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1 US-FIFRA VERSUS EU-BPR - An incomplete comparison Click to edit Master subtitle Ryan Clapper

2 Diplomatic relations between the EU and the US date back to 1953 Click to edit Master subtitle June 26 th, 2018

3 Travellers trials and tribulations Click to edit Master subtitle June 26 th, 2018

4 Senior citizen versus 5-year old toddler Information requirements Click to edit Master subtitle Old and wise? Young and reckless? Established system, Organic regulatory growth, stable rules Learning by doing, dynamic guidance, deadline-stressed 4 US-FIFRA 1947 Federal Insecticides, Fungicides and Rodenticides Act (7 U.S.C. 136 et seq.) Data requirements 40 CFR Part 158; new part 158W (2013) Grouped in 5 categories, 4 use patterns plus 1 other. One is AF. United States = United States of America Federal system - Comprising 50 states Not generally cause unreasonable effects Before EPA may register a pesticide under FIFRA, the applicant must show, among other things, that using the pesticide according to specifications "will not generally cause unreasonable adverse effects on the environment.'' FIFRA defines...:...any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide,... EU-BPR 2012 Biocidal Products Regulation (EU No. 582/2012) successor of BPD Directive (98/8/EC). Application Annex II active substances; Annex III biocidal products Essentially same for all 22 product types. European Union United States of Europe!..., BUT EU Member States plus few other countries Precautionary principle The purpose... to improve the functioning of the internal market through the harmonisation of the rules..., whilst ensuring a high level of protection of both human and animal health and the environment.... underpinned by the precautionary principle, the aim... safeguard the health of humans, the health of animals and the environment. Particular attention... protection of vulnerable groups.

5 United States of America...Europe? AI, MUP/EUP - Federal AS - Union Click to edit Master subtitle MUP/EUP - States BP Member States

6 United States of America...Europe? AI, MUP/EUP - Federal AS - Union Click to edit Master subtitle MUP/EUP - States Limited information package - State may set additional, stricter rules, requirements BP Member States

7 United States of America...Europe? AI, MUP/EUP - Federal AS - Union Click to edit Master subtitle MUP/EUP - States No Union Authorisation for AF paints! Mutual Recognition between MS, disagreement possible BP Member States

8 US - EPA Click to edit Master subtitle

9 40 CFR Part 158W US - EPA Click to edit Master subtitle

10 EU - ECHA Click to edit Master subtitle

11 EU - ECHA Antifouling-specific guidance Efficacy assessment for PT-21 Dermal absorption antifoulings Manual of Technical Agreements Click to edit Master subtitle Technical Agreements Biocides Excel calculation sheets for marinas dd.13 Oct !!! Dossier deadline most coppercontaining antifoulings Jan. 1st, 2018 June 26, 2018 th 11

12 Travellers trials and tribulations Click to edit Master subtitle June 26 th,

13 Ease of decisionmaking process inversely proportional to parties involved Actives and Products Administrator Click to Actives edit Master title Standing Committee Biocides Click to edit Master subtitle Products Outcome? Member States - Competent Authorities Mutual Recognition June 26 th,

14 ... causes issues with legal deadlines - delays June 26 th, 2018 Click to edit Master subtitle - registration PRIA categories - deadlines - registration (Challenge!) categories - separate fees - deadlines legislation (Congress!) (EU plus MS) - fees BPR

15 Application categories Click to edit Master subtitle June 26 th, 2018

16 Product families - group of products Product family EU BPR Products having similar uses, the same active substances, similar composition with specified variations, similar levels of risk and similar efficacy Click to edit Master subtitle June 26 th, 2018

17 BPR hazard-based exclusion criteria for AS Hazard based on intrinsic properties of a substance labelling classification, e.g. CMR about exposure versus safe levels Risk Click to edit Master subtitle

18 Risk assessment not only of the actives! Inerts! AI, MUP/EUP - Federal AS - Union Click to edit Master subtitle MUP/EUP - States Substances of Concern! BP Member States

19 From exclusion to exclusive use Click to edit Master subtitle Letter of Authorization always necessary in Exclusive Use period. 19 US-FIFRA Exclusive use Exclusive-use treatment for data means that the data may not be relied upon by other applicants or registrants to support FIFRA registration and reregistration actions without the permission of the data submitter. A 10-year period of protection for such data begins from the date of the original registration of the pesticide. Compensation After the exclusive use period has expired, the owner of the data may still be entitled to compensation. F.i. when data are within the 15-year compensatory period (period begins on the date the data were originally submitted to EPA). Applicants and registrants may not rely on data that retain compensation rights to support registration or reregistration unless they have first offered the data submitter compensation for the use of such data. Cite-all or selective Cite-All: The applicant cites to all the pertinent data in the Agency files for the requested registration action. Selective Method: The applicant selectively cites to individual studies, including the applicant s own data. EU-BPR Data protection Data submitted for the purposes of BPD or BPR shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where the data protection limit has expired or a Letter of Access has been provided. The protection period for data submitted: 10 years for approval of existing actives substance from approval decision, 15 years for new active substances. Data sharing/compensation obligatory for vertebrate studies Where the data are still protected the prospective applicant may, or shall in the case of vertebrate studies, request from the data owner all the related scientific and technical data as well as the right to refer to these data. Prospective applicant and data owner shall make every effort. Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner. Access to all or part of a dossier The prospective applicant might not own the data but nevertheless has reached an agreement with the data owner that it can use the data for BPR purposes. Usage of the data will depend on the agreement with the data owner and could include a Letter of Access (by reference or physical access).

20 Notions and hopes for the future EU best boy in class or world upside down? Risk perception toddler > risk perception senior citizen EU: Don t bite off more than you can chew Senior citizen to take toddler by the hand Toddler to inspire senior citizen Click to edit Master subtitle US: Pesticide product families? Connect!

21 QUESTIONS? drs. Linda Jones MSc Zandhuizerweg TC Zandhuizen Click to edit Master subtitle The Netherlands Mobile: +31 (0)

22 Mini-dictionaries Click to edit Master subtitle A new active ingredient is an active ingredient that is not currently contained as an active ingredient in any EPA registered pesticide product June 26 th, 2018 A new active substance is a substance which was not on the market on 14 May 2000, as an active substance of a BP for purposes other than scientific or product and process- orientated research and development (Article 3(1)(e) of the BPR).

23 BREXIT UK withdrawing from EU legislation Effective withdrawal March 2019 UK authority no longer available (New) approvals/authorisations Future role of UK-HSE Competent Authority in EU-process unknown Click to edit Master subtitle Advisory? ECHA guidance for questions on BREXIT June 26 th, 2018