Key Regulatory Issues, Updates, and Current Hot Topics Charles M. Bartish Director, Product Safety Air Products and Chemicals, Inc. September 12, 2006 Montreal, Canada
Feb 02, 2016
Key Regulatory Issues, Updates, and Current Hot Topics
Charles M. BartishDirector, Product Safety
Air Products and Chemicals, Inc.
September 12, 2006 Montreal, Canada
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Regulatory Affairs Agenda
Hot regulatory and compliance issues– HPV testing of epoxy chemicals – REACH implementation: an update
Controlled chemicals (ROHS and WEEE)
Global Harmonization System (GHS)
VOC implementation in the Northeast\
Request 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 $200M of testing costs
Consortium of suppliers working together under auspices of SPI define, fund, and carry out tests
– Air Products– CVC– Huntsman– Kemira– Hexion
At least for C12-C14-alkyl glycidyl ether, we are able to build upon mid-90’s Product Stewardship memorandum of understanding (MOU) with EPA
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HPV Status and Summary
HPV is a significant US initiative and impacts the Thermosets Industry
An ERSTG team is following the issue closely– Companies are working together to minimize
costs and duplication of effort
Testing results to date have not resulted in significant changes to labels or PPE
Final test reports sent to EPA on 28 August 2006
EHPV evaluated, but probably minimal impact. Cresyl glycidyl ether on the list
HPV work will help with future regulatory obligations, such as REACH
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What is the proposed REACH regulation?The proposed system is known as REACH
Registration
EEvaluation and
Authorization of
Chemicals
The scope is for (all) chemicals marketed in Europe, either manufactured or imported.
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Registration
For all 20,000 substances handled in quantities greater than 1 mt/yr, a tiered approach will be taken. Polymers exempt for now.
CMR > 1 mt/yr 2008
Registration > 1000 mt/yr 2008 (earliest est.)
Registration > 100 mt/yr 2011 (earliest est.)
Registration > 1 mt/yr 2016 (earliest est.)
CMR: Carcinogen, mutagen, reproductive toxin
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Costs and Timing
Test Categories Average Cost ($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 – but NLP are not
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 voted approval
ERSTG companies watching events closely
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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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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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Status in North America
United States– Expected implementation by 2008– OSHA is driver; Jennifer Silk announced retirement; – OSHA GHS Workshop set for Oct 20 in Washington
• Impact on MSDS, labels• Employee training• Costs to the business• Timing and OSHA communication plan
Canada– In process of implementation, final date expected 2008– Developed summary document (2/06) for affected sectors
• Final document to be released 10/06– Current ongoing processes:
• Phase-in options• Consultation with trading partners• Economic analysis• Development of final recommendations
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Status in Europe
EU Target 2008– In conjunction with REACH– Conducted study 2004 to assess the differences between current EU
system of classification and GHS.– Analysis of impact conducted 2005/2006 by independent contractors.– Launched a public internet consultation on a draft Regulation
implementing GHS into Community legislation.• Ongoing (3rd Quarter 2006)
CEFIC Recommendations– Add GHS classification to Section 16 of current MSDS– EU should only adopt Health Categories equal to what is currently
regulated. (i.e. Harmful)• Unofficial sources indicate EU will adopt Health Categories 1-4
– Companies should do cost assessments and provide feedback to regulators.
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Status in Asia
Japan– 2006 implementation
– Labels (Industry requesting transition period)– MSDS have 4 year transition (2010)
– Translated Classification Manual Available– http://www.meti.go.jp/policy/chemical_management/kokusai/GHS/GHS_Classification_Manual
.htm
– Plans to “Pre-classify” 1500 chemicals– ~700 completed– May be discrepancies as indicated by local sources
China - 2008– Work ongoing with no formal documents presented
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Asia (continued)
Korea– No official implementation date (2008?)– Different regulating bodies discussing– One government official noted that “GHS will not
cover all Korean regulations, therefore it will be supplemented”.
Taiwan– Originally targeted 2007– Translated version of GHS available
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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
Report from the TRFA VOC Task Force
Charles M. Bartish Air ProductsCharles Zarnitz CVCTom Geriak Garland FloorsDerek Kincaid Huntsman
September 11, 2006 Montreal, Canada
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TRFA and VOC’s: Background
New US regulations are sharply reducing levels of VOC’s acceptable in coatings formulations
Significant discussion in Regulatory Affairs session in Ft. Lauderdale re new VOC legislation
Coatings, Civil Engineering, Flooring Committee requested effort to address issue for TRFA
Team formed to address issue, focused on needs of TRFA companies
Purpose of this presentation is to update the membership on accomplishments to date
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Impact: Regulations are driving down allowable VOC content in coatings
VOC limit, gram/liter
Coating Category
US EPA today
CARB / OTC
SCAQMD Previous
SCAQMD July 06
Flat 250 100 100 100
Non-flat 380 150 150 50
Primer 350 200 200 100
Floor 400 250 100 50
Wood 600 250 250 100
Concrete 600 400 400 100
Indus. Maint. 450 250 / 340 250 100
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TRFA formed the VOC Task Force
Industry team members with interest, commitment to address issue
– Charlie Bartish Air Products and Chemicals– Charlie Zarnitz CVC Specialty Chemicals– Tom Geriak Garland Floors– Derek Kincaid Huntsman
Significant participation from TRFA administration– Jeri Church– Kathy Fatz
Benzyl alcohol suppliers asked, but declined to participate
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Task Force approaches outlined
Focus on VOC issues related to benzyl alcohol– Common ingredient in many formulated products– Limited volatilization; formulation dependent – Consider alternate performance-equivalent solvents;
supplier feedback pessimistic based on work to date
Define why benzyl alcohol should not be classified VOC– Existing analytical methods (EPA 24, ASTM 2369)
overstate VOC impact of benzyl alcohol– Develop and get new method approved– Components can be excluded, i.e. reactive diluents– EPA process, although tedious, exists to delist chemicals
from VOC list
Work closely with other organizations with common interests
– NPCA, ASTM, CARB, SCAQMD, EPA
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ASTM task group D01.21.24B proposed changes to ASTM 2369 ASTM task group leading efforts to change methods
– Addressing high (>90%) solids coatings– Fred Gelfant (Stonhard) chairs task group
Proposed changes include:– Sample size not limited to 0.3 g– Apply at thickness for product intended use– No solvent dilution required in test– Up to 24-hr cure time
These changes could benefit the benzyl alcohol case. – Stonhard data supports conclusion– TRFA will work more closely with ASTM
EPA letter will allow use of changes in certain areas
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Conclusions
New VOC regulations require a response from TRFA formulators to meet new requirements
Formulations containing benzyl alcohol need attention to meet new VOC limits
TRFA VOC Task Force is formed and has reviewed several options for solutions
Benzyl alcohol delisting or replacement low probability to meet time needs
Modification of analytical methods EPA 24 / ASTM 2369 offers good potential for success and may be usable in near future
TRFA VOC Task Force will work closely with ASTM to influence industry forward program
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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!