Topic: California Proposition 65

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WARNING: OEHHA announces proposed regulations and a safe harbor level for BPA

After several false starts, Proposition 65 warnings will be required for exposures to bisphenol A (BPA) starting on May 11, 2016. Because of tremendous uncertainty regarding the amount of BPA exposure that will require a warning, as well as the ubiquitous nature of the chemical, on March 17, 2016, California’s Office of Environmental Health Hazard Assessment announced an emergency rulemaking for temporary use of a point-of-sale warning for BPA exposures from canned and bottled foods and beverages, and a proposed safe harbor level for dermal exposure to BPA of 3 micrograms/day.

Background

On May 11, 2015, OEHHA placed BPA on … Continue Reading

Prop 65 exposure level set for DINP

Updating an issue we have been tracking, the California Office of Environmental Health Hazard Assessment finalized the No Significant Risk Level for DINP of 146 µg/day. The NSRL will got into effect April 1, 2016.

Once in effect, this will be the level of exposure at which a warning is required for DINP. This will remove one of the significant, and expensive, hurdles to defending against a Proposition 65 claim, as a company will not need to develop an NSRL as part of its case.

From a planning perspective, it also allows manufacturers to assess their products and, if … Continue Reading

Update: OEHHA issues revised Prop 65 warning regulations

Continuing the saga of revisions to the Prop 65 regulations, OEHHA has repealed its January 2015 clear and reasonable warning proposed rulemaking and replaced it with a new proposed regulation.

The new proposed rulemaking addresses many concerns raised by the business community, either addressing the issue or explaining why OEHHA will not change it.  A public meeting on the new proposed regulations will be held on January 13, 2016.  Written comments are due on January 22, 2015.

Below is a rundown of key differences and similarities between the January and November proposals.  We will continue to update this issue … Continue Reading

Proposition 65: the disconnect between rates of exposure and chemical composition

The difference between exposure rate and chemical composition is one of the most common issues that comes up when discussing Proposition 65. While many people get that Prop 65 requires warnings for significant chemical exposures, there is a common misconception that Prop 65 prohibits products from even containing certain amounts of chemicals – lead, cadmium, and phthalates seem to be the prime culprit.

Unlike CPSIA, for example, there are no static composition limits for any chemical. Prop 65 only prohibits failing to provide a warning when exposure to the chemical is significant. Whether an exposure is significant depends on the … Continue Reading

California Attorney General seeks to change Proposition 65 settlement landscape

Continuing a flurry of activity this year to reform Proposition 65 in California, the Office of the Attorney General is proposing amendments to the Proposition 65 regulations that would affect settlement terms, penalty amounts, and attorneys’ fees in civil actions filed by private persons in the public interest. For a more detailed discussion of Proposition 65 settlements in private enforcement actions, please see our prior post on this topic.

Per the Initial Statement of Reasons, this rulemaking is intended to:

  • ensure that OEHHA gets the civil penalties specified in Proposition 65,
  • limit the ability of private plaintiffs to
Continue Reading

California to open rulemaking into Prop 65 lead levels

In response to a petition from the Center for Environmental, the California Office of Environmental Health Hazard Assessment will initiate a rulemaking to update the current 0.5 µg/day safe harbor level for lead. The implications are huge, as years of Prop 65 settlements over lead have been premised on the existing safe harbor level. CEH argues in its petition that there is no safe level for lead – if OEHHA agrees with this position, any amount of lead in any consumer product would require a warning and could lead to a Prop 65 lawsuit.

The Petition

CEH’s petition is largely … Continue Reading

California puts BPA back on Prop 65 list

Effective May 11, 2015, California’s Office of Environmental Health Hazard Assessment has put bisphenol A, or BPA, back on the Proposition 65 list. This most recent listing is through the “state’s qualified expert” listing mechanism, as the OEHHA Developmental and Reproductive Toxicant Identification Committee concluded that scientifically valid testing according to generally accepted principles clearly show that BPA causes reproductive toxicity, based on the female reproductive endpoint. The Committee looked at a litany of hazard identification materials, as well as public comments, in reaching this conclusion.

BPA first made the Prop 65 list in April 2013 through … Continue Reading

Appellate ruling signals potential sea change in Prop 65 enforcement for reproductive toxins

A recent decision from the California Court of Appeal, First Appellate District, in Environmental Law Foundation v. Beech-Nut Corporation applied the familiar substantial evidence standard to uphold a trial court judgment in favor of defendants that has enormous implications for Prop 65 enforcement cases.

Beech-Nut Trial Court Holding

Beech-Nut involved claims that users were exposed to lead from fruits and fruit juices manufactured by the defendants. There was no dispute that the products contained trace amounts of lead, although there was a significant dispute over whether some or all of the lead was “naturally occurring,” and thus exempt … Continue Reading

The mysterious world of Prop 65, part 10: Settlements – the good, the bad, the ugly and the process

Virtually all Proposition 65 enforcement actions—whether brought by public prosecutors or private enforcers—resolve by a settlement agreement. In this post, we will discuss the features and mechanics of a settlement. We will focus on private enforcement actions, which make up well over 90 percent of all settlements.

The Good

Typically, a settlement will result in a release of all claims against a product manufacturer, distributor, and/or retailer, and all of their downstream customers. Settlements often allow for continued distribution of products that have left the possession of the manufacturer or distributor and are in the stream of commerce without the … Continue Reading

Proposition 65 Listed Chemical update

Here is the latest roundup of Proposition 65 chemical issues looming on the horizon for consumer products:

Listed in 2014 (warnings required in 2015):

  • N-Nitrosomethyl-n-alkylamines, Various CAS Nos., can be found in personal care products and household cleaning products due to reaction of ingredients (i.e., NMAs are not intentionally added to products), December 26, 2014
  • N,N-Dimethyl-p-Toluidine, CAS No. 99-97-8, component of artificial fingernail preparations, intermediate in dye and pesticide synthesis, May 2, 2014
  • Pulegone, CAS No. 89-82-7, flavoring for food, drinks, dental products; fragrance for perfumes and aromatherapy; component of herbal medicines, April 18, 2014
  • Methyl
Continue Reading

The mysterious world of Prop 65, part 9: The naturally occurring exemption

A hot topic of late is the so-called Proposition 65 “naturally occurring” exemption.  This is due largely to the addition of pulegone to the Prop 65 list in April 2014.  Pulegone is a naturally occurring chemical found in many essential oils, including peppermint oil. With warnings required on products containing pulegone that cause significant exposures as of April 18, 2015, Prop 65 forums have been peppered with questions about compliance for cosmetic and food products. Unfortunately, the naturally occurring exemption is unlikely to solve many Prop 65 pulegone problems.

The naturally occurring exemption

Regulations promulgated by OEHHA define the Continue Reading

The mysterious world of Prop 65, part 8: Acceptable risk levels

Just because a chemical is listed on the Prop 65 list doesn’t mean it is illegal to have the chemical in a product without a warning. OEHHA has developed “safe harbor” levels for roughly 300 of the more than 800 chemicals on the Prop 65 list. If the product exposes an individual to a chemical at a level below the maximum threshold for safety, there can be no liability for failure to provide a warning.

No Significant Risk Level for carcinogens

For substances that have been identified as causing cancer, the “no significant risk level” (“NSRL”) means that exposure to … Continue Reading

The mysterious world of Prop 65, part 7: Knowing and intentional

Because so many companies sued for alleged Proposition 65 violations seek to quickly settle claims against them, one might think Prop 65 is a strict liability statute. This is incorrect. Health & Safety Code § 25249.6 requires that an exposure without a warning be knowing and intentional:

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 clear and reasonable warning to such individual…. 

Ambiguity

To the layperson, this requirement probably suggests that a company must know that its … Continue Reading

Update: OEHHA issues new proposed Prop 65 warning regulations

Updating our prior post, California’s Office of Environmental Health Hazard Assessment issued new proposed regulations on clear and reasonable warnings for Proposition 65. This proposed regulation follows March and September drafts that were subject to public and stakeholder input. The current draft is similar in substance to the September iteration, leaving unchanged many of the business community’s significant concerns. OEHHA will conduct a public hearing on March 25, 2015, and the public comment period is open until April 8, 2015.

Safe harbor warnings

The proposed regulation maintains the safe harbor approach (reversing the mandatory warnings proposed in the … Continue Reading

The mysterious world of Prop 65, part 6: The private plaintiffs

When Prop 65 passed by voter initiative in 1986, the public undoubtedly hoped it would provide greater protections to consumers by warning them of potential exposure to chemicals. It is unlikely they envisioned Prop 65 becoming what it is today: a vehicle for the generation of bounties to private plaintiffs and their attorneys.

What’s a Private Settlement Worth? (2013) 

Year
Number
Total
Average
Avg Penalty
Avg Fee 
Avg Other 
2011
327
$15,891,728
$48,599
13%
74%
12%
2012
397
$20,435,772
$51,475
15%
71%
14%
2013
350
$16,812,396
$48,035
14%
75%
12%

Lawsuits for violation of Prop 65 are initiated by two … Continue Reading

The mysterious world of Prop 65, part 5: The notice

The infamous “60-day Notice” is the smoke before the Prop 65 fire. A 60-day Notice is often followed by a settlement demand, and then a complaint if you don’t settle the claims within the notice period.

The 60-day notice

Prop 65 authorizes public and private enforcement. Public enforcement is straightforward – the California Attorney general, any district attorney, and any city attorney of a city with 750,000 residents may bring a suit.

Private enforcement is where it gets complicated. Any person can bring a Prop 65 claim “in the public interest” if:

  • The private enforcer files the
Continue Reading

The mysterious world of Prop 65, part 4: The penalties

The obvious concern for many companies facing potential exposure for a Prop 65 violation is what is this going to cost me? The short answer: a lot. The potential for high civil penalties is daunting to many companies, a fact of which private litigants are well aware and bank on to incentivize quick settlements.

Penalty amount

Prop 65 authorizes monetary penalties of up to $2,500 “per day for each violation …” In determining how much to assess for each violation, a trial court considers:

  1. the nature and extent of the violation;
  2. the number of, and severity of, the violations;
  3. the
Continue Reading

UPDATE: OEHHA provides proposed NSRL for DINP

Just in time for the anniversary of the listing of DINP on California’s Proposition 65 chemical list, the California Office of Environmental Health Hazard Assessment issued a proposed No Significant Risk Level for DINP of 146 µg/day.

If finalized, this will be the level of exposure at which a warning is required for DINP. This will remove one of the significant, and expensive, hurdles to defending against a Proposition 65 claim, as a company will not need to develop an NSRL as part of its case.

From a planning perspective, it also allows manufacturers to assess their products and, if … Continue Reading

The mysterious world of Prop 65, part 3: the warning

Prop 65 plainly directs that any person in the course of doing business (meaning any private company that employs 10 or more persons) must provide a “clear and reasonable warning” before exposing individuals to listed carcinogens and reproductive toxins. When it first adopted regulations implementing the warning requirement in 1989, the Lead Agency (now OEHHA) was faced with turning that language into directions for businesses to follow to comply with the requirement.

The Lead Agency first interpreted the statute to mean that the “clear” part of the warning requirement applied to the language of the message, and the “reasonable” part … Continue Reading

The mysterious world of Prop 65, part 2: The list

To determine whether Prop 65 impacts your company, the starting point is the Prop 65 chemical list. Knowing the listed chemicals and keeping up to date on new additions could mean the difference between facing a lawsuit or avoiding thousands of dollars in legal fees and settlement payments through advanced compliance.

Adding chemicals to the list

Under Prop 65, the Office of Environmental Health Hazard Assessment can add chemicals to the list in four ways. Once OEHHA identifies a chemical for possible listing, it initiates a regulatory process including public notice of intent to list, a public comment … Continue Reading

The mysterious world of Prop 65, part 1: The law

To the average person in California, if they know anything about Proposition 65 at all, it is usually because they have a seen a warning sign in a bar or at a store. In most instances, after seeing the sign, they likely kept drinking or kept shopping.

Back in 1986, however, Californians’ concern over toxic chemicals in the environment, workplaces, and consumer products was a hot button issue because it was much more difficult to get information about everyday exposure to chemicals. As a result, 63% of California voters approved Proposition 65, and shortly thereafter, the ballot initiative became codified … Continue Reading

The mysterious world of California’s Proposition 65: A miniseries

If you are reading this blog, at some point, you have probably encountered what many consider to be the most vexing of all of California’s laws: Proposition 65.

While Proposition 65 appears relatively simple and straightforward―“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 clear and reasonable warning to such individual…”―a review of the current state of the law and its regulations reveals a complex and confusing web of real and “shadow” requirements that usually only become clear … Continue Reading

Proposition 65: OEHHA’S proposed revisions to warning regulations

In March 2014, OEHHA began the rulemaking process to amend the Clear and Reasonable Warning requirements for California’s Proposition 65. The proposed changes caused a great deal of concern for manufacturers, distributors, and retailers doing business in California. On September 23, 2014, OEHHA circulated a revised draft to some of the stakeholders. While the proposed changes appear to be an improvement on the March edition, there still are some significant concerns in the business community. Here are highlights of the September draft.

Safe harbor warnings

The current Prop 65 warning regulation, in effect since 1989, provides a generic description … Continue Reading

WARNING! This Post Contains Information on DINP and Proposition 65 in the State of California That May Help You Avoid a Lawsuit

On December 20, 2013, the Office of Environmental Health Hazard Assessment added the phthalate DINP to the California Proposition 65 chemical list. Under Proposition 65, products containing newly listed chemicals require a warning starting 12 months after the listing. For DINP, this is December 20, 2014.

Given recent experience with other newly listed chemicals, such as cocamide DEA, we expect private Proposition 65 plaintiffs will be taking advantage of holiday sales to shop for products likely to contain DINP.

DINP is used as a PVC plasticizer. DINP is found in a variety of consumer products containing soft plastic or … Continue Reading

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