Key Regulatory Issues, Updates, and Current Hot Topics

Key Regulatory Issues, Updates, and Current Hot Topics

Charles M. BartishDirector, Product Safety

Air Products and Chemicals, Inc.

November 15, 2005 Fort Lauderdale, FL

2 Bartish Nov. 2005TRFA Lauderdale

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Good Chemistry at Work

Regulatory Affairs Agenda

Hot regulatory and compliance issues– HPV testing of epoxy chemicals – REACH implementation: an update

Country regulatory updates– Canada, China, Korea

Controlled chemicals (ROHS and WEEE)

Animal activists and terrorism

Global Harmonization System (GHS)

VOC implementation in the Northeast

Plea for your continued input!


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The HPV Test Rule

Affects 2800 chemicals manufactured / imported into USA– Chemicals > 1MM lb in 1990; extended HPV (EHPV) to

add new chemicals– Parallel programs subsequently proposed globally

impacting ~1000 chemicals– Thermoset industry chemicals are affected

Exempts polymers, salts, SIDS chemicals– Polymers, not rigorously defined, but considered safe– SIDS (Screening Information Data Set)

• part of a globally recognized protocol to conduct a risk assessment on chemicals

Encourages grouping related chemicals for testing


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Costs and TimingTest Categories Average Cost ($M)

Human Health 230Environmental 30Ecotoxicity 25Physical / Chemical 15

300

Testing costs are for a chemical needing a complete test package.Doesn’t include personnel, travel, sweat equity, administrative costs.

All testing to be completed in mid-2000’s.

Thermoset industry chemicals affected Companies working together to conduct testing


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Thermoset Industry chemicals impacted by HPV

Chemical

Epoxy resin

Diluents – BGE– C12-C14 AGE

Various Hardeners

MOCA

Status

SIDS dossier, no testing

Consortium through SPI conducting testing

Variety of amines and polyamides being tested

Consortium sponsored

AGE: alkyl glycidyl etherBGE: butyl glycidyl ether


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Approach for Alkyl Glycidyl Ethers

Only C12-C14-AGE and BGE are subject to testing; estimate $200M of testing costs

Consortium of suppliers working together under auspices of SPI define, fund, and carry out tests

– Air Products– CVC– Huntsman– Kemira– Resolution Performance Products / Hexion

At least for C12-C14-alkyl glycidyl ether, we are able to build upon mid-90’s Product Stewardship memorandum of understanding (MOU) with EPA


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HPV Status and Summary

HPV is a significant US initiative and impacts the Thermosets Industry

An ERSTG team is following the issue closely– Companies are working together and

cooperating to minimize costs and duplication of effort

Testing results to date have not resulted in significant changes to labels or PPE

EHPV evaluated, but probably minimal impact. Cresyl glycidyl ether on the list

HPV work will help with future regulatory obligations, such as REACH


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What is the proposed REACH regulation?The proposed system is known as REACH

Registration

EEvaluation and

Authorization of

Chemicals

The scope is for (all) chemicals marketed in Europe, either manufactured or imported.


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Registration

For all 20,000 substances handled in quantities greater than 1 mt/yr, a tiered approach will be taken. Polymers exempt for now.

CMR > 1 mt/yr 2008

Registration > 1000 mt/yr 2008 (earliest est.)



CMR: Carcinogen, mutagen, reproductive toxin


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Costs and Timing

Test Categories Average Cost ($M)

Human Health 230Environmental 30Ecotoxicity 25Physical / Chemical 15

300

Test requirements similar to HPV program, likely staggered by volume and risk

Expect to use HPV data, wherever possible Industry expected to work together


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Chemical Safety Report required

From manufacturers and importers containing:– Human health and environmental assessment– Exposure assessment and risk characterization

for ALL uses

Options for downstream users:– Provide information about uses and exposure to

supplier / manufacturer– Create own chemical safety report for single use


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Evaluation and Authorization

There are two types of evaluation:

Dossier Evaluation– To be conducted by the competent authority on

all substances in volumes exceeding 100 mt/yr for all substances of very high concern.

Member State Evaluation of Substances.– Rolling plan covers three year period

Authorization is required for substances of very high concern, for example, carcinogens, PBT, etc.


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Vulnerable Situations

Sole customer

Non-EU supplier

Data is scarce/high hazard raw material

Unusual / High exposure end-use

Supplier unaware of end-use

Lack of alternative supplier

Lack of alternative raw material


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Impact on the Thermoset Industry

Cost impact may be relatively low; many chemicals already extensively tested

– SIDS, HPV, ICCA

Polymers are exempt

EU Parliament agreed to scale back (9 Nov 2005)– Parties agree to reduce scope– < 10 ton chemicals tested only if “risky”– Reduced testing for 10-100 ton chemicals– Minimal data in first 18 months of registration

process (i.e., MSDS information)– EU Parliament vote on 17 November 2005

ERSTG companies watching events closely


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Changing Country RegulationsCanada Changes effective 31 Oct 2005 Trigger volumes

– Only need to follow the yearly trigger volumes– New chemical substance not on NDSL notification

volumes have been increased from 20 to 100 kg/yr. – Notification packets for both polymers and chemicals are

required before reaching 1000, 10,000 and 50,000 kg/yr.

TSCA / NDSL– Substances on the public TSCA inventory will be placed

on the NDSL inventory 1 year later (compared to 5 years). – For substances on the NDSL there is an additional High

Volume Data requirement on reaching 50,000 kg/yr if there is significant consumer exposure or potential for aquatic release


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China

New Chemical Declaration and Registration– Difficulties getting chemicals registered under

New Chemical Substances law of 2003– New methods for testing acute fish toxicity and

biodegradation (effective 1 January 2006)

Looking Ahead– Industry efforts to get China to allow low volume

exemptions– Chinese regulators very willing to discuss issues

with industry


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South Korea

Changes Made– Increased enforcement of inventory

requirements– New chemical notification requires ecotoxicity

testing (1 January 2006)


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Controlled Chemicals -- Why? Regulatory agencies continually publish lists of chemicals

requiring administrative controls– Directives on Waste from Electrical and Electronic

Equipment (WEEE) and on the Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS)

– EU policy on Integrated Product Policy (IPP) and Future Framework Directive on Eco-design and End Use Equipment (EUE)

Using such chemicals might require additional environmental or industrial hygiene controls

Non-compliance with regulations can result in fines

Several industries want to be viewed as “green” and take sustainable development seriously

– Electronics, Automotive, Detergent


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Characteristics of controlled chemicals

Not permitted in products or packages

May be application specific, as certain applications may have higher risk potentials

Not chemicals, but unacceptable properties – Toxicological properties, such as reproductive

toxins, carcinogens and endocrine disrupters.

In addition there may be lists of chemicals that are not controlled, but of which there is concern.

– Chemicals that are global warmers would be a possibility for such a list.


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Controlled Chemicals SpecificsHeavy Metals Cadmium, lead (solder), mercury, hexavalent chromium and

their compounds

Chlorinated Organics

PCBs, PCNs, chlorinated paraffins, perchlorodecane

Brominated Organics

Polybrominated biphenyls, polybrominated diphenylethers

Organotins Tributyl tin compounds, triphenyl tin compounds

Asbestos Replace packing in acetylene cylinders

Azo Compounds

Compounds that produce amines on decomposition

Formaldehyde Common polymer raw material

Ozone Depleters

All materials listed in the Montreal Protocol

Residual Monomers

Vinyl chloride, vinyl acetate

Benzene Limited use as solvent; residual impurity


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What should suppliers / formulators do? Determine if specific chemicals are present

– In products intentionally or not intentionally– In packaging materials

Determine if specific chemicals were used in processing

Respond to customers’ inquiries– Letters– Certifications– Guarantees

Consider your own philosophy regarding formulating with “high visibility chemicals”


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Animal activists becoming violent

Activist groups taking strong message to stop animal testing

Targeted Huntingdon Life Sciences and Covance

Invaded labs, protest sites

Physically abusing company employees and relatives

Making public client names

Legislation underway to stiffen crime as terrorism


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Why Global Harmonization (GHS)?

Establish a global system for workplace hazard communication that would address

– Classification of chemicals– Labeling– (Material) Safety data sheets

Goal was not to create a new system, but to harmonize existing systems that would be accepted globally.

– Used by national and regional governments

Useful to target audiences – Emergency responders, consumers, industrial

and transport workers


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What are we harmonizing?

MSDS– 16-section format (reverse sections 2 and 3)– New ANSI revision will follow GHS

Labels– Signal words, pictograms, hazard statements

Classification– Hazardous chemicals according to their health,

environmental and physical hazards

Target for global implementation is 2008– Working over 15 yr– Why so long?


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Is there harmony in harmonization?

One example: Classification – Toxicity

Five categories now exist!

Based on LD50/LC50 values

Oral, dermal, or inhalation route


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acute oral toxicity

LD50 mg/ kg

//50 100 200 300 400 500 2000 5000

CH

Class 1 Class 2

Class 3

255

GHS

EU

Class 3 Class 4 Class 5

Category 1 Category 2

Category 3 Category 4 Category 5

T+ T Xn

EU is tougher! But GHS will include unclassified EU in Cat 5


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Classification - Acute Toxicity

Category 1 2 3 4 5

Symbol None

Signal word Danger Danger Danger Warning Warning

Hazard statement

Fatal if inhaled

Fatal if inhaled

Fatal if inhaled

Harmful if inhaled

May be harmful if inhaled


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GHS Business Impact Estimated Costs (for 1 medium-sized German paint company) :

- to change the calculation program 8,000

- to recalculate 14,000 recipes 24,000

- to change the pre-printed labels 340,000

- to print the new label versions up to 1,000,000

- to dispose the old labels up to 1,000,000

- to change the computer print program 2,000

- to relabel the containers in central stock ?????

- to prepare all new SDSs (IT) 257,000

- to distribute the new SDSs (paper+postal rates) 241,000

- TOTAL more than Є 1,872,000reference: J.G.Abbott; SGCI Chemie Pharma Schweiz; June 2004; ACC CEFIC meeting


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Why is there concern about VOCs?

Any volatile compound of carbon is a VOC for regulatory purposes, unless specifically exempted

VOC + NOx + Sunlight = O3

– Precursors: motor vehicle exhaust, industrial emissions, gasoline vapors, chemical solvents

– Sunlight, hot weather lead to harmful concentrations– Winds carry O3 and its precursors miles from sources

Harmful to health and the environment– Triggers health problems even at very low levels– Long-term exposure may cause permanent lung

damage– Damages plants and ecosystems


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VOC’s are regulated Federal Clean Air Revisions Act of 1996

– resulted in stricter national VOC regulations. – AIM (Architectural and Industrial Maintenance) regulations

became effective in 1999.

Some state regulations even tougher– Southern CA, Jefferson County, KY, and NJ have more

stringent regulations than federal requirements.

Ozone Transport Commission (OTC) regulations– Areas from Northern Virginia to New England adopted

lower VOC limits January 2005.

EPA continued actions– 2004 designated "non-attainment" areas exceeding 8-hr

standards– 2005 identified boundaries, designations, and

classifications for areas under the 1-hr ozone standard


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Ground-level Ozone – Strategy Shift Previous control strategies

– Focused locally in areas of high ground-level O3 concentrations

– EPA, States recognized need to address regional transport issues

New regional strategies– Reducing NOx emissions from power plants,

industrial sources – Improving motor vehicle emissions, fuels and

inspection programs – Addressing consumer products


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Ozone Transport Commission (OTC) Created by Congress in 1990 under the CAA and advises

EPA on transport issues Develops and implements regional measures to address

ground-level ozone in the Northeast, Mid-Atlantic regions, includes CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT and VA

Established rules for VOC content applicable to “any person who supplies, sells, offers for sale or manufactures any architectural coating for use within the jurisdiction of the state or local air pollution control agency…”

Does not apply to:– Coatings sold or manufactured for use outside of the

(jurisdiction of the state or local air pollution control agency) or for shipment to other manufacturers for reformulation or repackaging

– Any aerosol coating product– Coatings sold in containers w/volumes of 1 liter or less


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OTC Model Rule for Consumer Products Applies “to any person who sells, supplies,

offers for sale, or manufactures consumer products on or after January 1, 2005 for use in the state of OTC STATE.”

Includes:– Applicability and Definitions– Standards and Exemptions– Innovative Products– Administrative and Reporting Requirements– Variances– Test Methods– Severability– Alternative Control Plan


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Impact of OTC rules

VOC Content Limits, Wt %

Regulated Product Category Current EPA CARB OTC

Construction adhesive 40 40/15 15

Floor polish 7 7 7

Sealants - 4 4


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Resources

EPA: www.epa.gov - see 63 FR 176:48848

Ozone Transport Commission (OTC): – dep.state.ct.us/air2/siprac/2001/consu.pdf

Google: ozone transport commission regulations

South Coast Air Quality Management District (SCAQMD): www.aqmd.gov

California Air Resources Board (CARB): www.arb.ca.gov/coatings/arch/arch.htm

Midwest Regional Planning Organization/Lake Michigan Air Directors Consortium (MRPO/LADCO): www.ladco.org


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What do we expect from you?

Remember, we’re all in this together!

Much of Product Stewardship is based on practical experience

This entire meeting should be interactive– Contribute your ideas– Ask questions– Tell us how you did “it” at your company

Volunteer to present!


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Thanks to

Lynne Harris, SPI

Marie Martinko, SPI

Jeri Church, TRFA


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Glycidyl ether Test Plan

HPV Data Category Test Endpoint AGE BGE

Physical and Chemical Properties

Partition Coefficient Yes

Water Solubility Yes

Health Effects Chromosome Aberration Yes

Developmental Toxicity Yes

Environmental Fate and Pathways

Water stability Yes Yes

Biodegradation Yes

EcotoxicityAcute toxicity to:

Fish Yes

Aquatic invertebrates Yes

Aquatic Plants Yes

Estimated costs, $M $50 $150

Key Regulatory Issues, Updates, and Current Hot Topics

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