! 
Dr. Donald Fredrickson 
Page 3 
September 22, 1978 
United States and many foreign countries, particularly when the 
information at the time the minutes are available to the public 
is not adequate to support a patent application. Such premature 
disclosure would be particularly harmful if one desired to obtain 
patent protection in most significant foreign countries. Further- 
more, not all confidential or proprietary data and information are 
patentable. In the latter case, such data and information are re- 
garded as trade secrets and even though unpatented, they remain 
very valuable assets. The company does not object to the principle 
of providing some means for the public and the local community to 
be informed regarding its DNA research; however, it believes that 
there is more than one way to accomplish this objective. Thus, 
the public may be informed directly or through representatives . 
The company has no objection to informing the public directly by 
making the minutes available for their inspection provided this 
does not damage valuable company assets. However, if this would 
damage company assets, we believe that the interests of the public 
and the local community are adequately protected through the public 
representatives on the IBC . We believe that the public and the 
company can rely on the good judgment of the public representatives 
on the IBC to determine whether or not it is necessary to make public 
any confidential or proprietary data and information. The proposed 
amendment would allow the use of the second method for informing 
the public while preserving the company's assets, so long as that 
was not inconsistent with the public interest. It is noted that 
the company has more public representatives on its IBC than is 
required by the Proposed Revised Guidelines, i.e., the Guidelines 
would require only one public representative. Ref. IV-A-2, pg. 
33085. 
3 . IV-C-3-a- (4) . Amend this section to read : 
IV-C-3-a- (4) . Necessary, in the judgment of the Secretary or 
his designee, [the] to protect the public or the environment 
against an unreasonaFTe risk of injury to health or the en- 
vironment . The Secretary or his designee shall consult with 
the person who has submitted the information or who would be 
aFfected by disclosure before determining whether or not such 
information will be released under this subsection. If the 
Secretary or his designee rejects the person's request that 
such information not be released, the decision constitutes 
final agency action that is subject to judicial review 
pur- 
suant to 5 U.S.C. chapter 7. The person affected will 
be 
permitted 5 days after receipt of notification of such* 
[A-258] 
