What is Proposition 65?
The Safe Drinking Water and Toxic Enforcement Act of 1986, more commonly referred to as “Proposition 65,” requires California to publish a list (updated annually) of chemicals “known to the State of California to cause cancer, birth defects or other reproductive harm.” The Office of Environmental Health Hazard Assessment (OEHHA), which is part of the California Environmental Protection Agency, is the primary agency managing Proposition 65.
The Proposition 65 list includes a wide range of chemicals, including dyes, solvents, pesticides, drugs, food additives, and by-products from certain processes. These substances may be naturally occurring or manmade. Some are ingredients of common products, while others are used in very specific industrial applications.
How are chemicals listed?
There are several different procedures that OEHHA can use to list a chemical. In all procedures, there must be sufficient scientific evidence to support a listing.
First, a chemical can be listed if the “state’s qualified experts” – scientists and health professionals appointed by the Governor (the Carcinogen Identification Committee [CIC] and Developmental and Reproductive Toxicant Identification Committee [DARTIC]) – find that the chemical has been shown to cause cancer or birth defects or other reproductive harm.
Second, a chemical can be listed if it has been identified as known to cause cancer or reproductive toxicity by an organization that has been designated as an “authoritative body” for the purposes of Proposition 65. For carcinogens, authoritative bodies include the U.S. Environmental Protection Agency (USEPA), U.S. Food and Drug Administration, National Institute for Occupational Safety and Health, National Toxicology Program, and International Agency for Research on Cancer (IARC).
Third, a chemical can be listed under Labor Code listing mechanism if the chemical has been classified as a carcinogen or reproductive toxicant by the U.S. Occupational Safety and Health Administration (OSHA).
More information about Proposition 65 can be found by visiting OEHHA’s website at:
http://www.oehha.ca.gov/prop65.html.
Why did California add styrene to the Prop 65 list?
The California EPA Office of Environmental Health Hazard Assessment (OEHHA) determined that styrene meets the criteria for Proposition 65 listing as a chemical causing cancer under the authoritative bodies mechanism. The authoritative body referenced by OEHHA is the National Toxicology Program’s 12th Report on Carcinogens.
Does SIRC agree that OEHHA should have added styrene to the Prop 65 list?
No. SIRC strongly contends that the National Toxicology Program’s Report on Carcinogens classification does not satisfy the state’s statutory criteria for listing styrene under the authoritative bodies mechanism SIRC recognizes that OEHHA was obligated to consider an authoritative bodies listing for styrene based on a settlement agreement involving a number of chemicals. But, based on the scientific record before OEHHA today, there is no basis for listing styrene under the authoritative bodies mechanism. Proposition 65 requires that there be sufficient evidence in humans, or sufficient evidence in animals supported by additional evidence demonstrating the relevance of the animal data to human carcinogenicity. Authoritative bodies listing proposals require OEHHA to consider new scientific data and data not considered by NTP. A listing should not occur if the sufficiency of evidence criteria are not met. New human and mode of action studies that NTP did not consider preclude OEHHA from proceeding with an authoritative bodies listing. The impropriety of listing is further established by the absence of sufficient evidence of carcinogenicity in animal studies. For these reasons, the NTP listing did not satisfy the sufficiency of evidence criteria to support an authoritative bodies listing. For a detailed explanation, read SIRC’s full comments submitted to OEHHA on March 26, 2015 here.
Is styrene be banned by the Proposition 65 listing?
No. As stated by OEHHA, Proposition 65 “does not ban or restrict the use of any given chemical.” It is not a restriction on use; it is primarily a warning requirement that applies in certain instances. Proposition 65 is a California law and this listing does not affect other U.S. states or regulations in other countries.
Does a Proposition 65 listing mean that styrene (or a product that contains or is derived from styrene) is unsafe?
No. A Proposition 65 listing is not a safety determination. Indeed, according to OEHHA, the purpose of Proposition 65 is to notify consumers that they may be exposed to a listed substance, but a Proposition 65 product warning label does not mean that a product is in “violation of any product-safety standards.”
What obligations are created by the styrene listing?
Proposition 65 requires companies to determine whether styrene exposure from consumer products, in the workplace, or from environmental media require a warning statement. In addition, businesses must cease discharging listed chemicals into drinking water sources.
When do these requirements for styrene come into effect?
Companies must be in compliance with any applicable warning requirements one year after styrene is added to the Proposition 65 list through an official notice published by OEHHA.
Businesses are exempt from the discharge prohibition if the discharge will not cause any significant amount of the discharged chemical to enter any source of drinking water and the discharge otherwise conforms to applicable law. Also exempt are government agencies and businesses with less than 10 employees.
Must I place warnings on all my products or facilities?
No. It means your business must determine whether or not styrene exposure from products sold in California may exceed the “no significant risk level” (NSRL). If the NSRL may be exceeded, Proposition 65 requires an appropriate “clear and reasonable” warning (often in the form of a label). If a warning is required, it can be given in a variety of ways based on the particular circumstances, such as consumer product labels, or posting signs in the workplace or on the property fence line. The NSRL is considered a safe harbor level.
What does “safe harbor” mean?
For substances that are listed as causing cancer, the “safe harbor” level is called a “no significant risk level” (NSRL). An NSRL is defined as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the substance over a 70-year lifetime. In other words, a person exposed to the substance at the “no significant risk level” for 70 years would not have more than a “one in 100,000” chance of developing cancer as a result of that exposure. A business has a “safe harbor” from Proposition 65 warning requirements if exposure to a substance occurs at or below the NSRL.
Where do I find the NSRL?
At present, there is no official NSRL. OEHHA indicated that it plans to propose an NSRL after styrene is formally listed. Determination of an NSRL is a rulemaking process, and includes a 45-day public comment period.
In the absence of an OEHHA NSRL, what do I do?
If OEHHA has not issued an NSRL, OEHHA regulations and policies provide guidance upon which companies can estimate the NSRL. The OEHHA regulations for calculating an NSRL appear at Article 7 of Title 27, California Code of Regulations. OEHHA also developed a 2001 document titled “Proposition 65 Process for Developing Safe Harbor Numbers” which can be downloaded from the OEHHA website.
Determining anticipated levels of exposure to listed chemicals can be complex. Although a business has the burden of proving a warning is not required, you are discouraged from providing a warning that is not necessary and instead should consider consulting a qualified professional if you believe an exposure to a listed chemical may not require a Proposition 65 warning.
What do I need to know to be able to determine if a warning is required for my consumer product?
A warning is required if exposure from the use of a product will exceed the No Significant Risk Level for styrene. To determine this, identify: (a) the maximum level of exposure at which styrene poses no significant risk; and (b) the level of exposure to styrene from the product, based on the estimated exposure for users of the consumer product. If the exposure is at or below the No Significant Risk Level, Proposition 65 does not require a warning. This process is repeated separately for each product you market in California.
Do I have to consider exposure to styrene from other manufacturers’ products?
No. You do not need to estimate exposure to styrene from products of other manufacturers, but companies are responsible for evaluating the Proposition 65 status of all the products the company markets in California, even if manufactured by others.
Can I consider my products as a group?
No. Each product should be evaluated separately if you manufacture or market more than one product containing styrene.
Do I have to consider every possible exposure scenarios?
No. For consumer products, the exposure estimate may be based on the average rate of exposure for average users of the product. To the extent possible, the exposure estimate should be based on realistic assumptions about the frequency and manner of use of the product. OEHHA regulations and guidance provide the framework for making these assessments.
Nevertheless, the exposure assessment should be based on conservative assumptions. If a company’s exposure assessment indicates that a Proposition 65 warning is not required and the company is, in turn, alleged to have violated the law, the attorney representing the plaintiff will challenge the assessment’s validity. Accordingly, we recommend that conservative assumptions are used in order to increase the likelihood that the assessment will withstand challenge. Stated in different terms, if a plaintiff can demonstrate exposure to a lists substance at any level, the case can proceed for a jury or judge to decide whether the NSRL (safe harbor level) was exceeded.
What implications does this have – if any – on my compliance with safety regulations for my employees?
Proposition 65 is a chemical warning “right-to-know” law and it does not necessarily set safe exposure levels for chemicals . However, for California employers, Proposition 65 has been incorporated into the California Hazard Communication Standard and thus, assuming a warning is required, a “clear and reasonable” warning complying with the standard must be provided. Proposition 65 does not change the Hazard Communication Standard of the US Occupational Safety and Health Administration
(OSHA) or states other than California. Employee communications about the change in product labeling would certainly be prudent.
Who enforces Proposition 65?
Proposition 65 can be enforced by both public and private enforcers. Public enforcers include the California Attorney General, district attorneys and city attorneys. Private enforcers, however, file the great majority of Proposition 65 lawsuits. Private parties must notify the alleged violator, the State Attorney General and the relevant district attorneys and city attorneys at least 60 days before filing an action to enforce Proposition 65 in state court. The Attorney General, as well as district and city attorneys with jurisdiction, have the option of intervening in the case itself and preempting private action, or permitting the private plaintiffs to proceed. Even if the State Attorney General decides not to bring an action itself, it rarely discourages private parties from doing so.
Can I just add a warning?
The decision to include or not include a Proposition 65 warning ultimately rests on the individual company. It is a complex decision. Manufacturers and sellers of styrene resins and products should consult with their own technical and legal advisors and other appropriate sources of environmental, health and safety information for specific guidance relating to their products and Proposition 65. OEHHA discourages companies from providing a warning that is not necessary.
The decision of which NSRL to use rests with the responsible entity complying with California Proposition 65.
If styrene exposure exceeds the NSRL, what warning statement is required and where must it appear?
California’s requirements for warning statements and their placement are addressed in section 12601, Article 6, Title 22 of the California Code of Regulations, which can be accessed through the State’s Proposition 65 website.
For consumer products that contain a chemical known to the state to cause cancer, the statement would read: “WARNING: This product contains a chemical known to the State of California to cause cancer.” The California Proposition 65 regulation (Section 12601) requires that “the method employed to transmit the warning must be reasonably calculated, considering the alternative methods available under the circumstances, to make the warning message available to the individual prior to exposure.”
The question of how or where to place any required warning can vary based on the product and the circumstances surrounding its distribution and use. If a manufacturer or seller of polystyrene resins and products determines a warning is necessary under Proposition 65 it should consult with its own technical and legal advisors for specific
guidance relating to its products and the method employed to transmit the warning.
Please note that OEHHA has been working on revisions that would greatly increase the amount of detail required for Proposition 65 warning statements. Companies should be alert to potential changes in the form of required warnings.
What happens when California develops a state-issued NSRL?
OEHHA informally indicated that it plans to promulgate a state NSRL for styrene. The development of a state NSRL is the result of a public administrative process that involves issuance of a proposed state NSRL for a chemical, a request for public comment, and issuance by OEHHA of a final determination and publication of the state NSRL. The regulated community may participate in this process by filing comments and otherwise engaging in the rulemaking process. Once the state proposes an NSRL, members of the regulated community may wish to re-evaluate any NSRLs they may have separately developed. Once the state issues a final state NSRL, members of the regulated community will likely wish to use the state-promulgated NSRL, since that NSRL will have the force and effect of regulation.
What is a Proposition 65 “Bounty Hunter” lawsuit?
Proposition 65 includes provisions allowing litigation against parties who “violate or threaten to violate” the warning provisions of Proposition 65. These provisions allow private parties to bring legal action “in the interest of” the general public after providing notice to the Attorney General’s office and relevant district and city attorneys, and if those public enforcers do not take any action after 60 days (California Health and Safety Code § 25249.7).
Because the statue outlines potentially significant civil penalties ($2,500/day for each violation [read exposure]) and another state statute also allows recovery of legal fees by the attorney bringing forward the lawsuit, such actions are sometimes called “bounty hunter” lawsuits.
Businesses, particularly small businesses, are threatened with fines of up to $2,500 per day per violation, so they often settle to avoid further financial liability. A common tactic in such lawsuits is to seek a settlement from the business being sued before a trial occurs. This has proven to be a lucrative endeavor. In 2013 alone, there were 352 settlements for a total of $17,409,756. According to the Office of the Attorney General for California that amount, non-contingent civil penalties accounted for 15 percent ($2,680,059), payments in lieu of penalties accounted for 11 percent ($1,998,435), and attorney fees and costs accounted for 73 percent ($12,731,262).
The best defense is to learn about your obligations under Proposition 65 and carefully assess potential exposures from your products, be they styrene, polymers derived from styrene, or consumer or commercial products. Review materials from your suppliers
regarding Proposition 65 and ensure that your company’s Safety Data Sheets, labels and product information materials properly address any Proposition 65 obligations.
What resources area available to manufacturers and sellers of consumer products made with styrene in California to help determine if a warning label is needed?
SIRC, the Plastics Foodservice Packaging Group (PFPG), an American Chemistry Council (ACC) organization, and other industry groups are developing a styrene exposure-estimation workbook. The workbook contains technical guidance on how to estimate potential product exposures to styrene and compare it with the calculated exposure level and includes examples. Manufacturers and/or sellers of consumer products in California can use these tools to determine whether or not a warning maybe required for styrene-containing products. For more information, please contact SIRC@styrene.org.
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