Semiannual Program Review and Facility Inspection Checklist
About the checklist
The Semiannual Program Review and Facility Inspection Checklist is provided to assist institutions in
conducting their semiannual reviews of programs and facilities for the care and use of animals. The
Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), section
IV.B.1.-2., requires the Institutional Animal Care and Use Committee (IACUC) to review the institution's
program for humane care and use of animals and inspect all of the institution's animal facilities at least
once every 6 months using the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide)
as a basis for evaluation.

How to use the checklist
This checklist is a tool to assist IACUCs in conducting thorough semiannual reviews. IACUCs are notrequired to use this checklist but are encouraged to amend it as necessary to reflect institutional
programs and needs, or to develop their own checklist. If the checklist is modified, periodic review of thechecklist is recommended to ensure relevant topics are considered as the animal care and use programchanges.
The checklist covers the major topics of the Guide and the requirements of the PHS Policy. The checklist
does not replace the Guide, but should be utilized in conjunction with the Guide. The Guide provides thestandards, recommendations, and descriptions of desired outcomes necessary to evaluate and inspect ananimal care and use program. Relevant references for the Guide and the PHS Policy are noted. Endnotes
are included to reference specific U.S. Department of Agriculture (USDA) regulatory requirements thatdiffer from the PHS Policy. Topics that are new to this version of the checklist or identified as a “must” in
the Guide are highlighted. A column to identify changes that have occurred in the institution’s programfor animal care and use (PHS Policy IV.A.1.a.-i.) since the last review is also a new feature.
The checklist consists of the following sections:
I. Semiannual Program Review Checklist
 Institutional Policies and Responsibilities
 Veterinary CareII. Semiannual Facility Inspection Checklist
 Terrestrial Animal Housing and Support Areas Aquatic Animal Housing and Support Areas Cagewash
 Special Facilities: Aseptic Surgery
 Special Facilities: Procedure Areas, Non-survival Surgeries, Laboratories, Rodent Surgeries,
Imaging, Whole Body Irradiation, Hazardous Agent Containment, Behavioral Studies
III. Semiannual Program Review and Facility Inspection Report
IV. Endnotes
It is recommended that the Program Review section be completed during an IACUC meeting. Because
physical aspects of a program require visual observation to evaluate, it is recommended that the Facility
Inspection section be completed during an inspection of the facilities, including satellite facilities.
A table is provided, “Semiannual Program Review and Facility Inspection Report,” as a format for the IACUC
to organize and track information regarding deficiencies, and plans and schedules for correction. IACUCs may
choose to attach the table to the Semiannual Report to the Institutional Official.

Questions or comments?
Suggestions or comments about this checklist should be e-mailed to: olawdpe@mail.nih.gov.
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I. Semiannual Program Review Checklist i
Institutional Policies and Responsibilities
Date:
1. Animal Care and Use Program
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C NA

A* M

S

C NA

A* M

S

C NA

Disaster plans for each facility to include satellite locations are in place (Guide, p 35, p
75) [must]
施設の危機管理計画が準備されている。
Plans include provisions for euthanasia (Guide, p 35) [must]
危機管理計画には安楽死処置に関する記載が含まれている。
Plans include triage plans to meet institutional and investigators’ needs (Guide, p 35)
危機管理計画には機関の要望にあった動物のトリアージ計画が含まれている。
Plans define actions to prevent animal injury or death due to HVAC or other failures(Guide, p 35)
危機管理計画には換気、冷房、暖房、飲水供給などの制御にかかわるシステムの障害に起因する
動物の苦痛または死亡を回避するための行動が明示されている。
Plans describe preservation of critical or irreplaceable animals (Guide, p 35)
危機管理計画には重要性が高いまたは代わりの利かない動物の保護について記載されている。
Plans include essential personnel and their training (Guide, p 35)
危機管理計画書には緊急対応者の特定とその訓練に関する記載が含まれている。
Animal facility plans are approved by the institution and incorporated into overall
response plan (Guide, p 35)
危機管理計画書は機関によって承認を受け、機関全体の災害対応策に組み込まれている。
Law enforcement and emergency personnel are provided a copy and integration withoverall plan is in place (Guide, p 35)
法執行機関や救急隊員に機関全体の災害対応策のコピーが提供されている。

3. IACUC
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Responsibility for animal well-being is assumed by all members of the program (Guide,p 1) [must]
活動計画に関与するすべての者は、動物のウェルビーイングに対して責任を負っている。
IO has authority to allocate needed resources (Guide, p 13)
運営責任者は必要な資源の配分に関する権限を有している。
Resources necessary to manage program of veterinary care are provided (Guide, p 14)[must]
獣医学的ケア計画を運用するための資源が与えられている。
Sufficient resources are available to manage the program, including training of
personnel in accord with regulations and the Guide (Guide, pp 11, 15)
法令や Guide を遵守した、職員教育を含む活動計画を遂行するための十分な資源が提供されている。
Program needs are regularly communicated to IO by AV and/or IACUC (Guide, p 13)
活動計画において生じた要求は選任獣医師または動物実験委員会から定期的に運営責任者に伝達されている。
Responsibilities for daily animal care and facility management are assigned to specificindividual(s) when a full-time veterinarian is not available on site (Guide, p 14) [must]
常勤獣医師がいない場合、日々の動物の管理及び施設管理に関する責任者を決めている。
Inter-institutional collaborations are described in formal written agreements (Guide, p15)
共同研究は、公式な同意文書を交わして行っている。
Written agreements address responsibilities, animal ownership, and IACUC oversight(Guide, p 15)
同意文書には動物の所有権、動物実験委員会による審査・監督に関する責任体制について記述されている。

2. Disaster Planning and Emergency PreparednessA* M

Meets as necessary to fulfill responsibilities (Guide, p 25) [must]

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動物実験委員会はその責任を全うするために必要な頻度で開催している。
IACUC Members named in protocols or with conflicts recuse themselves from protocol
decisions (Guide, p 26) [must]
実験従事者として動物実験計画書に記載されている委員、もしくはその他の利害関係が絡む立場にある委員は当該実験計画の審査判定に加わっていない。
Continuing IACUC oversight after initial protocol approval is in place (Guide, p 33)
動物実験委員会は最初の実験計画を承認した後にモニタリングを実施している。
IACUC evaluates the effectiveness of training programs (Guide, p 15)
動物実験委員会は教育プログラムの妥当性を評価している。

4. IACUC Protocol Review - Special Considerations
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Humane endpoints are established for studies that involve tumor models, infectious
diseases, vaccine challenge, pain modeling, trauma, production of monoclonal
antibodies, assessment of toxicologic effects, organ or system failure, and models of
cardiovascular shock (Guide, p 27)
腫瘍モデル、感染症、ワクチンの効果試験、疼痛モデル、外傷、モノクローナル抗体の作製、毒性評価、臓器あるいは器官系の不全、循環器系ショックのモデルなどに関わる動物実験は特別な人道的エンドポイントが検討されている。
For pilot studies, a system to communicate with the IACUC is in place (Guide, p 28)
パイロット実験の場合、動物実験委員会との意見交換が行われるシステムがある。
For genetically modified animals, enhanced monitoring and reporting is in place(Guide, p 28)
遺伝子改変動物では、より頻繁な動物の観察が行われている。
Restraint devices are justified in the animal use protocols (Guide, p 29) [must]
拘束器具の使用については動物実験計画書に正当な理由を示している。
Alternatives to physical restraint are considered (Guide, p 29)
身体拘束に代わる方法を検討している。
Period of restraint is the minimum to meet scientific objectives (Guide, p 29)
拘束期間は、研究目的を果たすのに必要な最短時間としている。
Training of animals to adapt to restraint is provided (Guide, p 29)
拘束器具を使用する動物に対しては、訓練を実施している。
Animals that fail to adapt are removed from study (Guide, p 29)
拘束に順応しない動物は当該研究から除外している。
Appropriate observation intervals of restrained animals are provided (Guide, p 29)
拘束された動物は適切な頻度で観察している。
Veterinary care is provided if lesions or illness result from restraint (Guide, p 30)[must]
拘束に伴い外傷や体調不良が生じた動物には獣医学的ケアを施している。
Explanations of purpose and duration of restraint are provided to study personnel(Guide, p 30)
拘束の目的と期間について当該研究の従事者に明確に説明している。
Multiple surgical procedures on a single animal are justified and outcomes evaluated(Guide, p 30)
同じ個体に繰り返し外科的処置を加える場合は、当該動物のウェルビーイングに対する影響を判断している。
Major versus minor surgical procedures are evaluated on a case-by-case basis (Guide,
p 30)
処置が大規模か軽微かの判断はケースバイケースで評価している。
Multiple survival procedure justifications in non-regulated species conform to regulated
species standards (Guide, p 30)
規制対象外動物に複数回の繰り返し外科的処置を加える場合は規制動物種で求められる要件に準じて判断している。
Animals on food/fluid restriction are monitored to ensure nutritional needs are met(Guide, p 31)
給餌・給水制限を実施する動物は必要な栄養分に見合った量を摂取できていることを確認している。
Body weights for food/fluid restricted animals are recorded at least weekly (Guide, p31)

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給餌・給水制限を実施する動物の体重は少なくとも毎週測定している。
Daily written records are maintained for food/fluid restricted animals (Guide, p 31)
給餌・給水制限を実施する動物の毎日の記録は保管している。
Pharmaceutical grade chemicals are used , when available, for animal-related
procedures (Guide, p 31)
動物に対する実験処置については入手可能な場合には医薬品グレードの化合物類を使用している。
Non-pharmaceutical grade chemicals are described, justified, and approved by IACUC(Guide, p 31)
非医薬品グレードの化合物類を使用する場合にはその根拠を動物実験計画書に記載し、動物実験委員会が承認している。
Investigators conducting field studies know zoonotic diseases, safety issues, laws andregulations applicable in study area (Guide, p 32)
野外研究を行う動物実験責任者は、問題となる人獣共通感染症、関連する安全上の問題、適用される法律や規則について十分な知識を有している。
Disposition plans are considered for species removed from the wild (Guide, p 32)
野生動物を飼育する場合には、生息地に戻す計画が考慮されている。
Toe-clipping only used when no alternative, performed aseptically and with pain relief(Guide, p 75)
Toe-clipping 法は他の方法がない場合に限り無菌状態で痛みを和らげる方法で行っている。

5. IACUC Membership and Functions
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IACUC is comprised of at least 5 members, appointed by CEO (PHS Policy, IV.A.3.)
動物実験委員会は少なくとも5人の委員で構成されCEOによって指名されている。
Members include a veterinarian, a scientist, a nonscientist, and a nonaffiliated non-lab
animal user (Guide, p 24)ii
委員には獣医師、科学者、非科学者及び動物実験に関与しない者が含まれている。
IACUC authority and resources for oversight and evaluation of institution's program
are provided (Guide, p 14)
動物実験委員会は機関の活動計画を監視し評価するための権限と資源が付与されている。
IACUC conducts semiannual evaluations of institutional animal care and use program(PHS Policy, IV.B.)
動物実験委員会は機関の動物使用に関する活動計画を半年に一度評価している。
Conducts semiannual inspections of institutional animal facilities (PHS Policy, IV.B.)
動物実験委員会は動物実験施設の査察を半年に一度実施している。
IACUC organizationally reports to the Institutional Official (PHS Policy, IV.A.1.b.)
動物実験委員会の活動は運営責任者に報告されている。
Methods for reporting and investigating animal welfare concerns are in place (Guide, p23) [must]
動物福祉にかかわる問題を報告し、調査する方法がある。
Reviews and investigates concerns about animal care and use at institution iii (PHS
Policy, IV.B.)
機関の動物使用に関する問題を審査し、調査している。
Procedures are in place for review, approval, and suspension of animal activitiesiv(PHS Policy, IV.B.)
動物に関する活動を審査、承認、停止する方法がある。
Procedures are in place for review and approval of significant changes to approved
activities (PHS Policy, IV.B.)
承認された活動の変更を審査、承認する方法がある。
Policies are in place for special procedures (e.g., genetically modified animals,
restraint, multiple survival surgery, food and fluid regulation, field investigations,agricultural animals) (Guide, p 27-32)
特別な手順（遺伝子改変動物、拘束、複数回にわたる外科処置、給餌・給水制限、野外調査、家畜など）に対するポリシーが設定されている。
Requests for exemptions from major surgical procedure restrictions are made to
USDA/APHISv (Guide, p 30) [must]
大規模外科手術の適用から外れる場合にはUSDA/APHISに申請している。

6. IACUC Training
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All IACUC members should receive:すべての動物実験委員会の委員が受けるべきものは、
o Formal orientation to institution’s program (Guide, p 17)
o 機関の活動計画を理解するためのオリエンテーション
o Training on legislation, regulations, guidelines, and policies (Guide, p 17)
o 関連する法律・規則・指針。規範の教育
o Training on how to inspect facilities and labs where animal use or housing occurs(Guide, p 17)
o 動物使用場所となる動物施設及び実験室の査察方法の教育
o Training on how to review protocols as well as evaluate the program (Guide, p 17)o
動物実験計画書と活動計画の審査手順の教育
o Ongoing training/education (Guide, p 17)
o 継続的な訓練と教育

7. IACUC Records and Reporting Requirementsvi
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S

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S

C NA

Semiannual report to the IO (PHS Policy, IV.B.)運営責任者への半年に一度の報告書は、
o Submitted to IO every 6 months
o 半年に一度提出している。
o Compiles program review and facility inspection(s) results (includes all programand facility deficiencies)o 活動計画の審査と施設査察の結果（活動計画と施設の不備事項）を含んでいる。
o Includes minority IACUC viewso 動物実験委員会の少数意見も含んでいる。
o Describes IACUC-approved departures from the Guide or PHS Policy and thereasons for each departurevii
o 動物実験委員会が承認した Guide または PHS Policy からの逸脱事項とその逸脱の理由が記載されている。
o Distinguishes significant from minor deficiencies
o 重大な不備と軽微な不備に区別されている。
o Includes a plan and schedule for correction for each deficiency identified viii
o それぞれの記載された不備について改善するための計画と予定が含まれている。
Reports to OLAW (PHS Policy, IV.F.)
o Annual report to OLAW documents program changes, dates of the semiannual
program reviews and facility inspections and includes any minority viewso Promptly advises OLAW of serious/ongoing Guide deviations or PHS Policy
noncompliance (NOT-OD-05-034)
o Institute must promptly advise OLAW of any suspension of an animal activity by
the IACUC (NOT-OD-05-034)
Reports to U.S. Department of Agriculture (USDA) or Federal funding agencyix
o Annual report to USDA contains required information including all
exceptions/exemptions
o Reporting mechanism to USDA is in place for IACUC-approved exceptions to theregulations and standards
o Reports are filed within 15 days for failures to adhere to timetable for correction ofsignificant deficiencies
o Promptly reports suspensions of activities by the IACUC to USDA and any Federal
funding agency
Records (PHS Policy, IV.E.)
o IACUC meeting minutes and semiannual reports to the IO are maintained for 3
years
o 動物実験委員会の議事録と半年に一度の運営責任者への報告は 3 年間保管されている。
o Records of IACUC reviews of animal activities include all required informationx
o 活動計画に対する動物実験委員会の審査記録はすべての必要な情報が含まれている。
o Records of IACUC reviews are maintained for 3 years after the completion of thestudy
o 動物実験委員会の審査の記録は試験終了後 3 年間保管されている。

8. Veterinary Care (See also next section - Veterinary Care)

A* M

An arrangement for veterinarian(s) with training or experience in lab animal medicine
is in place including backup veterinary carexi

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トレーニングされた、または実験動物医療経験のある獣医師に関して、獣医学的ケアのバックア
ップを含む取り決めが適切にされている。
Veterinary access to all animals is provided (Guide, p 14) [must]
すべての動物への獣医学的アクセスができる。
Direct or delegated authority is given to the veterinarian to oversee all aspects ofanimal care and use (Guide, p 14) [must]
動物のケアと使用について全ての面を監督するために、直接的または委任された権限が獣医師に与えられている。
Veterinarian provides consultation when pain and distress exceeds anticipated level inprotocol (Guide, p 5) [must]
プロトコールで痛みと苦痛が予想されたレベルを超えた場合、獣医師は助言を与える。
Veterinarian provides consultation when interventional control is not possible (Guide, p5) [must]
調停がコントロールできない場合、獣医師は助言を与える。
If part time /consulting veterinarian, visits meet programmatic needs (Guide, p 14)
パートタイム/コンサルタント獣医師の場合、活動計画上の必要性に応じて出勤しているか。
Regular communication occurs between veterinarian and IACUC (Guide, p 14)
獣医師とIACUC間に定期的なコミュニケーションは行われているか。
Veterinarian(s) have experience and training in species used (Guide, p 15) [must]
獣医師は使用している動物種についてトレーニングまたは経験があるか。
Veterinarian(s) have experience in facility administration/management (Guide, p 15)
獣医師は施設運営/管理に経験があるか。

9. Personnel Qualifications and Training
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All personnel are adequately educated, trained, and/or qualified in basic principles oflaboratory animal science. Personnel included: [must]
全職員は高水準の科学と動物福祉を担保するために適切な教育や訓練を受けたもの、及び/または
実験動物学の基本原理についての有資格者である。
o Veterinary/other professional staff (Guide, p 15-16)獣医師/その他の専門職員
o IACUC members (Guide, p 17)動物実験委員会の委員
o Animal care personnel (Guide, p 16) 動物飼育担当者
o Research investigators, instructors, technicians, trainees, and students (Guide, pp
16-17)研究者、指導者、技術者、研修生、学生
Continuing education for program and research staff provided to ensure high quality
care and reinforce training (Guide, pp 16-17)
高水準の動物管理を行うため、さらに訓練を補強するために職員への継続教育が行われている。
Training is available prior to starting animal activity (Guide, p 17)
訓練は動物実験の開始前に行われている。
Training is documented (Guide, p 15)
訓練は記録されている。
Training program content includes: (Guide, p 17) 訓練プログラムに含まれているのは、o Methods for reporting concerns (Guide, p 17)
o 問題を報告する方法
o Humane practices of animal care (e.g., housing, husbandry, handling) xii
o 人道的な動物の取り扱い
o Humane practices of animal use (e.g., research procedures, use of anesthesia,
pre- and post-operative care, aseptic surgical techniques and euthanasia (Guide, p17)xiiio 人道的な動物使用（実験手技、麻酔薬の使用、術前・術後処置、無菌操作、安楽死処置など）
o Research/testing methods that minimize numbers necessary to obtain valid results(PHS Policy, IV.A.1.g.)
o 使用動物数を科学的に有意な結果を得るための必要最小限に抑えるための方法
o Research/testing methods that minimize animal pain or distress (PHS Policy,
IV.A.1.g.)o 動物の痛みと苦痛を最小限に抑えるための方法
o Use of hazardous agents, including access to OSHA chemical hazard notices whereapplicable (Guide, p 20)
o 危険物質の使用

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10.
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Animal care and use legislation (Guide, p 17)
動物の管理と使用に関する法律
IACUC function (Guide, p 17)
動物実験委員会の機能
Ethics of animal use and Three R’s (Guide, p 17)
動物使用の倫理と 3R の基本概念

Occupational Health and Safety of Personnel

A* M

S

C NA

Program is in place and is consistent with federal, state, and local regulations (Guide,p 17) [must]
連邦、州及び地域の法令に準拠した労働安全衛生計画が作られている。
Program covers all personnel who work in laboratory animal facilities (Guide, p 18)
労働安全衛生計画は動物実験施設で働くすべての職員をカバーしている。
Changing, washing, and showering facilities are available as appropriate (Guide, p 19)
更衣、洗浄、シャワー設備が適切に備えられている。
Hazardous facilities are separated from other areas and identified as limited access(Guide, p 19)
危険因子を取り扱う施設は他の場所から隔離し、出入りに制限を設けている。
Personnel training is provided based on risk (e.g., zoonoses, hazards, personal
hygiene, special precautions, animal allergies) (Guide, p 20)
リスクに応じた個人教育が行われている。（人獣共通感染症、危険要因、衛生管理、特別な注意事項、動物アレルギーなど）
Personal hygiene procedures are in place (e.g., work clothing, eating/drinking/smoking
policies) (Guide, p 20)
個人の衛生管理手順が整っている、（作業着、飲食場所、喫煙場所）
Procedures for use, storage, and disposal of hazardous biologic, chemical, and physicalagents are in place (Guide, p 21)
生物学的・科学的・物理学的危険因子の使用、保管、廃棄の手順が整っている。
Personal Protective Equipment for the work area is appropriate and available (Guide, p21)
個人防護器具が適切に供えられ使用可能である。
Program for medical evaluation and preventive medicine for personnel includes:職員の健康診断と疾病予防のプ
ログラムに含まれているのは、o Pre-employment evaluation including health history (Guide, p 22)
o 既往歴を含む雇用前の健康診断
o Immunizations as appropriate (e.g., rabies, tetanus) and tests as appropriate(Guide, p 22)
o 適切な予防接種（狂犬病、破傷風など）と適切なスクリーニング検査
o Zoonosis surveillance as appropriate (e.g., Q-fever, tularemia, Hantavirus, plague)(Guide, p 23)
o 適切な人獣共通感染症の監視（Q 熱、ツラレミア、ハンタウイルス、ペストなど）
o Procedures for reporting and treating injuries, including accidents, bites, allergies,
etc. (Guide, p 23)
o 事故、咬傷、アレルギーなどを含む傷病を報告し、治療する手順
o Promotes early diagnosis of allergies including preexisting conditions (Guide, p 22)
o アレルギー症状の早期発見
o Considers confidentiality and other legal factors as required by federal, state andlocal regulations (Guide, p 22) [must]o 連邦、州、地域の関連法令を勘案し、守秘およびその他の要因を考慮している。
o If serum samples are collected, the purpose is consistent with federal and statelaws (Guide, p 22) [must]o 血清サンプルを保存しているのであれば、その用途が連邦及び州の関連法規に抵触していない。
Waste anesthetic gases are scavenged (Guide, p 21)
余剰廃棄される麻酔ガスは吸着除去している。
Hearing protection is provided in high noise areas (Guide, p 22)
騒音の激しい区域では聴覚保護具を提供している。
Respiratory protection is available when performing airborne particulate work (Guide,

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p 22)
空気中に汚染微粒子の混入する区域では呼吸器保護具を提供している。
Special precautions for personnel who work with nonhuman primates, their tissues orbody fluids include: サル類またはその組織や体液に接触する機会がある者の注意点は、
o Tuberculosis screening provided for all exposed personnel (Guide, p 23)
o 結核検査を実施している。
o Training and implementation of procedures for bites, scratches, or injuries
associated with macaques (Guide, p 23)
o 咬傷・掻傷時またはマカク属のサルと関連した傷病時の手順の教育と実行。
o PPE is provided including gloves, arm protection, face masks, face shields, orgoggles (Guide, p 21)
o 手袋、腕カバー、フェースマスク、フェースシールドまたはゴーグルを含む個人防護器具が提供されている。
o Injuries associated with macaques are carefully evaluated and treatment
implemented (Guide, p 23)
o マカク属のサルに関連した傷病は慎重に判断し、適切な処置を実行している。
Occupational safety and health of field studies is reviewed by OSH committee or office(Guide, p 32)
野外実験の労働安全衛生は労働安全衛生委員会または担当部署で審査されている。

Personnel Security

A* M

S

C NA

A* M

S

C NA

Preventive measures in place include pre-employment screening, and physical and IT
security (Guide, p 23)
採用時の身元調査、及び警備体制の整備や情報通信技術のセキュリティ対策が行われている。

Investigating & Reporting Animal Welfare Concerns
Methods for investigating and reporting animal welfare concerns are established(Guide, p 23) [must]
動物福祉に関する問題を調査し報告する方法が確立している。
Reported concerns and corrective actions are documented (Guide, p 24)
報告された問題と改善点は記録されている。
Mechanisms for reporting concerns are posted in facility and at applicable website with
instructions (Guide, p 24)
問題を報告する方法に関する説明は施設内とウェブサイトに掲示されている。
o Includes multiple contacts (Guide, p 24)
o 複数の提出先を含んでいる。
o Includes anonymity, whistle blower policy, nondiscrimination and reprisal
protection (Guide, p 24)
o 匿名性を確保する仕組み、告発者保護に関する規範の遵守、報告した側とされた側を差別待遇
しないこと、報復からの保護などに配慮しているo* A = acceptable
M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable

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Veterinary Care
Date:
1. Clinical Care and Management
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2. Animal Procurement and Transportation/Preventive Medicine
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A* M

S

C NA

A* M

S

C NA

Veterinary program offers high quality of care and ethical standards (Guide, p 105)
[must]
獣医学的プログラムは高品質のケアと倫理基準を提供する。
Veterinarian provides guidance to all personnel to ensure appropriate husbandry,
handling, treatment, anesthesia, analgesia, and euthanasia (Guide, p 106)
獣医師は、各人が適切な飼養、取扱、麻酔、鎮痛および安楽死を確実にできるような指導を行う。
Veterinarian provides oversight to surgery and perioperative care (Guide, p 106)
獣医師は外科手術と周術期ケアについて監督する。
Veterinary care program is appropriate for program requirements (Guide, pp 113-114)
獣医学的ケアプログラムは活動計画の要求事項に適応している。
Veterinarian(s) is familiar with species and use of animals and has access to medical
and experimental treatment records (Guide, p 114)
獣医師は動物種や動物の使用に精通しており、医学的または実験上の処置記録にアクセスできる。
Procedures to triage and prioritize incident reports are in place (Guide, p 114)
トリアージ分類と報告の優先順位づけを行う手順がある。
Procedures are in place to address:
問題を処理する手順がある。
o Problems with experiments to determine course of treatment in consultation withinvestigator(Guide, p 114)
o 実験の問題について、研究者と相談して処置のコースを決定する
o Recurrent or significant health problems with the IACUC and documentation oftreatments and outcomes (Guide, p 114)
o IACUC についての再発または重大な健康上の問題および処置と結果の文書
o Veterinary review and oversight of medical and animal use records (Guide, p 115)o 医学的記録および動物使用記録の獣医学的な調査と監督
Procedures established for timely reporting of animal injury, illness, or disease (Guide,
p 114) [must]
動物の傷害、病気や疾病をタイムリーに報告するための手順が確立している。
Procedures established for veterinary assessment, treatment, or euthanasia (Guide, p114) [must]
獣医学的な判断、処置または安楽死の手順が確立している。
Veterinarian is authorized to treat, relieve pain, and/or euthanize (Guide, p 114)
[must]
獣医師は処置、痛みの軽減および/または安楽死の権限を与えられている。
Procedures for lawful animal procurement are in place (Guide, p 106) [must]
合法的な動物入手のための手順がある。
Sufficient facilities and expertise are confirmed prior to procurement (Guide, p 106)
入手前に十分な施設と専門的技術が確認されている。
Procurement is linked to IACUC review and approval (Guide, p 106)
入手は IACUC の調査と承認にリンクしている。
Random source dogs and cats are inspected for identification (Guide, p 106)
ランダムな源（実験動物業者ではなく保護施設などを指すと思われる）からのイヌとネコは個体識別の有無を調べる。（所有権の確認の意味で行うらしい）
Population status of wildlife species is considered prior to procurement (Guide, p 106)
入手前に野生種の生息数動態について考慮する。
Appropriate records are maintained on animal acquisition (Guide, p 106)
動物の入手について適切な記録が維持されている。
Animal vendors are evaluated to meet program needs and quality (Guide, p 106)
動物の供給業者について、活動計画の必要性に対応しているかと品質を評価する。

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Breeding colonies are based on need and managed to minimize numbers (Guide, p
107)
繁殖コロニーは必要性に基づいており、最少数で運営されているか。
Procedures for compliance with animal transportation regulations, includinginternational requirements, are in place (Guide, p 107) [must]
国際的要求事項を含む動物輸送の規定の遵守手順がある。
Transportation is planned to ensure safety, security and minimize risk (Guide, p 107)
輸送は、安全と保安を確実にし、リスクを最小化するように計画される。
Movement of animals is planned to minimize transit time and deliveries are planned toensure receiving personnel are available (Guide, pp 107- 108)
動物の移動は乗り換え時間を最小化するように計画され、配達は受け取り担当者が対応できることを確認して計画される。
Appropriate loading and unloading facilities are available (Guide, p 109)
適切な搬出および搬入施設が利用できる。
Environment at receiving site is appropriate (Guide, p 109)
搬入場所の環境は適切である。
Policies in place on separation by species, source, and health status (Guide, pp 109,111-112)
動物種、供給源や健康状態での分離に関する方針がある。
Procedures in place for quarantine to include zoonoses prevention (Guide, p 110)
人畜共通伝染病の予防を含む検疫手順がある。
Quarantined animals from different shipments are handled separately or physicallyseparated (Guide, p 110)
異なる出荷からの（別ロットの？）検疫動物は別々に取り扱う、または物理的に分けられる。
Procedures in place for stabilization/acclimation (Guide, pp 110-111)
安定化/馴化のための手順がある。
Policies in place for isolation of sick animals (Guide, p 112)
病気の動物の隔離についての方針がある。
Program is in place for surveillance, diagnosis, treatment and control of disease toinclude daily observation (Guide, p 112)
毎日の観察を含む、病気に関する監視、診断、処置、管理のプログラムがある。
Diagnostic resources are available for preventive health program (Guide, p 112)
予防的な健康プログラムとして診断のための資源を利用できる。

3. Surgery
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A* M

S

C NA

Surgical outcomes are assessed and corrective changes instituted (Guide, p 115)
外科的な結果は評価され、修正が加えられる。
Researchers have appropriate training to ensure good technique (Guide, p 115)
[must]
研究者は優れた技術のために適切なトレーニングを受ける。
Pre-surgical plans are developed and include veterinary input (e.g., location, supplies,
anesthetic and analgesic use, peri-operative care, recordkeeping) (Guide, p 116)
術前の計画を作成し、獣医学的インプット（例えば、場所、器具・器材の供給、麻酔・鎮痛薬の使用、周術期ケア、記録）を含む。
Aseptic surgery is conducted in dedicated facilities or spaces, unless exception justified
and IACUC approved (Guide, p 116)
無菌手術は、正当な例外であることを IACUC が認めない限りは、専用の施設またはスペースで行われる。
Surgical procedures including laparoscopic procedures are categorized as major orminor (Guide, pp 117-118)
腹腔鏡の手順を含む外科的手順は大規模か小規模に分類される。
For nonsurvival surgery, the site is clipped, gloves are worn and instruments and area
are clean (Guide, p 118)
非生存手術では、手術部位はクリップでとめ、手袋を着用し、器具とエリアは清潔に保たれている。
Aseptic technique is followed for survival surgical procedures (Guide, pp 118-119)
滅菌技術は生存手術の手順より先に行われる。
Effective procedures for sterilizing instruments and monitoring expiration dates onsterile packs are in place (Guide, p 119)

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器具の滅菌と滅菌パックの有効期限の監視についての有効な手順がある。
Procedures for monitoring surgical anesthesia and analgesia are in place (Guide, p119)
外科手術の麻酔と鎮痛の監視手順がある。
For aquatic species, skin surfaces are kept moist during surgical procedures (Guide, p119)
水生動物について、外科手術の間、皮膚表面の湿気が保たれている。
Post-operative monitoring and care are provided by trained personnel and documented(e.g., thermoregulation, physiologic function, analgesia, infection, removal of skinclosures) (Guide, pp 119-120)
術後のモニタリングとケアはトレーニングされた担当者によって行われ、記録される（例えば、体温調節、生理機能、鎮痛、感染、抜糸）

4. Pain, Distress, Anesthesia and Analgesia
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C NA

A* M

S

C NA

A* M

S

C NA

Methods are consistent with AVMA Guidelines on Euthanasia unless approved by the
IACUC (Guide, p 123)
IACUC が認める場合を除いて、安楽死についての方法は AVMA ガイドラインに従う。
Standardized methods are developed and approved by the veterinarian and IACUC
that avoid distress and consider animal age and species (Guide, pp 123-124)
苦痛を避け、動物の年齢と種を考慮した標準的な方法が開発され、獣医師と IACUC に承認されている。
Training is provided on appropriate methods for each species and considers
psychological stress to personnel (Guide, p 124)
それぞれの種に適切な方法のトレーニングが行われ、担当者の精神的ストレスを考慮している。
Procedures and training are in place to ensure death is confirmed (Guide, p 124)
[must]
死を確認する手順とトレーニングが行われている。

6. Drug Storage and Control
S

Guidelines for assessment and categorization of pain, distress and animal wellbeing
are provided during training (Guide, p 121)
痛み、苦痛と動物福祉の評価と分類の基準がトレーニングされる。
Selection of analgesics and anesthetics is based on professional veterinary judgment(Guide, p 121)
鎮痛と麻酔の選択は専門の獣医師の判断に基づく。
Painful procedures are monitored to ensure appropriate analgesic management(Guide, p 122)
苦痛の大きい手順は監視され、適切な鎮痛管理が行われる。
Nonpharmacologic control of pain is considered as an element of postprocedural care
(Guide, p 122)
非薬理学的な（薬物以外の？）痛みのコントロールが処置後のケアの要素として考えられている。
Procedures are in place to assure antinoception before surgery begins (Guide, p 122)
[must]
手術開始前の鎮痛を確認する手順がある。
Guidelines for selection and use of analgesics and anesthetics are in place andregularly reviewed and updated (Guide, p 122)
鎮痛薬と麻酔薬の選択と使用のガイドラインがあり、定期的に確認され更新されている。
Special precautions for the use of paralytics are in place to ensure anesthesiaxiv(Guide, p 123)
麻痺性薬物（神経筋遮断薬を示す？）の使用についての特別な注意があり、麻酔が確実に行われる。

5. Euthanasia
A* M

Program complies with federal regulations for human and veterinary drugs(Guide, p115) [must]
プログラムは、医薬品と動物用医薬品についての連邦規則に従う。
Drug records and storage procedures are reviewed during facility inspections (Guide, p
115)

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薬品の記録と保管手順は施設監査時にチェックされる。
Procedures are in place to ensure analgesics and anesthetics are used within
expiration date (Guide, p 122) [must]
鎮痛薬や麻酔薬が使用期限内に使用されることを確実にする手順がある。
Anesthetics and analgesics are acquired, stored, and their use and disposal arerecorded legally and safely (Guide, p 122)
鎮痛薬や麻酔薬の入手、保管、その使用および廃棄に関する記録は、法に従って安全に行われている。

* A = acceptable
M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable

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II. Semiannual Facility Inspection Checklist
Terrestrial Animal Housing and Support Areas
Date:
Location:
A* M
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S

C NA

Location:o animal areas separate from personnel areas (Guide, p 134)o 私的区域から動物区域
o separation of species (Guide, p 111)
o 種の区分
o separation by disease status (Guide, p 111)
o 疾病状態の区分
o security and access control (Guide, p 151)
o 警備と出入管理
Construction:o corridors (Guide, p 136)o 通路o animal room doors (Guide, p 137)
o 動物室のドアー
o exterior windows (Guide, p 137)o 外窓
o floors (Guide, p 137)o 床o drainage (Guide, p 138)o 排水路
o walls and ceilings (Guide, p 138)o 壁と天井o heating ventilation and air conditioning (Guide, p 139)o 暖房、換気及び空調
o power and lighting (Guide, p 141)
o 電力及び電光o noise control (Guide, p 142)o 防音o vibration control (Guide, p 142)o 防振o environmental monitoring (Guide, p 143)o 環境記録Room/Cage:o temperature and humidity (Guide, p 43)
o 温湿度
o ventilation and air quality (Guide, p 45)
o 換気と大気環境
o illumination (Guide, p 47)
o 照明
o noise and vibration (Guide, p 49)
o 音と振動Primary Enclosure:o space meets physiologic, behavioral xv, and socialxvi needs (Guide, pp 51, 55-63)
o 生理的、行動的、社会的要求に合ったスペースo secure environment provided (Guide, p 51)
o 安全な環境提供
o durable, nontoxic materials in good repair and no risk of injury (Guide, p 51)
o 修理しやすく，損傷のリスクもなく耐久性があり、無毒の材質

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flooring is safe and appropriate for species (Guide, p 51)
床が種にとって安全で、適している
adequate bedding and structures for resting, sleeping, breeding (Guide, p 52)
安静、睡眠、飼育にととって適した床構造
objective assessments of housing and management are made (Guide, p 52)
居住の管理に客観的評価が実施されている
procedures for routine husbandry are documented (Guide, p 52)
日常的な飼育の方法が文章化されている
socially housed animals can escape or hide to avoid aggression (Guide, p 55)
複数で飼育された動物が攻撃から隠れたり、避けることができる
cage height provides adequate clearance (Guide, p 56)
ケージの高さは適した空間距離を保っている
animals express natural postures, can turn around, access food and water, andrest away from urine and feces (Guide, p 56) [must]o 動物は自然体を示し、振り返ることもでき、エサや水の摂取もでき、糞尿からも離れて休息できる
o rationalexvii for Guide/USDA space exceptions approved by IACUC and based on
performance indices (Guide, p 56)
o Guide/USDA スペース例外の根拠は IACUC により承認されており、かつ行動指標に基づいている
o dogs and cats allowed to exercise and provided human interaction (Guide, p 58)
o イヌやネコは運動もでき、人との接触もできる
o nonhuman primates are socially housed except for scientific, veterinary or
behavior reasons (Guide, pp 58-59)
o 非ヒト霊長類は科学的、獣医的、行動上の理由以外は複数で飼育されている
o single housing of nonhuman primates is for shortest duration possible (Guide, p60)非ヒト霊長類は最短期間での個別飼育は可能である
o opportunities for release into larger enclosures is considered for single caged
nonhuman primates (Guide, p 60)
o より大きな檻に入れられるような場合、単一飼いされた非ヒト霊長類においては考慮すべきである
o agricultural animals are housed socially (Guide, p 60)
o 農畜動物は複数で飼育する
o food troughs and water devices for agricultural animals allow access for all animals(Guide, p 60)農畜動物エサ桶や給水はすべての動物にアクセスできる
Environmental Enrichment, Behavioral and Social Management:o structures and resources promote species typical behavior (Guide, pp 52-54)
o 態勢と人員は種の典型的な行動を促進する
o novelty of enrichment is considered (Guide, p 53)
o 新規性の充実を考慮すべきである
o species specific plans for housing including enrichment, behavior and activity aredeveloped and reviewed regularly by IACUC, researchers and veterinarian (Guide,
pp 53, 58, 60, 63)
o 新規なもの、行動、活動性を含んだ種特有の計画を展開し、かつ IACUC、研究者、獣医師により定期的にレビューされること
o animal care personnel receive training to identify abnormal animal behaviors(Guide, p 53)
o 動物のケアーとして異常動物の行動が同定できるよう職員には教育する
o stability of pairs or groups is monitored for incompatibility (Guide, p 64)
o ペアーやグループ間で仲良く維持するため、不仲が生じないようモニターする
o single housing is justified for social species (Guide, p 64)
o 個別飼いは種により判断する
o single housing is limited to the minimum period necessary (Guide, p 64)
o 個別飼いは最小限の期間に限る必要がある
o additional enrichment for single housed animals is provided (Guide, p 64)
o 個別飼いの動物においては不可的に新規なものを提供する
o single housing is reviewed regularly by IACUC and veterinarian (Guide, p 64)
o 個別飼いは IACUC や獣医師により定期的にレビューされる
o
o
o
o
o
o
o
o
o
o
o
o
o



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

















o habituation to routine procedures is part of enrichment program (Guide, p 64)
o 定法による馴化は新規なプログラムの部分である
Sheltered or Outdoor Housing: (e.g., barns, corrals, pastures, islands)
o weather protection and opportunity for retreat (Guide, p 54) [must]o appropriate size (Guide, p 54)
o ventilation and sanitation of shelter (no waste/moisture build-up) (Guide, p 54)
o animal acclimation (Guide, p 55)
o social compatibility (Guide, p 55)
o roundup/restraint procedures (Guide, p 55)
o appropriate security (Guide, p 55)
Naturalistic Environments:o animals added /removed with consideration of effect on group (Guide, p 55)
o adequate food, fresh water, and shelter ensured (Guide, p 55)
Food:o feeding schedule and procedures including caloric intake management (Guide, pp65-67) 摂取量を管理すとスケジュール
o contamination prevention (Guide, p 65)
害虫や害獣などが侵入しないよう。
o vendor quality control (Guide, p 66)研究レベルの飼料分析。
o storage in sealed containers (Guide, p 66)容器の中で保管する
o expiration date labeling (Guide, p 66) 期限ラベルo vermin control (Guide, p 66)
害虫駆除
o rotation of stocks (Guide, p 66)
飼料ローテーション
Water:o ad libitum unless justified (Guide, pp 67-68) 不断飲用
o QC procedures (Guide, pp 67-68) 水質が許容範囲内にあることを確認する
Bedding and Nesting Materials:
o species appropriate (Guide, pp 68-69) 種にふさわしいo keeps animals dry (Guide, pp 68-69) 水分を吸収する
o QC procedures (Guide, pp 68-69) 許容範囲内にあることを確認する
o minimizes scientific variables (Guide, pp 68-69) 実験データに影響を及ぼしない
Sanitation:o frequency of bedding/substrate change (Guide, p 70) 交換の頻度
o cleaning and disinfection of microenvironment (Guide, pp 70-71) ミクロ環境の清掃及び消毒
o cleaning and disinfection of macroenvironment (Guide, p 72) マクロ環境の清掃及び消毒
o assessing effectiveness (Guide, p 73) 効果を定期的に審査する
Waste Disposal:
o procedures for collection (Guide, pp 73-74) 回収手順
o procedures for storage and disposal (Guide, pp 73-74)
保管と廃棄手順o hazardous wastes are rendered safe before removal from facility (Guide, pp 7374) [must] 有害廃棄物は滅菌、またはその他の適切な方法によって安全性を確保する。
o animal carcasses (Guide, pp 73-74) 動物の死体処理
Pest Control:o regularly scheduled (Guide, p 74)定期的にスケジュール
o documented program including control of rodent pests and insecticide use (Guide,p 74) 害虫・害獣駆除プログラムを文書化し、殺虫剤を使用する記録を残す。
Emergency, Weekend, and Holiday Animal Care:o care provided by qualified personnel every day (Guide, p 74) 毎日、資格を有する担当者が飼育管理する。
o provision for accessible contact information (Guide, p 74) 連絡先氏名・電話番号等
o monitoring of backup systems (Guide, p 143) バックアップシステムモニタリング
o veterinary care available after hours, weekends, and holidays (Guide, pp 74, 114)
[must] 緊急獣医療をいつでも動物に提供できるように
o a disaster plan that takes into account both personnel and animals (Guide, p 75)
人間と動物の両方を考慮した災害対処法

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









*

Identification:o cage/rack cards contain required information (Guide, p 75) 情報の付いたケージカー
ド等がある。
o genotype information included and standardized nomenclature used whenapplicable (Guide, p 75) 遺伝子型情報も個体識別カードに記載する。
Recordkeeping:o clinical records accessible and contain appropriate information (Guide, pp 75-76)
臨床記録はいつでも容易に入手できるように。
o records are provided when animals are transferred between institutions (Guide, p75) 移動する場合は記録された関連記録を提供する。
Breeding Genetics and Nomenclature:o appropriate genetic records, management and monitoring procedures (Guide, p76)o phenotypes that affect wellbeing are reported to IACUC and effectively managed(Guide, p 77)
Storage:o adequate space for equipment, supplies, food, bedding and refuse (Guide, p 141)
保管用スペースは十分な広さ。
o bedding in vermin-free area and protected from contamination(Guide, p 141) 床
敷と飼料は、害虫や有毒物質あるいは危険物質による汚染が懸念される物品と区分された場所で保管する。
o food in vermin-free, temperature and humidity controlled area and protected fromcontamination (Guide, p 141) 床敷と飼料は、害虫や有毒物質あるいは危険物質による汚染が懸念される物品と区分された場所で保管する。
o refuse storage is separate (Guide, p 141) 廃棄物保管区域は一般の保管区域から分離する。
o carcass and animal tissue storage is separate, refrigerated below 7ºC andcleanable (Guide, p 141)
動物の死体や組織廃棄には、他の冷蔵保管区域とは別の区域にある、7oC 以内の保ち、掃除がやすい構造とする。
Personnel:o adequate space for locker rooms, administration and training (Guide, p 135)ロッカールーム、事務及び監督のためのスペース、教育訓練用スペースを含む。

A = acceptable
M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable

NOTES:

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Aquatic Animal Housing and Support Areas
Date:
Location:
A* M
















S

C NA

Location:o animal areas separate from personnel areas (Guide, p 134)
o separation of species (Guide, p 111)
o separation by disease status (Guide, p 111)
o security and access control (Guide, p 151)
Construction:o corridors (Guide, p 136)o animal room doors (Guide, pp 137, 150)
o exterior windows (Guide, p 137)o floors (Guide, pp 137, 150)
o drainage (Guide, pp 138, 150)
o walls and ceilings (Guide, pp 138, 150)o heating ventilation and air conditioning (Guide, pp 139, 150-151)
o power and lighting (Guide, pp 141, 150)
o noise control (Guide, p 142)o vibration control (Guide, p 142)o environmental monitoring (Guide, p 143)
Water Quality:o standards for acceptable quality are established (Guide, p 78)
o chlorine, chloramines, chemical, and reactive bioproducts are removed or
neutralized prior to use in aquatic systems (Guide, pp78, 86) [must]
Life Support System:o water source is based on appropriate controls and research requirements (Guide,p 79)
o biofilter is of sufficient size to process bioload (Guide, p 80) [must]
Temperature, Humidity and Ventilation/Illumination/Noise and Vibration:o temperature and humidity (Guide, pp 43, 80-81)
o ventilation and air quality (Guide, pp 45, 81)
o illumination (Guide, pp 47, 81)
o noise and vibration (Guide, pp 49, 81)
Primary Enclosure:o allows for normal physiological and behavioral needs (Guide, p 82)
o allows social interaction for social species (Guide, p 82)
o provides a balanced, stable environment (Guide, p 82)
o provides appropriate water quality and monitoring (Guide, p 82)
o allows access to food and waste removal (Guide, p 82)
o restricts escape and entrapment (Guide, p 82)
o allows undisturbed observation (Guide, p 82)
o constructed of nontoxic materials (Guide, p 82)
o prevents electrical hazards (Guide, p 82)
o space needs of species are evaluated by IACUC during program evaluations andfacility inspections (Guide, p 83)
Environmental Enrichment, Social Housing, Behavioral and Social Management:o enrichment elicits appropriate behaviors and is safe (Guide, p 83)
o semi-aquatic reptiles are provided terrestrial areas (Guide, p 83)
o handling is kept to a minimum and appropriate techniques are in place at facility
or protocol level (Guide, p 84)
o nets are cleaned, disinfected and managed to avoid contamination of systems(Guide, p 84)
Food:

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storage to prevent contamination, preserve nutrients and prevent pests (Guide, p84)
o delivery ensures access to all , minimizing aggression and nutrient loss (Guide, p84)
o storage times are based on manufacturer recommendations or accepted practice(Guide, p 84)
o a nutritionally complete diet is provided (Guide, p 84)
Substrate:
o amount, type and presentation of substrate is appropriate for the system and thespecies (Guide, p 85)
Sanitation, Cleaning and Disinfectiono frequency of tank/cage cleaning and disinfection is determined by water quality,
permits adequate viewing and health monitoring (Guide, p 86)
o cleaning and disinfection of macroenvironment (Guide, p 86)
Waste Disposal:
o procedures for collection (Guide, pp 73-74)
o hazardous wastes are rendered safe before removal from facility (Guide, pp 7374) [must]o animal carcasses (Guide, pp 73-74)
Pest Control:o regularly scheduled (Guide, p 74)
o documented program including control of pests and insecticide use (Guide, p 74)
Emergency, Weekend, and Holiday Animal Care:o care provided by qualified personnel every day (Guide, pp 74, 87)
o provision for accessible contact information (Guide, pp 74, 87)o emergency response plans in place to address major system failures (Guide, 87)o veterinary care available after hours, weekends, and holidays (Guide, pp 74, 114)
[must]
Identification:o cage/tank cards contain required information (Guide, pp 75, 87)o genotype information included and standardized nomenclature used whenapplicable (Guide, pp 75, 87)
Recordkeeping:o water quality parameters and frequency of testing recorded (Guide, p 88)
o records kept on feeding, nonexpired food supplies, live cultures (Guide, p 88)
Storage:o adequate space for equipment, supplies, food, substrate and refuse (Guide, p
141)
o substrate protected from contamination (Guide, p 141)o food in vermin-free, temperature and humidity controlled area and protectedfrom contamination (Guide, p 141)o refuse storage is separate (Guide, p 141)
o carcass and animal tissue storage is separate, refrigerated below 7ºC andcleanable (Guide, p 141)
Personnel:o adequate space for locker rooms, administration and training (Guide, p 135)
o

















*

A = acceptable
M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable

NOTES:

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Cagewash
Date:
Location:
A* M


*

S

C NA

Construction and Operation:o dedicated central area for sanitizing cages and equipment is provided (Guide, p143)o cage-washing equipment meets need (Guide, p 143)o doors, windows, floors, drainage, walls, ceilings (Guide, pp 136-138)
o convenient to animal areas/waste disposal (Guide, p 143)o ease of access (including door size) facilitates use (Guide, p 143)o sufficient space for staging and maneuvering (Guide, p 143)o safety precautions/clothing/equipment used for waste disposal/prewash/acidwash ((Guide, p 143)o traffic flow clean to dirty with no contamination of clean equipment by dirty
equipment and appropriate air pressurization (Guide, p 143)o insulation and/or sound attenuation present as needed (Guide, p 143)o utilities are appropriate (Guide, p 143)o ventilation meets heat and humidity load (Guide, p 143)o safety features (e.g., SOPs, warning signs, eyewash stations) are in use (Guide,p 143)o functioning safety devices to prevent entrapment in washer/sterilizers (Guide, p143)o cage wash temperatures are monitored and records are available (Guide, p 73)
o appropriate clean cage storage (Guide, p 141)

A = acceptable
M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable

NOTES:

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Special Facilities: Aseptic Surgery（特殊施設：無菌手術）
Date:（日時）
Location:（配置）
A* M












*

S

C NA

General Considerations: 一般原則
o location minimizes traffic/contamination (Guide, p 144)施設の分散化？汚染o functional components (surgical support, animal preparation, surgeon scrub,
operating room, postoperative recovery) are designed and separated (physicallyor otherwise) (Guide, p 144)
機能区域の設計（手術サポート，動物の準備，手術者の消毒，手術室，術後の回復室）及び分離（物理的、生理的環境）
o appropriate drug storage, control, expiration date monitoring (Guide, pp 115,122)
適切な薬物保管，コントロール，有効期限のモニタリング
o safe sharps disposal system (Guide, p 74)
安全なXX処理システム
o adequate records of anesthesia and perioperative care (Guide, p 122)
麻酔の適切な記録と手術時の注意
o aseptic procedures in use for all survival surgery (Guide, pp 118-119)
全ての生存手術に使用される無菌手順
Operating Room: 手術室o effective contamination control procedures (Guide, p 144)
有効な汚染防止法
o effective cleaning procedures/dedicated tools (Guide, p 145)
有効なクリーニング法と器具
o interior surfaces smooth and impervious to moisture (Guide, p 145)
室内表面と防湿o HVAC system meets Guide requirements (Guide, p 145)
空調システムのガイド必要条件
o lighting safe and appropriate (Guide, p 145)
安全で適切な照明
o outlets safe and appropriate (Guide, p 145)
適切で安全なアウトレット
o scavenging of anesthetic gases implemented (Guide, p 145)
麻酔用ガスの排気は十分かSurgical Support: 手術サポート
o facility for washing, sterilizing, storing instruments and supplies (Guide, p 145)
手術器具の保管，洗浄、殺菌
o autoclave monitoring procedures are implemented (Guide, pp 119, 145)
オートクレーブ滅菌のモニタリング方法は十分
o storage of autoclaved materials maintains sterility (Guide, p 145)
オートクレーブ滅菌した器具の保管は殺菌消毒が維持されている
o cold sterilization procedures are appropriate (Guide, p 119)
殺菌消毒方法は適切
Animal Preparation: contains large sink to facilitate cleaning of animal andoperative site (Guide, p 145)
動物準備: 動物と手術施設の清掃を容易にするための大シンク（洗浄）が含まれる
Surgeon Scrub: outside operating room, non-hand-operated sink (Guide, p 145)
：手術室外，ロボット手術システム
Postoperative Recovery: allows adequate observation, easily cleaned, supports
physiologic functions, minimizes risk of injury (Guide, p 145)
術後の回復：適切な観察，生理学的機能のサポート、傷害リスクの最小化
Dressing Area: place for personnel to change (Guide, p 145)
バリア施設？：人が出入りするための場所

A = acceptable
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M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable

NOTES:

Special Facilities: Procedure Areas, Non-survival Surgeries, Laboratories, Rodent Surgeries,
Imaging, Whole Body Irradiation, Hazardous Agent Containment, Behavioral Studies（特殊施設：手術施設，終末手術，実験室，齧歯類の手術，画像解析，全身照射，有害物質の封じ込め，行動実験）
Date:
Location:
A* M






S

C NA

General Considerations: 一般原則
o labs used to house animals only when scientifically required and limited tominimum period necessary (Guide, p 134)
実験動物は科学的に必要で、最低期間に限られた時のみ使用
o drug storage, control, and expiration dates (Guide, pp 115, 122)
薬剤保管，管理，有効期限
o sharps disposal (Guide, p 74)
鋏，刃，針などの整理
o anesthetic monitoring (Guide, p 120)
麻酔のモニタリングo scavenging of anesthetic gases (Guide, p 21)
麻酔ガスの排気o safety features (e.g., SOPs, safety signs, eyewash stations, secure gas cylinders)are in place (Guide, p 19)
安全対策は，あるか（SOP，安全標識，洗眼ステーション，安全なガスボンベ置き場）
o carcass disposal (Guide, pp 73-74)
死体処分
Additional Concerns for Survival Surgery: (rodent and minor procedures only)
生存手術のための懸念（齧歯動物とその手順）
o rodent survival surgery clean and uncluttered, not used for anything else during
surgery (Guide, p 144)
齧歯動物の生存手術は透明で手術以外の目的に使用されなかった
o records of peri-operative care (Guide, p 120)
術後のケアの記録類
o aseptic procedures (Guide, pp 118-119)
無菌手順
o autoclave monitoring procedures (Guide, pp 119, 145)
オートクレーブ滅菌のモニタリング方法
o storage of autoclaved materials (Guide, p 145)
オートクレーブ滅菌器具の保存
o cold sterilization procedures are appropriate (Guide, p 119)
殺菌消毒方法は適切
Imaging/Whole Body Irradiation:
画像解析/全身照射
o location of resource limits contamination risk (Guide, p 147)
資源置場は汚染の封じ込めが限定されている
o appropriate transportation methods are in place (Guide, p 147)
適切な輸送方法がある
o gas anesthesia provision, scavenging and monitoring are appropriate (Guide, p147)
ガス麻酔の供給（準備），排気，モニタリングは適切
o appropriate sensors and ventilation are provided for cryogen gases (Guide, p147) [must]
適切なセンサー類や換気は、寒剤ガス？のために供給されている

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imaging console is located away from radiation source (Guide, p 147)
画像解析装置は照射装置から離れた場所にある
Hazardous Agent Containment:
有害物質の封じ込め
o facility adheres to APHIS, USDA and CDC Select Agent Regulations and otherfederal, state and local regulations including security measures (Guide, p 148)
[must]
設備は、APHIS、USDAおよびCDC Select Agent Regulationsおよび他のセキュリティ対策を含む国、県および地方条例を順守する
Behavioral Studies:
行動実験
o facility minimizes airborne transmission of noise and ground-borne transmissionof vibration (Guide, p 149)o

設備は、可能な限り騒音や振動抑制しているooofloor coverings reduce sound transmission (Guide, p 149)
床材は音の伝わりを減少する（遮断）testing equipment allows for surface disinfection (Guide, p 150)
試験設備（実験装置）は消毒が可能
components that cannot be cleaned are not in ready contact with animals andkept covered when not in use (Guide, p 150)

清掃できないコンポーネントは動物を使用前だけでなく使用しない時も保たれたo*housing areas are contiguous with testing areas when appropriate (Guide, p 150)
住宅地域は試験地域に適切に隣接している

A = acceptable
承認できるM = minor deficiency
やや不十分
S = significant deficiency (is or may be a threat to animal health or safety)
明らかに不十分（動物の健康と安全に脅威となる可能性がある）
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
プログラムを変更する必要かある（IOおよびOLAWに対するアニュアルレポートを含む）
NA = not applicable
承認できないNOTES:

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22

III.

Semiannual Program Review and Facility Inspection Report

Date:
Members in Attendance:
Deficiency
Category**√√

Location

Deficiency andPlan for Correction

Responsible
Party

A = acceptable
M = minor deficiency
S = significant deficiency (is or may be a threat to animal health or safety)
C = change in program (PHS Policy IV.A.1.a.-i.) (include in semiannual report to IO and in annual report to OLAW)
NA = not applicable
Check if repeat deficiency

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Correction Scheduleand Interim Status

Date
Complete

IV.

Endnotesi

The PHS Policy requires that Assured institutions comply with the regulations (9 CFR, Subchapter A) issued by the U.S.
Department of Agriculture (USDA) under the Animal Welfare Act, as applicable. The endnotes below are specific USDA
regulatory requirements that differ from or are in addition to the PHS Policy. This list is not intended to be all inclusive.
For additional information please refer to 9 CFR Subchapter A - Animal Welfare.
iiPart 2 Subpart C - Research Facilities- 2.31(b)(2) - “The Committee shall be composed of a Chairman and at least two additional members;... at least one shallnot be affiliated in any way with the facility...such person will provide representation for general community interests inthe proper care and treatment of animals.” [PHS policy requires 5 members]
2.32(c)(4) - “...No facility employee, Committee member, or laboratory personnel shall be discriminated against or be
subject to any reprisal for reporting violations of any regulation or standards under the Act.” [USDA requirement
additional to PHS Policy]iii

2.31(d)(5) - “...shall conduct continuing reviews of activities...not less than annually.” [PHS Policy requires a complete
new review every 3 years utilizing all the criteria for initial review]iv

2.31(d)(1)(x) - “...no animal will be used in more than one major operative procedure from which it is allowed torecover unless...(it is) justified for scientific reasons...(or is) required as routine veterinary procedure...or other special
circumstances as determined by the Administrator on an individual basis.” [this last point is an additional USDA
justification for multiple survival surgeries]v

2.36 - “...each reporting facility shall submit an annual report to the APHIS, AC sector supervisor for the State where
the facility is located on or before December 1 of each calendar year.” [The USDA annual report has a list ofrequirements which differ from PHS annual report]vi

2.36(b)(3) - “...exceptions to the standards and regulations be specified and explained by the principal investigator andapproved by the IACUC. A summary of all such exceptions must be attached to the facility’s annual report.” [Refers to
USDA annual report]vii

2.31(c)(3) - “...Any failure to adhere to the plan and schedule that results in a significant deficiency remaining
uncorrected shall be reported in writing within 15 business days by the IACUC, through the institutional official, to
APHIS and any Federal agency funding that activity.” [PHS Policy requires prompt reporting to OPRR of serious orcontinuing noncompliance with the PHS Policy or serious deviations from the provisions of the Guide]viii

2.36 - “...each reporting facility shall submit an annual report to the APHIS, AC sector supervisor for the State where
the facility is located on or before December 1 of each calendar year.” [The USDA annual report has a list ofrequirements which differ from PHS annual report]ixx

In addition to PHS requirements for IACUC review/application for funding, USDA regulations require:2.31(d)(1)(ii) - “The principal investigator (PI) consider alternatives to procedures that cause more than momentary or
slight pain or distress to the animals, and has provided a written narrative description of the methods andsources...used to determine that alternatives were not available.”2.31(d)(1)(iii) - “The PI has provided written assurance that the activities do not unnecessarily duplicate previous
experiments.”
2.31(d)(1)(iv) - “Procedures that may cause more than momentary or slight pain or distress to the animals will:- involve in their planning, consultation with the attending veterinarian or his or her designee; [PHS Policy does not
specify veterinary consultation]- not include paralytics without the use of anesthesia;”

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2.31(d)(1)(x) - “No animal will be used in more than one major operative procedure from which it is allowed torecover, unless justified for scientific reasons by the principal investigator, in writing...”2.33(a)(1) - “In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall
include a written program of veterinary care and regularly scheduled visits to the research facility.” [USDA requirement
additional]xi

2.32(c) - “Humane methods of animal maintenance and experimentation, including the basic needs of each species,
proper handling and care for the various species of animals used by the facility, proper pre-procedural and post-proceduralcare of animals, and aseptic surgical methods and procedures.”
xii

xiii

2.32(c) - additional specifications include:- “proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility”- “methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care andtreatment reported by any employee of the facility...”- “utilization of services (e.g., National Agricultural Library, National Library of Medicine) to provide information on
appropriate animal care and use, alternatives to the use of live animals in research , that could prevent unintended andunnecessary duplication of research involving animals, and regarding the intent and requirements of the Act.” [USDA
training specifications are more detailed than PHS Policy].
2.31(d)(iv)(C) - “Procedures that may cause more than momentary or slight pain or distress to the animals will...notinclude the use of paralytics without anesthesia.”
xiv

Part 3 Subpart A 3.8 - “...research facilities must develop, document, and follow an appropriate plan to provide dogs
with the opportunity for exercise. In addition the plan must be approved by the attending veterinarian. The plan must
provide written standard procedures...”xv

Part 3 Subpart D 3.81 - “...research facilities must develop, document, and follow an appropriate plan for environment
enhancement adequate to promote the psychological well-being of nonhuman primates.”
xvi

Part 3 Subpart A 3.6(c)(1) - “Each dog housed in a primary enclosure must be provided with a minimum amount offloor space, calculated as follows:(length of dog in inches + 6)2 /144 = required floor space in square feet).”xvii- Part 3 Subpart D 3.80 (b) - “Primary enclosures [for nonhuman primates] must meet the minimum space requirements
provided in this subpart.”- In situations where the USDA regulations and the Guide differ with respect to space requirements, the larger of the twomust be followed.

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