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Tag Archives: Regulations.gov

Silver Nanoparticles: NIOSH Seeks Information and Comment

Today’s Federal Register carries a notice from the National Institute for Occupational Health and Safety (NIOSH) requesting information and comments regarding silver nanoparticles. NIOSH

has initiated an evaluation of the scientific data on silver nanoparticles (AgNPs) 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. . . .

. . . gathering data to determine whether a health risk to workers may exist from exposure to AgNPs and if specific risk management guidance is needed to prevent exposure. . . .  

Information is particularly needed for determining the relevance of bile duct hyperplasia and hepatocellular necrosis observed in AgNP exposed rats, as well as information on: (1) Sources of AgNP exposure, (2) factors that influence worker’s exposure, (3) in-place exposure control measures (e.g., engineering controls) and work practices that are effective in reducing worker exposures, and (4) appropriate measurement methods and exposure metrics for characterizing workplace exposures. . . .

Examples of requested information include the following:     (1) Identification of industries or occupations in which exposures to AgNPs may occur.     (2) Trends in the production and use of AgNPs.     (3) Description of work tasks and scenarios with a potential for exposure to AgNPs.     (4) Workplace exposure measurement data in various types of industries and jobs.     (5) Case reports or other health information demonstrating potential health effects in workers exposed to AgNPs.     (6) Research findings from in vitro and …

International Center for Technology Assessment et al v. Hamburg

On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California against Margaret A. Hamburg, Commissioner of the US Food and Drug Administration (FDA), requesting that "this Court enter an Order:

 

(1) Declaring that the Defendants have violated the Administrative Procedure Act by failing to respond to the 2006 Petition within a reasonable time;

(2) Declaring that the Defendants continue to be in violation of the Administrative Procedure Act by failing to respond to the 2006 Petition;

(3) Ordering Defendants to respond to the 2006 Petition as soon as reasonably practicable"

In May of 2006, ICTA filed a "Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically". The petition requested "that the Commissioner undertake the following actions with regards to all nanomaterial products:

1) Amend FDA regulations to include nanotechnology definitions necessary to properly regulate nanomaterial products . . . .

2) Issue a formal advisory opinion explaining FDA’s position regarding engineered nanoparticles in products regulated by FDA.

3) Enact new regulations directed at FDA oversight of nanomaterial products establishing and requiring . . .that: nanoparticles be treated as new substances; nanomaterials be subjected to nano-spefic paradigms of …

EPA Requests Public Comment on Obtaining Information Regarding Nanomaterials in Pesticides

On June 17, 2011, the Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it was seeking "comment on several possible appraoches for obtaining information about what nanoscale materials are present in registered pesticide products. . .  . and its potential effects on humans or the environment. . . ."

Under one approach to collecting this information, EPA would use the authority granted to it by the Federal Insecticide, Fungicide,and Rodenticide Act  (FIFRA) to require applicants to "provide any factual information of which [the applicant] is aware regarding unreasonable adverse effects of the pesticide on man and the environment". If EPA adopts this approach, it would require the inclusion of "such information with applications for registrations of pesticides or pesiticide products containing ‘nanoscale materials’".

Under a different section of FIFRA, EPA would gather information using Data Call-In notices.

EPA is required to collect information regarding pesticides under section 3(a) of FIFRA. Using the information collected, EPA can then determine

1) the validity of the products claims

2) that labelling complies with FIFRA requirements

3) that the pesticide or pesticide product will not cause unreasonably adverse harm to humans or the environment.

EPA "believes that certain information concerning pesticide ingredients" – in this case, nanoscale materials, defined by EPA as (1) between 1 and 100 nanometers, (2) " exhibit unique and novel properties compared to larger particlesof the same material" and (3) has been manufactured or engineered at the nanoscale level to take advantage of those unique or novel properties …

EPA Proposes TSCA Inventory Reporting Modifications

In the Federal Register issue of 08/13/2010, the Environmental Protection Agency (EPA) released for public comment a proposed rule that would, if adopted, significantly change the TSCA Inventory Update Reporting (IUR).

The first part of the notice, "Supplementary Information", explains the proposed changes to 40 CFR Parts 704, 710, and 711. The text of the proposed rule follows the Supplementary Information.

In the Supplementary Information, EPA states that it is proposing modifications to the IUR

 to meet four primary goals:     1. To tailor the information collected to better meet the Agency’s overall information needs.     2. To increase its ability to effectively provide public access to the information.     3. To obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory.     4. To improve the usefulness of the information reported. EPA believes that expanding the range of chemical substances for which comprehensive information is to be reported and adjusting the specific reported information, the method and

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frequency of collecting the information, and CBI requirements will accomplish these goals.

Reading the Supplemental Information reveals a fifth, unstated goal – the creation of uniform reporting standards that will provide EPA with the information it needs to "identify and take follow-up action on chemical substances that may pose potential risks to human health or the environment" in a more efficent and timely manner, cutting the amount of time EPA staff will need to spend reviewing submitted information, determining if EPA action is required …

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