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UL and the UL logo are trademarks of UL LLC © 2012 California Proposition 65 Can you afford not to label your products? Scott Steady UL Environment

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Presentation on theme: "UL and the UL logo are trademarks of UL LLC © 2012 California Proposition 65 Can you afford not to label your products? Scott Steady UL Environment"— Presentation transcript:

1 UL and the UL logo are trademarks of UL LLC © 2012 California Proposition 65 Can you afford not to label your products? Scott Steady UL Environment

2 What is Proposition 65? Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November Proposition 65 required the Governor of California to publish a list of chemicals that are known to the State of California to cause cancer, birth defects or other reproductive harm. The list is updated quarterly by the Californias Office of Environmental Health Hazard Assessment (OEHHA) - (http://www.oehha.ca.gov/prop65.html)http://www.oehha.ca.gov/prop65.html - there are ~900 chemicals on the list Before knowing and intentional exposure of a person in CA to listed chemicals, a business must provide clear and reasonable warning. 2 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

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4 Enforcementby Litigation Enforcement is carried out through civil lawsuits brought by the California Attorney General, or by a district attorney or city attorney Primary enforcement is by private plaintiffs attorneys (~95% of cases)* - Send written notice to public prosecutors and violator - Wait 60 days to make sure no public prosecutor sues Nearly 20,000 notices have been served since 1986* In the past 5 years, settlements have totaled about $75,000,000* - Almost 90% of the settlement money goes to plaintiffs attorney - Settlements typically require product reformulation and/or labeling 4 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE. * Statistics compiled from

5 The Burden of Proof The plaintiff only has to show detectable exposure to a listed chemical and then the burden of proof is on the defendant. Defendant must demonstrate that the level of exposure is not significant. Businesses that cause exposures greater than the safe harbor level must provide Proposition 65 warnings. OEHHA provides safe harbor levels for some listed chemicals. It is the manufacturers responsibility to develop a safe harbor level if none exists. 5 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

6 How do you know if your products need a warning label? Proposition 65 applies only to exposures to listed chemicals. It does not ban or restrict the use of any given chemical. Use your knowledge of the materials and chemicals used in your products. Review the Proposition 65 list to determine if there are any listed chemicals for which your products may be a source of exposure. (http://oehha.ca.gov/prop65/getNSRLs.html)http://oehha.ca.gov/prop65/getNSRLs.html Depending on the level of exposure, you may be required to provide a warning. 6 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

7 Contact your Attorney! If a notice is received, the client should contact their legal team. It is recommended to seek advice from lawyers who specialize in CA Prop 65. Even if you are proactively investigating risk for your products with respect to Proposition 65, it may be best to conduct the work under the direction of an attorney. 7 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

8 Essential Skills for Making a Proposition 65 Determination Legal Expertise Chemical Analysis Toxicology 8 Determining anticipated levels of exposure to listed chemicals can be very complex. Because a business has the burden of proving a warning is not required, you should consider consulting a qualified professional. (from OEHHA website FAQs) THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

9 Elements of a Proposition 65 Evaluation 1.Determine the potential listed chemicals that may be associated with your product. 2.Conduct testing to measure the level of listed chemical in your product or emitted from your product (leaching or off- gassing). 3.Use the data to perform an exposure assessment using conservative assumptions. 4.Develop a safe harbor level if one doesnt exist, and compare the exposure level to the safe harbor level. 9 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

10 Determining Chemicals of Concern Review MSDS Sheets from all suppliers (and their suppliers when possible) Require supplier disclosure of Prop 65 chemicals Identify settlement restrictions from past litigation Halloween costumes (Lead, Cadmium, Formaldehyde, Phthalates) Fashion Accessories (Lead) Electrical Cords (Lead) 10 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

11 Identify Potential Exposure Routes There are 3 primary routes of chemical exposure: Ingestion (oral) – food, water, accidental Skin absorption (dermal) – clothing or routinely handled objects Inhalation – gases (VOCs) or particles All exposure routes may need to be considered depending on how your product is used. Different types of testing are recommended depending on the routes of exposure for your product. 11 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

12 What tests need to be conducted? 12 The regulations provide no guidance on what test methods should be used. Determinations must be based on evidence and standards of comparable scientific validity to those that form the scientific basis for the listing of the chemical. The test methods will depend on the chemicals suspected to be present and the anticipated exposure route. Chemical Content Testing Wipe Testing Environmental Chamber Testing THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

13 13 Environmental Chamber Testing Air Purification and Conditioning Sample Preparation Environmental Chamber Testing Analysis and Reporting Predicting Indoor Exposure Levels THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

14 Environmental Chamber Guides Clean air generation systems Monitoring and control systems Chamber performance Sample collection and analysis equipment ISO Determination of the emission of volatile organic compounds from building products and furnishing Emission test chamber method ASTM D – Standard Guide for Small-Scale Environmental Chamber Determinations of Organic Emissions from Indoor Materials/Products ASTM D – Standard Practice for Full-Scale Chamber Determination of Volatile Organic Emissions from Indoor Materials/Products 14 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

15 15 VOC Measurement ASTM D 6196 / ISO Part 6 Collect chamber air on Tenax Sorbent Media, thermally desorb chemicals and analyze by GC/MS Applicable to the following listed compounds Benzene, ethyl Benzene, 1,4-dichloro Toluene (Methylbenzene) Ethanol, 2-ethoxy Ethanol, 2-ethoxy-, acetate (Ethylene glycol monoethyl ether acetate) ,4-Dioxane Ethene, 1,1,2,2-tetrachloro (Tetrachloroethylene) Hexanoic acid, 2-ethyl Benzene Ethene, 1,1,2-trichloro (Trichloroethylene) Pyrrolidinone, 1-methyl Naphthalene Propane, 1,2,3-trichloro Cyclohexene, 4-vinyl (4-Ethenylcyclohexene) THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

16 16 Aldehyde Measurement ASTM D 5197 / ISO Part 3 Collect chamber air on DNPH Cartridge, elute with acetonitrile and analyze by HPLC Applicable to formaldehyde and acetaldehyde Particle Measurement Applicable to titanium dioxide and other airborne particulate that may contain listed chemicals Captured on filters for further analysis THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

17 17 Building Product and Furniture Test Methods THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

18 Personal Exposure Studies 18 Perform activity in large chamber Recreate true consumer experience Measure concentrations in the breathing zone and/or in the rest of the room THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

19 Predicting Exposure Concentrations Define the product use environment -Room Volume -Product loading (surface area, units) -Ventilation (air changes per hour) Determine duration and frequency of exposure -Hours/day -Days/year -Product life (years) Compare the total exposure to the Safe Harbor Level -Average daily lifetime exposure (over 70 years) for Carcinogens -Maximum daily exposure for Reproductive Toxins 19 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

20 Safe Harbor Levels NSRL Carcinogen Safe Harbor Levels are termed No Significant Risk Levels (NSRL). They are based on the most sensitive study meeting certain requirements and calculations described in regulations for an exposure level that results in 1 excess cancer in an exposed human population of 100,000 over a 70-yr lifetime. MADL Reproductive Toxin Safe Harbor Levels are termed Maximum Allowable Dose Level (MADL). They are based on the most sensitive study meeting certain requirements at a level that is 1,000 fold below the no observable effect level (NOEL) of the study. 20 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

21 Legal Review Even if your product is shown to be under the safe harbor levels for any chemicals of concern, manufacturers should consult their attorney regarding the decision to label or not label their products! 21 THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

22 Questions? For more information on UL Environment services related to Proposition 65, please contact us at ul.com/environment


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