CHAPTER 19A.
RECOMBINANT DNA TECHNOLOGY.
Article I. In General.
;s 19A-1. Applicability.
;s 19A-2. Discontinuance of NIH guidelines.
;s 19A-3. Definitions.
Article II. Biosafety Committees.
;s 19A-4. Leominster biosafety committee (LBC).
;s 19A-5. LBC composition.
;s 19A-6. LBC responsibilities.
;s 19A-7. Institutional biosafety committee (IBC).
;s 19A-8. IBC responsibilities.
Article III. Permits.
;s 19A-9. Permit requirements.
;s 19A-10. Permit application information.
Article IV. Inspection, Restrictions and Penalties.
;s 19A-11. Inspection of institutions.
;s 19A-12. Containment restrictions.
;s 19A-13. Large scale use.
;s 19A-14. Releases to the environment.
;s 19A-15. Reporting accidental releases.
;s 19A-16. Violation– Penalty.
;s 19A-17. Permit revocation.
;s 19A-18. Assessments.
ARTICLE I. Sec. 19A-1. Applicability.
All activities associated with constructing recombinant DNA (rDNA) molecules and using organisms and viruses containing RDNA molecules within the city shall be performed in strict conformity with this chapter and with the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) published in the Federal Register of May 7, 1986, and any subsequent federal amendment thereto approved by the city board of health and the city council. This chapter does not apply to finished products which contain rDNA molecules and which have been approved for use by other government regulatory agencies.
(7-13-92.)
Sec. 19A-2. Discontinuance of NIH guidelines.
In the event that the National Institutes of Health shall discontinue or abolish their guidelines, those guidelines and amendments in effect and approved by the Leominster board of health and the city council at the time of such discontinuance shall remain in effect. Copies of the guidelines and amendments shall be filed with the city clerk.
(7-13-92.)
Sec. 19A-3. Definitions.
For the purpose of this chapter the following definitions are adopted:
"Institution" means any person, group of persons, business entity, association or any other organizations whether public or private, for profit or nonprofit.
"Large scale" means the use of more than ten liters of rDNA culture.
"NIH guidelines" means the National Institute of Health Guidelines for Research Involving Recombinant DNA Molecules published in the Federal Register of May 7, 1986 and any subsequent federal amendment thereto approved by the Leominster board of health and the city council.
"Recombinant DNA molecules (rDNA)" means deoxyribonucleic acid molecules which are constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell or DNA molecules which result from the replication of rDNA molecules.
(7-13-92.)
ARTICLE II. Sec. 19A-4. Leominster biosafety committee (LBC).
A Leominster biosafety committee (LBC) shall be established for the purpose of overseeing all rDNA research and technology in the city and advising the board of health on matters related to biotechnology.
(7-13-92.)
Sec. 19A-5. LBC composition.
The LBC shall be composed of the chairman of the board of health or a board member designated by the chairman, the Director of the city health department, and three other members to be appointed by the mayor with the approval of the city council.
(7-13-92.)
Sec. 19A-6. LBC responsibilities.
Specific responsibilities of the LBC shall include:
(a) Reviewing all amendments to the NIH guidelines and submitting recommendations for adoption to the board of health and the city council;
(b) Establishing procedures to aid the board of health in implementing this chapter and the NIH guidelines and adopted amendments. A copy of such procedures shall be filed in the office of the city clerk;
(c) Reviewing all applications for permits for rDNA research and use of rDNA technology in the city, for compliance with NIH guidelines;
(d) Reviewing manuals, worker training programs, health-safety programs and monitoring programs required by institutions involved in rDNA research and technology for compliance with NIH guidelines;
(e) Determining requirements and procedures for institutions and institutional biosafety committee application and report submission and reviewing submitted institutional documents and reports, for compliance;
(f) Determining institutional procedures for reporting violations of this chapter and NIH guidelines to the LBC and the board of health.
(7-13-92.)
Sec. 19A-7. Institutional biosafety committee (IBC).
(a) The institutional biosafety committee (IBC), established by the NIH guidelines, shall have five members, of whom two shall be affiliated with the institution, at least one affiliated representative shall be a member of the institution's biotechnician staff. Institutional affiliated members shall be appointed by the institution. Three members of the IBC shall not be affiliated with the institution. Nonaffiliated IBC members shall be appointed by the LBC and shall be persons active in environmental, occupational health or medical occupations in the city.
(b) The LBC designated members of the IBC shall have no financial interest in the institution or any other competitive institution. LBC designated representatives shall be bound by the same, nondisclosure and non-use of proprietary information and trade secrets provisions, as all other members of the IBC, except to the extent necessary to alleviate any public health hazard. As used in this chapter, proprietary information and trade secrets shall be as set forth under the laws of the Commonwealth of Massachusetts.
(7-13-92.)
Sec 19A-8. IBC responsibilities.
(a) The IBC shall meet on a regular basis, and forward all minutes to the LBC, and shall file a copy with the city clerk.
(b) The IBC shall review all rDNA use for compliance with the NIH guidelines and approve only those 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 or process conforms with NIH guidelines shall be filed with the LBC and a copy shall be filed with the city clerk.
Information sent to the LBC and the city clerk shall not include any proprietary information and/or trade secrets. However, the full text shall remain on file in the records of the institution for inspection at all reasonable time by any members of the IBC.
(7-13-92.)
ARTICLE III. Sec. 19A-9. Permit requirements.
All institutions planning to use rDNA for research or production, including small scale and large scale use, must obtain a permit from the board of health with the prior approval of the LBC before commencing said technology. All permits are issued for one year and may be revoked for cause. The fee for a permit or annual renewal thereof, shall be twenty-five dollars.
(7-13-92.)
Sec. 19A-10. Permit application information.
Institutions seeking such a permit from the board of health must first submit the following to the LBC:
(a) The location of the institution planning to use rDNA must be in either an industrial zone which use would constitute a permitted use in such a zone or in a planned development district provided the planning board issues site plan approval. In any of the above zones, however, such use is subject to any conditions imposed by the board of health in its issuing permit;
(b) A plot plan showing the proposed location of the facility and floor plan showing the internal layout of the facility;
(c) A list of the major taxonomic groups from which cell lines are obtained or strains are isolated; a list of all organisms which are known human pathogens; containment levels, and decontamination procedures to be employed. Experiments which make use of human fetal tissue shall be prohibited;
(d) A certification from the IBC, for any experiment with known human pathogens, that an applicable protocol exists covering resistance to antibiotics, symptoms of infection and emergency incident procedures;
(e) A plan for validation of waste and ventilation systems to assure that surviving rDNA organisms will not be released into the environment;
(f) A plan for systematic pest control management in laboratories, production areas, contiguous facilities and food service establishments in the same building;
(g) A plan for systematic security of the premises;
(h) 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:
(1) A preemployment medical examination for employees,
(2) Prompt reporting and full disclosure to the IBC and the board of health of employees' illnesses that are potentially related to rDNA use including, but not limited to, identification of the illness, infectious agent, possible reservoirs, transmission modes, incubation and communicability periods and the susceptibility of the population to the illness,
(3) 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 only with the consent of the employee,
(4) A training program of safeguards and safety procedures for personnel;
(i) The name(s) of the principal investigator(s) who shall be responsible for enforcing the policies of the IBC;
(j) A plan for orienting representatives and to the regional hazardous waste task force of the Leominster health, fire, and police departments, as to the physical plant and to procedures to be utilized in the event of an emergency;
(k) Written agreement to allow inspection of facilities and pertinent records by the board of health, the board's designated inspector and LBC members;
(l) A plan showing the methods and procedures to be employed so as to prevent the release of surviving rDNA organisms into the environment.
The LBC shall review the institution's application for a permit and supporting documents and make a recommendation of the same to the Leominster board of health within thirty days of the filing of such application. The Leominster board of health shall take final action on the permit application within forty-five days after the application is filed with such board. The period within which final action shall be taken may be extended for a definite period by mutual consent of the board of health and the applicant.
(7-13-92.)
ARTICLE IV. Sec. 19A-11. Inspection of institutions.
(a) All institutions involved in the use of rDNA shall allow inspection of their facilities, procedures and practices by the board of health or its designee in order to confirm compliance with this chapter.
(b) The Leominster 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 LBC and the institution involved.
(c) The Leominster board of health, its employees, the LBC and any individual or institution employed to perform inspections shall maintain the confidentiality of all proprietary information released to them by reason of the chapter.
(7-13-92.)
Sec 19A-12. Containment restrictions.
(a) rDNA use or experiments requiring BL4 containment shall not be permitted in the city.
(b) The institution shall submit to the LBC documentation of the approved containment level for any experiment for which containment level is not prescribed in the NIH guidelines prior to the commencement of such experiment.
(7-13-92.)
Sec. 19A-13. Large scale use.
Large scale rDNA use shall be permitted only with prior review and approval by the LBC and having obtained the permit set forth in section 19A-9.
(7-13-92.)
Sec. 19A-14. Releases to the environment.
There shall be no release into the environment, that is, to sewers, drains, or the air, of any organism containing rDNA.
(7-13-92.)
Sec. 19A-15. Reporting accidental releases.
The institution shall report immediately to the director of the board of health and the executive director of the Leominster regional wastewater utility and within twenty-four hours to the LBC, followed by a written report within five days to the LBC and the director of the board of health, any deviations from the NIH guidelines and any accidents or illnesses or releases related to the use of rDNA. An additional inspection of facilities and procedures may be deemed necessary by the LBC based upon judgment of the nature and extent of the problem.
(7-13-92.)
Sec. 19A-16. Violation– Penalty.
Any person who violates any provision of this chapter shall be subject to a fine of three hundred dollars for each such violation. In addition the facility in which the violation occurs may be closed by the board of health. Each day such violation occurs or continues shall constitute a separate and distinct offense. These penalties shall be in addition to any other penalties that may be prescribed by law.
IN GENERAL.
BIOSAFETY COMMITTEES.
PERMITS.
INSPECTION, RESTRICTIONS AND PENALTIES.