The 6th Harlan Laboratories Global Seminar & Symposium Regulatory Trend on Existing & New Chemicals and Nanomaterials Interpretation services are available in English, Korean, and Japanese Date: October 31, 2012 (Wed) Place: Gakushikaikan, Jinbocho Tokyo Organizer Nanomaterial Safety Evaluation Forum Supporter EO/EG Task Force Consortium BPA Safety Evaluation Forum NanoSafety Consortium For Carbon (USA) Shinshu University Harlan Laboratories Japan Co., Ltd The 6th Harlan Laboratories Global Seminar & Symposium Seminar October 31, 2012 (Wed.) 13:00 - 18:20 (doors open: 12:30) Gakushikaikan Room 202 [1 min walk from Jinbocho Station (Exit A9)] Reception 18:20 – 20:00 Gakushikaikan Room 202 (Free of charge) Organizer Nanomaterial Safety Evaluation Forum Co-organizer EO/EG Task Force Consortium BPA Safety Evaluation Forum NanoSafety Consortium For Carbon (USA) Shinshu University Harlan Laboratories Japan Co., Ltd Participation fee (including reception): ¥ 20,000 (¥ 10,000: Member of Nanomaterial Safety Evaluation Forum or Supporter) First Session: Global Regulatory Trend in Chemical Industries 13:00 – 13:40 “K-REACH Implementation, and Consolidated Investigation of Safety Assessment by the Authorities and Chemical Industries in Korea” Mr. Kim Jae Sung, Director of the Technology and Intelligence Department, Korea Chemicals Management Association (KCMA) Session chairperson: Ms. Ree Chae, Regulatory Manager, Harlan Laboratories (Korea) 13:40 – 14:20 “Current Regulatory Trend on Chemicals in China, Taiwan, and the Emerging Asian Countries” Mr. Meiguan Chen, Chief Executive Officer of HoneyComb Techno Research Inc. Session chairperson: Ms. Yumi Sano, Regulatory Manager, Harlan Laboratories (Japan) 14:20 – 14:50 “REACH Compliance, and Actions Required to Be Taken by Chemical Manufactures” Mr. John Handley, Vice President, Harlan Laboratories (UK) Session chairperson: Mr. Masamichi Kaminishi, Project Manager, Harlan Laboratories (Japan) 14:50 – 15:10 Coffee Break Second Session: Global Trend and Activities on Nanomaterial Safety Assessment 15:10 – 15:50 “A Global Trend of Regulation, and Research and Development on Nanomaterial Safety Evaluation” Atsuo Kishimoto, Ph.D., National Institute of Advanced Industrial Science and Technology (AIST) Session chairperson: Dr. Takayuki Anzai, General Manager, Harlan Laboratories (Japan and Korea) 15:50 – 16:30 “A Collective Approach to Environmental, Health, and Safety on Nanomaterials: The NanoSafety Consortium for Carbon” Mr. John C. Monica, Porter Wright Morris & Arthur LLP, U.S.A Session chairperson: Dr. John Handley, Vice President, Harlan Laboratories (UK) Spontaneous eye lesions and alterations in young adult rats of different strains ハーランラボラトリーズ （スイス）Dr. Klaus Weber 16:30 – 16:50 ® “Utility of a Multidimensional Evaluation Scheme (NanoDiversity ) for Nano Scale Materials” Takayuki Anzai, Ph.D., MBA, General Manager, Harlan Laboratories (Japan and Korea) Session chairperson: Dr. Atsuo Kishimoto, National Institute of Advanced Industrial Science and Technology (AIST) 16:50 – 17:30 “Physico-chemical Properties of Nanocarbon and its Advanced Technology Aimed at Further Industrialization” Professor Hideshi Tsuruoka, Department of Engineering, Shinshu University Session chairperson: Dr. Tamami Koyama, Facility Management of Safety Evaluation Center, Showa Denko, K.K. 17:30 – 18:00 “Histopathological Evaluation in Inhalation Studies for Carbon Nanotubes” Yoshimasa Okazaki, Ph.D., Senior Pathologist, Harlan Laboratories (Switzerland) Session chairperson: Toshihide Hayashi, Executive Director, Harlan Laboratories (Japan) 18:00 – 18:20 Panel Discussion 18:20 – 20:00 Reception (free of charge) Carbon Nanotube の病理学的評価に関して ) Anapath GmbH 岡崎 欣正 Gakushikaikan, Jinbocho Tokyo (refer to Access Map) Carbon Nanotube の病理学的評価に関して Anapath GmbH 岡崎 欣正 Room 202 Gakushikaikan, 3-28 Kanda Nishikicho, Chiyoda, Tokyo 101 -8459 Phone +81 3 3292 5936 By Metro: Toei-Mita Line, Toei-Shinjuku Line, Tokyo Metro-Hanzomon Line 1-minute walk from Jinbocho Station A9 exit （in the Tokyo Park tower, elevator is available ） By Taxi: 10-minute from Tokyo Station North Exit Organizer Contact: Ms. Megumi Nomura [email protected] Nanomaterial Safety Evaluation Forum Office Phone +81 3 5791 3771 FAX +81 3 5791 3772 Abstract & Lecturers’ Profile Mr. Kim Jae Sung Director of the Technology and Intelligence Department, Korea Chemicals Management Association (KCMA) Profile - Member of the Green Customs Committee (Korea Customs Service) - Member of the Chemical policy and Health Leadership Group (International Council of Chemical Association) - Administrator for the Chemical Policy and Health Committee (Korea Chemical Industry Council) - Member of the Voluntary Agreement Evaluation Board for the Reduction of Discharging Chemicals (Han River Basin Environmental Office) - Member of the green company evaluation board (Han River Basin Environmental Office) Abstract “K-REACH Implementation, and Consolidated Investigation of Safety Assessment by the Authorities and Chemical Industries in Korea” Korean - Japanese consecutive interpretation is available The registration and evaluation systems of chemical substances have been globally changed since changes to EU REACH and Japan CSCL. Korea is promoting the introduction of Act on Registration and Evaluation, etc of Chemical substance: Korea-REACH for industry competitiveness strength and improved management of chemical substance based on risk assessment to prevent accidents due to insufficient information on existing chemicals. In 2011 consultation among 8 ministries, preliminary announcement on legislation on Korea REACH (Feb-April, 2011) were conducted and Stakeholder’s opinions were collected in organized Forum, public hearing, and government/Industry meetings. In Policy Council and working level meeting between MOE and MKE, Korea REACH legislation and pilot project were agreed to be pushed forward simultaneously. Bill of Korea REACH will be submitted to the National Assembly in coming August through Regulatory judge, Legislative judge (Jun-July 2012). This presentation covers background, structure, details, enforcement plan, etc of Korea REACH. Mr. Meiguan Chen Chief Executive Officer of HoneyComb Techno Research Inc. Profile 多言語 MSDS 変換システムの設計構築、MSDS 作成支援総合システム開発を手がけ、中国・台湾 をメインにした MSDS 作成、化学物質登録、危険化学品の法規対応などに専門性を発揮する会社 の代表として、多岐に渡り実績を残し続けている。 現在は技術者・専門家チームのバックアップを受け、年間数百件以上も寄せられるお客様のご要望 にお応えする一方、中国・台湾の法規制動向を常にウォッチングし、お客様の中長期な戦略立案アド バイスに役立てている。お客様の「知りたい」「聞きたい」という実情から生まれるニーズに対し、法規 原文に基づく根拠と、実務経験に基づく実例によるコンサルテーションには定評がある Mr. Chen has experiences getting involved with development of various multiple language MSDS transformation processes, and MSDS production support systems. Mr. Chen has led a consulting company that specializes in registration and notification in China, Taiwan, and the emerging Asian countries, providing services including MSDS preparation and consultation on dangerous substance handling. With the support of on-site technical staff members, hundreds of registration work have been successfully completed on a yearly basis. Those achievements have been realized based on a certain policy of offering mid- or long- term strategic registration/notification scheduling, endorsed by precisely translating the original regulatory documents and abundant consultation experiences. Abstract “Current Regulatory Trend on Chemicals in China, Taiwan, and the Emerging Asian Countries” 急激に変化しつつある中国・台湾の法規制は、ますます厳しく、複雑化する一方であります。本セミナーでは、現 地の最新法規制動向を交えながら、中国・台湾における新規、既存化学物質、危険化学品、ナノマテリアルなど の規制の現状と今後の予定、そして、企業として、対応実務のポイントに絞って解説致します。 Regulations in China and Taiwan have drastically changed and become more complicated. This lecture introduces a current regulatory trend in China and Taiwan on existing and new chemicals including nanomaterials, and suggests actions to be taken the manufacturers and exporters. Mr John Handley BSc MSc CBiol FSB Vice President Global Operations, Harlan Laboratories Ltd Profile John Handley is Vice President Global Operations at Harlan Laboratories Ltd. He has some 26 years experience of working in the contract research industry. Following the completion of his Masters research in acid rain and the associated toxicity of aluminium to rainbow trout, he worked at the University of Cardiff on a research contract to the EU, developing methods for chemical registration. From there he moved to Huntingdon Research Centre where he worked in the Aquatic Toxicology department for 4 years. He moved to Safepharm Laboratories in 1989 to design and set up the ecotoxicology facility. In 2005 he became Operations Director for the company whilst still retaining management responsibility for the Department of Ecotoxicology until 2007 when the company was acquired by Harlan Laboratories Ltd and he was made General Manager for the UK. In January 2009 he was appointed Vice President Environmental Safety and Metabolism across all Harlan CRS sites. In August 2011 he took control of all Operational Units in the Harlan CRS structure. He is a member of the Society of Environmental Toxicology and Chemistry and participates on UK shadow OECD discussion panels for ecotoxicology and biodegradation. He is a EUROTOX registered toxicologist and fellow of the Society of Biology. Abstract “REACH Compliance, and Actions Required to Be Taken by Chemical Manufactures” English-Japanese simultaneous interpretation is available 2013 年 REACH 登録作業が活発化する最中、2010 年本登録物質に対する試験提案, Community Rolling Action Plan (CoRAP)、SDS 情報の公開及び秘匿に関する Q&A 公開等当局及び ECHA による見直し作業 が進められている。これら動向の総括に加え、2012 年改訂の一部でもある ECHA によるナノマテリアル に対する安全性評価見直しに関して検証する。 With regards to REACH ECHA has announced a lot of notification that require registrant’s awareness such as testing proposal, Community Rolling Action Plan (CoRAP), and SDS dissemination while 2013 registration deadline approaches. This lecture will explain about those trends, and ECHA’s attitude toward safety evaluation on nanomaterials that will be reflected in the revised REACH expected to be issued by the end of 2012. Dr. Atsuo Kishimoto National Institute of Advanced Industrial Science and Technology (AIST) Research professor, the Graduate School of Public Policy, the University of Tokyo Profile 様々な安全問題に関するリスク評価や、経済分析を含む影響評価といった、アカデミックな科学と政策意思決 定をつなぐためのレギュラトリーサイエンスを確立することを目的に各種研究を実施している。その中で、化学 物質のリスク評価・管理に関する研究実績をベースに、新興リスクのガバナンスを考えるうえでの重要なケー ススタディとして、工業ナノ材料のリスク評価のための技術開発に関する調査・研究を実施している。 With the purpose of establishing a concept “regulatory science” that realizes a connection between academic science and policy decision, Dr. Kishimoto has conducted researches of risk assessment and economic analysis on various safety issues. Among those researches is technology development of risk assessment on industrialized nanomaterials that is an important case study of risk governance against newly emerging safety issues. Abstract “A Global Trend of Regulation, and Research and Development on Nanomaterial Safety Evaluation” 既存の化学物質と比較した場合のナノ材料のリスク評価・管理の特徴と課題を挙げたうえで、前半はそれらに 対処するために、世界および日本の行政機関や国際機関によって試行されているアプローチ、および、先進 的な事業者が採用している安全性確保のための戦略について概説する。後半は、国内で実施されたナノ材料 のリスク評価研究のこれまでの成果と、現在進行中のいくつかの研究プロジェクトを紹介する。 The first half of the lecture will compare risk assessment and management between existing chemicals and nanomaterials, and explain about the approaches implemented by the domestic governments and international organizations, and introduce samples of strategically safety assessment adopted by the manufacturers or enterprises. The latter half will introduce achievements and progressing projects of nanomaterial risk assessment conducted in Japan. Mr. John C. Monica NanoSafety Consortium For Carbon, U.S.A Attorney at Law, Porter Wright Morris & Arthur LLP, U.S.A Profile The primary contact of a consortium NanoSafety Consortium For Carbon (NCC) that mainly comprises carbon nanomaterial manufacturers. The NCC submitted their proposed testing agreement, dated April 6, 2011, to the US Environmental Protection Agency. Abstract “A Collective Approach to Environmental, Health, and Safety on Nanomaterials: The NanoSafety Consortium for Carbon” English-Japanese simultaneous interpretation is available The NanoSafety Consortium for Carbon (NCC), the first group of nanoscale carbon manufacturers which have joined together to address environmental, health, safety, and regulatory issues in the U.S. in a joint fashion, have focused on U.S. issues and regulatory science needs as initial activities. In this lecture, an overview of how nanoscale carbon is regulated by the U.S. Environmental Protection Agency (USEPA) and how this approach fostered the need for NCC will be introduced. NCC’s 2011 proposal to USEPA of joint toxicity testing to satisfy regulatory requirements the Agency is imposing upon all nanoscale carbon manufacturers under the Toxic Substance Control Act, and the consortium’s scientific advisory and external liaison boards and the role they have in shaping NCC’s approach to regulatory science will be explained. Future projects NCC members are considering, including testing to determine the best methods for detecting potential release of nanoscale carbon from polymer matrices during reasonably foreseeable uses and end-of-life disposal will be also introduced. Takayuki Anzai, Ph.D., Dr.Med.Sc., MBA General Manager, Harlan Laboratories (Japan and Korea) Visiting Associate Professor, Showa Univ. School of Medicine Profile 日本における欧州 REACH 対応コンソーシアムの立ち上げから運営に携わり、欧州当局、関連団体との関係構 築、折衝等を数々手がけている。また、環境リスクアセスメント、ナノマテリアルについての安全性管理の在り方に ついて有用な論文を発表している。 また、ハーランラボラトリーズの世界的ネットワークを駆使した情報収集力を 武器に、日本の事業者が世界で戦うための後方支援を行っている。 Dr. Anzai has helped form and run several counterpart consortium that comprise Japan -based chemical companies, and established the profound relationships in communication between European authorities and the registrant in Japan since REACH was implemented in EU. Dr. Anzai has also published several journals that introduce safety management models on environmental risk assessment and nanomaterials, and supported the clients sharing timely information obtained through Halan’s global network. Abstract “Utility of a Multidimensional Evaluation Scheme (NanoDiversity®) for Nano Scale Materials” 既存の法規制を有効利用しつつ、工業用原材料としてのナノマテリアルと製品中のナノマテリアルを合理的に分 別し、さらにできるだけ無駄を省いた安全性評価を行うための画期的スキームが 2012 年 3 月の米国毒性学会で 発表された。この NanoDiv®はヒトへの安全はもとより環境曝露による影響評価までカバーしており、今後の法規 制の在り方を示唆するスキームとして注目されている。本講演においてはこの NanoDiv®の有用性を詳しく解説す る。 A safety evaluation sheme trademarked NanoDiv® that divides type of nanomaterials into raw materials for industrial use and consumer products while utilizing essences of currently implemented regulations were introduced at the annual meeting of the Society of Toxicology in the US held in March 2012. NanoDiv® covers not only human hazard assessment but also environmental exposure evaluation concurrently, and has been regarded a template design that might affect current regulations. Prof. Hideshi Tsuruoka Department of Engineering, Shinshu University Profile 2002 年よりナノカーボン研究に携わり 04 年から国内ナノ標準化準備委員参画、05 年から CNT の安全性評価へ 参画する。各国国研・主要研究機関との連携を行っている。11 年 2 月より現職。ナノカーボンの照射線吸収と安 全性評価研究が専門 Prof. Tsuruoka has researched nanocarbon technologies since 2002, and assigned a member of Japan Committee for Nanomaterial Standardization in 2004, and initiated safety assessment on carbon nanotube in 2005. Prof. Tsuruoka, assigned to current position in February 2011, specializes in nanocarbon capable of absorbing irradiated radiation and safety assessment on nanomaterials. Prof. Tsuruoka has also played a role of maintaining collaborative network with national research institutes among a lot of countries. Abstract “Physico-chemical Properties of Nanocarbon and its Advanced Technology Aimed at Further Industrialization” ナノカーボンの物性と応用可能性および工業化における安全性指針を中心に、事業者が留意すべき点、今後の ナノカーボンの将来性について、詳しく解説する。 Physico-chemical properties of nanocarbon and its potential application and industrial use including safety assessment will be introduced while future vision of nanocarbon technologies is discussed. Yoshimasa Okazaki, D.V.M., Ph.D. Senior Pathologist, Harlan Laboratories and AnaPath GmbH (Switzerland) Profile 農・医薬品、食品添加物から一般化学品まで、低分子化合物から高分子抗体医薬品まで、初期スクリーニングか らがん原性試験まで、また、ラット・マウスの小動物げっ歯類から、ウサギ、イヌ、霊長類まで、様々な分野、品 目、開発ステージで各動物種での安全性評価の経験を積んできた。現在も毒性試験の病理担当者として従事す るとともに、これまでの経験を生かして、主に病理学的側面から試験責任者のサポートを行っている。 Dr. Okazaki, the incumbent senior pathologist at Harlan Laboratories, has conducted toxicity evaluations at various stages, ranging from initial screening through carcinogenicity studies on pharmaceuticals, agrochemicals, food additives, and industrial chemicals. Abstract “Histopathological Evaluation in Inhalation Studies for Carbon Nanotubes” ナノマテリアル自身が持つ特性（サイズが小さい、表面積が大きい、酸素反応活性化能力が高い）のために、これ まで我々が経験してきた化合物・化学物質とは、その有害性が異なることが指摘されているものの、有害作用の 実態が明らかでないために未知の毒性懸念がことさら注目されてしまうことも少なくない。ナノマテリアルの毒性 評価は始まったばかりであり、この新素材が生体に及ぼす有害作用の特徴を知り、より適切な毒性評価体系を 構築し、的確に毒性評価を行うことで、その有用性をさらに高めることにつなげていくことが重要である。ここで は、ナノマテリアルを実験動物に投与したときに観察される所見について、主に組織形態学側面からその特徴を 整理し、毒性評価時の留意点についても触れてみたい。 Nano -specific characteristics (e.g. small size, large surface area, generation of reactive oxygen species) has suggested unknown toxicity concerns that differ from the hazardous effects generally caused by the conventional compounds and chemicals. It is therefore important to realize the trend of hazardous effects caused by nanomaterials and establish a more systematical toxicity evaluation as the first approach. This lecture will discuss those effects of morphological changes that are actually located after nanomaterials including carbon nanotube are dosed to experimental animals. Session Chairperson Profile Dr. Tamami Koyama Facility Management of Safety Evaluation Center, Showa Denko, K.K バイオの研究者として同社に入社後、英国立医学研究所（National Institute for Medical Research）に留学。帰国後、臨床診断システムの 開発業務等を経て、高分子エレクトロニクス分野に転向。 高分子有機 EL の開発リーダを経て、2 年間の内閣府総合科学技術会議での政策立案に携るなど 幅広い業務に従事。現在は安全性試験センター長。 Dr. Koyama who originally specializes in biotechnology has an experience of learning at the National Institute for Medical Research in the United Kingdom. After retuning to Japan, Dr. Koyama got involved wth development of clinical diagnosis system, followed by current researches in the arena of macromolecular electronics. Dr. Koyama also has experiences of leading development of macromolecular organic EL devices, and of 2-year policy making work at the Council for Science and Technology Policy of Cabinet Office. Ree Chae Regulatory Manager Harlan Laboratories (Korea) Toshihide Hayashi Executive Director Harlan Laboratories (Japan) Yumi Sano, MS Regulatory Manager Harlan Laboratories (Japan) Masamichi Kaminishi, BS Project Manager Harlan Laboratories (Japan) Access Map – Gakushikaikan, Jinbocho Tokyo Room 202 Gakushikaikan, 3-28 Kanda Nishikicho, Chiyoda, Tokyo 101-8459 Phone +81 3 3292 5936 By Metro: Toei-Mita Line, Toei-Shinjuku Line, Tokyo Metro-Hanzomon Line 1-minute walk from Jinbocho Station A9 exit（in the Tokyo Park tower, elevator is available） By Taxi: 10-minute from Tokyo Station North Exit Gakushikaikan
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