PROPOSTION 65 UPDATE. Carol Monahan Cummings Chief Counsel CalEPA Office of Environmental Health Hazard Assessment

Size: px

Start display at page:

Download "PROPOSTION 65 UPDATE. Carol Monahan Cummings Chief Counsel CalEPA Office of Environmental Health Hazard Assessment"

Osborne Harmon
5 years ago
Views:

1 PROPOSTION 65 UPDATE Carol Monahan Cummings Chief Counsel CalEPA Office of Environmental Health Hazard Assessment Information Technology Industry Council October 4, 2017

2 PROPOSITION 65 TOPICS Background on OEHHA Clear and reasonable warnings Overview of new regulation Retailer warnings accompanying sale Warnings website Listings Compliance assistance Safe Harbors Safe Use Determinations and Interpretive Guidance 2

OEHHA ASSESSMENTS SUPPORT CALEPA ENVIRONMENTAL AND PUBLIC HEALTH ACTIVITIES Cal/EPA Mission: To restore, protect and enhance the environment, to ensure public health,

3 OEHHA ASSESSMENTS SUPPORT CALEPA ENVIRONMENTAL AND PUBLIC HEALTH ACTIVITIES Cal/EPA Mission: To restore, protect and enhance the environment, to ensure public health, environmental quality and economic vitality. OEHHA Mission: To protect and enhance public health and the environment by objective scientific evaluation of risks posed by hazardous substances. 3

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT About 130 employees, $25 million budget Lead agency for Proposition 65 Maintain list of carcinogens and reproductive toxicants.

4 OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT About 130 employees, $25 million budget Lead agency for Proposition 65 Maintain list of carcinogens and reproductive toxicants. Provide guidance to businesses and the public. No enforcement authority. Attorney General s office enforces Proposition 65. Risk assessments form the basis for CA s air-quality regulations and drinking water standards. Fish consumption advisories, guidance on pesticides, identify CA disadvantaged communities highly impacted by pollution. 4

5 OEHHA S PROPOSITION 65 RESPONSIBILITIES Develop regulations to implement the statute Listing processes, safe harbor levels, guidance, calculating exposure, extent of exposure, warnings Maintain the Proposition 65 list For 4 mechanisms: State s qualified experts, authoritative bodies, labor code, formally required to be labeled. Assistance to interested parties 5

6 CLEAR AND REASONABLE WARNING Warnings Regulations Warnings Website

7 CLEAR AND REASONABLE WARNINGS CAL. CODE OF REGS., TITLE 27, ARTICLE 6 7

8 CLEAR AND REASONABLE WARNINGS CAL. CODE OF REGS., TITLE 27, ARTICLE 6 MOTIVATION FOR CHANGE Make warnings more meaningful to the public Reduce over-warning Resolve conflict between manufacturer-retailer responsibilities to provide warnings Provide more compliance assistance to businesses How to provide warnings Where to provide warnings Provide more product/place specific warnings Update warning methods to take into account technological advances (Internet, smart phones) Provide increased clarity regarding compliance 8

9 CLEAR AND REASONABLE WARNINGS CAL. CODE OF REGS., TITLE 27, ARTICLE 6 OVERVIEW Clarifies responsibilities to provide warnings Retains safe harbor approach for warnings to provide flexibility for businesses o Includes changes to warning methods and content o Provides for more specificity and clarity in warnings Added tailored warnings for specific kinds of exposures. o Examples: dental care, furniture, diesel engines, automobiles, recreational vessels, amusement parks. 9

10 SUBARTICLE 1 o Mandatory provisions applicable throughout Article 6 o o o Subsection (b) allows for warnings to be provided in accordance with the revised Article 6 prior to the twoyear effective (operative) date of 8/30/2018 Subsection (c) allows for businesses to request tailored warnings through a Petition for Rulemaking, and provides that Interpretive Guideline Requests and Safe Use Determinations are available under other OEHHA regulations. Subsection (e) states that OEHHA recognizes court ordered settlements and final judgments as to parties to those settlements and judgments 10

11 SUBARTICLE 1, CONT General, cont. o Subsection (f) makes clear that a business is not required to use the clear and reasonable warning methods and content in Subarticle 2 in order to comply with the Act Definitions Responsibility to Provide Consumer Product Exposure Warnings. o Sets forth manufacturer/retailer responsibilities 11

12 CLEAR AND REASONABLE WARNINGS MANUFACTURER/RETAIL SELLER RESPONSIBILITIES Product manufacturers have primary responsibility for warning. Manufacturer can label product or: o o Provide notice to distributor/importer/retail seller that a product may cause an exposure to a listed chemical. Provide warning signs, materials (unless they opt-out via contract). Retail sellers confirm receipt of notice act as pass-through for warning Provide non-english language warnings in certain situations. 12

13 CLEAR AND REASONABLE WARNINGS SAFE HARBOR METHODS AND CONTENT This product contains. This product can expose you to. The name of at least one chemical in the warning. Warning required for chemicals A and B. Business can include the name of A or B, or both. Named chemicals are those for which warning is being provided Business selects which chemical(s) to include in warning Answers question: What am I being exposed to? OEHHA web site URL ( Warning symbol for most warnings 13

14 SUBARTICLE 2. SAFE HARBOR METHODS AND CONTENT, CONT. Section Consumer Product Exposure Warnings, cont., o OEHHA web site URL o Warning symbol Section Environmental Exposure Warnings Methods of Transmission Section Environmental Exposure Warnings Content Section Occupational Exposure Warnings. o Substantially retained provisions of September 2008 version of regulations 14

15 SUBARTICLE 2. SAFE HARBOR METHODS AND CONTENT Section Specific Product, Chemical and Area Exposure Warnings. o Tailored warnings for specific types of exposures Food, alcohol, restaurants, prescription drugs, dental care, raw wood, furniture, diesel engines, vehicles, recreational vessels, enclosed parking facilities, service stations, vehicle repair facilities, smoking areas. o Warnings about the exposures that can occur through these products and facilities o Must use the tailored warning for the specific exposure type in order to meet the safe harbor o Significant stakeholder input in development of tailored warnings o Will continue to develop tailored warnings 15

16 Safe Harbor Warnings: Comparison of Current and New Content Consumer Product Exposure Warning WARNING: This product contains a chemical known to the State of California to cause cancer. Ex. 1 Current safe harbor warning WARNING: This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information go to Ex. 2 New safe harbor warning 16

17 Safe Harbor Warnings: Comparison of Current and New Content Consumer Product Exposure Warnings: On-product (Short-form) Warning WARNING: Cancer

Safe Harbor Warnings: Content Specific Exposure Warnings Food Exposure Warnings WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are]

18 Safe Harbor Warnings: Content Specific Exposure Warnings Food Exposure Warnings WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to

Safe Harbor Warnings: Content Specific Exposure Warnings Wood Dust Exposure Warnings WARNING: Drilling, sawing, sanding or machining wood products can expose you to wood dust, a substance known to

19 Safe Harbor Warnings: Content Specific Exposure Warnings Wood Dust Exposure Warnings WARNING: Drilling, sawing, sanding or machining wood products can expose you to wood dust, a substance known to the State of California to cause cancer. Avoid inhaling wood dust or use a dust mask or other safeguards for personal protection. For more information go to

20 Safe Harbor Warnings: Translations Consumer Product Exposure Warning Spanish ADVERTENCIA: Este producto puede exponerle a químicos incluyendo [name of one or more chemicals], que es (son) conocido (s) por el Estado de California como causante (s) de cáncer. Para mayor información, visite

21 Safe Harbor Warnings: Translations Consumer Product Exposure Warnings Chinese Traditional 警告 : 此產品可能會使您暴露於包括 [name of one or more chemicals] 化學物質 ] 在內在加州已知會致癌的化學物質欲瞭解更多資訊, 請查閱

22 Safe Harbor Warnings: Warnings Translations Consumer Product Exposure Warning: Vietnamese CẢNH BÁO: Sản phẩm này có thể phơi bầy quý vị với những hoá chất bao gồm [name of one or more chemicals], (những) hoá chất được Tiểu Bang California biết là nguyên nhân gây ung thư. Để biết thêm thông tin xin viếng trang mạng

23 Safe Harbor Warnings: Warnings Translations Consumer Product Exposure Warning (Short-Form) Vietnamese CẢNH BÁO: Ung Thư

24 CLEAR AND REASONABLE WARNINGS FUTURE EFFORTS Ongoing additions of new tailored warnings through new regulatory proposals Hotel Exposure Warnings Possible adjustments depending on how the regulation works in practice Article 6 cleanup rulemaking Clarification letters Q&A s for Businesses 24

25 Lead Agency Warnings Website Cal. Code of Regs., Title 27, Article 2, Section Effective April 1,

LEAD AGENCY WARNINGS WEBSITE Provides information on listed chemicals concerning Basic chemical information Exposure pathways and human exposures Strategies to reduce exposure Links to

26 LEAD AGENCY WARNINGS WEBSITE Provides information on listed chemicals concerning Basic chemical information Exposure pathways and human exposures Strategies to reduce exposure Links to authoritative information Provides the public a process to request correction of posted material Does not provide detailed technical information Links to OEHHA s main Proposition 65 pages (technical) 26

27 LEAD AGENCY WARNINGS WEBSITE CAL. CODE OF REGS., TITLE 27, ARTICLE 2, SECTION The regulation enables OEHHA to obtain information from manufacturers, distributors, etc. on why a warning is being given includes process to request that certain information be protected as a trade secret Compliance with the regulation does not satisfy the clear and reasonable warning requirement Failure to comply with the regulation is not a violation of the warning requirements 27

28 Currently on website: Fact sheets on certain chemicals, products and places Proposed and current safe harbor warnings Warning signs for download Some information multiple languages Questions and Answers for Businesses Plans for future Steadily populate website with more of the above 28

29 PROPOSITION 65 LISTINGS

30 RECENT LISTINGS UNDER PROPOSITION Dibenzanthracenes, N,N-Dimethyl-p-toluidine (c), Megestrol acetate (c), Methyl isobutyl ketone (d), 12 nitrosomethyl-alkyl amines (c), Pentosan polysulfate sodium (c), Pioglitazone (c), Pulegone (c), Triamterene (c), Trichloroethylene (DART) 2015 Aloe Vera (non-decolorized whole leaf extract), Bisphenol A (female), CMNP (pyrazachlor)(c), Ethylene glycol (ingested), Goldenseal root powder, 2,5-Hexanedione, Methyl-n-butyl ketone, Mitoxantrone hydrochloride, beta-myrcene, Teriparatide, Topiramate, Megestrol acetate, Methyl isobutyl ketone (MIBK), Pentosan polysulfate sodium, Pioglitazone 2016 Abiraterone acetate, Atrazine, Bromodichloroacetic acid, 1- Bromopropane (1-BP), Furfuryl alcohol, Malathion, Parathion, Pentachlorophenol and by-products of its synthesis (complex mixture), Sedaxane, Styrene, 6 Triazines (pesticides), Tetrachlorvinphos 2017 Vismodegib, Pertuzumab, Glyphosate, Pentabormodiphenyl ether mixture [DE-71 (technical grade)] 30

31 RECENT DELETIONS FROM THE PROPOSITION 65 LIST Chemical Health Effects Date n-butyl glycidyl ether Male Apr 4, 2014 Chlorsulfuron Developmental, female, male June 6, 2014 Diaminotoluene (mixed) Cancer Nov 20, 2015 Diglycidyl ether Male Apr 4, 2014 Methyl isopropyl ketone Developmental Apr 4, 2014 α-methyl styrene Female Apr 4, 2014 Phenyl glycidyl ether Male Apr 4,

32 CHEMICALS UNDER CONSIDERATION Chemicals currently being considered for authoritative bodies listing Perfluorooctane sulfonate (PFOS) (developmental) Perfluorooctanoic acid (PFOA) (developmental) Vinylidene chloride (cancer) Chemicals being considered by the DART IC in 2017 n-hexane Chlorpyrifos Chemical being considered by the CIC in 2017 Coumarin 32

33 COMPLIANCE ASSISTANCE

34 Safe Harbor Numbers Interpretive Guidelines Warning and Other Regulatory Amendments Safe Use Determinations Prop 65 page on OEHHA main website oehha.ca.gov Warnings Website P65warnings.ca.gov 34

35 SAFE HARBOR LEVELS > 300 REGULATORY LEVELS DEVELOPED No Significant Risk Levels for carcinogens Maximum Allowable Dose Levels for reproductive toxicants Example: Dermal MADL for bisphenol A 35

36 DEVELOPMENT OF INTERPRETIVE GUIDELINES OEHHA interprets Proposition 65 and its implementing regulations for specific facts or circumstances 36

37 SAFE USE DETERMINATONS OEHHA s determination whether an exposure to a listed chemical use of a specific product is subject to the warning requirement Recent safe use determinations Exposure to residents to diisononyl phthalate (DINP) in vinyl flooring products DINP exposures to professional carpet installers from modular vinyl carpet tiles Exposure to PVC roofing membrane products during installation 37

38 FOR MORE INFORMATION: Article 6 Clear and Reasonable Warnings rulemaking page: Proposition 65 Questions: P65.Questions@oehha.ca.gov Mario Fernandez Staff Counsel Ph: (916) mario.fernandez@oehha.ca.gov Or Carol Cummings Chief Counsel Ph: (916) carol.monahan-cummings@oehha.ca.gov 38

39 Questions? 39

Proposition 65 Update: Proposed Warnings, Website and other Woes

Proposition 65 Update: Proposed Warnings, Website and other Woes ACC Environmental & Sustainability Legal Quick Hit Laura Duncan, Principal September 10, 2015 This presentation is not intended as, nor