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Interpretation Response #99-0298 ([Micro-Med Industries, Inc.] [Mr. Charles N. Hendrix])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Micro-Med Industries, Inc.

Individual Name: Mr. Charles N. Hendrix

Location State: FL Country: US

View the Interpretation Document

Response text:

December 13, 1999

 

Mr. Charles N. Hendrix                 Ref. No. 99-0298
Vice President
Micro-Med Industries, Inc.
5169 West 12th Street
Jacksonville, FL 32254

Dear Mr. Hendrix:

This responds to your letter, dated October 22, 1999, addressed to Mr. Bill Stevens in the Research and Special Programs Administration’s Southern Region Office of Hazardous Materials Enforcement.  Your letter addresses inconsistent federal and state regulatory requirements for the transportation of regulated medical wastes.

You are correct that there appear to be some significant differences between the federal transportation requirements applicable to regulated medical wastes in the Hazardous Materials Regulations (HMR; 49 CFR Parts 17 1 -1 80) and requirements in effect in various states.  The federal hazardous material transportation law (49 U.S.C. 5 101 et seq.) preempts many state and local laws and regulations concerning hazardous materials transportation that are not the same as the federal requirements. (The enclosed index explains that preemption in detail.) Thus, where state requirements do not meet the preemption standards in the law, they are superseded by the HMR.

Your specific questions concerning transportation requirements for regulated medical wastes are paraphrased and answered below.

Q1.      Can a physician, clinic, or large facility offer for transport an untreated throat culture that is contaminated with the Streptococcus bacterium?  Must the contaminated throat culture be packaged according to UN or Packing Group J1 guidelines?  If UN or Packing Group III packaging is required, is it then acceptable for a solid waste garbage truck to receive and compact the package, thereby destroying its integrity during transport to its final destination at a transfer station or landfill?  Are shipping papers required?

Al:        Cultures and stocks of infectious substances are considered hazardous materials under the HMR.. Thus, a physician, clinic, or facility may offer an untreated throat culture contaminated with the Streptococcus bacterium for transportation if the shipment meets all applicable HMR requirements.  For example, under § 173.134(b)(4), a waste culture or stock of an infectious substance may be offered for transportation and transported as regulated medical waste under the following conditions: (1) the waste culture or stock must conform to Biosafety Level 1, 2, or 3 as defined by the Centers for Disease Control (see HHS Publication 93-8395); (2) the waste culture or stock must be packaged in packagings conforming to the Packing Group II performance level as specified in Part 178 of the HMR and to the requirements in § 173.197; and (3) the waste culture or stock must be transported by a private or contract carrier using a vehicle dedicated to the transportation of medical waste.  Waste cultures and stocks that do not conform to the conditions listed in § 173.134(b)(4) must be transported in packagings that conform to the requirements of § 173.196.

No person may offer for transportation or transport a waste culture or stock of an infectious substance unless the material is handled and transported in accordance with applicable requirements in the HMR, including those applicable to shipping papers, package marking and labeling, emergency response information, and employee training.  In addition, the shipment must also conform to the general packaging requirements in Subpart B of Part 173.  With specific reference to your question, § 173.24 requires that each package used for the shipment of hazardous materials must be designed, constructed, maintained, filled, and closed so that, under conditions normally incident to transportation, the package will retain its integrity and its contents.

Q2.      Can a physician, clinic, or large facility offer for transport blood-contaminated untreated syringes or needles in containers that do not meet UN or Packing Group 11 guidelines?  If UN or Packing Group II packaging is required, is it then acceptable for a solid waste garbage truck to receive and compact the package, thereby destroying its integrity during transport to its final destination at a transfer station or landfill?  Are shipping papers required for transport of contaminated syringes?

A2.      A syringe or needle contaminated with an infectious substance is considered regulated medical waste under the HMR.  Regulated medical waste must be packaged in packagings conforming to the requirements of Part 178 of the HMR at the Packing Group II performance level. In addition, the packagings must be rigid, leak-resistant, impervious to moisture, of sufficient strength to prevent tearing or bursting under normal conditions of use and handling; sealed to prevent leakage during transport; puncture ­resistant for sharps and break-resistant and tightly lidded or stoppered for fluids in quantities greater than 20 cubic centimeters (see § 173.197). Section 173.134(b)(3) of the HMR provides a packaging exception for a regulated medical waste that is transported by a private or contract carrier.  In such cases, the regulated medical waste may be packaged in a rigid, non-bulk packaging that conforms to the general packaging requirements in §§ 173.24 and 173.24a and the packaging requirements specified in regulations promulgated by the Occupational Safety and Health Administration (OSHA) at 29 CFR 1910.1030.

No person may offer for transportation or transport a regulated medical waste unless the material is handled and transported in accordance with applicable requirements in the HMR, including those applicable to shipping papers, package marking and labeling, emergency response information, and employee training.  In addition, the shipment must also conform to the general packaging requirements in Subpart B of Part 173.  With specific reference to your question, § 173.24 requires that each package used for the shipment of hazardous materials must be designed, constructed, maintained, filled, and closed so that, under conditions normally incident to transportation, the package will retain its integrity and its contents.

Q3:      What is DOT’s definition of an “infectious substance”?  Does the subjective judgement of the individual determining “infectious” require consideration of  OSHA’s “universal precautions”?  Is untreated discarded blood an infectious substance?

A3:       For purposes of the HMR, an infectious substance is a viable microorganism or its toxin that causes or may cause disease in humans or animals.  The term includes those agents listed in regulations of the Centers for Disease Control (see 42 CFR 72.3) and any other agent that causes or may cause severe disabling, or fatal disease.  Untreated discarded blood that is contaminated with an infectious substance is considered a regulated medical waste under the HMR.  The HMR do not incorporate the “universal precaution” standards that are the basis of OSHA’s regulations concerning the handling of blood borne pathogens in laboratories and other work environments (see 29 CFR 1910.1030).

Q4:       Are all offerors of regulated medical waste required to comply with DOT regulations?  Do these regulations apply to both small and, large facilities?

A4:       No person may offer for transportation or transport a regulated medical waste unless the shipment conforms to the requirements of the HMR.  The HMR apply irrespective of whether the offeror is a large or small facility.  Further, the HMR apply to all shipments of regulated medical waste, even those shipments transported wholly within a single state.

You may know that we are considering revisions to the current requirements in the HMR applicable to infectious substances, including regulated medical wastes.  On September 2, 1998, we published an advance notice of proposed rulemaking (ANPRM) in the Federal Register requesting comment on: (1) whether the HMR should incorporate international standards for transporting infectious substances, (2) possible revisions to the current exceptions in the HMR for diagnostic specimens and biological products, and (3) additional packaging options for transporting regulated medical wastes.  We expect to issue a notice of proposed rulemaking on these issues in the next year.  A copy of the ANPRM is enclosed.

I hope this information is helpful.  If you have further questions, please do not hesitate to contact this office.

Sincerely,

 

Edward Mazzullo
Director, Office of Hazardous Materials Standards

173.134

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions