Apresentação para a Palestra que explica um pouco do Direito Penal Brasileiro para, então, abordar a Lei 12.737, de 30 de novembro de 2012, também conhecida como Lei Carolina Dieckmann.
Apresentação para a Palestra que explica um pouco do Direito Penal Brasileiro para, então, abordar a Lei 12.737, de 30 de novembro de 2012, também conhecida como Lei Carolina Dieckmann.
17. １．食品安全問題を予防するための能力の向上
101条 記録の精査
102条 食品工場の登録
103条 危害分析とリスクベース
での予防コントロール
104条 履行基準
105条 農産物の安全に関わる
基準
106条 意図的汚染に対する防御
107条 手数料に対する権限
Sec. 101. Inspections of records.
Sec. 102. Registration of food
facilities.
Sec. 103. Hazard analysis and risk-
based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce
safety.
Sec. 106. Protection against
intentional adulteration.
Sec. 107. Authority to collect fees.
18. 108条 全国的農業と
フードディフェンス戦略
109条 食品と農業の調整評議会
110条 国内の能力の構築
111条 食品の衛生的な輸送
112条 食品アレルギーと
アナフィラキシー管理
113条 新しい食品原材料
114条 生牡蠣の収穫後の加工に関する
ガイダンスへの要求
115条 埠頭での購買
116条 アルコール関連施設
Sec. 108. National agriculture and
food defense strategy.
Sec. 109. Food and Agriculture
Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of
food.
Sec. 112. Food allergy and
anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance
relating to post harvest processing of
raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.
19. ２．食品安全問題を発見し対応するための
能力の向上
201条 国内外の施設や通関に対する
検査ソースの焦点
202条 食品分析のための
検査室の認定
203条 実験室ネットワークの
統合コンソーシアム
204条 追跡の拡大と食品トレースと
記録の維持
205条 サーベイランス
Sec. 201. Targeting of inspection
resources for domestic facilities,
foreign facilities, and ports of
entry; annual report.
Sec. 202. Laboratory accreditation
for analyses of foods.
Sec. 203. Integrated consortium
of laboratory networks.
Sec. 204. Enhancing tracking and
tracing of food and recordkeeping.
Sec. 205. Surveillance.
20. 206条 リコールを強制する権限
207条 経営上の食品の留保
208条 汚染除去と使い捨ての
基準と計画
209条 州、地域、エリアや民族の
公的な食品安全の改善的トレーニング
210条 食品安全の拡大
211条 報告可能な食品登記の改善
Sec. 206. Mandatory recall
authority.
Sec. 207. Administrative
detention of food.
Sec. 208. Decontamination and
disposal standards and plans.
Sec. 209. Improving the training
of State, local, territorial, and
tribal food safety officials.
Sec. 210. Enhancing food safety.
Sec. 211. Improving the
reportable food registry.
21. ３．輸入食品の安全のための改善
301条 外国供給業者検証プログラム
302条 任意適格輸入者プログラム
303条 食品の輸入証明書を要求する
ための権威
304条 輸入された食品の船積みの
優先的通知
305条 食品安全を重要視している
海外行政機関の能力養成
306条 海外食品施設の検査（査察）
307条 第三者監査による認定
308条 FDAの海外オフィス
309条 密輸された食品
Sec. 301. Foreign supplier
verification program.
Sec. 302. Voluntary qualified
importer program.
Sec. 303. Authority to require
import certifications for food.
Sec. 304. Prior notice of imported
food shipments.
Sec. 305. Building capacity of
foreign governments with respect to
food safety.
Sec. 306. Inspection of foreign food
facilities.
Sec. 307. Accreditation of third-
party auditors.
Sec. 308. Foreign offices of the Food
and Drug Administration.
Sec. 309. Smuggled food.
22. ４．その他の条項
401条 食品安全のための資金
402条 従業員の保護
403条 裁判権；権利
404条 国際的同意のある
コンプライアンス
405条 予算の結果からの決定
Sec. 401. Funding for food
safety.
Sec. 402. Employee
protections.
Sec. 403. Jurisdiction;
authorities.
Sec. 404. Compliance with
international agreements.
Sec. 405. Determination of
budgetary effects.
25. FSMAの規則（Rules）
• Final Rule: Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption
生鮮野菜果物の栽培、収穫、包装、保管における基準
• Final Rule: Food Supplier Verification Programs (FSVP) for
Importers of Food for Humans and Animals 食品及び飼料の輸入業
者のための外国供給業者検証プログラム
• Final Rule: Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Human Food
ヒト用食品における現行適正製造規範並びに危害分析とリスクベース予防
コントロール
• Final Rule: Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Food for Animals
動物飼料における現行適正製造規範並びに危害分析とリスクベース予防コ
ントロール
26. FSMAの規則（Rules）
• Final Rule: Accredited Third-Party Certification
第三者の監査機関による認定
• Proposed Rule: User Fee Program to Provide for
Accreditation of Third-Party Auditors/Certification Bodies
to Conduct Food Safety Audits and to Issue Certifications
第三者の監査機関による認定プログラムと費用に関する規則
• Proposed Rule: Amendments to Registration of Food
Facilities
27. FSMAの規則（Rules）
• Final Rule: Record Availability Requirements:
Establishment, Maintenance, and Availability of
Records
• Advance Notice of Proposed
Rulemaking: Implementation of the Food and Drug
Administration Food Safety Modernization Act
Amendments to the Reportable Food Registry
Provisions of the Federal Food, Drug, and Cosmetic
Act
28. FSMAの規則（Rules）
• Final Rule: Sanitary Transportation of Human and Animal
Food
食品と家畜飼料の衛生的な運送
• Proposed Rule: Focused Mitigation Strategies to Protect Food
Against Intentional Adulteration
意図的な食品への混入、汚染の防御戦略
• Final Rule: Information Required in Prior Notice of Imported
Food
輸入食品の事前報告において要求される情報
• Final Rule: Criteria Used to Order Administrative Detention of
Food for Human or Animal Consumption
37. Current Good Manufacturing Practice and Hazard Analysis
and Risk-Based Preventive Controls for Human Food
• 21 CFR 1 : General enforcement regulations
• 11 : Electronic records; electronic signatures
• 16 : Regulatory hearing before the food and drug administration
• 106 : Infant formula requirements pertaining to current good manufacturing
practice quality control procedures, quality factors, records and reports, and
notifications
• 110 : Current good manufacturing practice in manufacturing, packing, or holding
human food
→2018年9月17日を発効日としてpart110を削除し修正する
• 114 : Acidified Foods
• 117 : Current Good Manufacturing Practice Hazard Analysis and Risk Based
Preventive Controls for Human Food
• 120 : Hazard Analysis and Critical Control Point Haccp Systems
• 123 : Fish and Fishery Products
• 129 : Processing and Bottling of Bottled Drinking Water
• 179 : Irradiation in the Production Processing and Handling of Food
• 211 : Current Good Manufacturing Practice for Finished Pharmaceuticals
野菜・果物→中南米
果物の50％、野菜の20％、魚介類の80％が輸入→食品供給のグローバリーゼーション
1938年以来、米国の食品供給規 制に関して最も重要な変更
1930年 1927年にできた食品医薬農薬管理局が今の食品医薬管理局（FDA）に変更
1938年 The Federal Food ,Drug and Cosmetic Act（連邦食品医薬化粧品法）が成立
施設検査：是正措置、再検査
Mandatory Recall pursuant to FSMA §206
Designation as “High Risk Food” pursuant to FSMA §303
Suspension of Facility Registration pursuant to FSMA §102
Reinspection Fees pursuant FSMA §107
Refusal of Admission: per § 801(a)(3) of FD&CA
Prohibited Act: per § 301(zz) of FD&CA
Import Alert: Placement of company on Detent
