P.O. BOX 5000

> BROOKHAVEN NATIONAL LABORATORY UPTON, NEW YORK 11973-5000
>
> BROOKHAVEN SCIENCE ASSOCIATES TEL: (516) 344-2772

FAX: (516) 344-5803

Office of the Director E-MAIL: marburger@bnl.gov

> May 14, 1999
>
>   Brookhaven Science Associates, LLC
>
> Brookhaven National Laboratory
>
> Brookhaven Science Associates, LLC (BSA**)**/Brookhaven National
> Laboratory (BNL), hereinafter referred to as \"institution\", hereby
> gives assurance that it will comply with the Public Health Service
> Policy on Humane Care and Use of Laboratory Animals by Awardee
> Institutions, hereinafter referred to as PHS Policy.
>
> I. Applicability
>
> This assurance is applicable to all research, research training,
> experimentation, and biological testing and related activities,
> hereinafter referred to as activities, involving live, vertebrate
> animals supported by the Public Health Service (PHS) or any other
> funding agency, and conducted at this institution, or at another
> institution as a consequence of the subgranting or subcontracting of a
> PHS‑supported activity by this institution.
>
> II\. Institutional Policy
>
> A. This institution is committed to provide for humane treatment of
> all animals used by the Institution for research, testing and
> development, or teaching. BSA**/**BNL will use its best efforts to
> comply with all applicable provisions of the amended Animal Welfare
> Act (USDA), National Institutes of Health (NIH) Public Health Service
> policy (PHS), as well as the standards of the American Association for
> Accreditation of Laboratory Animal Care (AAALAC).
>
> B. This institution has established and will maintain a program for
> activities involving animals in accordance with the [Guide for the
> Care and Use of Laboratory Animals]{.underline} [(Guide)]{.underline},
> issued by the National Research Council (National Academy Press,
> 1996).
>
> C. This institution is guided by the \"U.S. Government Principles for
> the Utilization and Care of Vertebrate Animals Used in Testing,
> Research and Training\" set forth in Appendix D of the Guide.
>
> D. This institution acknowledges and accepts responsibility for the
> care and use of animals involved in activities covered by this
> Assurance. As partial fulfillment of this responsibility this
> institution will make a reasonable effort to require that all
> individuals involved in the care and use of laboratory animals
> understand their individual and collective responsibilities for
> compliance with this assurance as well as all other applicable laws
> and regulations pertaining to animal care and use.

III\. Institutional Program for Animal Care and Use.

> A. The lines of authority and responsibility for administering the
> program and ensuring compliance with this policy are:

![](media/image1.wmf)

B. The qualifications, authority and responsibility of the veterinarians
who will participate in the program include:

[Attending Veterinarian: Bruce A. Scharf]{.underline}

1\. Academic Degrees:

D.V.M.: 1986 Araneta University

Major:

License: License NYS \# 7033

> 2\. Experience: Combined Rockefeller/Cornell/Sloan Kettering
> laboratory animal medicine training program.

3\. Functions and Responsibilities:

a\. Assure the Chairman of the Medical Department and the cognizant
Department Chairmen/Division Heads of satellite facilities, that all
animal care procedures and facilities are in compliance with Federal and
State laws and the [Guide]{.underline}.

> b\. Oversee the daily care of animals, housing facilities and the
> maintenance of a sanitary environment.
>
> c\. Provide professional services to laboratory animal users including
> advice on animal selection, anesthesia, surgical procedures, other
> experimental manipulations.
>
> d\. Monitor animal health, diagnosis, treatment and control of disease
> and methods of euthanasia.

e\. Monitor the use of animals in ongoing experiments to ascertain that
humane and appropriate care is being consistently given.

> f\. In conjunction with the BNL Occupational Medicine Clinic and the
> Safety and Environmental Protection Division, assure that personnel
> caring for or using animals are provided an appropriate occupational
> health program and adequate safeguards from exposure to hazardous
> materials.

4\. Authority:

> The Attending Veterinarian has the authority to immediately terminate
> any animal use where he or she sees there is clear evidence that
> Federal statutes are being violated or when, in his/her opinion,
> appropriate measures to alleviate pain or discomfort are not being
> administered. Action can include euthanasia if necessary. Resumption
> of terminated activities, by the cognizant Department
> Chairman/Division Head, will be permitted only after review and
> written approval of corrective measures by the IACUC.

5\. Other:

Time devoted by B. Scharf to the program ‑20%

> In the absence of B. Scharf**,** attending veterinary functions will
> be performed by S. Singletary.
>
> The qualifications, authority and responsibility of the alternate
> attending veterinarian who will participate in the program include:

[Alternate Attending Veterinarian: S. Singletary]{.underline}

> 1\. Academic Degrees:

D.V.M.: Tuskegee University, School of Veterinary Medicine 1991

License: MD 4035

GA 4795

VA 6261

Washington DC 467

2\. Experience: Nine years experience in clinical and laboratory animal
care.

3\. Functions and Responsibilities:

As listed under Dr. B. Scharf, in his absence

4\. Authority:

As listed under Dr. B. Scharf, in his absence

> C. This institution has established an Institutional Animal Care and
> Use Committee (IACUC), which is qualified through the experience and
> expertise of its members to oversee the institution\'s animal
> programs, facilities, and procedures. The IACUC consists of ten
> members and one ex-officio**,** and its membership meets the
> compositional requirements set forth in the PHS Policy on Humane Care
> and Use of Laboratory Animals (PHS Policy) at Section IV.A.3.b.
> Attached is a list of the names, position titles, and earned degrees
> or other credentials of the IACUC chairperson and members.
>
> John H. Marburger, Ph.D., Laboratory Director, has responsibility for
> appointing members of the IACUC.

D. The IACUC will:

> 1\. Review at least once every six months the institution\'s program
> for humane care and use of animals, using the [Guide]{.underline} as a
> basis for evaluation;
>
> 2\. Inspect at least once every six months the institution\'s animal
> facilities (including satellite facilities) using the
> [Guide]{.underline} as a basis for evaluation.
>
> 3\. Prepare reports of the IACUC evaluations defined in paragraphs 1.
> and 2. above**,** as set forth in the PHS Policy at IV.B.3. and submit
> the reports to the Institutional Official**.**
>
> 4\. Review concerns involving the care and use of animals at the
> institution.
>
> 5\. Make written recommendations to the Institutional Official
> regarding any aspect of the institution\'s animal program, facilities,
> or personnel training.
>
> 6\. Review and approve, require modifications in (to secure approval),
> or withhold approval of those activities related to the care and use
> of animals as set forth in the PHS Policy at IV.C.
>
> 7\. Review and approve, require modifications in (to secure approval),
> or withhold approval of proposed significant changes regarding the use
> of animals in ongoing activities as set forth in the PHS Policy at
> IV.C.
>
> 8\. Notify investigators and the cognizant Department Chairmen/
> Division Heads in writing of its decision to approve or withhold
> approval of those activities related to the care and use of animals,
> or of modifications required to secure IACUC approval as set forth in
> the PHS Policy.
>
> 9\. Be authorized to suspend an activity involving animals as set
> forth in the PHS Policy at IV.C.4.
>
> E. The procedures which the IACUC will follow to fulfill the
> requirements set forth in the PHS Policy are:

1\. [IACUC Composition and Meetings:]{.underline}

The IACUC is composed of ten members with three year terms, all
appointed by the Laboratory Director. The Office of Research
Administration is responsible for arranging secretarial and
administrative assistance to the IACUC. The membership and their
credentials are listed on a separate sheet.

> Meetings will be held once a month with interim meetings convened as
> judged necessary by the IACUC Chairperson.

For official business to be conducted, a quorum of six members,
including one veterinarian, must be present. Motions will be passed by a
simple majority.

2\. [Institutional Program for Care and Use of Animals]{.underline}:

> The Committee shall, on a continuing basis but at least once every 6
> months, review the BSA/BNL program for humane care and use of animals
> as well as other concerns involving the care and use of animals at the
> institution.
>
> Matters of concern can be brought before the IACUC by written memo to
> the Laboratory Director, Institutional Official**,** the Chairman of
> the Medical Department, the Attending Veterinarian, the Department
> Chairmen/Division Heads of the Satellite Facilities on-site or the
> IACUC Chairperson. If not of an emergency nature, such matters of
> concern will be discussed and acted upon at the next scheduled IACUC
> meeting.

Approved actions and recommendations of the IACUC will be made in
writing to the Medical Department Chairman and appropriate Department
Chairmen/Division Heads.

3\. [Inspection of Facilities:]{.underline}

> The IACUC will inspect the institution\'s animal facilities at least
> every 6 months. All animal housing, as well as associated utility and
> procedural rooms will be inspected. Particular attention will be given
> to the physical plant and laboratory animal husbandry practices. After
> taking appropriate precautions, members may enter animal rooms and
> directly assess animal caging/housing, space allocations, environment
> (temperature, humidity, ventilation, noise) food, bedding and general
> sanitation procedures. Inspection of limited access facilities, such
> as primate quarters, will be done by only two committee members after
> donning required protective clothing. Complete barrier facilities will
> be inspected via view ports only.
>
> From these inspections, the committee members will determine whether
> the physical plant and husbandry practices conform with the standards
> set forth in the [Guide]{.underline}.
>
> Problems, concerns and/or suggestions resulting from these inspections
> will be submitted in writing to the Chairperson for consideration by
> the full committee at the next scheduled meeting. No response by a
> committee member is taken by the Chairperson as indicative of complete
> satisfaction with the facilities by that member. Recommendations will
> be forwarded in writing to the Medical Department Chairman and the
> appropriate Chairmen/Division Heads of the Satellite Facilities
> on-site, and the Institutional Official.

4\. [Review of New Research Applications and Proposals]{.underline}:

a\. [Receipt of Application and Proposals]{.underline}

> Forwarding of applications and proposals to the IACUC for review will
> be according to the BNL Standard Practice Instruction 7-05. This
> material is to be received by the IACUC at least one week prior to the
> next scheduled meeting.

b\. [Review of Application and Proposals]{.underline}

> Each Committee member will be provided with a completed Application
> for Approval of the Use of Laboratory Animals.
>
> Committee members with nonconflicting interests will review each
> application to confirm that the proposed activities are in accord with
> PHS Policy and will determine whether:
>
> 1\. There is justification for the use of animals, the choice of
> species and the numbers used.
>
> 2\. The activity will be conducted in accord with the Animal Welfare
> Act insofar as it applies to the activity, and that the activity is
> consistent with the [Guide]{.underline} unless acceptable
> justification for a departure is presented.
>
> 3\. The procedures with animals will avoid or minimize discomfort,
> distress and pain to the animals, consistent with sound research
> design.
>
> 4\. The procedures do not unnecessarily duplicate previous
> experiments, as verified by a MedLine or equivalent search.
>
> 5\. The procedures that may cause more than momentary or slight pain
> or distress to the animals will be performed with appropriate
> sedation, analgesia, or anesthesia, unless the procedure is justified
> for scientific reasons in writing by the investigator.
>
> 6\. The animals that would otherwise experience severe or chronic pain
> or distress that cannot be relieved will be painlessly sacrificed at
> the end of the procedure or, if appropriate, during the procedure.
>
> 7\. The living conditions of animals will be appropriate for their
> species and contribute to their health and comfort. The housing,
> feeding and nonmedical care of the animals will be directed by a
> veterinarian or other scientist trained and experienced in the proper
> care, handling and use of the species being maintained or studied.
>
> 8\. The medical care for animals will be available and provided as
> necessary by a qualified veterinarian.
>
> 9\. The personnel conducting procedures on the species being
> maintained or studied will be appropriately qualified and trained in
> those procedures.
>
> 10\. The methods of euthanasia used will be consistent with the
> recommendations of the American Veterinary Medical Association (AVMA)
> Panel on Euthanasia, unless a deviation is justified for scientific
> reasons in writing by the investigator.

The Committee will make one of the following recommendations:

1\. Approval

> 2\. Approval with modifications (to be specified in writing).
>
> 3\. Disapproval

c\. [IACUC Decisions and Actions]{.underline}

> 1\. Actions of the IACUC will be decided by a majority vote. Member(s)
> with a conflicting interest (i.e., personally involved in the project)
> will not participate in the review, vote, or contribute to
> constitution of the quorum.
>
> 2\. Minority views will be submitted in writing to the IACUC
> Chairperson. These reports will become a part of the permanent records
> associated with the Application.
>
> The IACUC may invite consultants to assist in the review of complex
> issues. Consultants may not approve or withhold approval of an
> application or proposal or vote with the IACUC.
>
> The IACUC will notify investigators and the appropriate Department
> Chairman/Division Head in writing of its decision to approve or
> withhold approval of those sections of applications or proposals
> related to the care and use of animals, or of modifications required
> to secure IACUC approval. If the IACUC decides to withhold approval of
> an application or proposal, it shall include in its written
> notification a statement of the reasons for its decision and give the
> investigator an opportunity to respond in person or in writing.

d\. [Review of Ongoing Activities]{.underline}

> The IACUC will review previously approved applications and proposals
> annually. The review procedures for the approval of changes in
> protocols previously approved by the IACUC will be the same as for new
> proposals. Principal Investigators may request interim review and
> approval for changes in an ongoing protocol. Interim approval will be
> granted, in appropriate circumstances, by the IACUC Chair, with
> concurrence by the Attending Veterinarian. Any change receiving
> interim approval will be approved by the full IACUC at the next
> scheduled meeting. Protocols are approved for a maximum of three
> years. Every three years, the investigators are required to submit a
> new application, to conform with an AAALAC suggestion that each
> protocol be fully reviewed on a tri-annual basis.
>
> The IACUC may suspend an activity that it previously approved if it
> determines that the activity is not being conducted in accordance with
> applicable provisions of the Animal Welfare Act, the
> [Guide]{.underline}, the institution\'s Assurance, or the requirements
> for approval listed under III, 4, b. The IACUC may suspend an activity
> only after review of the matter at a convened meeting of a quorum of
> the IACUC and with the suspension vote of a majority of the quorum
> present. Members with an invested interest cannot vote or contribute
> to the constitution of a quorum.
>
> If the IACUC suspends an activity, the cognizant Department
> Chairman/Division Head in consultation with the IACUC shall review the
> reasons for suspension, take appropriate corrective action and report
> that action with a full explanation to the Institutional Official and
> the Office for Protection from Research Risks (OPRR).
>
> F. The individuals authorized by this institution to verify IACUC
> approval of protocols related to the care and use of animals and
> prepare any reports to be submitted to regulatory authorities are the
> Chairperson of the IACUC, the Administrator of the Office of Research
> Administration Administrator and the Institutional Official.
>
> G. The health program for personnel who work in laboratory animal
> facilities or have frequent contact with animals is:
>
> The occupational health program for animal care personnel and others
> with substantial animal contact includes a pre‑employment physical
> examination with subsequent annual physical examinations by the
> Occupational Medicine Clinic.
>
> Medical care is available throughout the work week and weekends. Acute
> illness, work incurred injuries, including animal bites, etc., are
> immediately attended to by a physician or an EMT. Treatment, including
> tetanus immunizations may be given. If an employee is absent due to a
> health problem, the physician may require an additional examination
> before the employee is permitted to return to work. Detailed records
> of illnesses and work incurred injuries are on file in the
> Occupational Medicine Clinic.

Additional specific health programs include:

> 1\. Annual tuberculosis testing of all animal care personnel and
> others (investigators, technicians, etc.) working closely with
> primates.
>
> 2\. Radiation exposure is closely monitored by the Safety, Health
> Services Division as is the potential exposure to other toxic
> materials. Film badges are issued to all Brookhaven employees and
> collaborators who may be exposed to radiation.

H. The total gross number of square feet in each animal facility
(including each satellite facility), the species of animals housed
therein and the average daily inventory, by species, of animals in each
facility is provided in attached charts.

> I. Training and instruction for personnel involved in animal care,
> treatment or use:
>
> The Brookhaven Laboratory Animal Facility animal training program is
> provided for all staff who care for or use animals for research and
> testing in this institution. This two-part program has been developed
> to ensure training in the humane care and use of laboratory animals
> for personnel involved both directly and peripherally.
>
> Laboratory Animal Training 1 (LAT 1) is an introduction to federal,
> state and local laws which govern the use of animals in research and
> the consequences of non-compliance. All personnel are required to
> receive this training. The LAT 1 program format is as follows:
>
> 1\. Video tape: Purchased from LATA
>
> 2\. Hand-outs: Organizational charts, composition and functions of
> IACUC, institutional responsibilities, federal criteria for granting
> IACUC approval and alternative endpoints
>
> 3\. Discussion of hand-outs, institutional policies, compliance with
> federal, state and local laws, and governing agencies

4\. Open discussion, question/answer session.

> Laboratory Animal Training 2 (LAT 2) is a procedural training program
> which has been patterned after \"A Guide for Developing Institutional
> Programs\" ILAR), species-specific module. Only people who will be in
> direct contact with animals are required to participate in this
> training. The LAT 2 program format is as follows:
>
> 1\. Discussion: Hand-out of specific, approved Standard Operating
> Procedures
>
> 2\. Demonstration
>
> 3\. Participation
>
> 4\. Practice
>
> 5\. Performance
>
> 6\. Evaluation
>
> This specific, hands-on training is accomplished by identifying the
> individual\'s area of involvement, training for all procedures
> encompassed in that area, evaluation through demonstration of required
> skills and documentation of all procedural training.

IV\. Institutional Status

> As specified in the PHS Policy at IV.A.2 as Category 1, all of this
> institution\'s programs and facilities (including satellite
> facilities) for activities involving animals have been evaluated and
> accredited by the American Association for Accreditation of Laboratory
> Animal Care.

V. Record Keeping

A. This institution will maintain for at least three years:

> 1\. A copy of this assurance, and any modification thereto, as
> approved by PHS.
>
> 2\. Minutes of IACUC meetings, including records of attendance,
> activities of the Committee and Committee deliberations.
>
> 3\. Records of applications, proposals and proposed significant
> changes in the care and use of animals and whether IACUC approval was
> given or withheld.
>
> 4\. Records of semi-annual IACUC reports and recommendations as
> forwarded to the Institutional Official.
>
> 5\. Records of accrediting body determinations.
>
> B. This institution will maintain records that relate directly to
> applications, proposals, and proposed changes in ongoing activities
> reviewed and approved by the IACUC for the duration of the activity
> and for an additional three years after completion of the activity.
>
> C. All records shall be accessible for inspection and copying by
> authorized OPRR or other PHS representatives at reasonable times and
> in a reasonable manner.

VI\. Reporting Requirements

> A. At least once every 12 months, the IACUC through the Institutional
> Official, will report in writing to the Office for Protection from
> Research Risks (OPRR):
>
> 1\. Any change in the status of the institution (e.g., if the
> institution becomes accredited by AAALAC or AAALAC accreditation is
> revoked), any change in the description of the institution\'s program
> for animal care and use as described in this Assurance (e.g., changes
> in lines of authority or responsibility for administering the program,
> authority or responsibility of the veterinarian(s) and percentage of
> time devoted to the program by the veterinarian(s), IACUC procedures,
> occupational health program, training program, number and species of
> animals, and size of facilities where animals are housed) or any
> changes in IACUC membership. If there are no changes to report, this
> institution will submit a letter to OPRR stating that there are no
> changes.
>
> 2\. Notification of the dates that the IACUC conducted its semiannual
> evaluations of the institution\'s program and facilities (including
> satellite facilities) and submitted the evaluation to the
> Institutional Official**.**
>
> B. The IACUC, through the Institutional Official, will provide the
> OPRR promptly with a full explanation of the circumstances and actions
> taken with respect to:
>
> 1\. Any serious or continuing noncompliance with the PHS Policy.
>
> 2\. Any serious deviations from the provisions of the
> [Guide]{.underline}.
>
> 3\. Any suspension of an activity by the IACUC.
>
> C. Reports filed under (A) and (B) above shall include any minority
> views filed by members of the IACUC.

VII\. Institutional Endorsement and PHS approval

A. Authorized Institutional Official

Name: [J.H. Marburger]{.underline}

Title: [Laboratory Director]{.underline}

Address: [Brookhaven National Laboratory]{.underline}

[Bldg. 460]{.underline}

[PO Box 5000]{.underline}

[Upton, NY 11973-5000]{.underline}

Phone: [(516) 344-2772]{.underline}

FAX: [(516) 344-5308]{.underline}

E-Mail: [marburger@bnl.gov]{.underline}

Signature

Date:

B. PHS Approving Official

Name:

Title:

Address:

Phone:

Signature:

Date:

C. Effective Date of Assurance

D. Expiration Date of Assurance