Biomedical Engineering Reference
In-Depth Information
“unreasonable adverse effects” rested on “significantly understated risk assessments,” its decision
was not supported by substantial evidence and must be vacated.
On June 14, 2012, the EPA filed its answering brief, arguing that despite data gaps concerning
HeiQ AGS-20, it had determined it had sufficient evidence to conclude “that even a three-year-old
chewing and wearing a new AGS-20 treated textile every day for six months could potentially be
exposed to no more than 1/1000th of the quantity of nanosilver which did not cause any adverse
health effects in relevant scientific studies.” Given the low risk, the EPA stated that it reasonably
concluded that HeiQ AGS-20 will not cause unreasonable adverse effects to consumers, and its
risk assessment “warrants substantial deference from the Court.” On November 7, 2013, the Court
largely ruled in EPA's favor. The Court found objectionable EPA's decision to decline to decide to
require risk mitigation after calculating a margin of exposure for aggregate exposure to AGS-20
exactly of 1000. EPA and HeiQ subsequently revised the pesticide label to address this and the case
is now resolved
15.8 WORK PLACE CONCERNS
In addition to products and the environment, the federal government has also displayed interest
in regulating the workplaces where the products are manufactured. The National Institute for
Occupational Safety and Health (NIOSH) has been involved with nanoscale materials as they relate
to the issue of workplace exposure mentioned earlier. An early NIOSH effort is to request infor-
mation and comment on silver nanoparticles. According to the notice, the NIOSH has initiated an
evaluation of the scientific data on silver nanoparticles “to ascertain the potential health risks to
workers and to identify gaps in knowledge so that appropriate laboratory and field research studies
can be conducted.” Giving an indication of the sort of data and information that might be used to
regulate the workplace, the NIOSH wants to obtain additional information concerning:
1. Published and unpublished reports and findings from
in vitro
and
in vivo
toxicity studies
with silver nanoparticles
2. Information on possible health effects observed in workers exposed to silver nanoparticles
3. Information on workplaces and products in which silver nanoparticles can be found
4. Description of work tasks and scenarios with a potential for exposure
5. Information on measurement methods and workplace exposure data
6. Information on control measures (e.g., engineering controls, work practices, personal pro-
tective equipment) that are being used in workplaces where potential exposures to silver
nanoparticles occurs
NIOSH has also posted a document titled
General Safe Practices for Working with Engineered
Nanomaterials in Research Laboratories
, which contains recommendations on engineering con-
trols and safe practices for handling engineered nanomaterials in laboratories and some pilot-scale
operations.
*
The document is designed “to be used in tandem with well-established practices and
the laboratory's chemical hygiene plan.” The guidance notes that experimental animal studies indi-
cate that potentially adverse health effects may result from exposure to nanomaterials, and that the
routes of exposure include inhalation, dermal exposure, and ingestion. The guidance concludes that
“[t]he full range of occupational hygiene controls will be necessary to limit exposures to nanoma-
terials as a means to prevent adverse health outcomes in the research community. Engineering and
administrative controls can eliminate or minimize the amount of nanomaterials that will be present
in workplace air or settled on surfaces. Personal protective equipment can be used where other types
of controls are not available or practical.”
*
Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. 2012. General safe
practices for working with engineered nanomaterials in research laboratories. http://www.cdc.gov/niosh/docs/2012-147.
