COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Eleven 
I pointed out in my letter of February 20, 1976, 
the importance of specifying the intended requirements for 
physical containment. The experience of the Food and Drug 
Administration in monitoring "good laboratory practices" in 
the intervening two years underscores this point. FDA has 
discovered that industrial research laboratories maintain 
the best laboratory practices, contract laboratories are 
the second best, and academic laboratories are worst. In the 
face of this evidence and a growing concern by all regula- 
tory agencies about the need to establish guidelines for 
good laboratory practices, I believe it would be a serious 
mistake to eliminate Appendix D. 
2. Mere inclusion of Appendix D, moreover, would 
seem inadequate to assure that adequate physical containment 
is in fact achieved. The suggestion made at the December 
1977 meeting that the Guidelines be revised to require spe- 
cific training programs with respect to physical containment 
practices seems sensible. 
3. It became apparent at the December 1977 meet- 
ing that, even if the Guidelines are not promulgated as 
regulations governing all research on recombinant DNA 
molecules in the United States, they should be revised to 
permit the voluntary participation of industry and of other 
researchers who are not receiving funds from NIH or other- 
wise from the Federal government. Representatives of in- 
dustry stated that they are presently complying with the 
Guidelines and would appreciate the opportunity to partici- 
pate under them, on a voluntary basis, in full partnership 
with NIH. Revision of the Guidelines to reflect such 
voluntary participation would, in itself, do much to reassure 
the public that inappropriate research on recombinant DNA 
molecules is not being conducted. 
The only concern expressed at the meeting by the 
representatives of industry related to the need to protect 
trade secrets. As I stated at the meeting, this should pre- 
sent no problem whatever. As Part VIII of the enclosed 
letter to Dr. Omenn states, an existing Federal statute, 18 
U.S.C. 1905, explicitly provides that trade secret informa- 
tion provided to the government may not be released to the 
public by any government employee under pain of criminal 
penalty. The Interim Report of the Federal Interagency Com- 
mittee on Recombinant DNA Research, dated March 15, 1977, 
[Appendix A — 249] 
