REGULATIONS FOR USE OF RECOMBINANT DNA MOLECULE TECHNOLOGY

The Board of Health, City of Haverhill, Massachusetts acting under the authority of Section 31, Chapter III of the General Laws and amendments and additions thereto, and by any other power thereto enabling, has duly made and adopted the following rules and regulations in the interest of and for the preservation of the public health.

1. APPLICABILITY

All activities associated with constructing: a) recombinant DNA (RDNA) molecules and b) organisms and viruses containing RDNA molecules within the City of Haverhill shall be performed in strict accordance with these regulations and with the NIH Guidelines as defined in Section 2-c below. The regulations shall govern where they differ from the Guidelines. These regulations do not apply to finished products which contain RDNA molecules and which have been approved by other government regulatory agencies for medical or other purposes.

2. DEFINITIONS

For the purpose of these regulations, the following definitions are adopted:

a) Large-scale means the use of more than ten liters but less than 5000 liters of RDNA culture.

b) Significant deviation means any deviation that might have an adverse affect on personal or public health.

c) Guideline means:

1. National Institute of Health Guidelines for Research Involving Recombinant DNA Molecules published in the Federal Register of November 23, 1984, and any subsequent Federal amendment thereto approved by the Board of Health.

2. In the event that the National Institutes of Health shall discontinue or abolish their guidelines, those guidelines in effect and approved by the Board of Health at the time of such discontinuance shall remain in effect.

3. HAVERHILL BIOSAFETY COMMITTEE (HBC)

a) A Haverhill Biosafety Committee (HBC) shall be established for the purpose of overseeing all use of RDNA in Haverhill and advising the Board of Health.

b) Specific responsibilities of the HBC shall include:

1. Establishing policies, procedures and criteria to aid in the implementation of this ordinance.

2. Reviewing all amendments to the Guidelines before submitting their recommendations to the Board of Health for approval.

3. Reviewing all applications for permits for the use of RDNA in Haverhill for compliance with the Guidelines and conformity with such other regulations as the Board of Health may from time to time promulgate.

4. Reviewing institutions' manuals, worker training programs, health safety programs and monitoring procedures.

5. Determining the manner in which institutions and Institutional Biosafety Committees make reports, applications or recommendations to the HBC and the type of information required. Reviewing such reports, applications and recommendations and approving where appropriate.

Carrying out site visits to institutional facilities.

Approving the community members of the IBCs.

6. Developing a procedure for members of institutions to report to the HBC violations of these regulations, the Guidelines, or any other health regulations the Board of Health may promulgate.

c) The HBC shall be composed of the Chairman of the Board of Health or his/her designee, the Health Agent and a minimum of three other members to be appointed by the Mayor and approved by the Board of Health. Members appointed by the Mayor shall serve three year terms, provided, however, that of the first three members appointed to the Committee one shall serve for a term of one year, one shall serve for a term of two years, and one shall serve for a term of three years.

4. INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

a) The Institutional Biosafety Committee (IBC), established by the Guidelines, shall have as members, in addition to the corporate representatives, one community representative and the Health Agent or his/her designee. The community representative shall be appointed by the Mayor and approved by the HBC.

b) The IBC shall meet on a regular basis. All minutes of the HBC meetings must be forwarded to the Board of Health and the HBC.

c) The community member of the IBC and the Health Agent, or his/her designee shall have no financial interest in the institution or any other institution in competition therewith, and such representatives shall be bound to the same provisions as to non-disclosure and non-use of proprietary information and trade secrets as all other members of IBC, except to the extent necessary to alleviate any public health hazard. As used in this regulation, proprietary information and trade secrets shall be defined as set forth under the law of the Commonwealth of Massachusetts.

d) In accordance with the Guidelines the IBC, acting on behalf of the institution, reviews all RDNA use for compliance with the Guidelines and approves these projects that conform with the Guidelines. A description of each protocol approved by the IBC, including all organisms and the containment to be used, and a statement certifying that the experiment conforms with the Guidelines shall be filed with the HBC and the Board of Health.

e) The HBC shall retain a professional and competent person or agency to perform an annual inspection and review of procedures and practices of large scale RDNA use and compliance with his ordinance. The scope of this inspection shall be mutually agreed upon by the institution and the HBC. The institution shall reimburse the City for the expense of this inspection and review.

f) All information sent to the Board of Health and the HBC shall have any propriety information and trade secrets removed therefrom. The full test shall remain on file in the records of the institution for inspection at all reasonable times by any member of the IBC.

5. PERMITS

a) All institutions planning to use RDNA must obtain a permit from the Board of Health with the prior approval of the HBC before commencing said technology. All permits are issued for one year and may be revoked for cause.

b) Institutions seeking such a permit from the Board of Health must first submit the following to the HBC:

1. A plot plan showing the proposed location of the facility and a floor plan showing the internal layout of the facility.

2. A listing of all organisms, containment levels, and decontamination procedures to be employed.

3. A plan for a screening process to insure the purity of the strain of host organisms used in the experiments and to test organisms resulting from such experiments for their resistance to commonly used therapeutic antibiotics. Host organisms obtained from independent laboratories shall undergo the same screening process.

4. A plan for systematic monitoring of waste to assure that surviving RDNA organisms will not be released into the environment.

5. A plan for systematic pest control management in laboratories, contiguous facilities and food service establishments in the same building.

6. A plan for systematic security of the premises.

7. The institution's health monitoring, health surveillance and safety manuals, together with the plan for an appropriate medical surveillance program as determined by the IBC for all persons engaged in the use of RDNA. Such programs shall include, but shall not necessarily be limited to:

a) A pre-employment medical examination for employees.

b) Prompt reporting to the IBC of employee illnesses that are potentially related to RDNA use.

c) Retention of medical and health records for at least ten years. Medical or employee health records shall be made available for inspection and may be used for public health studies.

d) A training program of safeguards and safety procedures for personnel.

8. The name(s) of the Principal Investigator(s) who shall be responsible for enforcing the policies of the IBC.

9. A plan for orienting representatives of the Haverhill Health, Fire and Police Departments to the physical plant and to procedures to be utilized in the event of an emergency.

10. Written agreement to allow inspection of facilities and pertinent records by the HBC.

c) The HBC shall review the institution's application for a permit and supporting documents and make its recommendation of the same to the Board of Health. Copies of the application, supporting documents and the HBC's recommendation shall be filed with the Board of Health and the Planning Board within 45 days after the application is filed with the HBC. The Board of Health shall take final action on the permit application within 75 days after the application is filed with the HBC. The period within which final action shall be taken may be extended for a definite period by mutual onsent of the Board of Health and the applicant.

d) The fee for a permit granted by the Board of Health, or annual renewal thereof, shall be $500.00

6. INSPECTION AND REVIEW

a) All institutions involved in the use of RDNA shall allow inspection of their facilities, procedures and practices in order to confirm compliance with this ordinance.

b) The Board of Health shall retain a professionally competent person, agency or institution to perform inspections and reviews. The results shall be reported to the Board of Health, the HBC and the institution involved.

c) The Board of Health, its employees, all members of the HBC and any individual or institution employed to perform inspections shall maintain the confidentiality of all proprietary information released to them by reason of this ordinance.

7. RESTRICTIONS

a) "RDNA use classified by the guidelines as requiring any BL3 or BL4 physical containment measures as prescribed in Appendix G of the guidelines under Standard Microbiological Practices, Special Practices, Containment Practices, Containment Equipment or Laboratory Facilities shall not be permitted."

b) Experiments for which containment levels are not prescribed in the Guidelines shall be approved by the HBC before the experiment is initiated.

c) Large scale RDNA use shall not be permitted without prior review and approval by the HBC and approval of the Board of Health. Use of more than 5,000 liters of RDNA culture shall not be permitted.

d) There shall be no deliberate release into the environment, that is to sewers, drains or the air, of any organism containing RDNA.

e) The institution shall report within 24 hours to the Director of Health, followed by a written report within 15 days to the HBC, any significant deviations from the Guidelines and any significant accidents or illnesses or releases related to the use of RDNA. An additional inspection of facilities and procedures may be deemed necessary by the HBC based upon its judgement of the nature and extent of the problem.

8. PENALTIES

a) Violation of the conditions of this ordinance shall subject the violator to a fine of Five Hundred Dollars ($500.00) per day and in addition the facility in which the violation occurs may be closed by the Board of Health. Each day of violation shall constitute a separate and distinct offense.

b) Once a permit has been issued it may be revoked by the Board of Health upon determination, after due notice and hearing, that the institution involved has materially failed to comply with these regulations, the permit agreements or the guidelines; or if in the opinion of the Board of Health the RDNA use causes a nuisance or adversely affects the public health, safety and welfare in Haverhill.

9. ASSESSMENTS

The salaries and expenses paid by the City for inspections, reviews staff and consultants for work irectly related to carrying out the requirements of these regulations shall be assessed to the institutions holding permits under these regulations. An accounting of these costs will be furnished annually to each institution.

10. SEPARABILITY

Each part of these regulations is construed as separate to the end that if any section, item, sentence, clause or phrase is held invalid for any reason, the remainder of these regulations shall continue in full force and effect.

11. VARIANCE

The Board of Health may vary the application of any provision of these regulations with respect to any particular case when, it its opinion, the enforcements thereof would do manifest injustice; provided, that the decision of the Board of Health is not in conflict with the spirit of these standards. Any variance granted by the Board of Health must be in writing with a copy available to the public at all reasonable hours in the office of the City Clerk and in the office of the Board of Health.