proposition 65 update: clear and reasonable warnings

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Understanding Clear & Reasonable Warnings in Proposition 65

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Understanding Clear & Reasonable Warnings in Proposition 65




Today’s Moderator

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Valerie KuntzAssent ComplianceSubject Matter Expert - Materials Management




INTRODUCTION




Assent Product SuitesOur Market Leading Platform

Corporate Social Responsibility Product Compliance

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Today’s Presenter

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Mario FernandezOffice of Environmental Health Hazard AssessmentStaff Counsel




Proposition 65




Proposition 65 is also known as the Safe Drinking Water and Toxic Enforcement Act of 1986.

The authors wrote the law with the intention of protecting California's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm. It was also created to inform citizens about exposures to such chemicals.

It requires the Governor of California to publish a list of these chemicals on an annual basis.

The list is currently closing in on 1,000 substances.

Proposition 65

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Four Potential Listing Mechanisms1. Listed if either of the two following independent committees of scientists and health professionals, known as the

State’s Qualified Experts, finds that the chemical causes cancer, birth defects or other reproductive harm:a. Carcinogen Identification Committee (CIC)b. Development and Reproductive Toxicant (DART) Identification Committee

2. The CIC or DART has designated an authoritative body that identifies a chemical known to cause cancer or reproductive harm:a. U.S. EPA (Environmental Protection Agency)b. U.S. FDA (Federal Drug Administration)c. NIOSH (National Institute for Occupational Safety and Health)d. NTP (National Toxicology Program, and International Agency for Research on Cancer)

3. An agency requires a chemical to be labeled or identified as causing cancer, birth defects or other reproductive harm (usually prescription drugs)

4. A chemical meets scientific criteria and is identified in the California Labor Code as causing cancer, birth defects or other reproductive harm

How Are Chemicals Added to the List?

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Safe Harbor LevelThe law is not a restriction on substances in products, but requires manufacturers to notify individuals if they are exposed to chemicals above a Safe Harbor Level.

Safe harbor levels include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity.

These levels are measured in µg/day and must take into account all exposure routes (e.g. inhalation, oral, dermal).

If products do not expose individuals to any of the Proposition 65 listed substances above the safe harbor level, then no notification is required.

What Are the Restriction Limits?

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▪ Businesses that expose individuals to that chemical would be required to provide a Proposition 65 warning, unless the business can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm

▪ Regulations were adopted to provide guidance for calculating a level in absence of a safe harbor level

▫ Article 7 and 8 of Title 27, California Code of Regulation

What If There Is No Safe Harbor Level?

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▪ Businesses are required to provide a “clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical

▪ Examples of labeling:▫ Labeling a consumer product ▫ Posting signs at a workplace▫ Distributing notices at a rental housing complex▫ Publishing notices in a newspaper

▪ Required from one year of listing a chemical ▪ Not required if the company has less than 10 employees

How Do I Notify Individuals?

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A couple of ways…

▪ The California Attorney General’s Office enforces Proposition 65▪ Any district attorney or city attorney in cities with a population over 750,000▪ ANY individual acting in the public interest may enforce Proposition 65 by filing a lawsuit

against a business alleged to be in violation of this law

Penalties▪ Fines of up to $2,500 per day, per violation▪ Total settlements for 2014 were just under

$30 million – almost double from 2013

How Is This Enforced?

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Proposition 65 Update:Clear & Reasonable Warnings




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.




Office of Environmental Health Hazard Assessment (OEHHA)

▪ About 130 employees, $25 million budget

▪ Lead California agency for conducting health risk assessments of chemicals

▪ Lead agency for Proposition 65▫ Maintains list of carcinogens and reproductive toxicants

▫ Provides guidance to businesses and the public

▫ No enforcement authority; Attorney General’s office enforces Proposition 65

▪ Its risk assessments form the public health basis for California’s drinking water and air quality standards and regulations

▪ Issues sport-fish advisories and pesticide reviews, and identifies California’s disadvantaged communities that are highly impacted by pollution




OEHHA’s Proposition 65 Responsibilities

▪ Develops regulations to implement the statute ▫ Operationalizes listing mechanisms, derives safe harbor guidance, calculates exposure,

determines extent of exposure, issues warnings

▫ Codifies safe harbor levels

▪ Maintains the Proposition 65 list▫ For four mechanisms: State’s Qualified Experts, authoritative bodies, labor code,

formally required to be labeled

▪ Provides assistance to interested parties




Safe Harbor LevelsMore than 300 regulatory levels developed

▪ No Significant Risk Levels for carcinogens▪ Maximum Allowable Dose Levels for reproductive toxicants

EXAMPLE:Dermal MADL for bisphenol A




Development of Interpretive Guidelines

OEHHA interprets Proposition 65and its implementing regulations for specific facts or circumstances




Safe Use Determinations

▪ 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 of 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




Proposition 65: The Law

▪ Official name:▫ Safe Drinking Water and Toxic Enforcement Act of 1986

(CA Health and Safety Code section 25249.5, et. seq.)

▪ Approved in November 1986▫ by California voters as a ballot initiative by a 63-37 vote

▪ Amendments require a two-thirds vote in the California State Legislature

▫ And must “further the purpose” of the statute

NOVEMBER




Proposition 65: The LawHSC 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 reasonable warning to such individual…




Motivation for Change ▪ Make warnings more meaningful to the public

▪ Reduce over-warning

▪ Resolve conflict between manufacturer/retailer responsibilities to provide warnings

▪ Provide more product compliance assistance to business

▫ How to provide warnings

▫ Where to provide warnings

▫ Provide more product/place specific warnings

▫ Update methods to take into account technological advances (internet, smart phones)

Clear and Reasonable WarningsCal. Code of Regs., Title 27, Article 6

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Cal. Code of Regs., Title 27, Article 6Article 6 Updates: Overview

▪ Clarifies responsibilities to provide warnings

▪ Retains “safe harbor” approach for warnings to provide flexibility for businesses

▫ Includes changes to warning methods and content

▫ Provides for more specificity and clarity in warnings

▪ Added “tailored” warnings for specific kinds of exposures

▫ Examples: Dental care, furniture, diesel engines, automobiles, recreational vessels, amusement parks




Subarticle 1

▪ 25600. General

▫ Mandatory provisions applicable throughout Article 6

▫ Subsection (b) allows for warnings to be provided in accordance with the revised Article 6 prior to the two-year effective (operative) date of August 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) restates that OEHHA recognizes court ordered settlements and final judgments as to parties to those settlements and judgments




Subarticle 1

▪ 25600. General, continued

▫ 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

▪ 25600.1. Definitions

▪ 25600.2 Responsibility to Provide Consumer Product Exposure Warnings

▫ Sets forth manufacturer/retailer responsibilities




▪ Consumer product manufacturers have primary responsibility for warning

▪ Manufacturer can label consumer product or:▫ Provide notice to distributor/importer/retail seller that a product may cause an exposure to a listed

chemical▫ Provide warning signs and materials (unless they make other arrangements via contract) ▫ Can modify allocation of responsibility by entering into a written agreement with the retail seller so

long as the consumer receives a warning prior to exposure

▪ Retail sellers ▫ Confirm receipt of notice ▫ Act as “pass-through” for warning

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Section 25600.2Manufacturer/Retail Seller Responsibilities




Subarticle 2:Safe Harbor Methods & Content

▪ Section 25601 Safe Harbor Methods and Content▫ Sets forth methods and content for providing “safe harbor” warning

▪ Section 25602 Consumer Product Exposure Warnings - Methods of Transmission▫ Includes point of display warnings, electronic device or process, labels, on-product

(“short-form”) warning and internet purchase warnings

▪ Section 25603 Consumer Product Exposure Warnings - 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 the warning▫ Answers question: “What am I being exposed to?”





▪ Section 25603. Consumer Product Exposure Warnings▫ OEHHA web site URL: www.P65Warnings.ca.gov ▫ Warning symbol:

▪ Section 25604. Environmental Exposure Warnings - Methods of Transmission

▪ Section 25605. Environmental Exposure Warnings - Content

▪ Section 25606. Occupational Exposure Warnings▫ Substantially retained provisions of September 2008 version

of regulations



http://www.p65warnings.ca.gov



▪ Section 25607. Specific Product, Chemical and Area Exposure Warnings

▫ “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

▫ Warnings about the exposures that can occur through these products and facilities

▫ Must use the tailored warning for the specific exposure type in order to meet the “safe harbor”

▫ Significant stakeholder input in development of tailored warnings

▫ Will continue to develop tailored warnings




Safe Harbor Warnings: Comparison of Current & New Content

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 www.P65Warnings.ca.gov.

WARNING: This product contains a chemical known to the State of California to cause cancer.

Ex. 2 New safe harbor warning

Ex. 1 Current safe harbor warning


Consumer Product Exposure Warning




Safe Harbor Warnings: Translations

ADVERTENCIA: Este producto puede exponerle a químicos incluyendo arsenic, que es conocido por el Estado de California como causante de cáncer. Para mayor información, visite www.P65Warnings.ca.gov.

https://www.p65warnings.ca.gov/warning-translations-businesses

Consumer Product Exposure Warning: Spanish Translation



https://www.p65warnings.ca.gov/warning-translations-businesses


WARNING: Cancer - www.P65Warnings.ca.gov.

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Safe Harbor Warnings:Short-Form Warning


Consumer Product Exposure Warning: On-Product (Short-Form)




Phase-In

▪ Phase-in period of two years

▪ Operative date of regulation: August 30, 2018

▪ Consumer products manufactured prior to August 30, 2018 will not require new warnings if they meet existing safe harbor requirements

▪ Court-approved warnings expressly recognized and considered “clear and reasonable” for parties to litigation

30AUGUST




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




Proposition 65 Warnings Website https://www.p65warnings.ca.gov/



https://www.p65warnings.ca.gov/



Proposition 65 Warnings Website

Currently available on website:▪ Fact sheets about certain chemicals,

products and places

▪ Proposed and current safe harbor warnings

▪ Warning signs for download

▪ Some information in multiple languages

Plans for future▪ Steadily populate website with more of

the above




Proposition 65 Resources

▪ OEHHA website:▫ https://oehha.ca.gov ▫ Statute, regulations, listings, safe harbor numbers, fact sheets

▪ Proposition 65 Warnings website:▫ https://www.p65warnings.ca.gov/ ▫ Additional information on listed chemicals, exposure to listed chemicals from products and places,

information for businesses

▪ Attorney General website:▫ https://oag.ca.gov/prop65 ▫ Enforcement actions and settlements



https://oehha.ca.gov


https://oag.ca.gov/prop65


For More Information

▪ Proposition 65 questions: ▫ [email protected]

▪ Mario Fernandez▫ Staff Counsel

▫ Office of Environmental Health Hazard Assessment

◆ PHONE: (916) 323-2635

◆ EMAIL: [email protected]




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