SAIC Frederick Cancer Research — Hazardous Materials Safety Interpretation

Page 1400 Seventh St., S.W. Washington, D.C. 20590 Research and pecial Program: idministratior FEB 2 2 2002 Joseph P. Kozlovac, M.S., CBSP, RBP Ref. No. 02-0013 SAIC Frederick Cancer Research Biological Safety Officer and Development Center Frederick, MD 21702-1201 Dear Mr. Kozlovac: This responds to your December 10, 2001 letter requesting clarification on how to determine the proper shipping name for environmental samples, including water samples, under the Hazardous testing to determine whether or not a pathogen, such as Bacillus anthracis or Legionella Materials Regulations (HMR; 49 CFR Parts 171-180). You stated the samples will be sent for pneumophila, is present. Your company described these samples as infectious substances and packages them accordingly. However, you state your company has not found any sample to contain Bacillus anthracis and only a few samples over past several years to contain low levels of Legionella pneumophila. Section 172.101(c)(11) provides, in part, that a shipper may assign a tentative shipping name, hazard class and identification number to a material sent for testing, based on the shipper's tentative determination according to defining criteria in the regulations, hazard precedence prescribed in § 173.2, and the shipper's knowledge of the material. In § 173.22, it is the shipper's responsibility to determine the hazard class of the material to be transported. This Office does not perform that function. Based on the information you provided, it is this Office's opinion that these samples do not meet the definition of an infectious substance in § 173.134 because there is no reason to know or strongly suspect they contain an infectious substance. If a sample does not meet any other hazard class criteria in Part 173 and is not a hazardous substance, hazardous waste or marine pollutant, then it is not subject to the HMR. I hope this satisfies your request. Sincerely, INED Transportation Regulations Specialist Office of Hazardous Materials Standards HILINI 173.134 020013#

Page 2Edmonson SAIC Frederick §173.134 An Employee-Ownad Company 7® International Corporation A Division of Science Applications InfectionsSubstances December 10, 2001 02-0013 Mr. Edward Mazzullo DHM-10 Director, Office of Hazardous Materials Standard 400 7" Street, SW Research and Special Programs Administration Washington, DC 20590-0001 Dear Mr. Mazzullo: As the Biological Safety Officer employed by SAIC-Frederick, a subsidiary of Science Frederick, MD., I am responsible for overseeing the shipments of a variety of biological, Applications International Corporation (SAIC) based at the NCl-Frederick on Ft. Detrick, chemical, and radioactive dangerous goods on a daily basis. I am requesting for the purpose of determining the presence or absence of pathogens such as Bacillus clarification regarding the proper classification of shipments of environmental samples interpretation of 49 CFR 173.134 and 173.196 we classify, package, mark and label anthracis and Legionella pneumophila. Currentiy, based on our review and these shipments of environmental samples as infectious substances. However, one of to accept the samples if they are labeled as infectious substances. In regards to the testing laboratories to whom the samples are sent has indicated that it does not wish environmental sampling of B. anthracis, The NCI-Frederick has not been a target of biological terrorism, nor have we received any threats. We are doing the monitoring as a found to be negative for the presence of Bacillus anthracis, but monthly monitoring will precaution in the wake of the recent terrorist attacks. So far, the samples have all been continue to take place. In the case of environmental water samples sent to be tested for the presence of L. pneumophila, in most cases samples are negative however we have had samples in which low levels of the organism have been found a few times over the past several years. I look forward to receiving a written clarification of the regulations regarding the shipment of environmental samples that will be tested for the presence or absence of pathogens. Sincerely, Biological Safety Officer, SAIC-Frederick Joseph P. Kozlovac, M.s., CBSP, RBP NCI-Frederick Cancer Research and Development Center + P.O. Box B, Frederick, MD 21702-1201 + 301-846-1000#