us-fifra versus eu-bpr click to edit master title style jones.pdf · click to edit master title...

Click to edit Master title style

Click to edit Master subtitle style

1-7-2018 1

US-FIFRA VERSUS EU-BPRUS-FIFRA VERSUS EU-BPR- An incomplete comparison- An incomplete comparison

June 26th, 2018 ©

© Ryan Clapper



1-7-2018 2©June 26th, 2018 ICMCF Melbourne, Florida

Diplomatic relations between the EU and the US date back to 1953




Travellers’ trials and tribulations



1-7-2018 4©

Senior citizen versus 5-year old toddlerSenior citizen versus 5-year old toddler

ICMCF Melbourne, FloridaJune 26th, 2018

US-FIFRA EU-BPR1947Federal Insecticides, Fungicides and Rodenticides Act (7 U.S.C. §136 et seq.)

2012Biocidal Products Regulation (EU No. 582/2012) –successor of BPD Directive (98/8/EC). Application 2013.

Data requirements40 CFR Part 158; new part 158W (2013)Grouped in 5 categories, 4 use patterns plus 1 other. One is AF.

Information requirementsAnnex II – active substances; Annex III – biocidal productsEssentially same for all 22 product types.

United States= United States of AmericaFederal system - Comprising 50 states

European Union≠ United States of Europe!..., BUT... 28 EU Member States plus few other countries

Not generally cause unreasonable effectsBefore 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,...

Precautionary principleThe 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.

Old and wise?Established system, ‘Organic’ regulatory growth, stable rules.

Young and reckless?Learning by doing, ‘dynamic’ guidance, deadline-stressed



1-7-2018 5©

United States of America ...Europe?United States of America ...Europe?

June 26th, 2018 ICMCF Melbourne, Florida

BP – Member States

AS - UnionAI, MUP/EUP - Federal

MUP/EUP - States



1-7-2018 6©





MUP/EUP - States

Limitedinformation

package- State may set

additional, stricter rules, requirements



1-7-2018 7©





MUP/EUP - States

No Union Authorisationfor AF paints!Mutual

Recognitionbetween MS, disagreement

possible




US - EPAhttps://www.epa.gov/pesticide-registration/antimicrobial-policy-and-guidance-documents




US - EPAhttps://www.epa.gov/pesticide-registration/antimicrobial-policy-and-guidance-documents

40 CFRPart 158W




EU - ECHA

https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation




EU - ECHA

https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislationAntifouling-specific guidance

• Efficacy assessment for PT-21• Dermal absorption antifoulings• Manual of Technical

Agreements• Technical Agreements Biocides• ...• ...• Excel calculation sheets for

marinas – dd.13 Oct. 2017..!!!

Dossier deadline most copper-containing antifoulingsJan. 1st, 2018




Travellers’ trials and tribulations




Ease of decisionmaking process inversely proportional to parties involved

Administrator

Standing CommitteeBiocides

Member States -Competent Authorities

Activesand

ProductsActives

Products

Outcome?

Mutual Recognition




... causes issues with legal deadlines - delays

PRIA- registration categories

- deadlines (Congress!)

- fees

BPR- registration categories

- deadlines (Challenge!)

- separate feeslegislation (EU plus MS)




Application categories



1-7-2018 16©

Product families - group of productsProduct families - group of products


Product family – EU BPRProducts having similar uses,the same active substances,similar composition with specified variations,

similar levels of risk and similar efficacy



1-7-2018 17©

BPR – hazard-based exclusion criteria for ASBPR – hazard-based exclusion criteria for AS

Hazard – based on intrinsic properties of a substancelabelling classification, e.g. CMR

Risk – about exposure versus safe levels

Hazard – based on intrinsic properties of a substancelabelling classification, e.g. CMR

Risk – about exposure versus safe levels




1-7-2018 18©

Risk assessment not only of the actives!Risk assessment not only of the actives!




MUP/EUP - States

Inerts!

Substancesof Concern!



1-7-2018 19©

From exclusion to exclusive useFrom exclusion to exclusive use


US-FIFRA EU-BPRExclusive 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.

Data protectionData 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.

CompensationAfter 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.

Data sharing/compensation –obligatory for vertebrate studiesWhere 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.

Cite-all or selectiveCite-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.Letter of Authorization always necessary in Exclusive Use period.

Access to all or part of a dossierThe 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).



1-7-2018 20©

Notions and hopes for the futureNotions and hopes for the future EU best boy in class or ‘world upside down’?Risk perception toddler > risk perception senior citizen

Senior citizen to take toddler by the handEU: “Don’t bite off more than you can chew”

Toddler to inspire senior citizenUS: “Pesticide product families?”

Connect!

EU best boy in class or ‘world upside down’?Risk perception toddler > risk perception senior citizen

Senior citizen to take toddler by the handEU: “Don’t bite off more than you can chew”

Toddler to inspire senior citizenUS: “Pesticide product families?”

Connect!




1-7-2018 21©

QUESTIONS?QUESTIONS?

drs. Linda Jones MScZandhuizerweg 338389 TC ZandhuizenThe NetherlandsMobile: +31 (0) 622 422 [email protected]

drs. Linda Jones MScZandhuizerweg 338389 TC ZandhuizenThe NetherlandsMobile: +31 (0) 622 422 [email protected]





Mini-dictionaries

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).

A “new active ingredient” is an active ingredient that is not currently contained as an active ingredient in any EPA registered pesticide product.




BREXIT UK withdrawing from EU legislationEffective withdrawal March 2019

(New) approvals/authorisationsUK authority no longer available

Future role of UK-HSE Competent Authority in EU-process unknownAdvisory?

ECHA guidance for questions on BREXIThttps://echa.europa.eu/uk-withdrawal-from-

the-eu

UK withdrawing from EU legislationEffective withdrawal March 2019

(New) approvals/authorisationsUK authority no longer available

Future role of UK-HSE Competent Authority in EU-process unknownAdvisory?

ECHA guidance for questions on BREXIThttps://echa.europa.eu/uk-withdrawal-from-

the-eu

us-fifra versus eu-bpr click to edit master title style jones.pdf · click to edit master title...

Documents