Showing posts with label Chemical laws and regulations. Show all posts
Showing posts with label Chemical laws and regulations. Show all posts

December 30, 2023

Proposed changes to California Proposition 65 short form warnings (Jan 3 2024)

On October 27, 2023 the California Office of Environmental Health Hazard Assessment (OEHHA), the state agency that implements Proposition 65, introduced its third attempt to amend the “short form” warning provisions. This has been going on for a few years now but every time they get ready to amend the regulations they stop short and put it off for various "reasons". The fourth attempt may be the charm. Comments are due on the new regulations by January 3 2024. The proposed regulations (and rationale for changes) are here and the comment form is here. However I am gathering commitments from companies for our office to write a collective letter on all their behalves (so that they remain anonymous to the agency).  Please email me if you wish to join in out letter. The main problem with the proposed amendments is that OEHHA does not like the fact that manufacturers and distributors are defaulting to the use of the short form warning in order to escape the dragnet of plaintiff's lawsuits that are impossible to cost effectively defeat. OEHHA wants to force companies to have to run very costly tests on hundreds of potential chemicals (many not testable) so that they can list the chemical(s) in the warning text before they can use the safe harbor short form warning. Think of it as sort of a "penalty" for using the short form. All the arguments they make for this change are fallacious arguments. They don't like all the short form warnings being used as they feel its diluting the overall effect of Prop 65. That is not the industry's problem that's the regulators problem. Their rationales are comical if it were not so sad and costly for companies to deal with. They are also proposing some additional "catch all" warnings for motorsports parts that are just not workable/feasible or cost effective and are NOT going to make consumers safer at all. This is what we would expect from bureaucrats who have never worked in the recreational sports business or any product manufacturing business for that matter.

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2024 Conditions of Use

August 17, 2017

California Proposition 65 regulations amended to require more specificity on warnings

On August 30, 2016, (yes a year ago) the California Office of Administrative Law approved the adoption of amendments to Article 6, "Clear and Reasonable Warnings", of the California Code of Regulations.  This was a regulatory "repeal and replace" and not a legislative one so as a result it was further off the news "radar". The new regulations provide, among other things, methods of transmission and content of warnings deemed to be compliant with the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). Prop 65 regulations are promulgated by the Office of Environmental Health Hazard Assessment (OEHHA) which also maintains the Prop 65 chemical list and is one of 6 agencies under the California Environmental Protection Agency (CalEPA).

Most companies already know that any consumer product sold in California must comply with Proposition 65, meaning that their products sold in California cannot contain harmful amounts of the chemicals on its notorious 800 chemical list (and growing). Its important to keep in mind that this list continues to grow and is much more extensive than the EU REACH law/regulation (which currently lists only about 200 chemicals). Its also much more extensive that the US Consumer Product Safety Commission's (CPSC) regulations which are mostly confined to lead and Phthalates. There has been quite a bit of publicity surrounding Monsanto's futile legal efforts to keep RoundUp weed killer off the Prop 65 list.

The difficulty with the new warning requirement (which does not go into effect until August 30, 2018) is that if you test and if you find something on the list in your product you must now have specific "safe harbor" warnings that include any of the 800 chemicals on the list that might be in your product in harmful amounts. Under the old abolished regulations you could utilize a "safe harbor" (provision of a statute or a regulation that specifies that certain conduct will be deemed not to violate a given rule) warning that did not need to specify which of the 800 chemicals on the list might exist in the product. Now of course one can debate the merits of warnings generally, especially the efficacy of one that lists the offending complex chemical name over one that does not, but we don't have enough space on this post to have that debate. The point is this is now the current state of the law and my advice is to try to steer clear of Prop. 65 suits (just like ADA suits and host of others). Also these warnings cannot exist solely in user's manuals unless you are a vehicle manufacturer who got special dispensation under the new regulations (but even they still must have stand alone warnings)

The other interesting issue is that if your company was part of a settlement of a Prop 65 suit. Under the new law a company that is a party to a court-ordered settlement or final judgment establishing a warning method or content, is deemed to be providing a “clear and reasonable” warning for that exposure for purposes of the new law, if the warning fully complies with the order or judgment. This covers a few companies in the bicycle arena. It's not known how many total companies are exempted by this as that would depend a lot on the terms of the settlement and (I assume) the chemicals ("the exposure") involved in that particular suit.

Clearly there is going to be lots of work ahead in the next year for all consumer product manufacturers, brands, distributors, resellers, and retailers (on line and off). You can be sure Amazon, Walmart and all the big retailers are well aware of these issues and they will surely come up in contract negotiations with sellers to most large retailers.

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2013 Conditions of Use

April 13, 2015

Comment period closing April 15 2015 on Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates

The Consumer Product Safety Commission (CPSC) comment period to permanently ban certain phthalates closes in a few days (April 15) unless they agree to extend the comment period. If your products contain any type of phthalates its a good idea to at least review this regulation and comment here. On December 30, 2014, the Commission published an Notice of Proposed Rulemaking (NPR) in the Federal Register proposing to prohibit children's toys and child care articles containing specified phthalates. (79 FR 78324). This was a well written article about the upcoming vote/issue.

Here is a refresher on whether your product might be at issue in this regulation:

Section 108(a) of the CPSIA permanently prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of any ‘‘children’s toy or child care article’’ that contains concentrations of more than 0.1 percent of di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl phthalate (BBP). Section 108(b)(1) of the CPSIA prohibits on an interim basis (i.e., until the Commission promulgates a final rule), the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of ‘‘any children’s toy that can be placed in a child’s mouth’’ or ‘‘child care article’’ containing concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DNOP). The CPSIA defines a ‘‘children’s toy’’ as ‘‘a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.’’ Id. Section 108(g)(1)(B). A ‘‘child care article’’ is defined as ‘‘a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.’’ Id. Section 108(g)(1)(C). A ‘‘toy can be placed in a child’s mouth if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children’s product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.’’ Id. Section 108(g)(2)(B). These statutory prohibitions became effective in February 2009. The interim prohibitions remain in effect until the Commission issues a final rule determining whether to make the interim prohibitions permanent. Id. Section 108(b)(1).

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2013 Conditions of Use

April 22, 2013

Bisphenol A (BPA) Delisted on Proposition 65 banned chemical list in California

The info below is taken from a press release from the Office of Environmental Health Hazard Assessment (OEHHA) which is the California government agency which governs the so called "Proposition 65" list of banned chemicals. Again this delisting of bisphenol A (BPA) is only based on a preliminary injunction (read the Judge's order here or download) in the case now pending below which may or may not be finally resolved in favor of the plastics or chemical industries whose trade group (American Chemistry Council) brought the lawsuit. The Natural Resources Defense Council, an environmental advocacy group in San Francisco, said the decision was a "temporary setback". The NRDC encouraged California to place restrictions on BPA originally.

press release from the Office of Environmental Health Hazard Assessment:

Proposition 65
Chemical Delisted Effective April 19, 2013 As Known To The State Of California To Cause Reproductive Toxicity: Bisphenol A (BPA)[04/19/13]

Effective April 19, 2013, the Office of Environmental Health Hazard Assessment (OEHHA) is removing bisphenol A (BPA) (CAS No. 80-05-7) from the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of Proposition 65 fn1. The chemical was added to the list on April 11, 2013 based on reproductive endpoints (developmental toxicity).

On April 19, 2013, the Honorable Raymond M. Cadei issued a preliminary injunction requiring OEHHA to delist the chemical in American Chemistry Council v Office of Environmental Health Hazard Assessment, et al., Sacramento County case number 34-2013-00140720, pending final resolution of the case. A copy of the court’s order is included with this Notice.

A complete, updated chemical list will be published in an upcoming issue of the California Regulatory Notice Register and is available on the OEHHA website at

Please contact Carol Monahan Cummings, OEHHA Chief Counsel at (916) 322-0493 or if you have questions regarding this notice.

fn1 The Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code section 25249.5 et seq.

Law Offices of Steven W. Hansen | | 562 866 6228 © Copyright 1996-2008 Conditions of Use