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
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
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
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
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
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
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
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
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
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-2016-0636
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
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 www.risk21.rg Internatinal Life Sciences Institute/Health and Envirnmental Sciences Institute (ISLI/HESI) Risk21 prject De et al. Critical Reviews in Txiclgy 2015. Wlf et al. Critical Reviews in Txiclgy 2014.
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
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 + 20 50% 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
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. 2015. OECD Series n Testing and Assessment N. 215
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
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
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