米国で新規化学物質を製造もしくは輸入をする際には，TSCA (有害物質規制法: Toxic Substances Control Act)に基づき，新規化学物質届出をしなければならない．
TSCA Section 8(b)に従い，2017年のactive-inactive ruleに基づき，TSCAインベントリーに収載されている物質をForm AもしくはForm Bで報告するように要求され，収載されているすべての物質はactive or inactiveに指定された．物質の化学的アイデンティティを保護するため，申請者はCBI (Confidential Business Information: 企業の秘密情報) 請求をすることができた．
化学的アイデンティティがリバースエンジニアリングを通じて容易に発見可能かどうかを確認するため，2つの追加質問を含め，CBI請求のレビュー手順(Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory: TSCAインベントリー上の化学的アイデンティティに関するCBI請求のレビュー手順)が最終化された．
以下に本法規の概要を説明する．
- 法規
- 所管当局
- EPA (米国環境保護庁: Environmental Protection Agency)
- 届出者 (§710.43 (法規①))
- 対象 (§710.43(a) (法規①))
特定の化学的アイデンティティ（化学物質名やCAS番号など）に関して，既存のCBI 請求を維持することを要求し，Form Aを提出した者 - 免除 (§710.43(b) (法規①))
(1) §710.37(a)(1)に規定されている自主的な立証プロセスを完了した者は，§710.45(b) 1~6の質問への回答提出を免除される．ただし，§710.45(b) 7~8の質問への回答は提出する．
(2) 以下(i)および(ii)の条件に合致し，§710.45の全ての質問の回答情報を届出することによって，Form Aでの化学的アイデンティティのCBI 請求を以前に立証した者
i) 2015/11/1以降にEPAに立証を提出した
ii) 届出日，届出タイプ，case number，そしてtransaction IDもしくは立証を含む以前の届出のidentifierをEPAに報告する者
- 対象 (§710.43(a) (法規①))
- 届出種類 (§710.47 (法規①))
- 立証届出
§710.43(a)または(b)(1)に従って，立証を届出しなければならない． - 免除届出
§710.43(b)(2)に基づく免除を求める者は，§710.43(b)(2)(ii)の情報を届出しなければならない．
- 立証届出
- 届出内容 (§710.45(b) (法規①))
- Will disclosure of the information claimed as confidential likely cause substantial harm to your business’s competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information and the causal relationship between the disclosure and the harmful effects.
- To the extent your business has disclosed the information to others (both internally and externally), has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures, including but not limited to internal controls, that your business has taken to protect the information claimed as confidential.
- (i) Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
(ii) Does any of the information claimed as confidential otherwise appear in any public documents, including (but not limited to) safety data sheets; advertising or promotional material; professional or trade publications; state, local, or Federal agency files; or any other media or publications available to the general public? If yes, please explain why the information should be treated as confidential.
(iii) Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential. - Is the claim of confidentiality intended to last less than 10 years? If yes, please indicate the number of years (between 1-10 years) or the specific date/occurrence after which the claim is withdrawn.
- Has EPA, another Federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination.
- Is the confidential chemical substance publicly known (including by your competitors) to have ever been offered for commercial distribution in the United States? If yes, please explain why the specific chemical identity should still be afforded confidential status (e.g., the chemical substance is publicly known only as being distributed in commerce for research and development purposes, but no other information about the current commercial distribution of the chemical substance in the United States is publicly available).
- Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., as a product, effluent, or emission? If yes, please explain what measures have been taken, if any, to guard against the discovery of its identity.
- If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, or emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.
- Will disclosure of the information claimed as confidential likely cause substantial harm to your business’s competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information and the causal relationship between the disclosure and the harmful effects.
- 届出期間 (§710.47 (法規①))
- 2020年11月1日まで
- 届出後の管理 (§710.53 (法規①))
- 届出者は，EPAに報告した情報を2020年11月1日から5年間保持しなければならない．
- EPAのその後の対応 (§710.55 (法規①))
- レビューや承認・拒否
Form AのCBI要請は，TSCA Section 14および40 CFR Part 2, subpart Bに従い，レビューされ，承認または拒否される．
- 保護期間
2016/6/22より後の場合，特定の化学的アイデンティティは，最初のCBI請求から10年間開示されるのを保護される． - TSCAインベントリーの更新
Form AのCBI請求のレビュー結果に基づき，EPAは，TSCAインベントリーを定期的に更新する
- すべてのレビュー予定日
すべてのレビューが完了するまで，EPAは，各年の初めにレビューの年間目標と前年度に完了したレビューの数をEPAのウェブサイトに公開する．レビューは2024/2/19までに完了する予定である． - 延長
レビューに関する目標完了日を達成できないと判断した場合，延長およびすべてのレビューを2年以内に完了する連絡をFederal Registerで公開する．
- レビューや承認・拒否
- 参考
- EPA CBI claim情報 (HP)
以上