12 
] frequency' and manner of giving them such informa- 
2 tion, and 
3 “ (IV) the type and frequency of medical 
4 examinations to be given such personnel while en- 
5 gaged in such activities; 
6 “ (iii) prescribe requirements respecting reports to 
7 be made and records to be maintained by the holders 
8 of licenses issued under this section; 
9 “ (iv) include such special requirements as the 
10 Secretary determines necessary for the conduct of recom- 
11 binant DXA activities involving more than ten liters 
12 of cell cultures containing recombinant DNA and for 
13 the conduct of any commercial recombinant DNA ac- 
14 tivity which the Secretary determines may present a 
15 significant risk to health or the environment ; and 
16 “ (v) include such other provisions as the Secre- 
17 1ar} T determines necessary for the effective administration 
18 of the requirements of this section. 
19 “(B) Regulations required by subparagraph (A) shall 
20 be initially promulgated within one year of the date of the 
21 enactment of this part and shall take effect upon the expira- 
22 tion of one hundred and eight}* - days from the date of their 
23 promulgation. 
24 “(C) The Secretary shall consult with the Advisory 
25 Committee respecting the promulgation of the regulations 
[ 630 ] 
