SGS Helps Businesses Understand California Proposition 65
Companies operating in the US state of California must to be aware of Proposition 65, otherwise known as Prop 65, or, the ‘Safe Drinking Water and Toxic Enforcement Act of 1986”. It is a unique piece of legislation, a consumer ‘right-to-know’ law passed by Californian residents in November 1986.The unique nature of Prop 65 means there are often many questions about it. SGS provides training and seminars to help business, and these are some of the most commonly asked questions.
The most commonly asked question is, what is Prop 65? The simple answer is, it is a voter initiative designed to protect citizens and sources of drinking water from harmful chemicals. Prop 65 requires the State to maintain and publish a list of chemicals known to cause cancer, birth defects or other reproductive harm. This list is administered by the Office of Environmental Health Hazard Assessment (OEHHA) and is updated at least once a year. Since first being published in 1986, the list has grown to contain approximately 900 chemicals.
Following the listing of a chemical, all businesses operating in California are required to:
• Provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical. The warning can be given by a variety of means, including labeling, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. Enforcement begins twelve months after listing
• Cease discharging listed chemicals into sources of drinking water. Enforcement begins 20 months after listing
Exemptions include:
• Governmental agencies and public water utilities
• Businesses with nine or fewer employees
• Exposures that pose no significant risk of cancer
• Exposures that will produce no observable reproductive effect at 1,000 times the level in question
• Exposures to listed chemicals that occur naturally in foods
• Discharges that do not result in a "significant amount" of the listed chemical entering any source of drinking water
Enforcement for Prop 65 is carried out by the California Attorney General's Office, and district and city attorneys (in cities with populations above 750,000). Individuals, acting in the public interest, may also act if no attorney’s office has taken action. This is done by filing a lawsuit after they have provided at least a 60-day notice to the business and the appropriate attorney/attorneys.
The next question businesses often ask is, what is the Prop 65 list? This is a list of naturally occurring and synthetic chemicals that are known to cause cancer, birth defects or other forms of reproductive harm. They can be used in a wide variety of contexts, including as additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. The chemicals can also be used in manufacturing and construction, or occur as by-products of chemical processes, for example, motor vehicle exhaust.
The list contains information on the chemical, the type of toxicity, its listing mechanism, CAS Number, the date it was listed, and any safe harbor level. The list can be viewed on the OEHHA website.
This leads to the next question, what is a safe harbour level? Over 300 safe harbor levels have been established by the OEHHA, including:
• No Significant Risk Levels (NSRLs) for cancer-causing chemicals
• Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity
Safe harbor levels are a daily exposure limit (µg/day). This is completely different to the chemical total content of a product (mg/Kg) and there is no way to directly convert one into the other as they represent completely different conceptual measurements.
In instances where there is no safe harbour level, businesses should provide a ‘Prop 65 warning’. They may even find they are exempt, if they can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm. For OEHHA guidance on how to calculate levels for chemicals without safe harbour levels, stakeholders should refer to Articles 7 and 8 of Title 27.
This raises the question of the Proposition 65 warning, ‘Prop 65 warning. This label is applied to any product containing a listed chemical, unless the level of exposure is below the regulatory safe harbor level. Businesses should therefore firstly check if the chemical is listed and, if it is, whether the level in the product exceeds the safe harbor level. If it is not listed, or the level is below the safe harbor level, no ‘Prop 65 warning’ is required.
Prop 65 warnings for consumer products should be:
• Warning symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline and the word WARNING in bold type
• For exposures to listed carcinogens/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/birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
The on-product (short-form) warning should use the following elements:
• Warning symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline and the word WARNING in bold type
• For consumer products that cause exposures to both a listed carcinogen and a reproductive toxicant, the words, “Cancer/birth defects or other reproductive harm - www.P65Warnings.ca.gov.”
Warnings on consumer product packaging must be at least as large as the other informational type and not smaller than 6-point type. The warning should also be provided in all languages used on the packaging. If an on-product (short-form) warning is provided on the product label, the warning with the same content can also be used for catalog and internet purchases, though this version cannot be used on a sign.
In the main, responsibility for warnings rests with product manufacturers, producers, packagers, importers, suppliers and/or distributors. For consumer product exposures, businesses in the above categories must either provide a warning on the product or provide notice and warning materials to “the authorized agent” for a retail seller and receive an acknowledgment that the notice and materials were received. The retail seller is then responsible for placement and maintenance of the warning materials they have received.
Stakeholders should be aware that just because a product meets federal standards, this does not mean it is exempt from carrying a Prop 65 warning. Stakeholders should also be aware that new rules relating to a ‘clear and reasonable’ warning will come into effect on August 30, 2018. Products manufactured before this date can still use the September 2008 form of wording.
Proposition 65 can impact businesses manufacturing and supplying consumer products in California. If a business fails to comply, it is liable to civil penalties of $2,500 per day for each violation.
The final question asked is often, what should I do if I receive a 60-day notice from a private attorney? They should immediately seek the advice of a legal counsel who specializes in Prop 65. This should be followed by an assessment of the validity of the claim, which may require laboratory testing on exposure levels. If the plaintiff’s claim is found to be valid, the company must cease selling the product immediately. They should also instruct retailers to stop selling the product, instigate a product recall, and ensure that all new products have a Prop 65 warning.
SGS Solutions: Prop 65 Services
Through its global network of high-tech laboratories, SGS offers a comprehensive range of testing, product assessment and consultancy services for businesses operating in California. In addition to helping mitigate risk, we also offer training and information services to help businesses stay up-to-date with the latest developments with Prop 65 regulations. Learn more about SGS’s Prop 65 Services. [www.sgs.com/en/consumer-goods-retail/hardgoods/diy-tools-and-hardware/california-proposition-65]
For more information, please contact:
Hsin Chen (Rick)
Technical Manager - Restricted Substances
SGS - North America, Inc.
Tel: +1 (973) 461-7950
Email: crs.media@sgs.com
Website: www.sgs.com/hardlines
About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.
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