Chemicals Management Regulations and the Pressures on Marine Coatings

Stephen SidesVice President, Science, Technology and

Environmental Policy

American Coatings Association

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4th Gobal Marine Coatings Forum Goodwood Park Hotel

Singapore

Introduction• Chemicals are an integral part of daily life

in today’s world– Used throughout industry– No single business sector where they do not

have a role– Contribute positively to national and world

economies

• Therefore sound management of chemicals throughout their complex lifecycle is essential to avoid risks (+/- Externalities)

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Commercial Benefit of Chemicals

• 1970: US$170B and 2010: US$4.12T• OECD Share in 2000: 77% and 2010: 63%• BRIICS Share in 2000: 13% and 2010: 28%

Many national governments in the developing world will be enacting CHEMICAL CONTROL LAWS to manage this growing volume of commercial activity

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Chemicals Management Forecast• Variety and complexity of the chemical

business, supply chain, waste streams and end uses have EXPOSED GAPS in chemicals management, LAPSES in government oversight, and LAGS in international policies:

e.g. 2002 Johannesburg Plan: By 2020 all chemicals will be produced and used in ways that minimize significant adverse effects on the environment and human health

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UN Recognized Focus Concerns

• Penetration of “chemical intensive products” into national economies– Agricultural chemicals (pesticides/biocides) – Liquid chemical personal care products– Paints– Adhesives and lubricants– Articles – textiles, electronics, building

materials, toys and other recreational products, (i.e. lead, cadmium, mercury, flame retardants)

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UN Recognized Focus Concerns• Increased chemical emissions in developing

economies:– Chemical waste of all types– Pesticide run-off from agriculture– Heavy metals from:

• Mining• Coal combustion• Cement production• Ship-breaking (allied salvage efforts)• Tanning• Textile production• Electronics 6

UN Recognized Focus Concerns• Complex health and environmental

impacts:– Direct impacts (acute and chronic) of releases

to ecosystem– PBT and POP– Trans-boundary movement– “Collective” effects (i.e. inadequate permits and

or trade-off programs)– Limited chemical testing (uncertainty and the

“precautionary principle”)7

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UN Recognized Focus Concerns• The cumulative adverse impacts of

chemicals is not known?– Estimates place burden at 1.6% of annual

deaths, and 1.4% of annual disease

• Unrecognized and substantial costs – only understood in terms of specific chemicals (i.e. Asbestos: US$100B annually)

• Recognized substantial costs associated with environmental incidents

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Benefits of Industry Action to Manage Chemicals

• Avoidance of costs of inaction• Improved human and overall (environmental)

well-being• Reduced environmental risk and ecological

scarcities (avoid diminished commercial capacity – sustainability)

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Current Management Efforts• INDUSTRY: International Council of Chemical

Associations (ICCA) – Global Product Strategy (aimed at SME’s) and the UN Environmental Program’s Strategic Approach to International Chemicals Management (SAICM)

• INDUSTRY: Voluntary Environmental Programs (i.e. Responsible Care®, and Coatings Care®)

• GOVERNMENT: National “instruments” of control

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Framework for Product Stewardship

• Link chemical management practices with national social and economic policies– Regulatory compliance not sufficient anymore– Sustainability and life-cycle approaches offer

business efficiencies– Developing countries likely to “leap-frog” old

practices

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Framework for Product Stewardship

• Prepare for multi-stakeholder approaches to chemicals management problem solving– Government instruments– Corporate policies and related commitments– Understanding societal perception and

pressures

• Seek preventive practices that anticipate risk and promote alternatives

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Overview Chemical Control Laws (CCL) and Regulations

• CCL Types: Inventories, Product Registries, Lists, REACH– Similarities and Differences– Exclusions/Exemptions – Restrictions– Polymers

• OECD “Parallel Process”

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Types of Chemical Control Laws

1. Substance Inventory (e.g., TSCA, DSL, AICS)Individual substances, not products. Applies to all

manufacturers/importers (M/I)

2. Product Registry – applies to M/I individually

3. Restricted List – may apply to all M/I

4. EU – REACH Substance Use Registry

Applies to all M/I @ > 1MT/year, butOne Registration for each USE (millions of registrations)

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Types of Chemical Control Laws

Other Types (Safety Net for USES)• Food and Drug (e.g., FDA)• Insecticide and Biocides (e.g., FIFRA)• Consumer Products• Cosmetics• Other Industry-specific Req. (e.g., VOC emissions)• Labor Req.(e.g., OSHA)• Site-Related (e.g.,TRI)

Basis for Control

Laws: High level – affirms policy and what is to be done

Regulations: Offer details – how it is accomplished

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Inventory• List of substances

– Initial effort - Chemicals in commerce during a certain time period are nominated by industry

– Once the inventory is closed, nominated chemicals are generally assumed as safe for manufacture/import/processing (“Existing” substances)

– Substances not on list require notification (“New” substances)

– Inventories in general includes exemptions and exclusions

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Inventories – Names and Acronyms•US•Canada

•EU

•Australia•Korea•Japan

•Philippines•China•New Zealand•Taiwan•Switzerland

TSCA - Toxic Substance Control Act Inventory

DSL - Domestic Substance ListNDSL - Non-Domestic Substance List

EINECS - European INventory of Existing Chemical SubstancesELINCS - European LIst of Notified Chemical SubstancesNLP - No Longer Polymers List

AICS - Australia Inventory of Chemical Substances

KECI - Korea Existing Chemicals Inventory

ENCS - Handbook of Existing and New Chemical SubstancesISHL - Industrial Safety and Health Law

PICCS - Philippines Inventory of Chemicals and Chemical Substances

IECSC - Inventory of Existing Chemical Substances in China

NZIoC - New Zealand Inventory of Chemicals

NECSI - National Existing Chemical Substance Inventory

INNS - Inventory of Notified New Substances

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Does your product comply?

If all components of your product are listed on the inventory and are not otherwise restricted, you can manufacture/import/market.

(Assumes other information requirements are met including SDS, labeling and shipping)

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Exclusions and Exemptions

• Exclusions - Generally “automatic” (self-actuated)

• Exemptions - Some are automatic, but most have some requirements (e.g., limited notification, record keeping, etc.)

Bottom line: If an exclusion or exemption applies, new chemical notification is not required. This reduces work

for industry and regulatory agencies

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Exclusions• Mixtures, but not individual components• Naturally occurring substances (definition critical)• Hydrates (if parent is listed) and some salts (Japan only)• Articles - must meet country specific definition • Waste*• Unintended impurities Definition varies• By-products Definition varies• Threshold e.g.,1MT/yr for REACH• Pesticides* Not isolated intermediates• Biocides* Not all countries• Cosmetics* Not all countries• Some fully formulated products (limited)

* May be subject to other regulations and eligibility depends on individual country

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Exemptions – R&DDifferences

– Is “self-actuated” (e.g., US*, Japan) – Requires notification to the regulatory agency

(e.g., China, Philippines)– Requires notification to recipients (US) – Has a volume limit per year (Australia, Korea,

China, EU) – Includes record keeping requirements – Automatic if lab meets requirements (NZ)– May differ based on the type of R&D activity

(“applied” vs. “pure” research)

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Exemptions – Other Types• Low Volume

• Polymers• Non-isolated intermediates • “Site-limited” Intermediates• Export only• Trans-shipment • “Incidentally formed” substances

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New Substance Notification

Typical common data requirements:

Structure/composition

Physical properties (differences)

Manufacture process (if manufactured) Occupational exposure and control measures

Environmental release and control measures

End use human exposure and environmental release

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Toxicology Data Requirements• Varies widely• Cost: $01MM+• Variables (Country specific)

– Volume– Inherent toxicity (data on similar substances or

Quantitative Structure Activity Relationship (QSAR) data may be acceptable)

– Can be mitigated by end use– Waivers may be available for data that does not

contribute to risk assessment or is not possible to obtain– Negotiation possible, may be required– Reduced animal testing (REACH)

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Example: Multi-Country Test Status/Plan

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New Substance Notification -Days to Approval

(Not Including testing if required or delays if concerns identified)I

US: 90 minimum Canada: Depends on Schedule Australia: 90 for certificates; 4-20 for permits Philippines: 180 Japan: 90 manufacture, 120 import New Zealand: 85 (depends on notification type) Korea: 60

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RestrictionsBased on authority review, a new substance may be allowed in commerce only with restriction(s):– Limited volume or concentration– Controlled use (limited to specific use)– Controlled exposure (e.g., specified PPE or engineering

controls, training)– Controlled environmental release (e.g., no release to

surface water)– Recordkeeping and/or reporting requirements– Testing requirements– Additional notification requirements– Information disclosed on label and SDS

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Product Registries (and Lists)• Country requires information prior to import or an

annual submission of information– To support occupational health and safety or

emergency response and clean-up– Information required can be as simple as a SDS or

more (e.g., composition information)– Generally required for importer; may be needed by

the end user– May not be required unless the product is

"hazardous"– Fees and duration vary (one time vs annual)

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REACH Registration, Evaluation and Authorization of Chemicals

• Manufacturers and importers required to register all substances > 1MT/year to the European Chemicals Agency (ECHA)

• REACH changes “existing" and “new" chemicals to "phase-in" and “nonphase-in" substances– “Phase-in” substances eligible for pre-registration

• listed on EINECS• manufactured in the Community in the last fifteen years but not

placed on the market• “No-Longer Polymers."

– “Nonphase-in” substances must be registered prior to import/manufacture

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REACH – Pre-registration

• Pre-registration 6/1/08 -11/30/08• 65,000 entities registered in the REACH-IT system• 2.6 million pre-registrations• ~150,000 substances• Substance Information Exchange Forums (SIEF) (“one

substance, one registration”)• Most SIEFs have 1-9 participants• 2 SIEFs have > 5000 participants• SIEF roles: Leading, Involved, Passive, Dormant• Issues

– Substances of Very High Concern (SVHC)– Registration deadlines (tonnage-based)– SIEF Consortia

• Many SIEFs have no facilitator or the facilitator does not respond– Competition/Trade Laws

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REACH – Downstream Users (DU)

• Entire supply chain is responsible for managing the safe use of chemicals

• DUs must ensure that their SDS comply with the new "uses" requirement. Either:– Give the supplier enough information to include that use in a

chemical safety assessment (CSA) or– Conduct and document a CSA themselves

• DUs may also be responsible for registration if the supplier does not

• Registrants are obligated to conform to data sharing requirements

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REG

Timeline

1000 t/yR50/53 ( 100 t/y)CMR 1+2 ( 1 t/y)

100 t/y

1 t/y

08 11 14 17 20 23

REG

REG

Authorization / Restriction (SVHCs)

Non-”Phase-In” / New substances

Pre

-reg

istr

atio

n (

Jun

e1

-De

c1 2

00

8) EVAL: Evaluation

(European Chemical Agency)

Dossier and Substance Evaluation

REG: Registration(Manufacturer/ Importer)

EVAL

EVAL

EVAL

End of “Phase-in“

09 10 12 13 15 16 18 19 21 22

Dec1, 2010

Dec1, 2012

June1, 2013

June1, 2016

June1, 2018

June1, 2022

Ent

ry in

to F

orce

Jun

e 1,

200

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SVHC = Substances of Very High Concern (CMR, PBT, vPvB)

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Polymers – Why different?• High molecular weight limits absorption across

biological membranes– Human Health

• Synthetic polymers generally exhibit low acute and chronic mammalian toxicity and irritation potential to mammals via oral and dermal exposure

– Ecotoxicity• Generally low acute and chronic toxicity and some

polymers adsorb to sediment and are readily removed from the aquatic compartment

– Caveat• Reactivity of certain functional groups can produce toxic

effects• High content of low MW species can increase

bioavailability

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Polymers – Average Molecular WeightMn = number average molecular weight

– Total weight of all the polymer molecules in a sample, divided by the total number of polymer molecules in a sample

Mw = weight average molecular weight– Weighted average (accounts for the fact that the higher MW

molecules contain more of the total mass)

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Polymers – Nomenclature• Most inventory listings are “monomer-based” rather than

“structural repeating unit (SRU)” – Certain classes have unique nomenclature rules (e.g., isocyanates,

siloxanes)– Japan and Australia do not include free radical initiators in

inventory descriptions of polymers. Not required for US polymers listed prior to 7/28/89.

• In most countries a 2% exclusion or exemption is automatic– Japan polymers must include 98% of the reactants (a total of 2%

of reactants may be excluded) if all reactants are listed and 99% if the <1% reactant is unlisted

– Korea requires application for 2% exemption

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Polymer Exemptions – “Self actuated”

• US – Must meet criteria (monomer and oligomer fraction, not cationic,

elemental limitations). Also certain polyesters are exempt.– Requires annual report and recordkeeping but no notification (automatic)– http://www.epa.gov/oppt/newchems/pubs/guideman.htm

• EU – Polymers are exempt from REACH, but monomers and other reactants

used at > 2% must be registered• Philippines

– If all reactants > 2% are PICCS listed (automatic)– If a different polymer containing the 2 highest concentration reactants is

PICCS listed, polymer is exempt (automatic)– If notification is required an abbreviated notification is acceptable if the

polymer is listed on at least one other inventory

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OECD “Parallel Process”• New substance notification to multiple regulatory agencies

at the same time– Benefits: Efficiency and increased potential for waiver acceptance– Limitations: CBI and QSAR, no polymers

• Notifier responsibilities:– Gather existing data and fills gaps– Prepare draft hazard and risk assessment– Arrange pre-meeting with relevant authorities

• “Lead” agency– Issues hazard assessment– Conducts risk assessment– Provides assessments to “secondary” countries– Secondary countries accept hazard assessment and conduct risk

assessment if necessary.

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Contact: Marianne Heinrichmarianne.heinrich@bp.com

Basic Conclusions• Government will need to adopt more

effective regulatory policies and approaches• Corporations will need to assume more

responsibility for producing safe products and promoting sound management along the value chain

• In emerging economies, strengthen industry outreach and technical assistance

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Internet Resources 2012 Inventory/Regulation

UShttp://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/howto.htmlwww.epa.gov/opptintr/newchems/

Australiawww.nicnas.gov.au/Industry/AICS/Search.aspwww.nicnas.gov.au/

Chinahttp://www.crc-mep.org.cn/iecscweb/IECSC.aspx?La=1http://www.crc-mep.org.cn/English/E03.htm

Canadawww.ec.gc.ca/substances/nsb/search/eng/cp_search_e.cfmhttp://www.ec.gc.ca/substances/nsb/eng/home_e.shtml

EUhttp://echa.europa.eu/

Taiwanhttp://www.epa.gov.tw/en/epashow.aspx?list=113&path=168&guid=63cda26b-3de5-4e98-9947-af1d03acb162&lang=en-us

Turkeyhttp://www.kimyasallar.cevreorman.gov.tr/sources/default.asp

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Internet Resources 2012Inventory/Regulation

JapanHandbook of Existing and New Chemical Substances, The Chemical Daily Company, Ltd. http://www.jcw-online.com/http://www.safe.nite.go.jp/english/kasin.htmlhttp://www.meti.go.jp/english/information/data/cKashinLaw.htmlhttp://www.safe.nite.go.jp/english/kasinn/kaiseikasinhou.html

Koreahttp://ncis.nier.go.kr/en/SearchOpen_en.jsphttp://www.kcma.or.kr/eng_01.asphttp://eng.me.go.kr/main.do

Philippineshttp://www.emb.gov.ph/eeid/PICCS.htmhttp://www.emb.gov.ph/

New Zealandhttp://www.epa.govt.nz/search-databases/Pages/default.aspxhttp://www.epa.govt.nz/search-databases/Pages/nzioc-search.aspxhttp://www.epa.govt.nz/Pages/default.aspx

Malaysia http://www.e-ehs.doe.gov.my/

Russia http://www.tsouz.ru/db/techreglam/Pages/ProektVGS.aspx

India http://moef.nic.in/index.php

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