SENATE BILL REPORT

SB 6267

BYSenator Talmadge

Establishing the biotechnology review board.

Senate Committee on Environment & Natural Resources

Senate Hearing Date(s):January 28, 1988

Senate Staff:Gary Wilburn (786-7453)

AS OF JANUARY 22, 1988

BACKGROUND:

Biotechnology involves the genetic alteration of organisms for medical, agricultural, industrial, pollution cleanup, and many other purposes.  For example, pending or proposed genetically engineered products hold out promise for microbes that remove specific pollutants for groundwater, wastewater and soil; plants bred for nutritional composition and resistance to drought, salt and pests; improved mining and oil extraction methods; and low cost manufacture of medicines and proteins, enzymes and hormones used in medical treatment.  The technology is expanding at a very rapid pace and opponents of widespread use of these products contend that assessment of the possible risks has been inadequate.  This concern has been expressed particularly with respect to products intended for release into the outdoor environment, where less control upon potential adverse impacts is possible than in the laboratory.

Existing regulation of the experimentation and general use of biotechnology products is conducted primarily by federal agencies, under several federal laws with overlapping jurisdiction in many cases.  Under a 1986 policy developed by the Office of Science and Technology in the White House, lead responsibilities for coordinating review of proposed products were divided as follows:  (1) The Food and Drug Administration will regulate human and animal drugs, foods and food additives, medical devices and vaccines; (2) The U.S. Environmental Protection Agency will regulate pesticidal microoganisms and products involving organisms with intergeneric combinations of genetic material; and (3) the U.S. Department of Agriculture will regulate bioengineered plants, animals and pathogenic microorganisms.

There are no Washington State regulatory programs specific to the experimentation and use of biotechnology products.  The Washington Department of Agriculture licenses the use of certain agricultural chemicals which could be the subject of biotechnology, including pesticides, fertilizers and animal remedies.  Current research in the state in the fields of agricultural chemicals, aquaculture, forestry and pollution abatement indicate that proposed environmental releases for experimentation or general use may occur within the next few years.

SUMMARY:

The Legislature makes findings regarding the enormous potential benefits to society of biotechnology products, and that a biotechnology review board should be created to assure protection of human health and the environment as research proceeds in biotechnology.  The board is to consist of nine members, including Directors of the state Departments of Agriculture, Ecology, and Social and Health Services, and scientists and citizens appointed by the Governor with the advice and consent of the Senate.  The Director of the Department of Agriculture is to serve as Secretary and is to provide necessary staff and facilities.

Six-month notice of a proposed release into the open environment must be provided to the board and the local jurisdiction.  The notice must describe the release and document application for federal and state permits.  The board or local jurisdiction may hold an informational hearing on the proposed release, and may require information necessary for meaningful public comment.  The board may authorize the release, or prohibit it upon a finding that the release presents an unreasonable risk to public health, safety or the environment.  The Agriculture Director may seek injunctive relief to prevent violations, and civil penalties up to $10,000 for violations are included.  Laboratory research and uses within closed and secure buildings are expressly exempted.

The board is to submit a report to the Governor and Legislature assessing potential impacts from the environmental release of biotechnology products and the current federal regulatory programs.  An annual report on the board's review activities and progress of the state's biotechnology industry is also to be prepared.  The board is to assist biotechnology companies in identifying applicable local, state and federal regulatory requirements.  Local jurisdictions may not adopt laws prohibiting biotechnology product releases.

Appropriation:    unspecified

Revenue:    none

Fiscal Note:      requested January 19, 1988