The role of non-animal safety assessment methods in implementation of the new TSCA

Transcription

1 The rle f nn-animal safety assessment methds in implementatin f the new TSCA Catherine Willett Humane Sciety f the United States Humane Sciety Internatinal

2 The Frank R. Lautenberg Chemical Safety fr the 21st Century Act: Reductin f Testing n Vertebrates Sec. 4(h):Reductin f Testing n Vertebrates: IN GENERAL The Administratr shall reduce and replace, t the extent practicable, scientifically justified, and cnsistent with the plicies f this title, the use f vertebrate animals in the testing f chemical substances r mixtures under this title

3 The Frank R. Lautenberg Chemical Safety fr the 21st Century Act: Reductin f Testing n Vertebrates prir t making a request r adpting a requirement fr testing using vertebrate animals taking int cnsideratin reasnably available existing infrmatin scientifically valid test methds and strategies nt using vertebrate animals chemical gruping the frmatin f industry cnsrtia Requirement t replace vertebrate testing applies t required and vluntary testing Any persn develping infrmatin fr submissin under this title n a vluntary basis and nt pursuant t any request r requirement by the Administratr shall first attempt t develp the infrmatin by means f an alternative test methd r strategy

4 Implementatin f Alternative Methds T prmte the develpment and timely incrpratin f new scientifically valid test methds and strategies that are nt based n vertebrate animals the EPA shall: Create a strategic plan t prmte the develpment and implementatin f alternative test methds and strategies Within tw years f implementatin (by June 22, 2018) Priritize the develpment and implementatin f methds and appraches nt using vertebrate animals

5 Other elements impacting animal testing Decisins are risk based priritizatin and evaluatin are risk, nt hazard, based fr bth new and fr existing chemicals data requirements shuld be related t expsure/use Priritizatin f existing chemicals EPA has ne year t establish a risk-based screening prcess t determine whether existing chemicals are lw r high pririty Intentin is t priritize based n existing infrmatin and fcus resurces (testing) n chemicals f highest pririty Requirement fr tiered screening and testing When requesting any new infrmatin, the EPA must emply a tiered screening and testing prcess Intentin is fcus resurces n infrmatin necessary fr regulatin

6 Other impacting elements Tight timelines EPA has ne year t establish a risk-based screening prcess t determine whether existing chemicals are lw r high pririty Priritizatin prcess: 6-9 mnths Risk evaluatin determinatin: 3 yrs + 6 mnths pssible extensin EPA has tw years t develp the strategy fr reducing and replacing vertebrate animal testing

7 EPA interpretatin and prpsals Draft rules issued Jan 17, cmments due March 20, Final rules due June 22,2017 Requirement t reduce and replace vertebrate animal use is statutry and nt subject t rule-making Risk must encmpass all knwn, intended and reasnably freseen expsure scenaris (ne assessment per chemical) EPA will nt initiate chemical priritizatin until it has all f the infrmatin it expects t need fr a full risk assessment

8 Priritizatin draft rule + EPA is prpsing a fur-step prcess fr priritizatin: 1) pre-priritizatin mst data will be generated here 2) initiatin (public cmment) clck starts ticking: 6 9 mnths 3) prpsed designatin (public cmment) 4) final designatin: mves directly t risk assessment + High-Pririty designatin: may present an unreasnable risk because f a ptential hazard and a ptential rute f expsure a fairly lw bar all chemicals lacking sufficient infrmatin will default t high pririty Lw-Pririty designatin requires sufficient infrmatin fr all cnditins f expsure a fairly high bar

9 Priritizatin draft rule: cnsequences + Prpsed new phase f pre-priritizatin By-passes legislated deadlines Circumvents legislative intent t: Rapidly identify chemicals that require immediate attentin Priritize using largely existing infrmatin Increase public cnfidence abut large numbers f untested chemicals Des nt actually priritize chemicals Mst chemicals likely will be designated high-pririty Hazard infrmatin will likely be gathered n mst chemicals Culd result in REACH-like levels f testing (as a part f priritizatin) Des nt fcus resurces n chemicals f mst ptential risk Public (and regulated) cmmunities left in the dark regarding the vast majrity f chemicals

10 Priritizatin draft rule: suggestins + Pre-Priritizatin culd instead: Initially fcus n chemicals n existing lists f cncern Including EPA s wn TSCA wrk plan 90 chemicals in 2014 update And f these, data rich chemicals shuld be priritized fr initiatin This apprach wuld give EPA ample time t develp a cmprehensive and transparent priritizatin prcess Cmments frm Humane Sciety f the United States and Gradient Crp n Prpsed Rule: Prcedures fr Priritizatin f Chemicals fr Risk Evaluatin Under the Txic Substances Cntrl Act, Dcket ID EPA- HQ-OPPT

11 Priritizatin draft rule: suggestins Adapting existing prcess: + Canada's Chemical Management Prgram (CMP) + Australia's Natinal Industrial Chemicals Ntificatin and Assessment Scheme (NICNAS) + ILSI/HESI s RISK21 matrix + Pre-Priritizatin prcess shuld require n r very little new infrmatin generatin r new vertebrate animal testing

12 Priritizatin draft rule: suggestins RISK21 Decisin Matrix Matrix is decisin cntext-dependent Map chemicals based n existing infrmatin/predictin Includes uncertainty estimate Readily identifies where additinal infrmatin wuld reduce uncertainty Tiered data gathering fcused n reducing uncertainty Internatinal Life Sciences Institute/Health and Envirnmental Sciences Institute (ISLI/HESI) Risk21 prject De et al. Critical Reviews in Txiclgy Wlf et al. Critical Reviews in Txiclgy 2014.

13 Priritizatin draft rule: suggestins This type f apprach wuld: Allw transparent cmmunicatin f relative risk f chemicals in the active TSCA inventry Enhance public cnfidence that pririty chemicals were being addressed first Fcus resurces (and testing) n pririty chemicals Prvide industry with an incentive t prvide infrmatin (especially expsure) t reduce uncertainty

14 Risk evaluatin draft rule Must determine whether a chemical presents unreasnable risk within 3 years with pssible 6 m. Extensin Must have 20 assessments in prcess by 2019, and 20 nging thereafter: at least 50% frm 2014 TSCA wrk plan % manufacturer-requested Risk evaluatin Scping (6 m. after start f RA) affected ppulatins spectrum f knwn, expected and reasnably freseen expsures (public cmment) Hazard assessment Brad ptential cnsideratins n descriptin f hw infrmatin requests relate t risk assessment (ther than general fit fr purpse ) Includes dse-respnse infrmatin Expsure assessment Risk characterizatin

15 Risk evaluatin draft rule Prpsed prcess is similar t existing appraches t integrated testing and assessment, e.g. OECD IATA a structured apprach that strategically integrates and weights all relevant data t infrm regulatry decisins regarding ptential hazard and/r risk and/r the need fr further targeted testing and therefre ptimising and ptentially reducing the number f tests that need t be cnducted. Prblem frmulatin Gather existing infrmatin MORE INFORMATION NEEDED? Design nn-testing strategy Design testing strategy Repeat until questin is answered t necessary certainty Reprt f the Wrkshp n a Framewrk fr the Develpment and Use f IATA OECD Series n Testing and Assessment N. 215

16 Aviding vertebrate testing in risk evaluatin Build n existing and develping appraches Adptin f all available alternatives Acute txicity: reductin, waiving, bridging, cell-based Skin and eye crrsin and irritatin: cmplete replacements Sensitizatin: nearing cmplete replacement Cllabrate with OPP and internatinal effrts OECD test guidelines, guidance dcuments, IATA strategies Applies t industry supplied infrmatin as well as requests frm EPA

17 Implicatins/Opprtunities: summary Develp transparent priritizatin prcess Initial fcus n existing pririty chemicals Adapt existing risk matrix t priritize chemicals fr initiatin Adapt OECD IATA prcess in risk evaluatin Immediate adptin f available alternative assessment methds Build n OPPTS lng practice f apprpriate use f nn-test methds Adpt all available accepted alternatives Crdinate with ther ffices n prgrams n develpment and acceptance f additinal alternative methds

18 Thank yu! Catherine Willett, PhD Directr, Regulatry Testing Risk Assessment and Alternatives Humane Sciety f the United States Humane Sciety Internatinal Crdinatr, Human Txiclgy Prject Cnsrtium kwillett@humanesciety.rg