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How to Fulfill Global Regulatory Drivers and Requirements Beyond REACH and GHS
Margarethe Jaroszewski, Manager of Regulatory Consulting and Applied Toxicology
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Agenda
• Regulatory drivers • Regulatory trends (other than already
mentioned) • TSCA for non-US residents • Chemicals in focus • Compliance challenges
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Regulatory Drivers
• Authorities - Right of initiatives • Industry - Right of shaping the future • Public - Right to Know and to being demanding • NGO - Right of being critical • Headlines - Right to expose the results or their
lack
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Authorities - Initiators
• International bodies – UN Secretariats and organizations: UNEP, UNECE, IPCS, IARC, SAICM
• Supranational bodies – EU Commission, ASEAN, MERCOSUR, EEC
• National authorities – KEMI Sweden, US EPA More info: http://www.unep.org/chemicalsandwaste/ http://www.saicm.org/ http://ec.europa.eu/growth/sectors/ http://www.kemi.se/en https://www.epa.gov/laws-regulations/summary-toxic-substances-control-act https://www.canada.ca/en/services/environment/pollution/ceparegistry.html
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Influential Drivers
• Industry and its organizations: – CEFIC, AISE, COLIPA, FECC – Sector industries organizations:
• Outdoor Industry Association (OIA) • European Automotive Manufacturers Association (ACEA) • European Petroleum Refiners Association (CONCAWE)
• NGO – European Trade Unions (ETUC) – International Chemical Secretariat (ChemSec) – Consumer organizations
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Relationships
Regulators, Research
Industry
NGO, Public, Press
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Power of Consumers
• Denmark: Consumer apps
– Chemical magnifying glass (Kemiluppen) – Check the chemicals (Tjek Kemien)
http://kemi.taenk.dk/bliv-groennere/kemiluppen-tjek-din-personlige-pleje-uoensket-kemi http://tjekkemien.dk
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Power of Legislators
• France • Proposal for Substitution of Hazardous Chemicals • Positive message on consumer products: “Does not
contain SVHC”
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Power of Public Opinion
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• Germany • Ecolabeling:
http://www.ecolabelindex.com/ecolabels/?st=country,de
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Power of Scientific Community
• Cocktail effects of chemicals • Endocrine disrupters • Nanomaterials • IARC
• http://monographs.iarc.fr/ • https://www.niehs.nih.gov/health/topics/agents/sya-nano/ • http://www.greenfacts.org/en/chemical-mixtures/ • http://eng.mst.dk/topics/chemicals/endocrine-disruptors/combination-effectscocktail-effects/
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Regulatory Approach
• Global regulatory trends – Conventions: – Stockholm – Rotterdam – Montreal – OSPAR – Mercury and mercury compounds – Dual use – weapons (items)
• Europe - Regulatory fitness of chemical legislation
• National initiatives 11
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Stockholm Convention
• Stockholm Convention on Persistent Organic Pollutants (POPs) – 180 parties and 151 signatories
• From “Dirty twelve” (pesticides) to broadly used industrial chemicals: – Perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic
acid (PFOA), their salts and PFOA-related compounds – Brominated flame retardants
• Tetra-, penta-, hexa-, hepta-, decabromodiphenyl ethers • Hexabromocyclododecane (HBCD or HBCDD)
– Short-chain chlorinated paraffins 12
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Rotterdam Convention
• The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade – 155 parties
• Proposals: – Penta- and Octabromodiphenyl ethers – Chrysotile asbestos – Perfluorooctane sulfonic acid, sulfonates, amides
and perfluorooctanesulfonyls 13
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Montreal Convention
• Agreement on phase-down of HFC
• Substitution, e.g. by HFO-1234yf • Good news – with some concerns
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Global initiatives under SAICM
• The Chemicals in Products (CiP) Project • Lead Paint Alliance • Mercury Alliance • Endocrine Disrupting Chemicals • Nanomaterials and -technology
More info: http://www.unep.org/chemicalsandwaste/
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REFIT - EU Commission initiative
• Regulatory Fitness and Performance Programme (REFIT) in Relation to Chemicals
• Better regulation for better results (also simpler and cheaper)
• Chemicals regulations – covered by REFIT – REACH and CLP interactions with other regulations – Work place and occupational health and safety
legislation under scrutiny for overlap
• Public participation (deadline 27 May 2016) http://rpaltd.co.uk/uploads/page_files/fitness-check-list-of-
relevant-legislation.PDF
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Sweden
• Swedish proposals: – Hazardous substances in construction products – Reporting requirements for nanomaterials – Product Act on textiles now EU proposal
• Products Register • Action plan for a toxic-free everyday
environment 2015–2020 • PRIO Database: Priority tool for industry
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US TSCA for non-US Residents
• Exporting to US – Industrial applications – Consumer applications
• TSCA Overview: Applicable Scope – TSCA Reform/Safe Chemicals Act
• OSHA – HazCom 2012
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US Chemical Landscape
Exporting to US • Industrial applications
– Environmental Protection Agency (EPA) – Occupational Safety and Health Administration
(OSHA)
• Consumer applications – Consumer Product Safety Commission (CPSC) – Food and Drug Administration (FDA)
• CPSC: Title 16 Code of Federal Regulations, Chapter II - Consumer Product Safety Commission • http://www.cpsc.gov/en/Regulations-Laws--Standards/Regulations-Mandatory-Standards--Bans/Regulated-
Products/ • FDA: Title 21 Code of Federal Regulations - Food and Drugs
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US Chemical Landscape cont.,
Industrial Applications – Federal Level • EPA
– Toxic Substance Control Act (TSCA), 1976 and 2016 – the 21st Century Act
– Right To Know legislation: • Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA), • Superfund Amendments and Reauthorization Act (SARA) Title III
– Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) • OSHA
– Hazard Communication Standard 2012 • SDS • Labels
• EPA: Title 40 Code of Federal Regulations – Protection of Environment • OSHA: Title 29 Code of Federal Regulations - Labor
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History of TSCA • TSCA became law in October 1976 • Goal was to protect human health and
environment from unreasonable chemical risk • Filled gaps that existed in other federal laws • Purpose was to establish chemical inventory
• Section 8b • “New vs. Existing Chemicals”
• Screen new chemicals for hazards • Identify “unreasonable” risk • Criticized for inability to restrict or ban
chemicals
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TSCA Inventory – Global impact
•1976: TSCA Inventory: idea of new and existing chemicals
• 1979: EU - DSD 67/548/EEC, 6th Amendment - EINECS
• China: IECSC • Japan: ENCS and ISHL • Korea: KECL • Taiwan: TCSI • Australia: AICS • Canada: DSL and NDSL • New Zealand: NZIoC • Philippines: PICCS • Thailand, Mexico, Turkey
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TSCA Reform
• Frank R. Lautenberg Chemical Safety for the 21st Century Act
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TSCA
• Regulatory compliance in the US requires conformance with TSCA for all commercial non-drug, R&D, FDA, food, cosmetics and medical products
• Includes – consumer – industrial
• Dual use materials • Manufactured in US or imported into US
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Highlights of TSCA Reform • Chemical regulation process will now include risk evaluation • Requires EPA to develop a list of high and low priority
chemicals for further review through risk evaluation with specific deadlines
• Requires EPA to review all chemicals currently in commerce to refresh/reset the TSCA inventory
• Requires EPA to provide a hazard and exposure based “determination” for all PMNs and publish the result
• Advocates non-animal testing, such as Quantitative Structure-Activity Relationships “QSAR” and use of read-across data
• Requires science-based decisions, founded on weight of evidence
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Major Sections of TSCA
• Section 4: Testing of Chemicals • Section 5: Notifications for New Chemicals or New Uses • Section 6: Regulating Hazardous Chemicals, Imminent
Hazards • Section 8: Reporting and Record keeping and TSCA
Section 8(b)Inventory • Section 14: Confidential Business Information • Sections 16 & 17: Inspection, Penalties and Enforcement • Section 18: State Preemption • Section 26: Fees and EPA Budget
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TSCA Compliance is
• Complex – many sections • Challenging • Vital to Business success • Needs to be followed • Is the Law! And for each importer – No OR
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Top 16 items to note 1. Every chemical in commerce to be evaluated 2. Inventory reset – high priority, low priority, active, new, existing 3. CBI re-Substantiation 4. Immediate change to PMN/SNUN review process 5. Safety standard = unreasonable risk 6. Science to be a hallmark of decisions 7. Definition of and protection of vulnerable Populations 8. Preemption of states laws 9. Active Restrictions and Banning 10. Stated, enforceable deadlines 11. New fee structures 12. New and expanded authority and mandates given to EPA 13. Requirement to report progress to Congress 14. Putting the onus back on industry to prove safety and pay for proof 15. Engaging with other stakeholders through affirmative findings and actions 16. Transparency to the Public
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Business Impact for TSCA Reform
• TSCA Inventory Reset: • May require notifications for chemicals not used
in the past 10 years • Requires more information on chemicals • CBI claims can be lost if substantiation cannot be
provided or chemical is highly hazardous • From 83,000 substances to 25,000 (guess?)
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1st 5 chemicals for expedited action – Decabromodiphenyl ethers (DecaBDE), used as a flame
retardant in textiles, plastics and polyurethane foam; – Hexachlorobutadiene (HCBD), used in the manufacture
of rubber compounds and lubricants and as a solvent; – Pentachlorothiophenol (PCTP), used as an agent to make
rubber more pliable in industrial uses; – Tris (4-isopropylphenyl) phosphate, used as a flame
retardant in consumer products and other industrial uses; and
– 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.
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Chemicals in Focus
• Nanomaterials • Endocrine disrupters • Titanium dioxide
– Car Cat 1B, H350i – Community Rolling Action Plan (CoRAP) – REFIT
• Crystalline silica (OSHA and EU CM Directive) • Phthalates • Perfluorooctanoic and sulfonic acids and their salts
(news: PFOA: IARC 2B) • Methylisothiazolinone (MI), triclosan, BPA
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SVHC – Global picture
• REACH: SVHC in focus – ACRYLAMIDE (CAS 79-06-1) – 1,2-DICHLOROETHANE (CAS 107-06-2) – BIS(2-ETHYLHEXYL)PHTHALATE (DEHP)(CAS 117-81-7)
• REACH-like legislation – Switzerland: Chemicals Ordinance, ChemO (ChemV) and Chemical Risk Reduction
Ordinance (ChemRRV) – Japan: on PAC (Priority Assessment Chemicals) List of Chemical Substances
Control Law – China: Priority Chemical List of 12th Five Year Plan – Korea: K-REACH: Toxic Chemicals, Article 20; Designation of Toxic, Restricted or
Banned Chemicals Appendix 1, Designated Existing Chemicals Subject to Registration (''PEC'')
– Australia. Priority Existing Chemical (PEC) Assessment Reports – The US: TSCA Work Plan Chemicals under the EPA Existing Chemicals Management
Program (2014), TSCA Section 8(d) Health & Safety Data Reporting (40 CFR 716, Subpt. B), CAL PROP65
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The Compliance Challenge
• Are the ingredients you want to use on the respective chemical inventory, SVHCs, CMRs?
• What about emerging regulations that are looming in the distance?
• What about public opinion and expectations? • What is the focus when under scrutiny for
compliance? • How to avoid ending as a headline?
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Abbreviations and Acronyms
REACH= Registration, Evaluation, Authorization and Restrictions of Chemicals
TSCA= Toxic Substances Control Act R&D= Research & Development EPA = Environmental Protection Agency QSAR= Quantitative Structure Activity Relationships PBT= persistent, biodegradable, toxic CBI= Confidential Business Information PMN= Pre-manufacture Notification SNUN= Significant New Use Notice SNUR= Significant New Use Rule OR= Only Representative
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Q A
Thank You!
