Proposition 65

1. Proposition 65 October 28, 2009 Peter de la Cruz Partner Keller and Heckman LLP 1001 G Street, N.W. Washington, DC 20001 202-434-4141 delacruz@khlaw.com

2. Today’s Hypothetical Styrene is listed as a Prop 65 carcinogen. If so, • What is Proposition 65? • What action should I take?

3. What is Proposition 65? • Safe Drinking Water and Toxic Enforcement Act of 1986 • Enacted as a ballot initiative in November of 1986 • Designed to inform citizens about chemicals “known” to the State to cause • Cancer • Birth defects • Other reproductive harm

4. Proposition 65 Prohibitions • Prohibits the knowing discharge or release of significant amounts of listed chemicals into drinking water • Prohibits the knowing exposure of individuals to significant amounts of a listed chemical without providing a “clear and reasonable warning”

5. Warning Requirements • California Health and Safety Code Section 25249.6 “No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reason- able warning to such individual.”

6. Warning Language • “WARNING: This product contains a chemical known to the State of California to cause cancer [or reproductive harm].” • Warning statement required within one year of listing • No warning required if business can prove exposure poses “no significant risk” • If there is measureable exposure, it is a triable issue of fact as to whether exposure exceeds the no significant risk level (NSRL)

7. Exposure Scenarios • Covers exposures via • Consumer products • Workplace exposure • Environmental exposures

8. Proposition 65 Background • Requires publication of lists of chemicals known to the state of California to cause cancer or productive toxicity ~ 500 carcinogens ~ 250 reproductive toxicants • California EPA Office of Environmental Health Hazard (OEHHA) implements Proposition 65

9. Proposition 65 - Enforcement • Civil Penalties - $2500/day/per violation • Injunctive relief and criminal penalties also available • Citizen Suits • Similar to federal Clean Water Act and Clean Air Act citizen suit provisions • Private citizen suits permitted if California AG declines to act after 60-day notice • Compensation for successful private litigation

10. Exemptions • Exposures below the NSRL or MADL • Naturally Occurring • Federal Preemption • Exposure for which federal law governs warning in a manner that preempts state authority

11. Preemption of State Laws • Based on Supremacy Clause of U.S. Constitution • Direct preemption • Implied preemption • Federal law occupies the field • Inconsistent with purpose or effect of federal law

12. Unsuccessful Preemption Cases • Pesticides under FIFRA • Consumer products under FHSA • Medical Devices under FDCA

13. Successful Preemption Cases • Pharmaceuticals • Dowhal v. Smithkline Beecham Consumer Healthcare, CA S.Ct. (2004) • Nicotine replacement product • “Frustrate the purpose of federal law and policy” • Single-mindedness of Proposition 65 versus nuanced approach of FDA

14. Successful Preemption Case? Public Media Center v. Tri-Union Seafoods • San Francisco Superior Court (May 2006) • Warning for methyl mercury in tuna • FDA has a long history of health advisories • FDA suggested CA “not interfere” • Trial court agreed, finding FDA was entitled to “substantial deference” • Warning on a healthy product FDA encourages people to eat is misleading • Court of Appeal (March 2009) • Affirms on “naturally occurring” exemption

15. Compliance Framework Styrene or styrene-containing products made or sold in California? What are the estimated worker or consumer exposure levels? Does the estimated exposure level exceed NSRL? YES NO Warning No Warning

16. Is it Listed? • Determine whether any listed chemicals are used or created in the manufacture of the product, including by-products or impurities • Determine whether any of these chemicals are present in the finished product. If so, in what amount?

17. If it is on the list… • Has California adopted a No Significant Risk Level (NSRL)? • Reproductive toxicants use a Maximum Allowable Daily Exposure Level (MADL) = NOEL/1000 • If not, conduct assessment to determine the NSRL • SIRC retaining expert consultant to develop NSRL using California regulatory criteria • Burden of establishing NSRL or MADL is on the person causing exposure • Conduct an exposure analysis to determine whether the given or calculated NSRL may be exceeded by foreseeable use of the product

18. Calculating the NSRL • Section 12701: NSRL is level calculated to result in one excess case of cancer in an exposed population of 100,000 (1/105 or 10-5), assuming lifetime exposure • OEHHA is responsible for developing or adopting NSRLs • OEHHAmay adopt NSRLs based on reference levels developed by another state or federal agency (e.g., USEPA) • Or, an expedited risk assessment using a simplified approach can be used

19. NSRL Criteria • Prop 65 regulations provide that the determination of whether a level of exposure to a listed chemical poses no significant risk shall be based on evidence and standards of comparable scientific validity to the evidence and standards that formed the basis for the listing of the chemical.

20. NSRL Criteria • May use evidence, standards, risk assessment methodologies, principles, assumptions or levels not described in this article to establish that a level of exposure to a listed chemical poses no significant risk. • In other words, even if an NSRL developed by OEHHA exists, an individual or company may develop an alternative NSRL, based on more appropriate data or a more appropriate method • But, be prepared to defend!

21. Default NSRL Assumptions • Animal bioassay studies for quantitative risk assessment shall meet generally accepted scientific principles • The quality and suitability of available epidemiologic data shall be appraised to determine whether the study is appropriate • Risk analysis shall be based on the most sensitive study deemed to be of sufficient quality • The results obtained for the most sensitive study deemed to be of sufficient quality shall be applicable to all routes of exposure for which the results are relevant

22. More Science Policy Assumptions • Absence of a carcinogenic threshold assumed • No threshold model utilized • Linearized multistage model for extrapolation from high to low doses, with the upper 95% confidence limit • Human cancer potency shall be derived from data on human or animal cancer potency • Interspecies conversion of animal cancer potency to human cancer potency shall be determined by multiplying by a surface area scaling factor equivalent to the ratio of human to animal bodyweight, taken to the one-third power • Physiologic, pharmacokinetic and metabolic considerations can be used for inter-species, inter-dose, and inter-route extrapolations

23. Additional Assumptions • When the cancer risk applies to the general population, human body weight of 70 kilo- grams shall be assumed. When the cancer risk applies to a certain subpopulation, the following assumptions apply as appropriate: • Body weight for males (18+ years of age) 70 kg • Woman (18+ years of age ) 58 kg • Woman with conceptus 58 kg • Adolescent (11-18 years of age) 40 kg • Child (2-10 years of age) 20 kg • Infant (0-2 years of age) 10 kg

24. Workplace Exposure – Benzene in Styrene • Benzene NSRL 13 µg/day • Assume • Styrene contains 1 ppm of benzene • Worker will inhale 10 cubic meters (m3) of air during an 8-hour work day • Workers exposed to a maximum of 50 ppm of styrene • Inhaled styrene equals • 10 m3 of air x (50 x 10-6) styrene

25. Benzene in Styrene #2 • Inhaled benzene calculated as: 10 m3 air x (50 x 10-6) styrene x (1 x 10-6) benzene = 5 x 10-10 m3/day inhaled benzene • Total worker inhalation is 1.75 µg/day 3500 g x (5 x 10-10) x 106 = 1.75 µg • Even if styrene contains up to 7 ppm benzene, workers will be exposed to less than the 13 µg/day NSRL

26. Ethyl Benzene Workbook

27. Framework Styrene or styrene-containing products made or sold in California? What are the estimated worker or consumer exposure levels? Does the estimated exposure level exceed NSRL? YES NO Warning No Warning

28. Questions? Thank you