A two-day conference bringing together experts from the USA, Asia and Europe to discuss latest developments in the regulation of Biocides (Antimicrobials)

TWO-DAY CONFERENCE

1112

APRIL

BIOCIDES USA 20162ND ANNUAL US/GLOBAL BIOCIDES (ANTIMICROBIALS) REGULATION CONFERENCE

WASHINGTON DC

WHY ATTEND?EXPERT PANELListen to senior representatives from Institutions and Regulators together with industry representatives and service providers.

CURRENT THINKINGGain valuable insight into the current state of biocides regulation in North America, Europe and Asia.

TIME EFFICIENCYBring yourself completely up-to-date with the complex and changeable landscape of biocides regulation in North America, Europe and the Rest of the world by attending two conference days.

FOCUSMeet the experts and bring yourself up-to-date with the latest thinking across a wide range of jurisdictions.

Q&A PANEL SESSIONSHave your specific questions answered by making use of the multiple Q&A sessions. Remember - you can send in any questions you might have in writing in advance of the conference.

Who should attend? Representatives from producers, exporters. formulators and retailers of biocidal products

Regulators

Advisors

Competent authorities All other stakeholders

About this eventThis conference focuses on the regulation of biocides. The first day covers new developments in the US, including:

• Data requirements 158W

• US Regulation/Review program and data call-ins

• Food contact

• New Technologies

Day Two of the conferences looks at global development in the regulation of biocides.

Countries and legislation to be covered include:

• Masterbatches in the EU/USA

• China

• South Korea

• The rest of ASEAN

• Egypt, Gulf Cooperation Council and South Africa

• The EU

• The work of the OECD Task Force

• Electronic data submission - global cooperation

The conference closes with a round table session covering the challenges of working in a global market and will include cross-comparisons between the EU, US and China.

BIOCIDES USA 20162ND ANNUAL US/GLOBAL BIOCIDES (ANTIMICROBIALS) REGULATION CONFERENCE

11-12 APRIL 2016, WASHINGTON DC

DAY ONE – 11 APRIL 2016

08:30 Coffee and Registration

09:00 Chair’s Introduction

SESSION 1: Data Requirements 158W

09:10 Data Requirements 158W including Use Site Index, a status report and implementation of new data requirements• Data requirements for new applications in specific use sites• Concerns with application of data requirements to existing

registrationsJan Dhonau, Principal Scientist, Global Product Stewardship, Procter & Gamble, USA

09:35 Ecotox and Environmental Fate – Data Requirements and how data will be usedSeth Goldberg, Partner, Steptoe & Johnson LLP, USA

10:00 Q&A

SESSION 2: US Registration/Review program and data call-ins (a status report and implementation of new data requirements)

10:15 EPA update on anitmicrobial product reevaluaton and data call-ins• The role of the EPA's reregistration and registration review

programs• Updates about antimicrobial product data call-ins• Challenges and tips for responding to data call-insRose Kyprianou, Antimicrobials Division Reevaluation Team Leader, US EPA

10:40 View from Industry• EPA’s Data Call In Process Explained• Preparation for EPA Data Call In’s( DCI)• Strategy for Data Development In DCI Response• Implications for Certain Active Ingredients• How To Help on DCI Dossier Preparation David Swain, Vice President, Scientific and Regulatory Consultants Inc.

11:05 Round table session on 158W

11:35 Refreshments

SESSION 3: New Technologies

11:50 Current political climate – global acceptance of in vitro methods• Drivers of in vitro methods• Beyond the “six-pack” battery of acute toxicity tests: are in vitro

methods used for any of the following end points? - Acute oral toxicity - Acute dermal toxicity (oral vs dermal route comparison) - Acute inhalation toxicity - Ocular irritation (the EPA OPP testing strategy updated in

2015) - Skin irritation/corrosion - Skin sensitization

• Steps to accomplish global harmonization of the hazard classification schemes

Gertrude-Emilia Costin, Ph.D., M.B.A., Senior Toxicologist and Study Director, Institute for In Vitro Sciences, Inc. (IIVS)

12:15 Overview of Pesticide Devices• Pesticide device definition• Requirements for devices• Pestcide device of pesticide product?• Registration of device inputs and outputs• Claims and enforcementDemson Fuller, Product Manager, Team 32, Antimicrobials Division, US EPA

12:40 In-Situ biocidal agents• Background• EPA’s approach to regulating In Situ biocides• Generation via reaction between two or more chemicals• Generation via mechanical, electrical or similar actionSeth Goldberg

13:05 Q&A

13:20 Lunch

SESSION 4: Food Contact

14:20 An Overview of EPA/FDA Jurisdiction of Food Contact Antimicrobial Products• The Statutory Framework for Regulation of Food Contact

Antimicrobial products• Key definitions which drive jurisdiction between EPA and FDA• What are the implications of the current jurisdiction landscape

in the US for food contact antimicrobials• Resources to help determine how a food contact antimicrobial is

regulated by EPA and FDA• The value of pre-submission meetingsJohn Wood, Senior Director – Agency relations, Law & Regulatory Affairs, Ecolab

14:45 FDA Regulatory Considerations: Antimicrobials and Foods• How FDA reviews food contact notifications• How our review differs from those of EPA and USDA• A nuts-and-bolts description of the FDA review processThomas C. Zebovitz, Consumer Safety Officer, Food and Drug Administration,Office of Food Additive Safety, Division of Food Contact Notifications

15:10 Collaborative Reviews Between EPA and FDA on Antimicrobials: A Look Forward• The recent MOU between FDA and EPA• EPA’s Process in the Context of FDA’s Review• Goals for the Evolving Collaborative ProcessEric Miederhoff, Product Manager, Team 31, Antimicrobials Division, US EPA

15:45 The establishment of limits for residues of active substances contained in biocidal products under the EU Biocidal Product Regulation• Food safety in the EU• Overview of relevant EU legislation for biocidal residues• In which situations and/or under which conditions it is

considered necessary to establish limits for biocidal residues• The procedure/approach to set limits• State of play of EU policy discussionKarin Mahieu, European Registered Toxicologist, Centre for Nutrition Prevention and Health Services, Netherlands

DAY TWO – 12 APRIL 2016

16:10 Q&A

16:40 Refreshments

SESSION 5: Other Current US Issues

17:00 Regulation of Emerging Pathogen Claims• Explore current EPA Policy on Emerging Pathogen Claims• Discuss upcoming changes/new Draft Policy• Discuss impact of use of organism hierarchy models• Review EPA approval of prior Emerging Pathogen ClaimsDiane Boesenberg, Reckitt Benckiser Group, USA

17:25 Enforcement of Antimicrobial Regulation in the US• Overview of how antimicrobials are regulated under FIFRA• Introduction to enforcement under FIFRA• How EPA monitors antimicrobial product compliance• Noncompliance and enforcement trends involving

antimicrobial products• Highlights of enforcement actions initiatedDonald J Lott, Associate Director, Waste & Chemicals Enforcement Division, U.S. Environmental Protection Agency, Washington, D.C.

17:50 Q&A

18:10 Close of Day One

18:15 – 20:00 Optional evening workshop on the EU Biocidal Products Regulation (free of charge) to be presented by Lawyers from Steptoe & Johnson, Brussels OfficeOutline program:

• Fair compensation and access to the market under the BPR Data Compensation Rules

• Market Access for Treated Articles: Continuing issues in the EU Approach

• Choosing the best route to biocidal product (formulated product in the US) authorization under the BPR

SESSION 6: Intermediate Treated Articles

09:30 Masterbatches in the EU• Treated articles• Masterbatches• Guidance• ExampleThomas Raas, Redebel, Belgium

09:55 Intermediate Treated Articles in the USAdrian Krygsman, Troy

10:20 Q&A

SESSION 7: Update on Global Regulations

10:30 From National Laws to European Regulation (BPR) – Challenges and opportunities for Industry• National Schemes• Implementation of BPR’s principles• Challenges behind the BPR

- Deadlines and costs - Complexity of the legislation - IT tools management

• Opportunities behind the BPR - Mutual Recognition of authorization across EU - Regulatory opportunities

• Focus on Biocidal product familyThomas Raas, Regulatory affairs specialist for Biocidal products, Redebel, Belgium

11:00 Q&A

11:15 Coffee

11:35 China: The pesticide registration system and regulation of non-agricultural chemicals • China pesticides industry and pesticides registration• Authority of China Pesticides Registration• China pesticides registration system• Registration requirements of sanitary pesticidesYong Jiang, Project Director, Product Registration and Compliance Department, China National Chemical Information Centre, China

DAY ONE – 11 APRIL 2016

Reservations: www.chemicalwatch.com/Biocides-USA-2016Email: orders@chemicalwatch.com Tel: +44(0) 1743 818297

12:05 South Korea• Korean legislation that touches upon biocides:• Pharmaceutical Affairs Act - biocides, extirpators, repellents, etc.

(Ministry of Health and Welfare)• Regulation on Veterinary Drugs (Ministry of Agriculture, Food

and Rural Affairs)• Marine Environment Management Act (Ministry of Oceans and

Fisheries)• Drinking Water Management Act (Ministry of Environment)• Food Sanitation Act (Ministry of Food and Drug Safety)• K-REACH on potentially risky products (Ministry of

Environment• Future of biocides regulations in South KoreaCy Kim, Kim & Chang, South Korea

12:35 Q&A

13:00 Lunch

14:00 Round table session: The challenges of working in a global market: cross comparisons between EU-US and Asia

14:30 Biocides in Asea – a brief overview of biocide management in• Thailand• Malaysia• Philippines• Singapore• Indonesia• Vietnam• Including information on your obligations, responsibilities

and enforcementDeirdre Lawler, Head of Industsrial Chemicals & Biocides - Regulatory Affairs, Dr Knoell Consult GmbH, Germany

15:00 Biocides Regulation Framework in Egypt, GCC and South Africa• GCC:

- Regulatory framework - Main regulations and definitions - Registration - Labelling and packaging

• South Africa - Main regulations and definitions - Registration - Labelling and packaging

• EgyptZeina Attar, Senior Regulatory Analyst, 3E, USA

15:30 Q&A

15:45 Refreshments

SESSION 8: Other Global Developments/Global Cooperation

16:00 The work of the OECD Task Force• Objectives and goals• Activities• US Priorities• ChallengesJennifer Mclain, US EPA

16:30 Electronic Data Submission • Pesticide Submission Portal• Pesticide SmartLabel• eCFS/eCSPC• IUCLID• eSSTSRobert Schultz, Chief, Systems Design and Development Branch, Office of Pesticide Programs, US EPA and Dominique White, PMP, Senior IT Project Manager, Office of Pesticide Programs, US EPA

17:00 Close of conference

Reservations: www.chemicalwatch.com/Biocides-USA-2016Email: orders@chemicalwatch.com Tel: +44(0) 1743 818297

3 WAYS TO REGISTER

LOCATION & TIMINGS

www.chemicalwatch.com/Biocides-USA-2016

orders@chemicalwatch.com +44(0) 1743 818297

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PRICES

TWO-DAY CONFERENCE $1385 (Early Bird price if booked before 29/02/16) $1585 (Full price if booked after 29/02/16)

CHEMICAL WATCH SUBSCRIBERS $1285 (Early Bird price if booked before 29/02/16) $1485 (Full price if booked after 29/02/16)

Payment options:1. Invoice payable by bank transfer, credit card or check made payable to CW Research LLC.

2. Online using our secure order-form.

Renaissance Arlington Capital View2800 South Potomac Avenue, Arlington, VA, 22202Tel: 571.814.4028 Fax: 571.814.4084

We have arranged a special bedroom rate for Conference participants at the Renaissance Arlington Capital View Participants will be sent a link for booking hotel accommodation directly with the hotel.

CW Research LLC, One Democracy Plaza, 6701 Democracy Blvd. Suite 300, Bethesda, MD 20817, United States

EVENT TIMINGS:

Monday 11th April, 2016 08:30-18:10

Tuesday 12th April, 2016 09:00-17:00

Payment must be made before the event starts.

Reservations: www.chemicalwatch.com/Biocides-USA-2016Email: orders@chemicalwatch.com Tel: +44(0) 1743 818297