All activities associated with constructing and/or propagating recombinant DNA (rDNA) molecules and organisms and viruses containing rDNA molecules within the Town of Lexington shall be performed in strict accordance with these regulations and with the NIH Guidelines as defined in § 155-34 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.
For the purpose of these regulations, the following definitions are adopted:
- A. The most recent version and any additional approvals of the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules published in the Federal Register.
- B. 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.
- LARGE SCALE
- The use of more than 10 liters but less than 5,000 liters of rDNA culture.
- SIGNIFICANT DEVIATION
- Any deviation that might have an adverse effect on personal or public health.
A Lexington Biosafety Committee (LBSC) shall be established for the purpose of overseeing all uses of rDNA in Lexington and advising the Board of Health.
Specific responsibilities of the LBSC are as follows:
Establishing policies, procedures and criteria to aid in the implementation of this article.
Reviewing all amendments to the Guidelines before submitting its recommendations to the Board of Health for approval.
Reviewing all applications for permits for the use of rDNA in Lexington for compliance with the Guidelines and conformity with such other regulations as the Board of Health may from time to time promulgate.
Reviewing institutions' manuals, worker training programs, health-safety programs and monitoring procedures.
Determining the manner in which institutions and institutional biosafety committees make reports, applications or recommendations to the LBSC and the type of information required; reviewing such reports, applications and recommendations and approving where appropriate; carrying out site visits to institutional facilities; and approving the community members of the Institutional Biosafety Committees (IBCs).
Developing a procedure for members of institutions to report to the LBSC violations of these regulations, the Guidelines or any other health regulations the Board of Health may promulgate.
The LBSC shall be composed of the Chairman of the Board of Health or his/her designee, the Director of Health and a minimum of three other members to be appointed by the Town Manager and approved by the Board of Health. Members appointed by the Town Manager 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.
Written registration is required prior to commencement of work and includes:
Name and c.v. of a person in the organization familiar with the proposed rDNA work and the NIR Guidelines.
A brief summary from the above-named person describing the proposed work and giving:
Name and type of organisms [host/donor (foreign DNA)/vector] being used.
Reference to the section of the NIH Guidelines where the work falls.
If recombinant molecules containing eukaryotic viruses are propagated in cells, give the approximate percentage of viral genome present.
The scale (in filters) on which the organisms will be grown.
An assurance that all work will be carried out following the NIR Guideline, where applicable, at the appropriate BL level and that exempt work will be done at BL1.
Name of biological waste handler (if any) and written assurance that all waste will be disposed of according to all applicable federal, state and local codes.
An annual report summarizing the work performed over the past year and addressing any ongoing work according to the format given in Subsection B(2) above.
A registration fee of $100, due upon initial application and upon annual renewals.
Upon receiving and reviewing the submitted information, the LBSC may require additional information to be submitted, and it may recommend to the Board of Health other procedures or safeguards as it deems appropriate up to and including full permit application under the existing Town ordinance.
All institutions planning to use rDNA in any way other than those described in § 155-36, Registration, must obtain a permit from the Board of Health with the prior approval of the LBSC before commencing said technology. All permits are issued for one year and may be revoked for cause.
Institutions seeking such a permit from the Board of Health must first submit the following to the LBSC:
A plot plan showing the proposed location of the facility and a floor plan showing the internal layout of the facility.
A list of all organisms, containment levels and decontamination procedures to be employed.
A plan for a screening process to ensure 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.
A plan for systematic monitoring of waste to assure that surviving rDNA organisms will not be released into the environment.
A plan for systematic pest control management in laboratories, contiguous facilities and food service establishments in the same building. All waste disposal will be done in accordance with 105 CMR 480.000, Chapter VIII, State Sanitary Code, Storage and Disposal of Infectious or Physically Dangerous or Biological Waste.
A plan for systematic security of the premises.
Institutional Biosafety Committee (IBC).
The Institutional Biosafety Committee (IBC), established by the Guidelines, shall have as members, in addition to the corporate representatives, one community representative, the Director of Health or his/her designee. The community representative shall be appointed by the Town Manager and approved by the LBSC.
The IBC shall meet on a regular basis. All minutes of the IBC meetings must be forwarded to the Board of Health and the LBSC.
The community member of the IBC and the Director of Health 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 nondisclosure and nonuse 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 laws of the Commonwealth of Massachusetts.
In accordance with the Guidelines the IBC, acting on behalf of the institution, reviews all rDNA use for compliance with the Guidelines and approves those projects that conform to 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 to the Guidelines shall be filed with the LBSC and the Board of Health.
All information sent to the Board of Health and the LBSC shall have any proprietary information and trade secrets removed therefrom. The full text shall remain on file in the records of the institution for inspection at all reasonable times by any member of the IBC.
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 pre-employment medical examination for employees.
Prompt reporting to the IBC of employee illnesses that are potentially related to rDNA use.
Retention of medical and health records for at least 10 years. Medical or employee health records shall be made available for inspection and may be used for public health studies.
A training program of safeguards and procedures for personnel.
The name(s) of the principal investigator(s) responsible for enforcing the policies of the IBC.
A plan for orienting representatives of the Lexington Health, Fire and Police Departments to the physical plant and to procedures to be utilized in the event of an emergency.
Written agreement to allow inspection of facilities and pertinent records by the LBSC.
The LBSC 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 LBSC recommendation shall be filed with the Board of Health and the Planning Board within 45 days after the application is filed with the LBSC. The Board of Health shall take final action on the permit application within 75 days after the application is filed with the LBSC. 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.
The fee for a permit granted by the Board of Health or annual renewal thereof shall be $500.
All institutions involved in the use of rDNA shall allow inspection of their facilities, procedures and practices in order to confirm compliance with this article.
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 LBSC and the institution involved.
The Board of Health, its employees, all members of the LBSC and any individual or institution employed to perform inspections shall maintain the confidentiality of all proprietary information released to them by reason of this article.
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 Practice Containment Practices, Containment Equipment or Laboratory Facilities shall not be permitted.
Experiments for which containment levels are not prescribed in the Guidelines shall be approved by the LBSC before the experiment is initiated.
Use of more than 5,000 liters of rDNA culture shall not be permitted.
There shall be no deliberate release into the environment, that is, to sewers, drains or the air, of any organisms containing rDNA.
The institution shall report within 24 hours to the Director of Health, followed by a written report within 15 days to the LBSC, 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 LBSC based upon its judgment of the nature and extent of the problem.
Violation of the conditions of these regulations shall subject the violator to a fine of $500 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.
Once a permit has been issued or a registration filed, 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 Lexington.
The salaries and expenses paid by the Town for inspections, reviews, staff and consultants for work directly 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.
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.
The Board of Health may vary the application of any provision of these regulations with respect to any particular case when, in its opinion, the enforcement 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 Town Clerk and in the office of the Board of Health.