California’s Proposition 65 Runs Amok with Addition of BPA

plastic-bottlesOn May 11, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Bisphenol A (BPA) as a reproductive toxicant to be added to the list of chemicals subject to Proposition 65.  Given the widespread use of BPA in numerous consumer applications (e.g., plastics, adhesives, sealants, epoxy resin liners in food containers, and thermal paper such as the paper used to print cash register receipts), the addition of BPA is a significant development for a large number of businesses evaluating compliance with Proposition 65 with respect to BPA in products.

Proposition 65 provides a 12-month period from the date of listing before warnings are required.  Thus, warnings for exposures to BPA will be required starting on May 11, 2016, unless a person in the course of doing business can show that exposures are below the Maximum Allowable Dose Level (MADL) safe harbor limit for BPA.

OEHHA Takes Action with Deadline Approaching

As the deadline for the warning requirement is quickly approaching, OEHHA recently took emergency action with respect to the listing of BPA.  The first action was the issuance of a notice of proposed rulemaking to establish a MADL for dermal exposures from solid materials containing BPA.  The second was an emergency action to allow for the temporary use of a standard point-of-sale warning for BPA exposures from canned and bottled foods and beverages.

Proposed MADL

The warning requirements under Proposition 65 do not apply if a business can show that exposures from a product are less than the MADL established by OEHHA, which puts the business in a “safe harbor.”  Based on OEHHA’s review of the scientific studies, it has proposed a MADL of 3 micrograms/day (dermal exposure from solid materials) for BPA.  Significantly, the proposed MADL of 3 micrograms/day is a level believed to be above that which most people would encounter from a product in normal use.Bisphenol_A

Comments on the proposed MADL are due to OEHHA by May 16, 2016.  Note that this means that the proposed MADL will not be finalized until after the May 11, 2016 trigger date for warnings.

OEHHA Allows Uniform Point-of-Sale Warnings for Canned and Bottled Food and Beverages

OEHHA attempted to develop a MADL for oral exposure (as opposed to the dermal exposures discussed above) that could have precluded the need for an emergency action on the warnings.  However, OEHHA was unable to work through the technical, practical, and timing issues associated with adopting an oral exposure MADL.  Consequently, to avoid potential removal of many food products from the shelves in markets, OEHHA’s proposed solution, as presented in the emergency action, is to amend the regulations to provide for the temporary use of a standard point-of-sale warning as a compliance option.

The compliance option contemplates signs no smaller than 5 x 5 inches with the following warning language:

WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is a chemical known to the State of California to cause harm to the female reproductive system.  For more information go to:

OEHHA’s actions will have a significant impact on businesses seeking to comply with Proposition 65 for products carrying the potential for exposures to BPA.

How the California Green Chemistry Initiative Will Affect Consumer Product Companies

On March 13, the California Department of Toxic Substances Control (DTSC) took a step toward implementing the California Green Chemistry Initiative (CGCI) by identifying the first three consumer “Priority Products” that will be impacted by the program.

ETT BLOG_sleeping matThe first three Priority Products are (1) children’s foam-padded sleeping products, containing Tris(1,3-dichloro-2-propyl) phosphate or TDCPP; (2) spray polyurethane foam-containing unreacted diisocyantes, used in building insulation; and (3) paint and varnish strippers and surface cleaners containing methylene chloride.

DTSC will hold a series of public workshops in May and June to discuss the product-chemical combinations identified on the initial Priority Products list. For dates, times and locations, click here. Additional products will be announced in October, so all companies that sell consumer products in California will need to examine how CGCI will affect their businesses.

The initiative was signed so that instead of banning the use of a chemical without knowing the availability or safety of alternatives, the Safer Consumer Products (SCP) regulations provide a process for manufacturers to see whether the chemical is necessary or if there is a safer alternative to the chemical of concern.

The SCP regulations are part of CGCI to reduce public and environmental exposure to toxins through improved knowledge and regulation of chemicals.  CGCI has four components: (1) DTSC’s identification of “Candidate Chemicals”; (2) DTSC’s identification of Priority Products containing those Candidate Chemicals; (3) responsible entity (manufacturer, importers, assemblers, or retailers) notification and alternative analysis; and (4) DTSC’s imposition of regulatory responses to address hazards of the product or alternatives.

The announcement of the three product groups as proposed Priority Products does not trigger any duty on product manufacturers until the DTSC finalizes the list of Priority Products by adopting regulations.  However, manufacturers should be proactive and take steps to determine whether Candidate Chemicals can be removed from their products or replaced with safer alternative chemicals.  DTSC expects to initiate rulemaking to codify the initial Priority Products list in regulations in the latter part of 2014, a process that may take up to one year.  Once a Priority Product is formally listed, responsible entities must notify DTSC within 60 days if they manufacture, assemble, import, or sell one of the Priority Products, and then prepare an alternatives analysis within 180 days.

DTSC will enforce SCP regulations primarily through publication of noncompliant responsible entities and products on its website, but it may also initiate enforcement actions under the hazardous waste provisions of the California Health & Safety Code, which authorizes criminal and civil penalties. It may be costly for businesses to meet the requirements of this new regulation in terms of compliance and responding to enforcement.  SCP regulations also present obstacles for protection of proprietary information because they require public disclosure and industry reporting.

Image courtesy of Vermont Public Interest Research Group