Comments to the Department of Transportation on Notice of Proposed Rulemaking pertaining to Hazardous Materials (01)

April 23, 2001

Dockets Management System
U.S. Department of Transportation
Room PL-401
400 Seventh Street, SW
Washington, DC 20590-0001

Re: Docket Number RSPA-98-3971 (HM-226)

Dear Sir/Madam:

The American Industrial Hygiene Association (AIHA) expresses its appreciation to the Department of Transportation for the opportunity to comments on the DOT Notice of Proposed Rulemaking Ҡψazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-OrganismsӮ  Announcement of the notice of proposed rulemaking was published in the Federal Register Vol. 66, No. 14, January 22, 2001, beginning on page 6942.

As the world̳ largest association of occupational and environmental health professionals, AIHA members serve on the front line of worker health and safety.  AIHA members, as well as employees and employers, rely on federal and state requirements to protect against the health effects of infectious substances, including regulated medical waste.

As a precursor to AIHA̳ specific comments on the notice of proposed rulemaking, AIHA would like to thank the Department of Transportation for providing all stakeholders with the opportunity to comment on the proposed changes.  AIHA is aware that DOT believes that the current regulatory requirements applicable to transportation of specific hazardous materials should be strengthened.  In doing so, however, AIHA is hopeful that DOT will also recognize the detrimental impact such specific rule changes could have on existing accredited laboratories and laboratory accreditation programs in the United States.

AIHA offers the following:

Comments

The Environmental Microbiology Proficiency Analytical Testing (EMPAT) Program is a performance evaluation program, sponsored by the American Industrial Hygiene Association (AIHA), for environmental microbiology laboratories.  This program has been developed for microbiology laboratories specializing in analysis for microorganisms commonly detected in air, fluids and bulk samples collected from schools, offices, hospitals, industrial, agricultural and other work environments.  Since results of these analyses are used to determine the magnitude or presence of a problem in the workplace environment, it is vital that the laboratory analyzing the samples be proficient in producing high quality data on which important health decisions will be based.  Accreditation from AIHA is a mark of that capability.  Participation in the EMPAT is required.

When a laboratory is accredited by AIHA, the laboratory and its clients have the assurance that the laboratory has met defined standards for performance based on examination of a variety of criteria. When a laboratory is accredited by AIHA, it becomes part of an elite group of laboratories achieving and maintaining a high level of professional performance.  Accreditation also provides laboratory selection alternatives for the client assuring consistent analytical results at a consistent quality level.

The current proposed changes to the Department of Transportation hazardous materials standards for infectious substances and genetically modified microorganisms could have a detrimental impact on the ability to conduct microbiology proficiency testing programs by the AIHA, and other professional association and state organizations that provide similar testing systems.

Laboratories participating in the EMPAT program analyze pure cultures of environmental fungi and bacteria, which are shipped over the course of three rounds during a given year.  The sample is presented to the laboratory as an unknown  microbe, and the nature of the analysis is to provide identification.  Thus, the laboratory must not know what is in the sample, if the program is to be valid.  This is the manner in which samples are normally received in analytical laboratories.  Many of these organisms that occur in problem buildings are biodeteriogenic ϲotӠmolds or free-living soil microbes.  As such, these are widely occurring organisms in nature.  Compost, for example, would be a natural habitat for some of these organisms.

These samples are shipped in a preserved form, in small quantities within culti-loops.  Eventually, the proficiency testing samples will include mixed cultures of fungi and/or bacteria as well as samples of water, dust and building material.  Most of what is shipped are non-pathogenic, or at most, opportunists with regard to human pathology.  However, there may be occasions when a sample shipment may include an agent that could be considered as a Risk Group 2 agent, such as a bulk water sample inoculated with a known quantity of Legionella pneumophila.

Labeling requirements, as outlined in the standard, would allow participants to ϫnowӠthe test organisms, which would nullify the results of any proficiency-testing program.  An exception should be added to the proposed standards to include educational testing materials.  These types of materials, even when considered in higher risk group categories, have very limited potential for dissemination and transmission.

Additionally, an exception should be considered for environmental microbiological samples collected in the field (for example a piece of moldy wall board from a water damaged building, or a sample of settled dust from a ventilation system) to evaluate occupational and residential exposure risks.  The organisms in these types of samples (air and bulk) are predominantly from the environment rather than from humans; and therefore, pose limited risk of infection to the individual or community.

It appears that the intent of the regulation is focused on infectious agents as they relate to health care and related fields; slanting toward bloodborne pathogens, registered medical waste, etc.  This is evidenced in the RSPA assessment of impact on small entities, which was limited to offices and clinics and doctors of medicine, dentists, optometrists, podiatrists, and health practitioners; nursing and personal care facilities; hospitals; and medical and dental laboratories.  Also, sanitary waste, sewage (and sewage sludge), and compost are proposed exceptions.  AIHA submits that samples that are processed from the indoor environmental quality industry fall within the excepted category.  (Compost will harbor more Aspergillus spp. than will a wet gypsum board wall.)

Recommendation

After careful review, AIHA requests that when the proposed rule is announced, language be inserted that would provide for an exemption from this rule for the Proficiency Analytical Testing (PAT) samples forwarded to laboratories for analysis.  This exemption would assure that the quality of laboratory analyses for microorganisms would not suffer.  In addition, AIHA believes this exemption would assure the health of children in schools and employees in a variety of critical work environments, including hospitals.

Conclusion

AIHA would again like to thank the Department of Transportation for the opportunity to provide comments on this notice of proposed rulemaking.  In providing these comments and suggestions, AIHA is hopeful that the proposed rule will reflect our concerns and those of other laboratory accreditation programs.  Our suggestions and recommendations are intended to assure that we all work together to protect the health and safety of everyone.

If we can be of any further assistance, please contact me.

Sincerely,

(Signature)

Steven P. Levine, PhD, CIH
President
stevenlevine@mediaone.net

cc

AIHA Board of Directors

O. Gordon Banks, AIHA Executive Director