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What is Proposition 65?
Proposition 65, more formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a California law passed by citizen initiative with 63% of the popular vote. The statute reads:
"No person in the course of doing business shall knowingly discharge or release a chemical known to the state to cause cancer or reproductive toxicity into water or onto or into land where such chemical passes or probably will pass into any source of drinking water…" (CA Health and Safety Code, Section 25249.5)
"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 a clear and reasonable warning…" (CA Health and Safety Code, Section 25249.6)
Proposition 65 provides that the Legislature may amend the law by a two-thirds vote and only "to further its purposes."
What does Proposition 65 require?
List of chemicals: Proposition 65 requires the Governor to publish a list of chemicals that are known to the state of California to cause cancer or reproductive toxicity, and to update this list at least once a year. The Office of Environmental Health Hazard Assessment (OEHHA) maintains the list of chemicals regulated under Proposition 65. (CA Code of Regulations, Title 27, Section 27001)
The most recent list can be found here: http://www.oehha.ca.gov/prop65/prop65_list/files/P65single062212.pdf.
Businesses that expose individuals to listed chemicals, or discharge listed chemicals, must comply with the following requirements:
Clear and reasonable warnings: A business is required to warn a person before "knowingly and intentionally" exposing that person to a listed chemical. A business must be aware that it is causing an exposure, and the exposure must result from a deliberate act, like the sale of a product. There is no requirement that a business is aware that the exposure violates the law, or intends to violate the law or cause harm. The warning given must be "clear and reasonable" and must effectively reach the person before exposure. Warning requirements take effect 12 months after the date that a chemical is added to the Proposition 65 list.
Pre-approved ("safe harbor") warnings: The Proposition 65 regulations provide for certain warnings that, if properly transmitted, are deemed to be clear and reasonable. These are referred to as "safe harbor warnings." A discussion of the regulatory requirements for "safe harbor warnings" can be found here:
A business need not use the "safe harbor warning," and can provide an alternative warning as long as it is "clear and reasonable" under the statute.
Prohibition on discharges into drinking water: A business must not knowingly discharge or release a listed chemical into drinking water, or onto or into land where it passes or probably will pass into a source of drinking water. This prohibition takes effect 20 months after the date that a chemical is added to the Proposition 65 list.
Does Proposition 65 contain any exemptions?
Yes. The following are exempt:
Governmental agencies and public water utilities: All federal, state and local government agencies, as well as entities operating public water systems, are exempt.
Businesses with nine or fewer employees.
Exposures that pose no significant risk of cancer: A warning about listed chemicals known to cause cancer ("carcinogens") is not required if the business can demonstrate that the exposure occurs at a level that poses "no significant risk." This means the exposure is calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime. The Proposition 65 regulations identify "no significant risk" levels for certain carcinogens. The most recent list of no significant risk levels can be found here: http://www.oehha.ca.gov/prop65/getNSRLs.html.
Exposures that will produce no observable reproductive effect at 1,000 times the level in question: A warning is not required for chemicals known to the State to cause birth defects or other reproductive harm ("reproductive toxicants") if the business can demonstrate that the exposure will produce no observable effect, even at exposures 1,000 times the level in question. This is known as the "maximum allowable dose level." In other words, the level of exposure must be below the "no observable effect level (NOEL)," divided by 1,000, as required by the statute. The NOEL is the highest dose level that has not been associated with observable adverse reproductive or developmental effects. The most recent list of maximum allowable dose levels can be found here: http://www.oehha.ca.gov/prop65/getNSRLs.html.
Exposures to listed chemicals that occur naturally in foods: Listed chemicals can occur naturally in certain foods, as an inherent part of the food's composition, because chemicals that occur naturally in the soil are taken up by food crops, or for other reasons. To avoid excessive warnings on common food items, OEHHA regulations allow an exemption for listed chemicals in food that a business proves to be "naturally occurring" and reduced to the "lowest level currently feasible." The term "naturally occurring" is defined in specific and narrow terms in the regulations. (CA Code of Regulations, Title 27, Section 25501) These "naturally occurring" chemicals in food do not count toward the exposure under Proposition 65.
Discharges that do not result in a "significant amount" of the listed chemical entering into any source of drinking water: There is an exemption for businesses that can demonstrate that the discharge will not cause a "significant amount" of the listed chemical to enter any drinking water source, and complies with all other applicable laws, regulations, permits, requirements, or orders. A "significant amount" is any detectable amount, unless the business can prove that the discharge does not exceed the "no significant risk" or "maximum allowable dose" levels.
How is Proposition 65 enforced?
Enforcement is carried out through civil lawsuits brought by the California Attorney General, or by a district attorney or city attorney of a city with a population exceeding 750,000. Private parties acting in the public interest can also bring Proposition 65 lawsuits, but only if they have provided at least 60 days notice of the alleged violation to the business, as well as to the Attorney General and the appropriate district attorney and city attorney, and the Attorney General, district attorney or city attorney has not taken action. The notice must provide adequate information about the alleged violation and comply with the requirements specified in the regulations. (CA Code of Regulations, Title 27, Section 25903, and Title 11, Sections 3100-3102)
If a business is found to be in violation of Proposition 65, a court may order the business to stop committing the violation. The business is also subject to civil penalties of up to $2,500 per day for each violation.
Why are there Proposition 65 warnings on so many products and on the premises of so many businesses?
Proposition 65 is a "right to know" law based on the notion that members of the public have a right to know when they are being exposed to listed carcinogens or reproductive toxins. The law was designed to allow individual consumers and their families to decide for themselves whether to assume the chemical exposure risks of purchasing particular products or frequenting particular premises.
I just bought a consumer product that has a Proposition 65 warning. Is it unsafe?
A Proposition 65 warning informs a consumer that s/he is being exposed to carcinogens or reproductive toxins that exceed certain threshold levels. This is not the same as a regulatory decision that a product is "safe" or "unsafe." A consumer can seek information about the actual levels of exposure from the business that produces the product or causes the exposure in order to decide whether to accept, avoid, or take measures to mitigate the exposure risk.
The lobby of my apartment building has a Proposition 65 warning posted. Does my building contain a unique hazard?
Tenants should ask their landlords for information about a Proposition 65 warning in their apartment building. A fact sheet for tenants with common scenarios that prompt landlords to provide Proposition 65 warnings can be found here: http://www.oehha.ca.gov/prop65/background/P65ten.html.
Has Proposition 65 been successful in protecting consumers from toxic chemicals?
Yes. Proposition 65 has motivated businesses to eliminate or reduce toxic chemicals in numerous consumer products. Products that have been reformulated as a result of notices of violation or litigation include ceramic tableware, artificial turf, household faucets, children's jewelry, potato chips, candy, and vitamin supplements. Proposition 65 has also resulted in significant reductions in toxic air pollution – both outdoor (diesel school bus and grocery truck emissions) and indoor (salon worker exposures to formaldehyde, toxic solvents in nail products, and formaldehyde gas release from the building materials in portable classrooms). Proposition 65 has induced "quiet compliance" without the need for litigation, in which manufacturers voluntarily take steps to comply by providing their suppliers with specifications so that the ingredients in their products avoid or significantly limit exposure to listed chemicals. The law has also educated the general public about exposures to specific toxic chemicals in consumer products, buildings, and the environment, creating both demand and market reward for less-toxic products. Finally, Proposition 65 litigation has identified specific chemical exposure concerns and led to regulatory reforms to benefit public health at the state and national level. For example, the California Legislature adopted strict standards for lead in jewelry that were based on a Proposition 65 settlement over the failure to warn about lead in jewelry, and state and federal restrictions on lead in candy are based on the level established in a Proposition 65 case.
How do I know if I need to provide a Proposition 65 warning for a product?
First, you should check to see if chemicals in the product, or created through the use of the product, are on the Proposition 65 list. The current list can be found here: http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html.
Next, you should determine whether the manufacture or use of the product is likely to expose individuals to listed chemicals. If the product causes an exposure to a listed chemical, you should determine whether OEHHA has identified a regulatory safe harbor level for the chemical. The safe harbor levels, or levels of exposure that are exempt from the warning requirement, can be found here: http://www.oehha.ca.gov/prop65/getNSRLs.html. If you can show that the exposure you cause is below the regulatory safe harbor level, you need not provide a warning.
If there is no regulatory safe harbor level for a listed chemical, a business that knowingly exposes individuals to that chemical is generally required to provide a Proposition 65 warning, unless the business shows that the exposure to a listed chemical falls below the threshold levels specified in Proposition 65 and its accompanying regulations, i.e., the "no significant risk level" and the "maximum allowable dose level." Determining the threshold levels for a listed chemical and the exposure caused by the product is complex. It is recommended that any business that uses a listed chemical in its products, but believes the level of exposure does not exceed the applicable threshold(s) consult with a scientist who has experience in risk assessment.
Are small businesses exempt from Proposition 65?
Yes. Businesses with 9 or fewer employees are exempt from the requirements of Proposition 65. A"'person in the course of doing business' does not include any person employing fewer than 10 employees in his or her business." (CA Health and Safety Code, Section 25249.11 (b)) Generally speaking, an employee is "a person who provides services for remuneration," including full-time employees and part-time employees. (CA Code of Regulations, Title 27, Section 25102 (h))
Are out-of-state manufacturers of retail products exempt from Proposition 65?
No. The requirement to provide a consumer warning applies regardless of whether a business is located in California or out-of-state, as long as its products cause exposures to individuals in California.
If a product meets a federal standard for a listed chemical, do I still need to provide a warning?
It depends. The Proposition 65 warning requirements are independent of federal chemical use or composition standards. The warning requirements are tied to exposure levels from a product rather than the amount of the chemical that it contains. A product might be in compliance with a federal composition requirement because it contains no more than a certain percentage of lead, but not in compliance with Proposition 65 because it lacks a warning that consumers who use the product will be exposed to more than 0.5 micrograms of lead per day. Regardless of whether your product meets a federal use or composition standard, you need to conduct an exposure assessment to determine whether the level of a listed chemical leads to an exposure requiring a Proposition 65 warning.
If my product complies with standards in an existing consent judgment governing the same product, is it possible to "opt in" to that judgment? Will this offer protection from Proposition 65 litigation?
There is no inherent right to join a settlement between other parties. But a private settlement or a settlement with a public prosecutor will sometimes include an "opt-in" mechanism to allow qualifying entities to become parties to the agreement. In such cases, the settlement or another related public document will describe the requirements and process to opt in. More often, settlements do not include the option to opt in. Voluntary compliance with the terms of an existing settlement (e.g., providing specified warnings, or reformulating a product to the agreed-upon specifications) may or may not afford some protection against Proposition 65 litigation, or against penalties in the event of litigation.
Am I allowed to reformulate a product rather than provide a warning?
Yes. Businesses often reformulate products to remove a listed chemical, or to reduce its concentration so that any exposure is below the threshold. If a business does this, it does not need to provide a warning for the reformulated product. As a result of Proposition 65 litigation, manufacturers, including the makers of Mexican candy, artificial turf, and calcium supplements, have removed a listed chemical from a product, or greatly reduced its concentration.
Where can I get the Proposition 65 signs that businesses are required to post, or find out what information needs to be included?
Government agencies do not create or provide Proposition 65 signs or labels, but they are commercially available and can sometimes be acquired from trade organizations. The form, content, and suggested language for some Proposition 65 warnings can be found here: http://www.oehha.ca.gov/prop65/law/pdf_zip/RegsArt6.pdf. (CA Code of Regulations, Title 27, Sections 25601-25605.2)
Am I allowed to use warning language that differs from the safe harbor language? Is it possible to add an explanation to the warning?
Yes. Warning text may differ from the "safe harbor" language, as long as it clearly warns people that they are being exposed to a chemical or chemicals that cause cancer or reproductive harm. You are allowed to add language to explain the warning and inform consumers about how to lessen or avoid the exposure. However, you are not allowed to include language that contradicts or dilutes the force of the warning.
I have just been served with a 60-day notice by a private attorney. What should I do?
The Attorney General's Office cannot provide legal advice to private parties. A business that has been served with a 60-day notice should consider locating defense counsel to help evaluate the matter. Other prudent steps to take upon receiving a 60-day notice include: (1) promptly contact the noticing party to discuss the claim(s) of violation and obtain any testing or data the noticing party is willing to provide to evaluate whether the claim is justified (note: the plaintiff is not required to provide this information); (2) conduct laboratory product testing and/or obtain an exposure assessment to assess the validity of the plaintiff's claims; and (3) if you believe the claim may be valid, cease sale of the product, instruct retail customers to stop selling the product, recall the product, and/or provide proper warnings for the product.
What should I do if I receive a notice for something that I don't think is in violation of the law?
You can contact the private party who sent the notice of violation or their attorney to try and ascertain their basis for sending the notice, or to supply them with information to demonstrate there was no violation. They may request information in return, which you are not required to provide, however the informal exchange may facilitate a prompt resolution of the alleged violation.
What are my rights with respect to paying plaintiff's attorney's fees if I settle with a private plaintiff?
If there is an award of attorneys' fees in a Proposition 65 settlement, the trial court must determine that the award is "reasonable under California law" to approve the settlement. (CA Health & Safety Code, Section 25249.7, (f)(4)(B).) The Attorney General's settlement guidelines describe some of the factors considered in the evaluation of a fee award in private Proposition 65 settlements. (CA Code of Regulations, Title 11, Section 3201)
What type of release can I obtain if I settle with a private plaintiff? Can I be sued again, by either a private party or a public prosecutor?
The "release" in a settlement agreement refers to one or more provisions that preclude certain individuals or entities from bringing another lawsuit over claims that have been released. Parties to a settlement must agree upon the scope of any release. An attorney may be able to help you determine what claims can and cannot be released.
As a rule of thumb, if a settlement is completed out of court (i.e., before a complaint has been filed and without judicial approval), the plaintiff can release claims on its own behalf, but not "in the public interest." In other words, the same plaintiff could not sue you over the same violations, but a different private plaintiff or public enforcer could sue you over those violations. If the settlement is approved by a court, then the release may preclude other private plaintiffs from bringing additional lawsuits in the public interest. The Attorney General's legal position is that a private release cannot prevent a subsequent lawsuit by the Attorney General or other public enforcer. To the extent that a settlement is approved by the court, a private plaintiff acting in the public interest can release only the violations identified in the notice(s) sent to the settling party. And, to the extent that a private plaintiff is releasing claims "in the public interest," the release language should be consistent with the following:
Plaintiff acting on its own behalf and in the public interest releases Defendant [and other specified entities] from all claims for violations of Proposition 65 up through the Effective Date based on exposure to [Covered Chemicals] from [Covered Products or Covered Facilities] as set forth in the Notice(s) of Violation. Compliance with the terms of this Consent Judgment constitutes compliance with Proposition 65 with respect to exposures to [Covered Products or Covered Facilities] as set forth in the Notice(s) of Violation.A private plaintiff is free to release whatever claims it deems appropriate on its own behalf.
Does Proposition 65 prescribe what testing method to use?
No. The determination of whether an exposure poses a significant risk or has an observable effect must be based on evidence and standards of comparable scientific validity to those that form the scientific basis for the listing of the chemical.
When will the Attorney General's Office file suit based on a notice from a private party?
The Attorney General decides whether to file suit on a case-by-case basis. Among the factors that are considered: the seriousness of the violation and whether it presents a risk to public health; how widespread the violation is; and whether the case presents new issues of law and/or science that should be resolved on a statewide basis.
Why do I have to fill out the electronic reporting forms for my Proposition 65 cases?
Private enforcers must provide the Attorney General's Office with copies of 60-day notices and supporting documents. In 1999, the Legislature adopted SB 1269, which modified Proposition 65 to require that any person who brings a private enforcement action must notify the Attorney General when the case is filed, and of its outcome. The bill also requires the Attorney General's Office to make this information available to the public. Private enforcers must also serve copies of 60-day notices and supporting documents on the Attorney General and can do so either with hard copies or electronically, through the Attorney General's website.
If some or all of the documents in support of a certificate of merit were previously submitted, do I need to resubmit them?
No. However, you need to list the documents supporting each certificate of merit and identify the original notice that you submitted by its date, notice recipient, and AG Notice Number.
Do public prosecutors accept electronic service of 60-day notices?
Yes. The Attorney General's website includes a list of public prosecutors that accept electronic service of 60-day notices and instructions for electronic service that can be found here: https://www.oag.ca.gov/prop65/electronic-service. The Attorney General also accepts electronic service of 60-day notices: https://oag.ca.gov/prop65/add-60-day-notice.
Can I see the electronic reporting forms filed with the Attorney General?
Yes. The reporting forms and instructions for filing are available on the Proposition 65 Home page.
Does the Attorney General's Office report on its cases?
Although SB 1269 only applies to private enforcers, the Attorney General's Office makes complaints and settlements available to the public upon request, and posts frequently requested items to its website.
What are the requirements for private party settlements?
Major requirements for private party settlements include:
The requirements for private party settlements can be found in CA Health and Safety Code, Section 25249.7(f) and CA Code of Regulations, Title 11, Section 3003. The Attorney General has set forth non-binding settlement guidelines at Title 11, Section 3200 et seq.
Can I enter into a private confidential settlement?
No. All Proposition 65 settlements must be provided to the Attorney General and are posted on the Attorney General's website.
What is the Attorney General's role in reviewing settlements?
Private parties must report Proposition 65 settlements to the Attorney General and submit supporting documents to the Attorney General at least 45 days prior to the date of the hearing of the motion for judicial approval. The Attorney General may appear and provide comment or objection without intervening in the settlement action. The parties shall notify the court that the fact that the Attorney General does not object to a settlement shall not be construed as an endorsement of or a concurrence in any settlement.
In addition, the Attorney General has set non-binding guidelines on the review of private party settlements to assist the parties in fashioning settlements to which the Attorney General is not likely to object. (CA Code of Regulations, Title 11, Sections 3200-3204).
In addition to paying a penalty, is it possible for a defendant to settle a case by making a payment to be used for an environmental purpose?
Maybe. The Attorney General's guidelines recognize that the penalty amount may be "offset" by payments in lieu of a civil penalty, but these payments are required to meet certain criteria. In particular, funded activities must have a nexus to the basis for the litigation, and the recipient must be an accountable entity that can demonstrate how the funds will be spent. The Attorney General works to insure that money is not over-diverted from statutory penalties to payments in lieu of penalties, and to assure accountability in the use of payments in lieu of penalties.