"Recombinant DNA molecules contained in organisms or viruses 
shall be shipped under the requirements of the U.S. Public Health 
Service, the U.S. Department of Agriculture, and/or the U.S. 
Department of Transportation. For purposes of these Guidelines, 
microorganisms listed in Appendix B or contained in reference G- 
III-2, and/or are regulated as animal or plant pathogens or pests 
under titles 7 and 9 CFR, or are host organisms containing 
recombinant DNA derived from those organisms, shall be considered 
as etiologic agents." 
Dr. Atlas stated that the current Appendices H-I and H-II should be 
deleted. The current Appendix H-III would remain as H-I. 
Dr. McVicar asked if the proposed preamble would include Class 1 
agents. In addition, he asked if the Subcommittee should 
explicitly state that agents in Classes 2 through 4 are the 
relevant etiologic agents covered in the NIH Guidelines. Dr. 
McKinney believed that eliminating Class 1 agents, and thereby 
concentrating on agents from Classes 2 through 4, would allow 
flexibility and avoid excessive restriction of the CDC's policies. 
Dr. McVicar agreed, and stated that the CDC may change its 
regulations. Should the current definition of "etiologic agent" 
remain in effect, he asked if it would include recombinant DNA 
molecules in non-pathogenic hosts that may express themselves as 
etiologic agents. Dr. Atlas stated that they would be included. 
He asked if the proposed language was too stringent. 
Dr. Stevenson said that his chief concern was the volume of 
shipment. Questionable cases could be decided on a case-by-case 
basis. Dr. McKinney argued that standards for shipping purposes 
would then be determined for exceptions to Federal rules and the 
NIH Guidelines. Dr. McVicar reminded participants that DNA- 
containing material could become infectious under certain special 
conditions . 
Dr. Stevenson suggested adding the sentence: "simply the use of 
recombinant DNA techniques does not necessarily lead to the 
creation of etiologic agents." Dr. Atlas stated that only Appendix 
H of the NIH Guidelines labeled recombinant DNA materials as 
"etiologic agents." He believed that once Appendix H is amended to 
eliminate this label, there would be no need to make additional 
statements . 
Mr. Brewer asked if the proposals were too rigorous or too lenient. 
Dr. Atlas believed they were both; questions on inconsistencies or 
missing considerations would be raised in the RAC. Dr. McKinney 
agreed that the RAC would address such questions. He stated that 
all regulations concerning recombinant DNA and other biological 
products were currently evolving; subparts may change. The 
proposals must be written clearly and unambiguously. 
Recombinant DNA Research, Volume 13 
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