Wednesday, January 28, 2015

Cisco Says Goodbye to Traffic Jams

The traffic jam — disruptor of supply chains, snafu of shipping timetables, frustration of all drivers, from uptown shoppers to airport delivery vans. A better way would include far fewer traffic jams.

Well, Cisco believes there's a better way. And cities around the world are already implementing better ways. You've heard of a smart phone. Now we're being introduced to the smart city.

Simply put, a smart city employs digital technologies to enhance performance and well-being of citizens; using apps and wireless and networks to engage more effectively and actively with visitors and residents alike.

The Internet of Everything (IoE) is behind the revolution. Connected parking, lighting, and transit is what makes cities smarter. CiscoSiemens and Schneider Electric are on the leading edge.

To start, Cisco, the tech giant behind digital connectivity and networks, wants to make real world traffic jams a thing of the past. Clearing traffic jams may be the cornerstone of a smart city. Here's why.

It turns out that over 25% of traffic congestion is "non-recurrent," according to the Federal Highway Administration (FHA). This means 25% of all traffic congestion is incident related — an accident, a weather event, perhaps delivery trucks un/loading or a throng of people arriving at the same time for the same event.

Really, just try to get something delivered in Boston just before or after a Red Sox game. It's easy to appreciate how solving congestion could elevate an urban experience.

How the Internet of Everything (IoE) is awesome


From a logistics point of view, the interesting thing about eliminating traffic jams is that it would mean faster goods transport, more reliable shipment and arrival times. Seems simple from an overview.

But in terms of nuts and bolts, how does it work? Optimal traffic management comes together in four areas, as follows:
  1. Traffic Monitoring: View color-coded, live traffic conditions on a map, including overlays of camera feeds. Prioritize camera feeds based on high-incident areas. Make it easier for citizens to report traffic hazards and incidents.
  2. Incident Detection and Management: Use video feeds and analytics to verify and detect traffic incidents, traffic flows, and violations. Create incident records and collect all data regarding the incident lifecycles.
  3. Administration: Easily configure and manage sensors, video infrastructure, and policy rules.
  4. Analytics: Report traffic incident distribution over time, day, and location to aid planning. Identify areas with recurring traffic and flow issues.
You can download a brochure for more information on the guts of this, credit to Cisco, who have quite a lot of great information and references on their website. 

The cost of awesome


Mobile applications and devices allow cities and people to interact. For example, my smartphone can already alert me when there's an accident ahead, and advise an alternate route. Imagine if it could find me a parking spot, too (it can, actually). An integrated system where this functionality is reliable and expected is the crux of a smart city. It's as easy as G-P-S.

Tomorrow's cities are here today
Smart cities attract businesses and visitors. Simply because it's easier to do business in such an environment. It's easier to shop. It's easier to find your way to the game, to the opera, to the warehouse.

How do cities get smart? By investing in tech infrastructure. There's no way around that. "Expand, enhance and transform," says one smart city evangelical video. In other words, find some budget for this. Big budget.

Costs depend on what's in place already and what the goals and timeline are. Keep in mind that sometimes it's better to have very little in place in terms of infrastructure. Creating a new smart system from scratch can be a simpler implementation than tethering advanced protocols onto old.

Of note:  there's a conference and expo dedicated to smart cities, slated for November in Montreal. It's a global affair, not always held in North America, so Montreal is relatively close for a lot of us. (Maybe see you there, as this is getting very interesting indeed.)

Awesome security concerns


The security aspect of an Internet of Everything is not lost on anyone. How risky is it? Very.

Consider this piece by John Chambers, published January 21st, addressing the Internet of Everything and security. In the article, Chambers says that developing and implementing the Internet of Everything represents a $19 trillion global opportunity. And that there are risks.

In a startling statement he says that there are two kinds of businesses in this world: ones that have been hacked and ones that don't know they've been hacked. This has obvious parallels for smart city technology users. Any network you connect with is a relationship to be assessed, whether it's a .gov or otherwise.

We put our faith in companies that build smart city infrastructure, assuming that security measures will protect us.

The question is, how much risk are we willing to assume to get our goods delivered faster?

The answer is: we want our goods delivered faster.

And that — in so many ways — is the bottom line.

Thursday, January 22, 2015

Breast Cancer and Endocrine Disruptors

There's some buzzing about worker exposure to endocrine disruption and how it might contribute to the onset of certain breast cancers. The American Public Health Association (APHA) is a fairly momentus organization, with some 30,000 members throughout the world, The association has issued a new appeal for recognition of the occupational nature of some breast cancers.

In the view of APHA, research on the occupational and environmental causes of breast cancer must become a priority.
Until recently, women's occupational health hazards continued to be mostly invisible, studied inadequately and infrequently despite women's long-time participation in the workforce. This lack of gender perspective comes at a price: working women's health.
Bernard Fontaine, Jr., CIH, CSP, AIHA Fellow of the Windsor Consulting Group posted a summary saying that industries using endocrine disruptors chemicals are accordingly encouraged to evaluate their workplace and supply chain for potential occupational health risks. This includes raw materials, operations/process, waste discharge, and consumer use to protect workers, public, and the environment.

(Many companies are doing this already, for a variety of reasons. Supply chain traceability is king in 2015.)

Product substitution is encouraged wherever possible. Otherwise, administrative controls and the use of properly selected personal protective equipment and respirators can be used to mitigate potential risk. Biological monitoring and medical surveillance ought to be considered for high risk workers.

It's true that all stakeholders can be trained and educated relative the hazards and controls of endocrine disruptors. This an opportunity for all industries manufacturing and using these chemicals to do "the right thing" and hopefully, reduce the risk of breast cancer and other forms of cancer.

Wednesday, January 14, 2015

EPA Updates Waste Rule

The U.S. Environmental Protection Agency’s struggle to distinguish between a waste and a recyclable material, dating back to its original May 19, 1980 rulemaking under the Resource Conservation and Recovery Act. Here is another chapter in the effort to straighten things out.

Cradle-to-cradle


A new Definition of Solid Waste rule (DSW) will take effect on June 13th, 2014, six months after publication in the Federal Register bearing the final rule.

The 507-page final rule comes as the result of a settlement between EPA and the Sierra Club over the EPA's October 2008 rule on the same topic, in which the EPA amended the regulation of a form of recycling known as "reclamation."

The rule includes several provisions that result in both resource conservation and economic benefits by encouraging certain types of in-process recycling and re-manufacturing, as in circular economy type approaches:

  1. The rule addresses significant regulatory gaps in the 2008 rule by requiring off-site recycling at a facility with a RCRA permit or verified recycler variance, which will allow EPA and the states to verify that a facility has the equipment and trained personnel to safely manage the material, adequate financial assurance, is prepared to respond in case of an emergency, and can demonstrate that the recycling is not disposal in the guise of recycling. The new verified recycler exclusion also includes a public participation requirement for recyclers seeking variances, so that communities are notified prior to the start of recycling operations. 
  2. The rule affirms the legitimacy of the pre-2008 DSW exclusions, such as the scrap metal exclusion, and does not change the regulatory status of material legitimately recycled under these long-standing exclusions.
  3. The final rule includes a revised definition of legitimate recycling that re-affirms the legitimacy of in-process recycling and of commodity-grade recycled products, such as metal commodities. The rule retains the exclusion for recycling under the control of the generator, including recycling onsite, within the same company and through certain types of toll manufacturing agreements, which recognizes those generators who follow good business practices by taking responsibility for their recycling and maintaining control of their hazardous secondary materials.
  4. Finally, the final rule includes a targeted remanufacturing exclusion for certain higher-value hazardous spent solvents, which are being remanufactured into commercial-grade products. This allows manufacturers to reduce the use of virgin solvents, resulting in both economic and environmental benefits, including energy conservation and reduced greenhouse gas emissions.
More information about this rulemaking can be found on EPA’s website at: http://www.epa.gov/waste/hazard/dsw/rulemaking.htm.

Federal Register: http://www.gpo.gov/fdsys/pkg/FR-2015-01-13/pdf/2014-30382.pdf

Tuesday, January 6, 2015

Intel Sparks CES @ 4:20 California Time

My Intelligent Communications Accessory (MICA) is an interesting collaboration between Intel and hot clothier company, Opening Ceremony. MICA marks a new milestone in wearables — a device both beautiful and smart. The 18K gold coating and curved, sapphire glass touchscreen is sleek, while technology engineered by Intel allows wearers to view messages, their calendar, and alerts from specified contacts.
Image courtesy Opening Ceremony

Hm. What I want to know is how long until we can put on shirt and pants each day and program its appearance on the way to the office? Then reprogram for dinner and drinks? Then with a few button pushes, update the look once more to lounge poolside with the family after dinner? That would be some useful wearable tech.

Although that gadget (above) sure does look slick. Even useful.

Intel Keynote: He Needs To Talk 


At any rate, this year's CES 2015 Intel keynote promises to be hip, cool and catering to the young at heart. The burning-hot event fires up at 4:20 Pacific Time today, January 6th. Intel CEO Brian Krzanich will be this year's Voice of Tomorrow.

Witness the event, and find out more about the bracelet, here: CES 2015 Fires Up With Intel.

Tuesday, December 30, 2014

How Drugs Are Approved in USA

Recently, I've been asked a few times how drugs get approved in America. While I haven't identified reasons for the sudden particular interest, I can offer a summary of the approval process.

In the U.S., federal law generally requires that prescription drugs be shown to be both safe and effective prior to marketing.

Manufacturers Demonstrate Their Own Drugs' Safety


The FDA's evidence-based system of drug approval means the manufacturer bears the burden of proof. For instance, during the drug approval process, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity.

Naysayers contend that manufacturers should not be involved in drug approval. It's a conflict of interest. Naysayers point out that batch of drugs can fail to meet FDA standards one hundred times, but if it can be tweaked to meet FDA standards one time out of 101, FDA will approve it as being safe for market.

Well, actually, that is how it works.

But drug makers contend that it is not in their best interest to put unsafe drugs to market. For many reasons. The biggest reason is that repercussions of an unsafe drug will eventually come back to erase any market gain the unsafe drug engendered. So it's said.

Naysayers refute this by saying a manufacturer's Public Relations team simply blames the government, the FDA in particular and the EPA if possible, for letting an unsafe product get to market. This argument maintains that a manufacturer has every reason for getting something to market quickly and bearing consequences afterwards. Something like how in 1885 the U.S. manufacturer Parke-Davis made a fortune selling cocaine in various forms, including cigarettes, powder, and even a cocaine mixture that could be injected directly into the user's veins with the included needle. The company gained a lot of ground this way. Parke-Davis promised that its cocaine products would "supply the place of food, make the coward brave, the silent eloquent and render the sufferer insensitive to pain." It appears the marketing promises were accurate.... But the side effects were not so good.

The FDA was formed in 1906. Find out more about unapproved drugs here, and here is a list of drugs whose approval has been revoked.

But Don't Worry, Labels Are Updated


FDA says that its review of each applicant's labeling is key to this mix. That right labeling insures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.

The Agency has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.

Some naysayers believe that drugs marketed with FDA approval suffer the same condition of possibly being unfit for market.

Physicians and other healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the U.S. without required FDA approval. The manufacturers of unapproved drug products have not received FDA approval and do not conform to a monograph for making over-the-counter (OTC) drugs.

A lack of evidence (manufacturer supplied or otherwise) demonstrating that unapproved drugs are safe and effective is a significant public health concern. What to do about it? There is no current plan, aside from a public awareness campaign.

About the OTC monograph system


Over-the-counter (nonprescription) drugs are also called OTC drugs. FDA's review of OTC drugs is primarily handled by the Center for Drug Evaluation and Research (CDER, pronounced "see'-der") Office of Drug Evaluation IV. The Nonprescription Drug Advisory Committee meets regularly to assist the agency in evaluating issues surrounding these products. This committee has played a major role in the growth of prescription to OTC switches in recent years.

Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs. Classes are categories such as, for example, analgesics or antacids, instead of individual drug products.

For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Many of these monographs are found in section 300 of the Code of Federal Regulations.

Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.

New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process.

Tuesday, December 23, 2014

Delisting DINP

Can't a phthalate catch a break in today's manufacturing supply chain? Maybe, yes. California's Proposition 65 list of chemicals may be amended in Section 25705 for specific regulatory levels posing no significant risk for diisononyl phthalate or DINP.

In December of 2013, diisononyl phthalate (DINP) was listed as known to the State of California to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986, known as Proposition 65. Now, in December 2014, we see a proposal to reverse that listing.

To develop the proposed "No significant risk" status for 146 micrograms per day for diisononyl phthalate (DINP), the California Office of Environmental Health Hazard Assessment, or OEHHA, says it relied on a 2013 OEHHA document titled "Evidence on the Carcinogenicity of Diisononyl Phthalate (DINP)," a document which was apparently overlooked last year when DINP was listed to begin with (?) in December.

Is DINP hazardous?

Some research shows that DINP prohibits healthy male reproductive proclivity. Danish researchers found that DINP exposure affected the development of reproductive organs in male rats, and also other markers of fertility including sperm count and sperm's ability to move spontaneously and actively. The Danish study also found other endocrine related issues. It was was published in the Reproductive Toxicology journal.

DINP is widely used in consumer products, and increasingly as a substitute for DEHP. (The status of DEHP was updated just last week on the REACH Candidate List, see DEHP and Candidate List updates here). Danish scientists stress that their research clearly indicate DINP has similar effects on male offspring as those seen in numerous studies on DEHP and DBP.

Remember, some chemicals are listed on restricted lists pre-emptively, if it's known that manufacturers will switch from one very-hazardous chemical to a less-hazardous chemical, sometimes the less-hazardous chemical is restricted pre-emptively. An example is the pending listing of DIBP on the EU RoHS list of restricted substances.

Scientists have also stressed that further safety evaluation of the use of DINP is warranted.

Why delist DINP?

On June 11, 2014 the American Chemistry Council (ACC) filed a lawsuit to remove diisononyl phthalate (DiNP, CAS 28553-12-0) from Prop 65 list of hazardous substances, arguing that the listing is unwarranted and "defies the state of science." (Is the state of science the 51st state? Anyhoo...)

The ACC filed the case with the Sacramento County Superior Court.

To show how harmless DINP is, the ACC developed its own tool to determine whether DINP is dangerous for humans. Using that tool they developed for the very purpose of proving that DINP is not in fact hazardous for anybody, in current uses and at levels indicated by Prop 65, the ACC determined that DINP in fact poses no notable risk.

Those unfamiliar with the approvals for chemicals, materials, drugs and other possible hazardous entities will be surprised to learn that an ACC study would have any weight when such a flagrant conflict of interest can be demonstrated. Such readers would be advised to brush up on how laws are made and how chemicals are approved for the marketplace in the United States.

The defense for the chemical industry essentially running its own tests and having those test results matter in any way in terms of public health research, for anyone wondering, is this: it's believed that it is not in a chemical manufacturer's best interest to have toxic chemicals in the marketplace, because toxic products will eventually come back and affect the bottom line in the form of a public relations challenge and related profit loss and/or criminal charges brought against the organization.

The system seems to chug along with varying degrees of effectiveness this way. No one fusses too much.

For the record, in Europe, DINP is currently authorized as an additive in plastics food contact materials, which leads some to wonder how dangerous the chemical really is.

Yes or no: should DINP be listed on Prop 65? 

Any written comments concerning this proposed action must be received by OEHHA by 5:00PM on February 17, 2015, the designated close of the written comment period.

Mark your calendar with an auto-reminder for February 1st if you plan to respond. E-mail feedback is preferred, but you can snail-mail also, see this link for more information.

As usual, all comments will be posted on the OEHHA website at the close of the public comment period. So be succinct, use real data, and get your thoughts published.

Afterthoughts and links

Delisting of DINP would effect the electronics industry IEC 62474 Declarable Substance List.

In the United States DINP is used as a plasticizer under the Code of Federal Regulations (CfR) 178.374.

About DINP from the Australian Department of Health here, for a new party heard from, along with their phthalates hazard assessments.


Monday, December 22, 2014

Chromium, Nickel, Zinc in E-Cigarettes

When it comes to r-cigarettes, all roads lead to Shenzhen, China.

The New York Times calls those roads "an enormous — and virtually unregulated — supply chain that produces about 90 percent of the world’s e-cigarettes."
Experts say flawed or sloppy manufacturing could account for some of the heavy metals, carcinogens and other dangerous compounds, such as lead, tin and zinc, that have been detected in some e-cigarettes. - NY Times (good article)
Despite the lack of harmful organic material and a decrease in the majority of toxic metals emissions, e-cigarette smoke contains the toxic element chromium, absent from traditional cigarettes, as well as nickel at levels four times higher than normal cigarettes.

In addition, several other toxic metals such as lead and zinc were also found in secondhand e-cigarette smoke, though in concentrations lower than for normal cigarettes.

A dose by any other name...


E-cigarettes are also called e-hookahs and e-pens and probably a lot of other things. I have a friend who smokes them. She likes them, and I smell nothing in the air when she smokes them, even if she's sitting on the sofa nearby. No smoke, no foul, no problem. Right? (Frankly I do think it's a little weird. But that's just an opinion.)

Apparently e-cigarettes are highly addictive. To quote the US Food and Drugs Administration, e-cigarettes "turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user."

How are e-cigarettes regulated by FDA? Short version is that FDA has a proposed rule that would extend the agency's tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes. But currently this is just a proposed rule. So far use of e-cigarettes seems to be regulated on a more local level.

How is the manufacture of e-cigarettes regulated? It isn't.

For drawing attention to this issue in the LinkedIn EHS group called Environmental Health & Safety Compliance Network, thanks to Bernard Fontaine, Jr., CIH, CSP, AIHA Fellow, Managing Partner, The Windsor Consulting Group, Inc.