Prop 65

Proposition 65 ("Prop. 65") requires warnings prior to exposing individuals to chemicals known to the State of California to cause cancer or reproductive toxicity. Bisphenol A (BPA) was recently added to the Prop. 65 list as a chemical known to cause reproductive toxicity. BPA may be found, for example, in polycarbonate lenses and some spectacle frames.

Optometric offices may need to post multiple signs depending upon the type of exposure consumer, occupational, or environmental exposures. The retail seller is responsible for the placement and maintenance of warning materials, including warnings for products sold over the internet.

Allow patients to assess the risk for themselves. Prop. 65 is a warning statute. It requires that individuals who are exposed to chemicals known to the State of California to cause cancer or reproductive toxicity be warned before being exposed to the chemicals so that they can decide whether to expose themselves to the chemicals.

The risk will vary; for example, depending upon the concentration of the chemical(s), the method of exposure, the length of exposure, etc. As a result, you probably will not be in a position to advise patients about the risk to them.

Yes. For internet purchases, a consumer warning must be provided by including either the warning or a clearly marked hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.

If a warning is provided on the label using the short-form version then you can use the same short-form warning on the website. The business may also use a picture of the label on the product for the website warning.

A warning is not prominently displayed if the purchaser must search for it in the general content of the website.

A retail seller is responsible for providing the warning required by Section 25249.6 of the Act for a consumer product exposure only when one or more of the following circumstances exist:

• 1. The retail seller is selling the product under a brand or trademark that is owned or licensed by the retail seller or an affiliated entity;

  2. The retail seller has knowingly introduced a listed chemical into the product, or knowingly caused a listed chemical to be created in the product;

  3. The retail seller has covered, obscured or altered a warning label that has been affixed to the product pursuant to subsection (b);

  4. The retail seller has received a notice and warning materials for the exposure pursuant to subsections (b) and (c) and the retail seller has sold the product without conspicuously posting or displaying the warning; or

  5. The retail seller has actual knowledge of the potential consumer product exposure requiring the warning, and there is no manufacturer, producer, packager, importer, supplier, or distributor of the product who:

  6. Is a “person in the course of doing business” under Section 25249.11(b) of the Act, and

  7. Has designated an agent for service of process in California, or has a place of business in California.

The new system clarifies that manufacturers have the primary responsibility for providing Proposition 65 warnings. Manufacturers can choose whether to put warning labels on their products or to provide notices to their distributors, importers or retail outlets that a product may cause an exposure to a listed chemical that requires a warning provide warning signs or other warning materials. Manufacturers can also enter written agreements with retailers to modify this allocation of responsibility as long as the consumer receives a clear and reasonable warning before her or she is exposed to a Proposition 65 chemical.

A manufacturer, producer, packager, importer, supplier or distributor of a consumer product subject to Prop 65 can push the compliance responsibility to the retailer by doing the following:

• 1. Provide written notice directly to a retail seller’s authorized agent.

  2. State that the product may result in the exposure to one or more chemicals on the Prop 65 list.

  3. Provide the exact name or description of the product, or specific identifying information such as the UPC.

  4. Include all necessary warning materials, such as labels, shelf signs, or tags.

  5. Obtain confirmation either electronically or in writing of the retailer’s receipt of the notice.

  6. You must renew this notice within 6 months of the first time it is served, and then annually thereafter.

  7. An additional notice is required within 90 days when a new chemical(s) or end point(s) is included in the warning.

Retailers must confirm that they received the notice and must use the warning signs or other materials provided by the manufacturer.

You may be ordered to comply, and could be subject to a lawsuit, a civil penalty up to $2,500 per day for each violation, attorney fees and the costs of the lawsuit.

Small businesses with 9 or less employees – including full-time, part-time, and owner(s) - are exempt from Prop 65. Additionally, businesses are also exempt from posting if the chemicals fall within the ‘safe harbor’ level, meaning the exposures the chemicals cause are so low as to create no significant risk of cancer or are significantly below levels observed to cause birth defects or other reproductive harm.

Many products will most likely say they are exempt since they fall within the safe harbor levels. In this case you can elect to post, but it is not required. However, if they do not meet the safe harbor level, or there is no identified safe harbor level, you will need to provide warning notices.

The manufacturers of frames and lenses should be providing you this information. Ensure you read over the Prop 65 information they provide you so you know whether their products fall under the safe harbor level and any other pertinent information they may provide to you.

Businesses with fewer than 10 employees are exempt from the warning requirement. However, if your individual facility has fewer than 10 employees but is part of a larger company, even if that company is not located in California, then you will exceed the 10 employee exception. This will trigger the requirement to provide a Prop 65 warning.

A warning must meet the following requirements:

The word “WARNING:” in all capital letters and bold print, and:

• 1. For exposures to listed carcinogens, the words, “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. For more information go to www.P65Warnings.ca.gov.”

  2. For exposures to listed reproductive toxicants, the words, “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 birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

  3. For exposures to both listed carcinogens and reproductive toxicants, the words, “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 [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”

  4. For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, “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 www.P65Warnings.ca.gov.”

  5. Where a warning is being provided for an exposure to a single chemical the words “chemicals including” may be deleted from the warning content.

A short-form warning may be provided on the product label using all the following language:

• 1. The word “WARNING:” in all capital letters, in bold print.

  2. For exposures to listed carcinogens, the words, “Cancer - www.P65Warnings.ca.gov.”

  3. For exposures to listed reproductive toxicants, the words, “Reproductive Harm - www.P65Warnings.ca.gov.”

  4. For exposures to both listed carcinogens and reproductive toxicants, the words, “Cancer and Reproductive Harm - www.P65Warnings.ca.gov.”

  5. The warning does is not required to include within the text of the warning the name or names of a listed chemical.

A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”

You can download the warning symbol(s) here: https://www.p65warnings.ca.gov/warning-symbol

Consumer warning sign MUST:

• • Be prominently displayed on a label, labeling, or sign, and must be conspicuous, likely to be read, and call out the source of exposure.

    • There is no specific type size requirement.

Environmental warning MUST:

• • Use at least 72-point font.

Short form consumer warning MUST:

• • Not be in a type size smaller than 6-point type

You must identify by name one or more of the Prop 65 chemical substances found in your consumer product. If multiple chemicals are contained in a product, only one of the chemicals in a product known to cause cancer or reproductive toxicity needs to be listed or if the product has multiple chemicals causing both cancer and reproductive harm then only one chemical from each need be listed.

Example (1): there are five possible chemical exposures from a given product, and all five chemicals are listed only as carcinogens, then the practice would only be required to name one of those five chemicals in the warning. However, the business may identify any or all of the remaining four chemicals if it chooses to do so.

Example (2): there are exposures to both carcinogens and reproductive toxicants, a practice would be required to name one of the chemicals that is a carcinogen and one of the chemicals that is a reproductive toxicant, but the practice could choose to identify more chemicals in the warning.

Example (3): the warning covers exposure to a chemical that is listed as both a carcinogen and a reproductive toxicant, the warning would only need to name that one chemical, however both endpoints would need to be included in the warning. The business could choose to identify more chemicals covered by the warning.

The short-form warning is not a warning method applicable to a “sign”. The intent of the short-form warning is to provide an alternative notice that can be used on small products or where space is limited.

A “short-form” warning may be provided on a product label in if the entire warning be in a type size no smaller than the largest type size used for other “consumer information” on the product, and in any case the warning must not be in a type size smaller than 6-point type.

• • “Consumer information” includes warnings, directions for use, ingredient lists, and nutritional information, but does not include the brand name, product name, company name, location of manufacture, or product advertising.

Practices also need to warn their employees that they may be exposed to Prop. 65 chemicals. An occupational warning would be used, for example, in areas where incoming eyewear is opened and handled by employees for stocking a practice grinds polycarbonate lenses containing BPA in-office.