Town of Plainville, MA Biological Safety

Unless otherwise specified, are defined as:

(a)

NIH GUIDELINESNational Institute of Health (NIH) "Guidelines for Research Involving Recombinant DNA Molecules," as published in the Federal Registrar of April 27, 2016.

(b)

BMBLBiosafety in Microbiological and Biomedical Laboratories 5th Edition 2007.

INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

For purposes of these regulations, the NIH Guidelines, when applied to an institution that is subject to the NIH Guidelines solely by reason of these regulations, shall include the modifications to the NIH Guidelines set forth in Section IV-D thereof applicable to persons complying with NIH Guidelines on a voluntary basis. In the event that there is a conflict between the NIH Guidelines and the BMBL, the more restrictive shall control.

A committee that i) meets the requirements for membership specified in the guidelines and ii) reviews, approves, and oversees projects in accordance with the responsibilities as defined in the guidelines.

MASSACHUSETTS GENERAL LAW

Chapter 111, Section 31: "Boards of health may make reasonable health regulations."

REGULATED BIOLOGICAL AGENTS

Chapter 111, Section 122: "The board of health shall examine into all nuisances, sources of filth, and causes of sickness within its town, or on board of vessels within the harbor of such town, which may, in its opinion, be injurious to the public health, shall destroy, remove or prevent the same as the case may require, and shall make regulations for the public health and safety relative thereto and to articles capable of containing or conveying infection or contagion or of creating sickness brought into or conveyed form the town."

Identified as a "Recombinant and Synthetic Nucleic Acid Molecule" in Section I-B (Definition of Recombinant DNA Molecules) of the most recently adopted revision of the NIH Guidelines, as defined under "guidelines"; or

Classified as a Risk Group 3 through 4 Agent in the NIH Guidelines or the BMBL (as both are defined herein); or

Identified as a "select agent" by the United States Department of Health and Human Services (DHHS) or the United States Department of Agriculture (USDA).

SELECT AGENT

Any microbial and toxic agents listed at 42 Code of Federal Regulations (CFR) 73.3, 42 CFR 73.4, 42 CFR 73.5, 42 CFR 73.6, 7 CFR 331.3 and 9 CFR 121.4, and the rulings made by the CDC and the USDA relative thereto, as such regulations and rulings may be amended from time to time. However, "select agent" shall not include any de minimus amount of agents or toxins which are excluded from 42 CFR 73.00 et seq.

Acronyms. As used in this regulation, the following acronyms shall have the meanings indicated:

BMBL: Biosafety in Microbiological and Biomedical Laboratories.

BSL: Biosafety Level.

BOH: Board of Health.

(4)

CDC: Center for Disease Control and Prevention.

(5)

CFR: Code of Federal Regulations.

(6)

IBC: Institutional Biosafety Committee.

(7)

NIH: National Institute of Health.

(8)

rDNA: Recombinant DNA Molecule.

(9)

DHHS: Department of Health and Human Services.

(10)

USDA: United States Department of Agriculture.

§ 575-6 Responsibilities of Board of Health.

The Board of Health and/or its agent shall be responsible for overseeing all activities to which this regulation applies.

The Board of Health shall:

Review and act on all initial and renewal applications for permits under these regulations.

Determine the manner in which permit holders make reports or applications to the Board of Health, and the type of information required.

Review reports, applications, and recommendations from all IBC meetings and approve where appropriate.

(4)

Be responsible for revocation of a permit when an institution is not in compliance with these regulations.

§ 575-7 Permit requirements.

All institutions proposing the use or continuation of use of regulated biological agents at BSL-1 or BSL-2 containment levels must obtain an annual permit from the Plainville Board of Health before commencing any such use. Institutions receiving a permit shall conduct research, manufacturing or other use only as specifically set out in their permit applications. The use of regulated biological agents requiring BSL-3 and BSL-4 materials shall not be permitted in the Town of Plainville.

Institutions seeking a permit or renewal permit from the Board of Health must submit a completed application form, accompanied by a nonrefundable permit application fee, that will include the following information:

Company name and address.

Name(s) of corporate officer(s) authorized to sign the application and full contact information for those individuals signing on behalf of the institution.

State of incorporation.

(4)

Name of the institution's designated official responsible for compliance with this regulation (this is most often the designated biosafety officer, as defined in the NIH Guidelines).

(5)

Designation of the appropriate biosafety levels (as defined in this regulation) for all laboratory areas, which are consistent with the NIH Guidelines or BMBL for all IBC-approved protocols. This designation should be reflected in the IBC minutes before work commences in the permitted facility or, at latest, no more than 30 days after work commences.

(6)

Copy of a completed biosafety manual (first application only). Copies of updated biosafety manual(s) are to be submitted upon annual permit renewal.

(7)

Floor plans showing laboratory areas (first application only). All biosafety containment, biosafety levels, and designated waste storage areas should be indicated. Updated floor plans to reflect any changes in assigned biosafety level or expansion of laboratory areas shall be submitted upon annual permit renewal.

(8)

An emergency response plan for the purpose of orienting Town of Plainville representatives, including, but not limited to, the Board of Health, Fire and Police Departments, to the physical plant and to procedures to be utilized in the event of an emergency. This documentation must include a floor plan showing the internal layout of the facility with specific biological containment and non-biological laboratory areas, biological waste storage areas, and biological waste removal routes clearly indicated. Amendments to this plan must be submitted as they are incorporated.

(9)

Medical surveillance agreement. This service may be provided through the institution's internal clinical resources or through an independent third-party provider. A letter indicating the completion of a contractual agreement for provision of occupational medicine and medical surveillance services shall be submitted upon application and whenever the clinical provider of these services has changed thereafter.

(10)

Reporting of releases or adverse events. In addition to the aforementioned requirements, each institution shall provide a written summary of any incidents or adverse event involving regulated biological agents that may have resulted in an exposure to a human pathogen within the facility or in the release of a human pathogen from the facility through wastewater or direct airborne release or through improper disposal of potentially contaminated solid waste. This report shall be sent to the Board of Health as soon as it is feasible, but not more than seven days from the date of the incident. Animal bites will be considered to represent potential human exposures, unless the animal was known to be free of infection and can be documented upon request.

(11)

Submit project summaries or registration forms for all work involving regulated biological agents.

(12)

Submit a copy of all minutes from IBC meetings held during the previous year. These minutes should provide sufficient detail to allow the Board of Health and its staff, members of the BBC, or professional consultants to understand the risk assessment or risk assignment process by which the IBC determined that all work approved by the committee would be conducted safely at the assigned biosafety level using corresponding safety practices and any additional special safety practices as specified by the IBC.

(13)

Submit a detailed table of all protocols reviewed and approved by the IBC within the previous year, including, at a minimum, a listing of all biological agents utilized (e.g., host cell lines, biological vectors), any inserted gene sequences that would elevate risk (e.g., oncogenes), the BSLs assigned after IBC review and the rationale or guidance document upon which the selected BSL was based, and the name(s) of the principal investigator(s) who shall be responsible for each protocol.

(14)

Submit a protocol for strain verification of all known human pathogens that are considered to be attenuated or noninfectious approved by the IBC within the previous year for use within the permitted facility, if any, or sufficient documentation to demonstrate that such a screening process has been completed by another laboratory, in order to ensure the proper characterization of the virulence, replication competence, and extent of resistance to therapeutic antibiotics.

Permit renewal application and fees are to be submitted on or before December 1 for the following year beginning January 1. A permit shall remain in force and effect unless and until it is revoked by the Board of Health pursuant to any of these regulations. All permits are issued for the period of January 1 through December 31.

At the time of the initial permit application or request to the Board, the applicant shall pay a plan review fee to the Town of Plainville. The rate will be set by the Board.

After approval by the Board of Health, the applicant shall submit an annual permit fee and required documentation as described in this section. The fee for a permit granted by the Board of Health or annual renewal thereof shall be determined by the Board of Health.