The following opinion is presented on-line for informational use only and does not replace the official version. (Mich Dept of Attorney General Web Site - www.ag.state.mi.us)


STATE OF MICHIGAN

FRANK J. KELLEY, ATTORNEY GENERAL

Opinion No. 5425

January 22, 1979

DEPARTMENT OF PUBLIC HEALTH:

Recombinant DNA research

PUBLIC HEALTH CODE:

Recombinant DNA research

HEALTH AND SANITATION:

Recombinant DNA research

The Public Health Code provides for the registration of laboratories or other places where recombinant DNA research is performed and further provides for the safe sale, conveyance and shipment of the same; it does not provide for any other regulation.

Inasmuch as the Public Health Code authorizes the Department of Public Health to exercise broad rulemaking powers when it determines that certain conditions constitute a hazard to the public health, promote the spread of disease or create a source of contamination, if in the further scientific evidence indicates that recombinant DNA research creates such conditions, the Department may promulgate rules to the extent necessary to safeguard the public health.

Honorable Perry Bullard

State Representative

The Capitol

Lansing, Michigan 48933

You have requested my opinion on the following questions:

'Under any of the following statutes, is the Michigan Department of Public Health empowered to regulate recombinant DNA experiments conducted by private commercial laboratories, or business or industry in this state:

PA 308 of 1927 (MCL 325.51-325.53)

PA 235 of 1968 (MCL 325.81-325.92)

PA 154 of 1974 (MCL 408.1001-408.1094)

If authority to regulate such experimentation does not reside in any of the above statutes, does it reside in any other source?'

Recombinant DNA experimentation has been summarized as follows:

'The particular characteristics of any organism are determined by the DNA (deoxyribonucleic acid) in its chromosomes. The DNA molecules of an organism are arranged in the now familiar double helix pattern, and when a cell divides, this DNA structure is replicated, giving each of the new cells identical characteristics. This genetic information is ordinarily unique to a species, but recombinant DNA research makes possible exchanges of genetic material between species.' 7 Environmental Law Review 293, 294 (1977)

The public health and safety concern over recombinant DNA experimentation and research centers around the possibility that new and previously unknown strains of bacteria or virus may be developed and escape from the laboratory setting. Should such escape occur, existing life forms, without antibodies to fight the new and potentially deadly strains, could be defenseless. If potential dangers warrant concern, the State may invoke its police power to protect the public from the dangers of such contamination. Rogowski v City of Detroit, 374 Mich 408; 132 NW2d 16 (1965).

1927 PA 308, as amended, MCLA 325.51 et seq; MSA 14.51 et seq, and 1968 PA 235, as amended, MCLA 325.81 et seq; MSA 14.375(1) et seq, which you reference in your inquiry, have been repealed and replaced by the Public Health Code, 1978 PA 368, MCLA 333.1101 et seq; MSA 14.15(1101) et seq. An analysis of your question with regard to these two enactment will, therefore, be made with reference to the new provisions of the Public Health Code.

1974 PA 154, as amended, MCLA 408.1001 et seq; MSA 17.50(1) et seq, which you have also noted in your inquiry, is popularly known as the Michigan Occupational Safety and Health Act. The title of the act describes its purposes as follows:

'AN ACT to prescribe and regulate working conditions; to prescribe the duties of employers and employees as to places and conditions of employment; to create certain boards, commissions, committees, and divisions relative to occupational and construction health and safety; to prescribe their powers and duties and powers and duties of the department of labor and department of public health; to impose an annual levy to provide revenue for the safety education and training division; to provide remedies and penalties; and to repeal certain acts and parts of acts.'

It is apparent from a reading of these purposes that, rather than regulating scientific research and experimentation, 1974 PA 154, supra, seeks to prescribe and regulate working conditions. It would, therefore, be generally inapplicable to the regulation of recombinant DNA experimentation or research.

The recently enacted Public Health Code, however, at Secs. 20551-20554, specifically provides for the registration of laboratories or other places where recombinant DNA research is performed and further provides for the safe sale, conveyance and shipment of the same:

'(1) A laboratory or other place where live bacteria, fungi, mycoplasma, parasites, viruses, or other microorganisms of a pathogenic nature are handled, cultivated, sold, given away, or shipped from or to or where recombinant deoxyribonucleic acid research is done shall be registered with the department, and a registration number shall be issued to each place registered. An application for a registration number shall be made by the person in charge of the laboratory or other place where the pathogens are handled or where recombinant deoxyribonucleic acid research is done. The registration number is valid for 1 year and may be renewed upon application to the department.

(2) A clinical laboratory licensed in microbiology under sections 20501 to 20525 is registered for purposes of this section and section 20552, and its license number shall be used as its registration number.

(3) As used in sections 20551 and 20552, 'handled', 'cultivated', or 'shipped' does not include the collection of specimens, the initial inoculation of specimens into transport media or culture media, or the shipment to registered laboratories, but does include any additional work performed on cultivated pathogenic microogranisms or any recombinant deoxyribonucleic acid research is done.' 1978 PA 368, Sec. 20551 (Emphasis Added)

'The department shall register a laboratory or a department of a college, university, or school which is responsible for the handling, cultivating, selling, giving away, or shipping of the microorganisms described in section 20551(1) or is engaged in recombinant deoxyribonucleic acid research. The person in charge of the laboratory or department where the pathogens are handled or where recombinant deoxyribonucleic acid research is done shall apply for a registration number. The registration is valid for 1 year and may be renewed upon application.' 1978 PA 368, Sec. 20552 (Emphasis Added)

'Live pathogenic bacteria, fungi, mycoplasma, parasites, viruses, or other microorganisms or cultures of the microorganisms when sold, given away, or shipped by a laboratory or other person, shall bear a label on the container showing the registration number of the laboratory or other person sending the specimens and the name and address of the person to whom sent. A laboratory or person shall not sell or convey a live pathogenic microorganism or recombinant deoxyribonucleic acid materials to any other laboratory or person in this state without permission of the department unless each is registered under section 20551 or 20552. The laboratory or person shall keep a record of each sale, gift, or other distribution of live pathogenic microorganisms and cultures or recombinant deoxyribonucleic acid materials containing the name and laboratory address of the recipient or purchaser. The record shall be at all times open to examination and copying by a representative of the department.' 1978 PA 368, Sec. 20554 (Emphasis Added)

The above-cited provisions of the Public Health Code, 1978 PA 368, supra, provide only for the registration of specified laboratories or other places engaged in recombinant DNA research and did not provide for any other regulations. Apparently the legislature did not believe that there is a current need for regulation of recombinant DNA research; if such a need arises in the future, the legislature may amend the act.

It should be noted, however, that the provisions of the Public Health Code, 1978 PA 368, supra, Article 2, Part 22, provide rule-making powers to the Department of Public Health. Section 2226 of the code states, in pertinent part:

'The department may:

(d) Exercise authority and promulgate rules to safeguard properly the public health; to prevent the spread of diseases and the existence of sources of contamination; and to implement and carry out the powers and duties vested by law in the department.' 1978 PA 368, Sec. 2226(d)

Further, Sec. 2221 of the code broadly defines the purpose, scope and direction of departmental regulation, and specifically grants to the Department of Public Health all 'powers necessary or appropriate' to perform its duties and to exercise its lawful powers.

In addition, Sec. 2233 of the code authorizes the department to promulgate rules which are 'necessary or appropriate' to implement and carry out its duties and functions.

Accordingly, these provisions authorize the Department of Public Health to exercise broad rule-making powers whenever it determines that conditions exist which constitute a hazard to the public health, promote the spread of disease, or create a source of contamination. Thus if, in the future, scientific evidence or other medical findings indicate that recombinant DNA research constitutes a hazard to the public health, promotes the spread of disease, or creates a source of contamination, the Department of Public Health may promulgate rules to regulate the specific areas of concern to the extent necessary to safeguard the public health.

Frank J. Kelley

Attorney General