監修のことば

i

監修のことば（公社）日本作業環境測定協会は，認定オキュペイショナルハイジニストについて，我が国の多くの専門家のお力を頂いて平成 15 年からカリキュラムの策定に着手し，引き続いて養成講座テキスト（化学物質等のリスクアセスメント・リスクマネジメントハンドブック）の編集作業を行い，平成 20 年 3 月から養成講座が開始された．
当初は，93 時間の養成講座を A－E コースの 5 つに編成して実施していたが，受講のしやすさ等を考慮し 12 コースに再編成して現在に至っている．
養成講座テキストとして編集した初版の内容について，法令の改正や統計の更新など，一部見直しの必要が生じたことから，新たな養成講座用テキストを作成することとし，足掛け 4 年を費やしてようやく新版のテキストがここに完成するに至った．
新版では，持ち運びの便宜や使いやすさを考慮し，コースごとの分冊とした．
認定オキュペイショナルハイジニスト制度は，安全衛生における欧米の自律的管理の潮流がわが国にも影響を及ぼすことになることを前提に，英国や米国における専門家をめぐる状況も勘案して，適切な自律的管理の実践のためには，事業者における意識変化とともに，わが国においても事業者を実務面から支援する専門家が必要であり，それは，法令に定める有資格者ではなく，より包括的・分野横断的に労働衛生を理解し，実践できる専門家であるという見通しから着手したものである．
近年，安全衛生分野の自律的管理は，化学物質管理などを中心に少しずつ歩を進めつつある．労働災害の防止という観点から見れば，自律的管理への移行が即労働災害の減少に直結するような短絡的な図式ではないにしても，さまざまな作業に対するリスクアセスメントとそれに基づくリスクマネジメントが徐々に浸透すれば，事業者の意識も受動的で形式的なものから，労働者の安全健康に対する経営者の責任の自覚という観点で変わってくることになるのではないかと思われる．
認定オキュペイショナルハイジニストを志向し養成講座を受講する皆様もこのところ増えており，協会は，不断に養成講座の質的改善に努め，我が国のオキュペイショナルハイジーンを牽引する人材を少しでも多く全国に輩出できればと努力している．
新版のテキストがその橋渡しをしてくれることを願うものである．
令和 5 年 10 月
編集委員長
北里大学名誉教授

相澤好治

ii 目次目次

監修のことば ····································································································································································· i序

オキュペイショナルハイジニスト，その役割と特質 ·······································································1
1．オキュペイショナルハイジニストの役割と IOHA の国別認証制度 ·································· 1
2．オキュペイショナルハイジーンとオキュペイショナルハイジニスト ······························ 1
3．我が国の法制度とハイジニストの今後の重要性 ····································································· 24．オキュペイショナルハイジニストとその使命·········································································· 4

第 1 章 化学物質のリスク管理に関する日本の法制の概要等 ·····························································6
1.1

はじめに ············································································································································ 6

1.2法，社会法等 ··································································································································· 7

第 2 章 労働安全衛生法関係法令の考え方と組み立て············································································92.1

労働安全衛生法の目的と制定の経緯······················································································ 102.2

労働安全衛生法の施行の仕組み ······························································································ 102.3

労働衛生の 3 管理と法令 ··········································································································· 122.4

化学物質等に関する主な規制 ··································································································· 132.4.1

製造等の禁止（法第 55 条） ······························································································ 13

2.4.2

製造の許可（法第 56 条） ·································································································· 142.4.3

危険有害性の表示及び通知制度（法第 57 条，法 57 条の 2） ······························· 15

2.4.4

リスクアセスメントの実施（危険有害性の調査）（法第 57 条の 3） ·················· 172.4.5

化学物質等による職業がんの予防対策 ·········································································· 21

2.4.6有害性調査制度（法第 57 条の 4） ·················································································· 23

目次iii2.4.7

がん原性指針等の公表（法第 28 条関連） ··································································· 24

2.4.8

国による規制物質の特定（国によるリスク評価事業） ··········································· 25

2.5「職場における化学物質等の管理のあり方に関する検討会」報告に則した
化学物質管理施策の転換について ·························································································· 28

2.5.1

あらまし ··································································································································· 28

2.5.2

省令改正の骨子 ······················································································································ 30

第 3 章 労働契約法と安全配慮義務 ················································································································ 34
3.1

安全配慮義務違反の判例 ··········································································································· 34

3.2

労働契約法の安全配慮義務 ······································································································· 36

第 4 章 産業活動に伴う国民や一般環境へのリスク ············································································· 38
4.1

国民生活・環境リスクの管理 ··································································································· 38

4.1.1

化学物質の審査及び製造等の規制に関する法律（化審法） ··································· 38

4.1.2

特定化学物質の環境への排出量の把握等及び管理の改善の促進に関する法律（化管法） ······················································································································ 43

4.1.3

環境基本法 ······························································································································· 47

4.1.4

循環型社会形成推進基本法 ································································································ 52

4.1.5

生物多様性基本法·················································································································· 53

4.1.6

大気汚染防止法 ······················································································································ 55

4.1.7

水質汚濁防止法 ······················································································································ 58

4.1.8

悪臭防止法 ······························································································································· 60

4.1.9

振動規制法 ······························································································································· 62

4.1.10

騒音規制法 ···························································································································· 63

4.1.11

土壌汚染対策法 ···················································································································· 64

4.1.12

廃棄物の処理及び清掃に関する法律 ············································································ 65

4.1.13

水銀による環境の汚染の防止に関する法律 ······························································· 67

4.1.14ダイオキシン類対策特別措置法 ····················································································· 68

4.1.15

特定物質の規制等によるオゾン層の保護に関する法律 ········································· 70

4.1.16

有害物質を含有する家庭用品の規制に関する法律 ·················································· 71

iv 目次4.1.17

特定有害廃棄物等の輸出入の規制に関する法律 ······················································ 72

4.1.18

下水道法 ································································································································· 73

4.1.19公害紛争処理法 ···················································································································· 74

4.1.20消防法 ····································································································································· 75

4.2

産業活動の継続のためのリスク管理······················································································ 80

4.2.1

医薬品，医療機器等の品質，有効性及び安全性の確保等に関する法律（薬機法） ······························································································································· 80

4.2.2

毒物及び劇物取締法（毒劇法） ······················································································· 83

4.2.3

農薬取締法 ······························································································································· 86

4.2.4

高圧ガス保安法 ······················································································································ 88

4.2.5

原子力基本法 ·························································································································· 924.2.6

放射性同位元素等の規制に関する法律 ·········································································· 934.2.7

核原料物質，核燃料物質及び原子炉の規制に関する法律（原子炉等規制法） ············································································································· 94

4.2.8

石綿による健康被害の救済に関する法律 ······································································ 95

第 5 章 世界の安全衛生の動きの理解 ··········································································································· 97
5.1

英国労働健康安全法制定の経緯（ローベンス報告） ······················································· 97

5.1.1

英国労働健康安全法の特徴 ································································································ 98

5.1.2

合理的に実行可能な限りにおいて，合理的実行可能性 ··········································· 98

5.1.3

英国健康安全法と欧州法（EU 法）との関係 ······························································· 99

5.1.4

労働健康安全管理規則／職場安全衛生マネジメント規則 ····································· 100

5.1.5

有害物管理規則 ···················································································································· 101

5.1.6

COSHH Essentials ················································································································ 102

5.2

EU 安全衛生枠組み指令とリスクアセスメント ································································ 104

5.2.1

EU 法 ······································································································································· 104

5.2.2

欧州労働安全衛生機関 ······································································································· 106

5.2.3

労働安全衛生枠組み指令（89/391/EEC） ·································································· 106

5.2.4

指令 2004/37/EC - 発がん性物質，突然変異誘発物質，または職場における生殖毒性物質 ················································································· 111

目次

5.2.5v

指令 98/24/EC - 職場で化学物質にさらされるリスクからの労働者の保護に関する指令 ······························································································ 113

5.2.6
5.3

EU における予防原則 ········································································································· 116

電気・電子機器に含まれる有害物質···················································································· 118

5.3.1

電気・電子機器に含まれる特定有害物質の使用制限に関する
欧州議会および理事会指令 ······························································································ 118

5.3.2

電気・電子機器の廃棄に関する欧州議会および理事会指令 2012/19/EU（2012 年 7 月交付） ·········································································································· 120

5.3.3
5.4

セベソ指令 ····························································································································· 122

EU の化学物質関連規則 ··········································································································· 124

5.4.1

CLP 規則5.4.2

REACH 規則の成り立ちと概要 ······················································································· 126

5.5

欧州議会および欧州理事会規則 ······························································· 124

米国安全衛生法 ··························································································································· 131

5.5.1

労働安全衛生法の適用範囲 ······························································································ 133

5.5.2

OSHA のプログラム············································································································ 134

5.5.3

労働安全衛生法に基づく権利と責任 ············································································ 135

5.5.4

OSHA 基準（スタンダード） ·························································································· 136

5.5.5

OSHA の査察活動 ················································································································ 138

5.5.6

重度違反者取締りプログラム ·························································································· 138

5.5.7

報告および記録要件 ··········································································································· 139

5.5.8

OSHA の内部告発者プログラム，報復からの保護··················································· 139

5.5.9

OSHA の支援，サービスおよびプログラム ································································ 139

5.5.10

米国産業衛生専門家会議 ································································································ 141

5.5.11

米国産業衛生協会 ············································································································· 142

5.6

ILO の動き ···································································································································· 143

5.6.1

ILO の三者構成原則 ············································································································ 144

5.6.2

国際労働基準 ························································································································ 144

5.6.3

日本が批准した労働衛生関係の条約 ············································································ 145

5.6.4

労働安全衛生マネジメントシステムに関するガイドライン ································· 147

5.6.5

ILO コントロール・バンディング ················································································ 148

5.7

国連および国連機関の環境・安全の動き ··········································································· 1565.7.1

国際連合の憲章と機構 ······································································································· 156

vi 目次5.7.2

持続可能な開発 ···················································································································· 157

5.7.3

アジェンダ 21 第 19 章 ······································································································· 158

5.7.4

アジェンダ 2030 ··················································································································· 160

5.7.5

環境に関する国際条約 ······································································································· 161

5.7.6

国連 GHS 文書 ······················································································································ 164

5.7.7

IPCS と ICSC，EHC，CICAD ·························································································· 167

5.8OECD 化学品・バイオ技術委員会と環境政策委員会 ····················································· 168

5.9

IOHA International Occupational Hygiene Association ······················································· 170

1．オキュペイショナルハイジニストの役割と IOHA の国別認証制度

序1

オキュペイショナルハイジニスト，その役割と特質

1．オキュペイショナルハイジニストの役割と IOHA の国別認証制度
オキュペイショナルハイジニスト（以下，「ハイジニスト」という）の発祥は英国で，現在英国政府登録の公益法人として国際ハイジニスト協会（International Occupational Hygiene
Association 略称 IOHA）が設立されており，30 カ国を超える世界のハイジニスト養成機関がこれに加盟している．1）
IOHA の目的は，各国の勤労者の安全衛生の向上に貢献する人材として，オキュペイショナルハイジーン（後述）に関する高度な専門家であるハイジニストを育てることである．
そのために IOHA の活動の 1 つとして，各国のハイジニスト養成プログラムを審査し，優良なプログラムを認証（certify）する制度（National Accreditation and Recognition scheme；
略称 NAR）を設け，専門家としての質の維持向上を図っており，米国，英国，オーストラリアおよび日本（当協会のプログラム）2）等 17 カ国（2022 年 6 月現在）のプログラムが認証されている．

2．オキュペイショナルハイジーンとオキュペイショナルハイジニスト「オキュペイショナルハイジーンは，勤労者および関係者の健康と幸福・安寧を確保するため，労働環境における健康に関する危害を予測し，認識し，評価しそして制御する専門分野である．
」3）1） IOHA では，1 国の参加機関を 2 までとしており，米国（AIHA と ACGIH）と日本（当協会と日本労働衛生工学会）のみ 2 機関参加している．
2） （公社）日本作業環境測定協会では，安全衛生分野の世界的な自律的管理へのトレンドを考慮しつつ，我が国で職場におけるさまざまなリスク要因が適切に管理されて労働者の安全と健康が確保されるよう，労働環境における種々の化学物質や物理的因子，生物的因子等健康障害をもたらす要因（ハザード）とそれらハザードが働く人々の健康にもたらすリスクを的確に予測・認識・評価・管理するための知識と技術を有する高度な専門家を養成し，それら専門家が我が国の職場における労働者の健康の確保と福祉の増進に寄与することができるよう，2003（平成 15）年からカリキュラム開発に着手し，2008（平成 20）年からハイジニストの養成講座を実施してきた．2014（平成 26）年 2 月，非英語圏では初めて IOHA-NAR の認証を得て，これにより，世界的に英国オキュペイショナルハイジニスト，米国インダストリアルハイジニスト等と同様の専門家として認められた．
3） IOHA definition and objectives；Occupational Hygiene is defined as: the discipline o anticipating, recognizing,evaluating and controlling health hazards in the working environment with the objectives of protecting worker healthand well-being and safeguarding the community at large.

2 序 オキュペイショナルハイジニスト，その役割と特質

IOHA においては，労働環境における健康に関するリスクの管理について，化学的，物理的，生物学的ハザードおよびこれらによるリスクへの対処を挙げ，その際，人間工学的アプローチを考慮すべきことをあげている．
IOHA は，ハイジニストについて次のように述べている．
「ハイジニストは，勤労者および関係者の健康と安全の確保を使命として（committed），製造業，石油産業，医薬製造，鉄鋼，鉱業等の産業界のさまざまな業種で，また政府および政府関係機関や病院，公的施設で，また独立の技術専門家として，さらに大学で，直面する問題に取り組んでいる．オキュペイショナルハイジニストは，勤労者および関係者の健康と安全を確保するとともに，職場に関わるあらゆる法令の遵守を確保するため，職場の健康リスクを評価し，また有害物質を測定により同定し，工場の騒音レベルを測定するような活動や，建築物の安全な石綿除去作業の指揮監督，また考えられるさまざまな労働災害リスクから勤労者を防護するために必要な，実態に則した指導助言を関係者に行う．
」4）

3．我が国の法制度とハイジニストの今後の重要性
我が国では，細部にわたる法令の規定とその遵守のための労働基準監督制度のなかで，企業の自主的取り組みはあまり顕著とはいえず，そのためどちらかといえばこれまでは労働災害防止のための民間専門家が育ちにくい環境条件であったといえそうだ．
労働安全衛生は，第一義的に事業者（企業）の責任で確保されなければならないことは，国連機関である ILO（国際労働機構）が世界に提唱している基本原則であり，法令の制定と労働基準監督官制度による事業者の法令事項の遵守の確保を基本とし，各国もこれに準拠しているが法令はどうしても包括的事項にとどまり，個別・具体的な事業場の事情に対し細部にわたり対応することは難しいのが実情である．このため，法令は，国全体の安全衛生水準をある程度のレベルまで底上げすることには有効だが，さらにそれ以上に個々の4） 最も歴史があり，またハイジニストの活動が顕著である英国，米国の状況を見ると，英国では，法制上，法令に個別具体的な事業者の義務を規定せず，事業者による自律的管理に多くを任せているが，法令順守の有無を巡って，また労働災害が発生した場合の責任について，事業者が「合理的に可能な範囲でのリスク管理対策」を行ったことを実証することが求められ，このためにも事業者は，ハイジニストの専門的な指導を受けて安全衛生対策を実施することが必要になる．
米国では，企業が安全衛生分野において行うべきことを行っていないため労働災害を発生させた場合等は，企業は被災労働者等から訴訟を提起され，莫大な損害賠償金を支払うことになる場合がある．企業は，訴訟に備えるためにも，専門家であるハイジニストが企業として行うべき安全衛生に係るリスク管理対策を統括することとなる．米国では，企業のほか，政府や公的機関等さまざまな組織にも多くのハイジニストがおり，たとえば毎年 TLVs（OEL（職業的ばく露限界値）の 1 種．いわゆる許容濃度）を勧告している ACGIH（米国労働衛生専門家会議＝American Conference of Governmental Industrial Hygienists）もハイジニストにより支えられている．連邦政府の OSHA（米国連邦政府安全衛生庁）や州の相当部署の労働基準監督官には多くのハイジニストがおり，作業場所の有害物の測定等を自ら抜き打ちで実施することも珍しくない．

3．我が国の法制度とハイジニストの今後の重要性

3

企業の安全衛生水準の向上を図るには，法令を基盤としつつも，事業者の自主的自律的取り組みが重要となる．
しかし，企業の目的は，製品やサービスの提供を通じた事業・利潤の拡大にあり，安全衛生は副次的なものとの位置づけから，安全衛生分野での自律的取り組みは容易なことではない．
企業の仕事に詳しいことが，必ずしもそれから派生するリスクに詳しいことに直結しないため，個別・具体的問題に応じて相談し，解決の支援を求めることのできる企業外専門家の存在が必要になってくる．
前述のように我が国では，法令および通達と労働基準監督機関による監督指導制度が細部におよび，「労働安全衛生法令」に基づく種々の資格者はいても，それらは，法令の枠組みにはめられ，事業者による自主的な創意工夫ないしインセンティブに基づく安全衛生を支援する専門家の育つ土壌がこれまであまりなかったと思われる．
すなわち，労働安全衛生法には，作業環境測定士，労働衛生コンサルタント，衛生工学
衛生管理者，産業医等のさまざまな資格者を規定しているが，これらの資格者は法令の施行のために法令上一定の役割が割り当てられており，これらの資格者がそろっていることが，すなわち事業場の自主的自律的な安全衛生水準のレベルアップに必ずしも直結することを意味しない．むしろ，これら法令上の資格者が法令に規定する限定的役割を超えて安全衛生の実現に活躍するということは少なく，法令上の要件をクリアしたという受動的，消極的位置づけでとどまることも少なくないと思われる．しかし，企業等が今後求められることは，これら法定資格者をそろえて労働基準監督署から法令違反を指摘されないだけではなく，真に安全で健康的な作業環境を形成するため，主体的・自律的に現実の安全衛生問題に対応することだと考えられる．そのためには，職場のリスク管理およびこれに関連する分野の広い知識を持ち，必要に応じて法令に基づく資格者や関連する分野の技術者の力も活用して，現実の問題に取り組む専門家が必要となる．
我が国でも，近年，企業が自らの責任と判断でリスク評価とそれに基づく必要な措置を行う，いわゆる「自律的リスク管理」への移行を促進しようとする国の方向が見られる．
化学物質管理に関し，令和 3（2021）年 7 月に公表された「職場における化学物質等の管理のあり方に関する検討会」報告書では，事業者の自律的管理への移行を提言しており，その中で初めてハイジニストを自律的管理の実践の中核的専門家として位置づけた．
自律的管理の中で企業が事業者責任を果たすためには，今後ハイジニストの必要性が高まるものと考えられる．