Occupational Odds & Ends

A couple of news items to catch up on following the holidays that may be of interest to people.

First, the Occupational Safety & Health Administration (OSHA), has launched a dedicated website containing information such as: OSHA's definition of nanotechnology, the applicable OSHA standards, and workplace health effects related to nanotechnology.  Worth adding to your "bookmarks."

Second, the International Standards Organization (ISO) released ISO/TR 12885:2008, "Health and safety practices in occupational settings relevant to nanotechnologies."  The report addresses, "health and safety practices in occupational settings relevant to nanotechnologies."  The abstract further describes the report as follows: "ISO/TR 12885:2008 focuses on the occupational manufacture and use of engineered nanomaterials. It does not address health and safety issues or practices associated with nanomaterials generated by natural processes, hot processes and other standard operations which unintentionally generate nanomaterials, or potential consumer exposures or uses, though some of the information in ISO/TR 12885:2008 might be relevant to those areas.

Use of the information in ISO/TR 12885:2008 could help companies, researchers, workers and other people to prevent adverse health and safety consequences during the production, handling, use and disposal of manufactured nanomaterials. This advice is broadly applicable across a range of nanomaterials and applications."

Now that we are through the winter holidays and New Year (and a happy new year to you!), we expect the nano-related news and events to begin picking up soon.  Here's to whatever 2009 may hold!

Environmental Defense and NMSP

The advocacy group Environmental Defense Fund recently issued a press release declaring that all the data submitted to the EPA under the voluntary Nanoscale Materials Stewardship Program is entering a "black hole."  However, this conclusion is premature at best, and sector damaging at worst.

In its press release, Environmental Defense Fund cites to limited participation and the fact that after six months of existence, "EPA has made virtually no information public about the limited number of submissions it has received. As a result, the public can have little confidence that the program is providing the information the Agency will need to protect citizens, consumers, workers and the environment from the potential risks of nanotechnology, according to Environmental Defense Fund (EDF)."  In addition, EDF is comparing the participation in the NMSP to the weak response received by the United Kingdom's DEFRA on its voluntary program.  We've posted on the DEFRA program before.  EDF also points to EPA's original prediction of 240 submissions from 150 companies for the basic program and 15 participants in the in-depth program.  While these numbers may not have been fully realized, let's look closely at the facts now that the basic program submission deadline has passed.

First, while the NMSP has been running for six months, the entirety of that time was spent on collection submissions from voluntary participants.  There was no indication from EPA that they would release information collected on a rolling basis or somehow provide their evaluation as submissions were received.  EPA has stated that it will take time to evaluate all of the submissions and release its thoughts after a period of review.  In fact, EPA stated on its NMSP website: "EPA will publish an interim report on the program in approximately a year from its launching on January 28, 2008. A more detailed report and program evaluation will be published after approximately two years. At the time of the two-year report, EPA intends to determine the future direction of both the basic reporting and in-depth data development phases, although adjustments or decisions on future steps may be made at an earlier point if sufficient experience is gained. This would also include consideration of use of regulatory authorities under TSCA." (emphasis added).  Consequently, EPA is taking time to consider all of the information and publish two overall reports, including an interim evaluation.

Second, let's look at the numbers.  EPA received submissions from 20 organizations (including some household names) covering approximately 90 nanoscale materials.  Further, another 10 organizations committed to the basic program, but have not yet submitted.  Beyond the fact that this is potentially a significant amount of technical data to sift through, this is not analogous to DEFRA's program where, to date, eleven submission (including two in the last quarter, the report for which was just released) have been received since September 2006.  Comparing EPA's response to DEFRA's is simply unfair.  Additionally, three companies have committed to the in-depth program and more can still be added.  While its clear EPA did not receive the level of participation it hoped for, there potentially (depending on what was submitted) very significant information in the hands of EPA, and that should not be discounted.

Declaring failure minutes after the deadline for submission passes is irresponsible and does nothing more than contribute to rumor and hearsay.  EPA received a significant response from the nanotechnology sector and it will take time for the agency to fully understand the information it now possesses.  With perhaps over 100 materials to evaluate, EPA's response cannot be instantaneous, and for it to do so would conflict with its reasoned position of wanting to understand the questions surrounding nanomaterials before making statements.  Good regulation does not come from snap judgments and unconsidered public statements.  EDF should give the agency time to understand what it has.  EDF has two choices, wait for the release of the report, or file a public records request for all of the publicly available information that was submitted.  But declaring failure through a press release does not help the agency or sector get closer to the answers being sought.  Oh, and if EDF submits the records request to EPA and received copies of the submission, I wonder if a black hole will appear at EDF if it doesn't like the answers.

No Nano Regulation by FDA?

By: Tim Cahill and Michael Heintz:

FDA Week reported on July 6, 2007 that the FDA's Internal Nanotechnology Task Force is close to issuing its first report and is going to recommend that the agency not create "regulatory policies" for nanomaterials.  Instead, the task force is likely recommending that FDA create guidelines for "best practices."  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits. 

FDA Week also observes that an agency official stated as early as 2005 that the agency would not regulate products containing nanotechnologies any different than conventional products, and "The agency does not regulate the technology as a separate entity so products such as drugs or medical devices that employ nanotechnology are scrutinized while cosmetics are not. "  The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits.

The Task Force was created in August 2006 to assess regulatory approaches that encourage the development of safe and effective FDA-regulated products that use nanomaterials, and the Task Force held a public meeting on these issues on October 10, 2006.

Similarly, Senator Mark Pryor's office indicated a report addressing nanotechnology research and regulatory efforts at FDA, EPA, OSHA, and the Consumer Product Safety Commission by the General Accounting Office (GAO) is due out in the Spring of 2008.

Check back for more information on both of these reports as they are released.

New Report: Nanotechnologies for Energy and the Environment

Research and Market recently announced the publication of a new report addressing environmental uses and applications of nanomaterials.  The report covers many applications, environmental media, and toxicology, and, "describes nanotechnologies, nanomaterials, nanotechnology companies, universities and research centers related to nanotechnologies for new environmental technologies.  Areas covered by are leading edge research in emission reduction, environmental remediation and monitoring, green manufacturing, water filtration and treatment, energy conversion and storage, alternative energy and toxicology. "

The table of contents of the report is available here, and the full report can be purchased for EUR 1,584 (approximately $2,100.00).