California’s BPA Threshold

BPA has officially been assigned a maximum daily threshold limit by the California Office of Environmental Health Hazard Assessment (OEHHA). In policy and compliance terms, this means OEHHA has officially announced a proposal to adopt a Proposition 65 Maximum Allowable Dose Level (MADL).

The MADL for exposures to bisphenol A (BPA) is set at 290 micrograms per day.

The notorious B.P.A. BPA is being considered for Prop 65 listing due its being “known to cause reproductive toxicity.” (In the event that BPA does not wind up listed, OEHHA will not proceed with the adoption of this Maximum Allowable Dose Level (MADL)).

OEHHA says it is proposing the MADL of 290 micrograms per day at this time to assist the public in assessing the potential impact of the listing.

Here’s some context. In a 2011 study reported by Fox News, people who ate one serving of canned soup every day for five days had BPA levels of 20.8 micrograms per liter of urine. Compare this to the control group, who ate fresh soup for those five days and had just 1.1 micrograms per liter.

The difference in BPA levels represents a 1,221 % increase in humans— from just one serving of canned soup per day. There are other canned consumable goods people eat every day. BPA shows up in food from restaurants, in prepared and frozen foods, and in places you might not expect, like some paints, packaging and of course, plastic bottles. A person’s daily total exposure is the thing of concern here.

BPA and worker safety. The levels of BPA seen in the study participants were “among the most extreme reported in a nonoccupational setting,” the researchers wrote in their report.

This is a reminder that while consumers should watch their BPA exposures, folks in occupational settings should really watch theirs.

Packagers, technical supervisors, laboratory technicians and maintenance workers in BPA manufacturing facilities and facilities using BPA to manufacture, say, epoxy resin are examples of occupational environments where male workers in one Kaiser study showed four times as many endocrine-disruption related conditions. Male hormonal disruptions result in conditions such as, well, you know. And if you don’t know, read the study.

However, California Proposition 65 exists primarily to protect citizens of California, not so much as a worker safety measure. So news surrounding this BPA moment will focus on can linings and cash register receipts and other such areas where average citizens are exposed.

Feedback from industry. In legalese, setting a maximum threshold for exposure to BPA would happen via amendment of Section 25805(b) of Title 27 of the California Code of Regulations.

Any written comments concerning this proposed action, regardless of the form or method of transmission, must be received by OEHHA by 5:00 p.m. on March 11, 2013. All comments will be posted on the OEHHA website at the close of the public comment period, so don’t say anything your company won’t stand behind later.

Feedback from the public. Just because it’s usually industry who comments on these matters doesn’t mean the public shouldn’t (or, necessarily, should). Comment periods are open. If you have some knowledge of BPA and related issues and you have an opinion on the proposed threshold, you should email comments to: P65Public.Comments@oehha.ca.gov — they’ve asked that folks please include “BPA MADL” in the subject line.

The most recent Cal Prop 65 list can be found here: http://oehha.ca.gov/prop65/prop65_list/files/P65single010413.pdf

China Chemical Registration

As of March 1, 2013, the following must obtain an appropriate Registration Certificate for Environmental Management Registration for Hazardous Chemicals in China:

  • newly established companies that produce hazardous chemicals
  • companies using hazardous chemicals for production purposes
  • companies importing or exporting hazardous chemical.

Registration Certificates will be issued by China’s Environmental Protection divisions and will be valid for three years. Existing companies that produce or use hazardous chemicals for production purposes have a three-year transition period to complete registration— this registration is separate from the registration required by the State Administration of Work Safety and it is said to aim at better tracking of the environmental impact caused by hazardous chemicals, rather than the health and safety impact.

Perhaps the biggest concern with the new Chinese chemical policies overall is how they add to the larger international weave of chemical restrictions, standards and regulations. The way to handle China’s hazcom rules— all of them, new and future— is to make sure that the way your company handles REACH, RoHS, Prop 65, GHS and TSCA also handles any Asian restrictions as well, from South Korea to Japan to India and China.

Newbies, look out. Newly established manufacturers must register their hazardous chemicals before completion and final acceptance of their project, while importers must register before they import a hazardous chemical for the first time. And the Registration must be complete before the final acceptance of any new construction projects or expansion projects of hazardous chemical manufacturers and users.

Legacy. Entities in China that manufacture or import hazardous chemicals must register their hazardous chemicals with China’s State Administration of Work Safety and China’s Ministry of Environmental Protection (MEP), while entities that use hazardous chemicals must register with China’s Ministry of Environmental Protection (MEP). Hazardous chemical manufacturers and users must also engage in material disclosure, that is, public disclosure of information regarding their hazardous chemicals production and use.

Information to submit when registering includes:

  1. classification and labeling information
  2. physical and chemical properties
  3. primary use
  4. hazardous characteristics
  5. safety information for storage, use and shipment
  6. emergency response measures.

In addition, hazardous chemical manufacturers must maintain a 24-hour domestic telephone hotline to provide users with emergency consulting services and technical instructions and other assistance with respect to hazardous chemical accidents. Another option is to assign the hotline to the Chinese government.

Action. In light of these regulations, the legal firm Baker & McKenzie suggests that entities in China who are manufacturing, importing, or using hazardous chemicals should consider: Designating certain employees, or creating a specific department, to be in charge of hazardous chemical registration and ongoing compliance requirements Conduct due diligence on suppliers in China who may be subject to these requirements as part of

Supply Chain Management (SCM). Rather than setting up an entire department to manage these changing compliance requirements in Asia, we would suggest subscribing to a secure SaaS software that manages compliance for you. In the end, it’s the most cost-effective way to manage fluctuating global regulations and supplier relations around them.

Cal Prop 65 List + 2

California’s chemical law known as Cal Proposition 65 requires the State of California to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm.  Manufacturers and/or distributors selling products in CA must label products with a Toxicity Warning if the product contains any chemical on the list.

The updated Cal Prop 65 list can be downloaded here, in full. The list below was updated on July 24, 2012, and updates can be viewed in red at the top of the image.  The latest listed chemicals are:

  1. Isopyrazam (CAS No. 881685-58-1)
  2. 3,3′,4,4′ Tetrachloroazobenzene (CAS No. 14047-09-7)

About Prop 65.  Not all 800+ chemicals on the Prop 65 list should be avoided at all costs (and in some cases they might save your life, as with aspirin to thin the blood).  The Prop 65 list seeks to publish the identity of every chemical that can be a danger and to require products containing it or traces of it be clearly labeled as potentially toxic.  Labels are mandatory, although enforcement is spotty.

The idea, it’s said, is to alert consumers of possible dangers and let consumers decide whether to act on that knowledge.

Proper Etiquette: California Prop 65

California’s chemical law known as Proposition 65 requires the state to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm.  The Prop 65 list was first published in 1987.

The list was updated on Oct. 28. The latest chemical added is tris(1,3-dichloro-2-propyl) phosphate (TDCPP).

Businesses have one year to organize warning and labeling systems if manufacturing or selling products in California that contain this chemical.  What does a label look like?

Here is a sample label under Prop 65.

(That particular label makes you think, doesn’t it?  It made me think..!)

At the end of this post is a current list of chemicals on the Prop 65 list. Scroll down to that section if desired, and download the list in PDF form, to keep for your records.

What is Prop 65?  California Prop 65 is actually the “Safe Drinking Water and Toxic Enforcement Act of 1986.”  It manifests as a list of chemicals known to the state of California to cause either cancer or reproductive toxicity.  The list:

  1. must be updated at least once a year
  2. products and facilities containing these chemicals are asked to clearly post warnings indicating the presence of these chemicals
  3. must be published for all to see

The Prop 65 list currently includes approximately 800 chemicals.

Now, included on the Prop 65 list are things we sometimes think of as benign, such as alcohol and aspirin.  Alcohol makes the list because it obviously can be toxic in sufficient amounts.  Aspirin makes the list because it has been shown to cause reproductive harm in fetuses if ingested by women in advanced stages of pregnancy.

So not all 800 chemicals on the Prop 65 list should be avoided at all costs (and in some cases they might save your life, as with aspirin to thin the blood, or, arguably, alcohol to get through holidays with the in-laws).  The important thing is that even if a chemical is safe for you, it might not be safe for others; some chemicals, eerily, do not seem to harm women at all but mess with the male developmental system in undesirable ways.

And, while a chemical may be safe for some uses, it may be toxic in certain doses, or in other uses, or for another gender.  The Prop 65 list seeks to publish the identity of every chemical that can be a danger.

Requirements for business under Prop 65. All chemicals on the Prop 65 list require businesses to act in some way, typically by posting a warning in the workplace, or by affixing a label on a product that contains, say, a globally-regulated toxin such as cadmium (which is also on the list).

Again, to see an ironic sample Prop 65 label, click here:  toxic breast cancer ribbon.  There you will see one of the great ironies of modern culture, and also the reason I look forward to coming to work in the morning.  The link goes to the image of a Fight Breast Cancer pink ribbon that you pin on your shirt, the packaging bears a warning that the ribbon itself contains chemicals that are known to cause cancer.

For those that don’t know, besides being a practicing CIH and Professional Chemical Engineer, I cofounded a company 15 years ago that provides manufacturers with software for tracking chemical ingredients from suppliers.  This type of software, the hope is, will maybe one day eradicate the need for such “ironic” labels on a Fight Cancer ribbon, because greener, non-toxic alternatives have been identified and used.

Warnings and labels under Prop 65. Businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical. This warning can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. Once a chemical is listed, businesses have 12 months to comply with warning requirements.

Proposition 65 also prohibits companies that do business within California from knowingly discharging listed chemicals into sources of drinking water. Once a chemical is listed, businesses have 20 months to comply with the discharge prohibition.

Exemptions. Businesses with fewer than 10 employees and government agencies are exempt from Proposition 65’s warning requirements and prohibition on discharges into drinking water sources. Businesses are also exempt from the warning requirement and discharge prohibition if the exposures they cause are so low as to create no significant risk of cancer or birth defects or other reproductive harm.

Risk thresholds. For chemicals that are listed as causing cancer, the “no significant risk level” 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 chemical over a 70-year lifetime. In other words, a person exposed to the chemical 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.

CA Prop 65 “safe harbor numbers.” OEHHA develops numerical guidance levels, known as “safe harbor numbers,” for determining whether a warning is necessary or whether discharges of a chemical into drinking water sources are prohibited.

However, a business may choose to provide a warning simply based on its knowledge, or assumption, about the presence of a listed chemical without attempting to evaluate the levels of exposure.

Businesses do not file reports with OEHHA regarding what warnings they have issued and why, on that basis, or because of that, OEHHA is not able to provide further information about any particular warning, which is unfortunate. Instead, contact the business issuing the warning.

Enforcement and penalties. The California Attorney General’s Office enforces Proposition 65. Also, any district attorney or city attorney (for cities whose population exceeds 750,000) may enforce Proposition 65. So can an individual acting in “public interest” may enforce Proposition 65 by filing a lawsuit against a business alleged to be in violation.

Lawsuits have been filed by the Attorney General’s Office, district attorneys, consumer advocacy groups, and private citizens and law firms.  For enforcement information, contact the California Attorney General’s Office at (510) 622-2160 or visit http://ag.ca.gov/prop65/

Penalties for violating Proposition 65 go up to $2,500 per violation per day if businesses fail to provide notices.

For more information on the Proposition 65 list of chemicals, contact OEHHA’s Proposition 65 program at (916) 445-6900, or visit oehha.ca.gov/prop65.html.

Download the list of chemicals on California’s Prop 65 list, no registration required.  Be advised there are 23 pages of this list; below is a snapshot of just the first page.  This list was updated Oct. 28. It’s a good document to download and keep for your records.

Current list chemicals Prop 65 California