Key Regulatory Issues, Updates, and Current Hot Topics

1
Key Regulatory Issues, Updates, and Current Hot
Topics

• Charles M. Bartish
• Director, Product Safety
• Air Products and Chemicals, Inc.

November 15, 2005 Fort Lauderdale, FL
2
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!

3
The HPV Test Rule

• Affects 2800 chemicals manufactured / imported
  into USA
• Chemicals gt 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

4
Costs and Timing

• Thermoset industry chemicals affected
• Companies working together to conduct testing

Testing costs are for a chemical needing a
complete test package. Doesnt include personnel,
travel, sweat equity, administrative costs. All
testing to be completed in mid-2000s.
5
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 ether BGE butyl glycidyl
ether
6
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-90s Product Stewardship
  memorandum of understanding (MOU) with EPA

7
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

8
What is the proposed REACH regulation?

• The proposed system is known as REACH
• Registration
• Evaluation and
• Authorization of
• Chemicals
• The scope is for (all) chemicals marketed in
  Europe, either manufactured or imported.

9
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 gt 1 mt/yr 2008
• Registration gt 1000 mt/yr 2008 (earliest
  est.)
• Registration gt 100 mt/yr 2011 (earliest
  est.)
• Registration gt 1 mt/yr 2016 (earliest est.)
• CMR Carcinogen, mutagen, reproductive toxin

10
Costs and Timing

• Test requirements similar to HPV program, likely
  staggered by volume and risk
• Expect to use HPV data, wherever possible
• Industry expected to work together

11
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

12
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.

13
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

14
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
• lt 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

15
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

16
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

17
South Korea

• Changes Made
• Increased enforcement of inventory requirements
• New chemical notification requires ecotoxicity
  testing (1 January 2006)

18
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

19
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.

20
Controlled Chemicals Specifics
Heavy 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
21
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

22
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

23
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

24
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?

25
Is there harmony in harmonization?

• One example Classification Toxicity
• Five categories now exist!
• Based on LD50/LC50 values
• Oral, dermal, or inhalation route

26
acute oral toxicity
Class 1
Class 2
CH
Class 3
Class 3
Class 4
Class 5
Category 1
Category 2
GHS
Category 3
Category 4
Category 5
EU
T
T
Xn
//
50
100
200
300
400
500
2000
5000
25
5
LD50 mg/ kg
EU is tougher! But GHS will include unclassified
EU in Cat 5
27
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
28
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 (paperpostal
  rates) 241,000
• - TOTAL more than ?
  1,872,000
• reference J.G.Abbott SGCI Chemie Pharma
  Schweiz June 2004 ACC CEFIC meeting

29
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

30
VOCs 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

31
(No Transcript)
32
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

33
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

34
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

35
Impact of OTC rules
VOC Content Limits, Wt VOC Content Limits, Wt 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
36
Resources

• EPA www.epa.gov - see 63 FR 17648848
• 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

37
What do we expect from you?

• Remember, were 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!

38
Thanks to

• Lynne Harris, SPI
• Marie Martinko, SPI
• Jeri Church, TRFA

39
Glycidyl ether Test Plan
HPV Data Category Test Endpoint AGE BGE
Physical and Chemical Properties Partition Coefficient Yes
Physical and Chemical Properties Water Solubility Yes
Health Effects Chromosome Aberration Yes
Health Effects Developmental Toxicity Yes
Environmental Fate and Pathways Water stability Yes Yes
Environmental Fate and Pathways Biodegradation Yes
Ecotoxicity Acute toxicity to Fish Yes
Ecotoxicity Acute toxicity to Aquatic invertebrates Yes
Ecotoxicity Acute toxicity to Aquatic Plants Yes
Estimated costs, M 50 150