d) to accept retraining in the event of incidents, and (e) to accept a three-times-and-you-are-out determination which can be accompanied by a UPS phone call to the Department of Transportation.

6. U.S. Public Health Service. On October 24, 1996, the U.S. Public Health Service issued its Final Rule implementing the Anti-terrorism and Effective Death Penalty Act of 1996. These regulations impose tracking and accountability on shippers of Select Agents and were effective on April 15, 1997. These regulations mark the first time that the U.S. Department of Health and Human Services has been given enforcement powers reinforced by both criminal and civil penalties. 6. U.S. Public Health Service. On October 24, 1996, the U.S. Public Health Service issued its Final Rule implementing the Anti-terrorism and Effective Death Penalty Act of 1996. These regulations impose tracking and accountability on shippers of Select Agents and were effective on April 15, 1997. These regulations mark the first time that the U.S. Department of Health and Human Services has been given enforcement powers reinforced by both criminal and civil penalties.

7. Quarantine Rules & Infectious Disease Monitoring. 7. Quarantine Rules & Infectious Disease Monitoring. The White House recently redefined infectious diseases as a major national security threat. A presidential decision directive was issued ordering increased surveillance of global epidemics and rigorous quarantine rules for sick passengers at the nations airports. The general concern is that highly infectious diseases can be spread from remote locations in the world to the U.S. mainland within thirty-six hours.

8. U.S. Centers for Disease Control. The Public Health Service and CDC plan to issue new regulations which are expected to parallel the packaging requirements of IATA Rule 650 for all shipments of routine diagnostic specimens. If finalized as proposed, this regulation will eliminate the word "routine" from the description of diagnostic specimens and require substantially more intensive packaging for shipment of blood and specimens. 8. U.S. Centers for Disease Control. The Public Health Service and CDC plan to issue new regulations which are expected to parallel the packaging requirements of IATA Rule 650 for all shipments of routine diagnostic specimens. If finalized as proposed, this regulation will eliminate the word "routine" from the description of diagnostic specimens and require substantially more intensive packaging for shipment of blood and specimens.

9. U.S. Food & Drug Administration. 9. U.S. Food & Drug Administration. the Food and Drug Administration ("FDA") has stepped-up education and enforcement activities related to assurance of thermal performance of packaging used in shipments of blood and other biological products [21 CFR 606.65(e) & 610.40b(3)].

10. NEW CDC PACKAGING REGULATIONS - INFANT NEWBORN SCREENING 10. NEW CDC PACKAGING REGULATIONS - INFANT NEWBORN SCREENING The U.S. Centers for Disease Control and Prevention has published a booklet outlining new requirements for packaging of "blood spots" transported by U.S. Mail.

11. IATA DGR 3.6.8, Classification of Biological Products & Diagnostic Specimens

For the purposes of these regulations, biological products as defined in 3.6.7.3 and diagnostic specimens as defined in 3.6.7.4 are divided into the following groups:

(1) those known or reasonably expected to contain pathogens in risk groups 2, 3, or 4 and those where a relatively low probability exists that pathogens of risk group 4 are present. Such substances must be classified in Division 6.2 under UN 2814 or UN 2900, as appropriate. Specimens transported for the purpose of initial or confirmatory testing for the presence of pathogens fall within this group (see Packing Instruction 602);

(2) those where a relatively low probability exists that pathogens of risk group 2 or 3 are present. Specimens transported for the purpose of routine screening tests or initial diagnosis for other than the presence of pathogens fall within this group (see Packing Instruction 650);

-(3) those known not to contain pathogens (not restricted).

Note: Unless it has been specifically determined, i.e. by testing, that a diagnostic specimen contains no pathogens, the specimen must be considered to fall within either the grouping identified by bullet point 1 or 2 above."

12. United Nations Risk Groups - Division 6.2 Infectious Substances: 6.2 Definitions. Source - ICAO Technical Instructions12. United Nations Risk Groups - Division 6.2 Infectious Substances: 6.2 Definitions. Source - ICAO Technical Instructions

(a) Infectious substances are those substances containing viable micro-organisms, including a bacterium, virus, rickettsia, parasite, fungus, or a recombinant, hybrid or mutant, that are known or reasonably believed to cause disease in animals or humans. However, they are not subject to the recommendations for this division if the spread of disease to humans or animals exposed to such substances is considered unlikely.

Note: Infectious substances should be considered for classification in Division 6.2 and for assignment to UN 2814 or UN 2900 after allocation to four risk groups (1 through 4) based on criteria developed by the World Health Organization (WHO). The criteria according to the level of risk of infection are as follows:

- in risk group IV, (High individual risk, high community risk) are micro-organisms that cause severe human or animal disease and may present a high risk of spreading, and there is usually no effective prophylaxis or treatment available;

- in risk group III, (high individual risk, low community risk) are micro-organisms that cause severe human or animal disease and may present a high risk of spreading, but there is usually effective prophylaxis or treatment available;

- in risk group II, (moderate individual risk, limited community risk) are micro-organisms that cause human or animal disease but are unlikely to spread, and there is usually effective prophylaxis or treatment available.

- in risk group I, (low individual and community risk) are micro-organisms that are unlikely to cause human or animal disease; they can be disregarded in these Recommendations.

[GENETICALLY ALTERED SUBSTANCES ARE CONSIDERED INFECTIOUS]

13. Third Party Couriers. 13. Third Party Couriers. DOT's new authority to regulate intrastate shipment of dangerous goods should be of concern to shippers. Awareness of the effect this regulatory change has on previously lawful shipments, even those made locally to another health care facility or laboratory is essential. Every day, private couriers receive calls from health care providers requesting transport from the provider to any number of other locations. If the specimens in question are Infectious Substances, the transport will have to be construed in a different light from all past experience. Prior to October 1, 1998, it would have been lawful, with exception for air shipments, to request surface transportation for the following classes of shipments: 13. Third Party Couriers. DOT's new authority to regulate intrastate shipment of dangerous goods should be of concern to shippers. Awareness of the effect this regulatory change has on previously lawful shipments, even those made locally to another health care facility or laboratory is essential. Every day, private couriers receive calls from health care providers requesting transport from the provider to any number of other locations. If the specimens in question are Infectious Substances, the transport will have to be construed in a different light from all past experience. Prior to October 1, 1998, it would have been lawful, with exception for air shipments, to request surface transportation for the following classes of shipments:

(a) a courier is ordered to carry non-infectious specimens to the airport for commercial air transport,

(b) a courier is ordered to carry specimens across town to a bus station for intrastate surface transport,

(c) a courier, taxi, is ordered to carry specimens to a reference laboratory,

(d) a courier is ordered to carry specimens to the U.S. Post Office, or

(e) a courier is ordered to carry specimens to a county hospital

Under the new regulations, you, as the shipper, would be exposed to personal liability for violation of the HMR with possible exposure to criminal penalties not exceeding Five Hundred Thousand Dollars and/or five years in a federal jail. Since these types of shipments are now regulated, any movement of the specimens causes the shipper to bear responsibility for the shipment under Title 49 CFR. The active local presence of Federal Highway Administration and FAA inspectors--which can stop vehicles and issue tickets--along with a reporting arrangement between local emergency organizations and DOT, suggests that the situation has changed.

While couriers are responsible parties and subject to regulation under the HMR, they can also become plaintiffs in lawsuits in which they or their employees are exposed to hazardous materials, including Infectious Substances. In a lawsuit pending before the Hawaii State Court, six unnamed plaintiffs are suing Continental Airlines, all of the courier companies in the chain of custody, and the issuing laboratory for an exposure incident involving HIV positive blood sera that was transported inside plastic bags that were further enclosed within a secondary packaging consisting of a polystyrene ice chest. The lawsuit centered around claims of mental anguish and negligence.

INTERNET BIOSAFETY WEBB SITES

The following are some useful biosafety and transport related Internet Web addresses.

42 CFR Part 72 Select Agents Regs mandated by Bioterrorist Act and list of controlled agents - Appendix A

http://www.cdc.gov/od/ohs/biosfty/42cfr72.htm

http://www.cdc.gov/od/ohs/biosfty/42cfr72.htm#Appendix A

Biosafety in Microbiological and Biomedical Laboratories - CDC manual

http://www.cdc.gov/od/ohs/biosfty/bmbl/bmbl-1.htm

Office of Recombinant DNA Activities

http://www.nih.gov/od/orda/

NIH Guidelines for Research Involving Recombinant DNA Molecules

http://www.nih.gov/od/orda/toc.htm

-Lists of Agents by risk group

http://www.nih.gov/od/orda/apndxb.htm

USPHS/CDC Import permit applications for infectious agents

http://www.cdc.gov/od/ohs/biosfty/imprtper.htm

USDA/APHIS/National Center for Import/Export - Import permit applications for biological products from animals and plants - including tissue culture, restricted domestic plant, insect, and animal pathogens, etc.

http://aphisweb.aphis.usda.gov/NCIE

42 CFR Part 72 shipping regulations for packaging and transport of all of above

http://www.cdc.gov/od/ohs/biosfty/shipregs.htm

Guidelines for Isolation Precautions in Hospitals

http://www.cdc.gov/ncidod/hip/isolat/isolat.htm

Bibliography Of Recent FAA Enforcement Announcements

Subject: UNITED States. -- Federal Aviation Administration; FINES (Penalties)

Title: FAA gets tough on hazmat violations.

Source: American Shipper, May98, Vol. 40 Issue 5, p88, 2p, 1bw

Author: Gillis, Chris; Reyes, Brian

Abstract: States that the United States Federal Aviation Administration

(FAA) is thinking about issuing fines to careless shippers who ship hazardous materials by air. Information on the FAA's Dangerous Goods and Cargo Security Program; Insight to the fines; Comments from Charles N. Lovinski, manager of the FAA's Dangerous Goods and Cargo Security Program.

Subject: UNITED States. -- Federal Aviation Administration. --

Dangerous Goods & Cargo Division; AERONAUTICS, Commercial Freight

Title: New FAA office will bear down on air cargo carriers.

Source: Business & Commercial Aviation, May97, Vol. 80 Issue 5

Author: Gilbert, Gordon A.

Abstract: Air Carriers Under Close Scrutiny--Hazmat Shipments

Recent FAA Fines For Hazmat Violations

August 21, 1998

Akzo Nobel Shanghai Ltd. $95,500

Shipment destined for Stuttgart

Nature of shipment: paint

August 19, 1998

Midway Airlines $70,000

Miami Air Intl $70,000

BF Goodrich Aerospace $70,000

Fairchild Dornier, Inc $70,000

Saab Aircraft $60,000

Description: improper shipment of

oxygenator breathing units

Air Niugini, Boroko, New Guinea, $60,000

American General Supplies, $55,000

Wynn Oil,  Undeclared Flammable, $65,000

Most of these companies were "discovered" by FAA because their packages were leaking. Upon inspection by FAA inspectors, it was determined that most of the packages offered for shipment by air were chemicals, paints, solvents, or oxygenator units which are regulated as dangerous materials. The fines were, for the most part, single box shipments which contained primary containers of dangerous materials which were not properly described, marked, labeled, and documented, or were prepared by employees whom were untrained and certified for such shipments under the International Civil Aviation Organizations Technical Instructions.

Federal Express Dangerous Goods Acceptance Checklist

If you make shipments of Infectious Substances and other dangerous goods by Federal Express, you may wish to contact the FedEx Hazmat Hotline [800-GO-FedEx or 901-922-1666] and request a fax copy of the "Dangerous Goods Acceptance Checklist - 1998. This checklist describes ten categories including a total of 58 reasons for a package being rejected by FedEx.

We suggest that each shipper obtain this checklist--along with the packaging instructions from the Hazmat package manufacturer. It is extremely important that you complete the documentation, including: (1) "dangerous goods declaration", (2) the FedEx manifest, and (3) vigorously follow all instructions regarding the documentation, marking, and labeling of each package. Be certain to include the proper number of duplicates and originals with each package being shipped.

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