jerry brown vetoes california recombinant dna safety act

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1 Biotechnology Law Report 126 (August-September 1982) After leaving Genentech, they obtained seed capital from Adler & Co., to which they added funds of their own. They targeted the veterinary market from the begin- ning Dr. Sheehan said, because of the relative ease with which products could be brought throgh the regulatory approbal process and to the market. Armos has been oriented toward production, rather than research, from the start. The company developed four products, in some cases through cooperative ventures with other firms. Dr. Sheehan declined to identify the partner companies or the products, noting that the projects all are still in early stages of development and that their disclosure would be "premature." He said at least one human drug application would be included in the business plan to be used in present and future capital searches, but that the initial market for Armos would still be animal health care. # # # {BLR 66} State Legislation - California - Veto. JERRY BROWN VETOES CALIFORNIA RECOMBINANT DNA SAFETY ACT SACRAMENTO, CA 9/30/82—California Governor Edmund G. Brown Jr. has vetoed the bill entitled "Recombinant DNA Safety Act of 1982." The text of this bill appears at <BLR 25>, pages 47 to 48 of the March 1982 issue. The bill would have required state agencies, including the University of California, to follow the NIH Guidelines when performing recombinant DNA work. It also would have made the Guidelines evidence of the standard of care in "any civil or criminal action resulting from personal or property damage associated with recombinant DNA activities." In vetoing the bill, Governor Brown stated: "This bill would place into statute current national guidelines for recom- binant DNA research. I commend the author and the Legislature for its leader- ship in seeking to guarantee the safety of this research. Unfortunately, the bill imposes certain legal restrictions that could inhibit the growth of an innovative technology which is fundamental to advances in agriculture, medicine and pollution control. This whole subject bears very careful and thoughtful research." BASIS OF THE OPPOSITION Reportedly, opposition to the bill surfaced after its passage by the legisla- ture. Representatives of some biotechnology companies are said to have voiced concern to the Brown administration that enactment of the bill might crimp the growth of biotechnology developments in California. They are said to feel that, by establishing evidentiary standards that in effect shift the burden of proof, the bill would make the biotechnology company "guilty until proven innocent." It was also pointed out that the standards would have been applicable whether or not a hazardous infective agent was involved. Industry observers point out that Governor Brown has repeatedly expressed his interest in fostering high-technology industry. To that end, he chairs the blue- ribbon California Commission on Industrial Innovation. Cynics have suggested that the Governor may have been motivated by considerations of his Senatorial candidacy. 1

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Page 1: JERRY BROWN VETOES CALIFORNIA RECOMBINANT DNA SAFETY ACT

1 Biotechnology Law Report 126 (August-September 1982)

After leaving Genentech, they obtained seed capital from Adler & Co., to whichthey added funds of their own. They targeted the veterinary market from the begin-ning Dr. Sheehan said, because of the relative ease with which products could bebrought throgh the regulatory approbal process and to the market. Armos has beenoriented toward production, rather than research, from the start.

The company developed four products, in some cases through cooperative ventureswith other firms. Dr. Sheehan declined to identify the partner companies or theproducts, noting that the projects all are still in early stages of development andthat their disclosure would be "premature."

He said at least one human drug application would be included in the businessplan to be used in present and future capital searches, but that the initial marketfor Armos would still be animal health care.

# # #

{BLR 66} State Legislation - California - Veto.

JERRY BROWN VETOES CALIFORNIARECOMBINANT DNA SAFETY ACT

SACRAMENTO, CA 9/30/82—California Governor Edmund G. Brown Jr. has vetoed thebill entitled "Recombinant DNA Safety Act of 1982." The text of this bill appearsat <BLR 25>, pages 47 to 48 of the March 1982 issue. The bill would have requiredstate agencies, including the University of California, to follow the NIH Guidelineswhen performing recombinant DNA work. It also would have made the Guidelinesevidence of the standard of care in "any civil or criminal action resulting frompersonal or property damage associated with recombinant DNA activities."

In vetoing the bill, Governor Brown stated:

"This bill would place into statute current national guidelines for recom-

binant DNA research. I commend the author and the Legislature for its leader-ship in seeking to guarantee the safety of this research. Unfortunately, thebill imposes certain legal restrictions that could inhibit the growth of aninnovative technology which is fundamental to advances in agriculture, medicineand pollution control. This whole subject bears very careful and thoughtfulresearch."

BASIS OF THE OPPOSITION

Reportedly, opposition to the bill surfaced after its passage by the legisla-ture. Representatives of some biotechnology companies are said to have voicedconcern to the Brown administration that enactment of the bill might crimp thegrowth of biotechnology developments in California. They are said to feel that, byestablishing evidentiary standards that in effect shift the burden of proof, thebill would make the biotechnology company "guilty until proven innocent." It wasalso pointed out that the standards would have been applicable whether or not ahazardous infective agent was involved.

Industry observers point out that Governor Brown has repeatedly expressed hisinterest in fostering high-technology industry. To that end, he chairs the blue-ribbon California Commission on Industrial Innovation. Cynics have suggested thatthe Governor may have been motivated by considerations of his Senatorial candidacy. 1