EPA Induces ToxCast Labor, Hires 4 Companies

Interesting news:  The U.S. Environmental Protection Agency’s (EPA) ToxCast chemical screening program has awarded contracts to four United States-based companies to test up to 10,000 chemicals for potential toxicity to people and the environment. ToxCast is designed to determine how chemical exposures affect human health.

The idea behind ToxCast is that it will be able to screen thousands of chemicals in fast, cost-effective tests.  A key goal of the initiative is to reduce EPA’s reliance on slow and expensive animal toxicity tests, enabling the agency to screen chemicals more quickly and “to predict and identify potential risks to Americans.”  Frankly testing mice and bunnies does seem, besides distasteful, a bit archaic.

The companies are:

All four companies will likely hire new employees as a result of these contracts, and it’s good that EPA considered this in the selection.  The companies have offices across the U.S., including smaller markets such as Michigan.  Two of the companies — Vala Sciences and BioReliance — are small businesses.

The four companies will initially screen up to 1,000 chemicals currently in the ToxCast program using innovative technologies such as stem cell toxicity tests. These new technologies can quickly determine the potential for a chemical to cause harm to the human body.  Screening results from the new technologies will be combined with data already being generated by the other 500 rapid chemical tests used by EPA’s ToxCast program.

The chemicals ToxCast is now screening are found in industrial and consumer products, food additives and drugs.

EPA scientific studies using ToxCast have already been published in peer-reviewed science journals, and demonstrate the ability of ToxCast to predict a chemical’s potential to cause several diseases.

For more information on ToxCast database:  http://actor.epa.gov/actor/faces/ToxCastDB/Home.jsp

Image credit: Jack Dykinga – USFWS/public domain

The Notorious B.P.A. – EPA Takes Action

Bisphenol A (BPA) is currently banned in a checkered way across the United States and across the world. Canada and all the European Union have banned BPA in some uses, and now China and Malaysia have too. So where is the US at a federal level in regards to BPA regulation, you might wonder?

Well, wonder no more. Today the US Environmental Protection Agency (EPA) announced that because BPA has been shown to cause reproductive and developmental effects in animal studies, EPA is requesting public comment on possible toxicity testing and environmental sampling to study BPA’s potential environmental impacts.

BPA lines a can of worms. BPA is a chemical that has, in fact, been shown to mimic estrogen and has been linked to increased risk of cancer, altered brain development, early puberty and other metabolic changes. We’ve avoided discussing it in this blog because – frankly – it’s a can of worms.

You might think we mean the “public perception vs. industry interests” can of worms, but what we really mean is another can: many types of plastics, not just BPA, have tested positively for endocrine manipulation.

Time magazine pointed out a recent study in the journal Environmental Health Perspectives where researchers found that many plastic products leach endocrine-disrupting chemicals — even products labeled “BPA-free.”

In the study, researchers tested 455 common plastic products and found that 70% tested positive for estrogenic activity [EA]. Once those products were subject to real-world conditions—microwaving or dishwashing—the number rose to 95%. The study concluded: Almost all commercially available plastic products we sampled, independent of the type of resin, product, or retail source, leached chemicals having reliably-detectable EA [estrogenic activity], including those advertised as BPA-free. In some cases, BPA-free products released chemicals having more EA [estrogenic activity] than BPA-containing products.

Given that context, it sometimes seems there’s a witch hunt on for BPA. But if BPA is going to serve as a regulatory driver for health issues associated with consuming food stored or served in plastics in so many countries around the world, it’s likely to be at least discussed here in the U.S. too. The comments to EPA will likely be a rousing debate — so keep an eye on the discussions!

EPA, Dell, Sprint and Sony Have New E-Waste Policy

The US Environmental Protection Agency made a Big Announcement this week in Austin, TX, regarding e-waste and product stewardship — the announcement came as EPA head Lisa Jackson stood beside leaders from Sprint, Dell and Sony.

In Austin, EPA Administrator Jackson signed a voluntary commitment agreement with Dell CEO Michael Dell and Sprint CEO Dan Hesse to promote a US-based electronics recycling market. Sony Electronics Inc. representatives were apparently present and “also committed to improving the safe management of used electronics,” but it wasn’t clear whether they signed anything. But their presence indicates good intentions.

“Americans generate nearly 2.5 million tons of used electronics each year,” said Chris Nowak of Actio Corp., the New England-based company that tracks manufacturing regulations worldwide and bundles these findings into product stewardship compliance software.*

“This is a key commitment made today by Dell, Sony and Sprint,” Nowak said. “Evolving end-of-life policies such as these force designers, quality assurance personnel and manufacturers to think differently about their products and their product quality.”

Michael Dell, chairman and CEO, Dell Inc. said, regarding the stewardship initiative, “Last fiscal year, we diverted more than 150 million pounds of end-of-life electronics globally from landfills, and we are well on our way to meeting our goal of recycling 1 billion pounds by 2014. We encourage everyone in our industry to commit to easier, more responsible recycling as we all work to protect our planet.”

E-waste not, want not. Under the strategy announced today, the US General Services Administration (GSA) says if products do not comply with comprehensive and robust energy efficiency or environmental performance standards, those products will be removed from the information technology purchase contracts used by federal agencies.  GSA also says it will ensure that all electronics used by the Federal government are reused or recycled properly.

Key components of today’s announced strategy include:

  1. using certified recyclers
  2. increasing safe and effective management and handling of used electronics in the US
  3. working with industry in a collaborative manner to achieve that goal.

For more information on the EPA and industry collaboration, click here.

Electronics stew:  wardship and US policy. It’s not the first time we’ve heard rumblings of this sort. Last October, Lisa Jackson visited China — including a site visit to Guiyu, home of perhaps the most famous e-waste dump but certainly not the only one.   And just a few weeks ago a new e-waste bill was proposed by US Representatives Gene Green and Mike Thompson, with a focus on the exports of used electronics. It’s called the Responsible Electronics Recycling Act. It establishes a new category of “restricted electronic waste” — that is — waste that cannot be exported from the US to developing nations.

Exemptions from the bill include:

  1. used equipment can still be exported for reuse as long as it’s been tested and is fully functional
  2. nonhazardous parts or materials are also not restricted
  3. crushed cathode ray tube (CRT) glass cullet that is cleaned and fully prepared as feedstock into CRT glass manufacturing facilities.

WEEE WEEE WEEE. In other responsible product end-of-life news: in February 2011, members of the European Parliament (MEPs) passed new WEEE guidelines for electronic waste.  Key points are as follows:

  1. manufacturers would help pay for goods disposal
  2. EU governments would implement more stringent penalties for breaching, e.g, for falsely identifying shipments as “reusable”
  3. authorities would be able to target all WEEE categories
  4. current ambition levels for collection rates would be maintained
  5. European standards would be set for collection, recycling and treatment for WEEE management.

For full details, see article on the top 5 WEEE bits.

Europe accepts a RoHS. In related RoHS news, the Council of the European Union (“the Council”) officially revised the RoHS directive earlier this summer. In the Big Picture, this critical recast attempts to harmonize the directive across the European Union.

In the smaller picture, RoHS affects hazardous substances in electrical and electronic equipment.  The chemical restrictions will now apply to all electrical and electronic equipment, as well as to cables and spare parts, and to medical devices, medical equipment, control and monitoring equipment – which were previously exempt from RoHS compliance but are not exempt now.

ECHA Updates Criteria for Accredited Stakeholders

Ever wondered what it takes to become an accredited stakeholder in the eyes of ECHA, the European Chemicals Agency, which is the governing body of REACH regulation?

A stakeholder is defined within ECHA as “an individual, group, institution or government with an interest or concern, either economic, societal, or environmental, in a particular measure, proposal or event.”

ECHA´s Management Board just revised the criteria that defines how stakeholder organizations are granted an accreditation with ECHA.  Here are the five eligibility criteria for so-called Accredited Stakeholders, as amended:

Criteria 1 – Established in and for the EU

An entity seeking status as an accredited stakeholder must be legally established within the EU/EEA and have activities at the EU level.  This means that an eligible organisation has to be legally established in one of the EU Member States, Iceland, Liechtenstein or Norway.  EU level activities are activities targeted at an EU-wide audience, i.e. not limited to the local, national or regional level. To prove it, the place of legal establishment may be evidenced by the founding document or any other suitable document proving that the entity’s seat is located in the EU, Iceland, Liechtenstein or Norway. (Organisations can explain the scope of their activities in the application form.)

Criteria 2 – Legitimate interest

The entitiy must have a “legitimate interest” in the areas of work of ECHA. This means that the organisation applying for accredited stakeholdership represents a sector affected by the EU chemicals legislation (such as the REACH, CLP, Biocides or PIC Regulation) falling within the scope of the tasks of ECHA. An organisation is also considered to have a legitimate interest in the areas of work of ECHA if it represents a sector indirectly affected by the legislation; this can also include non-governmental organisations (NGOs) engaged in issues affected by the mentioned legislation.  Typcially, ECHA’s Accredited Stakeholders are active in industry, human health, animal welfare, environmental protection, scientific research and development, and consumer protection.  Organisations are expected to depict their legitimate interest in the application.

Criteria 3 – Representative

The entity must be “representative” in the field of their competence.  This means the organization must represent the interests of a substantial part of the actors in its field of competence.  ECHA’s Accredited Stakeholders should be representative of actors in their sector or field of competence.  The necessary number of member organisations and their size depends on the structure of the relevant sector.  (Note: the sector need not have a particular size, but must be distinguishable from other sectors with different fields of interest.)  Organisations are expected to set out why they can be considered “representative” in the application form.

Criteria 4 – Non-profit

Entities must be “non-profit” and not exclusively represent individual companies.  A non-profit organisation here means one which is not operating for its own commercial profit or gain but conducts its operations for the benefit of its members or of the general public.
Non-profit status may be evidenced by the founding document or any other suitable document and must be provided during the application process.

Criteria 5 – Register

Organization must be registered in the Register of Interest Representatives maintained by the European Commission. This criterion only applies in cases where the organization wishes to participate as an observer in the Committee and Forum meetings of ECHA. There is no charge to register, it’s necessary for tracking the flow of information.

All organizations are requested to indicate their registration number in the application form.

Note:  all accredited stakeholders who wish to attend ECHA Committee and Forum meetings need to sign up in the Transparency Register, which is operated by the European parliament and the European Commission.

REACH Guidance EZ – Documents For the Rest of Us

Those interested in REACH regulation should know that the European Chemicals Agency (ECHA) has published a new version of its Guidance in a Nutshell.  Relevant to any company that makes, sells, buys or even thinks about finished goods, it’s called “Guidance in a Nutshell on Requirements for Substances in Articles.”

The updated “Guidance in a Nutshell” is a good document for those of us who are engineers, and who are not lawyers or overly obsessed with the finer points of Policy minutiae. The document addresses in simple terms the primary bullet points of ECHA’s new version of the Guidance on Requirements for Substances in Articles, itself something of a monster (worth wrestling with for some of us, but not all).

The Nutshell document’s aim is to help companies who produce, import or supply articles.  Specifically, it will help them to identify their obligations regarding substances in articles under REACH.  The document briefly explains key bullets such as:

  1. the concept of an article
  2. obligations for registration, notification and communication
  3. possible exemptions from these obligations

Here are the links you need:
Guidance in a Nutshell on Requirements for Substances in Articles:
http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance_articles2_en.pdf

Guidance on requirements for substances in articles:
http://guidance.echa.europa.eu/docs/guidance_document/articles_en.htm

General ECHA guidance website:
http://guidance.echa.europa.eu/index_en.htm

EPA Provides Searchable Databases on Chemical Toxicity

The Environmental Protection Agency (EPA) has released two databases — the Toxicity Forecaster database (ToxCastDB) and a database of chemical exposure studies (ExpoCastDB) — making chemical toxicity and exposure data more available to scientists, industry and the public.  This is yet another step in the inevitable march towards greater material disclosure.

ToxCastDB uses advanced scientific tools to predict the potential toxicity of chemicals. The database also:

  1. helps determine which chemicals need further testing
  2. lets users download data from over 500 rapid chemical tests conducted on more than 300 environmental chemicals (data on an additional 700 chemicals will be available in 2012)

ExpoCastDB uses chemical measurements from homes and child care centers to consolidate human exposure data, including chemical amounts in:

  1. food
  2. drinking water
  3. air
  4. dust
  5. indoor surfaces
  6. urine

A data warehouse connects ToxCastDB and ExpoCastDB, providing one online resource of animal chemical toxicity studies from the past 30 years. The data warehouse, called Aggregated Computational Toxicology Resource (ACToR), collects data on more than 500,000 chemicals from over 500 public sources. ACToR links both exposure and toxicity data, which are required when considering potential risks posed by chemicals.

The ability to link and compare these different types of data better informs EPA’s decisions about chemical safety.  Arguably, it will help industry make better decisions in manufacturing.

“Chemical safety is a major priority of EPA and its research,” said Dr. Paul Anastas, assistant administrator of EPA’s Office of Research and Development. “These databases provide the public access to chemical information, data and results that we can use to make better-informed and timelier decisions about chemicals to better protect people’s health.”

Is Flat the Next Big Thing?

The Human Media Lab at Queen’s University, Canada and Arizona State University’s Motivational Environments Research group have teamed up to create what’s been dubbed the “PaperPhone.”  The phone was created with the same e-ink technology found in the Kindle e-book reader and in flexible printed circuits featuring an array of bend sensors.

E-history: the world is flat, but bendy. The first electronic paper, developed in the 1970s in Palo Alto, was called Gyricon and consisted of polyethylene spheres between 75 and 106 micrometers across. In the 1990s another type of electronic paper was invented by Joseph Jacobson, who later co-founded the E Ink Corporation.

In an electrophoretic display, particles with a diameter of one micrometer are dispersed in a hydrocarbon oil with a dark-colored dye with surfactants and charging agents. This mixture is placed between two parallel, conductive plates. With applied voltage, the particles will migrate electrophoretically to the plate bearing its opposite charge.  Arranging this movement into patterns — in this case pixels — is the basis for a paper thin display.

Although called the “PaperPhone”, the name doesn’t quite do the prototype justice. “SmartPaperPhone” may be more fitting. The device can perform several tasks, depending on what shape you form it into.  Want to make a phone call? Bend the paper into a concave shape. Have a favorite e-book? Bend the page corner to turn to the next page. You’ll even have an mp3 player that’s much thinner than your current iPod.

E-regulatory compliance. As far as regulating something like this is concerned “the electronic components and lithium batteries are not regulated as hazardous waste. The entire electronics assembly is RoHS (Restriction of Hazardous Substances) compliant and marked as such on the printed circuit board in the cover. All of it can be recycled through your local municipal waste program in the same manner as you dispose of household batteries. (Check local regulations for any further restrictions.) The paper can go in your paper recycling, and the protective foam in your plastic recycling.”

E-exciting or e-issues? While exciting, there are some issues with the PaperPhone. Batteries are still fairly clunky and won’t easily bend. The memory has to be kept somewhere as well. What good is a flexible electronic paper phone if most of is has to stay stationary to accommodate the required working innards?

It could be that buying a ream of cellphones at your local big-box retailer may not be that far off.

Learn more about the technology below:

http://www.hml.queensu.ca/paperphone
http://www.circuitsassembly.com/cms/magazine/209/9557/
http://www.esquire.com/features/how-e-ink-was-made
http://supply-chain-data-mgmt.blogspot.com/2011/05/green-chemistry-sleeper-hit-in-supply.html

Adam Baer (guest-blogger for Kal Kawar) manages materials regulation data and reports at Actio Corp.  He holds a B.A. in Journalism from the University of Maine.

RoHS Recast — Regulatory Update Made Official

The Council of the European Union (“the Council“) officially revised the RoHS directive on hazardous substances in electrical and electronic equipment.  The chemical restrictions will now apply to all electrical and electronic equipment, as well as to cables and spare parts, and to medical devices, medical equipment, control and monitoring equipment – which were previously exempt from RoHS compliance but are not exempt now.

Further, this recast will harmonize the directive across the European Union.

The product categories affected by RoHS include large household appliances, computer equipment, TVs, lighting, toys and video games, and vending and ATM machines – as well as the categories listed at the top of this article.  You can imagine then that almost all discrete manufacturing sectors are affected – as most use computer equipment in parts, components or assemblies.  RoHS creates a notable data management challenge in terms of supplied parts and compliance certification.

RoHS Recast provisions. Provisions are included in the recast to allow time for the market to adjust.

A three-year transitional period is allowed for some devices:

  • monitoring
  • control
  • medical

A five-year transitional period is allowed for:

  • in vitro medical devices

A six-year transitional period is allowed for:

  • industrial control appliances

Nanomaterials under RoHS. Everyone wants to know how nanomaterials will be regulated.  It’s a grey area.  Rightly, the European Commission says that work towards a common definition of nanomaterials is necessary (yes!) and ongoing. The EC intends to adopt a Commission Recommendation on a common definition “in the near future.”

The Commission considers that the RoHS provisions cover different forms (including nanoforms) of the substances which are currently banned. The Commission also considers that these RoHS provisions cover forms subject to a priority review under RoHS in the future.

RoHS Recast next steps. Next steps include:

  • Signatures and Journal publication
  • Transposition into EU member state laws
  • Industry implementation

There are a few good resources for more information. Design Chain Associates (DCA) has a good article and some (reasonably priced) on-demand webinars for more in depth review.

Would you accept this RoHS? It may be a good idea to review why we are gathered here today. While the ins and outs of regulations can be like jungle hacking – a look from the air is a good idea from time to time.

There are measurable environmental benefits to a well-executed and enforced RoHS program. Reported environmental benefits include:
•    reduction of lead (Pb) use in products by 82,700 tons in the EU
•    reduction of cadmium (Cd) use in products by 14,200 tons
•    reduction of mercury (Hg) use in products by 9,500 tons due to changes in copiers and fluorescent light bulbs
•    reduction of mercury in waste streams by 6,900 tons

RoHS restricted substances. RoHS focuses on six hazardous substances: lead, mercury, cadmium, hexavalent chromium and two types of flame retardants in plastics (PBB and PBDE). The restrictions have not changed since last November, but additional hazardous substances are now expected, whereas the list of substances of concern under the previous version of RoHS was considered more stable. Click here for the current list/threshold amounts.

To wit, RoHS is a directive, not a regulation. The difference is that a directive cares only about the result. With RoHS, for example, the required result is the restricted use of certain toxic metals in electronics manufacturing. A regulation, on the other hand, delineates to each entity under the umbrella of the regulation how to get the result.  A good example is the REACH regulation, which has a detailed process for substance registration, use, and data sharing.

ECHA to Add 7 Chemicals to REACH SVHC List

The European Chemicals Agency (ECHA) will shortly add seven new chemical-substances to REACH regulation’s Candidate List of Substances of Very High Concern (SVHC). The comment period was slated to last through July 4, but ECHA says that the consultation period is now over.

The seven candidates for SVHC are as follows:

  1. 2-ethoxyethyl acetate
  2. strontium chromate
  3. 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters
  4. Hydrazine
  5. 1-methyl-2-pyrrolidone
  6. 1,2,3-trichloropropane
  7. 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich
  8. Cobalt dichloride

The list shows eight substances because it includes cobalt dichloride. The status of cobalt dichloride is actually up for re-evaluation, due to its revised classification as both carcinogenic and toxic for reproduction. Cobalt chloride was originally identified in October 2008 as SVHC solely on its carcinogenic properties, says REACHtracker.

REACH update

The Candidate List is growing. There are now 46 SVHCs. The next ECHA consultation is planned for August, and that will kick off a busy time as the European Commission expects to have reviewed and listed 135 SVHCs by the end of 2012. The goal is to have reviewed, listed and regulated all relevant known SVHCs by 2020.

In the meantime, expect bi-annual updates to the Candidate List.

Further reading

For more on these chemicals, see Chemical Watch (pay site).

For detail on each chemical, here’s a good page from Safe Packaging.

The Actio chemical databases will be updated to reflect the change as soon as the Candidate List is updated; for now these chemicals are flagged as “probable SVHCs.” Wishing you good luck with quality assurance efforts and product development in this era of digital chemical management. It’s not easy!

Cadmium Banned in Europe in November

The European Commission announced May 20 that the European Union will ban cadmium in jewelry, brazing sticks and plastics beginning this November. A Commission press release states that the new legislation, which will be adopted as an amendment under the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, will prohibit the use of cadmium in all types of jewelry products, except antiques; brazing sticks, which are used to join dissimilar materials; and — in theory — all plastics.  

We say “in theory” in regards to the cadmium ban in “all plastics” because the Commission notice on the updated cadmium restriction appears to have inconsistencies regarding plastics.

The notice on World Trade Interactive suggests that cadmium will be banned in all plastics (with the exception of some recycled PVC).  But an article in British Plastics & Rubber points out semantic oddities in the Commission’s draft document.

The draft references the proposed amendment to Restriction 23 of Annex XVII, which covers cadmium and its compounds.  However, the Commission’s report contained no changes from the 2010 document regarding the list of materials that would be affected.  The wording of the recent statement says “all plastics” would be affected by the ban, but the itemized list of named plastics remains the same.

This leaves the door open for some agents to interpret that plastics not itemized on the list are exempt.

This language snarl is worth being aware of.  In the long view however, while it may delay a revision, it likely won’t stop the fact that cadmium use in virtually “all plastics” will be banned in the EU either in Q4 of this year or shortly thereafter.

And that, of course, is the “heads up.”  (For more on the language snarl, see article, Cadmium — banned or not?)

Cadmium backstory. Cadmium has many uses. It’s used in paint as a pigment, for starters. Or was. EPA and regulatory bodies around the world have been trying to restrict or prohibit cadmium use in paint for years. Often trace amounts of cadmium result in public-perception denigration and expensive product recalls that affect the bottom line; such events are arguably more of a deterrent for industry than the anti-cadmium regulations themselves.

Last summer, for instance, REACH compliance watchdogs found traces of cadmium in Shrek glasses for children. The glasses were manufactured to be sold at McDonald’s as part of the Shrek film promotion. McDonald’s had to recall over 12 million of the glasses that would have retailed for $2 each; that’s a loss of $24 million, plus the operational costs of the recall.

Many think recall events due to substances like cadmium are primarily a supply chain communication failure. While that is true, recalls also point to a regulatory gap and a supply chain that quite naturally tries to cut corners.

The EU appears to be ready to send a clear message:  no cadmium. And to many manufacturers — although probably not to the manufacturers of cadmium pigment — a clear regulation is a welcome regulation. Last year, EPA moved on this item as well when cadmium turned up in kids’ jewelry.

Cadmium alternatives. There’s no reason we need to be using cadmium in this day and age, right?  Problem is, especially for industrial uses, cadmium is very effective as a plating over steel as it’s remarkably resistant to corrosion.

A cadmium alternative for components must be, among other things:

  1. A panacea: act as a general corrosion coating for all seasons
  2. Specific protection: provide good salt spray and scribed corrosion protection
  3. Non-crackable case: cannot succumb to hydrogen embrittlement or stress corrosion cracking.

As a coating, the cadmium alternatives must, among other things:

  1. Retain thread profile/detail underneath, especially in jewelry
  2. Be solderable
  3. Be usable in electrical equipment in terms of conductivity and heat-effect limits.

At minerals.usgs.gov, the government says that coatings of zinc or vapor-deposited aluminum can substitute for cadmium in plating applications.

In 2002, a group published an evaluation of cadmium replacement alternatives for aircraft with notable results. Typically aircraft are exempt from cadmium legislation because of a “no known alternative” clause. In other words, nothing works as well so it is allowed for now.

This still creates a cost and a wrench in manufacturing process, however, due primarily to the problem of disposal of this known-toxic material at end-of-life. Where does cadmium go to die? We’ve all heard of the aircraft boneyard.  Aircraft manufacturers are responsible for end of life disposal of all parts and components (and substances).  The costs associated with end-of-life makes alternatives to cadmium look better and better.  For more on aircraft and replacements, see the Rowan Technology Group 2002 report on cadmium replacements.  It’s an interesting document.  Spoiler alert:  the report concludes that aluminum (Al) is the best cadmium replacement for uses in aerospace, automotive and electronic components in terms of behaving most like cadmium.

The point is that there are alternatives to cadmium — depending on application. For the most part, the replacements are sister- or cousin-metals.

For more on the cadmium ban coming in November under REACH regulation, review the European Commission’s press release.  Also, keep an eye on this blog as we’ll keep you posted on the critical cadmium (and similar) regulatory update status as we go through 2011.