We previously discussed Berkeley, California’s nanoparticle hazardous materials ordinance on a couple of occasions and also published a paper on this topic in last February’s edition of Nature Nanotechnology. Berkeley has since issued new Disclosure Guidelines implementing the ordinance. The Guidelines partially address our concerns, yet also impose more stringent requirements on Berkeley’s nanotechnology community than the ordinance itself. The filing deadline under the Guidelines is June 1, 2007.
The ordinance’s operative provisions are contained in a single sentence: "All facilities that manufacture or use manufactured nanoparticles shall submit a separate written disclosure of the current toxicology, to the extent known, and how the facility will safely handle, monitor, contain, dispose, track inventory, prevent release and mitigate such materials." The Guidelines, however, contain three pages of over 30 specific requirements, creating even further difficulties.
Here are some highlights:
Toxicology Reporting Requirements. On the positive side, the Guidelines make it clear that the City is only seeking published information and data. On the negative side, the City wants five types of toxicity data: (i) inhalation, (ii) dermal, (iii) oral, (iv) mutagenicity/genotoxicity, and (v) reproductive. This comprehensive data simply does not exist for any nanomaterial. Fortunately, the Guidelines allow reporting businesses to indicate such "information is not available" in instances where none has been published. We have previosuly discussed the legal implications with making such a written admission yet continuing to develop and market products containing nanomaterials. To compound matters, the Guidelines also take the following hard-line position: "If an exposure potential is present but insufficient toxicological information is available, a precautionary approach should be taken which assumes that the material is toxic." Because comprehensive toxicity data is not available across the broad range called for by Berkeley, arguably most if not all nanomaterials will be treated as "toxic" under the City’s approach. The legal ramifications created by the City’s presumption are problematic to say the least.
Control Banding. As a method to "contain costs for reporting," the Guidelines mandate that reporting entities use a "system of prioritizing high-risk activities into [four] control bands:" (i) low potential toxicity and no exposure pathways; (ii) moderate potential toxicity and exposure pathways; (iii) high potential for toxicity and possible exposure pathways; and (iv) unknown toxicity and exposure pathways. The last category requires the highest level of control measures. Setting aside the issue of whether the City even had legal authority to implement this control banding experiment, the methodology seems to fail from the outset. Because the toxicity of most nanomaterials is largely unknown — especially across all five of the specific categories identified by the City — virtually all nanomaterials are all going to fall into the City’s last category and require the highest levels of control. This is also in keeping with the City’s position that in such instances "a precautionary approach should be taken which assumes the material is toxic."
Costs. Based on an initial reading of the Guidelines, nanocompanies will need to retain several types of experts to comply with the ordinance: (i) nanotoxicologist qualified to address each of the five areas identified by the City; (ii) nano-industrial hygienist qualified to conduct a control banding review and also create and implement an occupational and environmental protection plan; (iii) nanochemist qualified to identify the physicochemical properties of the nanoscale materials; and (iv) legal counsel to pull all of this together. Further, given differing frequent sub-specializations, multiple experts may be needed in each category. Regardless of the number and types of experts employed, complying with the ordinance and Guidelines is not an inexpensive proposition.
Confidentiality. The Guidelines allow a reporting company to label a nanomaterial as a "trade secret" under California Health and Safety Code Section 25538, but still require submission of the information to the City. The City then determines whether or not the information is truly a trade secret. While this approach is headed in the right direction, the state statute needs some polishing to fit the City’s specific needs. Additionally, simply referencing the statute in the Disclosure Guidelines in passing is insufficient to make the statute’s protection’s part of Berkeley’s municipal law in this specific context.
There are many more issues presented by the Guidelines that warrant discussion which we will undoubtedly address in upcoming seminars and presentations. We will post these materials here as they are developed. Finally, despite the deficiencies we perceive with Berkeley’s ordinance and now its Guidelines, it is apparent that the City is at least trying to address some of the industry concerns raised after the fact. It is incumbent upon the industry to make sure its voice is heard in Berkeley and in other cities across the country considering such ordinances.