Tag Archives: Actio

Conflict Minerals, Meet US Sanctions

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Here comes another layer of “conflict minerals” restrictions.

President Obama last week set the stage for expanded sanctions against the Democratic Republic of the Congo and vicinity’s militia-ravaged region. A new Executive Order specifies that sanctions are called for against “individuals and groups tied to militias involved in the illicit trade of natural resources from the region” of the Democratic Republic of the Congo or DRC. If that criteria doesn’t include conflict minerals, what does?

Penalties to companies and individuals that fail to adhere to the expanding sanctions can include:

  1. Fines of at least $250,000
  2. Fines twice the amount of the underlying transaction
  3. Criminal penalties of up to $1,000,000
  4. Imprisonment for up to 20 years

Other conduct that will trigger future US sanctions:

  1. Actions or policies that threaten the peace, security, or stability of the DRC
  2. Actions or policies that undermine democratic processes or institutions in the region (DRC)
  3. The targeting of women and children with acts of violence (including killing, maiming, torture, and rape or other sexual violence), abduction, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through conduct that would constitute a serious abuse or violation of human rights or a violation of international humanitarian law
  4. The use or recruitment of children by armed groups or armed forces
  5. Obstructing the distribution of, or access to, humanitarian assistance
  6. Attacks against United Nations missions, international security presences, or other peacekeeping operations.

Earlier this month, ahead of the Executive Order, US and United Nations Security Council added a Ugandan rebel group, the Allied Democratic Forces, to the sanction lists for “targeting children in situations of armed conflict through rape, killing, abduction and forced displacement.”

As far as conflict minerals go, this is yet another reason to know thy product ingredients and to continue tracking conflict minerals for compliance.

Thanks to many sources for these updates, for this one in particular thanks to Christopher T. McClure, Crowe Horwath LLP.

RoHS July 2014 Deadline: Medical Devices and Control Instruments

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In 2011, the European Union issued a new directive that updates and supersedes RoHS; it has come to be known as the RoHS Recast or RoHS 2. Under the updated directive, as of July 22, 2014, RoHS restrictions will apply to Category 8, medical devices, and Category 9, monitoring and control instruments. Before we look at what those categories include specifically, here’s an overview of deadlines yet to come under the RoHS Directive.

So, what’s in Category 9, Monitoring and Control Instruments? The types of equipment that are in category 9 of the RoHS directive have a main function of monitoring or control, says Dr. Paul Goodman in Electronics Weekly, quoted here because it stands out as one of the better summaries of what to expect from Category 9. Monitoring, Goodman says, would include measurement – ergo thermometers, analytical spectrometers and digital voltmeters are all in category 9 because they monitor temperature, concentration, voltage, etc.

Monitoring and control functions are features of thermostats that monitor and control temperature and industrial process controllers that monitor and control a variety of process parameters. Other category 9 products include smoke detectors, fire alarms, traffic signals (control of traffic), X-ray imaging of luggage or electrical equipment (but not medical X-ray which is category 8), spectrum analyzers, etc. It is incorrect however, to assume that all laboratory equipment is in category 9 as these products must monitor or control as their main function. – Dr. Paul Goodman, EW

So, what’s in Category 8, Medical Devices? Medical devices were exempt in the original directive, which meant they could contain unlimited amounts of toxic metals and plastics and still be marketed as RoHS compliant. Not anymore. Medical devices are still a broad category, and note that RoHS is not targeting “in vitro diagnostic medical devices” yet in 2014.

So what is targeted? For example:  radiotherapy equipment, cardiology, dialysis, pulmonary ventilators, nuclear medicine, laboratory equipment; other appliances for detecting, preventing, monitoring, treating or alleviating illness, injury or disability; but specifically excludes all implanted and infected products.

How are companies handling RoHS compliance? Industry’s leading companies are managing their compliance at various stages. There are challenges.

Certainly one challenge with RoHS is the many different formats suppliers use to submit their information. We asked a group of manufacturing risk assessment professionals on LinkedIn, “What form of documentation do you typically get from suppliers?” Here are the myriad answers.

Note: a good software should eliminate that challenge, for instance, by loading all information into a uniform data repository, so the resulting standardized data parameters are searchable, rational and reportable.

 

BPA – The Data Game

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Over in Europe, the Member State Committee (MSC) has agreed that the European Chemicals Agency (ECHA) should request further information on six substances. This is the first batch of substance evaluations agreed on by the MSC.

Of particular note is the now infamous BPA. BPA is a carbon-based synthetic compound. It belongs to the group of diphenylmethane derivatives and bisphenols. BPA is used to make certain plastics and epoxy resins. The MSC has determined that more information is needed in order to properly assess the world’s most notorious plastic ingredient. In the US, the FDA has reached similar conclusions.

So why did the MSC agree that ECHA should request more information on six substances? This is essentially because the currently available information is insufficient to enable adequate health and environmental risk assessments. These particular six substances listed in the Community Rolling Action Plan (CoRAP) were evaluated by Germany, France, Denmark, the United Kingdom, Belgium and Spain.

Further information on Bisphenol-A (BPA) will be requested to clarify a number of concerns. First, the MSC agreed to request a new in vitro skin absorption study to assess the risk to consumers from, for example, toys and PVC articles. Second, information on the emissions and environmental exposure of BPA will be requested in order to assess the impact on the environment. The information will help to finalize the risk assessment. It will also help to determine whether further risk management measures are needed. There are on-going studies on BPA in the US which the German authority will also take into account in the next step of the assessment on endocrine disrupting properties for humans. See also BPA and California thresholds.

Other chemicals on the list

The MSC also agreed to request further information on the reproductive toxicity of carbon tetrachloride in an extended one generation reproductive toxicity study (EOGRTS, OECD 443). (More information on worker exposure to carbon tetrachloride will also be necessary).

The MSC agreed to request further information on oligomerisation and alkylation reaction products of 2-phenylpropane and phenol (previously registered as Phenol, methylstyrenated). The information requested is a bioaccumulation study in fish to clarify the concern for potential persistent, bioaccumulative and toxic properties. A combined repeated dose toxicity (90 day) and reproductive toxicity study is also requested (EOGRTS, OECD 443) to investigate endocrine disrupting effects.

The MSC agreed to ask for further information on worker exposure to imidazole and on its reproductive toxicity effects. Information will also be requested on short-term toxicity in the environment and on mutagenicity through an in vitro study.

The MSC agreed to request further information on N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine to clarify the concerns relating to persistent, bioaccumulative and toxic properties of the substance. A soil simulation test will be requested to look at aerobic and anaerobic transformation in soil.

Finally, information will be requested on a mixture of cis- and trans- tetrahydro-2-isobutyl-4-methylpyran-4-ol to clarify concerns relating to the environment. The requested study will be a short-term growth inhibition study, followed if necessary, by a long-term toxicity study in the aquatic environment.

Kal Kawar Joins Blogging Team

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I’d like to welcome our newest blogger, Kal Kawar of Actio.

A chemical regulations expert, Kal has a bachelor’s in chemical engineering and a master’s in industrial hygiene. His professional experience includes serving as staff industrial hygienist for IBM’s New York semiconductor manufacturing facility, and as industrial hygienist for IBM’s US headquarters. Now executive vice president of Actio, Kal taps more than 20 years’ worth of chemical engineering, industrial hygiene, and environmental engineering experience.  His far-reaching expertise with global regulatory challenges created by EPA, TSCA, REACH, RoHS, WEEE – and hundreds of others – aid in developing Actio software solutions for MSDS management, raw material disclosure compliance, and product stewardship in a supply chain.

Welcome, Kal!