"Spicy world of NanoScience"
What follows is a slight revision of my initial response to the RISK SCIENCE UNPLUGGED SERIES query "What keeps you awake at night?".
A: Ass-backwards, end-stage regulatory agency interventions in leapfrogged NanoProduct and NanoDevice deployments.
Of grave concern is the coming conundrum of NanoParticulate-induced workers’ compensation and disability claims whose litigants will bear future burden of proof for maladies subject to exclusionary, pre-existing conditions defenses.
Grievous to consider is the outcome for NanoTox patients subject to the rebuttable presumption clauses under current laws in some jurisdictions for their future afflictions, the insidious pathogenesis of which will produce elusive pathologies masked as other disorders.
Disadvantageous will be the fighting positions of workers’ attorneys doing battle against statute-of- limitations laws on behalf of afflicted clients whose disease latency periods will have lapsed years before cumulative molecular events ever bring them before the Bench, their untreated, misdiagnosed iillnesses having taken that long to be made fully manifest, properly diagnosed, and knowledgeably affirmed.
Dire will be the conditions of NanoTox patients dependent upon false-negative testing protocols, lurking variables, confounding factors, and dirty data while shadow-boxing their way back to wellness.
Going to fisticuffs will be lawyers of medical patients and retail consumers’ class-action-lawsuit representatives in disputatious NanoTox filings, fighting to survive dismissal motions, drubbing opponents’ willful misconduct and self-infliction counter-arguments, valiantly appealing grounds for denial of claims, going to the legislative mat with those embroiled in product recall, product liability, malpractice, general liability offenses.
Crowded will be the civil and criminal Courts as small business entities [who could not afford to offer group insurance plans nor health care coverage plans nor paid into municipal uninsured employers’ funds] face off against bankruptcy, former employees, fines, penalties, closures, convictions, and surcharges.
Inextricably caught up in this portent of cross-continental, trans-global catastrophe will be regional economies -originally bolstered by NanoTech’s nebulous promise of profitability- having to realistically bear the massive fiscal weight of taxed entitlements and underwriting of colossal medical costs for compromised workforces subject to dubious nano-ecotoxic environs, giving rise to chronic, long-term, elusive disorders; the proposed boosting aims of such enabled, accelerated enterprises thereby backfiring, undermined by a disabled, unhealthy citizenry.
Extenuating these patients’ decade-long pending cases will be the underlying, compounded confusions of twiddling treatises in the forms of non-commanding, regulatory “guidance” statements – rendered feeble, un-enforceable, non-binding, and ultimately feckless in the proving or disproving of liability.
On the pioneering frontlines of nanostructured immunogenicity exposure cases will be under-studied populations with particular susceptibility towards ultra-fine-particulate matter (such as those of non-European and mixed-race Afro-Caribbean descent with a prevalence of lupus sufferers which is comparably higher and more severe and whose conditions are worsened by occupational exposure to silica, pesticides, and mercury).
Party to this cacophony of compounded confusion will be the OBPs (opinion-based practitioners) whose oft-cited nanosafety strategy reviews:
1. got the maths wrong [the nanoscopic scale is marked at 10−9, that is, under 100nm, not 1-100nm, not “to the 100nm upper limit”, and, in any molecular event, of a mathematical certainty is not micro-; and whose methodologies should call for nano-pico data extraction, not micro-nano]
2. got the science wrong (holding on to flawed reasoning with prevailing deterministic risk assessment protocols rather than non-deterministic)
3. got the language wrong (with obfuscated, over-arching UFP terminologies and qualifiers, leaving just enough room for mis-interpretation and incomprehension to take broad, bureaucratic leaps into the lacuna of avoidance). Science is spoken in the dialect of math, neither of which should ever be subordinate to socio-political-economic prosody.
4. made all bark, no bite provisions that “guide” but ultimately fail to guard the injured at the point of probable litigation
5. granted such lengthy grace periods that earlier-injured workers claims will go unresolved while being sicker longer than later litigants
6. should have demarcated their ENM/ENP standards and testing protocols at quantum realm in accordance with calibrated, integrated PBPK, nano-QSAR, physiome, and systems biology modelling paradigms, which would have moved outstanding nanorisk/assessment/mitigation/management matters and questions coherently, cohesively closer towards concrete, straightforward nano-specific legislation strictly aligned in observance of the laws of nanophysics and nanomechanics [and all molecular events for which these allow], in keeping with laws of uncertainty and interatomic potentials.