New Draft Prop. 65 Warning Regulations: What Manufacturers and Suppliers Need to Know

On November 24, 2015, the Office of Environmental Health Hazard Assessment (“OEHHA”) issued proposed revisions to its January 15, 2015 draft Prop. 65 warning regulations. 27 CCR §§25600 et seq. The full text of the new draft regulations was published by the Office of Administrative Law on November 27.

OEHHA’s November draft proposes several changes to the January version, two of which stand out as significant.
 
1. Out With The “Dirty Dozen”

Existing regulations provide some guidance as to warning content, prescribing “safe-harbor” language designed to protect against Prop. 65 claims if used properly. They do not, however, require warnings to name any of the chemicals giving rise to the duty to warn (the “subject chemicals”). The January draft [§25602] changed that, specifying a list of 12 such chemicals that must be named if the warning is to achieve safe-harbor status. The November draft eliminated the list, but retained a truncated version of the chemical-naming requirement.

Under the new version [§25601(c)], safe harbor status is achieved if “one or more” of any of the subject chemicals is named in the warning. This is good news for those who sell products in California, as the November draft would eliminate the need to test for all 12 of the formerly listed chemicals to craft a warning that meets the chemical-naming requirement (which, by the way, does not apply to on-product warnings).

2. More Protection For Existing Inventory

The January draft [§25600(b)] provided a phase-in period of two years from the adoption of the new regulations. This was problematic because any products manufactured prior to adoption would have to be re-labeled if they were still on the shelves two years after adoption. The November draft [§25600(b)] fixed this problem, providing that products manufactured prior to adoption are protected indefinitely so long as their warnings comply with the prior (September 2008) regulations. Given that many products have shelf lives longer than two years, this change, if adopted, would avoid substantial – and wasteful – relabeling costs.

-- Brian Haughton and Julia Graeser

For more information, contact Brian Haughton at bsh@bcltlaw.com, (415) 228-5423, or Julia Graeser at jrg@bcltlaw.com, (415) 228-5481

California Appellate Court Agrees with Defendants on Prop. 65 Exposure Averaging

In one of the most significant appellate decisions interpreting California’s Prop. 65, the California Court of Appeal on March 17 ruled that, for purposes of establishing the Prop. 65 “safe harbor” defense, exposure to a listed chemical, such as lead, may be determined by averaging exposures over time and averaging concentrations of the chemical over multiple lots. The First Appellate District in Environmental Law Foundation v. Beech-Nut Nutrition Corp. is the first appellate court to address the issue of averaging exposure under Prop. 65--an issue that had been a point of contention ever since Prop. 65 was first enacted over 25 years ago. In affirming the judgment of the Alameda County Superior Court, the Court of Appeal’s conclusion in Beech-Nut is a direct rejection of the position that has long been advocated by both the Attorney General and the private plaintiffs’ bar, contending that a single, one-time exposure to lead that exceeds the safe harbor threshold is enough to require a warning.

In a thoroughly reasoned statement of its decision, the trial court in 2013 found that the language of Prop. 65 and its regulations, as well as the statement of reasons published by the Office of Environmental Health Hazard Assessment’s (OEHHA) when that agency listed lead as a Prop. 65 chemical, all support a conclusion that averaging exposures over time and over multiple lots was permissible. The trial court’s decision was also supported by expert testimony and analysis introduced by the defendants, which the court found “far more persuasive” than that of the plaintiff. The Court of Appeal affirmed, reviewing the trial court’s ruling under a substantial evidence standard of review.

It remains to be seen whether the California Supreme Court will ultimately weigh in on this case. In addition, OEHHA has suggested that it may attempt to limit the effect of the court’s decision, and invoke its regulatory authority over the issue of determining exposure in a Prop. 65 “safe harbor” defense. What appears certain is that this issue is far from settled.

A copy of the Court of Appeal’s opinion is available here.

- Joshua Bloom and Samir Abdelnour

For more information, contact Joshua Bloom at (415) 228-5406 or jab@bcltlaw.com, or Samir Abdelnour at (415) 228-5443 or sja@bcltlaw.com.

OEHHA Proposes New Proposition 65 Warning Regulations

On January 12, 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) published two notices of proposed rulemaking regarding the State’s Proposition 65 warning regulations.

OEHHA proposes to repeal sections 25601 through 25605.2 of the California Code of Regulations (C.C.R.), title 27, and replace them with new regulations governing the content of “safe harbor clear and reasonable” warnings, as well as the responsibility for and methods of providing such warnings, under Proposition 65. Among the changes proposed, the new regulations would require certain chemicals to be specifically identified in the text of a warning. The proposed regulations also include warning requirements specific to certain categories of products or facilities, such as prescription drugs, furniture, and enclosed parking facilities, among others.

OEHHA also proposes to adopt a new regulation authorizing the agency to establish a website “to collect and provide information to the public concerning exposures to listed chemicals for which warnings are being provided.” If adopted, the new website regulation would require a product manufacturer, producer, distributor, or importer, or a particular business subject to Proposition 65 warning requirements, to provide to OEHHA, upon request, specific information regarding any product, listed chemical, potential exposure, and “any other related information that the lead agency deems necessary” for which a warning is provided. However, in its notice, OEHHA expressly states that the proposed website regulation “is not enforceable by private plaintiffs,” in contrast to the warning regulations currently in effect and those being proposed.

OEHHA will conduct public hearings on both the proposed website and warning regulations on March 25, 2015, and will accept written comments regarding the proposed regulatory action until April 8, 2015.

OEHHA’s notices, statements of reasons, and proposed regulatory text are available here and here. 

We will continue to provide updates on the status of OEHHA’s proposed regulatory action throughout the rulemaking process.

-- Samir Abdelnour

For more information, contact Samir Abdelnour at (415) 228-5443 or sja@bcltlaw.com.

California Issues Draft MCL for Hexavalent Chromium

On Thursday, August 22, 2013, the California Department of Public Health (CDPH) published notice of a draft Maximum Contaminant Level (MCL) of 10 ppb (µg/L) for hexavalent chromium.  The MCL proposal is higher than the 0.02 ppb public health goal adopted by OEHHA in 2011, but is significantly below the existing California MCL, in existence since the 1970s, of 50 ppb for total chromium and the current federal MCL for total chromium of 100 ppb.  CDPH will seek public comment on the draft hexavalent chromium MCL between August 23 and October 11, 2013.  CDPH will also hold public hearings in Sacramento and in Los Angeles on October 11, 2013, to receive comments on the proposed regulations. 

The publication of the draft hexavalent chromium MCL follows an order commanding issuance of a hexavalent chromium proposed MCL by the Alameda Superior Court in the NRDC litigation discussed in Rick Coffin’s August 30, 2012 post.  See Natural Res. Def. Council v. Cal. Dep’t of Public Health, No. RG12-643520 (Alameda Sup. Ct. July 26, 2013).  The court’s order also requires a further hearing in October 2013 to determine if the court will set a deadline for issuance of the final hexavalent chromium MCL.  Id.

Barg Coffin will continue to monitor California’s efforts to develop a drinking water standard for hexavalent chromium as well as the status of the NRDC lawsuit.

--David Metres

For more information, please contact Rick Coffin at (415) 228-5420, rcc@bcltlaw.com, Tom Boer at (415) 228-5413, jtb@bcltlaw.com, or David Metres at (415) 228-5488, dmm@bcltlaw.com.