Understanding Clear and Reasonable Warnings in Proposition 65

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Understanding Clear & Reasonable Warnings in Proposition 65

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Today’s Moderator

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James CalderAssent ComplianceDirector, Compliance Programs







INTRODUCTION







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Feature PresentationUnderstanding Clear & Reasonable Warnings in Proposition 65







AKA The Safe Drinking Water and Toxic Enforcement Act of 1986

The authors wrote the law with the intention to protect California citizens and the State's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm. Also, to inform citizens about exposures to such chemicals

Requires the Governor of California to publish a list every year that contains chemicals that are known to cause cancer, birth defects, or other reproductive harm

The list is closing in on 1,000 substances

Proposition 65

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Four Potential Listing Mechanisms1. Listed if either of two independent committees of scientists and health professionals, “State’s Qualified Experts”,

finds that the chemical has been clearly shown to cause 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” who then identifies a chemical to cause cancer or reproductive harm:a. US EPA (Environmental Protection Agency)b. US 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 or 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 or birth defects or other reproductive harm

How Are Chemicals Added to the List?

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

Safe harbor levels, which 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 the 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 of 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 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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Today’s Presenter

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Mario FernandezOffice of Environmental Health Hazard AssessmentStaff Counsel






[email protected] / www.assentcompliance.com / 1 866 964 6931 / © Assent Compliance 2016 13







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/place-specific warnings

◆ Update methods to take into account technological advances

(Internet, smart phones)

◆ Provide increased clarity regarding compliance

◇ How and where to provide warnings

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

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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.

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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, cont.

⬦ 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







⬥ Product manufacturers have primary responsibility for warning.

⬥ Manufacturer can label 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

⬥ Provide non-English language warnings in certain situations.

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Section 25600.2, Cont.Manufacturer/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 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?”







Subarticle 2. Safe Harbor Methods & Content

⬥ Section 25603. Consumer Product Exposure Warnings, cont.,⬦ 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


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








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

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Safe Harbor Warnings: “Short-form” Warning


Ex. 2 New safe harbor short-form, on-product warning

Ex. 1 Current safe harbor warning








Subarticle 2. Safe Harbor Methods & Content

⬥ 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, BPA in canned products

⬦ 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







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







For More Information

⬥ Article 6 Clear and Reasonable Warnings rulemaking page:⬦ http://oehha.ca.gov/proposition-65/crnr/notice-adoption-article-6-clear-and-reasonable-warnings

⬥ Mario Fernandez⬦ Staff Counsel ⬦ Office of Environmental Health Hazard Assessment

■ p: (916) 323-2635■ [email protected]






http://oehha.ca.gov/proposition-65/crnr/notice-adoption-article-6-clear-and-reasonable-warnings

http://oehha.ca.gov/proposition-65/crnr/notice-adoption-article-6-clear-and-reasonable-warnings


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Q&A Discussion

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Date post:	13-Jan-2017
Category:	Education
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