Clean Source, a BFK Solutions LLC Newsletter

ForestPath

Volume XI, Issue 11

November 2014

IN THIS ISSUE

Feature Article - How will green and sustainable look in the near future? 

Regulatory Update: A lot is going on! The new Cal/OSHA HCl PEL is exceedingly low. SCAQMD is looking at worker safety issues. The EPA rule on HCFC-225 is in effect. The FDA wants your comments about additive manufacturing.

Knowledge is Power: Read about great resources and events.


“I enjoyed the heck out of your speech at the PCx show. Informative and yet entertaining. I also read each newsletter.”
Tom Kucklick
Industrial Market Manager
Graymills Corporation


FEATURE ARTICLE

The Future of Green, Safe, and Sustainable Cleaning

Barbara Kanegsberg, BFK Solutions

Ask someone involved in manufacturing, particularly a person involved in critical cleaning, about regulatory trends. The responses are apt to be strong and impassioned. Regardless of the portion of the political or environmental spectrum we occupy, we all have strong feelings. Everyone thinks we could be doing a better job – whatever “better” means. And we all know that government isn’t doing it right – whatever that means.

read more 


REGULATORY UPDATE

California  - Worker Safety Crossover
Two regulatory-related events in California show a trend to using evaluations by toxicologists at the Office of Environmental Health Hazard Assessment (OEHAA). While OEHHA does not set policy or regulations per se, it has had strong influence historically; and this influence is likely to increase. OEHHA is perhaps most widely known for determining risk factors for chemicals associated with the Proposition 65 list.  We know that what happens in the regulatory world in California may happen elsewhere. It is also apparent that risk factors set by OEHHA tend to result in lower allowable worker exposure limits and to a more stringent approach to regulations.

HCl PEL
While not yet formally posted, it has come to our attention that the Cal/OSHA Standards Board recently approved a PEL of 0.3 ppm for hydrogen chloride; this level will be legally-enforceable in California. The exposure level approved by the Board utilized analysis by OEHHA. 

The decision by the Board has resulted in a very low allowable inhalation level for HCl; and, in our view, this represents a step backward, both for worker safety and for manufacturing. We would like to see more transparent, dispassionate reviews of data.  We discussed HCl in a recent issue of Clean Source.

http://bfksolutions.com/index.php/newsletter/archived-newsletters/234-toxic-baby-burp

SCAQMD, Toxic Risk to Workers 
The South Coast Air Quality Management District (SCAQMD) held a one-day symposium, “Assessing and Managing Toxic Risk from Alternative VOC Compounds” on October 29.  SCAQMD is concerned with air quality issues, including VOCs and air toxics. In this program, however, the emphasis was on risks to workers. There appears to be at least some consideration of using OEHHA evaluations. In addition to representatives from industry, there were several proponents of the OEHHA approach. There were spirited exchanges. Those involved in selecting and managing chemicals will find the program, including the Q&A, to be illuminating.

The agenda and presentations are available on-line

http://www.aqmd.gov/home/regulations/compliance/vocs/toxic-symp

The webcast should be available shortly

http://www.aqmd.gov/home/library/webcasts

FDA Public Workshop  - Additive Manufacturing, Medical Devices
The FDA held a public workshop on October 8 – 9, 2014 with interactive discussion on technical considerations of 3D printing of medical devices. Critical cleaning is an important factor in device manufacture and in the manufacture of other high value product. In fact, there was a strong aerospace contingent at the workshop. Ed Kanegsberg moderated a break-out session. Ed and Barbara both provided verbal comments.

While we’ve listed this under the regulatory section, the workshop turned out to be one of the better technical conferences we have attended; there were ample opportunities for information exchange and discussion. 

The webcast can be found at;

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm#date

The FDA wants your comments

“The purpose of this workshop is to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3D printing.  The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

There is still time to provide comments about additive manufacturing to the FDA. Comments are due no later than November 10, 2014 and can be submitted online at http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0432-0001

HCFC-225 – Final Rule
Remember we discussed the HCFC-225 phaseout? 

http://bfksolutions.com/index.php/newsletter/archived-newsletters/229-epa-changes-direction-again

 EPA has provided a final rule on the use HCFC-225. Fortunately, manufacturers can continue to use virgin 225, but only if it was in inventory at the end of 2014. Products made with HCFC- 225 will have to be labeled; and other restrictions apply. Basically, you need to find a replacement! For an overview see

http://www.epa.gov/ozone/title6/downloads/Overview_Memo_2015-2019_HCFC_Allocation_Final_Rule.pdf


KNOWLEDGE IS POWER - USE IT

In writing

Greener?
What will green, safe, and sustainable look like in 2020? How will regulatory efforts and corporate policies influence manufacturing, cleaning, and contamination control? For a glimpse into the near- future, read, Part 1 of “Green, Safe, Sustainable,” by Barbara Kanegsberg and Ed Kanegsberg. It’s the lead article in the October, 2014 issue of Controlled Environments Magazine, and an accompaniment to the featured article in this issue of Clean Source.  Look for Part 2 in the November/December issue of Controlled Environments Magazine.

http://www.cemag.us/articles/2014/10/2020-vision-green-safe-sustainable—part-1

No More Monkeys Jumping in the Cleanroom
Barbara Kanegsberg explains why we need educated employees, not trained monkeys,  and she discusses how we ought to re-focus on the product not on the cleanroom. The interview with The Cleaning Lady and the Rocket Scientist appears in the current issue of “Cleanroom Magazin” in your choice of German or English.

http://www.cleanroom-media.com/de/cleanroom_magazin/index.html 

Events

This Thursday! Electronics Assembly, Southern California
The annual LA/Orange County Expo & Tech Forum will take place on November 6 in Long Beach. Come to 

”Ask the Experts About Contract Manufacturing/OEM Challenges,” apanel discussion moderated by Barb Kanegsberg. Pick the brains of industry. Attendance is free – and it’s time well-spent.  

http://www.laocsmta.org/TechExpo/index.html

Avoid Cleaning Catastrophes - Come to Parts Cleaning Expo (PCx), 2015
Hear Barbara Kanegsberg present “Cleaning Catastrophes and How You Can Avoid Them,” at PCx. The conference takes place April 21 – 23, 2015 in Columbus OH

http://www.pmts.com/zones/PMTS-2015


How BFK Solutions Helps You

We’re independent. We don’t sell chemicals or cleaning equipment; and we don’t take commissions. Instead, we work for you. This saves you cold hard cash. We use our 30 years of experience to help you make good decisions about your cleaning processes, your manufacturing processes, your business. Check our website; send us an email; give us a call. We always like to hear from you.

 

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