[Adopted 12-19-2023[1]]
All activities associated with the use of laboratory animals
within the Town of Lexington shall be performed in strict accordance
with all federal, state and local statutes, ordinances and regulations
concerning the welfare of animals, including the "Guide for the Care
and Use of Animals" of the National Institutes of Health, the Animal
Welfare Act (7 U.S.C. Chapter 54, §§ 2131 through 2159),
the Health Research Extension Act of 1985,[1] the "Public Health Service Policy on Humane Care and Use
of Laboratory Animals," MGL c. 140, § 174D, and 105 CMR
910.000 et seq., all as amended or revised from time to time.
[1]
Editor's Note: See 42 U.S.C. § 281 et seq.
As used in this article, the following terms shall have the
meanings indicated:
The proper care, use, and humane treatment of laboratory
animals produced for or used in research or testing.
Any procedure conducted by a research institution upon a
live animal.
Any facility operated in the Town of Lexington, any school
or college of medicine, public health, dentistry, pharmacy, veterinary
medicine, or agricultural, medical, biological, or diagnostic laboratory,
biological corporation, hospital or other educational or scientific
establishment within the Town of Lexington which, in connection with
any of its activities, investigates the structure and function of
living organisms or the causes, prevention, control or cure of diseases
or abnormal conditions of human beings or animals, or participates
in the development, marketing, or testing of any commercial product
utilizing live animals.
The individual who, as a representative of senior administration,
bears ultimate responsibility for the Animal Care and Use Program
and is responsible for resource planning and ensuring alignment of
program goals with the institution's mission.
Any live, vertebrate animal used or intended for use in research,
research training, experimentation, or biological testing or for related
purposes.
A Laboratory Animal Liaison (LAL) will oversee the care and
use of laboratory animals in the Town of Lexington. The liaison shall
not currently work for any business or organization in the Town, but
may be a current Town employee or official.
A.
All institutions planning to use laboratory animals must obtain a
permit from the Board of Health. All permits are issued for one year
and may be revoked at any time, subject to the notice and hearing
provisions of this regulation. No permit shall be transferred. Within
10 days of any changes in an institution's laboratory animal
use (including, but not limited to, change in species of animal, change
in housing of animals, significant change in number of animals), such
institution shall reapply for a new one-year permit. Failure to do
so will constitute cause to revoke the institution's permit.
B.
Institutions seeking such a permit from the Board of Health must
submit the following to the Laboratory Animal Liaison:
C.
An institution must update its permit within 10 days of making any
of the following changes:
A.
Each institution that performs research, experiments or biomedical
procedures using animals shall establish and maintain an Animal Care
and Use Committee that oversees all activities conducted by and at
an institution that have a direct impact on the well-being of animals,
including, but not limited to, animal and veterinary care, policies
and procedures, personnel and program management and oversight, occupational
health and safety, institutional Animal Care and Use Committee functions,
and animal facility design and management.
B.
Each institution will be required to have one community representative
from the New England region on its Animal Care and Use Committee.
The community representative must not be a laboratory animal user,
affiliated in any way with the institution, or a member of the immediate
family of a person who is affiliated with the institution.
Each Animal Care and Use Committee of each institution shall
provide the following information for the LAL's review at the
time of the LAL's annual visit:
A.
Number and species of animals used in previous year;
B.
Results of all state and federal inspections concerning animal care
and use in the previous year;
C.
The name and occupation of the community member on the Animal Care
and Use Committee;
D.
The names and membership roles of all other members of the Animal
Care and Use Committee;
E.
The dates of meetings of the Animal Care and Use Committee, as well
as the minutes of those meetings, including records of attendance,
activities of the Committee, and Committee deliberations;
F.
Animal Care and Use Committee-reviewed policies, guidelines, standard
operating procedures, and protocols;
G.
Records of accrediting body determinations;
H.
Semiannual program reviews; and
I.
Animal care and use semiannual inspection reports.
The LAL shall report any violations of the standards prescribed
in this article to the Chief Executive Officer/Institutional Official
of the research institution.
A.
All institutions involved in the use of laboratory animals as described
in this article shall allow annual inspection of their facilities,
procedures, and practices in order to confirm compliance with this
article.
B.
The LAL shall make at least one annual unannounced visit to each
institution to inspect animal research facilities.
C.
The LAL shall hold at least one annual meeting with the attending
veterinarian and/or Animal Care and Use Committee Chairperson to discuss
and review the Animal Care and Use Committee's work. The LAL
may inspect any Animal Care and Use Committee reports and documents
on the LAL's annual visit.
D.
The LAL shall report to the Board of Health from time to time and
may make recommendations regarding the care and use of laboratory
animals within the Town.
E.
The LAL shall report the results of the annual inspection to the
Board of Health and the institution involved.
F.
The Board of Health shall maintain the confidentiality of all proprietary
information released to it by reason of this article.
Any institution that violates this article be may by fined $500
per violation per day by an agent of the Board of Health. Each day
of violation shall constitute a separate offense.
A.
Variances may be granted only as follows: The Board of Health may
vary the application of any provisions of these regulations (except
where such variance is expressly forbidden in these regulations or
by applicable law/regulation) with respect to any particular case
when, in the Board's opinion:
B.
Every request for a variance shall be made in writing and shall state
the specific variance sought and the reasons therefor. Any variance
granted by the Board of Health shall be in writing. Any denial of
a variance shall also be in writing and shall contain a brief statement
of the reasons for the denial. A copy of each variance shall be available
to the public at all reasonable hours in the office of the City or
Town Clerk or the office of the Board of Health while it is in effect.
A.
Any person to whom the Board issues an order may request a hearing
before the Board by filing with the Board within seven days after
the day the order was served a written request for a hearing. Upon
receipt of a hearing request, the Board shall set a time and place
for the hearing and shall inform the business owner in writing. The
hearing shall commence within 30 days from the day on which the written
request was made, unless a later time is agreed to in writing by the
Board and the person requesting the hearing. At the hearing the person
requesting the hearing shall be given an opportunity to be heard and
show why the order should be modified or withdrawn. After the close
of the hearing, the Board shall issue a written decision to sustain,
modify, or withdraw the order and shall mail a copy of the decision,
by certified mail, return receipt requested, to the person who requested
the hearing. If the Board sustains or modifies the order, it shall
be carried out within the time period allotted in the original order
or in the modification.
B.
Every notice, order, or other record prepared by the Board in connection
with the hearing shall be entered as a matter of public record in
the office of the Lexington Town Clerk, or in the office of the Board.
C.
If a request for a hearing is not filed with the Board within seven
days after the day an order has been served or if after a hearing,
the order has been sustained in whole or any part, each day's
failure to comply with the order as issued or sustained shall constitute
a separate violation of a $500 fine.
Any person aggrieved by the decision of the Board of Health
with respect to the provisions of these regulations may seek relief
therefrom in any court of competent jurisdiction, as provided by the
laws of the Commonwealth of Massachusetts.
If any section, subsection, sentence, clause, phrase, heading,
or any portion of these regulations is for any reason held invalid
or unconstitutional by any court of competent jurisdiction in the
Commonwealth of Massachusetts, such provisions and such holding shall
not affect the validity of the remaining portions thereof.
