AREA CODE 6 O G 
PHONE 262-2177 
McARDLE LABORATORY 
FOR CANCER RESEARCH 
UNIVERSITY OF WISCONSIN • MADISON, WISCONSIN 53706 
August 29, 1978 
Dr. Donald S. Fredrickson, Director 
National Institutes of Health 
Building 1, Room 12A 
Bethesda, Maryland 2001 A 
Dear Doctor Fredrickson: 
I read carefully the Proposed Revised Guidelines (Federal Register A3 > 
1978, pp. 33069-33095) and I have three kinds of comments. 
1. These Guidelines are clearly superior to the 1976 Guidelines and should 
be rapidly approved by you, after modifying slightly as specified below 
and In the enclosure. 
2. There Is one great Inconsistency In the Proposed Guidelines which could 
eastly be corrected. At the end of column 1 on p. 33070 the following 
sentence should be added: "All other experiments employing the recombinant 
DNA technique are not prohibited when conducted as specified In the 
following sections; whenever a specification Is not provided, they should 
be conducted under P2 containment or containment specified by the local 
IBC or ABC". 
This addition Is very Important since otherwise a large class of 
"Inadvertently prohibited experiments" Is created which were never 
Intended to be prohibited and which could be excepted only after a 
lengthy process similar to that for the I-D Prohibitions. For Instance, 
all experiments for which no HVI vector was as yet approved (which takes 
often over a year) are "Inadvertently prohibited" even If they do not 
present any risk, as e.g. cloning genes coding for colic Ins (JE. col I 
antibiotic) In a St rep tomyces- bacteriophage host-vector system. 
This Is clearly a very serious omission and must be corrected since 
otherwise the Guidelines would de facto prohibit many classes of 
completely harmless and very beneficial research (Including studies 
on the synthesis of antibiotics), and thus clearly violate all original 
Intents as related to safety. Clearly, It Is not the mission of NIH 
to prohibit or hinder and delay beneficial medical research. 
Another Important change Is to modify line A In the second column 
on page 33070 to read "...described In sections I-D-l to I-D-3 as 
being...". Sections A, 5 and 6 do not apply to Exemptions. 
These and other suggestions for minor revisions and corrections of 
typographical errors are enclosed. 
[A-59] 
